Granted Patent B2

US 12,268,831 · App. 17/728,878 · Granted Apr 8, 2025

Inventor: Mir Imran (Los Altos Hills, CA)

Assignee: Rani Therapeutics, LLC

A61M31/002A61K9/0065A61K9/48A61K9/4808A61K31/155A61K38/17A61K38/22A61K38/2235A61K38/26A61K38/27A61K38/28A61K38/29A61K45/06A61M5/168A61M5/1723A61M5/20A61M2005/1401A61M5/14276A61M2005/14284A61M2210/106A61M2230/005

Abstract

Claims (42)

1. A swallowable device comprising:

a capsule sized to pass through a GI tract;

a drug disposed in the capsule;

a tissue penetrating member positioned in the capsule, the tissue penetrating member configured to contain the drug and having a tissue penetrating end for penetrating a stomach or intestine wall of the GI tract, wherein the tissue penetrating member comprises biodegradable material configured to degrade in the stomach or intestine wall;

a delivery member for delivering the drug from the tissue penetrating member into stomach or intestine tissue;

an actuating mechanism coupled to at least one of the tissue penetrating member or the delivery member, the actuating mechanism configured to advance the tissue penetrating member into the wall and advance the delivery member to deliver the drug; and

a release element operatively coupled to the actuating mechanism, the release element configured to degrade in the GI tract such that the actuating mechanism is actuated to release the tissue penetrating member to penetrate the stomach or intestine wall and advance the delivery member to deliver the drug.

2. The swallowable device of claim 1 , wherein the actuating mechanism comprises a spring or a balloon.

3. The swallowable device of claim 2 , wherein the actuating mechanism comprises the spring and the release element is coupled to the spring to retain the spring in a compressed state such that upon degradation of the release element, the spring is released from the compressed state to cause the tissue penetrating member to penetrate the wall.

4. The swallowable device of claim 1 , wherein the release element comprises a material configured to degrade in response to a condition in the GI tract.

5. The swallowable device of claim 1 , wherein the delivery member and the tissue penetrating member are configured for delivery of a liquid or a semi-liquid form of the drug.

6. The swallowable device of claim 1 , wherein the delivery member comprises a piston or a plunger.

7. The swallowable device of claim 1 , wherein the capsule comprises a reservoir for containing the drug.

8. The swallowable device of claim 1 , wherein the tissue penetrating member comprises a hollow needle.

9. The swallowable device of claim 8 , wherein upon degradation of the release element, the actuating mechanism is actuated to release the hollow needle to penetrate the wall and then advance the delivery member to deliver the drug through the hollow needle.

10. The swallowable device of claim 8 , wherein the actuating mechanism is further configured to withdraw the hollow needle from the wall.

11. The swallowable device of claim 1 , wherein upon degradation of the release element, the actuating mechanism is actuated to advance the tissue penetrating member into the wall and then advance the delivery member to deliver the drug.

12. A swallowable device comprising:

a capsule sized to pass through a GI tract;

a therapeutic agent preparation disposed in the capsule;

a tissue penetrating member disposed in the capsule, the tissue penetrating member having a lumen and a tissue penetrating end for penetrating a stomach or intestine wall of the GI tract, wherein the tissue penetrating member comprises biodegradable material configured to degrade in the stomach or intestine wall;

a delivery member for delivering the therapeutic agent preparation through the tissue penetrating member lumen into tissue;

an actuating mechanism coupled to at least one of the tissue penetrating member or the delivery member, the actuating mechanism configured to advance the tissue penetrating member into the stomach or intestine wall and advance the delivery member to deliver the therapeutic agent preparation; and

a release element operatively coupled to the actuating mechanism, the release element configured to degrade in response to a condition in the GI tract such that the actuating mechanism is actuated to release the tissue penetrating member to penetrate the stomach or intestine wall and advance the delivery member to deliver the therapeutic agent preparation.

13. The swallowable device of claim 12 , wherein the actuating mechanism comprises a spring or a balloon.

14. The swallowable device of claim 13 , wherein the actuating mechanism comprises the spring and the release element is coupled to the spring to retain the spring in a compressed state such that upon degradation of the release element, the spring is released from the compressed state to cause the tissue penetrating member to penetrate the stomach or intestine wall.

15. The swallowable device of claim 12 , wherein the wall is a wall of the stomach.

16. The swallowable device of claim 12 , wherein the wall is a wall of the intestine.

17. The swallowable device of claim 12 , wherein the delivery member comprises a piston or plunger.

18. The swallowable device of claim 12 , wherein the capsule comprises a reservoir for containing the therapeutic agent preparation.

19. The swallowable device of claim 12 , wherein upon degradation of the release element, the actuating mechanism is actuated to advance the tissue penetrating member into the wall and then advance the delivery member to deliver the drug.

20. A swallowable device comprising:

an enclosure sized to pass through a GI tract;

a therapeutic agent preparation disposed in the enclosure;

a hollow needle disposed in the enclosure, the hollow needle configured to penetrate a stomach or intestine wall of the GI tract, wherein the hollow needle comprises a biodegradable material configured to degrade in the stomach or intestine tissue;

a plunger for delivering the therapeutic agent preparation through the hollow needle into tissue;

a spring coupled to at least one of the hollow needle or the plunger, the spring configured to advance the hollow needle into the stomach or intestine wall and advance the plunger to deliver the therapeutic agent preparation; and

a release element operatively coupled to the spring, the release element configured to degrade in response to a condition in the GI tract to release the spring to cause the hollow needle to penetrate the stomach or intestine wall and advance the plunger to deliver the therapeutic agent preparation.

21. The swallowable device of claim 20 , wherein the wall is a wall of the stomach.

22. The swallowable device of claim 20 , wherein the wall is a wall of the intestine.

23. The swallowable device of claim 20 , wherein the plunger and the hollow needle are configured for delivery of a liquid or a semi-liquid form of the therapeutic agent preparation.

24. The swallowable device of claim 20 , wherein upon degradation of the release element, the spring is actuated to advance the hollow needle into the wall and then advance the plunger to deliver the therapeutic agent preparation.

Assignments (2)

Continuity (11)

References Cited (347)