Device and method for reducing calorie intake

Abstract

Devices and methods for substantially reducing the caloric efficiency of the digestive tract by capturing food being digested in the stomach 10 and/or anywhere else in the gastrointestinal (GI) tract, absorbing or encapsulating the captured food into multiple capturing members and moving such multiple capturing members containing the ingestible encapsulated food down the GI tract, practically out of reach of the GI absorption organs, thus excluding the entrapped ingredients from being involved in the digestion and\or absorption process. The device is designed for oral delivery. The system can be comprised of liquid, food bars or a capsule system. The capsule system is comprised of an external capsule that dissolves in accordance with a temporal or ph dependent preset, which allows the food intake to be at least partially fluidic. The capsule system is further comprised of a mechanism designed to capture and isolate a portion of the food being digested.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from the detailed description given herein below and the accompanying drawings, which are given by way of illustration only and thus not limitative of the present invention.

FIG. 1 is a view of the assembled device.

FIG. 2 a is a view of the external capsule.

FIG. 2 b is a view of the internal bag.

FIG. 2 c is a view of an expandable bead.

FIG. 2 d is a view of a coating capsule.

FIG. 3 illustrates a basic embodiment of this invention depicting an outer capsule containing super absorbent expandable beads.

FIG. 4 a illustrates of the capsule system entering the stomach at t1.

FIG. 4 b illustrates the external capsule dissolving at t2.

FIG. 4 c illustrates the expandable beads expanding as they absorb stomach fluids.

FIG. 4 d illustrates the expandable beads reaching the size limits of the internal bag at t4.

FIG. 4 e illustrates the rupture of the coating capsule at t4.

FIG. 4 f illustrates the internal capsule dissolving at t5.

FIG. 4 g and FIG. 3h illustrate the draining stage of the coated at t6.

FIG. 5 is a temporal illustration of a full cycle of the process.

FIGS. 6 a-d illustrates another embodiment of the invention.

FIGS. 7 a-c illustrates another embodiment of the invention.

FIGS. 8 a-c illustrates yet another embodiment of the invention.

FIG. 9 illustrates an embodiment for loading the force into the small structures.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Before explaining embodiments of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The materials, methods, and examples provided herein are illustrative only and not intended to be limiting.

In accordance with one basic embodiment of the present invention, illustrated in FIG. 3, the device is in a form of a pill comprises an outer capsule 200 made of Gelatin for example, which capsule 200 is at least partly filled with cross-linked polymer beads, such as Hydrogels, supper absorbent polymers, cross-linked polymers, known in the art, which beads having a diameter in the range of microns to few mm and are made of non toxic and non digestible polymer and are capable of absorbing fluids at a ratio of at least 5:1 (W/W), (liquid\bead) by diffusion, osmotic force, ionic interaction, and\or capillary force, and\or magnetic force, or other physic-chemical mechanism, such as polyacryl amid derivatives, which absorbing beads may also act as ion exchanger, exclusion gel such as a cross-linked polydextran (or possibly Cellulose Ethers like material), which beads optionally may also contain functional groups that improves permeability when the ambient is acidic (low pH—at the stomach), yet the permeability is reduced when the ambient pH is neutral or basic (small intestine).

In practice, the pill is ingested, and the capsule 100 dissolves at a temporal preset, beads 300 which are now in contact with the content of the food being digested, absorbs caloric enriched liquid and swells. Next the beads along with content of the stomach 10 are moved into the small intestine, where the entrapped content of the beads are practically not involved in the digestion and absorbing steps in the intestine. It is plausible to design the beads such that they will continue to absorb digested food in the small intestine and further down the GI tract.

In another embodiment, similar to the first embodiment, the beads are pre coated or pre absorbed by a composition capable of forming at least a partial nutrient barrier on small intestine. The composition helps further to reduce the absorption of food in case of leaking from the bead.

FIG. 1 is a view of the assembled capsule system. It comprises an external capsule 100 which can be made of a biocompatible material such as gelatin, an internal bag 200 which can be made from gelatin with a net like structure, absorbing beads 300 which can be made from Hydrogels and coating capsule(s) 400.

FIG. 2 a illustrates the opened external capsule, which opens into two halves 201 and 202 at time t2 (see FIG. 5). It cans also dissolve with control thickness or any other known technique.

FIG. 4 a illustrates the assembled capsule being swallowed by the patient at time t1 (see FIG. 5) which is a while after he started his meal at time t0 (see FIG. 5). FIG. 2b is a view of the internal bag 200, FIG. 2c is a view of an expandable bead 301 and FIG. 2d is a view of a coating capsule 400.

FIG. 4 b illustrates the dissolution of the external capsule in the stomach 10 at time t2. At this time the super absorbing expandable beads 300 are exposed to the stomach 10 fluids and start absorbing them, as illustrated in FIG. 4c and continue at time period t3 (see FIG. 5).

Optionally, after the expandable beads 300 fill out the space allowed by the internal bag 200, as illustrated in FIG. 4d, they press against the coating capsule(s) 400. This triggers at time t4 (see FIG. 5) the rupture, as illustrated in FIG. 4e, or dissolution of the coating capsule(s) 400, which contains an agent that coats and seals (see FIG. 4f) all the expandable beads such that they and their content remains untouched throughout their migration down the GI tract.

Once all the expandable beads 300 are coated, at time t5 (see FIG. 5), the internal bag dissolves, all the expandable beads are free to move about the GI tract, at time period t6 (see FIG. 5), and they are drained untouched through and out of the GI tract, as illustrated in FIGS. 4g and 4h. The expandable beads 300 dissolve after a preset number of days, in case they were not able to clear out of the GI tract. In another option, the patient drinks a liquid that dissolves expandable beads 300.

Thus the content of the expandable beads 300 which contains ingested food remains untouched, is not digested and absorbed by the body and hence reduces the calorie efficiency of the meal.

In another embodiment of this invention, time t5 (see FIG. 5), when the internal bag 200 dissolves and the expandable beads 300 are free to move about the GI tract, occurs only after the fed mode of the stomach 10 is finished, and the stomach 10 goes into its maintenance mode.

I another embodiment (not shown) the fluids pass on their way to the super absorbable beads through a filter which is wide on the outer side and narrow in the inner side. This makes it easy for the fluids the flow inward the beads and hard to flow back.

In yet another embodiment of this invention, a polymer capable of absorbing lipid having an prolonged equilibrium period in the range of 4-8 hours so as to keep the absorption step active during the relevant period in the digestion tract, is provided. One such polymer for example is Polypore, having high absorption ratio of 13 gr lipid to 1 gr polymer

Another embodiment of the present invention is to interfere with the micelles which are necessary for the lipid digestion activity. The purpose of the polymer is to disassemble the micelles and extract the lipids. Such a polymer is, for example, isss Gantrez® series, especially Gantrez 225 and Gantrez 425.

So when a mixture of Polypore and Gantrez are introduced to the small intestine, the Gantrez will interfere with the micelle formation equilibrium, and the polypore will absorb the free lipids without the highly competitive back extraction mechanism.

Another embodiment of this invention is illustrated in FIGS. 6a-6d in this embodiment the inner bag is in the form of a folded basket 202 which contains a stack of spheres 500 each of which is split into to halves 501 and 502 which are connected by a spring like connection 503 that the force embedded in it will close up the spheres to the poison 504 in a relaxed mode. When the external capsule 100 dissolves, the force embedded in the stacked up halve spheres 500 will cause the optional basket 202 to open up optionally locked into the position illustrated in FIG. 6d. This allows the half spheres to close up to position 504 which scoops up the food being digested while closing up. The sphere 504 is now small enough to leave the basket 202 through the opening 203, being pushed by the next pair of half spheres. The last pair of half spheres in the stack may remain in the basket 202, which dissolves after a preset time and clears out down the GI tract. The optional basket 202 is designed to avoid the possibility that the closing sphere will harm the stomach 10 inner walls. The spheres 500 are of a size appropriate to be able to travel through the GI tract. The closed spheres are made of a substantially ingestible biocompatible material and remain closed and untouched through the journey down and out of the GI tract. The spheres 500 dissolve after a preset number of days, in case they were not able to clear out of the GI tract. In another option, the patient drinks a liquid that dissolves spheres 500.

Another embodiment of this invention is illustrated in FIGS. 7a-7c. In this embodiment, the capsule is filled up with number of folded stent like structures 600. When the external capsule 100 dissolves, a force will cause the stents 600 to open up and lock into the position illustrated in FIG. 7c. The force can be embedded in the structures 600, apply via external or internal spring (not shown) or generated internally or externally via chemical reaction with the stomach 10 content. While stents 600 open up inside the stomach 10 they will suck up some of the content into the stents. The stents 600 are built such that they have entry holes 604 through which the content is sucked up. Optionally, entry holes 604 are equipped with a directional valve such that the stomach 10 content can only enter into the stents but can not escape. The size of the opened stents 600 is designed to be able to travel through the GI tract. The stents are made of a substantially ingestible material and remain closed and untouched throughout their journey down and out of the GI tract. The folded structures 601, 602, 603 can also be polymer beads and the force applied to them before delivery to compress the beads substantially so that they open inside the GI tract to capture various liquids. One such polymer, for example, is Polypore, having high absorption ratio of 13 gr lipid to 1 gr polymer and high ratio of its free form volume to its compressed form volume.

In another embodiment the force (such as spring force or elastic force) is being loaded into the small structures 700 before using the capsule. FIG. 9 shows a device 800 for compressing the small structures 700 and encapsulating them to form the pill to be swallowed. Turning the handle 802 in direction 806 moves the bar 804 in direction 808. The capsule half 101 is pushed towards the second half 102 and the small structures 700 are compressed. This will overcome the possibility that the force will deteriorate over time.

Another embodiment of this invention is illustrated in FIGS. 8a-8c. In this embodiment, the capsule is filled up with a number of folded structures 700. When the external capsule 100 dissolves, the force embedded within the structures will cause the structures 700 to open up into the position 702 illustrated in FIG. 8c. The force can be embedded in the structures 700, in the manufacturing process by taking a semi rigid structure and forcing it into a collapsed form by applying pressure. The kinetic energy stored in the structures 700 will be used to restore the structures into their natural form once the capsule 100 has opened up. This force is designed so that it can over come the pressure inside the stomach 10. While structures 700 open up inside the stomach 10 they will suck up some of the content into the structures 700. The structures 700 are made up such that they have entry holes 703 through which the content is sucked up. Optionally, entry holes 703 are equipped with a directional valve such that the stomach 10 content can only enter into the structures 700 but cannot escape. The size of the opened stents 700 is designed to be able to travel through the GI tract. The full structures 700 are made of a substantially ingestible material and remain closed and untouched throughout the journey down and out of the GI tract.

In another embodiment the folded structures are polymer beads and the force applied to them before delivery to compress the beads substantially so that they take less space on the intake but open inside the GI tract to capture various liquids. One such polymer, for example, is Polypore, having high absorption ratio of 13 gr lipid to 1 gr polymer and high ratio of its free form volume to its compressed form.

The invention being thus described in terms of several examples and embodiments, it will be obvious that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.

Claims

1. A device for reducing the caloric efficiency of the digestive tract, comprising of: a. Capturing means for capturing food ingredients or ingredients participating in food digestion in the gastrointestinal (GI) system, whereas said capturing means has high absorption capacity;b. Shielding means for shielding said captured food ingredients inside said device; andc. Moving means for moving said captured food ingredients through the gastrointestinal tract without said food ingredients being substantially digested.

2. A device as in claim 1 where the shielding of said captured food ingredients is achieved by a prolonged active absorption period.

3. A device as in claim 1 comprising a mixture of non soluble hydrophilic and/or hydrophobic agents.

4. A device as in claim 1 where the capturing agents are gels and/or hydrogels.

5. A device as in claim 1 where the capturing agent is Polypore.

6. A device as in claim 1 where said capturing and shielding of said captured food ingredients is achieved by mechanical means.

7. A device as in claim 1 where said capturing of said captured food ingredients is achieved by one member and said shielding of said captured food ingredients is achieved by a another member.

8. A device as in claim 1 further comprising decomposing means for decomposing at least part of food ingredients or ingredients participating in food digestion in the GI system;

9. A device as in claim 1, further comprising decomposing means for decomposing at least part of food ingredients or ingredients participating in food digestion in the GI system, whereas the means for decomposing at least part of ingredients participating in food digestion in the GI system are emulsifying agents.

10. A device as in claim 1, further comprising decomposing means for decomposing at least part of food ingredients or ingredients participating in food digestion in the GI system, whereas the means for decomposing at least part of ingredients participating in food digestion in the GI system is the emulsifying agent Gantrez which interferes with the micelles and decomposes them.

11. A device for reducing the caloric efficiency of the digestive tract, comprising of: a. Capturing means for capturing food ingredients or ingredients participating in food digestion in the GI system, whereas said capturing means is in compressed form and opens and is activated in the GI system;b. Competing means for competing with the absorption mechanism of the GI system; andc. Moving means for moving with the food through the gastrointestinal tract without said food ingredients being substantially digested.

12. The device of claim 111 whereas said device can encapsulate said captured food.

13. The device of claim 11 whereas said device further comprises multiple small devices that expand and are activated in the GI system, to capture some of the GI system content.

14. The device of claim 11 whereas said device further comprises multiple small devices that are capable of encapsulating the captured content.

15. The device of claim 11 whereas said device further comprises multiple small devices that each of which in its open form is still small enough to pass through the GI tract.

16. The device of claim 11 whereas said device further comprises multiple small devices that disintegrates after a preset time, incase they are not able to pass through the GI tract.

17. The device of claim 11 whereas said device further comprises multiple small devices, where the compressed members comprise of a gel.

18. The device of claim 11 whereas said device further comprises multiple small devices, where the compressed members are Polypore or contain Polypore.

19. A method for reducing the caloric efficiency of the digestive tract, including: a. Capturing food ingredients or ingredients participating in food digestion in the GI system, whereas said capturing means has high absorption capacity;b. Shielding said captured food ingredients from being digested; andc. Moving said captured food ingredients through the gastrointestinal tract without said food ingredients being substantially digested.

20. A method as in claim 19 where the shielding of said captured food ingredients is achieved by a prolonged active absorption period.

21. A method as in claim 19 comprising a mixture of non soluble hydrophilic and/or hydrophobic agents.

22. A method as in claimsl9, where the capturing agents are gels and/or hydrogels.

23. A method as in claim 19, where the capturing agent is Polypore.

24. A method as in claim 19 where said capturing and shielding of said captured food ingredients is achieved by mechanical means.

25. A method as in claim 19 where said capturing of said captured food ingredients is achieved by one member and said shielding of said captured food ingredients is achieved by a another member.

26. A method as in claim 19 also comprises of decomposing at least part of food ingredients or ingredients participating in food digestion in the GI system.

27. A method as in claim 19, also comprises of decomposing at least part of food ingredients or ingredients participating in food digestion in the GI system wherein said decomposing at least part of the ingredients participating in food digestion in the GI system is done by emulsifying agents.

28. A method as in claim 19, also comprises of decomposing at least part of food ingredients or ingredients participating in food digestion in the GI system wherein said decomposing at least part of the ingredients participating in food digestion in the GI system are done by emulsifying agents whereas the emulsifier agent is Gantrez.

29. A method for reducing the caloric efficiency of the digestive tract, comprising of: a. Capturing food ingredients or ingredients participating in food digestion in the GI system, whereas said method provides capturing agents which are in compressed form and open and are activated in the GI system;b. Competing with the absorption mechanism of the GI system; andc. Moving with the food through the gastrointestinal tract without said food ingredients being substantially digested.

30. The method of claim 29 whereas the capturing device can encapsulate said captured food.

31. The method of claim 29 whereas said capturing device further comprises of providing multiple small devices that expand and are activated in the GI system, to capture some of the GI system content.

32. The method of claim 29 whereas said capturing device further comprises of providing multiple small capturing devices that are further capable of encapsulating the captured content.

33. The method of claim 29 whereas said capturing device further comprises of providing multiple small capturing devices that each of which in its open form is still small enough to pass through the GI tract.

34. The method of claim 29 whereas said capturing device further comprises of providing multiple small capturing devices that disintegrate after a preset time, incase they are not able to pass through the GI tract.

35. The method of claim 29 whereas said capturing device further comprises of providing multiple small capturing devices that are comprised of a gel.

36. The method of claim 29 whereas said capturing device further comprises of providing multiple small capturing devices that are comprised of a gel which is Polypore.