METHOD AND APPARATUS FOR DELIVERING AN AGENT TO A KIDNEY

• US 20120203202A1
• Filed: 04/13/2012
• Published: 08/09/2012
• Est. Priority Date: 05/31/2007
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Consigny, Paul M., El-Nounou, Fozan O., Gale, David C., Kramer-Brown, Pamela A.
• Granted Patent: US 9,108,028 B2
• Time in Patent Office: Days
• US Class Current: 604/508
• 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: A61L 2300/40 characterised by a specific therapeutic activity or mode of action
• CPC Class Codes: A61L 2300/432 Inhibitors, antagonists A61L2300/402 - A61L2300/43 take precedence
• CPC Class Codes: A61L 2300/62 Encapsulated active agents, e.g. emulsified droplets
• CPC Class Codes: A61L 2430/26 for kidney reconstruction
• 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 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A method is described including introducing a delivery device to a point within a renal artery or a renal segmental artery and delivering a treatment agent from the delivery device according to conditions that create a turbulent blood flow and wherein the treatment agent is capable of inhibiting a biological process contributing to nephropathy. In other embodiments, an apparatus and kit are described including a delivery device for insertion to a point within a renal artery or renal segmental artery and delivery of a treatment agent capable of inhibiting a biological process contributing to nephropathy.

Claims

1. A method comprising:

introducing a delivery device to a point within a renal artery, the delivery device comprising at least one longitudinally disposed opening defined by a wall of the delivery device; and

delivering a treatment agent from the at least one longitudinally disposed opening in a direction perpendicular to a direction of blood flow to create a turbulent blood flow into the kidney in addition to any turbulent conditions from the presence of the delivery device in the renal artery, wherein said treatment agent is capable of inhibiting a biological process contributing to nephropathy.

2. The method of claim 1, wherein introducing the delivery device to a point comprises advancing the delivery device through an aorta into the renal artery.

3. The method of claim 1, wherein introducing the delivery device to a point comprises advancing the delivery device through a region of a retroperitoneal cavity surrounding the kidney into a region of a renal cortex adjacent to glomerular capillaries within the kidney.

4. The method of claim 1, wherein the treatment site is in one of a glomerular capillary or a renal cortex.

5. The method of claim 1, wherein conditions creating a turbulent blood flow comprise flowing blood through a first lumen and a second lumen wherein the second lumen has a diameter less than that of the first lumen.

6. The method of claim 1, wherein the conditions creating a turbulent blood flow comprise modifying a flow of blood through a lumen by injecting an amount of blood through the lumen.

7. The method of claim 1, wherein delivering the treatment agent further comprises delivering the treatment agent according to conditions that prevent back flow of the treatment agent into an aorta.

8. The method of claim 7, wherein conditions that prevent back flow comprise expanding one of a balloon or a sheath of the delivery device in a region of a lumen of the artery between the treatment site and a distal end of the delivery device before delivering the treatment agent to the treatment site.

9. The method of claim 7, wherein conditions that prevent back flow comprise releasing the treatment agent from a delivery port of the delivery device into a vessel lumen at a flow rate which is less than a natural flow rate of the vessel.

10. The method of claim 1, wherein the delivery device comprises a primary cannula having dimensions suitable for insertion into one of a renal artery or a renal segmental artery, wherein the primary cannula comprises a first end, a second end and a medial region along a length of the primary cannula between the first end and the second end, an aperture through a wall of the primary cannula at a region within the medial region, and the first end having a first port and a second port, wherein the first port is in fluid communication with the aperture and the second port is adapted for advancing a guidewire there through.

11. The method of claim 1, wherein the delivery device comprises a balloon expandable intralumenal framework comprising a first end and a second end defining a length dimension less than a length of a renal artery, the framework comprising axially-oriented anchor portions along the length dimension capable of anchoring to the renal artery, and a primary cannula wherein the anchor portions are wound around a distal end of the primary cannula such that a spacing between the windings and the primary cannula alters a speed of the blood flow to provide a turbulent blood flow.

12. The method of claim 1, wherein the delivery device comprises a guidewire cannula having dimensions suitable for insertion into a renal artery, a dilatable balloon assembly coupled to the guidewire cannula comprising a balloon having a proximal wall, wherein the proximal wall consists of pores along only a region of the proximal wall defined by a diameter of a lumen of the renal artery, and a delivery cannula having an end within the balloon for dilating the balloon assembly.

13. The method of claim 1, wherein the delivery device comprises a primary cannula having a first end, a second end and a medial portion along a length of the primary cannula between the first end and the second end, the at least one longitudinally disposed opening is formed through the wall of the primary cannula defining the first end.

14. The method of claim 1, wherein delivering includes release of the treatment agent over time.

15. The method of claim 1, wherein the treatment agent comprises a vasoactive agent to increase endothelial porosity and enhance uptake of the treatment agent into tissue.

16. The method of claim 1, wherein the treatment agent is encapsulated within a carrier selected from one of a nanoparticle, a microparticle and a liposome.

17. The method of claim 16, wherein a surface of the carrier comprises a property to enhance binding of the carrier to the treatment site.

18. The method of claim 16, wherein a diameter of the carrier is between 8 microns and 15 microns.

19. The method of claim 16, wherein a diameter of the carrier is between 1 micron and 2 microns.

20. The method of claim 1, wherein the delivery device comprises a balloon and a condition that creates turbulent blood flow comprises expanding the balloon to a diameter that partially occludes the renal artery.