Methods of assessing inner surfaces of body lumens or organs

• US 8,585,594 B2
• Filed: 05/24/2006
• Issued: 11/19/2013
• Est. Priority Date: 05/24/2006
• Status: Expired due to Fees

• Current Assignee: Phoenix Biomedical Corporation
• Original Assignee: Phoenix Biomedical Corporation
• Inventors: Forster, David C., Beckey, Brian, Walsh, Brandon, Heneveld, Scott
• Primary Examiner(s): KISH, JAMES M
• Application Number:
  US11/420,189
• Publication Number:
  US 20080009746A1
• Time in Patent Office: 2,736 Days
• Field of Search: 623/1.1, 623/1.24, 623/1.26, 623/1.3, 623 21- 242, 623901-904, 623/910, 623/913, 600/437, 600/443, 600/459, 600/462, 600/466, 600/467, 600/470, 600/481, 600/485, 600/498
• US Class Current: 600/437
• CPC Class Codes: A61B 5/0536 Impedance imaging, e.g. by tomography
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device
• CPC Class Codes: Y10S 623/902 Method of implanting
• CPC Class Codes: Y10S 623/903 Blood vessel
• CPC Class Codes: Y10S 623/904 Heart
• CPC Class Codes: Y10S 623/91 Heart
• CPC Class Codes: Y10S 623/913 Heart

Abstract

Devices and methods for assessing the size, shape, and topography of vessel lumens and hollow portions of organs are described. The devices and methods are particularly adapted for determining the size, shape, topography, and compliance of the native heart valves to facilitate the later implantation of a prosthetic heart valve. The devices are typically catheter-based having an assessment mechanism fixed to a distal end of the catheter. The assessment mechanism generally includes an expandable member, such as a balloon. The assessment mechanism may also include an imaging member, a physical assessment member, an electronic mapping construction, an alignment mechanism, a valvuloplasty balloon, or any combinations thereof. The methods typically comprise deploying the balloon percutaneously to a target location, expanding the balloon, and determining one or more physical parameters associated with the target location.

Claims

1. A method of assessing inner surfaces of a vessel lumen, or inner surfaces of a hollow portion of an organ, in a body of a patient, the method comprising:

shaping an assessment member into contours of the inner surfaces by pressing the assessment member outward against the inner surfaces;

dilating the inner surfaces by moving the assessment member outward against the inner surfaces;

measuring the outward movement of the assessment member with an imaging device contained within the assessment member;

detecting the shaped contours of the assessment member with the imaging device;

assessing compliance of the inner surfaces based on the measured outward movement of the assessment member; and

assessing the peripheral shape of the dilated inner surfaces based on the detected shaped contours of the assessment member.

2. The method of claim 1 wherein the assessment member is moved outward against the inner surfaces by deflecting the assessment member under pressure applied from within the assessment member.

3. The method of claim 2 wherein the assessment member is moved outward against the inner surface by expanding the assessment member.

4. The method of claim 3 wherein the assessment member is an inflatable balloon and is expanded by introducing an expansion medium into the balloon.

5. A method of assessing a body of a patient at inner surfaces of a vessel lumen, or inner surfaces of a hollow portion of an organ, for placement of an implant in a target area surrounded by the inner surfaces, comprising:

shaping an assessment member into contours of the inner surfaces about the periphery of the target area by pressing the assessment member outward against the inner surfaces;

dilating the target area against resistance of the inner surfaces by moving the assessment member outward against the inner surfaces;

measuring the outward movement of the assessment member and the shaped contours of the assessment member with an imaging device contained within the assessment member;

assessing the resistance of the inner surfaces, the dilation of the target area, and a dilated peripheral shape of the target area based on the measured outward movement of the assessment member and the measured shaped contours of the assessment member.

6. The method of claim 5 further comprising the steps of selecting an implant with reference to the assessed resistance, dilation, and peripheral shape;

removing the assessment member form the target area; and

subsequently placing the selected implant in the target area.

7. The method of claim 5 wherein the assessment member is moved outward against the inner surfaces by deflecting the assessment member under pressure applied from within the assessment member.

8. The method of claim 7 wherein the assessment member is moved outward against the inner surface by expanding the assessment member.

9. The method of claim 8 wherein the assessment member is an inflatable balloon and is expanded by introducing an expansion medium into the balloon.