Swallowable Self-Expanding Gastric Space Occupying Device

• US 20090192535A1
• Filed: 12/19/2008
• Published: 07/30/2009
• Est. Priority Date: 12/20/2007
• Status: Active Grant

• Current Assignee: 7L LLC
• Original Assignee: 7L LLC
• Inventors: KASIC, James II
• Granted Patent: US 8,287,562 B2
• Time in Patent Office: Days
• US Class Current: 606/157
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids

Abstract

Disclosed is a swallowable self-expanding gastric space occupying device and related methods of making and using the device to control obesity. The device has a membrane through which gastric liquid can pass, wherein the membrane provides an enclosure volume separated from the gastric environment by the membrane. A plurality of self-expanding components is contained in the enclosure volume, so that the components expand in volume upon contact with the gastric fluid, thereby expanding the device from an unexpanded volume to an expanded volume. Composite membranes provide the ability to precisely control how and when the membrane degrades in the stomach, to release the self-expanding components from the enclosure and to ensure that the released pieces are sufficiently small to not obstruct any portion of the gastrointestinal system.

Claims

1. A swallowable self-expanding gastric space occupying device comprising:

a. a membrane through which gastric fluid can pass, wherein said membrane provides an enclosure volume separated from the gastric environment by said membrane; and

b. a plurality of self-expanding components, wherein said components are contained in said enclosure volume;

wherein said components expand in volume upon contact with said gastric fluid, thereby expanding said device from an unexpanded volume to an expanded volume.

3. The device of claim 1, wherein said components are provided as a powder.

4. The device of claim 1, wherein said component is not substantially biodegradable.

5. The device of claim 1, wherein said component comprises a hydrogel material.

6. The device of claim 1, wherein said component is made from a material selected from the group consisting of:

a. polyacrylamide;

b. polyethelene oxide;

c. poly AMPS;

d. polyvinylalcohol;

e. sodium polyacrylate; and

f. acrylates.

7. The device of claim 1, wherein said enclosure is formed by a membrane having at least a portion that is selected from the group consisting of:

a. a mesh;

b. a porous layer;

c. a tortuous passage;

d. a woven fabric;

e. a welded material;

f. a sutured material; and

g. a tied material.

8. The device of claim 1 wherein said membrane comprises

a. a first material;

and

b. a second material operably connected to said first material to form said enclosure;

wherein said first material has a higher rate of decomposition in the gastric environment than said second material so that said enclosure opens upon dissolution of at least a portion of said first material, thereby releasing said components from said enclosure.

9. The device of claim 8, wherein said second material comprises a plurality of structural elements, wherein an individual structural element is connected to an adjacent structural element by said first material.

10. The device of claim 8 wherein said first material forms a structure that is selected from the group consisting of:

a. a suture;

b. a weld; and

c. a tie.

11. The device of claim 1, wherein said membrane is formed into a geometric shape that comprises invaginations to accommodate expansion of said components.

12. The device of claim 11, wherein said device further comprises an encapsulation layer that surrounds said membrane.

13. The device of claim 1, wherein said membrane is elastic.

14. The device of claim 1, wherein each of said expanded components has an individual volume that is sufficiently small to exit the stomach through the pyloric sphincter and that will not cause a small bowel obstruction.

15. The device of claim 1, wherein said device has an expanded volume that is greater than or equal to 20 cm³ and a shape that prevents said device from passing out of the stomach through the pyloric sphincter.

16. The device of claim 1, wherein the ratio of said expanded to unexpanded volume is selected from a range that is greater than 100 times and less than 250 times.

17. The device of claim 1, wherein said membrane maintains physical integrity in the stomach for a time range that is greater than or equal to one week and less than or equal to two months.

2. The device of claim 2, wherein said membrane maintains physical integrity in said gastric environment for 72 hours or greater.

18. A method of making a weight loss device, said method comprising:

a. providing a plurality of self-expanding components, wherein said components expand upon contact with a gastric fluid and said components do not substantially degrade when in contact with said gastric fluid; and

b. enveloping said plurality of self-expanding components with a membrane, wherein gastric fluid is capable of passing through said membrane to contact said components and said membrane is capable of accommodating expansion of said components without rupture.

19. The method of claim 18, wherein said membrane is substantially inelastic and said enveloping step further comprises:

a. providing invaginations in said enveloped membrane to accommodate volume expansion of said components upon contact with gastric fluid.

20. The method of claim 18, wherein said membrane comprises a material that degrades or dissolves over time in the stomach, thereby releasing said components.

21. The method of claim 18, further comprising:

a. forming said membrane by operably connecting a first material with a second material, wherein said first material has a higher rate of degradation in a gastric environment than said second material;

wherein upon substantial degradation of said first material said plurality of self-expanding compounds are released from within said envelope to the gastric environment during use.

22. The method of claim 21, wherein said forming step further comprise:

a. providing a plurality of structural elements made of said second material, wherein each of said structural elements has a size that is sufficiently small to pass from a gastric environment through a pyloric valve;

b. connecting each of said structural elements to adjacent structural elements by said first material; and

c. selectively degrading said first material, thereby releasing said plurality of structural elements and self-expanding components to the gastric environment, wherein said elements and components are capable of passing through the GI tract without substantial degradation.

23. A method of promoting weight loss in a patient, said method comprising:

a. positioning a plurality of self-expanding components in an internal volume formed by a membrane to form a self-expanding space occupying device;

b. orally ingesting said device so that said device is located in the patient'"'"'s gastric space;

c. contacting said components with gastric fluid that pass from the gastric environment through said membrane to said internal volume; and

d. expanding said components upon contact with gastric fluid, thereby expanding the volume of said device in the gastric space to promote a feeling of fullness in said patient.

24. The method of claim 24 further comprising:

a. degrading said membrane in said gastric space;

b. releasing said plurality of self-expanded components into said gastric space, wherein each self-expanded component has an expanded volume and shape configured to prevent a small-bowel obstruction; and

c. passing said plurality of self-expanded components out of the patient body by passage through the gastrointestinal system, wherein said components do not substantially degrade.

25. A swallowable self-expanding gastric space occupying device comprising:

a. a composite membrane through which gastric fluid can pass, wherein said membrane provides an enclosure volume separated from the gastric environment by said membrane, said membrane comprising a first and a second material having different degradation characteristics; and

b. a plurality of self-expanding components, wherein said components are contained in said enclosure volume and said components expand in volume upon contact with said gastric fluid, thereby expanding said device from an unexpanded volume to an expanded volume

wherein said first and second materials are operably connected to each other to provide said enclosure volume and controllable degradation of said membrane in said gastric environment.

26. The device of claim 25, wherein the composite membrane has at least a portion of said first material formed into a structure that is selected from the group consisting of:

a. a suture;

b. a stitch;

c. a bond;

d. a tie; and

e. a protective layer that at least partially covers a mesh opening in said membrane

wherein said structure operably connects adjacent membrane pieces formed from said second material.