FUNCTIONAL SIZER FOR A HEART VALVE IMPLANTABLE DEVICE
First Claim
1. A functional sizer for sizing an implantable heart valve device for heart valve repair or replacement, the functional sizer comprising a ring-like body with a central hole, the ring-like body being of a sterilisable material,wherein the ring-like body is one of the following two-dimensional shapes:
- (a) a closed loop;
(b) a penannular shape, andwherein the ring-like body substantially corresponds in inner circumference to a ring of suture threads positioned around a heart valve annulus for securing a heart valve implantable device of a predetermined size, each suture thread of the ring of suture threads having a free endwherein the functional sizer is adapted to be reversibly secured in position against the heart valve annulus, the reversibly secured functional sizer simulating an effect of a heart valve implantable device of a substantially corresponding size and form, thereby facilitating assessment of fit and function of the heart valve implantable device.
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Abstract
A functional sizer and method of sizing that overcome the problems of relying purely on visual assessment of size in selecting an implantable heart valve device (repair implant or a heart valve replacement prosthesis) and of being unable to test the fit and performance of the heart valve implantable device until after it has been stitched in position. The invention provides a functional sizer that is functional and can be reversibly secured in position, largely using the valve sutures under tension, thereby enabling assessment of fit and performance prior to permanently stitching a heart valve prosthesis.
5 Citations
25 Claims
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1. A functional sizer for sizing an implantable heart valve device for heart valve repair or replacement, the functional sizer comprising a ring-like body with a central hole, the ring-like body being of a sterilisable material,
wherein the ring-like body is one of the following two-dimensional shapes: -
(a) a closed loop; (b) a penannular shape, and wherein the ring-like body substantially corresponds in inner circumference to a ring of suture threads positioned around a heart valve annulus for securing a heart valve implantable device of a predetermined size, each suture thread of the ring of suture threads having a free end wherein the functional sizer is adapted to be reversibly secured in position against the heart valve annulus, the reversibly secured functional sizer simulating an effect of a heart valve implantable device of a substantially corresponding size and form, thereby facilitating assessment of fit and function of the heart valve implantable device. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A functional sizer for sizing an implantable heart valve device for heart valve repair or replacement, the functional sizer comprising a ring-like body with a central hole, the ring-like body being of a sterilisable material,
wherein the ring-like body is one of the following two-dimensional shapes: -
(a) a closed loop; (b) a penannular shape, and wherein the ring-like body substantially corresponds in inner circumference to a ring of suture threads positioned around a heart valve annulus for securing a heart valve implantable device of a predetermined size, each suture thread of the ring of suture threads having a free end wherein the functional sizer is adapted to be reversibly secured in position against the heart valve annulus, the reversibly secured functional sizer simulating an effect of a heart valve implantable device of a substantially corresponding size and form, thereby facilitating assessment of fit and function of the heart valve implantable device, and wherein said functional sizer is further adapted to be permanently secured in position on a heart annulus by one of the following; (a) stitching to the heart annulus; (b) retaining the self-clamping mechanism in a closed position; (c) retaining the magnetised cap on the ring-like body of the functional sizer.
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18. A method of sizing a heart valve implantable device including the steps of:
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(a) positioning a functional sizer in a heart, wherein the functional sizer is a ring-like body of sterilisable material of an approximately corresponding size to a heart valve implantable device of a predetermined size; (b) reversibly securing the functional sizer in position. - View Dependent Claims (19)
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20. A method of sizing a heart valve implantable device including the steps of:
- (a) positioning a functional sizer against a heart valve annulus,
wherein the functional sizer comprises a ring-like body with a central hole, the ring-like body being of a sterilisable material, wherein the ring-like body is one of the following two-dimensional shapes; i. a closed loop; ii. a penannular shape, and wherein the ring-like body substantially corresponds in inner circumference to a ring of suture threads positioned around the heart valve annulus for securing a heart valve implantable device of a predetermined size, each suture thread of the ring of suture threads having a free end; (b) drawing the free ends of said suture threads up through the ring-like body from underneath to over the ring-like body; (c) placing the one or more suture threads under tension after drawing the free ends up through and over the ring-like body such that when reversibly secured in position against the heart valve annulus by placing the one or more suture threads under tension, the functional sizer simulates an effect of a heart valve implantable device of a substantially corresponding size, shape and form, thereby facilitating assessment of fit and function of the heart valve implantable device. - View Dependent Claims (21, 22, 23, 24, 25)
- (a) positioning a functional sizer against a heart valve annulus,
Specification