Balloon and assembly method for prosthetic valve delivery device

Abstract

Embodiments of a balloon assembly are disclosed. The balloon assembly may include an inflatable balloon having an inflated state and a deflated state. The deflated balloon may include a valve retaining portion, a distal conical portion connected to the distal end of the valve retaining portion, a proximal conical portion connected to the proximal end of the valve retaining portion, a distal leg connected to the distal end of the distal conical portion, and a proximal leg connected to the proximal end of the proximal conical portion. The distal conical portion may include one or more axial folds. The proximal end of the distal conical portion may include a first radial fold connected to a second radial fold, the first radial fold and the second radial fold forming a distally extending recess at the proximal end of the distal conical portion.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefits of U.S. Provisional Application No. 62 / 911,861, filed October 7, 2019; U.S. Provisional Application No. 62 / 925,722, filed October 24, 2019; U.S. Provisional Application No. 62 / 981,412, filed February 25, 2020; U.S. Provisional Application No. 63 / 051,244, filed July 13, 2020; and U.S. Provisional Application No. 63 / 086,940, filed October 2, 2020, each of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates to embodiments of a balloon for a transcatheter delivery device for implanting medical devices (such as prosthetic heart valves), and embodiments of a method for assembling the delivery device. Background Technology

[0004] Intravascular delivery devices are used in a variety of procedures to deliver prosthetic medical devices or instruments to locations inside the body that are not easily accessible surgically or where surgical access is desired. Access to a target location within the body is achieved by inserting and guiding the delivery device through channels or cavities within the body—including, but not limited to, blood vessels, esophagus, trachea, any part of the gastrointestinal tract, lymphatic vessels, etc. (to name just a few)

[0005] Balloon-expandable prosthetic valves are generally preferred as replacements for calcified natural valves because the balloon of the delivery device can apply sufficient expansion force to expand the framework of the prosthetic valve and anchor it against the surrounding calcified tissue. In one known technique for delivering a prosthetic heart valve, the prosthetic heart valve can be folded onto the valve-retaining portion of the balloon of the delivery device before insertion into the patient. The delivery device may include a proximal shoulder and a distal shoulder located inside the balloon, which retain the folded prosthetic valve on the balloon as the delivery device is advanced through the patient's vascular system.

[0006] Forming and folding the balloon during the assembly of the delivery device is a time-consuming and labor-intensive process. Therefore, improvements in the way the balloon is formed and assembled in the delivery device are desired. Summary of the Invention

[0007] This document discloses balloon catheters, balloon assemblies for balloon catheters, and related methods for forming balloon assemblies and balloon catheters. Balloon catheters can be used to deliver medical devices, instruments, agents, or other therapies to locations within a subject's body. In some embodiments, balloon catheters can be used to deliver implantable medical devices, such as prosthetic valves, to a subject's heart. In some embodiments, balloon catheters can be components of delivery devices that can deliver prosthetic valves or other implantable medical devices.

[0008] Some embodiments of this disclosure relate to a balloon assembly including an inflatable balloon having an inflated state and a deflated state. The deflated inflatable balloon may include a valve retaining portion, a distal conical portion connected to the distal end of the valve retaining portion, a proximal conical portion connected to the proximal end of the valve retaining portion, a distal leg connected to the distal end of the distal conical portion, and a proximal leg connected to the proximal end of the proximal conical portion. The valve retaining portion may have a generally cylindrical shape and one or more axial folds. The proximal end of the distal conical portion may have a larger diameter than the distal end of the distal conical portion and the valve retaining portion. The distal end of the proximal conical portion may have a larger diameter than the proximal end of the proximal conical portion and the valve retaining portion. The distal conical portion may include one or more axial folds. The proximal end of the distal conical portion may include a first radial fold connected to a second radial fold. The first radial fold and the second radial fold can form a pocket extending distally at the proximal end of the distal tapered portion.

[0009] In some embodiments, the balloon assembly may include a restraining member extending around the outer surface of the valve holding portion to prevent one or more axial folds of the valve holding portion from unfolding.

[0010] In some embodiments, the balloon assembly may include a cover that encloses the inflatable balloon. The cover may include a proximal portion, a distal portion, and an intermediate portion between the proximal and distal portions. The proximal portion may define a proximal recess shaped to substantially match the shape of the proximal conical portion of the inflatable balloon. The distal portion may define a distal recess shaped to substantially match the shape of the distal conical portion of the inflatable balloon. The intermediate portion may define an intermediate recess shaped to substantially match the shape of a valve-retaining portion of the inflatable balloon.

[0011] In some embodiments, the covering may include a first covering element and a second covering element, the first covering element and the second covering element being complementary in construction such that they can be fitted together to surround the inflatable balloon in a deflated state.

[0012] In some embodiments, the balloon assembly may include an outer sleeve extending over the cover to prevent the first and second covers from separating from each other.

[0013] In some implementations, the inflatable balloon may include an inner cavity extending through the proximal cone portion, the valve retention portion, and the distal cone portion.

[0014] In some embodiments, the proximal cone portion of the inflatable balloon may include a proximal portion. One or more axial folds of the proximal cone portion do not extend into the proximal portion of the proximal cone portion.

[0015] In some embodiments, the distal conical portion of the inflatable balloon may include a distal portion. One or more axial folds of the distal conical portion do not extend into the distal portion of the distal conical portion.

[0016] In some embodiments, the distal end of the proximal conical portion may include a radial fold that forms an obtuse or right angle relative to the valve retaining portion.

[0017] In some embodiments, the first radial fold at the proximal end of the distal conical portion may form an obtuse or right angle relative to the valve retaining portion, and the second radial fold may form an acute angle relative to the valve retaining portion.

[0018] Some embodiments of this disclosure relate to another balloon assembly having an inflatable balloon in both an inflated and deflated state. The deflated inflatable balloon may include a valve retaining portion, a distal conical portion connected to the distal end of the valve retaining portion, a proximal conical portion connected to the proximal end of the valve retaining portion, folds extending axially along at least one or more sections of the distal and proximal conical portions, a distal leg connected to the distal end of the distal conical portion, and a proximal leg connected to the proximal end of the proximal conical portion. The valve retaining portion may have a generally cylindrical shape and one or more axial folds. The proximal end of the distal conical portion may have a larger diameter than the distal end of the distal conical portion and the valve retaining portion. The distal end of the proximal conical portion may have a larger diameter than the proximal end of the proximal conical portion and the valve retaining portion. The inflatable balloon may be in an unassembled state away from the delivery catheter.

[0019] In some embodiments, the balloon assembly may also include a restraint member extending around the outer surface of the valve retention portion to prevent one or more axial folds of the valve retention portion from unfolding.

[0020] In some embodiments, the balloon assembly may further include a cover surrounding the inflatable balloon. The cover may include a proximal portion, a distal portion, and an intermediate portion between the proximal and distal portions. The proximal portion may define a proximal recess shaped to substantially match the shape of a proximal conical portion of the inflatable balloon, and the distal portion may define a distal recess shaped to substantially match the shape of a distal conical portion of the inflatable balloon.

[0021] In some embodiments, the covering may include a first covering element and a second covering element, the first covering element and the second covering element being complementary in construction such that they can be fitted together to surround the inflatable balloon.

[0022] In some embodiments, the balloon assembly may also include an outer sleeve extending over the covering to prevent the first and second coverings from separating from each other.

[0023] In some implementations, the inflatable balloon may include an inner cavity extending through the proximal cone portion, the valve retention portion, and the distal cone portion.

[0024] In some embodiments, one or more axially extending folds do not extend into the proximal portion of the proximal tapered portion.

[0025] In some embodiments, one or more axially extending folds do not extend into the distal portion of the distal tapered portion.

[0026] In some embodiments, the proximal end of the distal tapered portion may include a first radial fold that connects to the second radial fold. The first and second radial folds may form a distally extending recess at the proximal end of the distal tapered portion.

[0027] In some embodiments, the first radial fold at the proximal end of the distal conical portion may form an obtuse or right angle relative to the valve retaining portion, and the second radial fold may form an acute angle relative to the valve retaining portion.

[0028] Some embodiments of this disclosure also relate to a method for assembling a delivery device. The method may include forming an inflatable balloon in a deflated state. The deflated balloon may have a valve holding portion, a distal conical portion connected to the distal end of the valve holding portion, a proximal conical portion connected to the proximal end of the valve holding portion, a distal leg connected to the distal end of the distal conical portion, and a proximal leg connected to the proximal end of the proximal conical portion. The method may further include: inserting a distal shoulder mounted on a first axis of the delivery device through the distal leg of the inflatable balloon and into the distal conical portion; inserting a proximal shoulder mounted on a second axis of the delivery device through the proximal leg of the inflatable balloon and into the proximal conical portion; securing the distal leg of the inflatable balloon to the distal shoulder; and securing the proximal leg of the inflatable balloon to the second axis and / or the proximal shoulder.

[0029] In some embodiments, the method may further include placing a restraint member around the outer surface of the valve retaining portion.

[0030] In some embodiments, the method may further include surrounding the inflatable balloon with a cover. The cover may include a first cover element and a second cover element, the first and second cover elements being complementary in construction such that they can be fitted together to surround the inflatable balloon. The cover may define an indentation whose geometry substantially matches the shape of the inflatable balloon in its deflated state.

[0031] In some embodiments, the method may also include placing a sleeve on the cover to prevent the first cover and the second cover from separating from each other.

[0032] In some embodiments, the proximal end of the distal shoulder may have a larger diameter than the diameter of the distal leg. Inserting the distal shoulder through the distal leg may include radial compression of the proximal end of the distal shoulder.

[0033] In some embodiments, the distal end of the proximal shoulder may have a larger diameter than the diameter of the proximal leg. Inserting the proximal shoulder through the proximal leg may include radial compression of the distal end of the proximal shoulder.

[0034] In some embodiments, forming an inflatable balloon may include forming a valve holding portion that is generally cylindrical in shape, with a diameter smaller than both the diameter of the proximal end of the distal cone portion and the diameter of the distal end of the proximal cone portion.

[0035] In some embodiments, forming an inflatable balloon may include forming one or more axially extending folds along at least a segment of the distal and proximal conical portions.

[0036] In some embodiments, forming an inflatable balloon may include a distal portion forming a distal conical portion, and the distal portion may not contain any one of one or more axially extending folds.

[0037] In some embodiments, forming an inflatable balloon may include a proximal portion forming a proximal conical portion, and the proximal portion may not contain any one of one or more axially extending folds.

[0038] In some embodiments, forming an inflatable balloon may include forming a radial fold at the distal end of the proximal conical portion, and the radial fold may form an obtuse or right angle relative to the valve retaining portion.

[0039] In some embodiments, forming an inflatable balloon may include forming a radial fold at the proximal end of the distal conical portion, and the radial fold may form an obtuse or right angle relative to the valve retaining portion.

[0040] In some embodiments, forming an inflatable balloon may include forming a first radial fold that connects to a second radial fold at the proximal end of the distal tapered portion. The first and second radial folds may form a distally extending recess at the proximal end of the distal tapered portion.

[0041] In some embodiments, the distal shoulder may include one or more distal shoulder fins that extend at least partially radially outward. Inserting the distal shoulder assembly into the distal tapered portion may include closely positioning at least some of the axially extending folds adjacent to one or more of the distal tapered portion of the distal shoulder fins.

[0042] In some embodiments, the proximal shoulder may include one or more proximal shoulder fins that extend at least partially radially outward. Inserting the proximal shoulder assembly into the proximal tapered portion may include at least some of the axially extending folds adjacent to one or more of the proximal tapered portion tightly accommodating one or more proximal shoulder fins.

[0043] In some embodiments, inserting the distal shoulder into the distal conical portion may include aligning a mark on the first axis with a predefined position on the valve-retaining portion of the inflatable balloon or on the proximal shoulder.

[0044] Some embodiments of this disclosure relate to another method for assembling a delivery device. The method may include forming an inflatable balloon in a deflated state. The deflated balloon may have a distal portion, a proximal portion, and a valve retaining portion between the distal and proximal portions. The method may further include: forming a plurality of axially extending folds along at least sections of the distal and proximal portions of the inflatable balloon; and mounting the deflated inflatable balloon onto a delivery device after forming the inflatable balloon and forming the plurality of axially extending folds.

[0045] In some embodiments, mounting an inflatable balloon on a delivery device may include inserting a distal shoulder mounted on a first axis of the delivery device through a distal leg of the balloon and inserting a proximal shoulder mounted on a second axis of the delivery device through a proximal leg of the balloon. The distal leg may be connected to the distal end of a tapered portion of the distal portion of the inflatable balloon, and the proximal leg may be connected to the proximal end of a tapered portion of the proximal portion of the inflatable balloon.

[0046] In some embodiments, the proximal end of the distal shoulder may have a larger diameter than the diameter of the distal leg. Inserting the distal shoulder through the distal leg may include radial compression of the proximal end of the distal shoulder.

[0047] In some embodiments, the distal end of the proximal shoulder may have a larger diameter than the diameter of the proximal leg. Inserting the proximal shoulder through the proximal leg may include radial compression of the distal end of the proximal shoulder.

[0048] In some embodiments, mounting an inflatable balloon on a delivery device may include inserting a distal shoulder into a tapered portion of the distal portion of the inflatable balloon, and inserting a proximal shoulder into a tapered portion of the proximal portion of the inflatable balloon.

[0049] In some embodiments, the distal shoulder may include one or more distal shoulder fins that extend at least partially radially outward. Inserting the distal shoulder into the tapered portion of the distal portion may include at least some of a plurality of axially extending folds in the tapered portion adjacent to the distal portion, where one or more distal shoulder fins are closely positioned.

[0050] In some embodiments, the proximal shoulder may include one or more proximal shoulder fins that extend at least partially radially outward. Inserting the proximal shoulder into the tapered portion of the proximal portion may include at least some of a plurality of axially extending folds adjacent to the tapered portion of the proximal portion, closely housing one or more proximal shoulder fins.

[0051] In some embodiments, inserting the distal shoulder into the tapered portion of the distal portion may include aligning a mark on the first axis with a predefined position on the valve-retaining portion of the inflatable balloon or on the proximal shoulder.

[0052] In some embodiments, forming an inflatable balloon may include a distal portion forming a distal portion, and the distal portion may not contain any of a plurality of axially extending folds.

[0053] In some embodiments, forming an inflatable balloon may include a proximal portion forming a proximal portion, and the proximal portion may not contain any of a plurality of axially extending folds.

[0054] In some embodiments, forming an inflatable balloon may include forming a valve holding portion that is generally cylindrical in shape, with a diameter smaller than both the diameter of the proximal end of the distal portion and the diameter of the distal end of the proximal portion.

[0055] In some embodiments, forming an inflatable balloon may include forming a radial fold at the distal end of the proximal portion, and the radial fold may form an obtuse or right angle relative to the valve retaining portion.

[0056] In some embodiments, forming an inflatable balloon may include forming a radial fold at the proximal end of the distal portion, and the radial fold may form an obtuse or right angle relative to the valve retaining portion.

[0057] In some embodiments, forming an inflatable balloon may include forming a first radial fold that connects to a second radial fold at the proximal end of the distal portion. The first and second radial folds may form a distally extending recess at the proximal end of the distal portion.

[0058] In some embodiments, mounting an inflatable balloon on a delivery device may include securing the distal leg to the distal shoulder and securing the proximal leg to a second axis and / or the proximal shoulder.

[0059] In some embodiments, the method may also include placing a restraint member around the valve retaining portion.

[0060] In some embodiments, the method may further include surrounding the inflatable balloon with a cover. The cover may include a first cover element and a second cover element, which are complementary in construction such that they can be fitted together to surround the inflatable balloon. The cover may define an indentation whose geometry substantially matches the shape of the inflatable balloon in its deflated state.

[0061] In some embodiments, the method may also include placing a sleeve around the cover to prevent the first cover and the second cover from separating from each other.

[0062] Some embodiments of this disclosure also relate to a prosthetic valve delivery assembly including a delivery device. The delivery device may include a shaft and an inflatable balloon mounted on the shaft in a collapsed state. The balloon in the collapsed state may include a valve holding portion having a generally cylindrical shape, a distal tapered portion connected to the distal end of the valve holding portion, and a proximal tapered portion connected to the proximal end of the valve holding portion. The proximal end of the distal tapered portion may include a first radial fold connected to a second radial fold. The first and second radial folds may form a distally extending recess at the proximal end of the distal tapered portion.

[0063] In some embodiments, the prosthetic valve delivery assembly may also include a restraint member extending around the outer surface of the valve holding portion.

[0064] In some embodiments, the prosthetic valve delivery assembly may further include a cover. The cover may include a first cover element and a second cover element, which are complementary in construction such that they can be mateably assembled together to surround the inflatable balloon. The cover may define an indentation whose geometry substantially matches the shape of the deflated inflatable balloon.

[0065] In some embodiments, the prosthetic valve delivery assembly may also include an outer sleeve extending over the covering to prevent the first and second coverings from separating from each other.

[0066] In some embodiments, the deflated balloon may include one or more axially extending folds along at least a segment of the distal and proximal conical portions.

[0067] In some embodiments, the distal tapered portion may include a distal portion that does not contain any one of the one or more axially extending folds.

[0068] In some embodiments, the balloon may also include a distal leg connected to the distal end of the distal cone portion and a proximal leg connected to the proximal end of the proximal cone portion.

[0069] In some embodiments, the delivery device may include: a distal leg mounted on a first axis extending through the distal part of the inflatable balloon and into the distal shoulder of the distal conical portion, and a proximal leg mounted on a second axis of the delivery device extending through the proximal part of the inflatable balloon and into the proximal shoulder of the proximal conical portion.

[0070] In some implementations, the distal leg can be fixed to the distal shoulder and the proximal leg can be fixed to the second axis or the proximal shoulder.

[0071] In some embodiments, the proximal end of the distal shoulder may have a larger diameter than the diameter of the distal leg, and the distal end of the proximal shoulder may have a larger diameter than the diameter of the proximal leg.

[0072] In some embodiments, the distal shoulder may include one or more distal shoulder fins that extend at least partially radially outward and are adjacent to at least some of the axially extending folds in one or more of the distal tapered portions. The proximal shoulder may include one or more proximal shoulder fins that extend at least partially radially outward and are adjacent to at least some of the axially extending folds in one or more of the proximal tapered portions.

[0073] In some embodiments, the first axis may include a mark aligned with a predetermined position on the valve holding portion of the inflatable balloon.

[0074] In some embodiments, the first axis may extend through the valve retaining portion, and the first axis may be separated from the valve retaining portion by an axially extending gap.

[0075] In some implementations, the distal end of the proximal conical portion may include a radial fold that forms an obtuse or right angle relative to the valve retaining portion.

[0076] In some embodiments, the first radial fold at the proximal end of the distal conical portion may form an obtuse or right angle relative to the valve retaining portion, and the second radial fold may form an acute angle relative to the valve retaining portion.

[0077] Some embodiments of this disclosure also relate to another method for assembling a delivery device. The method may include: forming an inflatable balloon in a deflated state, the deflated balloon having a distal portion, a proximal portion, and a valve-retaining portion between the distal and proximal portions; placing the balloon inside a cover; inserting a shaft of the delivery device through an opening in the cover and into the balloon while the balloon is inside the cover; and securing the balloon to a surface of the delivery device.

[0078] Some embodiments of this disclosure also relate to a balloon cover for a balloon catheter. The balloon cover may include a housing and an inner sleeve disposed within the housing. The inner sleeve may have an inner surface defining a lumen configured to receive at least a portion of the balloon of the balloon catheter. The inner sleeve is deformable under pressure exerted by the balloon on its inner surface upon balloon inflation, thereby radially expanding the lumen from a first diameter to a second diameter, wherein the second diameter is larger than the first diameter.

[0079] Some embodiments of this disclosure also relate to medical assemblies. A medical assembly may include a balloon catheter having an inflatable balloon and a balloon cover. The balloon cover may include a housing and an inner member disposed within the housing, and the inner member may have an inner surface defining a cavity. The balloon may be disposed within the cavity of the inner member. When the balloon inflates and applies radially outward pressure to the inner surface of the inner member, the inner member is capable of radial deformation.

[0080] Some embodiments of this disclosure also relate to a method of inflating a balloon catheter. The method may include fluidly connecting the balloon to a fluid source. The balloon may be in a deflated state and disposed within a balloon cover. The method may further include injecting inflating fluid from the fluid source into the balloon to at least partially inflate the balloon to a partially inflated state. The balloon cover may include a shell and an internal member disposed within the shell and surrounding the balloon. Inflating the balloon from a deflated state to a partially inflated state deforms a lumen of the internal member from an initial state to a deformed state. The lumen may have a first diameter in the initial state and a second diameter in the deformed state, and the second diameter may be larger than the first diameter.

[0081] Some embodiments of this disclosure also relate to a balloon cover for a balloon catheter. The balloon cover may include a housing and an inner sleeve disposed within the housing. The inner sleeve may have an inner surface defining a lumen configured to receive at least a portion of the balloon of the balloon catheter. The inner sleeve may include a first separable portion and a second separable portion, each having an inner surface defining a segment of the lumen. The first portion may have a longitudinal edge configured to engage a corresponding longitudinal edge of the second portion to form the lumen. When the balloon deflates, the lumen may have a first diameter, and when the balloon inflates, the lumen may have a second diameter, which is larger than the first diameter.

[0082] Some embodiments of this disclosure also relate to a balloon cover for a balloon catheter. The balloon cover may include a housing and an inner sleeve disposed within the housing. The inner sleeve may have an inner surface defining a lumen configured to receive at least a portion of the balloon of the balloon catheter. When the balloon deflates, the lumen may have a first diameter, and when the balloon inflates, the lumen may have a second diameter, which is larger than the first diameter. The inner sleeve may have a fixed axial length as the lumen expands from the first diameter to the second diameter.

[0083] Some embodiments of this disclosure also relate to medical assemblies. An assembly may include a balloon catheter having an inflatable balloon and a balloon cover. The balloon cover may include a housing and an inner member disposed within the housing. The inner member may have an inner surface defining a lumen. The balloon may be disposed within the lumen of the inner member. The lumen may be configured to expand to a second diameter when the balloon inflates and contract to a first diameter when the balloon deflates, the second diameter being larger than the first diameter.

[0084] Some embodiments of this disclosure also relate to a method of inflating a balloon catheter. The method may include: receiving a balloon disposed within a balloon cover, wherein the balloon is in a deflated state, and injecting expansion fluid from a fluid source into the balloon to at least partially inflate the balloon to a partially inflated state. The balloon cover may include a shell and an internal member disposed within the shell and surrounding the balloon. Inflating the balloon from a deflated state to a partially inflated state deforms a lumen of the internal member from an initial state to a deformed state. The lumen may have a first diameter in the initial state and a second diameter in the deformed state, and the second diameter is larger than the first diameter.

[0085] Some embodiments of this disclosure also relate to a balloon cover for a balloon catheter, the balloon cover having a first shell member and a second shell member configured to engage with each other to surround a distal portion of the balloon catheter. The first shell member may include a plurality of first wedges and a first lumen, and the second shell member may include a plurality of second wedges and a second lumen. The first wedges and first lumens may be configured to lock against corresponding second lumens and second wedges when the first and second shells engage with each other.

[0086] Some embodiments of this disclosure also relate to a medical assembly comprising: a balloon catheter having an inflatable balloon, and a balloon cover including a first shell member and a second shell member. The first shell member and the second shell member are configured to engage with each other to define a cavity configured to receive at least an inflatable balloon. The first shell member may include a plurality of first wedges and a first cavity, and the second shell member may include a plurality of second wedges and a second cavity. The first wedges and the first cavities are configured to lock interlock with corresponding second cavities and second wedges when the first shell and the second shell engage with each other.

[0087] Some embodiments of this disclosure also relate to a balloon cover for a balloon catheter, the balloon cover including a first shell member and a second shell member. The first and second shell members are configured to engage each other to define a lumen configured to receive a distal portion of a balloon catheter. The lumen may include a balloon segment configured to receive a balloon mounted on a distal portion of the balloon catheter. The balloon segment may include a proximal compartment configured to receive a proximal portion of the balloon, a distal compartment configured to receive a distal portion of the balloon, and an intermediate compartment between the proximal and distal compartments, wherein the intermediate compartment may be configured to receive a valve-retaining portion of the balloon. The distal compartment may include a proximal region, a distal region, and an intermediate region between the proximal and distal regions. The distal region may have a smaller diameter than the proximal region, and the intermediate region may have a smaller diameter than the distal region.

[0088] Some embodiments of this disclosure also relate to a balloon cover for a balloon catheter, the balloon cover including a first shell member and a second shell member, wherein the first shell member and the second shell member are configured to engage with each other such that the inner walls of the first shell member and the second shell member define a lumen adapted to receive a distal portion of the balloon catheter. The lumen may include a balloon segment configured to receive a balloon mounted on a distal portion of the balloon catheter. The balloon segment may include a proximal compartment configured to receive a proximal portion of the balloon, a distal compartment configured to receive a distal portion of the balloon, and an intermediate compartment between the proximal and distal compartments. The intermediate compartment may be configured to receive a valve-retaining portion of the balloon. The inner walls of the first shell member and the second shell member may be shaped to create a depression in at least one portion of the balloon when the balloon is held in the lumen.

[0089] Some embodiments of this disclosure also relate to medical assemblies including balloon catheters with an inflatable balloon. The balloon may have a proximal portion, a distal portion, and a valve-retaining portion between the proximal and distal portions. The assembly may also include a compression member configured to create at least one depression within the balloon.

[0090] Some embodiments of this disclosure also relate to a balloon cover assembly for a balloon catheter, the balloon cover assembly including a cover body defining a lumen configured to receive a balloon folded onto a distal portion of the balloon catheter. The balloon may include a proximal portion, a distal portion, and a valve retaining portion connecting the proximal and distal portions. The assembly may also include at least one compression member configured to radially compress at least one portion of the balloon.

[0091] Some embodiments of this disclosure also relate to a method comprising folding a balloon onto a distal portion of a delivery device when the balloon is in a deflated state. The balloon may have a proximal portion, a distal portion, and a valve holding portion connecting the proximal and distal portions. The distal end of the distal portion may have a smaller diameter than the proximal end of the distal portion, the distal end of the proximal portion may have a larger diameter than the proximal end of the proximal portion, and the valve holding portion may have a smaller diameter than both the proximal and distal ends of the distal portion. The method may further include radially compressing the distal portion of the balloon at a location between the distal and proximal ends of the distal portion.

[0092] The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description with reference to the accompanying drawings. Attached Figure Description

[0093] Figure 1 This is a three-dimensional view of a prosthetic heart valve according to one embodiment.

[0094] Figure 2AThis is a three-dimensional view of a prosthetic heart valve according to another embodiment.

[0095] Figure 2B yes Figure 2A A three-dimensional view of a prosthetic valve, in which components on the outside of the frame are shown in transparent lines for illustrative purposes.

[0096] Figure 3 This is a perspective view of the delivery of a prosthetic heart valve according to one embodiment.

[0097] Figure 4 yes Figure 3 Enlarged cross-sectional view of the distal portion of the delivery device.

[0098] Figure 5 yes Figure 3 Enlarged side front view of the distal portion of the delivery device.

[0099] Figure 6 This is an enlarged cross-sectional view of the distal portion of a delivery device according to another embodiment.

[0100] Figure 7 Showing Figure 6 A cross-section of the distal portion of the delivery device shown.

[0101] Figure 8 Showing Figure 6 The distal portion of the delivery device and the covering assembly of the balloon surrounding the delivery device, shown in cross-section.

[0102] Figure 9 yes Figure 8 Exploded view of the covering assembly.

[0103] Figure 10 The disassembled state is shown. Figure 8 A covering assembly in which the distal portion of the delivery device is placed in one of the covering portions of the covering assembly.

[0104] Figure 11 This is a side front view of a balloon for a delivery device according to another embodiment.

[0105] Figure 12 It is nested within the balloon cover according to one embodiment. Figure 11 Side view of the balloon.

[0106] Figure 13 It is a three-dimensional view showing the balloon cover in the open position, with the balloon inside the cover.

[0107] Figure 14 This is based on the use of one implementation method. Figure 11An example of a method for assembling and delivering a balloon.

[0108] Figure 15 Through Figure 14 A side cross-sectional view of the delivery device formed by the method shown.

[0109] Figure 16 yes Figure 15 Side view of the delivery device.

[0110] Figure 17 This is a perspective view showing a balloon cover according to another embodiment in its open state.

[0111] Figure 18 This is a three-dimensional view of a portion of a balloon catheter, showing the balloon, mounted on the catheter, positioned in a closed state. Figure 17 Inside the balloon covering.

[0112] Figure 19 Balloon catheters include Figure 18 A longitudinal cross-sectional view of the balloon and part of the balloon cover depicted in the image.

[0113] Figure 20 This is a perspective view showing the balloon cover according to an alternative embodiment in its open state.

[0114] Figure 21 It indicates that it is in a closed state. Figure 20 The image depicts a longitudinal cross-sectional view of the balloon cover.

[0115] Figure 22A This is a perspective view of the distal portion of a balloon catheter received in a balloon cover according to another embodiment, wherein the balloon cover is shown in cross section.

[0116] Figure 22B Is receiving in Figure 22A A cross-sectional view of the distal portion of the balloon catheter within the balloon cover, as depicted in the image.

[0117] Figure 23A yes Figure 22A A three-dimensional view of the balloon cover shows that the two shell components of the balloon cover are separated from each other to define the open state of the balloon cover.

[0118] Figure 23B yes Figure 23A The cross-sectional view of the balloon cover depicted in the image shows the shell components in a closed state.

[0119] Figure 24 This is a side front view of the distal portion of a delivery device including a folded balloon according to another embodiment.

[0120] Figure 25 yes Figure 25 The side view of the delivery device shows a folded balloon with different shapes.

[0121] Figure 26 It is configured to maintain according to one implementation method Figure 25 The image depicts a three-dimensional view of the balloon cover, in which the two shell components of the balloon cover are separated from each other, so that the balloon cover is in an open state.

[0122] Figure 27 yes Figure 26 The image depicts a cross-sectional view of the balloon cover, with two shell components in a closed state.

[0123] Figure 28 It is a cross-sectional view of the distal portion of the balloon cover in a closed state, wherein the distal portion of the delivery device and the balloon are held within the balloon cover.

[0124] Figure 29 This is a side front view of a balloon folded onto the distal portion of the delivery device according to an alternative embodiment. Detailed Implementation

[0125] Figure 1 A prosthetic heart valve 10 according to one embodiment is shown. The illustrated prosthetic valve is suitable for implantation in a natural aortic valve annulus, but in other embodiments, it may be suitable for implantation in other natural valve annulus of the heart (e.g., pulmonary valve, mitral valve, and tricuspid valve). The prosthetic valve may also be suitable for implantation in previously implanted prosthetic valves and other tubular organs or pathways in the body. The prosthetic valve 10 may have four main components: a stent or frame 12, a valve structure 14, an inner skirt 16, and a perivalvular sealing member or outer skirt 18. The prosthetic valve 10 may have an inflow portion 20, a middle portion 22, and an outflow portion 24.

[0126] Valve structure 14 may include three leaflets 26 that together form a leaflet structure, which may be configured to fold in a tricuspid arrangement, but in other embodiments there may be more or fewer leaflets (e.g., one or more leaflets 26). The leaflets 26 may be secured to each other at their adjacent sides to form commissures 28 of leaflet structure 14. The lower edge of valve structure 14 may have an undulating, curved, fan-shaped shape and may be secured to the inner skirt 16 by sutures (not shown). In some embodiments, leaflets 26 may be formed from pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials known in the art and described in U.S. Patent No. 6,730,118 (which is incorporated herein by reference).

[0127] The frame 12 may be formed with a plurality of circumferentially spaced slots, or adapted to mount the ferrule portion 28 of the valve structure 14 to the ferrule window 30 of the frame. The frame 12 may be made of any of a variety of suitable malleable expandable materials known in the art (e.g., stainless steel, cobalt-chromium alloys, etc.) or self-expanding materials (e.g., nickel-titanium alloys (NiTi), such as Nitinol). When constructed of a malleable expandable material, the frame 12 (and therefore the prosthetic valve 10) can be folded into a radially constricted configuration on the delivery catheter and then expanded in the patient via an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expanding material, the frame 12 (and therefore the prosthetic valve 10) can be folded into a radially constricted configuration and restrained in the constricted configuration by insertion into a sheath or equivalent mechanism of the delivery catheter. Once in the body, the prosthetic valve can be advanced from the delivery sheath, allowing the prosthetic valve to expand to its functional size.

[0128] Suitable malleable expansion materials for forming the frame 12 include, without limitation, stainless steel, biocompatible high-strength alloys (e.g., cobalt-chromium alloys or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In a specific embodiment, the frame 12 is made of a nickel-cobalt-chromium-molybdenum alloy (e.g., ... (SPS Technologies, Jenkintown, Pennsylvania) is made of an equivalent of UNS R30035 alloy (covered by ASTM F562-02). The UNS R30035 alloy comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. Further details regarding the prosthetic valve 10 and its components are described in WIPO patent application publication number WO2018 / 222799 (which is incorporated herein by reference).

[0129] Figure 2A This is a perspective view of a prosthetic heart valve 50 according to another embodiment. The valve 50 may have three main components: a stent or frame 52, a valve structure 54, and a sealing member 56. Figure 2B This is a perspective view of the prosthetic valve 50, in which, for illustrative purposes, the components outside the frame 52 (including the sealing member 56) are shown in transparent lines.

[0130] Similar to valve structure 14, valve structure 54 may include three leaflets 60 forming a leaflet structure that can be configured to fold in a tricuspid arrangement. Each leaflet 60 may be coupled to frame 52 along its inflow edge 62 (lower edge in the figure; also referred to as the leaflet's "cuspid edge") and at the junction 64 of valve structure 54—where adjacent portions of two leaflets connect to each other. Reinforcing elements (not shown), such as fabric strips, may be directly attached to the cuspid edge of the leaflet and struts attached to the frame to connect the cuspid edge of the leaflet to the frame.

[0131] Similar to frame 12, frame 52 can be made of any of the various suitable malleable or self-expanding materials known in the art and described above. Frame 52 in the illustrated embodiment includes a plurality of circumferentially extending rows of angled struts 72 defining rows of cells or openings 74 of the frame. Frame 52 may have a cylindrical or substantially cylindrical shape, as shown, having a constant diameter from the inlet end 66 to the outlet end 68 of the frame, or the diameter of the frame may vary along the height of the frame, as disclosed in U.S. Patent Publication No. 2012 / 0239142 (which is incorporated herein by reference).

[0132] In the illustrated embodiment, the sealing member 56 is mounted on the exterior of the frame 52 and serves to form a seal against surrounding tissue (e.g., natural leaflets and / or natural valve annulus) to prevent or at least minimize paravalvular leakage. The sealing member 56 may include an inner layer 76 (which may contact the outer surface of the frame 52) and an outer layer 78. The sealing member 56 can be attached to the frame 52 using suitable techniques or mechanisms. For example, the sealing member 56 can be sutured to the frame 52 via sutures that can extend around the strut 72 and through the inner layer 76. In an alternative embodiment, the inner layer 76 may be mounted on the inner surface of the frame 52, while the outer layer 78 is on the exterior of the frame 52.

[0133] The outer layer 78 can be configured or shaped to extend radially outward from the inner layer 76 and the frame 52 when the prosthetic valve 50 is deployed. When the prosthetic valve is fully expanded outside the patient's body, the outer layer 78 can expand away from the inner layer 76 to create space between the two layers. Therefore, when implanted in the body, this allows the outer layer 78 to expand to contact the surrounding tissues.

[0134] Further details regarding the prosthetic valve 50 and its components are described in U.S. Patent Publication No. 2018 / 0028310 (which is incorporated herein by reference).

[0135] Figure 3-5 Various embodiments and components of a delivery device 100 (also referred to as a “delivery apparatus”) for implanting a prosthetic heart valve (e.g., valve 10 or 50) into a patient are shown according to one embodiment. The delivery device 100 can also be used to implant other types of expandable prosthetic medical devices (such as stents or grafts) into a patient.

[0136] refer to Figure 3 The delivery device 100 in the illustrated embodiment is a balloon catheter, including a handle 102, a steerable outer first shaft 104 extending from the handle 102, and an intermediate second shaft 105 extending coaxially from the handle 102 through the steerable outer shaft 104 (see [link to original document]). Figure 4The delivery device 100 includes an inner third shaft 106 extending coaxially from the handle 102 through the intermediate shaft 105 and the operable shaft 104, an inflatable balloon 108 extending from the distal end of the intermediate shaft 105, and a nasal cone 110 disposed at the distal end of the delivery device 100. The distal portion 112 of the delivery device 100 includes the balloon 108, the nasal cone 110, and a balloon shoulder assembly. See below for further details. Figure 4 As further described, a prosthetic medical device, such as a prosthetic heart valve, can be mounted on the valve retention portion of balloon 108. As further described below, the balloon shoulder assembly is configured to maintain the prosthetic heart valve or other medical device in a fixed position on balloon 108 during delivery through the patient's vascular system.

[0137] Handle 102 may include an actuation mechanism configured to adjust the curvature of the distal portion 107 of the outer shaft 104. In the illustrated embodiment, for example, handle 102 includes an adjustment member, such as a rotatable knob 134, which is operatively coupled to the proximal portion of the draw wire (not shown). The draw wire extends distally from handle 102 through the outer shaft 104 and has a distal portion attached to the outer shaft 104 at or near its distal end. Rotating knob 134 effectively increases or decreases the tension in the draw wire, thereby adjusting the curvature of the distal portion 107 of the outer shaft 104 and thus the curvature of the distal portion 112 of the delivery device.

[0138] Figure 4 An embodiment of the distal portion 112 of the delivery device 100 is shown. (As...) Figure 4 As shown, the delivery device 100 is configured to mount a prosthetic valve (e.g., a prosthetic heart valve) 114 in a folded state onto a balloon 108 for inserting the delivery device 100 and the prosthetic valve 114 into the patient's vascular system.

[0139] like Figure 4 As shown, at the proximal end of the distal portion 112, the inner shaft 106 extends distally beyond the steerable shaft 104 and the intermediate shaft 105 and through the balloon 108. The balloon 108 can be supported on the balloon shoulder assembly 118. The balloon shoulder assembly 118 includes a proximal shoulder 120 connected to the distal end of the intermediate shaft 105 and a distal shoulder 122 mounted on the inner shaft 106. The balloon 108 includes a proximal portion 126 surrounding and / or folded thereon around the proximal shoulder 120 and a distal portion 128 surrounding and / or folded thereon around the distal shoulder 122. In some embodiments, the proximal portion 126 of the balloon 108 can be secured to the outer surface of the intermediate shaft 105. In some embodiments, the distal portion 128 of the balloon 108 can be secured to the outer surface of the nasal cone 110 (as shown), which can be mounted on or coupled to the inner shaft 106.

[0140] In the illustrated embodiment, the nose cone 110 and the distal shoulder 122 can be a one-piece or integral component; that is, the nose cone 110 is the distal portion of the integral component, and the distal shoulder 122 is the proximal portion of the integral component. In other embodiments, the nose cone 110 and the distal shoulder 122 can be separate components, and each can be mounted on the inner shaft 106 adjacent to each other or axially spaced apart.

[0141] The proximal shoulder 120 and the distal shoulder 122 are spaced apart from each other in the axial direction relative to the central longitudinal axis 124 of the delivery device 100. As a result, the balloon 108 defines a valve retention portion 130 in the space separating the proximal shoulder 120 and the distal shoulder 122 (e.g., between the open ends of the proximal shoulder 120 and the distal shoulder 122). Figure 4 As shown, the prosthetic valve 114 can be folded between the proximal shoulder 120 and the distal shoulder 122 onto the valve holding portion 130 of the balloon 108, thereby preventing or reducing axial movement of the prosthetic valve 114 relative to the balloon 108 during the insertion of the delivery device 100 into the patient and delivery of the prosthetic valve 114 to the target implantation site.

[0142] The outer diameter of the inner shaft 106 can be sized such that the annular space 132 is defined along the entire length of the intermediate shaft 105 between the inner shaft 106 and the intermediate shaft 105. The annular space 132 can be fluidly coupled to one or more fluid passages of the delivery device 100, which can be fluidly connected to a fluid source (e.g., a syringe) that can inject expanding fluid (e.g., saline) into the delivery device. In this way, fluid from the fluid source can flow through one or more fluid passages, through the annular space 132, and into the balloon 108 to inflate and expand the prosthetic valve 114. For example, the handle 102 may have a fluid port 103 configured to be coupled to a fluid source (see...). Figure 3 In use, expansion fluid from a fluid source can be injected into fluid port 103, through one or more fluid passages in handle 102, through annular space 132, and into balloon 108.

[0143] Figure 4 The flow of fluid through the annular space 132 and through channels in the proximal shoulder 120 and distal shoulder 122 is illustrated (indicated by arrow 109). Fluid can then flow into the proximal portion 126 and distal portion 128 of the balloon 108 to dilate the valve 114.

[0144] The shafts 104, 105, and 106 of the delivery device 100 can be formed from any of a variety of suitable materials, such as nylon, braided stainless steel wire, or polyether block amide (into...). Commercially available examples are just a few. Shafts 104, 105, and 106 may have longitudinal sections formed of different materials to vary the flexibility of the shaft along its length. The inner shaft 106 may have a cross-section made of... The liner or layer formed minimizes sliding friction with the guidewire. Shafts 104, 105, and 106 can also move axially and / or rotatably relative to each other and / or the handle portion 102.

[0145] Further details of the balloon shoulder assembly, control mechanism, and other components of the delivery device are disclosed in U.S. Publications 2007 / 0005131, 2009 / 0281619, 2013 / 0030519, and 2017 / 0065415 (which are incorporated herein by reference).

[0146] In some embodiments, the delivery device 100 does not need to include a manipulator or shaft 104 (in which case shaft 105 is the outer shaft of the delivery device). In some embodiments, the delivery device 100 does not need to include shaft 104 and may include a manipulator configured to adjust the curvature of shaft 105 (e.g., a drawing wire may extend through shaft 105).

[0147] Figure 5 The image shows an external side view of the distal portion 112 of the delivery device 100, including a prosthetic valve 114 folded over a balloon 108 mounted on the distal portion 112 of the delivery device. As explained above, a balloon-shoulder assembly including a proximal shoulder 120 and a distal shoulder 122 supports the balloon 108 thereon.

[0148] like Figure 5 As shown, balloon 108 includes a proximal portion 126 surrounding and / or folded thereon a proximal shoulder 120, a distal portion 128 surrounding and / or folded thereon a distal shoulder 122, and a valve retaining portion 130 located between the proximal portion 126 and the distal portion 128. Figure 5 As shown, the prosthetic valve 114 rests on and around the valve retaining portion 130 of the balloon 108.

[0149] Figure 6-7 An example is shown of a distal portion 112 of a delivery device according to another embodiment. In this embodiment, as shown, the balloon 108 includes a proximal portion 140, a distal portion 142, and a valve retaining portion 144 located between the proximal portion 140 and the distal portion 142.

[0150] In the illustrated configuration, the valve retaining portion 144 has a generally cylindrical shape. A distal portion 142 is connected to the distal end of the valve retaining portion 144. The distal portion 142 may have a tapered shape and is therefore referred to as a "distal tapered portion." For example, the proximal end 150 of the distal portion 142 may have a larger diameter than the distal end 152 of the distal portion 142. A proximal portion 140 is connected to the proximal end of the valve retaining portion 144. The proximal portion 140 may also have a tapered shape and is therefore referred to as a "proximal tapered portion." For example, the distal end 154 of the proximal portion 140 may have a larger diameter than the proximal end 156 of the proximal portion 140.

[0151] The valve retaining portion 144 may have one or more axially extending folds or pleats 146. Such axial folds 146 can be tightly compressed to minimize the profile of the balloon and the prosthetic heart valve 114 thereon. The axial length of the valve retaining portion 144 is approximately the same as or slightly longer than the axial length of the prosthetic heart valve 114 in its pleated configuration.

[0152] like Figure 6 As shown, the diameter (D1) of the proximal end 150 of the distal portion 142 and the diameter (D2) of the distal end 154 of the proximal portion 140 are both larger than the diameter of the valve retaining portion 144. In some embodiments, when the prosthetic heart valve 114 is folded onto the valve retaining portion 144, diameters D1 and D2 are configured to be approximately equal to or slightly larger than the outer diameter of the prosthetic heart valve 114. Therefore, when the balloon 108 and the prosthetic heart valve 114 folded thereon are surrounded by the balloon cover (described below), the cover will not scratch or damage the frame of the prosthetic heart valve 114.

[0153] The distal tapered portion 142 can protect the valve strut from contact with the inner surfaces of the loader device and the guide sheath during implantation, thereby preventing or minimizing damage to these components (as is known in the art, the loader device and guide sheath can be used to introduce the delivery device and prosthetic valve into the patient's vascular system). Furthermore, the distal tapered portion 142 can reduce the insertion force as the delivery device 100 is advanced through the patient's natural valve. The proximal tapered portion 140 can act as a landing support or stop for the prosthetic heart valve as it is pushed through the loader, guide sheath, and the patient's vascular system. Additionally, the proximal tapered portion 140 facilitates retrieval of the delivery device from the patient's vascular system after valve implantation.

[0154] In some embodiments, the inner shaft 106 also defines a lumen sized to receive a guidewire, which can extend coaxially through the inner shaft 106 and through the nasal cone of the delivery device. As is known in the art, this allows the delivery device 100 to be advanced over a guidewire previously inserted into the patient's vascular system.

[0155] In some embodiments, the inner axis 106 may include a radiopaque marker 135 aligned with a predefined portion of the balloon 108. For example, the marker 135 may be aligned with the center of the valve holding portion 144 of the balloon 108. The marker 135 may be used to align the prosthetic valve 114 with the natural valve under fluorescence examination during the implantation procedure.

[0156] In the illustrated embodiment, the balloon shoulder assembly includes a distal shoulder 160 mounted on the distal portion of the inner shaft 106 and a proximal shoulder 170 mounted on or connected to the distal portion of the intermediate shaft 105 (e.g., ...). Figure 4 (As shown in the diagram), this helps to retain the prosthetic valve 114 on the valve holding portion 144 of the balloon during delivery through the patient's vascular system. The distal shoulder 160 may include an open distal collar member 162 and a cylindrical shaft portion 163. The distal collar member 162 may have one or more distal shoulder fins 164 extending at least partially radially outward from the shaft portion 163. The proximal shoulder 170 may include an open proximal collar member 172 and a cylindrical shaft portion 173. The proximal collar member 172 may have one or more proximal shoulder fins 174 extending at least partially radially outward from the shaft portion 173.

[0157] The shaft portion 163 of the distal collar 160 can be attached to the distal portion of the inner shaft 106 by any known means, such as by welding, adhesive, mechanical fasteners, etc. The shaft portion 173 of the proximal shoulder 170 can be attached to the distal portion of the shaft 105 by any known means, such as by welding, adhesive, mechanical fasteners, etc.

[0158] The outer diameter of the inner shaft 106 can be set to define an annular space 132 between the inner shaft and the intermediate shaft. Figure 4 This defines a fluid passage through which inflatable fluid can flow from the handle through the passage to the balloon as previously described. As shown, the inner shaft 106 is separated from the valve retention portion 144 of the balloon 108 by an axially extending gap 137, which allows inflatable fluid to flow from the proximal cone portion 140 to the distal cone portion 142 of the balloon 108.

[0159] Figure 6 An example is shown where fluid flow (indicated by arrow 141) passes through annular space 132, proximal conical portion 140, axially extending gap 137, and distal conical portion 142 to inflate balloon 108. Furthermore, balloon 108 can be deflated by drawing expansion fluid from balloon 108 back through the aforementioned fluid pathway to a reservoir of expansion fluid source.

[0160] Figure 6The balloon 128 may also include a distal leg 180 connected to the distal end 152 of the distal cone portion 142 and a proximal leg 182 connected to the proximal end 156 of the proximal cone portion 140. The balloon 128 may define an inner lumen extending from the proximal leg 182 through the proximal cone portion 140, the valve holding portion 144, the distal cone portion 142 and reaching the distal leg 180.

[0161] The proximal leg 182 can be secured to the intermediate shaft 105. For example, the proximal portion 183 of the proximal leg 182 can be secured to the outer surface of the shaft 105. In some embodiments, the proximal portion 183 of the proximal leg 182 may have a tapered shape with a gradually decreasing diameter along the proximal direction to provide a tapered transition from the proximal leg 182 to the outer surface of the shaft 105. The proximal leg 182 can be secured to the shaft 105 using any known means, including but not limited to thermal bonding, adhesive bonding, mechanical locking, etc.

[0162] The distal leg 180 can be secured to the distal shoulder 160, such as to the distal portion of the shaft portion 163. Any known means, including but not limited to thermal bonding, adhesive bonding, and mechanical locking, can be used to secure the distal leg 180 to the distal shoulder 160. Figure 6 For illustrative purposes, a small gap is shown between the distal leg 180 and the shaft portion 163. However, it should be understood that the distal leg 180 may contact and be secured to the shaft portion 163 along its entire length, such that there is no gap between the two components.

[0163] In a particular embodiment, as shown, the distal shoulder 160 may have a nose cone portion 166 connected to and extending distally from the shaft portion 163. The nose cone portion 166 may be integrally connected to the shaft portion 163. The nose cone portion 166 may include a first tapered portion 167, a cylindrical portion 168 extending distally from the first tapered portion 167, and a second tapered portion 169 extending distally from the cylindrical portion 168 and defining the nose cone portion and the distal end of the delivery device. The first tapered portion 167 has an outer diameter that gradually decreases from the shaft portion 163 to the cylindrical portion 168. The second tapered portion has an outer diameter that gradually decreases from the cylindrical portion 168 to its distal end.

[0164] The conical portions 167 and 169 can facilitate passage through the natural valve leaflets by further reducing friction as the delivery device passes through the patient's natural valve.

[0165] In some embodiments, one or more sections of the nasal cone portion 166, such as the cylindrical portion 168 and / or the second cone portion 169, may be color-coded to indicate the dimensions of the balloon 108 and the prosthetic heart valve 114 used schematically with the delivery device 100.

[0166] In some embodiments, when the balloon is deflated and ready for insertion into the patient's vascular system, the distal tapered portion 142 of the balloon may include one or more axial folds or pleats 143. In some embodiments, when the balloon is deflated and ready for insertion into the patient's vascular system, the proximal tapered portion 140 of the balloon may include one or more axial folds or pleats 145. In some embodiments, the axial folds 143 or 145 may form an angle relative to the longitudinal axis of the valve holding portion 144. The folds 143, 145 reduce the overall profile of the distal portion 112 of the delivery device to facilitate the delivery device's passage through the guide sheath and the patient's vascular system.

[0167] In some embodiments, the distal conical portion 142 may have a distal segment 147 without any folds. For example, one or more axial folds 143 of the distal conical portion 142 are intended not to extend into the distal segment 147. During insertion of the delivery device through a natural heart valve (e.g., typically a calcified natural aortic valve), the foldless distal portion 147 (which has a relatively smooth outer surface) pushes open and passes through the patient's natural valve first, followed by the folded balloon segment (e.g., the segment of the distal conical portion containing the axial folds 143) passing through the natural valve. Thus, the distal segment 147 creates a folded gap that facilitates smooth passage through the patient's natural valve as the delivery device is advanced.

[0168] Similarly, the proximal cone portion 140 may have a proximal segment 149 without any folds. For example, one or more axial folds 145 of the proximal cone portion 140 are intended not to extend into the proximal segment 149. When the delivery device is retracted from the native valve during an implantation procedure, such as for repositioning the prosthetic valve, the foldless proximal segment 149 (which has a relatively smooth outer surface) first pushes open and passes through the patient's native valve, followed by the folded balloon portion (e.g., the segment of the proximal cone portion containing the axial folds 145) passing through the native valve. Thus, the proximal segment 149 creates a folded gap that facilitates smooth passage through the patient's native valve during retraction of the delivery device. The proximal segment 149 also facilitates retrieval of the delivery device through the guide sheath after valve implantation.

[0169] In some embodiments, the axial fold 145 may extend the entire length of the proximal tapered portion 140 (i.e., there is no fold gap in the proximal tapered portion). In some embodiments, the axial fold 143 may extend the entire length of the distal tapered portion 142 (i.e., there is no fold gap in the distal tapered portion).

[0170] like Figure 6As shown, the proximal conical portion 140 of balloon 108 can be folded around the distal end of proximal collar member 172 to form an obtuse-angled radial fold 188, which extends radially inward to a radial segment 190, which extends radially inward to the proximal end of valve retention portion 144. The obtuse-angled radial fold 188 provides a secure nesting of the prosthetic valve 114 while facilitating passage through the guide sheath. In the illustrated embodiment, a small gap exists between the fold 188 and the distal end of shoulder 170. However, in an alternative embodiment, the balloon can be folded tightly around the distal end of shoulder 170, such that there is little or no gap between the fold 188 and shoulder 170. Furthermore, in the deflated state of the balloon, the axially extending fold 145 desiccably contacts and extends along proximal collar member 172.

[0171] The distal conical portion 142 of the balloon 128 can fold around the distal collar member 162. For example... Figure 6 and 7 As shown, in some embodiments, the distal tapered portion 142 of the balloon 108 may include a first radial fold 184 connected to a second radial fold 185 extending to the distal end of the valve retaining portion 144. The first radial fold 184 may form an obtuse or right angle relative to the valve retaining portion 144, while the second radial fold 185 may form an acute angle relative to the valve retaining portion 144. Thus, the first radial fold 184 and the second radial fold 185 together form an S-shaped curve around the proximal end of the distal collar member 162. A recess 186 (or “crease”) may be formed at the intersection of the fold 185 and the valve retaining portion 144. In the deflated state of the balloon, the axially extending fold 143 desiccates into contact with and extends along the distal collar member 162.

[0172] The recess 186 formed by the radial folds 184, 185 helps to stabilize the prosthetic heart valve 114 during valve deployment. As described above, the axial length of the valve holding portion 144 is approximately the same as or slightly longer than the axial length of the prosthetic heart valve 114 folded thereon. When the balloon 108 inflates during valve deployment, the prosthetic heart valve 114 is radially expanded and axially shortened. Without the recess 186, this shortening of the prosthetic heart valve 114 during radial expansion would create an axial gap between the distal end of the prosthetic valve and the adjacent portion of the balloon, potentially causing displacement of the prosthetic heart valve 114 in place. However, the radial folds 184, 185 forming the recess 186 mitigate this undesirable displacement of the prosthetic valve in place. As the expanding fluid flows through the axially extending gap 137 and into the distal conical portion 142, the radial folds 184, 185 unfold under the pressure of the expanding fluid, causing the recess 186 to unfold proximally and maintain contact with the prosthetic valve 114. Thus, the unfolded recess provides additional volume within the distal conical portion 142, which can occupy or offset the axial gap that would otherwise be created by valve shortening. Therefore, the radially expanded prosthetic heart valve 110, despite its axial shortening, can remain stable along the valve retaining portion 144.

[0173] In the illustrated embodiment, a small gap exists between the folds 184, 185 and the proximal end of the distal collar member 162. However, in an alternative embodiment, the balloon can be folded tightly around the proximal end of the distal collar member 162, eliminating such a gap. In such an embodiment, an S-shaped curve can extend around the distal collar member, such that the recess 186 is located inside the distal collar member 162.

[0174] In another embodiment, the proximal portion 140 of the balloon 108 can be folded in the same manner as the distal portion 142, so that it also forms an S-shaped curve. In another embodiment, the distal portion 142 may have an obtuse-angled fold 188, while the proximal portion 140 may have folds 184, 185 forming an S-shaped curve. In another embodiment, each of the proximal portion 140 and the distal portion 142 may have an obtuse-angled fold 188.

[0175] As described above, the proximal collar member is closely positioned adjacent to at least some of the folds 145 extending axially along the proximal conical portion 140, and the distal collar member is closely positioned adjacent to at least some of the folds 143 extending axially along the distal conical portion 142. This close positioning of the proximal and distal collar members adjacent to the corresponding balloon folds 143, 145 helps to improve the stability of the folded prosthetic valve 114.

[0176] Figure 8-10 A protective cover assembly 200, according to one embodiment, is shown for protecting and maintaining the shape of a folded balloon 108 during pre-use transport and storage. After the delivery device 100 is fully assembled, the balloon 108 can be folded at the manufacturing site to include the various folds described above. The cover assembly 200 helps retain the folds in the balloon until the delivery device is removed from its packaging at the point of use to fold the prosthetic valve onto the balloon.

[0177] As shown in the figure, the cover assembly 200 in the illustrated embodiment may include a first cover portion 202a, a second cover portion 202b, and a sleeve 204. The cover portions 202a and 202b are configured to receive and surround the distal portion 112 of the delivery device. The first cover portion 202a may be positioned around one half of the distal portion 112, and the second cover portion 202b may be positioned around the other half of the distal portion 112 and mate with the first cover portion 202a. The mating cover portions 202a and 202b form an enclosure surrounding or accommodating the distal portion 112 of the delivery device—including the folded balloon 108 and, optionally, the distal portion of the ground axis 105. The sleeve 204 may slide on the cover portions 202a and 202b to hold these components together during transport and storage.

[0178] Each of the covering portions 202a and 202b may include a distal recess 206, a central recess 208, and a proximal recess 210. The distal recess 206 may be shaped to correspond to the shape of the distal portion 142 of the balloon and the nasal cone portion 166. The central recess 208 may be shaped to correspond to the shape of the valve holding portion 144 of the balloon. The proximal recess 210 may be shaped to correspond to the shape of the proximal portion 140 of the balloon and, optionally, the distal portion of the ground axis 105.

[0179] Therefore, when the folded balloon 108 is located inside the cover assembly 200, it can prevent it from expanding significantly or otherwise deviating from its folded shape. Furthermore, the cover assembly 200 can protect the balloon 208 from scratches, tears, etc., during transport and storage. Further, the cover assembly 200 can also facilitate pressure and / or vacuum testing of the balloon 108. More specifically, the balloon 108 can be tested in the cover assembly 200 by introducing gas, fluid, or vacuum at the assembly site and / or in the operating room before folding the prosthetic heart valve, because the balloon is held in its folded configuration by the contoured cavity of the cover assembly 200. Therefore, after balloon testing and before folding the prosthetic heart valve onto the balloon 108, the physician does not need to perform any folding steps.

[0180] In the illustrated embodiment, the covering portions 202a and 202b are completely separable from each other. However, in other embodiments, the covering portions 202a and 202b can be connected to each other via hinges along adjacent longitudinal edges, the hinges allowing the covering portions 202a and 202b to open and close around the distal portion 112 of the delivery device (similar to...). Figure 13 The cover 400 shown is described below. Instead of or other than the sleeve 204, the cover portions 202a, 202b may include complementary latching portions that hold the cover portions in a closed state around the distal portion 112 of the delivery device (similar to...). Figure 13 The latching portions 406a and 406b are as described below.

[0181] Figure 11 An inflatable balloon 300 folded in a collapsed state according to another embodiment is shown. The balloon 300 may be referred to as an "off-device formed balloon" because it can be fully formed and folded before being assembled onto a delivery device (e.g., delivery device 100).

[0182] Similar to balloon 108, balloon 300 in the illustrated embodiment may include a valve holding portion 302 having a generally cylindrical shape, a distal conical portion 304 connected to the distal end of the valve holding portion 302, a proximal conical portion 306 connected to the proximal end of the valve holding portion 302, a distal leg 308 connected to the distal end of the distal conical portion 304, and a proximal leg 310 connected to the proximal end of the proximal conical portion 306. Balloon 300 may be formed using techniques known in the art.

[0183] In some embodiments, the balloon 300 may include one or more markers or markings that indicate certain properties of the balloon, such as its size, for assembly of the delivery device. For example, a laser marker 312 may be placed on the proximal leg 310. Similarly, an optional laser marker 314 may be placed on the distal leg 308 of the balloon. It should be understood that markers 312 or 314 may be placed on other sections of the balloon. Furthermore, other types of markers may be used, such as markers formed by printing, painting, or etching on the balloon.

[0184] The valve retaining portion 302 may include a plurality of tightly compressed, axially extending folds 316. Additionally, the balloon 302 may include one or more axially extending folds 318 formed along the distal tapered portion 304 and the proximal tapered portion 306.

[0185] like Figure 11As further shown, the distal end 320 of the proximal conical portion 306 may have a radially folded portion 322, which forms an obtuse angle or a right angle with respect to the valve retaining portion 302 (similar to...). Figure 6 The fold portion 188). The proximal end 324 of the distal tapered portion 304 may have a radial fold portion 326, which forms an obtuse angle or a right angle with respect to the valve retaining portion 302 (similar to the fold portion 188). Figure 6 (Folding portion 188). Obtuse-angled radial folds 322, 326 provide a secure valve nesting area when the delivery device passes through the loader and guide sheath of the delivery system.

[0186] Although not shown, in other embodiments, one or both of the distal tapered portion 304 and the proximal tapered portion 306 may have two radially folded portions forming an S-shaped curve (similar to...). Figure 6 Folding parts 184 and 185).

[0187] like Figure 11 As shown, the distal tapered portion 304 may have a distal section 328 without any folds. Similarly, the proximal tapered portion 306 may have a proximal section 330 without any folds. (As described above...) Figure 6 As described in the implementation, the distal segment 328 creates a folded gap that facilitates smooth passage across the patient's natural valve during valve delivery. The proximal segment 330 creates a folded gap that facilitates smooth passage across the patient's natural valve during retraction of the delivery device (such as for repositioning of the prosthetic valve) and retrieval of the delivery device via a guide sheath after valve implantation.

[0188] like Figure 12-13 As depicted, after the balloon 300 is formed and the fold is created, the balloon can be enclosed in a protective cover 400 until it is ready to be assembled in a delivery device. Similar to cover 200, the internal geometry of cover 400 generally matches the shape of the folded balloon 300. In the illustrated embodiment, cover 400 may include a first complementary cover portion 402a and a second complementary cover portion 402b, each configured to receive half of the balloon. Cover portions 402, 402b can be connected by hinge 404 to form a clamshell configuration, which allows cover portions 402a, 402b to open and close around the balloon.

[0189] The first covering portion 402a and the second covering portion 402b may include corresponding latch portions 406a and 406b. When the covering portions 402a and 402b are positioned around the balloon in a closed state, the latch portion 406a may engage the latch portion 406b to hold the covering portion in a closed state. In some embodiments, the latch portion 406a may form a releasable snap-fit ​​connection with the latch portion 406b.

[0190] Each covering portion 402a, 402b may have a distal recess 408, a middle recess 410, and a proximal recess 412. The shape of the distal recess 408 may substantially correspond to the shape of the distal conical portion 304 and the distal leg 310. The shape of the middle recess 410 may substantially correspond to the shape of the valve retaining portion 302. The shape of the proximal recess 412 may substantially correspond to the shape of the proximal conical portion 306 and the proximal leg 310.

[0191] Instead of, or excluding, latch portions 406a, 406b, the cover 400 may be placed inside the sleeve 414 (e.g., ...). Figure 12 (As shown) to keep the covering portions 402a, 402b in a closed state surrounding the balloon.

[0192] In an alternative embodiment, the covering portions 402a, 402b may be completely separable (similar to...). Figure 8-10 (In the embodiment) and can be held in the closed state by sleeve 414 or other retaining device.

[0193] In some embodiments, instead of or in addition to the cover 400, a restraint member 350 (such as a sleeve) may be placed around the valve holding portion 302 of the balloon. As described below, the restraint member 350 helps hold the valve holding portion 302 of the balloon in a compressed and folded state until the balloon 300 is assembled onto the delivery device. The restraint member 350 may be formed from a relatively thin sheet of polymeric material, such as polyester, polyurethane, or fluorinated ethylene propylene (FEP). In some embodiments, the restraint member 350 may be removed by the manufacturer after the delivery device is assembled. In other embodiments, the restraint member may be held in place after assembly and removed by the end user before the prosthetic valve is folded onto the balloon. Furthermore, it should be understood that the restraint member 350 may be used in conjunction with other embodiments disclosed herein, such as balloon 108. In other embodiments, the restraint member 350 is not used, and only the cover 400 is used to hold the valve holding portion 302 in its compressed and folded state.

[0194] Figure 17-19Another balloon cover 600 for mounting on a folded balloon 680 on a delivery catheter 670, according to an alternative embodiment, is shown.

[0195] As described herein, balloon 680 may be any one of the balloons 108, 208, 300 disclosed above or any other type of foldable balloon, and delivery catheter 670 may be the same delivery device 100, 500 described above, or any other type of delivery device known in the art for implanting balloon-inflatable prosthetic valves.

[0196] For example, in the depicted embodiment, the delivery device 670 may include an outer shaft 672, an inner shaft 674 extending through a central cavity of the outer shaft 672, and a nasal cone 676 coupled to the inner shaft 674. A balloon 680 may be supported on a shoulder assembly of the delivery device 670. The shoulder assembly may include a proximal shoulder 690 connected to the distal end of the outer shaft 672 and a distal shoulder 692 mounted on the inner shaft 674. The balloon 680 may have a proximal portion 682 surrounding and / or folded thereon the proximal shoulder 690, a distal portion 684 surrounding and / or folded thereon the distal shoulder 692, and a valve holding portion 686 located between the proximal portion 682 and the distal portion 684. The proximal portion 682 of the balloon 680 may be secured to the distal portion of the outer shaft 672. The distal portion 684 of the balloon 680 may be secured to the outer surface of the nasal cone 676.

[0197] As shown, the balloon cover 600 may include an outer shell 602 and an inner sleeve 604 disposed within the outer shell 602. The inner sleeve 604 may have an inner surface 606 defining a cavity 608. In an example embodiment, the cavity 608 is configured to receive a valve retention portion 686 of the balloon 680.

[0198] Before the prosthetic valve is folded onto the balloon of the delivery device, the user typically performs a cyclical "de-gas" procedure, which involves injecting inflation fluid into the balloon using a syringe fluidly connected to the handle of the delivery device, followed by aspiration of the fluid from the balloon. The de-gas process can be more efficient when the balloon is allowed to inflate at least partially. However, balloon inflation to the outside of the balloon cover causes balloon deployment, which can inhibit or prevent the balloon from returning to its folded state when the inflation fluid is removed. As described more fully below, the inner sleeve 604 can deform under the pressure exerted by the balloon 680 on the inner surface 606 during balloon inflation, thereby radially enlarging the diameter of the cavity 608. This allows the balloon to inflate at least partially while the de-gas procedure is being performed, with the balloon contained within the cover. During de-gas, the deformable inner sleeve 604 can prevent the balloon from fully deploying and / or help the balloon return to its fully folded state after the inflation fluid is removed.

[0199] In some embodiments, the outer shell 602 may be more rigid than the inner sleeve 604. For example, the inner sleeve 604 may be made of an elastomer such as natural rubber, styrene-butadiene block copolymer, polyisoprene, polybutadiene, ethylene propylene rubber, EPDM rubber, silicone elastomer, fluorinated elastomer, polyurethane elastomer, nitrile rubber, or mixtures thereof. The inner sleeve 604 may also include a shape memory material as further described below. The outer shell 602 may be made of a non-deformable material such as polyvinyl chloride, glass, poly(methyl methacrylate), acrylonitrile-butadiene-styrene, styrene-acrylonitrile, polystyrene, silicone, cellulose, polyester, polyolefin, polyethylene, metal, ceramic, or mixtures thereof.

[0200] In the depicted embodiment, the outer shell 602 includes a first shell member 602a and a second shell member 602b. The first shell member 602a and the second shell member 602b can be connected by a hinge 610 forming a clamshell configuration that allows the shell members 602a, 602b to open and close around the sac 680.

[0201] In some embodiments, the first shell member 602a and the second shell member 602b may include corresponding latching portions. When the first shell member 602a and the second shell member 602b are positioned in a closed state around the balloon 680 and the inner sleeve 604, the corresponding latching portions may engage with each other, such as... Figure 18 As shown, shell components 602a and 602b are kept in a closed state.

[0202] For example, such as Figure 17 As best shown, one latching portion may be configured as a ridge 612a extending outward from the first shell member 602a, while the other latching portion may be configured as a cantilevered tab 612b extending outward from the second shell member 602b. The ridge 612a may have an enlarged edge or edge portion 614a along its free longitudinal edge, and the tab 612b may have a corresponding slot 614b. The position and size of the slot 614b may be set such that when the shell members 602a, 602b are positioned in a closed state around the balloon 680 and the inner sleeve 604, the enlarged edge 614a extends through to form a snap-fit ​​engagement.

[0203] In some embodiments, the width of the slot 614b may be slightly smaller than the width of the enlarged side 614a, and the fins surrounding the slot 614b may be made of an elastic or deformable material. Thus, by pressing the ridge 612a and the fins 612b against each other, the slot 614b can be slightly enlarged to allow the enlarged side 614a to extend through it, and then return to its original size and shape after the side 614a has passed through the slot 614b. The narrower slot 614b relative to the enlarged side 614a prevents the side 614a from unintentionally sliding back through the slot 614b in the opposite direction, thereby ensuring a tight interlocking between the ridge 612a and the fins 612b. To open the shell members 602a, 602b, the user can separate the ridge 612a from the fins 612b, for example, by manually pulling the enlarged side 614a out of the slot 614b. In some embodiments, the flap 612b may have a plurality of bumps and / or indents 616 on its surface to provide friction points for the user’s fingers to firmly grip the flap 612b, so that the ridge 612a and the flap 612b engage or disengage.

[0204] It should be understood that the above-described latching mechanism is merely an example embodiment. Other latching mechanisms known in the art can also be used for coupling and decoupling between housing members 602a and 602b, such as hook-and-loop fasteners, clamps, snaps, magnetic fasteners, etc.

[0205] In the depicted embodiment, when the shell members 602a and 602b are in the closed state, the outer shell 602 may define a proximal recess 620, a distal recess 622, and an intermediate recess 624 located between the proximal recess 620 and the distal recess 622.

[0206] The proximal recess 620 may have a tapered shape, such that the proximal end of the proximal recess 620 has a smaller diameter than the distal end of the proximal recess 620. In some embodiments, the shape of the proximal recess 620 may substantially correspond to the shape of the proximal portion 682 of the balloon 680.

[0207] The distal recess 622 may have a tapered shape, such that the distal end of the distal recess 622 has a smaller diameter than the proximal end of the distal recess 622. In some embodiments, the shape of the distal recess 622 may substantially correspond to the shape of the distal portion 684 of the balloon 680.

[0208] The central recess 624 may have an generally cylindrical shape configured to receive the inner sleeve 604.

[0209] In the depicted embodiment, shell members 602a and 602b have approximately the same circumferential dimensions, such that each defines half a segment of the proximal recess 620, the distal recess 622, and the intermediate recess 624. In other embodiments, shell members 602a and 602b may have different circumferential dimensions, such that one shell member defines a smaller segment while the other shell member defines the remaining (i.e., larger) segments of the recesses 620, 622, and 624.

[0210] In the depicted embodiment, the inner sleeve 604 has a first portion 604a and a second portion 604b. Each portion has a semi-cylindrical inner surface 606a or 606b defining half a segment of the cavity 606.

[0211] In other embodiments, the first portion 604a and the second portion 604b may have different circumferential dimensions, such that one portion defines less than half of the segment, while the other portion defines the remaining (i.e., more than half) segment of the cavity 608.

[0212] In the depicted embodiment, the first portion 604a of the inner sleeve 604 has two longitudinal edges 618a configured to engage with two corresponding longitudinal edges 618b of the second portion 604b of the sleeve 604 to form a cavity 606. Therefore, when the longitudinal edges 618a of the first portion 604a are aligned with the corresponding longitudinal edges 618b of the second portion 604b, the inner sleeve 604 can surround the valve holding portion 686 of the balloon 680 in a closed state.

[0213] In some embodiments, the first portion 604a and the second portion 604b are completely separable at two pairs of longitudinal edges 618a, 618b. In other embodiments, the first portion 604a and the second portion 604b are hingedly connected along one pair of longitudinal edges 618a, 618b, while they are separable at another pair of longitudinal edges 618a, 618b.

[0214] As described herein, for example, during degassing, when the balloon 680 inflates and applies radially outward pressure to the inner surface 606 of the inner sleeve 604, the inner sleeve 604 can deform radially. In other words, inflating the balloon 680 from a deflated state to an inflated state can deform the cavity 606 of the inner sleeve 604 from its initial state to its deformed state. The cavity 608 may have a first diameter in its initial state and a second diameter in its deformed state, and the second diameter is larger than the first diameter.

[0215] In the depicted embodiment, when the cavity 608 is radially expanded by inflating the balloon 680 from a deflated state to an inflated state, the inner surface 606 of the inner sleeve 604 can maintain the enclosure of the cavity 608 in a circumferentially continuous manner. In other words, the inner surface 606 can be circumferentially continuous, wherein there is no gap between any of the mating paired longitudinal edges 618a, 618b through which a portion of the balloon 680 can extend. Thus, the two semi-cylindrical inner surfaces 606a or 606b can form a complete cylindrical inner surface that defines the cavity 608, regardless of the cavity's diameter.

[0216] In some embodiments, the inner sleeve 604 may further define a tapered proximal opening 626 at the proximal end of the cavity 608 and a tapered distal opening 628 at the distal end of the cavity 608. The tapered proximal opening 626 connects the middle portion 630 of the cavity 608 to the proximal recess 620, and the tapered distal opening 628 connects the middle portion 630 of the cavity 608 to the distal recess 622.

[0217] In some embodiments, at least when the balloon 680 is in a deflated state (i.e., the cavity 608 is in its initial state), the diameter of the middle portion 630 of the cavity 608 may be smaller than both the conical proximal opening 626 and the conical distal opening 628.

[0218] In some embodiments, a tapered proximal opening 626 may be configured to receive an engagement region of the balloon 680, in which a valve retaining portion 686 is connected to a proximal portion 682, and a tapered distal opening 628 may be configured to receive an engagement region of the balloon 680, in which a valve retaining portion 686 is connected to a distal portion 684.

[0219] In some embodiments, the axial length of the inner sleeve 604 is configured to be approximately the same as the axial length of the intermediate recess 624 of the outer casing 602, such that the inner sleeve 604 and the valve retaining portion 686 of the balloon 680 can fit tightly within the intermediate recess 624. In some embodiments, the axial length of the inner sleeve 604 is configured to remain fixed when the balloon 680 is inflated from a deflated state to an inflated state. Therefore, regardless of whether the balloon 680 is in a deflated or inflated state, the inner sleeve 604 and the valve retaining portion 686 can remain tightly fitted within the intermediate recess 624.

[0220] In an example embodiment, the inner sleeve 604 includes an inner wall portion 632 surrounding a cavity 608 and one or more legs 634 extending radially outward from the inner wall portion 632 and axially spaced apart from each other along the length of the inner wall portion 632. Specifically, the inner wall portion 632 may be divided into two half-wall portions 632a and 632b, which respectively define semi-cylindrical inner surfaces 606a and 606b of the first separable portion 604a and the second separable portion 604b. When both the inner sleeve 604 and the outer shell 602 are in a closed state, one or more legs 634 may press against the inner surface 636 of the outer shell 602 to form one or more cavities 638 between the inner wall portion 632 of the inner sleeve 604 and the inner surface 636 of the outer shell 602.

[0221] In the depicted example, the inner sleeve 604 has seven legs 634 that divide the space between the inner wall portion 632 and the inner surface 636 into six cavities 638. In other embodiments, the number of legs (N) may be less than 7 (e.g., 2, 3, 4, 5, 6) or more than 7 (e.g., 8, 9 or more), and the number of cavities may be N-1.

[0222] like Figure 19 As shown, one or more legs 634 may be parallel to each other. In some embodiments, each of the one or more legs 634 may extend circumferentially around the inner wall portion 632.

[0223] For example, each leg 634 can be divided into a pair of half-legs, located on two half-wall portions 632a and 632b respectively. Each half-leg can extend approximately 180 degrees circumferentially around the corresponding half-wall portion 632a or 632b, so that when the two half-wall portions 632a and 632b are aligned together to surround the cavity 608, the pair of half-legs are adjacent to each other to form a complete leg 634 that completely surrounds the inner wall portion 632 (i.e., the leg 634 extends 360 degrees circumferentially around the inner wall portion 632). Therefore, the cavity between two adjacent complete legs can be a closed space isolated from any of its adjacent cavities.

[0224] In other embodiments, some of the legs 634 may not completely surround the inner wall portion 632. For example, the legs may extend circumferentially along one or more discontinuous segments of the inner wall portion 632, such that two cavities on opposite sides of the legs are connected to each other through gaps in the legs.

[0225] In some embodiments, one or more legs 634 may be compressible in the radial direction. For example, when the balloon 680 is inflated from a deflated state to an inflated state, the cavity 608 can radially expand from an initial state (with a relatively small diameter) to a deformed state (with a relatively large diameter). Correspondingly, the legs 634 can be compressed from an initial radial length to a shortened radial length. Therefore, the space occupied by the cavity 638 between the legs 634 can be reduced from an initial volume to a reduced volume.

[0226] Conversely, when the balloon 680 deflates from an inflated state to a deflated state, the cavity 608 can return from its deformed state to its initial state. For example, the legs 634 can be made of an elastomer or shape memory material, including any of a variety of polymers or alloys. Therefore, the legs 634 can return to their initial radial length after the radial pressure exerted by the inflated balloon is removed. Correspondingly, the space of each cavity 638 between the legs 634 can return to its initial volume. Note that contracting the cavity 608 can press inward against the balloon 680 and help prevent the folded balloon 680 (in its deflated state) from deploying.

[0227] In some embodiments, the inner surface 636 of the housing 602 may have a receptacle configured to receive at least one of the legs 634 to securely couple the inner sleeve 604 to the housing 602.

[0228] For example, such as Figure 19 As depicted, the first shell member 602a and the second shell member 602b may have a pair of receiving portions 640a, 640b, such as in the form of openings in the shell members 602a, 602b, located at the center (along the axial direction) of their respective inner surfaces. A pair of half-legs located at the center (along the axial direction) of the two half-wall portions 632a, 632b (which may be joined together to form an intermediate leg) may have enlarged feet 642a, 642b. The pair of receiving portions 640a, 640b may be configured to cooperatively receive the corresponding feet 642a, 642b, such that the first separable portion 604a and the second separable portion 604b of the inner sleeve can be securely coupled to the corresponding first shell member 602a and the second shell member 602b.

[0229] In some embodiments, the receiving portion and the coupling leg may be located remotely from the center (axially) of the balloon cover. In some embodiments, multiple receiving portions may be axially spaced on the housing 602, and each receiving portion may be configured to cooperatively receive a corresponding leg of the inner sleeve 604. In some embodiments, the inner surface 636 of the housing 602 may have one or more protrusions configured to cooperatively engage one or more corresponding receiving portions located on the legs 634 of the inner sleeve 604. In some embodiments, the legs 634 of the inner sleeve 604 and the inner surface 636 of the housing 602 may be securely coupled together by other mechanisms such as gluing, tongue and groove joints, clamps, snaps, magnetic fasteners, etc.

[0230] In some embodiments, the inner sleeve 604 and the outer shell 602 may be removably coupled together (i.e., they can be separated). In other embodiments, the inner sleeve 604 and the outer shell 602 may be fixedly coupled together (i.e., the inner sleeve 604 cannot be removed from the outer shell 602).

[0231] In other embodiments, the inner sleeve 604 may include only the inner wall portion 632 without the legs 634. For example, the inner wall portion 632 may be made of a compressible or viscoelastic material, such as polyurethane foam, latex, or other types of shape memory foam, or a superelastic alloy with shape memory properties. Thus, when the balloon 680 inflates from a deflated state to an inflated state, the expansion force of the balloon 680 can compress the inner wall portion 632 and reduce its thickness, thereby increasing the diameter of the cavity 608. Conversely, when the balloon 680 deflates from an inflated state to a deflated state, the inner wall portion 632 can return to its original shape and have a greater wall thickness, thereby reducing the diameter of the cavity 608. Thus, the contraction cavity 608 can press inward against the balloon 680 and help hold the deflated balloon 680 in its folded shape.

[0232] Figure 20-21 Another balloon cover 700 according to an alternative implementation is illustrated.

[0233] Similar to balloon cover 600, balloon cover 700 may have an outer shell 702 and an inner sleeve 704 disposed within the outer shell 702, and the outer shell 702 may be more rigid than the inner sleeve 704. The outer shell 702 may include a first shell member 702a and a second shell member 702b connected to each other by a hinge 710. Thus, the shell members 702a, 702b may form a clamshell configuration, allowing them to open and close around a balloon mounted on a delivery catheter (not shown). Similarly, the first shell member 702a and the second shell member 702b may include corresponding latch portions 712a, 712b, which may be configured to engage with each other to hold the shell members 702a, 702b in a closed state.

[0234] like Figure 20 As shown, the inner sleeve 704 may have a first separable sleeve portion 704a and a second separable sleeve portion 704b. The first sleeve portion 704a includes a wall portion 732a and five ribs 734a extending radially inward from the wall portion 732a, while the second sleeve portion 704b includes a wall portion 732b and five ribs 734b extending radially inward from the wall portion 732b.

[0235] Although each of the first sleeve portion 704a and the second sleeve portion 704b has five ribs, it should be understood that the number of ribs in each sleeve portion may be less than five (e.g., one to four) or more than five, and the same principles described herein apply.

[0236] In some embodiments, the ribs 734a and 734b are uniformly distributed along the longitudinal axis of the respective sleeve portions 704a and 704b. In other embodiments, the ribs 734a and 734b may be non-uniformly distributed along the longitudinal axis of the respective sleeve portions 704a and 704b.

[0237] Wall portion 732a includes a plurality of wall segments 736a separated by ribs 734a, and wall portion 732b includes a plurality of wall segments 736b separated by ribs 734b. The number of wall segments in each sleeve portion may be the number of ribs on the sleeve portion plus one (six in the depicted example).

[0238] Each wall segment 736a of the first sleeve portion 704a has two longitudinal edges 740a and a wall surface 742a extending between the two longitudinal edges 740a. Similarly, each wall segment 736b of the second sleeve portion 704b has two longitudinal edges 740b and a wall surface 742b extending between the two longitudinal edges 740b.

[0239] Each rib 734a of the first sleeve portion 704a has two radial edges 744a and a rib surface 746a extending between the two radial edges 744a. Similarly, each rib 734b of the second sleeve portion 704b has two radial edges 744b and a rib surface 746b extending between the two radial edges 744b.

[0240] Furthermore, the first sleeve portion 704a includes a proximal plate 733a and a distal plate 735a generally parallel to the rib 734a, while the second sleeve portion 704b includes a proximal plate 733b and a distal plate 735b generally parallel to the rib 734b. The proximal plate 733a has a pair of radial edges 743a and an inner surface 747a extending between the pair of radial edges 743a. The distal plate 735a has a pair of radial edges 745a and an inner surface 748a extending between the pair of radial edges 745a. Similarly, the proximal plate 733b has a pair of radial edges 743b and an inner surface 747b extending between the pair of radial edges 743b. The distal plate 735b has a pair of radial edges 745b and an inner surface 748b extending between the pair of radial edges 745b.

[0241] As described herein, the first sleeve portion 704a and the second sleeve portion 704b can be coupled together so that the inner sleeve 704 is in a closed state surrounding the balloon.

[0242] For example, the two radial edges 744a of each rib 734a of the first sleeve portion 704a can be configured to engage (e.g., by means of a mutual locking mechanism) the two radial edges 734b of the corresponding rib 734b of the second sleeve portion 704b, such that the rib surface 746a of the first sleeve portion 704a can abut the corresponding rib surface 746b of the second sleeve portion 704b to form five rib surrounds 750. In other words, the five rib surrounds 750 can be formed by engaging five corresponding pairs of ribs 734a, 734b. In some embodiments, all the rib surrounds 750 have approximately the same diameter.

[0243] Furthermore, the two longitudinal edges 740a of each wall segment 736a of the first sleeve portion 704a can be configured to align or engage with the two longitudinal edges 740b of the corresponding wall segment 736b of the second sleeve portion 704b, such that the wall surface 742a of the first sleeve portion 704a can abut the corresponding wall surface 742b of the second sleeve portion 704b to form six wall surrounds 752 separated by five pairs of ribs 734a, 734b. In some embodiments, all wall surrounds 752 have approximately the same diameter.

[0244] Furthermore, the paired radial edges 743a of the proximal plate 733a may be configured to align or engage with the paired radial edges 743b of the proximal plate 733b, such that the inner surfaces 747a, 747b of the proximal plates 733a and 733b can abut to form a proximal opening 726. Similarly, the paired radial edges 745a of the distal plate 735a may be configured to align or engage with the paired radial edges 745b of the distal plate 735b, such that the inner surfaces 748a, 748b of the distal plates 735a and 735b can abut to form a distal opening 728. In some embodiments, the proximal opening 726 and the distal opening 728 may have a tapered shape similar to the proximal opening 626 and the distal opening 628 described above.

[0245] In some embodiments, the rib surrounds 750 may define a cavity configured to receive the valve holding portion (e.g., 686) of the balloon (e.g., 680). For example, when the first sleeve portion 704a and the second sleeve portion 704b are matingly coupled together, all the rib surrounds 750 may have approximately the same diameter, which is approximately the same as the diameter of the valve holding portion of the balloon in its compressed or folded state. Thus, the valve holding portion of the folded balloon can be held within a plurality of rib surrounds 750 spaced apart from each other and distributed along the length of the inner sleeve 704.

[0246] In some embodiments, when the balloon held within the rib surround 750 is inflated, the inner sleeve 704 can deform under the pressure exerted by the balloon on the rib surfaces 746a, 746b, thereby radially expanding the diameter of the rib surround 750.

[0247] For example, the first sleeve portion 704a and the second sleeve portion 704b may also include a plurality of legs (not shown) extending radially outward from the wall portions 732a, 732b to the inner surfaces of the respective outer shell members 702a, 702b. Such legs may be similar to the legs 634 described above and are compressible in the radial direction. Thus, when the balloon is inflated from a deflated state to an inflated state, the rib surround 750 can radially expand from an initial state (with a relatively small diameter) to a deformed state (with a relatively large diameter), while the legs are compressed from their initial radial length to a shortened radial length. Conversely, when the balloon is deflated from an inflated state to a deflated state, the rib surround 750 can return from the deformed state to its initial state, while the legs return to their initial radial length after the radial pressure applied by the inflated balloon is removed.

[0248] Optionally, the ribs 734a and 734b may be made of a compressible or viscoelastic material with shape memory properties. Therefore, when the balloon inflates from a deflated state to an inflated state, the inflation force of the balloon can radially compress the ribs 734a and 734b, thereby increasing the diameter of the rib surround 750. Conversely, when the balloon deflates from an inflated state to a deflated state, the ribs 734a and 734b can return to their original shape, thereby decreasing the diameter of the rib surround 750.

[0249] In some embodiments, inflating the balloon not only increases the diameter of the rib surround 750, but also transmits force to the diameters of the wall segments 736a, 736b, resulting in a corresponding increase in the diameter of the wall surround 752. Conversely, when the balloon deflates, both the rib surround 750 and the wall surround 752 can return to their original (smaller) diameters.

[0250] In other embodiments, inflating the balloon can increase the diameter of the rib surround 750 without changing the diameter of the wall surround 752. This can occur, for example, when the ribs 734a, 734b are made of a compressible or viscoelastic material while the wall segments 736a, 736b are made of a more rigid material.

[0251] Generally, the diameter of the wall surrounding 752 is larger than the diameter of the rib surrounding 750, regardless of whether the balloon is in a deflated or inflated state. In some embodiments, when the balloon is inflated, although the balloon section is held within the rib surrounding 750, the portion of the balloon outside the rib surrounding 750 may partially protrude into the wall surrounding 752.

[0252] In some implementations, any two adjacent ribs can be configured to have a circumferential offset such that the two radial edges of one of the two adjacent ribs extend at an angle relative to the corresponding two radial edges of the other adjacent rib.

[0253] For example, such as Figure 20 As shown, the five ribs 734a of the first sleeve portion 704a are configured with alternating rotational positions, such that the corresponding radial edges of the first, third, and fifth ribs (numbered from the farthest to the nearest) extend along a first angular direction, while the corresponding radial edges of the second and fourth ribs extend along a second angular direction with a circumferential offset relative to the first angular direction. The five ribs 734b of the second sleeve portion 704b have similar alternating rotational positions.

[0254] Figure 21The diagram shows a cross-section of the cover 700 when the first sleeve portion 704a and the second sleeve portion 704b are in a closed configuration. The mating positions of adjacent radial edges 734a and 734b form parting lines 760a, 760b, 760c, 760d, and 760e. As shown, each parting line 760a-e is circumferentially offset relative to the central longitudinal axis of the cover 700 from the adjacent parting line. This offset between the parting lines minimizes the risk of the balloon extending outwards across the parting lines during balloon inflation.

[0255] In some embodiments, the multiple ribs do not have alternating rotational orientations. For example, the multiple ribs on the sleeve portion may be configured to rotate progressively clockwise (or counterclockwise) from the farthest rib to the nearest rib. In other embodiments, the multiple ribs on the sleeve portion may rotate randomly or in a predetermined pattern such that two adjacent ribs do not have radial edges extending in the same angular direction.

[0256] Figures 22-23 show another balloon cover 800 configured to receive a delivery device (such as delivery device 870) according to yet another embodiment.

[0257] As shown in the figure, the balloon cover 800 includes a first shell member 802a and a second shell member 802b configured to engage with each other. When the first shell member 802a and the second shell member 802b are engaged with each other, the balloon cover 800 is in a closed state, as shown in the figure. Figure 22B and 23B As shown. The respective inner surfaces (or "inner walls") 804a, 804b of the shell members 802a, 802b may define a cavity 806, which is configured to receive the distal portion of the balloon catheter 870, including an inflatable balloon 880 mounted thereon. When the shell members 802a, 802b are disengaged from each other, the balloon cover 800 is in an open state, as... Figure 23A As shown.

[0258] In the depicted embodiment, the delivery device 870 includes an outer shaft (not shown), an intermediate shaft 876 (also referred to as a "balloon shaft") extending through a cavity through the outer shaft, an inner shaft 878 extending through a cavity through the balloon shaft 876, and a nasal cone 874 connected to the distal portion of the inner shaft 878. Similar to the examples described above (see, for example...), Figure 6-7 The delivery device 870 may include a shoulder assembly 890 connected to the distal portion of the balloon shaft 876, and the balloon 880 may be folded onto the shoulder assembly 890.

[0259] In the depicted embodiment, the first shell member 802a has two opposing first longitudinal edges 840a and the second shell member 802b has two opposing second longitudinal edges 840b. The first longitudinal edges 840a may be configured to engage with the corresponding second longitudinal edges 840b to form two longitudinal separation lines.

[0260] In some embodiments, shell members 802a and 802b can be completely separated from each other, that is, both first longitudinal edges 840a can be separated from their respective longitudinal edges 840b (see example). Figure 23A In an alternative embodiment, the first shell member 802 and the second shell member 802b may be connected to each other via hinges (similar to hinges 610 or 710 described above) along a pair (and only a pair) of longitudinal edges 840a, 840b, thereby allowing the first shell member 802 and the second shell member 802b to open and close around the distal portion of the balloon catheter 870.

[0261] In some embodiments, the first shell member 802 and the second shell member 802b may have corresponding latches (similar to the latches 406a and 406b, or 612a and 612b described above) which are configured to engage with each other to keep the first shell member 802 and the second shell member 802b engaged in a cooperative manner (i.e., in a closed state).

[0262] In other embodiments, the balloon cover 800 may also include a sleeve (not shown, similar to the sleeve 204 described above) configured to slide on the first shell member 802a and the second shell member 802b to maintain the first shell member and the second shell member in a mating engagement (i.e., in a closed state).

[0263] In the depicted embodiment, cavity 806 may include a proximal shaft section 808 configured to receive the distal portion of the intermediate shaft 876 of delivery device 870, a distal nasal cone section 812 configured to receive the nasal cone 874 of balloon catheter 870, and an intermediate balloon section 810 configured to receive a balloon 880 mounted on shoulder assembly 890 of delivery device 870. The balloon section 810 is located between shaft section 808 and nasal cone section 812.

[0264] In another embodiment, the balloon cover 800 may be configured to have a cavity that includes only the balloon segment 810 and not the axial segment 808 or the nasal cone segment 812. In yet another alternative embodiment, the balloon cover 800 may be configured to have a cavity that includes only the balloon segment 810 and one of the axial segment 808 and the nasal cone segment 812.

[0265] As shown in the figure, balloon segment 810 may include a proximal shoulder portion 814 (also referred to as a "proximal compartment") of the proximal portion 882 of balloon 880 mounted on the proximal shoulder 892 of shoulder assembly 890, a distal shoulder portion 816 (also referred to as a "distal compartment") of the distal portion 884 of balloon 880 mounted on the distal shoulder 894 of shoulder assembly 890, and an intermediate portion 818 (also referred to as a "middle compartment") between the proximal shoulder portion 814 and the distal shoulder portion 816. The intermediate portion 818 may be configured to receive a valve retention portion 886 of balloon 880 located between the proximal portion 882 and the distal portion 884 of balloon.

[0266] In general, in addition to the wedge and cavity described below, the proximal shoulder portion 814 of the cavity may have a shape substantially corresponding to the outer contour of the proximal portion 882 of the balloon folded onto the proximal shoulder 892. Similarly, the distal shoulder portion 816 of the cavity may have a shape substantially corresponding to the outer contour of the distal portion 884 of the balloon folded onto the distal shoulder 894, and the intermediate portion 818 of the cavity may have a shape substantially corresponding to the outer contour of the folded valve holding portion 886 of the balloon. Specifically, in the depicted embodiment, the proximal shoulder portion 814 is radially tapered from its proximal end to its distal end, while the distal shoulder portion 816 is radially tapered from its distal end to its proximal end. The intermediate portion 818 has a generally cylindrical shape. The intermediate portion 818 has a smaller diameter than the proximal end of the distal shoulder portion 814 and the distal end of the proximal shoulder portion 816.

[0267] Generally, the diameter of the cavity can vary along its axial length. For example, as described above, the balloon portions 882, 884 folded around the corresponding shoulders 892, 894 can have a corresponding conical shape, and the valve retaining portion 886 can have a smaller diameter than the balloon portions 882, 884. Therefore, the intermediate portion 818 of the cavity can have a smaller diameter than the distal portion of the proximal shoulder portion 814 and the proximal portion of the distal shoulder portion 816.

[0268] In another embodiment, the shoulder assembly 890 of the delivery device 870 includes a distal shoulder 894 but no proximal shoulder 892. In this case, while the distal portion 884 of the balloon 880 may be mounted on the distal shoulder 894 of the shoulder assembly 890, the proximal portion 882 of the balloon 880 may be mounted on the distal end of the intermediate shaft 876, similar to the following Figure 24-25 The embodiment shown. A portion 814 of the balloon segment 810 of the cavity defined by the balloon cover 800 can still be configured to receive the proximal portion 882 of the balloon 880 (although without the proximal shoulder 892), similar to the following Figure 27 The implementation method shown.

[0269] In some embodiments, the nasal cone segment 812 of the cavity may have a neck 820. The neck 820 may be formed by two matching semicircular rings 822a, 822b projecting radially inward from corresponding inner surfaces 804a, 804b of the first and second shell members. Thus, when the balloon 800 is in the closed state, these two semicircular rings 822a, 822b can form the neck 820, which has a smaller diameter than the rest of the nasal cone segment 812. By restricting the space at the distal end of the cavity, the narrower neck 820 helps maintain the folded shape of the balloon 880.

[0270] In some embodiments, the axial segment 808 of the cavity may include a plurality of central channels or holes 824. Each central channel may be formed by a pair of opposing ribs 826a, 826b extending radially inward from the respective inner surfaces 804a, 804b of the first shell member 802 and the second shell member 802b. Each rib 826a (or 826b) may have two radial edges 828a (or 828b) and a semi-circular rib surface 830a (or 830b) extending between the two radial edges 828a (or 828b) such that when the balloon 800 is in the closed state, the two rib surfaces 830a, 830b can together define the inner surface of the respective central channel 824. As shown, any two adjacent central channels 824 may be separated by a chamber 832 located between the ribs 826a, 826b forming the two adjacent central channels 824.

[0271] Generally, the diameter of chamber 832 (measured across inner surfaces 804a, 804b) is larger than the diameter of the central channel 824 (measured across rib surfaces 830a, 830b). In some embodiments, multiple channels 824 may have different diameters (e.g., in...). Figure 23B In the example, the diameters of the two channels on the left are smaller than the diameters of the four channels on the right. In other embodiments, the multiple channels 824 may have approximately the same diameter.

[0272] In some embodiments, when the balloon cover 800 surrounds the distal portion of the balloon catheter 870 (including the balloon 880 mounted thereon), the balloon cover 800 may have a small cavity configured to receive the distal end of the outer shaft (e.g., in...). Figure 22A (Approximately at the location indicated by arrow 808). In some embodiments, this cavity (the proximal portion of the axial section 808 of the cover) is sized to receive the distal portion and the distal portion of the outer shaft, such as... Figure 24The outer shaft 972 and the distal portion 973. When the balloon cover 800 is in the open position and the distal portion of the balloon catheter is arranged in one of the shell members 802a, 802b, slightly pushing the balloon 800 in the proximal direction causes the proximal portion 882 of the folded balloon 800 to "puff up" or more closely conform to the shape of the proximal compartment 814 of the cover, which can help maintain the desired shape of the balloon during the storage of the balloon catheter.

[0273] According to one exemplary embodiment, a first shell member 802a includes a plurality of first wedges 842a arranged alongside a plurality of first cavities 844a, and a second shell member 802b includes a plurality of second wedges 842b arranged alongside a plurality of second cavities 844b. The first wedges 842a and the first cavities 844a are configured to lock against each other with corresponding second cavities 842b and second wedges 844b when the balloon cover 800 is in a closed state.

[0274] For example, the first cavity 844a can be positioned and sized to receive a corresponding second wedge 842b, and the second cavity 844b can be positioned and sized to receive a corresponding first wedge 842a. Therefore, when the balloon 880 is in the closed state (see, for example...), Figure 22B and 23B The first wedge 842a and the second wedge 842b are offset, such that the plurality of first wedges 842a are received by the plurality of second cavities 844b and the plurality of second wedges 842b are received by the plurality of first cavities 844a.

[0275] As described herein, the interlocking between the wedges 842a, 842b and the corresponding cavities 844a, 844b advantageously allows the balloon cover 800 to hold certain areas of the balloon 880 (e.g., areas in contact with the wedges) more tightly than other areas (e.g., areas not in contact with the wedges) as required by design. Furthermore, the interlocking nature of this design reduces the risk of slippage and / or displacement (misalignment) between the shell members 802a, 802b during the manufacture, transport, and / or storage of the balloon assembly comprising the balloon 880 and the balloon cover 800 (thereby reducing the risk of balloon damage).

[0276] As shown in the figure, the first wedge 842a and the second wedge 842b, as well as the first cavity 844a and the second cavity 844b, are located in the balloon segment 810 of the balloon. In the depicted embodiment, the wedges 842a, 842b and the cavities 844a, 844b are distributed in the proximal shoulder portion 814, the distal shoulder portion 816, and the intermediate portion 818. In other embodiments, the wedges 842a, 842b and the cavities 844a, 844b may be distributed only in selected portions (one or more) of the balloon segment 810.

[0277] As shown in the figure, the first wedge 842a and the first cavity 844a can be positioned adjacent to and along the first longitudinal edge 840a, and the second wedge 842b and the second cavity 844b can be positioned adjacent to and along the second longitudinal edge 844b.

[0278] As shown in the figure, the first wedge 842a can protrude from the first longitudinal edge 840a and the cavity 844a can be recessed below the first longitudinal edge 840a. Similarly, the second wedge 842b can protrude from the second longitudinal edge 840b and the cavity 844b can be recessed below the second longitudinal edge 840b.

[0279] In the depicted embodiment, a first wedge 842a and a first cavity 844a positioned along two opposing first longitudinal edges 840a are symmetrical about the axial axis of the first shell member 802a, and a second wedge 842b and a second cavity 844b positioned along two opposing second longitudinal edges 840b are symmetrical about the axial axis of the second shell member 802b. In other embodiments, the wedges 842a, 842b and the cavities 844a, 844b may be positioned asymmetrically about the corresponding axial axes of the shell member.

[0280] In the depicted embodiment, the wedges 842a, 842b and cavities 844a, 844b are distributed approximately uniformly along the axial axis of the balloon cover (i.e., the wedges and cavities on the cover members are axially spaced apart from each other at approximately equal distances). In other embodiments, the wedges 842a, 842b and cavities 844a, 844b may be distributed non-uniformly along the axial axis of the balloon cover. For example, the wedges 842a, 842b and cavities 844a, 844b located in the intermediate portion 818 may be configured to have a different density than those located in the proximal shoulder portion 814 and / or the distal shoulder segment 816 (i.e., a smaller distance between adjacent wedges or cavities), and vice versa.

[0281] In the depicted embodiments, wedges 842a and 842b have approximately the same size and shape. In other embodiments, wedges 842a and 842b may be configured to have different sizes and / or shapes (and cavities 844a and 844b may have corresponding sizes and / or shapes to receive the respective wedges 842a and 842b). For example, the cross-section of wedges 842a and / or 842b may be square, rectangular, circular, elliptical, or other shapes. In another example, the cross-section of wedges 842a and / or 842b in the intermediate portion 818 may be configured to have a smaller (or larger) surface area than that of wedges 842a and 842b and cavities 844a and 844b located on the proximal shoulder portion 814 and / or distal shoulder segment 816.

[0282] In some embodiments, shell members 802a and 802b may be made of a rigid material (similar to outer shells 602 and 702 described above), such that the cavity 806 cannot deform due to partial expansion of the balloon 880. In other embodiments, shell members 802a and 802b may be made of an elastic material (similar to inner shells 604 and 704 described above), such that the cavity 806 can partially deform (e.g., increase in diameter) due to partial expansion of the balloon 880. In some embodiments, shell members 802a and 802b may be configured to function in a manner similar to that of inner shells 604 and 704—for example, by including components similar to the legs 634 or ribs 734 described above, and then including another outer shell outside the shell members 802a and 802b.

[0283] Figure 24-25 The distal portion of a delivery device 970 for a prosthetic heart valve according to another embodiment is shown. The delivery device 970 in the illustrated embodiment includes an inflatable balloon 980 for expanding a prosthetic heart valve within a patient.

[0284] As shown in the figure, the delivery device 970 includes a first shaft 972 (an outer shaft in the illustrated embodiment), a second shaft 976 (an intermediate shaft in the illustrated embodiment; also referred to as a "balloon shaft") extending through a cavity through the outer shaft 972, a third shaft 978 (an inner shaft in the illustrated embodiment) extending through a cavity through the intermediate shaft 976, and a nasal cone 974 connected to the distal portion of the inner shaft 978. The inner shaft 978 may have a guidewire lumen for receiving a guidewire 979, as is known in the art. The balloon 980 may have a proximal portion 982p attached to a stepped-down end of the balloon shaft 976 and a distal portion 984d attached to the nasal cone 974.

[0285] In the depicted embodiment, a flexible distal member 973 is fixedly coupled to the distal end of an outer shaft 972. The distal end of the flexible distal member 973 may have a diameter larger than that of the outer shaft 972. The delivery device 970 may include a shoulder assembly 990 connected to the distal portion of an inner shaft 978, and at least a distal portion 984 of a balloon 980 may be folded around the shoulder assembly 990.

[0286] As shown in the figure, the shoulder assembly 990 in the illustrated embodiment includes only the distal shoulder 994 (unlike the shoulder assembly 890 described above, it lacks a proximal shoulder). Although the distal portion 984 of the balloon folds around the distal shoulder 994, the proximal portion 982 of the balloon can fold directly around the segment 992 of the inner axis 978 located proximal to the distal shoulder 994. The valve retaining portion 986 of the balloon 980 (located between the proximal portion 982 and the distal portion 984) can be positioned along the inner axis 978 connecting the distal shoulder 994 and the axis segment 992. As shown, when the balloon 980 is in a deflated and folded state, the valve retaining portion 986 can have a generally cylindrical shape. As shown, the proximal portion 984p of the distal portion 984 and the distal portion 982d of the proximal portion 982 both have a larger diameter than the valve retaining portion 986 of the balloon 980. In the depicted embodiment, the maximum diameter of the folded balloon 980 may be located at the proximal portion 984p of the distal portion 984.

[0287] The proximal portions of shafts 972, 976, and 978 may be coupled to a handle (e.g., handle 102) of the delivery device 970. In some embodiments, shafts 972, 976, and 978 may be axially (in the distal and proximal directions) and rotatably movable relative to each other. Further details of the delivery device 970 are disclosed in U.S. Application No. 63 / 069,567, filed August 24, 2020 (which is incorporated herein by reference).

[0288] Figure 24-25 The balloon 980 can take on different shapes during use.

[0289] For example, in Figure 24 In the embodiment shown, the proximal portion 982 of the balloon is radially conical from its distal portion 982d to its proximal portion 982p. In contrast, in... Figure 25In the illustrated embodiment, the proximal portion 982 of the balloon is shaped to form two portions with different shapes: a proximal portion 981 and a distal portion 983. While the distal portion 983 is radially tapered inward from its distal end to its proximal end, the proximal portion 981 has a generally constant diameter along its length. In one example embodiment, the proximal portion 981 and the distal portion 983 have equal or substantially equal lengths. In other embodiments, the proximal portion 981 and the distal portion 983 have different lengths.

[0290] In addition, Figure 24 In the embodiment shown, the distal portion 984 of the balloon is radially inwardly tapered from its proximal portion 984p to its distal portion 984d. In contrast, in... Figure 25 In the illustrated embodiment, the distal portion 984 of the balloon has a generally gourd-shaped or hourglass-shaped form, characterized by a radially concave central portion. Specifically, the distal portion 984 of the balloon is radially concave inward from its proximal portion 984p toward the radially concave central portion 984m, and then radially concave outward toward its distal portion 984d.

[0291] like Figure 24 The shaped balloon 980 shown can be held within the aforementioned balloon coverings 200, 400, 600, 700, or 800. For example... Figure 25 The shape of the balloon 980 shown can be derived from, for example... Figure 26-27 The balloon covering 900, as depicted and described more fully below, is formed.

[0292] Before the delivery device 970 is introduced into the patient, the prosthetic valve may be folded onto the valve holding portion 986 of the balloon 980. As previously described, prior to folding, the balloon 980 may undergo a cyclic degassing process, thereby introducing expansion fluid into the balloon and then withdrawing it. The process of introducing expansion fluid into the balloon and then withdrawing the expansion fluid may be repeated once or multiple times as needed. During the degassing process, the distal end 973 of the outer axis 972 is typically positioned proximally to the balloon to facilitate the inflow of expansion fluid into the proximal portion 982 of the balloon 980. In some embodiments, the degassing process may be performed while the balloon 980 is contained within the balloon cover. After the degassing process, the balloon cover can be removed from the balloon and the outer axis 972 may be moved relative to the intermediate axis 976 (and the inner axis 978) to a distal position extending on the proximal portion 981 of the proximal portion 982 of the balloon (e.g., Figure 25 (As shown by the dashed lines in the diagram). When the outer shaft 972 moves distally on the proximal portion 981, residual fluid from the degassing process in the proximal portion of the balloon can be pushed distally into the valve retention portion 986 and the distal portion 984 of the balloon. After the degassing process, Figure 25 The shape of the folded balloon depicted in the image can be compared to, in at least two aspects, [the shape of the balloon]. Figure 24 The shape depicted in the text is advantageous.

[0293] First, due to the gradual increase in balloon diameter from the proximal portion 982p to the distal portion 982d and / or the presence of residual fluid in the proximal portion of the balloon, Figure 24 The conical shape of the proximal portion 982 of the balloon shown can press against the flexible distal member 973 and resist distal propulsion of the outer axis 972 relative to the intermediate axis 976 and the balloon 980. In contrast, Figure 25 The smaller diameter of the cylindrical proximal portion 981 depicted in the figure facilitates axial movement between the outer shaft 972 and the intermediate shaft 976 with less resistance, especially when the inner diameters of the cavity of the outer shaft 972 and the cavity of the flexible terminal member 973 are configured to be approximately the same as or slightly larger than the outer diameter of the proximal portion 981 of the balloon.

[0294] Second, when the residual expansion fluid in the proximal portion 980 of the balloon is "squeezed" or pushed into the distal portion 984 of the balloon by advancing the outer shaft 972, the displaced residual fluid can enlarge the distal portion 984 of the balloon and increase the outer diameter of the proximal portion 984p, thereby increasing the overall crease profile of the delivery device 970. Furthermore, when the proximal portion 982 has… Figure 24 When the cone shape is shown, the effect of the displaced expanding fluid is even more significant. In contrast, by means of... Figure 25 The indentation along the middle portion 984m, as shown, avoids undesirable expansion of the proximal portion 984p. Therefore, when displaced expansion fluid is pushed into the distal portion 984 of the balloon, the middle portion 984m can receive the expansion fluid and partially expand from an hourglass shape (shown in solid lines) to a conical shape 984m' (shown in dashed lines), the conical shape 984m' having a diameter that gradually and continuously decreases from the proximal portion 984p to the distal portion 984d (shown in dashed lines). Thus, the radially concave middle portion 984m effectively creates a negative radial indentation that can compensate for displaced residual fluid, thereby preventing or minimizing expansion of the proximal portion 984p of the distal portion of the balloon. In this way, the overall crease profile of the delivery device 970 due to the propulsion of the outer shaft can be avoided.

[0295] Generally, the maximum diameter of the balloon and the folded prosthetic valve is typically where the inlet end of the prosthetic valve contacts the proximal portion (984p) of the distal part of the balloon; therefore, the overall folded profile of the delivery device can be determined by the diameter at this location. For example... Figure 24 The shaped balloon shown, in some instances, allows the displaced expansion fluid to increase the balloon diameter by approximately 0.25 mm at the inflow end of the prosthetic valve (at position 984p). In contrast, for example, for... Figure 25The shaped balloon shown, in some instances, results in a slight increase in balloon diameter (e.g., approximately 0.12 mm) at the inflow end of the prosthetic valve due to the displaced expansion fluid. Therefore, by adjusting the balloon shape from... Figures 24 to 25 By making changes, the increase in balloon diameter at the inflow end of the prosthetic valve caused by the displaced expansion fluid can be reduced by more than 50% (e.g., from about 0.25 mm to about 0.12 mm).

[0296] Various technologies and mechanisms can be used, including balloon covers with an inner cavity shaped to produce the desired balloon shape. Figure 25 The shape of the balloon shown.

[0297] Figure 26-27 A balloon cover 900, according to one embodiment, is shown, configured to receive a delivery device 970 and a balloon 980 folded thereon. Specifically, the balloon cover 900 is configured to receive and generate... Figure 25 The final shape of the balloon 980 shown. For example, Figure 28 The distal portion of the balloon cover 900 is shown, which maintains... Figure 25 The distal portion 984 of the hourglass-shaped balloon is depicted. As described more fully below, the balloon cover 900 is similar to the balloon cover 800 described above, except that it is configured to receive the shape of the cavity of the balloon.

[0298] As shown in the figure, the balloon cover 900 includes a first shell member 902a and a second shell member 902b configured to engage with each other. When the first shell member 902a and the second shell member 902b are engaged with each other, the balloon cover 900 is in a closed state, as... Figure 27 As shown. The respective inner surfaces (or "inner walls") 904a, 904b of the shell members 902a, 902b may define a cavity 906, which is configured to receive the distal portion of the delivery device 970, including a balloon 980 folded thereon. When the shell members 902a, 902b are disengaged from each other, the balloon cover 900 is in an open state, as... Figure 26 As shown. The first shell member 902a and the second shell member 902b can be coupled together or separated from each other along their respective longitudinal edges 940a, 940b. Similar to the balloon cover 800, the shell members 902a, 902b can be made of rigid or elastic materials, and they can be connected by hinges (e.g., as shown). Figure 13 (or as shown in 17) completely separated from or connected to each other.

[0299] Similar to the balloon cover 800, a first shell member 902a has a plurality of first wedges 942a alternating with a plurality of first cavities 944a along the length of the first shell member. A second shell member 902b has a plurality of second wedges 942b alternating with a plurality of second cavities 944b along the length of the second shell member. When the balloon cover 900 is in the closed state, the first wedges 942a and the first cavities 944a are configured to lock into each other with corresponding second cavities 944b and second wedges 942b. In the depicted embodiment, the first wedges 942a and the first cavities 944a are perpendicular to a first longitudinal edge 940a, and the second wedges 942b and the second cavities 944b are perpendicular to a second longitudinal edge 940b. As shown in the figure, when the cover is in the closed state, the first wedge 942a and the second wedge 942b can protrude on the corresponding first longitudinal edge 940a and the second longitudinal edge 940b, and the first cavity 944a and the second cavity 944b can be recessed under the corresponding first longitudinal edge 940a and the second longitudinal edge 940b.

[0300] Similar to balloon cover 800, the cavity 906 of balloon cover 900 includes a balloon segment 910 configured to receive a balloon 980 folded onto the distal portion of delivery device 970, an axis segment 908 configured to receive the distal portion of intermediate axis 976, and a nasal cone segment 912 configured to receive nasal cone 974. The balloon segment 910 is located between the axis segment 908 and the nasal cone segment 912. As shown, the balloon segment 910 includes a proximal compartment 914 configured to receive the proximal portion 982 of the balloon, a distal compartment 916 configured to receive the distal portion 984 of the balloon, and an intermediate compartment 918 located between the proximal compartment 914 and the distal compartment 916, and the intermediate compartment 918 is configured to receive the valve retention portion 986 of the balloon. The distal end 914d of the proximal compartment 914 may have a smaller diameter than the proximal end 916p of the distal compartment 916, and the intermediate compartment 918 may have a smaller diameter than the distal end 914d of the proximal compartment 914.

[0301] The axial segment 908 and nasal cone segment 912 of the balloon cover 900 may be similar to the corresponding axial segment 808 and nasal cone segment 812 of the balloon cover 800. The intermediate compartment 918 of the balloon cover 900 may be similar to the intermediate portion 818 of the balloon cover 800. However, the proximal compartment 914 and / or distal compartment 916 of the balloon cover 900 may have a different shape than the corresponding compartments 814, 816 of the balloon cover 800.

[0302] Specifically, the proximal compartment 914 may include a proximal portion 913 and a distal portion 911, which are shaped to receive... Figure 25 The balloon is depicted with corresponding proximal portion 981 and distal portion 983. (As shown) Figure 26 As shown, the distal portion 911 is radially tapered inward from its distal end to its proximal end, and the proximal portion 913 has a substantially constant diameter along its axial length. In the depicted embodiment, the proximal portion 913 has approximately the same axial length as the distal portion 911. In other embodiments, the proximal portion 913 and the distal portion 911 may have different lengths, provided they match the corresponding lengths of the proximal portion 981 and the distal portion 983 of the balloon.

[0303] In addition, such as Figure 26 As shown, the distal compartment 916 includes a proximal region 915, a distal region 917, and an intermediate region 916m located between the proximal region 915 and the distal region 917. Generally, the distal region 917 has a smaller diameter than the proximal region 915, and the intermediate region 916m has a smaller diameter than the distal region 917. Specifically, in the illustrated embodiment, the distal compartment 916 is radially tapered inward from the proximal region 915 to the intermediate region 916m, and then radially tapered outward from the intermediate region 916m to the distal region 917. The distal end 917d of the distal region 917 may have a smaller diameter than the proximal end 915p of the proximal region 915. Figure 28 As best shown, the distal compartment 916 has an overall gourd or hourglass shape and is configured to receive... Figure 25 The distal portion of the balloon is depicted in the image 984.

[0304] In some implementations, the deflated balloon can be initially folded to obtain Figure 24 The shape depicted in the image. A folded balloon may include, for example... Figure 6 , 8 The axial and / or radial folds shown in Figure 10. A compression mechanism or compression member can be applied to radially compress the distal portion 984 of the balloon to form... Figure 25 The hourglass shape depicted in the painting.

[0305] In some embodiments, the radial protrusion on the inner wall of the shell member at the intermediate region 916m can serve as a compression mechanism to radially compress and retain the intermediate portion 984m of the distal part of the balloon. For example, as... Figure 26 and 28 As shown, a first semi-circular radial protrusion 920a can extend radially inward from the inner wall 904a of the first shell member 902a, and a second semi-circular radial protrusion 920b can extend radially inward from the inner wall 904b of the second shell member 902b. When the first shell member 902a and the second shell member 902b are engaged with each other, the first semi-circular radial protrusion 920a and the second semi-circular radial protrusion 920b can form a circular radial protrusion extending radially inward.

[0306] In some embodiments, the shape of cavity 906 may be defined by the inner surfaces of wedges 942a, 942b. When the two shell portions 902a, 902b are closed, the distal compartment 916 of the cavity may have a smooth hourglass cross-sectional profile, and when the shell portions 902a, 902b are closed around the balloon, the distal portion 984 of the balloon will exhibit this shape. Figure 28 In the illustrated embodiment, the radial protrusions 920a, 920b may be defined by the inner surfaces of wedges 942a, 942b, which correspond to the minimum diameter of the intermediate portion 916m along the distal compartment. Therefore, the wedges 942a, 942b at the intermediate portion 916m can act as compression members to compress the distal portion 984 of the balloon to form... Figure 25 The hourglass shape depicted in the painting.

[0307] In some embodiments, the balloon cover 900 can cover the proximal portion 982 of the balloon from Figure 24 The initial shape is further shaped to Figure 25 The final shape. For example, when the shell portions 902a and 902b are closed around the sac, they have... Figure 24 The proximal portion 982 of the initial cone-shaped balloon can be modified through the proximal compartment 914 of the balloon cover into Figure 25 The shape shown (i.e., having a tapered distal portion 983 and a cylindrical proximal portion 981).

[0308] Figure 30 illustrates another compression mechanism or compression member configured to radially compress and retain the distal portion 984 of the balloon. As shown, the compression member may include an annular band or ring 922 configured to be positioned around the intermediate portion 984m of the distal portion 984 of the balloon. In one embodiment, the band 922 may be made of a relatively rigid and inelastic material (e.g., rigid plastic) having a fixed inner diameter—equal to the final desired diameter of the intermediate portion 984m of the distal portion of the balloon. In use, the band 922 can slide on the nasal cone 974 and onto the intermediate portion 984m of the distal portion of the balloon. When placed on the balloon, the band 922 creates a radial indentation along the intermediate portion 984m. In another embodiment, the band 922 may be made of an elastic material (e.g., rubber or synthetic elastomers such as polyurethane), such as an O-ring, which can expand to facilitate sliding of the band on the nasal cone. The inner diameter of the band is sized such that when placed on the balloon, the band creates a radial indentation along the middle portion 984m of the distal portion of the balloon. Furthermore, when positioned on the balloon, the elastic band allows at least partial inflation of the distal portion 984 of the balloon during deflation. After deflation, the band 922 can be removed from the balloon by sliding it distally on the nasal cone 974. In some embodiments, the band 922 may have sufficient elasticity to allow full inflation of the distal portion 984 of the balloon or at least sufficient to allow adequate deployment of the prosthetic valve and remain on the balloon during the implantation procedure.

[0309] In another embodiment, band 922 can be formed by wrapping a flexible cord or rope, such as a suture, around the middle portion 984m of the distal part of the balloon and tying the two ends of the cord together. The cord can be sufficiently tightened around the middle portion 984m to create a radial indentation.

[0310] In some embodiments, after the band 922 is placed around the middle portion, the distal portion of the delivery device 970 may be placed in the balloon cover (including any embodiment of the balloon cover disclosed herein) for storage and subsequent degassing.

[0311] In some embodiments, the compression member may include a flexible sheath 924 connected to the band 922, such as Figure 29 As shown. The sheath 924 is configured to surround the distal portion 984 of the balloon. The distal end 924d of the sheath 924 may be connected to the distal portion 984d of the distal portion of the balloon and / or the nasal cone 974.

[0312] In some embodiments, the sheath 924 may comprise an elastic or deformable material such that it can expand radially when the distal portion 984 of the balloon expands, such as during degassing. For example, the sheath 924 may be configured to move between a radially compressed configuration and a radially expanded configuration. When the sheath 924 is in a radially compressed configuration, the band 922 may radially compress the middle portion 984m of the balloon to create a radial indentation. When the sheath 924 is in a radially expanded configuration (e.g., after the distal portion 984 of the radially expanded balloon), the band 922 may expand radially. In some embodiments, after the band 922 and the sheath 924 are placed on the balloon, the distal portion of the delivery device 970 may be placed in a balloon cover (including any embodiment of the balloon cover disclosed herein) for storage and subsequent degassing.

[0313] After the degassing process, the band 922 and sheath 924 can be removed from the balloon by rolling up the band and sheath distally until the rolled-up band and sheath are on the nasal cone. In some embodiments, the band 922 and sheath 924 may allow the balloon to fully inflate for valve deployment and may remain in place on the balloon during the implantation procedure.

[0314] In some embodiments, there is no separate structure forming the band 922. Instead, the band 922 may be an integral part of the proximal portion 924p of the sheath 924. In one example, the sheath 924 may be relatively thicker and less elastic along the proximal portion 924p compared to the rest of the sheath 924, such that the proximal portion 924p can exert sufficient inward force on the middle portion 984m of the distal portion of the balloon to create a radial indentation along that portion of the balloon.

[0315] Although in the above examples the compression mechanism or compression member is arranged in the distal compartment of the balloon cover to radially compress the distal portion of the balloon, it should be understood that similar compression mechanisms or compression members may also be placed in other locations within the balloon cover (e.g., the proximal compartment and / or the intermediate compartment) as required by design (e.g., to radially compress a portion of the balloon to conform to a specific diameter or shape at that portion). For example, creating a depression in the proximal portion of the balloon may be desirable, which can facilitate the sliding of the outer shaft 972 on the proximal portion of the balloon.

[0316] In some embodiments, for example, the proximal compartment 914 and / or the intermediate compartment 918 may be formed with compression members (e.g., radial protrusions) to create depressions in portions of the balloon within these compartments. In some embodiments, the cover 900 may include one or more compression members (e.g., radial protrusions) at one or more locations along the length of the cover—including the proximal compartment 914, the intermediate compartment 918, and / or the distal compartment 916. Similarly, Figure 29The device can be sized so that the band 922 can be placed around any part of the balloon—including the proximal, middle, or distal part of the balloon.

[0317] It should be understood that the above-described compression mechanism is merely an example embodiment. Other embodiments may be used to radially compress the middle portion 984m of the balloon or other portions of the balloon, such that the compressed section of the balloon has an overall gourd or hourglass shape.

[0318] As described below, balloon cover 600 (or cover 200, 400, 700, 800 or 900) can facilitate degassing of balloon 680 by employing compressible internal components or layers that define an inner chamber for receiving the balloon.

[0319] Before the prosthetic valve is folded onto the balloon, the balloon typically undergoes a degassing process, which involves pushing inflatable fluid into the balloon and then withdrawing the fluid (e.g., using a syringe) to create a vacuum within the balloon. The degassing process is more successful when the balloon is allowed at least partial inflation. However, inflating a folded balloon without a balloon cover will cause the balloon to deploy, and it may then fail to return to its compressed folded shape. On the other hand, a rigid balloon cover may completely prevent balloon inflation.

[0320] The balloon cover 600 (or 200, 400, 700, 800, or 900) disclosed herein overcomes such problems. Advantageously, a flexible inner sleeve 604 (or 704; similarly, covers 200, 400, 700, 800, and 900 may include a flexible or deformable inner sleeve or layer forming a chamber for receiving the balloon) allows the folded balloon 680 to partially inflate within the inner sleeve 604 (or 704, or a similar component of covers 200, 400, 700, 800, and 900) during degassing without unfolding. Specifically, when inflation fluid is injected into the folded balloon 680, the balloon 680 can partially inflate, pressing against the inner sleeve 604, which deforms (e.g., by increasing the diameter of the cavity and shortening the legs) to accommodate the partially inflated balloon 680. The degree of flexibility of the inner sleeve 604 limits the partial inflation of the balloon 680. For example, the maximum diameter to which the balloon 680 can be inflated may be limited by the maximum diameter to which the cavity 608 (or the rib surround 750 or 810) can be extended, which may be further limited by the shortest radial length to which the leg 634 can be compressed, and inherently limited by the diameter of the central recess 624 of the outer shell 602.

[0321] When a vacuum is created in balloon 680 after the inflatable fluid is withdrawn from the balloon, the flexible inner sleeve 604 (or 704, or a similar component of the covers 200, 400, 700, 800, 900) can return to its original shape (e.g., by reducing the diameter of the cavity 608 (or the rib surround 750 or 810) and elongating the legs 634). Thus, the contracted inner sleeve 604 (or 704, 800, 900) can press inward against balloon 680 and help balloon 680 return to its original (folded) shape.

[0322] An example method for assembling the balloon 680 within the balloon cover 600 is described below (and similar methods can also be used to assemble the balloon 680 within balloon covers 200, 400, 700, 800, or 900).

[0323] According to one embodiment, the balloon 680 (in a deflated state) can be folded as follows: Figure 19 The shoulder assembly of the delivery device 670 shown includes a proximal shoulder 690, a distal shoulder 692, and a valve holding portion 686. A folded balloon 680 can be placed within the cavity 608 of an inner sleeve 604, for example, by aligning the corresponding longitudinal edges 618a, 618b of the first portion 604a and the second portion 604b to surround the valve holding portion 686 of the balloon 680. The inner sleeve 604 and the balloon 680 can then be placed within a housing 602. For example, housing members 602a, 602b can be placed around the balloon 680 such that the proximal portion 682 of the balloon 680 is placed within a proximal recess 620 of the housing 602, the distal portion 684 of the balloon is placed within a distal recess 622 of the housing 602, and the inner sleeve 604 is placed within a central recess 624 of the housing 602. Then, the housing 602 can be locked, for example, by extending the enlarged edge 614a through the slot 614b to form a snap-fit ​​engagement between the housing members 602a, 602b.

[0324] The following describes an example method for deflating a balloon 680 within a balloon cover 600, and it should be understood that the same method can also be used to deflat balloons within other balloon covers disclosed herein.

[0325] According to one embodiment, balloon 680 may be fluidly connected to a fluid source (e.g., a syringe). The fluid source may inject a predetermined amount of expansion fluid (e.g., saline) into balloon 680 to inflate balloon 680 to a partially inflated state. In the partially inflated state, balloon 680 may still remain partially folded (e.g., at least some of adjacent folds remain partially overlapping each other) and may return to its original (folded) shape after the inflation pressure is removed. As described above, the inflation of balloon 680 may deform the cavity 608 of inner sleeve 604 from its initial state (having a relatively small diameter) to a deformed state (having a relatively large diameter). The expansion fluid may then be removed from balloon 680 (e.g., drawn back into the inflation source) to create a vacuum inside balloon 680. The vacuum may cause balloon 680 to return from its partially inflated state to a deflated state. The cavity 608 of the inner sleeve 604 can also return from a deformed state (with a relatively large diameter) to its initial state (with a relatively small diameter), thereby pressing inward against the balloon 680 and helping the balloon 680 return to its original (folded) shape. In some embodiments, the steps of (a) inflating the balloon 680 from a deflated state to a partially inflated state and (b) deflating the balloon 680 from a partially inflated state to a deflated state can be repeated multiple times.

[0326] Figure 14 An example is provided of a method for assembling a delivery device to include a balloon 300 according to one embodiment. Figure 15-16 A fully assembled delivery device 500 is shown, on which a folded balloon 300 is mounted. The delivery device 500 includes a plurality of [unclear text - likely related to a specific type of delivery device]. Figure 3-7 The same components as the delivery device 100. Therefore, Figure 15-16 The same parts are assigned the same corresponding reference number and are not described further.

[0327] Although for illustrative purposes Figure 14-16 The image shows balloon 300, but it should be understood that the methods described below can be used to assemble delivery devices with other balloons (such as balloon 108) or balloons without any folds. While not ideal, in other embodiments, the balloon can be folded after being assembled onto the delivery device. For example, balloon 300 without any folds (e.g., folds 316, 318, 322, 326) can be assembled onto the delivery device (as described below), and then the balloon can be folded.

[0328] refer to Figure 14The distal shoulder 160 (which may include the nose cone portion 166) may be mounted on the distal portion of the first shaft 106 (which may be the inner shaft of the delivery device) to form a first subassembly 502 of the delivery device. The proximal shoulder 170 may be mounted on the distal portion of the second shaft 105 (which may be the intermediate shaft of the delivery device) to form a second subassembly 504 of the delivery device.

[0329] Figure 14 The image shows the balloon 300 with its protective cover 400 removed during assembly. In other embodiments, the protective cover 400 (or covers 200, 600, 700, 800, or 900) may be held in place around the balloon during assembly. Restraint member 350 ( Figure 14 (Not shown in the text) can be removed from the balloon just before the assembly process described below or after the balloon is assembled onto the delivery device, or alternatively, the restraint member 350 can be left in place for removal by the end user before the prosthetic valve is folded onto the balloon.

[0330] exist Figure 14 In the direction indicated by the middle arrow 506 (in) Figure 14 (From left to right) The proximal end of the first shaft 106 can be inserted into the distal end 340 of the opening of the distal leg 308. The first shaft can then be inserted through the balloon 300, through the proximal shoulder 170, and through the second shaft 105, after which the distal shoulder 160 can be at least partially inserted into the distal conical portion 304 of the balloon. Because the diameter of the distal collar member 162 is larger than that of the distal leg 306, the distal collar member 162 can be radially compressed and then inserted and passed through the distal collar member 162. The distal shoulder 160 can be inserted into the balloon until the distal leg 308 extends over the axial portion 163 of the distal shoulder 160. Because the distal collar member 162 is made of an elastic material, it can radially expand back to its original shape once it passes through the distal leg 308. The distal leg 308 of the balloon can then be secured to the distal shoulder 160 (e.g., to the shaft portion 163) by thermal bonding, adhesive bonding, mechanical locking, or any other suitable technique or method.

[0331] exist Figure 14 In the direction indicated by the middle arrow 508 (in) Figure 14(From right to left) The proximal shoulder 170 can be inserted into the distal end 342 of the opening of the proximal leg 310 of the balloon and inserted through the balloon until the proximal collar member 172 resides within the proximal conical portion 306 of the balloon and the proximal leg 310 extends over the axial portion 173 of the proximal shoulder 170. Because the diameter of the proximal collar member 172 is larger than that of the proximal leg 310, the proximal collar member 172 can be radially compressed before it is inserted and passes through the proximal leg 310. Because the proximal collar member 172 is made of an elastic material, it can radially expand back to its original shape once it passes through the proximal leg 310. The proximal leg 310 of the balloon can then be secured to the proximal shoulder 170 (e.g., to the axial portion 173) by thermal bonding, gluing, mechanical locking, or any other suitable technique or method.

[0332] For illustrative purposes, a small gap is shown between the legs 308, 310 and the shaft portions 163, 173. However, it should be understood that once the legs 308, 310 are secured to the shaft portions 163, 173, they can contact the shaft portions 163, 173.

[0333] One or more components of the balloon 300, as well as the distal shoulder 160 and proximal shoulder 170, may include markers or markings to facilitate alignment of the balloon relative to the distal shoulder 160 and proximal shoulder 170. For example, the distal leg 308 may include one or more markers aligned with one or more corresponding markers on the shaft portion 163 of the distal shoulder 160. Similarly, the proximal leg 308 may include one or more markers aligned with one or more corresponding markers on the shaft portion 173 of the proximal shoulder 170. Once the distal leg 308 and proximal leg 310 are aligned with the shaft portions 163 and 173, respectively, using the markers, the mating components can be attached to each other as described above. The markers can be of any type, including markers printed or painted on the components, markers formed by laser etching, or markers molded into the components.

[0334] The required axial distance L1 between the distal shoulder 160 and the proximal shoulder 170, and thus the distance between the distal cone portion 304 and the proximal cone portion 306 of the balloon, can be predetermined and selected to allow the prosthetic valve to fold between the distal cone portion 304 and the proximal cone portion 306. Desiredly, the axial distance L1 is selected such that when the prosthetic valve is folded onto the balloon, the distal cone portion 304 and the proximal cone portion 306 can contact the adjacent ends of the folded prosthetic valve. When the first subassembly 502 is assembled together with the second subassembly 504, this distance can be set by measuring a predetermined offset between components on the first subassembly 502 and components on the second subassembly 504, such as the distance L2 between the proximal shoulder 170 and the marker band 135. For example, when shaft 106 is inserted into shaft 105, the position of shaft 106 relative to shaft 105 can be adjusted until the distance between the proximal shoulder 170 and the marking band 135 is a predetermined distance L2, which corresponds to a predetermined distance L1 between the distal cone portion 304 and the proximal cone portion 306 of the balloon.

[0335] In an alternative implementation, other offsets may be used to set the distance L1, including (but not limited to): (i) the axial distance between the proximal shoulder 170 and the distal shoulder 160; (ii) the axial distance between the proximal shoulder 170 and the distal end of the valve holding portion 302 of the balloon; and (iii) the axial distance between the distal shoulder and the proximal end of the valve holding portion 302 of the balloon.

[0336] In some embodiments, the axial position of shaft 106 relative to shaft 105 is fixed, such as by directly fixing these components to each other, for example by welding, adhesives, mechanical fasteners, etc. The proximal portions of shafts 105, 106 may then be coupled to a handle (e.g., handle 102). Alternatively, the proximal portions of shafts 105, 106 may be fixed to a handle (e.g., handle 102) in a fixed position, thus fixing the position of shafts 105, 106 relative to each other.

[0337] In some implementations, the outer shaft 104 can be manipulated (such as...) Figure 3 (As shown) can be assembled on shafts 105 and 106.

[0338] As described above, in some embodiments, during assembly, the protective cover 400 (or covers 200, 600, 700, 800, or 900) can be held in place around the balloon 300. Figure 13 As shown, the cover 400 has a distal opening 414 and a proximal opening 416, which can be sized to allow components of the delivery device to be inserted into the cover 400 and pass through the openings 340, 342 of the balloon when the balloon is inside the cover 400.

[0339] The cover 400 facilitates alignment of the balloon with components of the delivery device. For example, when aligning the balloon relative to the distal shoulder 160 and proximal shoulder 170, the assembler may sometimes have difficulty visually locating the specific position of the balloon 300. Instead, the assembler can visually locate specific portions of the cover and align these portions with the distal and proximal shoulders (or other components of the delivery device to which the balloon is attached).

[0340] For example, a specific position on the distal recess 408 of the cover corresponding to a specific position of the leg 308 disposed within the recess 408 can be aligned with a predetermined position of the distal shoulder 160. Similarly, a specific position on the proximal recess 412 corresponding to a specific position of the leg 310 disposed within the recess 412 can be aligned with a predetermined position of the proximal shoulder 170. Optionally, one or more markings may be included on the cover 400 at these positions to further facilitate the alignment process. Furthermore, since the cover 400 is more rigid than the balloon 300, the cover 400 can further facilitate the alignment process because the balloon can be more easily manipulated (e.g., pushed and pulled) relative to the subassemblies 502, 504 when positioning and aligning the balloon by grasping and moving the cover rather than by directly grasping the balloon.

[0341] Once the balloon 300 is aligned with its predetermined positions relative to the distal and proximal shoulders (or other locations on subassemblies 502, 504), the assembler may optionally open the cover 400 before attaching the distal leg 308 and proximal leg 310 to the distal shoulder 160 and proximal shoulder 170 (e.g., by welding or applying adhesive to these components). After the balloon is secured in place, the cover 400 may be reclosed and left in place for the remainder of the assembly process and / or for transport and storage.

[0342] If the cover is removed from the balloon before assembly, the cover 400 can be placed back onto the balloon 300 for transport and storage. Optionally, if the initial cover 400 is not reusable, another cover can be placed around the balloon. As is known in the art, the combination of the delivery device and the cover can be further placed in a sterile package for transport and storage. It should be understood that the features and uses of the cover 400 described above are applicable to covers 200, 600, 700, 800, and 900.

[0343] Balloons formed by the release device, such as balloon 300 described above, offer numerous advantages. For example, the completed release device balloon can be inspected to verify its dimensional compliance before being assembled onto the delivery device. Importantly, release device balloons can be mass-produced, and their performance can be tested on a virtual device before being released into inventory and used to manufacture completed delivery devices. This not only reduces the variability in balloon performance due to variations in manufacturing parameters but also allows for the mass production of release device-formed balloons in one facility and their subsequent transport to another facility for installation into delivery devices. The latter allows for automation and increased production capacity in the delivery device assembly process by eliminating the time-consuming balloon formation step on the catheter production line. Furthermore, the production line used to assemble delivery devices requires less physical space and fewer production operators.

[0344] Therefore, in some implementations, the manufacturer may produce any number of fully formed and folded balloons (e.g., balloon 300) and optionally place the balloons in covers (e.g., covers 200, 400, 600, 700, 800, and 900). The pre-formed and pre-folded balloons can then be placed in stock for assembly of the delivery device in another manufacturing area at the assembly site, or, if the pre-formed and pre-folded balloons are manufactured at a different location, they can be shipped to another facility for assembly of the delivery device.

[0345] In some embodiments, a prosthetic valve (e.g., valve 10 or 50) intended for use with a delivery device may be stored in a container or canister containing hydration fluid. In use, the user removes the prosthetic valve from its container, removes the delivery device from its packaging, places the prosthetic valve around a balloon (e.g., balloon 108 or 300), and folds the prosthetic valve onto the balloon, between the distal and proximal shoulders (e.g., shoulders 160, 170). In some embodiments, the prosthetic valve may be folded onto the delivery device at a location offset from the valve mounting portion of the balloon—such as at a location on the proximal portion of the balloon, or on the portion of the axis located proximal to the balloon—as disclosed in U.S. Publication No. 2013 / 0030519 (which is incorporated herein by reference). Once inserted into the body and prior to deployment, the prosthetic valve may be moved (e.g., pushed) from its folded location onto the valve mounting portion of the balloon.

[0346] In an alternative embodiment, the prosthetic valve may have dry or substantially dry leaflets that can be stored without hydration fluid, as disclosed in U.S. Patent Nos. 8,007,992 and 8,357,387 (which are incorporated herein by reference). In this case, the manufacturer may fold the prosthetic valve onto the balloon of the delivery device (or fold it at a location offset from the balloon), and the assembly including the delivery device and the folded prosthetic valve may be placed in sterile packaging for transport and storage until use by a healthcare provider. For example, in some cases, the prosthetic valve may be folded onto the balloon at the same location where the delivery device is assembled, or alternatively, the fully assembled delivery device may be transported to another facility where the prosthetic valve is folded onto the delivery device and packaged for delivery to the end user.

[0347] Any delivery device disclosed herein can be used to implant a prosthetic valve (e.g., valve 10 or 50) into a natural valve (aortic, mitral, tricuspid, or pulmonary valve) using any of a variety of delivery techniques. For example, when implanting a prosthetic valve into a natural aortic valve, the delivery device and prosthetic valve can be inserted and passed through the femoral artery and across the aorta to reach the natural aortic valve (referred to as transfemoral delivery). Once the prosthetic valve is positioned at the desired implantation site, a balloon can be inflated to radially expand the prosthetic valve to engage with the surrounding tissue of the natural valve. In another delivery route, the delivery device and prosthetic valve can be inserted and advanced through a surgical opening at the apex of the heart to position the prosthetic valve within the natural aortic valve (referred to as transapical delivery).

[0348] General Precautions

[0349] It should be understood that the disclosed embodiments are applicable to the delivery and implantation of prosthetic devices in any natural valve annulus of the heart (e.g., pulmonary valve annulus, mitral valve annulus, and tricuspid valve annulus), and can be used with any of a variety of delivery routes (e.g., retrograde, antegrade, transseptal, transventricular, transatricular, etc.).

[0350] For the purposes of this description, certain aspects, advantages, and novel features of embodiments of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Rather, this disclosure relates individually, as well as in various combinations and sub-combinations with each other, to all novel and non-obvious features and aspects of the various disclosed embodiments. These methods, apparatuses, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not require the existence of any one or more specific advantages or the resolution of any one or more problems. Techniques from any instance can be combined with techniques described in any one or more other instances. Given the many possible embodiments to which the principles of the disclosed technology can be applied, it should be understood that the illustrated embodiments are merely preferred examples and should not be considered as limiting the scope of the disclosed technology.

[0351] Although some operations in the disclosed embodiments are described in a specific sequential order for ease of presentation, it should be understood that this descriptive approach includes rearrangement unless the specific language used in the following description requires a particular order. For example, in some cases, the sequentially described operations may be rearranged or performed concurrently. Furthermore, for brevity, the accompanying drawings may not show the various ways in which the disclosed methods can be combined with other methods. Additionally, the description sometimes uses terms such as “provide” or “implement” to describe the disclosed methods. These terms are high-level abstract expressions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and can be readily identified by one of ordinary skill in the art.

[0352] As used herein, with respect to other components of the prosthetic valve, delivery device, and delivery assembly, "proximal" refers to the location, orientation, or portion of the device closer to the delivery assembly handle outside the patient's body, while "distal" refers to the location, orientation, or portion of the device further away from the handle. Unless otherwise explicitly defined, the terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, respectively.

[0353] As used in this application and claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly indicates otherwise. Additionally, the term “comprising” means “including.” Furthermore, the terms “coupled” and “connected” generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or connected, and do not exclude the presence of intermediate elements between coupled or related items in the absence of specific contrasting language.

[0354] Orientation and other relevant references (e.g., inside, outside, top, bottom, etc.) are used to facilitate discussion of the figures and principles herein, but are not intended to be limiting. For example, certain terms such as “inner,” “outer,” “top,” “down,” “internal,” “external,” etc., may be used. Where applicable, these terms are used to provide a certain clarity of description in dealing with relative relationships, particularly with respect to the illustrated embodiments. However, these terms are not intended to imply absolute relationships, positions, and / or orientations. For example, for an object, simply flipping the object over can transform the “upper” portion into the “lower” portion. Nevertheless, it remains the same portion and the object remains unchanged. As used herein, “and / or” means “and” or “or,” as well as “and” and “or.”

[0355] Further description of the embodiments of interest

[0356] Clause 1. Balloon assembly, comprising:

[0357] An inflatable balloon having an inflated state and a deflated state, wherein the inflatable balloon in the deflated state includes:

[0358] A valve retaining portion having an overall cylindrical shape and one or more axial folds;

[0359] A distal cone portion connected to the distal end of the valve retaining portion, the proximal end of the distal cone portion having a larger diameter than the distal end of the distal cone portion and the valve retaining portion;

[0360] A proximal cone portion connected to the proximal end of the valve retaining portion, the distal end of the proximal cone portion having a larger diameter than the proximal end of the proximal cone portion and the valve retaining portion;

[0361] The distal leg connected to the distal end of the distal conical portion; and

[0362] The proximal leg connects to the proximal end of the proximal conical portion;

[0363] The distal tapered portion includes one or more axially folded portions, and the proximal tapered portion includes one or more axially folded portions, and

[0364] The proximal end of the distal tapered portion includes a first radial fold that connects to the second radial fold, and the first and second radial folds form a recess extending distally at the proximal end of the distal tapered portion.

[0365] Clause 2. The balloon assembly of Clause 1 further includes a restraint member extending around the outer surface of the valve retention portion to prevent the one or more axial folds of the valve retention portion from unfolding.

[0366] Clause 3. The balloon assembly of any one of Clauses 1-2 further includes a cover surrounding the inflatable balloon, wherein the cover includes a proximal portion, a distal portion, and an intermediate portion between the proximal and distal portions, wherein the proximal portion defines a proximal recess shaped to substantially match the shape of a proximal conical portion of the inflatable balloon, the distal portion defines a distal recess shaped to substantially match the shape of a distal conical portion of the inflatable balloon, and the intermediate portion defines an intermediate recess shaped to substantially match the shape of a valve-retaining portion of the inflatable balloon.

[0367] Clause 4. Clause 3's balloon assembly, wherein the covering includes a first covering and a second covering, the first covering and the second covering being complementary in construction such that they can be fitted together to enclose an inflatable balloon in a deflated state.

[0368] Clause 5. The balloon assembly of Clause 4 further includes an outer sleeve extending over the cover to prevent the first cover and the second cover from separating from each other.

[0369] Clause 6. A balloon assembly of any one of Clauses 1-5, wherein the inflatable balloon includes an inner lumen extending through the proximal cone portion, the valve retaining portion, and the distal cone portion.

[0370] Clause 7. A balloon assembly of any one of Clauses 1-6, wherein the proximal cone portion of the inflatable balloon includes a proximal portion, wherein one or more axial folds of the proximal cone portion do not extend into the proximal portion of the proximal cone portion.

[0371] Clause 8. A balloon assembly of any one of Clauses 1-7, wherein the distal cone portion of the inflatable balloon includes a distal portion, wherein one or more axial folds of the distal cone portion do not extend into the distal portion of the distal cone portion.

[0372] Clause 9. A balloon assembly of any one of Clauses 1-8, wherein the distal end of the proximal conical portion includes a radial fold that forms an obtuse or right angle relative to the valve retaining portion.

[0373] Clause 10. A balloon assembly of any one of Clauses 1-9, wherein a first radial fold at the proximal end of the distal conical portion forms an obtuse or right angle relative to the valve retaining portion, and a second radial fold forms an acute angle relative to the valve retaining portion.

[0374] Clause 11. Balloon assembly, comprising:

[0375] An inflatable balloon having an inflated state and a deflated state, wherein the inflatable balloon in the deflated state includes:

[0376] A valve retaining portion having an overall cylindrical shape and one or more axial folds;

[0377] A distal cone portion connected to the distal end of the valve retaining portion, the proximal end of the distal cone portion having a larger diameter than the distal end of the distal cone portion and the valve retaining portion;

[0378] A proximal cone portion connected to the proximal end of the valve retaining portion, the distal end of the proximal cone portion having a larger diameter than the proximal end of the proximal cone portion and the valve retaining portion;

[0379] A fold extending axially along at least one segment of the distal tapered portion and the proximal tapered portion;

[0380] The distal leg connected to the distal end of the distal conical portion; and

[0381] The proximal leg connects to the proximal end of the proximal conical portion;

[0382] The inflatable balloon is in an unassembled state, far from the delivery catheter.

[0383] Clause 12. The balloon assembly of Clause 11 further includes a restraint member extending around the outer surface of the valve retention portion to prevent one or more axial folds of the valve retention portion from deploying.

[0384] Clause 13. The balloon assembly of any one of Clauses 11-12 further includes a cover surrounding the inflatable balloon, wherein the cover includes a proximal portion, a distal portion, and an intermediate portion between the proximal and distal portions, wherein the proximal portion defines a proximal recess shaped to substantially match the shape of the proximal conical portion of the inflatable balloon, and the distal portion defines a distal recess shaped to substantially match the shape of the distal conical portion of the inflatable balloon.

[0385] Clause 14. A balloon assembly of Clause 13, wherein the covering includes a first covering element and a second covering element, the first covering element and the second covering element being complementaryly constructed such that they can be fitted together to surround an inflatable balloon.

[0386] Clause 15. The balloon assembly of Clause 14 further includes an outer sleeve extending over the cover to prevent the first cover and the second cover from separating from each other.

[0387] Clause 16. A balloon assembly of any of Clauses 11-15, wherein the inflatable balloon includes an inner lumen extending through a proximal cone portion, a valve-retaining portion, and a distal cone portion.

[0388] Clause 17. A balloon assembly of any one of Clauses 11-16, wherein one or more axially extending folds do not extend into the proximal portion of the proximal conical portion.

[0389] Clause 18. A balloon assembly of any of Clauses 11-17, wherein one or more axially extending folds do not extend into the distal portion of the distal conical portion.

[0390] Clause 19. A balloon assembly of any one of Clauses 11-18, wherein the proximal end of the distal cone portion includes a first radial fold connected to a second radial fold, the first radial fold and the second radial fold forming a distally extending recess at the proximal end of the distal cone portion.

[0391] Clause 20. Clause 19 of the balloon assembly, wherein a first radial fold at the proximal end of the distal conical portion forms an obtuse or right angle relative to the valve retaining portion, and a second radial fold forms an acute angle relative to the valve retaining portion.

[0392] Clause 21. A method for assembling a delivery device, the method comprising:

[0393] An inflatable balloon in a deflated state is formed, the balloon in the deflated state having a valve holding portion, a distal cone portion connected to the distal end of the valve holding portion, a proximal cone portion connected to the proximal end of the valve holding portion, a distal leg connected to the distal end of the distal cone portion, and a proximal leg connected to the proximal end of the proximal cone portion.

[0394] The distal shoulder, mounted on the first axis of the delivery device, is inserted through the distal leg of the inflatable balloon and into the distal conical section;

[0395] The proximal shoulder, mounted on the second axis of the delivery device, is inserted through the proximal leg of the inflatable balloon and into the proximal conical section;

[0396] Secure the distal leg of the inflatable balloon to the distal shoulder; and

[0397] Secure the proximal leg of the inflatable balloon to the second axis and / or the proximal shoulder.

[0398] The method of Clause 22.21 also includes placing a restraint member around the valve retaining portion.

[0399] The method of any one of Clauses 23 and 21-22 further includes surrounding an inflatable balloon with a cover, wherein the cover includes a first cover element and a second cover element, the first cover element and the second cover element being complementaryly constructed such that they can be fitted together to surround the inflatable balloon, and wherein the cover defines an indentation whose geometry substantially matches the shape of the inflatable balloon in a deflated state.

[0400] The method of Clause 24.23 also includes placing a sleeve on the cover to prevent the first cover and the second cover from separating from each other.

[0401] Clause 25. The method of any one of Clauses 21-24, wherein the proximal end of the distal shoulder has a diameter greater than the diameter of the distal leg, and inserting the distal shoulder through the distal leg including radial compression of the proximal end of the distal shoulder.

[0402] Clause 26. The method of any one of Clauses 21-25, wherein the distal end of the proximal shoulder has a diameter greater than the diameter of the proximal leg, and the proximal shoulder is inserted through the proximal leg including radial compression of the distal end of the proximal shoulder.

[0403] Clause 27. The method of any one of Clauses 21-26, wherein forming an inflatable balloon includes forming a valve retaining portion of generally cylindrical shape, the diameter of which is smaller than both the diameter of the proximal end of the distal cone portion and the diameter of the distal end of the proximal cone portion.

[0404] The method of Clause 28. Clause 27, wherein forming an inflatable balloon includes forming one or more axially extending folds along at least a segment of the distal cone portion and the proximal cone portion.

[0405] Clause 29. The method of Clause 28, wherein forming an inflatable balloon includes forming a distal portion of a distal conical portion, wherein the distal portion does not contain any of the one or more axially extending folds.

[0406] The method of any one of the clauses 30. and 28-29, wherein forming an inflatable balloon includes forming a proximal portion of a proximal conical portion, wherein the proximal portion does not contain any of the one or more axially extending folds.

[0407] Clause 31. The method of any one of Clauses 27-30, wherein forming an inflatable balloon includes forming a radial fold at the distal end of the proximal conical portion, the radial fold forming an obtuse or right angle relative to the valve retaining portion.

[0408] Clause 32. The method of any one of Clauses 27-31, wherein forming an inflatable balloon includes forming a radial fold at the proximal end of the distal conical portion, the radial fold forming an obtuse or right angle relative to the valve retaining portion.

[0409] Clause 33. The method of any one of Clauses 27-31, wherein forming an inflatable balloon includes forming a first radial fold that connects to a second radial fold at the proximal end of a distal conical portion, the first and second radial folds forming distally extending recesses at the proximal end of the distal conical portion.

[0410] Clause 34. The method of any one of Clauses 28-33, wherein the distal shoulder includes one or more distal shoulder fins extending at least partially radially outward, and the distal shoulder assembly is inserted into the distal tapered portion to tightly position at least some of the one or more axially extending folds adjacent to the distal tapered portion of the distal shoulder fins.

[0411] Clause 35. The method of any one of Clauses 28-34, wherein the proximal shoulder includes one or more proximal shoulder fins that extend at least partially radially outward, and the proximal shoulder assembly is inserted into the proximal conical portion, including at least some of the one or more axially extending folds adjacent to the proximal conical portion, to tightly place the one or more proximal shoulder fins.

[0412] Clause 36. The method of any one of Clauses 21-35, wherein inserting the distal shoulder into the distal conical portion includes aligning a mark located on the first axis with a predefined position on the valve-retaining portion of the inflatable balloon or on the proximal shoulder.

[0413] Clause 37. A method for assembling a delivery device, the method comprising:

[0414] An inflatable balloon is formed in a deflated state, the deflated balloon having a distal portion, a proximal portion, and a valve retaining portion between the distal and proximal portions;

[0415] Multiple axially extending folds are formed along at least sections of the distal and proximal portions of the inflatable balloon; and

[0416] After forming the inflatable balloon and the plurality of axially extending folds, the deflated inflatable balloon is mounted on the delivery device.

[0417] The method of Clause 38. Clause 37, wherein mounting an inflatable balloon on a delivery device includes inserting a distal shoulder mounted on a first axis of the delivery device through a distal leg of the balloon and inserting a proximal shoulder mounted on a second axis of the delivery device through a proximal leg of the balloon, wherein the distal leg is connected to the distal end of a tapered portion of the distal portion of the inflatable balloon, and the proximal leg is connected to the proximal end of a tapered portion of the proximal portion of the inflatable balloon.

[0418] The method of Clause 39. Clause 38, wherein the proximal end of the distal shoulder has a diameter larger than the diameter of the distal leg, and the distal shoulder is inserted through the distal leg including radial compression of the proximal end of the distal shoulder.

[0419] The method of any one of Clauses 40 and 38-39, wherein the distal end of the proximal shoulder has a diameter greater than the diameter of the proximal leg, and the proximal shoulder is inserted through the proximal leg including radial compression of the distal end of the proximal shoulder.

[0420] The method of any one of Clauses 41.38-39, wherein mounting an inflatable balloon on a delivery device comprises: inserting a distal shoulder into a conical portion of a distal portion of an inflatable balloon, and inserting a proximal shoulder into a conical portion of a proximal portion of an inflatable balloon.

[0421] Clause 42. The method of Clause 41, wherein the distal shoulder includes one or more distal shoulder fins extending at least partially radially outward, and at least some of the plurality of axially extending folds in the tapered portion of the distal portion, including the tapered portion adjacent to the distal portion, are closely positioned to hold the one or more distal shoulder fins.

[0422] Clause 43. The method of any one of Clauses 41-42, wherein the proximal shoulder includes one or more proximal shoulder fins that extend at least partially radially outward, and at least some of the plurality of axially extending folds in the conical portion of the proximal portion, including the conical portion adjacent to the proximal portion, are closely positioned to hold the one or more proximal shoulder fins.

[0423] Clause 44. The method of any one of Clauses 41-43, wherein inserting the distal shoulder into the tapered portion of the distal portion includes aligning a mark on the first axis with a predefined position on the valve-retaining portion of the inflatable balloon or on the proximal shoulder.

[0424] Clause 45. The method of any one of claims 37-44, wherein forming an inflatable balloon includes forming a distal portion of a distal portion, wherein the distal portion does not contain any of the plurality of axially extending folds.

[0425] Clause 46. The method of any one of claims 37-45, wherein forming an inflatable balloon includes forming a proximal portion of a proximal portion, wherein the proximal portion does not contain any of the plurality of axially extending folds.

[0426] Clause 47. The method of any one of Clauses 37-46, wherein forming an inflatable balloon includes forming a valve retaining portion of generally cylindrical shape, the diameter of which is smaller than both the diameter of the proximal end of the distal portion and the diameter of the distal end of the proximal portion.

[0427] The method of Clause 48. Clause 47, wherein forming an inflatable balloon includes forming a radial fold at the distal end of the proximal portion, the radial fold forming an obtuse or right angle relative to the valve retaining portion.

[0428] Clause 49. The method of any one of Clauses 47-48, wherein forming an inflatable balloon includes forming a radial fold at the proximal end of the distal portion, the radial fold forming an obtuse or right angle relative to the valve retaining portion.

[0429] The method of any one of Clauses 50 and 47-48, wherein forming an inflatable balloon includes forming a first radial fold that connects to a second radial fold at the proximal end of a distal portion, the first and second radial folds forming a distally extending recess at the proximal end of the distal portion.

[0430] Clause 51. The method of any one of claims 38-50, wherein mounting an inflatable balloon on a delivery device comprises: securing the distal leg to the distal shoulder and securing the proximal leg to a second axis and / or the proximal shoulder.

[0431] The method of any one of Clauses 52 and 37-51 further includes placing a restraint member around the valve retaining portion.

[0432] The method of any one of Clauses 53 and 37-52 further includes surrounding an inflatable balloon with a cover, wherein the cover includes a first cover element and a second cover element, the first cover element and the second cover element being complementaryly constructed such that they can be fitted together to surround the inflatable balloon, and wherein the cover defines an indentation whose geometry substantially matches the shape of the inflatable balloon in a deflated state.

[0433] The method of Clause 54. Clause 53 also includes placing a sleeve around the cover to prevent the first cover and the second cover from separating from each other.

[0434] Clause 55. Prosthetic valve delivery assembly, comprising:

[0435] Delivery device, the delivery device comprising:

[0436] Axis; and

[0437] An inflatable balloon mounted on the shaft in a deflated state;

[0438] The balloon in its deflated state includes a valve retaining portion having a generally cylindrical shape, a distal conical portion connected to the distal end of the valve retaining portion, and a proximal conical portion connected to the proximal end of the valve retaining portion; and wherein the proximal end of the distal conical portion includes a first radial fold connected to a second radial fold, the first radial fold and the second radial fold forming a distally extending recess at the proximal end of the distal conical portion.

[0439] Clause 56. Clause 55 of the prosthetic valve delivery assembly further includes a restraint member extending around the outer surface of the valve retaining portion.

[0440] Clause 57. The prosthetic valve delivery assembly of any of Clauses 55-56 further includes a cover, wherein the cover comprises a first cover element and a second cover element, the first cover element and the second cover element being complementaryly constructed such that they can be fitted together to surround an inflatable balloon, and wherein the cover defines an indentation whose geometry substantially matches the shape of the inflatable balloon in a deflated state.

[0441] Clause 58. The prosthetic valve delivery assembly of Clause 57 further includes an outer sleeve extending over the covering to prevent the first and second coverings from separating from each other.

[0442] Clause 59. A prosthetic valve delivery assembly of any of Clauses 55-58, wherein the deflated balloon includes one or more axially extending folds along at least a segment of the distal cone portion and the proximal cone portion.

[0443] Clause 60. Clause 59 of the prosthetic valve delivery assembly, wherein the distal tapered portion includes a distal portion excluding any one of the one or more axially extending folds.

[0444] Clause 61. A prosthetic valve delivery assembly of any of Clauses 55-60, wherein the balloon further comprises a distal leg connected to the distal end of the distal cone portion and a proximal leg connected to the proximal end of the proximal cone portion.

[0445] Clause 62. Clause 61's prosthetic valve delivery assembly, wherein the delivery device comprises: a distal leg mounted on a first axis extending through the inflatable balloon and into the distal cone portion of the distal shoulder, and a proximal leg mounted on a second axis of the delivery device extending through the inflatable balloon and into the proximal cone portion of the proximal shoulder.

[0446] Clause 63. Clause 62 of the prosthetic valve delivery assembly, wherein the distal leg is fixed to the distal shoulder and the proximal leg is fixed to the second axis or the proximal shoulder.

[0447] Clause 64. A prosthetic valve delivery assembly of any of Clauses 62-63, wherein the proximal end of the distal shoulder has a diameter greater than the diameter of the distal leg, and the distal end of the proximal shoulder has a diameter greater than the diameter of the proximal leg.

[0448] Clause 65. A prosthetic valve delivery assembly of any one of Clauses 62-64, wherein the distal shoulder includes one or more distal shoulder fins that extend at least partially radially outward and adjacent to at least some of the one or more axially extending folds in the distal conical portion, and wherein the proximal shoulder includes one or more proximal shoulder fins that extend at least partially radially outward and adjacent to at least some of the one or more axially extending folds in the proximal conical portion.

[0449] Clause 66. A prosthetic valve delivery assembly of any of Clauses 62-65, wherein the first axis includes a mark aligned with a predetermined position on the valve holding portion of the inflatable balloon.

[0450] Clause 67. A prosthetic valve delivery assembly of any of Clauses 62-66, wherein a first axis extends through a valve retaining portion and is separated from the valve retaining portion by an axially extending gap.

[0451] Clause 68. A prosthetic valve delivery assembly of any of Clauses 55-67, wherein the distal end of the proximal conical portion includes a radial fold that forms an obtuse or right angle relative to the valve retaining portion.

[0452] Clause 69. A prosthetic valve delivery assembly of any of Clauses 55-68, wherein a first radial fold at the proximal end of the distal conical portion forms an obtuse or right angle relative to the valve retaining portion, and a second radial fold forms an acute angle relative to the valve retaining portion.

[0453] Clause 70. A method for assembling a delivery device, the method comprising:

[0454] An inflatable balloon is formed in a deflated state, the deflated balloon having a distal portion, a proximal portion, and a valve retaining portion between the distal and proximal portions;

[0455] Place the ball bag inside the cover;

[0456] When the balloon is inside the cover, the shaft of the delivery device is inserted through the opening in the cover and into the balloon; and

[0457] Secure the balloon to the surface of the delivery device.

[0458] Clause 71. The method of Clause 70, wherein forming the balloon further includes forming a plurality of axially extending folds along at least a segment of the distal and proximal portions of the inflatable balloon.

[0459] Clause 72. The method of Clause 70, wherein the covering is more rigid than the balloon.

[0460] Clause 73. The method of Clause 70, the method further comprising aligning the position of the cover with the position on the delivery device before attaching the balloon to the surface of the delivery device.

[0461] Clause 74. The method of Clause 70, wherein the insertion action comprises: inserting a first axis of delivery through a first opening in a cover and through a balloon in a first direction, and inserting a second axis of the delivery device through a second opening in a cover and through a balloon in a second direction opposite to the first direction.

[0462] Clause 75. A balloon cover for a balloon catheter, comprising:

[0463] The outer shell; and

[0464] An inner sleeve disposed within a housing, wherein the inner sleeve may have an inner surface defining a cavity configured to receive at least a portion of the balloon of a balloon catheter;

[0465] The inner sleeve is deformable under the pressure exerted by the balloon on its inner surface when the balloon inflates, thereby causing the cavity to expand radially from a first diameter to a second diameter, wherein the second diameter is larger than the first diameter.

[0466] Clause 76. Clause 75 of the balloon cover, wherein the inner sleeve has a fixed axial length when the cavity expands from a first diameter to a second diameter.

[0467] Clause 77. A balloon covering of any of Clauses 75-76, wherein the outer shell is more rigid than the inner sleeve.

[0468] Clause 78. A balloon cover of any of Clauses 75-77, wherein the inner sleeve is made of an elastomer.

[0469] Clause 79. A balloon cover of any one of Clauses 75-78, wherein the inner sleeve includes a first separable portion and a second separable portion, each having a semi-cylindrical inner surface defining a cavity segment, wherein the first portion has a longitudinal edge configured to engage a corresponding longitudinal edge of the second portion to form a cavity.

[0470] Clause 80. A balloon cover of any of Clauses 75-79, wherein the outer shell comprises a first shell member and a second shell member, the second shell member being hingedly connected to the first shell member.

[0471] Clause 81. Clause 80's balloon cover, wherein a first shell member includes a first coupling member, a second shell member includes a second coupling member, wherein the first coupling member is configured to be releasably connected to the second coupling member such that the first coupling member and the second coupling member can be coupled to each other to form a clamshell.

[0472] Clause 82. Clause 81's balloon cover, wherein the first coupling member includes a ridge extending outward from the first shell member, and the second coupling member includes a cantilevered flap extending outward from the second shell member, wherein the ridge is configured to extend through a slot on the flap to form a snap-fit ​​locking element.

[0473] Clause 83. A balloon cover of any of Clauses 75-82, wherein the inner sleeve includes an inner wall portion surrounding a cavity and one or more legs extending outwardly from the inner wall portion, wherein the one or more legs press against an inner surface of the outer shell to form one or more cavities between the inner wall portion of the inner sleeve and the inner surface of the outer shell.

[0474] Clause 84. The balloon cover of Clause 83, wherein when the cavity of the inner sleeve has a first diameter, the one or more legs have a first length, and when the cavity of the inner sleeve changes to a second diameter, the one or more legs are compressed to a second length, the second length being shorter than the first length.

[0475] Clause 85. A balloon cover of any of Clauses 83-84, wherein the inner surface of the outer shell includes a receiving portion configured to receive at least one of the one or more legs to securely couple the inner sleeve to the outer shell.

[0476] Clause 86. A balloon cover of any of Clauses 83-85, wherein one or more legs are parallel to each other and extend circumferentially around an inner wall portion.

[0477] Clause 87. A balloon covering of any of Clauses 75-86, wherein the inner sleeve further defines a tapered proximal opening at the proximal end of the cavity and a tapered distal opening at the distal end of the cavity, wherein the intermediate portion of the cavity has a smaller diameter than both the tapered proximal opening and the tapered distal opening before radial expansion of the cavity.

[0478] Clause 88. A balloon covering of any of Clauses 75-87, wherein when the cavity is radially expanded to a second diameter, the inner surface of the inner sleeve maintains circumferentially continuous enclosing the cavity.

[0479] Clause 89. A balloon cover of any one of Clauses 75-88, wherein the outer shell includes a proximal recess configured to receive a proximal shoulder member of a balloon catheter, a distal recess configured to receive a distal shoulder member of a balloon catheter, and an intermediate recess between the proximal and distal recesses, wherein an inner sleeve is disposed in the intermediate recess.

[0480] Clause 90. Medical package, comprising:

[0481] A balloon catheter having an inflatable balloon; and

[0482] A balloon cover, the balloon cover comprising an outer shell and an inner member disposed within the outer shell, the inner member having an inner surface defining a cavity;

[0483] The balloon is placed inside the cavity of the internal structure;

[0484] When the balloon inflates and applies radial outward pressure to the inner surface of the inner component, the inner component can deform radially.

[0485] Clause 91. The assembly of Clause 90, wherein the inner member maintains a fixed axial length when the cavity is radially expanded by inflating the balloon.

[0486] Clause 92. An assembly of any of Clauses 90-91, wherein the outer shell is more rigid than the inner components.

[0487] Clause 93. An assembly of any one of Clauses 90-92, wherein the inner component is made of an elastomer.

[0488] Clause 94. An assembly of any one of Clauses 90-93, wherein the inner member comprises a first separable portion and a second separable portion, each having a semi-cylindrical inner surface of a segment defining a cavity, wherein the first portion has a longitudinal edge configured to engage a corresponding longitudinal edge of the second portion to form a cavity.

[0489] Clause 95. An assembly of any one of Clauses 90-94, wherein the housing comprises a first housing member and a second housing member, the second housing member being hingedly connected to the first housing member.

[0490] Clause 96. The assembly of Clause 95, wherein the first shell member includes a first coupling member, the second shell member includes a second coupling member, wherein the first coupling member is configured to be releasably connected to the second coupling member such that the first coupling member and the second coupling member can be coupled to each other to form a clamshell.

[0491] The assembly of Clause 97 and Clause 96, wherein the first coupling member includes a ridge extending outward from the first shell member, and the second coupling member includes a cantilevered wing extending outward from the second shell member, wherein the ridge is configured to extend through a slot on the wing to form a snap-fit ​​locking element.

[0492] Clause 98. An assembly of any one of Clauses 90-97, wherein the inner member includes an inner wall portion surrounding a cavity and one or more legs extending outwardly from the inner wall portion, wherein the one or more legs press against an inner surface of the housing to form one or more cavities between the inner wall portion of the inner member and the inner surface of the housing.

[0493] The combination of Clause 99 and Clause 98, wherein the one or more legs are shortened when the cavity is radially expanded by inflating the balloon.

[0494] An assembly of any one of Clauses 100 and 98-99, wherein the inner surface of the housing includes a receiving portion configured to receive at least one of the one or more legs to securely couple the inner member to the housing.

[0495] Clause 101. An assembly of any of Clauses 98-100, wherein the one or more legs are parallel to each other and extend circumferentially around the inner wall portion.

[0496] Clause 102. An assembly of any one of Clauses 90-101, wherein the inner member further defines a tapered proximal opening at the proximal end of the cavity and a tapered distal opening at the distal end of the cavity, wherein the intermediate portion of the cavity has a smaller diameter than both the tapered proximal opening and the tapered distal opening before balloon inflation.

[0497] Clause 103. An assembly of any one of Clauses 90-102, wherein the housing includes a proximal recess, a distal recess, and an intermediate recess between the proximal and distal recesses, wherein an internal member is disposed in the intermediate recess, a proximal shoulder member of the balloon catheter is disposed in the proximal recess, and a distal shoulder member of the balloon catheter is disposed in the distal recess.

[0498] Clause 104. The assembly of Clause 103, wherein the proximal recess has a tapered shape such that the proximal end of the proximal recess has a smaller diameter than the distal end of the proximal recess, and the distal recess has a tapered shape such that the diameter of the distal end of the distal recess is smaller than the diameter of the proximal end of the distal recess.

[0499] Clause 105. An assembly of any one of Clauses 90-104, wherein when the cavity is radially expanded by inflating the balloon, the inner surface of the inner member maintains its enclosure of the cavity in a circumferentially continuous manner.

[0500] Clause 106. A method for inflating the balloon of a balloon catheter, said method comprising:

[0501] The balloon is fluidly connected to a fluid source, wherein the balloon is in a deflated state and positioned inside the balloon cover; and

[0502] Injecting expansion fluid from a fluid source into the balloon to at least partially inflate the balloon to a partially inflated state;

[0503] The balloon covering includes an outer shell and internal components disposed inside the outer shell and surrounding the balloon;

[0504] The process involves inflating the balloon from a deflated state to a partially inflated state, and deforming the cavity of the internal component from an initial state to a deformed state. The cavity has a first diameter in the initial state and a second diameter in the deformed state, wherein the second diameter is larger than the first diameter.

[0505] The method of Clause 107. Clause 106 further includes removing expansion fluid from the balloon to restore the balloon from a partially inflated state to a deflated state, which causes the cavity of the internal component to return from a deformed state to its initial state.

[0506] Clause 108. The method of any one of Clauses 106-107, wherein the inner member maintains a fixed axial length when the cavity changes between an initial state and a deformed state.

[0507] Clause 109. The method of any one of Clauses 106-108, wherein the outer shell is more rigid than the inner components.

[0508] The method of any one of Clauses 110, 106-109, further includes inserting the balloon into the cavity of the internal component.

[0509] The method of any one of Clauses 111.106-110 further includes forming a cavity using a first separable portion and a second separable portion of an inner member, each portion having a semi-cylindrical inner surface, wherein forming the cavity includes engaging longitudinal edges of the first portion with corresponding longitudinal edges of the second portion such that their respective inner surfaces are joined together to form a circumferentially continuous inner surface.

[0510] The method of any one of Clauses 112.106-111 further includes locking the housing, wherein the housing includes a first housing member and a second housing member fixedly connected to each other at a hinged portion, wherein locking the housing includes coupling the unhinged portions of the first housing member and the second housing member together to form a clamshell.

[0511] The method of any one of Clauses 113.106-112, wherein the inner member includes an inner wall portion surrounding a cavity and one or more legs extending outwardly from the inner wall portion, wherein the one or more legs press against the inner surface of the outer casing to form one or more cavities between the inner wall portion of the inner member and the inner surface of the outer casing.

[0512] The method of any one of Clauses 114, 106-113 further includes: placing the proximal shoulder member of the balloon catheter in the proximal recess of the housing, placing the distal shoulder member of the balloon catheter in the distal recess of the housing, and placing the inner member in an intermediate recess between the proximal and distal recesses.

[0513] Clause 115. A balloon cover for a balloon catheter, said balloon cover comprising:

[0514] The outer shell; and

[0515] An inner sleeve disposed within a housing, wherein the inner sleeve may have an inner surface defining a cavity configured to receive at least a portion of the balloon of a balloon catheter;

[0516] The inner sleeve includes a first separable portion and a second separable portion, each having an inner surface of a segment defining a cavity, wherein the first portion has a longitudinal edge configured to engage a corresponding longitudinal edge of the second portion to form a cavity;

[0517] When the balloon deflates, the cavity has a first diameter, and when the balloon inflates, the cavity has a second diameter, which is larger than the first diameter.

[0518] Clause 116. Clause 115 balloon covering, wherein the inner sleeve has a fixed axial length when the cavity expands from a first diameter to a second diameter.

[0519] Clause 117. A balloon covering of any of Clauses 115-116, wherein the outer shell is more rigid than the inner sleeve.

[0520] Clause 118. A balloon cover of any of Clauses 115-117, wherein the inner sleeve is made of an elastomer.

[0521] Clause 119. A balloon cover of any of Clauses 115-118, wherein the outer shell comprises a first shell member and a second shell member, the second shell member being hingedly connected to the first shell member.

[0522] Clause 120. Clause 119 of the balloon cover, wherein a first shell member includes a first coupling member, a second shell member includes a second coupling member, wherein the first coupling member is configured to be releasably connected to the second coupling member such that the first coupling member and the second coupling member can be coupled to each other to form a clamshell.

[0523] Clause 121. A balloon cover of any of Clauses 115-120, wherein the inner sleeve includes an inner wall portion surrounding a cavity and one or more legs extending outwardly from the inner wall portion, wherein the one or more legs press against an inner surface of the outer shell to form one or more cavities between the inner wall portion of the inner sleeve and the inner surface of the outer shell.

[0524] Clause 122. The balloon cover of Clause 121, wherein when the cavity of the inner sleeve has a first diameter, the one or more legs have a first length, and when the cavity of the inner sleeve changes to a second diameter, the one or more legs are compressed to a second length, the second length being shorter than the first length.

[0525] Clause 123. A balloon cover of any of Clauses 121-122, wherein the inner surface of the outer shell includes a receiving portion configured to receive at least one of the one or more legs to securely couple the inner sleeve to the outer shell.

[0526] Clause 124. A balloon cover of any of Clauses 122-123, wherein one or more legs are parallel to each other and extend circumferentially around an inner wall portion.

[0527] Clause 125. A balloon cover for a balloon catheter, said balloon cover comprising:

[0528] The outer shell; and

[0529] An inner sleeve disposed within a housing, wherein the inner sleeve has an inner surface defining a cavity configured to receive at least a portion of the balloon of a balloon catheter;

[0530] When the balloon deflates, the cavity has a first diameter, and when the balloon inflates, the cavity has a second diameter, which is larger than the first diameter.

[0531] When the cavity expands from the first diameter to the second diameter, the inner sleeve has a fixed axial length.

[0532] Clause 126. Clause 125 balloon covering, wherein the outer shell is more rigid than the inner sleeve.

[0533] Clause 127. A balloon cover of any of Clauses 125-126, wherein the inner sleeve is made of an elastomer.

[0534] Clause 128. A balloon cover of any of Clauses 125-127, wherein the inner sleeve includes a first separable portion and a second separable portion, each having a semi-cylindrical inner surface defining a cavity segment, wherein the first portion has a longitudinal edge configured to engage a corresponding longitudinal edge of the second portion to form a cavity.

[0535] Clause 129. A balloon cover of any of Clauses 125-128, wherein the outer shell comprises a first shell member and a second shell member, the second shell member being hingedly connected to the first shell member.

[0536] Clause 130. Clause 129 of the balloon cover, wherein a first shell member includes a first coupling member, a second shell member includes a second coupling member, wherein the first coupling member is configured to be releasably connected to the second coupling member such that the first coupling member and the second coupling member can be coupled to each other to form a clamshell.

[0537] Clause 131. A balloon cover of any of Clauses 125-130, wherein the inner sleeve includes an inner wall portion surrounding a cavity and one or more legs extending outwardly from the inner wall portion, wherein the one or more legs press against an inner surface of the outer shell to form one or more cavities between the inner wall portion of the inner sleeve and the inner surface of the outer shell.

[0538] Clause 132. The balloon cover of Clause 131, wherein when the cavity of the inner sleeve has a first diameter, the one or more legs have a first length, and when the cavity of the inner sleeve changes to a second diameter, the one or more legs are compressed to a second length, the second length being shorter than the first length.

[0539] Clause 133. A balloon cover of any of Clauses 130-131, wherein the inner surface of the outer shell includes a receiving portion configured to receive at least one of the one or more legs to securely couple the inner sleeve to the outer shell.

[0540] Clause 134. A balloon cover of any of Clauses 125-133, wherein the inner sleeve further defines a conical proximal opening at the proximal end of the cavity and a conical distal opening at the distal end of the cavity, wherein the intermediate portion of the cavity has a smaller diameter than both the conical proximal opening and the conical distal opening before the balloon is inflated.

[0541] Clause 135. Medical package, comprising:

[0542] A balloon catheter, comprising an inflatable balloon; and

[0543] A balloon cover, the balloon cover comprising an outer shell and an inner member disposed within the outer shell, the inner member having an inner surface defining a cavity;

[0544] The balloon is placed inside the cavity of the internal structure;

[0545] The cavity is configured to expand to a second diameter when the balloon inflates and contract to a first diameter when the balloon deflates, the second diameter being larger than the first diameter.

[0546] The assembly of Clause 136 and Clause 135, wherein the inner member maintains a fixed axial length when the cavity expands from the first diameter to the second diameter or contracts from the second diameter to the first diameter.

[0547] Clause 137. An assembly of any of Clauses 135-136, wherein the outer shell is more rigid than the inner components.

[0548] Clause 138. An assembly of any one of Clauses 135-137, wherein the inner member comprises a first separable portion and a second separable portion, each having a semi-cylindrical inner surface of a segment defining a cavity, wherein the first portion has a longitudinal edge configured to engage a corresponding longitudinal edge of the second portion to form a cavity.

[0549] Clause 139. An assembly of any one of Clauses 135-138, wherein the housing comprises a first housing member and a second housing member, the second housing member being hingedly connected to the first housing member.

[0550] The assembly of Clause 140 and Clause 139, wherein the first shell member includes a first coupling member and the second shell member includes a second coupling member, wherein the first coupling member is configured to be releasably connected to the second coupling member such that the first coupling member and the second coupling member can be coupled to each other to form a clamshell.

[0551] Clause 141. An assembly of any one of Clauses 135-140, wherein the inner member includes an inner wall portion surrounding a cavity and one or more legs extending outwardly from the inner wall portion, wherein the one or more legs press against an inner surface of the housing to form one or more cavities between the inner wall portion of the inner member and the inner surface of the housing.

[0552] Clause 142. The assembly of Clause 141, wherein when the cavity expands from a first diameter to a second diameter, the one or more legs shorten from a first length to a second length, and when the cavity contracts from a second diameter to a first diameter, the one or more legs return from a second length to a first length, the first length being greater than the second length.

[0553] Clause 143. An assembly of any one of Clauses 141-142, wherein the inner surface of the housing includes a receiving portion configured to receive at least one of the one or more legs to securely couple the inner member to the housing.

[0554] Clause 144. An assembly of any one of Clauses 135-143, wherein the housing includes a proximal recess, a distal recess, and an intermediate recess between the proximal and distal recesses, wherein an internal member is disposed in the intermediate recess, a proximal shoulder member of the balloon catheter is disposed in the proximal recess, and a distal shoulder member of the balloon catheter is disposed in the distal recess.

[0555] Clause 145. A method for inflating the balloon of a balloon catheter, said method comprising:

[0556] Receives a balloon disposed inside the balloon cover, wherein the balloon is in a deflated state; and

[0557] Injecting expansion fluid from a fluid source into the balloon to at least partially inflate the balloon to a partially inflated state;

[0558] The balloon covering includes an outer shell and internal components disposed inside the outer shell and surrounding the balloon;

[0559] The process involves inflating the balloon from a deflated state to a partially inflated state, and deforming the cavity of the internal component from an initial state to a deformed state. The cavity has a first diameter in the initial state and a second diameter in the deformed state, wherein the second diameter is larger than the first diameter.

[0560] The method of Clause 146. Clause 145 further includes removing expansion fluid from the balloon to restore the balloon from a partially inflated state to a deflated state, which causes the cavity of the internal component to return from a deformed state to its initial state.

[0561] Clause 147. The method of any one of Clauses 145-146, wherein the inner member maintains a fixed axial length when the cavity changes between an initial state and a deformed state.

[0562] Clause 148. The method of any one of Clauses 145-147, wherein the outer shell is non-deformable when the balloon is inflated from a deflated state to a partially inflated state.

[0563] The method of any one of Clauses 145-148 further includes connecting the balloon to a fluid source.

[0564] The method of any one of Clauses 150, 145-149 further includes forming a cavity using a first separable portion and a second separable portion of an inner member, each portion having an inner surface, wherein forming the cavity includes engaging longitudinal edges of the first portion with corresponding longitudinal edges of the second portion such that their respective inner surfaces are joined together to form a circumferentially continuous inner surface.

[0565] The method of any one of Clauses 145-150 further includes locking the housing, wherein the housing includes a first housing member and a second housing member fixedly connected to each other at a hinged portion, wherein locking the housing includes coupling the unhinged portions of the first housing member and the second housing member together to form a clamshell.

[0566] Clause 152. The method of any one of Clauses 145-151, wherein the inner member includes an inner wall portion surrounding a cavity and one or more legs extending outwardly from the inner wall portion, wherein the one or more legs press against the inner surface of the outer casing to form one or more cavities between the inner wall portion of the inner member and the inner surface of the outer casing.

[0567] The method of any one of Clauses 153, 145-152, further includes: placing the proximal shoulder member of the balloon catheter in the proximal recess of the housing, placing the distal shoulder member of the balloon catheter in the distal recess of the housing, and placing the inner member in an intermediate recess between the proximal and distal recesses.

[0568] The method of any one of Clauses 154, 145-153, further includes cyclically inflating the balloon from a deflated state to a partially inflated state in multiple cycles, and then deflating the balloon from the partially inflated state to a deflated state.

[0569] Clause 155. A balloon cover of any one of Clauses 75-78, wherein the inner sleeve includes a first separable sleeve portion and a second separable sleeve portion, each of which includes a wall portion and one or more ribs extending radially inward from the wall portion, wherein each wall portion includes a plurality of wall segments separated by the one or more ribs, each wall segment including two longitudinal edges and a wall surface extending between the two longitudinal edges, and wherein each rib includes two radial edges and a rib surface extending between the two radial edges.

[0570] Clause 156. Clause 155 of the balloon cover, wherein two radial edges of each rib of the first sleeve portion are configured to engage with two radial edges of a corresponding rib of the second sleeve portion, such that a rib surface of the first sleeve portion abuts a corresponding rib surface of the second sleeve portion to form one or more rib surrounds defining a cavity, and wherein two longitudinal edges of each wall segment of the first sleeve portion are configured to engage with two longitudinal edges of a corresponding wall segment of the second sleeve portion, such that a wall surface of the first sleeve portion abuts a corresponding wall surface of the second sleeve portion to form a plurality of wall surrounds separated by the one or more ribs.

[0571] Clause 157. Clause 156 of the balloon covering, wherein when the cavity is in a first diameter, the plurality of surrounding walls define a third diameter, wherein the third diameter is greater than the first diameter.

[0572] Clause 158. Clause 157 of the balloon covering, wherein when the cavity is in the second diameter, the plurality of wall surroundings define a fourth diameter, wherein the fourth diameter is greater than the second diameter.

[0573] Clause 159. A balloon cover of any of Clauses 155-158, wherein any two adjacent ribs of the first sleeve portion or the second sleeve portion may be configured to have a circumferential offset such that the two radial edges of one of the two adjacent ribs extend at an angle relative to the corresponding two radial edges of the other adjacent rib.

[0574] Clause 160. A balloon cover for a balloon catheter, said balloon cover comprising:

[0575] A first shell member and a second shell member, wherein the first shell member and the second shell member are configured to engage with each other to define a lumen, the lumen being configured to receive a distal portion of a balloon catheter;

[0576] The first shell component includes a plurality of first wedges arranged in parallel with a plurality of first cavities, and the second shell component includes a plurality of second wedges arranged in parallel with a plurality of second cavities;

[0577] The first wedge and the second wedge are offset such that when the first shell member and the second shell member engage with each other, the plurality of first wedges are received by the plurality of second cavities and the plurality of second wedges are received by the plurality of first cavities.

[0578] Clause 161. Clause 160 balloon covering, wherein the first shell member and the second shell member are completely separable from each other.

[0579] Clause 162. Clause 160 balloon cover, wherein a first shell member and a second shell member are connected to each other by a hinge along adjacent longitudinal edges, the hinge allowing the first shell member and the second shell member to open and close around the distal portion of the balloon catheter.

[0580] Clause 163. Clause 162 of the balloon cover, wherein the first shell member and the second shell member include corresponding latches configured to engage with each other to retain the first shell member and the second shell member in a mating engagement.

[0581] Clause 164. The balloon cover of any of Clauses 160-163 further includes a sleeve configured to slide on the first shell member and the second shell member to maintain the first shell member and the second shell member in a mating engagement.

[0582] Clause 165. A balloon cover of any one of Clauses 160-164, wherein the lumen includes an axial section configured to receive a distal portion of the outer shaft of a balloon catheter, a nasal cone section configured to receive a nasal cone of the balloon catheter, and a balloon section configured to receive a balloon mounted on a shoulder assembly of the balloon catheter, wherein the balloon section is located between the axial section and the nasal cone section.

[0583] Clause 166. A balloon cover of Clause 165, wherein the balloon segment comprises: a proximal shoulder portion configured to receive a proximal portion of a balloon mounted on a proximal shoulder of a balloon assembly; a distal shoulder portion configured to receive a distal portion of a balloon mounted on a distal shoulder of a balloon assembly; and an intermediate portion between the proximal shoulder portion and the distal shoulder portion, wherein the intermediate portion is configured to receive a valve-retaining portion of the balloon located between the proximal and distal portions of the balloon.

[0584] Clause 167. Clause 166 of the balloon covering, wherein the cavity has a varying diameter defined by the inner surfaces of the first shell member and the second shell member, wherein the intermediate portion has a smaller diameter than the distal portion of the proximal shoulder portion and the proximal portion of the distal shoulder portion.

[0585] Clause 168. A balloon covering of any of Clauses 165-167, wherein the first wedge and the second wedge, as well as the first cavity and the second cavity, are located within the balloon segment.

[0586] Clause 169. A balloon covering of any of Clauses 165-168, wherein the nasal cone segment includes the neck, wherein the neck has a smaller diameter than the rest of the nasal cone segment.

[0587] Clause 170. A balloon covering of any one of Clauses 165-169, wherein the axial section includes a plurality of central channels, each central channel being formed by a pair of opposing ribs extending radially inward from the respective inner walls of a first shell member and a second shell member, wherein each rib includes two radial edges and a semi-circular rib surface extending between the two radial edges, such that the two rib surfaces of the opposing ribs together define the inner surface of the respective central channel, wherein any two adjacent central channels are separated by a chamber located between the ribs forming the two adjacent central channels, wherein the chamber has a diameter larger than the plurality of central channels.

[0588] Clause 171. A balloon covering of any of Clauses 160-170, wherein a first shell member has two opposing first longitudinal edges and a second shell member has two opposing second longitudinal edges, wherein the first longitudinal edges are configured to engage with the corresponding second longitudinal edges to form two longitudinal separation lines.

[0589] Clause 172. Clause 171 of the balloon cover, wherein a first wedge and a first cavity are adjacent to and positioned along a first longitudinal edge, and a second wedge and a second cavity are adjacent to and positioned along a second longitudinal edge.

[0590] Clause 173. Clause 172 of the balloon cover, wherein a first wedge and a first cavity positioned along two opposing first longitudinal edges are symmetrical about an axial axis of a first shell member, and a second wedge and a second cavity positioned along two opposing second longitudinal edges are symmetrical about an axial axis of a second shell member.

[0591] Clause 174. A balloon cover of any of Clauses 171-173, wherein the first wedge and the second wedge protrude at their respective first longitudinal edge and second longitudinal edge, and the first cavity and the second cavity are recessed below their respective first longitudinal edge and second longitudinal edge.

[0592] Clause 175. A balloon cover for a balloon catheter, said balloon cover comprising:

[0593] A first shell member and a second shell member are configured to engage with each other to surround the distal portion of the balloon catheter.

[0594] The first shell member includes a plurality of first wedges and a first cavity, and the second shell member includes a plurality of second wedges and a second cavity, wherein the first wedges and the first cavities are configured to lock with the corresponding second cavities and second wedges when the first shell and the second shell engage with each other.

[0595] Clause 176. Clause 175 balloon covering, wherein the first shell member and the second shell member are completely separable from each other.

[0596] Clause 177. Clause 175 of the balloon cover, wherein the first shell member and the second shell member are connected to each other by hinges along adjacent longitudinal edges, the hinges allowing the first shell member and the second shell member to open and close around the distal portion of the balloon catheter.

[0597] Clause 178. Clause 177 of the balloon cover, wherein the first shell member and the second shell member include corresponding latches configured to engage with each other to retain the first shell member and the second shell member in a mating engagement.

[0598] Clause 179. The balloon cover of any of Clauses 177-178 further includes a sleeve configured to slide on the first shell member and the second shell member to maintain the first shell member and the second shell member in a mating engagement.

[0599] Clause 180. A balloon cover of any one of Clauses 175-179, wherein the inner surfaces of the first shell member and the second shell member define a cavity including an axial section configured to receive a distal portion of the outer shaft of a balloon catheter, a nasal cone section configured to receive a nasal cone of the balloon catheter, and a balloon section configured to receive a balloon mounted on a shoulder assembly of the balloon catheter, wherein the balloon section is located between the axial section and the nasal cone section.

[0600] Clause 181. A balloon cover of Clause 180, wherein the balloon segment comprises: a proximal shoulder portion configured to receive a proximal portion of a balloon mounted on a proximal shoulder of a balloon assembly; a distal shoulder portion configured to receive a distal portion of a balloon mounted on a distal shoulder of a balloon assembly; and an intermediate portion between the proximal shoulder portion and the distal shoulder portion, wherein the intermediate portion is configured to receive a valve-retaining portion of the balloon located between the proximal and distal portions of the balloon.

[0601] Clause 182. Clause 181 of the balloon covering, wherein the cavity has a varying diameter defined by the inner surfaces of the first shell member and the second shell member, wherein the intermediate portion has a smaller diameter than the distal portion of the proximal shoulder portion and the proximal portion of the distal shoulder portion.

[0602] Clause 183. A balloon covering of any of Clauses 180-182, wherein the first wedge and the second wedge, as well as the first cavity and the second cavity, are in the balloon segment.

[0603] Clause 184. A balloon covering of any of Clauses 180-183, wherein the nasal cone segment includes a neck, wherein the neck has a smaller diameter than the rest of the nasal cone segment.

[0604] Clause 185. A balloon covering of any one of Clauses 180-184, wherein the axial section includes a plurality of central channels, each central channel being formed by a pair of opposing ribs extending radially inward from the respective inner walls of a first shell member and a second shell member, wherein each rib includes two radial edges and a semi-circular rib surface extending between the two radial edges, such that the two rib surfaces of the opposing ribs together define the inner surface of the respective central channel, wherein any two adjacent central channels are separated by a chamber located between the ribs forming the two adjacent central channels, wherein the chamber has a diameter larger than the plurality of central channels.

[0605] Clause 186. A balloon cover of any of Clauses 175-185, wherein a first shell member has two opposing first longitudinal edges and a second shell member has two opposing second longitudinal edges, wherein the first longitudinal edges are configured to engage with the corresponding second longitudinal edges to form two longitudinal separation lines.

[0606] Clause 187. Clause 186 of the balloon cover, wherein a first wedge and a first cavity are adjacent to and positioned along a first longitudinal edge, and a second wedge and a second cavity are adjacent to and positioned along a second longitudinal edge.

[0607] Clause 188. Clause 187 of the balloon cover, wherein a first wedge and a first cavity positioned along two opposing first longitudinal edges are symmetrical about an axial axis of a first shell member, and a second wedge and a second cavity positioned along two opposing second longitudinal edges are symmetrical about an axial axis of a second shell member.

[0608] Clause 189. A balloon covering of any of Clauses 186-188, wherein the first wedge and the second wedge protrude at their respective first longitudinal edges and second longitudinal edges, and the first cavity and the second cavity are recessed below their respective first longitudinal edges and second longitudinal edges.

[0609] Clause 190. Medical package, comprising:

[0610] A balloon catheter, comprising an inflatable balloon; and

[0611] A balloon cover, the balloon cover comprising a first shell member and a second shell member;

[0612] The first shell member and the second shell member are configured to engage with each other to define a cavity configured to receive at least an inflatable balloon;

[0613] The first shell member includes a plurality of first wedges and a first cavity, and the second shell member includes a plurality of second wedges and a second cavity, wherein the first wedges and the first cavities are configured to lock with the corresponding second cavities and second wedges when the first shell and the second shell engage with each other.

[0614] Clause 191. The assembly of Clause 190, wherein the first shell member and the second shell member are completely separable from each other.

[0615] Clause 192. The assembly of Clause 190, wherein the first shell member and the second shell member are connected to each other by hinges along adjacent longitudinal edges, the hinges allowing the first shell member and the second shell member to open and close around the distal portion of the balloon catheter.

[0616] The assembly of Clause 193 and Clause 192, wherein the first shell member and the second shell member include corresponding latches configured to engage with each other to retain the first shell member and the second shell member in a mating engagement.

[0617] Clause 194. An assembly of any one of Clauses 190-193 further includes a sleeve configured to slide on the first and second shell members to maintain a mating engagement of the first and second shell members.

[0618] Clause 195. An assembly of any one of Clauses 190-194, wherein the balloon catheter includes a first axis, a second axis extending through a lumen of the first axis, a shoulder assembly configured to mount a balloon thereon, and a nasal cone, wherein the shoulder assembly includes a proximal shoulder and a distal shoulder spaced axially from each other, wherein the proximal shoulder is connected to a distal portion of the second axis, and the distal shoulder is connected to the nasal cone.

[0619] The assembly of Clause 196 and Clause 195, wherein the cavity includes an axle segment configured to receive a distal portion of a first axle, a nasal cone segment configured to receive a nasal cone, and a balloon segment configured to receive a balloon mounted on a shoulder assembly.

[0620] The assembly of Clause 197 and Clause 196, wherein the balloon segment comprises: a proximal shoulder portion configured to receive a proximal portion of a balloon mounted on a proximal shoulder; a distal shoulder portion configured to receive a distal portion of a balloon mounted on a distal shoulder; and an intermediate portion between the proximal shoulder portion and the distal shoulder portion, wherein the intermediate portion is configured to receive a valve-retaining portion of the balloon located between the proximal and distal portions of the balloon.

[0621] Clause 198. An assembly according to Clause 197, wherein the cavity has a varying diameter defined by the inner surfaces of the first and second shell members, wherein the intermediate portion has a smaller diameter than the distal portion of the proximal shoulder portion and the proximal portion of the distal shoulder portion.

[0622] Clause 199. An assembly of any one of Clauses 196-198, wherein the first wedge and the second wedge, and the first cavity and the second cavity are in the balloon segment.

[0623] Combinations of any one of Clauses 200 and 196-199, wherein the nasal conus segment includes a neck, wherein the neck has a smaller diameter than the rest of the nasal conus segment.

[0624] Clause 201. An assembly of any one of Clauses 196-200, wherein the axial section includes a plurality of central channels, each central channel being formed by a pair of opposing ribs extending radially inward from the respective inner walls of a first shell member and a second shell member, wherein each rib includes two radial edges and a semi-circular rib surface extending between the two radial edges, such that the two rib surfaces of the opposing ribs together define the inner surface of the respective central channel, wherein any two adjacent central channels are separated by a cavity located between the ribs forming the two adjacent central channels, wherein the cavity has a diameter larger than the plurality of central channels.

[0625] Clause 202. An assembly of any one of Clauses 190-201, wherein the first shell member has two opposing first longitudinal edges and the second shell member has two opposing second longitudinal edges, wherein the first longitudinal edges are configured to engage with the corresponding second longitudinal edges to form two longitudinal separation lines.

[0626] Clause 203. The assembly of Clause 202, wherein the first wedge and the first cavity are adjacent to and positioned along the first longitudinal edge, and the second wedge and the second cavity are adjacent to and positioned along the second longitudinal edge.

[0627] The assembly of Clause 204 and Clause 203, wherein a first wedge and a first cavity positioned along two opposing first longitudinal edges are symmetrical about the axial axis of a first shell member, and a second wedge and a second cavity positioned along two opposing second longitudinal edges are symmetrical about the axial axis of a second shell member.

[0628] Clause 205. An assembly of any one of Clauses 202-204, wherein the first wedge and the second wedge protrude on respective first and second longitudinal edges, and the first cavity and the second cavity are recessed below their respective first and second longitudinal edges.

[0629] Clause 206. A balloon cover for a balloon catheter, said balloon cover comprising:

[0630] A first shell member and a second shell member, wherein the first shell member and the second shell member are configured to engage with each other to define a lumen configured to receive a distal portion of a balloon catheter;

[0631] The lumen includes a balloon segment configured to receive a balloon mounted on a distal portion of a balloon catheter, wherein the balloon segment includes a proximal compartment configured to receive a proximal portion of the balloon, a distal compartment configured to receive a distal portion of the balloon, and an intermediate compartment between the proximal and distal compartments, wherein the intermediate compartment is configured to receive a valve-retaining portion of the balloon;

[0632] The distal compartment includes a proximal region, a distal region, and an intermediate region between the proximal and distal regions, wherein the distal region has a smaller diameter than the proximal region, and the intermediate region has a smaller diameter than the distal region.

[0633] Clause 207. Clause 206 of the balloon covering, wherein the proximal compartment comprises a proximal portion and a distal portion, wherein the distal portion is radially conical from the distal end of the distal portion to the proximal end of the distal portion, and the proximal portion has a diameter that is substantially constant along its axial length.

[0634] Clause 208. A balloon covering of any of Clauses 206-207, wherein the proximal region of the distal compartment is radially conical from the proximal end of the proximal region to the distal end of the proximal region, and wherein the distal region of the distal compartment is radially conical from the distal end of the distal region to the proximal end of the distal region.

[0635] Clause 209. A balloon cover of any of Clauses 206-208, wherein the mid-compartment of the balloon segment has a smaller diameter than the proximal end of the distal compartment of the balloon segment and the distal end of the proximal compartment.

[0636] Clause 210. A balloon cover of any of Clauses 206-209, wherein the lumen includes an axial segment configured to receive a distal portion of the intermediate axis of a balloon catheter and a nasal cone segment configured to receive a nasal cone of the balloon catheter, wherein the balloon segment is located between the axial segment and the nasal cone segment.

[0637] Clause 211. A balloon cover of any of Clauses 206-210, wherein a first shell member has two opposing first longitudinal edges and a second shell member has two opposing second longitudinal edges, wherein the first longitudinal edges are configured to engage with the corresponding second longitudinal edges to form two longitudinal separation lines.

[0638] Clause 212. Clause 211's balloon cover, wherein a first shell member includes a plurality of first wedges and a first cavity and a second shell member includes a plurality of second wedges and a second cavity, and wherein the first wedges and the first cavities are configured to lock against each other with corresponding second cavities and second wedges when the first shell and the second shell engage with each other.

[0639] Clause 213. The balloon cover of Clause 212, wherein the first wedge and the first cavity are perpendicular to the first longitudinal edge, and the second wedge and the second cavity are perpendicular to the second longitudinal edge.

[0640] Clause 214. A balloon cover of any of Clauses 212-213, wherein the first wedge and the second wedge protrude at their respective first longitudinal edges and second longitudinal edges, and the first cavity and the second cavity are recessed below their respective first longitudinal edges and second longitudinal edges.

[0641] Clause 215. A balloon cover of any of Clauses 212-214, wherein a first wedge and a first cavity are arranged along a first longitudinal edge, and a second wedge and a second cavity are arranged along a second longitudinal edge.

[0642] Clause 216. A balloon cover for a balloon catheter, said balloon cover comprising:

[0643] A first shell member and a second shell member, wherein the first shell member and the second shell member are configured to engage with each other such that the inner walls of the first shell member and the second shell member define a lumen suitable for receiving a distal portion of a balloon catheter.

[0644] The lumen includes a balloon segment configured to receive a balloon mounted on a distal portion of a balloon catheter, wherein the balloon segment includes a proximal compartment configured to receive a proximal portion of the balloon, a distal compartment configured to receive a distal portion of the balloon, and an intermediate compartment between the proximal and distal compartments, wherein the intermediate compartment is configured to receive a valve-retaining portion of the balloon;

[0645] When the balloon is held in the cavity, the inner walls of the first and second shell members are shaped to create a depression in at least one portion of the balloon.

[0646] Clause 217. The balloon cover of Clause 216, wherein the inner walls of the first shell member and the second shell member include at least one radial protrusion that extends radially inward to create a recess in said at least one portion of the balloon.

[0647] Clause 218. Clause 217's balloon cover, wherein the radial protrusion includes a first semi-circular radial protrusion extending radially inward from the inner wall of a first shell member and a second semi-circular radial protrusion extending radially inward from the inner wall of a second shell member, wherein when the first shell member and the second shell member are engaged with each other, the first semi-circular radial protrusion and the second semi-circular radial protrusion form a circular radial protrusion.

[0648] Clause 219. A balloon cover of any of Clauses 216-218, wherein the first shell member and the second shell member are shaped along the inner wall of the distal compartment to create a depression in the distal portion of the balloon.

[0649] Clause 220. Clause 219 of the balloon covering, wherein the distal compartment comprises a proximal region and a distal region interconnected by an intermediate region, wherein the distal compartment is radially conical from the proximal region to the intermediate region and then radially conical from the intermediate region to the distal region.

[0650] Clause 221. Clause 220 balloon covering, wherein the distal end of the distal region has a smaller diameter than the proximal end of the proximal region.

[0651] Clause 222. A balloon covering of any one of Clauses 216-221, wherein the proximal compartment comprises a proximal portion and a distal portion, wherein the distal portion is radially conical from the distal end of the distal portion to the proximal end of the distal portion, and the proximal portion has a substantially constant diameter along its axial length.

[0652] Clause 223. A balloon covering of any of Clauses 216-222, wherein the distal end of the proximal compartment has a smaller diameter than the proximal end of the distal compartment, and the intermediate compartment has a smaller diameter than the distal end of the proximal compartment.

[0653] Clause 224. A balloon cover of any of Clauses 216-223, wherein the lumen includes an axial segment configured to receive a distal portion of the intermediate axis of a balloon catheter and a nasal cone segment configured to receive a nasal cone of the balloon catheter, wherein the balloon segment is located between the axial segment and the nasal cone segment.

[0654] Clause 225. A balloon cover of any of Clauses 216-224, wherein a first shell member includes a plurality of first wedges alternating with a plurality of first cavities along the length of the first shell member, and a second shell member includes a plurality of second wedges alternating with a plurality of second cavities along the length of the second shell member, wherein the first wedges and the second wedges are offset such that when the first shell member and the second shell member are engaged in a mating manner, the plurality of first wedges are received by the plurality of second cavities and the plurality of second wedges are received by the plurality of first cavities.

[0655] Clause 226. Medical package, comprising:

[0656] A balloon catheter comprising an inflatable balloon, the balloon including a proximal portion, a distal portion, and a valve-retaining portion between the proximal and distal portions; and

[0657] A compression member configured to create at least one depression within the balloon.

[0658] Clause 227. Clause 226 of the medical assembly wherein a compression member is configured to radially compress the distal portion of the balloon between the proximal and distal ends, such that the distal portion of the balloon has an overall hourglass shape.

[0659] The medical assembly of any one of Clauses 228 and 226-227 further includes a balloon cover having a cavity configured to receive a balloon, wherein the cavity includes a balloon segment comprising: a proximal compartment configured to receive a proximal portion of the balloon, a distal compartment configured to receive a distal portion of the balloon, and an intermediate compartment configured to receive a valve-retaining portion of the balloon, wherein the distal compartment includes a compression member.

[0660] Clause 229. The medical assembly of Clause 228, wherein the distal compartment comprises a proximal region and a distal region interconnected by an intermediate region, wherein the compression member comprises a radially projecting portion extending inward from the inner wall of the intermediate region.

[0661] Clause 230. A medical assembly of any of Clauses 228-229, wherein the balloon catheter includes a balloon shaft, an inner shaft extending through a lumen of the balloon shaft, a nasal cone, and a distal shoulder located within a distal portion of the balloon.

[0662] Clause 231. A medical assembly of Clause 230, wherein the cavity of the balloon cover includes an axial segment configured to receive a distal portion of the balloon axial segment and a nasal cone segment configured to receive a nasal cone, wherein the balloon segment is located between the axial segment and the nasal cone segment.

[0663] Clause 232. A medical assembly of any one of Clauses 230-231, wherein the proximal portion of the balloon comprises a proximal portion and a distal portion, wherein the distal portion is radially conical from the distal end of the distal portion to the proximal end of the distal portion, and the proximal portion has a substantially constant diameter along its axial length.

[0664] The medical assembly of any of Clauses 233, 226-227, wherein the compression member includes an annular band configured to extend around the balloon.

[0665] Clause 234. A medical assembly of Clause 230, wherein an annular band is connected to a sheath, wherein the distal end of the sheath is connected to the distal end of the balloon, such that the sheath at least partially covers the distal portion of the balloon.

[0666] The medical assembly of any of Clauses 235, 226-234 further includes a prosthetic valve arranged in a radially folded manner on the valve retention portion of the balloon.

[0667] Clause 236. A balloon cover assembly for a balloon catheter, said balloon cover assembly comprising:

[0668] A defining lumen covering body, the lumen being configured to receive a balloon folded onto a distal portion of a balloon catheter, wherein the balloon includes a proximal portion, a distal portion, and a valve-retaining portion connecting the proximal and distal portions; and

[0669] At least one compression member, said compression member being configured to radially compress at least one portion of the balloon.

[0670] Clause 237. Clause 236 of the balloon cover assembly, wherein the compression member includes a radially projecting portion of the inner wall of the cover body, wherein the radially projecting portion extends radially inward into the cavity to contact said at least one portion of the balloon.

[0671] Clause 238. Clause 237 balloon cover assembly, wherein a radial protrusion surrounds the cavity.

[0672] Clause 239. Clause 236 of the balloon cover assembly, wherein the compression member includes an annular band configured to extend around said at least one portion of the balloon.

[0673] Clause 240. Clause 239 of the balloon cover assembly, wherein the annular band is capable of radial compression around said at least one portion of the balloon.

[0674] Clause 241. A balloon covering assembly of any of Clauses 239-240, wherein the compression member further comprises a sheath connected to an annular band.

[0675] Clause 242. Clause 241 balloon cover, wherein the distal end of the sheath is connected to the distal end of the distal portion of the balloon.

[0676] Clause 243. Clause 236 of the balloon cover assembly, wherein the compression member includes sutures capable of tightening around said at least one portion of the balloon.

[0677] Clause 244. A balloon cover assembly of any one of Clauses 236-243, wherein a compression member is configured to radially compress said at least one portion of the balloon such that said at least one portion of the balloon has an overall hourglass shape.

[0678] Clause 245. A balloon cover assembly of any one of Clauses 236-244, wherein the cover body comprises a first separable shell portion and a second separable shell portion defining a cavity.

[0679] Clause 246. A balloon cover assembly of any one of Clauses 236-245, wherein the at least one compression member is configured to radially compress the distal portion of the balloon at a location between the proximal and distal ends of the distal portion of the balloon.

[0680] Clause 247. Methods, which include:

[0681] When the balloon is in a deflated state, it is folded onto the distal portion of the delivery device. The balloon has a proximal portion, a distal portion, and a valve-retaining portion connecting the proximal and distal portions. The distal end of the distal portion has a smaller diameter than the proximal end of the distal portion, the distal end of the proximal portion has a larger diameter than the proximal end of the proximal portion, and the valve-retaining portion has a smaller diameter than both the proximal and distal ends of the distal and proximal portions.

[0682] The distal portion of the balloon is radially compressed at a location between the distal and proximal ends of the distal portion.

[0683] The method of Clause 248 and Clause 247, wherein after radially compressing the distal portion of the balloon, the diameter of the distal portion of the balloon at a position between the distal and proximal ends is smaller than the diameter of the distal and proximal ends of the distal portion of the balloon.

[0684] Clause 249. The method of any one of Clauses 247-248, wherein the distal portion of the radially compressed balloon comprises placing the balloon in a balloon cover having a compression member that radially compresses the distal portion of the balloon.

[0685] The methods of Clauses 250 and 249, wherein the compression member includes a radially projecting portion of the inner wall of the balloon cover.

[0686] The method of any one of Clauses 251 and 247-248, wherein the distal portion of the radially compressed balloon comprises placing an annular band around the distal portion of the balloon.

[0687] The method of Clause 252. Clause 251 further includes placing the balloon cover on the balloon after placing the annular band around the distal portion of the balloon.

[0688] The method of any one of Clauses 253, 249, 250, or 252 further includes injecting inflatable fluid into the balloon while the balloon is inside the balloon cover and withdrawing the inflatable fluid from the balloon.

[0689] The methods of Clause 254 and Clause 253 further include removing the balloon cover from the balloon and sliding the axis of the delivery device on the proximal portion of the balloon.

[0690] Clause 255. The method of Clause 254, wherein sliding the axis of the delivery device on the proximal portion of the balloon causes the distal portion of the balloon to partially inflate.

[0691] Given the many possible implementations to which the principles of the disclosed invention can be applied, it should be understood that the exemplified embodiments are merely preferred examples and should not be considered as limiting the scope of the invention. Rather, the scope of the invention is defined by the appended claims.

Claims

1. A balloon assembly, comprising: An inflatable balloon having an inflated state and a deflated state, wherein the inflatable balloon in the deflated state comprises: A valve retaining portion having an overall cylindrical shape and one or more axial folds; A distal tapered portion connected to the distal end of the valve retaining portion, the proximal end of the distal tapered portion having a larger diameter than the distal end of the distal tapered portion and the valve retaining portion; A proximal conical portion connected to the proximal end of the valve retaining portion, the distal end of the proximal conical portion having a larger diameter than the proximal end of the proximal conical portion and the valve retaining portion; The distal leg connected to the distal end of the distal tapered portion; and The proximal leg is connected to the proximal end of the proximal conical portion; The distal tapered portion includes one or more axially folded portions, and the proximal tapered portion includes one or more axially folded portions. The proximal end of the distal tapered portion includes a first radial fold that connects to the second radial fold, the first radial fold and the second radial fold forming a distally extending recess at the proximal end of the distal tapered portion, and The distal end of the proximal conical portion includes a radial fold that forms an obtuse or right angle relative to the valve retaining portion.

2. The balloon assembly of claim 1, further comprising a restraint member extending around the outer surface of the valve holding portion to prevent one or more axial folds of the valve holding portion from unfolding.

3. The balloon assembly of any one of claims 1-2, further comprising a cover surrounding the inflatable balloon, wherein the cover includes a proximal portion, a distal portion, and an intermediate portion between the proximal portion and the distal portion, wherein the proximal portion defines a proximal recess shaped to substantially match the shape of a proximal conical portion of the inflatable balloon, the distal portion defines a distal recess shaped to substantially match the shape of a distal conical portion of the inflatable balloon, and the intermediate portion defines an intermediate recess shaped to substantially match the shape of a valve-retaining portion of the inflatable balloon.

4. The balloon assembly of claim 3, wherein the covering comprises a first covering and a second covering, the first covering and the second covering being complementary in construction such that they can be fitted together to surround the inflatable balloon in the deflated state.

5. The balloon assembly of claim 4, further comprising an outer sleeve extending over the cover to prevent the first cover and the second cover from separating from each other.

6. The balloon assembly according to any one of claims 1-2 and 4-5, wherein the inflatable balloon includes an inner cavity extending through the proximal conical portion, the valve retaining portion, and the distal conical portion.

7. The balloon assembly according to any one of claims 1-2 and 4-5, wherein the proximal conical portion of the inflatable balloon includes a proximal portion, wherein one or more axial folds of the proximal conical portion do not extend into the proximal portion of the proximal conical portion.

8. The balloon assembly according to any one of claims 1-2 and 4-5, wherein the distal conical portion of the inflatable balloon includes a distal portion, wherein one or more axial folds of the distal conical portion do not extend into the distal portion of the distal conical portion.

9. A method of forming a balloon for a delivery device, the method comprising: An inflatable balloon in a deflated state is formed, the balloon in the deflated state having a valve holding portion, a distal cone portion connected to the distal end of the valve holding portion, a proximal cone portion connected to the proximal end of the valve holding portion, a distal leg connected to the distal end of the distal cone portion, and a proximal leg connected to the proximal end of the proximal cone portion. The distal shoulder, mounted on the first axis of the delivery device, is inserted through the distal leg of the inflatable balloon and into the distal conical portion; The proximal shoulder, mounted on the second axis of the delivery device, is inserted through the proximal leg of the inflatable balloon and into the proximal conical portion; Secure the distal leg of the inflatable balloon to the distal shoulder; and Secure the proximal leg of the inflatable balloon to the second axis and / or the proximal shoulder. The formation of the inflatable balloon includes: The valve retaining portion, which is generally cylindrical, has a diameter smaller than both the diameter of the proximal end of the distal conical portion and the diameter of the distal end of the proximal conical portion. One or more axially extending folds are formed along at least a section of the distal tapered portion and the proximal tapered portion. A radial fold is formed at the distal end of the proximal conical portion, the radial fold forming an obtuse or right angle relative to the valve retaining portion, and A first radial fold is formed, which connects to a second radial fold at the proximal end of the distal tapered portion. The first and second radial folds form a distally extending recess at the proximal end of the distal tapered portion.

10. The method of claim 9, further comprising placing a restraint member around the valve retaining portion.

11. The method of any one of claims 9-10, further comprising surrounding the inflatable balloon with a cover, wherein the cover comprises a first cover element and a second cover element, the first cover element and the second cover element being complementaryly constructed such that they can be fitted together to surround the inflatable balloon, and wherein the cover defines an indentation whose geometry substantially matches the shape of the inflatable balloon in the deflated state.

12. The method according to any one of claims 9-10, wherein the proximal end of the distal shoulder has a diameter larger than the diameter of the distal leg, and inserting the distal shoulder through the distal leg includes radially compressing the proximal end of the distal shoulder.

13. The method according to any one of claims 9-10, wherein the distal end of the proximal shoulder has a diameter larger than the diameter of the proximal leg, and inserting the proximal shoulder through the proximal leg includes radially compressing the distal end of the proximal shoulder.

14. A prosthetic valve delivery assembly, comprising: Delivery device, the delivery device comprising: Axis; and A balloon assembly according to any one of claims 1-8, mounted in a deflated state on the shaft; The balloon in the deflated state includes a valve retention portion having a generally cylindrical shape, a distal conical portion connected to the distal end of the valve retention portion, and a proximal conical portion connected to the proximal end of the valve retention portion; and The proximal end of the distal tapered portion includes a first radial fold that connects to the second radial fold, the first radial fold and the second radial fold forming a distally extending recess at the proximal end of the distal tapered portion.

15. The prosthetic valve delivery assembly of claim 14, further comprising a restraint member extending around the outer surface of the valve holding portion.

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