# US 6,464,688 B1 · Osmotic pump delivery system with flexible drug compartment > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 6,464,688 B1 - Document ID: US6464688B1 - Status: Granted - Kind: B1 - Application number: 09/504,971 - Filed: 2000-02-15 - Granted: 2002-10-15 - Earliest claimed: 2000-02-15 - Assignees: MicroSolutions, Inc. - Inventors: Derek J. Harper; Charles F. Milo - Web page: https://patentgrep.com/patent/US6464688B1 ## CPC - A61M 5/14276: {specially adapted for implantation} - A61K 9/0004: {Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas} - A61M 5/1483: {using flexible bags externally pressurised by fluid pressure} - A61M 2005/14513: {with secondary fluid driving or regulating the infusion} - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## 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 ### Claim 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. ### Claim 2 (depends on 1) The pump system of claim 1, wherein each of the plurality of membrane assemblies includes a semipermeable membrane. ### Claim 3 (depends on 1) The pump system of claim 1, wherein the impermeable membrane is disposed away from the semipermeable membrane to define a fluid tight compartment therewith. ### Claim 4 (depends on 3) The pump system of claim 3, wherein the fluid tight compartment encloses a volume of saturated saline solution. ### Claim 5 (depends on 1) The pump system of claim 1, wherein the impermeable membrane includes a biologically inert material that is impermeable to water. ### Claim 6 (depends on 5) The pump system of claim 5, wherein the biologically inert material is radiopaque. ### Claim 7 (depends on 1) 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. ### Claim 8 (depends on 1) The pump system of claim 1, wherein the impermeable membrane includes a layer of one of gold, silver, platinum and platinum-iridium. ### Claim 9 (depends on 1) The pump system of claim 1, wherein the osmotic engine is a hygroscopic salt. ### Claim 10 (depends on 1) The pump system of claim 1, wherein the osmotic engine includes an absorbent polymer. ### Claim 11 (depends on 10) 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. ### Claim 12 (depends on 1) 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. ### Claim 13 (depends on 1) The pump system of claim 1, wherein the pharmaceutical agent includes an opioid. ### Claim 14 (depends on 1) 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. ### Claim 15 (depends on 1) 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. ### Claim 16 (depends on 1) 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. ### Claim 17 (depends on 16) The pump system of claim 16, wherein the pharmaceutical agent compartment includes a metallic layer. ### Claim 18 (depends on 17) The pump system of claim 17, wherein the metallic layer includes at least one of aluminum, platinum, gold and silver. ### Claim 19 (depends on 1) 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. ### Claim 20 (depends on 19) 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. ### Claim 21 (depends on 1) The pump system of claim 1, wherein the pump housing has a non-cylindrical shape. ### Claim 22 (depends on 1) The pump system of claim 1, wherein the pump housing has a shape that conforms to a patient anatomy at an implantation site. ### Claim 23 (depends on 1) 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. ### Claim 24 (depends on 1) 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. ### Claim 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. ### Claim 26 (depends on 25) 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. ### Claim 27 (depends on 25) 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. ### Claim 28 (depends on 25) 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. ### Claim 29 (depends on 25) 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. ### Claim 30 (depends on 29) The osmotic pump of claim 29, wherein the impermeable membrane is radiopaque. ### Claim 31 (depends on 25) The osmotic pump of claim 25, wherein the osmotic engine is at least co-extensive with the flexible pharmaceutical agent compartment. ### Claim 32 (depends on 25) The osmotic pump of claim 25, wherein the pump housing is cylindrical. ### Claim 33 (depends on 32) 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. ### Claim 34 (depends on 25) The osmotic pump of claim 25, wherein the pump housing has a non-cylindrical shape. ### Claim 35 (depends on 25) 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. ### Claim 36 (depends on 25) The osmotic pump of claim 25, wherein the pharmaceutical agent includes an opioid. ### Claim 37 (depends on 25) 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. ### Claim 38 (depends on 25) 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. ### Claim 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. ### Claim 40 (depends on 39) The pump system of claim 39, wherein the aqueous solution includes a saturated saline solution. ### Claim 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. ### Claim 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. ### Claim 43 (depends on 42) 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. ### Claim 44 (depends on 43) 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. ### Claim 45 (depends on 44) The osmotic pump system of claim 44, the aqueous solution includes a saturated saline solution.