Device for assessing a cardiac valve

• US 8,057,396 B2
• Filed: 05/07/2010
• Issued: 11/15/2011
• 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, Heneveld, Scott, Walsh, Brandon
• Primary Examiner(s): Casler; Brian
• Assistant Examiner(s): KISH, JAMES M
• Application Number:
  US12/776,289
• Publication Number:
  US 20100217119A1
• Time in Patent Office: 557 Days
• Field of Search: 600/437, 600/443, 600/459, 600/462, 600/466, 600/467, 600/470, 600/481, 600/485, 600/498, 623/1.1, 623/1.24, 623/1.26, 623/1.3, 623 21- 242
• US Class Current: 600/466
• 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 for assessing the size, shape, and topography of vessel lumens and hollow portions of organs are described. The devices 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 combination thereof.

Claims

1. A device for assessing a physical parameter of a cardiac valve and surrounding tissue in the body of a patient, comprising:

a flexible catheter shaft having a proximal end and a distal end;

an assessment mechanism carried at or near the distal end of the catheter, said assessment mechanism comprising an expandable member configured to determine at least one physical parameter of the cardiac valve and surrounding tissue in the body of the patient; and

a plurality of markers formed on said expandable member, said markers being indexed to indicate the physical parameter of the cardiac valve and surrounding tissue.

2. The device according to claim 1, wherein said markers are radiopaque and are oriented generally transversely to the longitudinal axis of the expandable member.

3. The device according to claim 1, wherein said markers are radiopaque and are oriented generally axially relative to the longitudinal axis of the expandable member.

4. The device according to claim 1, wherein said markers comprise a plurality of stepped portions formed on the distal-facing portion of the expandable member.

5. A device for assessing a physical parameter of inner surfaces of a vessel lumen, or inner surfaces of a hollow portion of an organ, in the body of a patient, comprising:

a flexible catheter shaft having a proximal end and a distal end;

an assessment mechanism carried at or near the distal end of the catheter, said assessment mechanism comprising an expandable member configured to determine at least one physical parameter of the inner surfaces in the body of the patient; and

a plurality of markers formed on said expandable member, said markers being indexed to indicate the physical parameter of the inner surfaces in the body of the patient.

6. The device according to claim 5, wherein said markers are radiopaque and are oriented generally transversely to the longitudinal axis of the expandable member.

7. The device according to claim 6, wherein said markers are radiopaque and are oriented generally axially relative to the longitudinal axis of the expandable member.

8. The device according to claim 5, wherein said markers comprise a plurality of stepped portions formed on the distal-facing portion of the expandable member.

9. A device for assessing a physical parameter of a cardiac valve and surrounding tissue in the body of a patient, comprising:

a flexible catheter shaft having a proximal end and a distal end;

an assessment mechanism carried at or near the distal end of the catheter, said assessment mechanism comprising an expandable member configured to determine at least one physical parameter of the cardiac valve and surrounding tissue in the body of the patient; and

an alignment mechanism comprising a plurality of alignment wires that are adapted to radially expand upon deployment;

wherein each alignment wire comprises a loop, and wherein each of the loops is adapted to lodge in a sinus located behind an aortic valve leaflet of the body of the patient.

10. A device for assessing a physical parameter of inner surfaces of a vessel lumen, or inner surfaces of a hollow portion of an organ, in the body of a patient, comprising:

a catheter shaft;

a guidewire shaft extending within the catheter shaft;

a guidewire extending within the guidewire shaft;

an inflation lumen extending within the catheter shaft over the guidewire shaft and having an open distal end;

a balloon having a closed distal end attached to the guidewire shaft and an open proximal end at the open distal end of the inflation lumen;

an imaging member shaft extending through the inflation lumen over the guidewire shaft, the imaging member shaft having a distal end portion located within the balloon and being movable independently of the guidewire shaft; and

,

an imaging head mounted on the distal end portion of the imaging member shaft, whereby the imaging head can be advanced, retracted, and rotated within the balloon by sliding and rotating the imaging member shaft relative to the guidewire shaft.

11. An apparatus as defined in claim 10 wherein the imaging head is movable into and out of the balloon by sliding the imaging member shaft over the guidewire shaft.

12. An apparatus as defined in claim 10 further comprising means for connecting the inflation lumen with means for inflating the balloon to expand the inner surfaces in the body of a patient.

13. An apparatus as defined in claim 12 wherein the inflating means comprises means for further inflating the balloon to perform a valvuloplasty procedure at the inner surfaces in the body of a patient.