Ellipticity measuring device

• US 9,186,094 B2
• Filed: 03/24/2015
• Issued: 11/17/2015
• 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:
  US14/667,555
• Publication Number:
  US 20150196230A1
• Time in Patent Office: 238 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 method for determining an axial alignment of an axis of an elongated member of a catheter relative to an axis of a tubular member of the body, said method comprising:

providing a balloon disposed at a distal end of said elongated member, said balloon having a first semi-compliant region,

said first semi-compliant region having a first span of radiopaque markers comprising a variable ring of radiopaque markers,

inflating said balloon to place said variable ring immediately adjacent with the tubular member of the body,

measuring major and minor diameters of said variable ring via an imaging camera, so as to determine said axial alignment of said axis of said elongated member relative to said axis of the tubular member, said major diameter extending between the furthest portions of said variable ring and said minor diameter extending between the closest portions of said variable ring.

2. The method of claim 1 wherein a spacing between individual radiopaque markers of said variable ring is used to determine said major and minor diameters of said variable ring.

3. The method of claim 1 wherein said elongated member further comprises a second region having a second span of radiopaque markers having a predetermined size,

measuring said predetermined size of said second span of radiopaque markers via an imaging camera to determine the ovality of said variable ring.

4. The method of claim 3 wherein a spacing between individual radiopaque markers of said second region is used to determine said major and minor diameters of said variable ring.

5. The method of claim 2 wherein said second region is located on a noncompliant region of said balloon and said second span is a fixed ring having said predetermined size.

6. The method of claim 2 wherein said second region is located on a central shaft of said elongated member and said second span is a linear fixed span having said predetermined size.

7. A method for determining an axial alignment and ovality of a tubular member of the body, said method comprising:

providing a balloon disposed at a distal end of an elongated member, said balloon having a first semi-compliant region,

said elongated member further comprising a second region located at said distal end of said elongated member,

said first semi-compliant region having a first span of radiopaque markers comprising a variable ring of radiopaque markers,

said second region having a second span of radiopaque markers having a predetermined size,

inflating said balloon to place said variable ring adjacent with the tubular member of the body,

measuring major and minor diameters of said variable ring via an imaging camera, so as to determine the axial alignment of an axis of said elongated member with an axis of the tubular member;

said major diameter extending between furthest portions of said variable ring and said minor diameter extending between closest portions of said variable ring,

measuring said predetermined size to determine the ovality of said variable ring.