Removable volume indicator for a syringe

Abstract

The present application relates to a detachable volume indicator for a syringe. A volume indicator for a syringe can include an indicator body configured to be detachably clipped onto a syringe body and a window portion extending through a thickness of the indicator body. The volume indicator can include an inflation indicia corresponding to a range of expanded diameters of a prosthetic heart valve. The volume indicator can include one or more first engagement elements corresponding to one or more second engagement elements on the syringe.

Description

[0001] This application is a divisional application of the original application with the filing date of June 3, 2019, the application number of 201980036979.9, and the invention title of “Detachable volume indicator for syringe”. TECHNICAL FIELD

[0002] The present disclosure relates to a detachable volume indicator for a syringe and, in particular, for a syringe used to inflate a balloon-expandable prosthetic heart valve. BACKGROUND

[0003] Prosthetic heart valves have been used for many years to treat heart valve disorders. The natural heart valves, such as the aortic valve, the pulmonary valve, and the mitral valve, play a critical role in ensuring that an adequate supply of blood flows in the proper direction through the cardiovascular system. Congenital, inflammatory, or infectious conditions can reduce the efficiency of these heart valves. This impairment to the valves can lead to serious cardiovascular damage or death. For many years, the definitive treatment for such disorders has been surgical repair or replacement of the valve during open-heart surgery, but such surgery is prone to a variety of complications. Due to the drawbacks associated with conventional open-heart surgery, percutaneous and minimally-invasive surgical methods are gaining strong interest. In one technique, a prosthetic valve is configured to be implanted through a catheterization procedure in a less-invasive procedure.

[0004] In this technique, the prosthetic valve is mounted in a crimped state on the end of a flexible catheter and is 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 on which the prosthetic valve is mounted. For example, U.S. Patent Nos. 5,411,522 and 6,730,118 describe crimpable transcatheter heart valves that can be introduced percutaneously on a catheter in a compressed state and expanded at the desired location either by balloon inflation or by utilizing a self-expanding frame or stent.

[0005] Transcatheter prosthetic heart valves generally have only one functional expanded diameter at which the leaflets of the prosthetic valve can work as intended. The general delivery instrument for balloon-expandable prosthetic valves can be fluidly connected to a syringe for injecting inflation fluid into the balloon to deploy the prosthetic valve at the implantation site. The balloon is generally designed or selected to be inflated by a predetermined amount of fluid corresponding to a specific 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.

[0006] Recently, transcatheter prosthetic heart valves have been developed that can be expanded over a range of functional sizes, as disclosed in U.S. Patent Application No. 2018 / 0028310. To implant such a prosthetic valve, a physician must be able to select an appropriate volume of inflation fluid from a range of fill volumes that corresponds to the selected prosthetic valve diameter. Using a conventional inflation syringe, a physician can have difficulty drawing into the syringe the precise amount of inflation fluid needed to expand the prosthetic valve to the desired size - if the required volume does not correspond to one of the volume indicators provided on the syringe.

[0007] Accordingly, 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. SUMMARY

[0008] Described herein are embodiments of a detachable volume indicator, primarily intended for use with an inflation syringe to inflate a balloon to expand a prosthetic heart valve, and methods of use thereof. The volume indicator can be used to draw a precise amount of fluid into a syringe when the required volume does not correspond to any of the volume markings present on the syringe.

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

[0010] In some embodiments, the volume indicator can further include inflation indicia adjacent the window portion. In some embodiments, the inflation indicia can include a protrusion extending at least partially across the window portion. In other embodiments, the inflation indicia can include 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 located between a first end of the indicator body and a second end of the indicator body, and can extend less than a full length of the indicator body.

[0013] In representative embodiments, an assembly includes a syringe and a volume indicator. The syringe can include a syringe body having one or more first engagement elements and a plunger. The volume indicator can include an indicator body and a window portion having an inflation indicium along a length thereof; the indicator body includes one or more second engagement elements configured to engage the first engagement elements.

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

[0015] In some embodiments, the volume indicator is configured to be detachably clipped onto the syringe body.

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

[0017] In some embodiments, the volume indicator can further include 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 can include an annular flange at a proximal end portion thereof. The body of the volume indicator can abut the flange such that, during inflation of a prosthetic valve with the syringe, a user can grip the ridges and press the plunger of the syringe. Pressing the plunger exerts a distal force on the syringe / volume indicator assembly, and a corresponding proximal force is required by the user to prevent movement of the assembly. The abutment of the volume indicator against the flange during the application of force helps to prevent the volume indicator from disengaging from the syringe.

[0018] In some embodiments, the syringe can further include one or more third engagement elements, and the volume indicator can further include one or more fourth engagement elements configured to engage with the one or more third engagement elements to prevent rotational movement of the volume indicator relative to the syringe.

[0019] In another representative embodiment, an assembly includes a syringe and a volume indicator. The syringe can include a syringe body having a first engagement element and a plunger. The volume indicator can include an indicator body and a window portion having expansion indicia along a length thereof; the indicator body including a second engagement element configured to engage 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 opening configured to engage 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 the third retention element to arrest rotational movement of the volume indicator relative to the syringe body.

[0020] In another representative embodiment, a method of using a volume indicator with a syringe can include arranging a volume indicator on a syringe, the syringe including a syringe body and a plunger received in the syringe body, and the volume indicator including 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 instrument for a prosthetic heart valve.

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

[0022] In some embodiments, the method can further include inserting a distal portion of the delivery instrument and the prosthetic heart valve into a patient's body, the prosthetic heart valve mounted in a radially compressed configuration on a balloon mounted on the distal portion of the delivery instrument.

[0023] In some embodiments, the method can further include advancing the distal portion of the delivery instrument and the radially compressed prosthetic valve through the patient's vasculature to position the prosthetic valve at a selected implantation site, and actuating the plunger of the 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 can be expandable to an expanded functional diameter within an expanded diameter range, 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 expanded diameter range.

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

[0026] In some embodiments, the volume indicators are selected from a volume indicator kit. 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 representative embodiment, the assembly includes a detachable volume indicator for mounting on a syringe, the volume indicator including an indicator body and expansion indicia spaced along a length thereof; and a delivery instrument for implanting a prosthetic heart valve, the instrument including a balloon mounted on a distal portion thereof.

[0028] In some embodiments, the assembly can further include a prosthetic heart valve expandable to an expanded functional diameter within an expanded diameter range, wherein the expansion indicia correspond to expanded diameters in the range.

[0029] In another representative embodiment, the kit can include at least first and second detachable volume indicators for mounting on the same syringe, each volume indicator including an indicator body and expansion indicia spaced along a length thereof, the expansion indicia of the first volume indicator corresponding to an expanded diameter range of a first prosthetic valve, and the expansion indicia of the second volume indicator corresponding to an expanded diameter range of a second prosthetic valve, the second prosthetic valve being 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 can further include a delivery instrument usable for implanting the first prosthetic heart valve and the second prosthetic heart valve, the instrument including a balloon mounted on a distal portion thereof. In some embodiments, the kit can further include the first prosthetic heart valve and / or the second prosthetic heart valve.

[0031] The various innovations of the present disclosure can be applied in combination or separately. This Summary has been presented for purposes of summary only and in order to provide a basic understanding of the concepts selected for discussion in this Summary. This Summary is not intended to be an extensive overview of the subject matter of the application, which is best captured by the following detailed description. The foregoing and other objects, features and advantages of the present disclosure will become more readily apparent from the following detailed description, which proceeds with reference to the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0032] Figure 1 is a side elevational view of a representative embodiment of a delivery instrument for implanting a prosthetic heart valve.

[0033] Figure 2 is a perspective view of a representative embodiment of a prosthetic heart valve.

[0034] Figure 3 is a perspective view of a representative embodiment of a syringe that can be used to inflate a balloon of a delivery instrument according to one embodiment.

[0035] Figures 4A-4C is a front elevation view of three different volume indicators that can be mounted on a syringe.

[0036] Figure 5 is an end view of a volume indicator of Figure 4A

[0037] Figure 6 is a perspective view of a volume indicator of Figure 3 mounted on a syringe body of Figure 4A

[0038] Figure 7 is a perspective view of an embodiment of a volume indicator disposed on a syringe of Figure 3

[0039] Figure 8 is a front elevation view of an embodiment of a volume indicator disposed on a syringe of Figure 3

[0040] Figure 9 is a perspective view of another embodiment of a volume indicator mounted on a syringe body.

[0041] Figure 10 is a cross-sectional view of a portion of a volume indicator of Figure 9 DETAILED DESCRIPTION

[0042] In a detailed description, a delivery assembly for implanting a prosthetic transcatheter heart valve via a patient's vasculature includes a syringe for inflating a balloon of a delivery instrument for the purpose of radially expanding a prosthetic valve radially crimped on the balloon. The balloon can be mounted on a distal end portion of a shaft of the delivery instrument. The balloon and the crimped prosthetic valve can be inserted into the patient's vasculature via an introducer sheath, and after the balloon and the crimped prosthetic valve reach a suitable location in the body, the prosthetic valve can be expanded at a treatment site (e.g., a native aortic valve).

[0043] Figure 1 ​​​​​A delivery instrument 100 is shown that is adapted to deliver a prosthetic heart valve, such as the example prosthetic heart valve 10, in accordance with one embodiment. The prosthetic heart valve 10 can be, for example, a prosthetic aortic valve that is adapted to be implanted in a native aortic valve, however in other embodiments the prosthetic valve 10 can be implanted in any other native valve of the heart (native mitral, tricuspid, or pulmonary valve). The delivery instrument 100 generally includes a handle 102, a first elongated shaft 104 extending distally from the handle 102, and a second elongated shaft 106 extending distally from the handle 102 and coaxially through the first shaft 104.

[0044] In some embodiments, the first shaft 104 can be configured as a steerable guide catheter having an adjustable curvature for steering the delivery instrument through the vasculature of a patient. For example, the first shaft 104 can include a steerable distal section 110 having a curvature that can be adjusted by an operator to assist in steering the instrument through the vasculature of a patient. A steering or pull wire (not shown) can extend through the shaft 104 and can have a distal end fixed at a location along the distal section 110 and a proximal end operably connected to an adjustment mechanism, such as an example knob 112, on the handle 102.

[0045] In some embodiments, the first shaft 104 and the second shaft 106 can be movable relative to one another (axially and / or rotationally) to facilitate delivery and positioning of the prosthetic valve 10 at an implant site within a patient. The handle 102 can include adjustment mechanisms to produce relative movement between the shafts 104, 106. For example, the handle can include a slidable adjustment knob 114 that is operably connected to the second shaft 106 and configured to produce axial movement of the second shaft 106 relative to the first shaft 104 in proximal and distal directions.

[0046] An inflatable balloon 116 can be mounted along a distal portion of the second shaft 106, which can be referred to as a balloon catheter. As shown, the prosthetic valve 10 can be radially crimped around the balloon 116 for delivery into the vasculature of a patient. After the prosthetic valve 10 reaches a desired implant site (e.g., within a native aortic valve), the balloon can be inflated to radially expand the prosthetic valve against surrounding tissue. Figure 1

[0047] The delivery instrument 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 instrument 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 that is in fluid communication with a lumen defined by the handle 102. The flush tube can terminate at or adjacent to a sealing member where the flush tube connects with internal passageways defined by the shaft 106 and / or the shaft 104. ​

[0048] The proximal port 118 may form a fluid passage that is fluidly connected to a fluid source (e.g., a syringe filled with saline, see below). Figure 3 This allows the balloon 116 to inflate and optionally flush the space between the inner and outer balloon catheter axes. Therefore, the fluid passage of the proximal port 118 is fluidly connected to the annular space between the first and second axes, allowing fluid from a fluid source to flow through this passage, through the space between the axes, and into the balloon 116 to inflate it and deploy the prosthetic valve 10. In an alternative embodiment, the proximal port 118 may communicate with the lumen of a second axis 106, which serves as a fluid passage for delivering inflating fluid from a fluid source to the balloon 116.

[0049] In some embodiments, the proximal port 118 may further include a thrombus (not shown) movable between an open position and a closed position (e.g., by manual actuation by a physician). Wherein, when the thrombus is in the open position, fluid from a fluid source can flow into the fluid passage, and wherein, when the thrombus is in the closed position, fluid from the fluid source is prevented from flowing into the fluid passage.

[0050] The first shaft 104 and the second shaft 106 can be formed from any of a variety of suitable materials, such as nylon, braided stainless steel wire, or polyether block amide (which can be (Commercial purchase), to name just a few. The shaft may have longitudinal sections formed of different materials to vary the flexibility of the shaft along its length. The second shaft 106 may have sections made of... The liner or inner layer is formed to minimize sliding friction with the guidewire.

[0051] Further details regarding the delivery device 100 and methods for delivering and deploying prosthetic valves using the delivery device can be found, for example, in U.S. Publication No. 2017 / 0065415. Other examples of delivery devices 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.

[0052] refer to Figure 2 The prosthetic heart valve 10 includes 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 adapted for implantation in a natural aortic valve and can be implanted in the body using, for example, the delivery device 100 described above. The frame 12 may include a malleably expandable material, such as stainless steel, nickel-based alloys (e.g., nickel-cobalt-chromium alloys), polymers, or combinations thereof, such that when the prosthetic valve is inflated by the balloon 116, it compresses radially from a folded configuration. Figure 1 Expanding to radially expanded configuration ( Figure 2) the frame 12 can plastically expand.

[0053] The valve structure 14 can include a plurality of leaflets 16 mounted on the inner side of the frame. Opposing sides of each leaflet 16 can pair with adjacent leaflets to form commissures 18 of the valve structure. The commissures 18 can be mounted to the frame via a reinforcing member 20. The prosthetic valve 10 can also include a sealing member 22 mounted on the outer side of the frame. The sealing member 22 is configured to help seal the prosthetic valve against surrounding tissue and prevent or minimize paravalvular leakage. The leaflets 16 can be made of 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 woven or non-woven materials (e.g., polyurethane). The reinforcing member 20 and the sealing member 22 are desirably made of a woven material such as polyethylene terephthalate (PET) fabric, although non-woven materials and natural tissue can also be used. Further details of the prosthetic valve 10 are disclosed in U.S. Patent Application 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. Patent Nos. 7,510,575; 7,993,394; and 9,393,110.

[0054] In particular embodiments, the prosthetic valve 10 can be radially expanded to an expanded state having an outer diameter in an expanded diameter range. This allows a physician to expand the prosthetic valve 10 to a size that closely corresponds to the diameter of the native valve annulus in which the prosthetic valve is intended to be implanted. For example, in one particular embodiment, a prosthetic valve 10 having a "nominal" size of 23 mm can be expanded to a diameter in a range from about 21.5 mm to about 23.3 mm in diameter. As used herein, the "nominal" size of a prosthetic valve is an approximation of the outer diameter of the prosthetic valve in the expanded state. The size range of the expanded diameter of a prosthetic valve generally includes the nominal size of the prosthetic valve. Generally, although not necessarily, the nominal size of a 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.

[0055] After the prosthetic heart valve 10 has been positioned at the desired implant 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 at which the prosthetic valve securely engages the annulus of the native heart valve without over- expanding the native annulus. Figure 3 One example of a syringe 126 that can be used to inject inflation fluid into the balloon 116 is shown. In some embodiments, the final diameter of the prosthetic valve 10 can be predetermined by measuring the native annulus using known techniques. In other embodiments, the final diameter of the prosthetic valve can be determined during the implant procedure (e.g., as the prosthetic valve is being expanded). The syringe 126 can be equipped with a volume indicator 200 Figures 4A-4CThe volume indicator 200 allows physicians to more accurately select or measure the fluid volume required to expand the prosthetic valve to the desired final diameter, as further described below.

[0056] refer to Figure 3 In an example embodiment, syringe 126 may have a cylindrical syringe body 128 having an internal chamber for receiving expanding fluid. Syringe body 128 has a diameter D1, a first end 130, and a second end 132. Syringe 126 may include a conduit 144 (e.g., a medical-grade flexible polymer conduit) extending from the first end 130 of body 128. The first end 130 of body 128 may have an opening that fluidly connects the internal chamber of body 128 to an adjacent end of conduit 144. Before the delivery device 100 is introduced into a patient's body, the opposite end (not shown) of conduit 144 may be fluidly connected to a proximal port 118 of the delivery device. For example, conduit 144 may be connected to proximal port 118 using a rotary Luer connector.

[0057] The syringe 126 may further include a plunger 134, the plunger 134 including a shaft 136 extending into an internal cavity of the body 128, and a plunger head 138 attached to one end of the shaft 136 and located within the internal cavity of the body 128. Figure 8 The syringe body 128 includes a plunger handle 140 attached to the other end of the shaft 136. A 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 mounted on the syringe body 128 and may be used to measure the pressure of the expanding fluid as fluid is expelled from the syringe and enters the delivery device.

[0058] The syringe grip portion 142 may be mounted against the second end 132 of the body and may include a central opening through which the plunger shaft 136 extends. Therefore, in use, a physician can grip the syringe grip portion 142 with one hand and 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 can fill the syringe body with the desired amount of expansion fluid by pulling the plunger 134 away from the syringe body 128 (this draws fluid into the internal chamber of the body (assuming the conduit 144 is fluidly connected to another source of expansion fluid)). Alternatively, expansion fluid can be introduced into the syringe body by completely removing the plunger 134 from the syringe body 128, allowing expansion fluid to be poured in through the opening at the second end 132 of the body. The physician can push the fluid out of the syringe body 128 by further pushing the plunger 134 into the internal chamber of the syringe body.

[0059] The syringe body 128 may be transparent or at least translucent to allow the user to see the amount of expanding fluid and the position of the plunger head 138 within the body. In some embodiments, the outer surface of the syringe body may include a series of markings or measurement indicators 146 that allow the user to measure the amount of expanding fluid within the body 128. In other embodiments, the syringe may be entirely without measurement indicators (e.g., it may be a blank syringe). Figure 3 As shown, in the example embodiment, the measurement mark 146 is arranged with a volume mark corresponding to the minimum value adjacent to the first end 130 of the body 128 (which is the outlet of the syringe body) and a volume mark corresponding to the maximum value adjacent to the second end 132 of the body. In this way, when the user draws fluid from the source into the syringe body 128 via the conduit 144 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 mark corresponding to the desired amount of fluid.

[0060] The syringe body 128 may further include one or more first engaging elements 148 projecting outward from the outer surface of the body. Each engaging element 148 may be a small cylindrical protrusion as shown, although in other embodiments the engaging elements may have any of a variety of other cross-sectional shapes (e.g., square, rectangular, triangular, elliptical, and / or combinations thereof). In some embodiments, the one or more first engaging elements 148 may include a plurality of first engaging elements spaced apart from each other 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 a specific embodiment, the single first engaging element 148 may be located at the first end portion 130 of the syringe and may be projected from its surface (e.g., Figure 9 The upward-facing surface (as shown in the diagram) extends outwards.

[0061] In a specific embodiment, syringe 126 includes a QL38 syringe available from Atrion Medical (Arab, AL), which is modified to include one or more first engagement elements 148 on the syringe body.

[0062] Known delivery systems typically feature a prosthetic valve with only one functional expansion diameter, which is expanded using a balloon that inflates with a predetermined amount of fluid corresponding to one of the volume indicators 146 on the syringe body 128 (typically, the fluid volume is an integer). This allows the user to fill the syringe with the precise amount of fluid required for the procedure. However, if the prosthetic valve has more than one functional expansion diameter and instead expands within a range of expansion diameters, the user may find it difficult to aspirate the precise amount of expansion fluid required to expand the prosthetic valve to the desired size into the syringe body—if the required volume falls between the two volume indicators 146.

[0063] Figures 4A-4C Representative embodiments of a set of removable volume indicators 200a, 200b, 200c used in conjunction with a syringe (such as syringe 126) are provided. The removable volume indicators can be used to aspirate a precise amount of fluid into the syringe when the desired volume does not correspond to any existing volume markings on the syringe. For ease of description, reference numeral 200 is used when describing common features of the various volume indicators 200a, 200b, 200c. Each volume indicator 200 may include an indicator body 202 having a window portion 204 formed within the indicator body. In some embodiments, the volume indicator may further include one or more second engagement elements 206 that may mate with one or more corresponding first engagement elements 148 on the syringe body 128.

[0064] like Figures 4A-4C As shown, each volume indicator 200 may correspond to a nominal prosthetic valve size. In some embodiments, a single volume indicator may be packaged and / or sold together with a prosthetic valve of the corresponding size and / or a suitable delivery device. In other embodiments, two or more volume indicators may form a component or kit, and the volume indicators of the kit may be packaged together for delivery to an end user. In some embodiments, the kit may further include a delivery device, a prosthetic valve, a syringe, and / or any combination of these elements. An exemplary kit may include two or more volume indicators 200, a delivery device 100, and a prosthetic valve 10. Alternatively, the prosthetic valve 10 may be packaged and sold separately from a kit including two or more volume indicators and a delivery device. The number of volume indicators included in a kit may be equal to the number of different nominal valve sizes that can be used with the same delivery device. Another exemplary component may include three volume indicators 200 and a delivery device 100. Yet another exemplary component may include two or more volume indicators 200 and a syringe 126.

[0065] During an implant procedure, a physician can have access to a plurality of volume indicators 200 (e.g., in a kit) and select an appropriate volume indicator corresponding to an appropriate size of a prosthetic valve. Regardless of the size of the prosthetic valve 10 that the physician ultimately selects, the various volume indicators allow a single syringe 126 to be used for the implant procedure. The volume indicators 200 can be labeled, marked, colored, and / or patterned to indicate the corresponding nominal prosthetic heart valve size. In an example embodiment, the volume indicators have molded reliefs 208 indicating the nominal diameter of the corresponding prosthetic valve. In other embodiments, the volume indicators 200 can be marked with, for example, pad printing, laser engraving, or other marking methods.

[0066] Referring now to Figure 4A , the indicator body 202 can have a length LI and can be sized to cover at least a portion of the measurement indicia 146 on the syringe body 128 (when such measurement indicia are present) when the volume indicator 200 is disposed on the syringe 126. In particular embodiments, the body 202 extends the full length of the syringe body 128 or substantially the full 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 can be opaque or substantially opaque such that the measurement indicia 146 of the syringe 126 are completely obscured, partially obscured, or otherwise minimized. Thus, the volume indicator 200 helps prevent the 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, in which the volume indicator is used with a blank syringe, the volume indicator can be opaque, transparent, substantially transparent, or translucent.

[0067] As shown in Figure 5 , the indicator body 202 can have a C-shaped cross-section with an opening of width Wl such that it can be removably clipped or "snapped" onto the syringe body 128. The width Wl of the opening can be slightly smaller than the diameter Dl of the syringe body 128 such that the body 202 is slightly deformed or expanded to allow the syringe body 128 to pass through the opening. The width Wl of the opening can help retain the syringe body 128 within the volume indicator 200. In particular embodiments, the inner diameter D2 of the indicator body 202 can be equal to or slightly smaller than the outer diameter Dl of the syringe body such that the indicator body 202 forms a tight or snug fit against the outer surface of the syringe body 128.

[0068] Referring again to Figures 4A-4C , in some embodiments, the one or more second engagement elements 206 (e.g., three, in Figures 4A-4CIn the illustrated embodiment, it can be configured to engage with a corresponding first engagement element 148 extending from the syringe body 128 (see, for example, Figure 3 Matching. As shown in the example embodiment, the one or more second engaging elements 206 may be C-shaped notches formed along the edge of the indicator body 202 and shaped to receive the one or more first engaging elements 148. Additionally, one or more of the engaging elements 206 may be configured to form a releasable connection with a corresponding first engaging element.

[0069] For example, such as Figure 4B As shown, second engaging elements 206a and 206c can be configured to form a snap-fit ​​connection with the corresponding first engaging element 148, while second engaging element 206b can be shaped to mate with the corresponding first engaging element 148, but not to form a snap-fit ​​or other type of secure connection with the corresponding first engaging element 148. Each second engaging element 206a, 206c may include two bow-shaped deflectable arms 230 configured to be arranged around the corresponding first engaging element 148. The arms 230 are sized and shaped to deflect 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 positioned between the arms. The snap-fit ​​connection helps to secure the volume indicator 200 against the syringe body 128 and prevents the volume indicator from moving relative to the syringe body. It should be noted that, in an alternative embodiment, all or only one second engaging element may be configured to form a snap-fit ​​connection with the corresponding first engaging element.

[0070] It should also be noted that, although in the example embodiment the second engaging element 206 is configured to receive a C-shaped notch of the corresponding cylindrical first engaging element 148, in other embodiments the second engaging element 206 may be any of a variety of sizes and shapes (e.g., circular, rectangular, oval, etc.) configured to match the first engaging element 148.

[0071] Furthermore, in an alternative embodiment, one or more of the second engaging elements 206 may be openings formed in the indicator body 202, which are configured to form a releasable connection with a corresponding first engaging element 148 (e.g., by snapping, clipping, or inserting the first engaging element into or through the second engaging element). See below for further details. Figures 9-10 Examples of this implementation are described in more detail.

[0072] refer to Figure 4CIn some embodiments, the one or more second engagement elements 206 can be spaced apart from each other along the length of the indicator body 202. In some embodiments, two or more of the one or more second engagement elements 206 can be disposed collinearly with another. The distance between adjacent engagement elements 206 can vary, such that the volume indicator 200 can only be connected to the syringe body 128 in one orientation, preventing improper mounting of the volume indicator on the syringe body from resulting in inaccurate measurements. For example, in the example embodiment, the second engagement elements 206a and 206b are spaced apart by a first distance XI, and the second engagement elements 206b and 206c are spaced apart by a second distance X2. The first distance XI and the second distance X2 can be different from each other. For example, XI can be greater than X2, as shown. The first engagement elements 148 on the syringe body 128 can correspondingly be spaced apart. In the example embodiment, the engagement elements 148, 206 are spaced apart from each other such that the volume indicator 200 can only be arranged on the syringe body 128 if the size indicator 208 is oriented at the second end portion 132 of the syringe body. Figure 4C The first engagement elements 148 on the syringe body 128 can correspondingly be spaced apart. In the example embodiment, the engagement elements 148, 206 are spaced apart from each other such that the volume indicator 200 can only be arranged on the syringe body 128 if the size indicator 208 is oriented at the second end portion 132 of the syringe body.

[0073] The window portion 204 can be formed within the indicator body 202 and can extend a length L2, where L2 is less than the length LI of the indicator body. Again referring to Figure 4A In some embodiments, the length L2 can be less than a majority of the length LI of the indicator body (i.e., less than 50% of the length LI). Thus, the window portion 204 in the example embodiment, which includes the expansion indicia 214 discussed below, is used to measure a volume that is substantially less than the total volume capacity of the syringe. However, in alternative embodiments, the window portion 204 (and corresponding indicia 214) can extend a length L2 that is greater than 50% of the length LI or substantially equal to the length LI. The window portion can have a first end 210 configured to be disposed closer to the first end portion 130 of the syringe body 128 when the volume indicator is arranged on the syringe body and a second end 212 configured to be disposed closer to the second end portion 132 of the syringe body 128 when the volume indicator is arranged on the syringe body.

[0074] In some embodiments, as shown in FIGS. 4-10, the window portion 204 can be an opening or hole that extends completely through the indicator body 202 such that a portion of the plunger 134 (e.g., the head 138) is visible through the window portion. In other embodiments, the window portion 204 can be a portion of the body 202 formed from a transparent, semi-transparent, or translucent material configured such that a portion of the plunger 134 is visible through the window.

[0075] Window portion 204 may further include expansion markings 214 corresponding to the fluid volume required to expand the prosthetic heart valve to a selected diameter within a specific range of prosthetic valve diameters. The expansion markings 214 may be a series of marks or protrusions that visually indicate to the physician the fluid volume required to expand the prosthetic heart valve to different diameters. In volume indicator 200a used with a prosthetic valve of nominal diameter 23 mm, the expansion markings may, for example, correspond to the fluid volumes required to expand the valve to diameters of 22.5 mm, 23 mm, and 23.5 mm, respectively. In volume indicator 200b used with a prosthetic valve of nominal diameter 26 mm, the expansion markings may, for example, correspond to the fluid volumes required to expand the valve to diameters of 24.5 mm, 25.8 mm, and 27 mm, respectively. In the volume indicator 200c used in conjunction with a prosthetic valve of nominal diameter 29 mm, the expansion markings may correspond, for example, to the fluid volumes required to expand the valve to diameters of 27.5 mm, 28.8 mm, and 30.0 mm, respectively. In an exemplary volume indicator used in conjunction with a prosthetic valve of nominal diameter 21 mm, the expansion markings may correspond, for example, to the fluid volumes required to expand the valve to diameters of 20.5 mm, 21 mm, and 21.5 mm, respectively.

[0076] like Figures 4A-4C As shown, the window portions 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 position of the window portion can correspond to a range of syringe volumes used to expand each different nominal size prosthetic valve to the corresponding diameter range. This variability among the volume indicators 200 allows the same syringe 126 to be used with each volume indicator and therefore with each prosthetic valve. In other embodiments, the window portions 204 of each volume indicator 200 can be positioned in the same location, and the expansion mark 214 can be positioned at different positions along the length of the window 204 depending on the nominal size and diameter range of the corresponding prosthetic valve. The position of the volume mark 214 within the window portion 204 can correspond to a range of syringe volumes used to expand each different nominal size prosthetic valve to the corresponding diameter range.

[0077] Now for reference Figure 4BIn example embodiments, the inflation indicia 214 are triangular protrusions 216 extending inwardly from the two sides 218, 220 of the window portion 204. As shown, each protrusion can extend partially across the width of the window portion. In other embodiments, the inflation indicia can extend across the entire width of the window portion 204; in other words, the indicia can comprise a plurality of bands spaced along the length of the window portion, with each band extending from one side 218 to the other side 220 of the window portion. In yet other embodiments, the inflation indicia can be notches in the sides 218, 220 of the window portion. The inflation indicia 214 can be labeled (e.g., numbered), colored, and / or patterned to indicate the prosthetic heart valve diameter corresponding to each indicator, so that a physician can quickly and easily assess whether the proper fluid volume is contained within the syringe body.

[0078] In some embodiments, the inflation indicia can be made of metal, plastic, and / or other materials. In some embodiments, the inflation indicia can be integrally formed with the window portion. Alternatively, the inflation indicia can be separately formed and then joined in the manufacturing process, such as by welding, adhesive, and / or mechanical means such as screws. In embodiments in which the window portion is a transparent portion of the indicator body, the inflation indicia can be a colored and / or patterned, transparent or translucent band integrally formed with the window portion.

[0079] In some embodiments, the inflation indicia can include markings conveying valve-specific information (e.g., the fluid volume within the syringe or the deployed valve diameter for each indicator marking). These markings can be created using, for example, molded relief, pad printing, laser engraving, or other marking methods.

[0080] In one particular embodiment, the inflation indicia 214 can 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 can 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.

[0081] In use, when Figure 7When the volume indicator 200 is arranged on the syringe, the physician can fill the syringe (e.g., by pulling the plunger 134 while the tubing 144 is connected to a fluid source) until, for example, the end face 150 of the plunger head 138 of the plunger 134 is aligned with the expansion indicator 214 corresponding to the selected diameter size. In other embodiments, the syringe can be filled by aligning an O-ring on the plunger head 138 with the expansion indicator 214 corresponding to the selected diameter size. Upon such alignment, the syringe body contains the volume of fluid needed 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 can fill the syringe until the plunger head 138 of the plunger 134 is aligned with the second expansion indicator 214b. The prosthetic valve can then be expanded, as explained in more detail below. It should be noted that any portion of the plunger head 138 can be used to measure the volume of fluid needed to expand the prosthetic valve to the selected size, as long as the volume indicators 214 are positioned at locations that provide the volume needed for expansion when aligned with the portion of the plunger head 138 used to measure the volume of fluid.

[0082] In another embodiment, the expansion indicators on the volume indicator can sequentially indicate or correspond to increasingly 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 expansion fluid, each indicator can correspond to the volume of fluid that would be expelled from the syringe body starting from the second end 132 of the syringe 126 for expanding the prosthetic valve to the selected diameter. For example, referring to Figure 8 , a volume indicator for use with a prosthetic valve having a nominal diameter of 23 mm can have a first expansion indicator 222a corresponding to a diameter of 21.5 mm, a second expansion indicator 222b corresponding to a diameter of 22.7 mm, and a third expansion indicator 222c corresponding to a diameter of 23.3 mm.

[0083] In some embodiments (see, e.g., Figure 9The body 202 of the volume indicator 200 may further include a gripping portion (e.g., a plurality of spaced ridges 226) configured to enhance the user's grip on the volume indicator 200 during use. The syringe may include an annular flange 156 at a second end portion 132 of the syringe body 128. The body 202 of the volume indicator 200 may have a length L1 such that the proximal end portion 228 of the volume indicator 200 abuts against the flange 156. During the inflation of the prosthetic valve using the syringe, the user may grip the ridges 226 of the volume indicator 200 and press the plunger 136 of the syringe 126. Pressing the plunger 136 applies a distal force to the syringe / volume indicator assembly, and the user needs to apply a corresponding proximal force to prevent movement of the assembly. During the application of forces in the proximal and distal directions, the proximal portion 228 of the volume indicator 200 abuts against the flange 156 of the syringe 126 to help prevent the volume indicator 200 from detaching from the syringe 126.

[0084] During use, when Figure 8 When the volume indicator 200 is positioned on the syringe 126, the syringe body 128 can be filled with fluid (e.g., using the method described above). To dilate the prosthetic valve, after 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 aligns with the expansion indicator corresponding to the selected diameter, thereby displacing the amount of fluid required to dilate the prosthetic valve to the selected diameter. For example, to dilate the prosthetic valve to a diameter of 21.5 mm, the physician can 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 dilates the prosthetic valve to the selected diameter. If further dilation of the prosthetic valve is required (e.g., from 21.5 mm to 22.7 mm in diameter), the plunger can be further actuated, as described in detail below.

[0085] In one specific method for implanting a prosthetic heart valve in a patient's heart, a physician may select a prosthetic heart valve 10 whose expansion diameter range is sized to accommodate the anatomical variability of a particular patient (e.g., selecting a size closest to the nominal size of the natural annulus to which the prosthetic valve will be implanted). If necessary, the size of the natural annulus to which the prosthetic heart valve will be implanted can be measured using conventional techniques and / or devices to facilitate the selection of an appropriately sized prosthetic heart valve. After selecting the size of the prosthetic valve (e.g., a 21-mm valve, a 23-mm valve, a 26-mm valve, or a 29-mm valve), the physician may select a corresponding volume indicator 200 having expansion markings 214 corresponding to the diameter range of the prosthetic valve.

[0086] Referring now to Figure 6 The selected volume indicator 200 can then be arranged onto the syringe body 128 (e.g., by clipping or snapping the cover onto the syringe body). The second engagement element 206 of the volume indicator can engage with the first engagement element 148 of the syringe body 128 and form a releasable connection, thereby keeping the volume indicator in place on the syringe body. After the volume indicator 200 is attached to the syringe 126, the physician can fill the syringe body 128 with inflation fluid (e.g., saline).

[0087] In embodiments in which the inflation fluid volume 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 the selected inflation indicator 214 corresponding to the selected dilated valve diameter (see, e.g., FIG. 2B). 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 detached from the syringe, or it can be left in place for the remainder of the procedure. Figure 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 detached from the syringe, or it can be left in place for the remainder of the procedure.

[0088] After filling, the syringe 126 can be fluidly coupled with the handle 102 at the proximal port 118 of the delivery instrument 100, such as by connecting the tubing 144 with the proximal port 118. The prosthetic heart valve 10 can be mounted on the balloon 116 on the distal end portion of the delivery instrument 100 in a crimped configuration. A representative method of implanting the prosthetic heart valve 10 using the delivery instrument 100 can be performed in the following manner. The distal end portion of the delivery instrument (together with the prosthetic valve 10) can be introduced into the patient’s vasculature, such as via an incision in the femoral artery. The distal end portion of the delivery instrument 100 (together with the prosthetic valve 10) can be advanced through the femoral artery and the aorta toward the native aortic valve. After the prosthetic heart valve 10 is positioned at the desired implantation site (generally within the native aortic valve annulus), the prosthetic heart valve can be deployed (e.g., radially expanded). Further details regarding the implantation procedure can be found, for example, in U.S. Pub. No. 2017 / 0065415.

[0089] To deploy the prosthetic valve 10, the physician can press the plunger 134 of the syringe 126 so that the entire volume of fluid within the syringe flows through the fluid passageway of the delivery instrument and into the balloon 116 to inflate it and deploy the prosthetic valve 10 to the selected diameter.

[0090] Referring to Figure 8In 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, for example, filled with fluid such that the plunger head 138 of the plunger 134 is at the second end 132. In this manner, the syringe body is filled with enough fluid to sequentially expand the prosthetic valve 10 to each of the diameter sizes in the range of prosthetic valve diameters. After filling, the syringe 126 can be fluidly coupled to the handle of the delivery instrument, and the prosthetic valve 10 can be advanced to the desired implantation location, as described above.

[0091] After the prosthetic heart valve 10 is in the desired implantation location, the prosthetic valve can be deployed to, for example, a first diameter in the range (e.g., the smallest diameter in the range) by pressing the plunger until the end face 150 of the plunger head 138 is aligned with the inflation indicator 222a that indicates the first diameter. The physician can then evaluate the fit of the prosthetic valve within the native valve annulus. If further expansion of the prosthetic valve is needed, the prosthetic valve can be expanded to, for example, a second diameter in the range by pressing the plunger until the end face 150 of the plunger head 138 is aligned with the inflation indicator 222b that indicates the second diameter. This process can be repeated as necessary until the prosthetic valve is expanded to the diameter that best fits the native valve annulus. For example, the prosthetic valve 10 is desirably expanded to a diameter that is sufficient to anchor the prosthetic valve in place against surrounding tissue without causing excessive expansion and rupture of the native valve annulus, with minimal or no paravalvular leakage.

[0092] Reference is now made to Figure 9-10 In some embodiments, the volume indicator 200 can be clamped onto the syringe 126 with one or more second engagement elements 206 (e.g., one, in example embodiments) that are configured to extend through an opening of the body 202 of the volume indicator 200. The syringe 126 can have one or more first engagement elements 148 (e.g., one, in example embodiments) that extend from a surface of the syringe body 128 and are configured to engage the second engagement elements 206. The second engagement elements 206 can be, for example, circular openings that extend through the body 202 of the volume indicator 200, and the first engagement elements 148 can be, for example, cylindrical protrusions that extend from a surface of the syringe body 128.

[0093] In some embodiments, as Figure 10As shown, the first engagement element 148 can have a tapered outer surface 152 that is configured to form an interference fit (e.g., a press fit or a friction fit) with the second engagement element 206. This ensures that the first engagement element 148 and the second engagement element 206 form a tight or snug fit against one another, thereby preventing movement or slippage of the volume indicator 200 relative to the syringe body 128. The tapered surface 152 ensures that even if the second engagement element 206 is slightly oversized (e.g., due to manufacturing tolerances), there is no play or slippage between the first engagement element 148 and the second engagement element 206, thereby ensuring accurate placement of the volume indicator 200, and thus the inflation marker 214, axially along the syringe 126. This can help prevent inaccurate measurements based on improper placement of the volume indicator. In some embodiments, instead of or in addition to the taper on the first engagement element 148, the second engagement element 206 can be configured as a tapered opening.

[0094] Referring again to Figure 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 and positioned along, for example, the second end portion 132 of the syringe body 128. The volume indicator 200 can include one or more corresponding additional engagement elements 224 configured to engage the engagement elements 154. Engagement of the engagement elements 154, 224 can prevent rotational movement of the volume indicator 200 relative to the syringe body 128 when the volume indicator is clamped onto the syringe body. As shown, the engagement elements 224 can be U-shaped notches formed along the proximal edge of the indicator body 202 adjacent the flange 156, and the engagement elements 154 can include corresponding U-shaped protrusions extending from the flange 156.

[0095] It should be noted that while the engagement elements 224 are U-shaped notch openings configured to receive corresponding U-shaped engagement elements 154 of the syringe body 128 in the example embodiments, in other embodiments, the one or more second engagement elements 224 can be any of a variety of sizes and shapes (e.g., circular, rectangular, triangular, etc.) configured to match one or more engagement elements 154 of a corresponding shape.

[0096] In some embodiments, the alignment of the engagement elements 154, 224 aligns the volume indicator 200 on the syringe 126 such that the engagement elements 148, 206 are positioned to engage one another. This allows the user to quickly and easily clamp the volume indicator 200 onto the syringe 126 in the proper orientation.

[0097] Figure 9 The window portion 204 in the embodiment of FIG. 1 is longer than the window portion 204 in the embodiment of FIG. 2Figure 6 the window portion 204 in embodiments of the present disclosure. Thus, Figure 9 the window portion in embodiments of the present disclosure. The relative edges 210, 212 are spaced farther from the volume indicia 214 than Figure 6 embodiments of the present disclosure. This can help avoid a user from using one of the relative edges 210, 212 to measure fluid when the edges 210, 212 are not intended to be used as volume indicia. In certain embodiments, the length L2 of the window portion 204 can be greater than a majority of the length LI of the indicator body to maximize the spacing between the volume indicia 214 and the relative edges 210, 212. However, in alternative embodiments, the indicator can be manufactured such that one or both of the edges 210, 212 are positioned to act as volume indicia to measure the amount of fluid used to expand the prosthetic valve to a desired size.

[0098] In embodiments in which the proximal port 118 includes a stopcock, a physician can actuate the stopcock from a closed position to an open position prior to actuating the plunger 134 such that fluid from the fluid source can flow through the stopcock and into the fluid passageway of the delivery apparatus 100.

[0099] While the disclosed embodiments generally relate to delivery apparatuses and methods for implanting a prosthetic heart valve in a native aortic valve, it should be understood that the disclosed embodiments can be used to implant a prosthetic device in any location of the heart or other location in the body. Additionally, while the disclosed embodiments generally relate to transfemoral delivery of a prosthetic device, it should be understood that the disclosed embodiments can be adapted for use with, for example, transapical procedures, transaortic procedures, trans-subclavian procedures, transradial procedures, or trans-diaphragmatic procedures.

[0100] General Considerations

[0101] For the purposes of this description, certain aspects, advantages, and novel features of the implementations of the present disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed implementations, alone and in various combinations and sub-combinations with one another. The methods, apparatuses, and systems are not limited to any specific aspect or feature or combination of aspects and features, nor do the disclosed implementations require that any one or more specific advantages be present or problems be solved.

[0102] Although the operations of some of the disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement of otherwise-illustrated operations unless a particular ordering is required by specific language set forth below. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures can not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like "provide" or "achieve" to describe the disclosed methods. Such terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to such terms can vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0103] All features described herein are independent of each other and can be used in combination with any other feature described herein, except where structurally impossible. For example, a volume indicator can include a window portion 204 as shown in Figures 4A-4C in combination with first and second engagement elements 148 and 206 as shown in Figures 9-10 in combination with first and second engagement elements 148 and 206 as shown in Figures 9-10 in combination with first and second engagement elements 148 and 206 as shown in Figures 4A-4C in combination with first and second engagement elements 148 and 206 as shown in

[0104] As used in this application and in the claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. In addition, the term "comprises" is intended to mean "includes." Further, the terms "coupled" and "associated" are used in this context to express either an electrical, electromagnetic, and / or physical (e.g., mechanical or chemical) coupling or connection between the entities that are coupled or associated, and are not restricted to direct or removable connections unless specifically so stated by the context.

[0105] In the context of this application, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow," respectively. Thus, for example, the lower end of a valve is its inflow end, and the upper end of a valve is its outflow end.

[0106] As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to a user and further from an implant site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is further from a user and closer to an implant site. Thus, for example, proximal movement of a device is movement of the device toward a user, while distal movement of a device is movement of the device away from a user. Unless explicitly limited, the terms "longitudinal" and "axial" refer to an axis that extends in the proximal and distal directions.

[0107] In view of the principles of the present disclosure being applicable to a variety of possible implementations, it should be appreciated that the example implementations are merely preferred examples and should not be used as limiting the scope of the present disclosure. Rather, the scope of the present disclosure is defined by the appended claims.

Claims

1. A volume indicator for a syringe, the syringe comprising a syringe body and a plunger received in the syringe body, the volume indicator comprising: an indicator body; 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, wherein the window portion further comprises a series of inflation indicia corresponding to a fluid volume required to expand a prosthetic heart valve to a selected diameter within a range of diameters of the prosthetic valve; and one or more engagement elements configured to engage corresponding elements on the syringe body to inhibit rotation and axial movement of the volume indicator relative to the syringe body, the one or more engagement elements being arranged on the indicator body such that the indicator body can be coupled to the syringe body in only one orientation; wherein the one or more engagement elements comprise deflectable arms configured to form a snap-fit connection with one or more corresponding elements on the syringe body; and wherein the indicator body is configured to be removably clipped onto the syringe body.

2. The volume indicator of claim 1, wherein the one or more engagement elements are disposed on a longitudinal edge of the indicator body.

3. The volume indicator of claim 1, wherein the one or more engagement elements comprise first, second, and third engagement elements axially spaced apart from one another, and wherein a distance between the first and second engagement elements is different from a distance between the second and third engagement elements such that the volume indicator can be disposed on the syringe body in only a selected orientation.

4. The volume indicator of claim 1, wherein the indicator body has a curved C-shaped cross-section defining an opening.

5. The volume indicator of claim 4, wherein the indicator body is configured to be removably clipped onto the syringe body by forcing the syringe body through the opening.

6. The volume indicator of claim 1, further comprising a gripping portion disposed on the indicator body.

7. The volume indicator of claim 1, wherein the one or more engagement elements are openings extending through the indicator body, the openings being configured to form a friction fit with the corresponding elements on the syringe body.

8. The volume indicator of claim 7, further comprising a further engagement element configured as a notch in a first end portion of the indicator body, the further engagement element being configured to inhibit rotational movement of the volume indicator relative to the syringe body.

9. A volume indicator for a syringe, the syringe comprising a syringe body and a plunger received in the syringe body, the volume indicator comprising: an indicator body having a curved C-shaped cross-section; a window portion extending through a thickness of the indicator body such that a portion of the plunger in the syringe body is visible through the window portion, wherein the window portion further comprises a series of inflation indicia corresponding to a volume of fluid required to expand a prosthetic heart valve to a selected diameter within a range of diameters of the prosthetic valve; one or more engagement elements configured to engage corresponding elements on the syringe body such that the volume indicator can be disposed on the syringe body in only a selected orientation; and wherein the indicator body is configured to be removably clipped onto the syringe body.

10. The volume indicator of claim 9, wherein the one or more engagement elements are disposed on a longitudinal edge of the indicator body.

11. The volume indicator of claim 10, wherein the one or more engagement elements comprise deflectable arms configured to form a snap-fit connection with one or more corresponding elements on the syringe body.

12. The volume indicator of claim 9, wherein the one or more engagement elements comprise a first engagement element, a second engagement element, and a third engagement element, and wherein a distance between the first and second engagement elements is different than a distance between the second and third engagement elements such that the volume indicator can be disposed on the syringe body in only a selected orientation.

13. The volume indicator of claim 9, further comprising a gripping portion disposed on the indicator body.

14. The volume indicator of claim 9, wherein the one or more engagement elements are openings extending through the indicator body configured to form a friction fit with the corresponding elements on the syringe body.

15. The volume indicator of claim 14, further comprising a further engagement element disposed in a first end portion of the indicator body configured to arrest rotational movement of the first end portion of the indicator body relative to the syringe body.

16. The volume indicator of claim 15, wherein the further engagement element comprises a U-shaped notch.

Images