Powered implant delivery system

Abstract

Systems, devices, and methods disclosed herein are provided for an electrically powered implant delivery system. The delivery system can utilize a processor to control at least one motor to actuate a delivery device. The delivery system can include a sensor configured to sense one or more of a condition of a patient's body or a condition of the delivery device. The processor can process signals provided by the sensor, which can include feedback signals to the processor.

Description

Technical Field

[0001] The various embodiments disclosed herein generally relate to delivery systems for implants. Some embodiments relate to delivery systems and implants for replacing diseased heart valves. Background Technology

[0002] The human heart has four valves: the aortic valve, mitral valve, tricuspid valve, and pulmonary valve. These valves primarily function as one-way valves, working in sync with the pumping heart to ensure blood flows downstream while preventing upstream flow. Diseased heart valves exhibit damage such as narrowing or regurgitation, which inhibits the valve's ability to control blood flow. This damage reduces the heart's pumping efficiency and can be a debilitating and life-threatening condition. For example, valvular insufficiency can lead to conditions such as cardiac hypertrophy and ventricular dilation. Therefore, significant efforts have been made to develop methods and devices to repair or replace damaged heart valves.

[0003] Prosthetic implants exist to correct problems associated with damaged heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace damaged natural heart valves. More recently, significant efforts have been devoted to developing replacement heart valves, particularly tissue-based replacement heart valves, which offer less trauma to patients during delivery compared to open-heart surgery. Replacement valves are designed for delivery via minimally invasive procedures or even percutaneous procedures. These replacement valves typically consist of a tissue-based valve body attached to an expandable frame, which is then delivered to the annulus of the natural valve.

[0004] The development of prosthetic implants, including but not limited to those for replacing heart valves and other types of implants that can be compressed for delivery and then controlledly expanded for controlled placement, has proven particularly challenging. Another challenge involves the ability of such prostheses to be secured in a non-invasive manner relative to intracavitary tissues (e.g., any body cavity or tissue within a cavity).

[0005] Delivering implants to the desired location in the body, such as via catheter-based procedures for replacing heart valves or other forms of implants for heart valve repair, can also be challenging. Access to procedures performed in the heart or other anatomical locations may require percutaneous delivery through tortuous vascular systems or via open or semi-open surgical procedures. The ability to control the deployment of implants at the desired location can also be challenging. Summary of the Invention

[0006] Embodiments of this disclosure relate to an electrically powered implant delivery system. Such a system can be used to deliver and / or controllably deploy implants, such as, but not limited to, heart valve replacements or heart valve repair implants, to desired locations within the body. In some embodiments, methods for replacing heart valves and for delivering replacement heart valves to natural heart valves or repairing heart valves (such as the mitral valve) are provided.

[0007] The delivery system may utilize a processor to control at least one motor for actuating the delivery device. The delivery system may include sensors configured to sense one or more of the patient's physical condition or the condition of the delivery device. The processor may process signals provided by the sensors, which may take the form of feedback signals to the processor. The sensors may be located on the catheter. The sensors may also take the form of imaging devices that provide information about the patient's anatomy and / or the location of the catheter and implant within the patient's body.

[0008] Embodiments of this disclosure include a delivery system for delivering an implant to a location within a patient's body. The system may include a delivery device configured to deliver the implant to a location within the patient's body. The system may include at least one motor configured to actuate at least a portion of the delivery device. The system may include a processor configured to operate the at least one motor to actuate at least said portion of the delivery device.

[0009] Embodiments of this disclosure include a delivery system for delivering an implant to a location within a patient's body. The system may include a delivery device configured to deliver the implant to a location within the patient's body. The system may include one or more sensors coupled to the delivery device and configured to sense one or more of the condition of the patient's body or the condition of the delivery device. The system may include a processor configured to provide output based on one or more of the condition of the patient's body or the condition of the delivery device sensed by the one or more sensors.

[0010] Embodiments of this disclosure include a delivery system for delivering an implant to a location within a patient's body. The system may include an elongated shaft configured to pass within the patient's body. The elongated shaft may include an outer sheath having an outer lumen and proximal and distal ends, at least a portion of which surrounds an implant holding region configured to hold the implant. The elongated shaft may include a rail shaft located within the outer lumen and having proximal and distal ends, the rail shaft being configured to be steerable. The elongated shaft may include an inner shaft located within the outer lumen and having proximal and distal ends. The elongated shaft may include an inner holding member coupled to the inner shaft and configured to be releasably coupled to the implant, wherein the outer sheath and the inner shaft are configured to move together relative to the rail shaft while the implant is held in the implant holding region, and wherein the outer sheath is configured to retract relative to the inner shaft to at least partially deploy the implant. The system may include at least one motor configured to actuate at least a portion of the elongated shaft.

[0011] Embodiments of this disclosure include methods of using the system. For example, the method may include extending a delivery device within a portion of a patient's body to deliver an implant to a body location, wherein at least a portion of the delivery device is actuated by at least one motor operated by a processor.

[0012] Another approach may include extending a delivery device within a portion of a patient's body to deliver an implant to a body location. The delivery device includes one or more sensors coupled to and configured to sense one or more of the condition of the patient's body and / or the condition of the delivery device. The approach may include utilizing a processor to provide output based on one or more of the condition of the patient's body or the condition of the delivery device sensed by the one or more sensors.

[0013] Embodiments of this disclosure include a delivery system for delivering an implant to a location within a patient's body. The system may include an elongated shaft having a proximal end and a distal end. The elongated shaft may include an implant holding region configured to hold the implant, a capsule configured to surround the implant holding region, and at least one electromagnet configured to attract or repel portions of the capsule to change the size of the capsule.

[0014] Another approach may include deploying an elongated shaft into a location within a patient's body, the elongated shaft including a capsule body surrounding an implantation retention area that holds an implant for implantation within the patient's body. The approach may include using at least one electromagnet to attract or repel portions of the capsule body to alter the size of the capsule body within the patient's body.

[0015] Embodiments of this disclosure include a delivery system for delivering an implant to a location within a patient's body. The system may include an elongated shaft having a proximal end and a distal end. The elongated shaft may include an implant holding region configured to hold the implant and an electrically detachable connector configured to be coupled to and at least partially detached from the implant.

[0016] Another approach may include extending the delivery device within a portion of the patient's body to deliver the implant to a body location. The approach may also include detaching at least a portion of the implant from an electrically detachable connector within the patient's body. Attached Figure Description

[0017] Figure 1 An implementation of the delivery system is shown.

[0018] Figure 2A Showing Figure 1 Loaded with Figure 3A A partial cross-sectional view of the distal end of the implant delivery system.

[0019] Figure 2B Showing Figure 1 Not containing Figure 3A A partial cross-sectional view of the distal end of the implant delivery system.

[0020] Figure 2C Showing Figure 1 A partial cross-sectional view of the far end of the delivery system, in which certain shaft components translate along the rail assembly.

[0021] Figure 3A A side view shows an embodiment of an implant in the form of a valve prosthesis that can be delivered using the delivery system described herein.

[0022] Figure 3B A side perspective view showing an embodiment of an aortic valve prosthesis that can be delivered using the delivery system described herein.

[0023] Figure 4 Showing Figure 1 A perspective view of the remote end of the delivery system.

[0024] Figure 5 Showing Figure 4 The components of the delivery system, wherein the outer sheath assembly moves proximally and out of view.

[0025] Figure 6A Showing Figure 5 The delivery system components, wherein the central axis assembly moves proximally and out of view.

[0026] Figure 6B The cross-section of the rail assembly is shown in the example.

[0027] Figure 7 Showing Figure 6A The components of the delivery system, wherein the rail assembly moves proximally and moves out of view.

[0028] Figure 8 Showing Figure 7 The components of the delivery system, wherein the inner component moves proximally and moves out of view.

[0029] Figure 9 An example of how to implement a rail assembly is provided.

[0030] Figure 10 A cross-sectional view illustrating an implementation of the delivery system handle and controller is provided.

[0031] Figure 11 A front plan view illustrating an embodiment of the connector is provided.

[0032] Figure 12 A side perspective view illustrating an embodiment of the coupling and drive rod is provided.

[0033] Figure 13 Example Figure 1 The handle shown is a perspective view.

[0034] Figure 14 Example Figure 1 A perspective view of the proximal portion of the handle shown.

[0035] Figure 15 A partial cross-sectional view illustrating an embodiment of the handle portion is shown.

[0036] Figure 16 A partial cross-sectional view illustrating an embodiment of the handle portion is shown.

[0037] Figure 17 The example shows a side perspective view of a delivery device being inserted into a patient's body.

[0038] Figure 18 Example Figure 10 The diagram shows a cross-sectional view of the delivery system handle and controller.

[0039] Figure 19 A cross-sectional view of the rail assembly is shown as an example.

[0040] Figure 20 Examples with Figure 19 The view shown is a cross-sectional view of the rail assembly viewed at a 90-degree angle.

[0041] Figure 21 A perspective view illustrating an implementation of the distal end of the slender sheath is shown.

[0042] Figure 22A perspective view illustrating an implementation of the distal end of the slender sheath is shown.

[0043] Figure 23 Example Figure 22 The image shows a cross-sectional view of the capsule body with a slender sheath.

[0044] Figure 24 Example Figure 22 The diagram shows a side view of the slender sheath used to deploy the implant onto the mitral valve.

[0045] Figure 25 A schematic diagram illustrating a delivery system that enters a patient's body is shown.

[0046] Figure 26 A schematic diagram illustrating an implant for deploying a mitral valve into a patient is provided.

[0047] Figure 27 A schematic diagram illustrating an implant for deploying a mitral valve into a patient is provided.

[0048] Figure 28 An example perspective view of the distal end of a slender sheath for deploying an implant is shown.

[0049] Figure 29 An example perspective view of the distal end of a slender sheath for deploying an implant is shown.

[0050] Figure 30 An example perspective view of the distal end of a slender sheath for deploying an implant is shown.

[0051] Figure 31 A schematic diagram illustrating a delivery system positioned within the right atrium of a patient's heart is shown.

[0052] Figure 32 An example is located in the right atrium of the patient's heart. Figure 31 The diagram shows a delivery system.

[0053] Figure 33 A schematic diagram of a prosthetic tricuspid valve implanted in a natural tricuspid valve is shown.

[0054] Figure 34 A schematic diagram illustrating a delivery system that extends through the aortic arch of a patient's heart is shown.

[0055] Figure 35 An example of the aortic arch that extends through the patient's heart. Figure 34 The diagram shows a delivery system.

[0056] Figure 36 A schematic diagram of a prosthetic aortic valve implanted in a natural aortic valve is shown.

[0057] Figure 37A perspective view illustrating an embodiment of the control device and output device is provided.

[0058] Figure 38 A perspective view illustrating an embodiment of the control device and output device is provided.

[0059] Figure 39 A flowchart illustrating a method according to an embodiment of this disclosure is provided.

[0060] Figure 40 A flowchart illustrating a method according to an embodiment of this disclosure is provided.

[0061] Figure 41 A cross-sectional view illustrating an embodiment of the delivery system handle is shown.

[0062] Figure 42 A perspective view illustrating an implementation of the implant is provided.

[0063] Figure 43 A perspective view illustrating an implementation of the implant is provided.

[0064] Figure 44 Example Figure 43 The top view of the implant shown.

[0065] Figure 45 An example is shown: a perspective view of the capsule body of the delivery system.

[0066] Figure 46 Example Figure 45 A perspective view of the capsule body of the delivery system shown.

[0067] Figure 47 An example is shown: a perspective view of the capsule body of the delivery system.

[0068] Figure 48 Example Figure 47 A perspective view of the capsule body of the delivery system shown.

[0069] Figure 49 A schematic diagram illustrating a delivery system that enters a patient's body is shown.

[0070] Figure 50 A schematic cross-sectional view of the implant holding area of ​​the slender shaft of the delivery system is shown.

[0071] Figure 51 An enlarged view illustrating the connection between the electrolytically detachable connector and the implant is shown.

[0072] Figure 52 Example Figure 50 A schematic cross-sectional view of the implant retention area shown.

[0073] Figure 53 Example Figure 50 A schematic cross-sectional view of the implant retention area shown.

[0074] Figure 54 A schematic cross-sectional view of the implant retention area of ​​the delivery system is shown.

[0075] Figure 55 A schematic cross-sectional view of the implant retention area of ​​the delivery system is shown.

[0076] Figure 56 A schematic cross-sectional view of the implant retention area of ​​the delivery system is shown.

[0077] Figure 57 An enlarged view illustrating the connection between the electrically detachable connector and the implant is shown.

[0078] Figure 58 A schematic cross-sectional view of the implant retention area of ​​the delivery system is shown.

[0079] Figure 59 Example Figure 58 A schematic cross-sectional view of the implant retention area shown. Detailed Implementation

[0080] This specification and accompanying drawings provide aspects and features of the present disclosure within the context of several embodiments of the delivery system and method. The delivery system and method are preferably used to improve accuracy and ease of use during the implantation of a medical device into the human body. Current medical device implantation is often performed using minimally invasive procedures, generally involving the advancement of a flexible, slender catheter through the patient's vasculature to the treatment site. Since there is no direct line of sight at the treatment site, clinicians must rely on fluorescein examination and other imaging, which can be challenging. Furthermore, clinicians often need to manipulate buttons and knobs on the delivery system handle during the procedure, which further distracts their attention. Therefore, enhanced delivery systems utilizing sensors, motors, and / or artificial intelligence have the potential to significantly improve the quality and consistency of results.

[0081] The delivery systems and methods described herein are configured for use in a patient's vascular system, such as for replacing or repairing a patient's natural heart valves. These embodiments may be discussed in conjunction with the replacement or repair of a specific valve, such as a patient's aortic, tricuspid, mitral, or pulmonary valve. However, it should be understood that the features and concepts discussed herein are applicable to devices other than heart valve implants. For example, delivery systems and methods may be applied to medical implants, such as other types of expandable prostheses, for use in other places in the body, such as arteries, veins, or other body cavities or locations. Furthermore, specific features of valves, delivery systems, methods, etc., should not be considered limiting, and features of any embodiment discussed herein may be combined with features of other embodiments as needed and where appropriate. While some embodiments described herein are described in conjunction with transfemoral / transseptal delivery methods, the embodiments disclosed herein are also well applicable to other delivery methods, such as, for example, transapical, transatrial, or transjugular methods. Furthermore, features described in conjunction with certain embodiments may be incorporated into other embodiments, including those described in conjunction with different delivery methods.

[0082] Figure 1 An embodiment of a delivery system 10 according to embodiments of the present disclosure is illustrated. Delivery system 10 can be used to deploy an implant, such as a prosthetic replacement heart valve, to a location within a patient's body. In some embodiments, delivery system 10 may provide multiple deflection planes (e.g., two planes) to aid navigation through the patient's blood vessels and improve accuracy during implant delivery. Replacement heart valves can be delivered through the patient's vascular system in various ways, such as via open surgery, minimally invasive surgery, and percutaneous or transcatheter delivery, to the patient's mitral (or tricuspid) valve annulus or other heart valve locations (such as the aortic or pulmonary valve). Although in some embodiments delivery system 10 may be described in conjunction with percutaneous delivery methods, more specifically, transfemoral delivery methods, it should be understood that the features of delivery system 10 can be applied to other delivery systems, including transapical, transatrial, or transjugular delivery methods.

[0083] Delivery system 10 can be used to deploy implants in the body, such as replacement heart valves, which may be described elsewhere in this specification. Delivery system 10 can receive and / or cover portions of the implant, such as... Figure 3A The implant 70 or prosthesis shown has a first end 301 and a second end 303. For example, the delivery system 10 can be used to deliver the expandable implant 70, wherein the implant 70 includes a first end 301 and a second end 303, and wherein the second end 303 is configured to be deployed or expanded prior to the first end 301.

[0084] Figure 2AAn example of implant 70 is further shown, which can be inserted into a portion of delivery system 10, specifically into implant holding area 16. For ease of understanding, in Figure 2A The image shows only a bare metal frame to illustrate the implant. Implants 70 or prostheses can be in any number of different forms. Figure 3A An example of an implant frame is shown; however, other frame configurations may be used in other embodiments. Implant 70 may include one or more sets of anchors, such as distal (or ventricular) anchors 80 (in... Figure 3A The distal anchor (marked in the middle) is coupled to the distal portion of the implant and extends generally proximally when the implant frame is in an expanded configuration. When the implant is used for mitral or tricuspid valve replacement, the distal anchor may be shaped to capture the natural leaflet between the anchor and the tubular body of the implant. The implant may also include a proximal (or atrial) anchor 82 for placement on the atrial side of the valve annulus, thereby further enhancing stability. When the implant frame is in an expanded configuration, the atrial anchor may extend radially and / or distally. The implant may further include a strut 72 at the atrial end, the strut 72 may be included at the first end 301 (in Figure 3A The tab 74 (marked in the middle) may provide an enlarged tip, such as a mushroom shape, which is sized to be placed in a corresponding holding area, such as a slot or recess, along the distal end of the delivery system, thereby ensuring a secure connection between the implant and the delivery system.

[0085] In some embodiments, the delivery system 10 can be used in conjunction with aortic valve replacement, such as... Figure 3B As shown. In some embodiments, the delivery system 10 may be modified to support and deliver the replacement aortic valve. However, the procedures and structures discussed below can be similarly used to replace the function of the mitral, tricuspid, pulmonary, or aortic valves, as well as other valves, such as venous valves in the human body. The principles, procedures, and structures of the disclosed embodiments are also fully applicable to other implants that can be used for other medical treatments (unrelated to heart valves).

[0086] Refer again Figure 1The delivery system 10 can be configured to deliver an implant to a location within a patient's body. The delivery system 10 may include an elongated shaft 12, which may include a shaft assembly and is configured to hold the implant. The elongated 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 the elongated shaft 12. The elongated shaft 12 can be used to support the implant for propulsion through the vascular system to a treatment location. The elongated shaft 12 may also include a relatively rigid live-on (or integrated) sheath 51 surrounding an inner portion of the shaft 12, which reduces unwanted movement of the inner portion of the shaft 12. The live-on sheath 51 may be attached to the proximal end of the shaft 12, proximal to the handle 14, for example, to a sheath hub.

[0087] refer to Figure 2A and 2B The slender shaft 12 may include an implant retention area 16 at its distal end for this purpose (e.g., Figure 2A -B is shown, where Figure 2A Implant 70 was shown, while Figure 2B The implant 70 has been removed. In some embodiments, the elongated shaft 12 may hold the expandable implant in a compressed state at the implant holding region 16 for advancing the implant 70 in the body. The shaft 12 can then be used to allow controlled expansion of the implant 70 at the treatment site. In some embodiments, the shaft 12 may be used to allow sequential controlled expansion of the implant 70, as discussed in more detail below. The implant holding region 16 is in Figure 2A-2B The implant 70 is shown at the distal end of the delivery system 10, but may be in other locations. In some embodiments, the implant 70 may be rotated within the implant holding area 16, such as by rotation via the inner shaft assembly 18 discussed herein.

[0088] like Figure 2A-2B The cross-sectional view shown indicates that the distal end of the delivery system 10 may include one or more components, such as the outer sheath assembly 22, the central shaft assembly 21, the rail assembly 20, the inner shaft assembly 18, and the nose cone assembly 31, as will be described in more detail below. In some embodiments, the delivery system 10 may not have all the components disclosed herein. For example, in some embodiments, the complete central shaft assembly may not be incorporated into the delivery system 10. In some embodiments, the radial order of the components may differ from that discussed.

[0089] Implementations of the disclosed delivery system 10 utilize an internal steerable rail in the rail assembly 20 to steer / deflect the distal end of the elongated shaft 12, thereby allowing the implant to be positioned more easily and accurately within the patient's body. As discussed in detail below, the steerable rail can be, for example, a rail shaft extending from the handle 14 through the elongated shaft 12, generally extending to the distal end of the elongated shaft 12. In some embodiments, the steerable rail has a distal end terminating proximally to the implant holding area 16. The user can manipulate the bending of the distal end of the rail, thereby bending the rail in a desired direction. In a preferred embodiment, the rail has more than one bend along its length, thereby providing multiple deflection planes. The rail preferably deflects the elongated shaft 12 in at least two planes. When the rail is bent, it presses against other components, causing them to bend as well, so that other components of the elongated shaft 12 can be configured to steer together with the rail as mating individual units, thereby providing full steerability along the distal end of the elongated shaft 12.

[0090] Once the track is oriented to the desired position within the patient's body, the implant 70 can be advanced and released into the body along or relative to the track by movement of other sheaths / axles relative to the track. For example, the track can be bent into the desired position within the body, such as guiding the implant 70 to a natural mitral valve or other valves intended for implantation (e.g., aortic, tricuspid, pulmonary, etc.). Other components (e.g., outer sheath assembly 22, central axis assembly 21, inner assembly 18, and nasal cone assembly 31) can passively follow the bending of the track. Furthermore, other components (e.g., outer sheath assembly 22, central axis assembly 21, inner assembly 18, and nasal cone assembly 31) can be advanced relative to the track together (e.g., relatively together, sequentially, simultaneously, almost simultaneously, at the same time, near the same time) while maintaining the implant 70 in a compressed position without releasing or expanding (e.g., within the implant holding area 16). Other components (e.g., outer sheath assembly 22, central axis assembly 21, inner assembly 18, and nasal cone assembly 31) may be advanced distally or proximally relative to the track. In some embodiments, only the outer sheath assembly 22, central axis assembly 21, and inner assembly 18 are advanced together on the track. Thus, the nasal cone assembly 31 can be held in the same position. Components may be translated individually, sequentially, or simultaneously relative to the inner assembly 18 to release the implant 70 from the implant holding area 16.

[0091] Figure 2CAn example is illustrated by the sheath assembly, specifically the outer sheath assembly 22, the central axis assembly 21, the inner axis assembly 18, and the nasal cone assembly 31, which translate distally together along the track assembly 20. In some embodiments, the outer sheath assembly 22, the central axis assembly 21, the inner axis assembly 18, and the nasal cone assembly 31 translate together (e.g., relatively together, sequentially with a single actuator, simultaneously, almost simultaneously, at the same time, or nearly at the same time). This distal translation can occur when the implant 70 is held in a compressed configuration within the implant holding region 16.

[0092] like Figure 2A-2C As shown and further as Figure 4-8 As shown, starting with the outermost component, the delivery system may include an outer sheath assembly 22 forming a radially outer cover or sheath to surround the implant holding area 16 and prevent radial expansion of the implant. Specifically, the outer sheath assembly 22 prevents radial expansion of the distal end of the implant. Radial inward movement and reference Figure 5 The central axis assembly 21 may consist of a central thorax tube 43, the distal end of which is attached to the outer retention member 42 or outer retention ring for radially retaining a portion of the implant in a compact configuration, such as the proximal end of the implant 70. The central axis assembly 21 may be located within the cavity of the outer sheath assembly 22. Further inward movement, and referencing... Figure 6A The rail assembly 20 can be configured to be steerable, as described above and further below. The rail assembly 20 can be located within the cavity of the central shaft assembly 21. Further inward movement and reference... Figure 7 The inner shaft assembly 18 may consist of an inner shaft, the distal end of which is attached to an inner retaining member or inner retaining ring 40 (such as a PEEK ring) to axially retain the prosthesis, for example, the proximal end of the prosthesis. The inner shaft assembly 18 may be located within the cavity of the rail assembly 20. Further, and referring to... Figure 8 The most radially inward component may be the nasal cone assembly 31, which includes a nasal cone shaft 27, the distal end of which is connected to a nasal cone 28. The nasal cone 28 may have a tapered tip. The nasal cone assembly 31 is preferably located within the cavity of the inner shaft assembly 18. The nasal cone assembly 31 may include a cavity to allow a guidewire to pass through it.

[0093] The slender shaft 12 and its components, and more specifically the nasal cone assembly 31, inner assembly 18, rail assembly 20, central shaft assembly 21, and outer sheath assembly 22, can be collectively configured to hold the implant 70 located within the implant holding area 16. Figure 2A(As shown) is delivered to the treatment location. One or more of the movable components then allow the implant 70 to be released at the treatment location. For example, one or more of the components may be movable relative to one or more of the other components. The handle 14 may include one or more motors, or other components, that can be used to actuate the various components. The implant 70 may be controllably loaded onto the delivery system 10 and then deployed in the body. Furthermore, the handle 14 may provide steering to the rail assembly 20, thereby providing bending / flexion / steering to the distal end of the elongated shaft 12.

[0094] refer to Figure 2A-2C The inner retaining member 40, the outer retaining ring 42, and the outer sheath assembly 22 can cooperate to support the implant 70 in a compact configuration. Figure 2A In the middle, the inner retaining member 40 is shown as engaging the strut 72 at the proximal end 301 of the implant 70. Figure 3A (Middle mark). For example, a slot between radially extending teeth on the inner retainer 40 may receive and engage a post 72, which may terminate in a mushroom-shaped protrusion 74 on the proximal end of the implant 70. Figure 3A (Central mark). The central axis assembly 21 can be positioned above the inner retaining member 40, such that the first end 301 of the implant 70 ( Figure 3A The implant 70 (with a central marking) is captured between the inner retaining member 40 and the outer retaining ring 42, thereby securely attaching it to the delivery system 10, located between the central shaft assembly 21 and the outer retaining ring 42. The outer sheath assembly 22 can be positioned to cover the second end 303 of the implant 70. Figure 3A (marked in the middle).

[0095] The outer retaining member 42 can be attached to the distal end of the central thiopan tube 43, and the central thiopan tube 43 can then be attached to the proximal end of the proximal tube 44. Figure 5 (Center mark), the proximal tube 44 can then be attached proximally to the handle 14. When in the compressed position, the outer retaining member 42 can provide further stability for the implant 70. The outer retaining member 42 can be positioned above the inner retaining member 40 such that the proximal end of the implant 70 is captured therebetween, thereby securely attaching it to the delivery system 10. The outer retaining member 42 can surround a portion of the implant 70, preferably the first end 301, thereby preventing the implant 70 from fully expanding. Further, the central axis assembly 21 can be translated proximally relative to the inner assembly 18 into the outer sheath assembly 22, thereby exposing the first end 301 of the implant 70 supported within the outer retaining member 42. In this way, the outer retaining member 42 can be used to help secure the implant 70 to or release it from the delivery system 10. Although the outer retaining member 42 can have a cylindrical or elongated tubular shape and can be referred to as an outer retaining ring, there is no limitation on the specific shape.

[0096] like Figure 2AAs shown, when the implant is delivered under compression, the distal anchor 80 ( Figure 3A The distal anchor 80 extends in a generally distal direction (as shown, axially away from the body of the implant frame and away from the handle of the delivery system). The outer sheath assembly 22 constrains the distal anchor 80 in this delivery configuration. Thus, when the outer sheath 22 is withdrawn proximally, the distal anchor 80 can flip its position (e.g., bend approximately 180 degrees) to a deployment configuration (e.g., generally pointing proximally). The flipping of the distal anchor occurs due to an offset or shape memory preset, which causes the anchor to flip without external force. Figure 2A Also shown is a proximal anchor extending distally within the outer sheath assembly 22 in its delivery configuration (see...). Figure 3A (82 in the text). In other embodiments, the distal anchor 80 may generally extend proximally and press against the body of the implant frame when in the delivery configuration, thereby eliminating the need for flipping during deployment.

[0097] The delivery system 10, pre-installed with the implant 70, can be provided to the user. In other embodiments, the implant 70 may be loaded onto the delivery system shortly before use, such as by a physician or nurse.

[0098] Figure 4-8 Other views of the delivery system 10 are shown, in which different components are translated proximally and described in detail.

[0099] from Figure 4 Starting with the outermost component shown, the outer sheath assembly 22 may include an outer proximal shaft 102 directly attached to the handle 14 at its proximal end and an outer submersible tube 104 attached to its distal end. A capsule body 106 may then be generally attached to the distal end of the outer submersible tube 104. In some embodiments, the capsule body 106 may be 28 French inches or smaller. These components of the outer sheath assembly 22 may form cavities to allow other sub-assemblies to pass through.

[0100] Capsule body 106 may be located at the distal end of the proximal axis 102. Capsule body 106 may be a tube formed of plastic or metal material. In some embodiments, capsule body 106 is formed of ePTFE or PTFE. In some embodiments, this capsule body 106 is relatively thick to prevent tearing and help maintain the self-expanding implant in a compact configuration. In some embodiments, the material of capsule body 106 is the same as the coating on the outer submersible tube 104. As shown, the diameter of capsule body 106 may be larger than that of outer submersible tube 104, but in some embodiments, the diameter of capsule body 106 may be similar to that of submersible tube 104. In some embodiments, capsule body 106 may include a larger diameter distal portion and a smaller diameter proximal portion. In some embodiments, a step or taper may be present between these two portions. Capsule body 106 may be configured to hold implant 70 in a compressed position within capsule body 106. Further construction details of capsule body 106 are discussed below.

[0101] The outer sheath assembly 22 is configured to slide independently relative to the other components. Furthermore, the outer sheath assembly 22 can slide distally and proximally relative to the rail assembly 22 together with the central shaft assembly 21, the inner assembly 18, and the nose cone assembly 31.

[0102] Moving radially inward, the next component is the central axis assembly 21. Figure 5 Showing with Figure 4 A similar view, but with the outer sheath component 22 removed, thus exposing the central axis component 21.

[0103] The central axis assembly 21 may include: a central axis thiocyanate tube 43 generally attached proximally to a central axis proximal tube 44, the central axis proximal tube 44 being further attachable proximally to a handle 14; and an outer retaining ring 42 located at the distal end of the central axis thiocyanate tube 43. Thus, the outer retaining ring 42 may generally be attached to the distal end of the central axis thiocyanate tube 43. These components of the central axis assembly 21 may form a cavity to allow other sub-assemblies to pass through.

[0104] The outer retaining ring 42 can be configured as a prosthesis retaining mechanism, which can be used to engage with the implant 70, as per [reference needed]. Figure 2A This is under discussion. For example, the outer retaining ring 42 may be a ring or cover configured to radially cover the strut 72 on the implant 70. Figure 3A (Central marking). The outer retaining ring 42 can also be considered part of the implant retaining area 16 and can be located proximally to the implant retaining area 16. When the strut or other part of the implant 70 engages with the inner retaining member 40, the outer retaining ring 42 can cover both the implant 70 and the inner retaining member 40 to secure the implant 70 to the delivery system 10. Thus, the implant 70 can be clamped between the inner retaining member 40 of the inner shaft assembly 18 and the outer retaining ring 42 of the central shaft assembly 21.

[0105] The central axis assembly 21 is arranged to slide independently relative to the other assemblies. Furthermore, the central axis assembly 21 can slide distally and proximally relative to the rail assembly 22 together with the outer sheath assembly 22, the intermediate inner assembly 18, and the nose cone assembly 31.

[0106] Next, on the radially inner side of the central axis assembly 21 is the rail assembly 20. Figure 6A Showing with Figure 5 The view is largely the same, but the central axis component 21 is removed, thus exposing the track component 20. Figure 6B A cross-section of the rail assembly 20 is further shown to observe the drawing wire. The rail assembly 20 may include a rail shaft 132 (or rail) generally attached proximally to the handle 14. The rail shaft 132 may consist of a rail proximal shaft 134 directly attached to the handle at its proximal end and a rail hypo tube 136 attached to the distal end of the rail proximal shaft 134. The rail hypo tube 136 may also include a non-invasive rail tip at its distal end. Further, as shown in FIG. 6, the distal end of the rail hypo tube 136 may be adjacent to the proximal end of the inner retaining member 40. In some embodiments, the distal end of the rail hypo tube 136 may be spaced apart from the inner retaining member 40. These components of the rail shaft assembly 20 may form cavities to allow other sub-assemblies to pass through.

[0107] like Figure 6B As shown, one or more pull wires are attached to the inner surface of the rail slat 136, which can be used to apply force to the rail slat 136 and steer the rail assembly 20. The pull wires may extend distally from the handle 14 to the rail slat 136. In some embodiments, the pull wires may be attached at different longitudinal locations on the rail slat 136, thereby providing multiple bending positions in the rail slat 136 to allow multidimensional steering. The rail slat 136 may allow the elongated shaft 20 to deflect in at least two planes.

[0108] In some embodiments, the distal pull wire 138 may extend to the distal section of the rail hyaluronic acid tube 136, while two proximal pull wires 140 may extend to the proximal section of the rail hyaluronic acid tube 136. However, other numbers of pull wires may be used, and the specific number of pull wires is not limited. For example, two pull wires may extend to the distal position, while a single pull wire may extend to the proximal position. In some embodiments, annular structures attached inside the rail hyaluronic acid tube 136, such as proximal ring 137 and distal ring 135, referred to as pull wire connectors, may be used as attachment points for the pull wires. In some embodiments, the rail assembly 20 may include a distal pull wire connector in the form of a distal ring 135 and a proximal pull wire connector in the form of a proximal ring 137. In some embodiments, the pull wires may be directly connected to the inner surface of the rail hyaluronic acid tube 136.

[0109] The distal pull wire 138 may generally be connected at the distal end of the rail hyaluronic acid tube 136 (alone or via a connector, such as distal ring 135). The proximal pull wire 140 may be connected at approximately one-quarter, one-third, or one-half of the length of the rail hyaluronic acid tube 136 from the proximal end (alone or via a connector, such as proximal ring 137). In some embodiments, the distal pull wire 138 may pass through a small-diameter pull wire cavity 139 (e.g., a tube, hyaluronic acid tube, cylinder) attached to the interior of the rail hyaluronic acid tube 136. This prevents the wire 138 from pulling the rail hyaluronic acid tube 136 near the distal connection. Furthermore, the cavity 139 may act as a compression coil to reinforce the proximal portion of the rail hyaluronic acid tube 136 and prevent undesirable bending. Therefore, in some embodiments, the cavity 139 is located only on the proximal half of the rail hyaluronic acid tube 136. In some embodiments, each distal draw wire 138 may use a plurality of cavities 139, such as longitudinally spaced or adjacent. In some embodiments, each distal draw wire 138 uses a single cavity 139. In some embodiments, the cavity 139 may extend into the distal half of the rail hyaluronic acid tube 136. In some embodiments, the cavity 139 is attached to the outer surface of the rail hyaluronic acid tube 136. In some embodiments, the cavity 139 is not used.

[0110] For the paired proximal pull wires 140, these wires may be spaced approximately 180° apart to allow for turning in both directions. Similarly, if a pair of distal pull wires 138 are used, these wires may be spaced approximately 180° apart to allow for turning in both directions. In some embodiments, the paired distal pull wires 138 and the paired proximal pull wires 140 may be spaced approximately 90° apart. In some embodiments, the paired distal pull wires 138 and the paired proximal pull wires 140 may be spaced approximately 0° apart. However, other positions of the pull wires may also be used, and the specific positions of the pull wires are not limited. In some embodiments, the distal pull wire 138 may pass through a cavity 139 attached to the cavity of the rail hysteresis tube 136. This prevents the axial force on the distal pull wire 138 from causing bending in the proximal section of the rail hysteresis tube 136.

[0111] The rail assembly 20 is arranged to slide on the inner shaft assembly 18 and the nasal cone assembly 31. In some embodiments, the outer sheath assembly 22, the central shaft assembly 21, the inner shaft assembly 22, and the nasal cone assembly 31 may be configured to slide together along or relative to the rail assembly 20, such as sliding together proximally and distally with or without bending of the rail assembly 20. In some embodiments, the outer sheath assembly 22, the central shaft assembly 21, the inner shaft assembly 22, and the nasal cone assembly 31 may be configured to hold the implant 70 in a compressed position when they slide simultaneously along or relative to the rail assembly 20.

[0112] Moving radially inward, the next component is the inner shaft assembly 18. Figure 7 Showing with Figure 6A The view is largely the same, but the rail component 20 has been removed, thus exposing the inner axis component 18.

[0113] The inner shaft assembly 18 may include an inner shaft 122 generally attached proximally 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 consist of an inner proximal shaft 124 directly attached proximally to the handle 14 and a distal segment 126 attached to the distal end of the inner proximal shaft 129. Therefore, the inner retaining ring 40 may generally be attached to the distal end of the distal segment 126. These components of the inner shaft assembly 18 may form cavities to allow other sub-assemblies to pass through.

[0114] The internal retaining member 40 can be configured as a prosthesis retaining mechanism for engagement with the implant 70, as per [reference needed]. Figure 2A The discussion focuses on the following: For example, the inner retention member 40 may be a ring and may include a strut 72 configured to engage with the implant 70. Figure 3A Multiple slots (marked in the middle) engage. The inner retaining member 40 can also be considered part of the implant retaining area 16 and may be located proximally to the implant retaining area 16. When the strut or other portion of the implant 70 engages with the inner retaining member 40, the outer retaining ring 42 may cover both the implant and the inner retaining member 40 to secure the prosthesis to the delivery system 10. Thus, the implant 70 may be clamped between the inner retaining member 40 of the inner axis assembly 18 and the outer retaining ring 42 of the central axis assembly 21.

[0115] The inner shaft assembly 18 is arranged to slide independently relative to the other assemblies. Furthermore, the inner assembly 18 can slide distally and proximally relative to the rail assembly 22 together with the outer sheath assembly 22, the central shaft assembly 21, and the nose cone assembly 31.

[0116] Figure 8As seen, the nasal cone assembly 31 is further inwardly movable from the inner shaft assembly 18. The nasal cone assembly may include a nasal cone shaft 27, and in some embodiments, may have a nasal cone 28 at its distal end. The nasal cone 28 may be made of polyurethane for non-invasive access and to minimize damage to the venous vascular system. The nasal cone 28 may also be radiopaque to provide visibility under fluorescence examination.

[0117] The nasal cone shaft 27 may include a cavity, which is sized and configured to slidably receive a guidewire, allowing the delivery system 10 to be advanced over the guidewire through the vascular system. However, embodiments of the system 10 discussed herein may not use a guidewire, and therefore the nasal cone shaft 27 may be solid in some embodiments. The nasal cone shaft 27 may be connected from the nasal cone 28 to a handle, or may be formed from different portions such as other components. Furthermore, the nasal cone shaft 27 may be formed from different materials (such as plastic or metal) similar to those described in detail above. In some embodiments, the nasal cone shaft 27 includes a guidewire guard 1200 located on a portion of the nasal cone shaft 27.

[0118] The nose cone assembly 31 is arranged so that it can slide independently relative to the other assemblies. Furthermore, the nose cone assembly 31 can slide distally and proximally relative to the rail assembly 22 together with the outer sheath assembly 22, the central shaft assembly 21, and the inner assembly 18.

[0119] In some embodiments, one or more spacer sleeves (not shown) may be used between different components of the delivery system 10. For example, spacer sleeves may be concentrically located between the central shaft assembly and the rail assembly 20, generally between the central shaft tube 43 and the rail tube 136. Spacer sleeves may generally be embedded in the tube 43 of the central shaft assembly 21, such as on the inner surface of the central shaft assembly 21. In some embodiments, spacer sleeves may be concentrically located between the rail assembly 20 and the inner assembly 18, generally within the rail tube 136. In some embodiments, spacer sleeves may be used between the outer sheath assembly 22 and the central shaft assembly 21. In some embodiments, spacer sleeves may be used between the inner assembly 18 and the nose cone assembly 31. In some embodiments, four, three, two, or one of the above-described spacer sleeves may be used. Spacer sleeves may be used in any of the above-described locations.

[0120] As discussed above, the outer sheath assembly 22, the central axis assembly 21, the inner assembly 18, and the rail assembly 20 may respectively include an outer sub-tube 104, a central sub-tube, a distal segment 126, and a rail sub-tube 136. Each of these sub-tubes / segments / axis can be laser-cut to include a number of slots, thereby creating a following curved path for the delivery system.

[0121] For example, Figure 9An embodiment of the rail-mounted hyaluronic acid tube 136 is shown (far end facing right). The rail-mounted hyaluronic acid tube 136 may also include multiple circumferential slots. The rail-mounted hyaluronic acid tube 136 can generally be decomposed into multiple distinct segments. At the proximal end is an uncut (or ungrooved) hyaluronic acid tube segment 231. Moving distally, the next segment is a proximal-grooved hyaluronic acid tube segment 233. This segment includes multiple circumferential slots cut into the rail-mounted hyaluronic acid tube 136. Generally, two slots are cut around each circumferential location, forming almost half a circumference. Thus, two backbones extending along the length of the hyaluronic acid tube 136 are formed between the slots. This is a segment that can be guided by the proximal traction wire 140. Moving further distally, there is a position 237 where the proximal traction wire 140 connects, thus avoiding the slots. Therefore, this segment is exactly distal to the proximal-grooved segment.

[0122] The distally slotted subwoofer section 235 is located distal to the proximal filament connection region. This section is similar to the proximal slotted subwoofer section 233, but has significantly more slots cut out of equal length. Therefore, the distally slotted subwoofer section 235 provides easier bending than the proximal slotted subwoofer section 233. In some embodiments, the proximal slotted section 233 may be configured to undergo a bend of approximately 90 degrees with a half-inch radius, while the distally slotted section 135 may bend at approximately 180 degrees within half an inch. Furthermore, as... Figure 9 As shown, the ridge of the distally slotted submersible section 235 is offset from the ridge of the proximal slotted submersible section 233. Therefore, these two sections will achieve different bending patterns, allowing for three-dimensional steering of the track assembly 20. In some embodiments, while the specific offset is not limited, the ridges may be offset by 30, 45, or 90 degrees. In some embodiments, the proximal slotted submersible section 233 may include a compression coil. This allows the proximal slotted submersible section 233 to maintain stiffness, enabling the distal slotted submersible section 235 to undergo specific bending.

[0123] The distal pull wire connection area 241 is at the farthest end of the grooved sub-tube section 235, which is also the non-grooved section of the rail sub-tube 136.

[0124] Refer again Figure 1A housing in the form of an elongated shaft 12 and a handle 14 can form a delivery device configured to deliver an implant 70 to a location within a patient's body. The delivery system 10 may include at least one motor configured to actuate at least a portion of the delivery device. Actuation of at least a portion of the delivery device may include deflection of a portion of the delivery device (including the elongated shaft) or other movement of the delivery device and may include actuation of operations of the delivery device. Operations may include other operations of the delivery device, such as deploying the implant 70 (whether wholly or partially) to a body position. The motor may include, for example, […]. Figure 10 The motor 500 shown may include Figure 41 Other types of motors, such as the multiple motors 502 shown (i.e., at least one motor).

[0125] like Figure 1 As shown, a housing in the form of a handle 14 can be positioned at the proximal end 11 of an elongated shaft 12. The proximal end 11 of the elongated shaft 12 can be coupled to the handle 14. The handle 14 may include a control device 504 configured to control at least one motor. Figure 1 The control device 504 shown may include multiple buttons; however, in other embodiments, other forms of control devices may be used. The control device 504 may be as follows: Figure 1 The position shown is on the handle 14, or it can be positioned remotely.

[0126] Figure 10 A cross-section of a handle 14 is illustrated, including a motor 500 and an actuation mechanism 506 that can be used to actuate at least a portion of the delivery device. In various embodiments, the motor and actuation mechanism can be used to actuate a traction filament during propulsion through a vascular system. The motor and actuation mechanism can be used to actuate an actuation shaft / shroud to deploy and release an implant at a treatment site. The body of the handle 14 may include multiple portions, including a distal portion 508 and a proximal portion 510. Figure 10 The distal portion 508 shown may be configured to hold the actuation mechanism 506, while the proximal portion 510 may be configured to hold the motor 500. In other embodiments, other components may be positioned in the respective distal and proximal portions 508 and 510, and in some embodiments, the handle 14 may comprise a single body. Figure 10 In the illustrated embodiment, the distal portion 508 and the proximal portion 510 can be configured to be connected via connectors 512, 514. Figure 13 and 14 The components (marked with a symbol) are linked together and can be separated from each other in some implementations.

[0127] Actuation mechanism 506 can be adopted as follows: Figure 10 The form shown may include multiple couplings 516a-g configured to engage with multiple drive rods 518a-g. Figure 12The drive rods 518f-g are marked in the diagram. Each connector 516a-g may include a plate or other body containing multiple holes. Figure 11 A front plan view of connector 516a is shown as an example. Figure 11 The connector 516a shown may include holes 520a-g and 522. Holes 520a-g can each be configured to allow corresponding drive rods 518a-g to pass through them (e.g., ...). Figure 12 (As shown). Holes 520b-g can each be configured as smooth support surfaces, not engaging the corresponding drive rods 518b-g. However, hole 520a can be configured with a threaded surface or other surface that engages drive rod 518a. For example, drive rod 518a may include gear threads and hole 520a may include threads that mate with gear threads. This configuration allows drive rod 518a to actuate engager 516a in two directions (distal and proximal) based on the direction of rotation of drive rod 518a. In other embodiments, other engagement forms may be utilized.

[0128] The center hole 522 allows other components of the actuation mechanism 506, such as component connectors, to pass through the center hole to be coupled to the remaining corresponding couplings 516a-g.

[0129] Figure 12 A perspective view of a connector 516a with representative drive rods 518a-g extending through holes 520a-g is shown.

[0130] Other connectors 516b-g may be configured similarly to connector 516a; however, each corresponding connector 516b-g may have a hole configured to engage a corresponding drive rod 518b-g, wherein the remaining holes include smooth support surfaces. For example, for connector 516b, an equivalent hole of hole 520b may be configured to engage drive rod 518b, while the remaining equivalent holes of holes 520a, 516c-g may include smooth support surfaces. Connectors 516c-g have similar corresponding holes and are configured to engage corresponding drive rods 518c-g. In this way, a single drive rod 518a-g may be configured to actuate a corresponding dedicated connector 516a-g. The remaining drive rods may pass through the remaining connectors without engaging them.

[0131] Refer again Figure 10 The couplings 516a-g can be configured to slide within the cavity of the housing including the handle 14. The outer surface of the couplings 516a-g can be positioned, for example, on a track within the handle 14 or otherwise configured to slide or move within the handle 14.

[0132] The drive rods 518a-g can extend longitudinally along the interior of the handle 14 and can be configured to engage the corresponding couplings 516a-g. For example, Figure 10Examples include a connector 516a engaged by a drive rod 518a and a connector 516g engaged by a drive rod 518e (in the configuration where the connector 516g is configured to be engaged by the drive rod 518e, other configurations, such as the connector 516g being engaged by the drive rod 518g, can be utilized). The proximal ends of the drive rods 518a-g can be configured to engage and be actuated by the motor 500.

[0133] Couplers 516a-g can be coupled to component connectors that are coupled to corresponding portions of the assemblies including pull wire assemblies 138 and 140 (outer sheath assembly 22, central shaft assembly 21, rail assembly 20, inner assembly 18, and nose cone assembly 31). In some embodiments, couplers 516a-g can be coupled to specific components constituting the respective assemblies; for example, in some embodiments, coupler 516a can be directly coupled to nose cone shaft 27. The coupling of couplers 516a-g to the component connectors allows coupler 516a to be coupled to component connector 521 of the outer sheath assembly 22. Coupler 516b can be coupled to component connector 523 of the central shaft assembly 21. Coupler 516c can be coupled to component connector 524 of the rail assembly 20. Coupler 516d can be coupled to component connector of the distal pull wire 138 or can be directly coupled to the distal pull wire 138. Connector 516e can be coupled to the component connector of the proximal pull wire 140 or can be directly coupled to the proximal pull wire 140. Connector 516f can be coupled to the component connector 526 of the inner component 18. Connector 516g can be coupled to the component connector 528 of the nose cone assembly 31. Component connectors 521, 523, 524, 526, and 528 may include sheaths extending concentrically over each other, or may include rods, wires, or other forms of connectors. Component connectors 521, 523, 524, 526, and 528 may be configured to pass through the center hole of the respective connector 516a-g (e.g., Figure 11 Hole 522 shown in the figure.

[0134] Component connectors 521, 523, 524, 526, and 528 may have proximal portions connected to the corresponding connectors 516a, b, c, f, and g, and distal portions connected to the corresponding components, in order to actuate the respective components. For example, component connector 521 may be connected to the outer sheath assembly 22, such that movement of component connector 521 moves the outer sheath, or the sheath of the outer sheath assembly 22, to expose the implant 70 in the capsule body 106. Component connector 523 may be connected to the central shaft assembly 21, such that movement of component connector 523 moves the outer retaining member 42. Component connector 524 may be connected to the rail assembly 20, such that movement of component connector 524 moves the rail assembly 20. Movement of connectors 516d and 516e may move the corresponding pull wires 138 and 140. Component connector 526 may be connected to the inner assembly 18, such that movement of component connector 526 moves the inner retaining member 40. Component connector 528 can be coupled to nose cone assembly 31 such that movement of component connector 528 causes nose cone 28 to move. Therefore, the corresponding drive rods 518a-g can be actuated by motor 500 to selectively move the corresponding couplings 516a-g and thus move the corresponding parts of the assembly (outer sheath assembly 22, central shaft assembly 21, rail assembly 20, inner assembly 18, and nose cone assembly 31).

[0135] Movement of the components (outer sheath assembly 22, central axis assembly 21, rail assembly 20, inner assembly 18, and nasal cone assembly 31) can be translation of the respective components, including traction wires 138, 140, to produce a desired movement (e.g., deflection) or operation (e.g., implant deployment). For example, motor 500 may be configured to translate the rail axis of rail assembly 20 relative to the inner sheath of inner assembly 18 and the outer sheath of outer sheath assembly 22. In some embodiments, motor 500 may be configured to translate the outer sheath of outer sheath assembly 22 relative to the inner sheath of inner assembly 18. Motor 500 may be configured to translate any component relative to each other to produce a desired result. Motor 500 may be configured to, for example, steer rail assembly 20 by actuating traction wires 138, 140. Other movements may include actuating the depth of elongated shaft 12 and actuating the elongated shaft 12, such as deploying implant 70 fully or partially.

[0136] In other embodiments, the delivery device actuated by motor 500 can be combined with... Figure 10 The different ways shown occur. In one embodiment, the configuration of the actuation mechanism 506 can be different. Figure 10 The configuration shown.

[0137] The delivery system 10 may include a controller 530 configured to control the operation of the motor 500 and thus control the actuation of parts of the delivery device. Figure 10The controller 530 shown may include input devices and output devices (labeled item 532). The controller 530 may include a memory 534 and a processor 536. The controller may include a power supply 538.

[0138] The input and output devices 532 may have various configurations, including electrical ports or terminals configured to transmit electrical signals. The input devices may be configured to receive signals from the motor 500 and from sensors positioned on the delivery system 10. The output devices may be configured to transmit signals to the motor 500 or other components of the system 10, which may be received from the processor 536 or other components of the system 10. In some embodiments, the input and output devices 532 may include wireless transmission devices, such as Wi-Fi or Bluetooth devices, or other devices configured for wireless communication. In embodiments where the controller 530 is remotely located from the delivery device, the input and output devices 532 may be configured to transmit and receive information via the Internet or other forms of communication media. In other embodiments, other forms of input and output devices may be utilized.

[0139] Memory 534 may be configured to store programs operated by processor 536, as well as other data desired to be stored in controller 530. Memory 534 may be configured to store and record data such as information about the patient and the operation of the delivery device and motor 500 during the procedure, thereby allowing the system to learn from past events. The learning aspect may be based on algorithms capable of identifying procedures that have produced positive results in the past, thereby allowing the system to continuously refine the procedure to increase the likelihood of successful outcomes. Preferably, data from different patients, different clinicians, and / or different hospitals may be aggregated. The compilation of data can be used to improve accuracy and improve the outcomes of future procedures. This can be achieved, for example, by comparing the characteristics of new patients with those of patients who have received treatment in the past. Data from procedures of past patients with similar anatomy and / or other parameters, such as the patient's sex, age, and health status, will be particularly useful. Other parameters may be incorporated into the algorithm, such as the clinician's skill level and experience and / or the facilities available at the hospital. This data can be used in machine learning algorithms that utilize data from past implantation procedures or data from patient characteristics.

[0140] The memory 534 may include various forms of memory, including hard disks, solid-state storage, various forms of RAM or ROM, or other forms of memory. In one embodiment, the memory 534 may be configured to be removable from the controller 530 for storage and / or data analysis. The individual memory 534 may be installed into or swapped out of the controller 530 as needed for specific operations.

[0141] Processor 536 may be configured to execute programs disclosed herein and may be configured to provide signals to components of system 10, such as motor 500, to execute desired programs. Processor 536 may be configured to operate motor 500, or at least one motor 500, to actuate at least a portion of the delivery device. Processor 536 may be configured to operate at least one motor 500 to move a portion of the delivery device (e.g., deflect or control the depth of the elongated shaft 12), or to perform operations of the delivery device, which may include deploying implant 70 from the delivery device. Processor 536 may be configured to execute programs stored in memory 534. Processor 536 may be configured to receive signals from components of system 10, such as controls of system 10 (e.g., control unit 504) or sensors. Processor 536 may be configured to process and perform operations based on these signals. Processor 536 may include a microprocessor or other forms of processor as needed. In one embodiment, processor 536 may include multiple processors and may be distributed in a cloud computing environment or similar environment in one embodiment.

[0142] Power source 538 may be configured to provide power to components of controller 530 and may also be configured to provide power to motor 500 or other components of system 10. According to some embodiments, power source 538 may include one or more batteries that are rechargeable and removable from other components of controller 530 or system 10 as needed. In one embodiment, power source 538 may include a power plug, such as an AC plug, and may include a power regulator for converting AC power into electricity usable by system 10. Other forms of power source 538 (e.g., supercapacitors, solar cells, etc.) may be used in other embodiments as needed.

[0143] The components of controller 530 can be as follows Figure 10 The components are positioned together or can be distributed as needed. The components of controller 530 can be located in a separate housing or control box and can be connected to delivery equipment via cables, etc. Figure 10 An example illustrates a cable connection between the controller 530 and the delivery device. In other embodiments, wireless communication between one or more components of the controller 530 and the delivery device is possible. In other embodiments, components of the controller 530 may be located within the housing of the delivery device, for example, in... Figure 41 In the configuration shown.

[0144] A power and signal connector 540 may extend between the controller 530 and the delivery device. For example, a signal connector 540 is shown extending along a portion of the handle 14 and may be coupled at an electrical connector 542 between the distal portion 508 and the proximal portion 510 of the handle 14. The power connector 540 may extend from the power supply 538 of the controller 530 to the motor 500.

[0145] Figure 13 A perspective view of the distal portion 508 of the handle 14 is shown. The distal portion 508 of the handle 14 can be configured to interact with the proximal portion 510. Figure 14 (As shown in the diagram). This configuration allows a specific portion of the delivery device's handle 14 to be used for implant delivery and then separated from another portion of the handle 14 (e.g., the proximal portion 510), enabling the distal portion 508 to be sterilized or discarded. This process separates the electrical components of the system 10—which may include a motor 500 located within the proximal portion 510, or may include a controller 530—from the portion that is inserted into or contacts the patient's body. This enhances the reusability of the system 10 and reduces the overall complexity associated with sterilizing the system 10. Figure 13 As shown, the proximal portions of the drive rods 518a-g extend proximally from the distal portion 508 of the handle 14 for engagement with corresponding holes 544a-g in the proximal portion 510 of the handle 14. The proximal portions of the drive rods 518a-g are engaged with the corresponding holes 544a-g to allow the motor 500 to engage the drive rods 518a-g. Electrical connectors 542 and 512 are also shown protruding from the distal portion 508 of the handle 14.

[0146] Figure 14 A perspective view of the proximal portion 510 of the handle 14 is shown. The proximal portion 510 may include a cable 546 or other connector for connecting the proximal portion 510 to the controller 530, the cable 546 or other connector being housed in a control box or the like.

[0147] Refer again Figure 13 A control device 504 is displayed on the distal portion 508 of the handle 14 and includes multiple buttons. The control device 504 can be configured to receive input from a user to operate the motor 500 and thus actuate portions of the delivery device. The control device 504 can be configured to send signals directly to the motor 500 or to the processor 536 of the controller 530 for processing. The control device 504 can be configured to control the deflection and movement of the delivery device. The control device 504 can be configured to control the operation of the delivery device, such as the deployment of the implant 70. The control device 504 can take various forms, and such as... Figure 13 The diagram may include sections designated for controlling certain movements or operations of the delivery device.

[0148] Figure 13 The control device 504 may include a button 548 that controls the rail assembly 20, and in particular the deflection direction of the rail assembly 20, which may be in multiple planes. The button 548 may be configured to control the direction of the rail assembly 20. A user can press a desired button 548 to actuate the motor to deflect the delivery device in the desired direction. Figure 13The control device 504 may include a button 550, which controls the depth of the elongated shaft 12, for example, by sliding an assembly including the outer sheath assembly 22, the central shaft assembly 21, the inner assembly 18, and the nose cone assembly 31 relative to the rail assembly 20. The button 550 allows the user to increase or decrease the depth. Figure 13 The control device 504 may include a button 552 for actuating the deployment of the implant 70. For example, the button 552 may cause a motor to actuate the delivery device to retract the outer sheath assembly 22 and the central shaft assembly 21 to deploy the implant 70. Figure 13 The control device 504 may include a button 554 that actuates movement of the nose cone assembly 31 to advance or retract the nose cone 28. Various control configurations can be used to deflect the delivery device or perform operations on the delivery device. Control signals from the control device 504 may be sent directly to the motor 500 for operation or may be sent to the processor 536 for the processor 536 to operate the motor 500 to actuate at least a portion of the delivery device. The configuration of the control device 504 may be varied in other embodiments.

[0149] Figure 15 For example, a cross-sectional portion of a part of the handle 14 is illustrated, wherein the control device 556 includes one or more of a touchpad 558 and a touchscreen 560 on the handle 14. The touchpad 558 may be configured to allow a user to provide directional control of the delivery device via the rail assembly 20. The touchscreen 560 may be configured to allow a user to provide other controls to the delivery device, including depth control, deployment of the implant 70, or movement of one or more components of the delivery device. The touchpad or touchscreen may include tactile, optical, or audio feedback to assist the user.

[0150] Figure 16 For example, a cross-sectional portion of a part of the handle 14 is illustrated, wherein the control device 562 includes a joystick 564 and one or more buttons 566. The joystick 564 may be configured to allow a user to provide directional control of the delivery device via the rail assembly 20. The one or more buttons 566 may be configured to allow a user to provide other controls to the delivery device, including depth control, deployment of the implant 70, or movement of one or more components of the delivery device.

[0151] By using a device such as a touchpad 558 or a joystick 564 to control the rail assembly 20, a user can move the rail assembly 20 simultaneously in combinations of directions. This is an improvement over existing methods that primarily use mechanical knobs or the like—where the user can only move the rail assembly 20 in a single plane at a time. When the rail assembly 20 is actuated by a motor 500, the rail assembly 20 can move in multiple planes simultaneously. Simultaneous control can be provided by providing corresponding signals from a control device to the motor 500. In one embodiment, simultaneous control can be provided to the motor 500 via a processor 536. For example, a user (e.g., a clinician) can provide input of a specific direction of movement via the joystick 564, which is sent to the processor 536. The processor 536 can process this input to control the motor 500 to move the elongated shaft 12 in that direction. The processor 536 can control the motor 500 to move in multiple directions; for example, the motor 500 can move the pull wires 138, 140 simultaneously or sequentially to produce movement in multiple directions. Processor 536 can be configured to operate motor 500 to deflect elongated shaft 12 in at least two planes and multiple other directions. Control devices for providing input to processor 536 or motor 500 may include buttons, joysticks, touchpads, touchscreens, knobs, or other forms of input such as motion sensors. Examples of motion sensors are shown... Figure 37 and 38 In this configuration, the control device 588 may be configured to sense the movement of the control device 588 (e.g., tilt or spatial displacement) to provide input to the processor 536 or the motor 500.

[0152] Refer again Figure 15 System 10 may include output devices of various forms. The output devices may be configured to provide a user with output indicating the status of the delivery device or the patient's condition. The output devices may be configured to provide indicators of the status of the delivery device or the patient's condition. For example, such as... Figure 15 As shown, the output device may include a lamp 568 that can be illuminated to indicate the status of the delivery device or the patient's status. The lamp 568 may illuminate to indicate that the delivery device has contacted or approached a surface of the patient's body (status of the delivery device), or it may illuminate to indicate a certain status of the patient's body, such as correct or incorrect pressure sensed within the patient's body. Other forms of output devices may be used, including tactile devices 570, such as vibration actuators, which can indicate the status of the delivery device or the patient's status. The output device may include... Figure 15 The touchscreen 560 shown has a display screen. Output devices may include, for example... Figure 37The display screen 584 is shown. The output device may include one or more of other forms of output devices such as a display screen, a lamp, a speaker, or a haptic device. Various forms of output devices may be used as needed. Indicators generated on the output device may include one or more of images, data, sound, light, or haptic signals. The output device may be configured to provide indicators based on the output provided by the processor 536.

[0153] Actuation of the delivery device may include deflection of portions of the delivery device and execution of operations of the delivery device. Actuation of the delivery device by at least one motor may include translation of the elongated shaft 12 and may include translation of the housing near the proximal end of the elongated shaft 12. Axial translation of the delivery device may be provided. Figure 17 For example, a side perspective view of a delivery device including an elongated shaft 572 and a housing 574 is illustrated. The delivery device is inserted into the patient's body 576 via the femur. The elongated shaft 572 may be configured similarly to the elongated shaft 12. The housing 574 may be configured similarly to the housing forming the handle 14; however, the housing 574 may not include a handle for the user to grip. However, the housing 574 may include a motor or be configured to run along a motor-driven rail 577.

[0154] Alternatively, it may actuate the axial movement of the delivery device into other components within the patient's body. The axial movement of the delivery device can be controlled by a control device positioned either close to or away from the housing 574. As discussed herein, the control device can be configured to perform other controls on the delivery device, including deflection of portions of the delivery device and execution of delivery device procedures. In this way, the user does not need to hold the housing 574 and can perform implant delivery procedures without contact with the delivery device or in the user's absence. As discussed herein, the processor 536 can provide control over the motor of the motor-driven rail 577 and any other motors for actuating the delivery device.

[0155] Motor 500 can be configured to selectively move one or more of the following: outer sheath assembly 22, central shaft assembly 21, inner assembly 18, rail assembly 20, assembly including distal pull wire 138, assembly including proximal pull wire 140, and nose cone assembly 31. (See also: Regarding...) Figure 10The motor 500 discussed can be configured to selectively move such components based on the configuration of the actuation mechanism 506. As an example of selective actuation of the motor 500, an example of depth control is provided. The depth of the elongated shaft 12 of the delivery device can be set by moving the outer sheath assembly 22, the central shaft assembly 21, the inner assembly 18, and the nose cone assembly 31 relative to the rail assembly 20. Such movement allows the outer sheath assembly 22, the central shaft assembly 21, the inner assembly 18, and the nose cone assembly 31 relative to the rail assembly 20, which can be deflected at an angle. The deflection of the rail assembly 20 allows the outer sheath assembly 22, the central shaft assembly 21, the inner assembly 18, and the nose cone assembly 31 to slide along the rail assembly 20 at this angle, and thus have depth in the direction toward the mitral or tricuspid annulus or similar annulus—including other annulus or body positions. Therefore, the relative movement of the outer sheath assembly 22, the central shaft assembly 21, the inner assembly 18, and the nose cone assembly 31 relative to the rail assembly 20 creates depth. For example... Figure 18 As shown, motor 500 can be configured to actuate such a depth by simultaneously actuating drive rods 518c, 518d, and 518e to move couplings 516c, 516d, and 516e. Couplings 516c, 516d, and 516e can move proximally, causing the rail assembly 20 and the drawstrings 138, 140 to also move proximally relative to the outer sheath assembly 22, the central shaft assembly 21, the inner assembly 18, and the nose cone assembly 31, resulting in a depth in the elongated shaft 12. Motor 500 can therefore be configured to simultaneously actuate the various portions of the elongated shaft 12 to produce the desired result. Motor 500 can cause the assembly including the drawstrings 138, 140 to move together with the rail assembly 20 to maintain tension in the drawstrings 138, 140. Although the operation of producing depth is shown, motor 500 can be configured to produce other combinations of movement. For example, as previously described, deflection of the rail assembly 20 in multiple planes can be provided. The motor 500 can be configured to simultaneously or sequentially actuate both the distal pull wire 138 and the proximal pull wire 140 to produce the desired movement of the rail assembly 20.

[0156] Motor 500 can therefore be configured to move one of the components (outer sheath assembly 22, central shaft assembly 21, inner assembly 18, rail assembly 20, assembly including distal traction wire 138, assembly including proximal traction wire 140, and nose cone assembly 31), each extending along its elongated axis relative to the other of the components. Components can be moved relative to another component positioned within a cavity of the component (e.g., rail assembly 20 can be positioned within a cavity of outer sheath assembly 22). Various components can be moved simultaneously (e.g., rail assembly 20 can move simultaneously with the assembly including distal traction wire 138, and the assembly including distal traction wire 138 can move simultaneously with the assembly including proximal traction wire 140). Processor 536 can be configured to control motor 500 to provide the movement disclosed herein.

[0157] In one embodiment, the motor 500 may be configured to compensate for movement of one portion of the elongated shaft 12 based on movement of another portion of the elongated shaft 12. For example, as one portion of the elongated shaft 12 is moved, the position of another portion of the elongated shaft 12 may also be undesirably moved. The motor 500 may be configured to compensate for the undesirable movement. Figure 19 For example, a side cross-sectional view of a portion of the rail assembly 20 is shown. The distal pull wire 138 has been pulled towards the proximal side, causing the distal portion of the rail assembly 20 to move along... Figure 19 The direction of deflection is shown. After the proximal pull wire 140 is subsequently pulled to deflect the proximal portion of the rail assembly 20, the distal pull wire 138 can be pulled as a result of the deflection of the proximal portion of the rail assembly 20. Figure 20 For example, it shows the relationship with Figure 19 The image shows a side cross-sectional view of the rail assembly 20 viewed at a 90-degree angle (rotated about the axial dimension of the rail assembly 20). The deflected distal portion of the rail assembly 20 faces... Figure 20 On the page. After pulling the proximal traction wire 140 to deflect the proximal portion of the rail device 20, the distal portion of the rail device 20 is thus deflected, as... Figure 20 As shown by the dashed lines in the diagram. In existing methods of controlling the rail assembly 20 using mechanical knobs or the like, shortening of the distal end of the rail assembly 20 is corrected by operating multiple mechanical knobs to move the distal pull wire 138. However, in this document, the motor 500 can be configured to automatically compensate for movement of one or more of the pull wires 138, 140 to reduce shortening of the distal portion of the rail assembly 20. In embodiments, the motor 500 can be configured to compensate for shortening or elongation of any portion of the elongated shaft 12, including portions of the outer sheath assembly 22, the central shaft assembly 21, the inner assembly 18, and the nose cone assembly 31. For example, the motor 500 can be configured to translate portions of the elongated shaft 12 other than the rail assembly 20 to compensate for deflection of the rail assembly 20.

[0158] Motor 500 can be configured to perform actions based on input from a control device (e.g., control device 504) or based on electrical transmission from motor 500, or a combination of both. Figure 18-20 The operation discussed. For example, if control device 504 requests simultaneous movement of two components of the elongated shaft 12, a signal can be provided to motor 500 to operate the corresponding drive rods of those components. If control device 504 requests movement of a portion of the elongated shaft 12 requiring compensation, motor 500 can be electrically powered to automatically perform such compensation. For example, motor 500 can be electrically powered to compensate for the movement of certain components based on the movement of other components.

[0159] In some embodiments, processor 536 can be used to automatically move components or other parts of the elongated shaft 12 to perform actions related to... Figure 18-20 The operation discussed above. For example, if a request is made to increase the depth of the elongated shaft 12 or to deploy the implant 70, the processor 536 may be configured to operate a program (which may be stored in memory 534) to control the motor 500 to move the corresponding component or other part of the elongated shaft 12. If a request for compensation is made, the processor 536 may be configured to operate a program (which may be stored in memory 534) to control the motor 500 to move the corresponding component or other part of the elongated shaft 12 to automatically perform such compensation. The processor 536 may be configured to operate the motor to move one of the components to compensate for the movement of another component. Specific movements and combinations of movements of components or other parts of the elongated shaft 12 may be programmed into memory 534 and operated by the processor 536. As discussed above, the programmed movements may be based on data “learned” from previous procedures, such as from previous procedures performed on patients with similar anatomy and / or other characteristics. Movements may be based on machine learning algorithms that utilize data from past implantation procedures or data from the patient’s characteristics. Therefore, procedural steps successfully performed on patients with similar anatomical structures can be repeated, thereby increasing the likelihood of successfully performing the procedure on the current patient. The processor 536 can be configured to automatically operate the motor 500 to actuate portions of the delivery device in a desired manner.

[0160] System 10 may include sensors configured to sense the condition of the delivery device and may also include sensors configured to sense the condition of the patient.

[0161] In some embodiments, sensors may be used to sense the condition of the delivery device. The sensors may include position sensors that can be used to determine the movement and / or position of one or more components. For example, a position sensor may be configured to sense the amount by which a motor 500 moves a component to track the position and movement of the component. The motor 500 may be electrically powered to track the movement of various components and perform a desired movement (e.g., simultaneous movement of components, or compensating movement of one or more components) based on signals from the position sensor. In one embodiment, signals from the position sensor may be provided to a processor 536 for the processor 536 to perform the desired movement. The signals from the position sensor may be feedback signals to the processor 536. For example, the position sensor may sense movement of a portion of the elongated shaft 12 in response to movement of another portion of the elongated shaft 12, and the processor 536 may operate the motor 500 based on this signal to produce compensating movement. As discussed herein, an indicator indicating the position of the delivery device may be provided on an output device. The indicator may be provided based on the position sensed by the position sensor.

[0162] A sensor can be used to sense the condition of the delivery device in the form of a motor torque sensor. The sensor can be used to determine the amount of torque applied by the motor 500. The motor torque sensor can be, for example, a current draw sensor capable of sensing the amount of current consumed by the motor 500. If the torque exceeds a certain amount, the motor 500 can be configured to automatically shut down or reverse its operation or reduce the torque. In one embodiment, a signal from the motor torque sensor can be provided to a processor 536 so that the processor 536 can perform the desired movement. The signal from the motor torque sensor can be a feedback signal to the processor 536. For example, the processor 536 can operate the motor 500 based on this signal to automatically shut down or reverse its operation or reduce the torque. As discussed herein, an indicator indicating the torque of the motor of the delivery device can be provided on the output device. The indicator can be provided based on the torque sensed by the motor torque sensor.

[0163] refer to Figure 21 Sensors configured to sense the patient's condition can be utilized. These sensors can be positioned on the delivery device as needed. The sensors configured to sense the patient's condition may include an ambient pressure sensor 578. This pressure sensor 578 can be configured to sense pressure within the patient's body, such as fluid pressure. The pressure sensor 578 can be used during and after the delivery of the implant 70 to determine whether the deployed implant 70 functions as expected after implantation, or to monitor the patient's condition generally before and after implantation. Figure 21In the illustrated embodiment, pressure sensor 578 may be positioned on the nasal cone 28 and pressure sensors may be positioned at other locations such as the capsule body 106. With this particular configuration of pressure sensor 578, one pressure sensor may be positioned in the left ventricle during implantation of the implant 70, and another pressure sensor may be positioned in the left atrium during implantation. Therefore, the pressure gradient across the mitral valve can be determined after implantation. The signal from pressure sensor 578 may be provided to an output device (such as output device 568, 570, or other output devices) for instruction to the user. In one embodiment, the pressure sensed by pressure sensor 578 may be used as feedback to system 10 (such as processor 536) to actuate a delivery device. For example, if an incorrect pressure is read, processor 536 may actuate the delivery device to redeploy the implant or perform another operation. In other embodiments, other locations and other pressure readings of pressure sensor 578 may be provided.

[0164] In one embodiment, a sensor configured to sense the condition of the delivery device may include a sensor configured to sense the spatial relationship between the delivery device and the patient's body surface. Such a sensor may be positioned on the delivery device. This sensor may include a contact sensor 580. The contact sensor 580 may include a force transducer or force gauge, or other forms of contact sensor 580 configured to sense forces applied to the delivery device. As shown, the contact sensor 580 may be positioned at multiple locations on the elongated shaft 12, including at the nasal cone 28 or other locations (e.g., typically on the outer surface of the elongated shaft 12). The contact sensor 580 may be configured to provide a signal when the elongated shaft 12 contacts a portion of the patient's body. This signal may indicate the likelihood of damage to the patient's body caused by the elongated shaft 12. The signal from the contact sensor 580 may be provided to an output device (e.g., output devices 568, 570, or other output devices) for instructing the user. In one embodiment, the contact sensed by the contact sensor 580 may be used as feedback to the system 10 (e.g., processor 536) to actuate the delivery device. For example, if contact with a surface is sensed, the processor 536 can actuate the delivery device to move away from the surface or stop the operation of the motor 500. In other embodiments, other locations may be provided for the contact sensor 580 and other contact sensors.

[0165] In one embodiment, a sensor configured to sense the condition of the delivery device may include a proximity sensor 582. The proximity sensor 582 may be configured to sense the spatial relationship between the delivery device and the patient's body surface. This sensor may be positioned on the delivery device. The proximity sensor 582 may include means for sensing the distance to a part of the patient's body, including using ultrasound, echo signals, or visual recognition. As shown, the proximity sensor 582 may be positioned at multiple locations on the elongated shaft 12, including on the nasal cone 28 or other locations (such as typically on the outer surface of the elongated shaft 12). The proximity sensor 582 may be configured to provide a signal when the elongated shaft 12 approaches a part of the patient's body and may provide such a signal to an output device (such as output devices 568, 570, or other output devices) for instructing a user. In one embodiment, proximity sensed by the proximity sensor 582 may be used as feedback to the system 10 (such as processor 536) to actuate the delivery device. For example, if proximity to a surface (e.g., the inner wall of a blood vessel) is sensed, the processor 536 may actuate the delivery device to move away from that surface or stop the operation of the motor 500. Thus, the delivery system can be advanced through the patient's vascular system without damaging the inner walls of the blood vessels. This "smart catheter" technology offers a significant improvement over current "blind catheters." For example, this technology can reduce or eliminate the possibility of vascular incision, a significant and life-threatening risk of current delivery systems. Although these embodiments have been described for illustrative purposes, it should be understood that other locations and other proximity readings of the proximity sensor 582 may be provided.

[0166] Figure 22-24 An embodiment of a sensor configured to sense a patient's condition is illustrated. The sensor includes a flow sensor capable of sensing fluid flow (e.g., blood flow) within the patient's body. Multiple sensors 583a-l (such as...) Figure 23 (The marked area) can be positioned on the delivery device to form an array of spaced sensors 583a-l. Sensors 583a-l can be configured to sense local fluid flow, such that sensors 583a-l can sense fluid flow in a local area of ​​the body that is different from the fluid flow sensed by other sensors 583a-l. Figure 22 An example is shown in the perspective view of the distal end of the slender shaft 12, in which sensors 583a-c are visible on the capsule body 106. Figure 23 A cross-sectional view of the capsule body 106 is shown, illustrating an array of spaced sensors 583a-l. Sensors 583a-l can be positioned on a delivery device to sense fluid flow at a location near the deployment site of the implant 70. Such a location may include the capsule body 106 or another part of the delivery device.

[0167] Figure 24Exemplary operation of sensor 583a-l is illustrated. Implant 70 may be deployed in a natural mitral or tricuspid valve, where one distal anchor 80a captures leaflet 1108 while another distal anchor 80b fails to capture leaflet 1108. Sensors 583k, 583l can sense blood flow through the mis-captured leaflet 1108 and can provide a signal accordingly. Sensors 583a-l may be configured to sense differential flow between sensors 583f, 583g near the captured leaflet 1108 and sensors 583k, 5831 near the mis-captured leaflet 1108. Flow sensor 583a-l may be configured to provide a signal upon sensing flow and may provide such a signal to an output device (such as output devices 568, 570, or other output devices) for indication to a user. In one embodiment, the flow sensed by the flow sensor 583a-1 can be used as feedback to system 10 (such as processor 536) to actuate the delivery device. For example, if the flow is sensed to indicate miscapture of the leaflet, processor 536 can actuate the delivery device to redeploy the implant 70 or perform another operation. In other embodiments, additional locations and additional flow readings of the flow sensor 583a-1 may be provided.

[0168] Sensors configured to sense the condition of the delivery device and sensors configured to sense the condition of the patient may be connected to the delivery device. However, in some embodiments, the sensors configured to sense the condition of the delivery device and sensors configured to sense the condition of the patient may not be connected to the delivery device and may be located outside the patient's body.

[0169] Signals from sensors configured to sense the condition of the delivery device and sensors configured to sense the condition of the patient can be utilized in various ways. In one embodiment, the signals can be provided as indicators on output devices (such as output devices 568, 570, or other output devices) to indicate to the user. For example, the condition of the delivery device can be indicated to the user in various forms, such as output devices including one or more other forms of output devices such as displays, lights, speakers, or haptic devices. Indicators generated on output devices can include one or more of images, data, sound, light, or haptic signals. The user can act accordingly based on the indicators. For example, if the indicator indicates that the delivery device has contacted a part of the patient's body, the user can act accordingly to move the delivery device away from the body. The condition of the patient's body can similarly be indicated to the user in various forms.

[0170] In this implementation, signals from sensors configured to sense the condition of the delivery device and sensors configured to sense the condition of the patient can be provided to processor 536. Processor 536 can provide various outputs based on one or more of the patient's physical condition or the condition of the delivery device sensed by one or more sensors. One such output includes a log of data from the implantation procedure using the delivery device. This log of data can be stored in memory 534. The data can be stored for later retrieval and analysis by the user, or it can be a log recording the actions taken by the delivery device. For example, position sensor signals can be recorded to document other forms of sensor signals, such as movement of the delivery device.

[0171] Processor 536 may provide output to an output device based on the condition of the patient's body or the delivery device sensed by one or more sensors. The output may generate an indicator on the output device (such as output device 568, 570, or other output devices) to instruct the user. For example, the condition of the delivery device may be indicated to the user in various forms; the output device may include one or more of other forms of output devices such as a display screen, a light, a speaker, or a haptic device. Processor 536 may process signals to generate the desired indicator for the user. For example, sensors 583a-1 may sense blood flow during the deployment of implant 70, and processor 536 may process these signals to provide the user with an indicator that a small lobule capture has occurred.

[0172] Processor 536 may provide outputs including control of motor 500 based on the patient's physical condition or the condition of the delivery device sensed by one or more sensors. Processor 536 may be configured to operate motor 500 to actuate the delivery device based on signals from the sensors. Signals from the sensors may include feedback signals input to processor 536 for the processor to control the operation of motor 500. For example, signals from contact sensor 580 or proximity sensor 582 may be provided to processor 536 as feedback that the delivery device has contacted or approached the patient's body surface. Processor 536 may thus provide outputs to operate motor 500 to avoid or retract from the patient's body surface. Signals from flow sensors 583a-l may cause processor 536 to provide outputs to motor 500 to redeploy implant 70 or move portions of the delivery device to recapture leaflet 1108. Signals from position sensors may provide processor 536 with feedback on whether the delivery device is performing correct movement, and, if necessary, processor 536 may operate motor 500 to perform correct movement (e.g., deflecting elongated shaft 12 if necessary). The processor 536 can be programmed to automatically respond to and generate output based on the condition of the patient's body or the condition of the delivery device sensed by one or more sensors. The programming of the processor 536 can be stored in memory 534 and operated by the processor 536.

[0173] The method of delivering implant 70 using system 10 is shown in Figure 25-30 The method can utilize any system or device disclosed herein. Delivery system 10 can be used for percutaneous delivery of a replacement mitral valve to treat patients with moderate to severe mitral regurgitation. However, it should be understood that the delivery system described herein can also be used as part of other methods, such as for valve repair implants and delivery of implants to other heart valves, as well as delivery of other implants.

[0174] like Figure 25 As shown, in one embodiment, the method may include extending a delivery device within a portion of the patient's body to deliver the implant to a body location. The delivery system 10 may be placed in the ipsilateral femoral vein 1074 and advanced toward the right atrium 1076. A transseptal puncture using known techniques may then be performed to access the left atrium 1078. The delivery system 10 may then be advanced into the left atrium 1078, and subsequently into the left ventricle 1080, passing through the aortic septum. Figure 25 A delivery system 10 extending from the ipsilateral femoral vein 1074 to the left atrium 1078 is shown. In embodiments of this disclosure, a guidewire is not required to position the delivery system 10, but in other embodiments, one or more guidewires may be used.

[0175] Therefore, it is advantageous for the user to be able to steer the delivery system 10 through complex areas of the heart to position the replacement mitral valve in line with the native mitral valve. This task can be performed with or without a guidewire using the system disclosed above. The distal end of the delivery system can be advanced into the left atrium 1078. The operable motor 500 then actuates the rail assembly 20 to target the distal end of the delivery system 10 to the appropriate area. As discussed herein, the motor 500 can be operated by the processor 536. The user can then proceed to maneuver the curved delivery system 10 through a transseptal puncture and into the left atrium 1078. The motor 500 can then be operated to create a greater curvature in the rail assembly 20. In a fully curved configuration, the user can then place the replacement mitral valve in the appropriate position.

[0176] The track assembly 20 is particularly advantageous for accessing the natural mitral valve. As discussed above, the track assembly 20 can form two bends, both of which can be located in the left atrium 1078. The bends in the track assembly 20 can position the implant 70 in the implant holding area 16 so that the implant 70 is coaxial with the natural mitral valve. Once the implant 70 is coaxial, the outer sheath assembly 22, the central axis assembly 21, the inner assembly 18, and the nasal cone assembly 31 can be advanced distally relative to the track assembly 20 (e.g., using the motor 500). These assemblies continuously advance the track assembly 20 in a straight line, thereby advancing them to coaxiality with the natural mitral valve until the implant 70 is to be released, while maintaining the implant 70 in a compressed configuration, as discussed below. Thus, the track assembly 20 provides the user with the ability to lock the angular position in place, allowing the user to subsequently advance other assemblies longitudinally on the track assembly 20 without making any angle changes, thereby greatly simplifying the procedure. The rail assembly 20 acts as a standalone steering component, where all components simply provide steering without further implant release functionality. Furthermore, the rail assembly 20, as described above, is constructed rigidly enough that when the rail assembly is actuated to its curved shape, the movement of other components (e.g., the outer sheath assembly 22, the central axis assembly 21, the inner assembly 18, and / or the nasal cone assembly 31, and the rail assembly 20) maintains their shape. Therefore, the rail assembly 20 can remain in the desired curved position while the other components slide relative to it, and the rail assembly 20 can help guide the other components to their final position. Proximal / distal translation of the other components on the rail assembly 20 allows for ventricular / atrial movement. Additionally, once the distal anchor 80 of the implant 70 has been released in the left ventricle 1080, but before full release, the other components can retract proximally on the rail assembly 20 to capture any lobules or chordae tendineae.

[0177] Now for reference Figure 26This illustration shows a partial schematic of an implementation of a replacement heart valve (implant 70) positioned within the natural mitral valve of the heart 83. A portion of the natural mitral valve, representing typical anatomy, is schematically shown, including a left atrium 1078 located above the valve annulus 1106 and a left ventricle 1080 located below the valve annulus 1106. The left atrium 1078 and the left ventricle 1080 communicate with each other via the mitral valve annulus 1106. Figure 26 The diagram also schematically shows a natural mitral valve leaflet 1108 with chordae tendineae 1110, which connects the downstream end of the mitral valve leaflet 1108 to the papillary muscle of the left ventricle 1080. The portion of the implant 70 positioned upstream of the valve annulus 1106 (towards the left atrium 1078) may be referred to as being above the annulus. The portion generally within the valve annulus 1106 is referred to as being inside the annulus. The portion downstream of the valve annulus 1106 is referred to as being below the annulus (towards the left ventricle 1080).

[0178] like Figure 26 As shown, the replacement heart valve (e.g., implant 70) can be positioned such that the mitral valve annulus 1106 is located between the distal anchor 80 and the proximal anchor 82. In some cases, implant 70 may, for example... Figure 26 The positioning shown in the diagram causes the end or tip of the distal anchor 80 to contact the valve annulus 1106. In some cases, the implant 70 may be positioned such that the end or tip of the distal anchor 80 does not contact the valve annulus 1106. In some cases, the implant 70 may be positioned such that the distal anchor 80 does not extend around the leaflet 1108.

[0179] like Figure 26 As shown, the replacement heart valve 70 can be positioned such that the distal end or tip of the distal anchor 80 is on the ventricular side of the mitral valve annulus 1106, while the distal 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 such that its distal end or tip extends beyond the free end of the chordae tendineae 1110 connected to the natural leaflet and is on the ventricular side of the natural leaflet. The distal anchor 80 can extend between at least some of the chordae tendineae 1110, and in some cases (such as...) Figure 26 In the cases shown, the distal anchor 80 may contact or engage the ventricular side of the valve annulus 1106. It is also considered that in some cases, while the distal anchor 80 may still contact the natural leaflet 1108, the distal anchor 80 may not contact the valve annulus 1106. In some cases, the distal anchor 80 may contact the tissue of the left ventricle 104 beyond the ventricular side of the valve annulus 1106 and / or leaflet.

[0180] During delivery, the distal anchor 80 (together with the frame) may be moved toward the ventricular side of the valve annulus 1106, for example, by translating other components (e.g., the outer sheath assembly 22, the central axis assembly 21, the inner assembly 18, and the nasal cone assembly 31) proximally relative to the rail assembly 20, wherein the distal anchor 80 extends between at least some of the chordae tendineae 1110 to provide tension on the chordae tendineae 1110. The degree of tension provided on the chordae tendineae 1110 may vary. For example, when the leaflet 1108 is shorter than or approximately the size of the distal anchor 80, there may be little or no tension in the chordae tendineae 1110. When the leaflet 1108 is longer than the distal anchor 80, there may be a greater degree of tension in the chordae tendineae 1110, thereby forming a compact shape and pulling proximally. When the leaflet 1108 is even longer than the distal anchor 80, there may be an even greater degree of tension in the chordae tendineae 1110. Leaflet 1108 can be long enough so that the distal anchor 80 does not contact the annulus 1106.

[0181] Proximal anchors 82 (if present) may be positioned such that the end or tip of the proximal anchor 82 extends beyond the valve annulus 1106 and is adjacent to the atrial side and / or left atrium 1078 of the valve annulus 1106. In some cases, some or all of the proximal anchors 82 may extend beyond the valve annulus 1106 and only occasionally contact or engage the atrial side and / or left atrium 1078 of the valve annulus 1106. For example, as Figure 26 As exemplified, the proximal anchor 82 may extend beyond the valve annulus 1106 to contact the tissue of the atrial side and / or left atrium 1078 of the valve annulus 1106. The proximal anchor 82 may provide axial stability for the implant 70. It is also conceivable that some or all of the proximal anchors 82 may extend beyond the valve annulus 1106 to contact the tissue of the atrial side and / or left atrium 1078 of the valve annulus 1106. Figure 27 An example of an implant 70 in the heart is shown. Although the example replacement heart valve includes both proximal and distal anchors, it should be understood that both are not necessary in all cases. For example, a replacement heart valve with only a distal anchor can securely hold the replacement heart valve within the valve annulus. This is because during cardiac systole, the greatest force on the replacement heart valve points towards the left atrium. Therefore, the distal anchor is crucial for anchoring the replacement heart valve within the valve annulus and preventing migration.

[0182] Figures 28-30 An example of the release mechanism of the delivery system 10 is illustrated. During the initial insertion of the implant 70 and the delivery system 10 into the body, the implant 70 may be located within the system 10, similar to... Figure 2A As shown in the diagram, the distal end 303 of the implant 70, and specifically the distal anchor 80, is restrained within the capsule body 106 of the outer sheath assembly 22, thereby preventing expansion of the implant 70. Similar to... Figure 2AAs shown, when positioned within the capsule body, the distal anchor 80 can extend distally. The proximal end 301 of the implant 70 is constrained within the capsule body 106 and within a portion of the inner retainer 40, and is therefore generally constrained between the capsule body 106 and the inner retainer 40.

[0183] By using the steering mechanism or other techniques discussed herein, the system 10 can first be positioned at a specific location within the patient's body, such as at the natural mitral valve.

[0184] Once the implant 70 is loaded into the delivery system 10, the user can insert a guidewire into the patient's body to the desired location. The guidewire passes through the cavity of the nasal cone assembly 31, so the delivery system 10 is generally advanced through the patient's body following the guidewire. The delivery system 10 can be advanced by the user manually moving the handle 14 in the axial direction. In some embodiments, the delivery system 10 can be placed on a stand while the handle 14 is being operated. In one embodiment, the delivery system can be used as... Figure 17 The motor shown propels the motor axially.

[0185] Once roughly inside the heart, the user can use motor 500 to begin steering the track assembly 20. Motor 500 can provide flexion / bending (distal or proximal) of the track assembly 20, thereby bending the distal end of the delivery system 10 into a desired configuration at one, two, or more locations. As discussed above, the user can provide multiple bends in the track assembly 20 to guide the mitral valve delivery system 10. Specifically, the bends in the track assembly 20 can guide the distal end of the delivery system 10 along a central axis passing through the natural mitral valve, and thus guide the capsule body 106. Therefore, when the implant 70 is compressed, and the outer sheath assembly 22, central axis assembly 21, inner assembly 18, and nasal cone assembly 31 are advanced together on the track assembly 20, the capsule body 106 travels directly to alignment with the axis to properly release the implant 70.

[0186] In the next step, the user can adjust the depth of the slender shaft 12. A motor 500 can be used for this operation. As discussed, adjusting the depth allows the inner shaft assembly 18, the central shaft assembly 21, the outer sheath assembly 22, and the nasal cone assembly 31 to advance together on / through the rail assembly 20, while the implant 70 remains in a compressed configuration within the implant holding area 16. Due to the rigidity of, for example, the inner shaft assembly 18, the central shaft assembly 21, and / or the outer sheath assembly 22, these assemblies travel straight forward in a direction aligned with the rail assembly 20.

[0187] Once in the release position, the motor 500 can be operated to individually translate the outer sheath assembly 22 relative to other components (such as the inner assembly 18) toward the handle 14 in a proximal direction (and thus translate the capsule body 106), as... Figure 28 As shown in the diagram. By doing so, the distal end 303 of the implant 70 is exposed in the body, thereby allowing the initiation of dilation. At this point, the distal anchor 80 can be flipped proximally, and the distal end 303 begins to dilate radially outward. For example, if the system 10 has been delivered to the natural mitral valve location via a transseptal path, the nasal cone is positioned in the left ventricle, preferably with the implant 70 aligned such that the implant 70 is generally perpendicular to the plane of the mitral valve annulus. The distal anchor 80 dilates radially outward within the left ventricle. The distal anchor 80 may be located above the papillary head, but below the mitral valve annulus and mitral leaflets. In some embodiments, the distal anchor 80 may contact the chordae tendineae in the left ventricle and / or extend between the chordae tendineae, and contact the leaflets as the distal anchor 80 dilates radially. In some embodiments, the distal anchor 80 may not contact the chordae tendineae and / or not extend between the chordae tendineae or contact the leaflets. Depending on the location of the implant 70, the distal end of the distal anchor 80 may be located at or below the free edge where the chordae tendineae connect to the natural leaflet.

[0188] As shown in the example embodiment, the distal end 303 of the implant 70 expands outward. It should be noted that during this step, the proximal end 301 of the implant 70 may still be covered by the outer retaining ring, such that the proximal end 301 remains in a radially compressed state. At this point, the system 10 may be retracted proximally, allowing the distal anchor 80 to capture and engage the mitral valve leaflet, or it may be moved proximally to reposition the implant 70. For example, the assembly may be moved proximally relative to the rail assembly 20. In some embodiments, after retraction of the outer sheath assembly 22, the distal anchor 80 may capture the natural leaflet and may be positioned between the chordae tendineae without causing any further movement of the system 10.

[0189] During this step, system 10 can be moved proximally or distally to properly capture the natural mitral valve leaflet with the distal or ventricular anchor 80. This can be accomplished by moving the outer sheath assembly 22, central axis assembly 21, inner assembly 18, and nasal cone assembly 31 relative to the rail assembly 20 via motor 500. In particular, the tip of the ventricular anchor 80 can be moved proximally to engage the ventricular side of the natural valve annulus, such that the natural leaflet is positioned between the anchor 80 and the body of the implant 70. When the implant 70 is in its final position, although the distal anchor 80 may be located among at least some of the chordae tendineae, tension may or may not be present on the chordae tendineae.

[0190] After the capsule body 106 retracts, the proximal end 301 of the implant 70 will remain within the outer retaining ring 42. For example... Figure 29As shown, once the distal end 303 of the implant 70 is fully dilated (or as fully dilated as possible at this point), the outer retaining ring 42 can be withdrawn proximally alone relative to the other components (particularly relative to the inner component 18) to expose the inner retaining member 40, thereby initiating dilation 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 can dilate in the left atrium after the distal or ventricular anchor 80 has been positioned between at least some of the chordae tendineae and / or engaged with the natural mitral valve annulus.

[0191] The outer retaining ring 42 can move proximally, allowing the proximal end 310 of the implant 70 to expand radially to its fully expanded configuration, such as... Figure 30 As shown in the diagram. After the implant 70 expands and expands, the inner component 18, nasal cone assembly 31, central axis assembly 21, and outer sheath assembly 22 can be simultaneously retracted proximally to their original positions along or relative to the track assembly 20 via motor 500. In some embodiments, they are not retracted relative to the track assembly 20 but remain in the expanded position. Further, the nasal cone 28 can be retracted through the center of the expanded implant 70 and into the outer sheath assembly 22 via motor 500. The system 10 can then be removed from the patient.

[0192] The methods disclosed herein can be used with the systems and apparatus disclosed herein. For example, motor 500 can deflect a portion of the delivery device or deploy an implant into a body location. Operation of motor 500 can be performed by processor 536. A user can provide input to processor 536 using control device 504.

[0193] Furthermore, in some embodiments, the sensors discussed herein may be utilized. The delivery device may include one or more sensors coupled to and configured to sense one or more of the condition of the patient's body or the condition of the delivery device. Processor 536 may be configured to provide output based on one or more of the condition of the patient's body or the condition of the delivery device sensed by the one or more sensors. For example, the processor may, based on the condition of the delivery device, cause the delivery device to at least partially avoid or retract from the surface of the patient's body.

[0194] In one embodiment, the delivery system 10 can be used in a percutaneous delivery method for tricuspid valve replacement, which can be used to treat patients with moderate to severe tricuspid regurgitation. This method can utilize any of the systems or devices disclosed herein. Reference Figure 31 For example, the delivery device can extend within a portion of the patient's body to deliver the implant to a body location. The portion of the patient's body could be the right atrium 1076, and the body location for implant delivery could be a natural tricuspid valve 1082. The delivery device can be related to... Figure 25The similar approach discussed extends within a part of the patient's body. For example, the delivery device may be placed in the ipsilateral femoral vein 1074 (in... Figure 25 (In the middle of the marked area), and advance towards the right atrium 1076. Other entry methods may be used as needed.

[0195] The delivery device can be extended into the right atrium 1076 within the inferior vena cava 1084. (See also: [link to information]) Figure 25 The mitral valve delivery illustrated herein may use one or more guidewires, or not, as needed. One or more motors—which may be operated by a processor 536 as discussed herein—may be used to extend the delivery device into the right atrium 1076.

[0196] A steerable delivery device traverses complex regions of the heart to position the replacement tricuspid valve in alignment with the native tricuspid valve. An operable motor 500 actuates the rail assembly 20 to target the distal end of the delivery device to the appropriate region. For example, the motor 500 can be used to steer the rail assembly 20 to a desired orientation relative to the tricuspid valve 1082. The motor 500 can be operated by a processor 536 as discussed herein. The rail assembly 20 may form one or more bends such that the distal end of the delivery device is oriented coaxially with the native tricuspid valve 1082.

[0197] Figure 32 For example, the delivery device is shown deflected within the right atrium 1076 toward the native tricuspid valve 1082. One or more bends may be formed within the right atrium 1076 and / or the inferior vena cava 1084. Once the implant 70 is positioned coaxially with the native tricuspid valve 1082, the outer sheath assembly 22, the central axis assembly 21, the inner assembly 18, and the nasal cone assembly 31 can be advanced distally toward the right ventricle 1086 relative to the track assembly 20 (e.g., using a motor 500). The depth of the elongated shaft 12 can be varied by operation of the motor 500 disclosed herein, which can be operated by a processor 536. Proximal / distal translation of the other components on the track assembly 20 allows movement of the ventricle and atrium.

[0198] The depth of the elongated axis 12 can be varied until the capsule body 106 is positioned relative to the natural tricuspid valve 1082 in the desired location. The distal end 303 of the implant 70, specifically the distal anchor 80, can be restrained within the capsule body 106 of the outer sheath assembly 22, thereby preventing expansion of the implant 70. Similar to... Figure 2A As shown, when positioned within the capsule body, the distal anchor 80 can extend distally. The proximal end 301 of the implant 70 is restrained within the capsule body 106 and within a portion of the inner retaining member 40, and is therefore generally restrained between the capsule body 106 and the inner retaining member 40. The implant 70 can then be coupled with... Figures 28-30The same approach discussed was used to deploy the natural tricuspid heart valve 1082. Figure 33 An example is an implant 70 deployed to a natural tricuspid valve 1082. The distal anchor of the implant 70 is on the leaflet 1088 of the tricuspid valve 1082 to engage with... Figure 26 The distal anchor shown extends in a similar manner to the leaflet 1108 of the natural mitral valve. The delivery device can then be withdrawn from the patient's right atrium 1076.

[0199] about Figures 31-33 The disclosed procedures can utilize the systems and apparatus disclosed herein. For example, motor 500 can deflect a portion of the delivery device or deploy an implant into a body position. Operation of motor 500 can be operated by processor 536. A user can provide input to processor 536 using control device 504. System 10 can be positioned using steering mechanisms or other techniques discussed herein. Delivery system 10 can be advanced by the user manually moving handle 14 in the axial direction. In some embodiments, delivery system 10 can be placed on a support while operating handle 14. In one embodiment, delivery system can be used as... Figure 17 The motor shown propels the motor axially.

[0200] Delivery devices can Figure 1 The form shown may be used, or other forms of delivery devices may be used, such as delivery devices configured to deliver the implant to a natural tricuspid valve.

[0201] Furthermore, the sensors discussed herein may be used in some implementations. The delivery device may include one or more sensors coupled to and configured to sense one or more of the condition of the patient's body or the condition of the delivery device. The processor 536 may be configured to provide output based on one or more of the condition of the patient's body or the condition of the delivery device sensed by the one or more sensors. For example, the processor 536 may, based on the condition of the delivery device, cause the delivery device to at least partially avoid or retract from the surface of the patient's body. Figure 31 and 32 For example, a proximity sensor 582 (such as...) that can be used for navigation within a patient's body is illustrated. Figure 21 The processor can navigate the delivery device to the desired orientation relative to the natural tricuspid valve to deploy the implant 70. The processor can actuate the delivery device to align it coaxially with the natural tricuspid valve and deliver the implant 70 to the natural tricuspid valve.

[0202] In one embodiment, the delivery system 10 can be used in a method of percutaneous delivery of aortic valve replacement. This method can utilize any system or device disclosed herein. Further, this method can utilize a delivery system including a delivery device configured for delivering a prosthetic aortic valve replacement. Such a delivery device may include... Figure 1 Similar components to the illustrated device, for example, a delivery device may include an elongated shaft 804, which includes a capsule body 806 surrounding an implantation holding region for retaining the implant, and may include a nasal cone 808 at the distal end of the elongated shaft 804. The delivery device may include a housing, which may be in the form of a handle at the proximal end of the elongated shaft 804. The delivery device may include, as described above... Figure 1 The embodiments disclosed herein include multiple components. These components can be controlled by a motor and by a controller including the processor disclosed herein. Thus, actuation of the delivery device can be controlled by both the motor and the processor. The delivery device can be configured to extend around the curve of the patient's aortic arch 1090 and deliver the implant to the aortic valve 1092. For example, a steering mechanism configured to steer around the curve of the patient's aortic arch 1090 can be used. The delivery device may also include, as needed, information regarding... Figure 1 The device shown discloses the sensors and other components.

[0203] refer to Figure 34 For example, the delivery device can extend within a portion of the patient's body to deliver the implant to a body location. The portion of the patient's body can be the aortic arch 1090, and the body location for implant delivery can be the natural aortic heart valve 1092. The delivery device can extend percutaneously within the portion of the patient's body; for example, the delivery device can be placed in the femoral vein and advanced toward the aortic arch 1090. Other access methods may be used as needed.

[0204] The delivery device can be advanced through the aortic arch 1090 and toward the natural aortic heart valve 1092. One or more guidewires may be used or not, as needed. One or more motors—which may be operated by a processor 536 as discussed herein—can be used to extend the delivery device through the aortic arch 1090.

[0205] An operable motor 500 actuates the rail assembly 20, or another steering mechanism of the delivery device, to target the distal end of the delivery device to an appropriate region. For example, the motor 500 can be used to steer the rail assembly 20 to a desired orientation relative to the natural aortic heart valve 1092. The motor 500 can be operated by a processor 536 as discussed herein. The rail assembly 20, or another steering mechanism of the delivery device, such as one or more traction wires, can form one or more bends such that the distal end of the delivery device is oriented coaxially with the natural aortic heart valve 1092.

[0206] Figure 35 For example, it is shown that the delivery device has been deflected within the aortic arch 1090 toward the natural aortic heart valve 1092. A bend may be formed within the aortic arch 1090. Once the implant is positioned coaxially with the natural aortic heart valve 1092, the capsule body 806 can be further advanced to the desired depth relative to the natural aortic heart valve 1092.

[0207] The depth of the capsule body 806 can be varied until it is positioned at the desired location relative to the natural aortic heart valve 1092. The implant can be restrained within the capsule body 806 of the outer sheath assembly, thereby preventing implant expansion. The implant can then be deployed by retracting the outer sheath of the capsule body 806 or otherwise moving it relative to the implant retention area. The implant can have various forms, including... Figure 3B The implant is shown in the illustration. In this embodiment, the implant may not be covered by the capsule body. For example, the implant may be a balloon-expandable or mechanically expandable implant that is not confined within the capsule body, or other implant forms. The implant may be deployed at the desired location.

[0208] Figure 36 An implant 810 is illustrated, which is deployed to a natural aortic heart valve 1092. The delivery device can be withdrawn from the patient's aortic arch 1090.

[0209] about Figures 34 to 36 The disclosed methods can utilize the systems and apparatus disclosed herein. For example, motor 500 can deflect a portion of the delivery device or deploy an implant into a body position. Operation of motor 500 can be operated by processor 536. A user can provide input to processor 536 using control device 504. System 10 can be positioned using steering mechanisms or other techniques discussed herein. The delivery system can be advanced by the user manually moving a handle in the axial direction. In some embodiments, the delivery system can be placed on a support while operating the handle. In one embodiment, the delivery system can be used as... Figure 17 The motor shown propels the motor axially.

[0210] Furthermore, in some embodiments, the sensors discussed herein may be utilized. The delivery device may include one or more sensors coupled to and configured to sense one or more of the condition of the patient's body or the condition of the delivery device. Processor 536 may be configured to provide output based on one or more of the condition of the patient's body or the condition of the delivery device sensed by the one or more sensors. For example, the processor may, based on the condition of the delivery device, cause the delivery device to at least partially avoid or retract from the surface of the patient's body. Figure 34 and 35For example, a proximity sensor 582 (such as...) can be used for navigation within a patient's body. Figure 21 The sensor signal 812 (e.g., echo signal) generated by the delivery device (marked in the middle) is used to sense the spatial relationship between the delivery device and the surface of the aortic arch. The sensor signal 812 shows the reflection from the surface of the aortic arch 1090. Based on the spatial relationship, the processor can actuate the delivery device to avoid or retract from the surface of the patient's body by deflecting within the aortic arch, and navigate around the aortic arch to the desired orientation relative to the natural aortic heart valve 1092 to deploy the implant 810. By continuously sensing the position of the delivery device relative to the aortic arch and modifying the deflection accordingly, navigation through the aortic arch can be achieved with little or no contact with the vessel wall. As described above, sensor feedback from the delivery device can be supplemented by imaging feedback, such as from a fluorescence microscope, to provide additional detail. The use of sensor feedback during advancement through a vessel (such as the aortic arch) provides an important improvement because it reduces the possibility of vessel cutting and / or particle detachment from the vessel wall. Another advantage is that the replacement valve can be precisely positioned relative to the natural aortic heart valve, which helps to accurately deploy the replacement valve across the natural aortic valve leaflets and within the diseased natural valve.

[0211] In other embodiments, other methods of delivering the implant to the natural aortic heart valve may be used, such as transapical, transseptal, or other methods.

[0212] Other locations for valve implants may include the pulmonary valve and other valves in the patient's body. Other forms of implants may be delivered to other body locations as needed.

[0213] In the embodiments disclosed herein, the implant can be delivered under fluorescence examination, allowing the user to view certain reference points for proper implant positioning. Furthermore, echocardiography can be used for proper implant positioning.

[0214] In one embodiment, proximity sensor 582 can be configured to provide a model of the patient's interior body and the spatial relationship between the elongated axis 12 and the patient's body surface. This model can provide... Figure 37 and 38 The output devices 584 and 586 shown are used as displays (provided on a monitor and on a virtual reality or augmented reality display). If desired, this model can also be provided by other sensors located outside the patient's body. This model can be a two-dimensional or three-dimensional map of the patient's body for the user to view and is used by the processor 536 as feedback to navigate through the patient's body and deliver the implant 70 to the desired location. This configuration can be used with any of the embodiments disclosed herein, including delivery of the implant to the natural aortic valve.

[0215] Figure 37 An embodiment of the delivery device is illustrated, in which operation can be performed remotely by a user. The user can use a control device 588, such as a joystick or other form of control device to control the movement of the delivery device and the elongated shaft 12. The control device 588 can be configured to sense movement of the control device to control the delivery device. The user can view the position of the elongated shaft 12 on an output device 584 in the form of a display screen. The position can be provided in various ways, including external sensing of the position via sensors using fluorescein examination or echocardiography. The position can also be provided via an image generated by a proximity sensor from the elongated shaft 12. The proximity sensor can be configured to generate an image of the spatial relationship between the elongated shaft 12 and the patient's body surface. A configuration including a motor for axial movement of the elongated shaft 12, such as… Figure 17 As shown, it can also be used for remote control procedures. This configuration can be used with any of the embodiments disclosed herein, including delivery of the implant to the natural aortic valve.

[0216] Figure 38 The example illustrates an implementation where the output device 586 is in the form of a display screen on a virtual reality or augmented reality display. The display screen may include a helmet (or other headset that allows enhanced visualization) for a user to wear, where the user can move his or her head to change the perspective of the view provided by the display screen. Similar to the description of... Figure 37 In the discussed implementation, the position of the elongated shaft 12 and the portion of the patient's heart seen in the output device 586 can be provided in various ways, including external sensing of the position via fluorescein examination or echocardiography. The position can also be provided via an image generated by a signal from a proximity sensor of the elongated shaft 12. The proximity sensor can be configured to generate an image of the spatial relationship between the elongated shaft 12 and the patient's body surface. Configurations including motors for axial movement of the elongated shaft 12, such as... Figure 17 As shown, it can also be used for remote control procedures. This configuration can be used with any of the embodiments disclosed herein, including delivery of the implant to the natural aortic valve.

[0217] Figure 39 Exemplary methods that can utilize the apparatuses and systems disclosed herein are illustrated. These methods are exemplary in nature, and features of the methods can be removed or added, and the order of steps can be changed as needed. Features of the methods can be combined with or replaced by other features of the apparatuses, systems, and methods disclosed herein. The features of the methods can be used in… Figures 25-36 The disclosed implementation method.

[0218] The method may include step 820 of extending a delivery device within a portion of the patient's body to deliver an implant to a body location. The delivery device may be configured similarly to any embodiment of the delivery device disclosed herein. The delivery device may be as follows: Figures 25-36 The embodiments shown or any other methods disclosed herein extend within a portion of the patient's body. The implant may be configured similarly to any of the implants disclosed herein, and the body location may include any of the locations disclosed herein. At least a portion of the delivery device may be actuated by at least one motor operated by a processor.

[0219] The delivery device can be advanced by a user (e.g., a clinician), such as an elongated shaft extending within a portion of the patient's body. The delivery device can be manually advanced by the user. For example, the user can manually grasp the handle or control mechanism of the delivery device to advance it. In embodiments, automation methods can be utilized, such as using a motor-driven rail 577, as... Figure 17 As shown, or actuating other components of the delivery device to move axially into the patient's body. In an embodiment, the delivery device can be remotely propelled by the user, for example, using... Figure 37 and 38 The remote control device 588 is shown. In other embodiments, other methods may be used to extend the delivery device within a part of the patient's body.

[0220] Referring to step 822, input may be provided to the control device. The input may be provided by the user to actuate at least a portion of the delivery device. The control device, such as... Figure 13 , 15 The control devices 504, 556, 562, 588, or other forms of control devices shown in 16, 37, or 38 may be used as needed. Inputs may be provided to control the movement of the delivery device. For example, the user may determine to deflect the delivery device or control the depth of the delivery device to a desired orientation. Figure 25 An example is shown of a slender shaft of a delivery device that deflects toward the natural mitral valve to the desired orientation. Figure 32 An example is shown of a slender shaft of a delivery device that deflects toward the natural tricuspid valve to the desired orientation. Figure 35 An example is illustrated by deflecting the elongated axis of a delivery device within the aortic arch to the desired orientation. Various forms of deflection, as well as variations in the depth of the delivery device, may occur. The user can further provide input to perform operations on the delivery device, such as fully or partially deploying the implant. The user can then output information through devices such as… Figure 37The display screen 584 shows the location of the delivery device inside the patient's body. Images on display screen 584 can be generated by sensors outside the patient's body, such as fluoroscopy or echocardiography sensors, and / or provided via signals from a proximity sensor on an elongated axis. The user can view a model of the patient's internal body on the output device, such as regarding... Figure 37 The subject of discussion.

[0221] In this implementation, the input can be provided remotely by the user, for example, using... Figure 37 and 38 The remote control device 588 shown.

[0222] The inputs provided by the control device can be used to operate the motor and can be provided to the processor 536. The processor 536 can therefore be used to operate the motor to produce the desired actuation of the delivery device.

[0223] Referring to step 824, signals may be received from one or more sensors. These signals may be received by processor 536 and may include feedback signals provided to processor 536 from the sensors. Sensors may include any sensors disclosed herein, including sensors for sensing the condition of the delivery device or the condition of the patient's body. Such sensors may include position sensors, motor torque sensors, contact sensors, proximity sensors, pressure sensors, flow sensors, or other types of sensors disclosed herein. Sensors may operate in the manner disclosed herein. Sensor signals may be provided during the implantation procedure and may be provided to processor 536 in real time as feedback signals during the procedure. For example, proximity sensor 582 may provide a signal indicating that the delivery device has contacted or approached a surface of the patient's body. Pressure sensor 578 may provide a signal indicating pressure within the patient's body, such as fluid pressure. Other sensors may be used and may operate in the manner disclosed herein. In embodiments, sensors may not be coupled to the delivery device and may be located outside the patient's body. Sensors may be, for example, sensors used in fluoroscopy and / or echocardiography, and may be provided to processor 536 for the processor to determine the location of the delivery device within the patient's body.

[0224] Referring to step 826, an output may be provided based on a signal. Processor 536 may provide an output based on a signal. Processor 536 may be configured to provide an output based on one or more of the patient's physical condition or the condition of the delivery device sensed by one or more sensors. The output may have a variety of forms as disclosed herein. For example, the output may include a data log 828. Such a data log may be used in the implantation procedure using the delivery device and may be stored in memory 534 and may have a form as disclosed herein. The data may be stored for later retrieval and analysis by a user, or may be a log recording the actions taken by the delivery device. For example, position sensor signals may be recorded to record other forms of sensor signals such as movement of the delivery device. In embodiments, the data log may be used to allow the system to learn from past events and may be used in machine learning algorithms to allow the system to continuously refine the procedure to increase the likelihood of success. The data log may include data from the implantation procedure or patient characteristics for use in machine learning algorithms that can utilize such data.

[0225] The output may include an indicator 830. The indicator may be generated by the processor 536 in a manner disclosed herein and may be provided on an output device. For example, it may indicate to the user the status of the delivery device or the patient's body in various forms; for example, the output device may include one or more of other forms of output devices such as a display screen, a light, a speaker, or a haptic device. The user is able to respond to the indicator. For example, if the indicator indicates that the proximity sensor 582 has sensed that the delivery device has contacted or approached a surface of the patient's body, the user is able to respond and actuate the delivery device away from the surface. Further, if the indicator indicates that the flow sensor 583 has sensed unwanted flow within the patient's body during implantation, the user is able to respond and redeploy the implant if necessary. The indicator may indicate whether the implantation procedure is proceeding as desired, or it may indicate undesired implantation procedure. Other forms of indicators may be provided as disclosed herein, and the user may respond in a manner desired.

[0226] The output may include at least partial actuation 832 of the delivery device. The processor 536 may provide outputs including control of the motor 500 based on signals from one or more sensors. For example, signals from contact sensor 580 or proximity sensor 582 may be provided to the processor 536 as feedback that the delivery device has contacted or approached the patient's body surface. The processor 536 may accordingly provide outputs to operate the motor 500 to avoid or retract from the patient's body surface based on the feedback from the sensors. Signals from flow sensors 583a-l may cause the processor 536 to provide outputs to the motor 500 to redeploy the implant 70 or move a portion of the delivery device to recapture the leaflet 1108. Signals from position sensors may provide the processor 536 with feedback on whether the delivery device is performing correct movement, and, if necessary, the processor 536 may operate the motor 500 to perform correct movement (e.g., deflecting the elongated shaft 12 if necessary). The processor 536 may be programmed to automatically respond to and generate outputs based on the condition of the patient's body or the condition of the delivery device sensed by one or more sensors. The programming of processor 536 can be stored in memory 534 and operated by processor 536.

[0227] In an implementation, processor 536 may be configured to adjust, for example, the input provided by the user in step 822 based on feedback from sensors. For instance, if the user provides control to guide an elongated shaft toward the surface of the patient's body, and proximity sensor 582 determines that such action brings the elongated shaft within a certain threshold of proximity to the surface, processor 536 may determine that the user's input is unsafe and may automatically adjust the input to avoid or retract from the surface of the patient's body. Thus, processor 536 may automatically operate the delivery device to adjust the user-provided input, which may include overriding the user-provided input. Similarly, if flow sensor 583 senses undesired flow during valve implantation, processor may automatically operate the delivery device to adjust the user-provided input for proper valve implantation. Processor 536 may operate based on any sensor signals disclosed herein to adjust the user-provided input.

[0228] The actuation generated by processor 536 can be based on machine learning algorithms utilizing data from past implantation procedures or from patient characteristics. The data can be "learned" from previous procedures, specifically from previous procedures performed on patients with similar anatomical structures and / or other characteristics. Therefore, procedural steps successfully performed on patients with similar anatomical structures can be repeated, thereby increasing the likelihood of successful procedure execution on the current patient. Processor 536 can utilize machine learning algorithms to control the actuation of the delivery device and can be used to adjust inputs provided by the user.

[0229] Furthermore, the actuation generated by processor 536 can be based on a series of programmed movements to be executed by the delivery device. Such a program can be pre-programmed into processor 536 or based on, for example, regarding... Figure 37 A model or diagram of the patient's anatomy is programmed. For example, external sensors can be used to determine the model or diagram of the patient's anatomy, and processor 536 can be programmed to move the implant to the desired body position. Programming can also be performed during the implantation procedure, for example, based on feedback from sensors. If input from the user deviates from the desired movement within a certain threshold, processor 536 can be configured to automatically adjust the input to move the delivery device in the desired manner. Thus, processor 536 can be programmed to reduce the likelihood of the user performing undesirable procedures during implantation.

[0230] Referring to step 834, confirmation of implantation can be provided. This confirmation may be provided by processor 536 and may be based on signals from sensors. For example, pressure sensors or flow sensors, or other forms of sensors, can determine that the implant has been implanted. Processor 536 may be configured to provide such implantation confirmation as an indicator on an output device, informing the user that the implant has been implanted. The user can then perform steps to withdraw the delivery device from the patient's body and otherwise complete the implantation procedure.

[0231] In relation to Figure 39 In the exemplary methods discussed, a user (e.g., a clinician) can provide input, which can be assisted by using components disclosed herein (e.g., processors, motors, and one or more sensors, etc.). However, in implementations, the implantation procedure can occur autonomously (i.e., adapting to the environment during operation). The processor can perform autonomous control of the delivery device to execute the implantation procedure. The user can provide some input during the procedure, allowing the procedure to occur semi-autonomously. Thus, the method can occur autonomously or semi-autonomously (or at least semi-autonomously).

[0232] Figure 40 For example, a method for autonomous control of a delivery device is illustrated. The user can provide input during the process, allowing the process to occur semi-autonomously or at least semi-autonomously. Similar to... Figure 39 Public methods Figure 40 The method is an exemplary method that can utilize the apparatus and systems disclosed herein. Features of the method can be removed or added, and the order of steps can be changed as needed. Features of the method can be combined with or replaced by other features of the apparatus, systems, and methods disclosed herein. Features of the method can be used... Figures 25-36 The disclosed implementation method.

[0233] The method may include step 840 of extending a delivery device within a portion of the patient's body to deliver an implant to a body location. The delivery device may be configured similarly to any embodiment of the delivery device disclosed herein. The delivery device may be as follows: Figures 25-36 The implant extends within a portion of the patient's body as shown in the embodiments or any other manner disclosed herein. The implant may be configured similarly to any implant disclosed herein, and the body location may include any of the locations disclosed herein.

[0234] The delivery device can be propelled by a motor, such as a delivery device with a slender shaft extending within a part of the patient's body. The motor can be controlled by a processor 536. For example, a motor-driven rail 577 can be used, such as... Figure 17 As shown, the delivery device may be driven axially to move into other components within the patient's body. In other embodiments, other methods may be used to extend the delivery device within a portion of the patient's body.

[0235] Referring to step 842, processor 536 may run a program to actuate the delivery device. Processor 536 may be programmed with a series of movements to actuate the delivery device to a desired location and for desired deployment operations. For example, processor 536 may be configured to determine the desired delivery location and the path and orientation to be followed to reach the desired delivery location based on external sensing of the location via fluorescein examination or echocardiography and / or via signals from a proximity sensor from the elongated axis 12. A programmed sequence of movements may be provided based on the geometry of the path leading to the desired implantation location and the orientation of the desired implantation location. Movement and deployment of the delivery device may be pre-programmed into processor 536 and may be embodied based on a specific path to be followed to the desired location in the patient's body. In some embodiments, processor 536 may utilize machine learning algorithms to control the actuation of the delivery device. For example, the path and orientation may also be supplemented with data from previous procedures from patients with similar characteristics. As disclosed with respect to step 840, processor 536 and programming may be used to extend the delivery device within a portion of the patient's body.

[0236] Referring to step 844, processor 536 may continue following the procedure and may receive signals from one or more sensors. Processor 536 may receive feedback from the sensors (as discussed herein) that caused processor 536 to generate an output in step 846. Signals from the sensors may be utilized by processor 536 in a manner similar to that disclosed with respect to step 826 and may generate an output similar to that disclosed with respect to step 826. Figure 39 Outputs 828, 830, 832 are similar to those disclosed in outputs 848, 850, 852. For example, processor 536 can be configured to... Figure 39The method disclosed herein generates data log 848 in a similar manner. Processor 536 can be configured to operate in accordance with... Figure 39 The indicator 850 is generated in a similar manner to that disclosed in the method. The indicator 850 can be provided to the user to determine whether to intervene in the procedure. For example, if the user (e.g., a clinician) receives an indicator that an autonomously operated delivery device has contacted a surface or that an implant has been improperly deployed, the user can intervene to attempt to correct this actuation.

[0237] Processor 536 can be configured to generate actuation 852 of the delivery device. Actuation 852 can be provided to processor 536 to complete the procedure using feedback from sensors such as those discussed herein, with minimal or no human interaction. For example, if a position sensor indicates that the delivery device is deviating from its intended path, processor 536 can automatically adjust the path. If a proximity sensor indicates that the delivery device is approaching a surface, processor 536 can automatically adjust the path. Processor 536 can be used to navigate to any desired location to deliver the implant. For example, in… Figure 25 , 31 Other forms of navigation, such as this type of navigation, are shown in 32, 34, and 35. In this method, any sensor and feedback operation from the sensors disclosed herein can be used. In some embodiments, the user may provide input during the program to correct the program or otherwise provide input to control the program.

[0238] Similar to about Figure 39 The discussed method involves the processor 536 generating actuation based on machine learning algorithms utilizing data from past implantation procedures or from patient characteristics. Actuation can be based on data “learned” from previous procedures, specifically data learned from previous procedures performed on patients with similar anatomical structures and / or other characteristics. Therefore, procedural steps successfully performed on patients with similar anatomical structures can be repeated, thereby increasing the likelihood of successful procedure execution on the current patient. The processor 536 can utilize machine learning algorithms to control the actuation of the delivery device.

[0239] Processor 536 may be configured to operate motor 500 to generate actuation of the desired delivery device. Processor 536 may be configured to automatically operate the motor to deflect the delivery device to a desired body position. Processor 536 may be configured to automatically operate the motor to deflect the delivery device in at least two planes. Processor 536 may be configured to automatically deploy implant 70 to the desired location and complete the delivery procedure. In some embodiments, processor 536 may be configured to complete the delivery procedure without user control or intervention. In step 854, it may be connected to... Figure 39Step 834 in the process provides implantation confirmation in a similar manner. Processor 536 can be configured to provide such implantation confirmation as an indicator on an output device, so that the user is informed that the implant has been implanted.

[0240] Figure 39 and 40 This method can be used to replace or repair heart valves in a patient's body. Heart valves may include one or more of the aortic, mitral, tricuspid, or pulmonary valves. Other valves or body locations for implantation may be addressed in other implementations. Available as needed. Figure 39 and 40 Changes in methods.

[0241] Figure 41 Examples with Figure 10 The delivery device shown is similarly configured in this embodiment; however, a plurality of motors 502 can be used to control the actuation of the delivery device. Each of the plurality of motors 502 can be configured, for example, to engage corresponding connectors 590, 592, 594, which are configured to actuate portions of the delivery device. The motors 502 can be configured to perform linear movement of the connectors 590, 592, 594 to actuate the delivery device. Furthermore, in Figure 41 In the implementation method, Figure 41 The processor, memory, and input and output devices can be provided on a printed circuit board 596 located within the handle. A power supply 598, such as a battery pack or other form of power, can also be provided within the handle. Figure 41 Implementations may include a self-contained handle unit that includes a processor for executing delivery procedures and receiving feedback from sensors, as well as performing data logging if necessary.

[0242] The motors disclosed in this article may include various types of motors, including electromagnetic motors, stepper motors, hydraulic motors, piezoelectric motors, etc.

[0243] Although the various systems and methods disclosed herein have been discussed regarding the implantation of prosthetic mitral valve implants, these systems and methods are also applicable to the replacement of other heart valves, such as the tricuspid, aortic, and pulmonary valves. It should also be understood that these systems and methods can be used to deliver a variety of implants, including those for repairing heart valves. For example, other types of heart valve implants that can be used are shown in… Figures 42-44 In addition, other types of implants (e.g., aortic valve implants and other repair implants).

[0244] The delivery device used in this article can be configured as follows: Figure 1The delivery device shown may have a variety of other configurations. For example, a delivery device may be used that is configured to deliver the implant to the natural aortic valve and may be configured to pass through the aortic arch. The delivery device may be configured according to the type of implant to be delivered and according to the delivery location of the implant. Other forms of delivery devices may be used as needed.

[0245] In some embodiments, the methods and systems disclosed herein may not be limited to implant delivery, but can be extended to any medical intervention or insertion into a patient's body, which may include performing medical procedures within the body. The methods and systems disclosed herein can be used as needed for the general purpose of catheters. For example, Figure 41 The handle and components disclosed therein may include a universal catheter handle in some embodiments. Furthermore, the configuration of the delivery device may be modified in other embodiments. For example, in an aortic valve delivery device, the configuration of the implant retention area and other features of the delivery device may be modified.

[0246] Figure 42 Examples of alternative implementations of implants that can be used according to the embodiments described herein are provided. Figure 42 The reference number is the same as the one mentioned above. Figure 3A The same points were discussed.

[0247] Next reference Figures 43-44 An alternative implementation of the implant 1600 in an expanded configuration is illustrated. The implant 1600 may 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.

[0248] First refer to Figures 43-44 The outer frame 1640 in the example can be attached to the inner frame 1620 using any known fasteners and / or techniques. Although the outer frame 1640 is illustrated as a separate component from the inner frame 1620, it should be understood that frames 1620 and 1640 can be formed integrally or as a single unit.

[0249] As shown in the example embodiment, the outer frame 1640 may include an outer frame body 1642. The outer frame body 1642 may 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 may 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 example embodiment, the upper region 1642a of the outer frame body 1642 may 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 portions of the implant 1600 by effectively increasing the wall thickness of the combined struts.

[0250] When in an expanded configuration (such as a fully expanded configuration), the diameters of the intermediate region 1642b and the lower region 1642c may be larger than the diameter of the upper region 1642a. The upper region 1642a of the outer frame body 1642 may have a diameter that decreases from the lower end to the upper end, such that the upper region 1642a is radially inclined or bent inward toward the longitudinal axis of the implant 1600. Although the outer frame body 1642 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the outer frame body 1642 may have a non-circular cross-section, such as, but not limited to, D-shaped, elliptical, or other oval cross-sectional shapes.

[0251] Continue to refer to Figure 43 The outer frame 1600 in the example, the outer frame body 1642 may include a plurality of pillars, wherein at least some of the pillars form units 1646a-c. Any number of pillar configurations can be used, such as the ring of undulating pillars shown, which are formed into ellipses, ovals, circular polygons and teardrop shapes, as well as V-shapes, rhombuses, curves and various other shapes.

[0252] The upper unit 1646a may 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 rolled up. Unit 1646a may be formed by an assembly of struts. As shown in the example embodiment, the upper portion of unit 1646a may be formed by a set of circumferentially expandable struts 1648a having a Z-shaped or undulating shape forming a repeating "V" shape. The struts 1648a may extend radially outward from the upper end to the lower end. These struts may generally match the size and / or shape of the struts of the inner frame 1620.

[0253] The middle part of unit 1646a may be formed by a set of pillars 1648b extending downward from the bottom end of each “V” shape. The pillars 1648b may extend radially outward from the top end to the bottom end. The portion of unit 1646a extending upward from the bottom end of the pillars 1648b can be considered as the substantially unshortened portion of the outer frame 1640.

[0254] The lower portion of unit 1646a may be formed by a set of circumferentially expandable struts 1648c having a Z-shaped or undulating shape forming a repeating “V” shape. As shown in the example embodiment, the struts 1648c may include curvature such that the lower end of the strut 1648c extends more parallel to the longitudinal axis than the upper end of the strut 1648c. One or more upper ends or tips of the circumferentially expandable struts 1648c may be “free” vertices not connected to the struts. For example, as shown in the example embodiment, every other upper end or tip of the circumferentially expandable strut 1648b is a free vertice. However, it should be understood that other configurations may be used. For example, each upper vertex along the upper end may be connected to a strut.

[0255] The middle row and / or bottom row units 1646b-c may have a different shape than the first row unit 1646a. The middle row unit 1646b and the bottom row unit 1646c may have a rhomboid or generally rhomboid shape. The rhomboid or generally rhomboid shape may be formed by an assembly of supports.

[0256] The upper portion of unit 1646b may be formed by a set of circumferentially expandable struts 1648c, such that unit 1646b shares struts with unit 1646a. The lower portion of unit 1646b may be formed by a set of circumferentially expandable struts 1648d. As shown in the example embodiment, one or more of the circumferentially expandable struts 1648d may generally extend in a downward direction generally parallel to the longitudinal axis of the outer frame 1640.

[0257] The upper part of unit 1646c may be formed by a set of circumferentially expandable supports 1648d, such that unit 1646c shares supports with unit 1646b. The lower part of unit 1646c may be formed by a set of circumferentially expandable supports 1648e. The circumferentially expandable supports 1648e may generally extend in a downward direction.

[0258] As shown in the example implementation, there can be a row of nine units 1646a and a row of eighteen units 1646b-c. Although each of the units 1646a-c is shown to have the same shape as the other units 1646a-c in the same row, it should be understood that the shapes of the units 1646a-c within a row can be different. Furthermore, it should be understood that any number of rows of units can be used, and any number of units can be contained in these rows.

[0259] As shown in the example embodiment, the outer frame 1600 may include a set of eyelets 1650. The upper set of eyelets 1650 may extend from the upper region 1642a of the outer frame body 1642. As shown, the upper set of eyelets 1650 may extend from the upper portion of unit 1646a (e.g., the upper apex of unit 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 may include one or more eyelets corresponding to the eyelets 1650. In such embodiments, the inner frame 1620 and the outer frame 1640 may be attached together via the eyelets 1650 and the corresponding eyelets on the inner frame 1620. For example, the inner frame 1620 and the outer frame 1640 may be sewn together through the eyelets, or attached by other means such as mechanical fasteners (e.g., screws, rivets, etc.).

[0260] As shown, the set of eyelets 1650 may include two eyelets extending in series from each “V”-shaped strut. This reduces 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 eyelets. Furthermore, it should be understood that fewer or more eyelets may extend from the “V”-shaped struts.

[0261] The outer frame 1640 may include a set of locking protrusions 1652 extending from or near the upper end of the upper region 1642a. As shown, the locking protrusions 1652 may extend upward from this set of eyelets 1650. The outer frame 1640 may include twelve locking protrusions 1652. However, it should be understood that a greater or lesser number of locking protrusions may be used. The locking protrusions 1652 may include longitudinally extending struts 1652a. At the upper end of the struts 1652a, the locking protrusions 1652 may include an enlarged head 1652b. As shown, the enlarged head 1652b may have a semi-circular or semi-elliptical shape, forming a "mushroom" shape with the struts 1652a. The locking protrusions 1652 may include eyelets 1652c, which may be positioned through the enlarged head 1652b. It should be understood that the locking protrusions 1652 may include eyelets in other locations, or may include more than one eyelet.

[0262] The locking protrusion 1652 can be advantageously used with a variety of delivery systems. For example, the shape of the strut 1652a and the enlarged head 1652b can be used to secure the outer frame 1640 to a slot-based delivery system, such as the inner retainer 40 described above. The eyeholes 1652c and / or 1650 can be used to secure the outer frame 1640 to a tether-based delivery system, such as a system that uses sutures, threads, or fingers to control the delivery of the outer frame 1640 and the implant 1600. This can advantageously facilitate the recapture and repositioning of the outer frame 1640 and the implant 1600 in situ.

[0263] An outer frame 1640, such as an outer frame body 1642, can be used to attach or secure the implant 1600 to a natural valve, such as a natural mitral valve. For example, the intermediate region 1642b of the outer frame body 1642 and / or the outer anchoring member 1644 can be positioned to contact or engage the natural valve annulus, tissue beyond the natural valve annulus, natural leaflets, and / or other tissue located at or around the implantation site 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 anchoring member 1624 such that tissue within the body cavity is positioned between the outer frame body 1642 and the inner frame anchoring member 1624, such as natural valve leaflets and / or natural valve annulus, which can be engaged or compressed to further secure the implant 1600 to the tissue. As shown, the inner frame anchoring member 1624 includes nine anchors; however, it should be understood that fewer or more anchors may be used. In some embodiments, the number of individual anchors may be selected as a multiple of the number of ferrules of the valve body 1660. For example, for a valve body 1660 with three ferrules, the inner frame anchoring member 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 ferrules of the valve body 1660.

[0264] Continue to refer to Figures 43-44 In the example implant 1600, the valve body 1660 is attached to the inner frame 1620 within the inner frame body 1622. The valve body 1660 acts as a one-way valve to allow blood to flow through the valve body 1660 in a first direction and to inhibit blood from flowing through the valve body 1660 in a second direction.

[0265] The valve body 1660 may include a plurality of leaflets 1662 joined at the commissure, such as three leaflets 1662. The valve body 1660 may include one or more intermediate members 1664. The intermediate member 1664 may be positioned between a portion or all of the leaflet 1662 and the inner frame 1620 such that at least a portion of the leaflet 1662 is connected to the frame 1620 via the intermediate member 1664. In this manner, a portion or all of that portion of the leaflet 1662 at the commissure and / or the arcuate edge of the leaflet 1662 is not directly connected or attached to the inner frame 1620, but is indirectly connected to or "floats" within the inner frame 1620.

[0266] Next reference Figure 43 The example shows an outer skirt 1680, which may be attached to the inner frame 1620 and / or the outer frame 1640. As shown, the outer skirt 1680 may be positioned around and secured to a portion or all of the exterior of the outer frame 1640. The outer skirt 1680 may be attached to the valve body 1660 and the outer skirt 1680. Figure 44 As shown, a first end of the inner skirt 1690 may be attached to the valve body 1660 along a portion of the valve body 1660 near the inner frame 1620. A second end of the inner skirt 1690 may be attached to the lower region of the outer skirt 1680. This creates a smooth surface beneath each leaflet. This beneficially enhances hemodynamics by allowing blood to circulate more freely and reducing stagnant areas.

[0267] Although the implant 1600 has been described as including an inner frame 1620, an outer frame 1640, a valve body 1660, and skirts 1680 and 1690, it should be understood that the implant 1600 does not need to include all components. For example, in some embodiments, the implant 1600 may include the inner frame 1620, the outer frame 1640, and the valve body 1660, while omitting the skirt 1680. Furthermore, although the components of the implant 1600 have been described and exemplified as separate components, it should be understood that one or more components of the implant 1600 may be formed integrally or monolithically. For example, in some embodiments, the inner frame 1620 and the outer frame 1640 may be formed integrally or monolithically as a single component.

[0268] Figures 45-48 An embodiment utilizing at least one electromagnet configured to attract or repel portions of the capsule body of a delivery device to change the size of the capsule body is illustrated. (Reference) Figure 45The capsule body 600 may be configured similarly to capsule body 106 or any other capsule body disclosed herein. The capsule body 600 may surround implant holding region 602, which may be configured similarly to implant holding region 16 or any other implant holding region disclosed herein. The capsule body 600 may be part of an elongated shaft of a delivery device, which may be configured in a manner similar to that disclosed herein. The implant holding region 602 may be configured to hold an implant, which may include implant 70 or another form of implant as disclosed herein.

[0269] At least one electromagnet 604 can be used to change the size of the capsule. For example... Figure 45 As shown, multiple electromagnets 604 can be used, or in other embodiments a single electromagnet 604 can be used. The electromagnet 604 can be coupled to and positioned on a first portion 606 of the capsule body 600, and can be configured to attract or repel a second portion 608 of the capsule body 600. Figure 45 The first portion 606 shown may include a sidewall of the capsule body 600 configured to surround the implant 70 within the implant holding area 602. The second portion 608 may similarly include a sidewall of the capsule body 600 configured to surround the implant 70. These sidewalls may be configured to apply a compressive force to the implant 70 when it is held within the implant holding area 602. The first portion 606 and the second portion 608 may include halves of the capsule body 600 and may extend along the axial length of the capsule body 600. In other embodiments, other configurations of portions of the capsule body 600 may be utilized. Furthermore, other locations of one or more electromagnets 604 may be utilized. For example, one or more electromagnets 604 may be positioned at other locations such as the nasal cone assembly 31, the inner assembly 18, the central axis assembly 21, etc. Figure 45 The electromagnet 604 shown is positioned on the outer sheath assembly 22, but the size of the capsule body 600 can be changed using other positions.

[0270] Parts 606 and 608 may be separated from each other by a gap 610 between them. The gap 610 may be an open gap 610 or a filled gap 610 filled with material—for example, a material that can be compressed if needed. The gap 610 may be as follows: Figure 45 The portion 606, 608 extends along the axial length of the capsule body 600 as shown, or may have other configurations as needed in other embodiments. The gap 610 provides a separation between the edges of the portions 606, 608, allowing the portions 606, 608 to move relative to each other to increase or decrease the size of the gap 610 and thus change the size of the capsule body 600.

[0271] A biasing body 612 may be used to bias portions 606, 608 toward or away from each other. The biasing body 612 may be configured to apply a biasing force to portions 606, 608. This biasing force may pull portions 606, 608 toward or away from each other as needed. The biasing force may counteract the direction of a force applied by at least one electromagnet 604. For example, in an embodiment where at least one electromagnet 604 attracts portions 606, 608 together, the biasing body 612 may move portions 606, 608 away from each other. In an embodiment where at least one electromagnet 604 repels portions 606, 608, the biasing body 612 may move portions 606, 608 toward each other. The biasing body 612 may include an elastic body configured to resist compression or expansion of the body 612. For example, when the body 612 is compressed, the body 612 may provide resistance to expansion, and when the body 612 is expanded, the body 612 may provide resistance to compression. The main body 612 may be positioned within or outside the gap 610 as needed. For example, the main body 612 may include a sheath placed on the outer surface of the gap 610 or the capsule body 600 as needed.

[0272] One or more electromagnets 604 may be positioned as needed to attract or repel portions of the capsule body 600 to alter the size of the capsule body 600. One or more electromagnets 604 may be coupled to electrical conduits 614a, b, which may extend along an elongated axis and be coupled to a power source 616, which may be connected to... Figure 10 The power supply 538 shown, or any other power supply disclosed herein, is similarly configured. Power supply 616 can be configured to provide electrical energy to at least one electromagnet 604. Power supply 616 can be configured to cause current to flow through electrical conduits 614a, b and through one or more electromagnets 604 to actuate the electromagnets 604 and cause the electromagnets 604 to provide attractive or repulsive forces. Power supply 616 can be configured as needed to reverse the direction of the current to vary from attractive or repulsive forces. Power supply 616 is also capable of changing the amount of current flowing through one or more electromagnets 604 to change the strength of the attractive or repulsive forces.

[0273] One or more electromagnets 604 may be configured to apply a magnetic force to a magnetically responsive material in the capsule 600 (e.g., a portion of the capsule 600 excluding the electromagnets 604, such as...). Figure 45 (See the second part 608 shown). The magnetically responsive material can be a metal or other form of magnetically responsive material, which can be coupled to the capsule body 600 at the desired location. In other embodiments, the electromagnet 604 can be configured to apply magnetic force to other electromagnets 604 or magnetic materials.

[0274] One or more electromagnets 604 can be used to change the radial dimension of the capsule body 600. The diameter of the implant holding region 602 can be varied, and the inner and outer diameters of the capsule body 600 can also be varied. Variations in the size of the capsule body 600 allow it to have a smaller profile size at one desired time and a larger profile size at another desired time. For example, a smaller profile size capsule body 600 may be needed when passing through a patient's vascular system. A larger profile size capsule body 600 may be needed to enhance the ease with which the implant 70 enters and exits the capsule body 600 at a desired time. For example, after the implant 70 has entered the capsule body 600 during a loading procedure, a larger size implant holding region 602 and capsule body 600 may be needed. Further, in, for example, as in... Figures 28-30 After the implant 70 is deployed from the capsule body in the illustrated procedure, a larger implant holding area 602 and capsule body 600 may be required. A larger implant holding area 602 and capsule body 600 can reduce friction on the implant 70 and capsule body 600 during implant loading and deployment. This allows for a reduced force to be applied to the capsule body 600 when it retracts to deploy the implant 70. The use of one or more electromagnets 604 allows the user to selectively change the size of the capsule body 600.

[0275] The capsule body 600 can be biased to have a larger size, wherein one or more electromagnets 604 are used to reduce the size of the capsule body 600. For example, as Figure 45 As shown, the biasing body 612 can apply a biasing force to portions 606 and 608 to increase the radial dimension of the capsule body 600. One or more electromagnets 604 can then be actuated to attract portion 606 to portion 608, thereby overcoming the biasing force and closing the gap 610. One or more electromagnets 604 can attract portion 608 to decrease the radial dimension of the capsule body 600. Figure 46 Examples with comparison Figure 45 The capsule body 600 has a reduced radial dimension. In such an embodiment, the capsule body 600 can be advanced into a desired location within the patient's body, wherein the capsule body 600 has a reduced radial dimension. At a desired time for deployment of the implant 70 positioned within the capsule body 600, one or more electromagnets 604 can be de-energized and the biasing body 612 can press portions 606, 608 apart to increase the radial dimension of the capsule body 600. The implant 70 can thus be deployed from the implant holding area 602 with reduced friction with the capsule body 600. The one or more electromagnets 604 can be re-energized after the implant 70 is deployed to reduce the radial dimension of the capsule body 600 for withdrawal of the capsule body 600 and delivery device from the patient's body.

[0276] In one embodiment, the biasing body 612 may be configured to reduce the radial dimension of the capsule body 600, wherein one or more electromagnets 604 apply a repulsive force to repel portions of the capsule body 600, thereby increasing the radial dimension of the capsule body 600. In such an embodiment, one or more electromagnets 604 may be energized at a desired time to overcome the force of the biasing body 612 and increase the radial dimension of the capsule body 600.

[0277] In implementations, a biasing body may be excluded. For example, one or more electromagnets 604 may alternately apply attractive or repulsive forces to change the size of the capsule body 600. One or more electromagnets 604 may be configured to apply attractive forces to hold the capsule body 600 in a low-profile configuration until a desired time. One or more electromagnets 604 may be configured to subsequently apply repulsive forces at a desired time to increase the radial dimension of the capsule body. The direction of the current through the electrical conduits 614a,b may be alternated to change the force between attractive and repulsive forces. The amount of current may also be controlled to change the intensity of the attractive and repulsive forces and set the size of the capsule body to a desired size. In implementations, a biasing body may be excluded and one or more electromagnets 604 may be configured only to provide attractive forces. The expansion force provided by the implant 70 within the implant holding region 602 may cause the size of the capsule body 600 to increase when the attractive forces of one or more electromagnets 604 cease. Configurations utilizing one or more electromagnets 604 may be provided.

[0278] Figure 47 and 48 An embodiment is shown in which the capsule body can be divided into multiple parts, wherein one or more electromagnets 604 are configured to attract or repel parts of the capsule body of the delivery device to change the size of the capsule body. The capsule body 618 may include portions 620, 622, 624, 626, which are separated by gaps and form the sidewalls of the capsule body 618, similar to portions 606, 608. However, the location and number of gaps may increase the overall dimensional variation of the capsule body 618. Furthermore, due to the symmetrically spaced placement of portions 620, 622, 624, 626, the dimensional variation around the capsule body 618 can be more uniform. One or more electromagnets 604 may be configured to... Figure 45 and 46 The size of capsule 618 is changed in a similar manner as discussed.

[0279] The electromagnet can be used with any implementation of the delivery system disclosed herein. As disclosed herein, the electromagnet can be controlled by a processor that can operate to actuate the electromagnet and thus change the size of the capsule body as needed. Such operation can occur in response to user input—via a control device or the like—or the processor can actuate the electromagnet automatically as needed. For example, the processor can actuate the electromagnet in response to sensor readings (e.g., one of the sensors disclosed herein) or in response to a procedure instructing that the size of the capsule body should be changed. The processor can be configured to automatically change the size of the capsule body and deploy the implant.

[0280] The power supply for the electromagnet can be connected to a controller, for example... Figure 18 The controller 530 shown is integrated. An electrical conduit for the electromagnet can extend to the controller. A processor can be configured to control the power supply, thereby controlling the electromagnet.

[0281] Available Figures 45-48 The method of implementation may include deploying an elongated shaft into a location within a patient's body, the elongated shaft including a capsule body surrounding an implant holding region, the capsule body holding the implant for implantation within the patient's body. At least one electromagnet may be used to attract or repel portions of the capsule body to alter the size of the capsule body within the patient's body. The radial dimension of the capsule body can be increased using at least one electromagnet. For example, at least one electromagnet may be energized to repel portions of the capsule body, or at least one electromagnet may be de-energized to allow a biased body to increase the size of the capsule body. The implant may be deployed from the capsule body with the increased radial dimension. Furthermore, the size of the capsule body may be increased to recapture portions of the implant. Further, the implant may be inserted into the capsule body with the increased radial dimension. The implant may be inserted into the capsule body during loading of the implant. The size of the capsule body is dynamically adjustable.

[0282] Figures 49-59 An embodiment including an electrically detachable connector configured to be coupled to and at least partially detached from an implant is illustrated. Figures 49-55 An implementation using an electrolytically detachable connector is shown.

[0283] refer to Figure 49 The electrolytically detachable connector can be electrolytically corroded using a circuit. The circuit may include electrical conduits 700a and b that can be connected to a power source 702. The electrical conduits 700a and b can be connected to electrical terminals. Patient blood and other fluids or materials can be used as conduits for the circuit to electrically connect to the electrical terminals. For example, as... Figure 49As shown, the electrical terminal 704 can be configured to be positioned on a part of a patient's body. The electrical terminal 704 can be configured to be coupled to the electrodes of a patch coupled to the patient's body. The patch can be positioned on the patient's skin and may be located near the shoulder or on the chest or other parts of the patient's body. In other embodiments, other forms of electrical terminals, such as clamps or other devices for coupling to the patient's body, may be utilized. The electrical terminal 704 can be coupled to an electrical conduit 700a coupled to a power source 702. The electrical conduit 700b can be coupled to the power source 702 and can extend along an elongated axis of the delivery device to reach the electrical terminal as part of an electrolytically detachable connector. The electrolytically detachable connector may include a first portion of a circuit, and the electrical terminal 704 may form a second portion of the circuit. The power source 702 can electrically couple the first portion of the circuit to the second portion of the circuit and can be configured to conduct current between the first and second portions.

[0284] Figure 50 For example, a schematic side cross-sectional view of an implant holding region—including an implant 706 positioned therein—is illustrated. Implant 706 may be configured similarly to implant 70 or another form of implant disclosed herein. Implant 706 may include a distal anchor 708 and a proximal anchor 710 and may be a self-expanding implant. Figure 50 The implant 706 shown can be in a compressed state within the implant holding area 712.

[0285] The capsule body 714 may surround the implant 706 within the implant retention area 712 and may be configured similarly to the capsule body 106 or any other capsule body disclosed herein. The capsule body 714 may be formed of an outer sheath 716 and an outer retention ring 718, which may be configured similarly to the corresponding outer sheath and outer retention ring 42 separately disclosed herein. The nasal cone shaft 720 may be coupled to the nasal cone 722, which may be configured similarly to the nasal cone shaft 27 and nasal cone 28, or any other nasal cone shaft or nasal cone disclosed herein.

[0286] Figure 50 The delivery device shown may include electrolytically detachable connectors 724a, b, which are coupled to implant 706. The electrolytically detachable connectors 724a, b may be coupled to the proximal end of implant 706, such as... Figure 50 As shown. Figure 51 A connection point is provided between the electrolytically detachable connector 724a and the implant 706 (in Figure 50 Enlarged view of (reference number 726a points to this location). Implant 706 may include proximal connector 726a, which can be positioned with... Figure 3A The mushroom-shaped protrusion 74 shown is in a similar position. Figure 51As shown, the proximal connector 726a may include a cavity or other form of connector receiving an electrolytically detachable connector 724a. The electrolytically detachable connector 724a may form a rigid connection with the proximal connector 726a. The electrolytically detachable connector 724a may include an exposed electrical terminal 728, which is exposed and in fluid contact with the patient during deployment of the implant 706. The exposed electrical terminal 728 may be electrically connected to an electrical conduit 700b, which may extend along an elongated axis to a power source 702, such as... Figure 49 As shown. The portion adjacent to the exposed electrical terminal 728 can be electrically insulated; for example, an electrically insulated portion 730 may be located close to the exposed electrical terminal 728 and another electrically insulated portion 732 may be positioned distal to the exposed electrical terminal 728. This prevents current from the electrical conduit 700b from reaching the implant 706. In other embodiments, the implant 706 can be electrically insulated.

[0287] The electrolytically detachable connector 724a can be configured such that when current flows through the electrical conduit 700b with power source 702, the exposed electrical terminal 728 can make electrical contact with the patient's fluid (which may be blood during the delivery of the implant to the patient's heart) and can utilize the fluid to complete the circuitry with terminal 704. The exposed electrical terminal 728 can disintegrate due to electrolytic corrosion and can be partially detached from the implant 706.

[0288] For example, such as Figure 52 As shown, the capsule body 714 can be placed in the desired location within the patient's body, and the outer sheath 716 and outer retaining ring 718 can be retracted to expose the implant 706. The implant 706 can begin the expansion process while remaining connected to the electrolytically detachable connectors 724a, b. After the implant 706 is positioned in the desired location, the power supply 702 can be supplied to allow current to flow through the electrical conduits 700a, b. The electrolytically detachable connectors 724a, b can disintegrate due to electrolytic corrosion and thus be removed from the implant 706, as... Figure 53 As shown. The implant 706 can then be held in the appropriate position within the patient's body as desired, for example, the implant 706 can be held deployed to the patient's heart valve. The delivery device can then be removed from the patient's body as disclosed herein.

[0289] The electrolytically detachable connectors 724a and 724b can be disassembled after assessing implant anchoring and hemodynamic stability. The electrolytically detachable connectors 724a and 724b provide a robust, rigid attachment capable of withstanding forces involved in repositioning and re-attaching the implant (if required). Furthermore, the use of the electrolytically detachable connectors 724a and 724b reduces the overall length and size of the deployment mechanism.

[0290] Figure 54Example Figures 50-53 A variation of the embodiment shown includes an electrical conduit 700a that can be coupled to an electrical terminal 734 positioned on an elongated shaft. For example, as... Figure 54 As shown, the electrical terminal 734 can be positioned on the nose cone shaft 720, but in other embodiments, other locations of the electrical terminal 734 can also be utilized. For example, the electrical terminal 734 can be positioned as needed on portions of the inner assembly, rail assembly, central shaft assembly, or outer sheath assembly. The electrical terminal 734 can be coupled to the electrical conduit 700a to form a return path to the electrical conduit 700b leading to the electrolytically detachable connectors 736a, b. Thus, in such an embodiment, it is unnecessary to use... Figure 49 The electrical terminal 704 shown forms a return path for the circuit because the electrical terminal 734 on the elongated shaft. Electrolytically detachable connectors 736a, b may include a first portion of the circuit, and the electrical terminal 734 may be coupled to the elongated shaft and form a second portion of the circuit. Further, as... Figure 54 As shown, the electrolytically detachable connectors 736a, b can be in the form of tethers extending to the proximal end of the implant 706 and connected to the implant 706. Thus, as the outer sheath 716 and outer retaining ring 718 are retracted, the implant 706 can be deployed to its fully expanded size. However, the electrolytically detachable connectors 736a, b remain connected to the implant 706 until the implant 706 needs to be removed from the elongated shaft. A power source can then be applied to allow current to flow through the electrical conduit, thereby disintegrating the electrolytically detachable connectors 736a, b due to electrolytic corrosion.

[0291] In some embodiments, an electrolytically detachable connector may be used to eliminate the need for one or more of the outer sheath 716 or outer retaining ring 718. For example, the electrolytically detachable connector may be used to retain the implant 706 by applying a force that restricts the expansion of the implant 706. Figure 55 For example, an embodiment in which an electrolytically detachable connector 738 extends on the outer surface of implant 706. The electrolytically detachable connector 738 may include a coil extending on implant 706, such as... Figure 55 As shown, or as required, it may have various other shapes (e.g., sheaths, longitudinal slats, meshes, etc.). However, the electrolytically detachable connector 738 can operate in a similar manner to that discussed with respect to other electrolytically detachable connectors disclosed herein, i.e., the electrolytically detachable connector 738 can disintegrate due to electrolytic corrosion and can be partially detached from the implant 706. The implant 706 can then expand after the electrolytically detachable connector 738 has disintegrated. A variety of other configurations of the electrolytically detachable connector may be used as required.

[0292] Figures 56-57An embodiment is shown in which an electrolytically detachable connector 740 is utilized, which disintegrates due to heat generated by the current flowing through it. For example, an electrical conduit—similar to conduits 700a, 700b—can be connected to a power source 702 and allow current to flow through the electrolytically detachable connector 740. The electrolytically detachable connector 740 may be made of a material that disintegrates due to the heat provided by the current flowing through it, thus operating in a manner similar to a fused wire or the like. The electrolytically detachable connector 740 can disintegrate at a desired time to be detached from the implant 742. The implant 742 may be configured similarly to the implant 70 or any other implant disclosed herein.

[0293] The electrolytically detachable connector 740 can Figure 57 The method shown in the enlarged diagram is connected to the implant 70 (in Figure 56 Reference numeral 744 points to this location. An electrolytically detachable connector 740 may include a connector 744 on a portion surrounding the implant 742 (e.g., as shown in the image). Figure 57 The proximal connector of the implant 742 shown passes through a ring. This ring can be coupled to catheters 700a and 700b, and the electrically detachable connector 740 can be thermally disintegrated and detached from the implant 742 when current flows through catheters 700a and 700b and the ring. Catheter 700a may include a first portion of a circuit coupled to a first portion of the electrically detachable connector 740, while catheter 700b may include a second portion of a circuit coupled to a second portion of the electrically detachable connector 740 (wherein the first and second portions of the electrically detachable connector 740 include portions of the ring). Both catheters 700a and 700b may extend along an elongated axis. Other configurations of the connector 740, including other coupling locations, may be used as needed.

[0294] Figures 58-59 An embodiment of an electrolytically detachable connector 746 including one or more electromagnets 748 is illustrated. The electromagnets 748 may be configured to magnetically attract portions of an implant 750, which may be configured similarly to implant 70, and may also include a magnetically responsive material 752 coupled to the electromagnets 748. One or more electromagnets 748 may be coupled to an electrical conduit that may be configured similarly to conduits 700a, 700b and extend along an elongated axis. Figure 59 As shown, after one or more electromagnets 748 are de-energized, the electrically detachable connector 746 can be removed from the implant 750.

[0295] The electrically detachable connector disclosed herein can be used with any embodiment of the delivery system disclosed herein. The electrically detachable connector can, for example, be used with a delivery device having an elongated shaft. The elongated shaft may include a steerable rail shaft and a shaft configured to move relative to the rail shaft. The shaft can be coupled to the electrically detachable connector. In embodiments, the elongated shaft may include an outer sheath having a cavity and proximal and distal ends, wherein at least a portion of the outer sheath surrounds an implant holding area, and wherein the shaft is positioned within the cavity and the rail shaft is positioned within the cavity. The outer sheath may be configured to retract relative to the shaft to expose at least a portion of the implant. An electrically detachable connector can be used instead of [other devices]. Figure 2A-2C The inner retaining ring 40 is shown, and the electrically detachable connector is in the same position.

[0296] As disclosed herein, the electrically detachable connector can be controlled by a processor operable to actuate the electrically detachable connector and thus detach at least a portion of the implant from the electrically detachable connector. Such operation may occur in response to user input—via a control device or the like—or the processor may actuate the electrically detachable connector automatically as needed. For example, the processor may actuate the electrically detachable connector in response to sensor readings (e.g., one of the sensors disclosed herein) or in response to a procedure instructing the electrically detachable connector to be actuated. The processor may be configured to automatically actuate the electrically detachable connector and deploy the implant.

[0297] The power supply for the electrically detachable connector can be connected to the controller, for example... Figure 18 The controller 530 shown is integrated. An electrical conduit for the electrically detachable connector can extend to the controller. The processor can be configured to control the power supply, thereby controlling the electrically detachable connector.

[0298] Available Figures 49-59 The method of implementation may include extending a delivery device within a portion of a patient's body to deliver an implant to a body location. At least a portion of the implant may be detached from an electrically detachable connector within the patient's body. The implant may be any form of implant disclosed herein, including a prosthetic replacement heart valve, including an expandable prosthetic replacement heart valve. The implant may be a self-expanding prosthetic replacement heart valve and may be a prosthetic mitral valve. Other forms of implants (including implants for repairing or replacing heart valves) may be used as needed. The electrically detachable connector may hold at least a portion of the expandable prosthetic replacement heart valve in a compressed state. The electrically detachable connector may be coupled to the proximal end of the expandable prosthetic replacement heart valve. Detachment of at least a portion of the implant from the electrically detachable connector allows that portion of the implant to expand. The implant may be deployed to a body location as disclosed herein.

[0299] As will be appreciated from the foregoing description, inventive products and methods for implant delivery systems have been disclosed. Although several components, techniques, and aspects have been described to a certain degree of specificity, it will be apparent that various modifications can be made to the particular designs, configurations, and methods described above without departing from the spirit and scope of this disclosure.

[0300] Some features described in this disclosure in individual embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in a single embodiment may also be implemented separately in multiple embodiments or in any suitable sub-combination. Furthermore, although features may be described above as operating in certain combinations, in some cases one or more features may be removed from a claimed combination, and the combination may be claimed as any sub-combination or variation of any sub-combination.

[0301] Furthermore, although methods may be depicted in the accompanying drawings or described in the specification in a specific order, it is not necessary to perform these methods in the specific order shown or in a sequential order, nor is it necessary to perform all methods to obtain the desired results. Other methods not depicted or described may be incorporated into the example methods and processes. For example, one or more other methods may be performed before, after, simultaneously with, or between any of the described methods. Additionally, methods may be rearranged or reordered in other embodiments. Moreover, the separation of various system components in the above embodiments should not be construed as requiring such separation in all embodiments, and it should be understood that the described components and systems can generally be integrated into a single product or packaged into multiple products. Furthermore, other embodiments are also within the scope of this disclosure.

[0302] Unless otherwise specifically stated or otherwise understood in the context in which they are used, conditional language (such as "may," "can," "may," or "will") is generally intended to convey whether certain implementations include or exclude certain features, elements, and / or steps. Therefore, such conditional language is generally not intended to imply that a feature, element, and / or step is necessary in any way for one or more implementations.

[0303] Unless otherwise specifically stated, connective language (such as the phrase "at least one of X, Y, and Z") is understood in context to generally convey that an item, term, etc., can be X, Y, or Z. Therefore, such connective language is not generally intended to imply that some implementation requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0304] The degree language used herein (such as the terms "approximately," "about," "generally," and "substantially") refers to a value, quantity, or characteristic that is close to the stated value, quantity, or characteristic and still performs the desired function or still produces the desired result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to a quantity that is less than or equal to 10% of the stated quantity, less than or equal to 5% of the stated quantity, less than or equal to 1% of the stated quantity, less than or equal to 0.1% of the stated quantity, or less than or equal to 0.01% of the stated quantity. If the stated quantity is 0 (e.g., none, not at all), then the ranges defined above can be specific ranges and not within a specific percentage of that value. For example, within 10 wt. / vol.% of the amount less than or equal to the amount, within 5 wt. / vol.% of the amount less than or equal to the amount, within 1 wt. / vol.% of the amount less than or equal to the amount, within 0.1 wt. / vol.% of the amount less than or equal to the amount, and within 0.01 wt. / vol.% of the amount less than or equal to the amount.

[0305] Some embodiments have been described with reference to the accompanying drawings. The drawings are drawn to scale, but such scale should not be limiting, as other dimensions and scales besides those shown are conceivable and within the scope of the disclosed invention. Distances, angles, etc., are merely exemplary and do not necessarily have a precise relationship to the actual size and layout of the illustrated device. Components may be added, removed, and / or rearranged. Furthermore, any particular feature, aspect, method, property, characteristic, quality, attribute, element, etc., of this disclosure may be used in combination with various embodiments in all other embodiments described herein. Additionally, it will be appreciated that any of the methods described herein can be practiced using any means suitable for performing the defined steps.

[0306] Although various embodiments and their variations have been described in detail, other modifications and methods of using them will be apparent to those skilled in the art. Therefore, it should be understood that various applications, modifications, materials, and substitutions may be made by equivalents without departing from the unique and inventive scope of this disclosure or the claims.

Claims

1. A delivery system (10) for delivering an implant to a location within a patient's body, the delivery system (10) comprising: A delivery device configured to deliver the implant (70) to the location within the patient's body; At least one motor (500) is configured to actuate at least a portion of the delivery device; A processor (536) is configured to operate the at least one motor (500) to actuate at least the portion of the delivery device; and One or more sensors are configured to sense one or more of the conditions of the delivery device. The processor (536) is configured to operate the at least one motor (500) based on signals from the one or more sensors to actuate at least the portion of the delivery device. The one or more sensors are configured to sense the spatial relationship between the delivery device and the surface of the patient's body. The processor is configured to operate at least one motor (500) based on signals from the one or more sensors to cause at least the portion of the delivery device to avoid or retract from the surface of the patient's body.

2. The delivery system of claim 1, wherein the processor (536) is configured to operate the at least one motor (500) to deflect at least the portion of the delivery device.

3. The delivery system of claim 1, wherein the processor (536) is configured to operate the at least one motor (500) to deploy the implant (70) from the delivery device.

4. The delivery system of claim 1, wherein the delivery device comprises a housing (14) and an elongated shaft (12) configured to hold the implant (70) and having a distal end (13) and a proximal end (11) coupled to the housing (14).

5. The delivery system of claim 4, wherein the processor (536) is configured to operate the at least one motor (500) to deflect the elongated shaft (12) in at least two planes.

6. The delivery system according to claim 4, wherein the processor (536) is configured to operate the at least one motor (500) to axially translate the elongated shaft (12) and the housing (14).

7. The delivery system of claim 4, wherein the elongated shaft (12) comprises a plurality of components (18, 20, 21, 22, 31) each extending along the length of the elongated shaft (12), and the processor (536) is configured to operate the at least one motor (500) to move the first of the plurality of components (18, 20, 21, 22, 31) relative to the second of the plurality of components (18, 20, 21, 22, 31).

8. The delivery system of claim 7, wherein the processor (536) is configured to operate the at least one motor (500) to cause the first of the plurality of components (18, 20, 21, 22, 31) to move simultaneously with the second of the plurality of components (18, 20, 21, 22, 31).

9. The delivery system of claim 7, wherein the first of the plurality of components (18, 20, 21, 22, 31) is located within the cavity of the second of the plurality of components (18, 20, 21, 22, 31).

10. The delivery system of claim 7, wherein the processor (536) is configured to operate the at least one motor (500) to move the first of the plurality of components (18, 20, 21, 22, 31) to compensate for the movement of the second of the plurality of components (18, 20, 21, 22, 31).

11. The delivery system of claim 1, wherein the one or more sensors are configured to sense one or more of the patient's physical condition.

12. The delivery system of claim 1, wherein one or more sensors are coupled to the delivery device.

13. The delivery system of claim 1, wherein the one or more sensors include one or more contact sensors or proximity sensors coupled to the delivery device.

14. The delivery system of claim 1, wherein the processor (536) is configured to operate a program to automatically operate the at least one motor (500) to actuate at least the portion of the delivery device.

15. The delivery system of claim 1, further comprising control means (504, 556, 562, 588) for providing input from a user to the processor (536), The control device (504, 556, 562, 588) includes one or more of a button, joystick, touchpad, touch screen, knob, or motion sensing device.

16. The delivery system according to claim 1, wherein: The one or more sensors are further configured to sense one or more of the patient's physical conditions; and The processor is further configured to provide output based on one or more of the patient's physical condition or the condition of the delivery device sensed by the one or more sensors.

17. The delivery system of claim 16, further comprising an output means for providing an indicator based on the output provided by the processor.

18. The delivery system of claim 17, wherein the output device is coupled to the delivery device.

19. The delivery system of claim 17, wherein the output device comprises one or more of a display screen, a lamp, a speaker, or a tactile device.

20. The delivery system of claim 17, wherein the indicator comprises one or more of an image, data, sound, light, or tactile signal.

21. The delivery system of claim 16, wherein the output includes a data log for an implantation procedure using the delivery device, and the delivery system further includes a memory for storing the data log.

22. The delivery system of claim 16, wherein the delivery device includes a housing and an elongated shaft configured to hold the implant and having a distal end and a proximal end coupled to the housing, and the output is configured to deflect at least a portion of the elongated shaft by the at least one motor.

23. The delivery system of claim 16, wherein the patient's physical condition includes one or more of pressure within the patient's body or flow within the patient's body.

24. The delivery system of claim 16, wherein the delivery device includes a handle and an elongated shaft configured to hold the implant and having a distal end and a proximal end coupled to the handle, and the one or more sensors are coupled to the elongated shaft, and the processor is positioned within the handle.

25. The delivery system of claim 24, further comprising a power source located within the handle.

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