Transluminal delivery system

Abstract

A delivery tool (2020) includes a shaft (2034), a proximal sac (2064), and a distal sac (2066), the delivery tool (2020) being percutaneously deliverable to the heart. The open end (2065) of the proximal sac faces the open end (2067) of the distal sac. The sac is coupled to the shaft in a manner allowing axial movement relative to the shaft. A prosthetic heart valve (2036) includes a tubular portion (2032) defining a lumen and a prosthetic leaflet disposed within the lumen. The prosthetic heart valve is constrained in a compressed state by the delivery tool such that the downstream end of the tubular portion is disposed within the distal sac. The distal sac is shaped to define an opening (2110) for viewing the sheath containing at least a portion of the downstream end of the tubular portion within the distal sac. Other embodiments are also described.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Application 17 / 399,594, filed August 11, 2021, entitled “Cavity Delivery System,” and is a continuation-in-part of that priority application, which claims priority to U.S. Provisional Application 63 / 120,808, filed December 3, 2020, also entitled “Cavity Delivery System.” Each of the foregoing applications is assigned to the assignee of this application and is incorporated herein by reference. Technical Field

[0003] Some applications of this invention generally relate to transcavitary implant delivery systems. More specifically, some applications of this invention relate to prosthetic heart valves and their transcavitary delivery systems. Background Technology

[0004] Dilation of the valvular annulus, such as that caused by ischemic heart disease, prevents the valvular leaflets from fully engaging when the valve closes. The return of blood from the ventricles to the atria leads to an increase in total stroke volume and a decrease in cardiac output, as well as the eventual weakening of the ventricles due to atrial volume overload and pressure overload. Summary of the Invention

[0005] The application of this invention relates to devices and methods for delivering implants to subjects.

[0006] For some applications, aspects of the invention include a transcavitary delivery device comprising a multi-catheter system and an implantable device. The implantable device has a distal portion configured for advancement into a subject, and a proximal portion including an external control system.

[0007] The catheter system typically includes a first catheter unit and a second catheter unit, each catheter unit including a corresponding catheter that is mounted to a corresponding handle at its proximal end. Selectively adjusting the axial and / or rotational position of each handle facilitates adjustment of the axial and / or rotational position of the corresponding catheter. Typically, the corresponding handle and the proximal portion of the implantable device are mounted on a mounting to ensure stability during use.

[0008] In some applications, the first catheter extends distally within the second catheter. In some such applications, the distal portion of the first catheter slides distally over the distal portion of the second catheter, encasing the distal portion of the second catheter within the distal portion of the first catheter, and the distal portion of the first catheter slides proximally over the distal portion of the second catheter, exposing the distal portion of the second catheter from the first catheter.

[0009] Typically, in this application, the actuation of the first catheter controller actively bends the distal portion of the first catheter via the first catheter control element, while the actuation of the second controller actively bends the distal portion of the second catheter via the second catheter control element.

[0010] For some applications, each control element includes a pull wire extending from the corresponding controller through a second lumen of the corresponding conduit to a distal portion of the conduit, the pull wire being secured to the distal portion of the conduit.

[0011] In some applications, each catheter (e.g., its distal end) can be bent along a corresponding actuation plane by actuation of a corresponding controller. In some such applications, the second catheter is oriented rotationally relative to the first catheter, such that when the distal end of the first catheter is bent in the first catheter actuation plane, the bending of the distal end of the second catheter causes the distal end of the second catheter to rotate relative to the distal end of the first catheter, causing the second catheter actuation plane to move in a direction perpendicular to the first catheter guidance plane.

[0012] In some applications, the distal portion of the second catheter is connected to the balloon assembly. In some such applications, the balloon assembly includes a proximal balloon and a distal balloon. For example, each balloon may have a corresponding open end facing the open end of the other balloon.

[0013] For some applications, the distal portion of the delivery tool includes a plurality of coaxial tubular members extending distally from the proximal portion of the instrument (e.g., through the second catheter of the catheter system). Typically for such applications, a balloon catheter extends distally through the second catheter and extends distally from the opening of the second catheter. Furthermore, typically for such applications, an axis extends distally from the proximal portion of the delivery tool, through the balloon catheter, and extends distally from the opening of the proximal balloon. For example, an installer (e.g., an implant to which can be engaged) can be securely attached to the distal end of the axis.

[0014] In some such applications, the rod extends beyond the distal end of the shaft, such that the distal portion of the rod is positioned outside the distal end of the shaft. Typically, in such applications, the rod is operatively coupled to the shaft such that the rod can be helically passed through the shaft.

[0015] Typically, the implant may be encased (e.g., to restrict expansion) within a capsule assembly. For some applications, the implant includes a proximal implant portion, a distal implant portion, and a flange. Typically for such applications, the implant is encased during delivery by the delivery tool such that at least one flange end of the proximal implant portion and the flange is confined within the proximal capsule. Furthermore, typically for such applications, the distal implant portion of the implant is confined within the distal capsule.

[0016] For some applications, the implant can be unsheathed from the distal capsule by linearly moving the distal capsule away from the implant (e.g., without twisting the distal capsule relative to the rod). For some such applications, the distal capsule is rotatably coupled to the distal portion of the rod such that rotation of the rod does not rotate the distal capsule. For example, by rotating the rod through the axis while the distal capsule is axially locked relative to the rod but rotatably connected to it, the distal capsule can be advanced away from the implant.

[0017] For some such applications, the bladder assembly includes a plurality of pins axially aligned with a circumferential recess defined by the rod. Typically, for such applications, the pin prevents rotation of the distal bladder by extending the distal bladder sufficiently close to the rod to prevent axial movement of the rod relative to the pin, while providing sufficient clearance between the pin and the rod (e.g., the recess thus defined) to allow the rod to rotate relative to the pin.

[0018] For some applications, the distal capsule is reversibly and rotatably locked or unlocked relative to the rod, such that the implant can be sheathed within the distal capsule by helically moving the distal capsule over the implant, and the implant can be ejected by linearly moving the distal capsule away from the implant. For example, an accessory (e.g., defining a pawl shaped to engage with a groove defined by the rod and the distal capsule) can be introduced to rotatably lock the rod relative to the distal capsule. In this way, the accessory can be attached for sheathing the implant within the distal capsule, and the accessory can then be removed before the implant is ejected (e.g., before transcavitary delivery).

[0019] For some applications, aspects of the invention include a delivery system comprising a delivery tool and a prosthetic valve. In some such applications, the delivery tool is used to deliver the prosthetic valve to a natural valve in a subject's heart. For example, the natural valve may be a tricuspid valve.

[0020] For some applications, the delivery tool has a proximal portion and a distal portion. In some such applications, the distal portion includes a proximal sac and a distal sac, each sac defining a corresponding open end.

[0021] Typically, for such applications, the opening of the proximal capsule faces the proximal end of the distal capsule. For some applications, the opening of the proximal capsule may face the opening of the distal capsule. For example, when the delivery device is in a delivery state for laparoscopic delivery to the heart, the intersacral gap may be separated between the openings of the proximal and distal capsules.

[0022] For some such applications, the prosthetic valve includes a tubular portion defining a lumen in which a plurality of prosthetic leaflets are disposed. Typically, for this application, the prosthetic valve also includes an upstream support extending from the tubular portion and defining a plurality of flanges. Each flange is coupled to the tubular portion at a coupling point, and the flange extends from the coupling point to a flange tip.

[0023] In some applications, the prosthetic valve is confined in a compressed state by the delivery tool when it is in the delivery state. In some such applications, the tubular portion of the prosthetic valve engages with the mounting portion of the delivery tool when it is in the delivery state. Alternatively or additionally, the prosthetic valve may engage with a portion of the shaft, with necessary modifications.

[0024] For some applications, when the delivery tool is in the delivery state, the downstream end of the mounting member and the tubular portion is disposed within the distal bladder, and the upstream support and the flange end are disposed within the proximal bladder. More typically, when the delivery tool is in the delivery state, a section of the tubular portion is disposed at the inter-bladder gap.

[0025] In some applications, the delivery tool is advanced transcavitally into the ventricle of the heart, such that the distal capsule is positioned within the ventricle. In some such applications, the delivery tool includes a flexible sheath, which is retracted to expose the proximal capsule from within the sheath.

[0026] For some applications, the delivery system includes a guidewire, and the delivery tool is advanced along the guidewire through the lumen into the heart. For some such applications, the delivery tool includes an anterior cone with a flexible distal portion. For example, the distal portion may have a relaxed, coiled shape, and the distal portion may be straightened when the guidewire occupies the distal portion.

[0027] For some applications, the delivery tool includes a shaft comprising a rigid proximal shaft segment extending from a proximal portion of the delivery tool to a distal portion of the delivery tool. For some such applications, the shaft includes a flexible shaft segment extending from the rigid proximal shaft segment to a rigid distal shaft segment. Typically, for such applications, the rigid distal shaft segment extends through at least a portion of the proximal and / or distal sac.

[0028] Typically, the proximal sac then retracts proximally, causing the flange end to release from the proximal sac and expand radially outward. For some applications, the delivery tool includes a disc assembly comprising a proximal disc rotatably coupled to a distal disc. The proximal disc defines an external thread complementary to the internal thread defined by the proximal sac. Typically, for such applications, rotation of the sac catheter, which is fixedly coupled to the proximal disc, screws the proximal sac relative to the mounting onto the disc assembly.

[0029] Further typically, the distal portion then retracts, causing the flange tip to contact the tissue of the native valve. The proximal sac then retracts, causing the upstream support portion to release from the proximal sac and expand radially outward. In this way, the tissue of the native valve is compressed between the upstream support portion and the flange tip.

[0030] Subsequently, the distal capsule is advanced relative to the mounting element, thereby releasing the downstream end of the mounting element and the tubular portion from the distal capsule. Consequently, the tubular portion expands radially outward at the natural valve, causing the prosthetic valve to be in an expanded state.

[0031] Subsequently, the proximal bladder is advanced toward the mount, such that the open end of the proximal bladder abuts against the distal bladder. In some applications, the open end of the proximal bladder abuts against the open end of the distal bladder. In some applications, the distal bladder retracts toward the mount before the proximal bladder is advanced. As the proximal bladder abuts against the distal bladder, the distal portion of the delivery tool retracts through the lumen of the tubular portion.

[0032] Therefore, according to the application of the present invention, a device for use in the heart of a subject is provided, the device comprising:

[0033] Delivery tool, sized for percutaneous delivery to the heart, the delivery tool having a distal portion defining a central longitudinal axis and comprising:

[0034] Axis; and

[0035] The proximal capsule and the distal capsule, each of the proximal capsule and the distal capsule:

[0036] Having a corresponding opening end, the opening end of the proximal sac faces the opening end of the distal sac; and

[0037] Coupled to the shaft in a manner that allows the bladder to move axially relative to the shaft, along the central longitudinal axis at the distal portion; and

[0038] Prosthetic heart valves, including:

[0039] The tubular portion that defines the lumen; and

[0040] Multiple prosthetic leaflets placed in the lumen, and:

[0041] The prosthetic heart valve is constrained in a compressed state by the delivery tool, such that the downstream end of the tubular portion is positioned within the distal capsule; and

[0042] The distal sac is shaped to define an opening for viewing at least a portion of the downstream end of the tubular portion within the sheath of the distal sac.

[0043] In one application, the opening defines a window.

[0044] In one application, the delivery tool further includes a mounting piece surrounding the axis and configured to engage the downstream end of the tubular portion, wherein the opening is configured to allow visualization of the mounting piece and the downstream end of the tubular portion.

[0045] In one application, the mounting member is shaped to define one or more slots, and wherein the downstream end of the tubular portion is shaped to define one or more adapters, each of the adapters being configured to be received within a corresponding one of the one or more slots to facilitate engagement between the mounting member and the downstream end of the tubular portion.

[0046] In one application, under the compressed state of the prosthetic heart valve, the distal sac maintains the coupling between the downstream end of the tubular portion and the mounting by surrounding the one or more adapters and holding each of the one or more adapters within a corresponding slot of the mounting.

[0047] In one application, the prosthetic heart valve includes:

[0048] An upstream support portion, which extends from the tubular portion; and

[0049] Each of the flanges is coupled to the tubular portion at a corresponding coupling point downstream of the upstream support, and extends from the coupling point to the corresponding flange end of the flange.

[0050] In one application, the prosthetic heart valve can be confined to the compressed state by the delivery tool, such that the upstream support and the flange end are positioned within the proximal capsule.

[0051] According to the application of the present invention, a method for preparing a prosthetic heart valve for implantation is also provided, the method comprising:

[0052] Using a curling tool, the prosthetic heart valve is curled around the distal portion of the axis of the delivery tool; and

[0053] After the curling, the prosthetic heart valve is encased in the sac by (i) directly coupling the sheathing tool to the distal portion externally and (ii) applying a rotational force to the sheathing tool to influence the linear movement of the sac relative to the prosthetic heart valve.

[0054] In one application:

[0055] Following the sheath, the prosthetic heart valve of the sheath and the distal portion of the delivery tool are advanced into the subject, while the proximal portion of the delivery tool remains outside the subject; and

[0056] Subsequently, the prosthetic heart valve is deployed from the sac into the subject's heart by applying an opening force externally to a controller at the proximal portion of the delivery tool.

[0057] In one application:

[0058] The sac is a distal sac;

[0059] The delivery tool also includes a proximal capsule, each of the proximal and distal capsules:

[0060] Having a corresponding opening end, the opening end of the proximal sac faces the opening end of the distal sac; and

[0061] Coupled to the shaft in a manner that allows the bladder to move axially relative to the shaft, along the central longitudinal axis at the distal portion; and

[0062] Encasing the prosthetic heart valve within a capsule includes:

[0063] The downstream end of the prosthetic heart valve is embedded in the distal capsule; and

[0064] Subsequently, the upstream end of the prosthetic heart valve is fitted into the proximal capsule.

[0065] In one application, the sheathing tool is a distal balloon sheathing tool, and wherein sheathing the downstream end of the prosthetic heart valve includes applying a first sheathing force to the distal portion of the delivery tool using the distal balloon sheathing tool, which is directly coupled to the distal balloon.

[0066] In one application, the method includes directly coupling the distal sac wrapping tool to the distal sac.

[0067] In one application, encasing the upstream end of the prosthetic heart valve in the proximal sac includes applying a second encasing force to the distal portion of the delivery tool using a proximal sac encasing tool directly coupled to the distal portion.

[0068] In one application, the method includes:

[0069] After encapsulating the upstream end of the prosthetic heart valve, the encapsulated prosthetic heart valve and the distal portion of the delivery tool are advanced into the subject's heart while the proximal portion of the delivery tool remains outside the subject; and

[0070] Subsequently, by applying an opening force externally to a controller at the proximal portion of the delivery tool, the prosthetic heart valve is deployed from the proximal and distal sacs into the subject's heart.

[0071] In one application, the method further includes, during the process of enclosing the downstream end of the prosthetic heart valve in the distal sac, making at least a portion of the enclosing of the downstream end of the prosthetic heart valve in the distal sac visible through an opening defined in the distal sac for visualizing the enclosing.

[0072] In one application, the delivery tool further includes an mounting element surrounding the axis and configured to engage the downstream end of the prosthetic heart valve, and wherein visibility of the sheath of at least a portion of the downstream end of the prosthetic heart valve within the distal sac includes visibility of the mounting element and the downstream end of the prosthetic heart valve.

[0073] In one application:

[0074] The mounting element is shaped to define one or more grooves;

[0075] The downstream end of the prosthetic heart valve is shaped to define one or more adapters, each of which is configured to be received within a corresponding slot in the one or more slots to facilitate engagement between the mounting member and the downstream end of the prosthetic heart valve; and

[0076] Encasing the downstream end of the prosthetic heart valve in the distal capsule includes encasing the downstream end of the prosthetic heart valve such that one or more adapters mate in one or more slots.

[0077] In one application, encasing the downstream end of the prosthetic heart valve in the distal sac includes maintaining the coupling between the downstream end of the prosthetic heart valve and the mounting device by encasing the downstream end of the prosthetic heart valve in the distal sac.

[0078] According to the application of the present invention, a method for preparing a prosthetic heart valve for implantation is also provided, the method comprising:

[0079] Using a curling tool, the prosthetic heart valve is curled around the distal portion of the axis of the delivery tool; and

[0080] After the curling, the downstream end of the prosthetic heart valve is encased in a sac, and during the encasing, at least a portion of the downstream end of the prosthetic heart valve is made visible in the sac by defining an opening in the sac for visualizing the encasing.

[0081] In one application:

[0082] The sac is a distal sac, and the opening is defined within the distal sac;

[0083] The delivery tool also includes a proximal capsule, each of which:

[0084] Having a corresponding opening end, the opening end of the proximal sac faces the opening end of the distal sac; and

[0085] Coupled to the shaft in a manner that allows the bladder to move axially relative to the shaft, along the central longitudinal axis at the distal portion; and

[0086] Encasing the prosthetic heart valve within the capsule includes:

[0087] The downstream end of the prosthetic heart valve is encased in the distal capsule; and

[0088] Subsequently, after the downstream end of the prosthetic heart valve is encased in the distal capsule, the upstream end of the prosthetic heart valve is encased in the proximal capsule.

[0089] In one application, the downstream end of the prosthetic heart valve is sheathed by applying a first sheathing force to the distal portion of the delivery tool using a distal sac sheathing tool directly coupled to the distal sac.

[0090] In one application, the method further includes directly coupling the distal capsule sheathing tool to the distal capsule.

[0091] In one application, the method further includes applying a second sheathing force to the distal portion of the delivery tool by using a proximal sheathing tool directly coupled to the distal portion, and sheathing the upstream end of the prosthetic heart valve in the proximal capsule after sheathing the downstream end of the prosthetic heart valve in the distal capsule.

[0092] In one application, the method includes:

[0093] After encapsulating the upstream end of the prosthetic heart valve, the encapsulated prosthetic heart valve and the distal portion of the delivery tool are advanced into the subject's heart while the proximal portion of the delivery tool is held outside the subject; and

[0094] Subsequently, the prosthetic heart valve is deployed from the capsule into the subject's heart by applying an opening force externally to a controller at the proximal portion of the delivery tool.

[0095] In one application, the delivery tool further includes an mounting element surrounding the axis and configured to engage the downstream end of the prosthetic heart valve, and wherein visibility of the sheath of at least a portion of the downstream end of the prosthetic heart valve within the distal sac includes visibility of the mounting element and the downstream end of the prosthetic heart valve.

[0096] In one application:

[0097] The mounting element is shaped to define one or more grooves;

[0098] The downstream end of the prosthetic heart valve is shaped to define one or more adapters, each of which is configured to be received within a corresponding slot in the one or more slots to facilitate engagement between the mounting member and the downstream end of the prosthetic heart valve; and

[0099] Encasing the downstream end of the prosthetic heart valve in the distal capsule includes curling the downstream end of the prosthetic heart valve such that one or more adapters engage in one or more slots.

[0100] In one application, encasing the downstream end of the prosthetic heart valve in the distal sac includes maintaining the coupling between the downstream end of the prosthetic heart valve and the mounting device by encasing the downstream end of the prosthetic heart valve in the distal sac.

[0101] According to the application of the present invention, an apparatus is also provided, comprising:

[0102] Delivery tool for use with prosthetic heart valves, the delivery tool comprising:

[0103] tubular shaft;

[0104] Rod:

[0105] Extending from the shaft at its distal end, such that the distal portion of the rod is disposed outside the distal end of the shaft; and

[0106] Operablely coupled to the shaft such that rotational motion of the rod relative to the shaft is converted into axial motion of the rod relative to the shaft; and

[0107] The proximal capsule and the distal capsule, each of the proximal capsule and the distal capsule:

[0108] It has a corresponding opening end, with the opening end of the proximal sac facing the opening end of the distal sac;

[0109] Coupled to the shaft in a manner that allows the bladder to move axially relative to the shaft, along the central longitudinal axis at the distal portion; and

[0110] A first attachment, including a pawl, is coupled to the distal sac such that the pawl rotatably locks the distal sac to the rod; and

[0111] A second attachment, operatively coupled to the proximal sac, such that rotational motion of the second attachment relative to the axis is converted into axial motion of the distal sac relative to the axis.

[0112] In one application, the prosthetic heart valve includes:

[0113] The tubular portion that defines the lumen; and

[0114] Multiple prosthetic leaflets placed in the lumen, and:

[0115] The prosthetic heart valve is confined in a compressed state by the delivery tool, such that the downstream end of the tubular portion is disposed within the distal sac, and the upstream end of the tubular portion is disposed within the proximal sac.

[0116] In one application, the second accessory includes a sleeve shaped to surround the shaft, and wherein the sleeve comprises:

[0117] A user grip portion is provided to facilitate rotation of the second accessory relative to the axis; and

[0118] The remote coupling portion is configured to reversibly couple the second accessory to the remote portion.

[0119] In one application, the size of the distal coupling portion is adapted to fit within an opening in the distal portion to couple the second accessory to the distal portion.

[0120] In one application, the distal coupling portion includes one or more pins shaped to engage within corresponding holes defined by the distal portion to couple the second accessory to the distal portion.

[0121] According to the application of the present invention, a device for use with a prosthetic heart valve is also provided, the device comprising:

[0122] Delivery tool for delivering the prosthetic heart valve to the heart of a subject, the delivery tool comprising:

[0123] A catheter system, comprising one or more catheters, the catheter system having a catheter system outer diameter;

[0124] A housing for accommodating a prosthetic heart valve, the housing being disposed at the distal portion of the catheter system and having an inner diameter greater than the diameter of at least one catheter in the catheter system;

[0125] The catheter alignment mechanism includes:

[0126] An elongated outer sheath, shaped to define an elongated outer sheath lumen for slidable passage through a catheter system;

[0127] An auxiliary tube, coupled to the distal end of the elongated outer sheath, is shaped to define an auxiliary tube lumen, the size of which is adapted to encapsulate at least a portion of the housing during (1) delivery of the distal portion of the delivery tool via the lumen to at least a portion of the heart, and (2) retraction of the housing from the subject's body.

[0128] An alignment tube, positioned between the outer sheath and one or more catheters of the catheter system during delivery; and

[0129] An aligner is disposed between the alignment tube and the auxiliary tube and is configured to align one or more tubes of the catheter system relative to the auxiliary tube.

[0130] In one application, the aligner includes a ring.

[0131] In one application, the aligner is advanced distally along the one or more catheters to advance the aligner distally. The aligner and the distal portion of the aligner can slide axially within the lumen of the auxiliary tube from proximal to distal, so as to align the one or more catheters of the catheter system relative to the auxiliary tube before encapsulating the at least a portion of the housing within the auxiliary tube.

[0132] In one application, the catheter alignment mechanism:

[0133] It has an unlocked state, in which the aligner can slide axially within the auxiliary tube lumen along a proximal-to-distal axis; and

[0134] It has a locked state in which the aligner is fixedly disposed inside the auxiliary tube.

[0135] In one application:

[0136] In the unlocked state, the distal portion of the aligner and the aligning tube can slide axially within the auxiliary tube lumen along a proximal-to-distal axis;

[0137] In the locked state, the aligner and the distal portion of the alignment tube are fixedly disposed within the auxiliary tube.

[0138] In one application, the delivery tool further includes an alignment locking mechanism operatively connected to the catheter alignment mechanism to switch the catheter alignment mechanism from the locked state to the unlocked state.

[0139] In one application, the housing has an outer diameter that is larger than the outer diameter of at least one conduit in the conduit system.

[0140] In one application, the auxiliary tube has an outer diameter that is larger than the outer diameter of the slender outer sheath.

[0141] In one application, the elongated outer sheath has an elongated outer sheath outer diameter, and wherein the auxiliary tube has an auxiliary tube outer diameter that is larger than the elongated outer sheath outer diameter.

[0142] In one application, the alignment tube is slidable within the elongated outer sheath lumen and the auxiliary tube lumen, allowing the alignment device to slide between the auxiliary tube and one or more conduits.

[0143] In one application, the aligner includes a ring and has an inner diameter that is 0.05-3.0 mm larger than the outer diameter of the largest of one or more conduits passing through the aligner.

[0144] In one application, the auxiliary tube has an inner diameter, and the alignment tube has an outer diameter that is 1.9-5.5 mm smaller than the inner diameter of the auxiliary tube.

[0145] In one application:

[0146] The shell includes a proximal sac and a distal sac, each of the proximal sac and the distal sac having a corresponding open end, the open end of the proximal sac facing the open end of the distal sac.

[0147] In a compressed state, the prosthetic heart valve can be confined within a housing by a delivery tool such that the upstream portion of the prosthetic heart valve is encased by the proximal capsule, and the downstream portion of the prosthetic heart valve is encased by the distal capsule; and

[0148] The dimensions of the auxiliary tube lumen are adapted to encapsulate at least the proximal portion of the proximal sac and the distal sac.

[0149] In one application, the delivery tool is configured such that during the delivery state, the intersacral space separates the open end of the proximal sac from the open end of the distal sac, and a segment of the prosthetic heart valve is disposed at the intersacral space.

[0150] In one application:

[0151] During the delivery of the instrument into the subject's body, the auxiliary tube surrounds at least the proximal portion of the proximal and distal capsules, and the segment of the prosthetic heart valve positioned in the intercapsular space; and

[0152] Upon entry, the proximal sac, at least the proximal portion of the distal sac, and the prosthetic heart valve are exposed from the auxiliary cannula and advanced toward the heart by the advancement of at least one catheter of the catheter system.

[0153] In one application, the prosthetic heart valve includes:

[0154] The tubular portion that defines the lumen;

[0155] Multiple prosthetic leaflets are disposed in the lumen;

[0156] An upstream support portion, which extends from the tubular portion; and

[0157] Multiple flanges, each flange being coupled to the tubular portion at a corresponding coupling point downstream of the upstream support, and extending from the coupling point to the corresponding flange end of the flange.

[0158] In one application:

[0159] The shell includes a proximal sac and a distal sac, each of the proximal and distal sacs having a corresponding open end, the open end of the proximal sac facing the open end of the distal sac; and

[0160] The distal portion is configured such that, when the delivery tool is in the delivery state, the prosthetic heart valve engages with the delivery tool, such that:

[0161] The downstream end of the tubular portion is disposed within the distal sac; and

[0162] The upstream support and the flange end are disposed within the proximal bladder.

[0163] In one application, during the delivery of the instrument into the subject's body, the auxiliary tube surrounds at least the proximal portion of the proximal sac and the distal sac.

[0164] In one application, during the removal of the delivery tool from the subject's body, the auxiliary tube surrounds the proximal pouch, with the distal end of the auxiliary tube abutting against the distal pouch.

[0165] According to the application of the present invention, a method is also provided, comprising:

[0166] Using a delivery tool, a prosthetic heart valve, constructed for implantation in the subject's heart, is introduced into the subject's vascular system, the delivery tool comprising:

[0167] A catheter system, comprising one or more catheters, the catheter system having a catheter system outer diameter;

[0168] A housing for accommodating the prosthetic heart valve, the housing being disposed at the distal portion of the catheter system and having an inner diameter greater than the diameter of at least one catheter of the catheter system;

[0169] The catheter alignment mechanism includes:

[0170] An elongated outer sheath, shaped to define an elongated outer sheath lumen for slidable passage through a catheter system;

[0171] An auxiliary tube, coupled to the distal end of the elongated outer sheath, is shaped to define an auxiliary tube lumen, the size of which is adapted to encapsulate at least a portion of the housing during (1) at least a portion of a delivery state in which the distal portion of the delivery tool is delivered via the lumen to the heart, and (2) during the retraction of the housing from the subject's body.

[0172] Alignment tube, positioned between the outer sheath and one or more catheters of the catheter system; and

[0173] An aligner is disposed between the aligning tube and the auxiliary tube and is configured to align one or more tubes of the catheter system relative to the auxiliary tube;

[0174] The housing is exposed from within the auxiliary tube;

[0175] The housing is advanced into the heart by pushing the one or more catheters distally;

[0176] The prosthetic heart valve is deployed from within the housing and, during exposure, implanted into the heart;

[0177] Following the implantation, the shell is retracted proximally toward the auxiliary tube by retracting one or more catheters proximally;

[0178] (i) Aligning one or more catheters of the catheter system relative to the auxiliary tube, thereby (ii) aligning the housing relative to the auxiliary tube by moving the aligner, and orienting the aligner by moving it so that one or more catheters of the catheter system are aligned relative to the auxiliary tube;

[0179] After the alignment, the one or more catheters are retracted proximally, and the housing is encapsulated within the auxiliary tube by the retraction; and

[0180] After the encapsulation, the delivery tool is removed from the subject's body.

[0181] In one application:

[0182] The step of orienting the aligner includes switching the alignment mechanism from an unlocked state to a locked state:

[0183] In the unlocked state, the aligner can slide axially within the auxiliary tube lumen along a proximal-to-distal axis, and

[0184] In the locked state, the aligner is fixedly disposed inside the auxiliary tube.

[0185] In one application:

[0186] The step of orienting the aligner includes switching the alignment mechanism from an unlocked state to a locked state:

[0187] In the unlocked state, the aligner and the distal portion of the aligning tube are axially sliding within the auxiliary tube lumen along a proximal-to-distal axis.

[0188] In the locked state, the aligner and the distal portion of the alignment tube are fixedly disposed within the auxiliary tube.

[0189] In one application:

[0190] The delivery tool includes an alignment locking mechanism operably connected to the catheter alignment mechanism, and

[0191] The step of switching the alignment mechanism from the unlocked state to the locked state includes manipulating the alignment locking mechanism.

[0192] In one application, the method further includes: prior to the step of encapsulating the housing within the auxiliary tube, switching the alignment mechanism from an unlocked state to a locked state.

[0193] In the unlocked state, the aligner can slide axially within the auxiliary tube lumen along a proximal-to-distal axis; and

[0194] In the locked state, the aligner is fixedly disposed inside the auxiliary tube.

[0195] In one application:

[0196] The step of switching the alignment mechanism from the locked state to the unlocked state includes switching the alignment mechanism from the locked state to the unlocked state:

[0197] In the locked state, the aligner and the distal portion of the aligning tube are fixedly disposed within the auxiliary tube, and

[0198] In the unlocked state, the distal portion of the aligner and the aligning tube can slide axially within the auxiliary tube lumen along a proximal-to-distal axis.

[0199] In one application:

[0200] The delivery tool includes an alignment locking mechanism operably connected to a catheter alignment mechanism; and

[0201] The step of switching the alignment mechanism from the locked state to the unlocked state includes manipulating the alignment locking mechanism.

[0202] In one application, the alignment includes straightening a portion of the one or more catheters such that the one or more catheters and the auxiliary tube are concentrically positioned.

[0203] In one application, exposing the housing from the auxiliary tube includes pushing the one or more catheters distally while holding the outer sheath in place.

[0204] In one application, the alignment includes (i) aligning one or more catheters of the catheter system relative to the auxiliary tube, and thereby (ii) aligning the housing relative to the auxiliary tube within the vascular system at a location outside the subject's heart.

[0205] In one application, the distal portion of at least one catheter of the catheter system is configured to present a curved orientation.

[0206] In one application, when no force is applied to the distal portion, the distal portion is biased to exhibit the bending orientation.

[0207] In one application, moving the aligner includes moving the aligner to a distal end.

[0208] In one application, moving the aligner to the distal end includes pushing the alignment tube to the distal end.

[0209] In one application, the method further includes retracting the one or more catheters proximally while the aligner is moved distally.

[0210] In one application, exposing the housing from within the auxiliary tube includes retracting the outer sheath proximally relative to the one or more conduits.

[0211] In one application, exposing the housing from the auxiliary tube includes advancing the one or more catheters distally while the outer sheath retracts proximally.

[0212] According to the application of the present invention, a device for use in the heart of a subject is also provided, the device comprising:

[0213] A delivery tool, sized for percutaneous delivery to the heart, the delivery tool having a distal portion defining a distal portion axis, and the delivery tool comprising:

[0214] Axis; and

[0215] The proximal capsule and the distal capsule, each of the proximal capsule and the distal capsule:

[0216] Having a corresponding opening end, the opening end of the proximal sac faces the opening end of the distal sac; and

[0217] So that the bladder is coupled to the shaft in such a manner as to allow axial movement of the bladder relative to the shaft along the axis of the distal portion; and

[0218] Prosthetic valves, including:

[0219] The tubular portion that defines the lumen;

[0220] Multiple prosthetic leaflets are disposed in the lumen;

[0221] An upstream support portion, which extends from the tubular portion; and

[0222] Multiple flanges, each of the flanges being:

[0223] Coupled to the tubular portion at a corresponding coupling point downstream of the upstream support; and

[0224] Extending from the coupling point to the corresponding flange end of the flange;

[0225] The prosthetic valve can be confined in a compressed state by the delivery tool, such that:

[0226] The downstream end of the shaft and the tubular portion is disposed within the distal sac; and

[0227] The upstream support and the flange end are disposed within the proximal sac.

[0228] In one application, the distal bladder is coupled to the shaft in a manner that allows the distal bladder to move relative to the proximal and distal ends of the shaft.

[0229] In one application, the proximal sac and the distal sac are coupled to the shaft in a manner that facilitates the proximal and distal movement of the proximal and distal sacs relative to the shaft.

[0230] In one application, the proximal sac is coupled to the shaft in a manner that allows the proximal sac to move relative to the proximal and distal ends of the shaft.

[0231] In one application, the device includes:

[0232] A balloon catheter that extends proximally from the distal portion of the delivery instrument; and

[0233] A disc assembly, coupled to the balloon duct, the disc assembly comprising:

[0234] A proximal disc, fixedly coupled to the cyst catheter and shaped to define an external thread, and a distal disc, rotatably connected to the proximal disc.

[0235] In one application, the proximal capsule formation is defined as follows:

[0236] The longitudinal track is configured to engage the distal disk; and

[0237] Internal thread, the internal thread:

[0238] Complementary to the external thread; and

[0239] Transverse to the longitudinal track; and

[0240] The disk assembly is disposed within the proximal sac such that:

[0241] The external thread mates with the internal thread; and

[0242] The rotation of the cyst duct in the first direction facilitates:

[0243] The proximal disk rotates along a first direction; and

[0244] The proximal capsule moves longitudinally relative to the disc assembly.

[0245] In one application, the remote disk includes a locking pin disposed within a longitudinal track.

[0246] In one application, the proximal capsule includes a proximal capsule assembly having an inner proximal capsule and an outer proximal capsule, the outer proximal capsule being longitudinally movable relative to the inner proximal capsule.

[0247] In one application, the inner proximal capsule fits snugly within the outer proximal capsule.

[0248] In one application:

[0249] The inner proximal bladder defines the proximal portion of the internal thread;

[0250] The external proximal sac defines the distal portion of the internal thread; and

[0251] The rotation of the cyst duct in the first direction facilitates:

[0252] The proximal disc rotates a first helical distance along the internal thread in the first direction, so as to allow longitudinal movement of the proximal bladder assembly relative to the disc assembly; and

[0253] The proximal disc rotates a second helical distance along the internal thread in the first direction to facilitate longitudinal movement of the outer proximal bladder relative to the inner proximal bladder and the disc assembly.

[0254] In one application, the delivery tool is configured such that when the distal portion of the delivery tool is in a delivery state for lacunarly delivery of the delivery tool to the heart:

[0255] The prosthetic valve is confined to a compressed state by the delivery tool; and

[0256] The proximal capsule and the distal capsule are oriented relative to each other such that:

[0257] The intercapsular space separates the opening of the proximal capsule from the opening of the distal capsule; and

[0258] A section of the tubular portion is disposed at the intercystic space.

[0259] In one application, a distal sac and a proximal sac are respectively connected to a shaft, and the distal sac and the proximal sac are respectively coupled to the shaft such that the distal sac can be translated toward the proximal sac, such that the open end of the proximal sac meets the open end of the distal sac, thereby closing the intersacral gap.

[0260] In one application, both the distal and proximal capsules are coupled to the axis such that the distal capsule cannot translate toward the proximal capsule before the prosthetic valve detaches from the axis, so that the opening end of the proximal capsule meets the opening end of the distal capsule, thereby closing the intercapsular gap.

[0261] In one application, the delivery tool is configured such that when the distal portion of the delivery tool is in the delivery state, the length of the intercystic gap is greater than 5 mm and less than 25 mm.

[0262] In one application, the delivery tool is configured such that when the distal portion of the delivery tool is in the delivery state, the length of the intercystic space is greater than 10 mm.

[0263] In one application, the delivery tool is configured such that when the distal portion of the delivery tool is in the delivery state, the length of the intercystic gap is less than 15 mm.

[0264] In one application, the proximal sac and the distal sac are respectively coupled to the shaft, such that the distal portion of the delivery tool can be switched from the delivery state to the deployed state, such that (a) the intersacral gap of the distal portion in the deployed state is longer than (b) the intersacral gap of the distal portion in the delivery state.

[0265] In one application, the delivery tool is configured such that when the distal portion of the delivery tool is in the deployed state, the intervesicular gap is 50%-200% larger than the gap when the distal portion is in the delivery state.

[0266] In one application, the delivery tool is configured such that when the distal portion of the delivery tool is in the deployed state, the intervesicular gap is 100%-200% larger than the gap when the distal portion is in the delivery state.

[0267] In one application, the delivery tool is configured such that when the distal portion of the delivery tool is in the deployed state, the length of the intercapsular gap is greater than 15 mm and less than 40 mm.

[0268] In one application, the delivery tool is configured such that when the distal portion of the delivery tool is in the deployed state, the length of the intercapsular gap is greater than 20 mm and less than 35 mm.

[0269] According to the application of the present invention, a method for use in the heart of a subject is also provided, the method comprising:

[0270] A transcavitary delivery system is used to deliver the contents of the heart to the heart, the delivery system comprising:

[0271] A delivery tool having a distal portion defining a distal portion axis, the distal portion including a proximal sac and a distal sac, each of the proximal and distal sacs having a corresponding open end, the open end of the proximal sac facing the open end of the distal sac; and

[0272] Implants, including:

[0273] Proximal implantation portion;

[0274] Distant implantation portion;

[0275] A flange with a flanged end;

[0276] The implant is constrained by the delivery tool such that:

[0277] The proximal implant portion and the flange end are disposed within the proximal capsule; and

[0278] The distal implant portion of the implant is disposed within the distal capsule; and

[0279] The implant is deployed at the heart using the following methods:

[0280] The proximal capsule is retracted proximally relative to the implant, such that the flange end is released from the proximal capsule;

[0281] Subsequently, the distal portion of the delivery tool is retracted proximally so that the flange end contacts the tissue of the heart;

[0282] Subsequently, the proximal capsule is further retracted proximally relative to the implant, causing the proximal implanted portion to be released from the proximal capsule; and

[0283] Subsequently, the distal capsule is advanced distally relative to the implant, causing the distal implanted portion to be released from the distal capsule.

[0284] In one application:

[0285] The transcavitary advancement step includes advancing the distal portion of the delivery tool into the heart via the cavity, while the proximal sac and the distal sac are aligned along the axis of the distal portion such that the intersacral gap separates the opening end of the proximal sac from the opening end of the distal sac.

[0286] In one application, the transcavitary advancement step includes transcavitary advancement of the distal portion of the delivery tool such that a segment of the implant is positioned at the intercapsular space.

[0287] In one application:

[0288] The delivery tool further includes a flexible sheath surrounding the intercapsular space such that the sheath covers the segment of the implant; and

[0289] The method further includes exposing the segment from the sheath by retracting the sheath proximally before the proximal capsule retracts proximally relative to the implant.

[0290] In one application:

[0291] The implant includes a frame, which is constrained by the delivery tool, such that:

[0292] The proximal implant portion includes the proximal portion of the frame; and

[0293] The distal implant portion includes the distal portion of the frame; and

[0294] The step of further retracting the proximal capsule proximally includes further retracting the proximal capsule proximally relative to the proximal portion of the frame, such that the proximal portion of the frame is released from the proximal capsule; and

[0295] The step of advancing the distal bladder distally includes advancing the distal bladder distally relative to the distal portion of the frame, such that the distal portion of the frame is released from the distal bladder.

[0296] In one application:

[0297] The frame is an inner frame;

[0298] The flange is the first flange among a plurality of flanges;

[0299] The implant also includes an outer frame that defines a plurality of flanges;

[0300] Each of the flanges:

[0301] Coupled to the inner frame at corresponding coupling points located longitudinally between the proximal portion and the distal portion of the inner frame; and

[0302] Extending from the coupling point to the corresponding flange end; and

[0303] The step of retracting the proximal capsule proximally includes retracting the proximal capsule proximally relative to the implant, such that the corresponding flange end is released from the proximal capsule; and

[0304] The step of retracting the distal portion of the delivery tool proximally includes retracting the distal portion of the delivery tool proximally such that the corresponding flange end contacts the tissue of the heart.

[0305] In one application:

[0306] The implant includes a prosthetic valve, wherein:

[0307] The inner frame has a tubular portion that defines a lumen;

[0308] Multiple prosthetic leaflets are placed inside the lumen;

[0309] The proximal portion of the inner frame includes an upstream support extending from the tubular portion; and

[0310] The distal end of the inner frame includes the downstream end of the tubular portion;

[0311] The distal portion of the delivery tool further includes a shaft, and the proximal sac and the distal sac are respectively coupled to the shaft, and

[0312] The steps of transcavitary propulsion include:

[0313] When the delivery tool is in the delivery state, it is delivered transcavitally to the heart, wherein, in the delivery state, the prosthetic valve is confined in a compressed state by the delivery tool, such that:

[0314] The tubular portion engages with a portion of the shaft;

[0315] The portion of the shaft and the downstream end of the tubular portion are confined within the distal bladder;

[0316] The upstream support and the flange end are confined within the proximal sac;

[0317] The proximal sac and the distal sac are aligned along the axis of the distal portion such that the intersacral gap separates the opening end of the proximal sac from the opening end of the distal sac; and

[0318] The tubular portion is disposed at the intervesicular space; and

[0319] The delivery tool is advanced transcavitally into the ventricle of the heart, such that the distal capsule is positioned within the ventricle; and

[0320] Deploying the implant at the heart includes deploying the prosthetic valve at the heart's natural valve, such that the prosthetic valve automatically expands from the compressed state to the expanded state in the following manner:

[0321] The proximal sac retracts relative to the axial proximal end, causing the corresponding flange end to expand radially outward;

[0322] The distal portion of the delivery tool is retracted proximally so that the corresponding flange end contacts the tissue of the natural valve;

[0323] The proximal sac is further retracted proximally relative to the axis, such that:

[0324] The upstream support is released from the proximal capsule and expands radially outward; and the tissue of the natural valve is compressed between the upstream support and the flange end; and the distal capsule is advanced relative to the axial distal end, such that:

[0325] The downstream end of the tubular portion is released from the distal sac; and

[0326] The tubular portion expands radially outward.

[0327] In one application:

[0328] After the distal capsule is advanced relative to the axial distal end, the delivery device is withdrawn from the heart in the following manner:

[0329] The proximal sac is advanced relative to the distal end of the axial direction such that the opening end of the proximal sac abuts against the opening end of the distal sac; and

[0330] Subsequently, the distal portion of the delivery tool is retracted proximally through the lumen of the tubular portion.

[0331] In one application, the method includes, prior to advancing the proximal sac relative to the axial distal end:

[0332] The distal sac retracts proximally relative to the axial direction.

[0333] In one application:

[0334] The delivery system also includes a guidewire;

[0335] The delivery tool also includes a front cone with a flexible distal portion;

[0336] The method further includes advancing the guidewire through the lumen into the heart;

[0337] Advancing the delivery system into the heart via the lumen includes advancing the delivery tool along the guidewire via the lumen, such that the guidewire enters the distal portion of the anterior cone; and

[0338] Deploying the implant at the heart includes retracting the guidewire proximally from the distal portion of the anterior cone before retracting the proximal capsule relative to the implant.

[0339] In one application, the method further includes advancing the guidewire into the distal portion after advancing the distal capsule distally relative to the implant.

[0340] In one application:

[0341] The distal portion of the delivery tool further includes a shaft, and the proximal sac and the distal sac are respectively coupled to the shaft;

[0342] The proximal capsule formation is defined as follows:

[0343] Longitudinal track

[0344] An internal thread that passes through the longitudinal track;

[0345] The delivery tool includes:

[0346] A balloon catheter extending from the distal portion of the delivery tool towards the proximal portion; and a disc assembly comprising:

[0347] A proximal disc is fixedly coupled to the cystic duct, the proximal disc being shaped to define an external thread complementary to the internal thread;

[0348] The remote disk, the remote disk:

[0349] The dimensions are set to engage the longitudinal track;

[0350] Fixedly coupled to the shaft, and

[0351] Rotatably coupled to the proximal disk;

[0352] Wherein, the disk assembly is disposed within the proximal sac, such that the external thread engages with the internal thread; and

[0353] The proximal retraction of the capsule relative to the implant includes rotating the capsule catheter in a first direction such that:

[0354] The proximal disk rotates along the internal thread in the first direction; and

[0355] The proximal capsule moves relative to the following along the axis of the distal portion:

[0356] The disk assembly, and

[0357] The implant.

[0358] In one application:

[0359] The proximal capsule includes a proximal capsule assembly having an inner proximal capsule and an outer proximal capsule; and

[0360] The step of retracting the proximal capsule proximally includes:

[0361] The proximal capsule assembly retracts proximally relative to the disk assembly; and

[0362] The outer proximal sac retracts proximally relative to the inner proximal sac and the disc assembly.

[0363] In one application:

[0364] The inner proximal bladder defines the proximal portion of the internal thread;

[0365] The external proximal sac defines the distal portion of the internal thread; and

[0366] The proximal capsule assembly retracts proximally relative to the disc assembly, comprising:

[0367] The balloon catheter is rotated a first helical distance along the internal thread in the first direction to allow longitudinal movement of the proximal balloon assembly relative to the disc assembly and the implant; and

[0368] The cyst catheter is rotated a second helical distance along the internal thread in the first direction, so that the external proximal cyst is moved longitudinally relative to:

[0369] The internal proximal capsule

[0370] The disk assembly, and

[0371] The implant.

[0372] In one application:

[0373] The distal disk includes a locking pin disposed within the longitudinal track; and

[0374] Rotating the cyst catheter along the first direction includes advancing the locking pin along the longitudinal track.

[0375] According to the application of the present invention, a device for use in the heart of a subject is also provided, the device comprising:

[0376] A delivery tool having a distal portion defining a distal portion axis, and the delivery tool comprising:

[0377] The proximal capsule and the distal capsule, each of the proximal capsule and the distal capsule:

[0378] Having corresponding open ends, the proximal capsule's open end faces the distal capsule's open end, such that when the distal portion of the delivery tool is in a delivery state involving transcavitary delivery of the delivery tool to the heart, the intersacral gap separates the open ends of the proximal capsule and the distal capsule; and

[0379] An implant, said implant being confined in a compressed state by said delivery tool; and

[0380] One segment of the implant is disposed in the intercapsular space.

[0381] In one application, the implant includes a prosthetic valve.

[0382] In one application, the prosthetic valve includes:

[0383] The tubular portion that defines the lumen;

[0384] Multiple prosthetic leaflets are disposed in the lumen;

[0385] An upstream support extending from the tubular portion; and

[0386] A plurality of flanges, each of which is coupled to the tubular portion at a corresponding coupling point downstream of the aforementioned downstream support portion, and extends from the coupling point to a corresponding flange end of the flange.

[0387] In one application, the distal portion is configured such that when the delivery tool is in the delivery state, the prosthetic valve engages with the delivery tool, such that:

[0388] The downstream end of the tubular portion is disposed within the distal sac;

[0389] The upstream support and the flange end are disposed within the proximal sac; and

[0390] The tubular portion is a section of the implant disposed in the intercapsular space.

[0391] In one application, the device further includes a flexible sheath surrounding the intercapsular space such that the sheath covers the segment of the implant.

[0392] In one application, the proximal sac is covered by the sheath.

[0393] In one application, the distal end of the sheath abuts against the distal pouch.

[0394] In one application, the distal end of the sheath is partially disposed within the distal bladder.

[0395] In one application, the sheath comprises a polymer.

[0396] In one application, the sheath comprises fabric.

[0397] According to the application of the present invention, an apparatus for percutaneously delivering an implant to a subject is also provided, the apparatus comprising:

[0398] Guide wire; and

[0399] A delivery tool having a proximal portion and a distal portion, the delivery tool comprising:

[0400] An external controller located at the proximal portion of the delivery tool;

[0401] A delivery catheter that connects the external controller to the distal portion of the delivery tool, the delivery catheter being configured such that the guidewire can extend through the delivery catheter; and

[0402] A capsule at the distal portion of the delivery tool, the capsule being configured to accommodate an implant, the capsule including an anterior cone having a flexible distal portion, wherein:

[0403] When the guidewire is not present from the distal portion, the distal portion has a curled, stationary shape; and

[0404] When the guidewire is located within the distal portion, the distal portion is straightened.

[0405] According to an application of the present invention, a device for percutaneously delivering an implant to a subject, the device comprising a delivery tool, the delivery tool comprising:

[0406] An external controller located at the proximal portion of the delivery tool;

[0407] A sac at the distal portion of the delivery tool, wherein the sac defines a chamber; and

[0408] A shaft extending from the external controller to the capsule, and comprising:

[0409] A rigid proximal shaft segment extending distally from the external controller;

[0410] A flexible shaft segment extending distally from the rigid proximal shaft segment; and

[0411] A rigid distal shaft segment extending distally from the flexible shaft segment, the rigid distal shaft segment extending through at least a portion of the chamber of the sac, each rigid shaft segment being more rigid than the flexible shaft segment.

[0412] In one application, the delivery tool further includes at least one pull cord operably connecting the distal portion of the delivery tool to the controller, such that operation of the controller facilitates manipulation of the distal portion using the pull cord.

[0413] In one application, the rigid distal shaft segment extends distally out of the chamber of the bladder.

[0414] In one application, the rigid distal shaft segment is a first rigid distal shaft segment, and the delivery tool further includes a second rigid distal shaft segment, wherein the first rigid distal shaft segment and the second rigid distal shaft segment are configured to slide extensibly relative to each other.

[0415] In one application, the device includes an implant, wherein:

[0416] The delivery tool further includes a mounting element attached to the rigid distal shaft segment; and

[0417] The implant:

[0418] Engage with the mounting component; and

[0419] It is compressed onto a portion of the rigid distal shaft segment.

[0420] In one application, the implant is at least partially housed within the cavity of the capsule.

[0421] In one application, the length of the rigid proximal shaft segment is greater than 50 cm and less than 100 cm.

[0422] In one application, the length of the rigid proximal shaft segment is greater than 70 cm and less than 75 cm.

[0423] In one application, the length of the flexible shaft segment is greater than 5 cm and less than 10 cm.

[0424] In one application, the length of the flexible shaft segment is greater than 6 cm and less than 8 cm.

[0425] In one application, the length of the rigid distal shaft segment is greater than 2 cm and less than 10 cm.

[0426] In one application, the length of the rigid distal shaft segment is greater than 4 cm and less than 7 cm.

[0427] According to the application of the present invention, a method is also provided, comprising:

[0428] An implant placed within a capsule is advanced into the subject, the capsule being coupled to a flexible capsule catheter that extends through a flexible second catheter and protrudes from a distal portion of the second catheter, the distal portion of the second catheter abutting against the capsule;

[0429] Subsequently, by axially separating the second catheter from the balloon, the distal portion of the balloon catheter is exposed from the second catheter; and

[0430] Subsequently, the implant is released from the capsule by retracting the distal portion of the capsule catheter back into the second catheter and moving the capsule proximally away from the implant.

[0431] In one application, the advancement step includes advancing the implant into the subject in the following situations:

[0432] The distal portion of the second catheter is disposed within the flexible first catheter;

[0433] The bladder is positioned away from the second catheter; and

[0434] The distal portion of the first catheter abuts against the capsule.

[0435] In one application, the method further includes exposing a distal portion of the second catheter from the first catheter by axially separating the second catheter from the capsule after the advancement step and before the release step.

[0436] In one application, the method further includes, after exposing the distal portion of the second catheter and before releasing the implant from the capsule:

[0437] The distal portion of the second catheter is bent relative to the first catheter by actuating the bending actuator of the external control system.

[0438] In one application:

[0439] The bending actuator is a second catheter bending actuator operably connected to one or more second catheter bending control elements, the second catheter bending control elements extending from the second catheter bending actuator along the second catheter to a distal portion of the second catheter; and

[0440] Bending the distal portion of the second catheter relative to the first catheter includes tensioning at least one of the second catheter bending control elements by actuating the second catheter bending actuator to bend the distal portion of the second catheter relative to the first catheter.

[0441] In one application, the method further includes, prior to releasing the implant from the capsule, bending the distal portion of the first catheter by actuating a first catheter bending actuator of the external control system, the first catheter bending actuator being operatively coupled to one or more first catheter bending control elements extending from the first catheter bending actuator along the first catheter to the distal portion of the first catheter; wherein bending the distal portion of the first catheter includes tensioning at least one of the first catheter bending control elements by actuating the first catheter bending actuator to bend the distal portion of the first catheter.

[0442] In one application, during the advancement process, the implant is coupled to an mount, the mount is coupled to a shaft that extends through the balloon catheter and into the balloon, and wherein retracting a distal portion of the balloon catheter into the second catheter includes sliding the distal portion of the balloon catheter proximally on the shaft.

[0443] In one application:

[0444] The capsule is a first capsule having an open distal end;

[0445] The rod extends distally from the shaft;

[0446] The second sac is coupled to the distal portion of the rod and includes a circumferential wall extending from the distal portion of the rod toward the proximal end to define (i) a chamber and (ii) an opening proximal end facing the distal end of the opening of the first sac.

[0447] During the advancement process, a first portion of the implant is disposed within the first capsule, and a second portion of the implant is disposed within the second capsule; and

[0448] The method further includes moving the rod distally through the axis, and releasing the second portion of the implant from the second capsule by moving the second capsule distally relative to the mount.

[0449] In one application, the rod defines a thread, and moving the rod distally through the shaft includes rotating the rod such that the thread converts the rotation of the rod into axial movement of the rod.

[0450] In one application, releasing the second portion of the implant from the second capsule includes releasing the second portion of the implant from the second capsule before releasing the first portion of the implant from the first capsule.

[0451] In one application, releasing the second portion of the implant from the second capsule includes releasing the second portion of the implant from the second capsule before releasing the distal portion of the capsule catheter from the second catheter.

[0452] In one application, the method further includes bending the distal portion of the balloon catheter relative to the second catheter by actuating a bending actuator of an external control system after exposing the distal portion of the balloon catheter and before releasing the implant from the balloon.

[0453] In one application:

[0454] During the advancement process, the implant is coupled to the mounting element, the mounting element is coupled to the shaft, and the shaft extends through the cyst catheter and into the cyst;

[0455] The bending actuator is a shaft bending actuator operatively coupled to one or more shaft bending control elements, the shaft bending control elements extending along the shaft to a distal portion of the shaft; and

[0456] Bending the distal portion of the balloon catheter relative to the second catheter includes bending the distal portion of the axial end, while the distal portion of the axial end is disposed within the distal portion of the balloon catheter, while bending the distal portion of the balloon catheter relative to the second catheter.

[0457] According to an application of the invention, the device includes a delivery tool for use with an implant, the delivery tool comprising:

[0458] An external control system at the proximal portion of the delivery tool, the control system including a second catheter bending actuator and an shaft bending actuator;

[0459] A flexible second conduit extends distally from the control system and includes one or more first tube bending control elements operatively coupled to a first tube bending actuator, the first tube bending control elements extending distally from the control system and along the second conduit to a first tube distal portion of the second conduit.

[0460] A flexible balloon catheter, extending distally from the control system via a second catheter to the distal portion of the balloon catheter; and

[0461] A flexible shaft, extending distally from the control system via the endoscopic catheter, and including one or more shaft bending control elements operatively coupled to the shaft bending actuator, the shaft bending control elements extending distally from the control system along the shaft to a distal portion of the shaft; and

[0462] Through the control system:

[0463] (i) the distal portion of the first tube is axially slidable distally on the distal portion of the balloon catheter to enclose the distal portion of the balloon catheter within the distal portion of the first tube, and (ii) the distal portion of the first tube is axially slidable proximally away from the distal portion of the balloon catheter to expose the distal portion of the balloon catheter from the second catheter.

[0464] (i) the distal portion of the balloon catheter is axially slidable distally on the distal portion of the axial end to enclose the distal portion of the balloon catheter within the distal portion of the balloon catheter, and (ii) the distal portion of the balloon catheter is axially slidable proximally away from the distal portion of the axial end to expose the distal portion of the axial end from the balloon catheter.

[0465] The actuation of the first tube bending actuator actively bends the distal portion of the first tube via the first tube bending control element;

[0466] The actuation of the shaft bending actuator actively bends the distal portion of the shaft via the shaft bending control element;

[0467] The control system does not include a cyst catheter bending actuator, and the cyst catheter does not include a bending control element that allows the distal portion of the cyst catheter to be actively bent.

[0468] In one application:

[0469] Each of the first tube bending control elements includes a corresponding pull wire extending from the first tube bending actuator and passing through a corresponding secondary lumen of the second conduit, and the pull wire is secured to the second conduit at the distal portion of the first tube; and

[0470] Each of the shaft bending control elements includes a corresponding draw wire that extends from the shaft bending actuator and passes through a corresponding secondary lumen of the shaft, and the draw wire is secured to the shaft at a distal portion of the shaft.

[0471] In one application, each of the shaft bending control elements includes a corresponding drawwire that extends from the shaft bending actuator and through a corresponding secondary lumen of the shaft, and the drawwire is distally secured to the shaft from the cystic catheter.

[0472] In one application, the distal portion of the balloon catheter is flexible enough that when the distal shaft portion is encased within the distal portion of the balloon catheter, the bending of the distal shaft portion caused by the actuation of the shaft bending actuator results in the passive bending of the distal portion of the balloon catheter.

[0473] In one application, the distal portion of the balloon catheter is flexible enough that when the distal portion of the balloon catheter is encased within the distal portion of the first tube, the bending of the distal portion of the first tube caused by the actuation of the first tube bending actuator results in the distal portion of the balloon catheter being passively bent.

[0474] In one application, where:

[0475] The delivery tool includes a pole and a bag;

[0476] The rod extends distally from the shaft;

[0477] The sac is coupled to the distal portion of the rod and includes a circumferential wall extending proximally from the distal portion of the rod to define a chamber; and

[0478] The rod is axially movable relative to the axis, and the axial movement of the rod relative to the axis causes the sac to move axially relative to the sac catheter.

[0479] In one application, the delivery tool further includes a sac coupled distally to the sac catheter from the second catheter, and the sac is sized to accommodate at least a portion of the implant; wherein the axially distally extending portion extends through the sac, and wherein axial sliding of the distal portion of the sac catheter away from the axially distal portion causes the sac to slide proximally along the axially distal portion.

[0480] In one application, each of the shaft bending control elements includes a corresponding draw wire that extends from the shaft bending actuator and passes through a corresponding secondary lumen of the shaft, and the draw wire is secured to the shaft within the bladder.

[0481] In one application, the distal portion of the second catheter can slide axially distally to abut against the capsule.

[0482] In one application, where:

[0483] The control system also includes a first conduit bending actuator;

[0484] The delivery tool further includes a flexible first catheter extending distally from the control system, and the flexible first catheter includes one or more first catheter bending control elements; the first catheter bending control elements are operatively coupled to a first catheter bending actuator, and the first catheter bending control elements extend from the control system along the first catheter to a first catheter distal portion of the first catheter;

[0485] The shaft extends distally from the control system through the first conduit to the distal portion of the shaft, and (i) the shaft slides axially proximally through the first conduit such that the distal portion of the shaft is encased within the distal portion of the first conduit, and (ii) the shaft slides axially distally through the first conduit such that the distal portion of the shaft is exposed from the first conduit; and

[0486] The actuation of the first catheter bending actuator actively bends the distal portion of the first catheter via the first catheter bending control element.

[0487] In one application, the control system includes an external first juxtaposed actuator operatively coupled to the first conduit and the second conduit, such that actuation of the external first juxtaposed actuator causes the second conduit to slide axially relative to the first conduit.

[0488] In one application, where:

[0489] The second catheter is rotatably locked to the first catheter by (i) a proximal lock defined by the control system and (ii) a distal lock; at the distal lock, the first catheter includes a first catheter coupler; and

[0490] The second catheter includes a second catheter coupler that is rotatably locked to the first catheter coupler.

[0491] In one application, the second catheter is rotatably locked to the first catheter.

[0492] According to the application of the present invention, an apparatus is also provided, comprising:

[0493] With the delivery tool used for the implant, the delivery tool includes:

[0494] tubular shaft;

[0495] Rod:

[0496] Extending from the distal end of the shaft within the shaft;

[0497] It has a distal portion disposed outside the distal end of the shaft; and

[0498] Operablely coupled to the shaft such that rotational motion of the rod relative to the shaft is converted into axial motion of the rod relative to the shaft; and

[0499] A sac, coupled to the distal portion of the rod, and including a circumferential wall; the circumferential wall extending from the distal portion of the rod towards the proximal end to define a chamber; and

[0500] The attachment includes a pawl; the attachment is coupled to the sac such that the pawl rotatably locks the sac to the rod.

[0501] In one application:

[0502] The delivery tool has an extended state and a retracted state, and the axial movement of the rod relative to the shaft causes the delivery tool to extend from the retracted state to the extended state;

[0503] In the retracted state, a portion of the shaft is disposed within the cavity; and

[0504] In the unfolded state, the portion of the shaft is positioned outside the chamber.

[0505] In one application, where:

[0506] The device includes a latch coupled to the rod;

[0507] The pouch defines a lateral pawl hole extending from outside the pouch toward the latch; and

[0508] The accessory is coupled to the pouch such that the pawl extends through the pawl hole and engages the latch to rotatably lock the pouch to the rod.

[0509] In one application, the accessory includes a clip, and the accessory can be coupled to the bladder by clipping the clip onto the bladder, such that the pawl rotatably locks the bladder to the rod.

[0510] In one application, the accessory includes a C-shaped clip, and the accessory can be coupled to the pouch via the C-shaped clip placed on the pouch, such that the pawl rotatably locks the pouch to the rod.

[0511] In one application, the delivery tool includes a mounting element coupled to the shaft, extending radially outward from the shaft, and shaped to define a plurality of implant receiving slots arranged circumferentially, each of the plurality of implant receiving slots being shaped to receive a corresponding portion of an implant.

[0512] In one application:

[0513] The delivery tool has an extended state and a retracted state, wherein axial movement of the rod relative to the distal end of the axial direction causes the delivery tool to extend toward the extended state, and axial movement of the rod relative to the proximal end of the axial direction causes the delivery tool to retract toward the retracted state.

[0514] In the retracted state, the plurality of implant receiving slots are disposed within the cavity; and

[0515] In the deployed state, the plurality of implant receiving slots are disposed outside the cavity.

[0516] In one application, the rod is shaped to define an external thread, and the external thread provides operable coupling between the rod and the shaft.

[0517] In one application, the shaft is shaped to define an internal thread, and the engagement between the internal thread and the external thread provides operable coupling between the rod and the shaft.

[0518] In one application, attachments include:

[0519] A first component, including the pawl and coupled to the pouch, such that the pawl rotatably locks the pouch to the rod; and

[0520] The knob, after the first component is coupled to the bladder, can be coupled to the first component and facilitates manual rotation of the accessory, the bladder, and the rod by manually grasping and rotating the knob.

[0521] In one application, the knob is shaped to define an opening that is sized to (i) allow the distal tip of the bladder to pass through the opening and (ii) accommodate and engage the first component.

[0522] According to the application of the present invention, a method is also provided, comprising:

[0523] The implant is placed on the distal portion of a delivery tool, the delivery tool: (a) having a proximal portion, and (b) including a capsule at the distal portion and a controller at the proximal portion;

[0524] The implant is externally encased in the capsule by spirally moving the capsule over the implant;

[0525] Subsequently, the sheathed implant and the distal portion of the delivery tool are advanced into the subject, while the proximal portion of the delivery tool remains outside the subject; and

[0526] Subsequently, the implant is deployed from within the capsule by linearly moving the capsule away from the implant.

[0527] In one application, enclosing the implant in a capsule involves enclosing the implant in a capsule by applying a rotational force to the capsule at the distal end of the delivery tool, thereby causing the capsule to move helically over the implant.

[0528] In one application, linearly moving the capsule away from the implant includes linearly moving the capsule away from the implant by applying an opening force to the controller at the proximal portion of the delivery tool.

[0529] In one application, the delivery tool includes a rod extending between the distal and proximal portions of the delivery tool, and wherein helically moving the capsule on the implant includes rotating the rod in a first rotational direction.

[0530] In one application, the delivery tool includes a shaft, a distal portion of the rod extending from the axial distal end, and wherein rotating the rod in the first rotational direction includes screwing the distal portion of the rod into the rod.

[0531] In one application, the capsule linearly exiting the implant includes rotating the rod in a second rotational direction opposite to the first rotational direction.

[0532] In one application, rotating the rod in the first rotational direction includes driving the rotation of the rod from the distal portion of the delivery tool, and wherein rotating the rod in the second rotational direction includes driving the rotation of the rod from the proximal portion of the delivery tool.

[0533] In one application:

[0534] Rotating the rod in the first rotational direction includes rotating the rod in the first rotational direction while the bladder is rotatably locked relative to the rod; and

[0535] The method further includes, after encapsulating the implant externally and before deploying the implant internally, rotating the capsule relative to the rod to unlock it.

[0536] In one application, rotating the capsule relative to the rod to unlock it includes rotating the capsule relative to the rod before the advancement step.

[0537] In one application:

[0538] Rotating the rod in the first rotational direction while the bladder is rotatably locked relative to the rod includes rotating the rod in the first rotational direction, while also including a pawl attachment coupled to the bladder such that the pawl rotatably locks the bladder to the rod; and

[0539] Unlocking the sac by rotating it relative to the rod includes decoupling the accessory from the sac.

[0540] In one application, rotating the rod in the first rotational direction includes using the attachment to drive the rotation of the rod.

[0541] According to the application of the present invention, a method is also provided, comprising:

[0542] The implant is placed on the distal portion of a delivery tool, the delivery tool having a proximal portion, and the delivery tool including a capsule at the distal portion and a controller at the proximal portion;

[0543] The implanted object is externally encased in the capsule by applying a sheathing force to the distal portion of the delivery tool externally;

[0544] Subsequently, the sheathed implant and the distal portion of the delivery tool are advanced into the subject, while the proximal portion of the delivery tool remains outside the subject; and

[0545] Subsequently, the implant is deployed from within the capsule by applying an opening force externally to the controller.

[0546] In one application, applying the sheathing force externally to the distal portion of the delivery tool includes applying the sheathing force externally to the sac.

[0547] In one application, applying the sheathing force externally to the distal portion of the delivery tool includes rotating the bladder.

[0548] In one application, the delivery tool includes a rod extending between the distal and proximal portions of the delivery tool, and wherein applying the sheathing force externally to the distal portion of the delivery tool includes rotating the rod in the first rotational direction by applying the sheathing force externally to the distal portion of the delivery tool.

[0549] In one application, applying the sheath-opening force externally to the controller includes rotating the rod in a second rotational direction, which is opposite to the first rotational direction, by applying the sheath-opening force externally to the controller body.

[0550] In one application:

[0551] Rotating the rod in the first rotational direction includes rotating the rod in the first rotational direction while the bladder is rotatably locked relative to the rod; and

[0552] The method further includes, after encapsulating the implant externally and before deploying the implant internally, rotating the capsule relative to the rod to unlock it.

[0553] In one application, rotating the capsule relative to the rod to unlock it includes rotating the capsule relative to the rod before the advancement step.

[0554] In one application:

[0555] Rotating the rod in the first rotational direction while the pouch is rotatably locked relative to the rod includes rotating the rod in the first rotational direction while coupling an attachment including a pawl to the pouch, such that the pawl rotatably locks the pouch to the rod; and

[0556] Unlocking the sac relative to the rod by rotating it includes decoupling the accessory from the sac.

[0557] In one application, the sheathing force is a rotational force, and wherein rotating the rod in the first rotational direction while the sheath is rotatably locked relative to the rod includes applying the rotational force to the attachment such that the attachment applies the rotational force to the rod.

[0558] According to the application of the present invention, a method is also provided, comprising:

[0559] A delivery tool having a proximal portion and a distal portion is used, and the delivery tool includes:

[0560] The sac in the distal portion,

[0561] Axis, and

[0562] A rod, extending from the proximal portion, passing through the shaft, and extending from the distal end of the shaft, and the rod being coupled to the sac:

[0563] The implant is placed on the delivery tool such that the implant is positioned around the axis;

[0564] The implant is externally encapsulated within the capsule by rotating the capsule relative to the axis but not relative to the rod; and

[0565] Subsequently, the implant is deployed internally from within the capsule by rotating the rod relative to the axis and relative to the capsule.

[0566] According to the application of the present invention, a method is also provided, comprising:

[0567] A delivery tool having a proximal portion and a distal portion is used, and the delivery tool includes:

[0568] The sac in the distal portion,

[0569] Axis, and

[0570] A rod extending between the proximal and distal portions, and coupled to the sac:

[0571] The implant is placed on the delivery tool from the capsule towards the proximal end;

[0572] Subsequently, the rod is rotated so that the rod and the capsule move proximally relative to the implant, thereby externally encapsulating the implant in the capsule;

[0573] Subsequently, at the proximal portion, the rod controller is engaged with the proximal region of the rod; and subsequently, the implant is deployed from within the capsule by rotating the rod relative to the axis using the rod controller to move the rod and the capsule distally relative to the implant.

[0574] In one application:

[0575] The delivery tool further includes a shaft, and the rod extends from the proximal region through the shaft and extends beyond the distal end of the shaft, and the rod is coupled from the distal end of the shaft to the pouch; and

[0576] Placing the implant on the delivery tool includes placing the implant on the delivery tool such that the implant restricts the axis from the capsule proximally.

[0577] In one application, the method includes, but is further, moving the capsule relative to the axial distal end while the rod controller is not engaged with the rod before placing the implant on the delivery tool.

[0578] In one application, the lever controller is disengaged from the lever before the bladder is moved relative to the axial distal end.

[0579] In one application, moving the bladder relative to the axial distal end includes rotating the proximal region of the rod between the fingers and the thumb.

[0580] According to the application of the present invention, an apparatus is also provided, comprising:

[0581] First catheter controller;

[0582] First catheter:

[0583] Extending distally from the first catheter controller; and

[0584] It has a first distal portion of a catheter, the first distal portion of which includes a first distal end of a catheter operatively coupled to a first catheter controller, so as to be able to bend in a first catheter manipulation plane by actuation of the first catheter controller;

[0585] Second catheter controller; and

[0586] Second catheter:

[0587] Extending distally from the second catheter controller through the first catheter; and

[0588] The device has a second distal portion, the second distal portion including a second distal end extending distally beyond the first distal end; and the second distal portion is operatively coupled to a second catheter controller to be flexible in a second catheter actuation plane by actuation of the second catheter controller, wherein:

[0589] The second catheter is rotatably oriented relative to the first catheter such that when the distal end of the first catheter bends within the first catheter manipulation plane, the bending of the distal end of the second catheter caused by the actuation of the second catheter controller results in the rotation of the distal end of the second catheter relative to the distal end of the first catheter, causing the second catheter manipulation plane to move in a direction perpendicular to the first catheter manipulation plane.

[0590] In one application:

[0591] The second catheter is rotatably locked to the first catheter by (i) a proximal lock defined by the control system and (ii) a distal lock; at the distal lock, the first catheter includes a first catheter coupler; and

[0592] The second catheter includes a second catheter coupler that is rotatably locked to the first catheter coupler.

[0593] In one application, the second catheter is rotatably locked to the first catheter.

[0594] According to the application of the present invention, a method is also provided, comprising:

[0595] Using a catheter system, the catheter system includes:

[0596] First catheter controller;

[0597] First catheter:

[0598] Extending distally from the first catheter controller; and

[0599] It has a first distal portion of a catheter, the first distal portion of which includes a first distal end of a catheter operatively coupled to the first catheter controller;

[0600] Second catheter controller; and

[0601] Second catheter:

[0602] Extending distally from the second catheter controller through the first catheter; and

[0603] The second catheter distal portion includes a second catheter distal end extending distally beyond the first catheter distal end, and the second catheter distal portion is operatively coupled to the second catheter controller.

[0604] By actuation of the first catheter controller, the distal end of the first catheter is bent within the first catheter manipulation plane; and

[0605] The distal end of the second catheter is bent in the second catheter manipulation plane by actuation of the second catheter controller;

[0606] Bending the distal end of the second catheter in the second catheter manipulation surface includes rotating the distal end of the second catheter relative to the distal end of the first catheter, such that the second catheter manipulation surface moves in a direction perpendicular to the first catheter manipulation surface.

[0607] In one application:

[0608] The catheter system further includes a lock configured to rotatably lock the first catheter relative to the second catheter; and

[0609] The method includes:

[0610] Before bending the distal end of the first catheter, the first catheter is rotated and locked relative to the second catheter; and

[0611] Before bending the distal end of the second catheter, the first catheter is unlocked by rotating it relative to the second catheter.

[0612] The invention will be more fully understood through the following detailed description of its application in conjunction with the accompanying drawings. Attached Figure Description

[0613] Figure 1A -C is a schematic diagram illustrating a delivery tool according to some applications of the present invention;

[0614] Figure 2A The diagram shows a known dual-catheter system in the prior art in boxes A and B, and a hypothetical state of the dual-catheter system in box C.

[0615] Figure 2B This is a schematic diagram illustrating a catheter system according to some applications of the present invention;

[0616] Figure 3A -D, Figure 4A -H, Figure 5A -B, Figure 6 as well as Figure 7 This is a schematic diagram illustrating delivery tools for implants in various states, according to some applications of the invention;

[0617] Figure 8A -G and Figure 9 This is a schematic diagram illustrating at least some steps of loading an implant into a capsule assembly of a delivery tool according to some applications of the present invention;

[0618] Figure 10A -E is a schematic diagram illustrating a delivery tool according to some applications of the present invention;

[0619] Figure 11 This is a schematic diagram illustrating a delivery tool when the prosthetic valve is in an expanded state, according to some applications of the present invention;

[0620] Figure 12 and 13A -B is a schematic diagram illustrating a prosthetic valve confined in a compressed state by a delivery tool according to some applications of the present invention;

[0621] Figure 14A -J is a schematic diagram illustrating a delivery tool for deploying a prosthetic valve at the tricuspid valve of a subject's heart, according to some applications of the invention;

[0622] Figure 15A -B is a schematic diagram illustrating a delivery tool according to some applications of the present invention;

[0623] Figure 16A -I is a schematic diagram illustrating some steps of loading a prosthetic valve onto the distal portion of a delivery tool according to some applications of the present invention;

[0624] Figure 16J-K is a schematic diagram illustrating the advancement of an alignment mechanism on a conduit system for a delivery tool according to some applications of the present invention;

[0625] Figure 17A -B is a schematic diagram illustrating the use of a delivery tool to advance a prosthetic valve toward the heart in some applications according to the present invention; and

[0626] Figure 18A -O is a schematic diagram illustrating the use of a delivery tool to deploy a prosthetic valve at the tricuspid valve of the heart in some applications according to the present invention, and the use of an alignment mechanism to withdraw the delivery tool from the subject; Figure 19A -T is a schematic diagram illustrating the use of a delivery tool to deploy a prosthetic valve at the tricuspid valve of the heart in some applications according to the present invention, and the use of an alignment mechanism to withdraw the delivery tool from the subject; and

[0627] Figure 20A -F is a schematic diagram illustrating a delivery tool for deploying a prosthetic valve at the tricuspid valve of the heart, according to some applications of the invention. Detailed Implementation

[0628] refer to Figure 1A -C, which is a schematic diagram of a delivery tool 100 according to some applications of the present invention.

[0629] As shown in Figure 1A, the delivery tool 100 is a multi-catheter transluminal (e.g., transfemoral) delivery tool, comprising two main components: a catheter system 110 and an implantation device 160.

[0630] The catheter system 110 includes a first catheter unit 120, which includes a first catheter (e.g., an external catheter) 122 coupled at its proximal end to a first catheter handle 124; and a second catheter unit 130, which includes a second catheter 132 coupled at its proximal end to a second catheter handle 134. The proximal opening of the second catheter 132 is accessible proximally from the first catheter 122, and the second catheter extends distally through the lumen of the first catheter 122 and extends distally out of the first catheter. Typically, the second catheter handle 134 is located proximal to the first catheter handle 124. Typically, handles 124 and 134 are mounted on a mounting bracket 108 to stabilize the handle during use. Further typically, the handles are mounted in a manner that facilitates selective adjustment of the axial and / or rotational position of the handle and thus facilitates selective adjustment of the corresponding catheter.

[0631] Typically, each of catheters 122 and 132 is steerable, and this steerability is controlled by a corresponding controller 126, 136 (which may optionally be referred to as a bending actuator) of the respective catheter unit. Each controller is operatively coupled to the steerable distal portion of its respective catheter via one or more bending control elements (e.g., a drawstring) extending along and within the respective catheter. This will be described in more detail below. It should be noted that the term “steerable” (including in the specification and claims) means actively steerable (e.g., by an external control system), and not merely sufficiently flexible to bend responsively when pressed against a surface. Controllers 126 and 136 are typically mounted on a corresponding handle of their respective catheter units. As shown, controllers 126 and 136 may be rotatable controllers, such as wheels.

[0632] Implantable devices 160 ( Figure 1A and 1C The delivery tool 100 has a proximal portion 161, which is generally disposed proximally from handles 124 and 134 and is also generally mounted on the mounting member 108. Handles 124, 134, and the proximal portion 161 are disposed at a proximal portion 104 of the delivery tool 100, which is configured to remain outside the subject during use. The proximal portion 104 can be considered an external control system. The distal portion 102 of the delivery tool 100 (e.g., the distal portion 163 of the implantation device 160) is configured to be advanced into the subject and includes a capsule assembly 200 that accommodates the implant 20 during this advancement.

[0633] The device 160 includes a plurality of tubular members extending distally from a proximal portion 161, said tubular members being coaxial about a central longitudinal axis ax1 of the delivery tool 100, and discussed in more detail below. The outermost of these tubular members is typically a balloon catheter 162, which extends distally from the proximal portion 161 through a catheter 132, extending distally from the opening of the catheter 132 to a distal portion 102. At the distal portion 102, the balloon catheter 162 abuts against, and / or couples to, the proximal balloon 202 of the balloon assembly 200. Figure 1B The proximal balloon 202 includes a circumferential wall extending distally from the balloon conduit 162 to define a chamber of the proximal balloon. The balloon assembly 200 also includes a distal balloon 204. Each of balloons 202 and 204 has a corresponding open end facing the open end of the other balloon (see reference below). Figure 14G (Description of open ends 1065 and 1067 in the text).

[0634] like Figure 1CThe upper illustration shows a cross-sectional view. The tubular component of the device 160 includes a shaft 164 that extends distally from the proximal portion 161 and coaxially through the balloon duct 162. Figure 3A As shown, shaft 164 typically extends through proximal sac 202 and protrudes from the opening end of the proximal sac.

[0635] As described below (for example, see references) Figure 4A -H) To deliver the implant 20, the implant is housed within the capsule assembly 200 and compressed about axis 164. For some applications, mounting element 172 ( Figure 1B , 3A -D) Engages with the implant, fixedly coupled to the distal end of shaft 164. Alternatively, or in addition to the mounting piece engaging the implant, the implant may engage with a portion of the shaft, with necessary modifications.

[0636] Typically, the downstream portion of the implant (e.g., see below) Figure 11 The downstream end 1016 of the prosthetic valve 1036 described in frame A is disposed within the distal capsule 204 and engages with the mounting 172 (e.g., its implant engagement groove 175), and the upstream portion of the implant (e.g., see reference) Figure 11 The upstream end 1014 of the prosthetic valve described in frame A is positioned within the proximal sac 202.

[0637] A rod 168 (top illustration of Figure 1) is coaxially disposed through a shaft 164. The rod 168 may define a guidewire lumen passing through it, and thus may be another tubular member of the instrument 160. The rod 168 extends distally from the shaft 164. Figure 1B The rod 168 is positioned outside the distal end of the shaft, such that the distal portion of the rod is located outside the distal end of the shaft. The rod 168 is operatively coupled to the shaft 164 such that rotational motion of the rod relative to the shaft is converted into axial motion of the rod relative to the shaft (e.g., along the longitudinal axis ax1). This is typically achieved by a shaft 164 defining an internal thread and a rod 168 defining a complementary external thread 167. Figure 1B ).

[0638] For some applications, and as shown in the figure, shaft 164 has a rigid distal portion 164d, within which an internal thread is defined. For such applications, the proximal portion of shaft 164 (in...) Figure 1B The portion 164p (represented by reference numeral 164d) is flexible. Although the flexibility of portions 164p and 164d differs, these portions are generally axially and rotationally locked and define a continuous lumen throughout the shaft 164.

[0639] The distal capsule 204 is coupled to the distal portion of the rod 168 and includes a circumferential wall extending proximally from the distal portion of the rod to define a chamber for the distal capsule. The distal capsule 204 is generally axially locked relative to the rod 168, meaning that axial movement of the rod distally or proximally moves the distal capsule distally or proximally. However, the distal capsule 204 is rotatably coupled to and rotatable relative to the rod 168, meaning that rotation of the rod does not necessarily require rotation of the distal capsule (e.g., if the distal capsule encounters rotational resistance). The inventors hypothesize that this advantageously facilitates a generally axial distal sliding disengagement of the distal capsule 204 from an implant disposed within the distal capsule 204 (e.g., instead of requiring helical rotation of the distal capsule relative to the implant, which could increase wear between the distal capsule and the implant).

[0640] For some applications, and such as Figure 1C As shown in the lower illustration, this axial locking and rotational coupling is provided by a pin 170 that extends laterally from the rod 168 across the distal sac 204. The pin 170 is generally located away from the chamber arrangement of the distal sac. The pin 170 is generally axially aligned with a circumferential recess 169 defined in the rod 168, such that the pin is close enough to the rod to prevent axial movement of the rod relative to the pin, while providing sufficient clearance between the pin and the rod (e.g., the recess 169) to allow the rod to rotate relative to the pin.

[0641] refer to Figure 3A -D, 4A-H, 5A-B, 6, and 7. According to some applications of the invention, it is a schematic diagram showing the delivery tool 100 for the implant 20 in its various states.

[0642] Figure 3A -D shows the capsule component 200 of the delivery tool 100 in various states. Figure 4A -H illustrates a delivery tool 100 for delivering implant 20 and transitioning between various states for implantation. Implant 20 is described herein as a prosthetic valve, but may be different implants for some applications. For some applications, implant 20 is the prosthetic valve 1036 described below, and / or may be the same as implant (prosthetic valve) 420 of Hariton et al. WO 2019 / 026059, which is incorporated herein by reference. Implant 20 is typically self-expanding.

[0643] Figure 3A The distal portion 163 of the device 160 (e.g., its capsule assembly 200) in the closed state is shown. In this state, and with the implant 20 disposed within the capsule assembly 200, the capsule assembly is advanced via a lumen (e.g., via the femoral side) to the natural valve 10 of the subject's heart 4. Figure 4A and 4B Although it is an appendix Figure 4A-H shows the natural valve 10 as the mitral valve. The delivery tool 100 can alternatively be used to deliver an implant (e.g., a prosthetic valve) to another natural valve of the heart, such as the tricuspid valve, aortic valve, or pulmonary valve, with necessary modifications.

[0644] For some applications, and such as Figure 4A As shown in -B, during the advancement of the delivery tool 100 through the lumen, the balloon assembly 200 can retract proximally to abut against the distal opening of the second catheter 132 and / or the distal opening of the first catheter 122. Figure 4A A delivery device 100 advanced in this manner is shown, wherein catheter 132 and balloon catheter 162 are concealed within catheter 122. Once within atrium 6, upstream of the natural valve 10 (in this case, the left atrium, upstream of the mitral valve), catheter 132 extends from catheter 122. Figure 4B ), and is manipulated to orient the capsule component 200 toward and through the natural valve.

[0645] For some applications, the juxtaposed actuator 176 is used. Figure 1A and 1C The actuation of catheter 132 extends from catheter 122 (e.g., by sliding catheter 132 relative to catheter 122). For some such applications, catheter 132 extends from catheter 122 while the catheters are rotate-locked relative to each other. For example, catheters 122 and 132 can be rotate-locked by a proximal lock defined by actuator 176. Alternatively or additionally, distal locks defined by corresponding couplings of catheters 122 and 132 can be rotate-locked relative to each other. For example, the couplings defining the distal locks can be in some manner similar to those described in U.S. Patent 9,949,828 to Sheps et al. (e.g., referring to Figure 1 therein), which is incorporated herein by reference.

[0646] For some applications, and such as Figure 4B As shown in -H, after the initial positioning of the capsule assembly 200 ( Figure 4B Catheters 122 and 132 remain stationary during subsequent operations of the balloon assembly. For this application, advance and retraction of balloon catheter 162 from and back into catheter 132 facilitates the advance and retraction of the entire balloon assembly 200 and the proximal balloon 202, independent of the distal balloon 204.

[0647] Subsequently, as Figure 4C and 3BAs shown, the distal capsule 204 is advanced distally to release the flange 54 of the implant 20, allowing the flange to expand radially outward automatically. It should be noted that the upstream end of the implant 20 remains within the proximal capsule 202, and at this stage, the mount 172 and the downstream end of the implant remain within the distal capsule 204. Because the mount 172 is fixedly coupled to the shaft 164, and the distal capsule 204 is axially locked relative to the rod 168, this distal advancement of the distal capsule 204 away from the implant 20 can be achieved by advancing the rod distally relative to the axial direction (e.g., by using the rod's helical shaft).

[0648] For some applications, as shown in the figure, the step of deploying flange 54 is performed simultaneously with setting the flange (and the seam between capsules 202 and 204) within the atrium 6. For such applications, the deployed state of capsule assembly 200 is typically maintained as follows: Figure 3B As shown, the capsule assembly then advances distally and downstream through the natural valve 10 ( Figure 4D -E), until imaging (e.g., fluorescence microscopy) determines that the leaflet 12 of the natural valve is upstream of the adjoining flange 54 during ventricular systole ( Figure 4E The inventors hypothesize that this facilitates reliable placement of the flange downstream of the leaflet while minimizing the distance the extended flange travels downstream of the leaflet, thereby advantageously reducing the likelihood of unintentional entanglement of ventricular tissues (such as chordae tendineae).

[0649] Subsequently, the deployed state of the capsule assembly 200 is typically maintained as follows: Figure 3B As shown, the capsule assembly retracts proximally and upstream until it is determined (e.g., by imaging, such as fluorescence examination) that flange 54 has engaged leaflet 12. Figure 4F ).

[0650] Subsequently, as shown in Figure 14G, the upstream support 40 of the implant 20 is deployed by releasing it from the proximal capsule 202 and by retracting the proximal capsule proximally relative to the mount 172 (and thus relative to the implant). Figure 3C This can be achieved by moving the balloon catheter 162 proximally (as shown), or by rotating the balloon catheter (with necessary modifications, for example, as described below with respect to delivery tool 1020). The upstream support 40 typically includes multiple radial arms and optionally includes a flexible sheet covering the arms, and the upstream support 40 is disposed on the upstream surface of the annulus of the natural valve 10. Figure 4G Therefore, leaflet 12 is at least slightly sandwiched between the upstream support 40 and flange 54.

[0651] Subsequently, as Figure 4H As shown, the implant 20 is fully deployed by advancing the distal capsule distally relative to the mounting member 172 and by releasing the distal end of the implant from the distal capsule 204. Figure 3DIn other words, the mounting 172 is typically shaped to engage the distal end of the implant (e.g., via a slot 175 defined by the mounting receiving adapter 22, which is defined by the distal end of the implant, as referenced below). Figure 8E (as described in -G), allowing complete release of the implant from the distal capsule by exposing the installer from the distal capsule.

[0652] In some such applications, distal advancement of the distal bladder 204 is achieved via axial movement of the lever 168. Typically, for this application, axial movement of the lever causes the delivery tool 100 to move from a retracted state. Figure 3A -C) to extended state ( Figure 3D In the retracted state, a portion of the shaft 164 and / or the implant receiving groove 175 is within the distal capsule 204, and in the extended state, the portion of the shaft and / or the groove is outside the distal capsule.

[0653] like Figure 4H As shown, the expansion of implant 20 opens the central channel of the implant to blood flow and allows the leaflets (not shown) of the implant to provide a one-way valve function. The expansion also typically compresses the leaflet 12 between the upstream support 40 and the flange 54, thereby securing implant 20 in place and suppressing paravalvular leakage.

[0654] Figure 5A -B,6 and 7 show that in Figure 4B The diagram shows a corresponding view of the distal portion 102 of the delivery tool 100 during its unfolding phase, but with some differences as described above, in order to illustrate some of the flexibility offered by the delivery tool 100, and some advantages assumed by the inventors. Figure 4B and Figure 5A In -B, the duct 122 extends through the fossa ovalis 14 into the atrium 6 and is manipulated toward the apex of valve 10 (e.g., the apex of the center of valve 10). Similarly, in Figure 4B and Figure 5A In -B, catheter 132 extends from catheter 122 and is manipulated downward toward valve 10, such that the capsule assembly 200 is positioned between the leaflets 12 of the valve. However, compared to Figure 4B ,exist Figure 5A In the example shown in -B, the cardiac anatomy is such that, in order to position the capsule assembly 200 between the leaflets, the capsule assembly has been advanced away from the duct 132 and no longer abuts against the duct. For example, this may be advantageous if the fossa ovalis 14 is particularly high above the natural valve 10. Compared to Figure 4B ,exist Figure 6 The cardiac anatomy in the example shown is such that additional manipulation is required to position the capsule assembly 200 between the lobules. Figure 7In the example shown, the cardiac anatomy makes the distance between the fossa ovalis 14 and the natural valve 10 greater than that between the two valves. Figure 4B The length of the distal portion of the conduit 122 and the distal portion of the conduit 132 will be too short to achieve the required angle of attack.

[0655] Figure 6 and 7 An additional drivable feature is shown, which, for some applications, is included in the delivery tool 100. This drivable feature is the shaft 164 (or proximal portion 164p). Figure 1B The maneuverability of at least one maneuverable distal region of the delivery tool 100 is assumed to advantageously increase the flexibility of the delivery tool 100 and its applicability to a wider range of anatomical structures.

[0656] like Figure 1C As shown in the upper illustration, the maneuverability of shaft 164 is provided by draw cables 364a and 364b, which extend from the maneuverable distal region of the shaft proximally into the shaft to the controller 166 of the proximal portion 161 of the implantable device 160, similar to the maneuverability of catheters 122 and 132, with necessary modifications. This will be described in more detail below.

[0657] exist Figure 6 In the example shown, in addition to manipulating the conduit 132, the shaft 164 is also manipulated. Figure 7 In the example shown, the manipulation of shaft 164 is used instead of the manipulation of conduit 132, which is barely exposed from conduit 122. It should be noted that, as shown, when shaft 164 is manipulated (meaning actively manipulated), it is positioned within conduit 162, which is flexible (but not itself manipulated) and therefore passively bends in response to the manipulation of shaft 164.

[0658] Refer again Figure 1C It includes a cross-section of the delivery tool 100, showing the arrangement of various tubular components and their draw cables. Two draw cables 322a and 322b extend from the steerable distal portion of conduit 122 to the proximal end of controller 126, the actuation of controller 126 actuating the steerable portion of conduit 122. Two draw cables 332a and 332b extend from the steerable distal portion of conduit 132 to the proximal end of controller 136, the actuation of controller 136 actuating the steerable portion of conduit 132. For applications where shaft 164 is steerable, two draw cables 364a and 364b extend from the steerable portion of shaft 164 to the proximal end of controller 166 (e.g., its shaft bending actuator), the actuation of controller 166 actuating the steerable portion of shaft 164.

[0659] refer to Figure 2AThe figure shows a schematic diagram of a known dual-catheter system 110' in its frames A and B. The elements of the dual-catheter system 110' are labeled with the same reference numerals as the corresponding elements of the catheter system 110, plus an apostrophe. As shown, the draw line plane p3' passes through the draw lines 332a' and 332b' of the inner catheter 132' and is rotationally offset relative to the draw line plane p2' of the draw lines 322a' and 322b' passing through the outer catheter 122'.

[0660] Typically, the draw planes p2' and p3' define catheters 122' and 132' along their respective maneuvering planes, thus allowing the catheter system 110' to be manipulated. The external catheter 122' and internal catheter 132' are typically rotated relative to each other, such that the draw planes p2' and p3' are offset by 90 degrees 1'. Figure 2A (Frame A).

[0661] like Figure 2A As shown in box B, the tension of the drawstring 322b' of the external catheter 122' may not significantly change the rotational orientation of the internal catheter 132' relative to the external catheter. That is, when the catheter system 110' is manipulated along the drawstring plane p2' of the external catheter 122', both the external catheter and the internal catheter 132' can be bent along the drawstring plane p2', such that the angle α1' remains at 90 degrees.

[0662] refer to Figure 2A Box C in the figure illustrates a hypothetical state of the dual-catheter system 110'. As shown, when the inner catheter 132' is manipulated along an actuation plane different from plane p2', the bending of the inner catheter can produce rotational slippage of the inner catheter relative to the outer catheter (rotation arrow). Therefore, manipulation of the inner catheter 132' within the bent outer catheter 122' can cause the draw planes p2' and p3' to become closer to coplanar, causing α1' to deviate by 90 degrees (e.g., becoming an arc in frame C). Thus, this rotational slippage can reduce the actuation range of the catheter system 110' and / or prevent the desired final actuation angle of the inner catheter 132' from being achieved.

[0663] Therefore, the inventors hypothesize an improved draw wire placement (when the catheter system is stationary) to address this issue of non-90-degree offset.

[0664] refer to Figure 2BThis is a schematic diagram illustrating a catheter system 110 according to some applications of the invention. In catheter system 110, the drawstring is positioned such that when at rest (e.g., without manipulation or bending of the catheter), the drawstring planes p2 and p3 do not deviate by 90 degrees. For example, as shown in box A, the obtuse angle α1 formed by the intersection of planes p3 and p2 can be greater than 95 degrees and / or less than 120 degrees (e.g., approximately 110 degrees). For some applications where catheters 122, 132 can be rotated and locked via proximal locking and / or distal locking, as referenced above... Figure 4A As described in -B, proximal and / or distal locking can maintain the offset of the pull-wire planes p2 and p3, such that angle α1 remains obtuse along the length of the catheter.

[0665] The tension of the drawstring 322b of the first catheter 122 does not significantly change the rotational orientation of the second catheter 132 relative to the first catheter. That is, when the catheter system 110 is manipulated along the drawstring plane p2 of the first catheter 122, both the first catheter and the second catheter 132 can be bent along the drawstring plane p2, such that the angle α1 remains an obtuse angle.

[0666] However, since angle α1 is obtuse when the catheter system 110 is stationary, the rotational slippage of the second catheter 132 relative to the first catheter 122 caused by manipulating the second catheter 13 along plane p3 ( Figure 2B The rotating arrow in box C makes the angle α1 close to 90 degrees, thereby improving the ease of manipulating the catheter system 110 relative to the catheter system 110'. For some applications where catheters 122 and 132 can be rotated and locked by proximal locking and / or distal locking, the proximal locking and / or distal locking can be unlocked before manipulating the second catheter 132 along plane p3, thereby allowing at least a portion of the second catheter to rotate relative to the first catheter, such that plane p3 moves in a direction perpendicular to plane p2.

[0667] Therefore, the inventors assume that the positioning wires 322a, 322b, 332a, 332b ensure that the wire planes p2 and p3 do not deviate by 90 degrees when at rest, thereby facilitating the biplane manipulation of the catheter system 110. Even if the rotational sliding in the catheter system 110 continues through a 90-degree position, causing the angle α1 to become less than 90 degrees, this resulting angle is advantageously greater than the angle produced by the steering system 110', where the initial angle is 90 degrees.

[0668] refer to Figure 8A -G and 9 are schematic diagrams illustrating at least some steps of loading the implant 20 into the capsule assembly 200 of the delivery tool 100 according to some applications of the invention. The inventors assume that it is advantageous to load the implant 20 into the distal capsule 204 in at least two steps. In the first step ( Figure 8A-B), the implant slides proximally across the distal capsule 204. In the second step ( Figure 8E -G), by manipulating the distal capsule from the distal portion 102 of the delivery tool 100 (as described below) rather than from the proximal portion 104 of the delivery tool, the distal capsule 204 slides over the implant. That is, as described above (e.g., Figure 4C During implant deployment, an opening force applied by the operator is applied to the actuator 176 of the proximal portion 161. The inventors hypothesize that it is advantageous to apply the sheathing force directly to the distal portion 102, for example, to allow a greater force to be applied to the implant, and / or to allow the application of the sheathing force to occur near the operating position of the implant 20, thereby improving the visibility of the implant sheath to the person, and / or improving control of the loading process.

[0669] For some applications, and such as Figure 8A As shown, before the implant 20 is encased in the distal capsule 204, the actuator 176 (in) Figure 1A and 1C (As can be seen in the image) completely removed from instrument 160. (Alternatively, instrument 160 may be provided with actuator 176 initially separate from the rest of the instrument.)

[0670] As described above, the distal sac 204 is rotatably coupled to the rod 168. Figure 1B And 3). Therefore, direct rotation of the distal capsule 204 (e.g., by grasping the distal capsule by hand) does not require rotation of the rod 168, and thus does not cause the distal capsule to move proximally past the mount 172 and the implant 20. Therefore, for some applications, accessory 240 is provided ( Figure 8B The distal portion 163 of the implantation device 160 (e.g., attached to the distal capsule 204) rotatably locks the distal capsule 204 to the rod 168, thereby allowing the implant 20 to be encased in the distal capsule by direct rotation of the distal capsule.

[0671] Figure 8A The distal portion 163 of the implantable device 160 is shown, with the capsule assembly 200 in... Figure 3D The structure shown is opened, allowing the installer 172 to be released proximally from the open end of the distal balloon 204. The implant 20 is positioned above the distal end of the catheter system 110, above and beyond the distal balloon 204. Figure 8B In the case of an implant 20 that is a prosthetic valve, the distal capsule 204 typically moves relative to the leaflet of the valve in an upstream-to-downstream direction (e.g., from the upstream end of the prosthetic valve to the downstream end of the prosthetic valve, as described below). Figure 11 (As described in frame A of the prosthetic valve 1036). Subsequently, attachment 240 is attached to the distal portion 163 of the implantation device 160 (e.g., attached to the distal capsule 204). Figure 8B-C).

[0672] Typically, attachment 240 includes (or defines) a pawl 242 and is configured to attach to distal pouch 204 such that the pawl rotatably locks the distal pouch to rod 168. For some applications, distal pouch 204 defines a locking pin hole 180, and attachment of attachment 240 to the distal pouch causes the pawl 242 to extend through the locking pin hole to rotatably lock the distal pouch to rod 168. For some such applications, delivery tool 100 (e.g., its catheter system 110) includes a latch to which the pawl 242 can engage. For example, catheter system 110 may define a recess 178 (… Figure 1B A pawl 242 is disposed therein. For some applications, the catheter system 110 includes a ring 174 that is rotatably and axially fixed relative to the rod 168 and defines a recess 178 (see [link to documentation]). Figure 1B and 3A -D). For some applications, rod 168 defines ring 174 and / or recess 178.

[0673] For some applications, accessory 240 includes a C-shaped clip 244, which is attached to the distal sac 204 by being placed on the distal sac (e.g., snapped into place). For such applications, a pawl 242 is attached to the clip 244 and typically extends radially inward from the point where it is attached to the clip.

[0674] For some applications, a knob 250 is subsequently introduced at the distal end of the catheter system 110. Figure 8C -D), and engages with clip 244 (and optionally with distal sac 204) to allow manual rotation of distal sac 204 relative to rod 168.

[0675] like Figure 18E As shown, the implant 20 is then compressed (“curled”) so that the implant engages with the mounting member 172, for example, the adapter 22 is received by the corresponding slot 175.

[0676] Subsequently, as Figure 8F As shown, the distal capsule 204 and the rod 168 are manually rotated in the first rotational direction (e.g., by grasping the distal capsule, attachment 240, and / or knob 250), causing the rod 168 to spiral into the shaft 164, thereby screwing the distal capsule proximally onto the implant 20 and the mount 172. In this way, at least the downstream end of the implant is sheathed by the distal capsule while maintaining engagement between the implant and the mount. Thus, the implant 20 is sheathed in the distal capsule 204 by spirally moving the distal capsule over the implant, but is sheathed by linearly moving it from the implant, as referenced above. Figure 3A -D and 4C-H are mentioned. For some applications, and as... Figure 8GAs shown, the proximal capsule 202 is advanced distally on the upstream end of the implant 20, thereby further encapsulating the implant within the capsule assembly 200.

[0677] After the implant sheath is applied, and before the capsule assembly 200 is used to deliver the implant 20, the attachment 240 (and knob 250, if present) is removed. Figure 9 Removing accessory 240 from distal capsule 204 causes the distal capsule to be rotatably unlocked relative to rod 168, thereby linearly moving the distal capsule away from the implant by an opening force (e.g., rotation of rod in a second rotational direction).

[0678] In any case, if the actuator 176 is not initially engaged with the rod 168, or is disengaged from the rod 168 by the operator before the implant 20 is sheathed onto the distal capsule 204, the actuator 176 engages (or re-engages) with the rod 168 before implantation. Typically, for such applications, an opening force is then applied to the distal portion 163 of the implantation device 160 via the actuator 176.

[0679] refer to Figure 10A -E is a schematic diagram illustrating a delivery tool 1020 according to some applications of the present invention.

[0680] Figure 10A The assembled delivery tool 1020 is shown. Figure 10B An exploded view of the distal portion 1024 of the delivery tool is shown. As shown, the delivery tool 1020 includes an external controller 1021 and a distal portion 1024, the distal portion 1024 being sized for delivery to a subject via a lumen (e.g., via the femur).

[0681] Delivery tool 1020 shares certain similarities with delivery tool 100. In particular, the distal portion 1024 of delivery tool 1020 is similar in some respects to the distal portion 163 of implantation device 160 of delivery tool 100. Components with the same name between delivery tool 100 and delivery tool 1020 generally share similar features and perform similar functions to each other.

[0682] As shown in the figure, the distal portion 1024 includes a shaft 1034 (e.g., extending distally from within the balloon duct 1072), to which a proximal balloon 1064 and a distal balloon 1066 (commonly defining the balloon assembly 1063) are coupled. Figure 10B As shown, each sac 1064, 1066 has a corresponding opening end 1065, 1067, such that the opening end 1065 of the proximal sac 1064 faces the proximal end of the distal sac 1066. For some applications, and as shown, the opening end 1067 is the proximal end of the distal sac 1066, such that the opening end 1065 of the proximal sac 1064 faces the opening end of the distal sac.

[0683] Similar to the distal portion 163 of the aforementioned device 160, the distal portion 1024 also includes an mounting element 1028 (e.g., defining a groove 1029) sized to engage the implant. Typically, the capsules 1064, 1066 can be moved relative to the mounting element via an external controller 1021 (e.g., along the distal portion axis ax 1018). For some applications, the external controller 1021 can controllably move the proximal capsule 1064 and / or the distal capsule 1066 relative to the stent 1028 distally (“advanced”) and proximally (“retracted”).

[0684] For some applications, and such as Figure 10B As shown, the distal portion 1024 includes a rod 1168 extending distally from the shaft 1034. Similar to the rod 168 described above for reference device 160, the delivery tool 1020 is configured to advance the distal pouch 1066 distally relative to the mounting member 1028 by helically passing the rod through the shaft 1034.

[0685] For some such applications, and more specifically, the distal sac 204 of device 160, the distal sac 1066 is rotatably coupled to and rotatable relative to the rod 1168, such that rotation of the rod 1168 does not necessarily require rotation of the distal sac 1066. Typically, for such applications, the pin 1170 engages within the distal sac 1066 with respect to a groove 1169 defined by the rod 1168 to axially secure the distal sac relative to the rod while allowing rotation of the rod relative to the pin, as described above regarding… Figure 1C and Figure 3A The device 160 of -D is described.

[0686] For some such applications, and as shown in the figure, the distal bladder 1066 defines a window 1110 and a hole 1180. For such applications, the hole 1180 is typically formed to facilitate the attachment 240 and / or the knob 250. Figure 10B Not shown in the text, please refer to the above. Figure 8B The attachment (as described in -G) is used to rotatably lock the distal bladder relative to the rod 1168. For example, a portion of the attachment 240 extends through the hole 1180 such that the portion occupies the recess 1178 defined by the ring 1174 fixedly coupled to the rod, thereby facilitating rotatable locking of the distal bladder 1066 to the rod 1168.

[0687] Although there are similarities between delivery tools 100 and 1020, the following description of delivery tool 1020 focuses on features unique to it. The difference between delivery tools 100 and 1020 lies in that the distal portion 1024 is configured to be advanced through the lumen into the heart in the delivery state. Figure 10A and 10CAn intercapsular space 1071a exists between the proximal capsule 1064 and the distal capsule 1066 (e.g., between the respective open ends 1065, 1067).

[0688] Typically, for applications where the bladders 1064 and 1066 can both advance and retract, the bladder can be axially moved within a certain range relative to the mounting member 1028. For some such applications, and such as... Figure 10D As shown, segments 1034c and 1034d of shaft 1034 can be slidably connected to each other, thereby facilitating the axial movement of capsules 1064 and 1066. Therefore, as... Figure 10D As shown, segments 1034c and 1034d can slide retractably relative to each other, such that the distal portion 1024 is in an deployed state, in which the intercapsular gap 1071b is longer than the gap 1071a when the distal portion is in the delivery state. Figure 10C ).

[0689] The intercystic space 1071b is typically at least 50% (e.g., at least 100%) larger and / or less than 200% (e.g., less than 150%) than the intercystic space 1071a.

[0690] For some applications, when the distal portion 1024 is in the delivery state, the length of the intercapsular gap 1071a is greater than 1 mm (e.g., greater than 5 mm, greater than 10 mm, greater than 15 mm, greater than 20 mm) and / or less than 25 mm (e.g., less than 20 mm, less than 15 mm, less than 10 mm, less than 5 mm). For example, the intercapsular gap 1071a can be 10-20 mm.

[0691] For some such applications, when the distal portion 1024 is in the deployed state, the length of the intercapsular space 1071b is greater than 15 mm (e.g., greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 35 mm) and / or less than 40 mm (e.g., less than 35 mm, less than 30 mm, less than 25 mm, less than 20 mm). For example, the intercapsular space 1071b can be 20-35 mm.

[0692] For some applications, the proximal capsule 1064 can be further advanced, and / or the distal capsule 1066 can be further retracted, such that the distal portion 1024 is in a retracted state, wherein the intercapsular gap is shorter than when the distal portion is in the delivery state (e.g., causing the gap to close or nearly close, such as...). Figure 10E As shown). Therefore, for some such applications, when the remote part 1024 is in a withdrawn state (as shown). Figure 10E When the distal portion is in the delivery state, the length 1074c of the capsule assembly from the proximal end of the proximal capsule 1064 to the distal end of the distal capsule 1066 is less than that when the distal portion is in the delivery state. Figure 10C The length of the capsule component is 1074a.

[0693] Although the states of the delivery tool 1020 (e.g., delivery state, unfolded state, retracted state) are described with respect to the remote portion 1024, they are typically implemented by the controller 1021. For example, the controller 1021 may define these states as discrete states by performing only certain operations and / or degrees of movement of its control elements (e.g., knobs, switches, levers, wheels, etc.), which are operatively coupled to the pouches 1064 and 1066, for example, via wires, rods, and / or cables. Furthermore, for some applications, the controller 1021 facilitates and / or performs the sequence of operations described below, for example, by selectively and / or sequentially locking and / or unlocking locking elements, wherein the locking elements selectively and / or sequentially enable and / or disable the controller's control elements.

[0694] Reference Figure 11 The diagram illustrates a delivery tool 1020 according to some applications of the invention, with the prosthetic valve 1036 in an expanded state. The prosthetic valve 1036 includes a frame assembly 1022 (shown in box A), within which a prosthetic leaflet 1058 (box B) is disposed.

[0695] The prosthetic valve 1036 is similar in some respects to that described in Hariton et al., WO 2019 / 026059 (e.g., referring to Figures 1, 2, and 18 therein), which is incorporated herein by reference. For some applications, delivery tool 1020 can be used to deliver the implant (prosthetic valve) 420 granted in Hariton et al., WO 2019 / 026059. The prosthetic valve 1036 is generally self-expanding.

[0696] like Figure 11 As shown in frame A, frame assembly 1022 includes an inner valve frame 1030 nested within an outer frame 1060. The valve frame 1030 is generally shaped to define: (i) a tubular portion 1032 defining a lumen 1038 between an upstream end 1014 and a downstream end 1016; and (ii) a plurality of arms 1046 collectively forming an upstream support 1040 extending upstream from the tubular portion. For some applications, and as shown, the valve frame 1030 also defines an adapter 1025, and a mount 1028 engages the adapter 1025 (e.g., by receiving the adapter 1025 in a slot 1029 defined by the mount).

[0697] As shown in the figure, the outer frame 1060 includes flanges 1054, each flange 1054 being coupled to the tubular portion 1032 at a corresponding coupling point 1052 located downstream of the upstream support portion 1040. Thus, each flange 1054 extends upstream from the coupling point 1052 to a corresponding flange end 1068.

[0698] Typically, as shown in box B, the prosthetic valve 1036 includes a plurality of prosthetic leaflets 1058 disposed within the lumen 1038 to facilitate unidirectional blood flow from the upstream end 1014 to the downstream end 1016. For some applications, and as shown, the prosthetic valve 1036 also includes an upstream cover 1048 disposed on the arm 1046 to define the upstream skirt, in order to reduce the risk of paravalvular leakage.

[0699] refer to Figure 12 and 13A -B, which is a schematic diagram of a prosthetic valve 1036 constrained in a compressed state by a delivery tool 1020 according to some applications of the present invention. Therefore, Figure 12 The delivery system 1010 in delivery state is shown (refer to above). Figures 10A to 10C (As described above), wherein the system is configured to be propelled through a lumen into the heart of a subject.

[0700] In the delivery state, the distal implant portion 1100, including the distal portion of the valve frame 1030 (e.g., the downstream end 1016 of the tubular portion 1032), engages with the mount 1028 (e.g., receiving the adapter 1025 via the slot 1029) such that both the downstream end and the mount are disposed within the distal capsule 1066 (e.g., within a cavity defined by the distal capsule), wherein the distal capsule restricts the downstream end from pressing against the mount, thereby maintaining engagement between the downstream end and the mount.

[0701] In the delivery state, the proximal implant portion 1102, including the proximal portion of the valve frame 1030 (e.g., the upstream support portion 1040), is disposed within (e.g., confined thereto) the proximal capsule 1064. Additionally, in the delivery state, each flange end portion 1068 is disposed within (e.g., confined thereto) the proximal capsule 1064.

[0702] Typically, segment 1056 of the prosthetic valve 1036 is located at the intersacral space 1071a. That is, segment 1056 is exposed by the intersacral space 1071a. Typically, segment 1056 includes a portion of the tubular portion 1032, a portion of each flange 1054, and / or coupling point 1052.

[0703] For some applications, and as shown in Figure 13, the delivery tool 1020 includes a flexible sheath 1044 (e.g., comprising a polymer and / or fabric) that covers segment 1056 by surrounding the interpouch gap 1071a. For some such applications, the distal end of the sheath may abut against and / or be partially disposed within the distal pouch 1066.

[0704] For some such applications, as shown in the figure, the sheath 1044 extends proximally from the intercapsular space 1071a, covering the proximal capsule 1064. The sheath 1044 can extend into and through a delivery catheter 1050, which connects the distal portion 1024 to an external controller 1021. Figure 14A -C), for example, the proximal end of the sheath remains outside the subject.

[0705] For some applications, the distal portion 1024 of the delivery tool 1020 includes a front cone 1026 having a flexible distal portion 1027. For some such applications, and as... Figure 13A As shown, the distal portion 1027 has a curled, stationary shape (e.g., in the absence of a straightening force that can be provided by a more rigid element such as guide wire 1023). Figure 13B The distal portion 1027 is shown to have been straightened by guidewire 1023, which has extended through balloon catheter 1072 and shaft 1034 and entered the distal portion. Typically, for this application, when guidewire 1023 is positioned within the distal portion... Figure 13B The axial lengths d1025 and d1025b of the front cone 1026 are greater than those without a guidewire (e.g., Figure 13A The lengths d1025 and d1025a in the figure are given. For some such applications, the shape memory of the distal portion 1027 tends to keep the distal portion in a static (e.g., curled) shape. That is, even after being straightened by the guidewire 1023, the distal portion 1027 automatically assumes a curled shape when the guidewire is removed from the distal portion. The inventors hypothesize that this curling of the anterior cone 1026 advantageously allows the anterior cone to be longer (and therefore have a shallower cone angle) than a similar anterior cone that is not curled, because allowing the anterior cone to bend is possible during periods when the long axis length of the anterior cone would otherwise be disadvantageous, for example, as follows regarding Figure 1A -As stated in B.

[0706] refer to Figure 14A -J, which is a schematic diagram illustrating a delivery tool 1020 for deploying a prosthetic valve 1036 at the tricuspid valve 1096 of a subject's heart 1090, according to some applications of the invention.

[0707] Figure 14AThe distal portion 1024 of the delivery tool 1020 is shown to have been advanced via the inferior vena cava 1092 and right atrium 1094 of the heart 1090, such that the anterior cone 1026 and distal capsule 1066 have entered the right ventricle 1098 through the tricuspid valve 1096.

[0708] For some applications, the delivery tool 1020 is advanced along the guidewire 1023 through the lumen (e.g., after the guidewire has been advanced into the heart 1090). Thus, the guidewire 1023 extends from the external controller 1021 to the delivery catheter 1050. For some applications, the controller 1021 is used to manipulate the guidewire 1023 (e.g., manipulating the guidewire as it is advanced into the heart). Alternatively or additionally, manipulation of the distal portion 1024 can be facilitated by the delivery tool 1020 including at least one drawstring operatively connecting the distal portion 1024 to the controller 1021. For example, the delivery catheter 1050 can be used with reference to the above. Figure 1C and 2B The catheter system 110 is used to extend the balloon catheter 1072 and shaft 1034 within the catheter system, with necessary modifications.

[0709] For some applications, manipulation of the distal portion 1024 can be further facilitated by a segmented shaft 1034, which has segments distinguished by their relative rigidity. Typically, for such applications, the shaft 1034 extends from the proximal portion of the delivery tool 1020 (e.g., from the external controller 1021) (e.g., within the delivery catheter 1050 and balloon catheter 1072, as...). Figure 14A (As shown in the left-hand illustration) extends distally. For some such applications, the rigid proximal shaft segment 1034a ( Figure 14A The lower left illustration shows the segment extending distally from the external controller 1021. Typically, for this application, the length of the rigid proximal shaft segment 1034a is greater than 50 cm (e.g., greater than 60 cm, greater than 70 cm, greater than 80 cm, greater than 90 cm) and / or less than 100 cm (e.g., less than 90 cm, less than 80 cm, less than 70 cm, less than 60 cm). The inventors hypothesize that the rigidity of the rigid proximal shaft segment 1034a facilitates the transmission of force from the proximal portion of the delivery tool 1020 (e.g., from the external controller 1021).

[0710] For some applications, as described above, the distal axial segment 1034b is relatively less rigid than the proximal axial segment 1034a and is constructed to have sufficient flexibility to deflect from the vena cava toward the tricuspid valve 1096 (e.g. Figure 14A (As shown). The flexible shaft segment 1034b of shaft 1034 extends from the rigid proximal shaft segment 1034a ( Figure 14A(The upper left illustration) extends distally. For some such applications, the length of the flexible shaft segment 1034b is greater than 5 cm (e.g., greater than 6 cm, e.g., greater than 8 cm) and / or less than 10 cm (e.g., less than 8 cm, e.g., less than 6 cm).

[0711] For some applications, the rigid distal shaft segment extends distally from the flexible shaft segment 1034b, such that the rigid distal shaft segment reaches the distal portion 1024 of the delivery tool 1020. That is, as... Figure 10C As shown in -D, rigid distal shaft segments 1034c and / or 1034d extend through at least a portion of the sacs 1064 and 1066. For example, rigid distal shaft segments 1034c and / or 1034d may extend distally into the proximal sac 1064. The inventors hypothesize that the rigidity of the rigid distal shaft segments 1034c and / or 1034d ensures that the sacs 1064 and 1066 are aligned along the distal portion axis ax1018, thereby facilitating axial movement of the sacs 1064 and 1066 along the distal portion axis.

[0712] For some such applications, the mounting 1028 is attached to a rigid distal segment (e.g., rigid distal segment 1034d, as shown). Typically, for such applications, the prosthetic valve 1036 is compressed onto the rigid distal segments 1034c and / or 1034d.

[0713] For some such applications, the rigid distal shaft segments 1034c and 1034d can slide retractably relative to each other, as referenced above. Figure 10D Therefore, when the distal portion 1024 is in the delivery state, the rigid distal shaft segments 1034c and 1034d together can be greater than 2 cm (e.g., greater than 3 cm, e.g., greater than 5 cm, e.g., greater than 8 cm) and / or less than 10 cm (e.g., less than 6 cm, e.g., less than 4 cm) in length.

[0714] For some such applications, rigid proximal shaft segment 1034a ( Figure 14A -C (lower left inset) and rigid distal shaft segments 1034c and 1034d can be correspondingly larger than flexible shaft segment 1034b ( Figure 14A -C (top left illustration) is more rigid.

[0715] The inventors hypothesize that the relative flexibility of the flexible shaft segments 1034, 1034b facilitates the manipulation of the distal portion 1024, particularly from the inferior vena cava 1092 to the right ventricle 1098. The inventors further hypothesize that the relative rigidity of the rigid proximal shaft segments 1034, 1034a provides support (e.g., resistance) to facilitate the manipulation of the distal portion 1024. Additionally, the inventors further hypothesize that the relative stiffness of the rigid distal shaft segments 1034, 1034c, 1034d facilitates maintaining the alignment of the capsule along the linear distal portion axis ax1018, for example, when the distal portion 1024 transitions between a delivery state, an deployed state, and a retracted state, as described above.

[0716] Figure 14A The distal portion 1027 is shown when straightened by the guidewire 1023, as described above. For some applications, it may be desirable to reduce the axial length d1025 of the anterior cone 1026. Figure 3A -B), before deploying the prosthetic valve 1036 at the site of the natural valve. This is typically used in such applications, and as... Figure 14B As shown, the guidewire 1023 is withdrawn from at least the distal portion 1027, thereby reducing the axial length d1025 of the anterior cone 1026 (as described above). Figure 13A (as described in -B). The inventors hypothesize that reducing the length d1025 by withdrawing the guidewire 1023 can facilitate the deployment of the prosthetic valve 1036 by reducing the amount of space within the right ventricle 1098 required to manipulate the distal portion 1024 (e.g., its distal capsule 1066).

[0717] Figure 14B The distal portion 1024 of the delivery tool 1020 is shown after the guidewire 1023 has been withdrawn from the distal portion 1027 of the anterior cone 1026 to the proximal portion.

[0718] Figure 14C The flexible sheath 1044 is shown to have been retracted, exposing segment 1056 and proximal sac 1064. For clarity, and similar to... Figure 12 The distal end 1024 is shown as being transparent, just as the proximal capsule 1064 and distal capsule 1066, to allow visualization of the orientation of the prosthetic valve 1036 within the respective capsules. As shown, the downstream ends of the mounting member 1028 and the tubular portion 1032 are disposed within the distal capsule 1066, while the upstream support portion 1040 and the flange end 1068 are disposed within the proximal capsule 1064, as referenced above. Figure 12 As stated above.

[0719] Subsequently, the proximal bladder 1064 retracts partially relative to the mounting member 1028, causing the flange end 1068 to be released from the proximal bladder. Figure 14DSince the outer frame 1060 typically comprises a shape memory elastic material (e.g., nitinol), the flange 1054 (e.g., its end 1068) automatically releases from the coupling point 1052 upon release from the proximal bladder 1064. Figure 11 It expands radially outward. However, since the distal end of the tubular portion 1032 is still restricted by the distal sac 1066 and the upstream support portion 1040 is still restricted by the proximal sac 1064, the valve frame 1030 remains in a compressed state.

[0720] Figure 14D The illustration shows a mechanism by which the proximal capsule 1064 retracts for certain applications. (For simplicity, the proximal capsule without a prosthetic valve is shown in the illustration.)

[0721] For some applications, and as shown, the delivery tool 1020 (e.g., its controller 1021) is configured to retract and / or advance the proximal pouch 1064 by converting rotational movement of the pouch catheter 1072 into longitudinal movement of the proximal pouch along axis 1018. For this purpose, a disc assembly 1086 including a proximal disc 1080 typically fits within the proximal pouch 1064, the proximal disc 1080 being rotatably coupled to and rotatably movable relative to the distal disc 1082. Further typically, the proximal disc 1080 has an external thread defined on its exterior, which is complementary to an internal thread 1089 defined by the interior of the proximal pouch 1064. Further typically used in such applications, and as shown, the proximal pouch 1064 is shaped to define a longitudinal track 1088 traversing the internal thread 1089.

[0722] Since the proximal disc 1080 is fixedly coupled to the bladder catheter 1072, rotation of the bladder catheter 1072 relative to the shaft 1034 (e.g., via the controller 1021) screws the proximal disc along the internal thread 1089 of the proximal bladder 1064. Simultaneously, the distal disc 1082 is prevented from rotating because the distal disc 1082: (1) is fixedly coupled to the shaft 1034, and (2) engages the track 1088 of the proximal bladder 1064 (e.g., via a locking pin 1084 already fitted into the track). Therefore, the screwing of the proximal disc 1080 along the track 1088 pushes the distal disc 1082, thereby converting the rotational motion of the proximal disc into an axial movement 1078 (e.g., retraction) of the proximal bladder 1064 relative to the disc assembly 1086 and the mounting 1028.

[0723] Figure 14E The continuous unfolding of the prosthetic valve 1036 at the tricuspid valve 1096 is shown. The distal portion 1024 has been retracted entirely relative to the cardiac tissue 1090 and the delivery catheter 1050. Thus, the flange 1054 (e.g., its end 1068) now engages with the tissue (e.g., leaflet) of the tricuspid valve 1096.

[0724] exist Figure 14F In the following deployment steps, as shown, the proximal balloon 1064 has been further retracted, thereby releasing the upstream support 1040 from the proximal balloon, causing the upstream support to expand radially outward. As shown, the proximal balloon 1064 retracts proximally relative to the balloon catheter 1072 and the delivery catheter 1050. Therefore, the proximal balloon 1064 typically has a sufficiently large inner diameter to allow the proximal balloon to retract over the balloon catheter 1072 and / or the delivery catheter 1050.

[0725] Similar to the outer frame 1060, the valve frame 1030 typically also includes a shape memory material, causing the upstream support 1040 to automatically expand upon release from the proximal capsule 1064. This compresses the tissue of the tricuspid valve 1096 between the upstream support 1040 and the flange 1054.

[0726] Figure 14G The distal bladder 1066, which has been advanced relative to the mounting member 1028, is shown, such that the distal portion 1024 presents the form described above. Figure 10D The deployed state. Release of the mounting member 1028 and the tubular portion 1032 from the distal sac allows the tubular portion 1032 to automatically expand radially outward, such that the frame assembly 1022 (and thus the prosthetic valve 1036 as a whole) has presented its expanded state.

[0727] Once the prosthetic valve 1036 is fully dilated at the tricuspid valve 1096, it is desirable to withdraw the distal portion 1024 from the heart 1090. To reduce the likelihood of the distal sac 1066 (e.g., its opening 1067) undesirably engaging the valve 1036 (e.g., its leaflet) during upstream retraction through the lumen 1038, the proximal sac 1064 is first advanced downstream through the lumen 1038, thereby closing the intersacral space 1071b (e.g., such that the opening 1065 of the proximal sac abuts the opening 1067 of the distal sac), as... Figure 10E and 14I As shown in the reference above. Figure 10D As described, the slidable coupling of segments 1034c and 1034d facilitates the closure of gap 1071b. For some applications, and as... Figure 14H As shown, the distal bladder 1066 is partially retracted (e.g., so that the distal bladder once again accommodates the mounting member 1028) to facilitate the closure of the interbladder gap 1071b.

[0728] Alternatively, or in addition to closing the intersacral space 1071b, re-advancing the guidewire 1073 into the distal portion 1027 of the anterior cone 1026 before or during the retraction of the distal portion 1024 through the lumen 1038 of the tubular portion 1032 can facilitate the retraction of the distal portion 1024 from the heart 1090. Re-advancing the guidewire 1073 into the distal portion 1027 typically straightens the distal portion, as described above. Figure 13B and 14A The inventors hypothesize that straightening of the anterior cone 1026 can facilitate the retraction of the distal portion 1024 through the prosthetic valve 1036 in a retrograde direction (i.e., opposite to the direction of the prosthetic leaflet 1058 configured to allow blood flow through the prosthetic valve 1036), for example, by reducing the likelihood of the anterior cone entering the prosthetic valve compared to when the anterior cone is curled.

[0729] Figure 14J This illustrates the retraction of the distal portion 1024 through the lumen 1038 of the tubular portion 1032. Also note the length of the capsule assembly 1074c. Figure 10E Although the distal portion 1024 is in the retracted state, it is smaller than the length 1074a of the capsule assembly in the delivery state. Figure 10C Therefore, the inventors hypothesize that closing the intercapsular space 1071b facilitates the removal of the delivery tool 1020 from the heart via the lumen.

[0730] refer to Figure 15A -B is a schematic diagram illustrating a delivery tool 2020 according to some applications of the present invention.

[0731] Unless otherwise stated, delivery methods 2020 are generally consistent with the above references. Figure 10A -B describes the same delivery tool 1020, and uses it similarly to the purpose of delivery tool 1020, with necessary modifications. Components with the same name between systems generally share similar characteristics and perform similar functions to each other. Thus, the following description of delivery tool 2020 focuses on the features specific to delivery tool 2020.

[0732] Figure 15A The assembled delivery tool 2020 is shown, and Figure 15B An exploded view of the distal portion 2024 of the delivery tool is shown. As shown, the delivery tool 2020 includes an external controller 2021 and a distal portion 2024, the distal portion 2024 being sized to be delivered to the subject via a lumen (e.g., via the femur).

[0733] As shown in the figure, the distal portion 2024 includes a tubular shaft 2034 (e.g., extending distally from within the sac duct 2072), with a proximal sac 2064 and a distal sac 2066 (commonly defining the sac assembly 2063) coupled to the tubular shaft 2034. For some applications, and compared to shaft 1034, shaft 2034 need not include segments distinguished by their relative rigidity.

[0734] As shown in the figure, each sac 2064, 2066 has a corresponding open end 2065, 2067, such that the open end 2065 of the proximal sac 2064 faces the open end 2067 of the distal sac 2066. Typically, sacs 2064, 2066 can be moved axially relative to an axis (e.g., along a central longitudinal axis ax2018) via an external controller 2021. For some applications, the proximal sac 2064 and / or the distal sac 2066 can be moved distally (“advanced”) and proximally (“retracted”) relative to an axis 2034.

[0735] For some applications, and as shown, the distal portion 2024 also includes a mount 2028 surrounding the axis 2034 and sized (e.g., defining a groove 2029) to engage the implant. For some applications, the distal capsule 2066 is shaped to define an opening (e.g., a window) 2110 that facilitates the use of the delivery capsule assembly 2063 with the implant (e.g., by allowing the user to visualize the mount 2028 and / or a portion of the implant), as referenced below. Figure 16E -G as described.

[0736] Usually and as Figure 15B As shown, the distal portion 2024 includes a rod 2168 having a distal portion extending from the distal end of the shaft 2034. Similar to that described above with reference to the delivery tool 1020, the delivery tool 2020 is configured to advance the distal pouch 2066 distally relative to the mounting member 2028 by screwing the rod through the shaft 2034.

[0737] For some applications, and more specifically, for delivery tool 1020, the distal bladder 2066 is rotatably movable relative to the rod 2168, such that rotation of the rod 2168 does not necessarily require rotation of the distal bladder 2066. Typically for such applications, and as shown, a pin 2170 is fitted within the distal bladder 2066, entering a groove 2169 defined by the rod 2168, to axially secure the distal bladder relative to the rod while allowing the rod to rotate relative to the pin, as described above.

[0738] Compared to delivery tool 1020, as shown in the figure, delivery tool 2020 includes a delivery bracket 2200 fixedly coupled to shaft 2034. Typically, delivery bracket 2200 includes a shape memory material such that when the implant is rolled up on the delivery bracket and shaft 2034 (see reference below) Figure 16E As described in section -I), the delivery stent is in a compressed state within the implant. The delivery stent 2200 is in... Figure 15A -B indicates an expanded state with no implant.

[0739] refer to Figure 16A -1 is a schematic diagram illustrating some steps of loading a prosthetic valve 2036 onto the distal portion 2024 of a delivery tool 600 according to some applications of the present invention.

[0740] Except as otherwise noted, delivery means 600 is similar in many respects to the above references. Figure 8A The delivery tool 100 described in -G is used similarly, with necessary modifications. Components with the same name across systems generally share similar characteristics and perform similar functions. Thus, the following description of the delivery tool 600 focuses on the characteristics specific to the delivery tool 600.

[0741] like Figure 16A As shown, delivery tool 600 is a multi-catheter transluminal (e.g., transfemoral) delivery tool comprising two main components: a catheter system 610 and an implantation device 660 at the proximal portion 604 of the delivery tool. Similar to the proximal portion 104 of delivery tool 100 described above, the implantation device 660 can be considered as an external control system for delivery tool 600, and the distal portion 663 is configured to be advanced into the subject.

[0742] The catheter system 610 includes an external catheter 622 coupled at its proximal end to an implantation device 660. The device 660 includes a plurality of tubular members extending distally from a proximal portion 604, said tubular members being coaxial about a central longitudinal axis ax1 of the delivery tool 600, and discussed in more detail below. The outermost of these tubular members is typically a delivery catheter 2050, which extends distally from the proximal portion 604 through the external catheter 622, exiting distal to the opening of the catheter 622.

[0743] Typically, as shown in the figure, the balloon catheter 2072 extends distally through the delivery catheter 2050 to reach the proximal balloon 2064 of the balloon assembly 2063. See the following reference... Figure 17A As described in section -B, the balloon assembly 2063 is used to enclose the prosthetic valve 2036 during advancement toward the heart. The catheter system 610 also includes an alignment mechanism 2300 for aligning the proximal balloon 2064 and the distal balloon 2066 during advancement toward and / or withdrawal from the heart, as described below.

[0744] Figure 16B-D indicates the attachment of an accessory (e.g., distal capsule sheathing tool 540) to fit the downstream end of the prosthetic valve 2036 into the distal capsule 2066. For example, the distal capsule sheathing tool 540 includes a clip 244 and a knob 250. The clip 244 is shaped to define a pawl 242, a portion of which extends within a pawl hole 2080. By extending the pawl 242 through the pawl hole 2080, the pawl occupies the space defined by the ring 2174 ( Figure 15A -B) Defines at least a portion of the groove 2178, with the ring 2174 fixedly coupled to the rod 2168. In this way, the distal sac 2066 is rotatably locked relative to the rod 2168. A knob 250 is generally connected to the clip 244 to allow manual rotation of the clip relative to the axis 2034, and thus manual rotation of the distal sac 2066 and the rod 2168. As described above with reference to the delivery tool 100, rotation of the rod relative to the axis screws the rod into the axis, causing linear (e.g., proximal) movement of the distal sac 2066 relative to the axis and the prosthetic valve 2036.

[0745] like Figure 16E -G then uses a curling tool to compress (“curl”) the prosthetic valve 2036 around the distal portion of shaft 2034, such that the downstream end of the prosthetic valve engages with mounting piece 2028 and, for example, with adapter 2022 received by a corresponding slot 2029. Figure 16E When the prosthetic valve 2036 is rolled up (or subsequently rolled up), for example by rotating the knob 250 directly coupled to the distal capsule 2066, a sheathing force is applied to the distal capsule sheathing tool 540.

[0746] By applying a sheathing force along the length of the catheter system 610 using the implantation device 660, it is desirable to apply the sheathing force directly to the distal pouch 2066, as direct application of the sheathing force generally avoids resistance that may be encountered along the length of the catheter system.

[0747] For some applications, and as shown in the figure, the distal capsule 2066 defines an opening (e.g., window 2110). Figure 16EAs shown in Figure -G, the user can use the opening to monitor the proximal advancement of the distal sac 2066 over the mount 2028 and the prosthetic valve 2036. The inventors hypothesize that using window 2110 to visualize the portion of the prosthetic valve 2036 encased by the distal sac 2066 (e.g., the downstream end of the prosthetic valve) increases the reliability of the delivery tool 600, for example, by reducing the risk of premature release of the prosthetic valve from the distal sac, which might result from the user estimating which portion of the prosthetic valve is encased within the distal sac. Instead, window 2110 allows the user to monitor the encasing portion of the prosthetic valve 2036. For example, as shown, the distal sac 2066 advances over the prosthetic valve 2036 until a portion of the mount 2028 and / or the prosthetic valve (e.g., its adapter 2022) becomes visible through window 2110. In this way, by ensuring that: (i) the mounting surrounds the adapter 2022, and (ii) each adapter is held within the corresponding slot 2029 of the mounting, the wrapping of the distal sac 2066 around the prosthetic valve 2036 serves to maintain the coupling between the prosthetic valve and the mounting 2028.

[0748] For some applications, and as shown in the figure, after the downstream end of the prosthetic valve 2036 is encased in the distal sac 2066, the upstream end of the prosthetic valve is encased in the proximal sac 2064. A coiling tool is typically used to compress the proximal portion of the prosthetic valve 2036, resulting in a compressed state, such as... Figure 16H As shown.

[0749] For some applications, the second sheathing force is applied directly to the distal portion 2024 of the delivery tool 600. Similar to the description above of sheathing the distal portion of the prosthetic valve 2036 within the distal sac 2066, it may be desirable to apply the sheathing force directly to the distal portion 2024 by applying the sheathing force along the length of the catheter system 610 to avoid resistance that may be encountered along the length of the catheter system.

[0750] For some applications, a second accessory, such as a proximal capsular tool like the 700, is attached to the distal portion of the 2024. Figure 16H This is used to apply a second sheathing force directly to the distal portion 2024. For some applications, and as shown, the clamp 700 includes a user grip portion 708, which is shaped to facilitate rotation of the clamp relative to the distal portion 2024. For example, as shown, the clamp 700 can be directly coupled to the proximal disc 2092 of the disc assembly 2086 of the distal portion 2024 to convert rotational movement of the clamp 700 into axial movement of the proximal capsule 2064 on the proximal portion of the prosthetic valve 2036.

[0751] Typically for this application, and as shown, the sleeve 700 also includes a distal coupling portion 706 configured to reversibly couple the sleeve to the proximal disk 2092 of the disk assembly 2086. For example, as shown, the distal coupling portion 706 includes one or more pins 702 shaped to fit within corresponding holes 704 defined by the proximal disk 2092. Alternatively or additionally, the distal coupling portion 706 is sized to fit within an opening in the proximal disk 2092.

[0752] Similar to disk component 1086 ( Figure 14D ), disk assembly 2086 ( Figure 15B The device includes: (i) a proximal disc 2092 defining an external thread complementary to an internal thread defined by the interior of the proximal sac 2064; and (ii) a distal disc 2090 rotatably coupled to and rotatably movable relative to the proximal disc. The distal disc 2090 is prevented from rotating because the distal disc: (1) is fixedly coupled to the shaft 2034, and (2) engages a track 2088 of the proximal sac 2064 (e.g., by a locking pin 2084 already fitted into the track). Therefore, tightening the proximal disc 2092 with the clamp 700 along the track 2088 pushes the distal disc 2090 and the locking pin 2084, converting the rotational movement of the proximal disc into advancement of the proximal sac 2064 relative to the shaft 2034, over the proximal portion of the prosthetic valve 2036. Figure 16H -I).

[0753] refer to Figure 16J -K, which is a schematic diagram illustrating the advancement of the alignment mechanism 2300 on the conduit system 610 of the delivery tool 600 according to some applications of the present invention.

[0754] Typically, as shown, the alignment mechanism 2300 includes an auxiliary tube 2310 coupled at a connection portion 2318 to the distal end of an elongated outer sheath 2320. The outer sheath 2320 is shaped to define an elongated outer sheath lumen through which the catheter system 610 (e.g., its balloon catheter 2072) slidably passes. Furthermore, the auxiliary tube 2310 is shaped to define an auxiliary tube lumen sized to encapsulate at least a portion of the housing (e.g., the balloon assembly 2063) during delivery of the distal portion 663 of the delivery tool to the heart via the lumen, while simultaneously retracting the housing outside the subject, as described in more detail below.

[0755] refer to Figure 17A -B, which is a schematic diagram illustrating the use of a delivery tool 600 to advance a prosthetic valve 2036 into the heart 1090 of a subject in some applications according to the present invention.

[0756] Figure 17A-B illustrates an operator using an implantation device 660 to laterally advance the distal portion 663 of the delivery tool 600 towards the heart 1092 from the inferior vena cava 1092. As shown, an auxiliary tube 2310 of the alignment mechanism 2300 surrounds a portion of the pouch assembly 2063 (e.g., the proximal pouch 2064). For example, as shown, the auxiliary tube 2310 may abut against the distal pouch 2066 while the distal portion 663 is advanced toward the heart. Alternatively, the auxiliary tube 2310 may encapsulate a portion of the distal pouch 2066 during advancement.

[0757] Typically, the remote portion 2024 is in the delivery state. Figure 18A The upstream portion of the prosthetic valve 2036 is encased by the proximal sac 2064, and the downstream portion of the prosthetic valve is encased by the distal sac 2066, such that the exposed segment 2056 of the prosthetic valve 2036 is located at the intersacral space, which separates the opening end 2065 of the proximal sac from the opening end 2067 of the distal sac 2066.

[0758] Figure 17A The upper illustration shows the distal portion 2024 of the delivery tool 600 in a delivery state, with the alignment tube 2314 of the alignment mechanism 2300 disposed between the outer sheath 2320 of the catheter system 610 and the balloon catheter 2072. When the distal portion 2024 is in the delivery state, the aligner 2312 of the alignment mechanism 2300 is typically disposed between the alignment tube 2314 and the auxiliary tube 2310. For some applications, and as shown, the aligner 2312 is shaped to form a ring that mates around the alignment tube 2314. The aligner 2312 typically comprises a material that is more rigid than the balloon catheter 2072. For example, the aligner 2312 may comprise metal or polycarbonate.

[0759] Typically, as shown, the aligner 2312 is positioned to align the balloon catheter relative to the auxiliary tube by occupying the space between the balloon catheter 2072 and the auxiliary tube 2310 (e.g., the aligner keeps the distal portion of the balloon catheter generally parallel to the auxiliary tube). For some applications, and as shown, the aligner 2312 is coupled to the distal end of the aligning tube 2314.

[0760] For some applications, the distal portions of the aligner 2312 and the aligning tube 2314 may slide axially along the catheter of the catheter system 610 (e.g., along the balloon catheter 2072) (e.g., independently of the auxiliary tube 2310). For some such applications, the distal portions of the aligner 2312 and the aligning tube 2314 may slide axially within the elongated sheath lumen and the auxiliary tube lumen. For example, before the balloon assembly 2063 is encapsulated within the auxiliary tube, the aligner 2312 may be advanced distally to align the balloon catheter 2072 relative to the auxiliary tube 2310.

[0761] The dimensions of the components including the catheter system 610 and the alignment mechanism 2300 are generally configured to facilitate sliding the alignment device 2312 between the balloon catheter 2072 and the auxiliary tube 2310. Therefore, for some applications, the inner diameter di2312 of the alignment device 2312 is 0.05-3.0 mm larger than the outer diameter do2072 of the balloon catheter 2072 (i.e., the largest catheter in the catheter system 610 via the auxiliary tube 2310 and the alignment device 2312), for example, 0.15 mm, and / or the alignment tube outer diameter do2314 of the alignment tube 2314 is 1.9-5.5 mm, for example, 4.9 mm, smaller than the auxiliary tube inner diameter di2310 of the auxiliary tube 2310. The outer diameter of the balloon catheter 2072 is approximately 6.7 mm, and the inner diameter of the alignment device 2312 is approximately 6.8 mm, as an example and not a limitation. The length of the alignment device 2312 is typically between 1-10 mm, for example, 8 mm.

[0762] Typically, the auxiliary tube 2310 comprises a more rigid material than the elongated outer sheath 2320 of the balloon catheter 2072. The outer diameter of the alignment tube 2314 is 1.9-2.4 mm smaller than the inner diameter of the elongated outer sheath 2320.

[0763] Typically, for this application, as shown in the figure, the outer diameter of the auxiliary tube do2310 is greater than the outer diameter of (i) the balloon catheter 2072 do2072 and (ii) the outer diameter of the slender outer sheath 2320 do2320.

[0764] For some applications, during the insertion of the delivery tool 600 into the body, the auxiliary tube 2310 surrounds the proximal portion of the proximal sac 2064 and at least the proximal portion of the distal sac 2066, as well as the exposed segment 2056 of the prosthetic valve 2036. Typically, for such applications, after insertion into the body, the proximal portions of the proximal sac 2064 and the distal sac 2066 are exposed from within the auxiliary tube 2310. Figure 17B And it is advanced toward the heart by advancing the balloon catheter 2072 distally relative to the outer sheath 2320 (e.g., by advancing the balloon catheter 2072 distally while holding the outer sheath 2320 in place and / or by retracting the outer sheath proximally relative to the balloon catheter 2072).

[0765] refer to Figure 19A -C, which is a schematic diagram illustrating a delivery tool 3600 with an alignment mechanism 3300 according to some applications of the present invention.

[0766] Delivery tool 3600 is identical to delivery tool 600 in many respects and is used in a similar manner to delivery tool 600, with necessary modifications. Components with the same reference numerals are generally interchangeable between delivery tool 600 and delivery tool 3600. For example, delivery tool 3600 includes an implantation instrument 660 and a capsule assembly 2063 at the distal portion 2024 of the delivery tool, the capsule assembly 2063 being used to enclose the prosthetic valve 2036. Components with the same name across systems generally share similar features and perform similar functions to each other. Thus, the following description of delivery tool 3600 focuses on features specific to delivery tool 3600.

[0767] Similar to alignment mechanism 2300, alignment mechanism 3300 is used to align proximal sac 2064 and distal sac 2066 during the advancement and / or retraction of delivery tool 3600, as described below. Further similar to alignment mechanism 2300, alignment mechanism 3300 includes an auxiliary tube 3310 for encapsulating a portion of sac assembly 2063. Figure 19B As shown in the figure, as described above regarding delivery tool 600, when the distal portion 2024 of delivery tool 3600 is in the delivery state, the aligner 3312 of alignment mechanism 3300 is typically positioned between alignment tube 3314 and auxiliary tube 3310 to align the balloon catheter 3072 relative to the auxiliary tube. Further similar to alignment mechanism 2300 of tool 600, the proximal portions of proximal balloon 2064 and distal balloon 2066 may protrude from within auxiliary tube 3310. Figure 19C ) and propel towards the heart (not shown).

[0768] The delivery tool 3600 includes an alignment locking mechanism 3400 operably connected to the alignment mechanism 3300. For some applications, as shown, the locking mechanism 3400 includes a sliding lock 3440 that is: i) longitudinally fixed relative to the alignment device 3312, and ii) slidable along the housing 3420 of the locking mechanism 3400 and relative to the auxiliary tube 3310. For example, as shown, the locking mechanism 3400 may be fixedly connected to the proximal end of the alignment tube 3314, and the alignment device 3312 may be fixedly connected to the distal end of the alignment tube. In this way, longitudinal movement of the sliding lock 3440 (e.g., along a proximal-to-distal axis) causes a similar longitudinal movement of the alignment device 3312. Therefore, from the proximal position (e.g., abutting the near-end cap 3412), Figure 19B ) to the distal position (e.g., abutting the distal end cap 3410, Figure 19C The sliding lock 3440 causes the aligner 3312 to move from the proximal position within the auxiliary tube 3310. Figure 19B Slide to the distal end to the distal position. Figure 19C ).

[0769] In some cases, it may be desirable for the aligner 3312 to remain in the distal position while advancing and / or retracting the distal portion 2024. Therefore, the alignment mechanism 3300 typically has a locked state. Figure 19C ) and unlock status ( Figure 19B In the locked state, the aligner is fixedly disposed within the auxiliary tube; in the unlocked state, the aligner 3312 can slide longitudinally within the auxiliary tube 3310. For some applications, the distal portion of the aligner tube 3314, together with the aligner 3312, switches between the unlocked and locked states.

[0770] For example, as shown, the aligner 3312 can be switched to a locked state (e.g., "locked") by sliding the lock 3440 through the latch 3430 protruding from the housing 3320 of the locking mechanism 3400. In this way, the lock 3440 is held securely between the distal end cap 3410 and the latch 3430.

[0771] refer to Figure 18A -O and Figure 19D -T, according to some applications of the invention, is a schematic diagram showing the deployment of a prosthetic valve 2036 at the tricuspid valve 1096 of the heart using delivery tools 600, 3600, and a schematic diagram showing the use of alignment mechanisms 2300, 3300 to facilitate the withdrawal of the delivery tool from the subject.

[0772] Typically, as shown in the figure, the balloon catheters 2072 and 3072 and the balloon assembly 2063 enclosing the prosthetic valve 2036 are advanced along the guidewire 2023 through the inferior vena cava 1092 and into the right atrium 1094 of the heart. Further typically, the prosthetic valve 1036 remains sheathed at least until the distal balloon 2066 is advanced into the right ventricle 1098 of the heart. Figure 18A , 19D ).

[0773] Refer to the above Figure 11 Similar to the prosthetic valve 1036, the prosthetic valve 2036 typically includes a tubular portion 2032 in which a plurality of prosthetic leaflets are disposed, and the tubular portion 2032 defines a lumen between an upstream end and a downstream end. For some applications, and as... Figure 18A As shown, the tubular portion 2032 and the upstream support portion 2040 together define the valve frame 2030.

[0774] Typically for this application, and as shown in the figure, multiple flanges 2054 are coupled to the tubular portion 2032 at a coupling point located downstream of the upstream support. As shown, the prosthetic valve 2036 engages with delivery tools 600, 3600 such that the downstream end of the tubular portion 2032 is positioned within the distal capsule 2066 and the upstream support 2040, and the ends 2068 of the flanges 2054 are positioned within the proximal capsule 2064.

[0775] Referring to 18B and 19E, it is shown that the capsule assembly 2063 has been further advanced distally, such that the exposed segment 2056 is partially disposed in the right atrium 1094 and partially disposed in the right ventricle 1098. Typically, as shown, at least a portion of the flange 2054 (e.g., its end 2068) remains enclosed within the proximal capsule 2064 at this stage.

[0776] Referring to 18C and 19F, the capsule assembly 2063 is shown after the guidewire 2023 has been withdrawn from the distal portion 2027 of the anterior cone 2026 towards the proximal end. (See above references) Figure 13A As described in -B, withdrawing the guidewire 2023 from the distal portion 2027 reduces the axial length of the anterior cone 2026, thereby facilitating the deployment of the prosthetic valve 2036 by reducing the amount of space required within the right ventricle 1098 for the manipulator assembly 2063 (e.g., its distal capsule 2066).

[0777] Referring to 18D and 19G, the proximal capsule 2064 is shown retracted relative to the mount 2028, such that the end 2068 of the flange 2054 is released from the proximal capsule. Typically, an opening force is applied externally to a controller, such as a knob or dial of the implantation device 660, to retract the proximal capsule 2064. As shown, the flange 2054 typically expands radially outward from its corresponding coupling point upon release from the proximal capsule 2064. However, the valve frame 2030 remains compressed because the distal end of the tubular portion 2032 is still constrained by the distal capsule 2066 and the upstream support portion 2040 is still constrained by the proximal capsule 2064.

[0778] Figure 18E and 19H The distal portion 2024, which has been advanced distally, is shown, such that the flange 2054 enters the right ventricle 1098 (e.g., such that the flange reaches the distal end of the leaflet 12 of the tricuspid valve 1096). Figure 18F and 19I The distal portion of the tricuspid valve 1096 is shown as being retracted from the entire valve, such that the flange 2054 (e.g., its end 2068) engages with the tissue of the tricuspid valve (e.g., leaflet).

[0779] Subsequently, the proximal bladder 2064 retracts further relative to the mounting member 2028, causing the upstream support portion 2040 to protrude from the proximal bladder. Figure 18G ,19J), and the distal capsule 2066 is advanced relative to the mounting member 2028, allowing the tubular portion 2032 to expand radially outward, thus allowing the prosthetic valve 2036 to present its expanded state. Typically, an opening force is applied externally by the implantation instrument 660 of the delivery tool 600 and the delivery tool 3600, as described above. Figure 14D The above has been revised as necessary.

[0780] like Figure 18H and 19K As shown, distal movement of the distal bladder 2066 relative to the adapter 2022 and / or the mounting member 2028 (e.g., relative to a point further away from the mounting member 2028, or at least further away from its slot 2029) releases the downstream end of the tubular portion 2032 from within the distal bladder 2066. As shown, the tubular portion 2032 expands radially, allowing the delivery bracket 2200 to expand into its expanded state.

[0781] Figure 18I and 19L The image shows the proximal sac 2064 advanced distally, such that the open end 2067 of the proximal sac meets the delivery stent 2200. Figure 18J and 19M The distal capsule 2066, advanced proximally, is shown such that its open end 2065 meets the delivery stent 2200. Typically, the delivery stent 2200 is configured to fit snugly between the proximal capsule 2064 and the distal capsule 2066 to allow the capsule assembly 2063 (e.g., its distal capsule) to retract smoothly through the prosthetic valve 2036. Figure 18K (19N), while the risk of damaging the prosthetic leaflet disposed within the tubular portion 2032 is relatively small. For some applications, the delivery stent 2200 includes a fabric cover (not shown), which further facilitates the smooth retraction of the capsule assembly 2063 through the prosthetic valve 2036.

[0782] Figure 18L -M and 19O-P show the distal portion 2024 of the delivery instrument 600, 3600 further retracted from within the prosthetic valve 2036 and into the inferior vena cava 1092. For some applications, the distal portion 2024 (e.g., its balloon assembly 2063) is retracted proximally toward the auxiliary tubes 2310, 3310 by retracting the balloon catheters 2072, 3072 and / or the delivery catheter 2050 proximally.

[0783] For some applications, and such as Figure 18M As shown, the distal portion of the balloon duct 2072 is configured (e.g., sufficiently flexible) to exhibit a curved orientation, while the balloon duct retracts through the vascular system. Figure 18M As shown in the lower illustration, there is sufficient space within the lumen of the auxiliary tube and the balloon duct 2072 to allow the distal portion of the balloon duct 2072 to be oriented in a curved manner. That is, the auxiliary tube 2310 does not necessarily need to apply an alignment force to the distal portion of the balloon duct 2072. The inventors hypothesize that when the distal portion of the balloon duct 2072 is in a curved orientation, fully retracting the balloon assembly 2063 into the auxiliary tube 2310 may result in incomplete fitting of the balloon assembly into the auxiliary tube 2310, which could complicate the retraction of the distal portion 2024 from the body.

[0784] For some applications, in order to facilitate better fitting of the balloon assembly 2063 into the auxiliary tube 2310 and to facilitate the withdrawal of the distal portion 2024 from the body, the alignment tube 2314 is positioned as a directional alignment device 2312 to straighten the distal portion of the balloon catheter 2072. Figure 18N An aligner 2312 is shown that moves distally, for example, by pushing the aligner tube 2314 proximally and / or by retracting the balloon catheter 2072 distally.

[0785] like Figure 18O As shown, the alignment device 2312 applies an alignment force to the balloon catheter 2072, thereby straightening the distal portion of the balloon catheter. Typically, for this application, straightening the distal portion of the balloon catheter 2072 when the balloon assembly retracts into the auxiliary tube ensures that the balloon assembly 2063 and / or the balloon catheter 2072 are concentrically positioned relative to the auxiliary tube 2310, thereby preventing the balloon assembly 2063 from entering the auxiliary tube at an angle.

[0786] Typically, the distal portion 2024 is then pulled out of the body while being housed within the auxiliary tube 2310 (e.g., when the auxiliary tube 2310 surrounds the proximal sac 2064 and when the distal end of the auxiliary tube abuts against the distal sac).

[0787] As mentioned above, and as Figure 19Q As shown, the latch 3430 protrudes from the housing 4320 of the locking mechanism 3400 and is held on the distal end cap 3410, thereby locking the aligner 3312 in the distal position. The inventors hypothesize that locking the aligner 3312 in the distal position while retracting the distal portion 2024 from the body simplifies the operation of the delivery tool 3600, for example, by avoiding the need for manual force to hold the aligner 3312 in the distal position.

[0788] As referenced above Figure 18OAt least a portion of the capsule assembly 2063 is typically enclosed within the auxiliary tube 3310, while the distal portion 2024 is retracted from the main body. To allow the capsule assembly 2063 into the auxiliary tube 3310, the aligner 3312 must typically slide distally. The alignment mechanism 3300 must therefore be transitioned from a locked state (e.g., "unlocked") to an unlocked state.

[0789] Figure 19R An embodiment of the alignment mechanism 3300 shown unlocks the locking mechanism 3400 by rotating the lock 3440 from state "A" to state "B". As shown, the lock 3440 is rotated such that the groove 3444 defined by the lock wall aligns with the latch 3430. In this way, the lock 3440 is no longer held tightly between the latch 3430 and the distal end cap 3410, thereby allowing the lock and the aligner 3312 to move longitudinally in response to a force (e.g., a pulling force applied to the lock).

[0790] In some applications, and as shown in the figure, a pin 3450 actuates the rotation of a lock 3440 to unlock the alignment mechanism 3300. The pin 3450 is fixedly coupled to the alignment tube 3314 and is disposed within a groove 3442 defined by the lock. As shown, the groove 3442 is sized such that the lock 3440 rotates in alternating directions, causing the pin 3450 to contact the opposite end of the groove, thereby reversibly locking or unlocking the alignment mechanism 3300.

[0791] Rotating lock 3440 to position "B" aligns groove 3444 with latch 3430, which facilitates movement of pin 3450 along longitudinal track 3422, causing lock 3440 and aligner 3312 to occupy their respective proximal positions. Figure 19S In this way, when the capsule assembly 2063 retracts into the auxiliary tube 3310, the aligner 3312 is aligned with the capsule catheter 3072, and the distal portion 2024 can be withdrawn from the body.

[0792] refer to Figure 20A -F, which is a schematic diagram illustrating a delivery tool 4020 for deploying a prosthetic valve 1036 at the tricuspid valve 1096 of the heart, according to some applications of the invention.

[0793] Unless otherwise stated, delivery tool 4020 is generally the same as and used similarly to delivery tool 1020 described above, with necessary modifications. Components that are named the same across systems generally share similar features and perform similar functions, and components with the same reference numerals between delivery tool 1020 and delivery tool 4040 are generally interchangeable. Thus, the following description of delivery tool 4020 focuses on the specific features of delivery tool 4020.

[0794] Figure 20A The image shows a delivery device 4020 within the heart, in the deployment phase of the prosthetic valve 1036, as described above. Figure 14C The stages described in the delivery tool 1020 are comparable. Compared to tool 1020, the proximal pouch of delivery tool 4020 includes a proximal pouch assembly 4064 having an inner proximal pouch 4064a and an outer proximal pouch 4064b. Typically, the outer proximal pouch 4064b is longitudinally movable relative to the inner proximal pouch 4064a. For some applications, and as shown, the inner proximal pouch 4064a fits snugly within the outer proximal pouch 4064b.

[0795] For some applications, and such as Figure 20B As shown, the proximal pouch assembly 4064 defines an internal thread 4089, which is similar to the internal thread 1089 defined by the proximal pouch 1064 of the delivery tool 1020. For some such applications, and as... Figure 20B As shown in the illustration, the proximal portion 4089p of the internal thread 4089 is defined by an inner proximal bladder 4064a, while the distal portion of the internal thread is defined by an outer proximal bladder 4064b. Typically, for this application, the proximal portions 4089p and 4089a of the internal thread 4089 are sized to engage with the external thread defined by the proximal bladder 4080 of the bladder assembly 4086 when the proximal disc is tightened along the internal thread. For example, as shown, the threaded insert 4070 of the outer proximal bladder 4064b mates within a window defined by the inner proximal bladder 4064a to engage the proximal bladder 4080. Figure 20C ).

[0796] References above Figure 14D Similar to that described in the delivery tool 1020, rotation of the balloon catheter 4072 relative to the shaft 4034 causes the distal disc 4080 to tighten along the internal thread 4089 of the proximal balloon assembly 4064. Simultaneously, the distal disc 4082 is prevented from rotating because it is (1) fixedly coupled to the shaft 4034 and (2) engages the track 4088 of the proximal balloon assembly 4064 (e.g., by locking a pin 4084 that has been fitted into the track). Therefore, the screwing of the proximal disc 4080 along the track 4088 pushes the distal disc 4082, thereby converting the rotational motion of the proximal disc into axial movement (e.g., retraction) of the proximal balloon assembly 4064 relative to the disc assembly 4086 and the prosthetic valve 1036.

[0797] like Figure 20C As shown, rotation of the balloon catheter 4072 causes the proximal disc 4080 to screw along the internal thread 4089, resulting in the proximal balloon assembly 4064 retracting proximally relative to the disc assembly 4086. This releases the flange end 1068 from the proximal balloon assembly, as referenced above. Figure 14DAs shown in the figure, the proximal balloon assembly 4064 is retracted proximally relative to the balloon catheter 4072 and the delivery catheter 4050. Therefore, the proximal balloon assembly 4064 typically has a sufficiently large inner diameter to allow the proximal balloon assembly to retract over the balloon catheter 4072 and / or the delivery catheter 4050.

[0798] Figure 20D The diagram shows the continuous unfolding of the human valve 1036 at the tricuspid valve 1096, wherein the distal portion 4024 has been retracted as a whole, such that the flange 1054 (e.g., its end 1068) now engages the tissue (e.g., leaflet) of the tricuspid valve 1096.

[0799] exist Figure 20E In this process, the proximal disc 4080 is further screwed along the internal thread 4089, causing the outer proximal capsule 4064b to retract proximally relative to the inner proximal capsule 4064a, the disc assembly 4086, and the prosthetic valve 1036. For example... Figure 20E As shown in the illustration, when the proximal disc 4080 is advanced from (a) the proximal portion 4089 of the internal thread 4089 defined by the inner proximal bladder to (b) the distal portion 4089a of the internal thread defined by the outer proximal bladder, the outer proximal bladder 4064b retracts onto the inner proximal bladder 4064a.

[0800] The retraction of the outer proximal balloon 4064b onto the inner proximal balloon 4064a results in the proximal balloon assembly 4064 having a shorter length after the release of the upstream support 1040 than before the release of the upstream support. The inventors hypothesize that this shortening of the proximal balloon assembly 4064 may facilitate deployment during the deployment of the prosthetic valve 1036, especially since the shorter proximal balloon assembly can more easily retract onto the curved portions of the balloon catheter 4072 and / or the delivery catheter 4050.

[0801] As shown in the figure, the retraction of the proximal bladder 4064b releases the upstream support 1040, causing the upstream support to expand radially outward. Figure 20F The distal bladder 4066, which has been advanced relative to the mounting 4028, is shown, such that the distal portion 4024 presents the form described above. Figure 10D and 14G The deployed state. Releasing the mounting 4028 and the tubular portion 1032 from the distal sac allows the tubular portion to automatically expand radially outward, so that the frame assembly 1022 (and thus the prosthetic valve 1036 as a whole) has presented its expanded state.

[0802] Those skilled in the art will understand that this invention is not limited to the specific details shown and described above. Rather, the scope of this invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereof not found in the prior art, as will occur to those skilled in the art upon reading the foregoing description.

Claims

1. A device for use with the heart of a subject, the device comprising: Delivery tool, sized for percutaneous delivery to the heart, the delivery tool having a distal portion defining a central longitudinal axis and comprising: Axis; and The proximal capsule and the distal capsule, each of the proximal capsule and the distal capsule: Having corresponding open ends, the open end of the proximal sac faces the open end of the distal sac, and an intersacral gap separates the open ends of the proximal sac and the distal sac; and Coupled to the shaft in a manner that allows the bladder to move axially relative to the shaft, along the central longitudinal axis at the distal portion; and Prosthetic heart valves, including: The tubular portion that defines the lumen; and Multiple prosthetic leaflets are disposed in the lumen; in: The prosthetic heart valve is constrained in a compressed state by the delivery tool, such that the downstream end of the tubular portion is positioned within the distal capsule, and a segment of the prosthetic heart valve is positioned at the intersacral space; and The distal sac is shaped to define an opening for viewing at least a portion of the downstream end of the tubular portion within the sheath of the distal sac. The delivery tool further includes a delivery bracket fixedly coupled to the shaft, the delivery bracket comprising a shape memory material such that when the prosthetic heart valve is rolled up on the delivery bracket and the shaft, the delivery bracket is in a compressed state within the prosthetic heart valve; After the tubular portion of the prosthetic heart valve is radially expanded, the delivery stent is allowed to expand to an expanded state. The delivery stent is configured to meet the opening end of the proximal sac that is advanced distally, and the opening end of the distal sac that is advanced proximally.

2. The apparatus according to claim 1, wherein, The opening defines a window, the delivery stent is configured to fit snugly between the proximal sac and the distal sac, and the delivery stent also includes a fabric cover.

3. The apparatus according to any one of claims 1-2, wherein, The delivery tool further includes a mounting element surrounding the axis and configured to engage the downstream end of the tubular portion, wherein the opening is configured to allow visualization of the mounting element and the downstream end of the tubular portion.

4. The apparatus according to claim 3, wherein, The mounting element is shaped to define one or more grooves, and wherein the downstream end of the tubular portion is shaped to define one or more adapters, each of the adapters being configured to be received in a corresponding groove among the one or more grooves to facilitate engagement between the mounting element and the downstream end of the tubular portion.

5. The apparatus according to claim 4, wherein, In the compressed state of the prosthetic heart valve, the distal sac maintains the coupling between the downstream end of the tubular portion and the mounting by surrounding the one or more adapters and holding each of the one or more adapters within a corresponding slot of the mounting.

6. The apparatus according to any one of claims 1-2, wherein, The prosthetic heart valve includes: an upstream support portion extending from the tubular portion; and... A plurality of flanges, each of which is coupled to the tubular portion at a corresponding coupling point downstream of the upstream support and extends from the coupling point to a corresponding flange end of the flange.

7. The apparatus according to claim 6, wherein, The prosthetic heart valve can be confined to the compressed state by the delivery tool, such that the upstream support and the flange end are positioned within the proximal capsule.

8. A method for preparing a prosthetic heart valve for implantation, performed using the apparatus for use in the heart of a subject as described in any one of claims 1 to 7, the method comprising: Using a curling tool, the prosthetic heart valve is curled around the distal portion of the axis of the delivery tool; as well as After the curling, the prosthetic heart valve is encased in the sac by (i) directly coupling the sheathing tool to the distal portion externally and (ii) applying a rotational force to the sheathing tool to influence the linear movement of the sac relative to the prosthetic heart valve.

9. The method according to claim 8, wherein: The sac is a distal sac; Encasing the prosthetic heart valve within a capsule includes: The downstream end of the prosthetic heart valve is encased in the distal capsule; Then, the upstream end of the prosthetic heart valve is encased in a proximal capsule.

10. The method according to claim 9, wherein, The sheathing tool is a distal balloon sheathing tool, and wherein sheathing the downstream end of the prosthetic heart valve includes applying a first sheathing force to the distal portion of the delivery tool using the distal balloon sheathing tool, which is directly coupled to the distal balloon.

11. The method of claim 10, further comprising directly coupling the distal capsule sheathing tool to the distal capsule.

12. The method according to claim 10, wherein, Encasing the upstream end of the prosthetic heart valve in the proximal capsule includes applying a second encasing force to the distal portion of the delivery tool using a proximal capsule encasing tool directly coupled to the distal portion.

13. The method according to claim 9, wherein, It also includes, during the process of enclosing the downstream end of the prosthetic heart valve in the distal sac, making at least a portion of the enclosing of the downstream end of the prosthetic heart valve in the distal sac visible through an opening defined in the distal sac for visualizing the enclosing.

14. The method according to claim 13, wherein, The delivery tool further includes an mounting element surrounding the axis and configured to engage the downstream end of the prosthetic heart valve, and wherein visibility of the sheath of at least a portion of the downstream end of the prosthetic heart valve within the distal sac includes visibility of the mounting element and the downstream end of the prosthetic heart valve.

15. The method of claim 14, wherein: The mounting element is shaped to define one or more grooves; The downstream end of the prosthetic heart valve is shaped to define one or more adapters, each of which is configured to be received in a corresponding slot among the one or more slots to facilitate engagement between the mounting and the downstream end of the prosthetic heart valve. as well as Encasing the downstream end of the prosthetic heart valve in the distal capsule includes encasing the downstream end of the prosthetic heart valve such that one or more adapters mate in one or more slots.

16. The method according to claim 15, wherein, Enclosing the downstream end of the prosthetic heart valve in the distal sac includes maintaining the coupling between the downstream end of the prosthetic heart valve and the mounting device by enclosing the downstream end of the prosthetic heart valve in the distal sac.

17. A method for preparing a prosthetic heart valve for implantation, performed using the apparatus for use in the heart of a subject as described in any one of claims 1 to 7, the method comprising: Using a curling tool, the prosthetic heart valve is curled around the distal portion of the axis of the delivery tool; as well as After the curling, the downstream end of the prosthetic heart valve is encased in a capsule, and during the encasing, at least a portion of the downstream end of the prosthetic heart valve is made visible in the capsule by defining an opening in the capsule for visualizing the encasing.

18. The method of claim 17, wherein: The sac is a distal sac, and the opening is defined within the distal sac; Encasing the prosthetic heart valve within the capsule includes: The downstream end of the prosthetic heart valve is encased in the distal capsule; as well as Subsequently, after the downstream end of the prosthetic heart valve is encased in the distal capsule, the upstream end of the prosthetic heart valve is encased in the proximal capsule.

19. The method according to claim 18, wherein, The downstream end of the prosthetic heart valve is sheathed by applying a first sheathing force to the distal portion of the delivery tool using a distal sac sheathing tool directly coupled to the distal sac.

20. The method of claim 19, further comprising directly coupling the distal capsule sheathing tool to the distal capsule.

21. The method of claim 19, further comprising applying a second sheathing force to the distal portion of the delivery tool by using a proximal sheathing tool directly coupled to the distal portion, and sheathing the upstream end of the prosthetic heart valve in the proximal capsule after sheathing the downstream end of the prosthetic heart valve in the distal capsule.

22. The method according to claim 17, wherein, The delivery tool further includes an mounting element surrounding the axis and configured to engage the downstream end of the prosthetic heart valve, and wherein visibility of the sheath of at least a portion of the downstream end of the prosthetic heart valve within the distal sac includes visibility of the mounting element and the downstream end of the prosthetic heart valve.

23. The method according to claim 22, wherein: The mounting element is shaped to define one or more grooves; The downstream end of the prosthetic heart valve is shaped to define one or more adapters, each of which is configured to be received in a corresponding slot among the one or more slots to facilitate engagement between the mounting and the downstream end of the prosthetic heart valve. as well as Enclosing the downstream end of the prosthetic heart valve within the distal capsule includes curling the downstream end of the prosthetic heart valve such that one or more adapters engage in one or more slots.

24. The method according to claim 23, wherein, Enclosing the downstream end of the prosthetic heart valve in the distal sac includes maintaining the coupling between the downstream end of the prosthetic heart valve and the mounting device by enclosing the downstream end of the prosthetic heart valve in the distal sac.

25. A device for use with a prosthetic heart valve, comprising: Delivery tool for use with prosthetic heart valves, the delivery tool comprising: tubular shaft; Rod: Extending from within the shaft at its distal end, such that the distal portion of the rod is disposed outside the distal end of the shaft; and Operablely coupled to the shaft such that rotational motion of the rod relative to the shaft is converted into axial motion of the rod relative to the shaft; and The proximal capsule and the distal capsule, each of the proximal capsule and the distal capsule: It has a corresponding opening end, with the opening end of the proximal sac facing the opening end of the distal sac; Coupled to the axis in a manner that allows the capsule to move axially relative to the axis along the central longitudinal axis at the distal portion, the intersacral gap separates the opening end of the proximal capsule from the opening end of the distal capsule, and a segment of the prosthetic heart valve is disposed at the intersacral gap; and A first attachment, including a pawl, is coupled to the distal sac such that the pawl rotatably locks the distal sac to the rod; and A second attachment, operatively coupled to the proximal sac, such that rotational motion of the second attachment relative to the axis is converted into axial motion of the distal sac relative to the axis; The delivery tool further includes a delivery bracket fixedly coupled to the shaft, the delivery bracket comprising a shape memory material such that when the prosthetic heart valve is rolled up on the delivery bracket and the shaft, the delivery bracket is in a compressed state within the prosthetic heart valve; After the tubular portion of the prosthetic heart valve is radially expanded, the delivery stent is allowed to expand to an expanded state. The delivery stent is configured to meet the opening end of the proximal sac that is advanced distally, and the opening end of the distal sac that is advanced proximally.

26. The apparatus according to claim 25, wherein, The prosthetic heart valve includes: a tubular portion defining a lumen; and Multiple prosthetic leaflets are disposed within the lumen; wherein: The prosthetic heart valve is confined in a compressed state by the delivery tool, such that the downstream end of the tubular portion is disposed within the distal sac, and the upstream end of the tubular portion is disposed within the proximal sac.

27. The apparatus according to any one of claims 25-26, wherein, The second accessory includes a sleeve formed to surround the shaft, and wherein the sleeve comprises: A user grip portion is provided to facilitate rotation of the second accessory relative to the axis; and The remote coupling portion is configured to reversibly couple the second accessory to the remote portion.

28. The apparatus according to claim 27, wherein, The dimensions of the distal coupling portion are adapted to fit within the opening of the distal portion to couple the second accessory to the distal portion.

29. The apparatus according to claim 27, wherein, The distal coupling portion includes one or more pins shaped to engage within corresponding holes defined by the distal portion to couple the second accessory to the distal portion.

30. A device for use with a prosthetic heart valve, the device comprising: A delivery tool for delivering the prosthetic heart valve to the heart of a subject, the delivery tool comprising: a catheter system including one or more catheters having a catheter system outer diameter; A housing for accommodating a prosthetic heart valve, the housing being disposed at the distal portion of a catheter system and having an inner diameter greater than the diameter of at least one catheter of the catheter system, the housing comprising a proximal sac and a distal sac, each of the proximal and distal sacs having a corresponding open end, the open end of the proximal sac facing the open end of the distal sac, an intersac space separating the open ends of the proximal and distal sacs, and a segment of the prosthetic heart valve being disposed at the intersac space; The catheter alignment mechanism includes: An elongated outer sheath, shaped to define an elongated outer sheath lumen for slidable passage through a catheter system; An auxiliary tube, coupled to the distal end of the elongated outer sheath, the auxiliary tube being shaped to define an auxiliary tube lumen, the size of which is adapted to encapsulate at least a portion of the housing during (1) the delivery of the distal portion of the delivery tool via the lumen to at least a portion of the heart, surrounding the proximal sac and at least the proximal portion of the distal sac, and the segment of the prosthetic heart valve disposed at the intersac space, and during (2) the retraction of the housing from the subject's body; An alignment tube, positioned between the outer sheath and one or more catheters of the catheter system during delivery; and An aligner is disposed between the aligning tube and the auxiliary tube and is configured to align one or more tubes of the catheter system relative to the auxiliary tube; The delivery tool further includes a shaft; and a delivery bracket fixedly coupled to the shaft, the delivery bracket including a shape memory material such that when the prosthetic heart valve is rolled up on the delivery bracket and the shaft, the delivery bracket is in a compressed state within the prosthetic heart valve; After the tubular portion of the prosthetic heart valve is radially expanded, the delivery stent is allowed to expand to an expanded state. The delivery stent is configured to meet the opening end of the proximal sac that is advanced distally, and the opening end of the distal sac that is advanced proximally.

31. The apparatus according to claim 30, wherein, The aligner includes a ring.

32. The apparatus according to claim 30, wherein, By advancing the alignment tube distally along the one or more catheters to advance the alignment device distally, the alignment device and the distal portion of the alignment tube are axially slidable from proximal to distal within the lumen of the auxiliary tube, so as to align the one or more catheters of the catheter system relative to the auxiliary tube before encapsulating the at least portion of the housing within the auxiliary tube.

33. The apparatus according to claim 32, wherein, The catheter alignment mechanism: It has an unlocked state in which the aligner can slide axially within the auxiliary tube lumen along a proximal-to-distal axis; as well as It has a locked state in which the aligner is fixedly disposed inside the auxiliary tube.

34. The apparatus according to claim 33, wherein: In the unlocked state, the distal portion of the aligner and the aligning tube can slide axially within the auxiliary tube lumen along a proximal-to-distal axis; In the locked state, the aligner and the distal portion of the alignment tube are fixedly disposed within the auxiliary tube.

35. The apparatus according to claim 33, wherein, The delivery tool also includes an alignment locking mechanism operatively connected to the catheter alignment mechanism to switch the catheter alignment mechanism from the locked state to the unlocked state.

36. The apparatus according to claim 30, wherein, The housing has an outer diameter that is larger than the outer diameter of at least one conduit in the conduit system.

37. The apparatus according to claim 30, wherein, The auxiliary tube has an outer diameter that is larger than the outer diameter of the slender outer sheath.

38. The apparatus according to claim 30, wherein, The elongated outer sheath has an elongated outer diameter, and the auxiliary tube has an auxiliary tube outer diameter that is larger than the elongated outer sheath outer diameter.

39. The apparatus according to claim 30, wherein, The alignment tube can slide within the elongated outer sheath lumen and the auxiliary tube lumen, allowing the alignment device to slide between the auxiliary tube and one or more conduits.

40. The apparatus according to any one of claims 30-39, wherein, The aligner includes a ring and has an inner diameter that is 0.05-3.0 mm larger than the outer diameter of the largest of one or more conduits passing through the aligner.

41. The apparatus according to claim 40, wherein, The auxiliary tube has an inner diameter, and the alignment tube has an outer diameter, the outer diameter of which is 1.9-5.5 mm smaller than the inner diameter of the auxiliary tube.

42. The apparatus according to any one of claims 30-39, wherein: In the compressed state, the prosthetic heart valve can be confined within a housing by a delivery tool such that the upstream portion of the prosthetic heart valve is encased by the proximal capsule and the downstream portion of the prosthetic heart valve is encased by the distal capsule. as well as The dimensions of the auxiliary tube lumen are adapted to encapsulate at least the proximal portion of the proximal sac and the distal sac.

43. The apparatus of claim 42, wherein the delivery tool enters the subject's body. Subsequently, the proximal capsule, at least the proximal portion of the distal capsule, and the prosthetic heart valve are exposed from the auxiliary tube and advanced toward the heart by the advancement of at least one catheter of the catheter system.

44. The apparatus according to any one of claims 30-39, wherein, The prosthetic heart valve includes: The tubular portion that defines the lumen; Multiple prosthetic leaflets are disposed in the lumen; An upstream support extending from the tubular portion; and Multiple flanges, each flange being coupled to the tubular portion at a corresponding coupling point downstream of the upstream support, and extending from the coupling point to the corresponding flange end of the flange.

45. The apparatus according to claim 44, wherein: The distal portion is configured such that, when the delivery tool is in the delivery state, the prosthetic heart valve engages with the delivery tool, such that: The downstream end of the tubular portion is disposed within the distal sac; and The upstream support and the flange end are disposed within the proximal sac.

46. ​​The apparatus according to claim 45, wherein, During the removal of the delivery device from the subject's body, the auxiliary tube surrounds the proximal pouch, with the distal end of the auxiliary tube abutting against the distal pouch.

47. A device for use with the heart of a subject, the device comprising: A delivery tool, sized for percutaneous delivery to the heart, the delivery tool having a distal portion defining a distal portion axis, and the delivery tool comprising: Axis; and The proximal capsule and the distal capsule, each of the proximal capsule and the distal capsule: Having corresponding open ends, the open end of the proximal sac faces the open end of the distal sac, and an intersacral gap separates the open ends of the proximal sac and the distal sac; and So that the bladder is coupled to the shaft in such a manner as to allow axial movement of the bladder relative to the shaft along the axis of the distal portion; and Prosthetic heart valves, including: The tubular portion that defines the lumen; Multiple prosthetic leaflets are disposed in the lumen; An upstream support extending from the tubular portion; and Multiple flanges, each of the flanges being: Coupled to the tubular portion at a corresponding coupling point downstream of the upstream support; and Extending from the coupling point to the corresponding flange end of the flange; The prosthetic heart valve can be confined in a compressed state by the delivery tool, such that: The downstream end of the shaft and the tubular portion is disposed within the distal sac; and The upstream support and the flange end are disposed within the proximal sac; and A segment of the prosthetic heart valve is disposed in the intercapsular space; The delivery tool further includes a delivery bracket fixedly coupled to the shaft, the delivery bracket comprising a shape memory material such that when the prosthetic heart valve is rolled up on the delivery bracket and the shaft, the delivery bracket is in a compressed state within the prosthetic heart valve; After the tubular portion of the prosthetic heart valve is radially expanded, the delivery stent is allowed to expand to an expanded state. The delivery stent is configured to meet the opening end of the proximal sac that is advanced distally, and the opening end of the distal sac that is advanced proximally.

48. The apparatus according to claim 47, wherein, The distal bladder is coupled to the shaft in a manner that allows for movement of the distal bladder relative to the proximal and distal ends of the shaft.

49. The apparatus according to claim 47, wherein, The proximal sac and the distal sac are coupled to the shaft in a manner that facilitates the proximal and distal movement of the proximal and distal sacs relative to the shaft.

50. The apparatus according to claim 47, wherein, The proximal sac is coupled to the shaft in a manner that allows for movement of the proximal and distal ends of the proximal sac relative to the shaft.

51. The apparatus according to any one of claims 47-50, further comprising: A balloon catheter extends from the distal portion of the delivery tool towards the proximal end; and a disc assembly coupled to the balloon duct, the disc assembly comprising: A proximal disc, fixedly coupled to the cyst catheter and shaped to define an external thread, and a distal disc, rotatably coupled to the proximal disc.

52. The apparatus according to claim 51, wherein, The proximal capsule is shaped to define: a longitudinal track configured to engage the distal disc; and Internal thread, the internal thread: Complementary to the external thread; and traversing the longitudinal track; Wherein, the disc assembly is disposed within the proximal sac, such that: The external thread mates with the internal thread; and the rotation of the cyst catheter along the first direction facilitates: The proximal disk rotates along the first direction; and The proximal sac moves longitudinally relative to the disc assembly.

53. The apparatus according to claim 52, wherein, The distal disc includes a locking pin disposed within the longitudinal track.

54. The apparatus according to claim 52, wherein, The proximal capsule includes a proximal capsule assembly having an inner proximal capsule and an outer proximal capsule, the outer proximal capsule being longitudinally movable relative to the inner proximal capsule.

55. The apparatus according to claim 54, wherein, The inner proximal capsule fits snugly within the outer proximal capsule.

56. The apparatus according to claim 54, wherein: The inner proximal bladder defines the proximal portion of the internal thread; The external proximal sac defines the distal portion of the internal thread; and The rotation of the balloon duct in the first direction facilitates: The proximal disc rotates a first helical distance along the internal thread in the first direction, so as to allow longitudinal movement of the proximal bladder assembly relative to the disc assembly; and The proximal disc rotates a second helical distance along the internal thread in the first direction to facilitate longitudinal movement of the outer proximal bladder relative to the inner proximal bladder and the disc assembly.

57. The apparatus according to claim 56, wherein, The distal sac and the proximal sac are respectively coupled to the shaft, so that the distal sac can be translated toward the proximal sac, so that the opening end of the proximal sac and the opening end of the distal sac meet, thereby closing the intersacral gap.

58. The apparatus according to claim 57, wherein, Both the distal sac and the proximal sac are coupled to the axis such that the distal sac cannot translate toward the proximal sac before the prosthetic heart valve detaches from the axis, so that the opening end of the proximal sac meets the opening end of the distal sac, thereby closing the intersacral space.

59. The apparatus according to claim 56, wherein, The delivery tool is configured such that when the distal portion of the delivery tool is in the delivery state, the length of the intercystic space is greater than 5 mm and less than 25 mm.

60. The apparatus according to claim 59, wherein, The delivery tool is configured such that when the distal portion of the delivery tool is in the delivery state, the length of the intercystic space is greater than 10 mm.

61. The apparatus according to claim 59, wherein, The delivery tool is configured such that when the distal portion of the delivery tool is in the delivery state, the length of the intercystic gap is less than 15 mm.

62. The apparatus according to claim 56, wherein, The proximal sac and the distal sac are respectively coupled to the shaft, such that the distal portion of the delivery tool can be switched from a delivery state to an unfolded state, such that (a) the intersac gap when the distal portion is in the unfolded state is longer than (b) the intersac gap when the distal portion is in the delivery state.

63. The apparatus according to claim 62, wherein, The delivery tool is configured such that when the distal portion of the delivery tool is in the deployed state, the interpouch gap is 50%-200% larger than the gap when the distal portion is in the delivery state.

64. The apparatus according to claim 63, wherein, The delivery tool is configured such that when the distal portion of the delivery tool is in the deployed state, the intervesicular gap is 100%-200% larger than the gap when the distal portion is in the delivery state.

65. The apparatus according to claim 62, wherein, The delivery tool is configured such that when the distal portion of the delivery tool is in the deployed state, the length of the intercystic gap is greater than 15 mm and less than 40 mm.

66. The apparatus according to claim 65, wherein, The delivery tool is configured such that when the distal portion of the delivery tool is in the deployed state, the length of the intercapsular gap is greater than 20 mm and less than 35 mm.

67. A device for use with the heart of a subject, the device comprising: A delivery tool having a distal portion defining a distal portion axis, and the delivery tool comprising: The proximal capsule and the distal capsule, each of the proximal capsule and the distal capsule: Having corresponding open ends, the proximal capsule's open end faces the distal capsule's open end, such that when the distal portion of the delivery tool is in a delivery state involving transcavitary delivery of the delivery tool to the heart, the intersacral gap separates the open ends of the proximal capsule and the distal capsule; and An implant, which can be constrained to a compressed state by the delivery tool; and a segment of the implant is disposed at the intercapsular space; The delivery tool further includes a shaft; and a delivery bracket fixedly coupled to the shaft, the delivery bracket including a shape memory material such that when the implant is rolled up on the delivery bracket and the shaft, the delivery bracket is in a compressed state within the implant. After radial expansion of the implant, the delivery stent is allowed to expand to an expanded state, the delivery stent being configured to meet the opening end of the proximal capsule advancing distally, and the opening end of the distal capsule advancing proximally.

68. The apparatus according to claim 67, wherein, The implant includes a prosthetic heart valve.

69. The apparatus according to claim 68, wherein, The prosthetic heart valve includes: The tubular portion that defines the lumen; Multiple prosthetic leaflets are disposed in the lumen; An upstream support extending from the tubular portion; and A plurality of flanges, each of which is coupled to the tubular portion at a corresponding coupling point downstream of the upstream support and extends from the coupling point to a corresponding flange end of the flange.

70. The apparatus according to claim 69, wherein, The distal portion is configured such that, when the delivery tool is in the delivery state, the prosthetic heart valve engages with the delivery tool, such that: The downstream end of the tubular portion is disposed within the distal sac; The upstream support and the flange end are disposed within the proximal sac; and The tubular portion is a section of the implant disposed in the intercapsular space.

71. The device according to any one of claims 67-68, further comprising a flexible sheath surrounding the intercapsular space such that the sheath covers the segment of the implant.

72. The apparatus according to claim 71, wherein, The proximal sac is covered by the sheath.

73. The apparatus according to claim 71, wherein, The distal end of the sheath abuts against the distal sac.

74. The apparatus according to claim 71, wherein, The distal end of the sheath is partially disposed within the distal bladder.

75. The apparatus according to claim 71, wherein, The sheath comprises a polymer.

76. The apparatus according to claim 71, wherein, The sheath comprises fabric.

77. A device for percutaneously delivering an implant to a subject, the device comprising a delivery tool, the delivery tool comprising: An external controller located at the proximal portion of the delivery tool; A sac at the distal portion of the delivery tool, wherein the sac defines a chamber; as well as A shaft extending from the external controller to the capsule, and comprising: A rigid proximal shaft segment extending distally from the external controller; A flexible shaft segment extending distally from the rigid proximal shaft segment; and A rigid distal shaft segment extending distally from the flexible shaft segment, the rigid distal shaft segment extending through at least a portion of the chamber of the sac, each rigid shaft segment being more rigid than the flexible shaft segment; The capsule includes a proximal capsule and a distal capsule, each of the proximal capsule and the distal capsule being: It has a corresponding open end, the open end of the proximal sac faces the open end of the distal sac, and the intersac gap separates the open end of the proximal sac from the open end of the distal sac. One segment of the implant is disposed at the intercapsular space; The delivery tool further includes a delivery bracket fixedly coupled to the shaft, the delivery bracket comprising a shape memory material such that when the implant is rolled up on the delivery bracket and the shaft, the delivery bracket is in a compressed state within the implant. After radial expansion of the implant, the delivery stent is allowed to expand to an expanded state, the delivery stent being configured to meet the opening end of the proximal capsule advancing distally, and the opening end of the distal capsule advancing proximally.

78. The apparatus according to claim 77, wherein, The delivery tool also includes at least one pull cord operably connecting the distal portion of the delivery tool to the controller, such that operation of the controller facilitates manipulation of the distal portion using the pull cord.

79. The apparatus according to claim 77, wherein, The rigid distal shaft segment extends distally out of the chamber of the bladder.

80. The apparatus according to claim 77, wherein, The rigid distal shaft segment is a first rigid distal shaft segment, and the delivery tool further includes a second rigid distal shaft segment, wherein the first rigid distal shaft segment and the second rigid distal shaft segment are configured to slide extensibly relative to each other.

81. The device according to any one of claims 77-80, further comprising the implant, wherein: The delivery tool further includes a mounting element attached to the rigid distal shaft segment; and the implant: Engage with the mounting component; and It is compressed onto a portion of the rigid distal shaft segment.

82. The apparatus according to claim 81, wherein, The implant is at least partially housed within the cavity of the capsule.

83. The apparatus according to any one of claims 77-80, wherein, The length of the rigid proximal shaft segment is greater than 50cm and less than 100cm.

84. The apparatus according to claim 83, wherein, The length of the rigid proximal shaft segment is greater than 70cm and less than 75cm.

85. The apparatus according to any one of claims 77-80, wherein, The length of the flexible shaft segment is greater than 5cm and less than 10cm.

86. The apparatus according to claim 85, wherein, The length of the flexible shaft segment is greater than 6cm and less than 8cm.

87. The apparatus according to any one of claims 77-80, wherein, The length of the rigid distal shaft segment is greater than 2cm and less than 10cm.

88. The apparatus according to claim 87, wherein, The length of the rigid distal shaft segment is greater than 4cm and less than 7cm.

89. A device for use with an implant, the device comprising a delivery tool for use with the implant, the delivery tool comprising: An external control system at the proximal portion of the delivery tool, the control system including a second catheter bending actuator and an shaft bending actuator; A flexible second catheter extends distally from the control system and includes one or more second catheter bending control elements operatively coupled to a second catheter bending actuator, the second catheter bending control elements extending distally from the control system and along the second catheter to a second catheter distal portion of the second catheter. A flexible balloon catheter extends distally from the control system via a second catheter to the distal portion of the balloon catheter; as well as A flexible shaft extends distally from the control system via the cystic duct and includes one or more shaft bending control elements operatively coupled to the shaft bending actuator, the shaft bending control elements extending distally from the control system along the shaft to a distal portion of the shaft. in: via control system: (i) the distal portion of the second catheter is axially slidable distally on the distal portion of the balloon catheter to enclose the distal portion of the balloon catheter within the distal portion of the second catheter, and (ii) the distal portion of the second catheter is axially slidable proximally away from the distal portion of the balloon catheter to expose the distal portion of the balloon catheter from the second catheter; (i) the distal portion of the balloon duct is axially slidable distally on the distal portion of the axial end to enclose the distal portion of the balloon duct within the distal portion of the balloon duct, and (ii) the distal portion of the balloon duct is axially slidable proximally away from the distal portion of the axial end to expose the distal portion of the axial end from the balloon duct; The actuation of the second catheter bending actuator actively bends the distal portion of the second catheter via the second catheter bending control element; the actuation of the shaft bending actuator actively bends the distal portion of the shaft via the shaft bending control element; The control system does not include a cyst catheter bending actuator, and the cyst catheter does not include a bending control element that allows the distal portion of the cyst catheter to be actively bent. The delivery tool also includes: The sac includes a proximal sac and a distal sac, each of the proximal sac and the distal sac being: It has a corresponding open end, the open end of the proximal sac faces the open end of the distal sac, and the intersac gap separates the open end of the proximal sac from the open end of the distal sac. One segment of the implant is disposed at the intercapsular space; The delivery tool further includes a delivery bracket fixedly coupled to the shaft, the delivery bracket comprising a shape memory material such that when the implant is rolled up on the delivery bracket and the shaft, the delivery bracket is in a compressed state within the implant. After radial expansion of the implant, the delivery stent is allowed to expand to an expanded state, the delivery stent being configured to meet the opening end of the proximal capsule advancing distally, and the opening end of the distal capsule advancing proximally.

90. The apparatus of claim 89, wherein: Each of the second catheter bending control elements includes a corresponding pull wire extending from the second catheter bending actuator and through a corresponding secondary lumen of the second catheter, and the pull wire is secured to the second catheter at a distal portion; and Each of the shaft bending control elements includes a corresponding draw wire that extends from the shaft bending actuator and passes through a corresponding secondary lumen of the shaft, and the draw wire is secured to the shaft at a distal portion of the shaft.

91. The apparatus according to claim 89, wherein, Each of the shaft bending control elements includes a corresponding drawwire that extends from the shaft bending actuator and passes through a corresponding secondary lumen of the shaft, and the drawwire is distally secured to the shaft from the cystic duct.

92. The apparatus according to claim 89, wherein, The distal portion of the cyst catheter has sufficient flexibility such that when the distal shaft portion is encased within the distal portion of the cyst catheter, the bending of the distal shaft portion caused by the actuation of the shaft bending actuator results in the passive bending of the distal portion of the cyst catheter.

93. The apparatus according to claim 89, wherein, The distal portion of the balloon catheter has sufficient flexibility such that when the distal portion of the balloon catheter is encased within the distal portion of the second catheter, the bending of the distal portion of the second catheter caused by the actuation of the second catheter bending actuator results in the passive bending of the distal portion of the balloon catheter.

94. The apparatus according to claim 89, wherein: The delivery tool also includes a pole; The rod extends distally from the shaft; The sac is coupled to the distal portion of the rod and includes a circumferential wall extending from the distal portion of the rod toward the proximal end to define a chamber. as well as The rod is axially movable relative to the axis, and the axial movement of the rod relative to the axis causes the sac to move axially relative to the sac catheter.

95. The device according to any one of claims 89-94, wherein the capsule is coupled from the distal end of the second catheter to the capsule catheter, and the capsule is sized to accommodate at least a portion of the implant; wherein, The axially distally extends through the sac, and wherein axial sliding of the distal portion of the sac catheter away from the axially distal portion causes the sac to slide proximally along the axially distal portion.

96. The apparatus according to claim 95, wherein, Each of the shaft bending control elements includes a corresponding draw wire that extends from the shaft bending actuator and passes through a corresponding secondary lumen of the shaft, and the draw wire is secured to the shaft within the bladder.

97. The apparatus according to claim 95, wherein, The distal portion of the second catheter can slide axially distally to abut against the capsule.

98. The apparatus according to any one of claims 89-94, wherein: The control system also includes a first conduit bending actuator; The delivery tool further includes a flexible first catheter extending distally from the control system, and the flexible first catheter includes one or more first catheter bending control elements; the first catheter bending control elements are operatively coupled to a first catheter bending actuator, and the first catheter bending control elements extend from the control system along the first catheter to a first catheter distal portion of the first catheter; The shaft extends distally from the control system through the first conduit to the distal portion of the shaft, and (i) the shaft slides axially proximally through the first conduit such that the distal portion of the shaft is encased within the distal portion of the first conduit, and (ii) the shaft slides axially distally through the first conduit such that the distal portion of the shaft is exposed from the first conduit; and The actuation of the first catheter bending actuator actively bends the distal portion of the first catheter via the first catheter bending control element.

99. The apparatus according to claim 98, wherein, The control system includes an external first juxtaposed actuator operatively coupled to the first conduit and the second conduit, such that actuation of the external first juxtaposed actuator causes the second conduit to slide axially relative to the first conduit.

100. The apparatus according to claim 98, wherein: The second catheter is rotatably locked to the first catheter by (i) a proximal lock defined by the control system and (ii) a distal lock; at the distal lock, the first catheter includes a first catheter coupler; and The second catheter includes a second catheter coupler that is rotatably locked to the first catheter coupler.

101. The apparatus according to claim 98, wherein, The second catheter is rotatably locked to the first catheter.

102. A device for use with an implant, comprising: With the delivery tool used for the implant, the delivery tool includes: tubular shaft; Rod: Extending from the distal end of the shaft within the shaft; It has a distal portion disposed outside the distal end of the shaft; and Operablely coupled to the shaft such that rotational motion of the rod relative to the shaft is converted into axial motion of the rod relative to the shaft; and A sac, coupled to the distal portion of the rod, and including a circumferential wall; the circumferential wall extending from the distal portion of the rod towards the proximal end to define a chamber; and The accessory includes a pawl; the accessory is coupled to the pouch such that the pawl rotatably locks the pouch to the rod; The capsule includes a proximal capsule and a distal capsule, each of the proximal capsule and the distal capsule being: Having a corresponding open end, the open end of the proximal capsule faces the open end of the distal capsule, and the intercapsular gap separates the open end of the proximal capsule from the open end of the distal capsule, with a segment of the implant disposed at the intercapsular gap. The delivery tool further includes a delivery bracket fixedly coupled to the shaft, the delivery bracket comprising a shape memory material such that when the implant is rolled up on the delivery bracket and the shaft, the delivery bracket is in a compressed state within the implant. After radial expansion of the implant, the delivery stent is allowed to expand to an expanded state, the delivery stent being configured to meet the opening end of the proximal capsule advancing distally, and the opening end of the distal capsule advancing proximally.

103. The apparatus according to claim 102, wherein: The delivery tool has an extended state and a retracted state, and the axial movement of the rod relative to the shaft causes the delivery tool to extend from the retracted state to the extended state; In the retracted state, a portion of the shaft is disposed within the cavity; In the deployed state, the portion of the shaft is positioned outside the chamber.

104. The apparatus according to claim 102, wherein: The device includes a latch coupled to the rod; The pouch defines a lateral ratchet hole extending from the outside of the pouch toward the latch; as well as The accessory is coupled to the pouch such that the pawl extends through the pawl hole and engages the latch to rotatably lock the pouch to the rod.

105. The apparatus according to claim 102, wherein, The accessory includes a clip, and the accessory can be coupled to the sac by clipping the clip to the sac, such that the pawl rotatably locks the sac to the rod.

106. The apparatus according to claim 102, wherein, The accessory includes a C-shaped clip, and the accessory can be coupled to the pouch by the C-shaped clip placed on the pouch, such that the pawl rotatably locks the pouch to the rod.

107. The apparatus according to any one of claims 102-106, wherein, The delivery tool includes a mounting element coupled to the shaft, extending radially outward from the shaft, and shaped to define a plurality of implant receiving slots arranged circumferentially, each of the plurality of implant receiving slots being shaped to receive a corresponding portion of an implant.

108. The apparatus according to claim 107, wherein: The delivery tool has an extended state and a retracted state, wherein axial movement of the rod relative to the distal end of the axial direction causes the delivery tool to extend toward the extended state, and axial movement of the rod relative to the proximal end of the axial direction causes the delivery tool to retract toward the retracted state. In the retracted state, the plurality of implant receiving slots are disposed within the cavity; In the deployed state, the plurality of implant receiving slots are disposed outside the cavity.

109. The apparatus according to any one of claims 102-106, wherein, The rod is formed with a defined external thread, and the external thread provides operable coupling between the rod and the shaft.

110. The apparatus according to claim 109, wherein, The shaft is formed with a defined internal thread, and the engagement between the internal thread and the external thread provides operable coupling between the rod and the shaft.

111. The apparatus according to any one of claims 102-106, wherein, The attachments include: A first component, including the pawl and coupled to the pouch, such that the pawl rotatably locks the pouch to the rod; and The knob, after the first component is coupled to the bladder, can be coupled to the first component and facilitates manual rotation of the accessory, the bladder, and the rod by manually grasping and rotating the knob.

112. The apparatus according to claim 111, wherein, The knob is shaped to define an opening, the size of which (i) allows the distal tip of the bladder to pass through the opening, and (ii) accommodates and engages the first component.

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