CATHETER SYSTEM FOR SEQUENTIAL DEPLOYMENT OF EXPANDABLE IMPLANTS - Patent application

Abstract

A system and method are provided for sequentially deploying cardiac implants, such as prosthetic heart valves, using a catheter system that includes an elongated shaft having a deployment assembly at one end and a handle at the other end. The deployment assembly can include one or more sleeves and anchor supports that maintain the cardiac implant in a partially collapsed state. The handle can include a first actuator and a second actuator, each designed to rotate relative to the body of the handle. The first actuator can be rotated to arch the elongated shaft. The second actuator can be rotated in a locked position to rotate or axially move the deployment assembly, or can be rotated in an unlocked position to allow expansion of the cardiac implant to an expanded state by moving the sleeves and anchor supports on the deployment assembly.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 384,843, filed November 23, 2022, the entire contents of which are incorporated herein by reference. [Technical Field]

[0002] The present invention relates generally to a catheter system for deploying cardiac implants. For example, systems and methods including a catheter system for precise sequential placement of self-expanding prosthetic heart valves are provided herein. [Background technology]

[0003] In medical technology, efforts have been made to treat or repair heart valve defects, such as aortic valve insufficiency or aortic valve stenosis, non-surgically, and therefore without invasive surgery, using transarterial interventional access via a catheter. Transcatheter aortic valve replacement (TAVR) and transcatheter aortic valve intervention (TAVI) procedures are becoming more common. Various insertion and stent systems, with different advantages and disadvantages, have been proposed and can be introduced into a patient's body via arteries, in part, via a catheter system.

[0004] However, in the medical devices known so far, the implantation procedure of the stent system to which the cardiac prosthesis is attached has proven to be relatively complicated, difficult and expensive. In addition to the complexity of implanting a cardiac prosthesis as a replacement for an inadequate or defective native cardiac valve, in the medical devices used so far there is a fundamental risk of incorrect positioning of the stent or cardiac prosthesis, which cannot be corrected without more extensive and invasive surgical intervention.

[0005] It is also considered to be a problem that when using the systems already known from the state of the art, improper positioning of the cardiac valve prosthesis or the associated cardiac valve stent can often only be avoided by a highly experienced cardiac surgeon or interventional cardiologist.

[0006] Improved delivery catheter systems are described, for example, in U.S. Patent Application No. 18 / 504,932, U.S. Patent No. 11,065,138 to Schreck, U.S. Patent No. 11,147,669 to Straubinger, and U.S. Patent No. 8,679,174 to Ottma, the entire contents of each of which are incorporated herein by reference.

[0007] There is a need for further improved systems and devices for introducing sequentially expandable heart valve stents into a patient's body, positioning the stent at a desired implantation site, and reducing risk to the patient during implantation. Summary of the Invention [Problem to be solved by the invention]

[0008] Provided herein are catheter systems and methods for implanting prosthetic heart valves in a sequential manner. The catheter system can be used to implant self-expanding prosthetic heart valves that have arms that allow the prosthetic heart valve to be fastened to the native valve. This attachment method allows the valve to be positioned within the heart without the need to sew the prosthetic valve to the heart. The delivery catheters described herein can be used to sequentially deploy the prosthetic valves. The delivery catheter may be capable of positioning the prosthetic valve at or near the native valve and sequentially releasing each portion of the prosthetic valve from the delivery catheter. The delivery catheter allows the prosthetic valve to be precisely positioned at the desired implantation location. The prosthetic valves can then be sequentially deployed in a controlled manner for improved precision and safety. [Means for solving the problem]

[0009] In one example, a catheter system for implanting a prosthetic heart valve can include an elongate shaft having a proximal region and a distal region, a deployment assembly located at the distal region of the elongate shaft and including a sleeve sized and shaped to be advanced with the prosthetic heart valve in a collapsed state to an implantation site located at the site of the native heart valve and configured to maintain at least a portion of the prosthetic heart valve therein during delivery, and a handle disposed at the proximal region of the elongate shaft and having a handle body, a first actuator designed to rotate relative to the handle body, and a second actuator designed to transition between a first position and a second position. When the second actuator is in the first position, rotation of the first actuator can be transmitted to the deployment assembly to rotate the deployment assembly, and when the second actuator is in the second position, rotation of the first actuator can move the sleeve longitudinally relative to the handle to expand and implant the prosthetic heart valve.

[0010] The handle can have a third actuator that, when in a first position, prevents operation of the first actuator when the second actuator is in the first position and, when in a second position, allows operation of the first actuator when the second actuator is in the first position. The handle can include a fourth actuator designed to rotate independently of the first actuator relative to the handle body, the fourth actuator connected to a distal portion of the elongate shaft and designed to deflect the elongate shaft. When the second actuator is in the second position, rotation of the first actuator can prevent rotation of the deployment assembly, and when the second actuator is in the first position, rotation of the first actuator can prevent longitudinal movement of the sleeve relative to the handle.

[0011] The deployment assembly may include a second sleeve proximal to the sleeve and coupled to the elongate shaft, and an anchor support located within the second sleeve and in mechanical communication with the sleeve. The anchor support may be designed to receive a proximal portion of the prosthetic valve, and the anchor support and the second sleeve may be designed to hold the proximal portion of the prosthetic heart valve in a compressed state. Longitudinal movement of the sleeve may cause longitudinal movement of the anchor support. When the second actuator is in a first position, the first actuator may be rigidly connected to the deployment assembly. The second actuator may include a protrusion, and when the second actuator is in the first position, the protrusion of the second actuator may be designed to engage a shaft disposed within the handle and rigidly connected to the deployment assembly.

[0012] The shaft may be threaded, and a cross section of the shaft may include at least one right angle. The handle may include a third actuator designed to interact with the one or more threads and the at least one right angle of the shaft to selectively constrain axial and rotational movement of the deployment assembly. The third actuator may include a pushable body having a central channel and a ridged wheel disposed within the central channel and designed to receive the shaft and rotate with the shaft, the third actuator designed to resist rotation of the ridged wheel in the locked position.

[0013] According to another aspect, a method for implanting a prosthetic heart valve is provided, the method including: advancing a deployment assembly located at a distal region of an elongate shaft, the deployment assembly including a sleeve configured to maintain at least a portion of the prosthetic heart valve therein in a collapsed state during delivery, together with the prosthetic heart valve in a collapsed state, to an implantation site located at the site of a native heart valve; rotating a first actuator of a handle coupled to the elongate shaft relative to a handle body of the handle when a second actuator of the handle is in a first position, whereby the rotation of the first actuator is transmitted to and rotates the deployment assembly; transitioning the second actuator from the first position to a second position; and rotating the first actuator when the second actuator is in the second position to longitudinally move the sleeve relative to the handle to expand and implant the prosthetic heart valve.

[0014] In another example, a catheter system for implanting a prosthetic heart valve may include: an elongate shaft having a proximal region and a distal region; a deployment assembly located on the distal region of the elongate shaft, the deployment assembly being sized and shaped to be advanced to an implantation site located at the site of the native heart valve together with the prosthetic heart valve in a collapsed state, the deployment assembly including a sleeve, an anchor support designed to be disposed within the sleeve during delivery and to maintain at least a portion of the prosthetic heart valve in a collapsed state between the sleeve and the sleeve, and a lock designed to lock the sleeve to the anchor support during delivery; and a handle located on the proximal region of the elongate shaft, the handle designed, when operated, to unlock the lock of the deployment assembly so that the anchor support can be moved longitudinally relative to the sleeve to expand and implant the prosthetic heart valve.

[0015] The lock may include a protrusion designed to extend into the receptacle to lock the sleeve to the anchor support and to be released from the receptacle to unlock the sleeve from the anchor support. The anchor support may include the protrusion, and the sleeve may include the receptacle. The lock may include a tube designed to extend the protrusion into the receptacle in a first position, the tube designed to move relative to the sleeve to a second position to release the protrusion from the receptacle. The protrusion may include a ball bearing designed to be retained in the receptacle when locked and to be released from the receptacle when unlocked. The protrusion may include a lever designed to be retained in the receptacle in a snap-fit ​​manner when locked and to be released from the receptacle when unlocked. The deployment assembly may include a second sleeve distal to the sleeve, and the sleeve may be connected to at least a portion of the elongate shaft.

[0016] The second sleeve may be designed to receive a distal portion of the prosthetic valve and maintain at least a distal portion of the prosthetic heart valve in a collapsed state. Longitudinal movement of the second sleeve may cause longitudinal movement of the anchor support. The deployment assembly may further include a tube located within the anchor support and designed to move longitudinally within the anchor support between a first position and a second position distal to the first position. The tube may have a non-uniform outer diameter. The tube may include a protrusion extending from an outer surface of the tube, the protrusion designed to engage with the anchor support such that, when the protrusion engages the anchor support, the anchor support moves with the tube. The tube may be connected to the second sleeve via a cable designed to cause distal movement of the tube in response to distal movement of the second sleeve. The handle may include a handle body and an actuator designed to rotate relative to the handle body, the actuator designed to move the anchor support longitudinally relative to the sleeve.

[0017] According to another aspect, a method for implanting a prosthetic heart valve using a catheter system is provided, the method including: guiding a deployment assembly, the deployment assembly including a sleeve located at a distal region of an elongate shaft, an anchor support disposed within the sleeve and configured to maintain at least a portion of the prosthetic heart valve in a collapsed state between the sleeve and the deployment assembly, and a lock configured to lock the sleeve to the anchor support, the deployment assembly loaded with the collapsed prosthetic heart valve to an implantation site located at the site of a native heart valve; and rotating an actuator on a handle located at a proximal region of the elongate shaft to distally move a first shaft extending between the actuator and the deployment assembly, thereby unlocking the lock so that the anchor support can be moved relative to the sleeve to expand at least a portion of the prosthetic heart valve to implant the prosthetic heart valve.

[0018] In another example, a catheter system for implanting a prosthetic heart valve may include an elongate shaft including a proximal region and a distal region, the elongate shaft including a notched hypotube including a proximal portion, a transition portion notched to have greater flexibility than the proximal portion, and a distal portion notched to have greater flexibility than the transition portion; a deployment assembly located in the distal region of the elongate shaft and sized and shaped to be advanced to an implantation site located at the site of the native heart valve along with the prosthetic heart valve in a collapsed state; and a handle located in the proximal region of the elongate shaft and designed, when manipulated, to release the prosthetic heart valve from the deployment assembly for expanding and implanting the prosthetic heart valve.

[0019] The catheter system may further include a deflection cable. The elongate shaft may further include a deflection shaft coupled to the deflection cable at its distal end. The cut hypotube and deflection cable may be disposed within the deflection shaft. The handle may further include a handle body and a deflection actuator in mechanical communication with the deflection cable and designed to retract the deflection cable proximally. The deflection actuator may be designed to deflect the deflection shaft. The elongate shaft may include a torque shaft disposed within the deflection shaft, the torque shaft designed to transmit axial and rotational motion from the handle to the deployment assembly. The torque shaft may include a second hypotube, a polymer layer disposed within the second hypotube, a braided layer disposed within the polymer layer, and a liner layer including a fluoropolymer disposed within the braided layer. The second hypotube may be slit to increase flexibility in a proximal to distal direction, the polymer layer may comprise a nylon polymer, the braided layer may comprise a metal braid, and the liner layer may comprise polytetrafluoroethylene (PTFE).

[0020] The elongate shaft may further include a guidewire shaft configured to receive a guidewire and disposed within the torque shaft, and the torque shaft and the guidewire shaft may be axially independent. The guidewire shaft may include a cut hypotube, a second polymer layer disposed within the hypotube, a second braided layer disposed within the second polymer layer, and a second liner layer including a fluoropolymer disposed within the second braided layer. The hypotube may be longer than the second hypotube and may have more cuts than the second hypotube. One or more of the hypotube or the second hypotube may be laser-cut or micromachined.

[0021] According to another aspect, a method for implanting a prosthetic heart valve is provided, the method including advancing a deployment assembly located at a distal region of an elongate shaft including a notched hypotube having a proximal portion, a transition portion notched to have greater flexibility than the proximal portion, and a distal portion notched to have greater flexibility than the transition portion, together with the prosthetic heart valve in a collapsed state to an implantation site located at the site of the native heart valve, and manipulating a handle located at the proximal region of the elongate shaft to release the prosthetic heart valve from the deployment assembly for expanding and implanting the prosthetic heart valve. [Brief explanation of the drawings]

[0022] [Figure 1] 1 illustrates an exemplary catheter system including a deployment assembly, an elongate shaft, and a handle according to some aspects of the present invention.

[0023] [Figure 2A] 1 illustrates a perspective view of an exemplary handle of a delivery system. [Figure 2B] 1 illustrates a perspective view of an exemplary handle of a delivery system.

[0024] [Figure 3A] 1 illustrates a perspective view of an exemplary deployment assembly. [Figure 3B] 1 illustrates a cross-sectional view of an exemplary deployment assembly. [Figure 3C] 1 illustrates a perspective view of an exemplary lead-in taper assembly. [Figure 3D] 1 illustrates a perspective view of an exemplary lead-in taper assembly. [Figure 3E] 1 illustrates a perspective view of an exemplary deployment assembly. [Figure 3F] 1 illustrates a cross-sectional view of an exemplary deployment assembly.

[0025] [Figure 4] 1 illustrates a cross-sectional view of layers of an exemplary elongate shaft.

[0026] [Figure 5] 1 illustrates a cross-sectional view of the layers of an exemplary torque shaft.

[0027] [Figure 6] 1 illustrates a cross-sectional view of an exemplary torque shaft.

[0028] [Figure 7] 1 illustrates a side view of an exemplary hypotube of a torque shaft.

[0029] [Figure 8] 1A-1C illustrate cross-sectional views of the layers of an exemplary guidewire shaft.

[0030] [Figure 9] 1 shows a cross-sectional view of a guidewire shaft.

[0031] [Figure 10] 1 shows a cross-sectional view of an exemplary hypotube of a guidewire shaft.

[0032] [Figure 11A] 1 illustrates a side view of an exemplary handle and positioning shaft. [Figure 11B] 1 illustrates a cross-sectional view of an exemplary handle and positioning shaft. [Figure 11C] 1 illustrates a cross-sectional view of an exemplary handle and positioning shaft.

[0033] [Figure 12A] 1 illustrates a perspective view of an exemplary unlocking actuator assembly and positioning shaft. [Figure 12B] 1 illustrates a perspective view of an exemplary unlocking actuator assembly and positioning shaft. [Figure 12C] 1 illustrates a perspective view of an exemplary unlocking actuator assembly and positioning shaft.

[0034] [Figure 13A] 1 illustrates a perspective view of an exemplary unlocking actuator assembly including a catch thread and an exemplary positioning shaft. [Figure 13B] 1 illustrates a perspective view of an exemplary unlocking actuator assembly including a catch thread and an exemplary positioning shaft.

[0035] [Figure 14A] 1 illustrates a perspective view of an exemplary inner threaded ring and an exemplary support drum. [Figure 14B] 1 illustrates a perspective view of an exemplary internally threaded ring. [Figure 14C] 1 illustrates a perspective view of an exemplary support drum.

[0036] [Figure 15] 1 illustrates a perspective exploded view of an exemplary positioning actuator.

[0037] [Figure 16A] 1 illustrates a cross-sectional view of a positioning actuator and an exemplary deployment base. [Figure 16B] 1 illustrates a cross-sectional view of a positioning actuator and an exemplary deployment base. [Figure 16C] 1 illustrates a cross-sectional view of a positioning actuator and an exemplary deployment base.

[0038] [Figure 17A] 1 shows a perspective view of a positioning actuator and a release actuator. [Figure 17B] 1 shows a perspective view of a positioning actuator and a release actuator.

[0039] [Figure 18A] 1 shows a perspective view of an example deployment screw and deployment base. [Figure 18B]1 shows a perspective view of an example deployment screw and deployment base. [Figure 18C] 1 shows a perspective view of an example deployment screw and deployment base.

[0040] [Figure 19] 10 illustrates the operation of a deflection actuator to deflect an elongate shaft.

[0041] [Figure 20A] 10 illustrates the operation of an exemplary positioning actuator to produce rotational and axial movement of a deployment assembly. [Figure 20B] 10 illustrates the operation of exemplary positioning and release actuators to axially move the distal sleeve and anchor support.

[0042] [Figure 21A] 1 illustrates an exemplary introducer sheath. [Figure 21B] 10 illustrates the movement of an exemplary deployment assembly across an introducer sheath.

[0043] [Figure 22A] 1 illustrates the operation of an exemplary deployment assembly to release an exemplary prosthetic heart valve. [Figure 22B] 1 illustrates the operation of an exemplary deployment assembly to release an exemplary prosthetic heart valve. [Figure 22C] 1 illustrates the operation of an exemplary deployment assembly to release an exemplary prosthetic heart valve. [Figure 22D] 1 illustrates the operation of an exemplary deployment assembly to release an exemplary prosthetic heart valve. [Figure 22E] 1 illustrates the operation of an exemplary deployment assembly to release an exemplary prosthetic heart valve.

[0044] [Figure 23A] 1 illustrates an exemplary deployment assembly having a proximal sleeve and an anchor support. [Figure 23B] 1 illustrates an exemplary deployment assembly having a proximal sleeve and an anchor support.

[0045] [Figure 24A] 1 shows a perspective view of an exemplary proximal sleeve and anchor support including an internal support and lock. [Figure 24B] 1 shows a perspective view of an exemplary proximal sleeve and anchor support including an internal support and lock. [Figure 24C] 10A-10C show cross-sectional views of an exemplary proximal sleeve and anchor support including an internal support and lock. [Figure 24D] 10A-10C show cross-sectional views of an exemplary proximal sleeve and anchor support including an internal support and lock. [Figure 24E] 10A-10C show cross-sectional views of an exemplary proximal sleeve and anchor support including an internal support and lock.

[0046] [Figure 25A] 1 shows a perspective view of an exemplary distal sleeve and anchor support including an internal support and a cantilever lock. [Figure 25B] 10A-10C show cross-sectional views of an exemplary distal sleeve and anchor support including an internal support and a cantilever lock. [Figure 25C] 10A-10C show cross-sectional views of an exemplary distal sleeve and anchor support including an internal support and a cantilever lock. [Figure 25D] 10A-10C show cross-sectional views of an exemplary distal sleeve and anchor support including an internal support and a cantilever lock. DETAILED DESCRIPTION OF THE INVENTION

[0047] The present invention relates to a catheter system for introducing a cardiac implant, such as a prosthetic heart valve, into a patient's body. Specifically, the catheter system can include an elongate shaft having a distal end connected to a deployment assembly designed to secure the cardiac implant and a proximal end connected to a handle used to manipulate the deployment assembly to sequentially deploy the prosthetic heart valve. The elongate shaft can have one or more hypotubes that can be laser cut, micromachined, and / or cut using any other known technique. The prosthetic heart valve can be a self-expanding prosthetic heart valve. The handle can include a deflection actuator and a positioning actuator that can rotate independently of each other. The deflection actuator, when rotated, can arch and / or bend the elongate shaft. When in a locked position, the positioning actuator can rotate and / or advance distally or retract proximally the deployment assembly. When in an unlocked position, the positioning actuator, when rotated, can sequentially release the prosthetic heart valves with the deployment assembly so that the prosthetic heart valves can transition to an expanded state.

[0048] The delivery catheters described herein are particularly suitable for the sequential deployment of self-expanding prosthetic heart valves having arms that can be anchored to the native valve, such as the prosthetic heart valve described in U.S. Pat. No. 11,154,398 to Straubinger, the entire contents of which are incorporated herein by reference. The delivery catheter may be capable of anchoring the prosthetic heart valve to the native valve leaflets by positioning the prosthetic heart valve at or near the native valve, allowing partial expansion of the prosthetic heart valve by releasing the arms of the prosthetic heart valve, aligning the arms with the native leaflets of the native valve, and allowing the prosthetic heart valve to fully expand by detaching the valve from the delivery catheter. The prosthetic heart valve, when implanted, is designed to treat or repair heart valve defects such as aortic regurgitation, aortic insufficiency, and / or aortic stenosis. One or more components of the delivery catheters described herein may be fabricated from plastics, metals, alloys, composites, and / or any other material known in the field of transcatheter cardiovascular devices.

[0049] Referring now to FIG. 1 , an exemplary catheter system for sequential deployment of cardiac implants, such as prosthetic heart valves, is shown. As shown in FIG. 1 , the catheter system 100 can include an elongate shaft 102 having a deployment assembly 104 at its distal end and a handle 106 at its proximal end. The elongate shaft 102 can house one or more tubes, cables, and / or wires therein. For example, the elongate shaft 102 can include concentric inner shafts that can move independently both rotationally and axially. In one example, the innermost inner shaft can be a guidewire shaft designed to allow the passage of a guidewire. The guidewire shaft can be disposed inside a larger torque shaft that can transmit torque across the elongate shaft 102. It is understood that the deployment assembly 104 and at least a portion of the elongate shaft 102 can be disposed within an introducer shaft for delivery to the implantation site.

[0050] The deployment assembly 104 may include a sleeve and a support designed to at least partially accommodate the prosthetic heart valve, maintain the prosthetic heart valve in an at least partially compressed state, and enable sequential expansion of the prosthetic heart valve. For example, the deployment assembly 104 may include an anchor support sized to receive the proximal end of the prosthetic heart valve and a proximal sleeve disposed over the anchor support to retain the proximal end of the prosthetic heart valve to the anchor support. Additionally, the deployment assembly 104 may include a distal sleeve designed to retain the distal end of the prosthetic heart valve. The anchor support and distal sleeve may be designed to move sequentially to sequentially expand the prosthetic heart valve. The distal sleeve may be connected to the guidewire shaft, and the distal sleeve may interact with the anchor support, such that movement of the guidewire shaft can be transmitted to the distal sleeve and / or the anchor support.

[0051] The elongate shaft 102 can be coupled to a handle 106, and internal components of the elongate shaft 102 can be mechanically connected to the handle 106. The handle 106 includes one or more actuators that, when actuated, cause predetermined movements in the deployment assembly 104. The actuators are preferably designed to cooperate with one another to cause various actions during the deployment procedure. For example, a first actuator can be designed to cause one movement in the deployment assembly when a second actuator is in a first position and another movement in the deployment assembly when the second actuator is in a second position. The actuators can be knobs, buttons, switches, etc. suitable for use in catheter systems. The handle 106 can include a handle body 108, a deflection actuator 110, a positioning actuator 112, and a positioning shaft 114. The deflection actuator 110 can be connected to the handle body 108 via a threaded connection and can be rotatable about the longitudinal axis of the handle body 108. The deflection actuator 110 may be connected to a cable that extends within the elongate shaft 102 and coupled to a distal region of the elongate shaft 102. The deflection actuator 110 may be rotated about the handle body 108 to retract the cable and cause the elongate shaft 102 to arch or bend.

[0052] The positioning actuator 112 engages with the handle body 108 via a positioning shaft 114 that can freely move in and out of and rotate relative to the handle body 108. Additionally, the positioning actuator 112 is designed to rotate relative to a deployment base housed within the positioning actuator 112. In a locked position, the positioning actuator 112 can engage with the positioning shaft 114, such that rotation of the positioning actuator 112 can cause rotation of the deployment assembly 104, and axial movement of the positioning actuator 112 can cause axial movement of the deployment assembly 104. In an unlocked position, the positioning actuator 112 disengages from the positioning shaft 114, such that rotation of the positioning actuator 112 can advance the deployment base and move the distal sleeve and / or anchor support of the deployment assembly 104 distally, thereby sequentially expanding and releasing the prosthetic heart valve. The catheter system 100 may be combined with an introducer sheath 107. For example, the introducer sheath 107 may have a larger diameter than the elongate shaft 102 and deployment assembly 104 and may include a handle at its proximal end. The introducer sheath 107 may also be coupled to a dilator at its distal end.

[0053] The elongate shaft 102 can include a proximal region and a distal region. The proximal region can be connected to a handle, and the distal region can be connected to a deployment assembly. The elongate shaft 102 can include one or more notched hypotubes having a proximal portion, a transition portion that is notched to have greater flexibility than the proximal portion, and a distal portion that is notched to have greater flexibility than the transition portion. For example, as shown in FIG. 7 , the elongate shaft 102 can include a hypotube 713 that can include a transition section 722 that can have an increasing density of notches moving from the proximal to the distal direction, a constant section 724 that can have a constant density of notches that can be denser than the transition section 722, and a non-notched section 726 that is free of notches, and the non-notched section 726 can be a distal region of the hypotube 713. In another example, as shown in FIG. 10 , the elongate shaft 102 can include a guidewire hypotube 1002 that can include a transition section 1006 that can have an increasing density of cuts moving in a proximal to distal direction, a low density section 1008 that can have a constant density of cuts that can be denser than the transition section 1006, the transition section 1008 that can have an increasing density of cuts moving in a proximal to distal direction and can be denser than the low density section 1008, and a high density section 1011 that can have a constant density of cuts that can be denser than the transition section 1008.

[0054] 2A-2B, a perspective view of an exemplary handle 206 is shown. The handle 206 may be the same as or similar to the handle 106 of FIG. 1. As shown in FIGS. 2A-2B, the handle 206 may be coupled to an elongate shaft 202. The elongate shaft 202 may be the same as or similar to the elongate shaft 102 of FIG. 1. The handle body 208 may be the same as or similar to the handle body 108 of FIG. 1.

[0055] The handle 206 may be disposed at a proximal region of the elongate shaft 206. The handle 206 may include a handle body 208 and a positioning actuator 212. The positioning actuator 212 may be designed to rotate relative to the handle body 208. The handle 206 may include a release actuator 206 that may be disposed on the positioning actuator 212 and / or may be designed to transition between a first position (e.g., a locked position) and a second position (e.g., an unlocked position). When the release actuator 206 is in the first position, rotation of the positioning actuator 212 may be transmitted to and rotate the deployment assembly. When the release actuator 224 is in the second position, rotation of the positioning actuator 212 may move a distal sleeve of the deployment assembly longitudinally relative to the handle 206 to expand and implant the prosthetic heart valve.

[0056] The handle body 208 may be tubular in shape and may be ergonomically sized and shaped to facilitate easy handling for the user. For example, the handle body may have an hourglass or diablo shape. Additionally, the handle body 208 may include an indicator 222, which may include a window or slot along which a pointer may move. The indicator 222 may be in mechanical communication with the deflection actuator 210 and may indicate the degree of actuation and / or deflection of the elongate shaft 202. Additionally, the handle body 208 may include a port 228, which may be in communication with an internal channel of the handle body 208 and / or one or more channels of the elongate shaft 202 and may be used to flush the handle body 208 and / or one or more channels of the elongate shaft 202 (e.g., with saline).

[0057] Additionally, the handle body 208 may include an unlock actuator 211, which may be disposed in a proximal region of the handle body 208. The unlock actuator 211 may be a button or other engageable (e.g., depressible) mechanism that may enable rotational and axial movement of the positioning actuator 212 and positioning shaft 214 relative to the handle body 208. For example, as shown in FIG. 2B , when the unlock actuator 211 is engaged (e.g., depressed) and thus unlocked, the positioning actuator 212 may be advanced axially distally while holding the handle body 108 in place. Distal advancement of the positioning actuator 212 similarly advances the elongate shaft 202 and all internal shafts, wires, cables, etc. distally, thus advancing the entire deployment assembly distally. Similarly, rotating the positioning actuator 212 when the unlock actuator 211 is in the unlocked position (i.e., depressed position) similarly rotates the elongate shaft 202. When the positioning actuator 212 is in a locked position (e.g., the release actuator 224 is in a locked position) such that the unlocking actuator 211 is not engaged and therefore in a locked position, and the positioning actuator 212 is fixed to the positioning shaft 214, the positioning actuator 212 and the positioning shaft 214 may be axially and / or rotationally fixed relative to the handle body 208.

[0058] The deflection actuator 210 may include internal threads that can engage threads housed within the handle body 208. The deflection actuator 210 may be tubular in shape, tapered at one end, and have a series of ridges to facilitate gripping by a user. The deflection actuator 210 may have an internal channel sized to receive a positioning shaft 214, which may be fixed to the handle body 208 and the positioning actuator 212. When the deflection actuator 210 rotates, it can move the internal threads of the handle body 208 proximally. The internal threads can be mechanically connected to a deflection indicator 222, which in turn can be mechanically connected to a wire or cable connected to an end region of the elongate shaft 202, such that retraction of the wire or cable can deflect (e.g., bend or arch) the elongate shaft 202. The degree of deflection of the elongate shaft 202 can be indicated by the deflection indicator 222.

[0059] The positioning actuator 212 may also be tubular in shape and tapered at one end. Also like the deflection actuator 210, the positioning actuator 212 may have a series of ridges to facilitate gripping by a user and may also have internal threads. The positioning actuator 212 may be selectively connected to the positioning shaft 214 and may include an internal channel sized to receive a deployment base. The deployment base may be rigidly connected to a guidewire shaft within the elongate shaft 202. When the release actuator 224 is in the unlocked position, the deployment base may selectively interact with the positioning actuator 212 via a threaded interface to distally advance the deployment base, and thus the guidewire shaft, thereby distally advancing the distal sleeve and anchor support of the delivery assembly. Additionally, the positioning actuator 212 may include a release actuator 224 that can reversibly secure the positioning actuator 212 to the positioning shaft 214. The release actuator 224 is slidably engageable with the positioning shaft 214 and can be transitioned from a locked position to an unlocked position.

[0060] 3A-3D, perspective and cross-sectional views of an exemplary deployment assembly 304 are shown. The deployment assembly 304 may be the same as or similar to the deployment assembly 104 of FIG. 1. As shown in FIGS. 3A and 3B, the deployment assembly 304 may be connected to an elongate shaft 302, which may be the same as the elongate shaft 102 of FIG. 1. For example, a proximal taper 324 may be connected to the elongate shaft 302. The proximal taper 324 may be a tapered structure and may taper toward the proximal end. The proximal taper 324 may be coupled to a proximal sleeve 320. For example, the proximal taper 324 may be rigidly coupled to the elongate shaft 302, and the proximal sleeve 320 may be rigidly connected to the proximal taper 324.

[0061] At least a portion of the elongate shaft 302, such as a torque tube, can be rigidly coupled to and terminate in a retraction taper assembly 314. The retraction taper assembly 314 can be designed to support a cardiac implant, such as a prosthetic heart valve. For example, the retraction taper assembly 314 can include a cylindrical seat portion 311 and a conical portion 310. The conical portion 310 can have two conical portions that meet at a larger diameter than the cylindrical seat portion 311. The conical portion 310 is compressible, allowing the conical portion 310 to be compressed to a smaller diameter than its uncompressed state.

[0062] The deployment assembly 304 may be sized and shaped to be advanced with the prosthetic heart valve in a collapsed state to an implantation site located at the site of the native heart valve. The deployment assembly 304 may include a proximal sleeve 320, an anchor support 322 that is positioned within the proximal sleeve 320 during delivery and can hold at least a portion of the prosthetic heart valve in a collapsed state between the proximal sleeve 320 and the proximal sleeve 320, and a lock (e.g., a ball or lever) designed to lock the proximal sleeve 320 to the anchor support 322 during delivery. A handle (e.g., disposed at a proximal region of the elongate shaft 302) may be designed to unlock the lock (e.g., a ball or lever) of the deployment assembly 304 during operation to allow the anchor support 322 to move longitudinally relative to the proximal sleeve 320 to expand and implant the prosthetic heart valve.

[0063] A retraction taper assembly is shown in Figures 3C and 3D. As shown in Figure 3C, the retraction taper 310 assembly can include a tubular portion 332 and a conical portion 334, which can have a central channel for receiving the tubular portion 332 and can be constrained in place by the tubular portion 332. It is understood that the conical portion 334 and / or the tubular portion 332 can be compressible and / or resilient (e.g., foam). Now referring to Figure 3D, an alternative retraction taper assembly, namely, retraction taper assembly 335, can be similar to retraction taper assembly 330 but can include a tubular portion 332, which can have a tubular shape, and a compressible mesh 339, which can be a metal mesh (e.g., laser-cut nitinol spheres). The tubular portion 332 can be compressible and / or resilient.

[0064] Referring again to FIGS. 3A and 3B , the guidewire shaft 313 may be disposed within the elongate shaft 302 and may extend to and terminate in the distal sleeve 312. The distal sleeve 312 may include or be connected to an end cone 306, which may be tapered proximally. The distal sleeve 312 may have a diameter larger than the cylindrical seat portion 311 but smaller than the conical portion 310. Thus, the open end of the distal sleeve 312 may be manipulated to abut against the conical portion 334. Furthermore, the distal sleeve 312 may be forced to move past the conical portion 310, compressing it, as shown in FIGS. 3A and 3B . It may be preferable for the distal sleeve 312 to move past the conical portion 310 so that the open end of the distal sleeve 312 can retain the distal end of a prosthetic heart valve positioned in the cylindrical seat portion 311. The distal sleeve 312 can further include an imaging marker 315 that can appear using known medical imaging. For example, the imaging marker 315 can be a ring located in the proximal region of the distal sleeve 312. This positioning can be desirable because it helps the person deploying the prosthetic heart valve know when the prosthetic heart valve exits the introducer sheath. In one example, the imaging marker 315 can be a radiopaque or other known imaging marker.

[0065] The distal sleeve 312 and / or end cone 306 may include an internal protrusion or catch (e.g., catch 323 in FIG. 3F ) that can engage or interact with the anchor connector 321 as the distal sleeve 312 moves distally. The anchor connector 321 may be a cable, wire, tube, etc., and may also include a protrusion or catch (e.g., catch 325 in FIG. 3G ) that engages or interacts with a protrusion or catch near or on the distal sleeve 312 and / or end cone 306. It is understood that the protrusion or catch on the distal sleeve 312 may be positioned such that the distal sleeve 312 can move distally a certain distance before the protrusion or catch on the distal sleeve 312 engages or interacts with the protrusion or catch on the anchor connector 321.

[0066] At the proximal end, anchor connector 321 can be connected to anchor support 322, which can be sized to fit within proximal sleeve 320. Alternatively, the anchor support can be connected to an internal support that is located within and interacts with anchor support 322. Anchor support 322 can be designed to receive one or more anchors or structural elements of the prosthetic heart valve and maintain the anchors or structural elements of the prosthetic heart valve between anchor support 322 and distal sleeve 320. When anchor connector 321 is moved distally by distal sleeve 312 and / or end cone 306, anchor support 322 can move distally by the same amount. Because proximal sleeve 320 is rigidly connected to proximal taper 324 and elongate shaft 302, proximal sleeve 320 remains in place as anchor support 322 advances distally. As a result, any anchors or structural elements disposed between the anchor support 322 and the proximal sleeve 320 can be exposed and released as the anchor support 322 advances distally from the proximal sleeve 320.

[0067] 3A and 3B, the deployment assembly 304 may be arranged to hold a cardiac implant, such as a self-expanding prosthetic heart valve, in a collapsed or partially collapsed state. For example, the distal end of the prosthetic heart valve may be disposed within the open distal end of the distal sleeve 312 so that the distal end of the prosthetic heart valve can be held and compressed by the distal sleeve 312. Similarly, the proximal end of the prosthetic heart valve may have one or more anchors or structural elements disposed between the anchor support 322 and the proximal sleeve 320 so that the proximal end of the prosthetic heart valve can be held and compressed by the proximal sleeve 320 and the anchor support 322.

[0068] 3E and 3F, deployment assembly 304 is shown positioned to release the prosthetic heart valve. As shown in FIGS. 3E and 3F, distal sleeve 312 and end cone 306 can be advanced distally past conical portion 310 of retraction taper assembly 314 to release the distal end of the prosthetic heart valve and allow at least a distal portion of the prosthetic heart valve to expand to an expanded state. Thereafter, anchor support 322 can be advanced distally by anchor connector 321 as anchor connector 321 is advanced distally by distal sleeve 312 and / or end cone 306. When anchor support 322 is advanced distally, anchor recess 327 of anchor support 322 can be exposed from distal sleeve 320.

[0069] The anchor recesses 327 may be recesses or structures (e.g., protrusions) on the anchor support designed to receive anchors or other structural features on the proximal end of the prosthetic heart valve. When the anchor recesses 327 are exposed from the proximal sleeve 320, the proximal end of the prosthetic heart valve can expand to an expanded state. It is understood that exposure of the anchor recesses 327 from the distal sleeve 320 can completely release the prosthetic heart valve from the deployment assembly 304.

[0070] Referring now to FIG. 4, a cross-sectional view of an exemplary elongate shaft is shown. The elongate shaft 402 may be the same as or similar to the elongate shaft 102 of FIG. 1. The elongate shaft 402 may include three separate shafts, including a deflection shaft 417, a torque shaft 415, and a guidewire shaft 413. It is understood that additional layers may be included in the elongate shaft 102. The deflection shaft 417, the torque shaft 415, and / or the guidewire shaft 413 may be capable of independent axial movement and / or rotation. In one example, the deflection shaft 417 and the torque shaft 415 may instead be fixed to one another. The deflection shaft 417 may function as the spine of the elongate shaft 402 and may be attached at a distal region to a deflection wire (not shown) that may extend from the handle to a distal region of the deflection shaft 417. The deflection shaft 417 may arch or bend as the handle moves the deflection wire axially proximally toward the handle.

[0071] The torque shaft 415 may be located within the deflection shaft 417 and may extend between the positioning shaft of the handle and the retraction taper assembly of the deployment assembly. In this manner, the torque shaft 415 may be designed to transmit torque from the positioning shaft to the deployment assembly. The guidewire shaft 413 may be located within the torque shaft 415 and may extend between the deployment base, located within the positioning actuator of the handle, and the distal sleeve and / or end cone of the deployment assembly.

[0072] Referring now to FIG. 5 , the torque shaft 515 may be made of several layers. For example, the torque shaft 515 may have a hypotube layer 520, which may be a hypotube strategically scored to increase flexibility in the proximal-to-distal direction. For example, the hypotube may be a laser-cut hypotube with multiple scored holes or slits formed using a laser. A polymer layer 522 may be disposed inside the hypotube layer 520. The polymer layer 522 may include a polymer jacket that may be located inside the hypotube. The polymer jacket may include a rigid polymer (e.g., a nylon polymer). A braided layer 524 may be disposed inside the polymer layer 522. The braided layer 524 may be a metal braid. It is understood that the polymer jacket may flow into the braided layer 524. In one example, the braided layer 524 may include a metal braid that may include stainless steel and Kevlar® fibers. The braid may be any other braid, including metal, alloy, and / or composite materials. A liner layer 526 may be the innermost layer located inside the braided layer 524. The liner layer 526 may be a liner including a fluoropolymer, such as polytetrafluoroethylene (PTFE), or other similar material. It is understood that the polymer layer 522, the braided layer 524, and the liner layer 526 may form a composite shaft. Furthermore, the torque shaft 515 may have additional layers or fewer layers than those shown in FIG. 5.

[0073] Referring now to FIG. 6, a side view and a cross-sectional view of a torque shaft 615 are shown. As shown in FIG. 6, the torque shaft 615 may be connected to a retraction taper assembly 614 at the distal end of the torque shaft 615. The retraction taper assembly 614 may be the same as or similar to the retraction taper assembly 314 of FIG. 3A or the retraction taper assembly 330 of FIG. 3C. The proximal region of the torque shaft 615 may include a composite shaft 611 (e.g., the polymer layer 522, the braided layer 524, and the liner layer 526 of FIG. 5) and a hypotube 613 that is slit to facilitate increased flexibility in the proximal-to-distal direction. The hypotube 613 may terminate near the distal region of the torque shaft 615, and only the composite shaft 611 of the torque shaft 615 may continue into the retraction taper assembly 614. This may facilitate reducing the diameter of the torque shaft 615 near its distal end. As shown in FIG. 620, the composite shaft 611 can extend into a leading taper assembly 614, which can include a composite shaft receiving channel 617 for securing the composite shaft 611.

[0074] Referring now to FIG. 7, a torque hypotube 713 is shown. The torque hypotube 713 may be the outermost layer of the torque shaft 515 of FIG. 5. The torque hypotube 713 may be, for example, metal, composite, and / or plastic and may be tubular in shape. In one example, the torque hypotube 713 may be stainless steel and may have a cut design from laser cutting. As shown in FIG. 7, the cuts formed in the torque hypotube 713 may be perpendicular to the longitudinal axis of the torque tube and may increase in density (e.g., number of cuts per given area) moving in a proximal to distal direction. A proximal region 720 of the hypotube 713 may be free of any cuts.

[0075] The hypotube 713 can have regions with a consistent, repeating pattern of cuts. For example, the hypotube 713 can include a transition section 722, which can have an increasing density of cuts moving in a proximal-to-distal direction, a constant section 724, which can have a constant density of cuts that can be denser than the transition section 722, and a non-cut section 726, which can be a distal region of the hypotube 713 that is devoid of cuts. In the transition section 722, the cuts can be gradual, such that the distance between each cut gradually decreases in a proximal-to-distal direction. Additionally, the cuts can be designed to spiral around the hypotube 713.

[0076] 7, the torque tube 713 may become more flexible in the proximal-to-distal direction as the density of the cuts increases from the proximal end to the distal end. It is understood that the size and design of the cuts may vary, but in one non-limiting example, the width of each cut may be 0.20 inches, the pitch may vary between 0.008 and 0.04, the length of the cuts may vary between 0.6 and 0.7, and the angle of the cuts may vary between 62 and 74 degrees. It is further understood that the placement and length of the various cut sections of the torque hypotube 713 may be the same.

[0077] Referring now to FIG. 8 , guidewire shaft 815 may be made of several layers. For example, guidewire shaft 815 may have hypotube layer 820, which may be a hypotube strategically cut to increase flexibility in the proximal-to-distal direction. For example, the hypotube may be a laser-cut hypotube. A polymer layer 822 may be disposed inside hypotube layer 820. Polymer layer 822 may include a polymer jacket that may be located inside the hypotube. The polymer jacket may include a rigid polymer (e.g., a nylon polymer). A braided layer 824 may be disposed inside polymer layer 822. Braided layer 824 may be a metal braid. It is understood that the polymer jacket may flow into braided layer 824. In one example, braided layer 824 may include a metal braid that may include stainless steel and Kevlar® fibers. The braid may also be any other braid including metals, alloys, and / or composite materials. Liner layer 826 may be the innermost layer located inside braided layer 824. The liner layer may be a liner including polytetrafluoroethylene (PTFE) or other similar material. It is understood that polymer layer 822, braided layer 824, and liner layer 826 may form a composite shaft.

[0078] 9, there is shown a side view and a cross-sectional view of a guidewire shaft 917. As shown in FIG. 9, the guidewire shaft 917 may be connected to a distal sleeve 902 and an end cone 904, which may be the same as or similar to the distal sleeve 312 and end cone 306, respectively, of FIG. 3A. As shown in FIG. 920, the guidewire shaft 917 may include a composite shaft 926 (e.g., the polymer layer 822, the braid layer 824, and the liner layer 826 of FIG. 8), and a hypotube 930 that is slit to provide increased flexibility in the proximal-to-distal direction. Near the distal region of the guidewire shaft 917, the hypotube 930 and / or composite shaft 926 may be connected to a catch assembly 908 that may include a catch body 905, which may be tubular in shape, a catch 906, which may be a cylindrical catch located at the proximal end of the catch body 905 and having a diameter larger than the catch body 905 but smaller than the distal sleeve 902, and threads 910, which may be a threaded portion located at the distal region of the catch body 905. The threads 910 may engage with a distal cone and facilitate a secure engagement between the catch assembly 908 and the end cone 904 and distal sleeve 902.

[0079] The catch assembly 908 can further include a slide 907, which can be tubular in shape and can slide over the catch body 905. The slide 908 can be connected to an anchor connector 910, which can be a wire or elongated structure extending from the catch assembly 908 to an anchor support (not shown). The catch 906 can have an outer diameter larger than the inner diameter of the slide 907, and can engage with the slide 907 to pull the anchor connector 910, and therefore the anchor support, distally when the guidewire shaft 917 is advanced distally, causing the slide 907 to move distally as well. As shown in FIG. 920, a hypotube 930 can extend distally past the catch assembly 908. An extension portion 922 of the hypotube 930 can be crimped and / or welded. For example, catch assembly 908 may be metallic and hypotube 930 may be welded to catch assembly 908 such that guidewire shaft 917 is rigidly connected to catch assembly 908. Composite shaft 926 may also extend past catch assembly 908. For example, composite shaft 926 and hypotube 930 may terminate within end cone 904. In one example, catch assembly 908 may be stainless steel, although it is understood that catch assembly 908 may be any other material.

[0080] Referring now to FIG. 10 , a guidewire hypotube 1002 is shown. The guidewire hypotube 1002 may be the outermost layer of the guidewire shaft 815 of FIG. 8 . The guidewire hypotube 1002 may be, for example, metal, composite, and / or plastic and may be tubular in shape. In one example, the guidewire hypotube 1002 may be stainless steel and may have a cut design from a laser cut. As shown in FIG. 10 , the cuts formed in the torque hypotube 1002 may be perpendicular to the longitudinal axis of the torque tube and may increase in density (e.g., number of cuts per given area) moving in a proximal-to-distal direction. The proximal region 1004 of the hypotube 1002 may be free of any cuts. Additionally, the distal region 1012 may be free of any cuts. For example, the distal region 1012 of the hypotube 1002 may be crimped or welded. It is understood that hypotube 1002 may have more cuts and / or may exhibit greater flexibility than hypotube 713 of Figure 7. It is further understood that hypotube 1002 may be longer than hypotube 713 of Figure 7.

[0081] The guidewire hypotube 1002 can have regions with a consistent, repeating pattern of cuts. For example, the guidewire hypotube 1002 can include a transition section 1006, which can have an increasing density of cuts moving in a proximal-to-distal direction, a low-density section 1008, which can have a constant density of cuts that can be denser than the transition section 1006, the transition section 1008, which can have an increasing density of cuts moving in a proximal-to-distal direction and can be denser than the low-density section 1008, and a high-density section 1011, which can have a constant density of cuts that can be denser than the transition section 1008. Between each constant section, the cuts can have a gradual transition in distance such that the distance between the cuts gradually decreases in a proximal-to-distal direction. Additionally, the cuts can be designed to spiral around the guidewire hypotube 1002.

[0082] 10 , the guidewire tube 1002 may become more flexible in the proximal-to-distal direction as the density of the cuts increases from the proximal end to the distal end. It is understood that the size and design of the cuts may vary, but in one example, the width of each cut may be 0.20 inches, the pitch may vary between 0.005 and 0.04 inches, the length of the cuts may vary between 0.0270 and 0.0370 inches, and the angle of the cuts may vary between 45 and 62 degrees. It is further understood that the placement and length of the various cut sites in the hypotube 1002 may be the same.

[0083] 11A and 11B, side and cross-sectional views of a handle 1106 are shown. The handle 1106 may be the same as or similar to the handle 106 of FIG. 1. For example, the handle 1106 may include a handle body 1108 that may be connected to a deflection actuator 1110, a positioning shaft 1114, and a positioning actuator 1112. The handle body 1108, deflection actuator 1110, positioning shaft 1114, and positioning actuator 1112 may be the same as or similar to the handle body 108, deflection actuator 110, positioning shaft 114, and positioning actuator 112 of FIG. 1. The handle 1106 may receive an elongated shaft 1102 that may be the same as or similar to the elongated shaft 102 of FIG. 1. The handle 1106 may further include a port 1115, which may be connected to one or more internal channels (e.g., the elongate shaft 1102) and may be used to flush the one or more internal channels (e.g., using saline).

[0084] 11B, a cross-sectional view of the handle 1106 is shown. The handle body 1108 may be a tubular shell and may be split in half. The handle body 1108 may have an open end at a proximal region of the handle body 1108. A drum support 1114 may be disposed inside the open end of the proximal region of the handle body. The drum support 1114 may be cylindrical in shape and may have a smaller diameter than the open end of the handle body 1108. The drum support 1114 may be secured to the handle body such that the drum support is suspended centrally from the open proximal end of the handle body 1108 and there is a gap between the outer diameter of the drum support 1114 and the handle body 1108. The drum support 1114 may extend proximally beyond the handle body 1108.

[0085] The open proximal end of the handle 1108 may be sized to receive the deflection actuator 1110. The deflection actuator 1110 may be cylindrical in shape and may include threads 1113 on the interior of the deflection actuator 1110. The threads 1113 may span all or most of the length of the deflection actuator 1110 and may extend distally beyond the deflection actuator 1110 such that a portion of the threads 1113 enters the open end of the handle body 1108 and is secured to the distal end of the drum support 1114 in a manner that restricts axial movement of the deflection actuator 1110 but allows rotational movement. A threaded slider 1115 may be supported by and slidable on the drum support 1114. The threaded slider 1115 may be cylindrical in shape and may have threads on its exterior surface designed to engage the threads of the threads 1113 of the deflection actuator 1110. As the deflection actuator 1110 rotates, the deployment threads 1113 rotate as well, causing the threaded slider to move either distally or proximally along the drum support 1114 depending on the direction of rotation.

[0086] The threaded slider 1115 may be connected to a deflection wire 1122, which may be any wire, cable, etc., and may be connected to a distal region of the deflection shaft 1130. The deflection wire 1122 may be led to the top of the handle body 1108 and engaged with an indicator 1126. The indicator 1126 may be any other visual indicator protrusion that may slide along an indicator window 1124 as the threaded slider 1115 is moved distally or proximally. For example, rotation of the deflection actuator 1110 may move the threaded slider 1115 proximally, pulling the deflection wire 1122 proximally, thereby moving the indicator 1126 proximally and sliding it along the indicator window 1124. The indicator window 1124 may indicate to a user the degree or amount of deflection being applied to the deflection shaft 1130. The deflection shaft 1130 may terminate at a distal region of the handle body 1108, and the deflection wire 1122 may be introduced into the deflection shaft 1130 within the handle body 1108. In one example, the deflection wire 1122 may be disposed between the deflection shaft 1130 and the torque shaft 1134. As shown in FIG. 11B , the support drum 1114 may be tubular and hollow, and the torque shaft 1134 and guidewire shaft 1136 may traverse the interior of the support drum 1114 and extend proximally beyond the drum support 1114, the handle body 1108, and the deflection actuator 1110.

[0087] 11C , a cross-sectional view of the handle 1106 engaged with a positioning shaft 1145 is shown. The positioning shaft 1145 may be the same as or similar to the positioning shaft 114 of FIG. 1 . The positioning shaft 1145 may include a threaded shaft 1144, a main shaft 1145, and a positioning support 1148. The threaded shaft 1144 may be generally tubular in shape and may include an internal channel and an outer surface with threads or ridges extending along a substantial portion of the shaft's outer surface. The main shaft 1145 may be tubular in shape and may have an internal channel that connects to the internal channel of the threaded shaft 1144. The positioning support 1148 may have the same or similar diameter as the main shaft 1146 and may have an internal shaft sized similar to the internal channel of the main shaft 1145. The threaded shaft 1144, main shaft 1145, and positioning support 1148 may be a unitary piece formed from the same material (eg, plastic), or may be separate pieces that are connected to one another.

[0088] FIG. 1160 shows the components within the handle body 1108, particularly the unlock actuator 1140. The unlock actuator 1140 may be the same as or similar to the unlock actuator 211 of FIGS. 2A and 2B. In an unrecessed position, the unlock actuator 1140 may engage the threaded shaft 1144 to axially and rotationally lock the threaded shaft 1144, and may be retractable to allow axial and rotational movement of the threaded shaft 1144. The threaded shaft 1144 may be rigidly connected to the torque shaft 1134 such that rotational and axial movement of the threaded shaft 1144 can be transmitted to the torque shaft 1144. The torque shaft 1134 may terminate within or at the threaded shaft 1144. It will be appreciated that the torque shaft 1134 may terminate within or at the threaded shaft 1144, while the guidewire shaft 1136 may extend beyond the threaded shaft 1144 and the main shaft 1146 to the positioning support 1148.

[0089] 11C , the threaded shaft 1144 can traverse the rotation limiter 1142. The rotation limiter 1142 can be cylindrical and can have a threaded outer surface and an internal channel with a right angle. The threaded outer surface can be disposed within and engage with a support drum (not shown). The threaded shaft 1144 can have a right angle designed to match and engage with the right angle of the rotation limiter 1142 so that when the threaded shaft 1144 rotates, the rotation limiter 1142 also rotates. The unlock actuator 1140 can be supported by the handle body 1108 and / or can rest on a spring assembly 1150 that can be coupled to the handle body 1108. The spring assembly 1150 can include a spring and a bar disposed on top of the spring. It is understood that when the unlock actuator 1140 is pressed, the spring assembly 1150 is compressed and the threaded shaft and / or main shaft 1145 can move further across the unlock actuator 1140 and into the handle body 108 and rotate relative to the unlock actuator 1140 and the handle body 1108.

[0090] 12A-12C, perspective cross-sectional views of an unlock actuator 1240 are shown. The unlock actuator 1240 may be the same as or similar to the unlock actuator 211 of FIGS. 2A and 2B. As shown in FIGS. 12A-12C, the unlock actuator 1240 may include an unlock body 1242, which may include an unlock button 1241 and a wheel housing 1243. The unlock button 1241 may be a depressible protrusion that may be rigidly connected to the wheel housing 1243. The wheel housing 1243 may be generally rectangular and may have a central channel for receiving a threaded shaft 1246, which may be identical to the threaded shaft 1144 of FIG. 11C. Additionally, the wheel housing 1243 may include a recessed circular channel sized to accommodate the ridged wheel 1244 for rotation within the wheel housing 1243. The ridged wheel 1244 may be ring-shaped and may have ridges 1248 extending from its outer surface. The ridges may be linear in shape and may extend the length of the ridged wheel 1244. The ridged wheel 1244 may further include inwardly extending horns 1249. The horns 1249 may extend the width of the ridged wheel 1244 and may extend into the threaded recesses 1255. Thus, rotation of the threaded shaft 1246 causes rotation of the ridged wheel 1244.

[0091] The unlock actuator 1240 can further include a spring assembly 1250 located at the bottom of the wheel housing 1243 and a bar 1224. The bar 1224 can be connected to the bottom of the wheel housing 1243 and oriented to be received by the ridge 1248. The spring 1250 can include a spring, which can be a coil spring. The spring 1250 can interact with the wheel housing 1243 at a lower end of the wheel housing 1243 such that downward movement of the wheel housing 1243 compresses the spring 1250. The recess in the wheel housing is sized to allow the wheel housing 1243 to move up and down while keeping the ridged wheel 1244 at the same height.

[0092] 12B, the unlock actuator 1240 can prevent rotation of the threaded shaft 1247. Specifically, in the locked position, which may be a default position, the spring 1250 can be uncompressed, forcing the bar 1224 onto the ridges of the ridged wheel 1244. The bar 1224's presence on the ridges of the ridged wheel 1244 prevents rotation of the ridged wheel 1244, and therefore prevents rotation of the threaded shaft 1247. As shown in FIG. 12C, moving the unlock actuator 1240 downward compresses the spring 1250 of the spring assembly 1250, thereby removing the bar 1224 from the ridges of the ridged wheel 1244. For example, a user can press the unlock button 1241 to compress the spring 1250. In the unlocked position shown in Figure 12C, which may be caused by depressing the unlock actuator downward, the ridged wheel 1244 may be allowed to rotate, thus allowing rotation of the threaded shaft 1247. Once the unlock actuator is released, the spring 1250 extends towards the neutral position and again assumes the locked position shown in Figure 12B.

[0093] 13A and 13B, an unlock actuator 1340 is shown engaged with a threaded shaft 1347. The unlock actuator 1340 may be the same as or similar to the unlock actuator 1240 of FIGS. 12A-12C, and the threaded shaft 1347 may be the same as or similar to the threaded shaft 1247 of FIGS. 12A-12C. As shown in FIGS. 13A and 13B, the unlock actuator 1340 may further include threads 1360 that may be located in or near a central channel 1362 of the wheel housing 1342, which may be the same recessed channel in which the ridged wheel (not shown) is disposed. The threads 1360 may be sized such that the threads 1360 can interact with one or more threads of the threaded shaft 1347 in a locked position (e.g., the locked position shown in FIG. 12B) in which the spring 1352 is extended. In the locked position, the threads 1360 of the unlock actuator 1340 prevent the threaded shaft 1347 from axially moving in either the distal or proximal direction. As shown in FIG. 13B, the unlock actuator 1340 transitions to the unlocked position (e.g., the unlocked position shown in FIG. 12C ) by compressing the spring 1352, which moves the wheel housing 1343, and therefore the threads 1360, downward. In the unlocked position shown in FIG. 13B , the threaded shaft 1347 can move axially proximally and distally without interference with the threads 1360.

[0094] 14A-14C, a support drum 1414 can be secured to the handle body 1408. The support drum 1414 can be the same as or similar to the support drum 1114 of FIG. 11B, and the handle body 1408 can be the same as or similar to the handle body 1408. The support drum 1414 can be tubular in shape and can include an inner surface having internal threads 1450 near the distal end of the support drum 1414. The support drum 1414 and the internal threads 1450 can engage with an internal threaded ring 1460. The internal threaded ring 1460 can be annular in shape and can have a threaded outer surface 1462. The threaded outer surface 1462 can engage with the threads 1450 of the support drum 1414 such that the internal threaded ring 1460 can rotate within the support drum 1414 along the threads 1450. In this manner, the support drum 1414 can guide the inner threaded ring 1460 as it rotates within the handle body 1408 .

[0095] The inner surface of the inner threaded ring 1460 may include a horn-like protrusion 1466 that may protrude inward from the inner threaded ring 1460. For example, the horn-like protrusion 1466 may include a right angle and may be sized to enter the threaded recess 1446 of the threaded shaft 1444. The threaded shaft 1446 may be the same as or similar to the threaded shaft 1246 of FIG. 12A , and the threaded recess 1446 may be the same as or similar to the threaded recess 1250. The threaded shaft 1444 may include a guide 1468 at its proximal end that may extend outward from the threaded shaft 1444, as shown in FIG. 14A , and the guide 1468 may maintain the threaded recess 1446 beyond the threads shown more distally. The threaded shaft 1444 may extend through the inner threaded ring 1460 such that the threaded shaft 1444 can receive the horn-like protrusion 1466 in the threaded recess 1446. As the threaded shaft 1444 rotates, the horns 1446 cause the inner threaded ring 1460 to rotate as well.

[0096] Referring now to FIG. 14B, an inner threaded ring 1460 is shown. As shown in FIG. 14B, the inner threaded ring 1460 can include a threaded outer surface 1462 and an inner surface having a horn-like protrusion 1466. The threaded outer surface 1462 can further include a stop protrusion 1470, which can be located at the beginning of the threaded outer surface 1462 so as to protrude from the stop. The stop protrusion 1470 shown in FIGS. 14A and 14B can be designed to engage with the stop protrusion 1472 of the handle body 1408 shown in FIG. 14A, such that the inner threaded ring 1460 can rotate clockwise and counterclockwise a set degree of rotation before being stopped by the handle body 1408 and further rotation is prevented. For example, the handle body 1408 can prevent the inner threaded ring 1460, and therefore the threaded shaft 1444, from rotating more than 360 degrees. It is understood that any other amount of rotation (e.g., 90, 180, 270, 720, etc.) can be achieved by varying the number and spacing of the threads and / or the location of the stop protrusions 1470. It is further understood that more than one stop protrusion may be included on the screw ring 1460.

[0097] 14C, a support drum 1414 is shown. As shown in FIG. 14C, the support drum 1414 may be tubular in shape having an inner and outer surface. The outer and inner surfaces may be generally smooth. The inner surface may include threads 1450 that can guide the inner threaded ring along the interior of the support drum 1414. In one example, the threads 1450 and / or the inner surface of the support drum 1414 may include one or more stop protrusions to prevent the inner threaded ring from rotating at a particular point along the support drum 1414. Alternatively, the stop protrusions may be located on the handle body.

[0098] Referring now to FIG. 15 , an exploded perspective view of a positioning actuator 1555 is shown. The positioning actuator 1555 may be the same as or similar to the positioning actuator 1112 of FIG. 11A . The positioning actuator 1555 may include positioning actuator housings 1554 and 1556, which may form the two halves of the positioning actuator 1555 and may cooperate to form a tubular shape. The positioning actuator 1555 may further include an actuator base 1558, which may be rigidly secured between the positioning actuator housings 1554 and 1556. The actuator base 1558 may have threads on its internal surface. The positioning actuator housings 1554 and 1556 may be secured to a positioning support 1548, which may be coupled to or otherwise extend from a positioning shaft 1546. The positioning support 1548 and the positioning shaft 1546 may be the same as or similar to the positioning support 1148 and the positioning shaft 1146, respectively, of FIG. 11C . The positioning actuator housing 1554 can include a release actuator 1552 that can releasably secure the positioning actuator 1555 to the positioning support 1548. As shown in FIG. 15 , the release actuator 1552 can be a button or similar protrusion that can slide along the positioning actuator housing 1554 and selectively engage a receiving area 1550 on the positioning support 1548. The receiving area 1550 can be a rectangular cavity, slit, catch, etc. on the positioning support 1548 for interacting with the release actuator 1552. Additionally or alternatively, the release actuator 1552 can be disposed on the positioning actuator housing 1556.

[0099] The deployment base 1570 may be disposed within the actuator base 1558 and may include a threaded shaft 1568 and an inner shaft 1560. The threaded shaft 1568 may be tubular in shape and may have an internal channel within which the inner shaft 1560 may be disposed. The threaded shaft 1568 may include a number of threads 1566 disposed on an outer surface of the threaded shaft 1568 to interact with internal threads of the actuator base 1558 such that rotation of the actuator base 1558 causes axial movement of the deployment base 1570. The pattern of the threads 1566 may be selected such that rotation of the actuator base 1558 causes the threaded shaft 1568 to advance or retract axially as the actuator base 1558 rotates. The inner shaft 1560 may be rigidly connected to a guidewire shaft 1536, which may be the same as or similar to the guidewire shaft 917 of FIG. 9 . Thus, axial movement of the inner shaft 1560 can cause axial movement of the guidewire shaft 1536.

[0100] The inner shaft 1560 may be tubular in shape and may include a rotational locking protrusion 1562 that may be connected to or otherwise interact with the threaded shaft 1568 such that rotational and / or axial movement of the threaded shaft 1568 is transmitted to the inner shaft 1560. The rotational locking protrusion 1562 may be a rectangular protrusion or any catch or interacting structure. The inner shaft 1560 may further include a proximal protrusion 1564 that may be cylindrical in shape and have a larger diameter than the main body of the inner shaft 1560. The proximal protrusion 1564 may interact with a proximal region 1570 of the threaded shaft 1568 to secure the inner shaft 1560 to the threaded shaft 1568 and prevent the inner shaft 1560 from advancing axially beyond a certain point. A spring 1575 may be disposed around the guidewire shaft 1536 and may interact with the distal end of the positioning shaft and the distal end of the inner shaft 1560. When the inner shaft 1560 is advanced, the spring can be compressed against the distal end of the positioning shaft, and as the inner shaft 1560 advances toward the distal end of the positioning shaft, the spring force from the spring 1575 can increase, increasing the proximal force on the inner shaft 1560. The spring 1575 can return the inner shaft 1562 to its proximal-most position when no axial force is being applied distally to the inner shaft 1560.

[0101] 16A and 16B, there is shown a cross-sectional view of an inner shaft 1660, a threaded shaft 1668, an actuator base 1658, positioning actuator housings 1654 and 1656, a positioning support 1650, a positioning shaft 1648, a guidewire shaft 1636, and a spring 1675. It will be understood that the inner shaft 1660, the threaded shaft 1668, the actuator base 1658, the positioning actuator housings 1654 and 1656, a positioning support 1648, a positioning shaft 1646, a guidewire shaft 1636, and a spring 1675 may be the same as or similar to the inner shaft 1560, the threaded shaft 1568, the actuator base 1558, the positioning actuator housings 1554 and 1556, a positioning support 1550, a positioning shaft 1548, a guidewire shaft 1536, and a spring 1575 of FIG.

[0102] The positioning actuator 1655 can include positioning actuator housings 1654 and 1656 and can further include a release actuator 1652 that can releasably secure the positioning actuator 1655 to a positioning support 1648 that can be connected to or extend from the positioning shaft 1646. The positioning actuator housings 1654 and 1656 can be secured to the positioning base 1658 such that the positioning support 1648 is located between the positioning actuator housings 1654 and 1656 and the positioning base 1658. The positioning base 1658 can include internal threads 1659. While the internal threads 1659 are shown near a distal region of the positioning base 1658, it is understood that the internal threads 1659 can be located near any other portion of the positioning base 1658.

[0103] The internal threads 1659 of the positioning base 1658 can interact with the threads 1669 of the threaded shaft 1668 such that the threaded shaft 1668 moves axially either distally or proximally when the positioning base 1659 is rotated. The inner shaft 1660 can be fixed to the threaded shaft 1668 such that axial movement of the threaded shaft 1668 is transmitted to the inner shaft 1660. The inner shaft 1660 can be fixed to the guidewire shaft 1636 (e.g., to a distal region of the inner shaft 1660). A spring 1675 can be disposed around the guidewire shaft 1636 and can resist axial movement of the inner shaft 1660 in the distal direction.

[0104] As shown in FIG. 16B , the inner shaft 1660 may include a rotational locking protrusion 1662 that may be connected to or otherwise interact with the threaded shaft 1568 such that rotational and / or axial movement of the threaded shaft 1568 is transferred to the inner shaft 1660. The rotational locking protrusion 1662 may be a rectangular protrusion or any catch or interacting structure. The inner shaft 1660 may further include a proximal protrusion 1664 that may be cylindrical in shape and have a larger diameter than the body of the inner shaft 1660. The proximal protrusion 1664 may interact with a snap fit 1670 at a proximal region of the threaded shaft to secure the inner shaft 1660 to the threaded shaft 1668 and prevent the inner shaft 1660 from advancing axially beyond the snap fit 1670. It is understood that the snap fit portion 1670 allows the proximal protrusion 1664 to traverse the snap fit portion 1670 in a proximal direction, but once the proximal protrusion 1664 traverses the snap fit portion 1670 in a proximal direction, it can prevent axial movement in a distal direction relative to the snap fit portion 1670.

[0105] 16C , a cross-sectional view of a positioning actuator 1657 is shown, which may be similar to the positioning actuator 1655 of FIG. 16A . The positioning actuator 1657 may include a positioning actuator housing 1654, which may include a release actuator 1652. The positioning actuator 1657 may further include a positioning actuator housing 1677, which may be similar to the positioning actuator housing 1656, but may further include a release actuator 1653, which may be the same as or similar to the release actuator 1652. It is understood that the release actuator 1652 or the release actuator 1653 may optionally be connected to one another such that movement of either the release actuator 1652 or the release actuator 1653 causes movement of the other. For example, as shown in FIG. 16D , the release actuator 1652 and the release actuator 1653 may be connected via a release structure 1678, which may be a tubular structure. It is further understood that the positioning shaft may be designed to receive one or both of the release actuators 1652 and 1653.

[0106] 17A and 17B, locking and unlocking of a positioning actuator 1755 using a release actuator 1752 is shown. The positioning actuator 1755 may be the same as or similar to the positioning actuator 1555 of FIG. 15. The positioning actuator 1755 may include a positioning actuator housing 1754 that can rotate on the positioning support 1748. The positioning actuator housing 1754 may further include a release actuator 1752 that can be operated by a user and that can be a button or protrusion that can slide along the positioning actuator housing 1754 to transition from the locked position shown in FIG. 17A to the unlocked position shown in FIG. 17B. The positioning actuator housing 1754 can include a locked indicator 1780 and an unlocked indicator 1782 to indicate the position of the release actuator 1752.

[0107] As shown in FIG. 17A , the release actuator 1752 can be in a locked position, which may be distal to the unlocked position. The release actuator 1752 can include a locking protrusion 1753 that can extend from an interior side of the release actuator 1752. In the locked position, the locking protrusion 1753 of the release actuator 1752 can be received in a receiving area 1750 of the positioning support 1748. As shown in FIG. 17A , the locking protrusion 1753 can be a rectangular protrusion, and the receiving area 1750 can also be rectangular in shape. However, it is understood that other shapes or designs can be used. In the locked position shown in FIG. 17A , the positioning actuator housing 1754 and the positioning support 1748 can be rotated together such that rotation of the positioning actuator housing 1754 causes rotation of the positioning support 1748.

[0108] 17B, ​​the release actuator 1752 can be moved proximally from the unlocked position to a locked position. In the unlocked position, proximal movement of the release actuator moves the locking projection 1753 proximally, thus disengaging the positioning actuator housing 1754 from the positioning support 1748 as the locking projection 1753 moves out of the receiving area 1750 of the positioning support 1748. In the unlocked position, the positioning actuator housing 1754 is free to rotate while the positioning support 1748 remains stationary.

[0109] 18A-18C, an actuator base 1858 and a threaded shaft 1868 are shown. As shown in FIG. 18A, the actuator base 1858 may be the same as or similar to the actuator base 1558 of FIG. 15 and may include threads 1859 near a distal region of the actuator base 1558. The actuator base 1858 may further include a proximal protrusion 1857 that can interact with and secure the actuator base 1858 to the positioning actuator housing. As shown in FIG. 18B, the threaded shaft 1868 may be disposed within the actuator base 1858. The threaded shaft 1868 may be the same as or similar to the threaded shaft 1568 of FIG. 15. As shown in FIG. 18B, the actuator base 1858 may be located at a proximal or central region of the threaded shaft 1868 in the non-deployed position. In the non-deployed position, a distal sleeve of the deployment assembly can retain the prosthetic heart valve. 18C , the threaded shaft 1868 can be advanced proximally by rotating the actuator base 1858. As the actuator base 1858 rotates, threads 1859 of the actuator base 1858 can engage threads 1863 of the threaded shaft 1868, and the threaded shaft 1868 can be advanced distally until the threads 1859 of the actuator base 1858 engage stop protrusion 1865, which can be a protrusion on the threaded shaft 1858 designed to prevent further movement of the threaded shaft 1868 relative to the actuator base 1858.

[0110] 19 , rotation of a deflection actuator 1910 of a catheter system 1900 to deflect an elongate catheter 1902 is shown. In particular, a user can rotate the deflection actuator 1910 of a handle 1906. Rotation of the deflection actuator 1910 can be relative to the handle body 1908, such that the deflection actuator 1910 can be rotated without moving the handle body 1908. Rotation of the deflection actuator 1910 deflects the elongate shaft 1902, which is attached to the deflection wire at a distal region, as the deflection wire and elongate shaft 1902 within the handle body 1908 are retracted proximally. Such deflection determines the position and orientation of a deployment assembly 1904 at the distal end of the elongate shaft 1902. The deflection actuator 1910 can be used to advance the elongate shaft 1902 and deployment assembly 1904 through a patient's vasculature and ultimately deliver a prosthetic heart valve carried by the deployment assembly 1904 to a deployment site. For example, the deflection actuator 1910 can be used to advance the elongate shaft 1902 and deployment assembly 1904 through the aortic arch and into the native aortic valve. It is understood that the degree of curvature of the elongate shaft 1902 can be determined by the degree and / or number of rotations of the deflection actuator 1910.

[0111] 20A-20B, operation of the positioning actuator of the handle 2006 to rotate and advance the deployment assembly and cause deployment is shown. As shown in FIG. 20A, when the positioning actuator 2012, which may be the same as the positioning actuator 112 of FIG. 1, is in the locked position, the release actuator 2052 is therefore in its distal-most position, and the unlocking actuator 2040, which may be the same as the unlocking actuator 1240 of FIG. 12, is pushed into the unlocked position, rotation of the positioning actuator 2012 and / or axial movement of the positioning actuator 2012 can be transmitted to the positioning shaft 2046. Because the positioning shaft 2046 is fixed to the torque shaft, rotation of the positioning shaft causes rotation of the torque shaft and therefore the elongated shaft 2003. Because the deployment assembly 2004 is fixed to the elongated shaft 2003, rotation and / or axial movement of the elongated shaft 2003 is translated into rotation and / or axial movement of the deployment assembly 2004. Thus, when the positioning actuator 2012 is in the locked position and the unlocking actuator 2040 is depressed, rotational and axial movement of the positioning actuator 2012 results in rotational and / or axial movement of the deployment assembly 2004 .

[0112] As shown in FIG. 20B , when the positioning actuator 2012 is in the locked position and the release actuator 2052 is therefore in its proximal-most position, rotation of the positioning actuator 2012 is transmitted to the threaded shaft and the inner shaft secured to the threaded shaft, advancing the threaded shaft and the inner shaft. Because the inner shaft is secured to the guidewire shaft, the guidewire shaft advances distally with the inner shaft. Because the guidewire shaft is secured at its distal end (e.g., via an end cone) to the distal sleeve 2008 of the deployment assembly 2004, which may be the same as or similar to the deployment assembly 304 of FIGS. 3E-3F , distal advancement of the guidewire shaft causes distal advancement of the distal sleeve 2008. Further advancement of the distal sleeve causes distal advancement of the anchor connector 2026s, which may be secured to the anchor support 2022. As the anchor connector 2026 advances distally, the anchor support 2022 can advance distally from its initial position within the proximal sleeve 2020. Thus, when the release actuator 2052 is in the unlocked position, rotation of the positioning actuator 2012 can cause distal movement of the distal sleeve 2008, the inner support 2021 (e.g., a tube), and the anchor support 2022, thereby deploying the prosthetic valve held by the deployment assembly 2004.

[0113] 21A and 21B, the initial steps for deploying a catheter system are shown. As shown in FIG. 21A, to deploy the catheter system, an introducer sheath 2100 can first be introduced at or near the delivery site. For example, a guidewire 2150 can be introduced into the patient's vasculature and advanced through the vasculature to the deployment site. In one example, a guidewire can be introduced through the femoral artery and advanced through the patient's vasculature to the aortic valve. An introducer sheath 2110 can then be advanced along the guidewire 2150 to or near the implantation site. For example, the introducer sheath 2110 can be combined with a dilator (not shown) that can be detached from the introducer sheath when the introducer sheath reaches the deployment site. As shown in FIG. 21A, it may be desirable to position the introducer sheath near the delivery site (e.g., on the outflow side of the aortic valve).

[0114] Once the introducer sheath is positioned at the delivery site, a catheter system 2100, which may be the same as or similar to the catheter system 100 of FIG. 1, can be delivered to the delivery site using the introducer sheath 2100, as shown in FIG. 21B. Specifically, the catheter system 2100 can be placed within the introducer sheath 2110 and moved through the introducer sheath 2110 to the delivery site. The deployment assembly 2104 can further include an imaging marker 2130 that can appear using well-known medical imaging. For example, the imaging marker 2130 can be a ring positioned in a proximal region of the distal sleeve of the deployment assembly 2104. Similarly, the distal end of the introducer sheath 2110 can include an imaging marker 2135 that identifies the end of the introducer sheath 2135. It may be useful for someone delivering the catheter system 2100 to the implantation site to know when the prosthetic heart valve exits the introducer sheath 2110 and / or approaches the end of the introducer sheath 2110. In one example, the imaging marker 2130 and / or the imaging marker 2135 may be radiopaque or other known imaging markers.

[0115] 22A-22D, the sequential deployment of a prosthetic heart valve is shown. Referring now to FIG. 22A, a deployment assembly 2204, which may be identical to the deployment assembly 2104 of FIG. 21B, is shown at the distal end of an introducer sheath 2210, which may be identical to the introducer sheath 2110 of FIG. 21B. The deployment assembly 2204 may be positioned such that the proximal portion of the distal sleeve 2220 is still retained by the introducer sheath 2210. In this position, the prosthetic heart valve 2224 may be fully constrained and compressed by the introducer sheath 1210 and the deployment assembly 2204. As shown in FIG. 22A, the distal sleeve 2220 and anchor support 2022 may be in their most proximal positions.

[0116] 22B , the deployment assembly 2204 is shown after it has fully exited the introducer sheath. Upon exiting the introducer sheath, the positioning arms 2225 of the prosthetic heart valve 2224 can spread, and the deployment assembly 2204 can be rotated and / or advanced to position the positioning arms 2225 over the leaflets of a native valve (e.g., an aortic valve). As shown in FIG. 22B , upon exiting the introducer sheath, the distal sleeve 2220 of the deployment assembly 2204 can be in its proximal-most position, thereby holding a distal portion of the prosthetic heart valve 2224 in a compressed state. Additionally, upon exiting the introducer sheath, the anchor support 2222 can be in its proximal-most position within the proximal sleeve 2223, thereby maintaining a proximal portion of the prosthetic heart valve 2224 in a compressed state. Thus, the positioning arms 2225 can be at least partially expanded while the proximal and distal portions of the prosthetic heart valve 2224 are maintained in a compressed state.

[0117] Referring now to FIG. 22C , the deployment assembly 2204 is shown with its distal portion in an expanded state while its proximal portion remains compressed. As shown in FIG. 22C , the retention arms of the prosthetic heart valve 2224 can be positioned against the cusps of the native leaflets of the aortic valve, similar to FIG. 22B . However, the distal sleeve 2220 of the deployment assembly 2204 can be moved distally, thereby releasing the distal portion of the prosthetic heart valve 2224 so that it can transition to the expanded state. In the expanded state, the distal portion of the prosthetic heart valve 2224 can secure the prosthetic heart valve 2224 to the native valve by pinning or otherwise sandwiching a portion of the native leaflet between the positioning arms and the distal portion of the prosthetic heart valve 2224. Even as the distal sleeve 2220 is moved distally, the anchor support 2222 can remain in its proximal-most position within the proximal sleeve 2223. Thus, the distal portion of the prosthetic heart valve can transition to an expanded state while the proximal portion of the prosthetic heart valve can remain in a compressed state.

[0118] 22D , the deployment assembly is shown with both the distal sleeve and anchor support in their distal-most positions. As shown in FIG. 22D , the distal sleeve 2220 can continue to move distally to the distal-most position, and as the distal sleeve 2220 moves distally, the distal sleeve 2220 and / or end cone can engage the anchor connector, causing the anchor support 2222 and / or inner support 2221 (e.g., tubing) to move distally as well, moving the anchor support 2222 out of the proximal sleeve 2223. As the anchor support 2222 moves distally from the proximal sleeve 2223, the proximal portion of the prosthetic heart valve 2224 is released from the proximal sleeve 2223 and the anchor support 2222 and can transition to an expanded state, thereby allowing the prosthetic heart valve 2224 to transition to a fully expanded state. It is understood that when the proximal portion of the prosthetic heart valve 2224 transitions to the expanded state, the compressive force on the native valve leaflets located between the positioning arms and the distal region of the prosthetic heart valve increases, further securing the prosthetic heart valve to the native valve (e.g., the aortic valve).

[0119] 22E , the deployment assembly 2204 is shown in a retracted position. As shown in FIG. 22E , after the distal sleeve 2200 reaches its distal-most position, it can be moved proximally to engage the proximal open end of the distal sleeve 2200 with the retracting taper assembly 2225 of the deployment assembly 2204. It will be appreciated that by engaging the proximal open end of the distal sleeve 2200 with the retracting taper assembly 2225, the deployment assembly 2204 can be removed from the prosthetic heart valve 2224 and the patient's vasculature without the proximal open end of the distal sleeve 2200 damaging the patient's vasculature or other tissue or the prosthetic heart valve 2224. Optionally, the anchor support 2222 and / or inner support (e.g., a tube) can again be moved distally further into the proximal sleeve 2223 to prevent the anchor support 2222 from damaging the patient's vasculature or other tissue or the prosthetic heart valve 2224.

[0120] 23A and 23B, an exemplary anchor support and proximal sleeve are shown. As shown in FIGS. 23A and 23B, the deployment assembly 2304 can include a distal sleeve 2320, a proximal sleeve 2323, an anchor support 2322, and a proximal taper 2327. The proximal taper 2327 can be secured to an elongate shaft 2332 that includes a torque tube. The proximal taper 2327 can be secured to a proximal sleeve 2323 that can include one or more tabs 2335. The proximal sleeve 2323 can be tubular in shape, and the tabs 2335 can be cantilevered such that a distal end of each tab 2335 can be deflected. The anchor support 2322 can be sized to fit within the proximal sleeve 2323 and can be selectively advanced distally such that at least a portion of the anchor support 2322 exits the proximal sleeve 2323, as shown in FIGS. 23A and 23B. The anchor support 2322 may include a recess 2334 which may be recessed or otherwise cut from the outer surface of the anchor support 2322. The recess 2324 may be shaped to receive the anchor 2352 of the prosthetic heart valve 2350. For example, the anchor 2352 may be circular in shape and the recess 2324 may also be circular in shape, but with a slightly larger diameter and recess depth so that the anchor 2352 can fit between the anchor support 2322 and the proximal sleeve 2323. However, it is understood that the recess 2324 may be any other shape (e.g., rectangular).

[0121] The tab 2335 can be designed to interact with the anchor 2352 such that the tab 2335 can resist distal movement of the anchor 2335 and / or the anchor support 2324. The introducer sheath 2334 can be designed to interact with the tab 2334 such that the introducer sheath can apply a downward force to the tab 2335 when the deployment assembly 2304 is moved through the introducer sheath 2335. When the proximal sleeve 2323 is within the introducer sheath 2334, the tab 2335 can prevent the anchor support 2324 from moving distally prematurely. Once the proximal sleeve 2323 and tab 2335 exit the introducer sheath 2334, the tab 2335 can allow the anchor support 2322 to exit the proximal sleeve 2323 when the distal sleeve applies a distal force to the anchor support 2322 via the anchor connector 2321.

[0122] 24A-24E, an alternative anchor support and proximal sleeve are shown. This anchor support and sleeve may be incorporated into the deployment assembly embodiments described above to enable locking features. As shown in FIGS. 24A and 24B, the anchor support 2422 may be tubular in shape. The deployment assembly may include a lock 2435 for locking the proximal sleeve 2427 to the anchor support 2422 during delivery. A handle at the proximal end, when manipulated, unlocks the lock 2435 on the deployment assembly, allowing the anchor support 2422 to be moved longitudinally relative to the sleeve 2427 for expansion and implantation of the prosthetic heart valve.

[0123] The lock 2435 can include a protrusion and a recess. The protrusion extends into the recess to lock the sleeve 2427 to the anchor support 2422 and is released from the recess to unlock the sleeve 2427 from the anchor support 2422. As shown, the anchor support 2422 can have the protrusion and the proximal sleeve 2427 can have the recess. In the embodiment shown in FIG. 24A, the protrusion is a ball bearing. Alternatively, as shown in FIGS. 25A-25D below, the protrusion can be a lever that is retained in the recess in a snap-fit ​​manner when locked and released from the recess when unlocked. In some embodiments, multiple protrusions and recesses are present to lock the anchor support to the proximal sleeve. As shown, multiple locking balls or levers can be spaced around the circumference.

[0124] The lock 2435 can further interact with a tube / internal support 2436 that extends the protrusion into the receptacle in a first position (shown in FIG. 24C) and moves to a second position (shown in FIG. 24E) relative to the anchor sleeve 2422 to release the protrusion from the receptacle.

[0125] The anchor support 2422 may fit within a proximal sleeve 2327, which may also be tubular in shape. The anchor support 2422 may include a recess 2444, which may be recessed or otherwise cut from the outer surface of the anchor support 2422. The recess 2444 may be shaped to receive an anchor of a prosthetic heart valve. For example, the anchor may be circular in shape and the recess may also be circular in shape. It is understood that the recess 2444 may be any other shape (e.g., rectangular).

[0126] The anchor support 2422 can further include a through hole 2446, which can be circular in shape, that can allow the lock 2435 to traverse the anchor support 2422 at the through hole 2446. The lock 2435 can be a ball structure or ball stopper (e.g., a plastic, rubber, or metal ball, etc.). The proximal sleeve 2427 can similarly include a through hole 2442 (e.g., a receiving portion), which can be circular in shape but can have a smaller diameter than the lock 2435 such that only a portion of the lock 2435 can extend through the through hole 2442. A distal taper 2434 can be secured to the proximal end of the proximal sleeve 2427. The internal support 2436 can be a tubular structure sized to fit inside the anchor support 2422. The internal support supports the lock 2435 and can maintain the lock 2435 in a locked position when the internal support 2436 is in its proximal-most position. The internal support 2436 can advance distally relative to the anchor support 2422 and the proximal sleeve 2427, such that the lock 2435 can no longer maintain the lock 2435 in the locked position. As the internal support 2436 advances distally, the lock can drop (e.g., move inward), allowing the anchor support 2422 to move distally relative to the proximal sleeve 2427 because the lock 2435 no longer interacts with the proximal sleeve 2427. As the anchor support 2422 moves distally relative to the proximal sleeve 2427, the recess 2444 can move out of the proximal sleeve 2427, releasing the anchor of the prosthetic heart valve. In this manner, the lock 2435 can prevent or allow axial movement of the anchor support 2422, and therefore deployment of the anchor. Although only one lock 2435 is shown, it is understood that multiple locks 2435 may be used and may be circumferentially spaced apart on the anchor support 2436 .

[0127] An inner support 2436 that moves distally and allows distal movement of the anchor support 2422 is shown in FIGS. 24C-24E. As shown in FIG. 24C, the inner support 2436 can be in its proximal-most position relative to the anchor support 2422 and the proximal sleeve 2427. As shown in FIG. 24C, when the inner support 2436 is in its proximal-most position, the lock 2435 is supported by an outer surface of the inner support 2436, and the lock 2435 resides within the through-hole 2442 and extends partially through the through-hole 2442 of the proximal sleeve 2427. In this manner, the lock 2435 can prevent the anchor support 2436 from moving distally when the inner support 2436 is in its proximal-most position and the lock 2435 is interacting with the proximal sleeve 2427.

[0128] 24D , the inner support 2436 can move distally without moving the anchor support 2422 and the proximal sleeve 2327. For example, an anchor connector connected to the distal sleeve and / or end cone may be connected to the inner support 2436, but not directly to the anchor support 2422. The inner support 2436 may be a protrusion extending outward from the outer surface of the inner support 2436 and may include a catch 2447 that can interact with the anchor support 2422 after the inner support 2436 has moved a certain amount distally. When the catch 2447 contacts the anchor support 2422, the anchor support 2422 and the inner support 2436 move distally together. The inner support 2436 may further include a locking recess 2450, which may be a recess or notch in the outer surface of the proximal region of the inner support 2436 that may be sized to allow the lock 2435 to at least partially enter. The lock recess 2450 may be angled at the proximal end to allow gradual entry of the lock 2435. As the inner support 2436 moves distally relative to the anchor support 2422 and the proximal sleeve 2427, the lock recess 2450 is positioned below the lock 2435, allowing the lock 2435 to enter the lock recess 2450, as shown in FIG. 24D . Once the lock 2435 enters the lock recess 2450, the lock 2435 drops below the proximal sleeve 2427, allowing the anchor support 2436 to move distally relative to the proximal sleeve 2427, as shown in FIG. 24E . In this manner, the recess in the anchor support 2436 can be exposed from the proximal sleeve 2437, allowing at least a proximal portion of the prosthetic heart valve to transition to the expanded state.

[0129] 25A-25D, an alternative anchor support and proximal sleeve are shown. As shown in FIGS. 25A-25D, the anchor support 2522 may be tubular in shape. The anchor support 2522 may fit within the proximal sleeve 2537, which may also be tubular in shape. The anchor support 2522 may include a recess 2544, which may be recessed or otherwise cut from the outer surface of the anchor support 2522. The recess 2544 may be shaped to receive an anchor of a prosthetic heart valve. The anchor support 2522 may further include a cantilever lock 2525 (e.g., a lock), which may be cantilevered and freestanding at the proximal end of the anchor support 2522. For example, the cantilever lock 2525 may be a lever. The cantilever lock 2435 may lock the anchor support 2522 to the proximal sleeve 2537 during delivery. The cantilever lock 2535 is resilient and capable of downward deflection. The cantilever lock 2535 may extend outward from the surface of the anchor support 2522 and may be designed to resist distal movement. The proximal sleeve may further include a throughbore 2542, which may be a receptacle sized and shaped to receive at least a portion of the cantilever lock 2535. The inner support 2536 (e.g., a tube) may be advanced distally relative to the anchor support 2522 and the proximal sleeve 2527, such that the cantilever lock 2535 may transition from a locked position to an unlocked position. In this manner, the cantilever lock 2535 may prevent or allow axial movement of the anchor support 2522. While only one cantilever lock 2535 is shown, it is understood that multiple cantilever locks 2535 may be used and spaced circumferentially on the anchor support 2522.

[0130] An inner support 2536 that moves distally and allows distal movement of the anchor support 2522 is shown in FIGS. 25B-25D. As shown in FIG. 25B, the inner support 2536 can be in its distal-most position relative to the anchor support 2522 and the proximal sleeve 2527. As shown in FIG. 25B, when the anchor support 2536 is in its proximal-most position, the cantilever lock 2535 is supported at its proximal end by the outer surface of the inner support 2536, and at least a portion of the cantilever lock 2535 extends through the through-hole 2542 of the proximal sleeve 2537. In this manner, the cantilever lock 2535 can prevent the anchor support 2522 from moving distally when the inner support 2536 is in its proximal-most position.

[0131] 25C , the inner support 2536 can be advanced distally without moving the anchor support 2522 and the proximal sleeve 2527. For example, an anchor connector connected to the distal sleeve and / or end cone may be connected to the inner support 2536, but may not be directly connected to the anchor support 2522. The inner support 2536 may be a protrusion extending outward from the outer surface of the inner support 2536 and may include a catch 2547 that can interact with the anchor support 2522 after the inner support 2436 has moved a certain amount distally. When the catch 2547 contacts the anchor support 2522, the anchor support 2522 and the inner support 2536 move distally together.

[0132] The internal support 2536 can further include a locking recess 2550, which can be a recess or notch in an outer surface of a proximal region of the internal support 2536 that can be sized to allow the lock 2435 to deflect or extend at least partially into the locking recess 2550. It is understood that the cantilever lock 2535 can be downwardly biased such that the proximal end of the cantilever lock 2535 is biased downward toward the internal support 2536. The locking recess 2450 can be angled at its distal end to allow the cantilever lock 2535 to gradually deflect or extend into the locking recess 2550. As shown in FIG. 25C , as the internal support 2536 moves distally relative to the anchor support 2522 and the proximal sleeve 2527, the locking recess 2550 is positioned below the cantilever lock 2535, allowing the cantilever lock 2535 to deflect or extend into the locking recess 2550. When the cantilever lock 2535 is deflected or extended into the locking recess 2550, the cantilever lock 2535 can be positioned below the proximal sleeve 2527, allowing the anchor support 2536 to move distally relative to the proximal sleeve 2527, as shown in FIG. 25D . In this manner, the recess in the anchor support 2522 can be exposed from the proximal sleeve 2537, allowing at least a proximal portion of the prosthetic heart valve to transition to the expanded state. The proximal sleeve 2535 can further include a distal through-hole 2580 into which the cantilever lock 2535 enters at its distal-most position, preventing further distal movement of the anchor support 2522 by the distal through-hole 2580.

[0133] The foregoing description of exemplary embodiments has been presented for purposes of illustration and description. It will be understood, of course, that the embodiments described herein are exemplary, and that the components can be arranged, substituted, combined, and designed in a wide variety of configurations, all of which are contemplated and within the scope of the present disclosure. It is not intended to be exhaustive or to be limited to the precise forms disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the disclosed embodiments. It is intended that the scope of the invention be defined by the appended claims and their equivalents.

Claims

1. 1. A catheter system for implanting a prosthetic heart valve, comprising: an elongate shaft having a proximal region and a distal region; a deployment assembly located at the distal region of the elongate shaft, the deployment assembly being sized and shaped to be advanced together with the prosthetic heart valve in a collapsed state to an implantation site located at the site of the native heart valve, the deployment assembly including a sleeve configured to maintain at least a portion of the prosthetic heart valve in the collapsed state therein during delivery; a handle disposed at a proximal region of the elongate shaft, the handle comprising a handle body, a first actuator configured to rotate relative to the handle body, and a second actuator configured to transition between a first position and a second position; Equipped with When the second actuator is in the first position, rotation of the first actuator is transmitted to the deployment assembly, causing it to rotate, and when the second actuator is in the second position, rotation of the first actuator moves the sleeve longitudinally relative to the handle to expand and implant the prosthetic heart valve.

2. 2. The catheter system of claim 1, wherein the handle comprises a third actuator, which, when in a first position, prevents operation of the first actuator when the second actuator is in the first position, and which, when in a second position, allows operation of the first actuator when the second actuator is in the first position.

3. 3. The catheter system of claim 2, wherein the handle comprises a fourth actuator configured to rotate relative to the handle body independently of the first actuator, the fourth actuator connected to a distal portion of the elongate shaft and configured to deflect the elongate shaft.

4. 2. The catheter system of claim 1, wherein when the second actuator is in the second position, rotation of the first actuator does not result in rotation of the deployment assembly, and when the second actuator is in the first position, rotation of the first actuator does not result in longitudinal movement of the sleeve relative to the handle.

5. 10. The catheter system of claim 1, wherein the deployment assembly further comprises a second sleeve proximal to the sleeve and coupled to the elongate shaft, and an anchor support located within the second sleeve and in mechanical communication with the sleeve.

6. 6. The catheter system of claim 5, wherein the anchor support is configured to receive a proximal portion of the prosthetic valve, and the anchor support and the second sleeve are configured to hold the proximal portion of the prosthetic heart valve in a compressed state.

7. The catheter system of claim 5 , wherein longitudinal movement of the sleeve causes longitudinal movement of the anchor support.

8. The catheter system of claim 1 , wherein the first actuator is rigidly connected to the deployment assembly when the second actuator is in the first position.

9. 2. The catheter system of claim 1, wherein the second actuator comprises a protrusion, and when the second actuator is in the first position, the protrusion of the second actuator is configured to engage with a shaft disposed within the handle and rigidly connected to the deployment assembly.

10. The catheter system of claim 9 , wherein the shaft is threaded and a cross section of the shaft comprises at least one right angle.

11. 11. The catheter system of claim 10, wherein the handle further comprises a third actuator configured to interact with one or more threads of the shaft and the at least one right angle to selectively constrain axial and rotational movement of the deployment assembly.

12. 12. The catheter system of claim 11, wherein the third actuator comprises a pushable body having a central channel and a ridged wheel disposed within the central channel and configured to receive the shaft and rotate with the shaft, the third actuator configured to resist rotation of the ridged wheel in a locked position.

13. 1. A method for implanting a prosthetic heart valve, comprising: advancing a deployment assembly located at a distal region of an elongate shaft, the deployment assembly including a sleeve configured to maintain at least a portion of the prosthetic heart valve in a collapsed state therein during delivery, together with the prosthetic heart valve in the collapsed state, to an implantation site located at the site of the native heart valve; rotating a first actuator of a handle coupled to the elongated shaft relative to a handle body of the handle when a second actuator of the handle is in a first position, whereby the rotation of the first actuator is transmitted to the deployment assembly, thereby rotating the deployment assembly; transitioning the second actuator from the first position to a second position; rotating the first actuator when the second actuator is in the second position to longitudinally move the sleeve relative to the handle to expand and implant the prosthetic heart valve; A method comprising:

14. 14. The method of claim 13, wherein the handle comprises a third actuator that, when in a first position, prevents operation of the first actuator when the second actuator is in the first position, and that, when in a second position, allows operation of the first actuator when the second actuator is in the first position.

15. 15. The method of claim 14, wherein the handle comprises a fourth actuator configured to rotate relative to the handle body independently of the first actuator, the fourth actuator connected to a distal portion of the elongate shaft and configured to deflect the elongate shaft.

16. 14. The method of claim 13, wherein when the second actuator is in the second position, rotation of the first actuator does not result in rotation of the deployment assembly, and when the second actuator is in the first position, rotation of the first actuator does not result in longitudinal movement of the sleeve relative to the handle.

17. 14. The method of claim 13, wherein the deployment assembly further comprises a second sleeve proximal to the sleeve and coupled to the elongate shaft, and an anchor support located within the second sleeve and in mechanical communication with the sleeve.

18. 18. The method of claim 17, wherein the anchor support is configured to receive a proximal portion of the prosthetic valve, and the anchor support and the second sleeve are configured to hold the proximal portion of the prosthetic heart valve in a compressed state.

19. The method of claim 17 , wherein longitudinal movement of the sleeve causes longitudinal movement of the anchor support.

20. The method of claim 1 , wherein the first actuator is rigidly connected to the deployment assembly when the second actuator is in the first position.

21. 1. A catheter system for implanting a prosthetic heart valve, comprising: an elongate shaft having a proximal region and a distal region; a deployment assembly located at the distal region of the elongate shaft, the deployment assembly being sized and shaped to be advanced to an implantation site at the site of a native heart valve together with the prosthetic heart valve in a collapsed state, the deployment assembly comprising: a sleeve; an anchor support configured to be disposed within the sleeve during delivery and to maintain at least a portion of the prosthetic heart valve in the collapsed state between the sleeve and the deployment assembly; and a lock configured to lock the sleeve to the anchor support during delivery. a handle disposed on a proximal region of the elongate shaft and configured, when manipulated, to unlock the lock of the deployment assembly so that the anchor support can be moved longitudinally relative to the sleeve to expand and implant the prosthetic heart valve; A catheter system comprising:

22. 22. The catheter system of claim 21, wherein the lock comprises a protrusion configured to extend into a receptacle to lock the sleeve to the anchor support and configured to release from the receptacle to unlock the sleeve from the anchor support.

23. The catheter system of claim 22, wherein the anchor support comprises the protrusion and the sleeve comprises the receiving portion.

24. 23. The catheter system of claim 22, wherein the lock further comprises a tube configured to extend the protrusion into the receptacle in a first position, the tube configured to move relative to the sleeve to a second position to release the protrusion from the receptacle.

25. 23. The catheter system of claim 22, wherein the protrusion comprises a ball bearing configured to be retained in the housing when locked and to be released from the housing when unlocked.

26. 23. The catheter system of claim 22, wherein the protrusion comprises a lever configured to be retained in the housing in a snap-fit ​​manner when locked and to be released from the housing when unlocked.

27. 22. The catheter system of claim 21, wherein the deployment assembly further comprises a second sleeve distal to the sleeve, the second sleeve coupled to at least a portion of the elongate shaft.

28. 28. The catheter system of claim 27, wherein the second sleeve is configured to receive a distal portion of the prosthetic valve and maintain at least the distal portion of the prosthetic heart valve in a collapsed state.

29. 28. The catheter system of claim 27, wherein longitudinal movement of the second sleeve causes longitudinal movement of the anchor support.

30. 22. The catheter system of claim 21, wherein the deployment assembly further comprises a tube located within the anchor support and configured for longitudinal movement within the anchor support between a first position and a second position distal to the first position, the tube having a non-uniform outer diameter.

31. 31. The catheter system of claim 30, wherein the tube comprises a protrusion extending from an outer surface of the tube, the protrusion configured to engage the anchor support such that the anchor support moves with the tube when the protrusion engages the anchor support.

32. 31. The catheter system of claim 30, wherein the tube is connected to the second sleeve via a cable configured to cause distal movement of the tube in response to distal movement of the second sleeve.

33. 31. The catheter system of claim 30, wherein the handle comprises a handle body and an actuator configured to rotate relative to the handle body, the actuator configured to move the anchor support longitudinally relative to the sleeve.

34. 1. A method for implanting a prosthetic heart valve using a catheter system, comprising: a deployment assembly located at a distal region of an elongate shaft, the deployment assembly comprising: a sleeve; an anchor support disposed within the sleeve and configured to maintain at least a portion of the prosthetic heart valve in a collapsed state between the sleeve and the deployment assembly; and a lock configured to lock the sleeve to the anchor support, wherein the deployment assembly loaded with the prosthetic heart valve in the collapsed state is guided to an implantation site located at the site of a native heart valve; releasing the lock so that the anchor support can be moved relative to the sleeve to expand at least a portion of the prosthetic heart valve to implant it by rotating an actuator on a handle located at a proximal region of the elongate shaft to distally move a first shaft extending between the actuator and the deployment assembly. A method comprising:

35. 35. The method of claim 34, wherein the lock comprises a protrusion configured to extend into a receiving portion to lock the sleeve to the anchor support and configured to release from the receiving portion to unlock the sleeve from the anchor support.

36. 36. The method of claim 35, wherein the anchor support comprises the protrusion and the sleeve comprises the receiving portion.

37. 36. The method of claim 35, wherein the lock further comprises a tube configured to extend the protrusion into the receptacle in a first position, the tube configured to move relative to the sleeve to a second position to release the protrusion from the receptacle.

38. 36. The method of claim 35, wherein the protrusion comprises a ball bearing configured to be retained in the receiving portion when locked and to be released from the receiving portion when unlocked.

39. 36. The method of claim 35, wherein the protrusion comprises a lever configured to be retained in the receptacle in a snap-fit ​​manner when locked and to be released from the receptacle when unlocked.

40. 35. The method of claim 34, wherein the deployment assembly further comprises a second sleeve distal to the sleeve, the second sleeve coupled to at least a portion of the elongate shaft.

41. 1. A catheter system for implanting a prosthetic heart valve, comprising: an elongate shaft having a proximal region and a distal region, the elongate shaft comprising a notched hypotube having a proximal portion, a transition portion notched to have greater flexibility than the proximal portion, and a distal portion notched to have greater flexibility than the transition portion; a deployment assembly located at the distal region of the elongate shaft and sized and shaped to be advanced, along with the prosthetic heart valve in a collapsed state, to an implantation site located at the site of the native heart valve; a handle disposed on a proximal region of the elongate shaft and configured, when manipulated, to release the prosthetic heart valve from the deployment assembly for expansion and implantation of the prosthetic heart valve; A catheter system comprising:

42. 42. The catheter system of claim 41, further comprising a deflection cable, the elongate shaft further comprising a deflection shaft coupled to the deflection cable at a distal end, the cut hypotube and the deflection cable disposed within the deflection shaft.

43. 43. The catheter system of claim 42, wherein the handle further comprises a handle body and a deflection actuator in mechanical communication with the deflection cable and configured to retract the deflection cable in a proximal direction, the deflection actuator configured to deflect the deflection shaft.

44. 43. The catheter system of claim 42, wherein the elongate shaft further comprises a torque shaft disposed within the deflection shaft, the torque shaft configured to transfer axial and rotational motion from the handle to the deployment assembly.

45. 45. The catheter system of claim 44, wherein the torque shaft comprises a second hypotube, a polymer layer disposed within the second hypotube, a braided layer disposed within the polymer layer, and a liner layer comprising a fluoropolymer disposed within the braided layer.

46. 46. ​​The catheter system of claim 45, wherein the second hypotube is slit to increase flexibility in a proximal to distal direction, the polymer layer comprises a nylon polymer, the braided layer comprises a metal braid, and the liner layer comprises polytetrafluoroethylene (PTFE).

47. 45. The catheter system of claim 44, wherein the elongate shaft further comprises a guidewire shaft configured to receive a guidewire and disposed within the torque shaft, the torque shaft and the guidewire shaft being configured to be axially independent.

48. 48. The catheter system of claim 47, wherein the guidewire shaft comprises the cut hypotube, a second polymer layer disposed within the hypotube, a second braided layer disposed within the second polymer layer, and a second liner layer comprising a fluoropolymer disposed within the second braided layer.

49. 48. The catheter system of claim 47, wherein the hypotube is longer than the second hypotube and has more cuts than the second hypotube.

50. 48. The catheter system of claim 47, wherein one or more of the hypotube or second hypotube is a laser cut hypotube or is micromachined.

51. 1. A method for implanting a prosthetic heart valve, comprising: advancing a deployment assembly located at a distal region of an elongate shaft, the deployment assembly including a notched hypotube having a proximal portion, a transition portion notched to have greater flexibility than the proximal portion, and a distal portion notched to have greater flexibility than the transition portion, together with the prosthetic heart valve in a collapsed state to an implantation site located at the site of the native heart valve; manipulating a handle disposed at a proximal region of the elongate shaft to release the prosthetic heart valve from the deployment assembly for expanding and implanting the prosthetic heart valve; A method comprising:

52. 52. The method of claim 51, further comprising a deflection cable, the elongate shaft further comprising a deflection shaft coupled to the deflection cable at a distal end, the cut hypotube and the deflection cable disposed within the deflection shaft.

53. 53. The method of claim 52, wherein the handle further comprises a handle body and a deflection actuator in mechanical communication with the deflection cable and configured to retract the deflection cable in a proximal direction, the deflection actuator configured to deflect the deflection shaft.

54. 53. The method of claim 52, wherein the elongate shaft further comprises a torque shaft disposed within the deflection shaft, the torque shaft configured to transfer axial and rotational motion from the handle to the deployment assembly.

55. 55. The method of claim 54, wherein the torque shaft comprises a second hypotube, a polymer layer disposed within the second hypotube, a braided layer disposed within the polymer layer, and a liner layer comprising a fluoropolymer disposed within the braided layer.

56. 56. The method of claim 55, wherein the second hypotube is slit to increase flexibility in a proximal to distal direction, the polymer layer comprises a nylon polymer, the braided layer comprises a metal braid, and the liner layer comprises polytetrafluoroethylene (PTFE).

57. 55. The method of claim 54, wherein the elongate shaft further comprises a guidewire shaft configured to receive a guidewire and disposed within the torque shaft, the torque shaft and the guidewire shaft being configured to be axially independent.

58. 58. The method of claim 57, wherein the guidewire shaft comprises the cut hypotube, a second polymer layer disposed within the hypotube, a second braided layer disposed within the second polymer layer, and a second liner layer comprising a fluoropolymer disposed within the second braided layer.

59. 58. The method of claim 57, wherein the hypotube is longer than the second hypotube and has more notches than the second hypotube.

60. 58. The method of claim 57, wherein one or more of the hypotube or second hypotube is a laser cut hypotube or is micromachined.

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