Devices and methods for low shearing local delivery of therapeutic agents to the wall of a bodily lumen

• US 8,568,354 B2
• Filed: 02/14/2011
• Issued: 10/29/2013
• Est. Priority Date: 02/16/2010
• Status: Expired due to Fees

• Current Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Inventors: Schoenle, Victor Leo, Welty, Ryan D., Jensen, Kristina Tibesar, Piippo Svendsen, Cassandra Ann, McBroom, Jeffrey A.
• Primary Examiner(s): Mehta, Bhisma
• Application Number:
  US13/026,567
• Publication Number:
  US 20120035588A1
• Time in Patent Office: 988 Days
• Field of Search: 604/96.01, 604/100.01, 604/100.02, 604/101.01, 604/101.02, 604/102.01, 604/102.02, 604/103.01, 604/103.02
• US Class Current: 604/101.02
• CPC Class Codes: A61M 2025/0018 having a plug, e.g. an inflatable plug for closing catheter lumens
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• 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 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

The invention relates generally to devices and methods for local delivery of therapeutic agents to the wall of a bodily lumen with minimal shearing damage to the therapeutic agents, more specifically to the wall of a blood vessel following atherectomy. A preferred delivery mechanism comprises a balloon, or double balloon, though any distal catheter design may be used to reduce shear stress and to conserve and/or isolate the therapeutic substance.

Claims

1. A device for loading at least one therapeutic agent into a balloon chamber for application to a patient'"'"'s lumen wall, comprising

an elongated and flexible catheter comprising proximal and distal ends and an inflation lumen and an injection lumen, the injection lumen comprising a proximal region with a diameter and a distal region with a diameter that is less than the diameter of the proximal region;

a substantially concentric pair of balloons disposed on the distal end of the catheter, the substantially concentric pair of balloons comprising an inner balloon having an inner chamber that is in fluid communication with the inflation lumen and an outer balloon comprising pores therethrough and substantially surrounding the inner balloon, the space between the inner balloon and the outer balloon defining a balloon chamber defining the distal region of the injection lumen and having a diameter that is smaller than the diameter of the proximal region of the injection lumen, the balloon chamber in fluid communication with the proximal region of the injection lumen;

an inflation device in operative and fluid communication with the inflation lumen and capable of delivering an inflation medium to the inner chamber of the inner balloon to inflate the inner balloon;

an injection port disposed near the proximal end of the catheter and in fluid communication with the injection lumen and further comprising a tapered section, the injection port allowing injecting access for a therapeutic dose of the at least one therapeutic agent to the injection lumen;

an isolation plug admitted through the injection port after injection of the at least one therapeutic agent, the isolation plug having a diameter that is slightly less than the diameter of the proximal region of the injection lumen and slightly larger than the diameter of the balloon chamber comprising the distal region of the injection lumen, wherein the isolation plug is axially slidable through the injection lumen until reaching the smaller diameter of the balloon chamber at a proximal end of the inner balloon where it is prevented from sliding into the balloon chamber; and

a pressuring means for pressuring the isolation plug to slide axially and distally through the injection lumen to the proximal end of the inner balloon, thereby also pressuring the at least one therapeutic agent through the injection lumen and into the balloon chamber where it is loaded in preparation for inflation of the inner balloon and subsequent extrusion of the at least one therapeutic agent out of the balloon chamber, through the outer balloon pores and into the patient'"'"'s lumen.

2. The device of claim 1, wherein the syringe comprises a saline injection provided by the syringe containing saline.

3. The device of claim 1, wherein the syringe comprises a marked wire in connection with the isolation plug, the wire connected with a plungeable piston and further comprising dosing markings thereon to allow perception and control of the amount of therapeutic agent provided to the balloon chamber, whereby at least one therapeutic dose of the at least one therapeutic agent may be provided to the balloon chamber.

4. The device of claim 1, wherein the isolation plug is formed from a material that is inert and non-reactive with the at least one therapeutic agent.

5. The device of claim 1, wherein the isolation plug comprises a ball shape.