Sizing catheters, methods of sizing complex anatomies and methods of selecting a prosthesis for implantation
First Claim
1. A method of selecting a prosthesis for implantation within a lumen of a patient'"'"'s anatomy comprising:
- providing a lumen sizing device comprising;
a handle assembly,a catheter extending from the handle assembly,a distal sizer positioned on the catheter proximal a distal end of the catheter, anda proximal sizer positioned on the catheter and spaced proximally from the distal sizer;
delivering the proximal and distal sizers to a target site within the lumen;
determining a first lumen dimension proximate the distal sizer, determining a second lumen dimension proximate the proximal sizer, and determining a distance between the distal and proximal sizers;
creating a three-dimensional model of the target site of the lumen based on a diameter of the first lumen, a diameter of the second lumen, and the distance between the first and second lumen diameters;
determining a plurality of potential prosthesis deployment positions and axis orientations relative to the three-dimensional model;
conducting a geometric fit analysis by iteratively comparing the geometry of a plurality of differently sized prostheses to the plurality of potential prosthesis deployment positions and axis orientations to identify one or more appropriately sized prostheses based on one or more geometric fit parameters; and
conducting a biomechanical interaction analysis between the one or more appropriately sized prostheses and the patient'"'"'s anatomy to select a prosthesis for implantation.
1 Assignment
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Accused Products
Abstract
Aspects of the disclosure include sizing catheters and methods for determining the size and other physical parameters of an internal orifice or lumen. Embodiments include a sizing catheter assembly having a handle assembly and a catheter assembly including at least one catheter extending from the handle assembly. The catheter assembly also includes at least two sizers, which can be adjustably spaced from each other. Each of the sizers are configured to conform to respective portions of a lumen of a patient'"'"'s anatomy. The sizing catheter is configured such that the sizers are configured to specify or determine first and second dimensions of the lumen and also distance between the sizers. The sizers can include valve leaflets or the sizing catheter can include a temporary valve. Additional aspects include software/methods of assessing and determining an appropriate implantable device that can include assessing the biomechanical interaction between the device and the anatomy.
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Citations
20 Claims
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1. A method of selecting a prosthesis for implantation within a lumen of a patient'"'"'s anatomy comprising:
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providing a lumen sizing device comprising; a handle assembly, a catheter extending from the handle assembly, a distal sizer positioned on the catheter proximal a distal end of the catheter, and a proximal sizer positioned on the catheter and spaced proximally from the distal sizer; delivering the proximal and distal sizers to a target site within the lumen; determining a first lumen dimension proximate the distal sizer, determining a second lumen dimension proximate the proximal sizer, and determining a distance between the distal and proximal sizers; creating a three-dimensional model of the target site of the lumen based on a diameter of the first lumen, a diameter of the second lumen, and the distance between the first and second lumen diameters; determining a plurality of potential prosthesis deployment positions and axis orientations relative to the three-dimensional model; conducting a geometric fit analysis by iteratively comparing the geometry of a plurality of differently sized prostheses to the plurality of potential prosthesis deployment positions and axis orientations to identify one or more appropriately sized prostheses based on one or more geometric fit parameters; and conducting a biomechanical interaction analysis between the one or more appropriately sized prostheses and the patient'"'"'s anatomy to select a prosthesis for implantation. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification