Delivery system for medical implant

Abstract

To deliver an implant to a desired location and to control deployment of prothesis at a desired location.SOLUTION: Embodiments of the present disclosure are directed to delivery systems, devices and / or methods of use to deliver and / or controllably deploy an implant in the form of a prosthesis such as, but not limited to, a replacement heart valve, to a desired location within the body. In some embodiments, a replacement heart valve and methods for delivering a replacement heart valve to a native heart valve such as a mitral valve, are provided. Features of the delivery systems are disclosed, as well as echogenic markers for delivery systems.SELECTED DRAWING: Figure 11

Description

[Technical Field]

[0001] Certain embodiments disclosed herein relate generally to delivery systems for implants. In particular, in some embodiments, the delivery systems and implants relate to replacement heart valves, such as replacement mitral or other heart valves. [Background technology]

[0002] Human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, essentially function as one-way valves that operate in sync with the beating heart. These valves allow blood to flow downstream but prevent blood from flowing upstream. Diseased heart valves exhibit defects, such as valve stenosis or regurgitation, that impair the valve's ability to control blood flow. Such defects reduce the heart's blood circulation efficiency and can lead to debilitating and life-threatening conditions. For example, valve failure can lead to conditions such as cardiac hypertrophy and ventricular dilation. Therefore, significant efforts have been made to develop methods and devices for repairing or replacing defective heart valves.

[0003] To solve the problems associated with defective heart valves, artificial implants exist. For example, mechanical and tissue-based heart valve prostheses can be used to replace defective natural heart valves. More recently, significant efforts have been made to develop replacement heart valves, particularly tissue-based replacement heart valves, which can be delivered with less trauma to the patient than open-heart surgery. Replacement valves are designed to be delivered via minimally invasive procedures, even percutaneous procedures. Such replacement valves often include a tissue-based valve body connected to an expandable frame that is delivered into the natural valve annulus.

[0004] The development of prosthetic implants, including but not limited to replacement heart valves, that can be miniaturized for delivery and then controllably expanded for controlled deployment has proven particularly challenging. A further challenge relates to the ability to atraumatically fix these prostheses relative to intraluminal tissue, such as tissue within any body cavity or lumen.

[0005] Delivering an implant to a desired location within the human body, such as delivering a replacement heart valve to the mitral valve, can also be difficult. To be able to perform a procedure within the heart or other anatomical location, it may be necessary to deliver the device percutaneously through a tortuous vascular system or by an open or semi-open procedure. Being able to control the placement of the prosthesis in the desired location can also be difficult.

[0006] It can also be difficult to adequately visualize or locate the implant delivery system, including using ultrasound imaging. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent No. 6,622,367 [Patent Document 2] US Patent Application Publication No. 2015 / 0328000A1 Summary of the Invention [Means for solving the problem]

[0008] Embodiments of the present disclosure are directed to delivery systems, devices, and / or methods of use for delivering and / or controllably positioning an implant in the form of a prosthesis, such as, but not limited to, a replacement heart valve, to a desired location within the body. In some embodiments, replacement heart valves and methods for delivering replacement heart valves to a native heart valve, such as the mitral valve, are provided.

[0009] In some embodiments, delivery systems and methods are provided for delivering a replacement heart valve to the location of the native mitral valve. The delivery systems and methods may utilize a transseptal approach. In some embodiments, components of the delivery system facilitate bending of the delivery system to steer the prosthesis from the septum to a location within the native mitral valve. In some embodiments, a capsule is provided to house the prosthesis for delivery to the location of the native mitral valve. In other embodiments, the delivery systems and methods may be adapted for delivery of an implant to a location other than the native mitral valve.

[0010] Embodiments herein include a delivery system for delivering an implant to a location within a patient's body, the delivery system comprising an elongate shaft having a proximal end and a distal end, the elongate shaft including an implant holding region configured to hold the implant, and a capsule including a hypotube having one or more incisions forming multiple rings configured to surround the implant holding region.

[0011] Embodiments herein include a delivery system for delivering an implant to a location within a patient's body, the delivery system comprising an elongate shaft having a proximal end and a distal end, the elongate shaft including an implant holding region configured to hold the implant, and a capsule including a hypotube configured to surround the implant holding region and having one or more notches that bias the flexibility of the hypotube in a certain direction.

[0012] Embodiments herein include a delivery system for delivering an implant to a location within a patient's body, the delivery system comprising an elongate shaft having a proximal end and a distal end, the elongate shaft including an implant holding region configured to hold the implant, and a capsule including a hypotube having one or more notches forming a spiral configured to surround the implant holding region.

[0013] Embodiments herein include methods including the steps of: disposing an elongate shaft at a location within a patient's body, the elongate shaft including a capsule surrounding an implant holding region that holds an implant to be implanted within the patient's body, the capsule including a hypotube having one or more incisions forming a plurality of rings; moving the capsule proximally to expose a portion of the implant within the patient's body; and moving the capsule distally to retrieve a portion of the implant within the patient's body.

[0014] Embodiments herein include a delivery system for delivering an implant to a location within a patient's body, the delivery system comprising an elongate shaft having a proximal end and a distal end, the elongate shaft including an implant holding region configured to hold the implant, a capsule configured to surround the implant holding region, a shaft portion located proximal to the capsule, and a coupler configured to couple the capsule to the shaft portion and allow the capsule to rotate relative to the shaft portion.

[0015] Embodiments herein include methods including the steps of: disposing an elongate shaft at a location within a patient's body, the elongate shaft including a capsule, a shaft portion proximal to the capsule, and a coupler coupling the capsule to the shaft portion, the coupler configured to allow the capsule to rotate relative to the shaft portion, the capsule surrounding an implant holding region that holds an implant to be implanted within the patient's body; and moving the capsule proximally to expose a portion of the implant within the patient's body while the capsule rotates relative to the shaft portion.

[0016] Embodiments herein include a delivery system for delivering an implant to a location within a patient's body, the delivery system comprising an elongate shaft having a proximal end and a distal end, the elongate shaft including an implant holding region configured to hold the implant, a sheath having a lumen, an inner shaft positioned within the lumen, and an expandable body positioned between the inner shaft and the sheath, configured to expand to support the sheath.

[0017] Embodiments herein include methods including the steps of: disposing an elongate shaft at a location within a patient's body, the elongate shaft including a sheath, an inner shaft positioned within a lumen of the sheath, and an implant holding region that holds an implant to be implanted within the patient's body; moving the sheath proximally to expose a portion of the implant within the patient's body; expanding an expandable body between the sheath and the inner shaft; and moving the sheath distally to retrieve a portion of the implant within the patient's body while the expandable body expands between the sheath and the inner shaft to support the sheath.

[0018] Embodiments herein include a delivery system for delivering an implant to a location within a patient's body, the delivery system comprising an elongate shaft having proximal and distal ends, the elongate shaft having an implant holding region configured to hold the implant, and a wall of the elongate shaft including an outer jacket layer, an inner liner layer, a braided layer positioned between the outer jacket layer and the inner liner layer, and a metal layer positioned between the braided layer and the inner liner layer.

[0019] Embodiments herein include a delivery system for delivering an implant to a location within a patient's body, the delivery system comprising an elongate shaft having proximal and distal ends, the elongate shaft including an implant holding region configured to hold the implant, a sheath configured to bend in at least one plane, a cable having a first end portion, a second end portion, and an intermediate portion extending between the first and second end portions, the first end portion coupled to a first side of the sheath and the second end portion coupled to a second side of the sheath opposite the first side, a cable router engaging the intermediate portion of the cable to allow the cable to move along the cable router when the sheath is bent in at least one plane, and a control mechanism for retracting the cable router and the sheath relative to the implant holding region.

[0020] Embodiments herein include methods including the steps of: disposing an elongate shaft at a position within a patient's body, the elongate shaft including an implant holding region that holds an implant to be implanted within the patient's body; a sheath; and a cable having a first end portion, a second end portion, and an intermediate portion extending between the first end portion and the second end portion, the first end portion coupled to a first side of the sheath and the second end portion coupled to a second side of the sheath opposite the first side, the intermediate portion engaging a cable router; bending the sheath in a plane such that a length of the cable between the cable router and the first end portion increases and a length of the cable between the cable router and the second end portion decreases; and retracting the cable router and the sheath relative to the implant holding region.

[0021] Embodiments herein include a delivery system for delivering an implant to a location within a patient's body, the delivery system comprising an elongate shaft having a proximal end and a distal end, the elongate shaft including an implant holding region configured to hold the implant, a sheath having an inner lumen and a capsule configured to surround the implant holding region, an inner shaft located within the inner lumen, and a stopper located on the inner shaft configured to prevent proximal movement of the capsule relative to the inner shaft.

[0022] Embodiments herein include methods including the steps of: positioning an elongate shaft at a location within a patient's body, the elongate shaft including a sheath having an inner lumen and a capsule that holds an implant to be implanted within the patient's body, the sheath including an inner shaft and a stopper located on the inner shaft; moving the capsule proximally until the sheath contacts the stopper to expose a first portion of the implant within the patient's body; and moving the capsule proximally over the stopper to expose a second portion of the implant located proximal to the first portion of the implant within the patient's body.

[0023] Embodiments herein include a delivery system for delivering an implant to a location within a patient's body, the delivery system comprising: an elongate shaft having a proximal end and a distal end, an implant holding region and an assembly configured to hold at least a portion of the implant within the implant holding region; and a handle including a control knob coupled to the proximal end of the elongate shaft and configured, when rotated, to move the assembly to release at least a portion of the implant from the implant holding region, the control knob including an exposed outer grip surface to be grasped around the entire circumference of the control knob.

[0024] Embodiments herein include a method including the steps of: disposing a delivery device at a location within a patient's body, the delivery device including an elongate shaft and a handle coupled to a proximal end of the elongate shaft, the elongate shaft including an implant holding region that holds an implant to be implanted within the patient's body and an assembly configured to hold at least a portion of the implant within the implant holding region, the handle including a control knob configured, when rotated, to move the assembly to release at least a portion of the implant from the implant holding region, the control knob including an exposed outer grip surface to be grasped around the entire circumference of the control knob; grasping the grip surface of the control knob; and rotating the control knob to move the assembly to release at least a portion of the implant from the implant holding region.

[0025] Embodiments herein include a delivery system for delivering an implant to a location within a patient's body, the delivery system comprising an elongate shaft having a proximal end and a distal end, the elongate shaft including an implant holding region configured to hold the implant and a marker configured to enhance echogenicity of the elongate shaft to define the location of a portion of the elongate shaft when viewed using ultrasound imaging.

[0026] Embodiments herein include methods that include disposing an elongate shaft at a location within a patient's body, the elongate shaft including an implant holding region that holds an implant to be implanted within the patient's body, and a marker that enhances the echogenicity of the elongate shaft to define the location of a portion of the elongate shaft when viewed using ultrasound imaging.

[0027] Embodiments herein include a delivery system for delivering an implant to a location within a patient's body, the delivery system comprising an elongate shaft having a proximal end and a distal end, the elongate shaft including an implant holding region configured to hold the implant, and a capsule configured to surround the implant holding region and including a distal end configured to extend radially outward.

[0028] Embodiments herein include methods including the steps of: disposing an elongate shaft at a location within a patient's body, the elongate shaft including a capsule surrounding an implant holding region that holds an implant to be implanted within the patient's body; moving the capsule proximally to expose a portion of the implant within the patient's body; and moving the capsule distally to retrieve a portion of the implant within the patient's body, passing the distal end of the capsule radially outwardly expanded over the retrieved portion of the implant.

[0029] Embodiments herein include a delivery system for delivering an implant to a location within a patient's body, the delivery system comprising an elongate shaft having proximal and distal ends, the elongate shaft including an implant holding region configured to hold the implant, and a pull tether coupled to a portion of the elongate shaft at or distal to the implant holding region and configured to deflect the distal end of the elongate shaft.

[0030] Embodiments herein include a delivery system for delivering an implant to a location within a patient's body, the delivery system comprising an elongate shaft having a proximal end and a distal end, the elongate shaft including an implant holding region configured to hold the implant, a nosecone located at the distal end of the elongate shaft, and a pull tether coupled to the nosecone and configured to deflect the nosecone.

[0031] Embodiments herein include methods that include the steps of: disposing an elongate shaft at a location within a patient's body, the elongate shaft including a proximal end, a distal end, and an implant holding region that holds an implant to be implanted within the patient's body; and deflecting the distal end of the elongate shaft using a pull tether coupled to a portion of the elongate shaft at or distal to the implant holding region.

[0032] Embodiments herein include a delivery system for delivering an implant to a location within a patient's body, the delivery system comprising: a steerable first elongate shaft having proximal and distal ends and extending along a first axis; a second elongate shaft having proximal and distal ends and extending along a second axis, the second elongate shaft including an implant holding region configured to hold the implant; and a coupler configured to couple the second elongate shaft to the first elongate shaft such that the second axis is offset from the first axis and the second elongate shaft can slide relative to the first elongate shaft.

[0033] Embodiments herein include methods that include disposing a first elongate shaft at a location within a patient's body, the first elongate shaft extending along a first axis and being steerable; and sliding a second elongate shaft along the first elongate shaft to a location within the patient's body, the second elongate shaft being coupled to the first elongate shaft, extending along a second axis offset from the first axis, and including an implant holding region that holds an implant therein.

[0034] Embodiments herein include a delivery system for delivering an implant to a location within a patient's body, the delivery system comprising: an elongate shaft having a proximal end and a distal end and including an implant holding region configured to hold the implant; and a coating layer on the elongate shaft including reinforcing fibers or beads.

[0035] Embodiments herein include a delivery system that includes a step of disposing an elongate shaft at a location within a patient's body, the elongate shaft including an implant holding region that holds an implant to be implanted within the patient's body, and a covering layer that includes reinforcing fibers or beads.

[0036] Embodiments herein include methods that include providing a mixture of polytetrafluoroethylene (PTFE) and reinforcing fibers or beads, and providing an elongate shaft of a delivery system for delivering an implant to a location within a patient's body, the elongate shaft including the mixture of polytetrafluoroethylene (PTFE) and reinforcing fibers or beads as a coating layer on the elongate shaft. [Brief explanation of the drawings]

[0037] [Figure 1] FIG. 1 illustrates an embodiment of a delivery system. [Figure 2A] 2A is a partial cross-sectional view of the distal end of the delivery system of FIG. 1 loaded with the valve prosthesis of FIG. 3A. [Figure 2B] 2B is a partial cross-sectional view showing the distal end of the delivery system of FIG. 1 without the valve prosthesis of FIG. 3A. [Figure 2C] 2C is a partial cross-sectional view of the distal end of the delivery system of FIG. 1 with a particular shaft assembly translated along a rail assembly. [Figure 3A] FIG. 3A is a side view illustrating an embodiment of a valve prosthesis that can be delivered using the delivery systems described herein. [Figure 3B] FIG. 3A is a side view illustrating an embodiment of an aortic valve prosthesis that can be delivered using the delivery systems described herein. [Figure 4] FIG. 4 is a perspective view of the distal end of the delivery system of FIG. [Figure 5] FIG. 5 illustrates the components of the delivery system of FIG. 4 with the outer sheath assembly moved proximally out of view. [Figure 6A] FIG. 6A illustrates the components of the delivery system of FIG. 5 with the central shaft assembly moved proximally and out of view. [Figure 6B] FIG. 6B is a cross-sectional view showing the rail assembly. [Figure 7] FIG. 7 illustrates the components of the delivery system of FIG. 6A with the rail assembly moved proximally and out of view. [Figure 8] FIG. 8 illustrates the components of the delivery system of FIG. 7 with the inner assembly moved proximally out of view. [Figure 9A] FIG. 9A illustrates an embodiment of a guidewire shield. [Figure 9B] FIG. 9B illustrates an embodiment of a guidewire shield. [Figure 10] FIG. 10 illustrates an embodiment of an outer hypotube. [Figure 11] FIG. 11 illustrates an embodiment of a central shaft hypotube. [Figure 12A] FIG. 12A illustrates the central shaft hypotube embodiment of FIG. 11 in a flat pattern. [Figure 12B] FIG. 12B illustrates an embodiment of an outer retaining ring. [Figure 13] FIG. 13 illustrates an embodiment of a rail assembly. [Figure 14] FIG. 14 illustrates an embodiment of the inner assembly. [Figure 15]FIG. 15 is a diagram showing a cross section of the capsule. [Figure 16] FIG. 16 illustrates an embodiment of the hypotube of the outer sheath assembly as a flat pattern. [Figure 17] FIG. 17 illustrates an embodiment of the hypotube of the outer sheath assembly as a flat pattern. [Figure 18] FIG. 18 illustrates an embodiment of the hypotube of the outer sheath assembly as a flat pattern. [Figure 19] FIG. 19 illustrates an embodiment of the hypotube of the outer sheath assembly as a flat pattern. [Figure 20] FIG. 20 illustrates an embodiment of the hypotube of the outer sheath assembly as a flat pattern. [Figure 21] FIG. 21 illustrates an embodiment of the hypotube of the outer sheath assembly in a flat pattern. [Figure 22] FIG. 22 is a cross-sectional view showing a distal portion of an elongate shaft of a delivery system including a coupler that couples the capsule to the shaft. [Figure 23] FIG. 23 is a perspective view showing a distal portion of an elongate shaft of a delivery system including a coupler that couples the capsule to the shaft. [Figure 24] FIG. 24 is a cross-sectional view showing a distal portion of an elongate shaft of a delivery system including a coupler that couples the capsule to the shaft. [Figure 25] FIG. 25 is a perspective view showing a distal portion of an elongate shaft of a delivery system including a coupler that couples the capsule to the shaft. [Figure 26] FIG. 26 is a cross-sectional view showing a distal portion of an elongate shaft of a delivery system including an expandable body positioned between an outer sheath and an inner shaft. [Figure 27] 27 is a cross-sectional view of the distal portion of the elongate shaft shown in FIG. 26 with the distal end bent and the expandable body expanded. [Figure 28] FIG. 28 is a side view of an embodiment of a braided layer. [Figure 29] FIG. 29 is a schematic cross-sectional view showing the structure of the wall surface of the elongated shaft. [Figure 30] FIG. 30 is a schematic cross-sectional view showing the components of an elongate shaft, including a sheath, a cable, and a cable router. [Figure 31] FIG. 31 is a schematic cross-sectional view showing the sheath shown in FIG. 30 in a bent state. [Figure 32A] FIG. 32A is a cross-sectional view showing the stopper of the capsule. [Figure 32B] FIG. 32B is a cross-sectional view showing the stopper of the capsule. [Figure 32C] FIG. 32C is a cross-sectional view showing the stopper of the capsule. [Figure 33A] FIG. 33A is a cross-sectional view showing the stopper of the capsule. [Figure 33B] FIG. 33B is a cross-sectional view showing the stopper of the capsule. [Figure 33C] FIG. 33C is a cross-sectional view showing the stopper of the capsule. [Figure 34A] FIG. 34A is a perspective view showing the stopper of the capsule. [Figure 34B] FIG. 34B is a perspective view showing the stopper of the capsule. [Figure 34C] FIG. 34C is a perspective view showing the stopper of the capsule. [Figure 35] FIG. 35 illustrates an embodiment of a handle for a delivery system. [Figure 36] FIG. 36 shows a cross section of the handle of the delivery system of FIG. [Figure 37] FIG. 37 is a perspective view of an embodiment of a handle of a delivery system. [Figure 38] 38 is a bottom view of the handle of the delivery system of FIG. 37. FIG. [Figure 39] 39 is a center cross-sectional view of the handle of the delivery system of FIG. 37 from the bottom view of FIG. 38. FIG. [Figure 40] 40 is a front perspective view of the handle of the delivery system of FIG. 37. FIG. [Figure 41] 41 is a perspective cross-sectional view of the handle of the delivery system of FIG. 37 taken along line AA of FIG. [Figure 42] 42 is a perspective cross-sectional view of the handle of the delivery system of FIG. 37 taken along line BB of FIG. 39. [Figure 43] 43 is a perspective cross-sectional view of the handle of the delivery system of FIG. 37 taken along line CC of FIG. 39. FIG. [Figure 44] 44 is a perspective cross-sectional view of the handle of the delivery system of FIG. 37 taken along line DD of FIG. 39. FIG. [Figure 45] 45 is a perspective cross-sectional view of the handle of the delivery system of FIG. 37 taken along line EE of FIG. [Figure 46] FIG. 46 is a side view of an embodiment of a nosecone. [Figure 47] 47 is a cross-sectional view of the nosecone of FIG. 46 taken along line AA of FIG. [Figure 48] FIG. 48 is a side view of an embodiment of a nosecone including markers. [Figure 49] FIG. 49 shows an echocardiogram. [Figure 50] FIG. 50 is a side view of an embodiment of a nosecone including markers. [Figure 51] FIG. 51 is a perspective view of an embodiment of a nosecone including markers. [Figure 52] FIG. 52 is a perspective view of an embodiment of a nosecone including markers. [Figure 53] FIG. 53 is a perspective view of an embodiment of a nosecone including markers. [Figure 54] FIG. 54 is a cross-sectional view showing an embodiment of a nosecone including markers. [Figure 55] FIG. 55 is a perspective view, partially in perspective, of an embodiment of a nosecone including markers. [Figure 56] FIG. 56 is a perspective view of the nosecone of FIG. [Figure 57] FIG. 57 is a perspective view of an embodiment of a nosecone including markers. [Figure 58] FIG. 58 is a cross-sectional view showing an embodiment of an outer sheath including a marker. [Figure 59] FIG. 59 is a cross-sectional view showing the marker of FIG. [Figure 60] FIG. 60 shows an echocardiogram. [Figure 61] FIG. 61 is a schematic diagram showing a transseptal delivery technique. [Figure 62] FIG. 62 is a schematic diagram showing a valve prosthesis positioned within the native mitral valve. [Figure 63] FIG. 63 shows a valve prosthesis frame positioned within the heart. [Figure 64] FIG. 64 illustrates steps in a method for delivering a valvular prosthesis to an anatomical location. [Figure 65] FIG. 65 illustrates steps in a method for delivering a valvular prosthesis to an anatomical location. [Figure 66] FIG. 66 illustrates steps in a method for delivering a valvular prosthesis to an anatomical location. [Figure 67A] FIG. 67A illustrates a method for a rail delivery system. [Figure 67B] FIG. 67B illustrates a method for a rail delivery system. [Figure 68] FIG. 68 is a side view showing an embodiment of an implant in the form of a valve prosthesis that can be delivered using the delivery systems described herein. [Figure 69] FIG. 69 illustrates an embodiment of an implant in the form of a valve prosthesis that can be delivered using the delivery systems described herein. [Figure 70] FIG. 70 is a cross-sectional view showing the arms of the implant extending from the capsule. [Figure 71] FIG. 71 is a cross-sectional view showing the distal end of the capsule extending radially outward. [Figure 72]FIG. 72 is a cross-sectional view showing a capsule having a distal end configured to extend radially outward. [Figure 73] FIG. 73 is a cross-sectional view of the capsule shown in FIG. [Figure 74A] FIG. 74A is a side view showing a capsule with a pull tether connected to a nosecone. [Figure 74B] FIG. 74B is a side view showing the capsule shown in FIG. 74A bent from the position shown in FIG. 74A. [Figure 75A] FIG. 75A is a side view showing the capsule and nosecone of the delivery system. [Figure 75B] FIG. 75B is a side view of the capsule and nosecone of the delivery system shown in FIG. 75A. [Figure 76A] FIG. 76A is a perspective view of a capsule of a delivery system. [Figure 76B] FIG. 76B is a perspective view of the capsule of the delivery system shown in FIG. 76A. [Figure 77A] FIG. 77A is a perspective view showing the capsule of the delivery system. [Figure 77B] FIG. 77B is a perspective view of the capsule of the delivery system shown in FIG. 77A. [Figure 78A] FIG. 78A is a perspective view showing the capsule of the delivery system. [Figure 78B] FIG. 78B is a perspective view of the capsule of the delivery system shown in FIG. 78A. [Figure 79] FIG. 79 is a side view showing a steerable elongate shaft. [Figure 80] 80 is a side view of an elongate shaft including an implant that slides along the steerable elongate shaft shown in FIG. 79. FIG. [Figure 81] 81 is a side view of an elongate shaft including an implant that slides along the steerable elongate shaft shown in FIG. 79. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0038] The present specification and drawings provide aspects and features of the delivery system and method disclosure in the context of several embodiments. The delivery systems and methods may be configured for use within a patient's vasculature, such as for replacing a patient's native heart valve. These embodiments may be described in the context of replacing a particular valve, such as a patient's aortic, tricuspid, or mitral valve. However, it should be understood that the features and concepts described herein may also be applied to products other than heart valve implants. For example, the delivery systems and methods may also be applied to medical implants, such as other types of expandable prostheses, used elsewhere in the body, e.g., in arteries, veins, or other body cavities or locations. Furthermore, specific features of valves, delivery systems, etc., should not be construed as limiting, and features of any one embodiment described herein may be combined with features of other embodiments, as desired and appropriate. While some of the embodiments described herein are described in the context of a transfemoral delivery approach, it should be understood that these embodiments may also be used with other delivery approaches, such as a transapical or transjugular approach. Furthermore, it should be understood that some of the features described in connection with some embodiments, including those described in connection with various delivery techniques, may be incorporated into other embodiments.

[0039] FIG. 1 illustrates an embodiment of a delivery system 10 in accordance with embodiments of the present disclosure. The delivery system 10 can be used to position an implant, such as a prosthetic replacement heart valve, within the body. In some embodiments, the delivery system 10 may use a dual-plane deflection technique to properly deliver the implant. The replacement heart valve can be delivered to the patient's mitral annulus or other heart valve location in a variety of ways, including open surgery, minimally invasive surgery, and percutaneous or transcatheter delivery through the patient's vasculature. While the delivery system 10 may be described in certain embodiments with reference to a percutaneous delivery technique, and more particularly, a transfemoral delivery technique, it should be understood that the features of the delivery system 10 can also be applied to other delivery systems, such as those for transapical delivery techniques.

[0040] Delivery system 10 can be used to deploy an implant within the body, such as a replacement heart valve described elsewhere herein. Delivery system 10 can receive and / or cover a portion of an implant, such as first end 301 and second end 303 of implant 70 or prosthesis shown in FIG. 3. For example, delivery system 10 can also be used to deliver an expandable implant 70, where implant 70 includes first end 301 and second end 303, with second end 303 configured to be deployed or expanded before first end 301.

[0041] FIG. 2A further illustrates an example of an implant 70 that can be inserted into a portion of the delivery system 10, specifically the implant holding region 16. For ease of understanding, the implant is shown in FIG. 2A with only a bare metal frame shown. The implant 70, or prosthesis, can take any number of different forms. A specific example of an implant frame is shown in FIG. 3A, although other designs may be utilized in other embodiments. The implant 70 may include one or more sets of anchors, such as distal (or ventricular) anchors 80 that extend proximally when the implant frame is in the expanded configuration, and proximal (or atrial) anchors 82 (shown in FIG. 3A) that extend distally when the implant frame is in the expanded configuration. The implant may further include struts 72 that can terminate in mushroom-shaped tabs 74 at a first end 301 (shown in FIG. 3A).

[0042] In some embodiments, delivery system 10 may be used in conjunction with a replacement aortic valve, such as that shown in Figure 3B. In some embodiments, delivery system 10 may be modified to support and deliver a replacement aortic valve, although the procedures and structures described below may be used for replacement mitral and aortic valves, as well as other replacement heart valves and other implants.

[0043] Referring to FIG. 1 , delivery system 10 may include an elongate shaft 12, which may comprise a shaft assembly. Elongate shaft 12 may include a proximal end 11 and a distal end 13, with a housing in the form of a handle 14 coupled to the proximal end of elongate shaft 12. Elongate shaft 12 may be used to hold and advance the implant through the vasculature to a treatment location. Elongate shaft 12 may further include a relatively rigid, live-on (or integral) sheath 51 surrounding an interior portion of shaft 12, which may reduce undesired movement of the interior portion of shaft 12. Rib-on sheath 51 may be attached to the proximal end of shaft 12 near handle 14, such as a sheath hub.

[0044] The elongate shaft 12 and a housing in the form of a handle 14 may comprise a delivery device configured to deliver the implant 70 to an internal body location.

[0045] 2A and 2B, the elongate shaft 12 may include an implant holding region 16 (shown in FIGS. 2A-2B, where FIG. 2A shows an implant 70 and FIG. 2B shows the implant 70 removed) at its distal end. In some embodiments, the elongate shaft 12 may hold an expandable implant in a compressed state in the implant holding region 16 for advancement of the implant 70 within the body. The shaft 12 may then be used to allow controlled expansion of the implant 70 at a treatment location. In some embodiments, the shaft 12 may be used to allow sequential, controlled expansion of the implant 70, as described in more detail below. While the implant holding region 16 is shown at the distal end of the delivery system 10 in FIGS. 2A-2B, it may be located elsewhere. In some embodiments, the implant 70 may be rotated in the implant holding region 16, such as by rotation of the inner shaft assembly 18, as described herein.

[0046] As shown in the cross-sectional views of Figures 2A-2B, the distal end of delivery system 10 can include one or more assemblies, such as an outer sheath assembly 22, a central shaft assembly 21, a rail assembly 20, an inner shaft assembly 18, and a nosecone assembly 31, which are described in further detail below. In some embodiments, delivery system 10 may not include all of the assemblies disclosed herein. For example, in some embodiments, the central shaft assembly may not be fully assembled into delivery system 10. In some embodiments, these assemblies may be in a different radial order than described.

[0047] The disclosed embodiments of the delivery system 10 can utilize steerable rails within the rail assembly 20 to steer the distal end of the elongate shaft 12 to properly position the implant within the patient. As described in detail below, the steerable rail can be, for example, a rail shaft that extends through the elongate shaft 12 from the handle 14 to approximately the distal end of the elongate shaft 12. In some embodiments, the steerable rail has a distal end that terminates proximal to the implant holding area 16. A user can manipulate the bend of the rail's distal end to bend the rail in a particular direction. In preferred embodiments, the rail has multiple bends along its length to achieve multiple bending directions. The rail can flex the elongate shaft 12 in at least two planes. Because the rail pushes against other assemblies, causing them to bend as it bends, the other assemblies of the elongate shaft 12 can be configured to be steered with the rail as a single, cooperating unit to achieve full steerability of the distal end of the elongate shaft 12.

[0048] Once the rail is steered into a specific location within the patient's body, the implant 70 can be advanced along or relative to the rail by moving the other sheath / shaft relative to the rail, releasing the implant 70 into the body. For example, the rail can be bent into a desired location within the body to direct the implant 70 toward the native mitral valve. The other assemblies (e.g., outer sheath assembly 22, central shaft assembly 21, inner assembly 18, and nosecone assembly 31) can passively follow the bending of the rail. Furthermore, the other assemblies (e.g., outer sheath assembly 22, central shaft assembly 21, inner assembly 18, and nosecone assembly 31) can be advanced together (e.g., somewhat together, sequentially, simultaneously, nearly simultaneously, together, or nearly together) relative to the rail while maintaining the implant 70 in a compressed position without releasing or expanding it (e.g., within the implant holding region 16). The other assemblies (e.g., outer sheath assembly 22, central shaft assembly 21, inner assembly 18, and nosecone assembly 31) can be advanced together in a distal or proximal direction relative to the rail. In some embodiments, only the outer sheath assembly 22, central shaft assembly 21, and inner assembly 18 are advanced together on the rail. In this manner, the nosecone assembly 31 can remain in the same position. To release the implant 70 from the implant holding area 16, the assemblies can be translated relative to the inner assembly 18 individually, sequentially, or simultaneously.

[0049] 2C illustrates the sheath assemblies, specifically the outer sheath assembly 22, the central shaft assembly 21, the inner shaft assembly 18, and the nosecone assembly 31, translated together distally along the rail assembly 20. In some embodiments, the outer sheath assembly 22, the central shaft assembly 21, the inner shaft assembly 18, and the nosecone assembly 31 translate together (to some extent together, sequentially by one actuator, simultaneously, nearly simultaneously, together, nearly together). This distal translation can occur while the implant 70 remains in a compressed configuration within the implant holding region 16.

[0050] As shown in FIGS. 2A-2C and further shown in FIGS. 4-8, starting from the outermost assembly, the delivery system may include an outer sheath assembly 22 that forms a radially outer covering or sheath surrounding the implant retention region 16 to prevent radial expansion of the implant. Specifically, the outer sheath assembly 22 may prevent radial expansion of the distal end of the implant. Moving radially inward, and referring to FIG. 5, the central shaft assembly 21 may comprise a central shaft hypotube 43 whose distal end is attached to an outer retention member 42 or outer retention ring for radially retaining a portion of the implant, such as the proximal end of the implant 70, in a compressed configuration. The central shaft assembly 21 may be located within the lumen of the outer sheath assembly 22. Moving further inward, and referring to FIG. 6A, the rail assembly 20 may be configured to be steerable, as described above and further below. The rail assembly 20 may be located within the lumen of the central shaft assembly 21. Continuing inward, and referring to FIG. 7, the inner shaft assembly 18 may comprise an inner shaft having a distal end attached to an inner retaining member or inner retaining ring 40 (e.g., a PEEK ring) for axially retaining an implant, e.g., the proximal end of the implant. The inner shaft assembly 18 may be located within the lumen of the rail assembly 20. Further, referring to FIG. 8, the radially innermost assembly may be a nosecone assembly 31 including a nosecone shaft 27 having a distal end connected to a nosecone 28. The nosecone 28 may have a tapered tip and form the distal end of the elongate shaft 12. The nosecone assembly 31 is preferably located within the lumen of the inner shaft assembly 18. The nosecone assembly 31 may include a lumen for passing a guidewire.

[0051] The elongate shaft 12 and its assemblies, more particularly the nosecone assembly 31, inner assembly 18, rail assembly 20, central shaft assembly 21, and outer sheath assembly 22, can be collectively configured to deliver an implant 70 located within the implant holding area 16 (shown in FIG. 2A ) to a treatment location. One or more of the assemblies can then be moved to allow the implant 70 to be released at the treatment location. For example, one or more of the assemblies can be moved relative to one or more of the other assemblies. The implant 70 can be controllably loaded into the delivery system 10 and subsequently disposed within the body. Additionally, the handle 14 can provide manipulation of the rail assembly 20 to allow bending / flexion / maneuvering of the distal end of the elongate shaft 12.

[0052] 2A-2C, the inner retaining member 40, the outer retaining member 42, and the outer sheath assembly 22 can cooperate to hold the implant 70 in a compressed configuration. In FIG. 2A, the inner retaining member 40 is shown engaging struts 72 (numbered in FIG. 3A) on the proximal end 301 of the implant 70. For example, slots located between radially extending teeth on the inner retaining member 40 can receive and engage struts 72 (numbered in FIG. 3A), which may terminate in mushroom-shaped tabs 74 on the proximal end of the implant 70. The central shaft assembly 21 can be positioned over the inner retaining member 40 such that the first end 301 (numbered in FIG. 3A) of the implant 70 is captured between the inner retaining member 40 and the outer retaining member 42, thereby securely attaching it to the delivery system 10 between the central shaft assembly 21 and the inner retaining member 40. The outer sheath assembly 22 can be positioned over the second end 303 (numbered in FIG. 3A) of the implant 70 .

[0053] The outer retention member 42 can be attached to the distal end of the central shaft hypotube 43, which can be attached at its proximal end to the proximal tube 44 (numbering shown in FIG. 5 ), which can be attached at its proximal end to the handle 14. The outer retention member 42 can provide additional stability to the implant 70 when in a compressed state. The outer retention member 42 can be positioned over the inner retention member 40 so that the proximal end of the implant 70 is captured therebetween, thereby providing a secure attachment to the delivery system 10. The outer retention member 42 can enclose a portion of the implant 70, particularly the first end 301, to prevent the implant 70 from expanding. Furthermore, the first end 301 of the implant 70, which is retained within the outer retention member 42, can be exposed by translating the central shaft assembly 21 proximally relative to the inner assembly 18 and into the outer sheath assembly 22. In this manner, the outer retention member 42 can be used to secure the implant 70 to the delivery system 10 or to aid in the release of the implant 70 from the delivery system 10. The outer retention member 42 may have a cylindrical or elongated tubular shape and may also be referred to as an outer retention ring, but is not limited to any particular shape.

[0054] The central shaft hypotube 43 itself (numbered in FIG. 5 ) can be constructed of, for example, high-density polyethylene (HDPE), as well as other suitable materials described herein. The central shaft hypotube 43 can be constructed of a longitudinally pre-compressed HDPE tube, which can provide certain advantages. For example, the pre-compressed HDPE tube can apply a distal force to the outer retention member 42, thereby preventing unintended, inadvertent, and / or premature release of the implant 70. Specifically, the distal force exerted by the central shaft hypotube 43 can maintain the distal end of the outer retention member 42 distal to the inner retention member 40, thereby preventing the outer retention member 42 from moving proximally relative to the inner retention member 40 before a user desires to release the implant 70. This is also true when the elongate shaft 12 is deflected at an acute angle.

[0055] As shown in FIG. 2A , the distal anchor 80 (numbered in FIG. 3A ) can be positioned in a delivery configuration in which the distal anchor 80 points generally distally (pointing axially away from the main body of the implant frame and the handle of the delivery system, as shown). The distal anchor 80 can be constrained in this delivery configuration by the outer sheath assembly 22. Thus, when the outer sheath 22 is retracted proximally, the distal anchor 80 can flip (e.g., bend approximately 180 degrees) to the deployed configuration (e.g., pointing generally proximally). FIG. 2A also shows the proximal anchor 82 extending distally within the outer sheath assembly 22 in the delivery configuration. In other embodiments, the distal anchor 80 can be held pointing generally proximally in the delivery configuration and pressed against the body of the implant frame.

[0056] The delivery system 10 may be provided to the user with the implant 70 pre-installed. In other embodiments, the implant 70 may be loaded into the delivery system 10 shortly before use, such as by a doctor or nurse.

[0057] 4-8 show additional views of delivery system 10 with various assemblies translated proximally, as will be described in detail.

[0058] Starting with the outermost assembly shown in FIG. 4, the outer sheath assembly 22 may include an outer proximal shaft 102 attached at its proximal end directly to the handle 14 and an outer hypotube 104 attached at its distal end. A capsule 106 may then be attached to approximately the distal end of the outer hypotube 104. In some embodiments, the capsule 106 may be 28 French or smaller in size. These components of the outer sheath assembly 22 may form a lumen for passing other subassemblies therethrough.

[0059] The outer proximal shaft 102 may be a tube, preferably constructed of plastic, but may also be a metal hypotube or other material. The outer hypotube 104 may, in some embodiments, be a metal hypotube that may be notched or slotted, as described in more detail below. The outer hypotube 104 may be coated or encapsulated with a layer of ePTFE, PTFE, or other polymer / material so that the outer surface of the outer hypotube 104 is generally smooth.

[0060] The capsule 106 can be located at the distal end of the outer hypotube 104. The capsule 106 can be a tube constructed of a plastic or metal material. In some embodiments, the capsule 106 is constructed of ePTFE or PTFE. In some embodiments, the capsule 106 is relatively thick to prevent tearing and help maintain the self-expanding implant in a compressed configuration. In some embodiments, the material of the capsule 106 is the same material as the coating of the outer hypotube 104. As shown, the capsule 106 can have a larger diameter than the outer hypotube 104, but in some embodiments, the capsule 106 can have a similar diameter to the hypotube 104. In some embodiments, the capsule 106 can include a larger diameter distal portion and a smaller diameter proximal portion. In some embodiments, there can be a step or taper between the two portions. The capsule 106 can be configured to hold the implant 70 in a compressed position within the capsule 106. Further structural details of the capsule 106 according to various embodiments are discussed below.

[0061] The outer sheath assembly 22 is configured to be independently slidable relative to the other assemblies, and furthermore, the outer sheath assembly 22, along with the central shaft assembly 21, inner assembly 18, and nosecone assembly 31, can slide distally and proximally relative to the rail assembly 2.

[0062] In embodiments, a hydrophilic layer may be applied to the elongate shaft of the delivery system 10, and particularly to the outer sheath assembly 22. The outer surface of the outer sheath assembly 22 may include a hydrophilic layer, which may reduce friction of the outer sheath assembly 22 as the elongate shaft is threaded through a patient's vasculature. The hydrophilic layer may cover the entire outer surface of the outer sheath assembly 22, may cover only the outer surface of the capsule 106, or may cover other components of the delivery system 10, depending on the embodiment.

[0063] In embodiments, the hydrophilic layer may be applied to a surface of the outer sheath assembly 22 that includes expanded polytetrafluoroethylene (ePTFE). The ePTFE surface may form the outer surface of the outer sheath assembly 22, which is then covered with a hydrophilic layer, which then becomes the outer surface of the outer sheath assembly 22. A process may be utilized in which the hydrophilic layer bonds to the ePTFE surface, with the plasma layer acting as an intermediate or tie layer between the ePTFE surface and the hydrophilic layer. Thus, in embodiments, the ePTFE outer surface may be provided, and then a plasma layer may be applied to the ePTFE outer surface. A hydrophilic layer may then be applied to the plasma layer (with the plasma layer acting as an intermediate layer).

[0064] In embodiments, other intermediate or tie layers may be utilized, for example, in embodiments, chemical etching or methods may be utilized as intermediate or tie layers.

[0065] In embodiments, the hydrophilic layer may be comprised of the PhotoLink® family of reagents, such as Photo-Polyvinylpyrrolidone (PV), Photo-Polyacrylamide (PA), and Photo-Crosslinker (PR), as well as Kollidon® non-photo polymer povidone reagents. In other embodiments, other formulations of hydrophilic layers may be utilized. In embodiments, the plasma layer may include a plasma hydroxyl treatment coating, which may be comprised of carbon, hydrogen, and oxygen species. In other embodiments, other forms of plasma layers may be utilized. The hydrophilic layers and / or intermediate or tie layers disclosed herein may be utilized alone or in conjunction with any of the other devices, systems, or methods disclosed herein.

[0066] Continuing radially inward, the next assembly is the central shaft assembly 21. Figure 5 is a view similar to Figure 4, but with the outer sheath assembly 22 removed to expose the central shaft assembly 21.

[0067] The central shaft assembly 21 can include a central shaft hypotube 43 generally attached at its proximal end to a central shaft proximal tube 44, which can be attached at its proximal end to the handle 14, and an outer retaining ring 42 located at the distal end of the central shaft hypotube 43. Thus, the outer retaining ring 42 can be attached generally to the distal end of the central shaft hypotube 43. These components of the central shaft assembly 21 can form a lumen for passing other subassemblies therethrough.

[0068] As with the other assemblies, the central shaft hypotube 43 and / or the central shaft proximal tubing 44 can include tubing such as hypodermic tubing or hypotubes (not shown). These tubing can be constructed from any one of a number of different materials, such as nitinol, stainless steel, and medical-grade plastic. These tubing can be single-piece tubing or multiple pieces connected together. Using multiple pieces of tubing allows for different properties, such as different stiffness and flexibility, in different sections. The central shaft hypotube 43 can be a metallic hypotube, which in some embodiments may be slit or slotted, as described in more detail below. The central shaft hypotube 43 can be coated or encapsulated with a layer of ePTFE, PTFE, or other material such that the outer surface of the central shaft hypotube 43 is substantially smooth.

[0069] The outer retaining ring 42 can be configured as a prosthesis retention feature that can be used to engage the implant 70, as described with reference to FIG. 2A . For example, the outer retaining ring 42 can be a ring or covering configured to radially cover struts 72 on the implant 70. The outer retaining ring 42 can also be considered part of the implant retaining region 16 and can be at the proximal end of the implant retaining region 16. With struts or other portions of the implant 70 engaged with the inner retaining member 40, described below, the outer retaining ring 42 can cover both the implant 70 and the inner retaining member 40 to secure the implant 70 on the delivery system 10. Thus, the implant 70 can be sandwiched between the inner retaining member 40 of the inner shaft assembly 18 and the outer retaining ring 42 of the central shaft assembly 21.

[0070] The central shaft assembly 21 is arranged to be independently slidable relative to the other assemblies, and further, the central shaft assembly 21, along with the outer sheath assembly 22, the inner shaft assembly 18, and the nosecone assembly 31, can slide distally and proximally relative to the rail assembly 20.

[0071] Next, radially inward of the central shaft assembly 21 is the rail assembly 2. FIG. 6A is a view similar to FIG. 5, but with the central shaft assembly 21 removed, exposing the rail assembly 20. FIG. 6B further illustrates a cross-section of the rail assembly 20, revealing the pull wires. The rail assembly 20 may generally include a rail shaft 132 (or rail) attached at its proximal end to the handle 14. The rail shaft 132 may include a rail proximal shaft 134 attached at its proximal end directly to the handle, and a rail hypotube 136 attached to the distal end of the rail proximal shaft 134. The rail hypotube 136 may further include an atraumatic rail tip at its distal end. Additionally, the distal end of the rail hypotube 136 may abut the proximal end of the inner retaining member 40, as shown in FIG. 6. In some embodiments, the distal end of the rail hypotube 136 may be spaced apart from the inner retaining member 40. These components of the rail shaft assembly 20 may form lumens for the passage of other subassemblies.

[0072] As shown in FIGURE 6B, one or more pull wires are attached to the inner surface of the rail hypotube 136 that can be used to apply force to the rail hypotube 136 and steer the rail assembly 20. The pull wires can extend distally from a knob in the handle 14, described below, to the rail hypotube 136. In some embodiments, the pull wires can be attached at different longitudinal locations on the rail hypotube 136 to provide multiple bend positions in the rail hypotube 136, allowing for multi-dimensional steering.

[0073] In some embodiments, the distal pull wire 138 can extend to the distal section of the rail hypotube 136, and two proximal pull wires 140 can extend to the proximal section of the rail hypotube 136, although other numbers of pull wires can be used, and this particular number of pull wires is not limiting. For example, two pull wires can extend to a distal location and one pull wire can extend to a proximal location. In some embodiments, ring-like structures attached to the interior of the rail hypotube 136, called pull wire connectors, such as the proximal ring 137 and distal ring 135, can be used as attachment locations for the pull wires. In some embodiments, the rail assembly 20 can include the distal ring 135, which can include a distal pull wire connector, and the proximal ring 137 can include a proximal pull wire connector. In some embodiments, the pull wires can be directly connected to the inner surface of the rail hypotube 136.

[0074] The distal pull wire 138 can be connected (either by itself or via a connector 135) to the generally distal end of the rail hypotube 136. The proximal pull wire 140 can be connected (either by itself or via a connector 137) approximately one-quarter, one-third, or one-half of the length of the rail hypotube 136 from the proximal end. In some embodiments, the distal pull wire 138 can be routed through a small diameter pull wire lumen 139 (e.g., a tube, hypotube, cylinder) attached to the inside of the rail hypotube 136. This prevents the wire 138 from pulling on the rail hypotube 136 proximal to the distal connection. Additionally, the lumen 139 can act as a compression coil to stiffen the proximal portion of the rail hypotube 136 and prevent undesired bending. Thus, in some embodiments, the lumen 139 is located only in the proximal half of the rail hypotube 136. In some embodiments, multiple lumens 139, such as longitudinally spaced or adjacent lumens, can be used per distal wire 138. In some embodiments, a single lumen 139 is used per distal wire 138. In some embodiments, the lumen 139 can also extend into the distal half of the rail hypotube 136. In some embodiments, the lumen 139 is attached to the outer surface of the rail hypotube 136. In some embodiments, no lumen 139 is used.

[0075] For the pair of proximal pull wires 140, the wires can be spaced approximately 180 degrees apart to allow for bidirectional steering. Similarly, if a pair of distal pull wires 138 is used, the wires can also be spaced approximately 180 degrees apart to allow for bidirectional steering. In some embodiments, the pair of distal pull wires 138 and the pair of proximal pull wires 140 can be spaced approximately 90 degrees apart. In some embodiments, the pair of distal pull wires 138 and the pair of proximal pull wires 140 can be spaced approximately 0 degrees apart. However, other pull wire locations can be used, and this particular pull wire location is not limiting. In some embodiments, the distal pull wires 138 can be routed within a lumen 139 attached within the lumen of the rail hypotube 136. This can prevent axial forces on the distal pull wires 138 from causing bending of the proximal section of the rail hypotube 136.

[0076] The rail assembly 20 is slidably disposed over the inner shaft assembly 18 and the nosecone assembly 31. In some embodiments, the outer sheath assembly 22, the central shaft assembly 21, the inner shaft assembly 18, and the nosecone assembly 31 can be configured to slide proximally and distally along or relative to the rail assembly 20, for example, with or without flexing the rail assembly 20. In some embodiments, the outer sheath assembly 22, the central shaft assembly 21, the inner shaft assembly 18, and the nosecone assembly 31 can be configured to hold the implant 70 in a compressed position when they simultaneously slide along or relative to the rail assembly 20.

[0077] Continuing radially inward, the next assembly is the inner shaft assembly 18. Figure 7 is similar to Figure 6A, but with the rail assembly 20 removed to expose the inner shaft assembly 18.

[0078] The inner shaft assembly 18 may include an inner shaft 122 that is generally attached at its proximal end to the handle 14, and an inner retaining ring 40 located at the distal end of the inner shaft 122. The inner shaft 122 itself may be comprised of an inner proximal shaft 124 that is attached directly to the handle 14 at its proximal end, and a distal section 126 that is attached to the distal end of the inner proximal shaft 124. Thus, the inner retaining ring 40 may generally be attached to the distal end of the distal section 126. These components of the inner shaft assembly 18 may form a lumen for passing other subassemblies therethrough.

[0079] Similar to the other assemblies, the inner proximal shaft 124 can include a tube, such as a hypotube or hypotube (not shown). The tube can be constructed from any one of a number of different materials, such as nitinol, cobalt chrome, stainless steel, and medical-grade plastic. The tube can be a single-piece tube or multiple pieces connected together. A multi-piece tube can provide different properties, such as different stiffness and flexibility, in different sections. The distal section 126 can be a metallic hypotube, which in some embodiments can be slit or slotted, as described in more detail below. The distal section 126 can be coated or encapsulated with a layer of ePTFE, PTFE, or other material so that the outer surface of the distal section 126 is substantially smooth.

[0080] The inner retention member 40 can be configured as an implant retention mechanism that can be used to engage with the implant 70, as described with reference to FIG. 2A . For example, the inner retention member 40 can be a ring and include a plurality of slots configured to engage with struts 72 on the implant 70. The inner retention member 40 can also be considered part of the implant retention region 16 and can be at the proximal end of the implant retention region 16. With struts or other portions of the implant 70 engaged with the inner retention member 40, the outer retention ring 42 can cover both the prosthesis and the inner retention member 40 to secure the prosthesis on the delivery system 10. Thus, the implant 70 can be sandwiched between the inner retention member 40 of the inner shaft assembly 18 and the outer retention ring 42 of the central shaft assembly 21.

[0081] The inner shaft assembly 18 is arranged to be independently slidable relative to the other assemblies, and further, the inner assembly 18, along with the outer sheath assembly 22, the central shaft assembly 21, and the nosecone assembly 31, can slide distally and proximally relative to the rail assembly 20.

[0082] Moving further radially inward from the inner shaft assembly 18 is the nosecone assembly 31, also shown in FIG. 8. This may be a nosecone shaft 27, which in some embodiments may have a nosecone 28 at its distal end. The nosecone 28 may be constructed of polyurethane for atraumatic insertion and to minimize damage to the venous vasculature. The nosecone 28 may also be radiopaque to provide visualization under fluoroscopy.

[0083] The nosecone shaft 27 may include a lumen sized and configured to slidably accommodate a guidewire so that the delivery system 10 can be advanced over the guidewire within the vasculature. However, embodiments of the system 10 described herein may not use a guidewire, and therefore the nosecone shaft 27 may be solid. The nosecone shaft 27 may be connected from the nosecone 28 to the handle or may be composed of different segments, such as other assemblies. Additionally, the nosecone shaft 27 may be composed of different materials, such as plastic or metal, as described in detail above.

[0084] In some embodiments, the nosecone shaft 27 includes a guidewire shield 1200 positioned over a portion of the nosecone shaft 27. Examples of such guidewire shields can be seen in FIGS. 9A-9B. In some embodiments, the guidewire shield 1200 can be proximal to the nosecone 28. In some embodiments, the guidewire shield 1200 can be translatable along the nosecone shaft 27. In some embodiments, the guidewire shield 1200 can be locked in place along the nosecone shaft 27. In some embodiments, the guidewire shield 1200 can also be positioned at least partially within the nosecone 28.

[0085] Advantageously, the guidewire shield 1200 can allow for smooth movement of the guidewire loaded with the implant 70 and can also provide a large diameter axial landing zone at the distal end of the implant 70 so that the distal end of the implant 70 can properly expand and be deployed in a uniform radial configuration. This uniformity allows for proper expansion. Furthermore, the guidewire shield 1200 can prevent kinking or breaking of the nosecone shaft 27 during compression / crimping of the implant 70, which can apply large compressive forces to the nosecone shaft 27. Because the implant 70 can be crimped onto the guidewire shield 1200 instead of directly onto the nosecone shaft 27, the guidewire shield 1200 can provide a protective surface.

[0086] As shown in FIG. 9A, the guidewire shield 1200 can include a lumen 1202 configured to surround the nosecone shaft 27. The guidewire shield 1200 can include a large-diameter distal end 1204 and a small-diameter proximal end 1206. In some embodiments, the dimensional change between the two ends can be tapered or can be a step 1208, as shown in FIG. 9A. The distal end 1204 can include several recesses 1210 to facilitate a user grip, although these need not be included in all embodiments. Both the proximal end 1206 and the distal end 1204 can be generally cylindrical, although the particular shape of the guidewire shield 1200 is not limiting.

[0087] The distal end of implant 70 can be crimped into radial contact with proximal end 1206 of guidewire shield 1200, allowing implant 70 to expand appropriately around the circumference of proximal end 1206 of guidewire shield 1200. In some embodiments, the distal end of implant 70 can longitudinally abut the proximal end of distal end 1204 (e.g., at step 1208), thereby providing a longitudinal stop.

[0088] 9B illustrates an alternative embodiment of a guidewire shield 1200' having a more tapered configuration. As shown, the proximal end 1206' of the guidewire shield 1200' can have a single radially outward taper 1208' to the distal end 1204' of the guidewire shield 1200', which can be generally cylindrical. The guidewire shield 1200' can also include an inner lumen 1202' for receiving the nosecone shaft 27.

[0089] The nosecone assembly 31 is arranged to be independently slidable relative to the other assemblies, and further, the nosecone assembly 31, along with the outer sheath assembly 22, the central shaft assembly 21, and the inner assembly 18, can slide distally and proximally relative to the rail assembly 20.

[0090] In some embodiments, the nosecone shaft 27 may be constructed of a nitinol material. This material may allow for flexibility of the nosecone shaft 27 while making the nosecone shaft 27 resilient and able to return to an undeflected state without kinking or breaking the shaft 27. Additionally, this material is relatively strong, allowing the delivery system 10 to flex and for the nosecone shaft 27 to withstand forces applied to the shaft 27 by the delivery system 10 during deployment of, or possibly retrieval of, the implant from the delivery system 10. In some embodiments, the nosecone shaft 27 may include a hypotube including a cut pattern that may increase the flexibility of the shaft 27 and reduce the likelihood of deformation of the shaft 27.

[0091] In embodiments, if the nosecone shaft 27 is constructed from a nitinol material, the guidewire shield 1200, 1200' may not be necessary. For example, a nitinol nosecone shaft 27 may be able to withstand the compressive / crimping forces of the implant 70 on the shaft 27, and therefore, the guidewire shield 1200, 1200' may not be necessary. However, in embodiments, the guidewire shield 1200, 1200' may be utilized in conjunction with a nosecone shaft 27 constructed from a nitinol material. The nitinol nosecone shafts described herein may be utilized alone or in conjunction with any of the other devices, systems, or methods disclosed herein.

[0092] In some embodiments, one or more spacer sleeves (not shown) can be used between different assemblies of the delivery system 10. For example, a spacer sleeve can be concentrically positioned between the central shaft assembly and the rail assembly 20, generally between the central shaft hypotube 43 and the rail hypotube 136. In some embodiments, a spacer sleeve can be substantially embedded in the hypotube 43 of the central shaft assembly 21, such as on the inner surface of the central shaft assembly 21. In some embodiments, a spacer sleeve can be concentrically positioned between the rail assembly 20 and the inner assembly 18, generally within the rail hypotube 136. In some embodiments, a spacer sleeve can be used between the outer sheath assembly 22 and the central shaft assembly 21. In some embodiments, a spacer sleeve can be used between the inner assembly 18 and the nosecone assembly 31. In some embodiments, four, three, two, or one of the spacer sleeves described above can be used. A spacer sleeve can be used in any of the above locations.

[0093] The spacer sleeve can be constructed of a polymeric material, such as braided Pebax®, and can have an inner diameter lined with, for example, PTFE, although this particular material is not limiting. The spacer sleeve is advantageous because it can reduce friction between the steerable rail assembly 20 and its surrounding assemblies. Thus, the spacer sleeve can act as a buffer between the rail assembly 20 and the inner assembly 18 / nose cone assembly 31. Additionally, the spacer sleeve can absorb any radial gap between the assemblies to prevent compression or serpentine of the assemblies during steering. In some embodiments, the spacer sleeve can include notches or slots to facilitate bending of the spacer sleeve. In some embodiments, the spacer sleeve can lack any slots and be a smooth cylindrical feature.

[0094] The spacer sleeve can be mechanically accommodated by the other lumens and components, and is not physically attached to any of the other components, allowing the spacer sleeve to "float" in the area. The floating aspect of the spacer sleeve allows it to move where needed during deflection to provide support and / or one or more lubricious bearing surfaces. This floating aspect therefore allows the delivery system 10 to maintain deflection forces. However, in some embodiments, the spacer sleeve can also be connected to other components.

[0095] The outer sheath assembly 22, the central shaft assembly 21, the inner assembly 18, and the nosecone assembly 31 each include a shaft. The outer sheath assembly 22, the central shaft assembly 21, and the inner assembly 18 each include a sheath having a lumen. The nosecone assembly 31 includes a sheath having a lumen in embodiments in which the nosecone assembly 31 includes a lumen along which a guidewire extends.

[0096] As described above, the outer sheath assembly 22, central shaft assembly 21, inner assembly 18, and rail assembly 20 can house the outer hypotube 104, central shaft hypotube 43, distal section 126, and rail hypotube 136, respectively. Each of these hypotubes / sections / shafts can be laser cut to include several slots to create the tortuous path followed by the delivery system. While various slot assemblies are described below, it will be understood that any of these hypotubes can have any of the slot configurations described below. Figures 10-14 show the various hypotubes in isolation.

[0097] The outer hypotube 104 shown in FIG. 10 can generally be comprised of one or more metal coils. In some embodiments, the outer hypotube 104 can be comprised of a proximal metal coil 107 and a distal metal coil 108. The proximal metal coil 107 and the distal metal coil 108 can be longitudinally separated by a tube portion 110, as shown in FIG. 10. However, in some embodiments, the proximal metal coil 107 and the distal metal coil 108 are connected. To form the complete outer hypotube 104, the proximal metal coil 107 and the distal metal coil 108 can be connected to the outer surface of the tube portion 110, for example, at the distal end of the proximal metal coil 107 and the proximal end of the distal metal coil 108. In some embodiments, the proximal metal coil 107 and the distal metal coil 108 are substantially identical. In some embodiments, the proximal metal coil 107 and the distal metal coil 108 differ, for example, in terms of coil-to-coil spacing, curvature, diameter, etc. In some embodiments, the distal metal coil 108 has a larger diameter than the proximal metal coil 107, such as when the distal metal coil 108 forms the larger diameter of the capsule 106. In some embodiments, they have the same diameter. In some embodiments, one or both of the metal coils 108 / 107 can form the capsule 106. These coils can be coated with a polymer layer, as described in more detail below in connection with the capsule structure. This coil structure can allow the outer hypotube 104 to follow a rail in any desired direction.

[0098] Continuing radially inward, FIGS. 11-12B show that the central shaft hypotube 43 can be a metallic laser-cut hypotube, such as a laser-cut Nitinol hypotube. FIG. 12A shows the flat pattern of FIG. 11. As shown in these figures, the hypotube 43 can have several cuts that form slots / openings in the hypotube. In some embodiments, the cut pattern can be the same throughout. In some embodiments, the central shaft hypotube 43 can have different sections with different cut patterns.

[0099] For example, the proximal end of the central shaft hypotube 43 can be a first section 211 having multiple circumferentially extending cut pairs 213 spaced along its length. Generally, two slots are cut around each circumferential location, approximately halfway around the circumference. Thus, two spines 215 are formed between the cuts 213, extending the entire length of the first section 211. The cut pairs 213 can be comprised of a first, narrow cut 217. The second cut 221 of each cut pair 213 can be thicker than the first cut 217, such as 1, 2, 3, 4, or 5 times thicker. In some embodiments, the second cut 217 can have approximately the same longitudinal thickness throughout the entire cut. Each cut of a cut pair 213 can also terminate in a drop shape 219 in some embodiments to facilitate bending.

[0100] Continuing distally, the central shaft hypotube 43 can include a second section 220 having several cut pairs 222. Similar to the first section 211, the second section 220 can have multiple circumferentially extending cuts spaced longitudinally along the second section 220. Generally, two cuts (e.g., a pair of cut pairs 222) are cut around each circumferential location, approximately halfway around the circumference. Thus, a “spine” 224 can be formed between the cuts, extending the entire length of the second section 220. Each cut pair 222 can include a first cut 226 that is generally thin and has no particular shape (i.e., can have the same appearance as the cut 213 of the first section 211) and a second cut 228 that is significantly thicker longitudinally than the first cut 226. The second cuts 228 can be curved by narrowing at their ends and thickening longitudinally in their central portion. Moving longitudinally along the second section 220, each cut pair 222 can be offset approximately 45 degrees or 90 degrees from its longitudinally adjacent cut pair 222. In some embodiments, a second cut pair 222 can be offset 90 degrees from the adjacent first cut pair 222, and a third cut pair 222 adjacent to the second cut pair 222 can have the same configuration as the first cut pair 222. This repeating pattern can extend along the length of the second section 220 to provide a specific bending direction achieved by the second cut 228 of these cut pairs 222. Thus, the "backbone" or spine 224 varies in circumferential position due to the offset of adjacent slot pairs 222, which vary in position. Each notch in a notch pair 222 may also terminate in a drop shape 229 in some embodiments to facilitate bending.

[0101] Continuing distally, the central shaft hypotube 43 can have a third section 230 with several cuts. An outer retaining ring 240 can be attached to the distal end of the third section 230. The third section 230 can have circumferentially extending cut pairs 232, with each cut in the cut pair extending approximately halfway around the circumference to form two backbones or spines 234. The cut pairs 232 can be configured with a first, narrow cut 236 similar to the cut 213 described in the first section 211. The second cut 238 in each cut pair 232 can be thicker than the first cut 236, such as 1, 2, 3, 4, or 5 times thicker. In some embodiments, the second cuts 238 can have approximately the same longitudinal thickness throughout the entire cut, unlike the second cuts 228 in the second section 220. The first notches 236 and second notches 238 may be circumferentially aligned along the length of the third section 230 such that all of the first notches 236 are at the same circumferential location and all of the second notches 238 are at the same circumferential location. The second notches 238 may be aligned with one of the circumferential locations of the second notches 228 in the second section 220. Each notch in a notch pair 232 may also terminate in a drop shape 239 in some embodiments to facilitate bending.

[0102] In some embodiments, the outer retaining ring stiffener 240, which can partially or completely surround the inner retaining member 40 circumferentially, can also have several notches / slots / holes / apertures, as shown in FIGS. 11-12 . This can allow the outer retaining ring stiffener to flex along curves, especially tight curves. In some embodiments, the distal end of the stiffener 240 includes several generally circular / oval holes 242, which can continue for approximately half the length of the stiffener 240. On the proximal half, the circumferential half of the stiffener 240 can include repeating thin notches 244 spaced apart by elongated oval holes 246. For example, two circumferentially spaced elongated oval holes 246 can be located between each thin notch 244. Each notch 244 can terminate in a drop-shaped shape 219 to facilitate bending. In the other circumferential half of the proximal section, the reinforcement 240 may include several large notches 248, such as one, two, three, four, or five longitudinally spaced large notches 248. The large notches 248 may be larger in the center and taper toward each circumferential end. The large notches 248 may also include end extensions 247 to promote flexibility.

[0103] Additionally, the outer retaining ring reinforcement 240 can provide strength to reduce deployment forces, protect the implant 70 from any metal layers, and provide additional strength. In some embodiments, the reinforcement 240 is a polymer such as PTFE, although the type of polymer or material is not limiting. In some embodiments, the reinforcement 240 can be metallic. In some embodiments, the reinforcement 240 can further include an outer polymer layer / jacket, such as a Pebax® jacket, which prevents the reinforcement 240 from catching on the outer sheath assembly 22.

[0104] In certain embodiments, the outer retaining ring 42 can further include an inner liner to glide smoothly over the implant 70. The inner liner can be PTFE or etched PTFE, although this particular material is not limiting and other friction-reducing polymers can be used. As shown in FIG. 12B, to prevent delamination during loading of the implant 70, the liner 251 can be displaced to the distal end of the outer retaining ring 42. Instead, the liner 251 can be extended and inverted at the distal end to cover the distal end of the outer retaining ring 42. In some embodiments, the liner 251 can also cover the outer surface of the reinforcement 240. This can create a seamless, rounded, and reinforced tip of the liner 251. The liner 251 can completely or partially cover the outer surface of the outer retaining ring 42, for example, 1 / 4, 1 / 3, 1 / 2, 2 / 3, 3 / 4 (or more than 1 / 4, 1 / 3, 1 / 2, 3 / 4), or even the entire outer retaining ring 42. This solution has advantages over previously known methods, such as those disclosed in U.S. Pat. No. 6,622,367, which is incorporated by reference in its entirety, in which the PTFE-lined coating does not adhere as well to the reinforcement component or outer jacket. By inverting the liner 251 and fusing it to the outer retaining ring 42 and / or the reinforcement 240 and / or the outer polymeric jacket over the reinforcement 240 / outer retaining ring 42, a seamless reinforced tip can be created that can mitigate delamination. Delamination is a serious concern because a delaminated liner can tear and jam during deployment, and a delaminated layer can significantly increase loading and deployment forces. The delaminated layer can also cause lumen translation problems by clogging the shaft, thereby increasing the translation force requirements.

[0105] Next, moving radially inward again, FIG. 13 shows an embodiment of a rail hypotube 136 (distal end on the right). The rail hypotube 136 may also include several circumferential cuts in the form of slots. The rail hypotube 136 may generally be divided into several different sections. At the proximal-most end is an uncut (or unslotted) hypotube section 231. Moving distally, the next section is the proximal slotted hypotube section 233. This section includes several circumferential slots cut into the rail hypotube 136. Generally, two slots are cut around each circumferential location, approximately halfway around the circumference. Thus, between these cuts 213, two spines are formed that run the entire length of the hypotube 136. This section is one that may be guided by the proximal pull wire 140. Moving further distally, there is a location 237 where the proximal pull wire 140 may connect, thereby avoiding the cuts. This section is immediately distal to the proximal slotted section.

[0106] Further distally, after this proximal pullwire connection region, is the distal slotted hypotube section 235. This section is similar to the proximal slotted hypotube section 233, but has significantly more slots cut into it over the same length. Therefore, the distal slotted hypotube section 235 can bend more easily than the proximal slotted hypotube section 233. In some embodiments, the proximal slotted hypotube section 233 can be configured to bend approximately 90 degrees with a half-inch radius, while the distal slotted hypotube section 235 can bend approximately 180 degrees within a half-inch radius. Furthermore, as shown in FIG. 13 , the spine of the distal slotted hypotube section 235 is offset from the spine of the proximal slotted hypotube section 233. Therefore, the two sections can achieve different bending patterns and enable three-dimensional steering of the rail assembly 20. In some embodiments, the spines can be offset by 30 degrees, 45 degrees, or 90 degrees, although this particular offset is not limiting. In some embodiments, the proximal slotted hypotube section 233 can include a compression coil, which allows the proximal slotted hypotube section 233 to remain rigid for a particular bend in the distal slotted hypotube section 235.

[0107] At the distal most end of the distal slotted hypotube section 235 is a distal pullwire connection region 241 , which is again a non-slotted section of the rail hypotube 136 .

[0108] 14 , the inner assembly 18 is generally comprised of two sections. The proximal section is a hypotube 129, which may or may not be slotted. The distal section 126 at least partially overlaps the outer surface of the proximal hypotube 129 and may be designed to be particularly flexible. For example, the distal section 126 may be more flexible than any of the other shafts described herein. In some embodiments, the distal section 126 may be more flexible than any of the shafts described herein other than the nosecone shaft 27. In some embodiments, the distal section 126 may be a flexible tube or hypotube. In some embodiments, the distal section 126 may be a cable, such as a flexible cable. For example, the cable may include several strands of metal, plastic, polymer, ceramic, etc., wrapped around each other to form a rope or cable. Because the cable is highly flexible, it may bend more easily along with the rail assembly 20. Additionally, the cables may be smooth, thereby eliminating the need for any inner liner on the rail assembly 20, as the rail assembly 20 may travel over a smooth surface.

[0109] Referring to FIG. 15 , the capsule 106 can be constructed of one or more materials, such as PTFE, ePTFE, polyether block amide (Pebax®), polyetherimide (Ultem®), PEEK, urethane, nitinol, stainless steel, and / or any other biocompatible material. The capsule preferably is compliant and flexible while maintaining sufficient radial strength to maintain the replacement valve within the capsule 106 without substantial radial deformation, which could increase friction between the capsule 106 and the replacement valve or implant 70 housed therein. The capsule 106 also preferably has sufficient column strength to resist capsule buckling and sufficient tear resistance to reduce or eliminate the possibility of tearing of the replacement valve and / or breakage of the capsule 106. The flexibility of the capsule 106 can be advantageous, particularly in transseptal procedures. For example, when retracted along a curved member, e.g., when traveling over a rail assembly as described herein, capsule 106 can flex to follow the curved member without applying significant forces to the curved member that could reduce the radius of the curved member. More particularly, capsule 106 can bend and / or twist when retracted along such a curved member such that the radius of the curved member is not substantially affected.

[0110] FIG. 15 illustrates an embodiment of a capsule 106 that can be used with embodiments of the delivery system 10. The capsule 106 can include any of the materials and properties described above. Because increased flexibility can lead to decreased compression resistance, multiple implant capsules are typically used to balance compression resistance and flexibility. Thus, a choice tends to be made between compression resistance and flexibility. However, disclosed are embodiments of the capsule 106 that can achieve both high compression resistance and high flexibility. Specifically, the capsule 106 can bend in multiple directions.

[0111] In particular, metallic hypotubes can provide radial strength and compression resistance, and specific cuts, such as slots, made in the hypotube can allow flexibility to the capsule 106. In some embodiments, a thin liner and jacket, such as a polymeric layer, can surround the capsule 106 to prevent any negative interaction between the implant 70 and the capsule 106.

[0112] In some embodiments, the capsule 106 can have a particular structure that allows it to achieve advantageous properties, as shown in Figure 15. The capsule 106 can be composed of several different layers to achieve these properties.

[0113] In some embodiments, the capsule 106 can be constructed with a metal layer 404 that provides the capsule 106 with its structure. This metal layer can include a coil as described with reference to Figure 10, or it can be one or more hypotubes. The outer surface of the capsule 106 is then coated with a polymer layer, and the inner surface is coated with a liner. All of these features are described in more detail below.

[0114] As mentioned, the metal layer 404 can be, for example, a metal hypotube or a laser-cut hypotube. In some embodiments, the metal layer 404 can be a metal coil or spiral, as described in detail above with reference to FIG. 10. Without being limited thereto, the metal layer 404 can have a thickness of 0.007 inches (or about 0.007 inches).

[0115] When using metal coils such as those shown in FIG. 10, the dimensions of the coils may be the same along the entire length of the metal layer 404. However, in some embodiments, the dimensions of the coils may vary along the length of the metal layer 404. For example, the coils may vary between coils having a 0.014 inch gap and a 0.021 inch pitch (e.g., small coils), coils having a 0.020 inch gap and a 0.02 inch pitch (e.g., large coils), and coils having a 0.020 inch gap and a 0.027 inch pitch (e.g., spaced large coils). However, these particular dimensions are merely examples, and other designs may be used.

[0116] The distal-most end of the metal layer 404 can be comprised of a small coil. Proceeding proximally, the metal layer 404 can then transition to a large coil section, followed again by a small coil section, and finally, the proximal-most section can be a spaced-apart large coil. As a non-limiting example of a set of lengths, the distal-most small coil section can have a length of 10 mm (or approximately 10 mm). Proceeding proximally, the adjacent large coil section can extend over a length of 40 mm (or approximately 40 mm) to 60 mm (or approximately 60 mm). These two sections are seen in the distal metal coil 108 shown in FIG. 10. Proceeding toward the proximal metal coil 107 shown in FIG. 10, the small coil section can have a length of 10 mm (or approximately 10 mm). The remainder of the proximal metal coil 107 can be spaced-apart large coil sections. The spaced apart large coil sections may have a length of 40 mm (or about 40 mm) to 60 mm (or about 60 mm).

[0117] As mentioned, the metal layer 404 (either the coil or the hypotube) can be coated with an outer polymeric layer or jacket 402. In some embodiments, the outer polymeric layer 402 is an elastomer, although this particular material is not limiting. In some embodiments, the outer polymeric layer 402 can comprise polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE). ePTFE can have very different mechanical properties than PTFE. For example, ePTFE can be much more flexible while maintaining good tensile / elongation properties. In some embodiments, the outer polymeric layer 402 can comprise a thermoplastic elastomer such as PEBAX®. In some embodiments, the outer polymeric layer 402 can be axially prestressed prior to application to the capsule. The thickness of the outer polymeric layer 402 can be approximately 0.006 inches to 0.008 inches, although this particular thickness is not limiting.

[0118] The outer polymeric layer 402 can be applied to the metal layer 404, such as by reflowing the polymer, to form an outer jacket. In some embodiments, the outer polymeric layer 402 can be applied directly to the metal layer 404. In some embodiments, an adhesive layer 406 can be disposed between the metal layer 404 and the outer polymeric layer 402 to facilitate attachment of the outer polymeric layer to the metal layer. For example, a fluoropolymer or other soft durometer fluoroelastomer can be applied between the metal layer 404 and the outer layer 402 to adhere them and prevent delamination. In some embodiments, an adhesive layer 406 is not used.

[0119] In some embodiments, other materials can be included between the metal layer 404 and the outer polymeric layer 402 to improve properties. For example, a fluorinated ethylene propylene (FEP) section 408 can improve radial strength, especially when the implant is in compression. While the FEP layer 408 is mentioned as a particular material, other high-strength polymers, metals, or ceramics can also be used, and this particular material is not limiting. The FEP layer 408 can also act as an adhesive in some cases.

[0120] FEP sections 408 can be included at the distal and proximal ends of capsule 106. FEP sections 408 can also overlap adhesive layer 406. Thus, FEP sections 408 can be located between adhesive layer 406 and metal layer 404 or between adhesive layer 406 and outer polymeric layer 402. In some embodiments, FEP sections 408 can be located in sections of capsule 106 that do not include adhesive layer 406.

[0121] The FEP section 408 located at the distal end of the capsule 106 can have a length of 10 mm (or approximately 10 mm), although this particular length is not limiting. In some embodiments, the thickness of the FEP section 408 is approximately 0.003 inches, although the thickness may vary and is not limited by this disclosure. In some embodiments, different FEP sections 408 (e.g., the proximal and distal sections) can have different thicknesses. In some embodiments, all of the FEP layers 408 have the same thickness. Exemplary thicknesses include 0.006 inches or 0.003 inches.

[0122] Moving inward from the metal layer 404, a liner 410 can be included on its radially inner surface. The liner 410 can be constructed of a low-friction and / or high-lubricity material that allows the capsule 106 to translate over the implant 70 without catching on or damaging portions of the implant 70. In some embodiments, the liner 410 can be PTFE, which can withstand radial expansion and reduce friction with the implant 70.

[0123] In some embodiments, the liner 410 is made of ePTFE. However, it can be difficult to reflow a standard ePTFE liner 410 onto the inner layer of the capsule 106. Therefore, the ePTFE liner layer 410 can be pre-compressed before being applied onto the inner layer of the capsule 106. In some embodiments, a portion of the outer polymeric layer 402 and the liner 410 can contact one another. Therefore, the ePTFE liner 410 and / or the outer polymeric layer 402 can be axially compressed before joining the two layers. These layers can then be joined by a reflow technique during manufacturing. For example, the ePTFE liner 410 can be compressed into an axial cavity, such as by a mandrel, and the outer polymeric layer 402 can be placed on top of it. The two layers can then be reflowed (e.g., melted under pressure) to connect them. The combined layers can be slid into and / or around a metal layer 404, as described herein, and again melted under pressure to form the final capsule 106. This technique may allow the capsule 106 to remain flexible and prevent breakage / tear.

[0124] As mentioned above, the inner liner 410 can be ePTFE in some embodiments, which can have a surface friction that is approximately 15% lower than standard PTFE and approximately 40% lower than standard extruded thermoplastics used in the art.

[0125] In certain embodiments, the liner layer 410 can extend only along the inner surface of the capsule 106 and terminate at the distal end. However, to prevent delamination during loading of the implant 70, the liner 410 may not be flush to the distal end of the capsule 106. Instead, the liner 410 can be extended and everted at the distal end to cover the outer diameter of the distal end of the capsule 106 and a portion of the outer polymeric layer 402. This can create a seamless, rounded, reinforced tip of the liner 410. This solution has advantages over previously known methods, such as that disclosed in U.S. Pat. No. 6,622,367, which is incorporated by reference in its entirety, in which the PTFE-lined coating does not adhere as well to the reinforcement component or outer jacket. By everting the liner 410 and fusing it to the outer polymeric layer 402, a seamless, reinforced tip can be created that can mitigate delamination. Delamination is a serious concern because the delaminated liner can tear and clog during deployment, and the delaminated layer can significantly increase the loading and deployment forces. The delaminated layer can also cause lumen translation problems by clogging the shaft, thereby increasing the translation force requirements.

[0126] In some embodiments, another FEP section 412 can be included between the liner 410 and the metal layer 404. This FEP section 412 can be located on the distal metal coil 108 as well as on the tube 110 at the transition between the distal metal coil 108 and the proximal metal coil 107. In some embodiments, the FEP section 412 can continue partially or completely into the proximal metal coil 107.

[0127] In some embodiments, the FEP section 412 can be included in the proximal-most portion of the proximal metal coil 107. This FEP section 412 has a length of about 0.5 inches. In some embodiments, there is a longitudinal gap between the proximal-most FEP section 412 and the FEP section 412 that extends over the distal metal coil 108. In some embodiments, the FEP section 412 is continuous.

[0128] 15, metal layer 404 may terminate proximal to the edges of outer polymeric layer 402, liner 410, and FEP section 412. In that case, the thickness of a portion of adhesive layer 409 at the distal end of metal layer 404 may be increased to match the distal ends of the other layers. However, this section may be removed during manufacturing so that the distal end of metal layer 404 becomes the distal end of capsule 106 and can be covered by liner 410. In some embodiments, these extended sections distal to metal layer 404 are not used.

[0129] In embodiments, a coating layer, which may include reinforcing fibers or beads, may be applied to the capsule 106. Thus, the delivery system may include an elongate shaft having a proximal end and a distal end including an implant-retaining region configured to retain an implant. The coating layer may be on the elongate shaft and may include reinforcing fibers or beads. The coating layer may form an inner liner of the elongate shaft. The coating layer may include the inner liner 410 of the capsule 106, or a liner of another capsule disclosed herein, or may be a liner of another portion of the delivery system 10. For example, the coating layer may include a liner extending from the capsule 106 along the interior of the outer sheath assembly 22 to the handle of the delivery system 10, thus forming an inner liner of the outer sheath. In embodiments, the coating layer may be applied to other components of the delivery system 10, such as the central shaft assembly or inner shaft assembly, among others. In embodiments, the coating layer may be applied as an outer layer of one or more of these components.

[0130] The cover layer may include reinforcing fibers or beads that provide strength to the cover layer. For example, the cover layer may include a material such as polytetrafluoroethylene (PTFE) mixed with reinforcing fibers or beads. PTFE can provide a lubricious surface, which is reinforced with reinforcing fibers or beads for strength. For example, the tensile strength of the cover layer may be improved by using reinforcing fibers or beads. Furthermore, in the embodiments shown in FIGS. 16-21 that utilize hypotubes with cut patterns in the capsule, the reinforcing fibers or beads can serve to protect the implant from the cut pattern of the hypotube. The reinforcing fibers or beads may include glass, and in embodiments, silicate fibers or beads or carbon (e.g., graphite) fibers or beads.

[0131] The cover layer may further provide toughness and durability to protect any of the cut patterns (e.g., laser cut members) of the hypotubes from bending during relative translation, such as when the notched hypotubes of the capsule are retracted or advanced relative to the notched hypotubes of the central assembly, which may reduce the likelihood of binding during relative translation.

[0132] The coating layer may be comprised of a mixture of a base material (e.g., PTFE) and reinforcing fibers or beads. For example, PTFE pellets may be mixed with the reinforcing fibers or beads in a desired ratio. This mixture may be heated and then extruded to form the coating layer. The remaining portions of the delivery system 10, such as the capsule 106 and other portions of the outer sheath assembly 22, may also be formed with the coating layer. For example, the coating layer may be applied as an inner liner of the capsule 106.

[0133] The ratio of substrate (e.g., PTFE) to reinforcing fibers or beads can be set to any desired ratio. In embodiments, this ratio can be a mixture of substrate (e.g., PTFE) and reinforcing fibers and beads, with 1% to 10% being reinforcing fibers or beads. In embodiments, this ratio can be a mixture of substrate (e.g., PTFE) and reinforcing fibers and beads, with 0.5% to 25% being reinforcing fibers or beads. In embodiments, this ratio can be a mixture of substrate (e.g., PTFE) and reinforcing fibers and beads, with 0.1% to 30% being reinforcing fibers or beads. In embodiments, this ratio can be a mixture of substrate (e.g., PTFE) and reinforcing fibers and beads, with 25% or 30% being reinforcing fibers or beads.

[0134] The method may include disposing an elongate shaft at a location within a patient, the elongate shaft including an implant-retaining region for retaining an implant to be implanted within the patient, and a covering layer including reinforcing fibers or beads. The method may include retracting a capsule surrounding the implant-retaining region, the covering layer forming an inner liner of the capsule. The method may include sliding an inner liner over the implant, which may reduce friction with the implant 70 and may provide a tougher, more durable inner liner.

[0135] The method may include providing an elongate shaft and providing a coating layer including reinforcing fibers or beads. The method may include providing a mixture of PTFE and reinforcing fibers or beads, or another substrate. The mixture may be extruded with the PTFE including the reinforcing fibers or beads. The extrusion may comprise the remainder of the elongate shaft, or may include another portion of the liner or outer sheath of the elongate shaft, such as an inner liner of a capsule. The coating layers disclosed herein may be utilized alone or in conjunction with any of the other devices, systems, or methods disclosed herein.

[0136] FIG. 16 illustrates an embodiment of a hypotube 500 in a flattened configuration that can be utilized with the assemblies of the present disclosure. The hypotube 500 may be utilized as a metal layer or metal portion of one or more of the assemblies disclosed herein, and may particularly include a portion of the capsule 106, as shown in FIG. 4. The hypotube 500 may be utilized with the capsule 106 configured to surround the implant-retaining region 16 of the elongate shaft 12. The hypotube 500 may be utilized as the metal layer 404 of the capsule, as shown in FIG. 15, or in other portions of an assembly that utilizes the hypotube, or in other portions of these assemblies. The hypotube 500 may be positioned between the outer jacket and liner layers disclosed herein, among other components disclosed in embodiments herein. While shown in a flattened configuration in FIG. 16, the hypotube 500 has outer portions 512, 514 that, when connected, define the cylindrical shape of the hypotube 500, similar to the hypotube shown in FIG. 11.

[0137] The hypotube 500 may have one or more notches 502a-502h that form multiple rings 504a-504d in the hypotube 500. The notches 502a-502h may be in the shape of a slot, as shown in FIG. 16, or may have any other shape desired. The multiple rings 504a-504d may be longitudinally spaced apart from one another and extend circumferentially around the hypotube 500.

[0138] The hypotube 500 may include a first section 506, which may be a distal portion of the hypotube 500. The distal portion of the hypotube 500 may form a distal portion of the capsule 106 or a distal portion of an assembly utilized with the hypotube 500. The first section 506 may include pairs of cuts (502a and 502b in one pair and 502c and 502d in another pair). The cuts 502a and 502c may be longitudinally aligned at the same circumferential location, and the cuts 502b and 502d may be longitudinally aligned at the same circumferential location, with spines 508, 510 located between the circumferentially spaced cuts 502a and 502b. The spines 508, 510 may extend longitudinally along the hypotube 500.

[0139] 16 in a flattened configuration, when the outer portions 512, 514 of the hypotube 500 are connected to form a cylinder, the first section 506 includes a set of circumferentially extending notches 502a, 502c on one side of the hypotube 500 and a set of circumferentially extending notches 502b, 502d on the opposite side of the hypotube 500. Each notch disclosed herein may terminate in a drop-shaped configuration to facilitate bending.

[0140] Each incision in the pair 502a, 502b may extend circumferentially approximately halfway around the circumference of the hypotube 500, and similarly, each incision in the pair 502c, 502d may extend circumferentially approximately halfway around the circumference of the hypotube 500. One incision 502a, 502c in the pair may be circumferentially spaced from the other incision and may have a greater longitudinal size or thickness than the other incision 502b, 502d in the pair. The thickness of the incisions 502a, 502c may be one, two, three, four, or five times the thickness of the other incision 502b, 502d in the pair, among others. By having the incisions 502a, 502c have a larger longitudinal extent or width than the other incisions 502b, 502d, the section 506 has a deflection bias in a direction away from the incisions 502b, 502d and toward the incisions 502a, 502c. Thus, when the first section 506 bends, the spines 508, 510 may extend along the neutral axis of bending.

[0141] Thus, the first section 506 may include a section of the hypotube 500 that is biased to flex in a single direction.

[0142] The hypotube 500 may include a second section 516. The second section 516 may be located proximal to the first section 506 and may include a proximal portion of the capsule 106 or other proximal portion of an assembly utilized with the hypotube 500.

[0143] The second section 516 may include longitudinally spaced rows of notches 502e-502h that are longitudinally spaced from one another and form rings 504c-504d of the hypotube 500 that extend circumferentially around the hypotube 500.

[0144] The cuts 502e-502h may form a pair of cuts 502e and 502f and a pair of cuts 502g and 502h. Each cut in the pair 502e, 502f may extend circumferentially approximately halfway around the circumference of the hypotube 500, and similarly, each cut in the pair 502g, 502h may extend circumferentially approximately halfway around the circumference of the hypotube 500.

[0145] One notch 502e, 502h in a pair may have a greater longitudinal size or thickness than the other notch 502f, 502g in the pair. The thickness of notches 502e, 502h may be 1, 2, 3, 4, or 5 times the longitudinal thickness of the other circumferentially spaced notch 502f, 502g in the pair. The pair of notches 502e, 502f and the pair of notches 502g, 502h may be circumferentially offset from one another, by approximately 90 degrees as shown in FIG. 16 , or by another desired offset. Thus, the pair of cuts 502e, 502f and the pair of cuts 502g, 502h may form two pairs of spines 518, 520 and 522, 524, with the spines 518, 520 longitudinally aligned with the spines 508, 510 of the first section 506. The pair of spines 518, 520 may be offset from the pair of spines 522, 524 by approximately 90 degrees, as shown in FIG. 16 , or by another desired offset. The spines within each pair may be located 180 degrees apart from each other. Such a configuration may be formed by a repeating pattern of staggered cuts, including the pair of cuts 502e, 502f and the pair of cuts 502g, 502h that are offset from each other along the length of the hypotube 500. The locations of spines 518, 520, and 522, 524, and the increased longitudinal extent or width of incisions 502e, 502h, result in section 516 having a deflection bias in two directions (a first direction and a second direction), toward incision 520e and toward incision 502h. Thus, spines 518, 520, and 522, 524, respectively, may extend along a neutral axis of bending when second section 516 is bent. More bending directions (e.g., at least two bending directions) may be provided if desired.

[0146] The hypotube 500 can provide support for assembly of the delivery system 10 and can provide support for the capsule 106. The multiple cuts shown in Figure 16 can provide flexibility for the capsule 106, particularly in the direction of deflection provided by the cut pattern.

[0147] The multiple rings 504a-504d of the hypotube 500 can provide support for the capsule 106. Additionally, the multiple rings 504a-504d can allow a distal force to be applied by the capsule 106. Such a force may be applied in embodiments utilizing the capsule 106 for retrieval of an implant that may have been incompletely deployed from the implant holding area 16 (as shown in FIG. 2C). For example, when the capsule 106 is retracted to deploy the implant from the implant holding area 16, it may be desirable to retrieve the incompletely deployed implant. In this case, the capsule 106 can be pushed distally to retrieve the incompletely deployed implant and, optionally, return the implant to the implant holding area 16. The structural strength provided by the hypotube 500 can allow this distal force to be applied to retrieve the incompletely deployed implant. The multiple rings 504a-504d of the hypotube 500 can compress against one another to allow for the application of this distal force.

[0148] Additionally, the biased flexibility provided by the multiple cuts can allow the hypotube 500, and thus the capsule 106, to flex to accommodate bending of the capsule 106, which may include bending caused by translation along a bent rail assembly. The first section 506 can be biased to bend in a single direction corresponding to this bending direction of the rail assembly. The second section 516 can be biased to bend in two directions (or at least two directions) corresponding to two bending directions (or at least two bending directions).

[0149] This configuration of the hypotube 500, including the use of multiple rings 504a-504d, can allow for improved application of distal force by the capsule 106 or another portion of an assembly utilizing the hypotube 500. The multiple rings 504a-504d can contact and press against one another to allow for application of distal force. However, in particular, the bending direction of the first section 506 and second section 516 must be aligned with the bending direction of the rail assembly or other bending direction of the elongate shaft 12 to allow for the desired bending of the hypotube 500. Therefore, it may be advantageous to create a hypotube configuration that does not bias bending in one direction.

[0150] FIG. 17 illustrates one embodiment of a hypotube 600 shown in a flattened configuration that may be utilized with the assemblies of the present disclosure. The hypotube 600 may be utilized as one or more metal layers or portions of the assemblies disclosed herein, and in particular, may comprise a portion of the capsule 106 shown in FIG. 4. The hypotube 600 may be utilized with the capsule 106 configured to surround the implant-retaining region 16 of the elongate shaft 12. The hypotube 600 may be utilized as the metal layer 404 for the capsule, as shown in FIG. 15, or in other portions of an assembly utilizing the hypotube. The hypotube 600 may be positioned between the outer jacket and liner layers disclosed herein, among other components disclosed in the embodiments herein. While the hypotube 600 is shown in a flattened configuration in FIG. 17, it has outer portions 608, 610 that, when connected, form the cylindrical shape of the hypotube 600, similar to the hypotube shown in FIG. 11.

[0151] The hypotube 600 has one or more cuts 602a-c that form multiple rings 604a-b of the hypotube 600. The multiple rings 604a-b may be longitudinally spaced from one another to form a pattern of rings that extend circumferentially around the length of the hypotube 600. The one or more cuts, designated as 602a-c in FIG. 17, are cut in a spiral pattern that extends circumferentially around the hypotube 600 across the length of the hypotube 600. The cuts may be separated by spines 606a, 606b, 606c that extend longitudinally along the hypotube 600 and connect the multiple rings 604a-b. The spines may be circumferentially offset from one another. The spines 606a, 606b, 606c may be positioned such that a single cut in the cut pattern extends more than 360 degrees around the hypotube 600.

[0152] The helical configuration of the hypotube 600 may allow the hypotube 600 to lack bias toward a bending direction. Thus, the hypotube 600 may be configured to bend in multiple directions without a specific bias toward one direction and may have equal flexibility in all radial directions. Such a feature may allow the hypotube 600 to have a greater variety of orientations relative to the bending direction of the rail assembly, since the hypotube 600 lacks a specific bias toward one direction of bending of the rail assembly. The helical configuration may allow the hypotube 600 to remain flexible and bend in various bending directions as needed.

[0153] Additionally, the helical configuration of the hypotube 600 may allow the multiple rings 604a-b to more strongly contact and compress one another, transmitting distal forces such as for implant retrieval. The gaps formed by the incisions 602a-c may be reduced in size as the hypotube 600 is compressed distally, resulting in a rigid rod structure being formed for implant retrieval. The lack of bias in the hypotube 600 may also reduce the likelihood of the hypotube 600 deflecting in one direction due to deflection bias in the hypotube 600.

[0154] FIG. 18 illustrates one embodiment of a hypotube 700 shown in a flattened configuration that may be utilized with the assemblies of the present disclosure. The hypotube 700 may be utilized as one or more metal layers or portions of the assemblies disclosed herein, and in particular, may comprise a portion of the capsule 106 shown in FIG. 4. The hypotube 700 may be utilized with the capsule 106 configured to surround the implant-retaining region 16 of the elongate shaft 12. The hypotube 700 may be utilized as the metal layer 404 for the capsule, as shown in FIG. 15, or in other portions of an assembly utilizing the hypotube. The hypotube 700 may be disposed between the outer jacket and liner layers disclosed herein, among other components disclosed in the embodiments herein. While the hypotube 700 is shown in a flattened configuration in FIG. 18, it has outer portions 712, 714 that, when connected, form the cylindrical shape of the hypotube 700, similar to the hypotube shown in FIG. 11.

[0155] The hypotube 700 has one or more cuts 702a-d that form multiple rings 704a-b in the hypotube 700. The multiple rings 704a-b may be longitudinally spaced from one another and form a pattern of rings that extend circumferentially across the length of the hypotube 700.

[0156] The one or more cuts 702a-d shown in FIG. 18 are cut in offset pairs (cuts 702a and 702b form a pair, and cuts 702c and 702d form a pair). The cuts 702a-d may have equal longitudinal widths and equal circumferential lengths. The one or more cuts 702a-d may form a repeating pattern of staggered cuts having equal sizes. The cuts may be separated by pairs of spines (706 and 708 form a pair, 710 and 712 form a pair), each offset from one another and extending longitudinally along the hypotube 700. Each spine in a pair may be offset 180 degrees from the other spine in the pair. The offset between the spine pairs may be 90 degrees as shown in FIG. 18, or another amount as desired.

[0157] The offset configuration of the cuts 702a-d in the hypotube 700 may allow the hypotube 700 to lack bias toward a bending direction. Thus, the hypotube 700 may be configured to bend in multiple directions without a specific bias toward one direction and may have equal flexibility in all radial directions. Such a feature may allow the hypotube 700 to have a greater variety of orientations relative to the bending direction of the rail assembly, since the hypotube 700 lacks a specific bias toward one direction of bending of the rail assembly. Furthermore, in FIG. 18 , the circumferential lengths and longitudinal widths of the cuts 702a-d are equal, and the offset of the cuts in the repeating rows of the cuts is equal.

[0158] Additionally, the small width of the notches 702a-d in the hypotube 700 may allow multiple rings 704a-b to contact and compress against one another, transmitting distal forces such as for implant retrieval. The gaps formed by the notches 702a-d may be reduced in size as the hypotube 700 is compressed distally, resulting in a rigid rod structure being formed for implant retrieval. The lack of bias in the hypotube 700 may also reduce the likelihood of the hypotube 700 deflecting in a certain direction due to deflection bias in the hypotube 700.

[0159] FIG. 19 illustrates one embodiment of a hypotube 800 shown in a flat configuration that may be utilized with the assemblies of the present disclosure. The hypotube 800 may be utilized as one or more metal layers or portions of the assemblies disclosed herein, and in particular, may comprise a portion of the capsule 106 shown in FIG. 4. The hypotube 800 may be utilized with the capsule 106 configured to surround the implant-retaining region 16 of the elongate shaft 12. The hypotube 800 may be utilized as the metal layer 404 for the capsule, as shown in FIG. 15, or in other portions of an assembly utilizing the hypotube. The hypotube 800 may be positioned between an outer jacket and a liner layer, among other components disclosed in the embodiments herein. While the hypotube 800 is shown in a flat configuration in FIG. 19, it has outer portions 804, 806 that, when connected, form the cylindrical shape of the hypotube 800, as shown in FIG. 19.

[0160] The hypotube 800 is configured similarly to the hypotube 700 shown in FIG. 18 , except that the size of one or more incisions 802a-d forming the hypotube's multiple rings 806a-b has been increased. However, the length and width of the incisions 802a-d remain the same. The increased size of the incisions 802a-d may allow for greater flexibility of the hypotube 800. The size of the incisions 802a-d may be reduced when the hypotube 800 is compressed distally, resulting in a rigid rod structure being formed for implant retrieval. The lack of bias in the hypotube 800 may also reduce the likelihood of the hypotube 800 deflecting in a certain direction due to the hypotube 800's deflection bias.

[0161] In some embodiments, hypotubes may be utilized that include a combination of cut patterns that have a bias for bending in one direction and cut patterns that lack a bias for bending in another direction. Figure 20 illustrates such a pattern, where a hypotube 900 includes a first section 902 with a cut pattern 908 configured as the cut pattern of hypotube 800 shown in Figure 19. The hypotube 900 includes a second section 904 with a cut pattern 906 configured as the cut pattern of section 506 of hypotube 500 shown in Figure 16. The first section 902 may be located proximally and the second section 904 may be located distally.

[0162] The hypotube 900 is shown in a flat configuration that may be utilized with the assemblies of the present disclosure. The hypotube 900 may be utilized as one or more metal layers or portions of the assemblies disclosed herein, and in particular, may comprise a portion of the capsule 106 shown in FIG. 4. The hypotube 900 may be utilized with the capsule 106 configured to surround the implant-retaining region 16 of the elongate shaft 12. The hypotube 900 may be utilized as the metal layer 404 for the capsule, as shown in FIG. 15, or in other portions of an assembly that utilizes the hypotube. The hypotube 900 may be disposed between an outer jacket and a liner layer, among other components disclosed in the embodiments herein. The hypotube 900, while shown in FIG. 20 in a flat configuration, has outer portions 910, 912 that, when connected, form the cylindrical shape of the hypotube 900, as shown in FIG. 20.

[0163] 20 may advantageously lack bias toward the direction of bending, but may provide flexibility in multiple bending directions. Hypotubes 600, 700, and 800 and cutting pattern 908 may also provide a compressive force that allows them to be utilized for implant retrieval, if desired.

[0164] FIG. 21 illustrates one embodiment of a hypotube 1000 shown in a flattened configuration that may be utilized with the assemblies of the present disclosure. The hypotube 1000 may be utilized as one or more metal layers or portions of the assemblies disclosed herein, and in particular, may comprise a portion of the capsule 106 shown in FIG. 4. The hypotube 1000 may be utilized with the capsule 106 configured to surround the implant-retaining region 16 of the elongate shaft 12. The hypotube 1000 may be utilized as the metal layer 404 for the capsule, as shown in FIG. 15, or in other portions of an assembly utilizing the hypotube. The hypotube 1000 may be positioned between an outer jacket and a liner layer, among other components disclosed in the embodiments herein. While the hypotube 1000 is shown in a flattened configuration in FIG. 21, it has outer portions 1010, 1012 that, when connected, form the cylindrical shape of the hypotube 1000, as shown in FIG. 21.

[0165] The pairs of incisions (one pair including incisions 1002a, b and the other pair including incisions 1002c, d) may be circumferentially offset from one another such that the spines 1006, 1008 form an angle with respect to the longitudinal direction. Thus, the incisions 1002a, b and 1002c, d may form an angled or swept pattern in which the hypotube 1000 has a bias to bend in a direction with the spines 1006, 1008 extending along the neutral axis of bending. Thus, the direction of the bending bias may vary along the length of the hypotube 1000. The gaps formed by the incisions 1002a, b and 1002c, d may be reduced in size when the hypotube 1000 is compressed distally, resulting in a rigid rod structure being formed for implant retrieval.

[0166] In particular, the bend bias direction of the hypotube 1000 should be aligned with the bend direction of the rail assembly. Therefore, it may be beneficial to rotate a portion of a delivery system including a hypotube with a biased bend direction to align the bias direction with the bend direction of the rail assembly or another structure that forms the bend in the delivery system. The hypotube embodiments disclosed herein may be utilized alone or in conjunction with any of the other devices, systems, or methods disclosed herein.

[0167] 22-25 illustrate embodiments in which the delivery system 10 may be configured to allow the capsule 106 to rotate. Rotation of the capsule 106 may allow the hypotube contained therein to rotate so that the bias direction of the hypotube's cut pattern aligns with the direction of bending of the rail assembly. The capsule 106 may be configured to surround the implant holding area 16. Thus, in embodiments of the hypotube 500, 900, 1000 that include a direction of flex bias, the capsule 106 may be capable of rotating to align the direction of flex bias with the direction of bending of the rail assembly. Such a feature may be useful to reduce the likelihood that a hypotube that includes a direction of flex bias will be misaligned with the direction of bending of the rail assembly and have reduced maneuverability.

[0168] 22 shows a distal portion of the delivery system including a coupler 1900 configured to couple the capsule 106 to a shaft portion 1902 of the elongate shaft 12 located proximally of the capsule 106. The shaft portion 1902 may comprise part of an outer shaft assembly, which may include the outer hypotube 104, or the shaft 102, or another portion of the outer shaft assembly, as desired.

[0169] The coupler 1900 may allow the capsule 106 to rotate about the axis of the elongate shaft 12. The coupler 1900 may take various forms and may include a protrusion 1904 located within a channel 1906. The protrusion 1904 may be configured to rotate relative to the channel 1906 to allow the capsule 106 to rotate. As shown in FIG. 22 , the protrusion 1904 may comprise a flexible material within the channel 1906. For example, the protrusion 1904 may be crimped within the channel 1906 and thus be able to rotate relative to the channel 1906. The protrusion 1904 may be coupled to the capsule 106, such as a proximal portion of the capsule 106, and the channel 1906 may be coupled to a distal portion of the shaft portion 1902. In other embodiments, the protrusion 1904 may be coupled to the shaft portion 1902, and the channel 1906 may be coupled to the capsule 106. The protrusions 1904 and channels 1906 may be located elsewhere on either the capsule 106 or the shaft portion 1902, as desired.

[0170] 23 shows a side perspective view of the exterior of elongate shaft 12 including coupler 1900. Capsule 106 may be configured to rotate about the axis of elongate shaft 12 relative to shaft portion 1902, as indicated by the arrow shown in FIG.

[0171] FIG. 24 shows one embodiment of a coupler 2000 including a protrusion 2002 that can be configured to rotate relative to a channel 2004 to allow the capsule 106 to rotate. As shown in FIG. 24 , the protrusion 2002 can include a pin. The channel 2004 can include a window. The pin can be configured to slide along the window to allow the capsule 106 to rotate. The window can be coupled to the capsule 106, such as a proximal portion of the capsule 106, and the pin can be coupled to a distal portion of the shaft portion 1902. In other embodiments, the window can be coupled to the shaft portion 1902, and the pin can be coupled to the capsule 106. The protrusion 2002 and the channel 2004 can be located elsewhere on either the capsule 106 or the shaft portion 1902, as desired.

[0172] 25 shows a side perspective view of the exterior of elongate shaft 12 including coupler 2000. Capsule 106 may be configured to rotate about the axis of elongate shaft 12 relative to shaft portion 1902, as indicated by the arrow shown in FIG.

[0173] The couplers 1900, 2000 shown in Figures 22-25 may take a variety of other forms and may be varied, if desired, from the projection and channel configurations shown in Figures 22-25. While the perspective views shown in Figures 23 and 25 show the couplers located on the exterior surface of the elongate shaft 12, in other embodiments the couplers may be covered by an outer jacket or another structure, if desired.

[0174] The couplers 1900, 2000 may advantageously allow the capsule 106 to rotate. Rotation of the capsule 106 may allow the hypotube contained therein to rotate so that the direction of bias of the hypotube cut pattern is aligned with the direction of bending of the rail assembly. Thus, in embodiments of the hypotube 500, 900, 1000 that include a direction of flexure bias, the capsule 106 may be capable of rotating to align the direction of flexure bias with the direction of bending of the rail assembly.

[0175] The hypotubes 500, 900, 1000 may be configured to passively rotate to align the direction of flex bias with the direction of bend of the rail assembly. Thus, as the hypotubes 500, 900, 1000 pass through a bend in the rail assembly, the reduced resistance to bending caused by aligning the direction of flex bias with the direction of bend of the rail assembly may allow the hypotubes 500, 900, 1000 to passively rotate.

[0176] While the couplers 1900, 2000 are shown in connection with the capsule 106, in other embodiments, other portions of the elongate shaft 12 may be configured to rotate through the use of the couplers 1900, 2000. Such portions may include a mid-shaft assembly, which may include an outer retaining ring 42, which may be configured to rotate similarly to the capsule 106. The mid-shaft assembly may include a hypotube, and the couplers may allow the outer retaining ring 42 to rotate such that the direction of bias of the hypotube's cut pattern aligns with the bending direction of the rail assembly. Other portions of the elongate shaft 12 may utilize couplers for rotation as needed.

[0177] Rotation of the portion of the elongate shaft 12 that may include the capsule 106 may enable rotation during proximal retraction or distal advancement of the portion of the elongate shaft 12. For example, the capsule 106 may rotate via one of the couplers 1900, 2000 when the capsule is being retracted proximally, or may rotate via one of the couplers 1900, 2000 when the capsule is being advanced distally. In particular, during distal advancement of the capsule 106, compressive forces may be applied to the capsule 106 proximally due to compression of the expandable implant and distally due to forces applied to the capsule 106 by the handle of the delivery system. It should be noted that such forces may result in structural damage, such as crushing of the capsule 106, if such forces are strong enough. The coupler and capsule embodiments disclosed herein may be utilized alone or in conjunction with any of the other devices, systems, or methods disclosed herein.

[0178] 26 shows a distal portion of a delivery system including an expandable body 2100. The expandable body 2100 may be configured to expand to support the sheath. Expansion of the expandable body 2100 may serve to reduce the possibility of structural damage to the sheath and may strengthen the sheath during distal movement, such as during implant retrieval.

[0179] 26, the sheath may comprise an outer sheath, which may include the capsule 106 and other portions, such as the outer hypotube 104 (shown in FIG. 4) and the shaft 102. The expandable body 2100 may be configured to expand to support the outer shaft as it expands distally. For example, when the capsule 106 expands distally for retrieval of an expandable implant, the expandable body 2100 may be inflated to provide support for the capsule 106 and other portions of the sheath. The support may reduce the likelihood of structural damage to the capsule 106 because structural strength is provided to the capsule 106.

[0180] 26, the expandable body 2100 may be positioned within the lumen of the sheath. The expandable body 2100 may be positioned on an inner shaft, which may be positioned within the lumen of the sheath. The expandable body 2100 may be positioned between the inner shaft and the sheath and configured to expand to support the sheath. The inner shaft may comprise the central shaft (mid-shaft) of the elongate shaft 12 as shown, or in other embodiments, may comprise a separate shaft within the elongate shaft 12. The expandable body 2100 may be positioned on the shaft adjacent to the sheath such that expansion of the expandable body 2100 causes contact with the inner surface of the sheath.

[0181] The conduit 2102 may be coupled to the expandable body 2100 and configured to provide fluid to inflate the expandable body 2100. The conduit 2102 may extend along the length of the elongate shaft 12 and may be located within the outer lumen of the outer shaft. The proximal end of the conduit 2102 may be coupled to an inflation port or the like for inflating the expandable body 2100. The conduit 2102 may extend between the outer sheath and the intermediate sheath, as shown in FIG. 26 . In other embodiments, the conduit 2102 may be located in other locations as desired.

[0182] The expandable body 2100 may include one or more balloons, which may be pleated or have another configuration. In other embodiments, the expandable body 2100 may have other configurations. The expandable body 2100 may be configured to exert sufficient force against the inner surface of the sheath such that the sheath is supported when the expandable body 2100 expands and contacts the inner surface of the sheath. Such support may occur as the sheath is advanced distally and may occur as the sheath is bent around the rail assembly 20.

[0183] FIG. 27 shows the expandable body 2100 expanding and supporting a sheath (shown as capsule 106 of the outer sheath) at the bend in the outer shaft. The capsule 106 is advanced distally, which may be for retrieval of an expandable implant (although the implant is not visible in FIG. 27). A force in direction 2104, shown by the dashed arrow in FIG. 27, may be applied to the capsule 106. Without the expandable body 2100, the force in direction 2104 could damage the capsule 106. However, the expandable body 2100 may expand to contact the inner surface of the capsule 106 and fill the space between the capsule 106 and the midshaft. The expandable body 2100 may then be deflated at a desired time.

[0184] Although the outer sheath is shown as capsule 106 in FIG. 27 , an expandable body may be utilized in any embodiment of the sheath. For example, the midshaft may include a sheath extending around the inner shaft, with the inner shaft positioned within the midshaft outer sheath. The expandable body may be positioned between the inner shaft and the midshaft sheath to support the midshaft as it advances proximally, such as for implant retrieval. The expandable body may be utilized in other locations as needed. The expandable body and shaft embodiments disclosed herein may be utilized alone or in conjunction with any of the other devices, systems, or methods disclosed herein.

[0185] In some embodiments, the elongate shaft 12 of the delivery system may include a wall having a tensile layer that provides strength to the elongate shaft 12 when pulled proximally. Figure 28 shows, for example, one embodiment of a tensile layer in the form of a braided layer 2200 that may be utilized to provide strength to the elongate shaft 12 when pulled proximally.

[0186] Braided layer 2200 may comprise a weave of overlapping metal wires or other forms of fibers forming a sheath, as shown in Figure 28. In other embodiments, other materials may be utilized to form braided layer 2200, as desired.

[0187] Figure 29 shows a cross-sectional view of the wall of the sheath of the elongate shaft including the braided layer of Figure 28. The wall 2203 extends circumferentially around the lumen 2201 to form the body of the sheath. The structure of the sheath wall 2203 is visible, including the braided layer 2200 surrounding the metal layer 2202. The inner liner layer 2204 is visible surrounded by the metal layer 2202. The outer jacket layer 2206 is visible extending around the braided layer 2200. The lumen 2201 is surrounded by the sheath.

[0188] Metal layer 2202 may be configured similarly to the metal layers disclosed within the present application, including the coil or hypotube embodiments disclosed herein, including the hypotubes shown in FIGS. 16-21. Braided layer 2200 may surround metal layer 2202 such that when an axial force 2210 providing tension is applied to braided layer 2200, braided layer 2200 compresses metal layer 2202. Compression is represented by arrows 2212. Metal layer 2202 resists compression of braided layer 2200 onto metal layer 2202, thus allowing braided layer 2200 to exhibit high tensile strength. Braided layer 2200 may therefore be utilized to reinforce the sheath of the elongate shaft, allowing a greater retraction force to be applied by the sheath of the elongate shaft.

[0189] A buffer layer 2214 may be located between the outer jacket layer 2206 and the braided layer 2200. The buffer layer 2214 may fill the interstices of the braided layer 2200 with material to prevent the outer jacket layer 2206 from flowing between the weaves of the braided layer 2200, thereby reducing the effectiveness of the braided layer 2200. The buffer layer 2214 may be constructed of a polymer and may include expanded polytetrafluoroethylene (ePTFE), or in other embodiments, may include other materials. The outer jacket layer 2206 may include PEBAX or another form of polymer.

[0190] The elongate shaft sheath wall configuration shown in Figure 29, including the use of braided layer 2200, may be utilized with various assemblies of a delivery system. For example, outer sheath capsule 106 may be configured to include the configuration shown in Figure 29. In other embodiments, other assemblies, including the outer sheath, intermediate sheath, or any portion of the inner assembly, may utilize the elongate shaft configuration shown in Figure 29. The sheath wall configurations disclosed herein may be utilized alone or in conjunction with any of the other devices, systems, or methods disclosed herein.

[0191] Other devices, alone or in combination with the braided layer, may improve the retraction force of a portion of the elongate sheath. FIG. 30 illustrates one embodiment of a delivery system utilizing a cable router 2300. The delivery system may utilize a cable 2302 having two ends 2304, 2306. The ends 2304, 2306 may be coupled to a sheath that may include the capsule 106 as shown in FIG. 30, but in other embodiments, may include other sheaths or portions of the delivery system, including the elongate shaft. The cable 2302 may include an intermediate portion 2308 that may extend between the ends 2304, 2306. The ends 2304, 2306 may be coupled to opposite sides of the sheath. For example, the end 2304 may be coupled to an inner surface of the sheath, and the end 2306 may be coupled to an inner surface of the sheath on the opposite side of the sheath. The ends 2304, 2306 may be separated by a lumen of the sheath. Ends 2304, 2306 may be attached to portions of the sheath that are located on either side of the sheath's neutral axis within the same bending plane. For example, end 2304 may be attached to a portion of the sheath that forms the inner curve of the sheath when the sheath is bent, and end 2306 may be attached to a portion of the sheath that forms the outer curve of the sheath when the sheath is bent. When the sheath is bent in the opposite direction, end 2304 may be attached to a portion of the sheath that forms the outer curve of the sheath, and end 2306 may be attached to a portion of the sheath that forms the inner curve of the sheath when the sheath is bent in the opposite direction.

[0192] The cable 2302 can be configured to slide along the length of the sheath and can extend within the lumen of the sheath. The cable 2302 can extend along the length of the sheath to engage the cable router 2300.

[0193] The cable router 2300 can take a variety of forms and can include a pulley wheel, as shown in Figure 30. The cable router 2300 can include channels that allow the cables 2302 to bend around the cable router 2300. The channels can include, for example, flex tubes that redirect the cables 2302. Other forms of cable router 2300 can be utilized as desired.

[0194] The cable router 2300 may be configured to engage an intermediate portion 2308 of the cable 2302 such that the cable 2302 may move along the cable router 2300 as the cable 2302 is slid through the flexion of a sheath, such as the capsule 106 shown in FIG. 30. For example, in an embodiment in which the cable router 2300 is a pulley wheel, the pulley wheel may rotate to allow the cable 2302 to move along the cable router 2300. In an embodiment in which the cable router 2300 is a channel, the channel may allow the cable 2302 to slide along the channel.

[0195] The delivery system may include a control mechanism 2310. The control mechanism 2310 may comprise a body configured to move the cable router 2300 by applying tension to the cable router 2300 to retract the cable router 2300 proximally. The control mechanism 2310 may be configured to retract the sheath as well. The control mechanism 2310 may include threads or the like to allow the control mechanism 2310 to be operated by a mechanism on the handle or other part of the delivery system. The cable router 2300 and control mechanism 2310 may be located within the handle of the delivery system or at another location, as desired.

[0196] During operation, the cable 2302 can be configured to passively change length between the end 2304 and the cable router 2300 and between the end 2306 and the cable router 2300 due to flexing of the sheath. For example, FIG. 31 illustrates the operation of the cable 2302 and the cable router 2300. The sheath, shown as capsule 106, can flex for a variety of reasons, which may include flexing of the rail assembly. The flexing of the sheath causes the end 2304 of the cable 2302 to move proximally and the end 2306 of the cable 2302 to move distally. The proximal movement (change in length) of the end 2304 of the cable 2302 can be equal to the distal movement (change in length) of the end 2306 of the cable 2302, and the length changes can occur simultaneously. The cable router 2300 can function to allow an intermediate portion 2308 of the cable 2302 to move along the cable router 2300 to transfer the length of the cable 2302 from end 2304 to end 2306. Alternatively, the sheath can be flexed in the opposite direction, with end 2304 extending distally and end 2306 extending proximally.

[0197] The length of the cable 2302 may be routed between the ends 2304 and 2306 to allow the cable 2302 to remain taut between the ends 2304 and 2306 without slack during sheath flexing. The control mechanism 2310 may retract the cable router 2300, allowing the cable 2302 to pull the sheath and increasing the sheath's tensile strength when the sheath is retracted. Such a feature may be utilized with the capsule 106, which may retract to allow an expandable implant to be deployed. Such a feature may be utilized with any other portion of the elongate sheath that retracts, such as an intermediate sheath that retracts to retract the outer retaining ring 42. A sheath coupled to a nosecone of the elongate shaft may also be retracted between other use positions. The cable routers disclosed herein may be utilized alone or with any of the other devices, systems, or methods disclosed herein.

[0198] 32-34 show a distal portion of a delivery system including a stopper located on the inner shaft of the delivery system and configured to prevent proximal movement of the capsule 106. FIG. 32A shows a side cross-sectional view of the distal portion of the delivery system. While the capsule 106 is shown in FIG. 32A as extending over an inner sheath assembly, in other embodiments, the capsule 106 may extend over another inner shaft, such as a midshaft assembly.

[0199] The inner shaft, shown as the distal section 126 of the inner shaft assembly, can include a stopper 2400 located thereon. The stopper 2400 can include a protrusion extending radially outward from the inner shaft. The stopper 2400 can be configured to apply a force to the proximal body 2402 of the capsule 106 that prevents proximal movement of the capsule 106. For example, FIG. 32B shows the capsule 106 being withdrawn, with the proximal body 2402 contacting the stopper 2400. Thus, the position of the capsule 106 can be maintained until additional force is applied to the capsule 106 to overcome the protrusion of the stopper 2400 and further move the capsule 106 proximally, allowing the expandable implant to deploy from the implant holding region 16. For example, FIG. 32C shows the capsule 106 being pulled proximally past the stopper 2400.

[0200] The stopper may have various other configurations as desired. For example, in Figures 33A-33C, the stopper 2404 may have the form of a thread on the inner shaft. The capsule may include a threaded portion 2406 that may allow the capsule 106 to rotate relative to the thread on the inner shaft to allow the capsule 106 to move proximally past the stopper 2404. For example, Figure 33C shows the capsule 106 pulled proximally past the stopper 2404.

[0201] 34A-34C, the stopper 2408 may have a keyed formation on the inner shaft. The capsule 106 may include a complementary keyed formation on the proximal body 2410 into which the stopper 2408 fits to allow the capsule 106 to move proximally past the stopper. The capsule 106 may rotate relative to threads on the inner shaft to allow the capsule 106 to move proximally past the stopper 2408. For example, FIG. 34C shows the capsule 106 pulled proximally past the stopper 2408.

[0202] The stoppers shown in FIGS. 32-34 may be configured to provide two-stage deployment of an implant held within the implant holding region 16. The stoppers may be located on the inner shaft and allow the capsule 106 to retract a predetermined distance, allowing a predetermined amount of partial release, exposure, or expansion of the implant upon contact. For example, as shown in FIG. 33B , the capsule 106 may retract a predetermined distance until contacting the stopper 2400. The predetermined distance may be a stopping point for a user of the delivery system to confirm that the implant is partially deployed in the desired location. The stopper 2400 may prevent the user from fully retracting the capsule 106 without first stopping to confirm that the expandable implant is partially deployed in the desired location. Once the user has made such confirmation, the capsule 106 may continue to retract beyond the stopper 2400 to allow expansion and deployment of the expandable implant to continue. Thus, stopper 2400 can function as tactile feedback to the user of the desired stop position, to confirm at this point that the expandable implant is partially disposed in the desired location. Stoppers 2404, 2408 can serve a similar function to stopper 2400. The stops can be located proximate capsule 106 to enable tactile feedback that is located proximate capsule 106, which can more fully allow the user to manipulate the delivery system. After the stops are overcome, full release, or exposure, or expansion of the implant can occur.

[0203] The stops may have a variety of configurations and positions beyond those shown in Figures 32-34, as desired. The stops may be located on an internal shaft, such as a central shaft (mid-shaft) or inner shaft, as desired, among other locations. The stops disclosed herein may be utilized alone or in conjunction with any of the other devices, systems, or methods disclosed herein.

[0204] Referring to Figure 35, the handle 14 is located at the proximal end of the delivery system 10. A cross section of the handle 14 is shown in Figure 36. The handle 14 may include several actuators, such as rotatable knobs, that can manipulate various components of the delivery system 10. While operation of the handle 14 is described with respect to delivery of a replacement mitral valve implant 70, the handle 14 and delivery system 10 may also be used to deliver other devices.

[0205] The handle 14 is generally composed of two housings, a rail housing 202 and a delivery housing 204, with the rail housing 202 positioned circumferentially around the delivery housing 204. The inner surface of the rail housing 202 may include a threadable portion configured to mate with the outer surface of the delivery housing 204. The delivery housing 204 is thus configured to slide (e.g., thread) within the rail housing 202, as described in more detail below. The rail housing 202 generally surrounds approximately half the length of the delivery housing 204, and thus the delivery housing 204 extends both proximally and distally outside of the rail housing 202.

[0206] The rail housing 202 may include two rotatable knobs, a distal pullwire knob 206 and a proximal pullwire knob 208. However, the number of rotatable knobs on the rail housing 202 may vary depending on the number of pullwires used. Rotation of the distal pullwire knob 206 provides a proximal force, thereby providing axial tension on the distal pullwire 138, which may cause the distal grooved portion 235 of the rail hypotube 136 to bend. The distal pullwire knob 206 may rotate in either direction, allowing for bending in either direction and controlling the anterior-posterior angle. Rotation of the proximal pullwire knob 208 provides a proximal force, and therefore axial tension, on the proximal pullwire 140, which may cause the proximal grooved portion 233 of the rail hypotube 136 to bend and controlling the medial-lateral angle. The proximal pullwire knob 208 may rotate in either direction, allowing for bending in either direction. Thus, when both knobs are actuated, two bends exist within the rail hypotube 136, which may allow for three-dimensional steering of the rail shaft 132 and, therefore, the distal end of the delivery system 10. Additionally, the proximal end of the rail shaft 132 is connected to the inner surface of the rail housing 202.

[0207] Flexion of the rail shaft 132 can be used to position the system, particularly the distal end, at a desired patient location, such as at the native mitral valve. In some embodiments, rotation of the pullwire knobs 206 / 208 can help steer the distal end of the delivery system 10 through the septum and left atrium and into the left ventricle so that the implant 70 is at the native mitral valve.

[0208] Turning to the delivery housing 204, the proximal ends of the inner shaft assembly 18, outer sheath assembly 22, mid-shaft assembly 21, and nosecone shaft assembly 31 may be connected to an inner surface of the delivery housing 204 of the handle 14. Thus, they can move axially relative to the rail assembly 20 and rail housing 202.

[0209] A rotatable outer sheath knob 210 can be disposed on the distal end of the delivery housing 204, distal to the rail housing 202. Rotation of the outer sheath knob 210 pulls the outer sheath assembly 22 axially proximally, thus pulling the capsule 106 away from the implant 70 and releasing the distal end 303 of the implant 70. The outer sheath assembly 22 therefore translates separately relative to the other shafts within the delivery system 10. The distal end 303 of the implant 70 can be released first, while the proximal end 301 of the implant 70 can remain radially compressed between the inner retention member 40 and the outer retention member 42.

[0210] A rotatable mid-shaft knob 214 is located on the delivery housing 204 and, in some embodiments, can be proximal to the rotatable outer sheath knob 210 and distal to the rail housing 202. Rotation of the mid-shaft knob 214 pulls the mid-shaft assembly 21 axially proximally, thus pulling the outer retaining ring 42 away from the implant 70 and exposing the inner retaining member 40 and the proximal end 301 of the implant 70, thereby releasing the implant 70. Thus, the mid-shaft assembly 21 translates separately relative to the other shafts in the delivery system 10.

[0211] The rotatable depth knob 212 can be located at the proximal end of the delivery housing 204, and thus proximal to the rail housing 202. As the depth knob 212 rotates, the entire delivery housing 204 moves distally or proximally relative to the rail housing 202, which remains in the same position. Thus, at the distal end of the delivery system 10, the inner shaft assembly 18, the outer sheath assembly 22, the mid shaft assembly 21, and the nosecone shaft assembly 31 move together (e.g., simultaneously) proximally or distally relative to the rail assembly 20, while the implant 70 remains in a compressed configuration. In some embodiments, operation of the depth knob 212 can move the inner shaft assembly 18, the outer sheath assembly 22, the mid shaft assembly 21, and the nosecone shaft assembly 31 sequentially relative to the rail assembly 20. In some embodiments, operation of the depth knob 212 can move the inner shaft assembly 18, the outer sheath assembly 22, the mid shaft assembly 21, and the nosecone shaft assembly 31 together relative to the rail assembly 20. Thus, the rail shaft 132 can be aligned in a particular direction, and other assemblies can be moved distally or proximally relative to the rail shaft 132 for final positioning without releasing the implant 70. Components can be advanced approximately 1, 2, 3, 5, 6, 7, 8, 9, or 10 cm along the rail shaft 132. Components can be advanced more than approximately 1, 2, 3, 5, 6, 7, 8, 9, or 10 cm along the rail shaft 132. An example of this is shown in FIG. 2C. The capsule 106 and outer retaining ring 42 can then be separately withdrawn relative to the inner assembly 18, as described above, releasing the implant 70, in some embodiments sequentially. The assemblies other than the rail assembly 20 can then be withdrawn back onto the rail shaft 132 by rotating the depth knob 212 in the opposite direction.

[0212] The handle 14 may further include a mechanism (knob, button, handle) 216 for moving the nosecone shaft 27, and thus the nosecone 28. For example, the knob 216 may be part of the nosecone assembly 31 that extends from the proximal end of the handle 14. Thus, a user may pull or push the knob 216 to translate the nosecone shaft 27 distally or proximally independently relative to the other shafts. This may be advantageous for translating the nosecone 28 proximally into the outer sheath assembly 22 / capsule 106, thus facilitating withdrawal of the delivery system 10 from the patient.

[0213] In some embodiments, the handle 14 can provide a lock 218, such as a spring lock, to prevent translational movement of the nosecone shaft 27 via the knob 216 described above. In some embodiments, the lock 218 can be always active, such that the nosecone shaft 27 will not move unless the user disengages the lock 218. The lock can be, for example, a spring lock that is always engaged until a button 218 on the handle 14 is pressed, thereby releasing the spring lock and allowing the nosecone shaft 27 to translate in the proximal / distal direction. In some embodiments, the spring lock 218 allows movement of the nosecone shaft 27 in one direction, either proximal or distal, but prevents movement in the opposite direction.

[0214] The handle 14 can further include communicating flush ports for flushing the various lumens of the delivery system 10. In some embodiments, a single flush port on the handle 14 can provide fluid connection to multiple assemblies. In some embodiments, the flush port can provide fluid connection to the outer sheath assembly 22. In some embodiments, the flush port can provide fluid connection to the outer sheath assembly 22 and the midshaft assembly 21. In some embodiments, the flush port can provide fluid connection to the outer sheath assembly 22, the midshaft assembly 21, and the rail assembly 20. In some embodiments, the flush port can provide fluid connection to the outer sheath assembly 22, the midshaft assembly 21, the rail assembly 20, and the inner assembly 18. Thus, in some embodiments, the rail shaft 132, the outer retaining ring 42, and the capsule 106 can all be flushed by a single flush port.

[0215] 37-45 show one embodiment of a handle 14' including control knobs 210', 214', 2500, each having an exposed outer grip surface for gripping around the entire circumference of the respective control knob 210', 214', 2500. This contrasts with the control knobs 210, 214 shown in, for example, FIG. 35, where a portion of the outer grip surface of the control knobs 210, 214 is covered by a bridge portion of the handle 14 that extends over the control knobs 210, 214.

[0216] 37 does not include a bridge on the respective control knobs 210′, 214′, 2500, and thus each control knob 210′, 214′, 2500 has an exposed outer grip surface for grasping around the entire circumference of the respective control knob 210′, 214′, 2500. Such a feature may advantageously allow a greater gripping force to be applied to the respective control knob 210′, 214′, 2500, more fully enabling a user to rotate the knob and move the respective portion of the delivery system to which the respective control knob 210′, 214′, 2500 is coupled. The absence of a bridge portion of the handle 14 on the control knobs 210′, 214′, 2500 improves the ergonomics of the handle 14′ and allows a greater gripping force to be applied to the control knobs 210′, 214′, 2500 by the user.

[0217] Handle 14' may include a rail housing 202 configured similarly to rail housing 202 shown in FIG. 35 and coupled to delivery housing 204' in a manner similar to how rail housing 202 couples to delivery housing 204. Pull wire knobs 206, 208 are not shown in FIGS. 37-45 for clarity, and depth knob 212 is also not shown for clarity, although pull wire knobs 206, 208 and depth knob 212 operate with handle 14' in the same manner as handle 14.

[0218] FIG. 37 shows a side perspective view of the handle 14′, and FIG. 38 shows a bottom view of the handle 14′. FIG. 39 shows a central cross-sectional view of the handle 14′ from the bottom view of FIG. 38. The internal structure of the handle 14′ is shown in FIG. 39. A distal-most control knob 210′ is located at the distal end of the handle 14′ and is configured to control the operation of the outer sheath assembly. A distal face 2502 (visible in FIG. 40) forms the distal face of the handle 14′ and connects opposite sides of the gripping surfaces of the control knob 210′. A middle control knob 214′ is located on the delivery housing 204′ and is configured to control the operation of the middle shaft assembly. A proximal control knob 2500 is located at the proximal end of the handle 14′ and is configured to control the operation of the nosecone assembly. The distal-most control knob 210′ and the middle control knob 214′ can each be configured to rotate to move their respective assemblies to release a portion of the implant from the implant holding region 16.

[0219] The delivery housing 204' may include an internal cavity that houses a respective slider 2504, 2506, 2508, each coupled to the outer sheath assembly, the midshaft assembly, and the nosecone assembly, respectively. The sliders may be configured to slide along the respective cavities that house them to enable the sliders 2504, 2506, 2508 to translate the respective assemblies.

[0220] The control knobs 210′, 214′, 2500 may be coupled to bodies 2501, 2503, 2505 having threads that engage with threads on the sliders 2504, 2506, 2508 to allow rotational movement of the control knobs 210′, 214′, 2500 to effect axial or linear sliding of the respective sliders 2504, 2506, 2508. One or more beams 2510, 2512 may be provided that may function to prevent rotation of the sliders 2504, 2506, 2508 when the respective control knobs 210′, 214′, 2500 are rotated. Each beam 2510, 2512 may include a channel shaped to match the shape of the respective slider 2504, 2506, 2508 to prevent rotation of the slider 2504, 2506, 2508 upon rotation of the control knob 210′, 214′, 2500. Because a portion of the body threads is covered by the respective beam, only a portion (e.g., half) of the body threads may engage the slider to cause movement of the slider. Each slider 2504, 2506, 2508 rests within the channel in the beam and slides along the channel to cause movement of the assembly to which the slider 2504, 2506, 2508 is coupled.

[0221] The beams 2510, 2512 may include walls located on either side of the recess to form respective channels in the beams 2510, 2512. Thus, the beams 2510, 2512 may have a "u" shape, as shown in Figures 41-45. Such a shape provides enhanced structural support for the handle 14' and resists torque applied to the beams 2510, 2512 upon rotation of the control knobs 210', 214', 2500.

[0222] The beams 2510, 2512 may each extend into the cavities that house the sliders 2504, 2506, 2508 and may depend within the cavities such that the threads of the control knobs 210′, 214′, 2500 do not engage or rotate the beams 2510, 2512. The beams 2510, 2512 may be supported by the delivery housing 204′ at supports 2514, 2516, 2518, 2520, 2522. The delivery housing 204′ may also include walls 2524, 2526, 2528 that separate the cavities of the delivery housing 204′ and function to hold the beams 2510, 2512 from rotating with their respective cavities in the delivery housing 204′.

[0223] 40 shows a front perspective view of the handle 14' without the elongated shaft visible. The distal face 2502 includes a central opening that allows the elongated shaft to pass therethrough.

[0224] Figure 41 shows a cross-sectional view along line AA of Figure 39. The "u" shape of the beam 2510 is visible, as is the key shape of the slider 2504.

[0225] Figure 42 shows a cross-sectional view taken along line BB of Figure 39. The support 2516 is shown as a protrusion that enters a portion of the beam 2510. A support wall 2524 abuts the beam 2510 to prevent rotation of the beam 2510 within the handle 14'.

[0226] Figure 43 shows a cross-sectional view taken along line CC in Figure 39. A support wall 2526 abuts the beam 2510 to prevent rotation of the beam 2510 within the handle 14'.

[0227] Figure 44 shows a cross-sectional view taken along line DD in Figure 39. The support 2520 is shown as a protrusion that enters a portion of the beam 2512. A support wall 2528 abuts the beam 2512 to prevent rotation of the beam 2512 within the handle 14'.

[0228] Figure 45 shows a cross-sectional view taken along line EE of Figure 39. The control knob 2500 is shown to include an unthreaded portion 2530 that acts as a stop to prevent the slider 2508 from passing past the proximal end of the handle 14'.

[0229] The handle 14' can be configured to control the length of the path of travel of each slider 2504, 2506, 2508 in a variety of ways. For example, the threads of the control knob can be interrupted at a point to prevent movement of each slider 2504, 2506, 2508. The size of the cavity through which the sliders 2504, 2506, 2508 travel can be reduced as needed. In some embodiments, stops in the form of protrusions can be located along the beams 2510, 2512 or otherwise within the path of travel to control the length of the path of travel of each slider 2504, 2506, 2508. In FIG. 39, the control knob 210' functions as a distal stop to prevent distal axial movement of the slider 2504. The handle 14' can be utilized with any embodiment of the delivery system disclosed herein. The handle 14' disclosed herein may be utilized alone or in conjunction with any of the other devices, systems, or methods disclosed herein.

[0230] Embodiments of the delivery systems disclosed herein may include markers configured to enhance the echogenicity of the elongate shaft of the delivery system to clarify the location of a portion of the elongate shaft when viewed under ultrasound imaging. Such markers may be located at various locations on the elongate shaft and may be located on a portion of the elongate shaft that is advantageously identified under ultrasound imaging to improve delivery of the expandable implant. Ultrasound imaging may include echocardiography, among other forms of ultrasound imaging.

[0231] Figure 46 shows a side view of the nosecone 28 of the delivery system. The nosecone 28 has a smooth, tapered outer surface that does not readily show up in ultrasound imaging. Additionally, Figure 47 shows a cross-sectional view of the nosecone 28 shown in Figure 46. The nosecone 28 is shown to include a homogenous structure made of a single type of material, which is preferably soft and pliable, such as a flexible polymer.

[0232] FIG. 48 shows a side view of a portion of the nosecone shown in FIG. 46 as nosecone 28′, including a marker configured to enhance the echogenicity of the elongate shaft (specifically, nosecone 28′) to clarify the location of the portion of the elongate shaft (nose cone 28′) when viewed under ultrasound imaging. The marker shown in FIG. 48 has the shape of a particular contoured portion of the nosecone 28′ that forms an edge 2600 of the nosecone 28′. The edge 2600 extends around the circumference of the nosecone 28′ and forms a planar surface 2602 that extends around the circumference of the nosecone 28′. The planar surface 2602 faces distally. The edge 2600 forms an abrupt transition in the acoustic impedance of the nosecone 28′, which enhances the echogenicity of the nosecone 28′. Additionally, the shape of the rim 2600 extending around the circumference of the nosecone 28' enhances acoustic reflection of incident ultrasound waves in various directions, thus enhancing the echogenicity of the nosecone 28'.

[0233] Figure 49 shows two echocardiographic images of the nosecone 28' including the edge 2600 shown in Figure 48. Edge 2600 appears brighter in the two echocardiographic images, as indicated by locations 2700 and 2702, which may allow a user to more easily identify the location of the nosecone 28' within the images.

[0234] 50 illustrates one embodiment of a nosecone 2800 including a marker including multiple edges 2802, 2804, 2806 that enhance the echogenicity of the elongate shaft (specifically the nosecone 2800) to clarify the location of a portion of the elongate shaft (the nosecone 2800) when viewed under ultrasound imaging. The multiple edges 2802, 2804, 2806 may function similarly to the edges 2600 illustrated in FIG. 48 and each may extend around the circumference of the nosecone 2800 and form a respective distally facing planar surface that extends around the circumference of the nosecone 2800. Multiple shelves may be formed by the multiple edges 2802, 2804, 2806.

[0235] 51 illustrates one embodiment of a nosecone 2900 including markers including edges 2902 that enhance the echogenicity of the elongate shaft (particularly the nosecone 2900) to clarify the location of a portion of the elongate shaft (the nosecone 2900) when viewed under ultrasound imaging. The edges 2902 may function similarly to the edges 2600 illustrated in FIG. 48 and may each extend around the circumference of the nosecone 2900 and form a distally facing planar surface that extends around the circumference of the nosecone 2900. The edges 2902 may spiral around the nosecone 2900 to form a helical pattern around the nosecone 2900.

[0236] 52 illustrates one embodiment of a nosecone 3000 including a marker that includes multiple edges 3002 that enhance the echogenicity of the elongate shaft (specifically the nosecone 3000) to clarify the location of a portion of the elongate shaft (the nosecone 3000) when viewed under ultrasound imaging. The edges 3002 may function similarly to the edges 2600 shown in FIG. 48 and may form a distally facing pattern on the nosecone 3000. The pattern may include multiple recesses in the form of dimples on the nosecone 3000.

[0237] 53 illustrates one embodiment of a nosecone 3100 including a marker that includes multiple edges 3102 that enhance the echogenicity of the elongate shaft (particularly the nosecone 3100) to clarify the location of a portion of the elongate shaft (the nosecone 3100) when viewed under ultrasound imaging. The edges 3102 may function similarly to the edges 2600 shown in FIG. 48 and may form a distally facing pattern on the nosecone 3100. The pattern may include multiple recesses in the form of grooves on the nosecone 3100.

[0238] The surfaces shown in Figures 48 and 50-53 may comprise the exterior surface of each nosecone, or in other embodiments, the markers may be encapsulated in a material. The encapsulating material may include a material with a different acoustic impedance than the markers, making the markers more echogenic. The encapsulating material may allow the nosecone to retain a smooth, tapered surface.

[0239] Figure 54 shows a side cross-sectional view of a nose cone 3200 comprising two materials with different acoustic impedances. One material forms the marker 3202 shown in Figure 54, and the other material, which has a different acoustic impedance than the material of the marker 3202, forms an adjacent encapsulating material that forms the exterior surface of the nose cone 3200. The marker 3202 may be encapsulated such that the nose cone 3200 retains a smooth tapered surface.

[0240] 55 shows a perspective view of a nosecone 3200 including a marker 3202. The marker may include multiple edges and may include multiple planar surfaces oriented along the axial plane of the nosecone 3200 and planar surfaces oriented along the radial plane. The edges may create an abrupt transition in the acoustic impedance of the nosecone 3200, which increases the echogenicity of the nosecone 3200. Additionally, the edges and orientation of the planar surfaces increase acoustic reflections for various directions of incident ultrasound waves, thus also increasing the echogenicity of the nosecone 3200. The marker 3202 includes multiple fins extending radially outward.

[0241] Figure 56 shows a perspective view of the nosecone 3200 including markers 3202 at a larger angle than shown in Figure 55. The orientation of the fins is visible.

[0242] FIG. 57 shows a perspective view of a nosecone 3300 including a marker 3302 configured similarly to marker 3202, but with more fins than that shown in FIG.

[0243] The markers disclosed herein may be made from a material having a relatively high acoustic impedance, including a metal, etc. The acoustic impedance may be greater than the impedance of the adjacent material to allow for enhanced echogenicity resulting from the use of the marker.

[0244] The markers disclosed herein may be utilized at various locations on the elongate shaft, not just on the nosecone comprising the tip of the elongate shaft. For example, the capsule, the outer retaining ring of the midshaft, and other locations on the outer sheath assembly, midshaft assembly, and inner shaft assembly may include markers, as desired.

[0245] 58 shows a side cross-sectional view of capsule 106 including a marker 3400 at the distal end of capsule 106. Marker 3400 may include multiple edges that increase the echogenicity of the elongate shaft (particularly the distal end of capsule 106) to clarify the location of a portion of the elongate shaft (the distal end of capsule 106) when viewed under ultrasound imaging.

[0246] FIG. 59 shows an enlarged perspective view of a marker 3400. The marker may include multiple edges 3402 that bound the apertures 3404 of the marker 3400. The multiple apertures 3404 may be circumferentially spaced around the marker 3400. The apertures 3404 may allow for an acoustic impedance transition between the body of the marker 3400 and the apertures 3404, which may be filled with a material having a different acoustic impedance than the body of the marker 3400. The apertures 3404 may each have an oval shape with adjacent apertures 3404 overlapping each other, such that a vertical scan slice taken through the marker along the vertical direction, represented by line 3406, passes through the apertures 3404, allowing for the acoustic impedance transition caused by the apertures 3404. Additionally, the angled profile of the apertures 3404 may enhance acoustic reflectivity for various directions of incident ultrasound waves. The marker 3400 in the form of a ring extends about the longitudinal axis of the elongate shaft, with a plurality of apertures positioned circumferentially about the longitudinal axis.

[0247] The position of the aperture 3404 in the vertical direction on the body of the marker 3400 also increases the likelihood that an acoustic slice will pass through the aperture 3404 when extending laterally, as represented by plane 3408 in FIG.

[0248] The markers 3400 may comprise bands of material having a different acoustic impedance than adjacent materials and may be located as desired. Markers 3400 may be located, for example, on the outer retaining ring of the midshaft and on the nosecone or tip. Other locations on the outer sheath assembly, midshaft assembly, and inner shaft assembly may include markers as desired.

[0249] 60 shows two echocardiographic images of a capsule including a marker 3400. The marker 3400 appears brighter in the two echocardiographic images, as indicated by locations 3500 and 3502, which may allow a user to more easily identify the location of the capsule within the images. The marker may be coupled to the tip of the elongate shaft, or any other location, and may appear brighter than the remainder of the tip or the remainder of the elongate shaft using ultrasound imaging, such as echocardiography.

[0250] The marker may be configured to be activated in embodiments herein. The marker may be configured to have greater echogenicity when activated. An activation mechanism or another system may be utilized to activate the marker as disclosed herein. FIG. 75A, for example, illustrates one embodiment of a marker 3800 configured to be activated. The distal end of a delivery system including a nose cone 3802 and a capsule 3804 is illustrated in FIG. 75A. The outer surface of the nose cone 3802 and the outer surface of the capsule 3804 may comprise smooth surfaces that form a smooth outer contour in the configuration shown in FIG. 75A. In such a configuration, for example, the delivery system may pass through a patient's body with a smooth outer contour that reduces the likelihood of damaging the surface of the patient's body.

[0251] The capsule 3804 can be configured to retract to activate the marker 3800 and allow the marker 3800 to increase the echogenicity of the elongate shaft of the delivery system. Thus, the activation mechanism can include the capsule 3804 and an indicator 3806, which can be located on a proximal portion of the elongate shaft. The indicator 3806 can be configured as a stop, as shown in FIG. 75A , or in embodiments, can be configured as a tactile, audible, or other form of indicator.

[0252] When a user desires to activate the marker 3800, a first portion of the elongate shaft may move relative to a second portion of the elongate shaft, activating the marker 3800. For example, the capsule 3804 may be retracted a length 3810 (shown in FIGS. 75A and 75B) to form a gap 3812 (shown in FIG. 75B) between two portions of the delivery system (e.g., the capsule 3804 and the nosecone 3802). FIG. 75B, for example, shows the capsule 3804 retracted a length 3810. The capsule 3804 moves axially relative to the nosecone 3802.

[0253] 75B , the gap 3812 formed by the movement of the capsule 3804 exposes the edges 3814, 3816 of the capsule 3804 and nosecone 3802, respectively, and may therefore activate the marker 3800. In such a configuration, a user may be able to identify the marker 3800 using ultrasound imaging. The marker 3800 includes contoured portions that form the edges 3814, 3816 of the elongate shaft. The planar surface formed by the edge 3814 may face distally, and the planar surface formed by the edge 3816 may face proximally.

[0254] In embodiments, indicator 3806 may indicate to the user to retract capsule 3804 a relatively short distance to maintain the proximity between edges 3814, 3816. The proximity of edges 3814, 3816 may increase the echogenicity of marker 3800. When the user desires to further retract capsule 3804 (e.g., to deploy an implant), indicator 3806 may be overcome, for example, by riding over a stop or otherwise continuing movement past indicator 3806. For example, indicator 3806 may be moved (e.g., pushed or slid) to allow capsule 3804 to continue retracting.

[0255] In such a configuration, the portion of the delivery system containing the marker 3800 may have a smooth outer contour, with the edges 3814, 3816 only exposed at the desired time by the user operating the activation mechanism. Thus, the potential for injury to the patient's body caused by an uneven outer contour may be reduced until the desired time of activation of the marker 3800.

[0256] Other configurations of activatable markers may be utilized in embodiments. FIG. 76A, for example, shows one embodiment in which a first portion of the elongate shaft (e.g., a strip of material 3818) forms the outer surface of the delivery system (e.g., the outer surface of the capsule 3820). The portion shown may comprise the capsule or another portion of the elongate shaft, if desired. The strip of material 3818 may move relative to a second portion of the elongate shaft (e.g., an adjacent portion of the elongate shaft), forming a gap 3822 between the portions. A user may operate an activation mechanism, for example, as disclosed herein. The gap 3822 may expose an edge 3824 of the marker 3826 (shown in FIG. 76B). The material 3818 may slide axially.

[0257] FIG. 77A shows an embodiment in which a first portion of the elongate shaft (e.g., a strip of material 3828) forms the exterior surface of the delivery system (e.g., the exterior surface of the capsule 3830). The strip of material 3828 may move to form a gap 3832 (as shown in FIG. 77B) and expose an edge 3834 of the marker 3836. The material 3828 may rotate relative to a second portion of the elongate shaft (e.g., an adjacent portion of the elongate shaft) to activate the marker 3836. A user may, for example, operate an activation mechanism disclosed herein to rotate the strip of material 3828.

[0258] In embodiments, multiple markers may be located on the delivery system. The markers may be spaced apart a distance so that a user viewing the markers on ultrasound imaging can identify their relative locations on the delivery system. FIG. 78A, for example, shows one embodiment in which multiple markers 3840 are spaced apart in a stepped fashion on the delivery system. The markers 3840 may form a spiral pattern. Thus, when the markers 3840 (shown in FIG. 78B) are activated, multiple locations on the delivery system are indicated. A user may operate an activation mechanism, for example, as disclosed herein. The strips of material forming the outer surface of the delivery system may each move to form gaps and expose the edges of the markers 3840. A user may be able to match the locations of the markers 3840 to their respective locations on the delivery system. Additionally, a user may be able to determine relative scaling on the imaging system based on the imaged distances between the markers 3840. For example, if a user perceives that each marker is 3 millimeters apart, that scaling can be used to determine the distance at which they appear on the imaging system.

[0259] Use of the markers disclosed herein may allow a user to more easily locate a portion of the elongate shaft under ultrasound imaging, which may include echocardiography. The user may be able to more easily determine the deployment location of the expandable implant, which may include the depth of the expandable implant and its relationship to structures in the patient's heart, including the papillary muscles and any valve septum, including the mitral valve septum. The user may advantageously visualize the location of the portion of the elongate shaft without relying solely on fluoroscopy for visualization. The markers disclosed herein may be utilized on catheters, intravenous or digestive systems, or any portion of an implant, or any other device for insertion into the human body where a specific location needs to be identified by ultrasound imaging or echocardiography. The markers disclosed herein may be utilized alone or in conjunction with any of the other devices, systems, or methods disclosed herein.

[0260] Methods of using the delivery system 10 in connection with a replacement mitral valve will now be described. In particular, the delivery system 10 may be used in methods for percutaneous delivery of a replacement mitral valve to treat patients with moderate to severe mitral regurgitation. The following methods are merely examples of how the delivery system may be used. It will be understood that the delivery systems described herein may be used as part of other methods as well. The embodiments shown in Figures 16-60 may be incorporated and utilized as needed.

[0261] As shown in FIG. 61 , in one embodiment, the delivery system 10 can be placed into the ipsilateral femoral vein 1074 and advanced toward the right atrium 1076. A transseptal puncture using known techniques can then be performed to gain access to the left atrium 1078. The delivery system 10 can then be advanced into the left atrium 1078 and then into the left ventricle 1080. FIG. 61 shows the delivery system 10 extending from the ipsilateral femoral vein 1074 to the left atrium 1078. In embodiments of the present disclosure, a guidewire is not required to position the delivery system 10 in the appropriate location, although in other embodiments, one or more guidewires can be used.

[0262] Therefore, it may be advantageous for a user to be able to navigate the delivery system 10 through complex regions of the heart to position the replacement mitral valve along the native mitral valve. This may be performed with or without the use of a guidewire in conjunction with the systems disclosed above. The distal end of the delivery system may be advanced into the left atrium 1078. The user may then manipulate the rail assembly 20 to direct the distal end of the delivery system 10 to the appropriate region. The user may then continue to thread the bent delivery system 10 into the left atrium 1078 via a transseptal puncture. The user may then further manipulate the delivery system 10 to create an even greater bend in the rail assembly 20. Additionally, the user may apply torque to the entire delivery system 10 to further manipulate and control the position of the delivery system 10. In the fully bent configuration, the user may then place the replacement mitral valve in the appropriate position. This may advantageously enable delivery of a replacement valve to an in situ implantation site, such as a native mitral valve, via a wider variety of approaches, such as a transseptal approach.

[0263] The rail assembly 20 may be particularly advantageous for entering the native mitral valve. As described above, the rail assembly 20 may form two bends, both of which may be positioned within the left atrium 1078. The bends of the rail assembly 20 may position the implant 70, positioned within the implant holding region 16, so that it is coaxial with the native mitral valve. Once the implant 70 is coaxial, the outer sheath assembly 22, midshaft assembly 21, inner assembly 18, and nosecone assembly 31 may be advanced distally relative to the rail assembly 20 (e.g., using the depth knob 212 of the handle 14). These assemblies advance linearly from the rail assembly 20, thus maintaining the implant 70 in a compressed configuration while advancing these assemblies coaxially with the native mitral valve until the implant 70 is released, as described below. Thus, the rail assembly 20 provides the user with the ability to lock the angular position in place, thereby eliminating the need for angle changes and allowing the user to simply advance the other assemblies longitudinally over the rail assembly 20, significantly simplifying the procedure. The rail assembly 20 functions as an independent steering assembly; all assemblies are provided with steering and no additional prosthesis release function. Furthermore, the structure of the rail assembly 20 described above is sufficiently rigid so that when the rail assembly is actuated into its bent shape, it maintains its shape despite movement of other components, such as the outer sheath assembly 22, midshaft assembly 21, inner assembly 18, and / or nosecone assembly 31. Thus, the rail assembly 20 can remain in a desired bent position while the other assemblies slide relative to the rail assembly 20, and the rail assembly 20 can help guide the other assemblies into their final position. Proximal / distal translation of the other assemblies over the rail assembly 20 allows for ventricular-atrial movement.Additionally, once the distal anchor 80 of the implant 70 is released within the left ventricle 1080, the other assembly can be retracted proximally on the rail assembly 20 to capture any valve leaflets or chordae tendineae prior to full release.

[0264] Reference is now made to FIG. 62, which shows a schematic diagram of a portion of one embodiment of a replacement heart valve (implant 70) positioned within the native mitral valve of a heart 83. Further details regarding how the implant 70 may be positioned within the native mitral valve are described in U.S. Patent Application Publication No. 2015 / 0328000 A1, which is incorporated herein by reference in its entirety, including, but not limited to, FIGS. 13A-15 and paragraphs

[0036] -

[0045] . A portion of the native mitral valve is shown schematically, depicting typical anatomical structures including a left atrium 1078 located above the annulus 1106 and a left ventricle 1080 located below the annulus 1106. The left atrium 1078 and the left ventricle 1080 are in communication with each other via the mitral valve annulus 1106. The leaflets 1108 of the native mitral valve are also shown schematically in FIG. 62 with chordae tendineae 1110 connecting their downstream ends to the papillary muscles of the left ventricle 1080. A portion of the implant 70 positioned upstream of the annulus 1106 (towards the left atrium 1078) can be referred to as being supranuclearly positioned. A portion generally within the annulus 1106 is referred to as being intraannularly positioned. A portion downstream of the annulus 1106 (towards the left ventricle 1080) is referred to as being subannularly positioned.

[0265] As shown in FIG. 62 , a replacement heart valve (e.g., implant 70) can be positioned so that the mitral valve annulus 1106 is located between the distal anchor 80 and the proximal anchor 82. In some circumstances, the implant 70 can be positioned so that the end or tip of the distal anchor 80 contacts the annulus 1106, for example, as shown in FIG. 62 . In some circumstances, the implant 70 can be positioned so that the end or tip of the distal anchor 80 does not contact the annulus 1106. In some circumstances, the implant 70 can be positioned so that the distal anchor 80 does not extend around the valve leaflets 1108.

[0266] As shown in FIG. 62 , the prosthesis, specifically the implant 70 in the form of a replacement heart valve, can be positioned so that the end or tip of the distal anchor 80 is on the ventricular side of the mitral valve annulus 1106 and the end or tip of the proximal anchor 82 is on the atrial side of the mitral valve annulus 1106. The distal anchor 80 can be positioned so that the end or tip of the distal anchor 80 is on the ventricular side of the native valve leaflet, beyond the location where the chordae tendineae 1110 connect to the free ends of the native valve leaflets. The distal anchor 80 can extend between at least a portion of the chordae tendineae 1110 and, in some situations, such as those shown in FIG. 62 , can contact or engage the ventricular side of the annulus 1106. It is also contemplated that in some situations, the distal anchor 80 may not contact the annulus 1106, but the distal anchor 80 may still contact the native valve leaflets 1108. In some circumstances, the distal anchor 80 can contact tissue of the left ventricle 1080 beyond the ventricular side of the annulus 1106 and / or leaflets.

[0267] During delivery, the distal anchor 80 (together with the frame) can be moved toward the ventricular side of the annulus 1106, such as by translating the other assemblies (e.g., the outer sheath assembly 22, the midshaft assembly 21, the inner assembly 18, and the nosecone assembly 31) proximally relative to the rail assembly 20, so that the distal anchor 80 extends between at least a portion of the chordae tendineae 1110 and applies tension to the chordae tendineae 1110. The degree of tension applied to the chordae tendineae 1110 can vary. For example, there may be little or no tension in the chordae tendineae 1110 whose leaflets 1108 are shorter than or similar in size to the distal anchor 80. A greater degree of tension may be present in the chordae tendineae 1110, with the leaflets 1108 being longer than the distal anchor 80 and therefore assuming a compressed configuration and being pulled proximally. If the leaflets 1108 are longer relative to the distal anchor 80, a greater degree of tension may exist in the chordae tendineae 1110. The leaflets 1108 may be long enough so that the distal anchor 80 does not contact the annulus 1106.

[0268] The proximal anchor 82, if present, may be positioned such that an end or tip of the proximal anchor 82 is adjacent to tissue on the atrial side of the annulus 1106 and / or beyond the annulus 1106 in the left atrium 1078. In some circumstances, some or all of the proximal anchor 82 may only occasionally contact or engage tissue on the atrial side of the annulus 1106 and / or beyond the annulus 1106 in the left atrium 1078. For example, as shown in FIG. 62 , the proximal anchor 82 may be spaced from tissue on the atrial side of the annulus 1106 and / or beyond the annulus 1106 in the left atrium 1078. The proximal anchor 82 may provide axial stability to the implant 70. It is also contemplated that some or all of the proximal anchor 82 may contact tissue on the atrial side of the annulus 1106 and / or beyond the annulus 1106 in the left atrium 1078. 63 shows the implant 70 implanted in the heart. While the illustrated replacement heart valve includes both proximal and distal anchors, it will be appreciated that proximal and distal anchors are not required in all cases. For example, a replacement heart valve having only a distal anchor may be able to firmly maintain the replacement heart valve within the valve annulus. This is because the greatest force on the replacement heart valve is directed toward the left atrium during systole. Therefore, the distal anchor is most important for securing the replacement heart valve within the valve annulus and preventing migration.

[0269] 64-66 illustrate the release mechanism of the delivery system 10. During initial insertion of the implant 70 and delivery system 10 into the body, the implant 70 may be positioned within the system 10 similar to that shown in FIG. 2A. The distal end 303 of the implant 70, specifically the distal anchor 80, is restrained within the capsule 106 of the outer sheath assembly 22, thus preventing expansion of the implant 70. Similar to that shown in FIG. 2A, the distal anchor 80 can extend distally once positioned within the capsule. The proximal end 301 of the implant 70 is restrained within the capsule 106 and within a portion of the inner retention member 40, and thus is generally restrained between the capsule 106 and the inner retention member 40.

[0270] The system 10 can be initially positioned at a particular location within the patient's body, such as at the native mitral valve, through the use of the steering mechanisms or other techniques discussed herein.

[0271] Once the implant 70 is loaded into the delivery system 10, the user can thread a guidewire to the desired location within the patient. The guidewire passes through the lumen of the nosecone assembly 31, so that the delivery system 10 can be advanced through the patient's body, generally following the guidewire. The delivery system 10 can be advanced by the user manually axially moving the handle 14. In some embodiments, the delivery system 10 can be placed in a stand while manipulating the controls on the handle 14.

[0272] Once fully within the heart, the user can begin steering the rail assembly 20 using the distal pullwire knob 206 and / or the proximal pullwire knob 208. By rotating either knob, the user can provide bending / flexion of the rail assembly 20 (either the distal or proximal end), thus bending the distal end of the delivery system 10 into a desired configuration at one, two, or more positions. As described above, the user can provide multiple bends in the rail assembly 20 to orient the delivery system 10 toward the mitral valve. In particular, the bends in the rail assembly 20 can orient the distal end of the delivery system 10, and therefore the capsule 106, along a central axis that passes through the native mitral valve. Thus, as the outer sheath assembly 22, midshaft assembly 21, inner assembly 18, and nosecone assembly 31, together with the compressed implant 70, advance over the rail assembly 20, the capsule 106 advances directly along the axis to properly release the implant 70.

[0273] The user may also rotate and / or move the handle 14 itself within the stand for further fine adjustment of the distal end of the delivery system 10. The user may sequentially rotate the proximal and / or distal pullwire knobs 208 / 206 and move the handle 14 itself to orient the delivery system 10 for release of the implant 70 within the body. The user may also move other assemblies further relative to the rail assembly 20, such as in a proximal or distal direction.

[0274] In the next step, the user may rotate the depth knob 212. As described above, rotating these knobs 212 together advances the inner shaft assembly 18, mid shaft assembly 21, outer sheath assembly 22, and nosecone assembly 31 over / through the rail assembly 20 while the implant 70 remains in a compressed configuration within the implant holding area 16. For example, the rigidity of either the inner shaft assembly 18, mid shaft assembly 21, and / or outer sheath assembly 22 causes these assemblies to move straight forward in the direction aligned by the rail assembly 20.

[0275] Once in the released position, the user can rotate the outer sheath knob 210, which separately translates the outer sheath assembly 22 (and thus the capsule 106) proximally toward the handle 14 relative to the other assemblies, particularly the inner assembly 18, as shown in FIG. 64 . By doing so, the distal end 303 of the implant 70 is exposed within the body, allowing expansion to begin. At this point, the distal anchor 80 can be inverted proximally, and the distal end 303 begins to expand radially outward. For example, if the system 10 is delivered to the native mitral valve position via a transseptal approach, the nosecone is positioned within the left ventricle, preferably aligning the implant 70 so that it is approximately perpendicular to the plane of the mitral valve annulus. The distal anchor 80 expands radially outward within the left ventricle. The distal anchor 80 can be positioned above the heads of the papillary muscles but below the mitral valve annulus and mitral valve leaflets. In some embodiments, the distal anchor 80 may contact and / or extend between the chordae tendineae in the left ventricle and contact the valve leaflets as the distal anchor 80 radially expands. In some embodiments, the distal anchor 80 may not contact and / or extend between the chordae tendineae or contact the valve leaflets. Depending on the location of the implant 70, the distal end of the distal anchor 80 may be at or below where the chordae tendineae connect to the free edges of the native valve leaflets.

[0276] As shown in the illustrated embodiment, the distal end 303 of the implant 70 is expanded outward. Note that the proximal end 301 of the implant 70 may remain covered by an outer retaining ring during this step so that the proximal end 301 remains radially compressed. At this point, the system 10 may be pulled proximally so that the distal anchors 80 capture and engage the mitral valve leaflets, or may be moved proximally to reposition the implant 70. For example, these assemblies may be moved proximally relative to the rail assembly 20. Additionally, the system 10 may be torqued, which may cause the distal anchors 80 to tension the chordae tendineae through which at least some of the distal anchors may extend. However, in some embodiments, the distal anchors 80 may not tension the chordae tendineae. In some embodiments, the distal anchors 80 may capture the native valve leaflets and be between the chordae tendineae after retraction of the outer sheath assembly 22 without further movement of the system 10.

[0277] During this step, system 10 may be moved proximally or distally to cause distal or ventricular anchor 80 to properly capture the leaflets of the native mitral valve. This may be done by moving outer sheath assembly 22, midshaft assembly 21, inner assembly 18, and nosecone assembly 31 relative to rail assembly 20. In particular, the tip of ventricular anchor 80 may be moved proximally to engage the ventricular side of the native annulus, so that the native leaflets are positioned between anchor 80 and the body of implant 70. When implant 70 is in its final position, there may or may not be tension on the chordae tendineae, but distal anchor 80 may be positioned between at least some of the chordae tendineae.

[0278] The proximal end 301 of the implant 70 remains within the outer retaining ring 42 after retraction of the capsule 106. As shown in FIG. 65 , once the distal end 303 of the implant 70 is fully expanded (or as fully expanded as possible at this point), the outer retaining ring 42 can be pulled separately in a proximal direction relative to the other assemblies, particularly the inner assembly 18, to expose the inner retention member 40 and thus initiate expansion of the proximal end 301 of the implant 70. For example, in a mitral valve replacement procedure, the proximal end 301 of the implant 70 may be expanded within the left atrium after the distal or ventricular anchor 80 is positioned between at least some of the chordae tendineae and / or engages the native mitral valve annulus.

[0279] The outer retaining ring 42 can be moved proximally to allow the proximal end 310 of the implant 70 to radially expand to its fully expanded configuration, as shown in FIG. 66 . After expansion and release of the implant 70, the inner assembly 18, nosecone assembly 31, midshaft assembly 21, and outer sheath assembly 22 can be simultaneously pulled proximally along or relative to the rail assembly 20 to return to their original positions. In some embodiments, they are not pulled relative to the rail assembly 20 and remain in the expanded position. Additionally, the nosecone 28 can be retracted into the outer sheath assembly 22 through the center of the expanded implant 70, such as by translating the knob 216 proximally. The system 10 can then be removed from the patient.

[0280] 67A-67B show the advancement of various assemblies on the rail assembly 20. Fig. 67A shows the assembly in its most proximal position on the rail assembly 20. Fig. 67B shows the assembly in its most distal position compared to the rail assembly 20 shown in Fig. 2C, etc. Thus, the assemblies snake along the rail assembly 20, extending away from each other in the distal direction.

[0281] In some embodiments, the implant 70 may be delivered under fluoroscopy so that the user can see specific reference points for proper positioning of the implant 70. Additionally, echocardiography may be used for proper positioning of the implant 70.

[0282] The following is a description of another implantation method for delivering a replacement mitral valve to the mitral valve position. The following elements can be incorporated into the above description, or vice versa. The access site to the patient can be dilated before inserting the delivery system 10. Additionally, the dilator can be flushed with, for example, heparinized saline before use. The delivery system 10 can then be inserted over a guidewire. In some embodiments, any flush port on the delivery system 10 can be oriented vertically. Additionally, if an introducer tube is used, integrated, or otherwise applied, it can be stabilized. The delivery system 10 can be advanced through the septum until the distal end of the delivery system 10 crosses the septum and is positioned within the left atrium 1078. Thus, the distal end of the delivery system 10 can be positioned within the left atrium 1078. In some embodiments, the delivery system 10 can be rotated to a desired position, such as under fluoroscopy. The rail can be bent to point the distal end of the delivery system 10 toward the septum and mitral valve. The position of the delivery system 10 and the implant 70 therein may be confirmed using echocardiographic and fluoroscopic guidance.

[0283] In some embodiments, the implant 70 may be positioned above, along, or below the mitral valve annulus 1106 prior to release. In some embodiments, the implant 70 may be positioned completely above, along, just below, or completely below the mitral valve annulus 1106 prior to dilation. In some embodiments, the implant 70 may be positioned partially above, along, or partially below the mitral valve annulus 1106 prior to dilation. In some embodiments, a pigtail catheter may be introduced into the heart to perform a ventriculogram for proper observation.

[0284] In some embodiments, the location of the mitral valve plane and the height of any papillary muscles on the fluoroscopic monitor may be marked to indicate exemplary target landing zones. If desired, the delivery system 10 may be unbent, reduced-rotated, and retracted to reduce tension on the delivery system 10 and reduce contact with the left ventricular wall, left atrial wall, and / or mitral valve annulus 1106.

[0285] Additionally, the delivery system 10 can be positioned to be coaxial with the mitral valve annulus 1106, or at least as coaxial as possible, while still reducing contact with the left ventricular wall, left atrial wall, and / or mitral valve annulus 1106 and reducing tension on the delivery system. The echo probe can be positioned to view the anterior mitral valve leaflet (AML), posterior mitral valve leaflet (PML) (leaflets 1108), mitral valve annulus 1106, and outflow tract. Using fluoroscopy and echo imaging, the implant 70 can be confirmed to be positioned coaxially with the mitral valve annulus 1106 at a particular depth.

[0286] The outer sheath assembly 22 can then be retracted to expose the ventricular anchor 80, thereby releasing the ventricular anchor 80. In some embodiments, once exposed, the outer sheath assembly 22 can be reversed in a direction that releases the tension on the outer sheath assembly 22. In some embodiments, the reversal of direction can also serve to partially or completely capture the implant 70.

[0287] The distal anchors 80 can be released within the left atrium 1078. Furthermore, the proximal anchors 82, if included in the implant 70, have not yet been exposed. Furthermore, the body of the implant 70 has not undergone any expansion at this point. However, in some embodiments, one or more of the distal anchors 80 can be released within the left atrium 1078 (e.g., supranullar release), or released entirely along the mitral annulus 1106 (e.g., intraannular release), or released just below the mitral annulus 1106 (e.g., subannular release). In some embodiments, all of the distal anchors 80 can be released together. In other embodiments, a subset of the distal anchors 80 can be released while in the first position, and another subset of the distal anchors 80 can be released while in the second position. For example, some of the distal anchors 80 may be released within the left atrium 1078 and some of the distal anchors 80 may be released while generally along or just below the mitral valve annulus 1106.

[0288] If the distal anchor 80 is released "just below" the mitral valve annulus 1106, the distal anchor 80 may be released 1 inch, 3 / 4 inch, 1 / 2 inch, 1 / 4 inch, 1 / 8 inch, 1 / 10 inch, or 1 / 20 inch below the mitral valve annulus 1106. In some embodiments, the distal anchor 80 may be released less than 1 inch, 3 / 4 inch, 1 / 2 inch, 1 / 4 inch, 1 / 8 inch, 1 / 10 inch, or 1 / 20 inch below the mitral valve annulus 1106. This may cause the distal anchor 80 to snake through the chordae tendineae as it is released. This may advantageously allow the implant 70 to contract slightly as it is turned sharply downward toward the mitral valve. In some embodiments, this may eliminate the need for a guidewire to aid in crossing the mitral valve. In some embodiments, the guidewire may be retracted within the delivery system 10 before or after the release of the distal anchor 80.

[0289] In some embodiments, the distal anchor 80 can be released immediately after crossing the septum, and then the final trajectory of the delivery system 10 can be determined. Thus, the delivery system 10 can cross the septum, release the ventricular anchor 80, establish a trajectory, and move into the left ventricle to capture the valve leaflets.

[0290] As described in detail above, the distal anchors 80 can be flipped from a distally extending state to a proximally extending state upon release from the delivery system 10. This flip can be approximately 180 degrees. Thus, in some embodiments, the distal anchors 80 can be flipped within the left atrium 1078 (e.g., supranullar flip), or flipped entirely along the mitral valve annulus 1106 (e.g., intraannular flip), or flipped just below the mitral valve annulus 1106 (e.g., subannular flip). The proximal anchors 82, if present, can remain within the delivery system 10. In some embodiments, all of the distal anchors 80 can be flipped together. In other embodiments, a subset of the distal anchors 80 can be flipped while in a first position, and another subset of the distal anchors 80 can be released while in a second position. For example, some of the distal anchors 80 may be inverted within the left atrium 1078 and some of the distal anchors 80 may be inverted while generally along or just below the mitral valve annulus 1106.

[0291] In some embodiments, the distal anchor 80 may be positioned along or just below the annulus 1106 in a non-inverted position. In some embodiments, the distal anchor 80 may be positioned along or just below the annulus 1106 in an inverted position. In some embodiments, the distal-most portion of the implant 70 may be positioned within or below the mitral valve annulus 1106, such as just below the mitral valve annulus 1106, prior to inversion. However, inverting the anchor may move the distal-most portion of the implant 70 / anchor 80 upward and into the left atrium 1078 or along the mitral valve annulus 1106 without any other movement of the delivery system 10. Thus, in some embodiments, the distal anchor 80 may begin to invert at the annulus 1106, but upon inversion, be completely within the left atrium 1078. In some embodiments, the distal anchor 80 can begin to invert below the annulus 1106 but, once inverted, is completely within the annulus 1106 .

[0292] In some embodiments, the distal anchor 80, upon release and inversion, may be proximal to the free end of the mitral valve leaflet 1108 (e.g., toward the left atrium 1078). In some embodiments, the distal anchor 80, upon release and inversion, may be along the free end of the mitral valve leaflet 1108 (e.g., toward the left atrium 1078). In some embodiments, the distal anchor 80, upon release and inversion, may be proximal to the free end of the mitral valve annulus 1106 (e.g., toward the left atrium 1078). In some embodiments, the distal anchor 80, upon release and inversion, may be along the free end of the mitral valve annulus 1106 (e.g., toward the left atrium 1078).

[0293] Thus, in some embodiments, the distal anchor 80 may be released / inverted above the location where the chordae tendineae 1110 attach to the free end of the native leaflet 1108. In some embodiments, the distal anchor 80 may be released / inverted above the location where some of the chordae tendineae 1110 attach to the free end of the native leaflet 1108. In some embodiments, the distal anchor 80 may be released / inverted above the location where all of the chordae tendineae 1110 attach to the free end of the native leaflet 1108. In some embodiments, the distal anchor 80 may be released / inverted above the mitral valve annulus 1106. In some embodiments, the distal anchor 80 may be released / inverted above the mitral valve leaflets 1108. In some embodiments, the distal anchor 80 may be released / inverted entirely along the mitral valve annulus 1106. In some embodiments, the distal anchor 80 may be released / inverted entirely along the mitral valve leaflets 1108. In some embodiments, the tip of the distal anchor 80 may be released / inverted generally along the mitral valve annulus 1106. In some embodiments, the tip of the distal anchor 80 may be released / inverted generally along the mitral valve leaflets 1108. In some embodiments, the distal anchor 80 may be released / inverted below the location where some of the chordae tendineae 1110 attach to the free ends of the native valve leaflets 1108. In some embodiments, the distal anchor 80 may be released / inverted below the location where all of the chordae tendineae 1110 attach to the free ends of the native valve leaflets 1108. In some embodiments, the distal anchor 80 may be released / inverted below the mitral valve annulus 1106. In some embodiments, the distal anchor 80 may be released / inverted below the mitral valve leaflets 1108.

[0294] Once the distal anchor 80 is released and inverted, the delivery system 10 can be translated through the mitral valve annulus 1106 toward the left ventricle 1080 such that the distal anchor 80 enters the left ventricle 1080. In some embodiments, the distal anchor 80 can be compressed as it passes through the mitral valve annulus 1106. In some embodiments, the implant 70 can be compressed as it passes through the mitral valve annulus 1106. In some embodiments, the implant 70 does not compress as it passes through the mitral valve annulus 1106. The distal anchor 80 can be delivered to any position within the left ventricle 1080 between the valve leaflets 1108 and the heads of the papillary muscles.

[0295] In some embodiments, the distal anchor 80 is fully expanded before passing through the mitral valve annulus 1106. In some embodiments, the distal anchor 80 is partially expanded before passing through the mitral valve annulus 1106, and continued movement of the delivery system 10 can fully expand the distal anchor 80 within the left ventricle 1080.

[0296] As the distal anchor 80 enters the left ventricle 1080, the distal anchor 80 can pass through the chordae tendineae 1110 and move behind the mitral valve leaflets 1108, thereby capturing the leaflets 1108. In some embodiments, the distal anchor 80 and / or other portions of the implant 70 can push the chordae tendineae 1110 and / or the mitral valve leaflets 1108 outward.

[0297] Thus, after release of the distal anchor 80, the delivery system 10 can then be repositioned as needed so that the end of the left distal anchor 80 is level with the free ends of the native mitral valve leaflets 1108. The delivery system 10 can also be positioned to be coaxial with the mitral valve annulus 1106, if possible, while still reducing contact with the left ventricular wall, left atrial wall, and / or annulus 1106.

[0298] In some embodiments, only the distal anchor 80 is released within the left atrium 1078 before the implant 70 moves into position within or below the annulus. In some alternative embodiments, the distal end of the implant 70 may be further expanded within the left atrium 1078. Thus, instead of the distal anchor 80 everting and not expanding any portion of the body of the implant 70, a portion of the implant 70 may be exposed and expanded within the left atrium 1078. This partially exposed implant 70 may then pass through the annulus 1106 and into the left ventricle 1080. Additionally, the proximal anchor, if any, may be exposed. In some embodiments, the entire implant 70 may be expanded within the left atrium 1078.

[0299] To facilitate passage through the valve annulus 1106, the delivery system 10 can include a leader element (not shown) that passes through the annulus 1106 before the implant 70 passes through the annulus 1106. For example, the leader element can include an expandable member, such as an expandable balloon, which can maintain the shape of the annulus 1106 or help expand the annulus 1106. The leader element can have a tapered or rounded shape (e.g., conical, frustoconical, hemispherical) to facilitate positioning and expansion of the annulus 1106. In some embodiments, the delivery system 10 can include an engagement element (not shown) that can apply a force to the implant 70 to pass the implant 70 through the valve annulus 1106. For example, the engagement element can include an expandable member, such as an expandable balloon, located within or above the implant 70.

[0300] In some embodiments, to facilitate passage through the annulus 1106, a user can reorient the implant 70 before passing the implant 70 through the annulus 1106. For example, a user can reorient the implant 70 so that the implant 70 passes laterally through the annulus 1106.

[0301] However, if only the distal anchor 80 is everted and no other expansion occurs, the prosthesis may be partially expanded within the ventricle 1080. Thus, when the implant 70 is in place, the distal end may be allowed to expand to capture the valve leaflets 1108. If the distal end is already expanded, no further expansion occurs, or the distal end may be allowed to expand further.

[0302] Additionally, the PML and AML 1106 may be captured by, for example, adjusting the depth and angle of the implant 70. If a larger prosthesis diameter is required to capture the leaflets 1108, the outer sheath assembly 22 can be retracted until the desired diameter of the implant 70 is achieved. Capture of the leaflets 1108 can be confirmed by echo imaging. In some embodiments, the user can confirm that the implant 70 is still at the appropriate depth and has not advanced into the left ventricle 1080. Its position can be adjusted as needed.

[0303] In some embodiments, once the distal anchor 80 enters the left ventricle 1080, the system 10 can be pulled posteriorly (e.g., toward the left atrium 1078) to fully capture the leaflet 1108. In some embodiments, the system 10 does not need to be pulled posteriorly to capture the leaflet 1108. In some embodiments, systolic pressure can push the leaflet 1108 upward so that it is captured by the distal anchor 80. In some embodiments, after the leaflet 1108 is captured and the implant 70 is fully or partially released, systolic pressure can push the entire implant 70 up toward the mitral annulus 1106. In some embodiments, the user can rotate the delivery system 10 and / or implant 70 before and / or while pulling the delivery system 10 posteriorly. In some cases, this can beneficially engage a greater number of chordae tendineae.

[0304] The outer sheath assembly 22 can be further retracted to fully expand the prosthesis. Once the implant 70 is fully exposed, the delivery system 10 can be manipulated to be coaxial and flush with the mitral valve annulus 1106, such as by flexing, translating, or rotating the delivery system 10. If necessary, the implant 70 can be repositioned to capture the free ends of the native mitral valve leaflets 1108. Once full engagement of the leaflets 1108 is confirmed, the implant 70 can be placed perpendicular (or nearly perpendicular) to the plane of the mitral valve annulus.

[0305] Subsequently, the midshaft assembly 21 can be pulled. The midshaft assembly 21 can then be reversed in direction to release any tension on the delivery system 10.

[0306] Although a description of the proximal anchor 82 is provided below, some embodiments of the implant 70 may not include the proximal anchor 82. In some embodiments, the proximal anchor 82 may not be released from the system 10 until the distal anchor 80 captures the valve leaflet 1108. In some embodiments, the proximal anchor 82 may be released from the system 10 before the distal anchor 80 captures the valve leaflet 1108. In some embodiments, the proximal anchor 82 can be released when the distal anchor 80 is on or within the valve annulus, and the expanded implant 70 (partially or fully expanded) can be translated through the mitral valve annulus 1106. In some embodiments, the proximal anchor 82 can be released when the distal anchor 80 is subannular, and the entire implant 70 can be pulled up into the left atrium 1078 such that the proximal anchor 82 is on the valve annulus before release. In some embodiments, the proximal anchor 82 may be within the annulus before release, and systolic pressure may push the implant 70 into the atrium so that the proximal anchor 82 ends up on the annulus.

[0307] Leaflet capture and positioning of the implant 70, along with its perpendicular position relative to the mitral annular plane, can then be confirmed. In some embodiments, the nosecone 28 can then be retracted until it is within the implant 70. The midshaft assembly 21 can be further retracted until the implant 70 is released from the delivery system 10. Proper positioning of the implant 70 can be confirmed using TEE and fluoroscopic imaging.

[0308] The delivery system 10 may then be centered within the implant 70. The nosecone 28 and delivery system 10 may then be retracted into the left atrium 1078 and removed.

[0309] This intra- and supranuclear release can have several advantages. For example, it allows the distal anchor 80 to be properly aligned when contacting the chordae tendineae 1110. If the distal anchor 80 were released within the left ventricle 1080, this could cause dislocation or damage to cardiac tissue, such as the valve leaflets 1108 or chordae tendineae 1110.

[0310] In an alternative delivery approach, the delivery system 10 can be translated into the left ventricle 1080 prior to release of the implant 70. Thus, the distal end of the implant 70, and thus the distal anchor 80, can be released and partially or fully everted within the left ventricle 1080. Thus, in some embodiments, the anchor 82 can be released / everted below the mitral valve annulus 1106, directly below the mitral valve annulus 1106, and / or below the free end of the valve leaflet 1108. Additionally, the anchor 82 can be released above the head of the papillary muscle. A similar method to that described above can then be used to properly position the implant 70 and remove the delivery system 10 to deliver the implant 70. Furthermore, in some embodiments, the distal anchor 80 can be released without first expanding the prosthesis within the ventricle 1080.

[0311] While many of the systems and methods disclosed herein have been described with respect to implanting a prosthetic mitral valve implant, it will be understood that these systems and methods may be utilized to deliver a variety of implants, including implants for heart valve repair. For example, other types of heart valve implants that may be utilized, among other types of implants (e.g., aortic valve implants and other repair implants), are shown in Figures 68-69.

[0312] The methods and systems disclosed herein, in some embodiments, may not be limited to delivering implants, but may extend to any medical intervention or insertion into a patient's body, which may include performing a medical procedure within the body. The methods and systems disclosed herein may be utilized in general catheter use, as needed. For example, the handles shown in FIGS. 35 and 37 and the components disclosed therein may, in some embodiments, comprise a general catheter handle. Additionally, in other embodiments, the configuration of the delivery device may be modified. For example, in an aortic valve delivery device, the configuration of the implant holding region and other features of the delivery device may be modified.

[0313] 68-69, an alternative embodiment of an implant 1600 is shown in an expanded configuration. The implant 1600 can include an inner frame 1620, an outer frame 1640, a valve body 1660, and one or more skirts, such as an outer skirt 1680 and an inner skirt 1690.

[0314] Referring first to the outer frame 1640 shown in Figures 68-69, the outer frame 1640 can be attached to the inner frame 1620 using any known fasteners and / or techniques. Although the outer frame 1640 is shown as a separate component from the inner frame 1620, it should be understood that the frames 1620, 1640 can be unitarily or integrally formed.

[0315] As shown in the illustrated embodiment, the outer frame 1640 can include an outer frame body 1642. The outer frame body 1642 can have an upper region 1642a, a middle region 1642b, and a lower region 1642c. At least a portion of the upper region 1642a of the outer frame body 1642 can be sized and / or shaped to generally match the size and / or shape of the upper region 1622a of the inner frame 1620. As shown in the illustrated embodiment, the upper region 1642a of the outer frame body 1642 can include one or more struts that generally match the size and / or shape of the struts of the inner frame 1620. This can locally reinforce a portion of the implant 1600 by effectively increasing the wall thickness of the combined struts.

[0316] When in an expanded configuration, such as a fully expanded configuration, the middle region 1642b and the lower region 1642c can have a diameter greater than the diameter of the upper region 1642a. The upper region 1642a of the outer frame body 1642 can have a diameter that decreases from its lower end to its upper end such that the upper region 1642a slopes or curves radially inward toward the longitudinal axis of the implant 1600. Although the outer frame body 1642 has been described and illustrated as being cylindrical or having a circular cross-section, it should be understood that all or a portion of the outer frame body 1642 can have a non-circular cross-section, such as, but not limited to, a D-shaped, oval, or otherwise oval cross-sectional shape.

[0317] 68-69, the outer frame body 1642 can include a plurality of struts, with at least some of the struts forming cells 1646a-c. Any number of strut configurations can be used, such as rings of wavy struts shown to form oval, elliptical, rounded polygonal, and teardrop shapes, as well as angled, diamond, curved, and various other shapes.

[0318] The upper row of cells 1646a can have an irregular octagonal shape, such as a "heart" shape. This additional space can advantageously allow the outer frame 1640 to maintain a smaller profile when pleated. The cells 1646a can be formed via a combination of struts. As shown in the illustrated embodiment, the upper portion of the cells 1646a can be formed from a set of circumferentially expandable struts 1648a having a zigzag or wavy shape that forms a repeating "V" shape. The struts 1648a can extend radially outward from their upper ends to their lower ends. These struts can approximately match the size and / or shape of the struts of the inner frame 1620.

[0319] The middle portion of the cells 1646a can be formed from a set of struts 1648b extending downward from the bottom end of each "V" shape. The struts 1648b can extend radially outward from the top to the bottom. The portion of the cells 1646a extending upward from the bottom ends of the struts 1648b can be considered to be a substantially shorter portion of the outer frame 1640 than appears in the figure.

[0320] The lower portion of the cell 1646a can be formed from a set of circumferentially expandable struts 1648c having a zigzag or wavy shape that forms a repeating "V" shape. As shown in the illustrated embodiment, the struts 1648c can include curves in which the lower ends of the struts 1648c extend more parallel to the longitudinal axis than the upper ends of the struts 1648c. One or more of the upper ends or tips of the circumferentially expandable struts 1648c can be "free" vertices that are not connected to a strut. For example, as shown in the illustrated embodiment, every other upper end or tip of the circumferentially expandable struts 1648b is a free vertex. However, it should be understood that other configurations can be used. For example, every upper vertex along the upper end can be connected to a strut.

[0321] The middle and / or lower rows of cells 1646b-c can have a different shape than the first row of cells 1646a. The middle row of cells 1646b and the lower row of cells 1646c can have a diamond or approximately diamond shape. The diamond or approximately diamond shape can be formed by a combination of struts.

[0322] An upper portion of cell 1646b can be formed from a set of circumferentially expandable struts 1648c such that cell 1646b shares struts with cell 1646a. A lower portion of cell 1646b can be formed from a set of circumferentially expandable struts 1648d. As shown in the illustrated embodiment, one or more of the circumferentially expandable struts 1648d can extend generally in a downward direction substantially parallel to the longitudinal axis of the outer frame 1640.

[0323] An upper portion of cell 1646c can be formed from a set of circumferentially expandable struts 1648d such that cell 1646c shares a strut with cell 1646b. A lower portion of cell 1646c can be formed from a set of circumferentially expandable struts 1648e. Circumferentially expandable struts 1648e can extend generally downward.

[0324] As shown in the illustrated embodiment, there may be nine columns of cells 1646a and eighteen columns of cells 1646b-c. While each of the cells 1646a-c is shown as having the same shape as the other cells 1646a-c in the same column, it should be understood that the shapes of the cells 1646a-c within a column may vary. Furthermore, it should be understood that any number of columns of cells may be used and any number of cells may be included in those columns.

[0325] As shown in the illustrated embodiment, the outer frame 1640 can include a set of eyelets 1650. The upper set of eyelets 1650 can extend from an upper region 1642a of the outer frame body 1642. As shown, the upper set of eyelets 1650 can extend from an upper portion of the cells 1646a, such as the upper apexes of the cells 1646a. The upper set of eyelets 1650 can be used to attach the outer frame 1640 to the inner frame 1620. For example, in some embodiments, the inner frame 1620 can include one or more eyelets corresponding to the eyelets 1650. In such embodiments, the inner frame 1620 and the outer frame 1640 can be attached to each other via the eyelets 1650 and corresponding eyelets on the inner frame 1620. For example, the inner frame 1620 and the outer frame 1640 can be sewn to each other through the eyelets or attached via other means, such as mechanical fasteners (e.g., screws, rivets, etc.).

[0326] As shown, the set of eyelets 1650 may include two eyelets extending consecutively from each "V" shaped strut. This may reduce the likelihood of the outer frame 1640 twisting along the axis of the eyelets. However, it should be understood that some "V" shaped struts may not include an eyelet. Additionally, it should be understood that a fewer or greater number of eyelets may extend from a "V" shaped strut.

[0327] The outer frame 1640 may include a set of locking tabs 1652 extending from or near the upper end of the upper region 1642a. As shown, the locking tabs 1652 may extend upward from a set of eyelets 1650. The outer frame 1640 may include twelve locking tabs 1652, although it should be understood that a greater or lesser number of locking tabs may be used. The locking tabs 1652 may include longitudinally extending posts 1652a. At the upper ends of the posts 1652a, the locking tabs 1652 may include enlarged heads 1652b. As shown, the enlarged heads 1652b may have a semicircular or semi-elliptical shape that forms a "mushroom" shape with the posts 1652a. The locking tabs 1652 may include eyelets 1652c that may be positioned through the enlarged heads 1652b. It should be understood that the locking tab 1652 may include eyelets in other locations or may include more than one eyelet.

[0328] The locking tabs 1652 can be advantageously used with multiple types of delivery systems. For example, the shape of the posts 1652a and enlarged head 1652b can be used to secure the outer frame 1640 to a "channel"-based delivery system, such as the inner retention member 40 described above. The eyelets 1652c and / or eyelets 1650 can be used to secure the outer frame 1640 to a "tether"-based delivery system, such as those that utilize sutures, wires, or fingers to control the delivery of the outer frame 1640 and implant 1600. This can advantageously facilitate in situ retrieval and repositioning of the outer frame 1640 and implant 1600.

[0329] The outer frame 1640, such as the outer frame body 1642, can be used to attach or secure the implant 1600 to a native valve, such as a native mitral valve. For example, the intermediate region 1642b of the outer frame body 1642 and / or the outer fixation features 1644 can be positioned to contact or engage the native valve annulus, tissue beyond the native valve annulus, the native valve leaflets, and / or other tissue at or around the implantation location during one or more phases of the cardiac cycle, such as systole and / or diastole. As another example, the outer frame body 1642 can be sized and positioned relative to the inner frame fixation features 1624 such that tissue of the body cavity located between the outer frame body 1642 and the inner frame fixation features 1624, such as the native valve leaflets and / or the native valve annulus, can be engaged or clamped to further secure the implant 1600 to the tissue. As shown, the inner frame fixation features 1624 include nine anchors, although it should be understood that a fewer or greater number of anchors can be used. In some embodiments, the number of individual anchors may be selected as a multiple of the number of commissures on the valve disc 1660. For example, if the valve disc 1660 has three commissures, the inner frame fixation feature 1624 may have three individual anchors (1:1 ratio), six individual anchors (2:1 ratio), nine individual anchors (3:1 ratio), twelve individual anchors (4:1 ratio), fifteen individual anchors (5:1 ratio), or any other multiple of three. In some embodiments, the number of individual anchors does not correspond to the number of commissures on the valve disc 1660.

[0330] 68-69, the valve disc 1660 is attached to the inner frame 1620 on the inside of the inner frame body 1620. The valve disc 1660 functions as a one-way valve, allowing blood flow in a first direction through the valve disc 1660 and preventing blood flow in a second direction through the valve disc 1660.

[0331] The disc 1660 can include multiple leaflets 1662, for example, three leaflets 1662, joined at commissures. The disc 1660 can include one or more intermediate components 1664. The intermediate components 1664 can be positioned between some or all of the leaflets 1662 and the inner frame 1620 such that at least a portion of the leaflets 1662 is coupled to the frame 1620 via the intermediate components 1664. In this manner, the portions of the leaflets 1662 at the commissures and / or some or all of the arcuate edges of the leaflets 1662 are not directly coupled or attached to the inner frame 1620, but are indirectly coupled or “floating” within the inner frame 1620.

[0332] Referring now to the outer skirt 1680 shown in FIGS. 68-69 , the outer skirt 1680 can be attached to the inner frame 1620 and / or the outer frame 1640. As shown, the outer skirt 1680 can be positioned around and secured to a portion or all of the exterior of the outer frame 1640. The inner skirt 1690 can be attached to the valve disc 1660 and the outer skirt 1680. As shown in FIG. 69 , a first end of the inner skirt 1690 can be coupled to the valve disc 1660 along a portion of the disc 1660 proximate the inner frame 1620. A second end of the inner skirt 1690 can be attached to an underside region of the outer skirt 1680. Doing so can create a smooth surface along the underside of each of the valve leaflets. This can advantageously improve hemodynamics by allowing blood to circulate more freely and reducing stagnant areas.

[0333] Although the implant 1600 has been described as including an inner frame 1620, an outer frame 1640, a valve disc 1660, and skirts 1680, 1690, it should be understood that the implant 1600 need not include all of the components. For example, in some embodiments, the implant 1600 can include the inner frame 1620, the outer frame 1640, and the valve disc 1660 while omitting the skirt 1680. Furthermore, while the components of the implant 1600 have been described and illustrated as separate components, it should be understood that one or more components of the implant 1600 can be integrally or monolithically formed. For example, in some embodiments, the inner frame 1620 and the outer frame 1640 can be integrally or monolithically formed as a single component.

[0334] The systems, devices, and methods disclosed herein can be utilized in retrieving a fully or partially deployed implant. For example, in the methods disclosed with respect to Figures 61-67B, the capsule 106 can be configured to slide distally for retrieval of a partially or, in some cases, fully deployed implant 70. Thus, the capsule 106 can move distally, retracting all or a portion of the implant 70 into the capsule 106 and retrieving the implant 70.

[0335] 64, for example, implant 70 is shown partially disposed from capsule 106. The arms of implant 70, in the form of distal anchors 80, extend outward from capsule 106 and are bent proximally relative to their orientation when positioned within capsule 106 (e.g., as shown in FIG. 2A). Notably, in this configuration, distal anchors 80 may extend between chordae tendineae 1110, as shown, for example, in FIG. 62.

[0336] 70 shows a cross-sectional view of capsule 106 in a plane transverse to the axis of capsule 106. Distal anchor 80 is shown extending radially outward from the outer surface of capsule 106, for example, as shown in the perspective view of FIG. 64. Tip 3610 of distal anchor 80 extends proximally, for example, as shown in the perspective view of FIG.

[0337] 70 , the chordae tendineae 1110 may be located within the narrow space 3612 between adjacent distal anchors 80. After full or partial deployment of the implant 70, when the capsule 106 advances distally to retrieve the implant 70, the distal anchors 80 may pinch one or more chordae tendineae 1110 located within the narrow space 3612. As the distal anchors 80 are retracted into the capsule 106, the chordae tendineae 1110 may compress the capsule 106 at a radial distance causing the chordae tendineae 1110 to be pinched within the narrow space 3612. This potential complex relationship may result in damage to the chordae tendineae 1110, including, in some cases, severing one or more of the chordae tendineae 1110.

[0338] 71 shows a side cross-sectional view of one embodiment of a capsule 3614 having a distal end 3616 configured to expand radially outward. The capsule 3614 may be otherwise configured similarly to capsule 106 or any other embodiment of a capsule disclosed herein. For example, the capsule 3614 may be configured to surround an implant-retaining area.

[0339] The distal end 3616 can be configured to bend radially outward. The distal end 3616 shown in FIG. 71 can be configured to bend radially outward relative to the proximal portion 3618 of the capsule 3614. The distal end 3616 can include an opening 3620 in which the implant 70 is disposed.

[0340] The distal end 3616 may be configured to flare outward relative to the proximal portion 3618 of the capsule 3614. The distal end 3616 may include a contact surface 3622 configured to contact and apply a force to the chordae tendineae 1110 to wipe any chordae tendineae 1110 off the anchor 80 as the anchor 80 is being pulled back into the capsule 3614 during retrieval. The flare of the distal end 3616 may allow the contact surface 3622 to contact the chordae tendineae 1110 at a greater radial position than the position of the chordae tendineae 1110 shown in FIG. 70 , and therefore, the chordae tendineae 1110 may be less likely to become pinched in the narrow space 3612 between the anchors 80. Thus, the likelihood of damage to the chordae tendineae 1110 during retrieval of the implant 70 may be reduced.

[0341] The distal end 3616 may be configured to passively flare outward, which may be caused by an outward force of the anchors 80 against the inner surface of the distal end 3616. In other embodiments, the distal end 3616 may be configured to be controlled to flare the distal end 3616 in a desired manner.

[0342] The distal end 3616 may be constructed of a flexible material, which may include an elastomer or another form of flexible material. The distal end 3616 may be configured to be pliable, thus providing a large contact surface area against the anchors 80 for wiping the chordae 1110 off the anchors 80. The distal end 3616 may be pliable to pass through the spaces between the anchors 80. The distal end 3616 may be resilient to return to its initial shape upon retrieval of the implant 70 and to resist permanent deformation while the distal end 3616 is expanding. Other configurations for the distal end 3616 may be utilized as desired.

[0343] 72 shows a side cross-sectional view of one embodiment of a capsule 3624 having a distal end 3626 configured to expand radially outward. The capsule 3624 may be otherwise configured similarly to capsule 106 or any other embodiment of a capsule disclosed herein. For example, the capsule 3624 may be configured to surround an implant-retaining area. The distal end 3626 of the capsule 3624 may be configured to expand radially outward by expanding radially outward.

[0344] The distal end 3626 may include an expandable body 3628 configured to expand. The expandable body 3628 may include a balloon or other form of expandable body configured to expand and spread the distal end 3626 radially outward. The distal end 3626 may include a contact surface 3630 (shown in FIG. 73 ) that functions similarly to the contact surface 3622 shown in FIG. 71 . Thus, the contact surface 3630 of the distal end 3626 may be configured to contact and wipe any chordae tendineae 1110 away from the anchor 80 as it is being pulled back into the capsule 3624 during retrieval. The spread of the distal end 3626 may allow the contact surface 3630 to contact the chordae tendineae 1110 at a greater radial position than the position of the chordae tendineae 1110 shown in FIG. 70 , and therefore, the chordae tendineae 1110 may be less likely to become pinched in the narrow spaces 3612 between the anchors 80. Thus, the likelihood of damage to the chordae tendineae 1110 may be reduced during retrieval of the implant 70. The expandable body 3628 may be adapted such that a portion of the expandable body 3628 may be positioned between the anchors 80.

[0345] The distal end 3626 can be configured to vary in size. FIG. 72 shows the distal end 3626 in an unexpanded, uninflated, or undeployed configuration, and FIG. 73 shows the distal end 3626 in an expanded, expanded, or deployed configuration. The distal end 3626 in the expanded, expanded, or deployed configuration has a larger size and a larger radial extent than the unexpanded, uninflated, or undeployed configuration. At least one inflation conduit 3632 extends along the elongate shaft of the delivery system and can be configured to inflate the expandable body 3628 of the distal end 3626 with a fluid or other substance to inflate the distal end 3626. The inflation conduit 3632 can be controlled from a proximal portion of the delivery system to inflate or deflate the distal end 3626, thus controlling the size and radial extent of the distal end 3626.

[0346] The distal end 3626 may be configured to be expanded, inflated, or deployed at a desired time for retrieval of the implant, and then unexpanded, contracted, or undeployed after retrieval or a time for retracting the delivery system from a portion of the patient's body. Thus, the distal end 3626 may move from the configuration shown in FIG. 73 back to the configuration shown in FIG. 72. Other configurations of the distal end 3626 may be utilized as needed.

[0347] The embodiments disclosed herein may be utilized in a method including disposing an elongate shaft at a location within a patient, the elongate shaft including a capsule surrounding an implant-retaining region that retains an implant for implantation within the patient. The capsule may be moved proximally to expose a portion of the implant within the patient. The capsule may then be moved distally to retrieve a portion of the implant within the patient and pass the distal ends 3616, 3626 of the capsule, which are radially expanded outward, over the retrieved portion of the implant. The retrieved portion of the implant may include implant arms, which may include implant anchors. The distal ends 3616, 3626 of the capsule may be positioned between the arms of the implant such that the distal ends 3616, 3626 can push the chordae tendineae between the arms. The method may include using the distal ends 3616, 3626 of the capsule to push the chordae tendineae away from the arms of the implant.

[0348] The distal end embodiments disclosed in Figures 71-73 may be utilized alone or in conjunction with any embodiment of the delivery system or other systems, devices, or methods disclosed herein.

[0349] 74A and 74B illustrate an embodiment in which a delivery system may utilize a pull tether 3700 coupled to a portion of the elongate shaft of the delivery system at or distal to the implant holding region and configured to flex the distal end of the elongate shaft. Referring to FIG. 2B , for example, the implant holding region 16 is shown surrounded by a capsule 106 and has a nosecone shaft 27 extending within the implant holding region 16. However, the steerable rail assembly 20 is positioned proximal to the implant holding region 16. Thus, as the steerable rail assembly 20 flexes, the nosecone 28 at the distal end of the elongate shaft follows the flex created by the steerable rail assembly 20 at a location proximal to the implant holding region 16. However, the embodiment of FIGS. 74A and 74B couples the pull tether 3700 at a location at or distal to the implant holding region 16. Thus, greater torque and control of the distal end of the delivery system may be provided.

[0350] 74A and 74B, for example, the distal end of the pull tether 3700 is coupled to the nosecone 28. The distal end of the pull tether 3700 may be located at a distal portion of the nosecone 28. For example, the nosecone 28 may include a proximal portion 3702 and a distal portion 3704, and the pull tether 3700 may be coupled to the distal portion 3704 of the nosecone 28. The distal coupling location of the pull tether 3700 may increase the torque imparted on the nosecone 28. In other embodiments, other coupling locations, such as on the proximal portion 3702 of the nosecone 28, may be utilized.

[0351] The pull tether 3700 may have various configurations and may include a pull wire or another form of tether as disclosed herein. The pull tether 3700 shown in FIGS. 74A and 74B may have at least a portion extending outside the elongate shaft. Such a configuration may allow for increased torque on the distal end of the elongate shaft. At least a portion of the pull tether 3700 may then extend into a channel 3706 inside the elongate shaft such that the pull tether 3700 does not extend completely outside the elongate shaft. For example, as shown in FIGS. 74A and 74B, the pull tether 3700 may extend outside the capsule 106. The pull tether 3700 may be tensioned and released to control deflection of the distal end of the elongate shaft.

[0352] The distal end of the pull tether 3700 may be coupled to other locations as needed. For example, with reference to FIG. 2B , the distal end of the pull tether 3700 may be coupled to the inner nosecone shaft 27, which is coupled to the nosecone 28. The implant holding region 16 may include a proximal portion 3708 and a distal portion 3710, and the pull tether 3700 may be coupled to a portion of the elongate shaft within the distal portion 3710 of the implant holding region 16. Thus, the pull tether 3700 is located proximally of the implant holding region 16 and may apply torque to the distal end of the elongate shaft in addition to any torque applied by the steerable rail assembly 20 configured to deflect the portion of the elongate shaft located proximally of the implant holding region 16.

[0353] Thus, the innermost assembly of the elongate shaft, shown in Figure 2B as nosecone assembly 31, may be steerable. A pull tether 3700 may extend proximally from the distal end of the elongate shaft for manipulation at the proximal end of the delivery system to control deflection of the distal end of the delivery system.

[0354] Coupling the pull tether 3700 to a portion of the elongate shaft of the delivery system at or distal to the implant-retaining region can allow for greater control of the distal end of the elongate shaft. Thus, the nosecone 28 and nosecone shaft 27, which form the tip of the elongate shaft, can have additional direction and degrees of flexion than those provided by the steerable rail assembly 20. Furthermore, the pull tether 3700 can impart flexion distal to the steerable rail assembly 20. Thus, the pull tether 3700 can allow for sharper rotation and greater control of the distal end of the elongate shaft. In embodiments, the pull tether 3700 can be configured to allow flexion in the same plane as that provided by the steerable rail assembly 20, or in a different plane.

[0355] The pull tether 3700 may also allow for the elimination of the use of a guidewire, if desired. For example, the nosecone shaft 27 may lack a lumen for a guidewire. The additional control afforded by the pull tether 3700 may allow for control of the distal end of the elongate shaft such that a guidewire is not needed to guide the distal end of the elongate shaft. In other embodiments, a guidewire may be utilized. In other embodiments, the configuration of the pull tether 3700 may be modified.

[0356] In embodiments herein, a delivery system may include two or at least two elongate shafts that can be utilized in combination to deliver an implant to a location within a patient's body. A first elongate shaft may be steerable, and another or second elongate shaft may include an implant-retaining region configured to retain the implant and may include a deployment mechanism. Each elongate shaft may include a respective axis along which the shaft extends. A coupler may couple the elongate shafts together such that the elongate shaft containing the implant can slide relative to the steerable elongate shaft with the shaft axes offset from one another.

[0357] For example, FIG. 79 illustrates one embodiment of a steerable elongate shaft 3900 of a delivery system. The elongate shaft 3900 may be steerable utilizing the mechanisms disclosed herein, for example, through the use of a pull tether, or may be steerable via another mechanism. The elongate shaft 3900 may be configured to form one or more bends in the elongate shaft 3900 and may be configured to be steerable and bend in at least one plane, or at least two planes, as disclosed herein. The steerable elongate shaft 3900 may be configured to be inserted into a patient's body and moved to a desired implantation site for the implant.

[0358] The elongate shaft 3900 may be configured to be steerable and may be constructed in a manner similar to the rail assemblies 20 disclosed herein. For example, pull tethers may be utilized to control the deflection of the elongate shaft 3900 in one or more planes, or at least two planes, as needed. The elongate shaft 3900, unlike the rail assemblies 20 disclosed herein, may be inserted into a patient's body without an implant and its capsule to hold the implant.

[0359] The embodiments disclosed herein may be utilized in a method that includes disposing an elongate shaft at a location within a patient, the elongate shaft including a proximal end, a distal end, and an implant holding region that holds an implant for implantation within the patient. The method may include deflecting the distal end of the elongate shaft using a pull tether coupled to a portion of the elongate shaft at or distal to the implant holding region. The pull tether 3700 and pull tether 3700 configuration may be utilized alone or in conjunction with any of the other devices, systems, or methods disclosed herein.

[0360] The elongate shaft 3900 may include a lumen 3902 that may be configured to hold components for a delivery system, such as an imaging sensor 3904, such as an intracardiac echo (ICE) sensor, or any other form of imaging sensor as desired, configured to be located within the lumen 3902. The distal end 3906 of the shaft 3900 may include an expandable body 3908 that may be configured to expand to secure the distal end 3906 of the shaft 3900 in position and / or to determine whether a path formed by the shaft 3900 is clear (e.g., whether the distal end 3906 passes between the chordae tendineae of the patient's heart).

[0361] The elongate shaft 3900 may be first introduced into the patient and maneuvered to the desired implantation site.

[0362] 80 , the elongate shaft 3910 can comprise a shaft configured to hold an implant for deployment. The shaft 3910 can include, for example, a capsule 3912 at its distal end that holds the implant. The capsule 3912 can surround an implant holding area and hold the implant therein, as disclosed herein. The shaft 3910 can include a deployment mechanism for deploying the implant from the capsule 3912, as disclosed herein. For example, the capsule 3912 can be retracted to expose and deploy the implant. The shaft 3910 can be flexible, passively flexible, to allow the shaft 3910 to follow the path formed by the steerable elongate shaft 3900.

[0363] A coupler 3914 may couple the elongate shaft 3910 to the steerable elongate shaft 3900. The coupler 3914 may have a variety of forms and may include a loop as shown in FIG. 80 , or may include one or more of a magnet, hook, loop, or joint between the shafts 3910, 3900. The coupler 3914 may be configured to allow the elongate shaft 3910 to slide relative to the shaft 3900. In embodiments, the coupling may occur inside the patient's body, or, if desired, outside the patient's body.

[0364] The elongate shafts 3900, 3910 may be coupled to one another such that the respective axes of the shafts 3900, 3910 are offset from one another. The coupler 3914 may be configured to couple the shafts 3900, 3910 to one another such that the shafts 3900, 3910 can slide with their respective axes parallel to one another and with their outer surfaces adjacent to one another. Thus, the deployment mechanism (utilized with the elongate shaft 3910) may be separated into a separate shaft from the steering mechanism (utilized with the elongate shaft 3900). Thus, the complexity of each shaft may be reduced from the embodiment shown in FIG. 1 . Furthermore, the capsule 3912 in such an embodiment is not located distal to the bent portion, which may improve the maneuverability of the capsule 3912 in the embodiment shown in FIG. 80 .

[0365] In embodiments, the coupler 3914 can be configured to couple the shafts 3900, 3910 together in a defined orientation. For example, a joint, such as a dovetail joint, can be provided on either of the shafts 3900, 3910 so that the shafts 3900, 3910 can only be coupled in a defined orientation. Thus, the circumferential position of the shaft 3900 relative to the shaft 3910 can be defined. Such a feature can be beneficial in embodiments in which an asymmetric implant is to be deployed. Such an implant can be deployed with a steerable shaft 3900 in a defined position, which can aid in the deployment of the asymmetric implant. In embodiments, the coupler 3914 can be configured to allow the coupling to be rotated to orient the implant to optimize the position of the implant for deployment. In other embodiments, other forms of coupling can be utilized.

[0366] 79 , during operation, the steerable elongate shaft 3900 may be advanced to a desired location for implantation within a patient. The steerable elongate shaft 3900 may be bent into a desired configuration and retain that configuration within the patient. The distal end 3906 of the elongate shaft 3900 may be steered, for example, to the mitral valve or other valve as needed. In embodiments, as shown in FIG. 80 , an expandable body 3908 may be inflated to secure the distal end 3906 of the shaft 3900 in position and / or to determine if the path formed by the shaft 3900 is clear.

[0367] The steerable elongate shaft 3900 in position within the patient's body may act as a rail along which the implant-bearing elongate shaft 3910 slides. The elongate shaft 3910 may be passed through a separate entrance within the patient's body, for example, a separate leg or a separate venous body of the patient's body. In embodiments, a coupler 3914 may couple the shafts 3900, 3910 together within the patient's body such that the shaft 3910 can slide along the steerable shaft 3900. The shaft 3910 may be advanced along the steerable shaft 3900 through the patient's body to the desired implantation site, as shown in FIG. 80 .

[0368] The shaft 3910 can be configured to flex around any bend in the steerable shaft 3900, as shown in FIG. 81 . The flexing of the shaft 3910 can be passive, if desired. The shaft 3910 can then be utilized to deploy the implant from the capsule 3912. A deployment mechanism disclosed herein can be operated, and the capsule 3912 can be retracted to deploy the implant. After deployment, the shaft 3910 can be retracted, followed by the shaft 3900. The shaft 3900, 3910 configuration can be utilized alone or in conjunction with any of the other devices, systems, or methods disclosed herein.

[0369] It will be appreciated from the foregoing description that the present invention discloses an approach for an implant delivery system and product. While certain components, techniques, and aspects have been described with a degree of particularity, it will be apparent that many modifications can be made to the specific designs, configurations, and methods described herein without departing from the spirit and scope of the present disclosure. The present disclosure is not limited to the systems and devices disclosed herein, nor to methods utilizing such systems and devices.

[0370] Some features described in this disclosure in the context of separate implementations may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented in multiple implementations separately or in any suitable subcombination. Furthermore, while features may be described above as acting in several combinations, one or more features from a claimed combination may, in some cases, be deleted from the combination, and the combination may be claimed as any subcombination or a variation of any subcombination.

[0371] Furthermore, while methods may be shown in the figures or described herein in a particular order, such methods need not be performed in the particular order or sequence shown, and not all methods need be performed to achieve desirable results. Other methods not shown or described may be incorporated into the example methods and processes. For example, one or more additional methods may be performed before, after, simultaneously with, or between any of the described methods. Moreover, in other implementations, methods may be rearranged or reordered. Also, the separation of various system components in the above-described implementations should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems may generally be integrated together in a single product or packaged in multiple products. Moreover, other implementations are within the scope of this disclosure.

[0372] Conditional language such as "can," "could," "might," or "may," unless specifically stated otherwise or understood otherwise within the context in which it is used, is generally intended to convey that some embodiments include or do not include certain features, elements, and / or steps. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in some way required for one or more embodiments.

[0373] Conjunctive language, such as the phrase "at least one of X, Y, and Z," unless specifically stated otherwise, is understood differently in the context in which it is generally used to convey that an item, term, etc. can be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that some embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0374] As used herein, language of degree, such as the terms "approximately," "about," "generally," and "substantially," refers to a value, amount, or characteristic that is close to a stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to an amount that is within 10% or less, 5% or less, 1% or less, 0.1% or less, and 0.01% or less of the stated amount. When a stated amount is 0 (e.g., absent), the ranges recited above can be specific ranges, not within a specific percentage of the value. For example, within 10 wt. / vol.% or less, within 5 wt. / vol.% or less, within 1 wt. / vol.% or less, within 0.1 wt. / vol.% or less, and within 0.01 wt. / vol.% or less of the stated amount.

[0375] Several embodiments have been described in connection with the accompanying drawings. While the figures are drawn to scale, such scale should not be considered limiting, as dimensions and proportions other than those shown are contemplated and within the scope of the disclosed invention(s). Distances, angles, and the like are merely illustrative and do not necessarily bear an exact relationship to the actual dimensions and layout of the illustrated devices. Components may be added, removed, and / or rearranged. Furthermore, any particular features, aspects, methods, properties, characteristics, qualities, attributes, elements, etc. disclosed herein in connection with various embodiments may be used in all other embodiments described herein. Furthermore, it will be recognized that any method described herein may be practiced using any apparatus suitable for performing the recited steps.

[0376] While several embodiments and variations thereof have been described in detail, other modifications and methods of use thereof will become apparent to those skilled in the art. It is therefore to be understood that various adaptations, modifications, materials, and substitutions can be made from equivalents without departing from the inherent inventive disclosure herein or the scope of the claims. [Explanation of symbols]

[0377] 10 Delivery System 11 Proximal end 12 Thin shaft 13 distal end 14 Handle 14' Handle 16 Implant Retention Area 18 Inner Shaft Assembly 20 Rail Assembly 21 Central shaft assembly, intermediate shaft assembly 22 Outer sheath assembly 27 Nose cone shaft 28 Nosecone 31 Nosecone assembly, nose cone shaft assembly 40 Inner retaining ring, inner retaining member 42 Outer retaining ring, outer retaining member 43 Hypotube 44 Proximal Tube 51 Rib on Sheath 70 Implants, Replacement Mitral Valve Implants 72 Strut 74 Mushroom-shaped tub 80 Distal Anchor 82 Proximal anchor 83 Heart 102 outer proximal shaft, shaft 104 Outer Hypotube 106 capsules 107 Proximal Metal Coil 108 Distal Metal Coil 110 Tube part 124 Inner Proximal Shaft 126 Distal Section 132 Rail shaft 134 Rail Proximal Shaft 135 Connector 136 Rail Hypotube 137 Proximal Ring 138 Distal pull wire 139 Lumen 140 Proximal pull wire 202 Rail housing 204 Delivery Box 204' Delivery Box 206 Distal pull wire knob 208 Proximal pull wire knob 210 Outer sheath knob, control knob 210' control knob, distal most control knob 211 First Section 212 Depth knob 213 Cut 214 Intermediate shaft knob, control knob 214' Control knob, intermediate control knob 215 Spine 216 Nobu 217 First Thin Slit 218 Rock 220 Second Section 222 Cutting pair 226 First cut 228 Second Cut 229 Droplet shape 230 Third Section 231 Hypotube Section 232 Cutting Pair 233 Proximal slotted hypotube section, proximal grooved section 235 Distal slotted hypotube section, distal grooved section 236 First Thin Notch 237 position 238 Second Cut 239 Droplet shape 240 Outer retaining ring, outer retaining ring reinforcement 241 Distal pull wire connection area 244 Thin cut 246 Long, oval hole 247 Terminal extension 249 Droplet shape 251 Liner 301 first end 303 Second end 402 outer polymer layer, jacket 404 Metal layer 406 Adhesive layer 408 Fluorinated Ethylene Propylene (FEP) Section 410 Liner 500 Hypotube 502a~502h Cutting 504a~504d Ring 506 First Section 508 Spine 510 Spine 512 Outer part 514 Outer part 516 Second Section 518 Spine 520 Spine 522 Spine 524 Spine 600 Hypotube 602a~602c Cutting 604a, 604b Ring 606a~606c Spine 700 Hypotube 702a~702d Cutting 704a, 704b Ring 706 Spine 708 Spine 710 Spine 712 Spine 800 Hypotube 802a~802d Cutting 806a, 806b ring 900 Hypotube 1000 Hypotube 1006 Spine 1008 Spine 1074 Ipsilateral femoral vein 1076 Right atrium 1078 Left atrium 1080 left ventricle 1106 Mitral annulus 1108 Mitral valve leaflets 1110 Chordae tendineae 1200 Guidewire Shield 1200' Guidewire Shield 1202 Lumen 1202' lumen 1204 distal end 1204' distal end 1206 Proximal end 1206' proximal end 1208 Step 1600 implants 1620 Inner frame 1624 Inner Frame Fixing Feature 1644 External fixation feature 1640 outer frame 1646a~1646c Cell 1648a~1648e Post 1652 Locking tab 1652a Post 1660 Valve body 1664 Intermediate Components 1662 Valve Leaflet 1680 outer skirt 1690 Inner skirt 1900 Coupler 1902 Shaft part 1904 Protrusion 2000 Coupler 2002 protrusion 2004 Channel 2100 Inflatable body 2102 Conduit 2200 braided layer 2202 Metal layer 2204 Inner liner layer 2214 buffer layer 2206 outer jacket layer 2300 Cable Router 2302 Cable 2310 Control Mechanism 2400 Stopper 2404 Stopper 2500 control knob, proximal control knob 2504 slider 2506 Slider 2508 Slider 2510 Beam 2512 Beam 2514 Support 2516 Support 2518 Support 2520 Support 2522 Support 2800 Nosecone 2900 Nosecone 3000 Nosecone 3100 Nosecone 3200 Nosecone 3202 Marker 3300 Nosecone 3302 Marker 3400 markers 3404 Aperture 3614 capsules 3624 capsules 3628 Inflatable body 3632 Expansion conduit 3700 Pull Tether 3706 Channel 3800 markers 3802 Nosecone 3804 capsules 3806 Indicator 3820 capsules 3826 Marker 3830 capsules 3836 Marker 3840 Marker 3900 Thin Shaft 3904 Image sensor 3908 Inflatable body 3910 Thin Shaft 3912 capsules 3914 Coupler

Claims

1. 1. A delivery system for delivering an implant to a location within a patient's body, comprising: an implant holding area configured to hold the implant; a capsule configured to surround the implant holding area, the capsule including a hypotube having one or more cuts forming a plurality of rings; 1. A delivery system comprising an elongate shaft having a proximal end and a distal end, comprising:

2. The delivery system of claim 1 , wherein the hypotube includes one or more spines connecting at least two of the plurality of rings.

3. The delivery system of claim 2 , wherein the one or more spines extend longitudinally along the hypotube.

4. The delivery system of claim 1 , wherein the one or more notches bias the flexibility of the hypotube in a predetermined direction.

5. 5. The delivery system of claim 4, wherein the hypotube includes two spines each configured to extend along a neutral axis of bending when the hypotube is bent in the predetermined direction.

6. 6. The delivery system of claim 1, wherein the one or more incisions include a first incision circumferentially spaced from a second incision, the first incision being larger in size than the second incision.

7. 7. The delivery system of claim 1, wherein the one or more incisions include a first plurality of incisions each longitudinally aligned and having a size larger than a second plurality of incisions each longitudinally aligned and each circumferentially spaced apart from the first plurality of incisions.

8. 8. The delivery system of claim 7, wherein the first plurality of incisions are located on the hypotube opposite the second plurality of incisions.

9. 9. The delivery system of claim 4, wherein the predetermined direction is a first direction and the one or more notches bias the flexibility of the hypotube in a second direction.

10. 10. The delivery system of claim 1, wherein the one or more incisions comprise a repeating pattern of staggered incisions.

11. 11. The delivery system of claim 1, wherein the hypotube comprises a first pair of spines positioned 180 degrees apart from each other and a second pair of spines positioned 180 degrees apart from each other and offset 90 degrees from the first pair of spines.

12. 12. The delivery system of claim 1, wherein the hypotube includes a distal section in which the one or more notches bias the flexibility of the section in a single direction, and the hypotube includes a proximal section in which the one or more notches bias the flexibility of the section in at least two directions.

13. 13. The delivery system of claim 1, wherein the one or more incisions form a spiral.

14. 14. The delivery system of claim 1, wherein the hypotube includes one or more spines connecting at least two of the plurality of rings.

15. 15. The delivery system of claim 1, wherein the plurality of rings are configured to contact one another when a force is applied distally to the hypotube.

16. 16. The delivery system of claim 1, wherein the one or more incisions comprise a repeating pattern of staggered incisions, each of equal size.

17. 17. The delivery system of claim 1, wherein the one or more cuts provide equal flexibility of the hypotube in all radial directions.

18. 18. The delivery system of claim 1, wherein the hypotube includes a first pair of spines positioned 180 degrees apart from each other and a second pair of spines offset 90 degrees from the first pair of spines.

19. 19. The delivery system of claim 1, wherein the capsule is configured to move proximally relative to the implant holding area to allow deployment of the implant.

20. 20. The delivery system of claim 1, wherein the capsule is configured to move distally relative to the implant holding region to retrieve the implant.

21. 1. A delivery system for delivering an implant to a location within a patient's body, comprising: an implant holding area configured to hold the implant; a capsule configured to surround the implant holding area, the capsule including a hypotube having one or more notches that bias the flexibility of the hypotube in a predetermined direction; 1. A delivery system comprising an elongate shaft having a proximal end and a distal end, comprising:

22. 22. The delivery system of claim 21, wherein the hypotube includes two spines each configured to extend along a neutral axis of bending when the hypotube is bent in the predetermined direction.

23. 23. The delivery system of claim 21 or 22, wherein the one or more incisions include a first incision circumferentially spaced from a second incision, the first incision being larger in size than the second incision.

24. 24. The delivery system of any one of claims 21 to 23, wherein the one or more incisions include a first plurality of incisions each longitudinally aligned and having a size larger than a second plurality of incisions each longitudinally aligned and each circumferentially spaced apart from the first plurality of incisions.

25. 25. The delivery system of claim 24, wherein the first plurality of incisions are located on opposite sides of the hypotube from the second plurality of incisions.

26. 26. The delivery system of claim 24 or 25, wherein the first plurality of incisions are configured to decrease in size when the hypotube is bent in the predetermined direction.

27. 27. The delivery system of any one of claims 21 to 26, wherein the predetermined direction is a first direction and the one or more notches bias the flexibility of the hypotube in a second direction.

28. 28. The delivery system of any one of claims 21 to 27, wherein the one or more incisions comprise a repeating pattern of staggered incisions.

29. 29. The delivery system of any one of claims 21 to 28, wherein the hypotube comprises a first pair of spines positioned 180 degrees apart from each other and a second pair of spines offset 90 degrees from the first pair of spines.

30. 1. A delivery system for delivering an implant to a location within a patient's body, comprising: an implant holding area configured to hold the implant; a capsule configured to surround the implant holding area, the capsule including a hypotube having one or more cuts forming a spiral; 1. A delivery system comprising an elongate shaft having a proximal end and a distal end, comprising:

31. 31. The delivery system of claim 30, wherein the hypotube includes one or more spines extending longitudinally along the hypotube.

32. 32. The delivery system of claim 31, wherein the one or more spines include a first spine and a second spine circumferentially offset from the first spine.

33. 33. The delivery system of any one of claims 30 to 32, wherein the spiral forms a plurality of rings configured to contact each other when a force is applied distally to the hypotube.

34. 34. The delivery system of any one of claims 30 to 33, wherein the helix provides equal flexibility of the hypotube in all radial directions.

35. disposing an elongate shaft at a location within a patient's body, the elongate shaft including a capsule surrounding an implant holding region for holding an implant to be implanted within the patient's body, the capsule including a hypotube having one or more cuts forming a plurality of rings; moving the capsule proximally to expose a portion of the implant within the patient; moving the capsule distally to retrieve a portion of the implant within the patient; A method comprising:

36. 36. The method of claim 35, wherein the one or more cuts bias the flexibility of the hypotube in a predetermined direction.

37. 37. The method of claim 36, further comprising bending the capsule in the predetermined direction when moving the capsule proximally.

38. 38. The method of any one of claims 35 to 37, wherein the rings contact one another when the capsule is moved distally.

39. 39. The method of any one of claims 35 to 38, wherein the one or more cuts provide equal flexibility of the hypotube in all radial directions.

40. 40. The method of any one of claims 35 to 39, wherein the one or more cuts form a spiral.

41. 1. A delivery system for delivering an implant to a location within a patient's body, comprising: an implant holding area configured to hold the implant; a capsule configured to surround the implant holding area; a shaft portion located proximal to the capsule; a coupler configured to couple the capsule to the shaft portion and to allow the capsule to rotate relative to the shaft portion; 1. A delivery system comprising an elongate shaft having a proximal end and a distal end, comprising:

42. 42. The delivery system of claim 41, wherein the coupler includes a protrusion located within the channel.

43. 43. The delivery system of claim 42, wherein the protrusion comprises a material that deflects into the channel.

44. 44. The delivery system of claim 42 or 43, wherein the channel comprises a window and the protrusion comprises a pin configured to slide along the window.

45. 45. The delivery system of any one of claims 41 to 44, wherein the elongate shaft includes a rail assembly configured to bend in at least one plane.

46. 46. The delivery system of claim 45, wherein the capsule comprises a hypotube having one or more notches that bias the flexibility of the hypotube in a predetermined direction.

47. 47. The delivery system of claim 46, wherein the coupler is configured to allow the capsule to rotate to align the predetermined direction with a bending direction of the rail assembly.

48. disposing an elongate shaft at a location within a patient's body, the elongate shaft including a capsule, a shaft portion proximal to the capsule, and a coupler coupling the capsule to the shaft portion, the coupler configured to allow the capsule to rotate relative to the shaft portion, the capsule surrounding an implant holding region that holds an implant for implantation within the patient's body; moving the capsule proximally to expose a portion of the implant within the patient while the capsule rotates relative to the shaft portion; A method comprising:

49. 49. The method of claim 48, wherein the capsule has a biased flexibility in a predetermined direction, and the capsule rotates to cause the predetermined direction to coincide with a direction of bending of a rail assembly of the elongate shaft.

50. 50. The method of claim 49, wherein the coupler passively rotates to align the direction of deflection of the capsule with the direction of bending of the rail assembly of the elongate shaft.

51. 1. A delivery system for delivering an implant to a location within a patient's body, comprising: an implant holding area configured to hold the implant; a sheath having an internal lumen; an inner shaft located within the lumen; an expandable body positioned between the inner shaft and the sheath and configured to expand to support the sheath; 1. A delivery system comprising an elongate shaft having a proximal end and a distal end, comprising:

52. 52. The delivery system of claim 51, wherein the expandable body comprises one or more balloons.

53. 53. The delivery system of claim 51 or 52, wherein the sheath includes a capsule configured to surround the implant holding area, and the expandable body is configured to support the capsule.

54. 54. The delivery system of any one of claims 51 to 53, wherein the elongate shaft includes an inner shaft, the inner shaft comprising a central shaft located between the inner shaft and the sheath.

55. 55. The delivery system of claim 54, wherein the central shaft includes a retaining ring that retains the implant within the implant holding area.

56. 56. The delivery system of any one of claims 51 to 55, wherein the elongate shaft is steerable and configured to bend, and the expandable body is configured to support the sheath at bends in the elongate shaft.

57. 57. The delivery system of any one of claims 51 to 56, wherein the sheath comprises a hypotube having one or more cuts forming a plurality of rings, and the expandable body is configured to support the plurality of rings of the hypotube.

58. positioning an elongate shaft at a location within a patient's body, the elongate shaft including a sheath, an inner shaft positioned within a lumen of the sheath, and an implant holding region for holding an implant for implantation within the patient's body; moving the sheath proximally to expose a portion of the implant within the patient; Inflating an expandable body between the sheath and the inner shaft; moving the sheath distally to retrieve a portion of the implant within the patient's body while the expandable body expands between the sheath and the inner shaft to support the sheath; A method comprising:

59. 59. The method of claim 58, wherein the sheath includes a capsule that moves distally to retrieve a portion of the implant.

60. 60. The method of claim 58 or 59, wherein the expandable body, when expanded, fills the space between the sheath and the inner shaft.

61. 1. A delivery system for delivering an implant to a location within a patient's body, comprising: an implant holding area configured to hold the implant; an outer jacket layer; inner liner layer, a braided layer positioned between the outer jacket layer and the inner liner layer; and a metal layer positioned between the braided layer and the inner liner layer; a wall of the elongated shaft comprising:

1. A delivery system comprising an elongate shaft having a proximal end and a distal end, comprising:

62. 62. The delivery system of claim 61, further comprising a buffer layer positioned between the outer jacket layer and the braided layer to prevent inflow of the outer jacket layer into the braided layer.

63. 63. The delivery system of claim 62, wherein the buffer layer is composed of a polymer and the outer jacket layer is composed of a polymer.

64. 64. The delivery system of claim 62 or 63, wherein the buffer layer is composed of expanded polytetrafluoroethylene.

65. 65. The delivery system of any one of claims 61 to 64, wherein the metal layer comprises one or more of a coil or a hypotube having one or more cuts forming multiple rings.

66. 66. The delivery system of any one of claims 61 to 65, wherein the braided layer is configured to compress the metal layer when an axial force is applied to the braided layer.

67. 67. The delivery system of any one of claims 61 to 66, wherein the elongate shaft comprises a sheath having a lumen and an inner shaft positioned within the lumen, and one or more of the sheath or the inner shaft comprises the wall surface.

68. 68. The delivery system of any one of claims 61 to 67, wherein the elongate shaft includes a capsule configured to surround the implant holding area, the capsule including the wall surface.

69. 1. A delivery system for delivering an implant to a location within a patient's body, comprising: an implant holding area configured to hold the implant; a sheath configured to bend in at least one plane; a cable having a first end portion, a second end portion, and an intermediate portion extending between the first end portion and the second end portion, the first end portion being coupled to a first side of the sheath and the second end portion being coupled to a second side of the sheath opposite the first side; an elongate shaft having a proximal end and a distal end, a cable router that engages the intermediate portion of the cable and allows the cable to move along the cable router when the sheath is bent in the at least one plane; and a control mechanism for retracting the cable router and the sheath relative to the implant holding region; A delivery system comprising:

70. 70. The delivery system of claim 69, wherein the cable router comprises one or more of a pulley wheel or a channel.

71. 71. The delivery system of claim 69 or 70, wherein the intermediate portion of the cable is wrapped around the cable router.

72. 72. The delivery system of any one of claims 69 to 71, wherein the cable router is configured to engage the intermediate portion of the cable such that when the sheath is bent in the at least one plane, a length of the cable between the cable router and the first end portion of the cable increases while a length of the cable between the cable router and the second end portion of the cable simultaneously decreases.

73. 73. The delivery system of claim 72, wherein an increase in the length of the cable between the cable router and the first end portion of the cable is equal to an decrease in the length of the cable between the cable router and the second end portion of the cable.

74. 74. The delivery system of any one of claims 69 to 73, wherein the sheath comprises a capsule configured to surround the implant holding area.

75. 75. The delivery system of any one of claims 69 to 74, wherein the first side of the sheath and the second side of the sheath both lie in the at least one plane and are separated by a lumen of the sheath.

76. disposing an elongate shaft at a location within a patient's body, the elongate shaft including an implant holding region for holding an implant to be implanted within the patient's body, a sheath, and a cable having a first end portion, a second end portion, and an intermediate portion extending between the first end portion and the second end portion, the first end portion coupled to a first side of the sheath, the second end portion coupled to a second side of the sheath opposite the first side, and the intermediate portion engaging a cable router; bending the sheath in a plane such that a length of the cable between the cable router and the first end portion increases and a length of the cable between the cable router and the second end portion decreases; retracting the cable router and the sheath relative to the implant holding area; A method comprising:

77. 77. The method of claim 76, wherein the cable router is located within a handle coupled to the elongated shaft and comprises one or more of a pulley wheel or a channel.

78. 78. The method of claim 76 or 77, wherein the intermediate portion of the cable is wrapped around the cable router.

79. 79. The method of any one of claims 76 to 78, wherein an increase in the length of the cable between the cable router and the first end portion of the cable is equal to a decrease in the length of the cable between the cable router and the second end portion of the cable.

80. 80. The method of any one of claims 76 to 79, wherein the sheath comprises a capsule configured to surround the implant holding area.

81. 1. A delivery system for delivering an implant to a location within a patient's body, comprising: an implant holding area configured to hold the implant; a sheath having an internal lumen and a capsule configured to surround the implant holding region; an inner shaft located within the lumen; a stopper located on the inner shaft configured to prevent proximal movement of the capsule relative to the inner shaft; 1. A delivery system comprising an elongate shaft having a proximal end and a distal end, comprising:

82. 82. The delivery system of claim 81, wherein the stopper comprises a protrusion extending radially outward from the inner shaft.

83. 83. The delivery system of claim 82, wherein the protrusion is configured such that a proximal force overcomes the protrusion, allowing the capsule to move proximally relative to the inner shaft.

84. 84. A delivery system according to any one of claims 81 to 83, wherein the stopper comprises a threaded portion on the inner shaft.

85. 85. The delivery system of any one of claims 81 to 84, wherein the inner shaft is configured to rotate relative to the capsule to allow the capsule to move proximally relative to the inner shaft.

86. 86. A delivery system according to any one of claims 81 to 85, wherein the stopper comprises a key feature on the inner shaft, and the sheath is configured to move relative to the inner shaft to accommodate the key feature and allow the capsule to move proximally relative to the inner shaft.

87. 87. The delivery system of any one of claims 81 to 86, wherein the stopper is positioned on the inner shaft such that when the stopper prevents proximal movement of the capsule relative to the inner shaft, the capsule can move proximally to expose only a portion of the implant.

88. 88. The delivery system of claim 87, wherein the capsule is configured to fully expose the implant when the stopper that prevents proximal movement of the capsule is overcome.

89. 89. The delivery system of any one of claims 81 to 88, wherein the elongate shaft includes an inner shaft, the inner shaft comprising a central shaft located between the inner shaft and the sheath.

90. 90. The delivery system of any one of claims 81 to 89, wherein the sheath is located proximal to the capsule and includes a shaft portion coupled to the capsule, and the stopper is configured to contact the shaft portion to prevent proximal movement of the capsule relative to the inner shaft.

91. placing an elongate shaft at a location within a patient's body, the elongate shaft including a sheath having an inner lumen and a capsule for holding an implant to be implanted within the patient's body, the sheath including an inner shaft and a stopper located on the inner shaft; moving the capsule proximally until the sheath contacts the stopper to expose a first portion of the implant within the patient; overcoming the stopper and moving the capsule proximally to expose a second portion of the implant within the patient proximal to the first portion of the implant; A method comprising:

92. 92. The method of claim 91, wherein the stopper comprises a protrusion extending radially outward from the inner shaft.

93. 93. The method of claim 92, wherein overcoming the stopper comprises applying a proximal force to the sheath to overcome a contact force applied by the stopper.

94. 94. The method of any one of claims 91 to 93, wherein the stopper comprises a threaded portion on the inner shaft.

95. 95. The method of any one of claims 91 to 94, wherein overcoming the stopper comprises rotating the inner shaft relative to the capsule.

96. 96. The method of any one of claims 91 to 95, wherein the stopper comprises a key feature on the inner shaft, and the step of overcoming the stopper comprises the step of moving the sheath relative to the inner shaft to accommodate the key feature.

97. 97. The method of any one of claims 91 to 96, wherein the stopper is located on the inner shaft at a position that defines the amount of the implant exposed from the capsule.

98. 98. The method of any one of claims 91 to 97, further comprising the step of completely releasing the implant from the implant holding area.

99. 99. The method of any one of claims 91 to 98, wherein the elongate shaft includes an inner shaft, the inner shaft comprising a central shaft located between the inner shaft and the sheath.

100. 100. The method of any one of claims 91 to 99, wherein the sheath is located proximal to the capsule and includes a shaft portion coupled to the capsule, and the stopper is configured to contact the shaft portion to prevent proximal movement of the capsule relative to the inner shaft.

101. 1. A delivery system for delivering an implant to a location within a patient's body, comprising: an elongate shaft having a proximal end and a distal end, an implant holding region, and an assembly configured to hold at least a portion of the implant within the implant holding region; a handle including a control knob coupled to the proximal end of the elongate shaft and configured, when rotated, to move the assembly to release at least a portion of the implant from the implant holding area, the control knob including an exposed outer grip surface to be grasped around an entire circumference of the control knob; A delivery system comprising:

102. 102. The delivery system of claim 101, wherein the assembly includes a capsule that surrounds the implant holding area and is configured to release at least a portion of the implant from the implant holding area when moved proximally by the control knob.

103. 103. The delivery system of claim 101 or 102, wherein the assembly includes a sheath extending around the inner shaft of the elongate shaft.

104. 104. The delivery system of any one of claims 101 to 103, wherein the assembly includes a retaining ring configured to extend over at least a portion of the implant and to release at least a portion of the implant from the implant holding area when moved proximally by the control knob.

105. 105. A delivery system according to any one of claims 101 to 104, wherein the assembly includes an inner shaft located within a sheath of the elongate shaft.

106. the control knob is a first control knob, the assembly is a first assembly, and the delivery system is a second assembly including a capsule configured to surround the implant holding area and hold at least a portion of the implant within the implant holding area; a second control knob configured to be rotated to move the capsule and release at least a portion of the implant held by the capsule from the implant holding area, the second control knob including an exposed outer grip surface to be grasped around the entire circumference of the second control knob; 106. The delivery system of any one of claims 101 to 105, further comprising:

107. 107. The delivery system of claim 106, wherein the first control knob and the second control knob are both coupled to a housing of the handle.

108. The handle a housing having an internal cavity; a beam including a channel located within the internal cavity; a slider coupled to the assembly and positioned within the channel; 108. A delivery system according to any one of claims 101 to 107, wherein the control knob is configured to, when rotated, slide the slider along the channel to move the assembly.

109. 109. The delivery system of claim 108, wherein the beam has a U-shape.

110. 110. A delivery system according to claim 108 or 109, wherein the control knob is coupled to a body having a threaded portion that engages with a threaded portion of the slider, allowing the control knob to rotate the body and slide the slider axially.

111. 111. A delivery system according to any one of claims 108 to 110, wherein the control knob includes a stopper configured to stop axial movement of the slider.

112. 112. A delivery system according to any one of claims 108 to 111, wherein the beam depends between a threaded portion of the body and the slider.

113. 113. A delivery system according to any one of claims 108 to 112, wherein the housing includes one or more supports that support the beam.

114. 114. A delivery system according to any one of claims 108 to 113, wherein the housing includes a wall that prevents rotation of the beam within the internal cavity.

115. 115. The delivery system of any one of claims 101 to 114, wherein the elongate shaft includes a nose cone located distal to the implant holding area, the control knob is a first control knob, and the handle includes a second control knob configured to move the nose cone proximally or distally relative to the implant holding area when rotated, the second control knob including an exposed outer grip surface to be grasped around the entire circumference of the second control knob.

116. disposing a delivery device at a location within a patient's body, the delivery device including an elongate shaft and a handle coupled to a proximal end of the elongate shaft, the elongate shaft including an implant holding region for holding an implant to be implanted within the patient's body and an assembly configured to hold at least a portion of the implant within the implant holding region, the handle including a control knob configured, when rotated, to move the assembly to release at least a portion of the implant from the implant holding region, the control knob including an exposed outer grip surface to be grasped around the entire circumference of the control knob; gripping a gripping surface of the control knob; rotating the control knob to move the assembly and release at least a portion of the implant from the implant holding area; A method comprising:

117. 117. The method of claim 116, wherein the control knob is not gripped on a bridge of the handle.

118. 118. The method of claim 116 or 117, wherein the assembly includes a capsule configured to surround the implant holding area, and wherein rotating the control knob moves the capsule proximally to release at least a portion of the implant from the implant holding area.

119. 119. The method of any one of claims 116 to 118, wherein the assembly includes a retaining ring configured to extend over at least a portion of the implant, and wherein rotating the control knob moves the retaining ring proximally to release at least a portion of the implant from the implant holding area.

120. The handle a housing having an internal cavity; a beam including a channel located within the internal cavity; a slider coupled to the assembly and positioned within the channel; 120. The method of any one of claims 116 to 119, wherein rotating the control knob causes the slider to slide along the channel to move the assembly.

121. 1. A delivery system for delivering an implant to a location within a patient's body, comprising: an implant holding area configured to hold the implant; a marker configured to enhance echogenicity of the elongate shaft when viewed using ultrasound imaging, the marker defining the location of a portion of the elongate shaft; 1. A delivery system comprising an elongate shaft having a proximal end and a distal end, comprising:

122. 122. The delivery system of claim 121, wherein the marker comprises a contoured portion that forms an edge of a portion of the elongate shaft.

123. 123. The delivery system of claim 121 or 122, wherein the marker comprises a planar surface facing distally.

124. 124. A delivery system according to any one of claims 121 to 123, wherein the marker comprises one or more edges that form a spiral.

125. 125. The delivery system of any one of claims 121 to 124, wherein the elongate shaft includes a tip located distal to the implant holding region, the tip including the marker.

126. 126. The delivery system of any one of claims 121 to 125, wherein the marker comprises a shaped portion that forms a pattern on a portion of the elongate shaft.

127. 127. The delivery system of claim 126, wherein the pattern comprises a plurality of recesses on a portion of the elongate shaft.

128. 128. A delivery system according to any one of claims 121 to 127, wherein the marker comprises a first material, the first material having an acoustic impedance different from the acoustic impedance of a second material of the elongate shaft adjacent to the first material.

129. 129. The delivery system of claim 128, wherein the marker comprises a ring containing a plurality of openings.

130. 130. The delivery system of claim 129, wherein the second material is located within the plurality of openings.

131. 131. The delivery system of claim 129 or 130, wherein the ring extends about a longitudinal axis of the elongate shaft and the plurality of openings are positioned circumferentially about the longitudinal axis.

132. 132. A delivery system according to any one of claims 129 to 131, wherein each of the plurality of openings has an oval shape and is positioned on the ring such that adjacent openings overlap axially and laterally.

133. 133. The delivery system of any one of claims 121 to 132, wherein the elongate shaft includes a capsule configured to surround the implant holding area, the capsule including the marker.

134. 134. A delivery system according to any one of claims 128 to 133, wherein the first material is encapsulated within the second material.

135. 135. A delivery system according to any one of claims 128 to 134, wherein the elongate shaft includes a nosecone having a smoothly tapered profile, and the marker is encapsulated within the nosecone such that a second material forms the outer surface of the nosecone.

136. 136. A delivery system according to any one of claims 121 to 135, wherein the marker comprises a plurality of radially extending fins.

137. 137. A delivery system according to any one of claims 121 to 136, wherein the marker is configured to be activated.

138. 138. The delivery system of claim 137, wherein a first portion of the elongate shaft is configured to move relative to a second portion of the elongate shaft to activate the marker.

139. 139. The delivery system of claim 138, wherein the first portion of the elongate shaft is configured to move relative to the second portion of the elongate shaft to form a gap.

140. 140. The delivery system of claim 138 or 139, wherein the first portion of the elongate shaft is configured to move axially or rotate relative to the second portion of the elongate shaft to activate the marker.

141. disposing an elongate shaft at a location within a patient's body, the elongate shaft including an implant holding region for holding an implant to be implanted within the patient's body, and a marker for enhancing echogenicity of the elongate shaft to define the location of a portion of the elongate shaft when viewed using ultrasound imaging; A method comprising:

142. 142. The method of claim 141, wherein the marker comprises a shaped portion that forms an edge of a portion of the elongate shaft.

143. 143. The method of claim 141 or 142, wherein the marker is coupled to the tip of the elongate shaft and appears brighter than the remainder of the tip when viewed using ultrasound imaging.

144. 144. The method of any one of claims 141 to 143, wherein the marker comprises a first material, the first material having an acoustic impedance different from the acoustic impedance of a second material of the elongate shaft adjacent to the first material.

145. 145. The method of any one of claims 141 to 144, wherein the marker comprises a ring containing a plurality of apertures.

146. 146. The method of claim 145, wherein the ring extends about a longitudinal axis of the elongate shaft and the plurality of openings are positioned circumferentially about the longitudinal axis.

147. 147. The method of any one of claims 141 to 146, wherein the elongate shaft includes a capsule configured to surround the implant holding area, the capsule including the marker.

148. 148. The method of any one of claims 141 to 147, further comprising the step of activating the marker.

149. 149. The method of claim 148, further comprising moving a first portion of the elongate shaft relative to a second portion of the elongate shaft to activate the marker.

150. 150. The method of claim 149, further comprising creating a gap by moving the first portion of the elongate shaft relative to the second portion of the elongate shaft.

151. 1. A delivery system for delivering an implant to a location within a patient's body, comprising: an implant holding area configured to hold the implant; a capsule configured to surround the implant holding area and including a distal end configured to extend radially outward; 1. A delivery system comprising an elongate shaft having a proximal end and a distal end, comprising:

152. 152. The delivery system of claim 151, wherein the distal end is configured to bend radially outward.

153. 153. A delivery system according to claim 151 or 152, wherein the capsule includes a proximal portion and a distal end configured to bend radially outward relative to the proximal portion.

154. 154. The delivery system of any one of claims 151 to 153, wherein the distal end includes an opening for disposing the implant.

155. 155. A delivery system according to any one of claims 151 to 154, wherein the distal end is constructed from a flexible material.

156. 156. A delivery system according to any one of claims 151 to 155, wherein the distal end is constructed from a pliable material.

157. 157. A delivery system according to any one of claims 151 to 156, wherein the distal end comprises a contact surface configured to apply force against chordae tendineae of the patient's heart.

158. 158. A delivery system according to any one of claims 151 to 157, wherein the distal end is configured to expand radially outward.

159. 159. A delivery system according to any one of claims 151 to 158, wherein the distal end comprises an expandable body configured to expand.

160. 160. The delivery system of claim 159, further comprising at least one inflation conduit extending along the elongate shaft and configured to inflate the expandable body.

161. disposing an elongate shaft at a location within a patient's body, the elongate shaft including a capsule surrounding an implant holding region that holds an implant for implantation within the patient's body; moving the capsule proximally to expose a portion of the implant within the patient; moving the capsule distally to retrieve a portion of the implant within the patient's body and passing the distal end of the capsule radially outwardly expanded over the retrieved portion of the implant; A method comprising:

162. 162. The method of claim 161, wherein the portion of the implant that is retrieved comprises an arm of the implant.

163. 163. The method of claim 162, further comprising the step of positioning the distal end of the capsule between the arms of the implant.

164. 164. The method of claim 162 or 163, wherein the arms of the implant are provided with anchors.

165. 165. The method of any one of claims 161 to 164, wherein the distal end of the capsule bends radially outward.

166. 166. The method of any one of claims 161 to 165, wherein the distal end of the capsule is constructed from a flexible material.

167. 167. The method of any one of claims 161 to 166, wherein the distal end of the capsule expands radially outward.

168. 168. The method of any one of claims 161 to 167, wherein the distal end of the capsule comprises an expandable body configured to expand.

169. 169. The method of any one of claims 161 to 168, wherein the distal end of the capsule includes a contact surface, the method further comprising applying the contact surface to chordae tendineae of the patient's heart.

170. 170. A method according to any one of claims 161 to 169, wherein the retrieved portion of the implant includes an anchor of the implant, and the method further comprises the step of pushing the chordae tendineae away from the anchor of the implant with the distal end of the capsule.

171. 1. A delivery system for delivering an implant to a location within a patient's body, comprising: an implant holding area configured to hold the implant; a pull tether coupled to a portion of the elongate shaft at or distal to the implant holding region, the pull tether configured to deflect the distal end of the elongate shaft; 1. A delivery system comprising an elongate shaft having a proximal end and a distal end, comprising:

172. 172. The delivery system of claim 171, wherein the elongate shaft includes a nosecone at a distal end of the elongate shaft, and the pull tether is coupled to the nosecone.

173. 173. The delivery system of claim 172, wherein the nosecone includes a proximal portion and a distal portion, and the pull tether is coupled to the distal portion of the nosecone.

174. 174. The delivery system of any one of claims 171 to 173, wherein at least a portion of the pull tether extends outside the elongate shaft.

175. 175. A delivery system according to any one of claims 171 to 174, wherein at least a portion of the pull tether extends within a channel within the elongate shaft.

176. 176. A delivery system according to any one of claims 171 to 175, wherein the elongate shaft includes a capsule surrounding the implant holding area, and at least a portion of the pull tether extends outside the capsule.

177. 177. A delivery system according to any one of claims 171 to 176, wherein the elongate shaft includes a nose cone at a distal end of the elongate shaft and an inner shaft coupled to the nose cone and extending within the implant holding area, the pull tether coupled to the inner shaft.

178. 178. A delivery system according to any one of claims 171 to 177, wherein the implant holding region includes a distal portion and a proximal portion, and the pull tether is coupled to a portion of the elongate shaft within the distal portion of the implant holding region.

179. 179. The delivery system of any one of claims 171 to 178, wherein the elongate shaft includes a steerable rail assembly located proximal to the implant holding area.

180. 180. The delivery system of claim 179, wherein the steerable rail assembly is configured to deflect a portion of the elongate shaft located proximal to the implant holding region.

181. 1. A delivery system for delivering an implant to a location within a patient's body, comprising: an elongated shaft having a proximal end and a distal end, the elongated shaft comprising: an implant holding area configured to hold the implant; a nosecone located at the distal end of the elongate shaft; a pull tether coupled to the nosecone and configured to deflect the nosecone; A delivery system comprising:

182. 182. The delivery system of claim 181, wherein the nosecone includes a proximal portion and a distal portion, and the pull tether is coupled to the distal portion of the nosecone.

183. 183. The delivery system of claim 181 or 182, wherein at least a portion of the pull tether extends outside of the elongate shaft.

184. 184. A delivery system according to any one of claims 181 to 183, wherein at least a portion of the pull tether extends within a channel within the elongate shaft.

185. 185. A delivery system according to any one of claims 181 to 184, wherein the elongate shaft includes a capsule surrounding the implant holding area, and at least a portion of the pull tether extends outside the capsule.

186. disposing an elongate shaft at a location within a patient, the elongate shaft including a proximal end, a distal end, and an implant holding region for holding an implant for implantation within the patient; deflecting the distal end of the elongate shaft using a pull tether coupled to a portion of the elongate shaft at or distal to the implant holding region; A method comprising:

187. 187. The method of claim 186, wherein the elongate shaft includes a nosecone at the distal end of the elongate shaft, and the pull tether is coupled to the nosecone.

188. 188. The method of claim 186 or 187, wherein at least a portion of the pull tether extends outside of the elongate shaft.

189. 189. The method of any one of claims 186 to 188, wherein the elongate shaft includes a capsule surrounding the implant holding area, and at least a portion of the pull tether extends outside the capsule.

190. 190. The method of any one of claims 186 to 189, wherein the elongate shaft includes a nose cone at the distal end of the elongate shaft and an inner shaft coupled to the nose cone and extending into the implant holding area, and the pull tether is coupled to the inner shaft.

191. 1. A delivery system for delivering an implant to a location within a patient's body, comprising: a steerable first elongate shaft having a proximal end and a distal end and extending along a first axis; a second elongate shaft having a proximal end and a distal end and extending along a second axis, the second elongate shaft including an implant holding region configured to hold the implant; a coupler configured to couple the second elongated shaft to the first elongated shaft such that the second axis is offset from the first axis and the second elongated shaft can slide relative to the first elongated shaft; A delivery system comprising:

192. 192. The delivery system of claim 191, wherein the coupler is configured to couple the second elongated shaft to the first elongated shaft such that the second axis is parallel to the first axis and the second elongated shaft can slide relative to the first elongated shaft.

193. 193. The delivery system of claim 191 or 192, wherein the first elongate shaft includes an outer surface, the second elongate shaft includes an outer surface, and the coupler is configured to couple the second elongate shaft to the first elongate shaft such that the outer surface of the first elongate shaft is adjacent to the outer surface of the second elongate shaft.

194. 194. The delivery system of any one of claims 191 to 193, wherein the second elongate shaft includes a capsule configured to surround the implant holding region and hold the implant therein.

195. 195. A delivery system according to any one of claims 191 to 194, wherein the coupler comprises one or more of a magnet, a hook, a loop, or a joint.

196. 196. The delivery system of any one of claims 191 to 195, wherein the first elongate shaft is configured to be steerable in at least one plane.

197. 197. The delivery system of any one of claims 191 to 196, wherein the first elongate shaft is configured to be steerable in at least two planes.

198. 198. The delivery system of any one of claims 191 to 197, wherein the second elongate shaft is configured to flex around a bend in the first elongate shaft.

199. 199. The delivery system of any one of claims 191 to 198, further comprising an expandable body at a distal end of the first elongate shaft.

200. 200. The delivery system of any one of claims 191 to 199, wherein the first elongate shaft includes an inner lumen, and the delivery system further comprises an imaging sensor configured to be positioned within the inner lumen.

201. disposing a first elongate shaft at a location within a patient, the first elongate shaft extending along a first axis and being steerable; sliding a second elongated shaft along the first elongated shaft to a position within the patient, the second elongated shaft being coupled to the first elongated shaft and extending along a second axis offset from the first axis, the second elongated shaft including an implant holding region for holding an implant therein; A method comprising:

202. 202. The method of claim 201, further comprising sliding the second elongated shaft with the second axis parallel to the first axis.

203. 203. The method of claim 201 or 202, wherein a first elongate shaft includes an outer surface and a second elongate shaft includes an outer surface, the method further comprising the step of sliding the second elongate shaft so that the outer surface of the first elongate shaft is adjacent to the outer surface of the second elongate shaft.

204. 204. The method of any one of claims 201 to 203, wherein the second elongated shaft includes a capsule surrounding the implant holding area, the method further including the step of retracting the capsule to position the implant.

205. 205. The method of any one of claims 201 to 204, wherein a coupler couples the second elongate shaft to the first elongate shaft and includes one or more of a magnet, a hook, a loop, or a joint.

206. 206. The method of any one of claims 201 to 205, further comprising steering the first elongate shaft in at least one plane.

207. 207. The method of any one of claims 201 to 206, further comprising steering the first elongate shaft in at least two planes.

208. 208. The method of any one of claims 201 to 207, further comprising the step of bending the second elongate shaft about a bend in the first elongate shaft.

209. 209. The method of any one of claims 201 to 208, further comprising the step of inflating an expandable body at a distal end of the first elongate shaft.

210. 210. The method of any one of claims 201 to 209, wherein the first elongate shaft includes an inner lumen, the method further comprising the step of positioning an imaging sensor within the inner lumen.

211. 1. A delivery system for delivering an implant to a location within a patient's body, comprising: an elongate shaft having a proximal end and a distal end, the shaft including an implant holding region configured to hold the implant; a coating layer on the elongate shaft comprising reinforcing fibers or beads; A delivery system comprising:

212. 212. The delivery system of claim 211, wherein the covering layer comprises polytetrafluoroethylene (PTFE) intermixed with the reinforcing fibers or beads.

213. 213. The delivery system of claim 211 or 212, wherein the coating layer forms an inner liner of the elongate shaft.

214. 214. The delivery system of any one of claims 211 to 213, wherein the elongate shaft includes an outer sheath and the coating layer forms an inner liner of the outer sheath.

215. 215. The delivery system of any one of claims 211 to 214, wherein the elongate shaft includes a capsule configured to surround the implant holding area, and the coating layer forms an inner liner of the capsule.

216. 216. A delivery system according to any one of claims 211 to 215, wherein the reinforcing fibers or beads comprise one or more of silicate or carbon.

217. 217. A delivery system according to any one of claims 211 to 216, wherein the reinforcing fibers or beads comprise glass.

218. placing an elongate shaft at a location within a patient's body, the elongate shaft including an implant holding region for holding an implant to be implanted within the patient's body and a covering layer including reinforcing fibers or beads; A method comprising:

219. 219. The method of claim 218, wherein the coating layer comprises polytetrafluoroethylene (PTFE) mixed with the reinforcing fibers or beads.

220. 220. The method of claim 218 or 219, wherein the coating layer constitutes an inner liner of the elongate shaft.

221. 221. The method of any one of claims 218 to 220, wherein the elongate shaft includes a capsule configured to surround the implant holding area, and the coating layer forms an inner liner of the capsule.

222. 222. The method of claim 221, further comprising the step of retracting the capsule and sliding the inner liner along the implant.

223. 223. The method of any one of claims 218 to 222, wherein the reinforcing fibers or beads comprise one or more of silicate or carbon.

224. 224. The method of any one of claims 218 to 223, wherein the reinforcing fibers or beads comprise glass.

225. providing a mixture of polytetrafluoroethylene (PTFE) and reinforcing fibers or beads; providing an elongate shaft of a delivery system for delivering an implant to a location within a patient's body, the elongate shaft comprising the mixture of polytetrafluoroethylene (PTFE) and the reinforcing fibers or beads as a coating layer on the elongate shaft; A method comprising:

226. 226. The method of claim 225, further comprising extruding the mixture of the polytetrafluoroethylene (PTFE) and the reinforcing fibers or beads.

227. 227. The method of claim 225 or 226, wherein the elongate shaft includes an outer sheath and the coating layer constitutes an inner liner of the outer sheath.

228. 228. The method of any one of claims 225 to 227, wherein the elongate shaft includes a capsule configured to surround an implant holding area for holding the implant, and the coating layer forms an inner liner of the capsule.

229. 229. The method of any one of claims 225 to 228, wherein the reinforcing fibers or beads comprise one or more of silicate or carbon.

230. 230. The method of any one of claims 225 to 229, wherein the reinforcing fibers or beads comprise glass.

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