Catheter system for sequential deployment of expandable implants

Abstract

Systems and methods are provided for sequentially deploying heart implants, such as prosthetic heart valves, using a catheter system having an elongate shaft, and a deployment assembly at one end and a handle at the other end. The deployment assembly may include one or more sleeves and anchor supports that maintain the cardiac implant in a partially collapsed state. The handle may include a first actuator and a second actuator each designed to rotate relative to a body of the handle. The first actuator may rotate to cause the elongate shaft to arch. The second actuator may rotate in a locked position to cause the deployment assembly to rotate or axially move, or may rotate in an unlocked position to cause the sleeve and anchor support on the deployment assembly to move, thereby allowing the cardiac implant to expand to an expanded state.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 384,843, filed on November 23, 2022, the entire content of which is incorporated herein by reference. Technical Field

[0003] The present invention generally relates to catheter systems for deploying cardiac implants. For example, provided herein are systems and methods including catheter systems for precisely and sequentially placing self - expanding artificial heart valves. Background Art

[0004] In medical technology, there have been efforts to non - surgically treat or repair heart valve defects, such as aortic insufficiency or aortic stenosis, via a trans - arterial interventional approach through a catheter, thereby obviating the need for invasive surgical procedures. Transcatheter aortic valve replacement (TAVR) and transcatheter aortic valve intervention (TAVI) procedures have become increasingly common. Various insertion systems and stent systems with different advantages and disadvantages have been proposed, and these insertion systems and stent systems can be introduced into a patient's body partially via a catheter system through the artery.

[0005] However, in previously known medical devices, it is evident that the implantation procedure of the stent system to which an artificial heart valve is attached is relatively complex, difficult, and expensive. In addition to the complex implantation of the artificial heart valve as a replacement for a dysfunctional or defective native heart valve, currently used medical devices also have a fundamental risk of incorrect positioning of the stent or artificial heart valve, which cannot be corrected without more extensive and invasive surgical intervention.

[0006] It is also considered problematic that when using systems known in the prior art, incorrect positioning of the artificial heart valve or the associated heart valve stent can generally be avoided only when a cardiac surgeon or interventional cardiologist is particularly experienced.

[0007] For example, improved delivery catheter systems are described 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 content of each of these patents being incorporated herein by reference.

[0008] There is a need for further improved systems and devices for introducing a sequentially expandable cardiac valve stent into a patient, for positioning the stent at a desired implantation site, and for reducing the risk to the patient during implantation. Summary of the Invention

[0009] The present disclosure provides a catheter system and method for implanting an artificial heart valve in a sequential manner. The catheter system can be used to implant a self-expandable artificial heart valve having arms that allow the artificial heart valve to be clamped to an autologous valve. This attachment method allows the valve to be placed in the heart without having to suture the artificial valve into the heart. The delivery catheter described herein can be used to sequentially deploy the artificial valve. The delivery catheter can be capable of positioning the artificial valve on or near the autologous valve and sequentially releasing portions of the artificial valve from the delivery catheter. The delivery catheter allows the artificial valve to be precisely positioned at the desired implantation site. The artificial valve can then be sequentially deployed in a controlled manner to improve accuracy and safety.

[0010] In one example, a catheter system for implanting an artificial 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, the deployment assembly sized and shaped to advance to an implantation site at an autologous heart valve site with the artificial heart valve in a collapsed state, the deployment assembly including a sleeve designed to maintain at least a portion of the artificial heart valve within the sleeve in a collapsed state during delivery; a handle positioned at the proximal region of the elongate shaft, the handle having a handle body, a first actuator, and a second actuator, the first actuator designed to rotate relative to the handle body, the 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 transferred to the deployment assembly to cause the deployment assembly to rotate, and when the second actuator is in the second position, rotation of the first actuator can cause the sleeve to move longitudinally relative to the handle to expand and implant the artificial heart valve.

[0011] The handle can have a third actuator that prevents the first actuator from moving when in a first position and the second actuator is in the first position, and allows the first actuator to move when the third actuator is in a second position and the second actuator is in the first position. The handle can include a fourth actuator designed to rotate relative to the handle body and independently of the first actuator, the fourth actuator can be connected to the distal portion of the elongate shaft and designed to cause the elongate shaft to deflect. When the second actuator is in the second position, rotation of the first actuator can not cause the deployment assembly to rotate, and when the second actuator is in the first position, rotation of the first actuator can not cause the sleeve to move longitudinally relative to the handle.

[0012] The deployment assembly can include: a second sleeve that is proximal to the sleeve and coupled to the elongate shaft; and an anchor support that is positioned within the second sleeve and in mechanical communication with the sleeve. The anchor support can be designed to receive the proximal portion of the prosthetic valve, and the anchor support and the second sleeve can be designed to hold the proximal portion of the prosthetic heart valve in a compressed state. Longitudinal movement of the sleeve can cause longitudinal movement of the anchor support. When the second actuator is in the first position, the first actuator can be rigidly connected to the deployment assembly. The second actuator can include a protrusion, and when the second actuator is in the first position, the protrusion of the second actuator can be designed to engage a shaft that is positioned within the handle and rigidly connected to the deployment assembly.

[0013] The shaft can be threaded, and the cross-section of the shaft can include at least one right angle. The handle can include a third actuator that is designed to mate with one or more threads of the shaft and the at least one right angle to selectively restrict axial and rotational movement of the deployment assembly. The third actuator can include a depressible body having a central channel and a ridged wheel that is positioned within the central channel and designed to receive the shaft and rotate with the shaft, and wherein the third actuator is designed to resist rotation of the ridged wheel in a locked position.

[0014] According to another aspect, a method for implanting a prosthetic heart valve is provided. The method can include: advancing a deployment assembly at a distal region of an elongate shaft to an implantation site at a native heart valve site with the prosthetic heart valve in a collapsed state, the deployment assembly including a sleeve configured to maintain at least a portion of the prosthetic heart valve in a collapsed state within the sleeve during delivery; rotating a first actuator of a handle relative to a handle body of the handle while a second actuator of the handle is in a first position such that rotation of the first actuator is transferred to the deployment assembly to cause the deployment assembly to rotate; transitioning the second actuator from the first position to a second position; and rotating the first actuator while the second actuator is in the second position to cause the sleeve to move longitudinally relative to the handle to expand and implant the prosthetic heart valve.

[0015] In another example, a catheter system for implanting an artificial heart valve may include: 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 advance to an implantation site at an autologous heart valve site with the artificial heart valve in a collapsed state, the deployment assembly including a sleeve, an anchor support, and a lock, the anchor support being designed to be positioned within the sleeve during delivery to maintain at least a portion of the artificial heart valve in a collapsed state between the sleeve and the anchor support, the lock being designed to lock the sleeve to the anchor support during delivery; and a handle positioned at the proximal region of the elongate shaft, the handle being designed to cause the lock of the deployment assembly to unlock when actuated, such that the anchor support is longitudinally movable relative to the sleeve to expand and implant the artificial heart valve.

[0016] The lock may include a protrusion designed to extend into a receiving portion to lock the sleeve to the anchor support and designed to be released from the receiving portion to unlock the sleeve from the anchor support. The anchor support may include a protrusion and the sleeve may include a receiving portion. The lock may include a tube designed to cause the protrusion to extend into the receiving portion when in a first position and designed to move relative to the sleeve to a second position to release the protrusion from the receiving portion. The protrusion may include a ball bearing designed to be held within the receiving portion when locked and designed to be released from the receiving portion when unlocked. The protrusion may include a lever designed to be held within the receiving portion in a snap-fit manner when locked and released from the receiving portion 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.

[0017] The second sleeve may be designed to receive the distal portion of the artificial valve and maintain at least the distal portion of the artificial 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 positioned within the anchor support and designed to longitudinally move 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 includes a protrusion extending from the outer surface of the tube, the protrusion being designed to engage the anchor support to cause the anchor support to move with the tube when the protrusion engages the anchor support. 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 being designed to cause longitudinal movement of the anchor support relative to the sleeve.

[0018] According to another aspect, a method for implanting an artificial heart valve using a catheter system is provided. The method may include guiding a deployment assembly loaded with an artificial heart valve in a collapsed state to an implantation site at a native heart valve site, the deployment assembly being positioned at a distal region of an elongated shaft and comprising a sleeve, an anchor support, and a lock, the anchor support being configured to be disposed within the sleeve to maintain at least a portion of the artificial heart valve in a collapsed state between the sleeve and the anchor support, the lock being configured to lock the sleeve to the anchor support; and rotating an actuator of a handle positioned at a proximal region of the elongated shaft to cause a first axis extending between the actuator and the deployment assembly to move distally, thereby releasing the lock to allow the anchor support to move relative to the sleeve to expand at least a portion of the artificial heart valve, thereby implanting the artificial heart valve.

[0019] In another example, a catheter system for implanting an artificial heart valve may include: a slender shaft, a deployment assembly, and a handle, the slender shaft including a proximal region and a distal region, the slender shaft including a cut sea wave tube, the cut sea wave tube including a proximal portion, a transition portion cut to have greater flexibility than the proximal portion, and a distal portion cut to have greater flexibility than the transition portion; the deployment assembly is located at the distal region of the slender shaft, the size and shape of the deployment assembly are determined to be advanced to the implantation site at the native heart valve site when the artificial heart valve is in a collapsed state; the handle is positioned at the proximal region of the slender shaft, the handle is designed to cause the deployment assembly to release the artificial heart valve when actuated to expand and implant the artificial heart valve.

[0020] The catheter system may further include a deflection cable. The elongated shaft may further include a deflection shaft, which is coupled to the deflection cable at the distal end. The cutting hypotube and the deflection cable may be positioned in the deflector shaft. The handle may further include a handle body and a deflection actuator, which is mechanically connected to the deflection cable and is designed to cause the deflection cable to retract proximally. The deflection actuator may be designed to cause the deflection shaft to deflect. The elongated shaft may include a torque shaft, which is positioned in the deflection shaft and is designed to translate the axial movement and rotational movement of the handle to the deployment assembly. The torque shaft may include a second hypotube, a polymer layer positioned in the second hypotube, a braided layer positioned in the polymer layer, and a lining layer comprising a fluoropolymer positioned in the braided layer. The second hypotube may be cut to increase flexibility in a proximal to distal direction, the polymer layer may include a nylon polymer, the braided layer may include a metal braid, and the lining layer may include polytetrafluoroethylene (PTFE).

[0021] The elongated shaft may further include a guidewire shaft, which is designed to receive a guidewire and can be positioned in a torque shaft, and the torque shaft and the guidewire shaft can be axially independent. The guidewire shaft may include a cutting hypotube, a second polymer layer positioned in the hypotube, a second braided layer positioned in the second polymer layer, and a second lining layer comprising a fluoropolymer positioned in the second braided layer. The hypotube may be longer than the second hypotube and have a greater number of incisions than the second hypotube. One or more of the hypotube or the second hypotube may be laser cut hypotubes or micromachined.

[0022] According to another aspect, a method for implanting an artificial heart valve is provided. The method may include: advancing a deployment assembly at a distal region of an elongated shaft to an implantation site at a native heart valve site when the artificial heart valve is in a collapsed state, the elongated shaft comprising a cut hypotube, the cut hypotube comprising a proximal portion, a transition portion cut to have greater flexibility than the proximal portion, and a distal portion cut to have greater flexibility than the transition portion; and actuating a handle disposed at the proximal region of the elongated shaft to cause the deployment assembly to release the artificial heart valve, thereby expanding and implanting the artificial heart valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 An exemplary catheter system according to aspects of the present disclosure is presented that includes a deployment assembly, an elongated shaft, and a handle.

[0024] Figures 2A to 2B A perspective view of an exemplary handle of a delivery system is shown.

[0025] Figure 3A 3F show perspective and cross-sectional views of an exemplary deployment assembly and a perspective view of an exemplary retraction cone assembly.

[0026] Figure 4 A cross-sectional view of the layers of an exemplary elongated shaft is shown.

[0027] Figure 5 A cross-sectional view of the layers of an exemplary torque shaft is shown.

[0028] Figure 6 A cross-sectional view of an exemplary torque shaft is shown.

[0029] Figure 7 A side view of an exemplary hypotube showing a torque shaft.

[0030] Figure 8 A cross-sectional view of the layers of an exemplary guidewire shaft is shown.

[0031] Figure 9 A cross-sectional view of the guidewire shaft is shown.

[0032] Figure 10 A cross-sectional view of an exemplary hypotube showing a guidewire shaft.

[0033] Figures 11A to 11C Side and cross-sectional views of an exemplary handle and positioning shaft are shown.

[0034] Figures 12A to 12C A perspective view of an exemplary unlock actuator assembly and detent shaft is shown.

[0035] Figures 13A to 13B A perspective view of an exemplary unlocking actuator assembly including locking threads and an exemplary positioning shaft is shown.

[0036] Figures 14A to 14C A perspective view of an exemplary internally threaded ring and an exemplary support cylinder is shown.

[0037] Figure 15 A perspective exploded view of an exemplary positioning actuator is shown.

[0038] Figures 16A to 16C A cross-sectional view of a positioning actuator and an exemplary deployment base is shown.

[0039] Figures 17A to 17B A perspective view and a cross-sectional view of a positioning actuator and a release actuator are shown.

[0040] Figures 18A to 18C A perspective view of an exemplary deployment thread and deployment base is shown.

[0041] Figure 19 Manipulation of the deflector actuator to deflect the elongated shaft is demonstrated.

[0042] Figure 20A Manipulation of an exemplary positioning actuator to cause rotational and axial movement of a deployment assembly is shown, and Figure 20B Manipulation of an exemplary positioning actuator and a release actuator to cause the distal sleeve and the anchor support to move axially is shown.

[0043] Figures 21A to 21B An exemplary introducer sheath is shown with an exemplary deployment assembly traversing the introducer sheath.

[0044] Figures 22A to 22E Manipulation of any of the example deployment assemblies to release an example prosthetic heart valve is demonstrated.

[0045] Figures 23A to 23B An exemplary deployment assembly is shown with a proximal sleeve and anchor support.

[0046] Figures 24A to 24EShows perspective and cross-sectional views of an exemplary proximal sleeve and an anchor support, the anchor support including an internal support and a lock.

[0047] Figures 25A to 25D Shows perspective and cross-sectional views of an exemplary distal sleeve and an anchor support, the anchor support including an internal support and a cantilever lock. Detailed Description

[0048] The present invention relates to a catheter system for introducing a heart implant, such as an artificial heart valve, into a patient. Specifically, the catheter system may include an elongate shaft having a distal end connected to a deployment assembly and a proximal end connected to a handle, the deployment assembly being designed to secure the heart implant, the handle being for manipulating the deployment assembly to sequentially deploy the artificial heart valve. The elongate shaft may have one or more hypotubes, which may be laser cut, micro-machined, and / or cut using any other well-known techniques. The artificial heart valve may be a self-expanding artificial heart valve. The handle may include a deflection actuator and a positioning actuator that can rotate independently. The deflection actuator, when rotated, may cause the elongate shaft to arch and / or bend. The positioning actuator may, when in the locked position, cause the deployment assembly to rotate and / or advance distally or retract proximally. When in the unlocked position, the positioning actuator, when rotated, may cause the deployment assembly to sequentially release the artificial heart valve to allow the artificial heart valve to transition to the expanded state.

[0049] The delivery catheter described herein is particularly suitable for sequentially deploying a self-expanding artificial heart valve having arms that can be clamped to an autologous valve, such as those described in U.S. Patent No. 11,154,398 to Straubinger, the entire content of which is incorporated herein by reference. The delivery catheter may be capable of positioning the artificial heart valve on or near the autologous valve, releasing the arms of the artificial heart valve to allow partial expansion of the artificial heart valve, aligning the arms with the autologous cusps of the autologous valve, and allowing the artificial heart valve to fully expand by disconnecting the valve from the delivery catheter, thereby clamping the artificial heart valve to the autologous valve leaflets. Once implanted, the artificial heart valve 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 catheter described herein may be made of plastic, metal, alloy, composite material, and / or any other material well known in the field of transcatheter cardiovascular devices.

[0050] Now referring to Figure 1 , shows an exemplary catheter system for sequentially deploying a heart implant, such as an artificial heart valve. As Figure 1As shown, the catheter system 100 may include an elongate shaft 102, a deployment assembly 104 at the distal end, and a handle 106 at the proximal end. The elongate shaft 102 may internally accommodate one or more tubes, cables, and / or wires. For example, the elongate shaft 102 may include concentric inner shafts that may be independently rotationally and axially movable. In one example, the innermost inner shaft may be a guide wire shaft designed to allow a guide wire to pass through. The guide wire shaft may be positioned within a larger torque shaft that may transfer torque across the elongate shaft 102. It should be understood that at least a portion of the deployment assembly 104 and the elongate shaft 102 may be positioned within a guide shaft for delivery to an implantation site.

[0051] The deployment assembly 104 may include a sleeve and a support, which are designed to at least partially accommodate an artificial heart valve, maintain the artificial heart valve in at least a partially compressed state, and allow the artificial heart valve to expand sequentially. For example, the deployment assembly 104 may include an anchor support and a proximal sleeve, the size of the anchor support being determined to receive the proximal end of the artificial heart valve, and the proximal sleeve being positioned on the anchor support to hold the proximal end of the artificial heart valve within the anchor support. The deployment assembly 104 may further include a distal sleeve, which is designed to hold the distal end of the artificial heart valve. The anchor support and the distal sleeve may be designed to move sequentially to expand the artificial heart valve sequentially. The distal sleeve may be connected to the guide wire shaft, and the distal sleeve may dock with the anchor support such that movement of the guide wire shaft may be translated to the distal sleeve and / or the anchor support.

[0052] The elongate shaft 102 may be coupled to the handle 106, and the internal components of the elongate shaft 102 may be mechanically connected to the handle 106. The handle 106 includes one or more actuators that, when actuated, cause a predetermined movement at the deployment assembly 104. These actuators are preferably designed to communicate with each other during the deployment sequence to cause various actions. For example, a first actuator may be designed to cause one movement at the deployment assembly when a second actuator is in a first position and a different movement at the deployment assembly when the second actuator is in a second position. These actuators may be knobs, buttons, switches, etc. suitable for use in a catheter system. The handle 106 may include a handle body 108, a deflection actuator 110, a positioning actuator 112, and a positioning shaft 114. The deflection actuator 110 may be connected to the handle body 108 via a threaded connection and may rotate 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 is coupled to the distal region of the elongate shaft 102. When the deflector actuator 110 rotates about the handle body 108, the cable may be retracted and may cause the elongate shaft 102 to arch or bend.

[0053] The positioning actuator 112 is engaged with the handle body 108 via a positioning shaft 114 that is freely movable into and out of the handle body 108 and rotatable relative to the handle body. The positioning actuator 112 is also designed to rotate relative to a deployment base received within the positioning actuator 112. In the locked position, the positioning actuator 112 can engage the positioning shaft 114, and rotation of the positioning actuator 112 can cause the deployment assembly 104 to rotate, and axial movement of the positioning actuator 112 can cause axial movement of the deployment assembly 104. In the unlocked position, the positioning actuator 112 can be disengaged from the positioning shaft 114 such that rotation of the positioning actuator 112 can cause the deployment base to advance, thereby causing the distal sleeve and / or the anchor support of the deployment assembly 104 to move distally, thereby sequentially expanding and releasing the prosthetic heart valve. The catheter system 100 can be combined with a guide sheath 107. For example, the guide sheath can have a greater diameter than the elongate shaft 102 and the deployment assembly 104 and can include a handle at the proximal end. The guide sheath 107 can also be combined with a dilator at the distal end of the guide sheath 107.

[0054] The elongate shaft 102 can include a proximal region and a distal region. The proximal region can be connected to the handle, and the distal region can be connected to the deployment assembly. The elongate shaft 102 can include one or more cut hypotubes having a proximal portion, a transition portion cut to have greater flexibility than the proximal portion, and a distal portion cut to have greater flexibility than the transition portion. For example, as Figure 7 shown, the elongate shaft 102 can include a hypotube 713 that can include a transition section 722 where the cut density can increase in the proximal-to-distal direction, a constant section 724 that can have a constant cut density that can be denser than the transition section 722, and a non-cut section 726 that can be the non-cut distal region of the hypotube 713. In another example, as Figure 10 shown, the elongate shaft 102 can include a guidewire hypotube 1002 that can include a transition section 1006 where the cut density can increase in the proximal-to-distal direction, a low-density section 1008 that can have a constant cut density that can be denser than the transition section 1006, a transition section 1008 where the cut density can increase in the 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 cut density that can be denser than the transition section 1008.

[0055] Now referring to Figures 2A to 2B , a perspective view of an exemplary handle 206 is shown. The handle 206 can be the same or similar to the Figure 1 handle 106. As Figures 2A to 2B shown, the handle 206 can be coupled to the elongate shaft 202. The elongate shaft 202 can be the same asFigure 1 The elongated shaft 102 is the same or similar. The handle body 208 can be Figure 1 the same or similar to the handle body 108.

[0056] The handle 206 can be disposed at the proximal region of the elongated shaft 206. The handle 206 can include a handle body 208 and a positioning actuator 212. The positioning actuator 212 can be designed to rotate relative to the handle body 208. The handle 206 can include a release actuator 206, which can be located on the positioning actuator 212 and / or can 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, the rotation of the positioning actuator 212 can be transferred to the deployment assembly to cause the deployment assembly to rotate. When the release actuator 224 is in the second position, the rotation of the positioning actuator 212 can cause the distal sleeve of the deployment assembly to move longitudinally relative to the handle 206 to expand and implant the artificial heart valve.

[0057] The handle body 208 can be tubular in shape and can be ergonomic in size and shape for easy manipulation by the user. For example, the handle body can have an hourglass shape or a streamline (diablo) shape. The handle body 208 can further include an indicator 222, which can include a window or a slot, and the indicator can traverse along the window or the slot. The indicator 222 can be in mechanical communication with the deflection actuator 210 and can indicate the degree of activation and / or deflection in the elongated shaft 202. The handle body 208 can further include a port 228, which can be in fluid communication with an internal channel in the handle body 208 and / or one or more channels of the elongated shaft 202, and can be used to flush the handle body 208 and / or one or more channels of the elongated shaft 202 (e.g., with a saline solution).

[0058] The handle body 208 can further include an unlocking actuator 211, which can be positioned in the proximal region of the handle body 208. The unlocking actuator 211 can be a button or other engagable (e.g., depressible) feature that allows the positioning actuator 212 and the positioning shaft 214 to rotate and move axially relative to the handle body 208. For example, as Figure 2BAs shown, when the unlocking actuator 211 is engaged (e.g., depressed) and thus unlocked, the positioning actuator 212 can be axially advanced in the distal direction while the handle body 108 remains in place. Advancing the positioning actuator 212 distally causes the elongate shaft 202 and all internal shafts, wires, cables, etc. to similarly advance distally, thereby causing the entire deployment assembly to advance distally. Similarly, when the unlocking actuator 211 is in the unlocked position (i.e., the depressed position), rotating the positioning actuator 212 causes the elongate shaft 202 to similarly rotate. When the unlocking actuator 211 is not engaged and is thus in the locked position and the positioning actuator 212 is in the locked position (e.g., the release actuator 224 is in the locked position) such that the positioning actuator 212 is fixed to the positioning shaft 214, the positioning actuator 212 and the positioning shaft 214 can be fixed axially and / or rotationally relative to the handle body 208.

[0059] The deflection actuator 210 can include internal threads that can engage and be received inside the handle body 208. The deflection actuator 210 can be tubular in shape, can be tapered at one end, and can have a series of ridges to facilitate user grasping. The deflation actuator 210 can have an internal passage sized to receive the positioning shaft 214, which can be fixed to the handle body 208 and the positioning actuator 212. When the deflection actuator 210 rotates, the deflection actuator 210 can cause the internal threaded structure of the handle body 208 to move proximally. This internal threaded structure can be mechanically connected to the deflection indicator 222 and can further be mechanically connected to a wire or cable connected to the distal end region of the elongate shaft 202 such that retraction of the wire or cable causes the elongate shaft 202 to deflect (e.g., bend or arch). The degree of deflection of the elongate shaft 202 can be displayed via the deflection indicator 222.

[0060] The positioning actuator 212 is similarly tubular in shape and can be tapered at one end. Also similar to the deflector actuator 210, the positioning actuator 212 can have a series of ridges to facilitate user grasping and can also have internal threading. The positioning actuator 212 can be selectively connected to the positioning shaft 214 and can include an internal passage sized to receive the deployment base. The deployment base can be rigidly connected to a guide wire shaft within the elongate shaft 202. When the release actuator 224 is in the unlocked position, the deployment base can selectively dock with the positioning actuator 212 via a threaded interface to cause the deployment base and thus the guide wire to advance distally, thereby causing the distal sleeve and the anchor support of the delivery assembly to advance distally. The positioning actuator 212 can further include a release actuator 224 that can reversibly fix the positioning actuator 212 to the positioning shaft 214. The release actuator 224 can slidably engage the positioning shaft 214 and can transition from the locked position to the unlocked position.

[0061] Now refer to Figures 3A to 3D , which shows a perspective view and a cross-sectional view of an exemplary deployment assembly 304. The deployment assembly 304 can be the same as or similar to the Figure 1 deployment assembly 104. As shown in Figure 3A and Figure 3B , the deployment assembly 304 can be connected to an elongate shaft 302, which can be the same as the Figure 1 elongate shaft 102. For example, a proximal cone 324 can be connected to the elongate shaft 302. The proximal cone 324 can be a conical structure and can taper towards the proximal end. The proximal cone 324 can be coupled to a proximal sleeve 320. For example, the proximal cone 324 can be rigidly coupled to the elongate shaft 302, and the proximal sleeve 320 can be rigidly connected to the proximal cone 324.

[0062] At least a portion of the elongate shaft 302 (such as a torque tube) can be rigidly coupled to and terminate at the retractable cone assembly 314. The retractable cone assembly 314 can be designed to support a heart implant, such as an artificial heart valve. For example, the retractable cone assembly 314 can include a cylindrical seat portion 311 and a conical portion 310. The conical portion 310 can have a double conical portion, the diameter of which at the meeting point of the two conical portions is larger than the diameter of the cylindrical seat portion 311. The conical portion 310 can be compressible, allowing the conical portion 310 to be compressed to a smaller diameter than in the uncompressed state.

[0063] The size and shape of the deployment assembly 304 can be determined to advance to an implantation site at the native heart valve site when the artificial heart valve is in a collapsed state. The deployment assembly 304 can include a proximal sleeve 320, an anchor support 322, and a lock (such as a ball or a lever), the anchor support 322 can be positioned within the proximal sleeve 320 during delivery to maintain at least a portion of the artificial heart valve in a collapsed state between the proximal sleeve 320 and the anchor support 322, and the lock is designed to lock the proximal sleeve 320 to the anchor support 322 during delivery. A handle (such as positioned in the proximal region of the elongate shaft 302) can be designed to cause the lock (such as a ball or a lever) of the deployment assembly 304 to unlock when actuated, such that the anchor support 322 can move longitudinally relative to the proximal sleeve 320 to expand and implant the artificial heart valve.

[0064] Figures 3C to 3D The retractable cone assembly is shown in Figure 3CAs shown, the retractable cone member 310 assembly can include a tubular portion 332 and a conical portion 334. The conical portion 334 can have a central passage to receive the tubular portion 332 and can be constrained in position by the tubular portion 332. It should be understood that the conical portion 334 and / or the tubular portion 332 can be compressible and / or elastic (e.g., foam). Now referring to Figure 3D , an alternative retractable cone member assembly (retractable cone member assembly 335) can be similar to the retractable cone member assembly 330, but can include a tubular portion 332 and a compressible mesh 339. The tubular portion can have a tubular shape, and the compressible mesh can be a metal mesh (e.g., laser-cut nitinol spheroids). The tubular portion 332 can be compressible and / or elastic.

[0065] Referring again to Figures 3A to 3B , the guidewire shaft 313 can be positioned within the elongate shaft 302 and can extend distally to the distal sleeve 312 and terminate at the distal sleeve 312. The distal sleeve 312 can include or be connected to an end cone 306, which can taper in the proximal direction. The distal sleeve 312 can have a diameter that is larger than the cylindrical seat portion 311 but smaller than the conical portion 310. Accordingly, the open end of the distal sleeve 312 can be manipulated to abut the conical portion 334. The distal sleeve 312 can also be forced across the conical portion 310, causing the conical portion 310 to compress, as Figures 3A to 3B shown. It may be preferred that the distal sleeve 312 cross the conical section 310 such that the open end of the distal sleeve 312 can hold the distal end of the prosthetic heart valve positioned on the cylindrical seat portion 311. The distal sleeve 312 can further include an imaging marker 315, which can be visualized using well-known medical imaging. For example, the imaging marker 315 can be a ring position on the proximal region of the distal sleeve 312. Such positioning may be desirable because it may help the individual deploying the prosthetic heart valve know when the prosthetic heart valve has exited the guide sheath. In one example, the imaging marker 315 can be radiopaque or other well-known image markers.

[0066] The distal sleeve 312 and / or the end cone 306 may include internal protrusions or latches (e.g., latch 323 of FIG. 3F) that may engage or dock with the anchor connector 321 when the distal sleeve 312 is moved distally. The anchor connector 321 may be a cable, wire, tube, etc., and may similarly include protrusions or latches (e.g., latch 325 of FIG. 3G) that engage or dock with the protrusions or latches near or on the distal sleeve 312 and / or the end cone 306. It should be understood that the protrusions or latches of the distal sleeve 312 may be positioned such that the distal sleeve 312 may move distally a certain length before the protrusions or latches of the distal sleeve 312 engage or dock with the protrusions or latches of the anchor connector 321.

[0067] At the proximal end, the anchor connector 321 may be connected to an anchor support 322 sized to fit within the proximal sleeve 320. Alternatively, the anchor support may be connected to an internal support that fits within and docks with the anchor support 322. The anchor support 322 may be designed to receive one or more anchors or structural elements of the artificial heart valve and maintain the anchors or structural elements of the artificial heart valve between the anchor support 322 and the distal sleeve 320. When the anchor connector 321 is moved distally by the distal sleeve 312 and / or the end cone 306, the anchor support 322 may move distally the same amount. Since the proximal sleeve 320 is rigidly connected to the proximal cone 324 and the elongate shaft 302, the proximal sleeve 320 remains in place when the anchor support 322 is advanced distally. Thus, any anchors or structural elements positioned between the anchor support 322 and the proximal sleeve 320 may be exposed and released when the anchor support 322 is advanced distally from the proximal sleeve 320.

[0068] In Figure 3A and Figure 3B the arrangement shown, the deployment assembly 304 may be positioned to hold a cardiac implant, such as a self-expanding artificial heart valve, in a collapsed or partially collapsed state. For example, the distal end of the artificial heart valve may be positioned within the open distal end of the distal sleeve 312 such that the distal end of the artificial heart valve may be held and compressed by the distal sleeve 312. Similarly, the proximal end of the artificial heart valve may have one or more anchors or structural elements positioned between the anchor support 322 and the proximal sleeve 320 such that the proximal end of the artificial heart valve may be held and compressed by the proximal sleeve 320 and the anchor support 322.

[0069] Now referring Figure 3E to FIGS. 3F, the deployment assembly 304 is shown and is positioned for releasing the artificial heart valve. As Figure 3EAs shown in FIGS. 3A-3F, the distal sleeve 312 and the end cone 306 can be advanced distally past the conical section 310 of the retracted cone assembly 314, thereby releasing the distal end of the artificial heart valve and allowing at least the distal portion of the artificial heart valve to expand to an expanded state. Subsequently, when the anchor connector 321 is advanced distally by the distal sleeve 312 and / or the end cone 306, the anchor support 322 can be advanced distally by the anchor connector 321. When the anchor support 322 is advanced distally, the anchor recess 327 of the anchor support 322 can be exposed from the distal sleeve 320.

[0070] The anchor recess 327 can be a recess or structure (e.g., a protrusion) on the anchor support that is designed to receive an anchor or other structural feature of the proximal end of the artificial heart valve. When the anchor recess 327 is exposed from the proximal sleeve 320, it allows the proximal end of the artificial heart valve to expand to an expanded state. It should be understood that the exposure of the anchor recess 327 from the distal sleeve 320 can fully release the artificial heart valve from the deployment assembly 304.

[0071] Now referring to Figure 4 , a cross-sectional view of an exemplary elongate shaft is shown. The elongate shaft 402 can be the same as or similar to the elongate shaft 102 of Figure 1 . The elongate shaft 402 can include three different shafts, including a deflection shaft 417, a torque shaft 415, and a guidewire shaft 413. It should be understood that additional layers can be included in the elongate shaft 102. The deflection shaft 417, the torque shaft 415, and / or the guidewire shaft 413 can move axially and / or rotationally independently. In one example. The deflection shaft 417 and the torque shaft 415 can alternatively be fixed to each other. The deflection shaft 417 can serve as the spine of the elongate shaft 402 and can be attached to a deflection wire (not shown) in the distal region, which can extend from the handle to the distal region of the deflection shaft 417. When the handle causes the deflection wire to move axially and proximally towards the handle, the deflection shaft 417 can be caused to arch or bend.

[0072] The torque shaft 415 can be positioned within the deflection shaft 417 and can extend between the positioning shaft of the handle and the retracted cone assembly of the deployment assembly. In this way, the torque shaft 415 can be designed to transfer torque from the positioning shaft to the deployment assembly. The guidewire shaft 413 can be positioned within the torque shaft 415 and can extend between the deployment base positioned within the positioning actuator of the handle and the distal sleeve and / or end cone of the deployment assembly.

[0073] Now referring to Figure 5, the torque shaft 515 can be made of several layers. For example, the torque shaft 515 can have a hypotube layer 520, which can be a hypotube strategically cut to increase flexibility in the proximal to distal direction. For example, the hypotube can be a laser-cut hypotube with multiple cut through holes or slits produced using a laser. The polymer layer 522 can be positioned within the hypotube layer 520. The polymer layer 522 can include a polymer sheath that can be positioned within the hypotube. The polymer sheath can include a rigid polymer (e.g., a nylon polymer). The braided layer 524 can be positioned within the polymer layer 522. The braided layer 524 can be a metal braid. It should be understood that the polymer sheath can flow into the braided layer 524. In one example, the braided layer 524 can include a metal braid that can include stainless steel and Kevlar fibers. The braid can be any other braid, including metal, permeable and / or composite materials. The lining layer 526 can be the innermost layer positioned within the braided layer 524. The lining layer 526 may be a lining including a fluoropolymer such as polytetrafluoroethylene (PTFE) or other similar material. It should be understood that the polymer layer 522, the braided layer 524, and the lining layer 526 may form a composite shaft. It should be further understood that the torque shaft 515 may have a greater Figure 5 More or fewer layers than those shown.

[0074] Reference now Figure 6 , showing a side view and a cross-sectional view of the torque shaft 615. Figure 6 As shown, the torque shaft 615 can be connected to the retraction cone assembly 614 at the distal end of the torque shaft 615. The retraction cone assembly 614 can be connected to the Figure 3A The retracting cone assembly 314 or Figure 3C The torque shaft 615 may include a composite shaft 611 (e.g., Figure 5 The invention also provides a plurality of embodiments of the present invention, wherein the composite shaft 611 of the torque shaft 615 can be a plurality of polymer layers 522, a braided layer 524, and a lining layer 526) and a hypotube 613 cut to facilitate increased flexibility from the proximal to distal direction. Near the distal region of the torque shaft 615, the hypotube 613 can terminate and only the composite shaft 611 of the torque shaft 615 can continue to the retraction cone assembly 614. This can facilitate the torque shaft 615 to reduce in diameter near the distal end of the torque shaft 615. As shown in view 620, the composite shaft 611 can extend within the retraction cone assembly 614, and the retraction cone assembly can include a composite shaft receiving channel 617 to secure the composite shaft 611.

[0075] See now Figure 7 , showing a torque hypotube 713. The torque hypotube 713 may be Figure 5The outermost layer of the torque shaft 515. The torque bellows tube 713 can be, for example, metallic, composite, and / or plastic and can be of a tubular shape. In one example, the torque bellows tube 713 can be stainless steel and can have a cut design made by laser cutting. As Figure 7 shown, the cuts made in the torque bellows tube 713 can be perpendicular to the longitudinal axis of the torque tube and their density (e.g., the number of cuts per given area) can increase in the proximal to distal direction. The proximal region 720 of the bellows tube 713 can not have any cuts.

[0076] The bellows tube 713 can have sections with a consistent repeating cut pattern. For example, the bellows tube 713 can include a transition section 722 where the cut density can increase in the proximal to distal direction, a constant section 724 that can have a constant cut density that can be denser than the transition section 722, and a non-cut section 726 that can be the distal region of the bellows tube 713 without cuts. In the transition section 722, the cuts can gradually transition as the distance between each cut gradually decreases in the proximal to distal direction. Additionally, the cuts can be designed to be helical around the bellows tube 713.

[0077] By Figure 7 the cut arrangement shown, the flexibility of the torque tube 713 can increase in the proximal to distal direction as the cut density increases from the proximal end to the distal end. Although it should be understood that the size and design of the cuts can vary, in one non-limiting example, the width of each cut can be 0.20 inches, the pitch can vary between 0.008 and 0.04, the cut length can vary between 0.6 and 0.7, and the cut angle can vary between 62 and 74 degrees. It should be further understood that the arrangement and length of the various cut sections of the torque bellows tube 713 can be the same.

[0078] Now refer to Figure 8, the guidewire shaft 815 can be made of several layers. For example, the guidewire shaft 815 can have a hypotube layer 820, which can be a hypotube strategically cut to become more flexible in the proximal to distal direction. For example, the hypotube can be a laser cut hypotube. A polymer layer 822 can be positioned in the hypotube layer 820. The polymer layer 822 can include a polymer sheath that can be positioned in the hypotube. The polymer sheath can include a rigid polymer (e.g., a nylon polymer). A braided layer 824 can be positioned in the polymer layer 822. The braided layer 824 can be a metal braid. It should be understood that the polymer sheath can flow into the braided layer 824. In one example, the braided layer 824 can include a metal braid that can include stainless steel and Kevlar fibers. The braid can be any other braid, including metal, permissible and / or composite materials. A lining layer 826 can be the innermost layer positioned in the braided layer 824. The lining layer can be a liner including polytetrafluoroethylene (PTFE) or other similar materials. It should be appreciated that polymer layer 822, braided layer 824, and lining layer 826 may form a composite shaft.

[0079] Reference now Figure 9 , showing a side view and a cross-sectional view of the guidewire shaft 917. Figure 9 As shown, the guidewire shaft 917 can be connected to the distal sleeve 902 and the end cone 904, which can be respectively connected to the distal sleeve 902 and the end cone 904. Figure 3A The distal sleeve 312 and the end cone 306 are the same or similar. As shown in view 920, the guidewire shaft 917 may include a composite shaft 926 (e.g., Figure 8 The invention also provides a plurality of composite shafts 926 and ...

[0080] The lock assembly 908 may further include a slider 907, which may be tubular in shape and slide on the lock body 905. The slider 908 may be connected to an anchor connector 910, which may be a wire or elongated structure extending from the lock assembly 908 to the anchor support (not shown). The lock 906 may have an outer diameter greater than the inner diameter of the slider 907, and the lock 906 may engage the slider 907 when the guidewire shaft 917 is advanced distally, thereby causing the slider 907 to similarly move distally, thereby pulling the anchor connector 910 and therefore the anchor support distally. As shown in view 920, the hypotube 930 may extend distally beyond the lock assembly 908. The extension 922 of the hypotube 930 may be curled and / or welded. For example, the buckle assembly 908 can be metal, and the hypotube 930 can be welded to the buckle assembly 908 so that the guidewire shaft 917 is rigidly connected to the buckle assembly 908. The composite shaft 926 can also extend beyond the buckle assembly 908. For example, the composite shaft 926 and the hypotube 930 can terminate at the end cone 904. In one example, the buckle assembly 908 can be stainless steel, but it should be understood that the buckle assembly 908 can be any other material.

[0081] Reference now Figure 10 , showing a guide wire hypotube 1002. The guide wire hypotube 1002 may be Figure 8 The outermost layer of the guidewire shaft 815. The guidewire hypotube 1002 can be, for example, metal, composite and / or plastic, and can be tubular in shape. In one example, the guidewire hypotube 1002 can be stainless steel and can have a cutting design that is cut by laser cutting. Figure 10 As shown, the cuts made in the torque hypotube 1002 can be perpendicular to the longitudinal axis of the torque tube and their density (e.g., the number of cuts per given area) increases in the proximal to distal direction. The proximal region 1004 of the hypotube 1002 can be free of any cuts. Further, the distal region 1012 can be free of any cuts. For example, the distal region 1012 of the hypotube 1002 can be crimped or welded. It should be understood that the hypotube 1002 can have more than 100 cuts. Figure 7 The hypotube 713 may have a greater number of cutouts and / or may exhibit greater flexibility. It should be further understood that the hypotube 1002 may be larger than Figure 7 The hypotube 713 is longer.

[0082] The guidewire hypotube 1002 may have a section with a consistent repeating cut pattern. For example, the guidewire hypotube 1002 may include a transition section 1006 where the cut density may increase in the proximal to distal direction, a low-density section 1008 that may have a constant cut density that may be denser than the transition section 1006, a transition section 1008 where the cut density may increase in the proximal to distal direction and may be denser than the low-density section 1008, and a high-density section 1011 that may have a constant cut density that may be denser than the transition section 1008. Between each constant section, the distance between the cuts may gradually transition, where the distance between the cuts decreases gradually in the proximal to distal direction. Additionally, the cuts may be designed to be helical around the guidewire hypotube 1002.

[0083] Through Figure 10 the cut arrangement shown, the flexibility of the guidewire tube 1002 may increase in the proximal to distal direction as the cut density increases from the proximal end to the distal end. Although it should be understood that the size and design of the cuts may vary, 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 cut length may vary between 0.0270 and 0.0370 inches, and the cut angle may vary between 45 and 62 degrees. It should be further understood that the arrangement and length of the respective cut sections of the hypotube 1002 may be the same.

[0084] Now referring to Figure 11A and Figure 11B , a side view and a cross-sectional view of the handle 1106 are shown. The handle 1106 may be the same or similar to the handle 106 of Figure 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, the deflection actuator 1110, the positioning shaft 1114, and the positioning actuator 1112 may be the same or similar to the handle body 108, the deflection actuator 110, the positioning shaft 114, and the positioning actuator 112 of Figure 1 . The handle 1106 may receive the elongate shaft 1102, which may be the same or similar to the elongate shaft 102 of Figure 1 . The handle 1106 may further include a port 1115 that 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 a saline solution).

[0085] Now referring to Figure 11B, showing a cross-sectional view of the handle 1106. The handle body 1108 can be a tubular shell and can be divided into two halves. The handle body 1108 can have an open end in the proximal region of the handle body 1108. The cylindrical support 1114 can be positioned within the open end on the proximal end of the handle body. The cylindrical support 1114 can be of a cylindrical shape and the diameter can be smaller than the open end of the handle body 1108. The cylindrical support 1114 can be fixed to the handle body such that the cylindrical support hangs in the middle of the open proximal end of the handle body 1108, so that there is a gap between the outer diameter of the cylindrical support 1114 and the handle body 1108. The cylindrical support 1114 can extend proximally beyond the handle body 1108.

[0086] The size of the open proximal end of the handle 1108 can be determined to receive the deflection actuator 1110. The deflection actuator 1110 can be of a cylindrical shape and can include threads 1113 on the inside of the deflection actuator 1110. The threads 1113 can extend the entire or most of the length of the deflection actuator 1110 and can 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 fixed to the distal end of the cylindrical support 1114 in a manner that restricts the axial movement of the deflection actuator 1110 but allows its rotational movement. The threaded slider 1115 can be supported by the cylindrical support 1114 and can slide thereon. The threaded slider 1115 can be cylindrical and can have a threaded structure on its outer surface, which is designed to engage with the threaded structure of the threads 1113 of the deflection actuator 1110. When the deflection actuator 1110 rotates, the deployment threads 1113 rotate similarly, causing the threaded slider to move distally or proximally along the cylindrical support 1114, depending on the direction of rotation.

[0087] The threaded slider 1115 can be connected to the deflection wire 1122, which can be any wire, cable, etc. and can be connected to the distal region of the deflection shaft 1130. The deflection wire 1122 can be guided to the upper portion of the handle body 1108 and engaged with the indicator 1126. The indicator 1126 can be a protrusion of any other visual indicator that can slide along the indicator window 1124 when the threaded slider 1115 moves distally or proximally. For example, when the deflection actuator 1110 rotates, it can cause the threaded slider 1115 to move proximally, thereby pulling the deflection wire 1122 proximally, which in turn causes the indicator 1126 to move proximally and slide along the indicator window 1124. The indicator window 1124 can indicate to the user the degree or amount of deflection applied to the deflection shaft 1130. The deflection shaft 1130 can terminate in the distal region of the handle body 1108, and the deflection wire 1122 can be introduced into the deflection shaft 1130 within the handle body 1108. In one example, the deflection wire 1122 can be positioned between the deflection shaft 1130 and the torque shaft 1134. As Figure 11B shown, the support cylinder 1114 can be tubular and hollow, and the torque shaft 1134 and the guide wire shaft 1136 can traverse the interior of the support cylinder 1114 and extend proximally beyond the cylinder support 1114, the handle body 1108, and the deflection actuator 1110.

[0088] Now referring to Figure 11C , a cross-sectional view of the handle 1106 engaged with the positioning shaft 1145 is shown. The positioning shaft 1145 can be the same or similar to the positioning shaft 114 of Figure 1 . The positioning shaft 1145 can include a threaded shaft 1144, a main shaft 1145, and a positioning support 1148. The threaded shaft 1144 can be generally tubular in shape, having an internal channel and an outer surface with a threaded structure or ridge extending along most of the outer surface of the shaft. The main shaft 1145 can be tubular in shape and have an internal channel connected to the internal channel of the threaded shaft 1144. The positioning support 1148 can have the same or similar diameter as the main shaft 1146 and can have an internal shaft with dimensions similar to the internal channel of the main shaft 1145. The threaded shaft 1144, the main shaft 1145, and the positioning support 1148 can be an integral piece formed of the same material (such as plastic), or can be separate pieces connected together.

[0089] View 1160 shows the components within the handle body 1108, specifically depicting the unlocking actuator 1140. The unlocking actuator 1140 can be associated with Figures 2A to 2Bis the same as or similar to the unlocking actuator 211 in. The unlocking actuator 1140 can engage with the threaded shaft 1144 in the unpressed position to axially and rotationally lock the threaded shaft 1144, and can be depressible to allow axial and rotational movement of the threaded shaft 1144. The threaded shaft 1144 can be rigidly connected to the torque shaft 1134 such that rotational and axial movement of the threaded shaft 1144 can be transferred to the torque shaft 1134. The torque shaft 1134 can terminate at or within the threaded shaft 1144. It should be understood that although the torque shaft 1134 can terminate at or within the threaded shaft 1144, the guide wire shaft 1136 can extend beyond the threaded shaft 1144, the main shaft 1146, and into the positioning support 1148.

[0090] As Figure 11C shown, the threaded shaft 1144 can cross 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 positioned within and engaged with a support cylinder (not shown). The threaded shaft 1144 can have right angles that are designed to align with and engage the right angles of the rotation limiter 1142 such that when the threaded shaft 1144 rotates, the rotation limiter 1142 also rotates. The unlocking actuator 1140 can rest on a spring assembly 1150 that can be supported and / or coupled to the handle body 1108. The spring assembly 1150 can include a spring and a rod positioned on top of the spring. It should be understood that when the unlocking actuator 1140 is depressed, the spring assembly 1150 is compressed, and the threaded shaft and / or the main shaft 1145 can be allowed to cross the unlocking actuator 1140 and further into the handle body 108, and can be allowed to rotate relative to the unlocking actuator 1140 and the handle body 1108.

[0091] Now referring to Figures 12A to 12C , a three-dimensional cross-sectional view of the unlocking actuator 1240 is shown. The unlocking actuator 1240 can be the same as or similar to Figures 2A to 2B the unlocking actuator 211 of. As Figures 12A to 12C shown, the unlocking actuator 1240 can include an unlocking body 1242 that can include an unlocking button 1241 and a wheel housing 1243. The unlocking button 1241 can be a depressible protrusion that can be rigidly connected to the wheel housing 1243. The wheel housing 1243 can be generally rectangular and can have a central channel for receiving a threaded shaft 1246 that can be associated with Figure 11Cis the same as the threaded shaft 1144. The wheel housing 1243 can further include a recessed circular channel sized to receive the ridged wheel 1244 such that the ridged wheel 1244 can rotate within the wheel housing 1243. The ridged wheel 1244 can be annular and can have ridges 1248 extending from its outer surface. These ridges can be linear in shape and extend the length of the ridged wheel 1244. The ridged wheel 1244 can further include inwardly extending angular protrusions 1249. The angular protrusions 1249 can extend the width of the ridged wheel 1244 and can extend into the threaded recess 1255. Thus, rotation of the threaded shaft 1246 will cause rotation of the ridged wheel 1244.

[0092] The unlocking actuator 1240 can further include a spring assembly 1250 at the bottom of the wheel housing 1243, and a rod 1224. The rod 1224 can be connected to the bottom portion of the wheel housing 123 and can be oriented such that the ridges 1248 can receive the rod 1224. The spring 1250 can include a spring that can be a helical spring. The spring 1250 can abut against the wheel housing 1243 at the bottom end of the wheel housing 1243 such that downward movement of the wheel housing 1243 compresses the spring 1250. The recessed portion of the wheel housing is sized such that the wheel housing 1243 can move up and down while the ridged wheel 1244 remains at the same height.

[0093] The unlocking actuator 1240 can prevent rotation of the threaded shaft 1247 when in the locked position, as Figure 12B shown. Specifically, in the locked position (which can be the default position), the spring 1250 can assume an uncompressed state, thereby pushing the rod 1224 into the ridges of the ridged wheel 1244. In the case where the rod 1224 resides in the ridges of the ridged wheel 1244, rotation of the ridged wheel 1244 will be prevented and thus rotation of the threaded shaft 1247 will be prevented. As Figure 12C shown, moving the unlocking actuator 1240 downward will cause the spring 1250 of the spring assembly 1250 to compress, thereby removing the rod 1224 from any of the ridges of the ridged wheel 1244. For example, a user can press down on the unlock button 1241 to compress the spring 1250. In Figure 12C the shown unlocked position (which can be caused by pressing down on the unlocking actuator), rotation of the ridged wheel 1244 can be allowed, thereby allowing rotation of the threaded shaft 1247. Once the unlocking actuator is released, the spring 1250 will expand towards the neutral position and again assume the Figure 12B shown locked position.

[0094] Now referring to Figures 13A to 13B , the unlocking actuator 1340 is shown engaging the threaded shaft 1347. The unlocking actuator 1340 can be associated with Figures 12A to 12Cis the same as or similar to the unlocking actuator 1240, and the threaded shaft 1347 can be the same as or similar to Figures 12A to 12C the threaded shaft 1247 of Figures 13A to 13B As shown, the unlocking actuator 1340 can further include threads 1360 that can be positioned in or near a central channel 1362 of the wheel housing 1342, and the central channel can be the same recessed channel in which a ridged wheel (not shown) rests. The size of the threads 1360 can be determined such that when the spring 1352 is in the deployed locked position (e.g., Figure 12B the locked position shown), the threads 1360 can mate with one or more threads of the threaded shaft 1347. In the locked position, the threads 1360 of the unlocking actuator 1340 will prevent the threaded shaft 1347 from moving axially, either distally or proximally. As Figure 13B shown, the unlocking actuator 1340 can be transitioned to the unlocked position (e.g., Figure 12C the unlocked position shown) by compressing the spring 1352, thereby moving the wheel housing 1343 and thus the threads 1360 downward. In Figure 13B the unlocked position shown, the threaded shaft 1347 can move axially proximally and distally without mating with the threads 1360.

[0095] Now referring to Figures 14A to 14C , the support cylinder 1414 can be fixed to the handle body 1408. The support cylinder 1414 can be the same as or similar to Figure 11B the support cylinder 1114 of

[0096] The inner surface of the internal thread ring 1460 can include angular protrusions 1466 that can project inwardly from the internal thread ring 1460. For example, the angular protrusions 1466 can include right angles and can be sized to fit into the thread recesses 1446 of the threaded shaft 1444. The threaded shaft 1446 can be the same as or similar to Figure 12A the threaded shaft 1246 of Figure 12Ais the same as or similar to the threaded recess 1250. The threaded shaft 1444 may include guides 1468 at the proximal end, which may extend outwardly from the threaded shaft 1444 and may maintain the threaded recess 1446 beyond the threads shown more distally, as Figure 14A shown. The threaded shaft 1444 may extend through the internal threaded ring 1460 such that the threaded shaft 1444 may receive the angular projection 1466 in the threaded recess 1446. When the threaded shaft 1444 rotates, the angular projection 1446 causes the internal threaded ring 1460 to rotate similarly.

[0097] Now referring to Figure 14B , the internal threaded ring 1460 is shown. As Figure 14B shown, the internal threaded ring 1460 may include a threaded outer surface 1462 and an inner surface having an angular projection 1466. The threaded outer surface 1462 may further include a stop projection 1470, which may be positioned at the start of the threaded outer surface 1462 such that the stop projection. Figures 14A to 14B The stop projection 1470 shown may be designed to engage a stop projection 1472 on the handle body 1408 ( Figure 14A shown), such that the internal threaded ring 1460 may rotate only a set number of degrees clockwise and counterclockwise before being stopped by the handle body 1408 and prevented from further rotation. For example, the handle body 1408 may prevent the internal threaded ring 1460 and thus the threaded shaft 1444 from rotating more than 360 degrees. It should be understood that any other amount of rotation (e.g., 90, 180, 270, 720, etc.) may be achieved by varying the number and pitch of the threads and / or the position of the stop projection 1470. It should further be understood that more than one stop projection may be included on the threaded ring 1460.

[0098] Now referring to Figure 14C , the support cylinder 1414 is shown. As Figure 14C shown, the support cylinder 1414 may be tubular in shape, having an inner surface and an outer surface. The outer surface may be generally smooth. The inner surface may include threads 1450, which may guide the internal threaded ring along the interior of the support cylinder 1414. In one example, the threads 1450 and / or the inner surface of the support cylinder 1414 may include one or more stop projections for preventing the internal threaded ring from rotating at a certain point along the support cylinder 1414. Alternatively, the stop projection may be positioned on the handle body.

[0099] Now referring to Figure 15 , a perspective exploded view of the positioning actuator 1555 is shown. The positioning actuator 1555 may be associated with Figure 11AThe positioning actuator 1112 is the same or similar. The positioning actuator 1555 may include positioning actuator housings 1554 and 1556, which may form two halves of the positioning actuator 1555 and together may be tubular in shape. The positioning actuator 1555 may further include an actuator base 1558, which may be rigidly fixed between the positioning actuator housings 1554 and 1556. The actuator base 1558 may be threaded on its inner surface. The positioning actuator housings 1554 and 1556 may be fixed 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 respectively the same as or similar to Figure 11C the positioning support 1148 and the positioning shaft 1146. The positioning actuator housing 1554 may include a release actuator 1552, which may releasably fix the positioning actuator 1555 to the positioning support 1548. As Figure 15 shown, the release actuator 1552 may be a button or similar protrusion, which may slide along the positioning actuator housing 1554 and may selectively engage a receiving area 1550 of the positioning support 1548. The receiving area 1550 may be a rectangular void, slit, latch, etc. on the positioning support 1548 for docking with the release actuator 1552. The release actuator 1552 may also or alternatively be positioned on the positioning actuator housing 1556.

[0100] The deployment base 1570 may be positioned 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, in which the inner shaft 1560 may be positioned. The threaded shaft 1568 may include a number of threads 1566 disposed on the outer surface of the threaded shaft 1568, which mate with the 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 as the actuator base 1558 rotates, the rotation of the actuator base 1558 axially advances or retracts the threaded shaft 1568. The inner shaft 1560 may be rigidly connected to a guide wire shaft 1536, which may be the same as or similar to Figure 9 the guide wire shaft 917. Accordingly, axial movement of the inner shaft 1560 may cause axial movement of the guide wire shaft 1536.

[0101] The inner shaft 1560 can be tubular in shape and can include a rotation fixing projection 1562 that can be connected to or otherwise docked with the threaded shaft 1568 such that rotational movement and / or axial movement of the threaded shaft 1568 is transferred to the inner shaft 1560. The rotation fixing projection 1562 can be a rectangular projection or any latch or docking structure. The inner shaft 1560 can further include a proximal projection 1564 that can be cylindrical in shape and can have a diameter greater than that of the body of the inner shaft 1560. The proximal projection 1564 can dock with the proximal region 1570 of the threaded shaft 1568 to fix the inner shaft 1560 to the threaded shaft 1568, thereby preventing the inner shaft 1560 from axially advancing beyond a certain point. The spring 1575 can be positioned around the guide wire shaft 1536 and can dock with the distal end of the positioning shaft and the distal end of the inner shaft 1560. As 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 is advanced toward the distal end of the positioning shaft, the spring force from the spring 1575 can increase, thereby causing an increasing force in the proximal direction against the inner shaft 1560. The spring 1575 can cause the inner shaft 1562 to return to its most proximal position with no axial force applied to the inner shaft 1560 in the distal direction.

[0102] Now referring to Figures 16A to 16B , a cross-sectional view is shown 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 guide wire shaft 1636, and a spring 1675. It should be understood that the inner shaft 1660, the threaded shaft 1668, the actuator base 1658, the positioning actuator housings 1654 and 1656, the positioning support 1648, the positioning shaft 1646, the guide wire shaft 1636, and the spring 1675 can be the same as or similar to Figure 15 the inner shaft 1560, the threaded shaft 1568, the actuator base 1558, the positioning actuator housings 1554 and 1556, the positioning support 1550, the positioning shaft 1548, the guide wire shaft 1536, and the spring 1575 of

[0103] The positioning actuator 1655 may include positioning actuator housings 1654 and 1656, and may further include a release actuator 1652 that may releasably fix the positioning actuator 1655 to a positioning support 1648 that may be connected to or extend from a positioning shaft 1646. The positioning actuator housings 1654 and 1656 may be fixed to a positioning base 1658 such that the positioning support 1648 is positioned between the positioning actuator housings 1654 and 1656 and the positioning base 1658. The positioning base 1658 may include internal threads 1659. Although the internal threads 1659 are shown near the distal region of the positioning base 1658, it should be understood that the internal threads 1659 may be positioned near any other part of the positioning base 1658.

[0104] The internal threads 1659 of the positioning base 1658 may mate with the threads 1669 of a threaded shaft 1668 such that when the positioning base 1659 rotates, it causes the threaded shaft 1668 to axially move distally or proximally. An inner shaft 1660 may be fixed to the threaded shaft 1668 such that the axial movement of the threaded shaft 1668 is transferred to the inner shaft 1660. The inner shaft 1660 may be fixed to a guide wire shaft 1636 (e.g., fixed to the distal region of the inner shaft 1660). A spring 1675 may be positioned around the guide wire shaft 1636 and may resist the axial movement of the inner shaft 1660 in the distal direction.

[0105] As Figure 16B shown, the inner shaft 1660 may include a rotation fixing protrusion 1662 that may be connected to or otherwise mate with the threaded shaft such that the rotational movement and / or axial movement of the threaded shaft is transferred to the inner shaft 1660. The rotation fixing protrusion 1662 may be a rectangular protrusion or any latch or docking structure. The inner shaft 1660 may further include a proximal protrusion 1664 that may be cylindrical in shape and may have a larger diameter than the body of the inner shaft 1660. The proximal protrusion 1664 may mate with a snap-fit member 1670 in the proximal region of the threaded shaft to fix the inner shaft 1660 to the threaded shaft 1668, thereby preventing the inner shaft 1660 from axially advancing beyond the snap-fit member 1670. It should be understood that the snap-fit member 1670 may allow the proximal protrusion 1664 to pass over the snap-fit member 1670 in the proximal direction, but once the proximal protrusion 1664 has passed over the snap-fit member 1670 in the proximal direction, it may prevent axial movement in the distal direction relative to the snap-fit member 1670.

[0106] Now referring to Figure 16C , a cross-sectional view of the positioning actuator 1657 is shown and may be associated with Figure 16Ais similar to the positioning actuator 1655. 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 should be understood that the release actuator 1652 or the release actuator 1653 may optionally be connected to each other such that the movement of the release actuator 1652 or the release actuator 1653 causes the movement of the other. For example, as Figure 16D shown, the release actuator 1652 and the release actuator 1653 may be connected via a release structure 1678, which may be a tubular structure. It should be further understood that the positioning shaft may be designed to receive one or both of the release actuator 1652 and the release actuator 1653.

[0107] Now referring to Figures 17A to 17B , the use of the release actuator 1752 to lock and unlock the positioning actuator 1755 is shown. The positioning actuator 1755 may be the same as or similar to the positioning actuator 1555 of Figure 15 . The positioning actuator 1755 may include a positioning actuator housing 1754, which may rotate on a positioning support 1748. The positioning actuator housing 1754 may further include a release actuator 1752, which may be a button or a protrusion that may be engaged by a user and slide along the positioning actuator housing 1754 to transition from the Figure 17A shown locked position to the Figure 17B shown unlocked position. The positioning actuator housing 1754 may include a lock indicator 1780 and an unlock indicator 1782 to indicate the position of the release actuator 1752.

[0108] As Figure 17A shown, the release actuator 1752 may assume a locked position, which may be distal to the unlocked position. The release actuator 1752 may include a locking protrusion 1753, which may extend inwardly from the release actuator 1752. In the locked position, the locking protrusion 1753 of the release actuator 1752 may be received by a receiving area 1750 of the positioning support 1748. As Figure 17A shown, the locking protrusion 1753 may be a rectangular protrusion, and the receiving area 1750 may also be rectangular in shape. However, it should be understood that other shapes or designs may be used. In the Figure 17A shown locked position, the positioning actuator housing 1754 and the positioning support 1748 may be caused to rotate together such that the rotation of the positioning actuator housing 1754 causes the rotation of the positioning support 1748.

[0109] As Figure 17B shown, the release actuator 1752 can transition from an unlocked position to a locked position proximally. In the unlocked position, when the release actuator is moved proximally, the locking projection 1753 is caused to move proximally, thereby moving the locking projection 1753 out of the receiving area 1750 of the positioning support member 1748, such that the positioning actuator housing 1754 is disengaged from the positioning support member 1748. In the unlocked position, the positioning actuator housing 1754 is free to rotate while the positioning support member 1748 remains stationary.

[0110] Now referring Figures 18A to 18C , the actuator base 1858 and the threaded shaft 1868 are shown. As Figure 18A shown, the actuator base 1858 can be the same as or similar to the actuator base 1558 of Figure 15 and can include threads 1859 in the vicinity of the distal region of the actuator base 1558. The actuator base 1858 can further include a proximal projection 1857 that can dock with the positioning actuator housing and secure the actuator base 1858 to the positioning actuator housing. As Figure 18B shown, the threaded shaft 1868 can be positioned within the actuator base 1858. The threaded shaft 1868 can be the same as or similar to the threaded shaft 1568 of Figure 15 . As Figure 18B shown, in the undeployed position, the actuator base 1858 can be positioned on the proximal region or the central region of the threaded shaft 1868. In the undeployed position, the distal sleeve of the deployment assembly can hold the prosthetic heart valve. As Figure 18C shown, the threaded shaft 1868 can be advanced proximally by rotating the actuator base 1858. When the actuator base 1858 rotates, the threads 1859 of the actuator base 1858 can engage the threads 1863 of the threaded shaft 1868 and can cause the threaded shaft 1868 to advance distally until the threads 1859 of the actuator base 1858 engage the stop projection 1865, which can be a projection of the threaded shaft 1858 that is designed to prevent any further advancement of the threaded shaft 1868 relative to the actuator base 1858.

[0111] Now referring Figure 19, shows the rotational deflection actuator 1910 of the catheter system 1900 for causing deflection of the elongate catheter 1902. In particular, the user can rotate the deflection actuator 1910 of the handle 1906. The rotation of the deflection actuator 1910 can be relative to the handle body 1908 such that the deflection actuator 1910 can rotate while the handle body 1908 remains stationary. When the rotation of the deflection actuator 1910 causes the deflection wire and the elongate shaft 1902 within the handle body 1908 to retract proximally, the elongate shaft 1902 attached to the deflection wire at the distal region is caused to deflect. This deflection determines the position and orientation of the deployment assembly 1904 at the distal end of the elongate shaft 1902. The deflector actuator 1910 can be used to steer the elongate shaft 1902 and the deployment assembly 1904 through the patient's vasculature to ultimately deliver an artificial heart valve held by the deployment assembly 1904 to the deployment site. For example, the deflector actuator 1910 can be used to steer the elongate shaft 1902 and the deployment assembly 1904 through the aortic arch and to the native aortic valve. It should be understood that the degree of curvature in the elongate shaft 1902 can be determined by the degree of rotation and / or the number of turns of rotation of the deflector actuator 1910.

[0112] Now referring to Figures 20A to 20B , shows actuating the positioning actuator of the manipulation handle 2006 to rotate, advance the deployment assembly, and effect deployment of the deployment assembly. As Figure 20A shown, when the positioning actuator 2012 (which can be the same as the positioning actuator 112 of Figure 1 ) is in the locked position such that the release actuator 2052 is in its most distal position and the unlock actuator 2040 (which can be the same as the unlock actuator 1240 of FIG. 12) is pressed into the unlocked position, rotation of the positioning actuator 2012 and / or axial movement of the positioning actuator 2012 can be transferred to the positioning shaft 2046. Since the positioning shaft 2046 is fixed to the torque shaft, rotation of the positioning shaft causes rotation of the torque shaft and thus rotation of the elongate shaft 2003. Since the deployment assembly 2004 is fixed to the elongate shaft 2003, rotation and / or axial movement of the elongate shaft 2003 is transferred to rotational movement and / or axial movement of the deployment assembly 2004. Accordingly, when the positioning actuator 2012 is in the locked position and the unlock actuator 2040 is depressed, rotational movement and axial movement of the positioning actuator 2012 results in rotation and / or axial movement of the deployment assembly 2004.

[0113] As Figure 20BAs shown, when the positioning actuator 2012 is in the locked position such that the release actuator 2052 is in its most proximal position, the rotation of the positioning actuator 2012 is transferred to the threaded shaft and the inner shaft fixed to the threaded shaft, thereby causing the threaded shaft and the inner shaft to advance. Since the inner shaft is fixed to the guide wire shaft, the guide wire shaft advances distally together with the inner shaft. Since the guide wire shaft is fixed to the distal sleeve 2008 of the deployment assembly 2004 (which may be the same or similar to the deployment assembly 304 of FIGS. 3A to 3F) at the distal end (e.g., via the end cone), the distal advancement of the guide wire shaft will cause the distal sleeve 2008 to advance distally. Further advancement of the distal sleeve will cause the distal advancement of the anchor connector 2026, which may be fixed to the anchor support 2022. When the anchor connector 2026 advances distally, the anchor support 2022 may advance distally from its initial position within the proximal sleeve 2020. Thus, when the release actuator 2052 is in the unlocked position, the rotation of the positioning actuator 2012 can cause the distal movement of the distal sleeve 2008, the inner support 2021 (e.g., a tube), and the anchor support 2022, thereby deploying the artificial valve held by the deployment assembly 2004. Figure 3E to the distal sleeve 2008 of the deployment assembly 304 of FIGS. 3A to 3F), the distal advancement of the guide wire shaft will cause the distal sleeve 2008 to advance distally. Further advancement of the distal sleeve will cause the distal advancement of the anchor connector 2026, which may be fixed to the anchor support 2022. When the anchor connector 2026 advances distally, the anchor support 2022 may advance distally from its initial position within the proximal sleeve 2020. Thus, when the release actuator 2052 is in the unlocked position, the rotation of the positioning actuator 2012 can cause the distal movement of the distal sleeve 2008, the inner support 2021 (e.g., a tube), and the anchor support 2022, thereby deploying the artificial valve held by the deployment assembly 2004.

[0114] Now referring to Figures 21A to 21B , the initial steps for deploying the catheter system are shown. As Figure 21A shown, to deploy the catheter system, the guide sheath 2100 may first be introduced into or near the delivery site. For example, a guide wire 2150 may be introduced into the patient's vasculature and navigated through the vasculature to the deployment site. In one example, the guide wire may be introduced through the femoral artery and navigated through the patient's vasculature to the aortic valve. Next, the guide sheath 2110 may be advanced along the guide wire 2150 to the implantation site or near it. For example, the guide sheath 2110 may be combined with a dilator (not shown), which may be removed from the guide sheath after the guide sheath reaches the deployment site. As Figure 21A shown, it may be desirable to position the guide sheath near the delivery site (e.g., on the outflow side of the aortic valve).

[0115] Once the guide sheath is positioned at the delivery site, the catheter system 2100 (which may be the same or similar to the catheter system 100 of Figure 1 ) may be delivered to the delivery site using the guide sheath 2100, as Figure 21BAs shown. Specifically, the catheter system 2100 can be positioned within the guide sheath 2110 and advanced through the guide sheath 2110 to the delivery site. The deployment assembly 2104 can further include an imaging marker 2130, which can be visualized using well-known medical imaging. For example, the imaging marker 2130 can be a ring positioned on the proximal region of the distal sleeve deployment assembly 2104. Similarly, the distal end of the guide sheath 2110 can include an imaging marker 2135 that identifies the end of the guide sheath 2135. This can help the individual delivering the catheter system 2100 to the implantation site know when the artificial heart valve has left the guide sheath 2110 and / or is approaching the end of the guide sheath 2110. In one example, the imaging marker 2130 and / or the imaging marker 2135 can be radiopaque or other well-known imaging markers.

[0116] Now referring to Figures 22A to 22D , the sequential deployment of the artificial heart valve is shown. Now referring to Figure 22A , at the distal guide sheath 2210, a deployment assembly 2204 is shown that can be the same as the deployment assembly 2104 of Figure 21B , and the distal guide sheath can be the same as the guide sheath 2110 of Figure 21B . The deployment assembly 2204 can be positioned such that the proximal portion of the distal sleeve 2220 is still held by the guide sheath 2210. In this position, the artificial heart valve 2224 can be fully constrained and compressed by the guide sheath 1210 and the deployment assembly 2204. As Figure 22A shown, the distal sleeve 2220 and the anchor support 2022 can be in their most proximal positions.

[0117] Now referring to Figure 22B , the deployment assembly 2204 after completely leaving the guide sheath is shown. After the guide sheath is present, the positioning arm 2225 of the artificial heart valve 2224 can be allowed to expand, and the deployment assembly 2204 can be rotated and / or advanced such that the positioning arm 2225 can be positioned into the native cusps of the native valve (e.g., the aortic valve). As Figure 22B shown, after the deployment assembly 2204 leaves the guide sheath, the distal sleeve 2220 of the deployment assembly 2204 can be in its most proximal position and can thus hold the distal portion of the artificial heart valve 2224 in a compressed state. Moreover, after the deployment assembly 2204 leaves the guide sheath, the anchor support 2222 can be in its most proximal position within the proximal sleeve 2223 and can thus maintain the proximal portion of the artificial heart valve 2224 in a compressed state. Accordingly, when the proximal and distal portions of the artificial heart valve 2224 are maintained in a compressed state, the positioning arm 2225 is allowed to expand at least partially.

[0118] Now referring to Figure 22C, the deployment assembly 2204 is shown with its distal portion in an expanded state, but its proximal portion is held in a compressed state. As Figure 22C shown, the retention arms of the artificial heart valve 2224 can be positioned in the tips of the native leaflets of the aortic valve, similar to Figure 22B . However, the distal sleeve 2220 of the deployment assembly 2204 can be moved distally, thereby releasing the distal portion of the artificial heart valve 2224 such that the distal portion of the artificial heart valve 2224 can transition to an expanded state. In the expanded state, the distal portion of the artificial heart valve 2224 can sandwich or otherwise clamp a portion of the native leaflet between the positioning arm and the distal portion of the artificial heart valve 2224, thereby anchoring the artificial heart valve 2224 to the native valve. Although the distal sleeve 2220 moves distally, the anchor support 2222 can remain in its most proximal position within the proximal sleeve 2223. Accordingly, the proximal portion of the artificial heart valve can remain in a compressed state while the distal portion of the artificial heart valve is allowed to transition to an expanded state.

[0119] Now referring to Figure 22D , the deployment assembly is shown with both the distal sleeve and the anchor support in their most distal positions. As Figure 22D shown, the distal sleeve 2220 can continue to move distally to its most distal position, and as the distal sleeve 2220 moves distally, the distal sleeve 2220 and / or the end cone can engage the anchor connector and cause the anchor support 2222 and / or the inner support 2221 (e.g., a tube) to move distally similarly, thereby causing the anchor support 2222 to move out of the proximal sleeve 2223. When the anchor support 2222 moves distally from the proximal sleeve 2223, the proximal portion of the artificial heart valve 2224 can be released from the proximal sleeve 2223 and the anchor support 2222 and can be allowed to transition to an expanded state such that the artificial heart valve 2224 can transition to a fully expanded state. It should be understood that as the proximal portion of the artificial heart valve 2224 transitions to an expanded state, the compressive force on the native leaflet positioned between the positioning arm and the distal region of the artificial heart valve can increase, thereby further securing the artificial heart valve to the native valve (e.g., the aortic valve).

[0120] Now referring to Figure 22E , the deployment assembly 2204 is shown in its retracted position. As Figure 22EAs shown, the distal sleeve 2200 can move proximally after reaching its most distal position, such that the proximal open end of the distal sleeve 2200 engages the retraction cone assembly 2225 of the deployment assembly 2204. It should be understood that by causing the proximal open end of the distal sleeve 2200 to engage the retraction cone 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 the inner support (e.g., a tube) can be further moved distally back 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.

[0121] Now referring to Figures 23A to 23B , an exemplary anchor support and proximal sleeve are shown. As Figures 23A to 23B shown, the deployment assembly 2304 can include a distal sleeve 2320, a proximal sleeve 2323, an anchor support 2322, and a proximal cone 2327. The proximal cone 2327 can be fixed to the elongate shaft 2332 (including the torque tube). The proximal cone 2327 can be fixed to the proximal sleeve 2323, which 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 the distal end of each tab 2335 can deflect. The size of the anchor support 2322 can be determined 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 Figures 23A to 23B shown. The anchor support 2322 can include recessed portions 2334 that can be recessed or otherwise cut away from the outer surface of the anchor support 2322. The shape of the recessed portions 2324 can be determined to receive the anchors 2352 of the prosthetic heart valve 2350. For example, the anchors 2352 can be circular in shape, and the recessed portions 2324 can similarly be circular in shape with a slightly larger diameter and recess depth such that the anchors 2352 can fit between the anchor support 2322 and the proximal sleeve 2323. However, it should be understood that the recessed portions 2324 can be any other shape (e.g., rectangular).

[0122] The tab 2335 can be designed to interface with the anchor 2352 such that the tab 2335 can resist distal movement of the anchor 2335 and / or the anchor support 2324. The guide sheath 2334 can be designed to interface with the tab 2335 such that the guide sheath can apply a downward force on the tab 2335 as the deployment assembly 2304 traverses the guide sheath 2334. When the proximal sleeve 2323 is within the guide sheath 2334, the tab 2335 can prevent premature distal movement of the anchor support 2324. Once the proximal sleeve 2323 and the tab 2335 exit the guide sheath 2334, the tab 2335 can permit the anchor support 2322 to move away from the proximal sleeve 2323 once the distal sleeve applies a distal force on the anchor support 2322 via the anchor connector 2321.

[0123] Now referring to Figures 24A to 24E , an alternative anchor support and proximal sleeve are shown. Such an anchor support and sleeve can be incorporated into the deployment assembly of the above embodiments to allow features to be locked together. As Figures 24A to 24B shown, the anchor support 2422 can be tubular in shape. The deployment assembly can include a lock 2435 for locking the proximal sleeve 2427 to the anchor support 2422 during delivery. Actuation of the handle at the proximal end causes the lock 2435 of the deployment assembly to unlock such that the anchor support 2422 can move longitudinally relative to the sleeve 2427 to expand and implant the artificial heart valve.

[0124] The lock 2435 can include a protrusion and a receptacle. The protrusion extends into the receptacle to lock the sleeve 2427 to the anchor support 2422 and is released from the receptacle to unlock the sleeve 2427 from the anchor support 2422. As shown, the anchor support 2422 can have a protrusion and the proximal sleeve 2427 can have a receptacle. In the Figure 24A embodiment shown, the protrusion is a ball bearing. Alternatively, as Figures 25A to 25D shown below, the protrusion can be a lever that is retained in the receptacle in a snap-fit manner when locked and released from the receptacle when unlocked. In some embodiments, there are multiple protrusions and receptacles for locking the anchor support relative to the proximal sleeve. As shown, there can be multiple locking balls or levers spaced circumferentially.

[0125] The lock 2435 can further interface with a tube / internal support 2436 that causes the protrusion to extend into the receptacle in a first position ( Figure 24C shown). The tube / internal support 2436 is moved relative to the anchor sleeve 2422 to a second position ( Figure 24E shown) to release the protrusion from the receptacle.

[0126] The anchor support 2422 can be assembled within the proximal sleeve 2327, which can also be tubular in shape. The anchor support 2422 can include recessed portions 2444 that can be recessed or otherwise cut away from the outer surface of the anchor support 2422. The shape of the recessed portions 2444 can be configured to receive the anchors of the artificial heart valve. For example, the anchors can be circular in shape, and the recessed portions can similarly be circular in shape. It should be understood that the recessed portions 2444 can be of any other shape (e.g., rectangular).

[0127] The anchor support 2422 can further include a through hole 2446, which can be circular in shape and can allow the lock 2435 to traverse the anchor support 2422 through the through hole 2446. The lock 2435 can be a ball structure or a ball stopper (e.g., a plastic ball, a rubber ball, or a 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 diameter smaller than that of the lock 2435, such that only a portion of the lock 2435 can extend through the through hole 2442. The distal cone 2434 can be fixed to the proximal end of the proximal sleeve 2427. The inner support 2436 can be a tubular structure sized to be assembled within the anchor support 2422. When the inner support 2436 is in its most proximal position, the inner support can support the lock 2435 and maintain the lock 2435 in the locked position. The inner support 2436 can be advanced distally relative to the anchor support 2422 and the proximal sleeve 2427, and thus, the lock 2435 can no longer maintain the lock 2435 in the locked position. When the inner support 2436 is advanced distally, since the lock 2435 is no longer docked with the proximal sleeve 2427, the lock can be allowed to drop (e.g., move inward), thereby allowing the anchor support 2422 to move distally relative to the proximal sleeve 2427. When the anchor support 2422 moves distally relative to the proximal sleeve 2427, the recessed portions 2444 can move out of the proximal sleeve 2427 and can release the anchors of the artificial heart valve. In this way, the lock 2435 can prevent or allow the axial movement of the anchor support 2422 and thus prevent the deployment of the anchors. Although only one lock 2435 is shown, it should be understood that multiple locks 2435 can be used, and these locks can be circumferentially spaced apart on the anchor support 2436.

[0128] Figures 24C to 24E Shown is the inner support 2436 moving distally and allowing the anchor support 2422 to move distally. As Figure 24C shown, the inner support 2436 can be in its most proximal position relative to the anchor support 2422 and the proximal sleeve 2427. As Figure 24CAs shown, at the most proximal position of the inner support member 2436, the lock 2435 can be supported by the outer surface of the inner support member 2436 such that the lock 2435 rests within the through hole 2442 and extends partially through the through hole 2442 of the proximal sleeve 2427. In this way, when the inner support member 2436 is in its most proximal position and the lock 2435 is docked with the proximal sleeve 2427, the lock 2435 can prevent the anchor support member 2436 from moving distally.

[0129] As Figure 24D shown, the inner support member 2436 can move distally while the anchor support member 2422 and the proximal sleeve 2327 remain stationary. For example, an anchor connector connected to the distal sleeve and / or the end cone can be connected to the inner support member 2436 and not directly connected to the anchor support member 2422. The inner support member 2436 can include a latch 2447, which can be a protrusion extending outward from the outer surface of the inner support member 2436 and can dock with the anchor support member 2422 after the inner support member 2436 has moved distally by a certain amount. Once the latch 2447 contacts the anchor support member 2422, the anchor support member 2422 and the inner support member 2436 will move distally together. The inner support member 2436 can further include a lock recess 2450, which can be a recess or notch in the outer surface of the proximal region of the inner support member 2436, and the size of the lock recess can be determined to allow the lock 2435 to enter at least partially. The lock recess 2450 can be inclined at the proximal end to allow the lock 2435 to enter gradually. As Figure 24D shown, when the inner support member 2436 moves distally relative to the anchor support member 2422 and the proximal sleeve 2427, the lock recess 2450 is positioned below the lock 2435, and the lock 2435 is allowed to enter the lock recess 2450. When the lock 2435 enters the lock recess 2450, the lock 2435 falls below the proximal sleeve 2427, thereby allowing the anchor support member 2436 to move distally relative to the proximal sleeve 2427, as Figure 24E shown. In this way, the recessed portion of the anchor support member 2522 can be exposed from the proximal sleeve 2437 to allow at least the proximal portion of the artificial heart valve to transition to the expanded state.

[0130] Now refer to Figures 25A to 25D , which shows an alternative anchor support member and proximal sleeve. As Figures 25A to 25DAs shown, the anchor support 2522 can be tubular in shape. The anchor support 2522 can be assembled within the proximal sleeve 2537, which can also be tubular in shape. The anchor support 2522 can include recessed portions 2544 that can be recessed or otherwise cut away from the outer surface of the anchor support 2522. The shape of the recessed portions 2544 can be configured to receive the anchors of an artificial heart valve. The anchor support 2522 can further include a cantilever lock 2525 (e.g., a lock) that can be cantilevered and stand independently at the proximal end of the anchor support 2422. For example, the cantilever lock 2525 can be a lever. The cantilever lock 2435 can lock the anchor support 2522 to the proximal sleeve 2537 during delivery. The cantilever lock 2535 has elastic properties and can deflect downward. The cantilever lock 2535 can extend outwardly beyond the surface of the anchor support 2522 and can be designed to resist movement in the distal direction. The proximal sleeve can further include a through-hole 2542 that can 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) can be advanced distally relative to the anchor support 2522 and the proximal sleeve 2527, and thus, the cantilever lock 2535 can transition from a locked position to an unlocked position. In this way, the cantilever lock 2535 can prevent or permit axial movement of the anchor support 2522. Although only one cantilever lock 2535 is shown, it should be understood that multiple cantilever locks 2535 can be used and these can be circumferentially spaced around the anchor support 2522.

[0131] Figures 25B to 25D The inner support 2536 is shown moving distally and allowing the anchor support 2522 to move distally. As Figure 25B shown, the inner support 2536 can be in its most distal position relative to the anchor support 2522 and the proximal sleeve 2527. As Figure 25B shown, at the most proximal position of the anchor support 2536, the cantilever lock 2535 can be supported by the outer surface of the inner support 2536 at the proximal end such that the cantilever lock 2535 extends at least partially through the through-hole 2542 of the proximal sleeve 2537. In this way, when the inner support 2536 is in its most proximal position, the cantilever lock 2535 can prevent the anchor support 2522 from moving distally.

[0132] As Figure 25CAs shown, the inner support member 2536 can be advanced distally while the anchor support member 2522 and the proximal sleeve 2527 remain stationary. For example, an anchor connector that is connected to the distal sleeve and / or the end cone can be connected to the inner support member 2536 and not directly connected to the anchor support member 2522. The inner support member 2536 can include a latch 2547, which can be a protrusion that extends outward from the outer surface of the inner support member 2536 and can dock with the anchor support member 2522 after the inner support member 2436 has moved distally a certain amount. Once the latch 2547 contacts the anchor support member 2522, the anchor support member 2522 and the inner support member 2536 will move distally together.

[0133] The inner support member 2536 can further include a locking recess 2550, which can be a recess or notch in the outer surface of the proximal region of the inner support member 2536, and the size of the locking recess can be determined to allow the lock 2435 to be at least partially deflected or otherwise extend into the locking recess 2450. It should be understood that the cantilever lock 2535 can be biased downward such that the proximal end of the cantilever lock 2535 is biased downward toward the inner support member 2536. The locking recess 2450 can be inclined at the distal end to allow the cantilever lock 2535 to be gradually deflected or otherwise extend into the locking recess 2550. As Figure 25C shown, when the inner support member 2536 moves distally relative to the anchor support member 2522 and the proximal sleeve 2527, the locking recess 2550 is positioned below the cantilever lock 2535, and the cantilever lock 2535 is allowed to be deflected or otherwise extend into the locking recess 2550. When the cantilever lock 2535 is deflected or otherwise extends into the locking recess 2550, the cantilever lock 2535 can be positioned below the proximal sleeve 2527, thereby allowing the anchor support member 2536 to move distally relative to the proximal sleeve 2527, as Figure 25D shown. In this way, the recessed portion of the anchor support member 2522 can be exposed from the proximal sleeve 2537 to allow at least the proximal portion of the artificial heart valve to transition to the expanded state. The proximal sleeve 2535 can further include a distal through-hole 2580, and the cantilever lock 2535 can enter its most distal position in the distal through-hole 2580, such that the distal through-hole 2580 can prevent the anchor support member 2522 from moving further distally.

[0134] For purposes of illustration and description, the foregoing description of the illustrative embodiments has been presented. Of course, it should be understood that the embodiments described herein are illustrative, and that components may be arranged, substituted, combined, and designed in a variety of different configurations, all of which are contemplated and fall within the scope of the present disclosure. It is not intended to be exhaustive or 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. The scope of the invention is intended to be defined by the appended claims and their equivalents.

Claims

1. A catheter system for implanting an artificial heart valve, the catheter system comprising: A slender shaft including a proximal region and a distal region; A deployment assembly located at the distal region of the slender shaft, the size and shape of the deployment assembly being configured to advance to an implantation site at an autologous heart valve site with the artificial heart valve in a collapsed state, the deployment assembly including a sleeve configured to maintain at least a portion of the artificial heart valve within the sleeve in the collapsed state during delivery; And A handle disposed at the proximal region of the slender shaft, the handle including a handle body, a first actuator, and a second actuator, the first actuator being configured to rotate relative to the handle body, the second actuator being configured to transition between a first position and a second position, Wherein when the second actuator is in the first position, rotation of the first actuator is transferred to the deployment assembly to cause the deployment assembly to rotate, and when the second actuator is in the second position, rotation of the first actuator causes the sleeve to move longitudinally relative to the handle to expand and implant the artificial heart valve.

2. The catheter system according to claim 1, wherein, The handle includes a third actuator that prevents the first actuator from moving when the second actuator is in the first position and allows the first actuator to move when the second actuator is in the first position and the third actuator is in a second position.

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

4. The catheter system according to claim 1, wherein, When the second actuator is in the second position, rotation of the first actuator does not cause the deployment assembly to rotate, and when the second actuator is in the first position, rotation of the first actuator does not cause the sleeve to move longitudinally relative to the handle.

5. The catheter system according to claim 1, wherein, The deployment assembly further includes: A second sleeve proximal to the sleeve and coupled to the slender shaft; and An anchor support positioned within the second sleeve and in mechanical communication with the sleeve.

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

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

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

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

10. The catheter system according to claim 9, wherein, The shaft is threaded and the cross-section of the shaft includes at least one right angle.

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

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

13. A method for implanting an artificial heart valve, the method comprising: Advancing a deployment assembly at a distal region of an elongate shaft to an implantation site at an autologous heart valve site with the artificial heart valve in a collapsed state, the deployment assembly including a sleeve configured to maintain at least a portion of the artificial heart valve within the sleeve in the collapsed state during delivery; Rotating a first actuator of the handle relative to a handle body of the handle while a second actuator of the handle coupled to the elongate shaft is in a first position such that rotation of the first actuator is transferred to the deployment assembly to cause rotation of the deployment assembly; Transitioning the second actuator from the first position to a second position; And Rotating the first actuator while the second actuator is in the second position to cause longitudinal movement of the sleeve relative to the handle to expand and implant the artificial heart valve.

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

15. The method according to claim 14, wherein, The handle includes a fourth actuator configured to rotate relative to the handle body and independently of the first actuator, the fourth actuator being connected to a distal portion of the elongate shaft and configured to cause deflection of the elongate shaft.

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

17. The method according to claim 13, wherein, The deployment assembly further includes: A second sleeve proximal to the sleeve and coupled to the elongate shaft; and An anchor support positioned within the second sleeve and in mechanical communication with the sleeve.

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

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

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

21. A catheter system for implanting an artificial heart valve, the catheter system comprising: An elongate shaft including a proximal region and a distal region; A deployment assembly located at the distal region of the elongate shaft, the deployment assembly sized and shaped to be advanced to an implantation site at an autologous heart valve site with the artificial heart valve in a collapsed state, the deployment assembly including a sleeve, an anchor support, and a lock, the anchor support configured to be disposed within the sleeve during delivery to maintain at least a portion of the artificial heart valve between the sleeve and the anchor support in the collapsed state, the lock configured to lock the sleeve to the anchor support during delivery; And A handle disposed at the proximal region of the elongate shaft, the handle configured to cause the lock of the deployment assembly to unlock when actuated, such that the anchor support is longitudinally movable relative to the sleeve to expand and implant the artificial heart valve.

22. The catheter system according to claim 21, wherein, The lock includes 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.

23. The catheter system according to claim 22, wherein, The anchor support includes the protrusion and the sleeve includes the receiving portion.

24. The catheter system according to claim 22, wherein, The lock further includes a tube configured to cause the protrusion to extend into the receiving portion when in a first position and configured to move relative to the sleeve to a second position to release the protrusion from the receiving portion.

25. The catheter system according to claim 22, wherein, The protrusion includes a ball bearing configured to be retained within the receiving portion when locked and released from the receiving portion when unlocked.

26. The catheter system according to claim 22, wherein, The protrusion includes a lever configured to be snap - retained within the receiving portion when locked and released from the receiving portion when unlocked.

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

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

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

30. The catheter system according to claim 21, wherein, The deployment assembly further includes a tube positioned within the anchor support and configured to longitudinally move 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. The catheter system according to claim 30, wherein, The tube includes a protrusion extending from an outer surface of the tube, the protrusion configured to engage the anchor support to cause the anchor support to move with the tube when the protrusion engages the anchor support.

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

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

34. A method for implanting a prosthetic heart valve using a catheter system, the method comprising: guiding a deployment assembly loaded with the prosthetic heart valve in a collapsed state to an implantation site at a native heart valve site, the deployment assembly being positioned at a distal region of the elongated shaft and comprising a sleeve, an anchor support, and a lock, the anchor support being configured to be disposed within the sleeve to maintain at least a portion of the prosthetic heart valve between the sleeve and the anchor support in the collapsed state, the lock being configured to lock the sleeve to the anchor support; as well as Rotate an actuator of a handle positioned at a proximal region of the elongated shaft to cause a first axis extending between the actuator and the deployment assembly to move distally, thereby releasing the lock to allow the anchor support to move relative to the sleeve to expand at least a portion of the prosthetic heart valve, thereby implanting the prosthetic heart valve.

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

36. The method according to claim 35, wherein The anchor support includes the protrusion, and the sleeve includes the receiving portion.

37. The method according to claim 35, wherein, The lock further includes a tube configured to cause the protrusion to extend into the receiving portion when in a first position, the tube configured to move relative to the sleeve to a second position to release the protrusion from the receiving portion.

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

39. The method according to claim 35, wherein, The protrusion includes a lever configured to be snap-retained in the receiving portion when locked and to be released from the receiving portion when unlocked.

40. The method according to claim 34, wherein The deployment assembly further includes a second sleeve distal to the sleeve, and wherein the sleeve is coupled to at least a portion of the elongated shaft.

41. A catheter system for implanting an artificial heart valve, the catheter system comprising: an elongated shaft comprising a proximal region and a distal region, the elongated shaft comprising a cut hypotube comprising a proximal portion, a transition portion cut to have greater flexibility than the proximal portion, and a distal portion cut to have greater flexibility than the transition portion; a deployment assembly located at a distal region of the elongated shaft, the deployment assembly being sized and shaped to be advanced to an implantation site at a native heart valve site with the prosthetic heart valve in a collapsed state; as well as A handle is disposed at a proximal region of the elongated shaft, the handle being configured to, when actuated, cause the deployment assembly to release the prosthetic heart valve for expansion and implantation of the prosthetic heart valve.

42. The catheter system according to claim 41, further comprising a deflection cable, wherein, The elongated shaft further includes a deflection shaft coupled to the deflection cable at a distal end, and wherein the cutting hypotube and the deflection cable are disposed within the deflector shaft.

43. The catheter system according to claim 42, wherein, The handle further includes a handle body and a deflection actuator in mechanical communication with the deflection cable and configured to proximally retract the deflection cable, wherein the deflection actuator is configured to deflect the deflection axis.

44. The catheter system according to claim 42, wherein, The elongated shaft further includes a torque shaft disposed within the deflection shaft and configured to translate axial and rotational movement of the handle to the deployment assembly.

45. The catheter system according to claim 44, wherein, The torque shaft includes a second hypotube, a polymer layer disposed within the second hypotube, a braided layer disposed within the polymer layer, and a lining layer including a fluoropolymer disposed within the braided layer.

46. The catheter system according to claim 45, wherein, The second hypotube is cut to increase in 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. The catheter system according to claim 44, wherein, The elongated shaft further includes 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. The catheter system according to claim 47, wherein The guidewire shaft includes the cutting hypotube, a second polymer layer disposed within the hypotube, a second braided layer disposed within the second polymer layer, and a second lining layer comprising a fluoropolymer disposed within the second braided layer.

49. The catheter system according to claim 47, wherein, The hypotube is longer than the second hypotube and has a greater number of cutouts than the second hypotube.

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

51. A method for implanting an artificial heart valve, the method comprising: advancing a deployment assembly at a distal region of an elongated shaft to an implantation site at a native heart valve site with the prosthetic heart valve in a collapsed state, the elongated shaft comprising a cut hypotube, the cut hypotube comprising a proximal portion, a transition portion cut to have greater flexibility than the proximal portion, and a distal portion cut to have greater flexibility than the transition portion; as well as A handle disposed at a proximal region of the elongated shaft is actuated to cause the deployment assembly to release the prosthetic heart valve, thereby expanding and implanting the prosthetic heart valve.

52. The method according to claim 51, further comprising deflecting the cable, wherein, The elongated shaft further includes a deflection shaft coupled to the deflection cable at a distal end, and wherein the cutting hypotube and the deflection cable are disposed within the deflector shaft.

53. The method according to claim 52, wherein, The handle further includes a handle body and a deflection actuator in mechanical communication with the deflection cable and configured to proximally retract the deflection cable, wherein the deflection actuator is configured to deflect the deflection axis.

54. The method according to claim 52, wherein, The elongated shaft further includes a torque shaft disposed within the deflection shaft and configured to translate axial and rotational movement of the handle to the deployment assembly.

55. The method according to claim 54, wherein, The torque shaft includes a second hypotube, a polymer layer disposed within the second hypotube, a braided layer disposed within the polymer layer, and a lining layer including a fluoropolymer disposed within the braided layer.

56. The method according to claim 55, wherein, The second hypotube is cut to increase in 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. The method according to claim 54, wherein, The elongated shaft further includes 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. The method according to claim 57, wherein, The guidewire shaft includes the cutting hypotube, a second polymer layer disposed within the hypotube, a second braided layer disposed within the second polymer layer, and a second lining layer comprising a fluoropolymer disposed within the second braided layer.

59. The method according to claim 57, wherein, The hypotube is longer than the second hypotube and has a greater number of cutouts than the second hypotube.

60. The method according to claim 57, wherein, One or more of the hypotube or the second hypotube is a laser cut hypotube or micromachined.

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