Osmotic pump delivery system with flexible drug compartment

• US 6,464,688 B1
• Filed: 02/15/2000
• Issued: 10/15/2002
• 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): JACYNA, J CASIMER
• Application Number:
  US09/504,971
• Time in Patent Office: 973 Days
• Field of Search: 604/890.1, 604/891.1, 604/892.1, 424/422, 424/424
• 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: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1483 using flexible bags externally pressurised by fluid pressure

Abstract

An implantable osmotic pump system includes a rigid pump housing defining an opening adapted to receive a catheter; one or more membrane assemblies fitted to the pump housing; an osmotic engine within the rigid pump housing and a flexible pharmaceutical agent compartment disposed within the pump housing. The flexible pharmaceutical agent compartment is adapted to enclose a volume of a pharmaceutical agent and to cause the pharmaceutical agent to be infused through the opening as water crosses the membrane assembly or assemblies and increases the volume of the osmotic engine. The flexible pharmaceutical agent compartment may include polyethylene teraphthalate (PET), for example, and/or may include a metallic layer such as gold, silver, platinum and/or aluminum, for example, to inhibit the transfer of gas or liquid across the compartment. A catheter may be bonded to the opening of the pump housing and to a corresponding opening in the flexible pharmaceutical agent compartment. The flexible pharmaceutical agent compartment may be free floating inside the pump housing, being only attached to the catheter and/or to the opening of the pump housing. As the present implantable osmotic pump does not include a movable piston, the pump housing may have a cylindrical shape in which the height of the pump housing is less than the diameter thereof, a non-cylindrical shape and/or a shape that conforms to the patient'"'"'s anatomy at the implant site.

Claims

1. An implantable osmotic pump system, comprising:

a rigid pump housing defining an opening;

a plurality of membrane assemblies fined to the pump housing, at least one of the plurality of membrane assemblies including a semipermeable membrane and an impermeable membrane initially sealing the semipermeable membrane;

an osmotic engine within the rigid pump housing, and

a flexible pharmaceutical agent compartment disposed within the rigid pump housing, the flexible pharmaceutical agent compartment being in fluid communication with the opening.

2. The pump system of claim 1, wherein each of the plurality of membrane assemblies includes a semipermeable membrane.

3. The pump system of claim 1, wherein the impermeable membrane is disposed away from the semipermeable membrane to define a fluid tight compartment therewith.

4. The pump system of claim 3, wherein the fluid tight compartment encloses a volume of saturated saline solution.

5. The pump system of claim 1, wherein the impermeable membrane includes a biologically inert material that is impermeable to water.

6. The pump system of claim 5, wherein the biologically inert material is radiopaque.

7. The pump system of claim 1, wherein the impermeable membrane includes at least one of titanium and stainless steel, polyethylene, polyethylene teraphthalate (PET), PETG and/or PETE.

8. The pump system of claim 1, wherein the impermeable membrane includes a layer of one of gold, silver, platinum and platinum-iridium.

9. The pump system of claim 1, wherein the osmotic engine is a hygroscopic salt.

10. The pump system of claim 1, wherein the osmotic engine includes an absorbent polymer.

11. The pump system of claim 10, wherein the absorbent polymer includes a material selected from a group including poly(acrylic acid), potassium salt;

poly(acrylic acid), sodium salt;

poly(acrylic acid-co-acrylamide), potassium salt;

poly(acrylic acid), sodium salt-graft-poly(ethylene oxide);

poly(2-hydroxethyl methacrylate);

poly(2-hydroxypropyl methacrylate) and poly(isobutylene-co-maleic acid) or derivatives thereof.

12. The pump system of claim 1, wherein the pharmaceutical agent is therapeutically effective for at least one therapy selected from pain therapy, hormone therapy, gene therapy, angiogenic therapy, anti-tumor therapy and chemotherapy.

13. The pump system of claim 1, wherein the pharmaceutical agent includes an opioid.

14. The pump system of claim 1, wherein the pharmaceutical agent includes at least one of an agonist, a partial agonist, an agonist-antagonist and an alpha 2-adrenoreceptor agonist.

15. The pump system of claim 1, wherein the pharmaceutical agent includes at least one drug selected from a group including morphine, hydromorphone, levorphanol, methadone, fentanyl, suientanil, buprenorphine, pentazocine and butoxphanol.

16. The pump system of claim 1, wherein the flexible pharmaceutical agent compartment includes at least one of polyethylene, polyethylene teraphthalate (PET), PETG, PETE, nylon, urethane and co-polymers.

17. The pump system of claim 16, wherein the pharmaceutical agent compartment includes a metallic layer.

18. The pump system of claim 17, wherein the metallic layer includes at least one of aluminum, platinum, gold and silver.

19. The pump system of claim 1, further comprising a catheter attached to the opening and to a corresponding opening in the flexible pharmaceutical agent compartment so as to define a fluid path from the flexible pharmaceutical agent compartment through the opening of the pump housing to the catheter.

20. The pump system of claim 19, wherein the flexible pharmaceutical agent compartment is free floating inside the pump housing and is attached only to at least one of the catheter and the opening of the pump housing.

21. The pump system of claim 1, wherein the pump housing has a non-cylindrical shape.

22. The pump system of claim 1, wherein the pump housing has a shape that conforms to a patient anatomy at an implantation site.

23. The pump system of claim 1, wherein the pump housing includes a proximal end, a distal end and a sidewall, and wherein the at least one membrane assembly is fitted to the sidewall.

24. The pump system of claim 1, wherein the at least one membrane assembly includes an array of membrane assemblies, each of which includes a semipermeable membrane initially sealed by a radiopaque impermeable membrane adapted to be breached with a lancet.

25. An implantable osmotic pump, comprising:

a pump housing;

an osmotic engines, the osmotic engine being disposed within the pump housing;

a plurality of semipermeable membranes, each of the plurality of semipermeable membranes being configured to allow water to cross from a patient into the pump housing to the osmotic engine, and

a flexible pharmaceutical agent compartment adapted to enclose a volume of pharmaceutical agent.

26. The osmotic pump of claim 25, wherein the flexible pharmaceutical agent compartment is adapted to infuse the volume of pharmaceutical agent at a selected infusion rate as the osmotic engine hydrates and swells with the water from the patient, the selected infusion rate being related to at least one of a thickness, a composition and a surface area of the semipermeable membrane.

27. The osmotic pump of claim 25, wherein the pump housing includes a proximal end, a distal end and a sidewall, the semipermeable membrane being fitted to the sidewall.

28. The osmotic pump of claim 25, wherein the pump housing includes a proximal end, a distal end and a sidewall, the semipermeable membrane being fitted to the proximal end.

29. The osmotic pump of claim 25, wherein each of the plurality of semipermeable membranes is fitted with an impermeable membrane that initially seals the semipermeable membrane.

30. The osmotic pump of claim 29, wherein the impermeable membrane is radiopaque.

31. The osmotic pump of claim 25, wherein the osmotic engine is at least co-extensive with the flexible pharmaceutical agent compartment.

32. The osmotic pump of claim 25, wherein the pump housing is cylindrical.

33. The osmotic pump of claim 32, wherein the pump housing has a height and a diameter and wherein the height of the pump housing is no greater than the diameter of the pump housing.

34. The osmotic pump of claim 25, wherein the pump housing has a non-cylindrical shape.

35. The osmotic pump of claim 25, wherein the phamaceutical agent is therapeutically effective for at least one therapy selected from pain therapy, hormone therapy, gene therapy, angiogenic therapy, anti-tumor therapy and chemotherapy.

36. The osmotic pump of claim 25, wherein the pharmaceutical agent includes an opioid.

37. The osmotic pump of claim 25, wherein the pharmaceutical agent includes at least one of an agonist, a partial agonist, an agonist-antagonist and an alpha 2-adrenoreceptor agonist.

38. The osmotic pump of claim 25, wherein the pharmaceutical agent includes at least one drug selected from a group including morphine, hydromorphone, levorphanol, methadone, fentanyl, sufentanil, buprenorphine, pentazocine and butorphanol.

39. An implantable osmotic pump system, comprising:

a rigid pump housing defining an opening;

at least one membrane assembly fitted to the pump housing, the membrane assembly including a semipermeable membrane and an impermeable membrane initially sealing the semipermeable membrane and adapted to be breached by a lancet, the impermeable membrane being disposed away from the semipermeable membrane to define a fluid tight compartment, the fluid tight compartment enclosing a volume of an aqueous solution;

an osmotic engine within the rigid pump housing, and

a flexible pharmaceutical agent compartment disposed within the rigid pump housing, the flexible pharmaceutical agent compartment being in fluid communication with the opening.

40. The pump system of claim 39, wherein the aqueous solution includes a saturated saline solution.

41. An implantable osmotic pump system, comprising:

a rigid pump housing defining an opening;

at least one membrane assembly fitted to the pump housing, the membrane assembly including a semipermeable membrane and an impermeable membrane initially sealing the semipermeable membrane and adapted to be breached by a lancet, the impermeable membrane including a layer of one of gold, silver, platinum and platinum-iridium;

an osmotic engine within the rigid pump housing, and

a flexible pharmaceutical agent compartment disposed within the rigid pump housing, the flexible pharmaceutical agent compartment being in fluid communication with the opening.

42. An implantable osmotic pump system, comprising:

a rigid pump housing defining an opening;

a plurality of membrane assemblies fitted to the pump housing;

an osmotic engine within the rigid pump housing, and

a flexible pharmaceutical agent compartment disposed within the rigid pump housing, the flexible pharmaceutical agent compartment being in fluid communication with the opening.

43. The osmotic pump system of claim 42, wherein at least one of the plurality of membrane assemblies includes a semipermeable membrane that is fined with an impermeable membrane that initially seals the semipermeable membrane.

44. The osmotic pump system of claim 43, wherein the impermeable membrane being disposed away from the semipermeable membrane to define a fluid tight compartment, the fluid tight compartment enclosing a volume of an aqueous solution.

45. The osmotic pump system of claim 44, the aqueous solution includes a saturated saline solution.