Claims
- 1. An improved delivery device for storing and protecting a beneficial agent formulation and for dispensing the beneficial agent formulation to an animal, the delivery device comprising:
- a) a housing comprising a fluid impermeable portion and a fluid permeable portion, the portions forming an internal compartment;
- b) a beneficial agent formulation in the internal compartment;
- c) expandable means in the compartment for pushing the beneficial agent formulation from the delivery device; and
- e) exit means for delivering the beneficial agent formulation from the internal compartment to the animal over a prolonged period of time, wherein the improvement comprises headspace formed in a part of the portion of the internal compartment which contains the beneficial agent formulation which headspace is located away from the exit means and which head space serves to accumulate an air volume in a part of the portion of the internal compartment which contains the beneficial agent formulation away from the exit means.
- 2. A delivery device according to claim 1 wherein the housing includes an end cap, the end cap comprising an inwardly extending portion, the inwardly extending portion and defining a space therebetween.
- 3. A delivery device according to claim 2, further including means for maintaining a seal between the exterior environment and the interior chamber until the osmotic pressure within the device reaches a predetermined pressure of between greater than 5 and 10 psi.
- 4. A delivery device according to claim 2, wherein the end cap includes mating means for adapting the end cap to ultrasonic welding to the, the mating means positioned where the end cap and the fluid impermeable portion join.
- 5. A delivery device as set forth in claim 4, wherein end cap further comprises a first side and a second side, and wherein the mating means includes a tenon extending outwards from the second side of the end cap, the fluid impermeable portion defining a mortise therein, the tenon sized and positioned for receipt within the mortise.
- 6. A delivery device for storing and protecting a beneficial agent formulation and for minimizing the dilution of the beneficial agent formulation during the dispensing of the beneficial agent to an animal, the delivery device comprising:
- a) a housing comprising a first wall section and a second wall section assembled together to form an internal compartment, wherein the first wall section is substantially impermeable to the passage of fluid, wherein the second wall section is permeable in at least a portion, to a predetermined rate of fluid from the external environment into the internal compartment comprised by the second wall section;
- b) a beneficial agent formulation in a portion of the internal compartment comprised by the first wall section;
- c) expandable means in a portion of the compartment comprised by the second wall section for pushing the beneficial agent formulation from the delivery device; and
- d) an exit passageway through the first wall section, the exit passageway comprising a seal wherein said seal is discharged, leaches or erodes to become unsealed when the pressure within the compartment reaches a predetermined level and which seal thereafter remains unsealed to allow continuous release of beneficial agent during the entire time of delivery, and the exit passageway having a length and area which maintains sufficient outflow of the beneficial agent formulation to prevent an inward flow of fluid from the external environment.
- 7. A delivery device according to claim 6, the wherein the beneficial agent is bovine somatotrophin and the predetermined rate of fluid from the external environment is about 10 to about 15 mg/water per day.
- 8. A delivery device according to claim 7, wherein the predetermined rate of fluid is attained by a selected thickness of the second wall section, a selected surface area of the second wall section, and second wall section comprising a selected material.
- 9. A device according to claim 6, wherein the exit passageway further includes the first wall section defining a passageway of a predetermined inner diameter sufficient to generate a sufficient outward velocity of the beneficial agent formulation to prevent an inward flow of fluid from the external environment to dilute the beneficial agent in the portion of the compartment comprised by the first wall section.
- 10. A device according to claim 9 wherein the exit passageway further includes means for compensating for slight variations in the outward flow rate.
- 11. A device according to claim 10 wherein the means for compensating for slight variations in the outward flow rate includes adjusting the thickness of the first wall section defining the exit passageway therein.
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of application Ser. No. 08/269,596, filed Jul. 1, 1994, now U.S. Pat. No. 5,728,088, which is a continuation-in-part of application Ser. No. 07/513,361 filed Apr. 20, 1990, abandoned, which is a divisional of application Ser. No. 07/283,359 filed Dec. 13, 1998 now U.S. Pat. No. 5,034,229.
This application is also related to U.S. Ser. No. 07/512,301, filed Apr. 20, 1990, now U.S. Pat. No. 5,174,999; Ser. No. 07/513,327, filed Apr. 20, 1990, now U.S. Pat. No. 5,057,318; Ser. No. 513,328, filed Apr. 20, 1990, now U.S. Pat. No. 5,037,420; Ser. No. 07/513,330, filed Apr. 20, 1990, now U.S. Pat. No. 5,110,596; Ser. No. 07/513,363, filed Apr. 20, 1990, now U.S. Pat. No. 5,135,523; and Ser. No. 07/513,528, filed Apr. 23, 1990, now U.S. Pat. No. 5,059,423; all of which are divisions of U.S. Ser. No. 08/283,359 (above); Ser. No. 07/681,848, filed Apr. 8, 1991, now abandoned, which is a continuation of U.S. Ser. No. 07/513,328 (above); Ser. No. 07/789,241, filed Nov. 7, 1991, now U.S. Pat. No. 5,320,616, which is a continuation of U.S. Ser. No. 07/513,369, filed Apr. 20, 1990, now abandoned; and Ser. No. 08/203,967, filed Mar. 1, 1994, now U.S. Pat. No. 5,630,808, which is a continuation of Ser. No. 789,241 (above).
All of the above applications are assigned to ALZA Corporation, Palo Alto, Calif.
US Referenced Citations (18)
Divisions (1)
|
Number |
Date |
Country |
Parent |
283359 |
Dec 1988 |
|
Continuations (1)
|
Number |
Date |
Country |
Parent |
269596 |
Jul 1994 |
|
Continuation in Parts (1)
|
Number |
Date |
Country |
Parent |
513361 |
Apr 1990 |
|