Method and apparatus for treating critical limb ischemia

• US 11,547,583 B2
• Filed: 09/11/2017
• Issued: 01/10/2023
• Est. Priority Date: 09/09/2016
• Status: Active Grant

• Current Assignee: Micro Medical Solutions, Inc.
• Original Assignee: Micro Medical Solutions, Inc.
• Inventors: Sullivan, Gregory
• Primary Examiner(s): Dukert, Brian A
• Assistant Examiner(s): Zimmerman, Rebecca Lynee
• Application Number:
  US15/701,021
• Publication Number:
  US 20180071120A1
• Time in Patent Office: 1,947 Days
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A system and method for treating critical limb ischemia (CLI) including a radiopaque micro stent disposed for cross ankle stenting as well as retrograde pedal/tibial artery access, in conjunction with antegrade access for the recanalization of impaired tibial vessels. A radiopaque medical device is constructed from a tubular-shaped body having a thin wall defining a specific strut pattern. In an additional aspect, the present apparatus introduces a new radiopaque medical device, such as a stent, wherein the tubular body includes a super elastic, nickel-titanium (nitinol) alloy.

Claims

1. A method of treating critical limb ischemia (CLI) comprising the steps of:

utilizing a self-expanding radiopaque stent constructed from a tubular-shaped body having a wall defining a specific strut pattern and configured for usage in procedures below the knee and the ankle strap area, wherein the self-expanding radiopaque stent is configured to expand across the ankle joint from above the ankle to below the ankle;

utilizing a below-the-knee revascularization method to a body of a patient;

entering the body with the self-expanding radiopaque stent through a pedal access point below the knee or at the ankle;

delivering the self-expanding radiopaque stent from the lateral plantar to the distal posterior tibial;

utilizing an ultrasound machine to assist in the delivery of the self-expanding radiopaque stent;

utilizing a continuous medical X-ray image to provide real-time monitoring of the positioning of the self-expanding radiopaque stent;

delivering and seating the self-expanding radiopaque stent via an image from the ultrasound machine;

unblocking tibial artery occlusions;

reutilizing the pedal access point below the knee or at the ankle; and

proceeding antegrade around the ankle or retrograde in below-the-knee area to reach lesions and occlusions on an opposing side of the pedal access point.