Ellipticity measuring device

• US 9,498,151 B2
• Filed: 11/12/2015
• Issued: 11/22/2016
• Est. Priority Date: 02/13/2012
• Status: Active Grant

• Current Assignee: InterValve Medical, Inc.
• Original Assignee: InterValve, Inc. (Venus Medtech (Hangzhou), Inc.)
• Inventors: Drasler, William J., Ungs, Mark
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US14/939,206
• Publication Number:
  US 20160066819A1
• Time in Patent Office: 376 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/485 involving fluorescence X-ray imaging
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties with different compartments A61M2025/1072
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• 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
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A balloon catheter is used for dilating tubular members of the body such as dilating stenotic aortic valve leaflets found in the aortic root, and measuring the shape and dimensions of the annulus. The balloon has two larger diameter bulbous regions; one is positioned in the left ventricular outflow tract (LVOT) and the other in the aortic sinus; a smaller diameter waist region is positioned across the aortic annulus. During inflation of the balloon, the balloon waist expands in diameter until it comes into contact with the aortic annulus. The balloon pressure and inflation volume is monitored during inflation so that an inflection point in the dP/dV curve is seen at the point of contact of the waist with the annulus. Radiopaque rings and/or marker bands in the device allow the size and orientation of the elliptical annulus to be calculated.

Claims

1. A catheter for determining the size and shape of a tubular member of the body, said catheter comprising:

a balloon having a first semi-compliant region and a second region;

said first semi-compliant region having a first span of radiopaque markers comprising a variably-spaced ring of radiopaque markers;

said second region having a second span of radiopaque markers expanding to a predetermined size;

said second region having a larger diameter than said first region during inflation of said balloon;

wherein said first span of radiopaque markers changes spacing relative to each other and said second span of radiopaque markers maintain spacing relative to each other so as to allow size and shape determinations of the tubular member of the body.

3. The catheter of claim 1 wherein said second span of radiopaque markers have a predetermined, fixed spacing from which a major and minor diameter of said variable ring can be determined.

4. The catheter of claim 3 wherein said second region is a non-compliant region of said balloon and said second span of radiopaque markers is a ring having said predetermined size.

2. A catheter for determining the size and shape of a tubular member of the body, said catheter comprising:

an elongated member;

a balloon disposed at a distal end of said elongated member;

said balloon having a first region comprising semi-compliant material and a second region comprising non-compliant material;

said first region located adjacent to said second region;

a first ring of radiopaque markers located around said first region;

said first ring of radiopaque markers comprising a first plurality of radiopaque deposits that increase in distance from each other along said first region during inflation of said balloon;

a fixed span of radiopaque markers located along said elongated member;

wherein comparison of said fixed span of radiopaque markers with said first ring of radiopaque markers allow size and shape determinations for the tubular member of the body.

5. The catheter of claim 2 wherein said fixed span of radiopaque markers have a predetermined, fixed spacing from which a major and minor diameter of said first ring of radiopaque markers can be determined.

6. The catheter of claim 5 wherein said fixed span of radiopaque markers is a linear fixed span having a predetermined size.