Gas generating device for delivering beneficial agents to a body cavity

• US 5,951,538 A
• Filed: 08/07/1997
• Issued: 09/14/1999
• Est. Priority Date: 08/07/1997
• Status: Expired due to Fees

• Current Assignee: Microlin LLC
• Original Assignee: Ceramatec, Inc.
• Inventors: Palma, Giorgio di, Joshi, Ashok V., Wold, Truman
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Sadula, Jennifer R.
• Application Number:
  US08/908,687
• Time in Patent Office: 768 Days
• Field of Search: 604/890.1, 604/891.1, 604/73, 604/93, 604/131, 604/140-141, 604/143, 604/145, 604/257, 604/262, 604/403, 604/408, 604/410, 128/DIG. 24, 222/92, 222/206
• US Class Current: 604/500
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

A controlled delivery device for holding and administering a biologically active agent includes a housing having a first end portion, a second end portion, and a port associated with the housing. Enclosed within the housing is a displacing member, a chemical or electrochemical gas generating cell, activation and control circuitry. The electrochemical or chemical cell generates gas within the housing, forcing the displacing member against the beneficial agents contained within the housing and forcing the beneficial agents through an outlet port and into an animal'"'"'s body cavity at a predetermined rate. An anchoring mechanism may be associated with the housing for securing the housing inside the body cavity of the animal being treated. Also disclosed are methods of delivering the beneficial agents into the animal'"'"'s body cavity using the delivery device of the present invention.

Claims

1. A method of delivering a beneficial agent into a body cavity of a being comprising the steps of:

providing an apparatus including an enclosure having a volume and at least one chamber, each such chamber having a self-contained gas generating cell integrally associated therewith, said volume containing the beneficial agent, and an outlet port configured so as to permit passage of the beneficial agent from within the apparatus;

inserting the apparatus within a body cavity;

activating a gas generating cell and, in turn, generating a gas to create sufficient force against the beneficial agent; and

controllably forcing the beneficial agent out of said enclosure via the outlet port in fluid communication with a body cavity, thus dispersing the beneficial agent into a body cavity.

2. The method of claim 1, wherein said gas is generated at a controlled rate to disperse the beneficial agent into the body cavity at a controlled rate.

3. The method of claim 2, wherein the beneficial agent is dispersed over a period of 1 to 700 days.

4. The method of claim 1, wherein said controlled displacing member comprises a fluid-tight bag.

5. The method according to claim 1 further comprising the step of:

deploying an anchoring member, to, in turn, preclude inadvertent removal of the apparatus from within a body cavity.

6. The method according to claim 5 wherein the step of deploying an anchoring member further comprises the step of deploying at least one collapsible section into a deployed position.

7. The method according to claim 6 wherein the step of deploying the at least one collapsible section further includes the step of temporarily precluding deployment of the at least one collapsible section until desired.

8. The method according to claim 7 wherein the step of temporarily precluding deployment comprises the steps of:

securing the at least one collapsible section with a soluble band; and

dissolving the soluble band.

9. The method according to claim 1 wherein:

the apparatus includes at least two separate beneficial agents, and at least two self-contained gas generating cells, the step of activating further including the steps of;

activating the first self contained gas generating cell; and

activating the second self contained gas generating cell, and

the step of controllably forcing further including the steps of;

controllably forcing the first beneficial agent out of the opening of the apparatus by way of the gas generated by the first self-contained gas generating cell; and

controllably forcing the second beneficial agent out of the opening of the apparatus by way of the gas generated by the second self-contained gas generating cell.

10. The method according to claim 9 wherein the step of first beneficial agent is delivered at higher rate than the second beneficial agent.

11. The method according to claim 1 wherein the apparatus includes two agents, the step of controllably forcing the at least one beneficial agent comprises the step of:

controllably forcing the first beneficial agent through the opening in the apparatus; and

controllably forcing the second beneficial agent through the opening in the apparatus sequentially, after substantial depletion of the first beneficial agent.

12. The method according to claim 1 wherein the step of activating comprises the step of:

transmitting a signal to a receiver associated with the gas generating cell;

receiving the signal at the gas generating cell, to, in turn, activate the cell.

13. The method according to claim 1 wherein the step of activating comprises the step of:

setting a timer associated with the gas generating cell, wherein expiration of the timer activates the cell.

14. The method according to claim 1 wherein the apparatus includes a controlled displacing member associated with the chamber, the step of activating the gas generating cell, generates a gas to create sufficient force to move the controlled displacing member against the beneficial agent.

15. The method of claim 1, wherein said controlled displacing member comprises a piston.