Non-invasive method for direct delivery of therapeutics to the spinal cord in the treatment of spinal cord pathology

• US 10,285,935 B2
• Filed: 12/20/2016
• Issued: 05/14/2019
• Est. Priority Date: 12/22/2015
• Status: Active Grant

• Current Assignee: University of South Florida (State University System of Florida)
• Original Assignee: US Department of Veterans Affairs (Government of the United States of America), University of South Florida (State University System of Florida)
• Inventors: Garbuzova-Davis, Svitlana, Borlongan, Cesario Venturina, van Loveren, Harry Ronald, Nelson, Peter Richard
• Primary Examiner(s): Osinski, Bradley J
• Assistant Examiner(s): Shah, Nilay J
• Application Number:
  US15/384,808
• Publication Number:
  US 20170173307A1
• Time in Patent Office: 875 Days
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0085 Brain, e.g. brain implants; Spinal cord
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

Most spinal cord therapies are administered systemically, with only a small portion of the therapeutic reaching the spinal cord. A novel method for delivering therapeutics directly to the spinal cord is provided. The method uses a dual balloon catheter to isolate the microvasculature around a region of the spinal cord. Once isolated, one or more therapeutics are delivered directly to the spinal cord blood supply. This allows for smaller, safer therapeutic dose to be utilized.

Claims

1. A method for treating a neurological disorder characterized by spinal cord pathology in a patient in need thereof comprising:

advancing a catheter into a spinal cord artery, wherein the catheter comprises a plurality of balloons disposed on a catheter shaft, at least one injection port disposed on the catheter shaft and between the plurality of balloons;

guiding the catheter to a point distal to segmental spinal arteries so that at least one of the plurality of balloons is positioned distal to the segmental spinal arteries and at least another of the plurality of balloons is positioned proximal to the segmental spinal arteries;

inflating the plurality of balloons to isolate a discrete region of a spinal cord to treat neurons affected by the neurological disorder;

administering a therapeutically effective amount of a composition through the at least one injection port to the patient in need thereof, wherein the composition is a motor neuron therapeutic;

allowing the composition to contact the affected neurons;

deflating the plurality of balloons; and

withdrawing the catheter;

wherein the neurological disorder is selected from the group consisting of Amyotrophic Lateral Sclerosis (ALS), traumatic injury of the spinal cord, spinal cord stroke and perioperative spinal cord ischemia.

2. The method of claim 1, wherein the segmental spinal arteries are selected from the group consisting of cervical, thoracic and lumbar segmental spinal arteries.

3. The method of claim 2, wherein the plurality of balloons comprises two balloons that are disposed on the catheter shaft.

4. The method of claim 1, wherein the motor neuron therapeutic administered is stem cells.