Osmotic pump delivery system with pre-hydrated membrane(s) and/or primable catheter

• US 6,616,652 B1
• Filed: 02/15/2000
• Issued: 09/09/2003
• Est. Priority Date: 02/15/2000
• Status: Expired due to Fees

• Current Assignee: Microsolutions Incorporated
• Original Assignee: Microsolutions Incorporated
• Inventors: Harper, Derek J., Milo, Charles F.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): DESANTO, MATTHEW F
• Application Number:
  US09/504,603
• Time in Patent Office: 1,302 Days
• Field of Search: 604/890.1, 604/891.1, 604/892.1, 604/288, 604/93.01, 424/422-424
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L

Abstract

An implantable osmotic pump system includes a pre-hydrated semipermeable membrane to reduce the time interval between implantation of the system into the patient and full operation of the pump system. The semipermeable membrane is maintained in a hydrated state prior to implantation by fluid contact with a saline solution maintained in a saturated state by a salt tablet. As the differential osmotic pressure across the hydrated semipermeable membrane is negligible as the saline concentration on both sides of the membrane is the same, the pump system does not operate and does not infuse the pharmaceutical agent as long as this osmotic equipotential state is maintained. When the saturated saline solution is removed from fluid contact with the semipermeable membrane and the system is implanted in a patient, the osmotic pressure differential across the semipermeable membrane increases, thereby causing the pump to immediately begin operation at or near its intended and designed steady state infusion rate. To further decrease the delay between implantation and effusion of a pharmaceutical agent from the system, the infusion lumen of an attached catheter may be at least partially flushed with the same or a different pharmaceutical agent as is loaded in the pharmaceutical agent compartment of the pump system.

Claims

1. A kit, comprising:

a liquid tight container, enclosing;

an implantable osmotic pump, the pump including a semipermeable membrane;

a salt tablet, and

an aqueous solution, wherein the aqueous solution is in fluid contact at least with the salt tablet and the semipermeable membrane, and wherein the salt tablet and the aqueous solution are enclosed by the liquid tight container and separate from the implantable osmotic pump, and maintain the semipermeable membrane in a hydrated state.

2. The kit of claim 1, further comprising a catheter attached to osmotic pump.

3. The kit of claim 2, wherein the catheter includes a flushing valve near a proximal end thereof.

4. The kit of claim 3, wherein the catheter is formed of an elastomer, polymeric or composite materials and wherein the flushing valve includes a longitudinal slit in the catheter.

5. The kit of claim 3, further including:

an ampoule containing a pharmaceutical agent therein, and

a syringe fitted with an extension tube, a distal end of which is dimensioned to fit within the proximal valve of the catheter.

6. The kit of claim 1, wherein the osmotic pump is preloaded with a pharmaceutical agent.

7. The kit of claim 6, wherein the osmotic pump is preloaded with at least one pharmaceutical agent for at least one therapy selected from a group including pain therapy, hormone therapy, gene therapy, angiogenic therapy, anti-tumor therapy, chemotherapy and other pharmaceutical therapy.

8. The kit of claim 6, wherein the pharmaceutical agent includes at least one of fentanyl, sufentanil, clonidine and mixtures thereof.

9. The kit of claim 1, wherein the catheter includes a distal valve mechanism adapted to prevent fluid back flow into the catheter.

10. The kit of claim 1, wherein the saturated saline solution is in fluid contact with the osmotic pump and the tablet.

11. The kit of claim 1, wherein the container includes a flexible fluid tight bag.

12. The kit of claim 1, wherein the bag includes at least one of polyethylene, PET, PETG and a gas permeable barrier film.

13. An implantable osmotic pump system, comprising:

a pump housing having a proximal and a distal end, the pump housing including a pharmaceutical agent compartment and an osmotic agent compartment separated by a movable piston;

a semipermeable membrane fitted to the proximal end;

an impermeable membrane disposed over and away from the semipermeable membrane to define a fluid tight hydration compartment between the semipermeable membrane and the impermeable membrane, the impermeable membrane being configured to be breached prior to implantation of the osmotic pump system in a patient, and

a saturated saline solution within the hydration compartment.

14. The pump system of claim 13, further comprising a salt tablet in the hydration compartment.

15. The pump system of claim 14, wherein the salt tablet includes NaCl.

16. The pump system of claim 13, wherein the pharmaceutical agent compartment is preloaded with a pharmaceutical agent.

17. The pump system of claim 16, wherein the pharmaceutical agent includes at least one of fentanyl, sufentanil and clonidine.

18. The pump system of claim 13, further including a catheter attached to the distal end of the pump housing and in fluid communication with the pharmaceutical agent compartment.

19. The pump system of claim 18, wherein the catheter includes an infusion lumen and an elastomeric proximal flushing valve.

20. The pump system of claim 18, wherein the catheter includes a distal valve mechanism adapted to prevent fluid back flow into the catheter.

21. The pump system of claim 13, wherein the impermeable barrier includes at least one of titanium, stainless steel platinum, platinum-iridium, polyethylene, PET and PETG.

22. The pump system of claim 13, wherein the osmotic pump system is preloaded with at least one pharmaceutical agent for at least one therapy selected from a group including pain therapy, hormone therapy, gene therapy, angiogenic therapy, anti-tumor therapy, chemotherapy and other pharmaceutical therapy.

23. A kit, comprising:

an implantable osmotic pump system, comprising;

a pump housing having a proximal and a distal end, the pump housing including a pharmaceutical agent compartment and an osmotic agent compartment separated by a movable piston;

a semipermeable membrane fitted to the proximal end;

an impermeable membrane disposed over and away from the semipermeable membrane to define a fluid tight hydration compartment between the semipermeable membrane and the impermeable membrane, the impermeable membrane being configured to be breached prior to implantation of the osmotic pump system in a patient and an aqueous solution within the hydration compartment, and

a lancet adapted to breach the impermeable barrier.

24. The kit of claim 23, further including a catheter attached to the distal end of the pump housing and in fluid communication with the pharmaceutical agent compartment.

25. The kit of claim 24, wherein the catheter includes an infusion lumen and an elastomeric proximal flushing valve.

26. The kit of claim 25, further including a syringe adapted to inject pharmaceutical agent into the infusion lumen through the proximal valve.

27. The kit of claim 26, wherein the syringe includes an extension tube fitted thereto, the free end thereof being adapted to fit into the proximal flushing valve.

28. The kit of claim 26, further including an ampoule containing a sufficient volume of pharmaceutical agent to flush the infusion lumen prior to implantation of the osmotic pump system.

29. The kit of claim 23, wherein the pharmaceutical agent compartment is preloaded with a pharmaceutical agent.

30. The kit of claim 29, wherein the pharmaceutical agent includes at least one of fentanyl, sufentanil and clonidine.

31. The kit of claim 23, further including a salt tablet in the hydration compartment.

32. The kit of claim 23, wherein the impermeable barrier includes at least one of titanium and stainless steel.

33. The kit of claim 23, wherein the impermeable membrane is configured to be breached with a lancet prior to implantation of the osmotic pump system in a patient.

34. The kit of claim 23, wherein the osmotic pump system is preloaded with at least one pharmaceutical agent for at least one therapy selected from a group including pain therapy, hormone therapy, gene therapy, angiogenic therapy, anti-tumor therapy, chemotherapy and other pharmaceutical therapy.

35. The kit of claim 24, wherein the catheter includes a distal valve mechanism adapted to prevent fluid back flow into the catheter.