Accuracy-guide balloon inflation measure for transcatheter aortic valve implantation deployment

Abstract

A delivery device for delivering a prosthetic heart valve may include a balloon catheter shaft having a distal end, an inner shaft extending through the balloon catheter in a proximal to distal direction, an atraumatic distal tip positioned at the distal end of the inner shaft, and a balloon positioned between the distal end of the balloon catheter shaft and the atraumatic distal tip. In an uninflated state of the balloon, the balloon may include a proximal bulge, a distal bulge, and an intermediate section having a diameter less than a diameter of the proximal bulge and less than a diameter of the distal bulge. The distal protrusion may extend a first length in a proximal-to-distal direction, and the proximal protrusion may extend a second length in the proximal-to-distal direction, the first length being different than the second length.

Description

Background Technology

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 578,810, filed on August 25, 2023, the contents of which are incorporated herein by reference. Summary of the Invention

[0002] According to one aspect of this disclosure, a delivery device for delivering an artificial heart valve includes: a balloon catheter shaft having a distal end, an inner shaft extending through the balloon catheter in a proximal-to-distal direction, a non-traumatic distal tip positioned at the distal end of the inner shaft, and a balloon positioned between the distal end of the balloon catheter shaft and the non-traumatic distal tip. The balloon may have an inflated state and an inflated state. In the inflated state, the balloon may include a proximal bulge, a distal bulge, and an intermediate segment located between the proximal bulge and the distal bulge, the intermediate segment having a diameter smaller than the diameter of both the proximal and distal bulges. The distal bulge may extend a first length in a proximal-to-distal direction, and the proximal bulge may extend a second length in a proximal-to-distal direction, the first length being different from the second length. The balloon catheter shaft may include an inflatable lumen in fluid communication with the internal volume of the balloon, such that pushing the inflation medium through the inflatable lumen in a proximal-to-distal direction causes the inflation medium to enter the proximal bulge before entering the distal bulge. The first length may be approximately 1, 1.1, 1.2, 1.3, 1.4, and approximately 1.5 times longer than the second length. In the inflated state of the balloon, the diameters of the proximal bulge, the distal bulge, and the intermediate segment may all be substantially equal.

[0003] According to another embodiment of this disclosure, a delivery device for delivering an artificial heart valve includes: a balloon catheter shaft having a distal end, an inner shaft extending through the balloon catheter in a proximal-to-distal direction, a non-traumatic distal tip positioned at the distal end of the inner shaft, and a balloon positioned between the distal end of the balloon catheter shaft and the non-traumatic distal tip. The balloon can have an inflated state and an inflated state. In the inflated state, the balloon includes a proximal bulge, a distal bulge, and an intermediate section located between the proximal and distal bulges, the intermediate section having a diameter smaller than that of both the proximal and distal bulges. An inflation lumen adjuster can be positioned on the inner shaft, and the position of the inflation lumen adjuster within the internal volume of the balloon can be axially aligned with the position of the intermediate section. The inflation lumen adjuster can be a solid cylindrical member, with the inner shaft passing through the interior of the inflation lumen adjuster. In the uninflated state, the total fillable internal volume of the central segment of the balloon can be smaller than that of the central segment without an inflation lumen adjuster. When the balloon transitions from an uninflated state to an inflated state, the proximal bulge, the central segment, and the distal bulge can expand at substantially equal rates.

[0004] According to another aspect of this disclosure, a delivery device for delivering an artificial heart valve includes: a balloon catheter shaft having a distal end, an inner shaft extending through the balloon catheter in a proximal-to-distal direction, a non-traumatic distal tip positioned at the distal end of the inner shaft, and a balloon positioned between the distal end of the balloon catheter shaft and the non-traumatic distal tip. The balloon can have an inflated state and an inflated state. In the inflated state, the balloon may include a proximal bulge, a distal bulge, and an intermediate segment located between the proximal and distal bulges, the intermediate segment having a plurality of folds or pleats such that the length of the intermediate segment is greater than the length from the distal end of the proximal bulge to the proximal end of the distal bulge. The diameter of the intermediate segment may be smaller than the diameter of both the proximal and distal bulges. When the balloon transitions from an inflated state to an inflated state, the plurality of folds or pleats of the intermediate segment can be defolded or expanded. In its uninflated state, the balloon may have a first length between the proximal end of the proximal bulge and the distal end of the distal bulge, and in its inflated state, the balloon may have a second length between the proximal end of the proximal bulge and the distal end of the distal bulge, the first length being approximately equal to the second length. In the uninflated state, the contact between multiple folds or pleats and the inner surface of the artificial heart valve can result in greater friction compared to the friction between the inner surface of the artificial heart valve and an equivalently formed balloon with a smooth outer surface and no folds.

[0005] According to another aspect of this disclosure, a delivery device for delivering an artificial heart valve may include: a balloon catheter shaft having a distal end; an inner shaft extending through the balloon catheter in a proximal-to-distal direction; an outer shaft extending on the balloon catheter shaft in a proximal-to-distal direction; a non-traumatic distal tip positioned at the distal end of the inner shaft; and a balloon positioned between the distal end of the balloon catheter shaft and the non-traumatic distal tip. The balloon may have an inflated state and an inflated state. At least one spacer may be coupled to the outer surface of the inner shaft and may contact the inner surface of the outer shaft, such that the inner and outer shafts are coaxial. The at least one spacer may include a plurality of spacers positioned at intervals along the inner shaft. The at least one spacer may be fixed to the inner shaft. The spacer may be annular, having an inner circular hole through which the inner shaft passes, and an outer circumference contacting the inner surface of the outer shaft. The distal end of the outer shaft may terminate proximally to the balloon.

[0006] According to another aspect of this disclosure, an artificial heart valve system includes a delivery device and an expandable artificial heart valve. The delivery device may include: a balloon catheter shaft having a distal end, an inner shaft extending through the balloon catheter in a proximal-to-distal direction, a non-traumatic distal tip positioned at the distal end of the inner shaft, and a balloon positioned between the distal end of the balloon catheter shaft and the non-traumatic distal tip. The balloon may have an inflated state and an inflated state. The balloon may include a distal connecting member and a proximal connecting member, the distal connecting member extending radially outward from the outer surface of the balloon at a distal end adjacent to the balloon, and the proximal connecting member extending radially outward from the outer surface of the balloon at a proximal end adjacent to the balloon. When the artificial heart valve receives the balloon passing through it, the distal connecting member may contact the inflow portion of the artificial heart valve, and the proximal connecting member may contact the outflow portion of the artificial heart valve. As the balloon transitions from an uninflated state to an inflated state, the distal connecting member can maintain contact with the inflow portion of the artificial heart valve, and the proximal connecting member can maintain contact with the outflow portion of the artificial heart valve. Attached Figure Description

[0007] Figure 1A This is a perspective view of a stent for an artificial heart valve according to one embodiment of the present disclosure.

[0008] Figure 1B yes Figure 1A A schematic front view of a section of the support frame.

[0009] Figure 1C It is based on Figure 1A A schematic front view of a segment of a stent, representing an alternative embodiment of an artificial heart valve.

[0010] Figures 1D to 1E They are Figure 1C The front view of the support section when it is in a collapsed state and an expanded state.

[0011] Figures 1F to 1G They are based on Figure 1C A side view of a portion of the support in both the collapsed and expanded states of an embodiment.

[0012] Figure 1H It is based on Figure 1C The flattened view of the bracket in the embodiment looks as if it has been cut and flattened.

[0013] Figures 1I to 1J These include Figure 1C Front and side views of the stent-supported artificial heart valve.

[0014] Figure 1K The illustration shows an additional outer cuff attached to the support frame. Figure 1H The view.

[0015] Figure 2A The illustration shows an artificial heart valve coiled on a balloon in a delivery device.

[0016] Figure 2B yes Figure 2A This is a diagram of the balloon after it has been inflated.

[0017] Figure 3A The illustration shows a support structure that is in a collapsed state and positioned near the target deployment area.

[0018] Figure 3B The diagram illustrates the expanded version. Figure 3A The support structure.

[0019] Figure 4A The illustration shows a support structure that is in a collapsed state and positioned near the target deployment area.

[0020] Figure 4B The diagram illustrates the expanded version. Figure 4A The support structure.

[0021] Figure 5 It is the cross-section of the distal end of the balloon catheter, with pre-formed bulges of different sizes in the uninflated balloon.

[0022] Figure 6 It is the cross-section of the distal end of the balloon catheter, including the inflation lumen regulator.

[0023] Figure 7A It is a cross-section of a balloon used with a balloon catheter according to another aspect of this disclosure.

[0024] Figure 7B It is before and after the expansion. Figure 7A A schematic view of the height of the balloon.

[0025] Figure 7C It is before and after the expansion. Figure 7A A height-schematic view of an alternative form of balloon.

[0026] Figure 8 It is a schematic cross-section of the delivery device that unfolds an artificial heart valve into the natural aortic valve.

[0027] Figure 9 This is an isolated view of the balloon of a balloon catheter delivery device according to another aspect of this disclosure. Detailed Implementation

[0028] As used herein, when used in conjunction with an artificial heart valve, the term "inflow end" refers to the end of the artificial valve from which blood first enters when the valve is implanted in the intended position and orientation, while the term "outflow end" refers to the end of the artificial valve from which blood exits when the valve is implanted in the intended position and orientation. Furthermore, for an artificial aortic valve, the inflow end is the end closer to the left ventricle, and the outflow end is the end closer to the aorta. The use of intended position and orientation is for convenience in describing the valves disclosed herein; however, it should be noted that the use of the valve is not limited to intended position and orientation, but can be deployed in any type of lumen or channel. For example, although the artificial heart valve is described herein as an artificial aortic valve, the same or similar structures and features can be used for other heart valves (e.g., pulmonary valves, mitral valves, or tricuspid valves). Further, when used in conjunction with a delivery device or system, the term "proximal" refers to the direction relatively close to the user when used as intended, while the term "distal" refers to the direction relatively far from the user. In other words, when used as intended, the front end of the conveying equipment or system is positioned away from the rear end of the conveying equipment or system. As used herein, the terms “substantially,” “generally,” “approximately,” and “about” are intended to indicate that slight deviations from absolute values ​​are also included within the scope of terms modified in this way. As used herein, a support may be in an “expanded state” and a “collapsed state,” referring to the relative radial dimensions of the support.

[0029] Figure 1AThe illustration shows a perspective view of a stent 100 for an artificial heart valve according to an embodiment of the present disclosure. The stent 100 may include a frame extending in an axial direction between an inlet end 101 and an outlet end 103. The stent 100 includes three generally symmetrical segments, each spanning approximately 120 degrees around the circumference of the stent 100. The stent 100 includes three vertical struts 110a, 110b, 110c extending in an axial direction substantially parallel to the direction of blood flow through the stent, which may also be referred to as the central longitudinal axis. Each vertical strut 110a, 110b, 110c may extend substantially the entire axial length between the inlet end 101 and the outlet end 103 of the stent 100 and may be positioned between two segments and shared by the two segments. In other words, each segment is defined by the portion of the stent 100 between two vertical struts. Furthermore, each vertical strut 110a, 110b, 110c is also spaced approximately 120 degrees around the circumference of the stent 100. It should be understood that if the stent 100 is used in an artificial heart valve with three leaflets, the stent may include the three segments shown in the figure. However, in other embodiments, if the artificial heart valve has two leaflets, the stent may include only two of the segments.

[0030] Figure 1B The diagram shows a stent segment 107 of the stent 100, which will be described in more detail herein and represents all three segments. Figure 1BThe support segment 107 depicted includes a first vertical support 110a and a second vertical support 110b. The first vertical support 110a extends axially between a first inflow node 102a and a first outer node 135a. The second vertical support 110b extends axially between a second inflow node 102b and a second outer node 135b. As shown, the vertical supports 110a and 110b can extend over almost the entire axial length of the support 100. In some embodiments, the support 100 can be formed as a single unit (e.g., by cutting the support from a tube using a laser). The term "node" can refer to the location where two or more supports of the support 100 intersect each other. A pair of sequentially inverted V-shapes extend between the inflow nodes 102a and 102b, including a first inflow inverted V-shape 120a and a second inflow inverted V-shape 120b joined to each other at the inflow node 105. The first inflow inverted V-shape 120a includes a first outer lower support 122a extending between the first inflow node 102a and the first central node 125a. The first inflow inverted V-shape 120a also includes a first inner lower support 124a extending between the first central node 125a and the inflow node 105. The second inflow inverted V-shape 120b includes a second inner lower support 124b extending between the inflow node 105 and the second central node 125b. The second inflow inverted V-shape 120b also includes a second outer lower support 122b extending between the second central node 125b and the second inflow node 102b. Although described as inverted V-shapes, these structures can also be described as half-units, each half-unit being a semi-rhomboid unit, wherein the opening of the half-unit is located at the inflow end 101 of the support 100.

[0031] The support section 107 further includes a first central support column 130a extending between the first central node 125a and the upper node 145. The support section 107 also includes a second central support column 130b extending between the second central node 125b and the upper node 145. The first central support column 130a, the second central support column 130b, the first inner lower support column 124a, and the second inner lower support column 124b form a rhomboid unit 128. The support section 107 includes a first outer upper support column 140a extending between the first outer node 135a and the first outflow node 104a. The support section 107 further includes a second outer upper support column 140b extending between the second outer node 135b and the second outflow node 104b. The support section 107 includes a first inner upper support column 142a extending between the first outflow node 104a and the upper node 145. The support section 107 further includes a second inner upper support column 142b extending between the upper node 145 and the second outflow node 104b. The support section 107 includes an outflow inverted V-shape 114 extending between the first outflow node 104a and the second outflow node 104b. A first vertical support 110a, a first outer upper support 140a, a first inner upper support 142a, a first central support 130a, and a first outer lower support 122a form a first overall kite-shaped unit 133a. A second vertical support 110b, a second outer upper support 140b, a second inner upper support 142b, a second central support 130b, and a second outer lower support 122b form a second overall kite-shaped unit 133b. The first kite-shaped unit 133a and the second kite-shaped unit 133b are symmetrical and opposite to each other on the support section 107. Although the term "kite-shaped" has been used above, it should be understood that this shape is not limited to the precise geometric definition of a kite. The outflow inverted V-shape 114, the first inner upper support 142a, and the second inner upper support 142b form an upper unit 134. The upper unit 134 is generally kite-shaped and axially aligned with the rhomboid unit 128 on the support section 107. It should be understood that, although designated as individual supports, the various supports described herein can be part of a single integral structure as described above. However, in other embodiments, the support 100 does not need to be formed as a single integral structure, and therefore the supports can be different structures (or parts of different structures) connected together.

[0032] Figure 1CA schematic diagram of a support section 207 according to an alternative embodiment of this disclosure is illustrated. Unless otherwise stated, similar reference numerals refer to elements similar to those in the support 100 described above but with a series of 200- designations. Support section 207 is substantially similar to support section 107, including inflow nodes 202a, 202b, vertical supports 210a, 210b, a first inflow inverted V-shape 220a and a second inflow inverted V-shape 220b, and outflow nodes 204a, 204b. The structure of support section 207 differs from that of support section 107 in that it does not include the outflow inverted V-shape. Figure 1C The purpose of this embodiment of the structure of the support section 207 shown is to reduce the force required to expand the outflow end 203 of the support 200 compared to the support 100, thereby promoting uniform expansion relative to the inflow end 201. The outflow nodes 204a, 204b are connected by a suitably oriented V-shape formed by a first inner upper support 242a, an upper node 245, and a second inner upper support 242b. In other words, the supports 242a, 242b can form a semi-rhomboid unit 234, with the open end of the semi-unit oriented towards the outflow end 203. The semi-rhomboid unit 234 is axially aligned with the rhomboid unit 228. Adding the outflow inverted V-shape connecting the outflow nodes 204a, 204b introduces additional material, which increases resistance to modifying the shape of the support and requires additional force to expand the support. Excluding material from the outlet 203 reduces resistance to expansion at the outlet 203, which can promote uniform expansion of both the inlet 201 and the outlet 203. In other words, the inlet 201 of the support 200 does not include a continuous circumferential structure, but rather has a semi-unit that is mostly open or fully open, with the open portion of the semi-unit oriented towards the inlet 201, while the majority of the outlet 203 comprises a substantially continuous circumferential structure via supports corresponding to supports 140a, 140b. All else being equal, a substantially continuous circumferential structure may require greater force to expand compared to a similar but open structure. Furthermore, the inlet 101 of the support 100 may require greater force to expand radially compared to the outlet 103. By omitting the inverted V-shape 114, the support 200 is obtained, and the required force to expand the outlet 203 of the support 200 can be reduced to an amount closer to the inlet 201.

[0033] Figure 1D A front view of the collapsed support section 207 is shown, and Figure 1E A front view of the support segment 207 in its expanded state is shown. It should be understood that... Figures 1D to 1EThe stent 200 is illustrated as having an opaque tube extending through the interior of the stent; this is purely for the purpose of illustrating the stent, and it can represent the balloon on which the stent segment 207 is coiled. As described above, the stent comprises three symmetrical segments, each spanning approximately 120 degrees around the circumference of the stent. Figures 1D to 1E The support section 207 shown in the diagram is defined by the area between the vertical supports 210a and 210b. Support section 207 represents all three sections of the support. Support section 207 has an arc-shaped structure so that when the three sections are connected, they form a complete cylinder. Figures 1F to 1G The side view illustrates a portion of the support structure. In other words, with... Figures 1D to 1E Compared to the view, Figures 1F to 1G The view of bracket 200 in the middle is rotated by about 60 degrees. Figures 1F to 1G The view of the support structure depicted is centered on the vertical column 210b, showing approximately half of each of two adjacent support segments 207a, 207b located on each side of the vertical column 210b. The segments 207a, 207b surrounding the vertical column 210b are mirror images of each other. Figure 1F The images show support sections 207a and 207b in a collapsed state, while... Figure 1G The stent sections 207a and 207b in the expanded state are shown.

[0034] Figure 1H The illustration shows a flattened view of a support 200 comprising three support sections 207a, 207b, and 207c, as if the support had been longitudinally cut and laid flat on a table. As depicted, sections 207a, 207b, and 207c are symmetrical to each other, and adjacent sections share a common vertical support. As mentioned above, the support 200 is shown in a flattened view, but each section 207a, 207b, and 207c has an arc spanning 120 degrees to form a complete cylinder. Figure 1H The image further depicts blades 250a, 250b, and 250c connected to the support 200. However, it should be understood that... Figure 1H Only the connection of blades 250a, 250b, and 250c is illustrated. In other words, each blade 250a, 250b, and 250c typically includes free edges, which are used to engage with each other to prevent retrograde blood flow through the stent 200, and the free edges move radially outward toward the inner surface of the stent to allow antegrade blood flow through the stent. These free edges are not shown in the diagram. Figure 1H The diagram in the middle shows the attachment edges of blades 250a, 250b, and 250c. Figure 1HThe diagram is illustrated with dashed lines. Although the attachment can be via any suitable form, the attachment edges can preferably be sewn to the stent 200 and / or sewn to the interventional cuff or skirt located between the stent and the blades 250a, 250b, 250c. Each of the three blades 250a, 250b, 250c extends about 120 degrees from end to end around the stent 200, and each blade includes a belly that can extend toward the radial center of the stent 200 when the blades are joined together. Each blade extends between the upper nodes of adjacent segments. The first blade 250a extends from the first upper node 245a of the first stent segment 207a to the second upper node 245b of the second stent segment 207b. The second blade 250b extends from the second upper node 245b to the third upper node 245c of the third stent segment 207c. The third blade 250c extends from the third upper node 245c to the first upper node 245a. Therefore, each upper node includes a first end of a first blade and a second end of a second blade attached thereto. In the illustrated embodiment, each end of each blade is stitched to its corresponding node. However, any coupling device can be used to attach the blades to the stent. It is also contemplated that the stent may include any number of segments and / or blades. For example, the stent may include two segments, each extending 180 degrees around the circumference of the stent. Further, the stent may include two blades to simulate a bicuspid valve. Furthermore, it should be noted that each blade may include a protrusion or other structure (not shown) located at the confluence between the free edge and the attachment edge of the blade, and each protrusion of each blade may be coupled to a protrusion of an adjacent blade to form a fusion portion. In the illustrated embodiment, the blade fusion portion is illustrated as being attached to a node where the struts intersect at that node. However, in other embodiments, the stent 200 may include fusion attachment features built into the stent to facilitate such attachment. For example, fusion attachment features may be formed in the scaffold 200 at nodes 245a, 245b, 245c, wherein the fusion attachment features include one or more holes to facilitate suturing the blade fusion portion to the scaffold. Furthermore, the blades 250a, 250b, 250c may be formed of biological materials (such as animal pericardium) or may additionally be formed of synthetic materials (e.g., plastics, fabrics, and / or polymers, including ultra-high molecular weight polyethylene (UHMWPE)).

[0035] Figures 1I to 1JAn artificial heart valve 206 is shown, comprising a stent 200, a cuff 260 (e.g., via sutures) attached to the stent 200, and leaflets 250a, 250b, 250c (e.g., via sutures) attached to the stent 200 and / or the cuff 260. The artificial heart valve 206 is intended for replacing an aortic valve, but the same or similar structures can be used in artificial valves to replace other heart valves. The cuff 260 is disposed on the luminal surface or inner surface of the stent 200, but the cuff may alternatively or additionally be disposed on the luminal surface or outer surface of the stent. The cuff 260 may include an inlet end disposed substantially along the inlet end 201 of the stent 200. Figure 1I A front view of valve 206 is shown, illustrating a support portion 207 located between vertical struts 210a, 210b, including a cuff 260 and the outlines of two leaflets 250a, 250b sewn to the cuff 260. Various methods can be used to sew the leaflets to the cuff and to sew the leaflets and / or cuff to the support, many of which are described in U.S. Patent No. 9,326,856, which is incorporated herein by reference. In the illustrated embodiment, the upper (or outflow) edge of cuff 260 is sewn to a first central node 225a, an upper node 245, and a second central node 225b, extending along the first central strut 230a and the second central strut 230b. The upper (or outflow) edge of cuff 260 continues to extend generally between a segment of the second central node and an adjacent segment of the first central node. Cuff 260 extends between the upper node 245 and the inflow end 201. Furthermore, the cuff 260 covers the unit of the support portion 207 formed by the pillar located between the upper node 245 and the inflow end 201, including the rhomboid unit 228. Figure 1J A side view of the support 200 is shown, including the outlines of the cuff 260 and the blade 250b. In other words, with... Figure 1I Compared to the view, Figure 1J The view of valve 206 in the middle is rotated by about 60 degrees. Figure 1J The view depicted, centered on the vertical strut 210b, shows approximately half of each of two adjacent stent segments 207a, 207b located on each side of the vertical strut 210b. The segments 207a, 207b surrounding the vertical strut 210b are mirror images of each other. As described above, the cuff can be positioned on the inner surface or lumen surface of the stent, on its outer surface or lumen surface, and / or on both surfaces. The cuff ensures that blood does not flow solely around the valve leaflets if the valve or valve assembly is not optimally positioned within the valve annulus. The cuff, or a portion of a cuff positioned on the outside of the stent, can help minimize or eliminate leakage around the outside of the valve (the latter being referred to as perivalvular leakage or "PV" leakage). Figures 1I to 1JIn the illustrated embodiment, the cuff 260 covers only about half of the axial extent of the stent 200, leaving about half of the stent uncovered. This configuration requires less cuff material compared to a cuff covering more or all of the stent 200. Less cuff material allows the artificial heart valve 206 to curl downwards into a smaller profile upon collapse. It is conceivable that the cuff can cover any amount of the surface area of ​​the cylinder formed by the stent. For example, the upper edge of the cuff can extend straight around the circumference of any cross-section of the cylinder formed by the stent. The cuff 260 can be formed from any suitable material, including biological materials such as animal pericardium, or synthetic materials (e.g., UHMWPE).

[0036] As mentioned above, Figures 1I to 1J The cuff 260 is shown positioned inside the bracket 200. Figure 1K The diagram illustrates an example of an additional outer cuff 270. It should be understood that the outer cuff 270 can take the form of, in addition to... Figure 1K Other shapes besides those shown. May include... Figure 1KThe illustrated example shows an outer cuff 270 without an inner cuff 260, but preferably the outer cuff 270 is provided together with the inner cuff 260. The outer cuff 270 may be integrally formed with the inner cuff 260 and folded (e.g., wrapped around) the inflow edge of the support, or it may be provided as a separate component from the inner cuff 260. The outer cuff 270 may be formed from any material described herein in relation to the inner cuff 260. In the illustrated embodiment, the outer cuff 270 includes an inflow edge 272 and an outflow edge 274. If the inner cuff 260 and the outer cuff 270 are formed separately, the inflow edge 272 may be (e.g., via stitching, ultrasonic welding, or any other suitable attachment method) attached to the inflow end of the support 200 and / or the inflow edge of the inner cuff 260. The connection between the inflow edge 272 of the outer cuff 270 and the stent 200 and / or the inner cuff 260 is preferably such that a seal is formed between the inner cuff 260 and the outer cuff 270 at the inflow end of the artificial heart valve, preventing retrograde blood flowing into the space between the inner cuff 260 and the outer cuff 270 from passing beyond the inflow edges of the inner cuff 260 and the outer cuff 270. The outflow edge 274 may be connected to the strut of the stent 200 and / or to the inner cuff 260 at selected locations around the circumference of the stent 200 (e.g., via sutures). With this configuration, an opening can be formed circumferentially between the inner cuff 260 and the outer cuff 270 between adjacent connection points, such that retrograde blood flow will tend to flow into the space between the inner cuff 260 and the outer cuff 270 through the opening, and will not be able to continue beyond the inflow edges of the cuffs. When blood flows into the space between the inner cuff 260 and the outer cuff 270, the outer cuff 270 can roll outwards, thereby creating an even better seal between the outer cuff 270 and the natural valve ring against which it rests. The outer cuff 270 can be provided as a continuous cylindrical member or as a strip wrapped around the outer circumference of the stent 200 using side edges, wherein the side edges may be parallel or not parallel to the central longitudinal axis of the artificial heart valve, and are attached to each other such that the outer cuff 270 covers the entire circumference of the stent 200.

[0037] The stent can be formed from biocompatible materials, including metals and metal alloys (e.g., cobalt-chromium (or cobalt-chromium alloys) or stainless steel), but in some embodiments, the stent can be formed from shape memory materials (e.g., nitinol). In some embodiments, cobalt-chromium can be used to form the stent with additional metals or metal alloys (e.g., nickel and / or molybdenum). The stent is further configured to collapse when rolled to a smaller diameter and / or expand when forcibly opened (e.g., via balloon expansion within the stent), and the stent will substantially retain the shape modified when it is at rest. The stent can be rolled to collapse in the radial direction and elongate (to a certain extent) in the axial direction, thereby reducing its profile at any given cross-section. The stent can also expand in the radial direction and shorten (to a certain extent) in the axial direction.

[0038] Artificial heart valves can be delivered via any suitable transvascular route (e.g., transapical or transfemoral). Typically, transapical delivery uses a relatively stiff catheter that punctures the apex of the left ventricle through the patient's chest, causing relatively more trauma compared to the transfemoral route. In the transfemoral route, the delivery device containing the valve is inserted through the femoral artery and advanced against the flow of blood into the left ventricle. In either delivery method, the valve may first collapse on an inflatable balloon while the balloon is deflated. The balloon can be attached to or located within a delivery system that transports the valve through the body and heart to the aortic valve, positioned above the balloon (and in some cases, below the overlying sheath). Upon reaching the aortic valve or adjacent aortic valve, the surgeon or operator of the delivery system can align the artificial valve as desired within the natural valve ring as the artificial valve collapses on the balloon. When the desired alignment is achieved, the overlying sheath (if included) can be retracted (or advanced) so that the artificial valve is not covered, and then the balloon can be inflated so that the artificial valve expands in the radial direction, wherein at least a portion of the artificial valve shortens in the axial direction.

[0039] refer to Figure 2A An example of a PHV (prosthetic heart valve, which may include a stent similar to stent 100 or stent 200) is shown curled above balloon 380 of balloon catheter 390, with balloon 380 in a deflated state. It should be understood that... Figures 2A to 2B Other components of the delivery device are omitted (e.g., handles for steering and / or deployment, and syringes for inflating the balloon 380). The artificial heart valve PHV can be delivered intravascularly, for example through the femoral artery, around the aortic arch, into the natural aortic valve annulus, and simultaneously in… Figure 2AThe balloon is in a coiled state as shown. Once the desired position is achieved, fluid can be pushed through the balloon catheter 390 to inflate the balloon 380, as... Figure 2B As shown. Figure 2B The artificial heart valve PHV is omitted, but it should be understood that when balloon 380 is inflated, it forces the artificial heart valve PHV to expand into the natural aortic valve annulus (however, it should be understood that the concepts described herein can be used to replace other heart valves). In the example shown, fluid flows from a syringe (not shown) through the lumen within balloon catheter 390 into balloon 380 and into one or more ports 385 located inside balloon 380. Figure 2B In a specific illustrated example, the first port 385 may be one or more holes in the sidewall of the balloon catheter 390, and the second port 385 may be the distal opening of the balloon catheter 390, which may terminate within the internal space of the balloon 380.

[0040] A potential complication of most expandable artificial heart valves is that they typically shorten axially as they expand radially into the natural valve ring during deployment. Another potential complication is axial displacement of the artificial heart valve during insertion into the patient and / or during tracking (e.g., around the aortic arch), which can adversely affect inflation accuracy. This is generally true for both self-deploying valves and balloon-expandable valves. This axial shortening can be problematic because the axial position of some valve elements relative to the natural valve ring before expansion is often different from the axial position of those valve elements relative to the natural valve ring after expansion. In other words, if the artificial heart valve has a specific alignment shown by visualization (e.g., fluoroscopy) before deployment, there will typically be at least some axial displacement of that relative alignment during deployment, and if this displacement is not minimized or otherwise compensated for, the final position of the deployed artificial heart valve may be suboptimal. In some cases, if the balloon is unwrapped, unfolded, or unzipped during inflation, there may also be rotational displacement of the artificial heart valve relative to the natural valve annulus during deployment, which may make fusion alignment difficult.

[0041] The above example of axial displacement is in Figures 3A to 3B As shown in the image. Figure 3A The illustration shows a stent of an artificial heart valve collapsed on a balloon inside a patient, where the image is a fluorescence fluoroscopic (e.g., X-ray) image, making only the metal stent 400 of the valve easily visible. When deploying an artificial heart valve, it is generally important that the inlet end of the artificial heart valve has the desired alignment relative to the natural valve ring in which the artificial heart valve deploys. Figures 3A to 3BIn this design, the desired target location of the inflow end 410 of the artificial heart valve is indicated by the target line 430. The positioning of the outflow end 420 relative to the natural valve annulus is generally less important (though not unimportant) than the alignment of the inflow end 410. Figure 3A In the initial deployment, the stent 400 remains collapsed on the balloon, and the inlet end 410 is precisely aligned with the target line 430. However, as deployment occurs, the stent 400 expands radially and shortens axially, such that after deployment, the inlet end 410 of the stent 400 is now a distance D1 away from the target line 430. In other words, because axial shortening occurs, and because this axial shortening is not (1) minimized and / or (2) otherwise compensated for, the initial relative positioning of the stent 400 to the anatomy (when collapsed) is not a reliable indicator of the final positioning of the stent 400 relative to the anatomy (when expanded). One way to compensate for this change in positioning is to attempt to advance the inlet end 410 of the stent 400 beyond the target line 430 before deployment, hoping that the compensated distance will be equal to the axial displacement of the inlet end 410, so that the stent 400 is finally in the desired position after deployment. However, this may not be a particularly reliable method and may lead to inconsistent results. Preferably, features in the artificial heart valve itself and / or in the delivery device enable more accurate placement of the artificial heart valve during deployment and minimize the need for subjective positioning compensation at the start of deployment.

[0042] For example, Figures 4A to 4B The illustration shows an example of the expected deployment of a stent 500 for an artificial heart valve via balloon dilation. Figure 4A The illustration shows a stent 500 of an artificial heart valve collapsed on a balloon inside a patient's body, where the image is a fluorescence-guided (e.g., X-ray) image, making only the metal stent 500 of the valve easily visible. Similar to... Figures 3A to 3B ,exist Figures 4A to 4B In the diagram, the desired target location of the inflow edge 510 of the artificial heart valve is indicated by the target line 530. Figure 4A During deployment, the stent 500 remains collapsed on the balloon, and the inflow edge 510 is precisely aligned with the target line 530. When deployment occurs (and the balloon inflates), the stent 500 expands radially and shortens axially. However, with... Figures 3A to 3B The situations are different. Figures 4A to 4BThe stent 500 is expanded such that, after deployment, the inflow edge 510 of the stent 500 remains precisely (or nearly precisely) aligned with the target line 530. One way this is achieved is because, as the balloon expands, the outflow segment 520 of the stent will be significantly shortened than the inflow segment 510. In other words, the inflow edge 510 of the stent 500 can be used as a reliable visual indicator before expansion or deployment, indicating where the inflow edge of the inflow segment 510 of the stent 500 will be positioned after expansion or deployment. This reduces or eliminates the need to compensate for axial shortening in other ways, such as by advancing the stent 500 "beyond" the target line 530 before deployment to attempt to achieve the correct final positioning of the inflow end of the stent 500 at the target line 530 after deployment. This eliminates a great deal of guesswork during deployment and generally increases the accuracy of the final axial positioning of the stent relative to the natural valve ring after deployment.

[0043] Although the design of artificial heart valves (and especially their frames) can be modified to attempt to achieve... Figures 4A to 4B The unfolded configuration, but the conveying equipment itself can be designed to facilitate the realization of Figures 4A to 4B The unfolding configuration, or other desired stability of the artificial heart valve during unfolding, can help achieve at least some of these goals. The embodiments described below can help achieve at least some of these goals.

[0044] Figure 5 The illustration shows a cross-section of the distal end of a delivery device for a balloon-expandable artificial heart valve. The delivery device may include an inner lumen or shaft 610 (e.g., sized to receive a wire passing through it), which at its distal end is coupled to a non-invasive distal tip or anterior cone 620. The delivery device may also include a shaft 630 having a distal end coupled to the proximal end of a balloon 640, wherein the distal end of the balloon 640 is coupled to the anterior cone 620. To inflate the balloon 640 to deploy the artificial heart valve mounted thereon, fluid may be (e.g., by directing the fluid in the distal direction...) Figure 5 In the view (facing right), it enters the interior of the balloon 640 through the lumen of axis 630.

[0045] Figure 5The balloon 640 is shown in a mostly deflated or completely deflated state. For example, the balloon 640 may be heat-treated or otherwise shaped such that it includes a "pre-pillow" section that has a raised shape even before fluid enters the balloon 640. In the illustrated embodiment, the balloon 640 includes a proximal occipital portion or proximal bulge 642, a distal occipital portion or distal bulge 644, and an intermediate section 646 connecting the proximal bulge 642 and the distal bulge 644. In the deflated or deflated state of the balloon 640, the proximal bulge 642 and the distal bulge 644 may extend radially outward from the central longitudinal axis of the guide shaft 610 by a greater distance than the intermediate section 646. Using this configuration, the artificial heart valve can be mounted mostly or completely above the intermediate segment 646 for delivery, and the proximal ridge 642 and distal ridge 644 can serve as shoulders to help ensure the artificial heart valve remains securely in place during delivery. In other words, the outflow end of the artificial heart valve can contact the distal end of the proximal ridge 642, while the inflow end of the artificial heart valve can contact the proximal end of the distal ridge 644 (similar to...). Figure 6 The configuration shown helps the artificial heart valve maintain its initial axial positioning relative to the balloon 640 during delivery. The distal ridge 644 can also provide edge protection to the anterior edge of the artificial heart valve (for the inflow end delivered via the femur), for example, to help prevent the inflow edge of the artificial heart valve from contacting natural tissue (e.g., the inner wall of the aortic arch), which could otherwise cause displacement of the artificial heart valve relative to the balloon 640.

[0046] If two bulges 642 and 644 of equal size are provided, and the inflation medium enters the balloon 640 from the proximal end (e.g., via the distal end of the shaft 630), the bulges 642 and 644 may not deploy at the same rate. This is especially true for artificial heart valves with a relatively rigid inflow segment (which may be particularly suitable for anchoring in the natural valve annulus) and a relatively flexible outflow segment (which may be obtained by minimizing the structure at the outflow end to provide maximum coronary artery space). Artificial heart valves with an inflow segment that is stiffer than its outflow segment are described in more detail in U.S. Provisional Patent Application No. __ / __, ___, filed in 2023 entitled "TAVI Deployment Accuracy – Stent Frame Improvements," the disclosure of which is incorporated herein by reference. In other words, if the inflow section of the artificial heart valve is more resistant to expansion, the two equally sized bulges 642, 644 can cause the outflow section of the artificial heart valve to expand faster than the inflow section. Furthermore, the problem may be exacerbated because the outflow section of the artificial heart valve is positioned close to the inflow section, as fluid will enter the proximal bulge 642 before entering the distal bulge 644. If the bulges 642, 644 of the balloon 640 expand at different rates during the deployment of the artificial heart valve, the artificial heart valve may expand in an uncontrolled and / or unintended manner, potentially leading to inaccurate positioning of the artificial heart valve within the natural valve annulus. In some embodiments, preferably, the bulges 642, 644 can expand at substantially equal rates when the inflation medium enters the balloon 640 from the proximal end. To achieve this equal expansion rate, the distal bulge 644 may be provided with a length L1 greater than the length L2 of the proximal bulge 642. In the illustrated embodiment, when the balloon 640 is in an uninflated state, the increased length L1 relative to length L2 also results in the internal volume of the distal bulge 644 being larger than the internal volume of the proximal bulge 642. For example, in some embodiments, the distal bulge 644 may have a length L1 that is 10% to 200% larger than length L2, including approximately 25%, approximately 50%, approximately 75%, and approximately 100% larger. Similarly, in the uninflated state, the distal bulge 644 may have an internal volume that is 10% to 200% larger than the internal volume of the proximal bulge 642, including approximately 25%, approximately 50%, approximately 75%, and approximately 100% larger. In one example, length L1 is approximately 50% larger than length L2, and when inflation medium is pushed into the balloon 640 from the proximal end, the proximal bulge 642 and the distal bulge 644 will expand at approximately the same rate. It should be understood that during the expansion of balloon 640, the middle portion 646 will also be expanded.By utilizing the substantially uniform expansion rate of different parts of the balloon 640, the artificial heart valve mounted on the balloon 640 can be deployed with greater predictability.

[0047] In other embodiments, the dimensions of the proximal bulge 642 and the distal bulge 644 can be manipulated to provide preferential filling of one of the bulges before the other bulge, which can be used to form a specific deployment configuration of the artificial heart valve. For example, the “curled area” of the balloon 640 can be the intermediate portion 646 between the two bulges 642, 644, which can be further opened or further blocked to control the amount of flow resistance involved in inflating the distal bulge 644. A larger blockage will increase the flow resistance to the distal bulge 644, while a smaller blockage will decrease the flow resistance to the distal bulge 644. In some embodiments, the design of the cone angle of the balloon 640 can affect the preferential filling of the proximal balloon portion relative to the distal balloon portion. As used herein, the term “cone angle” generally refers to the angle of the inclined region between the balloon leg and the balloon body. Due to the nature of blow-molded balloons, steeper cone angles typically result in thicker walls, which can lead to greater expansion resistance compared to portions of balloon 640 with thinner walls. It should be understood that after balloon 640 has been filled with the inflation medium, the outer diameters of the proximal bulge 642, distal bulge 644, and intermediate section 648 can all be substantially equal.

[0048] Figure 6 The illustration shows a cross-section of the distal end of a delivery device for a balloon-expandable artificial heart valve according to another aspect of this disclosure. The delivery device may include an inner lumen or shaft 710 (e.g., sized to receive a wire passing through it), which at its distal end is coupled to a non-invasive distal tip or anterior cone 720. The delivery device may also include a shaft 730 having a distal end coupled to a proximal end of a balloon 740, wherein the distal end of the balloon 740 is coupled to the anterior cone 720. To inflate the balloon 740 to deploy the artificial heart valve mounted thereon, fluid may enter the interior of the balloon 740, for example, by directing the fluid in a distal direction (in... Figure 6 It enters through the lumen of shaft 730 in the view (facing to the right).

[0049] Similar to Figure 5 The balloon 640, Figure 6 The balloon 740 can form two bulges, or "occipital regions," on each side of the central portion of the balloon when it is not inflated. However, in Figure 6 In a particular embodiment, each ridge has substantially the same size. Figure 6The artificial heart valve PHV, coiled on the middle portion of balloon 740, is also shown, illustrating more clearly how the bulge pre-formed into balloon 740 helps maintain the artificial heart valve PHV in the desired position relative to balloon 740 during delivery, while also providing active protection of the leading edge of the artificial heart valve PHV during delivery. For example, Figure 6 This illustrates how the distal inflow and distal outflow edges of the artificial heart valve PHV directly contact the complementary shoulders of each pre-formed bulge of the balloon 740 when the balloon 740 is in an inflated state.

[0050] and Figure 5 Similar to the implementation examples, in order to fill Figure 6 The balloon 740 is used to deploy the artificial heart valve PHV. The user can deliver the inflation medium distally into the balloon 740, for example, via an inflation lumen located between the lead shaft 710 and the balloon catheter shaft 730. In the illustrated embodiment, an inflation lumen adjuster 750 is disposed within the balloon 740. In this particular example, the inflation lumen adjuster 750 is positioned within the middle portion of the balloon 740 (e.g., between two pre-formed bulges) and (e.g., around the lead shaft 710) around the lead shaft 710. In the illustrated embodiment, the inflation lumen adjuster 750 is a solid cylindrical member, with the lead shaft 710 passing through the interior of the inflation lumen adjuster 750. The inflatable lumen modulator 750 can be formed of any suitable material (including, for example, a soft polymer that can be overmolded onto the balloon catheter shaft or lead shaft 710, including, for example, 25D-45D polyether block amide) and effectively acts as a strategically placed gap filler. In other words, as Figure 6 As shown, the inclusion of the inflator lumen regulator 750 reduces the amount of open volume around the central portion of the balloon 740. This additional solid material increases the resistance to fluid flowing into the distal end of the balloon 740. Without the inflator lumen regulator 750, the flow resistance would be reduced, and the distal end of the balloon 740 would be inflated faster than with the regulator. Furthermore, the size and location of the inflator lumen regulator 750 can be selected to achieve the desired resistance to fluid flow and thus the desired rate of filling and expansion of the distal end of the balloon 740 relative to the proximal end. Utilizing Figure 6 In the specific embodiment shown, the position of the inflation lumen regulator 750 helps ensure that the balloon 740 expands relatively uniformly when the inflation medium enters the balloon 740, which in turn leads to more predictable expansion of the artificial heart valve PHV.

[0051] Figure 7AThis is a cross-section of balloon 840 in its uninflated state. Similar to other embodiments of the balloon catheter described herein, balloon 840 can be used with a balloon catheter to deploy an artificial heart valve. Like balloons 640 and 740, balloon 840 may include pre-shaped (or “pre-pillow”) proximal ridges 842 and 844, separated by an intermediate portion 846 configured to receive the artificial heart valve thereon. Unlike other embodiments disclosed herein, the intermediate portion 846 of balloon 840 includes excess material forming multiple folds or flaps 848. The folds or flaps 848 can provide two separate functions. First, the folds 848 can generate greater friction between balloon 840 and the artificial heart valve rolled up thereon, particularly compared to a balloon that is equivalently formed but has a smooth outer surface without folds. This additional friction helps the artificial heart valve mounted on balloon 840 to retain its position more reliably after being curled up due to the additional friction. Second, as the inflation medium enters balloon 840 and balloon 840 begins to inflate, the fold 848 can begin to unfold or expand. In other words, when balloon 840 is not inflated, the length of the intermediate segment 846 (e.g., the length along the outline of fold 848) is greater than the length from the distal end of proximal bulge 842 to the proximal end of distal bulge 844. This can be compared to the inflated state of balloon 840. Figure 7B As shown, the additional material of the fold 848 allows the length L3 of the balloon 840 to remain substantially constant during balloon 840 expansion. In other words, while the natural tendency of the balloon 840 is to shorten axially during expansion, the unfolding of the fold 848 during expansion compensates for this tendency, thus allowing the balloon 840 to maintain a constant length L3. This should be consistent with... Figure 7C Compared to an alternative version of the balloon 840' shown, this alternative version is identical to the balloon 840 except for the absence of a fold in the middle portion 846'. Without the fold, the balloon 840' has a first length L4 in its uninflated state, but when the balloon 840' inflates, its total length shortens axially to a smaller length L5.

[0052] One benefit of reducing or eliminating axial shortening of balloon 840 during expansion is that the artificial heart valve mounted on it can experience less shortening. In other words, if the artificial heart valve is mounted on balloon 840', it may tend to pull on the artificial heart valve and shorten it along with the balloon as balloon 840' expands and contracts. However, the construction of balloon 840 can reduce the amount of shortening of the artificial heart valve during balloon 840 expansion, which in turn helps to achieve more accurate positioning of the artificial heart valve into the natural valve ring.

[0053] Figure 8 This is a schematic cross-section of the height of the conveying device 900 according to another aspect of this disclosure. Figure 8 In this configuration, the delivery device 900 has advanced through the femoral artery, across the aortic arch AA of the aorta A, and the distal end of the delivery device 900 is positioned within the aortic valve annulus VA, wherein the anterior cone 920 of the delivery device 900 extends into the left ventricle LV. Like other delivery devices described herein, the delivery device 900 may include a balloon catheter shaft 930 connected to an expandable balloon 980 (e.g., having an inflatable lumen connecting the balloon catheter shaft 930 to the interior of the balloon 980). When deflated, the balloon-expandable artificial heart valve PHV can be coiled around the balloon 980, and... Figure 8 The illustration shows an inflated balloon 980, which is used to deploy the artificial heart valve PHV into the aortic valve annulus VA.

[0054] Figure 8 The delivery device 900 may further include an external catheter shaft 940 through which the balloon catheter shaft 930 extends. In the illustrated embodiment, the external catheter shaft 940 terminates proximally near the balloon 980. The external catheter shaft 940 may be steerable, for example via one or more drawstrings extending through the wall of the external catheter shaft 940 to a steering ring mounted to the external catheter shaft 940. The steerability of the external catheter shaft 940 can aid in the navigation of the delivery device 900 (including navigation around the aortic arch AA) while minimizing or avoiding contact between the collapsed prosthetic heart valve PHV and the tissue of the aortic arch AA. Figure 8In some embodiments, the delivery device 900 includes one or more spacers 950 extending between the balloon catheter shaft 930 and the outer catheter shaft 940. Although two spacers 950 are shown, it should be understood that one, two, or more than two spacers 950 may be provided along the length of the delivery device 900. The spacers 950 may be formed of any suitable material having sufficient rigidity to maintain the desired clearance between the balloon catheter shaft 930 and the outer shaft 940. Suitable materials may include soft polymers that can be overmolded onto the balloon catheter shaft 930, wherein the soft nature of the material allows for the desired amount of flexibility. In some examples, the spacers 950 may be formed as annular disks (or cylindrical disks with a central through-hole). For example, each spacer 950 may include an internal cylindrical or circular through-hole having a diameter approximately equal to the outer diameter of the balloon catheter shaft 930 and may extend to an outer diameter approximately equal to the inner diameter of the balloon catheter shaft 940. With this configuration, each spacer 950 receives a balloon catheter shaft 930 passing through it and includes an outer periphery that contacts the inner diameter of the outer shaft 940. In some embodiments, each spacer 950 is fixed to both the balloon catheter shaft 930 and the outer shaft 940. However, in other embodiments, each spacer 950 is fixed only to the balloon catheter shaft 930 (or only to the outer shaft 940) to allow axial and / or rotational movement of the balloon catheter shaft 930 relative to the outer shaft 940. Figure 8 The described configuration allows the spacer 950 to force the balloon catheter shaft 930 and the outer shaft 940 to remain coaxially positioned relative to each other, wherein the gap between the two shafts is equal to the size of the spacer 950.

[0055] When delivering and deploying a prosthetic heart valve PHV via balloon 980 using delivery device 900, spacer 950 can provide one or more benefits. For example, if the outer axis 940 is steerable, by steerable the outer axis 940 to be substantially aligned (e.g., coaxial) with the natural valve ring VA, spacer 950 can force balloon catheter shaft 930 to be coaxial with the outer axis 940, and thus also with the natural valve ring VA. Spacer 950 can also help resist changes in the relative positioning between balloon catheter shaft 930 and outer axis 940. For example, when balloon 980 is inflated and the prosthetic heart valve PHV is deployed into the natural valve ring VA, the forces from balloon expansion and the forces from the contact between the prosthetic heart valve PHV and the natural valve ring VA can tend to change the position of balloon catheter shaft 930 relative to outer axis 940. However, including spacer 950 can resist this relative movement, thereby increasing the overall stability of delivery device 900 and the accuracy of placing the prosthetic heart valve PHV within the natural valve ring VA.

[0056] Figure 9The remote end of a conveying device according to another aspect of this disclosure is shown. Specifically, Figure 9 The diagram illustrates the distal connection of the balloon catheter shaft 1030 to the balloon 1080 (the balloon 1080 is in...). Figure 9 (shown as being in an inflated state), where the inner axis 1010 passes through the balloon 1080 and reaches the undamaged distal tip or anterior cone (in Figure 9 (Not visible in the middle). Although Figure 9 It is not shown, but it should be understood that when balloon 1080 is not inflated for delivery, the balloon-expandable artificial heart valve will be rolled up on balloon 1080, and when the inflation medium enters the interior of balloon 1080 through balloon catheter shaft 1030, the artificial heart valve will be inflated together with balloon 1080. Figure 9 The balloon 1080 includes one or more features for temporarily attaching the balloon 1080 to an artificial heart valve coiled thereon.

[0057] exist Figure 9In the specific embodiment shown, balloon 1080 includes a distal connector or inflow connector 1082 and a proximal connector or outflow connector 1084. In this embodiment, the distal connector 1082 is secured to the outer surface of balloon 1080 near the distal end of balloon 1080 and may have a generally "L" shape, with one member extending radially outward from balloon 1080 and a second member extending proximally. The proximal connector 1084 is also secured to balloon 1080 near the proximal end of balloon 1080 and may have a single member (e.g., as a simple short bar) extending radially outward from balloon 1080. Proximal connector 1082 and distal connector 1084 may be formed of any suitable material, preferably including materials with sufficient rigidity to maintain contact with the artificial heart valve when balloon 1080 expands. In some embodiments, connectors 1082, 1084 may be formed of amide-based polymers, for example, to allow chemical bonding to balloon 1080. In some embodiments, connectors 1082 and 1084 may be formed of a material with a melt temperature higher than that of the balloon 1080. In such embodiments, connectors 1082 and 1084 can be overmolded onto a preform before blow molding the balloon 1080. During blow molding, connectors 1082 and 1084 can move outward while maintaining their geometry. In some embodiments, connectors 1082 and 1084 can be attached to the balloon 1080 after blow molding. In such embodiments, connectors 1082 and 1084 can be overmolded onto the balloon; however, the thickness of the balloon 1080's walls may make such overmolding difficult. However, even with these difficulties, this process allows for more precise placement of connectors 1082 and 1084 because the blow molding of the balloon 1080 is completed before the attachment of connectors 1082 and 1084.

[0058] In use, when the artificial heart valve is rolled up on an uninflated balloon 1080, the two connectors 1082, 1084 can contact the struts of the frame forming the artificial heart valve (which can be any artificial heart valve described herein, or any other balloon-expandable artificial heart valve). When the balloon 1080 inflates, the contact between the connectors 1082, 1084 and the artificial heart valve helps ensure that the artificial heart valve remains in the desired position relative to the balloon 1080 during inflating. For example, in some embodiments, the bottom inflow apex of a unit of the artificial heart frame can hook onto the distal end of the distal connector 1082, and the top outflow apex of a unit of the frame can hook onto the proximal end of the proximal connector 1084. With this configuration, when the balloon 1080 inflates, the connectors 1082, 1084 limit the ability of the artificial heart valve to shorten because the connectors 1082, 1084 prevent axial movement of the ends of the frame relative to the balloon. However, in other embodiments, it may be desirable to allow only one end of the artificial heart valve (e.g., the outflow end) to be shortened. In this case, the top outflow apex of the frame unit may contact (rather than hook) the distal end of the proximal connector 1084. This contact typically helps maintain the positional (e.g., rotational) stability of the outflow end of the artificial heart valve relative to the balloon 1080, but does not restrict the shortening of the outflow end of the artificial heart valve. Other positioning is possible, for example, the "L"-shaped distal connector 1082 hooking onto a strut at or near the inflow end of the frame of the artificial heart valve to similarly help stabilize the inflow end of the artificial heart valve without restricting its shortening.

[0059] although Figure 9 Two specific connectors 1082, 1084 on balloon 1080 are illustrated, but it should be understood that additional connectors may be provided (e.g., multiple pairs of connectors 1082 and 1084 may be provided along the circumference of the balloon, even if only one pair is shown). In other embodiments, either connector 1082, 1084 may be omitted, or additional connectors may be provided (e.g., between connectors 1082, 1084) to provide additional stability. It should also be understood that connectors 1082, 1084 may be provided on other embodiments described herein. For example, balloon 1080 may be provided with a similar coupling. Figures 5 to 7C The pre-bulged or pre-pillow-shaped segment is shown, and the connector can be located at the end of the middle (non-pillow-shaped) segment of the balloon, wherein when the artificial heart valve is rolled up on the uninflated balloon 1080, the opposite end of the artificial heart valve contacts the shoulder formed by the pre-bulged or pre-pillow-shaped segment.

[0060] The delivery devices described above are generally described with a focus on the distal end of the device. However, it should be understood that any embodiment described herein may include a proximal end comprising handles for controlling various aspects of the process, such as those known in the art, including actuators for controlling the orientation of the external axis of the artificial heart valve, actuators for providing rotation of the balloon catheter axis to align the commissure of the artificial heart valve with the commissure of the natural heart valve, one or more ports for introducing fluid into the system (e.g., flushing ports and / or inflation ports), etc. Furthermore, although an exemplary balloon-expandable artificial heart valve is described herein, it should be understood that other balloon-expandable artificial heart valves may be equally suitable for use with any delivery device (or delivery device feature) described herein. Moreover, although various features are described herein as part of various embodiments, it should be understood that features of different embodiments may be combined with each other. For example, Figure 5 The unevenly sized pre-bulge can be applied to any other balloon described herein. Similarly, combined with Figure 6 The described inflation lumen adjuster can be applied to any other balloon described herein. Figure 7A The folds or flaps 848 of the middle section 846 of the balloon can be similarly combined with any other balloon described herein. Figure 8 The described spacer 950 can be used with the delivery device of any other embodiment described herein. Similarly, connectors 1082, 1084 (and variations thereof described above) can be applied to any balloon described herein. Finally, it should be understood that more than two (including all) of these features can be combined in a single embodiment, and the benefits of each feature can be applied to the combined device. These benefits generally relate to more accurate deployment of the artificial heart valve from a collapsed state to an expanded state, including by limiting the shortening of the artificial heart valve (particularly at the inlet end) or by otherwise stabilizing the position of the artificial heart valve during deployment as it expands.

[0061] While the invention has been described with respect to specific embodiments, it should be understood that these embodiments are merely exemplary illustrations of the principles and applications of the invention. Therefore, it should be understood that many modifications can be made to the exemplary embodiments, and other arrangements can be designed, without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. A delivery apparatus for delivering a prosthetic heart valve, the delivery apparatus comprising: a balloon catheter shaft having a distal end; an inner shaft extending through the balloon catheter in a proximal-to-distal direction; an atraumatic distal tip positioned at a distal end of the inner shaft; and a balloon positioned between the distal end of the balloon catheter shaft and the atraumatic distal tip, the balloon having an inflated state and an uninflated state, wherein in the uninflated state of the balloon, the balloon comprises a proximal bulge, a distal bulge, and an intermediate section between the proximal bulge and the distal bulge, the intermediate section having a diameter that is less than a diameter of the proximal bulge and less than a diameter of the distal bulge, the distal bulge extending a first length in a proximal-to-distal direction, and the proximal bulge extending a second length in a proximal-to-distal direction, the first length being different than the second length.

2. The delivery apparatus of claim 1, wherein the balloon catheter shaft comprises an inflation lumen in the balloon catheter shaft that is in fluid communication with an interior volume of the balloon, such that pushing inflation media through the inflation lumen in a proximal-to-distal direction causes the inflation media to enter the proximal bulge before entering the distal bulge.

3. The delivery apparatus of claim 1, wherein the first length is about 1.1 times to about 1.5 times longer than the second length.

4. The delivery apparatus of claim 3, wherein in the inflated state of the balloon, the diameter of the proximal bulge, the diameter of the distal bulge, and the diameter of the intermediate section are all substantially equal.

5. A delivery apparatus for delivering a prosthetic heart valve, the delivery apparatus comprising: a balloon catheter shaft having a distal end; an inner shaft extending through the balloon catheter in a proximal-to-distal direction; an atraumatic distal tip positioned at a distal end of the inner shaft; and a balloon positioned between the distal end of the balloon catheter shaft and the atraumatic distal tip, the balloon having an inflated state and an uninflated state, wherein in the uninflated state of the balloon, the balloon comprises a proximal bulge, a distal bulge, and an intermediate section between the proximal bulge and the distal bulge, the intermediate section having a diameter that is less than a diameter of the proximal bulge and less than a diameter of the distal bulge. wherein an inflation lumen regulator is positioned on the inner shaft, and a position occupied by the inflation lumen regulator within an interior volume of the balloon is axially aligned with a position of the intermediate section.

6. The delivery apparatus of claim 5, wherein the inflation lumen regulator is a solid cylindrical member through an interior of which the inner shaft passes. ​ ​ 7. The delivery apparatus of claim 5, wherein in the un-inflated state of the balloon, the total fillable internal volume of the middle section of the balloon is less than the total fillable internal volume of the middle section of the balloon without the inflation lumen regulator.

8. The delivery apparatus of claim 5, wherein the proximal bulge, the middle section, and the distal bulge expand at substantially equal expansion rates when the balloon transitions from the un-inflated state to the inflated state.

9. A delivery apparatus for delivering a prosthetic heart valve, the delivery apparatus comprising: a balloon catheter shaft having a distal end; an inner shaft extending through the balloon catheter in a proximal to distal direction; an atraumatic distal tip positioned at a distal end of the inner shaft; and a balloon positioned between the distal end of the balloon catheter shaft and the atraumatic distal tip, the balloon having an inflated state and an un-inflated state, wherein in the un-inflated state of the balloon, the balloon comprises a proximal bulge, a distal bulge, and a middle section between the proximal bulge and the distal bulge, the middle section having a plurality of folds or pleats such that a length of the middle section is greater than a length from a distal end of the proximal bulge to a proximal end of the distal bulge, the middle section having a diameter that is less than a diameter of the proximal bulge and less than a diameter of the distal bulge.

10. The delivery apparatus of claim 9, wherein the plurality of folds or pleats of the middle section unfold or uncrease when the balloon transitions from the un-inflated state to the inflated state.

11. The delivery apparatus of claim 10, wherein in the un-inflated state of the balloon, the balloon has a first length between a proximal end of the proximal bulge and a distal end of the distal bulge; and in the inflated state of the balloon, the balloon has a second length between the proximal end of the proximal bulge and the distal end of the distal bulge, the first length being approximately equal to the second length.

12. The delivery apparatus of claim 9, wherein in the un-inflated state of the balloon, contact between the plurality of folds or pleats and an inner surface of a prosthetic heart valve results in greater friction than friction between an inner surface of a prosthetic heart valve and a balloon that is identically formed but has a smooth outer surface without folds.

13. A delivery apparatus for delivering a prosthetic heart valve, the delivery apparatus comprising: a balloon catheter shaft having a distal end; an inner shaft extending through the balloon catheter in a proximal to distal direction; an outer shaft extending over the balloon catheter shaft in the proximal to distal direction; an atraumatic distal tip positioned at a distal end of the inner shaft; and a balloon positioned between the distal end of the balloon catheter shaft and the atraumatic distal tip, the balloon having an inflated state and an un-inflated state, wherein in the un-inflated state of the balloon, the balloon comprises a proximal bulge, a distal bulge, and a middle section between the proximal bulge and the distal bulge, the middle section having a plurality of folds or pleats such that a length of the middle section is greater than a length from a distal end of the proximal bulge to a proximal end of the distal bulge, the middle section having a diameter that is less than a diameter of the proximal bulge and less than a diameter of the distal bulge. a balloon positioned between a distal end of the balloon catheter shaft and the atraumatic distal tip, the balloon having an inflated state and an uninflated state, wherein at least one spacer is coupled to an outer surface of the inner shaft and in contact with an inner surface of the outer shaft such that the inner shaft is coaxial with the outer shaft.

14. The delivery apparatus of claim 13, wherein the at least one spacer comprises a plurality of spacers positioned at spaced distances along the inner shaft.

15. The delivery apparatus of claim 13, wherein the at least one spacer is fixed to the inner shaft.

16. The delivery apparatus of claim 13, wherein the spacer is annular, the spacer having an inner bore through which the inner shaft passes and an outer circumference in contact with the inner surface of the outer shaft.

17. The delivery apparatus of claim 13, wherein a distal end of the outer shaft terminates proximate a proximal end of the balloon.

18. A prosthetic heart valve system comprising a delivery apparatus and an expandable prosthetic heart valve, the delivery apparatus comprising: a balloon catheter shaft having a distal end; an inner shaft extending through the balloon catheter in a direction from proximal to distal; an atraumatic distal tip positioned at a distal end of the inner shaft; and a balloon positioned between a distal end of the balloon catheter shaft and the atraumatic distal tip, the balloon having an inflated state and an uninflated state, wherein the balloon comprises a distal connecting member extending radially outward from an outer surface of the balloon proximate a distal end of the balloon and a proximal connecting member extending radially outward from an outer surface of the balloon proximate a proximal end of the balloon such that when the prosthetic heart valve receives the balloon therethrough, the distal connecting member is in contact with an inflow portion of the prosthetic heart valve and the proximal connecting member is in contact with an outflow portion of the prosthetic heart valve.

19. The prosthetic heart valve system of claim 18, wherein the distal connecting member remains in contact with an inflow portion of the prosthetic heart valve and the proximal connecting member remains in contact with an outflow portion of the prosthetic heart valve when the balloon transitions from the uninflated state to the inflated state.

20. The delivery apparatus of any one of claims 5-12, wherein in the uninflated state of the balloon, the distal bulge extends a first length in a direction from proximal to distal and the proximal bulge extends a second length in a direction from proximal to distal, the first length being different than the second length.

21. The delivery apparatus of any one of claims 1-4 or 9-12, wherein an inflation lumen regulator is positioned on the inner shaft and a position occupied by the inflation lumen regulator within an interior volume of the balloon is axially aligned with a position of the intermediate section.

22. The delivery apparatus of any one of claims 1-8, wherein in an un-inflated state of the balloon, the intermediate section of the balloon has a plurality of folds or pleats such that a length of the intermediate section is greater than a length from a distal end of the proximal bulge to a proximal end of the distal bulge.

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