OSMOTIC PUMP APPARATUS AND ASSOCIATED METHODS

• US 20110184389A1
• Filed: 03/31/2011
• Published: 07/28/2011
• Est. Priority Date: 11/01/2006
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gordon, John Howard, Joshi, Ashok V., Van Antwerp, William P., Grovender, Eric A., Bhavaraju, Sai
• Application Number:
  US13/077,655
• Publication Number:
  US 20110184389A1
• Time in Patent Office: Days
• US Class Current: 604/891.1
• 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
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2039/242 designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

Apparatuses and methods for pumping fluids such as fluid medications are disclosed. Embodiments of the invention provide an osmotic pump fluid delivery apparatus including elements designed to control the fluid delivery rate. Typical embodiments of the invention include an arrangement of elements such as solute reservoirs that can manipulate the solute concentrations within an inner osmotic compartment or compartments of an osmotic pump so as to control fluid delivery from the pump. Other embodiments include sealed electro-osmotic pumps that do not discharge ions into the surroundings or require water from an external source. These embodiments of the invention provide new ways to control fluid delivery in apparatuses that employ osmotic processes to function.

Claims

1. A fluid delivery apparatus comprising:

a first osmotic compartment coupled to a stationary semi-permeable membrane, wherein;

the stationary semi-permeable membrane permits fluid migration across the membrane and into the first osmotic compartment; and

the first osmotic compartment is adapted to initially include a chemical composition that functions to alter osmotic pressure within the first osmotic compartment upon fluid migration across the stationary semi-permeable membrane;

a second osmotic compartment coupled to a portion of the stationary semi-permeable membrane, wherein the second osmotic compartment contains a fluid capable of migrating from the second osmotic compartment across the stationary semi-permeable membrane into the first osmotic compartment;

a displaceable barrier member coupled to the first osmotic compartment, wherein the displaceable barrier member is displaced in response to alterations in osmotic pressure within the first osmotic compartment;

a medication reservoir including a fluid outlet for delivering a fluid medication from the medication reservoir, wherein the medication reservoir is coupled to the displaceable barrier member such that a fluid medication is delivered from the medication reservoir through the fluid outlet upon displacement of the displaceable barrier member;

a solute reservoir including a fluid conduit that is capable of delivering a solute fluid from the solute reservoir into the first osmotic compartment, wherein delivery of the solute fluid into the first osmotic compartment functions to alter osmotic pressure within the first osmotic compartment;

a solute delivery system that delivers the solute fluid from the solute reservoir into the first osmotic compartment; and

a solute delivery controller that controls delivery of the solute fluid from the solute reservoir into the first osmotic compartment.

2. The fluid delivery apparatus of claim 1, wherein the apparatus is implantable within an individual.

3. The fluid delivery apparatus of claim 2, wherein the stationary semi-permeable membrane is exposed to a body fluid of the individual and the apparatus uses water in a body fluid of the individual to modulate osmotic pressure within the apparatus as the water migrates across the stationary semi-permeable membrane into the first osmotic compartment.

4. The fluid delivery apparatus of claim 1, wherein a portion of the stationary semi-permeable membrane is disposed on the apparatus to be exposed to a fluid in an external environment, such that the fluid in the external environment can migrate across the stationary semi-permeable membrane into the first osmotic compartment.

5. The fluid delivery apparatus of claim 1, wherein the medication reservoir contains a fluid medication selected from the group consisting of an antibiotic agent, an antiviral agent, a chemotherapeutic agent, an anti-inflammatory agent, or combinations thereof.

6. The fluid delivery apparatus of claim 1, further comprising a second displaceable barrier member coupled to the second osmotic compartment.

7. The fluid delivery apparatus of claim 1, wherein the first osmotic compartment includes a first electrode and the second osmotic compartment includes a second electrode so as to form an electrochemical cell,

wherein the first and second osmotic compartments include a fluid electrolyte in communication with the first and second electrodes and further wherein the first and second electrodes are coupled to a controller that controls an electrical signal sent to or received from the first or second electrodes.

8. The fluid delivery apparatus of claim 1, wherein the solute reservoir further includes a fluid conduit capable of delivering a solute fluid from the solute reservoir into the second osmotic compartment, wherein delivery of the solute fluid into the second osmotic compartment modulates the osmotic pressure within the first osmotic compartment, the second osmotic compartment or the first osmotic compartment and the second osmotic compartment.

9. The fluid delivery apparatus of claim 8, wherein fluid conduit capable of delivering a solute fluid from the solute reservoir into the second osmotic compartment and/or the fluid conduit capable of delivering a solute fluid from the solute reservoir into the first osmotic compartment comprises a valve to direct or meter fluid flow.

10. The fluid delivery apparatus of claim 1, wherein the first osmotic compartment, the second osmotic compartment or the first osmotic compartment and the second osmotic compartment comprise a fluid bleed member that can modulate the fluid volume in the first osmotic compartment, the second osmotic compartment or the first osmotic compartment and the second osmotic compartment.

11. The fluid delivery apparatus of claim 10, wherein a fluid bleed member comprises a valve to direct or meter fluid flow.

12. The fluid delivery apparatus of claim 2, wherein the apparatus uses body fluids within the individual as a water supply that functions to modulate osmotic pressure within the apparatus.

13. The fluid delivery apparatus of claim 2, wherein operation of the apparatus produces ions that are released into the body of the individual.

14. The fluid delivery apparatus of claim 2, wherein operation of the apparatus produces ions that are released into a moveable or deformable trap member so that the ions are not released into the body of the individual.

15. The fluid delivery apparatus of claim 14, wherein the moveable or deformable trap member is coupled to the medication reservoir such that fluid medication is delivered from the medication reservoir through the fluid outlet upon displacement of the moveable or deformable trap member.

16. The fluid delivery apparatus of claim 14, wherein the moveable or deformable trap member comprises a piston, a bellows, a bladder, a diaphragm, a plunger or a balloon or combinations thereof.

17. The fluid delivery apparatus of claim 7, wherein the first osmotic compartment or the second osmotic compartment comprises a chemical reagent which expands upon a chemical and/or electrochemical reaction.

18. A method of modulating fluid medication delivery from a medication reservoir within a fluid medication delivery apparatus, wherein the apparatus comprises:

a first osmotic compartment coupled to a stationary semi-permeable membrane, wherein;

the stationary semi-permeable membrane permits fluid migration across the membrane and into the first osmotic compartment; and

the first osmotic compartment is adapted to initially include a chemical composition that functions to alter osmotic pressure within the first osmotic compartment upon fluid migration across the stationary semi-permeable membrane;

a second osmotic compartment coupled to a portion of the stationary semi-permeable membrane, wherein the second osmotic compartment contains a fluid capable of migrating from the second osmotic compartment across the stationary semi-permeable membrane into the first osmotic compartment;

a displaceable barrier member coupled to the first osmotic compartment, wherein the displaceable barrier member is displaced in response to alterations in osmotic pressure within the first osmotic compartment;

a medication reservoir including a fluid outlet for delivering a fluid medication from the medication reservoir, wherein the medication reservoir is coupled to the displaceable barrier member such that fluid medication is delivered from the medication reservoir through the fluid outlet upon displacement of the displaceable barrier member;

a solute reservoir including a fluid conduit that is capable of delivering a solute fluid from the solute reservoir into the first osmotic compartment, wherein delivery of the solute fluid into the first osmotic compartment functions to alter osmotic pressure within the first osmotic compartment;

a fluid delivery system that delivers the solute fluid from the solute reservoir into the first osmotic compartment; and

a solute delivery controller that controls delivery of the solute fluid from the solute reservoir into the first osmotic compartment;

the method comprising;

delivering an amount of the solute fluid from the solute reservoir into the first osmotic compartment, wherein the amount of fluid delivered from the solute reservoir into the first osmotic compartment is sufficient to alter the osmotic pressure within the first osmotic compartment so as to displace the displaceable barrier member and modulate delivery of the fluid medication from the medication reservoir through the fluid outlet.

19. The method of claim 18, wherein the amount of the solute fluid delivered from the solute reservoir into the first osmotic compartment is sufficient to produce an oscillating fluid delivery profile.

20. The method of claim 18, wherein the apparatus further comprises a fluid medication disposed in the medication reservoir and the amount of the solute fluid delivered from the solute reservoir into the first osmotic compartment is sufficient to produce a fluid medication delivery profile comprising a first amount of fluid medication delivered within hours 1-10 after initiating fluid delivery and a second amount of fluid medication delivered within hours 11-20 after initiating fluid delivery, wherein the first amount of fluid medication delivered within hours 1-10 is at least 2, 3, 4, 5, 7, 8 or 9 times the second amount of fluid medication delivered within hours 11-20.