Reduction of inflammatory mass with spinal catheters

• US 8,137,334 B2
• Filed: 12/23/2003
• Issued: 03/20/2012
• Est. Priority Date: 12/23/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Heruth, Kenneth T., Lent, Mark S.
• Primary Examiner(s): VU, QUYNH-NHU HOANG
• Application Number:
  US10/745,897
• Publication Number:
  US 20040220546A1
• Time in Patent Office: 3,010 Days
• Field of Search: 604/890.1, 604/891.1, 604/500, 604/506, 604/508, 604/512, 604/523, 604/537, 604/93.01, 604/113
• US Class Current: 604/508
• 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 for preventing inflammatory mass formation associated with continuous intrathecal infusion of a first solution comprising a first drug through a first infusion section of a catheter into a patient'"'"'s spinal canal at a first vertebral level, wherein the first drug has a local concentration over time at the first vertebral level in the patient'"'"'s spinal canal, and wherein the first infusion section of the catheter has a first length, the method comprising:

reducing the local concentration of the first drug over time at the first vertebral level in the patient'"'"'s spinal canal relative to the first drug infused continuously through the first infusion section of a catheter intrathecally into a patient'"'"'s spinal canal at the first vertebral level,

wherein reducing the local concentration over time comprises periodically replacing continuous infusion of the first drug with intermittent bolus infusion of the first drug.

2. The method of claim 1, wherein the periodic replacement is automatic.

3. The method of claim 1, wherein reducing the local concentration over time comprises, in addition to replacing continuous infusion of the first drug with intermittent bolus infusion of the first drug, one or more of:

altering the density of a solution comprising the first drug;

replacing the first drug with a second drug;

changing the concentration of the first drug in a solution comprising the first drug; and

changing the vertebral location where the first drug is delivered.

4. A method for preventing inflammatory mass formation associated with continuous intrathecal infusion of a first solution comprising a first drug through a first infusion section of a catheter into a patient'"'"'s spinal canal at a first vertebral level, wherein the first drug has a local concentration over time at the first vertebral level in the patient'"'"'s spinal canal, and wherein the first infusion section of the catheter has a first length, the method comprising,

reducing the local concentration of the first drug over time at the first vertebral level in the patient'"'"'s spinal canal relative to the first drug infused continuously through the first infusion section of a catheter intrathecally into a patient'"'"'s spinal canal at the first vertebral level,

wherein reducing the local concentration over time comprises periodically altering the density of the solution.

5. The method of claim 4, wherein altering the density of the solution comprises replacing the solution with a second solution having a different density.

6. The method of claim 5, wherein replacing the solution comprises refilling a reservoir with the second solution, wherein the reservoir is coupled to the catheter.

7. The method of claim 5, wherein the solution having an initial density is housed in a first reservoir coupled to the catheter, and wherein replacing the solution having an initial density comprises selecting the second solution from a second reservoir coupled to the catheter.

8. The method of claim 4, wherein altering the density of the solution comprises mixing in a drug delivery apparatus solutions with different densities prior to delivery of the mixed solution to the catheter.

9. The method of claim 4, wherein altering the density of the solution having an initial density comprises mixing the solution having an initial density with a solution having a second density.

10. The method of claim 9, wherein the mixing occurs in the catheter prior to delivery of the mixed solution to the spinal canal.

11. The method of claim 4, wherein altering the density of the solution comprises heating the solution prior to delivery of the solution to the spinal canal.

12. The method of claim 11, wherein the heating occurs within the catheter.

13. The method of claim 4, wherein reducing the local concentration over time comprises, in addition to altering the density of a solution comprising the first drug, one or more of:

replacing continuous infusion of the first drug with intermittent bolus infusion of the first drug;

replacing the first drug with a second drug;

changing the concentration of the first drug in a solution comprising the first drug; and

changing the vertebral location where the first drug is delivered.

14. A method for preventing inflammatory mass formation associated with continuous intrathecal infusion of a first solution comprising a first drug through a first infusion section of a catheter into a patient'"'"'s spinal canal at a first vertebral level, wherein the first drug has a local concentration over time at the first vertebral level in the patient'"'"'s spinal canal, and wherein the first infusion section of the catheter has a first length, the method comprising:

reducing the local concentration of the first drug over time at the first vertebral level in the patient'"'"'s spinal canal relative to the first drug infused continuously through the first infusion section of a catheter intrathecally into a patient'"'"'s spinal canal at the first vertebral level,

wherein reducing the local concentration over time comprises periodically replacing the first drug with a second drug.

15. The method of claim 14, wherein the first drug and the second drug are useful for treating the same disease.

16. The method of claim 14, wherein replacing the first drug comprises refilling a reservoir with a solution comprising the second drug, wherein the reservoir is coupled to the catheter.

17. The method of claim 14, wherein the first drug is housed in a first reservoir coupled to the catheter, and wherein replacing the first drug comprises selecting the second drug from a second reservoir coupled to the catheter.

18. The method of claim 14, wherein reducing the local concentration over time comprises, in addition to replacing the first drug with a second drug, one or more of:

replacing continuous infusion of the first drug with intermittent bolus infusion of the first drug;

altering the density of a solution comprising the first drug;

changing the concentration of the first drug in a solution comprising the first drug; and

changing the vertebral location where the first drug is delivered.

19. A method for preventing inflammatory mass formation associated with continuous intrathecal infusion of a first solution comprising a first drug through a first infusion section of a catheter into a patient'"'"'s spinal canal at a first vertebral level wherein the first dru has a local concentration over time at the first vertebral level in the patient'"'"'s spinal canal, and wherein the first infusion section of the catheter has a first length, the method comprising:

reducing the local concentration of the first drug over time at the first vertebral level in the patient'"'"'s spinal canal relative to the first druginfused continuously through the first infusion section of a catheter intrathecally into a patient'"'"'s spinal canal at the first vertebral level,

wherein reducing the local concentration over time comprises periodically changing the concentration of the first drug in a solution comprising the first drug.

20. The method of claim 19, wherein the changing the concentration of the drug comprises replacing the solution comprising the first drug with a second solution comprising the first drug in a second concentration.

21. The method of claim 20, wherein replacing the solution comprises refilling a reservoir with a solution comprising the second drug, wherein the reservoir is coupled to the catheter.

22. The method of claim 20, wherein the solution is housed in a first reservoir coupled to the catheter, and wherein replacing the solution comprises selecting the second solution from a second reservoir coupled to the catheter.

23. The method of claim 19, wherein reducing the local concentration over time comprises, in addition to changing the concentration of the first drug in a solution comprising the first drug, one or more of:

replacing continuous infusion of the first drug with intermittent bolus infusion of the first drug;

altering the density of a solution comprising the first drug;

replacing the first drug with a second drug; and

changing the vertebral location where the first drug is delivered.

24. A method for preventing inflammatory mass formation associated with continuous intrathecal infusion of a first solution comprising a first drug through a first infusion section of a catheter into a patient'"'"'s spinal canal at a first vertebral level, wherein the first drug has a local concentration over time at the first vertebral level in the patient'"'"'s spinal canal, and wherein the first infusion section of the catheter has a first length, the method comprising:

reducing the local concentration of the first drug over time at the first vertebral level in the patient'"'"'s spinal canal relative to the first drug infused continuously through the first infusion section of a catheter intrathecally into a patient'"'"'s spinal canal at the first vertebral level,

wherein reducing the local concentration over time comprises periodically changing the vertebral location where the drug is delivered from the first vertebral location to a second vertebral location.

25. The method of claim 24, wherein the changing the vertebral location comprises delivering the first drug through a second infusion site in the catheter.

26. The method of claim 24, wherein reducing the local concentration over time comprises, in addition to changing the vertebral location where the first drug is delivered, one or more of:

replacing continuous infusion of the first drug with intermittent bolus infusion of the first drug;

altering the density of a solution comprising the first drug;

replacing the first drug with a second drug; and

changing the concentration of the first drug in a solution comprising the first drug.