SWALLOWABLE DRUG DELIVERY DEVICE AND METHODS OF DRUG DELIVERY
Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Some embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. The device comprises a capsule sized to be swallowed and pass through the intestinal tract. The capsule can include at least one guide tube, one or more tissue penetrating members positioned in the guide tube, a delivery member, an actuating mechanism and a release element. The release element degrades upon exposure to various conditions in the intestine so as to release and actuate the actuating mechanism. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.
1 . A swallowable device for delivering a therapeutic agent into an intestinal wall of a patient, the device comprising:
a swallowable capsule comprising a biodegradable material configured to degrade in a gastrointestinal tract of the patient;
an expandable member disposed in the capsule;
a therapeutic agent preparation comprising at least one therapeutic agent disposed in the capsule; and
a tissue penetrating member coupled to the expandable member, the tissue penetrating member configured to penetrate the intestinal wall upon expansion of the expandable member;
wherein the capsule is configured to degrade in an intestine of the patient to cause the expandable member to expand and the tissue penetrating member to penetrate the intestinal wall to deliver the at least one therapeutic agent.
2 . The device of claim 1 , wherein the capsule further comprises an enteric coating configured to protect the capsule from stomach acids and permit biodegradation of the capsule in a small intestine of the patient.
3 . The device of claim 1 , further comprising a release element coupled to the expandable member in the capsule, the release element formed from a material configured to degrade at a selected pH in the intestine to cause the expandable member to expand.
4 . The device of claim 1 , wherein the expandable member comprises a balloon.
5 . The device of claim 1 , wherein the expandable member comprises a shape memory material.
6 . The device of claim 1 , wherein the tissue penetrating member is hollow.
7 . The device of claim 1 , wherein the tissue penetrating member has a curved or arcuate shape.
8 . The device of claim 1 , wherein the tissue penetrating member comprises a biodegradable material configured to degrade in the intestinal wall.
9 . The device of claim 1 , wherein the capsule comprises a reservoir, and wherein the therapeutic agent preparation is disposed in the reservoir in a semi-liquid or liquid form.
10 . The device of claim 1 , wherein the therapeutic agent preparation is formed into the shape of, or is disposed in a cavity of, the tissue penetrating member.
11 . The device of claim 1 , wherein the tissue penetrating is coupled to a surface of the expandable member.
12 . A swallowable device for delivering a therapeutic agent into an intestinal wall of a patient, the device comprising:
a swallowable capsule comprising a biodegradable material configured to degrade in a gastrointestinal tract of the patient;
an actuation mechanism disposed in the capsule;
a therapeutic agent preparation comprising at least one therapeutic agent disposed in the capsule; and
a tissue penetrating member coupled to the actuation mechanism, the tissue penetrating member configured to penetrate the intestinal wall upon actuation of the actuation mechanism;
wherein the capsule is configured to degrade in an intestine of the patient to cause the actuation mechanism to actuate and the tissue penetrating member to penetrate the intestinal wall to deliver the at least one therapeutic agent.
13 . The device of claim 12 , wherein the capsule further comprises an enteric coating configured to protect the capsule from stomach acids and permit biodegradation of the capsule in a small intestine of the patient.
14 . The device of claim 12 , further comprising a release element coupled to the actuation mechanism, the release element formed from a material configured to degrade at a selected pH in the intestine of the patient to cause the actuation mechanism to actuate.
15 . The device of claim 14 , wherein the actuation mechanism comprises a spring, and wherein 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.
16 . The device of claim 12 , wherein the tissue penetrating member is hollow.
17 . The device of claim 12 , wherein the tissue penetrating member has a curved or arcuate shape.
18 . The device of claim 12 , wherein the tissue penetrating member comprises a biodegradable material configured to degrade in the intestinal wall.
19 . The device of claim 12 , wherein the capsule comprises a reservoir, and wherein the therapeutic agent preparation is disposed in the reservoir in a semi-liquid or liquid form.
20 . A swallowable device for delivering a therapeutic agent into an intestinal wall of a patient, the device comprising:
a swallowable capsule comprising a biodegradable material configured to degrade in a gastrointestinal tract of the patient and a coating configured to protect the capsule from stomach acids and permit biodegradation of the capsule in a small intestine of the patient;
an expandable member disposed in the capsule;
a release element coupled to the expandable member, the release element formed from a material configured to degrade at a selected pH in the small intestine to cause the expandable member to expand;
a therapeutic agent preparation comprising at least one therapeutic agent disposed in the capsule; and
a tissue penetrating member coupled to the expandable member, the tissue penetrating member configured to penetrate the intestinal wall upon expansion of the expandable member;
wherein the capsule is configured to degrade in the small intestine to cause the release element to degrade and the expandable member to expand to thereby cause the tissue penetrating member to penetrate the intestinal wall and deliver the at least one therapeutic agent.