IP Library Granted Patent US 12673191
Granted Patent B2
US 12673191 · App. 18/541,489 · Granted Jul 7, 2026

Removable volume indicator for syringe

Inventors: Ilan Tamir (Irvine, CA); Michael R. Bialas (Lake Forest, CA)
Assignee: Edwards Lifesciences Corporation
A61M25/10188A61F2/2433A61M25/10182A61M2205/3379
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Quick Facts
Patent No.
US 12673191
App. No.
18/541,489
Granted
Jul 7, 2026
Kind
B2
Abstract

A volume indicator for a syringe can include an indicator body configured to removably clip onto a syringe body and a window portion extending through a thickness of the indicator body. The volume indicator can include inflation indicia corresponding to a range of expanded diameters for a prosthetic heart valve. The volume indicator can include one or more first engagement elements that correspond to one or more second engagement elements on a syringe.

Claims (35)

1 . A method comprising:

placing a volume indicator on a syringe comprising a syringe body by seating an engagement element on the syringe body within a corresponding engagement element that extends from an inner surface of the volume indicator laterally outwardly into a wall of the volume indicator, the syringe comprising the syringe body and a plunger received in the syringe body and the volume indicator comprising an indicator body and volume indicia on the indicator body, wherein the engagement element on the syringe body comprises a protrusion extending from a surface of the syringe body;

filling the syringe body with an amount of fluid corresponding to one of the volume indicia on the indicator body; and

fluidly connecting the syringe to a delivery apparatus for a prosthetic valve.

2 . The method of claim 1 , wherein the engagement element on the syringe body is a first engagement element and the corresponding engagement element on the volume indicator is a first corresponding engagement element, and wherein the act of placing the volume indicator on the syringe comprises further engaging a second engagement element on the syringe body with a second corresponding engagement element on the indicator body.

3 . The method of claim 1 , further comprising inserting into a body of a patient a distal end portion of the delivery apparatus and a prosthetic heart valve mounted in a radially compressed configuration on a balloon mounted on the distal end portion of the delivery apparatus.

4 . The method of claim 3 , further comprising:

advancing the distal end portion of the delivery apparatus and the radially compressed prosthetic valve through the patient's vasculature to position the prosthetic valve at a selected implantation area; and

actuating the plunger of the syringe to inject the fluid into the balloon, thereby inflating the balloon and radially expanding the prosthetic heart valve.

5 . The method of claim 3 , wherein the prosthetic heart valve can be expanded to an expanded functional diameter within a range of expanded diameters, and wherein the act of filling the syringe body comprises selecting a fill volume needed to expand the prosthetic heart valve to a selected expanded diameter within the range of expanded diameters.

6 . The method of claim 1 , wherein the volume indicia on the indicator body are not aligned with volume indicia on the syringe body when the volume indicator is placed on the syringe.

7 . The method of claim 1 , wherein the volume indicator is selected from a kit of volume indicators.

8 . The method of claim 7 , wherein each volume indicator in the kit corresponds to a different nominal valve size.

9 . The method claim 7 , wherein the volume indicator is a first volume indicator corresponding to a prosthetic heart valve having a nominal size of 20 mm, and wherein the kit further comprises a second volume indicator corresponding to a prosthetic heart valve having a nominal size of 23 mm, a third volume indicator corresponding to a prosthetic heart valve having a nominal size of 26 mm, and a fourth volume indicator corresponding to a prosthetic heart valve having a nominal size of 29 mm.

10 . The method of claim 1 wherein the volume indicator comprises a window portion extending through a thickness of the indicator body such that a portion of the syringe plunger in the syringe body is visible through the window portion.

11 . The method of claim 10 wherein the volume indicator further comprises inflation indicia adjacent the window portion.

12 . The method of claim 10 , wherein the volume indicator further comprises inflation indicia comprising protrusions extending at least partially across the window portion.

13 . The method of claim 1 , wherein the corresponding engagement element on the volume indicator is an opening that extends from an inner surface of the volume indicator laterally into a thickness of the wall of the volume indicator and wherein the engagement element on the syringe body is a projection that extends laterally from a surface of the syringe body, the projection having a circular shape in cross-section.

14 . A method for using a volume indicator with a syringe for inflating a balloon to expand a prosthetic heart valve, the method comprising:

placing a volume indicator on a syringe by engaging first and second engagement elements of a syringe body with first and second corresponding engagement elements of the volume indicator, the syringe comprising a syringe body and a plunger received in the syringe body and the volume indicator comprising an indicator body and volume indicia on the indicator body, wherein the first corresponding engagement element is disposed at a first end portion of the indicator body and wherein the second corresponding engagement element is disposed at a second end portion of the indicator body;

filling the syringe body with an amount of fluid corresponding to one of the volume indicia on the indicator body; and

fluidly connecting the syringe to a delivery apparatus for a prosthetic valve.

15 . The method of claim 14 , wherein the first and second engagement elements of the syringe body are protrusions extending from a surface of the syringe body and wherein the first and second corresponding engagement elements are openings extending into the thickness of the indicator body.

16 . The method of claim 14 , further comprising inserting into a body of a patient a distal end portion of the delivery apparatus and a prosthetic heart valve mounted in a radially compressed configuration on a balloon mounted on the distal end portion of the delivery apparatus.

17 . The method of claim 16 , further comprising:

advancing the distal end portion of the delivery apparatus and the radially compressed prosthetic valve through the patient's vasculature to position the prosthetic valve at a selected implantation area; and

actuating the plunger of the syringe to inject the fluid into the balloon, thereby inflating the balloon and radially expanding the prosthetic heart valve.

18 . The method of claim 16 , wherein the prosthetic heart valve can be expanded to an expanded functional diameter within a range of expanded diameters, and wherein the act of filling the syringe body comprises selecting a fill volume needed to expand the prosthetic heart valve to a selected expanded diameter within the range of expanded diameters.

19 . The method of claim 14 , wherein the volume indicia on the indicator body are not aligned with volume indicia on the syringe body when the volume indicator is placed on the syringe.

20 . The method of claim 14 , wherein the volume indicator is selected from a kit of volume indicators.

21 . A method for using a volume indicator with a syringe for inflating a balloon to expand a prosthetic heart valve, the method comprising:

placing a volume indicator on a syringe by engaging first and second engagement elements of a syringe body with first and second corresponding engagement elements of the volume indicator, the syringe comprising a syringe body and a plunger received in the syringe body and the volume indicator comprising an indicator body and volume indicia on the indicator body, wherein the first corresponding engagement element is disposed at a first end portion of the indicator body and wherein the second corresponding engagement element is disposed at a second end portion of the indicator body;

filling the syringe body with an amount of fluid corresponding to one of the volume indicia on the indicator body;

fluidly connecting the syringe to a delivery apparatus for a prosthetic valve; and

wherein the volume indicator is a first volume indicator selected from a kit of volume indicators, the first volume indicator corresponding to a prosthetic heart valve having a nominal size of 20 mm, and wherein the kit comprises a second volume indicator corresponding to a prosthetic heart valve having a nominal size of 23 mm, a third volume indicator corresponding to a prosthetic heart valve having a nominal size of 26 mm, and a fourth volume indicator corresponding to a prosthetic heart valve having a nominal size of 29 mm.