Drug delivery system

• US 7,766,885 B2
• Filed: 06/07/2004
• Issued: 08/03/2010
• Est. Priority Date: 06/07/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Olsen, James M.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Bouchelle; Laura A
• Application Number:
  US10/862,775
• Publication Number:
  US 20050273082A1
• Time in Patent Office: 2,248 Days
• Field of Search: 604/9, 604/118, 604/141, 604/144, 604/146, 604/288.01, 604/288.04, 604/93.01, 604/891.1
• US Class Current: 604/288.04
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1483 using flexible bags externally pressurised by fluid pressure
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28

Abstract

A drug delivery system (10) has a positive pressure drug reservoir (15). A pump (19) is in fluid communication with the reservoir (15) via a first fluid passageway (18). The outlet (19b) of the pump (19) is in fluid communication with a first regulator (21). The regulator (21) includes a housing (24) that has a first subchamber (24a) and a second subchamber (24b). The second subchamber (24b) is divided into a lower chamber (28a) and a middle chamber (28b) by a diaphragm (28). A third fluid passageway (32) is positioned between the lower chamber (28a) and the drug reservoir (15), whereby accidental flow from the reservoir (15) to an outlet (21b) is prevented.

Claims

1. A drug delivery system for implantation in a body for delivery of a liquid drug, the system comprising:

a) an infusion housing defining a drug reservoir, a propellant chamber within the infusion housing and proximate the drug reservoir, wherein a positive pressure drug reservoir is created;

b) the drug reservoir having a reservoir inlet for receiving the liquid drug and a reservoir outlet;

c) a pump having a pump inlet and a pump outlet;

d) a first fluid passageway operable to transfer the liquid drug between the reservoir outlet and the pump inlet;

e) a first regulator having a first subchamber having a first regulator outlet and a second subchamber having a first regulator inlet;

f) a first opening between the first subchamber and the second subchamber;

g) a first diaphragm positioned in the second subchamber, the diaphragm moveable between an open position and a closed position to open and close the first opening, the diaphragm separating the second subchamber into a first middle chamber and a first lower chamber;

h) a second fluid passageway operable to transfer the liquid drug between the pump outlet and the first regulator inlet, the first regulator inlet positioned in the first middle chamber; and

i) a third fluid passageway between the lower chamber and the drug reservoir, whereby accidental flow from the reservoir to the first regulator outlet is prevented.

2. The drug delivery system of claim 1, further comprising a dividing member, the dividing member forming the first subchamber and the second subchamber.

3. The drug delivery system of claim 2, wherein the first opening is defined by the dividing member and the first opening is centrally located in the dividing member.

4. The drug delivery system of claim 3, wherein the diaphragm is closed when the pump is not activated, thereby maintaining a high pressure in the regulator to prevent formation of bubbles.

5. The drug delivery system of claim 3, wherein the opening is less than 0.020 inches in diameter.

6. The drug delivery system of claim 3, wherein pressure from delivery of the drug to the first regulator acts on at least 95 percent of the diaphragm, whereby hysteresis of the diaphragm is reduced.

7. The drug delivery system of claim 1, further comprising a second regulator, the second regulator comprising:

a) third subchamber having a second regulator outlet and a fourth subchamber having a second regulator inlet;

b) a second opening between the third subchamber and the fourth subchamber;

c) a second diaphragm positioned in the fourth subchamber, the second diaphragm moveable between an open position and a closed position to open and close the second opening, the second diaphragm separating the fourth subchamber into a second middle chamber and a second lower chamber; and

d) a fourth fluid passageway between the first regulator outlet and the second regulator inlet.

8. A drug delivery system for implantation in a body for delivery of a liquid drug, the system comprising:

a) an infusion housing defining a drug reservoir, a propellant chamber within the infusion housing and proximate the drug reservoir, wherein a positive pressure drug reservoir is created;

b) the drug reservoir having a reservoir inlet for receiving the liquid drug and a reservoir outlet;

c) a pump having a pump inlet and a pump outlet;

d) a first fluid passageway operable to transfer the liquid drug between the reservoir outlet and the pump inlet;

e) a first regulator having a first subchamber having a first regulator outlet and a second subchamber having a first regulator inlet;

f) a first opening between the first subchamber and the second subchamber;

g) a first diaphragm positioned in the second subchamber, the first diaphragm moveable between an open position and a closed position to open and close the first opening, the diaphragm separating the second subchamber into a first middle chamber and a first lower chamber;

h) a second fluid passageway operable to transfer the liquid drug between the pump outlet and the first regulator inlet, the first regulator inlet positioned in the first middle chamber;

i) a second regulator having a third subchamber having a second regulator outlet and a fourth subchamber having a second regulator inlet;

j) a second opening between the third subchamber and the fourth subchamber;

k) a second diaphragm positioned in the fourth subchamber, the second diaphragm moveable between an open position and a closed position to open and close the second opening, the second diaphragm separating the fourth subchamber into a second middle chamber and a second lower chamber;

l) a third fluid passageway between the first regulator outlet and the second regulator inlet; and

m) a fourth fluid passageway between the first lower chamber and the drug reservoir, whereby accidental flow from the reservoir to the second regulator outlet is prevented.

9. The drug delivery system of claim 8, further comprising a fifth fluid passageway between the second lower chamber and the drug reservoir.

10. The drug delivery system of claim 9, wherein the first and second openings are centrally located.

11. The drug delivery system of claim 10, wherein the diaphragm is closed when the pump is not activated, thereby maintaining a high pressure in the regulator to prevent formation of bubbles.

12. The drug delivery system of claim 11, wherein the openings are less than 0.020 inches in diameter.

13. The drug delivery system of claim 12, wherein pressure from delivery of the drug to the first regulator acts on at least 95 percent of the diaphragms, whereby hysteresis of the diaphragm is reduced.

14. A drug delivery system for implantation in a body for delivery of a liquid drug, the system comprising:

a) an infusion housing defining a drug reservoir, a propellant chamber within the infusion housing and proximate the drug reservoir, wherein a positive pressure drug reservoir is created;

b) the drug reservoir having a reservoir inlet for receiving the liquid drug and a reservoir outlet;

c) a pump having a pump inlet and a pump outlet;

d) a first fluid passageway operable to transfer the liquid drug between the reservoir outlet and the pump inlet;

e) a first regulator having a first dividing member, the first dividing member forming a first subchamber and a second subchamber, the first dividing member defining a first opening centrally located in the first dividing member;

f) a first diaphragm positioned in the second subchamber, the first diaphragm moveable between an open position and a closed position to open and close the first opening, the first diaphragm separating the second subchamber into a first middle chamber and a first lower chamber;

g) a second fluid passageway operable to transfer the liquid drug between the pump outlet and the first regulator inlet, the first regulator inlet positioned in the first middle chamber;

h) a second regulator having a second dividing member, the second dividing member forming a third subchamber and a fourth subchamber, the second dividing member defining a second opening centrally located in the second dividing member;

i) a second diaphragm positioned in the fourth subchamber, the second diaphragm moveable between an open position and a closed position to open and close the second opening, the second diaphragm separating the fourth subchamber into a second middle chamber and a second lower chamber; and

j) a third fluid passageway between the first regulator outlet and the second regulator inlet; and

k) a fourth fluid passageway between the first lower chamber and the drug reservoir, whereby accidental flow from the reservoir to the second regulator outlet is prevented.

15. The drug delivery system of claim 14, further comprising a fifth fluid passageway between the second lower chamber and the drug reservoir.

16. The drug delivery system of claim 15, wherein the first and second openings are centrally located.

17. The drug delivery system of claim 16, wherein the diaphragm is closed when the pump is not activated, thereby maintaining a high pressure in the regulator to prevent formation of bubbles.

18. The drug delivery system of claim 17, wherein the openings are less than 0.020 inches in diameter.

19. The drug delivery system of claim 18, wherein pressure from delivery of the drug to the first regulator acts on at least 95 percent of the diaphragms, whereby hysteresis of the diaphragm is reduced.