Method and apparatus for improving delivery of an agent to a kidney

• US 9,364,586 B2
• Filed: 06/06/2011
• Issued: 06/14/2016
• Est. Priority Date: 05/31/2007
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Leonard, Michael J, Nguyen, Binh T
• Primary Examiner(s): Bosworth, Kami A
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US13/154,258
• Publication Number:
  US 20110238039A1
• Time in Patent Office: 1,835 Days
• Field of Search: 604/508
• US Class Current: 1/1
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 2300/432 Inhibitors, antagonists A61L2300/402 - A61L2300/43 take precedence
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• 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 2206/20 having means for promoting or enhancing the flow, actively or passively
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

Methods for more uniformly delivering drugs or other treatment agents locally to the vasculature of a mammal are disclosed. These methods use one or more strategies to facilitate rapid mixing with the blood flowing past a device or otherwise improve the uniformity of drug delivery. Some of these strategies employ medical devices with diffusion members.

Claims

1. A method comprising delivering a solution having a concentration of a therapeutic agent to an organ having branched vessels wherein delivering comprises at least one step that improves the therapeutic agent concentration uniformity among the branched vessels, wherein the step that improves the therapeutic agent concentration comprises normalizing a viscosity of the therapeutic agent solution towards that of blood such that a relative standard deviation measurement corresponding to the concentration uniformity of the therapeutic agent among the branched vessels is less than 29 percent.

2. The method of claim 1 wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels further comprises a step of

delivering a delivery catheter comprising a delivery port such that the deployed position of the delivery catheter causes the delivery port to be located downstream enough of any upstream arterial branches not leading to the organ to prevent substantial drug delivery down the upstream arterial branches and upstream enough of the organ to allow substantial mixing of the solution with the blood;

delivering a delivery catheter comprising a delivery port with a geometry that causes increased mixing between the blood and therapeutic agent solution;

delivering a delivery catheter comprising at least one delivery port and at least one diffusion member wherein the diffusion member fosters increased turbulence near or downstream of the delivery port;

decreasing the infusion rate of the therapeutic agent solution;

or

increasing the number of delivery ports.

3. The method of claim 2 wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels comprises a step of delivering a delivery catheter comprising a delivery port with a geometry that causes increased mixing between the blood and therapeutic agent solution.

4. The method of claim 2 wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels comprises a step of delivering a delivery catheter comprising at least one delivery port and at least one diffusion member wherein the diffusion member fosters increased turbulence near or downstream of the delivery port.

5. The method of claim 2 wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels comprises a step of decreasing the infusion rate of the therapeutic agent solution.

6. The method of claim 2 wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels comprises a step of increasing the number of delivery ports.

7. The method of claim 2 wherein improving the therapeutic agent concentration uniformity among the branched vessels means that the range of therapeutic agent concentrations delivered to the vessels is small enough so that the average amount of drug delivered to each vessel falls within a range defined as a 85, 90, 95, 98, or 99 percent confidence interval calculated from a standard deviation of the average amount of drug delivered for the vessel with the highest such standard deviation.

8. The method of claim 2 wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels means that

the range of therapeutic agent concentrations delivered to the vessels is small enough so that the total drug delivery to the vessel that receives the highest concentration falls within a maximum therapeutic dose

while the total drug delivery to the vessel that receives the lowest concentration is 100-300 percent of a minimum therapeutic dose.

9. The method of claim 2 wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels means that

the range of therapeutic agent concentrations delivered to the vessels is small enough so that the total drug delivery to the vessel that receives the lowest concentration exceeds a minimum therapeutic dose

while the total drug delivery to the vessel that receives the highest concentration is 75-175 percent of a maximum therapeutic dose.

10. The method of claim 2 wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels comprises a step of delivering a delivery catheter comprising a delivery port such that the deployed position of the delivery catheter causes the delivery port to be located downstream enough of any upstream arterial branches not leading to the organ to prevent substantial drug delivery down the upstream arterial branches and upstream enough of the organ to allow substantial mixing of the solution with the blood.

11. The method of claim 1 wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels means that

the range of therapeutic agent concentrations delivered to the vessels is small enough so that the total drug delivery to the vessel that receives the lowest concentration exceeds a minimum therapeutic dose

while the total drug delivery to the vessel that receives the highest concentration is 50-200 percent of a maximum therapeutic dose.

12. The method of claim 11 wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels means that

the range of therapeutic agent concentrations delivered to the vessels is small enough so that the total drug delivery to the vessel that receives the lowest concentration exceeds a minimum therapeutic dose

while the total drug delivery to the vessel that receives the highest concentration is 75-175 percent of a maximum therapeutic dose.

13. The method of claim 12 wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels means that

the range of therapeutic agent concentrations delivered to the vessels is small enough so that the total drug delivery to the vessel that receives the lowest concentration exceeds a minimum therapeutic dose

while the total drug delivery to the vessel that receives the highest concentration is 90-150 percent of a maximum therapeutic dose.

14. The method of claim 1 wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels means that

the range of therapeutic agent concentrations delivered to the vessels is small enough so that the total drug delivery to the vessel that receives the highest concentration falls within a maximum therapeutic dose

while the total drug delivery to the vessel that receives the lowest concentration is 100-300 percent of a minimum therapeutic dose.

15. The method of claim 14 wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels means that

the range of therapeutic agent concentrations delivered to the vessels is small enough so that the total drug delivery to the vessel that receives the highest concentration falls within a maximum therapeutic dose

while the total drug delivery to the vessel that receives the lowest concentration is 150-250 percent of a minimum therapeutic dose.

16. The method of claim 15 wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels means that

the range of therapeutic agent concentrations delivered to the vessels is small enough so that the total drug delivery to the vessel that receives the highest concentration falls within a maximum therapeutic dose

while the total drug delivery to the vessel that receives the lowest concentration is 175-225 percent of a minimum therapeutic dose.

17. The method of claim 1 wherein improving the therapeutic agent concentration uniformity among the branched vessels means that the range of therapeutic agent concentrations delivered to the vessels is small enough so that the average amount of drug delivered to each vessel falls within a range defined as a 85, 90, 95, 98, or 99 percent confidence interval calculated from a standard deviation of the average amount of drug delivered for the vessel with the highest such standard deviation.

18. A method comprising delivering a solution having a concentration of a therapeutic agent to an organ having branched vessels wherein delivering comprises at least one step that improves the therapeutic agent concentration uniformity among the branched vessels;

wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels comprises a step of

normalizing the viscosity of a therapeutic agent solution towards that of blood;

delivering a delivery catheter comprising a delivery port such that the deployed position of the delivery catheter causes the delivery port to be located downstream enough of any upstream arterial branches not leading to the organ to prevent substantial drug delivery down the upstream arterial branches and upstream enough of the organ to allow substantial mixing of the solution with the blood;

delivering a delivery catheter comprising a delivery port with a geometry that causes increased mixing between the blood and therapeutic agent solution;

delivering a delivery catheter comprising at least one delivery port and at least one diffusion member wherein the diffusion member fosters increased turbulence near or down-stream of the delivery port;

decreasing the infusion rate of the therapeutic agent solution;

or

increasing the number of delivery ports;

and

wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels means that

the range of therapeutic agent concentrations delivered to the vessels is small enough so that the total drug delivery to the vessel that receives the highest concentration falls within a maximum therapeutic dose

while the total drug delivery to the vessel that receives the lowest concentration is 100-300 percent of a minimum therapeutic dose.

19. A method comprising delivering a solution having a concentration of a therapeutic agent to an organ having branched vessels wherein delivering comprises at least one step that improves the therapeutic agent concentration uniformity among the branched vessels;

wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels comprises a step of

normalizing the viscosity of the therapeutic agent solution towards that of blood;

delivering a delivery catheter comprising a delivery port such that the deployed position of the delivery catheter causes the delivery port to be located downstream enough of any upstream arterial branches not leading to the organ to prevent substantial drug delivery down the upstream arterial branches and upstream enough of the organ to allow substantial mixing of the solution with the blood;

delivering a delivery catheter comprising a delivery port with a geometry that causes increased mixing between the blood and therapeutic agent solution;

delivering a delivery catheter comprising at least one delivery port and at least one diffusion member wherein the diffusion member fosters increased turbulence near or down-stream of the delivery port;

decreasing the infusion rate of the therapeutic agent solution;

or

increasing the number of delivery ports;

and

wherein a step that improves the therapeutic agent concentration uniformity among the branched vessels means that

the range of therapeutic agent concentrations delivered to the vessels is small enough so that the total drug delivery to the vessel that receives the lowest concentration exceeds a minimum therapeutic dose

while the total drug delivery to the vessel that receives the highest concentration is 50-200 percent of a maximum therapeutic dose.

20. A method comprising delivering a solution having a concentration of a therapeutic agent to an organ having branched vessels wherein delivering comprises at least one step that improves the therapeutic agent concentration uniformity among the branched vessels, wherein the step that improves the therapeutic agent concentration uniformity among the branched vessels comprises a step of delivering a delivery catheter comprising a delivery port and a self-expanding diffusion member such that a deployed position of the delivery catheter causes the delivery port to be located downstream enough of any upstream arterial branches not leading to the organ to prevent substantial drug delivery down the upstream arterial branches and upstream enough of the organ to allow substantial mixing of the solution with a turbulent blood flow caused by a flow of the blood through the self-expanding diffusion member prior to delivering the solution to the organ.