Trailing system for evaluation of the efficacy of the treatment

• US 20040220543A1
• Filed: 12/23/2003
• Published: 11/04/2004
• Est. Priority Date: 12/23/2002
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Heruth, Kenneth T., Lent, Mark S., Blanco, Justin A.
• Application Number:
  US10/745,719
• Publication Number:
  US 20040220543A1
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2025/0007 Epidural catheters
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow general flow characteristics A61M2206/10
• CPC Class Codes: A61M 2202/0464 Cerebrospinal fluid
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407

Abstract

Devices, systems and methods for delivering one or more drugs to one or more internal body locations (such as the cerebrospinal fluid) are disclosed. In various aspects, the systems and methods may involve catheters having infusion sections with permeable membranes that develop significant back pressure to enhance uniform delivery of the drug over an infusion section; catheters that have two or more infusion sections spaced apart along the length of the same catheter, catheters that include two or more infusion sections serviced by independent lumens (such that, e.g., different drug solutions can be delivered to the different infusion sections); implantable drug delivery systems with pumps and multiple reservoirs from which drugs can be delivered; systems that are capable of delivering drug solutions with selected densities; etc. Methods for treating diseases, including pain and spasticity are also discussed, as well as methods for screening patients and optimizing therapies. In addition, methods for delivering a drug to a brain through a spinal canal are described.

Claims

1. A method of optimizing treatment parameters, the method comprising:

intrathecally administering to a spinal location a therapeutic composition comprising a drug, wherein the therapeutic composition is delivered at a rate and has a baricity and a hydrophobicity; and

altering one or more parameter associated with the administration of the therapeutic composition; and

determining whether altering the parameter enhanced efficacy of the therapeutic composition.

2. The method of claim 1, wherein altering one or more parameter comprises altering the baricity of the therapeutic composition.

3. The method of claim 2, wherein a plurality of therapeutic compositions having predetermined baricities are administered.

4. The method of claim 1, wherein altering one or more parameter comprises altering the hydrophobicity of the therapeutic composition.

5. The method of claim 1, wherein altering one or more parameter comprises altering the drug.

6. The method of claim 5, wherein altering the drug comprises replacing the drug with a salt, polymorph, or hydrate of the drug.

7. The method of claim 5, wherein altering the drug comprises replacing the drug with a different drug.

8. The method of claim 5, wherein altering the drug comprises altering the concentration of the drug in the therapeutic composition.

9. The method of claim 1, wherein altering one or more parameter comprises altering the flow rate.

10. The method of claim 9, wherein the flow rate is changed from continuous infusion to intermittent bolus infusion or from intermittent bolus infusion to continuous infusion.

11. The method of claim 1, wherein altering one or more parameter comprises altering the location.

12. The method of claim 11, wherein the therapeutic composition is initially administered through a catheter at a first infusion site, and wherein the location is altered by administering the therapeutic composition at a second infusion site of the catheter.

13. The method of claim 12, wherein the first and second infusion site are at the same vertebral level, and wherein the second infusion site is covered by a permeable membrane.

14. The method of claim 13, wherein the first infusion site is in fluid communication with a first lumen of the catheter and the second infusion site is in fluid communication with a second lumen of the catheter, and wherein the location is altered by switching delivery of the therapeutic composition from the first lumen to the second lumen.

15. The method of claim 12, wherein the first infusion site is located on the catheter at an axial distance of 20 mm or more from the second infusion site.

16. The method of claim 1, wherein altering one or more parameter comprises altering one or more parameters selected from the group consisting of:

the baricity of the therapeutic composition, the hydrophobicity of the therapeutic composition, the drug, the flow rate, the location, and the presence of a permeable membrane.