Granted Patent B2

US 12,263,325 · App. 18/481,857 · Granted Apr 1, 2025

Inventors: Mir Imran (Los Altos Hills, CA); Peter Herrmann (San Jose, CA); Baber Syed (Palo Alto, CA); Timothy H. Williams (Campbell, CA); Chang Jin Ong (Fremont, CA); Greg Method (San Jose, CA)

Assignee: Rani Therapeutics, LLC

A61M5/155A61K38/13A61K38/21A61K38/26A61K38/27A61K38/28A61K38/29A61K38/30A61K38/55A61M5/14244A61M31/002A61K9/4808A61M37/0069A61M2205/3331A61M2210/1042

Abstract

Claims (38)

1. A method of delivering a therapeutic agent preparation into a gastrointestinal (GI) wall of a patient, the method comprising:

administering, by swallowing by a patient, a swallowable device sized to pass through a GI tract, wherein the device comprises a capsule, the therapeutic agent preparation disposed within the capsule, an aligner, and a delivery mechanism for advancing the therapeutic agent preparation from the capsule into the GI wall, wherein the delivery mechanism comprises an expandable member and a piston-cylinder assembly operably coupled to the expandable member, wherein the piston-cylinder assembly comprises a piston slidably disposed in a cylinder, and wherein the piston-cylinder assembly is at least partially disposed in the expandable member;

wherein, upon swallowing of the device, the piston-cylinder assembly is oriented relative to the GI wall via the aligner such that a long axis of the piston-cylinder assembly is perpendicular to a surface of the GI wall; and

wherein the expandable member causes the piston to advance through the cylinder to deliver the therapeutic agent preparation into the GI wall.

2. The method of claim 1 , wherein the therapeutic agent preparation is formed as a tissue penetrating member disposed in the capsule and configured to be advanced into the GI wall by the piston-cylinder assembly.

3. The method of claim 1 , wherein the therapeutic agent preparation is disposed in a cavity of a tissue penetrating member, and wherein the tissue penetrating member is disposed in the capsule and is configured to be advanced into the GI wall by the piston-cylinder assembly.

4. The method of claim 1 , wherein the expandable member comprises a first compartment and a second compartment separated by a releasable valve which releases upon exposure to fluid in the GI tract.

5. The method of claim 4 , wherein the piston-cylinder assembly is oriented relative to the GI wall in response to the releasable valve releasing.

6. The method of claim 4 , wherein the expandable member further comprises a first reactant contained in one of the first or second compartments and a second reactant contained in the other of the first or second compartments, wherein, when the releasable valve releases, the first and second reactants mix to produce a gas.

7. The method of claim 6 , wherein the first and second reactant comprise an acid and a base, respectively.

8. The method of claim 6 , wherein the first reactant comprises potassium bicarbonate and the second reactant comprises citric acid.

9. The method of claim 1 , wherein the piston-cylinder assembly comprises a pressure sensitive release that prevents the piston from advancing through the cylinder until the expandable member generates a threshold force.

10. The method of claim 9 , wherein the pressure sensitive release comprises a tab, a latch, or an O-ring.

11. The method of claim 1 , wherein the capsule comprises a capsule wall, wherein at least a portion of the capsule wall degrades upon exposure to a selected pH in an intestine while protecting the capsule wall from degradation in a stomach of the patient.

12. The method of claim 1 , wherein delivering the therapeutic agent preparation into the GI wall comprises delivering the therapeutic agent preparation past a mucosal or submucosal layer of the GI wall.

13. The method of claim 1 , wherein the GI wall is a wall of an intestine.

14. The method of claim 1 , wherein the aligner comprises a joint configured to exert a force on the piston-cylinder assembly to bias the piston-cylinder assembly into a vertical orientation.

15. The method of claim 1 , wherein the aligner comprises an aligner balloon.

16. The method of claim 1 , wherein the therapeutic agent preparation comprises a growth hormone, parathyroid hormone, an antibody, a chemotherapeutic agent, insulin, one or more glucagon-like peptides, an immune suppression agent, a vaccine, or an anti-parasitic agent.

17. A swallowable device for delivering a therapeutic agent preparation into a gastrointestinal (GI) wall of a patient, the device comprising:

a capsule sized to pass through a GI tract;

the therapeutic agent preparation disposed within the capsule;

an aligner; and

a delivery mechanism for advancing the therapeutic agent preparation from the capsule into the GI wall, wherein the delivery mechanism comprises:

an expandable member; and

a piston-cylinder assembly operably coupled to the expandable member, wherein the piston-cylinder assembly comprises a piston slidably disposed in a cylinder, and wherein the piston-cylinder assembly is at least partially disposed in the expandable member;

wherein, upon swallowing the device, the piston-cylinder assembly is aligned relative to the GI wall via the aligner such that a long axis of the piston-cylinder assembly is oriented perpendicular to a surface of the GI wall; and

wherein the expandable member causes the piston to advance through the cylinder to deliver the therapeutic agent preparation into the GI wall.

18. The swallowable device of claim 17 , wherein the aligner comprises a joint configured to exert a force on the piston-cylinder assembly to bias it into a vertical orientation or an aligner balloon.

19. A swallowable device for delivering a therapeutic agent preparation into a gastrointestinal (GI) wall of a patient, the device comprising:

a capsule sized to pass through a GI tract;

the therapeutic agent preparation disposed within the capsule; and

a delivery mechanism for advancing the therapeutic agent preparation from the capsule into the GI wall, wherein the delivery mechanism comprises:

an expandable member comprising an aligner; and

a piston-cylinder assembly operably coupled to the expandable member, wherein the piston-cylinder assembly comprises a piston slidably disposed in a cylinder, and wherein the piston-cylinder assembly is at least partially disposed in the expandable member;

wherein, upon swallowing the device, the piston-cylinder assembly is aligned relative to the GI wall via the aligner such that a long axis of the piston-cylinder assembly is oriented perpendicular to a surface of the GI wall; and

wherein the expandable member causes the piston to advance through the cylinder to deliver the therapeutic agent preparation into the GI wall.

20. The swallowable device of claim 19 , wherein the aligner comprises a pre-stressed portion of the expandable member.

Assignments (2)

Continuity (9)

References Cited (319)