Removable volume indicator for syringes

Abstract

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

Description

[Technical field]

[0001] The present disclosure relates to a removable volume indicator for a syringe, particularly for a syringe used to inflate a balloon-expandable prosthetic heart valve. [Background technology]

[0002] Prosthetic heart valves have been used for many years to treat valvular heart disease. Natural heart valves (such as aortic, pulmonary, and mitral valves) perform a critical function in ensuring the forward flow of adequate blood supply through the cardiovascular system. These heart valves can be compromised in function by congenital, inflammatory, or infectious conditions. Such damage to the valves can lead to serious cardiovascular disorders or death. For many years, the definitive treatment for such disorders has been the surgical repair or replacement of the valves during open-heart surgery, but such surgeries are prone to many complications. Due to the drawbacks associated with traditional open-heart surgery, percutaneous, minimally invasive surgical approaches have attracted strong attention. In one technique, prosthetic valves are configured to be implanted in a much less invasive procedure by catheterization.

[0003] In this technique, the prosthetic valve is attached in a crimped state to the end of a flexible catheter and advanced through the patient's blood vessels until the prosthetic valve reaches the implantation site. The prosthetic valve at the catheter tip is then expanded to its functional size at the site of the defective native valve, such as by inflating a balloon to which the prosthetic valve is attached. For example, U.S. Patent No. 5,233,633 and U.S. Patent No. 5,233,633 describe collapsible transcatheter heart valves that can be percutaneously introduced in a compressed state on a catheter and expanded at the desired location by balloon inflation or by the use of a self-expanding frame or stent.

[0004] A transcatheter prosthetic heart valve typically has only one functional expanded diameter at which the leaflets of the prosthetic valve can operate as intended. A typical delivery device for a balloon-expandable prosthetic valve can be fluidly connected to a syringe that is used to inject an inflation fluid into the balloon to deploy the prosthetic valve at the implantation site. The balloon is typically designed or selected to be inflated with a predetermined amount of fluid that corresponds to an inherent volume indicator on the syringe. This allows the user to fill the syringe with the exact amount of fluid needed to expand the prosthetic valve to its functional size.

[0005] More recently, transcatheter prosthetic heart valves have been developed that can be expanded within a range of functional sizes, as disclosed in U.S. Patent No. 5,399,633. For implantation of such prosthetic valves, a physician must be able to select an appropriate amount of inflation fluid from a range of fill volumes that corresponds to the diameter of the selected prosthetic valve. Using conventional inflation syringes, it can be difficult for a physician to draw into the syringe the exact amount of inflation fluid needed to expand the prosthetic valve to the desired size if the required amount does not match one of the volume indicators provided on the syringe.

[0006] Therefore, there is a need for improved devices and methods for accurately measuring the amount of inflation fluid needed to expand a prosthetic valve to a selected functional size within a range of functional sizes using an inflation syringe. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Pat. No. 5,411,522 [Patent Document 2] U.S. Patent No. 6,730,118 [Patent Document 3] US Patent Application Publication No. 2018 / 0028310 Summary of the Invention [Means for solving the problem]

[0008] Described herein are embodiments of a removable volume indicator primarily intended for use with a syringe for inflating a balloon to expand a prosthetic heart valve, as well as methods for using the same. If the required volume does not match any of the existing volume markings on the syringe, the volume indicator can be used to draw the correct amount of fluid into the syringe.

[0009] The removable volume indicator can include an indicator body and a window portion extending through a thickness of the indicator body, the indicator body configured to removably clip onto a syringe. The syringe can have a syringe body and a plunger received within the syringe body, and the window portion of the volume indicator can be configured such that a portion of the syringe plunger within the syringe body is visible through the window portion.

[0010] In some embodiments, the volume indicator can further comprise an expansion indicia adjacent the window portion. In some embodiments, the expansion indicia can comprise a protrusion extending at least partially across the window portion. In other embodiments, the expansion indicia can comprise a band extending across the window portion.

[0011] In some embodiments, the indicator body can be at least partially opaque, for example, the indicator body can be completely opaque, translucent, or patterned.

[0012] In some embodiments, the window portion can be disposed between the first end of the indicator body and the second end of the indicator body, and can extend along less than the entire length of the indicator body.

[0013] In an exemplary embodiment, the assembly includes a syringe and a volume indicator. The syringe can include a syringe body and a plunger, the syringe body having one or more first engagement elements. The volume indicator can include an indicator body and a window portion having expansion indicia along a length thereof, the indicator body including one or more second engagement elements configured to engage with the first engagement elements.

[0014] In some embodiments, the window portion is configured such that a portion of a plunger within the syringe body is visible through the window portion. In some embodiments, the syringe body can include volume indicia. In some embodiments, when the volume indicator is disposed on the syringe, the volume indicia on the indicator body does not align with the volume indicia on the syringe body. In other embodiments, the syringe body can be blank.

[0015] In some embodiments, the volume indicator is configured to removably clip onto the syringe body.

[0016] In some embodiments, the one or more first and second engaging elements are disposed on the syringe body and the indicator body such that the volume indicator can be clipped to the syringe in only one direction.

[0017] In some embodiments, the volume indicator may further comprise a gripping portion (e.g., one or more ridges) configured to allow a user to grip the volume indicator during use. In some embodiments, the syringe may comprise an annular lip at its proximal end. The body of the volume indicator may abut against the lip such that a user may grasp the ridges and depress the plunger of the syringe when using the syringe to inflate the prosthetic valve. Depressing the plunger applies a distal force to the syringe / volume indicator assembly, which requires the user to apply a corresponding proximal force to prevent movement of the assembly. The abutment of the volume indicator against the lip during application of force helps to prevent the volume indicator from becoming dislodged from the syringe.

[0018] In some embodiments, the syringe may further comprise one or more third engaging elements, and the volume indicator may further comprise one or more fourth engaging elements configured to engage with the one or more third engaging elements such that the volume indicator is inhibited from rotational movement relative to the syringe.

[0019] In another exemplary embodiment, the assembly includes a syringe and a volume indicator. The syringe can include a syringe body and a plunger, the syringe body having a first engagement element. The volume indicator can include an indicator body and a window portion having an expansion indicia along its length. The indicator body includes a second engagement element configured to engage with the first engagement element. In some embodiments, the first engagement element can be a protrusion extending from an outer surface of the syringe. In some embodiments, the second engagement element can be an aperture configured to engage with the protrusion. The syringe body can further include a third engagement element, and the volume indicator can further include a fourth engagement element configured to engage with the third retention element to restrain the volume indicator from rotational movement relative to the syringe body.

[0020] In another exemplary embodiment, a method of using a volume indicator with a syringe may include disposing the volume indicator on a syringe, the syringe comprising a syringe body and a plunger received within the syringe body, and the volume indicator comprising an indicator body and volume indicia on 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 device for the prosthetic valve.

[0021] In some embodiments, the act of disposing the volume indicator on the syringe can include engaging one or more first engaging elements on the syringe body with one or more second engaging elements on the indicator body.

[0022] In some embodiments, the method can further comprise inserting into the patient a distal end of the delivery device and the prosthetic heart valve mounted in a radially compressed state on a balloon attached to the distal end of the delivery device.

[0023] In some embodiments, the method can include advancing a distal end of a delivery device and the radially compressed prosthetic valve through the patient's vasculature to position the prosthetic valve at a selected implantation area, and actuating a plunger of a syringe to inject fluid into the balloon, thereby inflating the balloon and radially expanding the prosthetic heart valve.

[0024] In some embodiments, the prosthetic heart valve is capable of expanding to an expanded function diameter within a range of expanded diameters, and the act of filling the syringe body includes selecting a fill volume required to expand the prosthetic heart valve to a selected expanded diameter within the range of expanded diameters.

[0025] In some embodiments, when the volume indicator is placed on the syringe, the volume indicia on the indicator body is not aligned with the volume indicia on the syringe body.

[0026] In some embodiments, the volume indicator is selected from a kit of volume indicators. In some embodiments, each volume indicator in the kit corresponds to a different nominal valve size. In some embodiments, the kit includes a first volume indicator corresponding to a prosthetic heart valve having a nominal size of 20 mm, 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.

[0027] In another exemplary embodiment, an assembly includes a removable volume indicator for attachment to a syringe, the volume indicator having an indicator body and inflation indicia spaced along its length, and a delivery device for implanting a prosthetic heart valve, the delivery device having a balloon attached to a distal portion thereof.

[0028] In some embodiments, the assembly may further comprise a prosthetic heart valve expandable to an expanded function diameter within a range of expanded diameters, the expansion indicia corresponding to the range of expanded diameters.

[0029] In another exemplary embodiment, the kit can include at least first and second removable volume indicators for attachment to the same syringe, each volume indicator comprising an indicator body and expansion indicia spaced apart along its length, the expansion indicia of the first volume indicator corresponding to a range of expanded diameters of the first prosthetic valve and the expansion indicia of the second volume indicator corresponding to a range of expanded diameters of a second prosthetic valve larger than the first prosthetic valve. In some embodiments, the kit can further include a third volume indicator and a fourth volume indicator.

[0030] In some embodiments, the kit may further comprise a delivery device that can be used to implant the first and second prosthetic heart valves, the device comprising a balloon attached to a distal portion thereof. In some embodiments, the kit may further comprise the first and / or second prosthetic heart valves.

[0031] The various innovations of the present disclosure can be used in combination or separately. This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter. The above and other objects, features, and advantages of the present disclosure will become more apparent from the following Detailed Description taken in conjunction with the accompanying figures. [Brief description of the drawings]

[0032] [Figure 1]FIG. 1 is a side view of an exemplary embodiment of a delivery device for implanting a prosthetic heart valve. [Diagram 2] FIG. 1 is a perspective view of an exemplary embodiment of a prosthetic heart valve. [Diagram 3] FIG. 1 is a perspective view of a representative embodiment of a syringe that can be used to inflate a balloon of a delivery device, according to one embodiment. [Figure 4A] 1A-1C are front views of different volume indicators that can be attached to the syringe. [Figure 4B] 1A-1C are front views of different volume indicators that can be attached to the syringe. [Figure 4C] 1A-1C are front views of different volume indicators that can be attached to the syringe. [Diagram 5] FIG. 4B is an end view of the volume indicator of FIG. 4A. [Figure 6] 4B is a perspective view of the volume indicator of FIG. 4A shown disposed on the body of the syringe of FIG. 3. [Figure 7] FIG. 4 is a perspective view of an embodiment of a volume indicator disposed on the syringe of FIG. 3. [Figure 8] FIG. 4 is a front view of an embodiment of a volume indicator disposed on the syringe of FIG. 3. [Figure 9] 13 is a perspective view of another embodiment of a volume indicator shown attached to a syringe body. FIG. [Figure 10] 10 is a cross-sectional view of a portion of the volume indicator of FIG. 9. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] In certain embodiments, a delivery assembly for implanting a prosthetic transcatheter heart valve through a patient's vasculature includes a syringe for inflating a balloon of the delivery device to radially expand a prosthetic valve radially crimped on the balloon. The balloon can be attached to a distal end of a shaft of the delivery device. The balloon and crimped prosthetic valve can be inserted into the patient's vasculature through an introducer sheath, and when the balloon and crimped prosthetic valve reach an appropriate location in the body, the prosthetic valve can be expanded at the treatment site (e.g., a native aortic valve).

[0034] 1 illustrates a delivery device 100 according to one embodiment configured to deliver a prosthetic heart valve, such as the illustrated prosthetic heart valve 10. The prosthetic heart valve 10 may be, for example, a prosthetic aortic valve configured to be implanted into a native aortic valve, although in other embodiments, the prosthetic valve 10 may be implanted into any of the other native valves of the heart, such as the native mitral, tricuspid, or pulmonary valves. The delivery device 100 generally includes a handle 102, a first elongate shaft 104 extending distally from the handle 102, and a second elongate shaft 106 extending distally from the handle 102 and coaxially through the first shaft 104.

[0035] In some embodiments, the first shaft 104 can be configured as a steerable guide catheter having an adjustable curvature for use in steering the delivery apparatus through the patient's vasculature. For example, the first shaft 104 can include a steerable distal section 110, the curvature of which can be adjusted by an operator to aid in guiding the device through the patient's vasculature. A steering or pull wire (not shown) can extend through the shaft 104 and can have a distal end fixed at a position along the distal section 110 and a proximal end operably connected to an adjustment mechanism, such as the illustrated knob 112, on the handle 102.

[0036] In some embodiments, the first shaft 104 and the second shaft 106 can be moved (axially and / or rotationally) relative to one another to facilitate delivery and positioning of the prosthetic valve 10 at an implantation site within a patient's body. The handle 102 can include an adjustment mechanism for producing relative motion between the shafts 104, 106. For example, the handle can include a slidable adjustment knob 114 operably connected to the second shaft 106 and configured to produce axial motion of the second shaft 106 in the proximal and distal directions relative to the first shaft 104.

[0037] An inflatable balloon 116 can be mounted along the distal end of the second shaft 106, which can be referred to as a balloon catheter. As shown in FIG 1, the prosthetic valve 10 can be radially crimped around the balloon 116 for delivery into the patient's vasculature. Once the prosthetic valve 10 reaches the desired implantation site (e.g., within the native aortic valve), the balloon can be inflated to radially expand the prosthetic valve against the surrounding tissue.

[0038] The delivery device 100 can include a proximal port 118 extending from the handle 102. The proximal port 118 is in fluid communication with a longitudinally extending fluid passageway of the delivery device for delivering inflation fluid to the balloon 116. The handle 102 can further include a side arm 120, which can be, for example, a flush tube having an internal passageway in fluid communication with a lumen defined by the handle 102. The flush tube can terminate at or adjacent to a seal member where the flush tube connects with an internal passageway defined by the shaft 106 and / or shaft 104.

[0039] The proximal port 118 may be formed by a fluid passageway fluidly connectable to a fluid source (e.g., a syringe filled with saline, see FIG. 3) for inflating the balloon 116 and optionally flushing the space between the inner and outer balloon catheter shafts. Thus, the fluid passageway of the proximal port 118 may be in fluid communication with the annular space between the first and second shafts such that fluid from the fluid source may flow through the fluid passageway, through the space between the shafts, and into the balloon to inflate the balloon 116 and deploy the prosthetic valve 10. In an alternative embodiment, the proximal port 118 may be in communication with a lumen of the second shaft 106 that serves as a fluid passageway for delivering inflation fluid from a fluid source to the balloon 116.

[0040] In some embodiments, the proximal port 118 can further include a stopcock (not shown) operable (e.g., by manual manipulation by a physician) between an open position and a closed position. When the stopcock is in the open position, fluid from the fluid source can flow into the fluid passageway, and when the stopcock is in the closed position, fluid from the fluid source is prevented from flowing into the fluid passageway.

[0041] The first and second shafts 104, 106 can be formed from any of a variety of suitable materials, such as nylon, braided stainless steel wire, or polyether block amide (commercially available as Pebax®), to name a few. The shafts can have longitudinal sections formed from different materials to vary the flexibility of the shaft along its length. The second shaft 106 can have an inner liner or layer formed from Teflon® to minimize sliding friction with the guidewire.

[0042] Further details regarding the delivery apparatus 100 and methods for using the delivery apparatus to deliver and deploy prosthetic valves can be found, for example, in U.S. Patent Application Publication No. 2017 / 0065415. Other examples of delivery apparatus that can be used to implant prosthetic heart valves using the devices disclosed herein are described in U.S. Patent Nos. 8,568,472 and 9,061,119.

[0043] 2, the prosthetic heart valve 10 comprises a stent or frame 12 and a valve structure 14 supported by the frame and configured to regulate blood flow through the prosthetic valve. In some embodiments, the prosthetic valve 10 is configured to be implanted into a native aortic valve and can be implanted in vivo, for example, using the delivery device 100 described above. The frame 12 may be constructed from a plastically expandable material, such as stainless steel, a nickel-based alloy (e.g., a nickel-cobalt-chromium alloy), a polymer, or a combination thereof, such that upon inflation of the balloon 116, the frame 12 plastically expands as the prosthetic valve expands from a crimped, radially compressed configuration (FIG. 1) to a radially expanded configuration (FIG. 2).

[0044] The valve structure 14 can include a number of leaflets 16 attached to the inside of a frame. The opposing surfaces of each leaflet 16 can mate with an adjacent leaflet to form a commissure 18 of the valve structure. The commissures 18 can be attached to the frame via a reinforcing member 20. The prosthetic valve 10 can also include a sealing member 22 attached to the outside of the frame. The sealing member 22 is configured to seal the prosthetic valve against surrounding tissue and help prevent or minimize perivalvular leakage. The leaflets 16 can be fabricated from any of a variety of suitable biocompatible materials, including natural tissue, such as bovine pericardial tissue (or pericardial tissue from other sources), or synthetic materials, such as any of a variety of cloth or non-cloth materials (e.g., polyurethane). The reinforcing member 20 and the sealing member 22 are desirably made of a cloth material, such as a polyethylene terephthalate (PET) cloth, although non-cloth materials and natural tissues can also be used. Further details of the prosthetic valve 10 are disclosed in U.S. Patent Application Publication No. 2018 / 0028310. Other types of prosthetic heart valves that can be deployed using any of the devices and methods disclosed herein are described in U.S. Pat. Nos. 7,510,575, 7,993,394 and 9,393,110.

[0045] In certain embodiments, the prosthetic valve 10 can be radially expanded to an expanded state having an outer diameter within a range of expanded diameters. This allows a physician to expand the prosthetic valve 10 to a size that closely corresponds to the diameter of the native annulus in which the prosthetic valve is to be implanted. For example, in one particular embodiment, the prosthetic valve 10 having a "nominal" size of 23 mm can be expanded to a diameter within a diameter range of about 21.5 mm to about 23.3 mm. As used herein, the "nominal" size of the prosthetic valve is an approximation that corresponds to the outer diameter of the prosthetic valve in the expanded state. The size range of the expanded diameter of the prosthetic valve typically includes the nominal size of the prosthetic valve. Usually, but not necessarily, the nominal size of the prosthetic valve defines the upper limit of the size range of the expanded diameter or is close to the upper limit of the size range of the size range.

[0046] Once the prosthetic heart valve 10 is positioned at the desired implantation location, the physician can introduce an appropriate amount of inflation fluid into the balloon 116 to radially expand the prosthetic valve to a desired diameter that will ensure that the prosthetic valve engages the annulus of the native heart valve without overstretching the native annulus. FIG. 3 shows an example of a syringe 126 that can be used to inject inflation fluid into the balloon 116. In some embodiments, the final diameter of the prosthetic valve 10 can be pre-determined by measuring the native annulus using known techniques. In other embodiments, the final diameter of the prosthetic valve can be determined during the implantation procedure, for example, as the prosthetic valve is being expanded. The syringe 126 can be equipped with a volume indicator 200 (FIGS. 4A-4C) that allows the physician to more precisely select or measure the amount of fluid required to expand the prosthetic valve to the desired final diameter, as described further below.

[0047] 3, in the illustrated embodiment, the syringe 126 can have a cylindrical syringe body 128 having an internal chamber for containing an inflation fluid. The syringe body 128 has a diameter D1, a first end 130 and a second end 132. The syringe 126 can include a conduit 144 (e.g., a medical grade flexible polymer tubing) extending from the first end 130 of the body 128. The first end 130 of the body 128 can be formed by an opening that fluidly connects the internal chamber of the body 128 with an adjacent end of the conduit 144. Prior to introducing the delivery device 100 into the patient's body, an opposite end (not shown) of the conduit 144 can be fluidly connected to the proximal port 118 of the delivery device. For example, the conduit 144 can be connected to the proximal port 118 using a rotating Luer connector.

[0048] The syringe 126 may further include a plunger 134 having a shaft 136 extending into the internal chamber of the body 128, a plunger head 138 ( FIG. 8 ) attached to one end of the shaft 136 and disposed within the internal chamber of the body 128, and a plunger handle 140 attached to the other end of the shaft 136. The second end 132 of the body 128 may have an opening through which the shaft 136 of the plunger 134 extends. A pressure gauge 150 may be attached to the syringe body 128 and may be used to measure the pressure of the inflation fluid as the fluid is being expelled from the syringe into a delivery device.

[0049] The syringe gripping portion 142 may be attached to the body second end 132 and may include a central opening through which the plunger shaft 136 extends. Thus, during use, a physician may grasp the syringe gripping portion 142 with one hand and grasp the handle 140 of the plunger 134 with the other hand to adjust the position of the plunger head 138 within the body 128. The physician may fill the syringe body with a desired amount of inflation fluid (assuming the conduit 144 is fluidly connected to another source of inflation fluid) by pulling the plunger 134 away from the syringe body 128, thereby drawing fluid into the body's internal chamber. Alternatively, inflation fluid may be introduced into the syringe body by completely removing the plunger 134 from the syringe body 128 so that the inflation fluid may be poured through the opening at the body's second end 132. The physician can force fluid out of the syringe body 128 by depressing the plunger 134 further into the internal chamber of the syringe body.

[0050] The syringe body 128 may be transparent or at least translucent so that the user can see the amount of inflation fluid and the position of the plunger head 138 within the body. In some embodiments, the exterior surface of the syringe body may include a series of markings or measurement indicia 146 that allow the user to measure the amount of inflation fluid within the body 128. In other embodiments, the syringe may be completely devoid of measurement indicia (e.g., it may be a blank syringe). As shown in FIG. 3, in the illustrated embodiment, the measurement indicia 146 are arranged with a volume marking corresponding to a minimum adjacent the first end 130 of the body 128 (which is the outlet of the syringe body) and a volume marking corresponding to a maximum adjacent the second end 132 of the body. In this way, when the user draws fluid from the source through the conduit 144 into the syringe body 128 by pulling the plunger handle 140, the user can draw a predetermined amount of fluid into the syringe body 128 by aligning the plunger head 138 with the volume marking corresponding to the desired amount of fluid.

[0051] The syringe body 128 may further comprise one or more first engaging elements 148 that protrude outwardly from an outer surface of the body. Each engaging element 148 may be a small cylindrical protrusion as shown, although the engaging elements may have any of a variety of other shapes in cross section (e.g., square, rectangular, triangular, oval, and / or combinations thereof) in other embodiments. In some embodiments, the one or more first engaging elements 148 may comprise a plurality of first engaging elements that may be spaced apart from one another along the length of the syringe body 128. In other embodiments, the one or more first engaging elements 148 may be a single engaging element. In certain embodiments, the single first engaging element 148 may be disposed at the first end 130 of the syringe and may extend outwardly from a surface thereof (e.g., the surface facing upward in the orientation shown in FIG. 9).

[0052] In a particular embodiment, the syringe 126 comprises a model QL38 syringe available from Atrion Medical (Arabia, Alabama) that has been modified to include one or more first engaging elements 148 on the syringe body.

[0053] Known delivery systems typically include a prosthetic valve having only one functional expansion diameter that is expanded using a balloon that is inflated with a predetermined amount of fluid that corresponds to one of the volume indicators 146 on the syringe body 128 (usually an integer number of fluid amounts). This allows a user to fill the syringe with the exact amount of fluid required for a procedure. However, if the prosthetic valve has multiple functional expansion diameters, or instead can be expanded within a range of expansion diameters, it may be difficult for a user to draw into the syringe body the exact amount of inflation fluid required to expand the prosthetic valve to the desired size if the required volume falls between two of the volume markings 146.

[0054] 4A-4C show an exemplary embodiment of a set of removable volume indicators 200a, 200b, 200c for use with a syringe, such as syringe 126. The removable volume indicators can be used to draw a precise amount of fluid into a syringe when the required volume does not match any of the syringe's existing volume markings. For ease of explanation, reference number 200 is used when describing features common to each volume indicator 200a, 200b, 200c. Each volume indicator 200 can comprise an indicator body 202 having a window portion 204 formed within the indicator body. In some embodiments, the volume indicator can further comprise one or more second engagement elements 206 that can mate with one or more corresponding first engagement elements 148 on the syringe body 128.

[0055] As shown in FIGS. 4A-4C, each volume indicator 200 can correspond to a nominal prosthetic valve size. In some embodiments, a single volume indicator may be packaged and / or sold with a correspondingly sized prosthetic valve and / or an appropriate delivery device. In other embodiments, two or more volume indicators can form an assembly or kit, and the volume indicators of the kit can be packaged together for delivery to an end user. In some embodiments, the kit can further include a delivery device, a prosthetic valve, a syringe, and / or any combination of these elements. An exemplary kit can include two or more volume indicators 200, a delivery device 100, and a prosthetic valve 10. Alternatively, the prosthetic valve 10 can be packaged and sold separately from a kit that includes two or more volume indicators and a delivery device. The kit can include a number of volume indicators equal to the number of different nominal valve sizes that can be used with the same delivery device. Another exemplary assembly can include three volume indicators 200 and a delivery device 100. Yet another exemplary assembly can include two or more volume indicators 200 and a syringe 126.

[0056] During the implantation procedure, the physician can, for example, access multiple volume indicators 200 in the kit and select an appropriate volume indicator that corresponds to an appropriately sized prosthetic valve. The variety of volume indicators allows a single syringe 126 to be used for the implantation procedure regardless of the size of prosthetic valve 10 ultimately selected by the physician. Each volume indicator 200 can be labeled, marked, colored, and / or patterned to indicate the corresponding nominal prosthetic heart valve size. In the illustrated embodiment, each volume indicator has a molded embossment 208 that indicates the nominal diameter of the corresponding prosthetic valve. In other embodiments, the volume indicators 200 can be labeled using, for example, pad printing, laser engraving, or other marking methods.

[0057] 4A, the indicator body 202 can have a length L1 and may be sized to cover at least a portion of the measurement indicia 146 of the syringe body 128 when the volume indicator 200 is placed on the syringe 126 (if such measurement indicia are present). In certain embodiments, the body 202 extends the entire length of the syringe body 128 or substantially the entire length of the syringe body 128 and covers all of the measurement indicia 146 on the syringe body 128. In some embodiments, the indicator body 202 may be opaque or substantially opaque such that the measurement indicia 146 of the syringe 126 are fully obscured, partially obscured, or otherwise minimized. Thus, the volume indicator 200 helps to prevent a physician from confusing the measurement indicia 146 on the syringe body 128 with the volume indicated by the volume indicator 200 itself. In other embodiments where a volume indicator is used with a blank syringe, the volume indicator may be opaque, transparent, substantially transparent, or translucent.

[0058] 5, the indicator body 202 can have a C-shaped cross-section with an opening of width W1 so that it can be removably clipped or "snap" fitted onto the syringe body 128. The width W1 of the opening can be slightly smaller than the diameter D1 of the syringe body 128 so that the body 202 deforms or expands slightly to allow the syringe body 128 to pass through the opening. The width W1 of the opening can help retain the syringe body 128 within the volume indicator 200. In certain embodiments, the indicator body 202 can have an inner diameter D2 that is the same as or slightly smaller than the outer diameter D1 of the syringe body so that the indicator body 202 forms a tight or snug fit against the outer surface of the syringe body 128.

[0059] 4A-4C, in some embodiments, one or more second engagement elements 206 (e.g., three in the embodiment shown in FIGS. 4A-4C) can be configured to mate with a corresponding first engagement element 148 extending from the syringe body 128 (see, e.g., FIG. 3). As shown in the illustrated embodiment, the one or more second engagement elements 206 can be C-shaped notches formed along an edge of the indicator body 202 and shaped to receive the one or more first engagement elements 148. Additionally, the one or more engagement elements 206 can be configured to form a releasable connection with a corresponding first engagement element.

[0060] For example, as shown in FIG. 4B, the second engaging elements 206a and 206c can be configured to form a snap-fit ​​connection with the corresponding first engaging element 148, while the second engaging element 206b can be shaped to mate with the corresponding first engaging element 148 but not form a snap-fit ​​or other type of secure connection with the corresponding first engaging element 148. Each second engaging element 206a, 206c can include two arcuate bendable arms 230 configured to be disposed around the corresponding first engaging element 148. The arms 230 are sized and shaped to bend away from each other when the corresponding first engaging element 148 is inserted between the free ends of the arms and then return to their original shape when the first engaging element 148 is fully disposed between the arms. The snap-fit ​​connection helps secure the volume indicator 200 to the syringe body 128 and prevents movement of the volume indicator relative to the syringe body. It should be noted that in alternative embodiments, all of the second engagement elements or only one of the second engagement elements can be configured to form a snap-fit ​​connection with a corresponding first engagement element.

[0061] It should also be noted that in the illustrated embodiment, the second engagement element 206 is a C-shaped notch configured to receive the correspondingly shaped cylindrical first engagement element 148, however, in other embodiments, the second engagement element 206 may have any of a variety of sizes and shapes (e.g., circular, rectangular, oval, etc.) configured to mate with the first engagement element 148.

[0062] Additionally, in alternative embodiments, one or more of the second engagement elements 206 may be apertures formed in the indicator body 202 configured to form a releasable connection with a respective first engagement element 148 (e.g., by snapping, clipping, or inserting the first engagement element into or through the second engagement element). Examples of such embodiments are described in more detail below with reference to Figures 9 and 10.

[0063] With reference to FIG. 4C, in some embodiments, the one or more second engaging elements 206 can be spaced apart from one another along the length of the indicator body 202. In some embodiments, two or more of the one or more second engaging elements 206 can be collinear with one another. The distance between adjacent engaging elements 206 can vary such that the volume indicator 200 can only be connected to the syringe body 128 in one direction, preventing erroneous measurements due to incorrect attachment of the volume indicator to the syringe body. For example, in the illustrated embodiment, the second engaging elements 206a and 206b are spaced apart by a first distance X1, and the second engaging elements 206b and 206c are spaced apart by a second distance X2. The first and second distances X1 and X2 can be different from one another. For example, X1 can be greater than X2, as shown in FIG. 4C. The first engaging elements 148 on the syringe body 128 can be spaced apart correspondingly. In the illustrated embodiment, the engagement elements 148, 206 are spaced apart from one another such that the volume indicator 200 is disposed only on the syringe body 128 and the size indicator 208 may be directed toward the second end 132 of the syringe body.

[0064] The window portion 204 can be formed in the indicator body 202 and can extend over a length L2, where L2 is less than the length of the indicator body L1. Referring again to FIG. 4A, in some embodiments, the length L2 can be less than a majority of the length L1 of the indicator body (i.e., less than 50% of the length L1). Thus, the window portion 204 of the illustrated embodiment (which includes the expansion indicia 214 described below) is used to measure a specific range of volumes that are much less than the total volume capacity of the syringe. However, in alternative embodiments, the window portion 204 (and corresponding indicia 214) can extend over a length L2 that is greater than 50% of the length L1 or that is substantially equal to the length L1. The window portion can have a first end 210 configured to be positioned near the first end 130 of the syringe body 128 when the volume indicator is positioned on the syringe body, and a second end 212 configured to be positioned near the second end 132 of the syringe body 128 when the volume indicator is positioned on the syringe body.

[0065] 4-10, the window portion 204 may be an opening or hole that extends completely through the indicator body 202 such that a portion of the plunger 134 (e.g., head 138) is visible through the window portion. In other embodiments, the window portion 204 may be a portion of the body 202 formed from a transparent, translucent, or opalescent material configured to allow a portion of the plunger 134 to be visible through the window.

[0066] The window portion 204 may further include an expansion indicia 214 corresponding to the amount of fluid required to expand the prosthetic heart valve to a selected diameter within a particular prosthetic valve diameter range. The expansion indicia 214 may be a series of markings or protuberances that visually indicate to the physician the amount of fluid required to expand the prosthetic heart valve to different diameters. For a volume indicator 200a for use with a prosthetic valve having a nominal diameter of 23 mm, the expansion indicia may correspond, for example, to the volume of fluid required to expand the valve to diameters of 22.5 mm, 23 mm, and 23.5 mm, respectively. For a volume indicator 200b for use with a prosthetic valve having a nominal diameter of 26 mm, the expansion indicia may correspond, for example, to the volume of fluid required to expand the valve to diameters of 24.5 mm, 25.8 mm, and 27 mm, respectively. In an exemplary volume indicator 200c for use with a prosthetic valve having a nominal diameter of 29 mm, the inflation indicia may correspond, for example, to the volume of fluid required to expand the valve to diameters of 27.5 mm, 28.8 mm, and 30.0 mm, respectively. In an exemplary volume indicator for use with a prosthetic valve having a nominal diameter of 21 mm, the inflation indicia may correspond, for example, to the volume of fluid required to expand the valve to diameters of 20.5 mm, 21 mm, and 21.5 mm, respectively.

[0067] As shown in FIGS. 4A-4C, the window portion 204 of each indicator 200a, 200b, 200c can be located at different positions along the length of the indicator body 202 depending on the nominal size and diameter range of the corresponding prosthetic valve. The positions of the window portions can correspond to a range of syringe volumes used to expand each different nominal size prosthetic valve to a corresponding range of diameters. This variability between the volume indicators 200 allows the same syringe 126 to be used with each volume indicator, and therefore each prosthetic valve. In other embodiments, the window portion 204 can be located at the same position for each volume indicator 200, and the inflation indicia 114 can be located at different positions along the length of the window 204 depending on the nominal size and diameter range of the corresponding prosthetic valve. The positions of the volume indicia 210 within the window portion 204 can correspond to a range of syringe volumes used to expand each different nominal size prosthetic valve to a corresponding range of diameters.

[0068] 4B, in the illustrated embodiment, the expansion indicia 214 are triangular projections 216 extending inwardly from both sides 218, 220 of the window portion 204. Each projection can extend partially across the width of the window portion as shown. In other embodiments, the expansion indicia can extend across the entire width of the window portion 204. In other words, the indicia can include multiple bands spaced apart along the length of the window portion, each band extending from one side 218 to the other side 220 of the window portion. In yet other embodiments, the expansion indicia can be a notch in the sides 218, 220 of the window portion. The expansion indicia 214 can be marked (e.g., numbered), colored, and / or patterned to indicate the diameter of the prosthetic heart valve corresponding to each indicator so that a physician can quickly and easily assess whether the correct amount of fluid is contained within the syringe body.

[0069] In some embodiments, the expansion indicia can be made from metal, plastic and / or other materials. In some embodiments, the expansion indicia can be integrally formed with the window portion. Alternatively, the expansion indicia can be formed separately and joined later in the manufacturing process, such as by welding, adhesives and / or mechanical means such as screws. In embodiments where the window portion is a transparent portion of the indicator body, the expansion indicia can be a colored and / or patterned, transparent or translucent band integrally formed with the window portion.

[0070] In some embodiments, the expansion indicia can include markings that convey valve-specific information (e.g., the amount of fluid in the syringe or the diameter of the deployed valve for each indicator mark. These markings can be formed, for example, using mold embossing, pad printing, laser engraving, or other marking methods.

[0071] In one particular embodiment, the inflation indicia 214 may indicate successively larger diameter sizes from the first end 210 to the second end 212 of the window. For example, referring now to Figure 7, a volume indicator 200 for use with a valve having a nominal diameter of 23 mm may have a first inflation indicator 214a corresponding to a diameter of 21.5 mm, a second inflation indicator 214b corresponding to a diameter of 22.7 mm, and a third inflation indicator 214c corresponding to a diameter of 23.3 mm.

[0072] In use, when the volume indicator 200 of FIG. 7 is placed on a syringe, the physician may fill the syringe (e.g., by pulling on the plunger 134 while the conduit 144 is connected to a fluid source) until, for example, the end face 150 of the plunger head 138 of the plunger 134 aligns with the expansion indicator 214 corresponding to the selected diameter size. In other embodiments, the syringe may be filled by aligning an O-ring on the plunger head 138 with the expansion indicator 210 corresponding to the selected diameter size. When so aligned, the syringe body holds therein the amount of fluid necessary to expand the prosthetic valve 10 to the selected diameter size. For example, to expand the prosthetic valve to a diameter of 22.7 mm, the physician may fill the syringe until the plunger head 138 of the plunger 134 aligns with the second expansion indicator 214b. The prosthetic valve may then be expanded as described in more detail below. It should be noted that any portion of the plunger head 138 can be used to measure the amount of fluid required to expand the prosthetic valve to a selected size, so long as the volume indicia 214 is positioned in a position that, when aligned with the portion of the plunger head 138 used to measure the amount of fluid, provides the volume required for expansion.

[0073] In another embodiment, the inflation indicia on the volume indicator can indicate or correspond to successively larger diameter sizes from the second end 212 to the first end 210 of the window 204. Assuming the entire syringe body is filled with inflation fluid, each indicator can correspond to the amount of fluid that would be expelled from the syringe body, beginning at the second end 132 of the syringe 126, to expand the prosthetic valve to a selected diameter. For example, with reference to FIG. 8, a volume indicator for use with a prosthetic valve having a nominal diameter of 23 mm can have a first inflation indicator 222a corresponding to a diameter of 21.5 mm, a second inflation indicator 222b corresponding to a diameter of 22.7 mm, and a third inflation indicator 222c corresponding to a diameter of 23.3 mm.

[0074] In some embodiments (see, e.g., FIG. 9 ), the body 202 of the volume indicator 200 may further include a gripping portion, e.g., a plurality of spaced ridges 226, configured to enhance grip of the volume indicator 200 by a user during use. The syringe may include an annular lip 156 at the second end 132 of the syringe body 128. The body 202 of the volume indicator 200 may have a length L1 such that the proximal end 228 of the volume indicator 200 abuts the lip 156. During use of the syringe to inflate the prosthetic valve, a user may grasp the ridges 226 of the volume indicator 200 and depress the plunger 136 of the syringe 126. Depressing the plunger 136 applies a distal force to the syringe / volume indicator assembly, which requires the user to apply a corresponding proximal force to prevent movement of the assembly. The abutment of the proximal end 228 of the volume indicator 200 against the lip 156 of the syringe 126 during application of proximal and distal forces helps to inhibit the volume indicator 200 from becoming dislodged from the syringe 126 .

[0075] In use, once the volume indicator 200 of FIG. 8 is positioned on the syringe 126, the syringe body 128 can be completely filled with fluid (e.g., using the methods described above). To expand the prosthetic valve, once the syringe is coupled to the delivery device, the physician can actuate the plunger 134 of the syringe (e.g., by pushing it into the syringe body) until the end face 150 of the plunger head 138 of the plunger 134 is aligned with the expansion indicator corresponding to the selected diameter, thereby displacing the amount of fluid necessary to expand the prosthetic valve to the selected diameter. For example, to expand the prosthetic valve to a diameter of 21.5 mm, the physician can completely fill the syringe, fluidly connect the syringe to the delivery device 100, deliver the prosthetic valve to the desired implantation site, and actuate the plunger until the end face 150 of the plunger head 138 reaches the expansion indicator 222a. This expands the prosthetic valve to the selected diameter. If further expansion of the prosthetic valve is required (eg, from a diameter of 21.5 mm to 22.7 mm), the plunger can be actuated further, as described in more detail below.

[0076] In one particular method for implanting a prosthetic heart valve in a patient's heart, a physician can select a prosthetic heart valve 10 having an expanded diameter range sized to accommodate the anatomical variations of a particular patient (e.g., selecting a nominal size that is closest to the native annulus into which the prosthetic heart valve will be implanted). If desired, conventional techniques and / or devices can be used to measure the size of the native annulus into which the prosthetic heart valve will be implanted to facilitate selection of an appropriately sized prosthetic heart valve. Once the size of the prosthetic valve is selected (e.g., a 21 mm valve, a 23 mm valve, a 26 mm valve, or a 29 mm valve), the physician can select a corresponding volume indicator 200 having an expansion indicia 214 that corresponds to the diameter range of that prosthetic valve.

[0077] 6, the selected volume indicator 200 may be placed on the syringe body 128 (e.g., by clipping or snapping a cover onto the syringe body). The second engaging element 206 of the volume indicator may engage and form a releasable connection with the first engaging element 148 of the syringe body 128, thereby holding the volume indicator in place on the syringe body. Once the volume indicator 200 is attached to the syringe 126, the physician may fill the syringe body 128 with inflation fluid (e.g., saline).

[0078] In embodiments where the volume of inflation fluid is measured from the first end 130 of the syringe body, during filling, the end face 150 of the plunger head 138 can be aligned with a selected inflation indicator 214 that corresponds to a selected inflation valve diameter (see, e.g., FIG. 7). In this manner, the syringe body is filled with the appropriate amount of fluid needed to inflate the prosthetic heart valve 10 to the selected diameter. At this point, the volume indicator 200 can be removed from the syringe or kept in place for the remainder of the procedure.

[0079] Once filled, the syringe 126 can be fluidly coupled to the handle 102 of the delivery device 100 at the proximal port 118, such as by connecting the tube 144 to the proximal port 118. The prosthetic heart valve 10 can be mounted in a crimped state on the balloon 116 on the distal end of the delivery device 100. A representative method of implanting the prosthetic heart valve 10 using the delivery device 100 can proceed as follows: The distal end of the delivery device (with the prosthetic valve 10) can be introduced into the patient's vasculature, for example, via an incision in the femoral artery. The distal end of the delivery device 100 (with the prosthetic valve 10) can be advanced through the femoral artery and aorta toward the native aortic valve. Once the prosthetic heart valve 10 is located at the desired implantation location (typically within the native aortic annulus), the prosthetic heart valve can be deployed (e.g., radially expanded). Additional details regarding the implantation procedure are described, for example, in U.S. Patent Application Publication No. 2017 / 0065415.

[0080] To deploy the prosthetic valve 10, the physician can depress the plunger 134 of the syringe 126 so that the total amount of fluid in the syringe flows through the fluid passage of the delivery device and into the balloon 116, inflating it and deploying the prosthetic valve 10 to a selected diameter.

[0081] 8, in embodiments in which the volume of inflation fluid is measured from the second end 132 of the syringe body 128, the syringe body can be completely filled with fluid such that, for example, the plunger head 138 of the plunger 134 is disposed at the second end 132. In this manner, the syringe body is filled with sufficient fluid to sequentially inflate the prosthetic valve 10 to each of the diameter sizes within the range of prosthetic valve diameters. Once completely filled, the syringe 126 can be fluidly coupled to the handle of a delivery device, and the prosthetic valve 10 can be advanced to the desired implantation location, as described above.

[0082] Once the prosthetic heart valve 10 has reached the desired implantation location, the prosthetic valve can be expanded, for example, to a first diameter within the range (e.g., the smallest diameter within the range) by depressing the plunger until the surface 150 of the plunger head 138 aligns with the expansion indicator 222a, which indicates the first diameter. The physician can then evaluate the fit of the prosthetic valve within the native annulus. If further expansion of the prosthetic valve is required, the prosthetic valve can be expanded, for example, to a second diameter within the range, by depressing the plunger until the end surface 150 of the plunger head 138 aligns with the expansion indicator 222b, which indicates the second diameter. This process can be repeated as necessary until the prosthetic valve is expanded to an optimal diameter for the native annulus. For example, the prosthetic valve 10 is desirably expanded to a diameter sufficient to press the prosthetic valve against the surrounding tissue and secure it in place with minimal or no paravalvular leakage and without overstretching and rupturing the native annulus.

[0083] 9 and 10, in some embodiments, the volume indicator 200 can be clipped to the syringe 126 using one or more second engagement elements 206 (e.g., one in the illustrated embodiment) configured as an aperture extending through the body 202 of the volume indicator 200. The syringe 126 can have one or more first engagement elements 148 (e.g., one in the illustrated embodiment) extending from a surface of the syringe body 128 and configured to engage with the second engagement element 206. The second engagement element 206 can be, for example, a circular aperture extending through the body 202 of the volume indicator 200, and the first engagement element 148 can be, for example, a cylindrical protrusion extending from a surface of the syringe body 128.

[0084] In some embodiments, as shown in FIG. 10, the first engaging element 148 can have a tapered outer surface 152 configured to form an interference fit (e.g., a press fit or friction fit) with the second engaging element 206. This ensures that the first and second engaging elements 148, 206 form a tight or snug fit with each other such that the volume indicator 200 is inhibited from moving or sliding relative to the syringe body 128. The tapered surface 152 ensures that there is no loosening or slippage between the first and second engaging elements 148, 206 even if the second engaging element 206 is slightly larger (e.g., due to manufacturing tolerances), thereby ensuring accurate placement of the volume indicator 200, and thus the inflation indicia 114, axially along the syringe 126. This can help prevent inaccurate measurements based on incorrect placement of the volume indicator. In some embodiments, instead of or in addition to tapering the first engaging element 148, the second engaging element 206 can be configured as a tapered opening.

[0085] 9 , in some embodiments, the syringe body 128 can further include one or more additional engagement elements 154 extending from a surface of the syringe body 128, for example, disposed along the second end 132 of the syringe body 128. The volume indicator 200 can include one or more corresponding additional engagement elements 224 configured to engage with the engagement elements 154. Engagement of the engagement elements 154, 224 can restrain the volume indicator 200 from rotational movement relative to the syringe body 128 when the volume indicator is clipped to the syringe body. As shown, the engagement element 224 can be a U-shaped notch formed along a proximal edge of the indicator body 202 adjacent the lip 156, and the engagement element 154 can include a corresponding U-shaped protrusion extending from the lip 156.

[0086] In the illustrated embodiment, the engaging element 224 is a U-shaped cutout opening configured to receive a corresponding U-shaped engaging element 154 of the syringe body 128, however, it should be noted that in other embodiments, the one or more second engaging elements 224 may have any of a variety of sizes and shapes (e.g., circular, rectangular, triangular, etc.) configured to mate with one or more engaging elements 154 of a corresponding shape.

[0087] In some embodiments, the volume indicator 200 is aligned on the syringe 126 such that the engaging elements 148, 206 are positioned to engage with one another by aligning the engaging elements 154, 224. This allows a user to quickly and easily clip the volume indicator 200 onto the syringe 126 in the correct orientation.

[0088] The window portion 204 in the embodiment of FIG. 9 is longer than the window portion 204 in the embodiment of FIG. 6. Thus, the opposing edges 210, 212 of the window portion in the embodiment of FIG. 9 are positioned farther away from the volume indicia 210 than in the embodiment of FIG. 6. This may help to avoid a user using one of the opposing edges 210, 212 to measure fluid when the edge 210, 212 is not intended to be used as a volume indicia. In certain embodiments, the length L2 of the window portion 204 may be longer than the majority of the length L1 of the indicator body to maximize the spacing between the volume indicia 214 and the opposing edges 210, 212. However, in alternative embodiments, the indicator may be manufactured such that one or both edges 210, 212 are positioned to function as a volume indicia to measure the amount of fluid to expand the prosthetic valve to a desired size.

[0089] In embodiments in which the proximal port 118 includes a cock, before actuating the plunger 134, the physician can actuate the cock from a closed position to an open position so that fluid from the fluid source can flow through the cock and into the fluid passage of the delivery device 100.

[0090] Although the disclosed embodiments generally relate to delivery apparatus and methods for implanting a prosthetic heart valve into a native aortic valve, it is understood that the disclosed embodiments can be used to implant a prosthetic device at any location in the heart or elsewhere in the body. Additionally, although the disclosed embodiments generally relate to transfemoral delivery of prosthetic devices, it is understood that the disclosed embodiments can be adapted for use in, for example, transapical, transaortic, transsubclavian, transradial or transseptal procedures.

[0091] General Considerations For purposes of this description, certain aspects, advantages and novel features of the disclosed embodiments are described herein. The disclosed methods, devices and systems should not be construed as limiting in any way. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both alone and in various combinations and subcombinations with one another. The methods, devices and systems are not limited to certain aspects, features or combinations thereof, and the disclosed embodiments do not require that any one or more particular advantages exist or problems be solved.

[0092] Although some operations of the disclosed embodiments are described in a particular sequential order for convenient presentation, it should be understood that the method of description includes rearrangements unless a particular order is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed simultaneously. Moreover, for simplicity, the accompanying figures may not show the various ways in which the disclosed methods can be used in combination with other methods. Furthermore, the description may use terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation, which is readily discernible by one of ordinary skill in the art.

[0093] All features described herein are independent of one another and may be used in combination with any other feature described herein, unless structurally impossible. For example, the volume indicator may comprise a window portion 204 in combination with the first and second engagement elements 148, 206 as shown in Figures 9-10. In another embodiment, the volume indicator may comprise a window portion 204 as shown in Figures 9-10 in combination with the first and second engagement elements 148, 206 as shown in Figures 4A-4C.

[0094] As used in this application and the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "comprising" means "consisting of." Additionally, the terms "coupled" and "associated" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked and do not exclude the presence of intermediate elements between coupled or associated items in the absence of specific language to the contrary.

[0095] In the context of this application, the terms "lower" and "upper" are used interchangeably with the terms "inlet" and "outlet," respectively. Thus, for example, the lower end of a valve is its inlet end and the upper end of a valve is its outlet end.

[0096] As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and away from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device toward the user, while distal movement of a device is movement of the device away from the user. The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless expressly specified otherwise.

[0097] In view of the many possible embodiments to which the principles of the present disclosure may be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be considered as limiting the scope of the disclosure, the scope of which is defined by the claims. [Explanation of symbols]

[0098] 10 Artificial valves 12 Frames 14 Valve structure 16 Leaflet 18 commissure 20 Reinforcement members 22 Sealing materials 100 Delivery device 102 Handle 104 First Shaft 106 Second Shaft 110 Distal Section 112 Knob 114 Adjustment knob 114b Second expansion indicator 116 Balloon 118 Proximal Port 120 Sidearm 122a First expansion indicator 122b Second expansion indicator 126 Syringe 128 Syringe body 130 First end 132 Second End 134 Plunger 136 Plunger shaft 138 Plunger Head 140 Plunger Handle 142 Syringe gripping part 144 Conduit 146 Measurement Mark 148 first engagement element 150 End face 152 Tapered Surface 154 Engagement element 156 Annular Lip 200 Volume Indicator 200a Volume Indicator 200b Volume Indicator 200c volume indicator 202 Indicator body 204 Window section 206 Second engagement element 206a second engagement element 206b second engagement element 206c Second engagement element 208 Size indicator (embossed) 210 First end 212 Second End 214 Expansion indicator 214a First expansion indicator 214b Second expansion indicator 214c Third expansion indicator 216 Protrusion 218 sides 220 sides 222a Expansion indicator 222b Expansion indicator 222c 3rd expansion indicator 224 Second engagement element 226 Prominence 228 Proximal end 230 Arm

Claims

1. 1. A volume indicator for a syringe comprising a syringe body and a plunger received within the syringe body, comprising: The indicator body, a window portion extending through a thickness of the indicator body such that a portion of the syringe plunger within the syringe body is visible through the window portion, the window portion including an expansion volume indicator adjacent to the window portion; Equipped with the indicator body includes a first engagement element and a second engagement element; the first engagement element being an aperture extending through the indicator body and configured to engage a first protrusion of the syringe body; the second engagement element being an aperture extending through the indicator body and configured to engage a second protrusion extending from a lip of the syringe body; The first and second engaging elements, when engaged with corresponding projections on the syringe body, prevent rotation of the volume indicator. Volume indicator.

2. The volume indicator of claim 1 , wherein the expansion volume indicator comprises a protrusion extending at least partially across the window portion.

3. The volume indicator of claim 1 , wherein the expansion volume indicator comprises a band extending across the window portion.

4. A volume indicator according to any one of claims 1 to 3, wherein the indicator body is at least partially opaque.

5. 5. A volume indicator as claimed in any one of claims 1 to 4, wherein the window portion is disposed between a first end of the indicator body and a second end of the indicator body and extends over a distance less than the entire length of the indicator body.

6. 1. An assembly comprising: A syringe including a syringe body and a plunger, the syringe body having a first protrusion and a second protrusion on an outer surface of the syringe body, the first protrusion and the second protrusion having different shapes; a volume indicator having an indicator body and a window portion having an expansion volume indicator along its length; Equipped with the indicator body includes a first engagement element and a second engagement element; the first engagement element being an aperture extending through the indicator body and configured to engage a first protrusion of the syringe body; the second engagement element being an aperture extending through the indicator body and configured to engage a second protrusion extending from a lip of the syringe body; The first and second engaging elements, when engaged with corresponding projections on the syringe body, prevent rotation of the volume indicator. assembly.

7. The assembly of claim 6 , wherein the window portion is configured to allow a portion of the plunger within the syringe body to be visible through the window portion.

8. 8. The assembly of claim 6 or 7, wherein the one or more first and second engaging elements are disposed on the syringe body and the indicator body such that the volume indicator is coupleable to the syringe in only one direction.

9. 9. The assembly of claim 6, wherein the one or more first engaging elements are posts having tapered sides configured to form an interference fit with the one or more second engaging elements.

10. 10. The assembly of claim 6, wherein the volume indicator is configured to removably clip onto the syringe body.

11. 11. The assembly of claim 6, wherein the one or more first engagement elements are configured to engage with the one or more second engagement elements to inhibit rotational movement of the volume indicator relative to the syringe.

12. 12. The assembly of claim 11, wherein the one or more first engaging elements are protrusions extending from an outer surface of the syringe body, and the one or more second engaging elements are notches sized to engage with the first engaging elements.

13. disposing a volume indicator on a syringe, the syringe comprising a syringe body and a plunger received within the syringe body, the volume indicator comprising an indicator body and an expansion volume indicator on the indicator body, the syringe body having a first protrusion and a second protrusion, the indicator body comprising a first engagement element and a second engagement element, the first engagement element being an opening extending through the indicator body and configured to engage with the first protrusion of the syringe body, the second engagement element being an opening extending through the indicator body and configured to engage with the second protrusion, the first engagement element and the second engagement element preventing rotation of the volume indicator when engaged with corresponding protrusions of the syringe body; filling the syringe body with an amount of fluid corresponding to one of the expansion volume indicators on the indicator body; fluidly connecting the syringe to a delivery device for the prosthetic valve; Including, method.

14. 14. The method of claim 13, wherein the act of disposing the volume indicator on the syringe includes engaging one or more first engaging elements on the syringe body with one or more second engaging elements on the indicator body.

15. 15. The method of claim 13 or 14, wherein when the volume indicator is placed on the syringe, the expanded volume indicator on the indicator body does not align with the expanded volume indicator on the syringe body.

16. 16. The method of any one of claims 13 to 15, wherein the volume indicator is selected from a kit of volume indicators.

17. The method of claim 16 , wherein each volume indicator in the kit corresponds to a different nominal valve size.

18. 18. The method of claim 16 or 17, wherein the kit includes a first volume indicator corresponding to a prosthetic heart valve having a nominal size of 20 mm, 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.

19. 1. An assembly comprising: a removable volume indicator for attachment to a syringe, the removable volume indicator comprising an indicator body and an expansion volume indicator spaced along a length thereof, the indicator body comprising a first engaging element and a second engaging element, the first engaging element being an opening extending through the indicator body and configured to engage a first protrusion on the syringe body, and the second engaging element being an opening extending through the indicator body and configured to engage a second protrusion extending from a lip of the syringe body; A delivery device for implanting a prosthetic heart valve, the device including a balloon attached to a distal portion thereof; Equipped with the syringe includes a first protrusion and a second protrusion on an exterior surface of the syringe, the second protrusion extending from a lip of the syringe; the first and second engagement elements of the indicator body are configured to engage the first and second protrusions, the first engagement element being an aperture extending through the indicator body; The first and second engaging elements, when engaged with corresponding projections on the syringe body, prevent rotation of the volume indicator. assembly.

20. 20. The assembly of claim 19, further comprising a prosthetic heart valve expandable to an expanded function diameter within a range of expanded diameters, said expansion volume indicator corresponding to said range of expanded diameters.

21. A kit comprising: At least first and second removable volume indicators for attachment to the same syringe, each volume indicator comprising an indicator body and an expansion volume indicator spaced apart along a length thereof. Equipped with the expansion amount indicator of the first volume indicator corresponds to a range of expansion diameters of a first prosthetic valve, and the expansion amount indicator of the second volume indicator corresponds to a range of expansion diameters of a second prosthetic valve that is larger than the first prosthetic valve; Each of the indicator bodies includes an engagement element configured to engage a syringe engagement element on an exterior surface of the syringe. kit.

22. 22. The kit of claim 21, further comprising a third volume indicator and a fourth volume indicator.

23. 23. The kit of claim 21 or 22, further comprising a delivery device that can be used to implant the first and second prosthetic heart valves, the device comprising a balloon attached to a distal portion thereof.

24. 24. The kit of any one of claims 21 to 23, further comprising the first prosthetic heart valve or the second prosthetic heart valve.

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