Patent ID: 12227888

DETAILED DESCRIPTION

The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

Although certain preferred embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Further, one or more steps disclosed with respect to one method may be incorporated into other methods disclosed herein. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein. Features described with respect to one exemplary embodiment may be incorporated into other embodiments disclosed herein even if not specifically described with respect to the embodiment.

Overview

Prosthetic heart valve implants, as well as many other types of prosthetic implant devices and other types of devices, can include various sutured components and/or portions. For example, a sealing portion, skirt, etc. can be sutured to a frame of a prosthetic heart valve to help prevent blood from leaking around the outer edges or circumference of the prosthetic heart valve. Execution of sutures by a human operator may be relatively difficult and/or cumbersome in certain conditions. For example, where small stitches are to be made with high precision, the complexity and/or associated operator burden may result in injury and/or undesirably low quality of products. Furthermore, certain heart valve implant devices may require upward of a thousand sutures, which can involve substantially labor-intensive and error-susceptible suturing procedures. Therefore, collaborative suturing aids can be desirable to improve quality and/or to reduce the possibility of operator strain.

Certain embodiments disclosed herein provide collaborative heart valve suturing systems, devices, and/or methods for providing suturing assistance for point-by-point suturing procedures based on the physical manipulation and/or positioning of one or more automated mechanical articulating fixtures, components, and/or subassemblies. Such articulating fixture(s) or component(s) may be configured to hold or secure a prosthetic human heart valve implant device or other suturing subject or implant device having one or more components or portions that may advantageously be sutured together. Suture assistance systems, devices, and/or processes in accordance with the present disclosure may implement a focused visual display system configured to provide visual aids for stitch targeting, operator instruction communication, or the like. The various embodiments relating to heart valve suturing presented herein can be applicable to heart valves having any type of suturing and/or structural configuration or pattern. Examples of heart valve structures and heart valve suturing techniques that may be applicable to certain embodiments presented herein are disclosed in WIPO Publication No. WO 2015/070249, the entire contents of which is hereby expressly incorporated by reference for all purposes.

FIG.1illustrates an implantable prosthetic human valve device110according to one or more embodiments. The features of valve110described herein can apply to other valves, including other valves described elsewhere herein. The valve110can be, for example, a transcatheter heart valve (THV), balloon-expandable heart valve, and/or mechanically-expandable heart valve. The valve110in the illustrated embodiment can generally comprise a frame, or stent,112, a leaflet structure193supported by the frame112, and a sealing member or skirt116secured (e.g., sutured) to the outer surface of the leaflet structure193. In certain embodiments, the valve110may be configured to be implanted in the annulus of a native heart valve of a human, such as an aortic valve. However, the valve110can additionally or alternatively be adapted to be implanted in other native valves of the heart, or in various other vasculature, ducts, or orifices of the body, or in grafts, docking stents, docking stations, rings, etc. implanted in the body. The lower end180, according to the illustrated orientation, of the valve110may represent an inflow end, while the upper end182, according to the illustrated orientation, of the valve110may represent an outflow end.

The valve110and the frame112may be configured to be radially collapsible to a collapsed or crimped state/configuration for introduction into the body using a delivery catheter, and further may be configured to be radially expandable to an expanded state/configuration for implanting the valve at a desired location in the body (e.g., the native aortic valve). In certain embodiments, the frame112may comprise a plastic, polymer, shape memory material, or metal expandable material that permits crimping of the valve110to a smaller profile for delivery and expansion of the valve. In one embodiment, an expansion device, such as the balloon of a balloon catheter or a tool for mechanical expansion, may be used to expand or help expand the valve. In certain embodiments, the valve110may be a self-expanding valve, wherein the frame is made of a self-expanding material such as a shape memory material or metal (e.g., Nitinol). Self-expanding valves may be able to be crimped to a smaller profile and held in the crimped state with a restraining device, such as a sheath covering the valve. When the valve is positioned at or near the target site, the restraining device may be removed or retracted to allow the valve to self-expand to its expanded, functional size or to a deployed configuration.

The sealing portion or skirt116may comprise a single piece or multiple pieces or material (e.g., cloth, polymer, etc.) with opposite ends that are secured to each other to form the annular shape shown inFIG.1or extend around a circumference of the valve. In certain embodiments, the upper edge of the sealing portion or skirt116can have an undulating shape that generally follows the shape of struts of the frame112. In this manner, the upper edge portions of the sealing portion or skirt116can be tightly secured to respective struts with sutures156. The sealing portion or skirt116may be placed on the outside of the frame112or on the inside of the frame112(as shown) and an upper edge portion of the sealing portion or skirt116may be wrapped around the upper surfaces of the frame struts and secured in place with sutures. The sutures156may serve to provide a durable attachment of the sealing portion or skirt116to the frame112.

The leaflet structure193can comprise three leaflets (as shown inFIG.1) in certain embodiments, which can be arranged to collapse in a tricuspid arrangement. Although a three-leaflet embodiment is illustrated, it should be understood that valve implants sutured according to embodiments disclosed herein may have any number of leaflets, such as, for example, two or four. The leaflets193may be formed from separate flaps of material or tissue, such as, for example, xenograft tissue (e.g., bovine pericardium), or all three leaflets can be derived from a single xenograft valve (e.g., a porcine valve). The lower edge of leaflet structure193may have a variety of shapes. In certain embodiments, the lower edge of the leaflet structure193may have an undulating, curved, and/or scalloped shape that may be sutured to the frame112. The leaflets193can be secured to one another at their adjacent sides to form commissures184of the leaflet structure, where the edges of the leaflets come together. The leaflet structure193can be secured to the frame112using any suitable techniques and/or mechanisms. For example, the commissures184of the leaflet structure may be aligned with the support posts118and secured thereto, e.g., using sutures, adhesive, clamping portions, crimping, and/or other attachment means. In one embodiment, the point of attachment of the leaflets193to the posts118can be reinforced, e.g., with bars comprising a relatively rigid material, such as stainless steel.

FIG.2is a perspective view of a prosthetic human heart valve210in accordance with one or more embodiments. The heart valve210may include a peripheral sealing ring structure291configured to provide support for nesting the heart valve210in a heart valve cavity and/or resting upon, or attached to, an annulus or other structure of the heart. The valve210can further include a frame member292, such as a metal frame, which may provide support for a plurality of flexible leaflets293and can define three upstanding commissure posts294, wherein the leaflets293can be supported between the commissure posts294. In one embodiment, as shown inFIG.2, the sealing ring291can attach around the periphery of the frame member294at the inflow end of the valve210, with the commissure posts294projecting in the outflow direction.

The leaflets293may be formed from separate flaps of material or tissue, such as, for example, xenograft tissue (e.g., bovine pericardium), or all three leaflets can be derived from a single xenograft valve (e.g., a porcine valve). The leaflets293can be secured and supported both by the commissure posts294, as well as along arcuate cusps of the frame member between the commissure posts.

FIG.3Ashows a frame392for a support stent for a surgical heart valve such as the valve210ofFIG.2. The frame392can include multiple cusps curved toward an axial inflow end alternating with multiple commissures322projecting toward an axial outflow end, the support stent392defining an undulating outflow edge. The support stent392can comprise a wireform320having three upstanding commissures322alternating with three cusps324which generally circumscribe a circumference. A stiffening band326may be disposed within or without the wireform320. The inflow edge of the band326can conform or at least partially conform to the cusps324of the wireform320and may be curved in the outflow direction in between in the region of the wireform commissures322, e.g., as shown inFIG.3A. In certain embodiments, the support stent392provides the supporting structure of a one-way prosthetic heart valve like the valve210ofFIG.2.

FIG.3Billustrates the frame ofFIG.3Acovered with fabric340, wherein the fabric340may be sutured in one or more portions to secure the fabric340as a covering for the frame392. The fabric-covered support stent342may be generally tubular and may include multiple cusps344curved toward an axial inflow end alternating with multiple commissures346projecting toward an axial outflow end. The support stent342may comprise an undulating outflow edge about which the fabric340is secured held. In certain embodiments, a seam350may be sutured adjacent an inflow edge352that secures the fabric340about the support stent. The seam350is shown slightly axially above the inflow edge352for clarity, although it may be located directly at the inflow edge or even inside the support stent. In one embodiment, one or more seams may be located in other positions along the fabric. The sutures of the support stent342may be executed or added in multiple ways. Furthermore, although certain stitches are illustrated inFIG.3B, the support stent342and/or valve implant210ofFIG.2can comprise any type or number of stitches or sutures. For example, the support stent342and/or one or more other components of the associated implant device, can also have leaflets and/or other materials sutured thereto.

Suturing of prosthetic heart valve devices and/or other implant devices, such as those described above, can be performed in various ways. For example, certain handheld processes for suturing prosthetic human implant devices can be implemented in which an operator utilizes both hands for holding, securing, and/or suturing the implant device.FIG.4illustrates an operator405performing operations on a prosthetic human implant device410. For example, the operator405may suture an outer wireframe of the device410to an inner skirt or cloth, as described above, where the implant device410is a transcatheter heart valve device. In some embodiments, the implant device410may be a surgical valve device, or other type of implant device. The implant device410can be the same as or similar to any of the valves described herein or can be a different type of valve or implant device.

As illustrated in the diagram ofFIG.4, in some processes, an operator405may need to utilize both of the operator's hands for executing relevant suturing operations. For example, a first hand406may be used to hold and/or secure the implant device410, wherein a second hand407may be used to manually operate a suturing needle or the like.

For the operator405to effectively execute the relevant suturing operations on the implant device410, it may be necessary or desirable for the view of the implant device410to be magnified or otherwise enhanced in some manner. For example, as shown, the operator may further utilize a magnification system460, such as a microscope, which may comprise an eyepiece component461as well as one or more lenses and/or refractive elements463. In certain embodiments, the magnification system460may be designed such that the operator405may have a line of sight409at a first angle, wherein the magnification system460is configured to at least partially reflect light therein at a downward angle408to provide a depth of field at a targeted distance from the refractive elements463. By holding the implant device410, or target portion thereof, within the depth of field of the magnification system460, the operator405may be able to observe an enhanced view of the implant device410or target portion thereof, which may be desirable or necessary to execute the precise suturing operations for effectively suturing the implant device410.

In certain configurations, the use of a microscope as a visual aid in suturing implant devices may present ergonomic issues with respect to posture and/or vision of the operator405. For example, the working plane presented by the microscope, with which the operator may be aligned when operating the microscope, may not adequately conform to the natural body position of the operator. To bring the operator's eyes into necessary proximity with the eyepiece461of the magnification system460, undesirable neck and/or back strain or stress may be caused as the operator maintains the necessary posture for viewing the implant device410through the eyepiece461. Therefore, use of a microscope, or similar magnification or viewing system, may be undesirable with respect to ergonomic and/or vision concerns.

Alternative systems and methods for visual aid in implant suturing may involve, for example, digital video systems, which may help to reduce the possibility of operator neck strain, among other possible benefits. However, such systems may present difficulty with regards to focusing the implant or part being operated on under the camera associated with the video system when the implant or part is manually handled by the operator. With handheld operation, focus of the camera may be blurred and/or distorted when the implant or target part moves or is not aligned correctly with the lens axis, which may result in a loss of depth perception and/or other problems. For example, displays of a camera image can appear blurred due to slow pixel response times, refresh times, etc. when an implant or target part moves. This can be especially problematic when displaying high resolution images/video and/or magnifying the images/video. Furthermore, where the operator is required to hold the target implant, alteration of the viewing angle may further require twisting and/or contorting of the operator's hands in order to position the target implant, which may result in sub-optimal positioning. In addition, the location of the target implant may be such that a different viewing angle is required by the operator to view the target part than is required to view the monitor of the video system, which may cause eyestrain and/or other issues. Alternative solutions for visual aid in implant suturing operations may involve the use of a glass visor or the like, which may provide beneficial performance with respect to hand-eye coordination and/or neck placement. However, such tools may provide relatively poor zooming capabilities, and may cause eyestrain for the operator over extended periods of time.

FIG.5illustrates a close-up view of a prosthetic human implant device being sutured using manual holding and suturing, as described above. As shown, for handheld suturing solutions, a first hand506may be required to hold the target implant device510, while a second hand507may be required to manipulate the suturing needle509, or the like. According to certain processes, the operator may be required to hold one or more hands in a substantially constant position over prolonged periods of time to maintain the target implant device510(or desired portion thereof) within the depth of field of a microscope. Furthermore, the operator may be required to squeeze, push, pull, or otherwise exert manual force on one or more portions of the target implant device510and/or suture needle509, thereby causing strain on muscles, joints, or the like, of the operator's hands and/or other anatomy. In certain embodiments, up to 20 pounds or more of force may be required to be exerted by the operator's hands in certain operations. Such forces may be required repeatedly throughout a suturing process and may result in various injuries to the operator.

Visual magnification and/or accurate positioning of an implant device may be necessary or desirable due at least in part to the dimensions of the cloth or other material being sutured in an implant suturing operation. For example,FIG.6illustrates a close-up view of a fabric associated with an implant device according to one or more embodiments. Such fabrics may comprise woven strands forming ribs having relatively small gaps therebetween. For example, each rib in a fabric region to be sutured may have a thickness t of approximately 0.2 mm, or less. For certain processes, the operator may necessarily or desirably wish to position and sew such a fabric within one-rib accuracy. Therefore, precise positioning and focusing of suturing components and targets is desirable.

In certain implementations, suturing (e.g., implant suturing) or other processes could be performed using one or more holder devices, such as a handheld gooseneck holder or mounted holder type device. However, such devices may not be rapidly adjustable to new locations, which may negatively impact performance efficiency or speed. Furthermore, refocusing of a microscope or other vision system to a location associated with such a holder device may be difficult. Handheld holders and tools may require operators to hold the holder or tool with one hand, thereby limiting the ability of the operator to use such holding hand to adjust the fabric or other material for tensioning and/or realignment.

Certain embodiments disclosed herein provide systems and processes for suturing components and/or devices (e.g., prosthetic human implant devices) using multi-access assist systems, such as in a direct-human-assist mode for suturing implant devices. Such systems can be configured to articulate a component/device (e.g., an implant device such as a human prosthetic heart valve device, etc.) precisely underneath an imaging system or visualization system (e.g., a high-definition (HD) camera, multiple cameras, etc.), wherein the precise positioning of the component or device can allow for necessary or desirable focusing and imaging of a desired position or target position (e.g., a current suture position or other position to be processed, inspected, etc.). Furthermore, the system can be further configured to reposition the component and/or imaging system to anticipate a subsequent position (e.g., a subsequent suture position, review or inspection position (e.g., for quality control inspection), or other position). In certain embodiments, a display associated with the system or implant suturing system can include visual aids to assist the operator in locating and/or interpreting an operation (e.g., a suture operation, review or inspection operation, processing operation, training operation, or other operation) to be performed. For example, such a display monitor may provide crosshairs, visual aids, overlays, comparative images, patterns, maps, and/or a type of reticle, or the like, to indicate the desired position or result (e.g., the desired suture position or completed suture).

Embodiments disclosed herein may provide improved ergonomics for operators, which may reduce medical costs and/or liabilities associated with hand, neck, shoulder, and/or vision injuries, for example. Furthermore, embodiments disclosed herein may provide improved reliability and/or repeatability for suturing processes, review or inspection, or other processes. For example, suturing an implant device or heart valve can require suture accuracy within a millimeter, half a millimeter, or less, but a suture location may be easily missed between ribs or threads, especially when implementing dual-handheld suturing procedures. Embodiments of the present disclosure can facilitate improved precision and can also provide the freedom of only requiring a single hand for certain suturing operations and/or other operations (e.g., inspection, processing, etc.).

Positional accuracy may be improved with respect to embodiments of the present disclosure through the use of systems incorporating one or more cameras, articulation arms, automated fixtures, monitors, etc., and/or a combination of more than one of these. Such systems can be used to position a target component or device (e.g., an implant device such as a human prosthetic heart valve device, etc.) in a desirable position with a relatively high degree of accuracy and repeatability. Such systems can also facilitate identifying desired positions (e.g., suture positions, inspection positions, etc.), such as with respect to frame and skirt suturing for a transcatheter heart valve.

Embodiments disclosed herein and the incorporation of features according to the present disclosure can provide or be used for training and/or technology transfer that may ultimately result in substantially reduced process or operation times and can help reduce the difficulty of operations and procedures. For example, it can be relatively difficult to convey training to an operator with respect to a particular procedure, and improved solutions disclosed herein can help reduce the complexity of certain procedures with enhanced training and/or by diverting certain procedures to mechanical components configured to manipulate the target device or component as necessary. Training of operators may be completed with improved efficiency, thereby potentially reducing costs and time. Embodiments can be used to guide operators through desired procedures or operations and demonstrate correct positioning and results. Quality-control feedback can also be provided to further improve quality for manufacturing and training. For example, heart valve implant suturing processes can be relatively labor-intensive and involve relatively long process times, which can result in increased costs and/or injuries. Embodiments disclosed herein and incorporation of features according to the present disclosure may provide for operator training and/or technology transfer that may ultimately result in substantially reduced process times, as well as reducing the difficulty of certain operations of implant suturing procedures. According to certain implementations, it can be relatively difficult to convey training to an operator with respect to suture locations for a particular procedure, especially where such procedures are implemented using dual-hand body mechanics to hold and manipulate the target device. Improved solutions disclosed herein can reduce the complexity of certain operations by diverting certain operations to mechanical components (e.g., automated fixtures) configured to manipulate the target device as necessary. Training of operators is simplified and may be completed with improved efficiency, thereby potentially reducing costs and time. Correct positioning and images of correct suturing can also be demonstrated and displayed to aid training. Quality-controlled feedback for further improving quality for manufacturing and training purposes can be implemented, e.g., the system may be able or programmed to move to key locations for inspection and/or recognition software may be able to detect issues, e.g., to detect whether a suture looks correct or incorrect. This can operate similar to facial recognition software with modifications to determine if the device or component appears to be correctly made or configured (e.g., has the correct shape of suture, or other features, etc.). Similar recognition software can be used for other processes as well to detect whether the target device looks like it should after a particular step, process, operation, etc. Various systems and/or devices disclosed herein may allow for fully automated processes or partially automated processes (e.g., at least partially automated implant suturing).

Operation Assist Articulation System

Embodiments disclosed herein provide for systems, devices, methods, etc. for executing one or more procedures or operations (e.g., suturing operations, attachment operations, review or inspection operations, and/or other operations) for prosthetic heart valve implant devices for humans and/or other types of devices or components.FIG.7Aillustrates a suturing system700A according to one or more embodiments. One or more components of the system700A may be utilized for suturing heart valve devices or other implant devices, as described herein. In one embodiment, the system700A includes a controller730A configured to direct one or more components of an automated fixture assembly770A (often referred to as an automated suture fixture assembly herein but can be an automated fixture or articulation device used for other operations or procedures beyond suturing/sewing as well) according to a particular process (e.g., a suture-assist process). The controller730A can comprise one or more hardware and/or software components designed to generate and/or provide fixture control signals (e.g., suture fixture control signals) and/or data associated with one or more steps of a suturing process or other process. For example, the controller730A can comprise a computing device including one or more processors732, as well as one or more data storage devices or components734, which can include volatile and/or nonvolatile data storage media. Although illustrated as a separate component in the diagram ofFIG.7A, the controller730A can be a component of the automated suture fixture assembly770A. In some embodiments, the data storage734is configured to store process script data (e.g., suture process script data), which can comprise data indicating positioning of one or more components of the system700A for various steps and/or stages of the suturing process or other process (e.g., for inspection, procedures, etc.). A process comprising a plurality of steps can be represented at least in part by numeric or other data sets representing positioning information for one or more components of the automated fixture assembly and/or one or more additional components of the system700A for each respective step or stage of the process. For example, a suturing process comprising a plurality of suturing steps can be represented at least in part by numeric or other data sets representing positioning information for one or more components of the automated suture fixture assembly770A and/or one or more additional components of the system700A for each respective step or stage of the suturing process.

The automated fixture assembly770A can comprise one or more components configured to articulate, operate, and/or position one or more motorized actuators773A to present a target710A (e.g., a heart valve or suture target), in a desirable or suitable position/presentation for convenient engagement or interaction therewith by an operator executing at least part of a process (e.g., a suturing process). In certain embodiments, the automated fixture assembly770A includes a plurality of motorized actuators773A that are mounted, attached, or connected to one another in a desirable configuration to provide a desirable range of motion for the automated fixture (e.g., automated suture fixture) for the purpose of articulating a target710A (e.g., a suture target) associated with or held by the automated fixture770A. In certain embodiments, a target holder component/assembly771A can be associated with, or connected to, one or more of the motorized actuators773A. The motorized actuators773A can each comprise one or more rotating, translating, or otherwise articulating members driven by a motor, a piston, or the like. Examples of automated suture fixture assemblies and associated components are described in greater detail herein with reference toFIGS.10,11,18-25,28-30, and33-35.

The motorized actuators773A can be configured to provide a number of degrees of freedom of movement for the target holder771A and, consequently, a suture target710A coupled to the target holder771A. In some embodiments, the number of degrees of freedom is greater than or equal to 3, greater than or equal to 4, greater than or equal to 5, or greater than or equal to 6. The degrees of freedom can include positioning in any of the three spatial dimensions (e.g., movement in the x-axis, y-axis, and z-axis; horizontal movement, vertical movement, or a combination of horizontal and vertical movement), rotation (e.g., rotation about the x-axis, about the y-axis, and/or about the z-axis), and/or rotation of the target holder771A around a longitudinal axis of the suture target710A (e.g., keeping the position and pointing direction of the suture target710A fixed while rotating the suture target710A around its longitudinal axis to expose a different portion of the suture target710A to an operator and/or camera system760A).

In certain embodiments, the controller730A can provide control signals for directing the positioning of the motorized actuators773A based on a positioning script, suture process script, and/or user input provided by an operator. For example, the system700A can include a user input device715A, which can be used by an operator to provide input directing the operation of the controller730A and/or automated fixture assembly770A. For example, user input device715A can comprise any suitable user input interface, such as a mechanism for user input in connection with a graphic user interface associated with an electronic display, wherein an operator can provide input through interaction with the interface. In some embodiments, the user input device715A can comprise one or more physical switches, buttons, pedals, sensors, or the like, wherein a user may provide input through engagement of such mechanism(s). In some embodiments, the input can be provided using voice commands and/or voice recognition software. In some embodiments, the user input device715A comprises a foot pedal that can be pressed or otherwise engaged by the operator substantially at the same time as the operator is interacting with one or more other components of the suturing system700A. For example, the operator can activate the foot pedal while sitting or standing at a suturing station and engaging with the suture target710A with one or more hands of the operator. For example, the operator can engage the foot pedal as a signal to advance from one step or stage of the present suturing operation to a subsequent step or stage, e.g., the input device715A can provide input to the controller to advance the system through a script moving the automated fixture and target to each position in sequence.

In some embodiments, the system700A includes a visualization system or camera system760A, which can be configured to perform various imaging functionality for assisting with the suturing procedure being executed by the operator. The visualization systems or camera systems herein can include one or multiple imaging devices or cameras, e.g., multiple imaging devices or cameras might be used to add dimensions or depth to the images. The visualization/camera system760A can be configured to generate an image, such as a close-up image and/or high definition image, of the suture target710A (e.g., an image of a portion of the target710A to be sutured, inspected, treated, etc.) and/or associated components of the automated suture fixture assembly770A for the purpose of providing a visual aid for the operator in executing suturing operations, inspections, or other operations. The camera system760A can capture image data for quality control or other purposes at various stages of the suturing procedure or other operation. The camera system760A can operate in connection with a display system750A, such as an electronic computer display, or the like. Therefore, in certain embodiments, the operator can view enlarged imaging of a suture target (e.g., an image of a portion of the target to be sutured) while executing suturing operations thereon, or otherwise inspecting or engaging therewith. In certain embodiments, the camera system760A maintains a constant focus or depth of field during multiple steps of a suturing process, while the automated suture fixture770A articulates the suture target710A in such a way as to bring a target portion of the suture target710A into the depth of field of the camera760A substantially automatically and hold it in place during each step of the process so that the suture target710A remains in focus.

FIG.7Billustrates an operator705executing suture operations with respect to a prosthetic human implant device (e.g., heart valve)710B using a suture assist system700B in accordance with one or more embodiments. Although a plurality of components and devices are illustrated in the system700B ofFIG.7B, it should be understood that suture assist functionality may be implemented in systems having one or more additional components and/or systems that omit one or more components illustrated inFIG.7B. In certain embodiments, the system700B includes an automated suture fixture770B, which may comprise one or more actuator devices (e.g., servo actuator devices), which may be coupled in one of various configurations allowing for an articulation arm778B to be articulated to provide multiple degrees of freedom when manipulating and positioning the coupled implant device710B. For example, the automated suture fixture770B can be configured to articulate the arm778B towards and/or away from the operator705, up and/or down, in a clockwise and/or counterclockwise direction relative to one or more different axes of rotation (e.g., to move or flip the inflow end and outflow end so one or the other is closer to the operator), in various directions/positions relative to x-, y-, and z-axes, and/or in other directions/movements. Furthermore, the arm778B of the suture fixture770B and/or an associated implant holder component771B can be configured to rotate (e.g., rotate about a central or longitudinal axis of the holder771A,771B and/or of the target710A,710B) clockwise or counterclockwise in order to present different portions or regions of the implant device710B to the user705. A distal arm portion778B of the automated suture fixture770B can allow for the operator705to move the target or implant device710B in a position to expose one or more portions of the implant device710B (1) to a viewing assembly760B (e.g., a camera or microscope assembly), or lens thereof and/or (2) to the operator705(e.g., to the operator's hand and/or eye) to perform a procedure (e.g., a suturing step, inspection step, etc.).

In certain embodiments, the automated fixture770B comprises a plurality of motorized actuators (e.g., servo actuators) physically coupled to one another. By constructing the automated suture fixture770B using a plurality of motor components (e.g., servo motor components), the system700B may be relatively inexpensive and/or advantageously provide an enhanced range of motion, as well as multiple axes of rotation. In certain embodiments, the automated suture fixture770B comprises a plurality of actuator devices (e.g., servo actuator devices) daisy-chained together and implemented using a software script to provide cooperative functionality for the purpose positioning the implant device710B. For example, the actuator devices or servo actuator devices (e.g., servo motor devices) can be mounted, or configured to be mounted, horizontally or vertically or at an angle, and may be articulated in any desirable direction. For example, the automated suture fixture770B can be configured to articulate in a snake-like and/or crane-like configuration.FIGS.18-25and28-30illustrate examples of snake-like configurations of an automated fixture that can be used in suturing procedures as an automated suture fixture and/or in other procedures.

The configuration of the automated suture fixture770B can provide the weight and/or size for the automated suture fixture770B that is relatively small and convenient for use in applications designed to assist in the positioning and manipulation of relatively small devices, such as the prosthetic human implant device710B. The relatively small size of the system and automated fixture also allows for use in a more compact workspace like those often used for suturing prosthetic heart valve implants, e.g., the small size can fit and be used even on a relatively small desk/table, which allows for more efficient use of building and work areas. In certain embodiments, the individual actuator devices (e.g., the individual servo actuator devices) of the automated suture fixture770B can comprise brushless potentiostat and/or magnetic encoder devices. In certain embodiments the actuator devices can be implemented using piezoelectric control with analog voltage signals. In certain embodiments, one or more components of the automated suture fixture770B can be controlled using pulse width modulation control signals, such as control signals spaced by between 0 to 2 μs, for example. In certain embodiments, multiple motor components (e.g., multiple servo motor components) of the automated suture fixture770B can share one or more common leads with a multiplex signal, such as a three-lead connection. In some embodiments, the automated suture fixture770B comprises four or five or more servo motor devices. Devices and fixtures disclosed herein can be remote-controllable or at least partially remote-controllable.

The automated fixture770B (e.g., automated suture fixture) can further comprise a target holder assembly771B (e.g., a suture target holder assembly), which can be configured to hold or secure the target710B (e.g., suture target, prosthetic human implant device, etc.) that is the subject of the process that the operator is engaged in. In certain embodiments, the suture assist system700B comprises a camera subsystem760B. In certain embodiments, the camera761B remains in a substantially static configuration during execution of a suturing procedure, wherein the automated suture fixture770B articulates the target implant device into desirable focus with the camera761B during the procedure. In certain embodiments, the camera system760B can be configured to manually or automatically articulate and/or focus to a target position to provide a precise image of a target suture position for the operator's benefit. For example, the positioning/configuration of the camera760B can be controlled at least in part by a controller executing a suture process script as described herein. In certain embodiments, the system700B includes multiple cameras configured to provide multiple-perspective imaging (e.g., a dual-perspective imaging) of the implant device710B and/or automated suture fixture770B, which can help to eliminate or reduced blind spots and/or improve ease of operation. The suture assist system700can further comprise a display monitor750B (or multiple display monitors), which can work in concert with the camera assembly760B and/or automated suture fixture770B to present to the operator705an image identifying a target position (e.g., a target suture position) to further improve precision and ease-of-use of the system700B.

The assist system700B can represent a multi-access assist system for use in a direct human assist for procedures (e.g., for suturing prosthetic human implants, such as heart valves, for inspection and quality control, and/or for other procedures). In certain embodiments, the automated suture fixture770B can hold the target device or implant device710B and articulate the target device or implant device710B to a desired position underneath the camera lens761B, which can be, for example, a high-definition (HD) camera, which can provide further precision in monitoring the procedure (e.g., in the suturing procedure, inspection, or other procedure). The automated suture fixture770B can advantageously position the implant device710B or target device to a desired in-focus position within the depth of field of the camera761B, e.g., with respect to a point or region on the implant device710B that is to be sutured according to the suturing process.

Configuring the holder assembly771B of the automated suture fixture770B to hold, secure, articulate, or move the prosthetic human implant device710B can allow for execution of suturing operations by the operator705using one less hand than may be required in systems in which an operator is required to manually hold the implant device in the desired suturing position. The free hand of the operator705may be available to perform various operations not available in procedures in which both hands of the operator are required for handling and suturing the implant device. For example, a free hand of the operator705may be used to adjust cloth being sutured, reposition suturing threads, assist with tying knots, push or pull the needle, and/or the like. Further, allowing the free hand to rest may beneficially reduce the possibility of pain for an operator.

The automated suture fixture770B can be configured to align the target or implant device710B with the focal position of the camera system760B without the need for the operator705to determine and execute the appropriate positioning to provide a view of the target or a portion of the target (e.g., a desired suture point) on the display device750B. In some embodiments, the camera system760B may further be configured to align the camera761B with the plane of operation presented by the automated suture fixture770B.

In certain embodiments, the gear train slop present in the automated suture fixture770B can advantageously be less than ½ mm at a distal portion thereof. The automated suture fixture770B can comprise one or more encoders for articulating the various components of the device. The position of the one or more encoders can be designed in order to provide satisfactory precision of position of the distal end of the actuator arm778B to allow for precise positioning of the target device710B for imaging thereof. In certain embodiments, one or more encoders can be connected at an output portion of the automated suture fixture770B, such that slop in the system can be corrected to position the implant device710B at the precise position as directed by the script by which the automated suture fixture770B is operated. In certain embodiments, one or more magnetic encoders having, for example, 12-bit resolution or other resolutions, can be utilized in connection with the automated suture fixture770B.

In certain embodiments, a distal articulation arm778B of the automated suture fixture770B can generally present a downward-angled position to allow for proper positioning of the implant device710B with respect to the position of the operator705, as shown inFIG.7B. Furthermore, the camera761B can advantageously provide an at least partial side angle of the implant device710B, which can provide a good working view of the target suture position with respect to the operator705orientation shown. With the automated suture fixture770B configured to position the implant device710B substantially within the depth of field of the camera761B, it may not be necessary for the camera761B to adjust focus from one step of the suturing procedure or other procedure to the next.

The suture assist system700B can be configured such that the articulation arm778B of the automated suture fixture770B can be manually or electronically altered by the operator705to train the automated fixture770B to a custom position, e.g., to record/program position information so the system or automated fixture770B can return to that position automatically during a procedure. For example, the operator705may manipulate the articulation arm778B to provide accessibility to as much of the target or valve710B as possible vis-à-vis the desired work position or posture of the operator705. The articulation arm778B may be mechanically moved into the desired position and frozen or held in that position, wherein in the frozen/held position, a data capture is executed representing the position of the arm778B, such that the position can be re-created at a future time in connection with a similar operation/procedure. The position information (e.g., information representative of a position or that can be used to cause the automated fixture and/or articulation arm to move to a particular position) can be saved as part of a procedure script (e.g., a suturing procedure script, inspection script, etc.). For example, since a procedure for suturing and/or a procedure for inspecting the implant device710B can, and generally will, involve multiple different positions of the implant device710B, the system700B can be configured to store a data script comprising information relating to each step and/or position of the procedure, such that the specific positions/steps may be replayed at a later time connection with the procedure (e.g., an implant suturing and/or inspection procedure associated with the implant device710B).

In certain embodiments, utilization of an automated suture fixture like that shown inFIG.7Band described above may allow for improved quality and/or convenience associated with whip-type stitches of certain implant devices.FIG.8Aillustrates an operator805executing a suturing operation on a prosthetic transcatheter heart valve implant device810comprising a wireframe812disposed about a skirt component816. The operation executed by the operator805can involve a whip-type stitch, wherein a needle809and thread817are passed from outside of the implant device cylinder, through the implant device cylinder, and drawn out from within the implant device cylinder.FIG.8Ashows the process step of puncturing the outside of the implant device cylinder with the needle809, wherein an articulation arm878of the automated suture fixture870that holds the implant device810is in a slightly downward-angled position to thereby present the exterior surface of the implant device to the operator with the target suture position851focused thereon. At each stage and/or step of the suturing process represented inFIGS.8A-8C, the display850may show an image (e.g., a close-up image and/or high-definition image) of the relevant target position for the respective stage/step.

FIG.8Billustrates the operator805drawing out the needle809and/or thread817from the inside819of the cylinder of the implant device810after the needle809has punctured the implant device810from the outside of the cylinder portion of the implant device810, which is shown inFIG.8A. When the operator805draws the needle809out of the inner cylinder819, the articulation arm878can articulate to present (or make more accessible) the inside (e.g., a desired portion of the inside) of the implant device cylinder to the operator to allow the operator to more easily locate and grasp the needle809and/or draw the needle809and thread817out, which can reduce the risk of catching or snagging. In some embodiments, the implant device810can be maintained in the same position or at the generally downward projecting angle associated with the puncture operation ofFIG.8Awhen drawing the needle809and thread817from inside of the cylinder of the implant device810. The display monitor850can remain focused on the suture position associated with the puncture ofFIG.8Ato show the threaded suture formed by puncturing the outer cylinder of the implant device810as shown inFIG.8Aor can focus on another portion of the target or implant device810(e.g., on the location where the needle809will be pulled out). Presentation of the inside of the implant device cylinder819to the operator805can be accomplished at least in part through the rotation of the implant device810about a central or longitudinal axis893thereof. For example, the holder component880coupled to the articulation arm may be configured to rotate about the axis893.

FIG.8Cillustrates the articulation arm878positioned in a generally upward-projecting position in order to present to the operator805a portion of the inside819of the cylinder of the implant device810. By presenting the inner surface of the cylinder of the implant device810to the operator and to the camera lens861, the articulation arm878can allow for the operator805to more conveniently access the target suture position for pulling the needle809through and/or using the needle809to puncture the inside surface of the cylinder of the implant device810(e.g., an inside surface of the transcatheter heart valve skirt component, as described in greater detail above). Presenting the inner surface of the cylinder of the target device or implant device810can also allow the camera lens861to be focused on the target suture position851and allow better display and viewing of the target suture position. With the target suture position851prominently displayed on the display monitor850, the operator805can be instructed and/or assisted in an inside-to-outside suturing step for completing the suture wrapping around the frame821of the implant device810. By providing convenient repositioning of the articulation arm878for exterior and interior needle puncturing operations, the system800may provide a means for suturing a transcatheter heart valve or other type of implant or target device requiring exterior-to-interior stitches and vice versa. The precise repositioning of the articulation arm878(e.g., according to a particular script or program) can reduce the risk of thread wrapping or other mis-stitching by the operator805.

Point Imaging

FIG.9illustrates a display, screen, or monitor950for displaying an image of a target position or target suture position951of a target device or prosthetic human implant device, e.g., the image of a target suture position can be displayed for a suturing procedure in accordance with one or more embodiments. For example, the display monitor950can be the same as or similar in certain respects to the display monitors750A,750B described herein with reference toFIGS.7A and7Band/or display monitor850described herein with reference toFIGS.8A-8C. In certain embodiments, the display950can be configured to display an image captured by a camera system associated therewith (not shown), such as may be similar to certain camera systems illustrated in other figures and described in detail herein (e.g., camera system760A,760B). The display950can provide visual targeting of a target location/target stitch location951or general area using one or more on-screen visual aids. For example, the display950may have disposed or projected thereon one or more crosshair guidelines952,953, and/or other reticle tool, such as a circular reticle955, which may encompass the target suture point951. With respect to embodiments comprising crosshair guides (e.g., vertical and horizontal crosshair guides), the intersection of such crosshairs may be at a target point, which can be designated as the target suture point951. Although a circle reticle is illustrated, it should be understood that reticles and/or other visual aids associated with the display monitor950may comprise any suitable or desirable shape configuration, or the like. Optionally, a target location or point may be positioned at a particular location on the display950(e.g., the target location or point may always or sometimes be positioned at the center of the monitor or display) regardless of whether other visual aids are or are not used. Furthermore, in certain embodiments, animation overlays may be superimposed on a camera image displayed on the display950to further assist the operator in interpreting or identifying the target suture point and/or the associated suturing action or other procedure the operator is to take.

With the aid of the display950(e.g., monitor, screen, or other display), it may not be necessary for the operator to be burdened with manually focusing the implant device being sutured to specific focus points. For example, manual focus may be unnecessary when the display950is part of a suture assist system comprising target implant articulation mechanics and/or a camera system configured to collectively achieve the desired focus at the target suture point or other target point for a given step of a suturing procedure or other procedure. As another example, an articulation arm securing or holding the target implant device may be configured to position the suture point of the implant device within the depth of field or focal length of the associated camera system. With the focused image presented clearly on the display950, the operator may be spared at least in part eye strain or other potential discomfort which may be associated with efforts to visually inspect and/or configure an implant device to achieve the desired focus. Further, proper positioning may make various steps and procedures easier to accomplish and easier on the hands and arms of an operator.

In certain embodiments, the visual aid(s) (e.g., crosshair952,953and/or circular reticles955) can be displayed as stitch-counting visual aids. The reticle955can be calibrated to a desired position. Furthermore, while the crosshair target951can identify the target stitch location, the circular reticle955can comprise additional notches or indicators providing further information with respect to a current stitch operation, such as a numbered stitch count. For example, the circular reticle955can rotate with each stitch as a means of identifying stitch count in certain embodiments. The reticle(s) can be used to index certain stitches accurately on the display950. With the circular reticle955, it may not be required for the operator to count stitches, and therefore the mental burden on the operator may be at least partially reduced and human error in the counting can be eliminated or reduced. Furthermore, with the operator able to maintain focus on stitch without relying on himself or herself to hold the position of the implant device in the desired orientation with respect to the magnification or visualization system, the operator can expend energy towards other aspects of the process, thereby potentially improving quality and/or efficiency. Markings associated with various visual aids (e.g., markings of the visual assistance reticle(s)) may be useful in alignment, placement, and/or measurement of stitches and/or other suturing operations. In certain embodiments, the field-of-view of the display monitor950can be adjustable to conform to the preferences of the operator, to be placed in an ergonomically beneficial position, or as appropriate for a particular suturing operation or other operation.

In certain embodiments, the display950can be configured to present thereon operator instructions for executing suturing operations or other operations, as well as other information which may be pertinent to the procedure or otherwise associated with the procedure (e.g., step by step instructions, reference images of correctly completed suture steps or procedure steps, warnings/cautions, tips/suggestions, FAQs, etc.). For example, the display950can present timing elements, which can be used to improve efficiency and/or aid the operator in determining points or periods of time during which certain operations are to be executed. In some embodiments in which the target implant device may comprise materials that are required to maintain a certain degree of moisture in order to retain desired functional properties or qualities (e.g., tissue used to form leaflets of a valve can be required to maintain a certain degree of moisture), reminders and/or instructions may be presented on the display950to the to the operator to remind the operator to saturate or moisten such components. Furthermore, in certain embodiments, the display950can present qualitative measurement or analysis information with respect to the procedure being executed by the operator, such as sensed characteristics of the implant device and/or one or more components or features thereof, such as moisture levels, tension readings with respect to certain stitches, or the like. The system can include sensors configured to detect these characteristics, e.g., moisture level sensors, tension sensors, etc. The system can include a timer, clock, or other time tracking device/operation to track how long the various steps, operations, procedures, etc. take and/or to allow an operator or other person (e.g., a supervisor) to review different times or images associated with different times.

In certain embodiments, still images can be captured as displayed on the display950and/or captured by the associated camera system (not shown). Such captured images can be used to provide quality-control data points. For example, image file data can be compiled and stored in association with the specific implant device of the procedure, the procedure, and/or the operator involved in the procedure, wherein such information can be used to evaluate the quality and/or other aspects of the implant device, procedure, and/or operator. The display950can be positionable for viewing by the operator in any desirable position, which may allow for relatively low-stress posture and/or interaction of the operator to improve ergonomics.

Automated Suture Fixture

As illustrated inFIG.7Aand described in detail herein, suture assist systems in accordance with the present disclosure can comprise an automated suture fixture for articulating a suture target (e.g., prosthetic human heart valve implant) to a desired suture position or other process position.FIG.10illustrates a block diagram illustrating an exemplary control system1000for controlling an automated suture fixture1070(although shown as an automated suture fixture, it can be an automated fixture used for other operations or procedures instead of or in addition to suturing) according to one or more embodiments. The system1000includes an automated suture fixture1070configured to receive control signals from a controller module1030. The controller module1030can comprise a combination of software and/or hardware components configured to generate control signals for at least partially directing the operation of the automated suture fixture1070and/or one or more components thereof.

In certain embodiments, the controller1030includes one or more processors and/or controller circuitry configured to access suturing script information1034or other script/program information maintained by the controller in data storage thereof, or otherwise accessed by the controller1030. The controller1034can include positioning control circuitry1032designed to interpret suturing script information or other script/program information and generate control signals for controlling the automated suture fixture1070based at least in part thereon.

The suturing script information1034or other script/program information can comprise sequential positioning information for one or more components of the automated suture fixture1070with respect to one or more suturing processes or other processes that the controller1030is designed to implement. For example, in some embodiments, the positioning control circuitry1032can be configured to provide position information for each step of a suturing process in a sequential manner. The advancement from one position step to another can be directed by the controller1030based on a timer, user input, or other mechanism. For example, user input may be received by the controller1030from a user input device1015, such as a foot pedal or other input device communicatively coupled to the controller1030. In certain embodiments, input can be provided using (e.g., pressing or clicking) an icon or electronic button on a display that can be clicked on or toggled to provide input to the controller to advance the procedure and/or move the automated fixture (e.g., to the next position). In certain embodiments, input can be provided using voice commands and/or voice recognition software to provide input to the controller to advance the procedure and/or move the automated fixture1070(e.g., to the next position).

The automated suture fixture1070can include a plurality of motorized actuators1071, which can be communicatively coupled to the controller1030. In certain embodiments, the motorized actuators1071can be coupled to one another in a daisy-chain configuration, wherein two or more of the motorized actuators1071are coupled or wired together in sequence.

Each of the motorized actuators1071can include a motor, such as a DC, AC, or brushless DC motor. The motor can be a servo motor. In certain embodiments, the motor1072is controlled using pulse-coded modulation (PCM), as directed by the motor control circuitry1076. For example, the motor control circuitry1076can apply a pulse application for a certain period of time, wherein the angular positioning of a rotor component1073is determined at least in part by the length of the pulses. The amount of power applied to the motor1072may be proportional to the rotational distance of the rotor1073.

In certain embodiments, the motorized actuators1071can be servo actuator devices including one or more servo feedback component(s)1074, such as a position sensor (e.g., a digital encoder, magnetic encoder, laser(s), etc.). Use of servo feedback component(s)1074can be desirable in order to achieve a desirable level of confidence that the motorized actuators1071are positioned as directed by the controller1030with an acceptable degree of accuracy. The servo feedback component(s)1074can provide an analog signal to the motor control circuitry1076indicating a position and/or speed of the rotor1073, which can advantageously allow for relatively precise control of position for faster achievement of a stable and accurate rotor position. Relatively accurate positioning of an implant device may be necessary or desirable due at least in part to the dimensions of the cloth of a heart valve or other implant device that is sutured in an implant suturing operation using the automated suture fixture1070. For example, the fabric being sutured may comprise woven strands forming ribs having relatively small gaps therebetween. In certain embodiments, the automated suture fixture1070may be required to articulate a suture target prosthetic human implant device within 0.2 mm accuracy, or less. Although servo motor devices and components are described herein in the context of certain embodiments, in certain embodiments, one or more motorized actuators1071comprise stepper motors, or other types of motor subsystems.

The motorized actuators1071can further comprise motor control circuitry1076, which can drive the motor1072according to the control signals received from the controller1030. In certain embodiments, the motor1072, in combination with the servo feedback mechanism1074and/or motor control circuitry1076, can advantageously be configured to retain the rotor1073and/or attached support member in a set position for desired periods of time. The motor1072can provide relatively smooth commutation and/or accurate positioning of the associated rotor1073. The motor1072can be relatively powerful relative to its size and may draw power proportional to the mechanical load present on the rotor1073and/or associated support member.

In certain embodiments, the servo feedback component1074comprises a potentiometer that is connected to the rotor1073, which can be considered the output device of the motorized actuator1071. The rotor1073can link to the potentiometer and control circuitry1076, wherein the potentiometer, coupled with signals from the control circuitry, controls the angle of the rotor1073(and associated support member) across a rotational range, such as between 0°-180°, or further. In certain embodiments, the rotational range of the rotor1073can be restricted by one or more mechanical stops, which may be built into associated gear mechanism(s). The potentiometer (or other servo mechanism, such as an internal rotary encoder) can allow the control circuitry1076to monitor the current angle of the motor1072and/or rotor1073. When the rotor1073is at the correct or targeted angle or position, the motor1072can idle or lock in place until the next positioning signal is received from the controller1030.

The automated suture fixture1070can further include a suture target holder device or assembly1080(although called a suture target holder or assembly herein, this can be another type of target holder device or assembly to hold target devices/components for other procedures). The suture target holder1080can be physically coupled to one of the motorized actuators1071, such as to distal extension arm actuator device of the plurality of actuators. The suture target holder1080can be configured to hold or have mounted thereto a prosthetic heart valve device, or other prosthetic human implant device, which is desired to be sutured. The suture target holder1080can have any suitable or desirable shape, configuration and/or dimensions and can be configured to hold or otherwise secure a target device or implant device in a variety of different ways. Example embodiments of suture target holder devices and assemblies are described in detail below in connection withFIGS.12-15and31. However, it should be understood that such embodiments are provided as examples only, and other types of suture target holders can be implemented in the system1000. In certain embodiments, the distal motorized actuator includes a rotating support member configured to rotate about a first rotational axis. In some embodiments, the suture target holder is coupled to the support member of the distal motorized actuator and configured to rotate about an axis that is parallel to the first rotational axis of the support member. In some embodiments, the suture target holder is coupled to the support member of the distal motorized actuator and configured to rotate about an axis that is orthogonal to the first rotational axis of the support member.

FIG.11illustrates a perspective view of an exemplary embodiment of an automated suture fixture1170in accordance with one or more embodiments. The automated suture fixture1170includes a plurality of motorized actuators1101,1102,1103, and1104. The motorized actuators1101-1104can be physically and/or communicatively coupled in a desired configuration to provide a targeted range of motion and positioning for a distal actuator1101(referred to herein in certain contexts as a distal articulation arm) suitable for presenting a suturing target device to an operator in accordance with embodiments of the present disclosure. While four motorized actuators are shown (i.e.,1101-1104), additional motorized actuators and/or other actuators could be used to provide more degrees/types of movement and/or different types of movement (e.g., linear movement, movement in other patterns, etc.).FIGS.18-25and28-30illustrate exemplary configurations of automated fixtures that include different arrangements of motorized actuators. The automated fixtures described herein with reference to these figures can move up and down to different heights and articulate in additional directions, including horizontal directions.

An end or distal actuator can hold or comprise (or be modified to hold or comprise) a holder device or assembly (e.g., a holder device or assembly described herein with reference toFIGS.12-15, and/or18-31) and/or target device (e.g., valve). For example, the automated fixture shown inFIGS.18-25and28-30(and other automated fixtures described or shown herein) can be modified to include, at an end thereof, the holder assembly/device shown inFIGS.26,27and/or31. In some embodiments, bags can be configured to at least partially cover linkages from ingress.

With reference toFIG.11, each of the motorized actuators1101-1104can comprise a base portion1171and a rotating support member1177mechanically fixed to a rotor component1105. In certain embodiments, the rotor component1105is associated with a magnetic motor (not shown), wherein rotation of the rotor component1105is caused by the interaction between conductive windings and magnetic fields designed to produce a torque around the rotor's axis (e.g.,1193a,1193b,1193c, respectively). The motor can utilize a set of gears to rotate the output rotor and a potentiometer at the same time. The potentiometer, which can at least partially control the angle of the servo motor, can allow the control circuitry (not shown) to monitor the current angle of the servo motor. The motor, through a series of gears, can be configured to turn the output rotor and the potentiometer simultaneously. The potentiometer feedback signal can be fed into the servo control circuit, wherein when the control circuit detects that the position is correct, it stops the servo motor. If the control circuit detects that the angle is not correct, it can continue to turn the servo motor the correct direction until the angle is correct. While rotating actuators are described, actuators that move linearly can also be used (e.g., to raise and lower or move in and out a portion of the fixture).

In certain embodiments, the automated suture fixture1170includes a plurality of stages. For example, as shown, the fixture1170can comprise a base stage1172that includes motorized actuators1103,1104. In the illustrated embodiment, the base stage1172includes two separate actuators (1103,1104) that provide base support for the fixture1170but it is to be understood that the number of motorized actuators can be any suitable number such as one, two, three, four, five, or more than five. In some embodiments, the actuators1103,1104of the base stage1172can be secured mechanically to one another in any suitable or desirable way. For example, as shown, the actuators1103,1104can each be mounted to a common reference structure, such as an attachment plate1189, or other structure. Each of the actuators1103,1104can comprise a rotating support member (1177c,1177d) configured to rotate about a common rotational axis1193c, as shown.

The automated suture fixture1170includes a second stage1173, which can comprise one or more motorized actuators. For example, as shown, the stage1173can comprise a single actuator device1102in some embodiments. The base portion1171bof the actuator1102can be fixed or secured to one or advantageously both of the rotating support members of the base stage actuators1103,1104, as shown. Where the base actuators1103,1104, are separated horizontally from one another by a certain distance, it may be desirable to use a support plate or structure1179for fixing the support members of the base stage actuators1103,1104to one another, wherein the second stage actuator1102is fixed to the support plate1179. That is, the support plate1179can be secured or fixed, such as through the use of one or more bolts, screws, nuts, and/or the like, to both of the support members of the base stage1172, and further secured or fixed to the base of the second-stage actuator1102through any suitable or desirable means.

The second-stage actuator1102may further comprise a rotating support member1177bconfigured to rotate about the rotor axis1193b. Therefore, the second stage actuator1102can provide an additional degree of movement of the automated suture fixture1170when combined with the base-stage actuators in the attachment configuration illustrated. The automated suture fixture1170can yet provide an additional degree of movement through implementation of the distal actuator1101illustrated. Although a third stage1174is shown in the diagram ofFIG.11, it should be understood that in certain embodiments the fixture1170can include only the base stage1172and the second stage1173. Furthermore, although the illustrated embodiment comprises three stages, it should be understood that embodiments disclosed herein can be implemented using automated suture fixture assemblies having more than three stages (e.g., 4, 5, 6, 7, 8 or more stages) and/or having more than four motorized actuator devices (e.g., 5, 6, 7, 8, 9, or more actuator devices).

The distal third-stage actuator1101can be fixed or secured at a base1171athereof to the rotating support member1177bof the second-stage actuator1102, as shown. Furthermore, the distal actuator1101can further comprise a rotating support member1177a, which can be configured to rotate to provide yet another degree of movement for the fixture1170. In certain embodiments, the distal actuator1101can have attached thereto (e.g., at the rotating support member1077a) a suture target holder assembly or target holder assembly in accordance with embodiments of the present disclosure.

The automated fixture1170is illustrated in the diagram ofFIG.11in a substantially erect arrangement, in which the respective support members are positioned in a vertical arrangement, such that the rotational axes of the respective actuator devices lie substantially in a single vertical plane. However, the additional degrees of movement provided by the fixture1170may allow for rotation of the various support members, such that the axes of rotation of the respective rotors of the second- and third-stage actuator devices may ultimately lie in separate vertical planes from the rotational axis of the support members1177c,1177dof the base-stage actuator devices1103,1104.

The various motorized actuator devices of the automated suture fixture1170can be controlled in any suitable or desirable way. For example, in some embodiments, the various motorized actuator devices of the fixture1170can be configured to receive wireless control signals over a wireless connection with a control system, device or module, such as the controller1030ofFIG.10described above, or the like. In some embodiments, the actuators can be configured to receive wired control signals, such as over the various wired connections1191illustrated. For example, certain embodiments, two or more of the stages and/or actuator devices of the fixture1170can be communicatively coupled using a wired connection in a daisy-chain configuration, as described herein.

FIGS.18-25illustrate an exemplary automated suture fixture1970. The automated suture fixture1970includes an articulating arm1978having a plurality of actuator devices1973A-1973D daisy chained together to provide movement of a distal target mount point1971. The distal target mount point1971can be configured to secure a suture target holder device or assembly such as those illustrated inFIGS.26,27, and31. The suture target holder can be physically coupled to the distal target mount point1971or it can be integrally formed as part of the distal target mount point1971. The suture target holder can be configured to hold or have mounted thereto a prosthetic heart valve device, or other prosthetic human implant device, which is desired to be sutured.

The automated suture fixture1970also includes a vertical translation stage1972configured to vertically move the articulation arm1978. This further increases the range of movement of the automated suture fixture1970while maintaining a desirably small footprint. The vertical translation stage1972can include a piston configuration that attaches to the proximal actuator device1973A so that the vertical translation stage1972can cause the entire articulation arm1978to raise and lower. The vertical translation stage1972can be configured to not be exactly vertical and can be tilted or angled away from perfectly vertical.

The automated suture fixture1970can include a base or base plate1979to support the vertical translation stage1972and to define a workspace for manufacturing the target device. In certain embodiments, the working zone for the fixture1970may be approximately 6.75″ high (e.g., the articulation arm1978can translate about 6.75″ vertically or at least 4″ and/or less than or equal to about 10″). In some embodiments, the height of the vertical translation stage1972, H, is about 26″ or at least about 20″ and/or less than or equal to about 36″, at least about 22″ and/or less than or equal to about 30″, or at least about 24″ and/or less than or equal to about 28″. In some embodiments, the depth of the base plate1979, D, is about 18″ or at least about 12″ and/or less than or equal to about 24″, at least about 14″ and/or less than or equal to about 22″, or at least about 16″ and/or less than or equal to about 20″. In some embodiments, the length of the base plate1979, L, is about 20″ or at least about 12″ and/or less than or equal to about 30″, at least about 15″ and/or less than or equal to about 26″, or at least about 18″ and/or less than or equal to about 24″.

With respect toFIGS.19and20, the illustrated positions of the fixture1970can correspond to a bottom of a stroke of the vertical translation stage1972in a z-direction. In certain embodiments, the distal target mount point1971can be configured to tilt approximately 54 degrees upward. With respect toFIGS.21and22, the fixture1970can change the position and orientation of the distal target mount point1971while at the bottom of the stroke of the vertical translation stage1972. This can be done by actuating the articulation arm1978.

With respect toFIGS.23and24, the illustrated positions of the fixture1970can correspond to a top of a stroke of the vertical translation stage1972in the z-direction. In certain embodiments, the distal target mount point1971can be configured to tilt approximately 15 degrees down from horizontal. With respect toFIG.25, the illustrated position of the fixture may represent an approximately 45-degree downward tilt for implementing a “dipping” step.

FIGS.28and29illustrate another example automated suture fixture2870having a different configuration for an articulation arm2878. The fixture2870includes a plurality of actuator devices2873that are oriented to provide additional vertical support. By orienting rotors so that the axis of rotation is substantially vertical, the support members can provide additional support against downward forces as opposed to relying on the motor to resist downward forces. This may be of increased importance closer to the proximal end of the articulation arm due to the increase in torque the further from the pivot point a force is applied (e.g., a downward force at a distal end of the articulation arm2878can cause more torque at the proximal end than at the distal end). The automated suture fixture2870can be coupled to different target holders, such as target holders2880aand2880brespectively illustrated inFIGS.28and29. The target holder2880acan be the same as or similar to the target holder3180described herein with reference toFIG.31. The target holder2880bcan be geared (e.g., similar to target holder2680) to allow for rotation of the target holder and/or target without blocking the view of the visualization system. The target holder2880bis also beneficially configured to allow access to the interior of the target from both ends or leave the interior open on both ends so that an operator can insert a finger and/or retrieve a needle from inside at either end of the target.

FIG.30illustrates another example automated suture fixture3070having a different configuration for an articulation arm3078. The articulation arm3078has a crane-like configuration and is configured to substantially enclose the actuation devices within a housing or a plurality of housings. The articulation arm3078secures a target assembly3080that is similar to the target assembly3180described herein with reference toFIG.31.

Suture Target Holder

FIG.12illustrates an articulation arm1878coupled to an exemplary holder component1880according to one or more embodiments. The articulation arm1878can be the same as or similar to the articulation arms778,878described herein with reference toFIGS.7A,7B,8A,8B, or8C and/or one or more actuators described or shown elsewhere herein. The holder component1880can be the same as or similar to other target holder components, devices, or assemblies (e.g.,771,880,1080,1180,1380) described elsewhere herein. In certain embodiments, the holder component1880can be fixed or secured to the distal articulation arm1878or end actuator of an automated suture fixture for the purpose of providing an interface for securing an implant device or other target form or device. The holder component/assembly1880can be designed or configured to hold or secure an implant device or other target device, or portion thereof, for the purpose of allowing suturing thereof according to any process or embodiment disclosed herein.

The holder component1880can be configured to secure or otherwise include a cylinder form1885, which can be sized or dimensioned to have pulled thereover the target device or implant (e.g., a fabric-covered support stent for a surgical valve implant device1818). For example, the valve implant device1818may comprise a plurality of commissure post portions1892, as shown, which may be positioned such that they are oriented in a direction towards the holder component1880, such that a seam1818may be stitched above what will ultimately represent an inflow edge of the implant device1818. The cylindrical form/component1885may be designed in a similar manner to a handheld implant device holder, which may be used in certain embodiments in executing suturing procedures without the assistance of the articulation arm1878and associated components. The cloth1825can be disposed about a rigid wireframe structure, wherein the seam of stitches1818is executed in order to substantially cover the wireframe with the cloth1825. The seam1818can secure the cloth1825about a stiffening band, as described herein with reference toFIG.3A.

The holder component1880can be designed for a particular application, such as for a transcatheter heart valve suturing application, or a surgical heart valve suturing operation, or other implant suturing procedure. The valves can be for animal (e.g., for human) use. Although a surgical valve configuration is shown inFIG.12, it should be understood that the holder device1880and/or other components ofFIG.12may be designed or configured to support suturing processes and/or other processes for a transcatheter heart valve or other valve or other device. For example, while the diagram ofFIG.12illustrates a cylindrical form1885designed to hold the implant device1818in a desired position, such cylindrical form may not be necessary with respect to a transcatheter heart valve. For example, in place of the cylindrical form1885, the holder1880can instead be configured to secure a rigid cylindrical wireframe of a transcatheter heart valve, an embodiment of which is illustrated and described above in connection withFIG.1.

With the target or implant device1818secured to the holder device1880, an operator may conveniently be able to execute stitching operations using, for example, a needle1809and thread1817. For example, the system can facilitate or make it easier for an operator to perform exterior circumferential stitching operations (e.g., with respect to surgical heart valves), interior-to exterior stiches, and/or exterior-to-interior stitches (e.g., for certain transcatheter heart valve stitching operations). The holder device1880and/or associated components can be designed to efficiently allow for the target or implant device1818be presented to the operator such that multiple degrees of freedom are available for the operator and articulation arm1878to further simplify and assist with suturing or other procedures.

In certain embodiments, the holder component1880and/or one or more components associated with the holder component1880(e.g., the cylinder form, etc.) can be configured to rotate about a central or longitudinal axis1893thereof. Central axis1893can represent a central axis of the target or implant device1810, cylinder1885, and/or other portion of the holder component1880(e.g., when the device1810, cylinder1885, and/or other component is connected or mounted to the holder component1880). The rotation of the holder component1880and/or components associated therewith may allow for presentation of different surface areas of the target or implant device1810to the operator during different stages of a suturing procedure or other procedure.

The specific type of holder that is utilized for a procedure or application (e.g., for a suture assist application) may be determined on a process-by-process basis. That is, specific adapters may be suitable or desirable for each of separate operations/procedures, or for separate types of valves or other targets. In certain embodiments, a single suturing procedure of an implant device can involve use of multiple different types of holder devices.

FIG.13illustrates an exemplary holder component/device1180in accordance with one or more embodiments disclosed herein. For example, the holder device1180may be the same as or similar in certain respects to the holder device1880described herein with reference toFIG.12and/or other holder devices, components, assemblies, etc. (e.g.,771,880,1080,1380) described elsewhere herein. The holder component1180can comprise one or more features or components designed to allow for a cylindrical holder and/or component of a target or implant device to be secured thereto. For example, the holder1180may allow for securing of a cylindrical holder and/or component of the implant device in such a manner as to provide radial symmetry for precise positioning thereof. In certain embodiments, the holder1180comprises a plurality of jaw or clamp forms1135, which may be arranged in a radially symmetrical pattern about a circumference of the holder1180. The jaws1135may be configured to be tightened to hold the cylindrical holder and/or target or implant device component or may comprise one or more other mechanisms for securing the cylindrical holder and/or target or implant device about a central hub component1139. For example, the jaw forms1135may comprise one or more apertures for utilizing set screws therein, which may be configured to grip or secure the cylindrical holder and/or target or implant device component.

FIG.14illustrates an implant device fit about a cylindrical holder1285, the implant device comprising a plurality of commissure posts1292formed of a frame (e.g., a wireframe) (not shown), wherein the frame or wireframe is at least partially covered by a cloth1225, the cloth1225being sutured to secure the cloth1225about the frame structure of the implant device1210.FIG.14illustrates an exemplary back stitched seam1218that can be implemented to secure the cloth1225about the support structure, but other types of stiches and seams could also or alternatively be used. Although wireframes are described in detail and used as examples of frames herein in connection with certain surgical valves, it should be understood that any type of stiffening or support frame forms or components may be utilized, e.g., to provide the described commissure posts and/or stiffening bands associated with certain surgical valve devices. For example, one or more plastic bands, metal bands, or other stiffening or rigid support structures can be used to form the, sure posts and/or stiffening band of a surgical valve. As shown inFIG.14, suturing of certain implant devices may involve utilizing temporary stitches that can be removed upon completion of certain stitched seams or other suturing operations.

Gimbal Mount Holder

Certain embodiments disclosed herein provide for holding and/or positioning of an implant device that is the subject of a suturing procedure using a gimbal-type holder assembly1380, as shown inFIG.15. Further, the automated fixture, articulation arm, and/or various actuators of the automated fixture can also or alternatively be configured to function similar to a gimbal. While certain embodiments of implant device holder components as disclosed herein may generally present one end of the implant device and/or circumferential surfaces or features of the device to the operator, certain of such embodiments may not allow for free operation by the operator about both front and back ends of the implant device and/or holder device. For example, one end of the implant or holder device may be secured at least in part to a component of an articulation arm and/or other holder device. The valve holder device ofFIG.15and/or other portions of the automated fixture can provide a mount that allows for operational access at multiple ends of an implant device, and may essentially be configurable to float or rotate to the proper position for manufacturing, thereby relieving the operator of the burden of removing the implant device from the holder and rotating and re-securing the implant device in order to have access to both ends of the implant device during a suturing procedure or other procedure.

The gimbal assembly1380and/or other gimbal-like arrangements of an automated fixture can be configured to articulate a heart valve or other target or implant device to substantially any desired orientation for ease of access and use for an operator. For example, the gimbal assembly1380can comprise a three-axis gimbal allowing for three degrees of freedom. Furthermore, where the gimbal assembly1380is mounted to an articulation arm and/or device, additional degrees of freedom may be provided. For example, the combination of the gimbal assembly1380with the associated automated suture fixture can provide six degrees of freedom of manipulation. In certain embodiments, the gimbal assembly1380may be a two-axis gimbal.

When having secured thereto a target or implant device, such as a transcatheter heart valve or surgical valve implant device, the gimbal assembly1380and/or other gimbal-like arrangement of an automated fixture can be configured to position the target or implant device accurately in multiple orientations. For example, the gimbal assembly1380can be configured to execute circumferential rotation of a heart valve, while maintaining the outer surface (or a desired portion of the outer surface) of the target or implant device or valve within a focal plane or depth of field of an associated camera and/or magnification system.

The gimbal assembly1380includes a cylindrical implant holder1385having disposed thereon a surgical implant device1310, which may represent a suturing target implant in accordance with certain embodiments. However, although a cylindrical implant holding form1385is illustrated inFIG.15, it should be understood that, in certain embodiments, the gimbal assembly1380may not include the cylindrical implant holding form1385, and can instead be configured to hold a different holder component (e.g., a rigid cylindrical or otherwise-shaped component) or to directly hold a heart valve or other target or implant device or portion thereof, such as a cylindrical wireframe of a transcatheter heart valve as described herein. A different holder component or target or implant device could be held where the cylindrical holder1385is shown. For purposes of discussion, the illustrated component or cylinder1385may be referred to below as a holder component and/or as the target or implant device (or valve) itself, indicating that the target or implant device to be sutured, or otherwise engaged, can be disposed and/or secured in the same position shown by the disposition of the cylinder1385inFIG.15. Descriptions of the component1385apply to any holder or target device held in the position of component1385, regardless of whether it is referred to as a component, device, holder, valve, etc. in the description.

Rotation of the target or implant device or valve1385may be implemented by rotating a hub component1382, which can be attached or associated with a rotating servo head of an articulation arm or actuator (not shown inFIG.15), wherein the hub component1382can be associated with an arm component1383that allows for rotation of the target or implant device or valve1385about a central or rotational axis1301of the hub component1382and the target or implant device1385. That is, where the target or implant device or valve1385is connected to the arm1383via a connector form1388, such as a Y-connector form, it may be desirable for the connector form1388to be adjusted such that the central or longitudinal axis of the target or implant device is aligned or substantially aligned with the rotational axis1301of the hub component1382. When the target or implant device1385and the hub component1382are thus aligned, rotation of the hub component may be possible while maintaining coaxial alignment of the target or implant device1385with the hub1382, thereby allowing for consistent presentation of an outer surface or region of the target or implant device1385in the depth of field of the associated visualization system (e.g., camera). Therefore, the target or implant device1385can be circumferentially rotated without moving the target or implant device, or target suture position thereof, out of focus of the camera system.

The connector form or Y-connector1388can be configured to nest in a base portion of the arm1383and can further be adjustable and provide an indexing feature to allow for movement in and out of the base component1389to thereby allow for precise positioning of the target or implant device1385. In certain embodiments, the hub component1382may be coupled magnetically with an associated articulation arm or actuator of an automated fixture. Optionally, the connector form or Y-connector can be rotatable within the base component1389to provide for more degrees of movement and positioning possibilities (e.g., to allow the target device to be flipped toward or away from the hub component1382and/or rotated to any angle with respect to the axis1301. The base component1389may include a motor or be a motorized actuator to cause movement or rotate the connector form or Y-connector1388, e.g., so the system can be programmed or scripted to move automatically to a desired position/rotation for a procedure.

The automated fixtures and/or holders described herein can be configured such that a point (e.g., a centermost point) within a target device can remain fixed/stationary while the target device is rotated or repositioned to expose different portions of the target device for a particular operation/step in a procedure.

While various other multi-axis gimbal devices may not be designed to have manufacturing done to them, the gimbal assembly1380shown inFIG.15can advantageously provide for precise positioning of the distal end of the connector form or arm1388and the target or implant device1385in order for manufacturing to be performed thereon. Furthermore, with one or two side points of attachment1386, multiple degrees of freedom can be presented by the gimbal assembly1380, thereby providing convenience and ease-of-use for the operator. With the multiple-axis (e.g., three-axis) functionality of the gimbal assembly1380or other gimbal arrangement of the automated fixture, the target or implant device can be allowed freedom to move to a wide variety of positions and angles to make it easier for the operator to engage with (e.g., suture, inspect, etc.) the target or implant device or valve and to maneuver fingers or other items at a desired location thereon. The multiple-axis (e.g., three-axis) functionality can also make it easier for an operator to view from one side through to the other side of the target or implant device1385without substantial obstruction.

Geared Mount Holder

FIG.26shows an exemplary mount or holder assembly2680that can be used with the assist systems, automated fixtures, gimbal assemblies or arrangements, etc. disclosed herein. The holder device2680can be attached or connected to another holder and/or to a motorized actuator (e.g., the same as or similar to those discussed or shown elsewhere herein), e.g., at a proximal end, distal end, back end, end opposite the rotating portion or ring, etc. The holder assembly2680can comprise a motor and/or motorized actuator (e.g., a rotational motor/motorized actuator). The holder assembly2680can include a portion2681or mechanism configured to hold and rotate a target device (e.g., heart valve).

FIG.27illustrates an exemplary holder ring2681that can be used to hold and to rotate a target device (e.g., a heart valve). The holder ring2681can include a geared portion2686(e.g., with gear teeth) or other interlocking or friction-engaging portion, etc. that can interact with another gear2683, interlocking component, friction-engaging component, etc. to cause rotation of the holder ring2681. The other gear2683, interlocking component, friction-engaging component, etc. can be connected to a drive shaft (not shown). The drive shaft can connect between a motor and the other gear2683, interlocking component, friction-engaging component, etc. such that the motor can cause the gear, interlocking component, friction-engaging component, etc. to rotate. Rotation of the gear2683, interlocking component, friction-engaging component, etc. can cause the holder ring2681to rotate.

The holder ring2681can include an inner surface2682configured to hold and engage the target device. Though, in one embodiment, the outer surface can be configured to hold and engage the target device with the target device fitting over and around the outer surface. Features2687can be included on the inner surface2682(or outer surface) to improve the hold or better secure the target device. The holder ring2681(and/or its inner surface2682) can be configured to cover only a small surface area of the target device, e.g., to leave portion of the target device to be operated on, treated, sutured, etc. open and unobstructed. The interior of the target device can beneficially be left accessible and open from both ends to allow an operator access from either end to the interior of the target device. Using a rotating holder assembly2680allows an automated fixture to rotate a target device without having to rotate the entire holder assembly. This allows the automated fixture to keep the target device (e.g., a portion of the target device or surface thereof) within a depth of field of a visualization system (e.g., a camera) throughout 360-degree rotation of the target device without requiring movement of the visualization system or adjustment of the focus, and without ever having an arm or other portion of the holder assembly2680rotate into the visualization system's (e.g., camera's) view.

While an exemplary implementation is shown inFIGS.26and27, other implementations of the concepts described are also possible that may include additional elements or components, different elements or components, or not include some elements or components.

Example Extended Holder Assembly

FIG.31illustrates another example holder or holder assembly3180that extends distally from an articulation arm to allow access to an internal portion of a target device (e.g., a valve) from both an in-flow end and an out-flow end of the target device. In other words, the holder assembly is configured such that it does not block or leaves open the ends. The holder assembly3180includes a support arm3181that extends from a base3182that couples to an articulation arm, examples of which are described herein. In some embodiments, the articulation arm and/or base3182are configured to rotate about a central or longitudinal axis of a support3183(e.g., a cylinder support) of the holder assembly3180. The support3183is coupled to the support arm3181and is configured to secure the target device to the holder assembly3180in the same or similar manner as other holder assemblies described herein.

Point-By-Point Suture Assistance

Embodiments disclosed herein provide for systems, devices, and methods for providing point-by-point assistance (e.g., point-by-point suture assisting) functionality in connection with procedures (e.g., the suturing of implant devices, inspection, or other procedures). For example, a suture assist system in accordance with the present disclosure may provide point-by-point (e.g., step-by-step) assistance to an operator through the use of one or more of an automated suture fixture, a visualization system (e.g., a microscope and/or magnification system, and/or an image display system), and/or other associated systems, devices, or components.FIG.16illustrates a flow diagram of an exemplary process1600for training/programming a system to implement and/or facilitate implementation of a particular procedure. For example, the steps in the process1600can be used to train/program a suture assist system to implement a suture assist procedure or suturing procedure according to one or more embodiments. The process1600may provide a programmable process, wherein a computing system, in combination with hardware systems as disclosed herein, can be configured to read positioning of an automated fixture or automated suture fixture, store position information according to a desired script or program, and/or play the stored script/program back for the purpose of allowing an operator to execute the procedure associated with the script/program. The process1600may allow for relatively easy programming of the suture assist procedure script/program through the positioning and/or recording of positioning of an articulation device and/or visualization system (e.g., a microscope or camera system). For example, at block1602, the process1600may involve an operator manipulating an automated fixture or automated suture fixture to a desired position associated with a first step of an implant suturing procedure or other procedure in accordance with the present disclosure. For example, the operator may exert or cause to be exerted torque or other force on one or more portions of the automated fixture or automated suture fixture, such as an articulation arm or distal end portion thereof to bring the distal end into a position associated with a suturing operation or other operation or step.

The automated fixture or automated suture fixture can be manipulated and/or repositioned in any suitable or desirable manner. For example, in certain embodiments, the operator can manually manipulate at least a portion of the automated fixture or automated suture fixture, such as an articulation arm thereof, to a desired position. In certain embodiments, manipulation of the automated fixture or automated suture fixture and/or articulation arm thereof can be effected through the use of a control signal, which can be generated using a joystick, buttons, or other operator input device, or through the use of any type of software command/instruction entry or other programming (e.g., using numeric position representation), or the like. In certain embodiments, manipulation of the automated fixture or automated suture fixture can be achieved through the manipulation of a corresponding fixture which can be configured such that movement or manipulation thereof is at least partially mirrored by the automated fixture or automated suture fixture, or wherein the automated fixture or automated suture fixture is configured to be repositioned in response to movement of the mirroring device or system.

In certain embodiments, the process1600can involve focusing a visualization system (e.g., a camera or magnification system) to a target position or point associated with the automated fixture or automated suture fixture, such as to a portion of a target or implant device that may be held or secured by the automated fixture or automated suture fixture. However, it should be understood that in certain embodiments, camera focusing may not be required where the process step1602involves manipulating the automated fixture or automated suture fixture in order to bring the target position into focus with a stationary visualization system or a camera. That is, the manipulation of the automated fixture or automated suture fixture in step1602can involve proper placement of the target implant device, or target portion thereof, into the focal plane of the camera or magnification system, as desired.

At block1606, the process1600can involve capturing the position information associated with the manipulated automated fixture or automated suture fixture, or portion thereof, as executed in accordance with process step1602. For example, capturing the position information may involve saving one or more values or data representative of a position of the automated fixture or automated suture fixture and/or portion thereof, and/or positioning or focusing of the visualization system (e.g., camera or magnification system).

At block1608, the process1600can involve storing the positioning information in connection with the procedure associated with the position of the automated fixture or automated suture fixture. The position information can be stored along with or be associated/correlated with additional metadata indicating various parameters associated with the position information, such as operator information, patient information, timing information, or the like. The additional metadata or other information can be stored, associated, or applied to the script at the time the positioning information is stored in step1608. Also, the script can be stored without the additional metadata or other information in step1608, and the additional metadata or other information can optionally be applied to the script at a later time, e.g., to customize the script for different operator, for example to allow adjustment of the script positioning to accommodate operators of different sizes/heights or other characteristics (e.g., to flip the script positioning for left vs. right handed operators).

At decision block1610, the process1600can involve determining whether additional steps of the procedure remain to be programmed, or whether the position programmed in the preceding steps represents a final position or whether the set of positions programmed previously represent a full set of steps of the procedure. If so, the process1600can come to an end, as represented by block1612. If additional positions or steps in the procedure remained to be program, the process1600can proceed back to block1602, where an additional positioning of the automated suture fixture can be programmed in accordance with blocks1602through1608. In certain embodiments, the storing process represented at block1608may not be performed until after all steps of the procedure have been programmed. In certain embodiments, each of the manufacturing steps or positions of the automated suture fixture and/or camera/magnification system can be recorded in sequential order in order to retain such order when playing back the stored procedure. In certain embodiments, where operator-specific metadata is recorded in connection with the process1600, different operators may be able to store modified versions of the procedure that are specific to the particular operator. That is, an individual operator may be able to train the implant articulation system to his or her desired ergonomics or preferences. Optionally, individual operator information (e.g., profiles) can be applied at a later time to a process script to adjust the script to individual operator characteristics and/or preferences.

In certain embodiments moving from one step of the process1600to another, or looping back to program a new position at block1602, can be triggered through the use of a foot pedal, other operator-input triggered device, voice commands, and/or other electronic input.

FIG.17illustrates a process1700for executing a suturing procedure according to one or more embodiments. While described in terms of a suturing procedure, similar steps can be used for other procedures (e.g., for inspection procedures, other treatment or processing procedures, etc.) For example, the process1700can be performed after a suture assist system has been preprogrammed with a certain procedure, program, or script, such as can be created using to the training/programming process1600described above in connection withFIG.16. One or more computer components, such as one or more processors and/or memory devices, can be utilized to store and execute a procedure-directing script/program, such that a procedure script/program can be played back for an operator on-demand.

At block1702, the process can involve loading a pre-programmed suturing process script or program, which may have been previously programmed in connection with the training/programming process as described above. The desired script/program can be loaded in various ways, e.g., by providing input to the system or a computer of the system to load the desired script/program from storage or memory (e.g., stored memory, internal memory, external memory, portable memory, disk, thumb drive, download, etc.), loading the desired script/program from an external source, inputting or providing a code (e.g., scanning a barcode on the target device or materials associated with the target device) such that the system automatically loads the correct script/program for the target device (e.g., based on the input code, scanned barcode, etc.), providing voice commands to load a script/program, and other ways of loading the desired script/program. In certain embodiments, the process1700involves selectively loading either a right-handed or left-handed version of the process script based on a preference of the operator or based on an operator profile, or applying operator information to a script to adjust the script to individual operator preferences (e.g., to flip the script positioning for left vs. right handed operators, to adjust positioning for other operator characteristics, for example, size, height, etc.). In certain embodiments, the operator may alternate between right- and left-handed versions as desired, even mid-procedure, which may beneficially allow the operator to rest a fatigued hand, for example. This could be done by applying different information or parameters to the script at different times.

At block1704, the process involves triggering the positioning of an automated suture fixture (or automated fixture) and/or associated visualization system (e.g., camera or magnification system) to a current process position associated with a current step of the suturing procedure or other procedure. It should be understood that in certain embodiments, performance of step1704does not involve positioning, or triggering the positioning of, a visualization system or a camera. For example, an associated camera or other visualization/imaging system can be substantially static, wherein the articulation device controls positioning of the target device at the proper focus or focal length for the visualization/imaging system or camera. The triggering of the automated suture fixture can be input or implemented in a suitable or desirable manner. For example, the operator can activate a foot pedal, other switch, physical trigger button, mechanism, voice command, and/or electronic input (e.g., a touchscreen icon/button, etc.) in order to trigger the set-up of the suture assist system to the next step in the suturing procedure.

At block1706, the process1700can involve identifying a target suture position or other position (e.g., inspection position, other treatment or processing position, etc.) on a monitor display. For example, the target suture position may be identified using one or more visual aids or reticles, or the like, as described above. In addition, identification of the target suture position may be achieved using instructions, or other visual overlays, examples, and/or guidance displayed on the monitor display. The target position can be identified by the operator (e.g., by clicking on a target position, dragging a visual aid to the target position, entering coordinates, or in other ways), and/or the target position can be identified by the script or program automatically to sense and/or indicate where the next step, operation, suture, inspection, etc. should occur.

At block1708, the process1700can involve executing a suturing operation or other operation or step using the monitor display (or other visualization system viewing area) as guidance. For example, the visualization system (e.g., the monitor display, in combination with the operation of an associated camera or magnification system), can present the target suture position in focus, wherein the operator may visually evaluate the suturing position and execution of the operation/step using the monitor display (or other visualization system viewing area).

Once the suturing operation or other operation/step has been executed at block1708, if the relevant suturing operation or other operation/step represents a final operation/step of the suturing procedure or other procedure, the process1700may end as shown at block1712. However, if additional steps of the suturing operation/procedure or other operation or procedure remain, the process1700may return to block1704, where a subsequent step of the suturing process or other process may be triggered, such that the process1700may involve completion of subsequent step(s). In certain embodiments, the process1700may involve capturing an image of the suture target prior to the repositioning of the automated suture fixture. For example, image capture can be triggered by user input or other event indicating the completion of a step of the process1700. Such captured images can be used for a variety of purposes including training and inspection. Optionally, the entire procedure can be recorded (e.g., as a movie file) for training, inspection, quality control, and/or other purposes. Bookmarks or indicators can be stored at times when an operation/step is completed to allow an operator, supervisor, or other person to jump through the video to key times/frames, e.g., for inspection, training, or other purposes. Additionally, the images, video, frames, etc. can be sent/transmitted and graphically displayed on another device (e.g., phone, computer, mobile device, etc.), e.g., sent to a device of a manager and/or quality control person for review.

Where the suture assist system has been programmed to implement, or direct the implementation of, a suturing procedure or other procedure, such procedure may be repeatable over many iterations, thereby providing improved efficiency and completion of procedures (e.g., improved suturing of implant devices).

In certain embodiments, the process1700can allow for the operator to make modifications at a given step of the suturing procedure to the positioning of the automated suture fixture and/or camera system in order to further customize such step. In certain embodiments, such altering by the operator can be programmed back into the procedural script executed by the suture assist system in connection with the particular procedure, such that future execution of the procedure can incorporate the modifications implemented by the operator during the process1700. Furthermore, in certain embodiments, the process1700can allow for the operator to temporarily pause the process1700prior to completion thereof. For example, the operator may wish to step away from the operating environment, such as for a break or other purpose, wherein the process1700can allow for the operator to reinsert him or herself into a stage of the process at which the process was paused. Therefore, such availability of pausing and reentering the process may allow for the operator to reduce strain or burden associated with prolonged engagement with the suture assist system.

Certain suturing procedures (or other procedures) may involve suturing (or other processing, treatment, etc.) of implant devices that have certain requirements with respect to moisture and/or other parameters associated with one or more components of the implant device. For example, with respect to prosthetic heart valves, suturing operations or other operations associated with valve leaflets may require that such leaflets not become dried out, because drying out can adversely affect the physical properties thereof. For example, where the valve leaflets comprise biological material, such as pericardial leaflets, it may be necessary or desirable to periodically expose such leaflets to moisture, such as in the form of a liquid solution, gas, or the like. In certain embodiments, the process1700, and/or other processes or procedures disclosed herein, can be implemented in connection with a mechanism for allowing the operator or system (e.g., an automated portion of the system) to periodically, or on an as-needed basis, moisturize one or more components of the implant device being sutured. For example, the system can allow the operator to immerse or otherwise saturate or cover at least a portion of the implant device in, for example, glutaraldehyde, or other or liquid. In certain embodiments, an articulation arm in a suture assist system can be configured to implement, as part of an automated procedure, the dipping or immersion, spraying, or other means of exposure, of an implant device or portion thereof in a moisturizing solution. For example, such immersion or other type of moistening of the implant device can be performed substantially automatically and may or may not require engagement by the operator. In certain embodiments, a timer can be implemented in connection with a suturing procedure in accordance with the present disclosure, wherein the timer indicates and/or notifies an operator of moisturizing requirements for an implant device being operated on. For example, with respect to the process1700ofFIG.17, an interrupt routine may be implemented which is designed to interrupt the operator and/or the process executed by the suture assist system when it is determined that it is necessary or desirable for the operator to moisturize the implant device or portion thereof. In certain embodiments, sensors, light, lasers, and/or other techniques can be used to detect the moisture level or other characteristics of the target or implant device or leaflets. In certain embodiments, the process1700may not continue until the operator has performed the moisturizing step, or alternatively the articulation positioning device that holds the implant device may execute the moisturizing operation in response to the interrupt routine.

Suture Tension Management

Certain embodiments disclosed herein provide for systems, devices and methods for assisting in suturing operations through the use of tensioning functionality, which may be useful with respect to improvement in quality, efficiency, and/or quality control evaluation. For example, where suturing involves passing a needle through one or more layers of material of an implant device, varying pinch forces may be required in order to penetrate the layers with the proper amount of tension. Certain systems involve the use of an automated suture fixture that is designed to present to the operator varying tension settings in one or more stages of the articulation device, such as at an articulation arm or at a base of the automated suture fixture. The tension management of the system may promote consistent force of needles and puncturing certain materials of the implant device and can be used in combination with an automated needle delivery system to thereby improve the tensioning execution by the automated needle delivery system.

In certain embodiments, tension management can be implemented through the use of a pressure-sensitive pressure plate, device, or structure, which can be disposed on or in physical contact with a base portion of the automated suture fixture, or other portion of the automated suture fixture. The pressure sensitive device can be configured to provide a readout of tensions experienced by the automated suture fixture, which may indicate whether the operator has exacted excessive torque or pressure on the implant device, or not enough force, which may provide an indication of quality of operator performance.

Articulation and/or tensioning of the articulation arm may be designed to present a desired sewing angle or sewing tension and/or resistance for a specific stitch. Tensioning of the articulation arm or other component of the automated suture fixture may provide controlled pinch forces for penetrating, for example, heart valve implant device leaflets. Tension management may be used to provide consistent force for needle delivery, wherein tighter tension may be desirable for certain punctures, while looser tension may be desirable or others.

Fully Automated System

In certain embodiments, a fully or mostly automated system can be used. The fully or mostly automated system can include one or multiple automated fixtures (e.g., one, two, three, four, five, six, or more than six automated fixtures). For example, a first automated fixture (which can be the same as or similar to the automated fixtures or automated suture fixtures described and shown herein) can be used to articulate and move an implant device to various desired positions for processing operations/step (e.g., suturing, treatment, applications, etc.), while a second and/or third automated fixture or device can be used to perform the processing operations/steps at the various desired positions. For example, a second automated fixture could act similar to a sewing machine that moves a needle in and out (e.g., which can be done in a single path, in a single plane, along a linear path, in two-dimensional space, in three-dimensional space, etc.) to add the sutures to a target or implant device while the first automated fixture moves the target or implant device to the correct position to receive the desired suture in the correct location on the target or implant device. In various embodiments, a second automated fixture and a third automated fixture can work together to move and to receive a needle in a sewing operation, e.g., passing the needle from the second fixture to the third fixture and from the third fixture to the second fixture after passing the needle through the desired portion of a target device held as the target device is moved to the desired positions by the first fixture, etc. Suture tensioning management could also be used, which could, for example be similar to that described herein to maintain and to use proper tensioning and pressure in the suture, needle, cover, and/or other materials. Optionally, the second automated fixture (and/or an additional third automated fixture and/or more fixtures) could be configured and used to apply another material (e.g., a polymer, coating, or other material) to the target or implant device (e.g., the full device or a portion thereof) without suturing, e.g., in a sputtering procedure, electrospinning procedure, treatment procedure, coating procedure, and/or other procedure.

A mostly automated system, as used herein, can include systems that utilize minimal operator input, such as controlling when to proceed to a next step in the process, repeat a step in the process, pause during or after a step in the process, and the like. Mostly automated systems may also utilize operator input to verify when a step is performed correctly by the system before proceeding in the programmed process. Similarly, a mostly automated system can include an operator that modifies or otherwise manipulates the pre-programmed process during the procedure based on one or more manufacturing considerations. Mostly automated systems may also allow but not require operator input in any of the situations described herein.

The disclosed automated systems may be programmable such that multiple fixtures can be coordinated with each other to follow or to implement a previously specified or programmed operation on a target device (e.g., one or more previous specified or programmed sewing pattern(s) for a heart valve). The systems may then step through the programmed operation with or without operator intervention.

In some embodiments, one of the automated fixtures can be a multi-axis robotic arm with a needle handling component, which can be configured to perform sewing operations, replacing steps or procedures typically performed by hand in the manufacture of an implant device. In conjunction with one or more other automated fixtures (e.g., other automated fixtures disclosed elsewhere herein, such multi-axis robotic arms), can be configured to maneuver a needle to suture an implant device according to a procedure script (e.g., a pre-programmed suturing procedure script or suturing script). In certain implementations, the implant device can be sutured using the robotic arms or suturing arms without intervention of a human operator (or with only occasional intervention such as 1-10 times a day) during the manufacturing process.

In certain embodiments, a fully automated suturing system can include two automated fixtures configured as dual coordinated suturing arms configured to suture an implant device in conjunction with a third automated suture fixture for manipulating or moving the suture target, examples of which are described herein. The fully automated suturing system can suture an implant device based on a pre-programmed suturing procedure, examples of which are described herein. Each suturing arm can include a component at a distal end of the arm configured for handling and transferring a needle from one arm to the other (e.g., one or more needle holders). The fully automated suturing system can be configured to provide positional targeting of sutures on the implant device. This allows coordination of movements between suturing arms and the automated suture fixture holding the suture target during a suturing procedure. The fully automated suturing system can include a targeting system configured to provide feedback to the system for targeting the needle in the placement of sutures. For example, the targeting system can include a camera that allows image analysis programs to determine a targeted needle location for specified stitch points on the implant device being manufactured. The fully automated suturing system can be configured to utilize single-tipped needles (e.g., a needle with a single pointed end and an eyelet on the opposite end to hold the thread) or double-tipped needles (e.g., a needle with both ends being pointed and an eyelet between the tips to hold the thread). In some embodiments, double-tipped needles can be advantageous because they reduce the need to re-orient the needle between stitches or steps in the suturing procedure.

FIG.32illustrates a block diagram of an example of a fully or mostly automated system3200with an automated fixture3270for holding and manipulating/moving the target device (or suture target) and one or more automated fixtures configured for performing operations on the target device. In the embodiment shown inFIG.32, these additional automated fixtures are configured as suturing arms3280(though other types or configurations of automated fixtures are also possible, e.g., for electrospinning, other procedures, etc.). The fully automated system3200is configured to execute one or more procedures or operations (e.g., suturing operations or other processing operations) for target devices, such as prosthetic heart valve implant devices for humans and/or other types of devices or components. In some embodiments, the system3200can be configured to suture an implant device without a human operator suturing any portion of the device. In various implementations, the system3200can be configured to perform a suturing procedure with little (e.g., 1-10 times in a procedure, 1-10 times per day, or the like) or no intervention from a human operator.

The system3200includes a controller3230configured to direct one or more components of the automated fixture assembly3270according to a suitable or pre-programmed process to manufacture an implant device. The controller3230is also configured to direct one or more components of the suturing arm3280according to the process to manufacture the implant device. The controller3230can also be configured to communicate with a targeting system3260configured to provide feedback regarding the procedure or process (e.g., suturing procedure, etc.). Although illustrated as a separate component in the diagram ofFIG.32, the controller3230can be a component of the automated fixture assembly3270, the targeting system3260, and/or the additional fixture or suturing arm3280. Similarly, the controller3230can be distributed among two or more of the fixture assembly3270, the targeting system3260, and/or the additional fixture/suturing arm3280.

The exemplary controller3230includes one or more hardware and/or software components designed to generate and/or to provide fixture control signals (e.g., suture fixture control signals), fixture/suturing arm control signals, and/or data associated with one or more steps of a suturing process or other process. For example, the controller3230can include a computing device that has one or more processors3232, as well as one or more data storage devices or components3234, which can include volatile and/or nonvolatile data storage media. In some embodiments, the data storage3234is configured to store process script data (e.g., suture process script data), which can include data indicating positioning of one or more components of the system3200for various steps and/or stages of the procedure (e.g., suturing process). A procedure can be represented at least in part by numeric or other data sets representing positioning information for one or more components of the automated fixture3270, the fixture/suturing arm3280, and/or one or more additional components of the system3200for each respective step or stage of the procedure. For example, a suturing process comprising a plurality of suturing steps can be represented at least in part by numeric or other data sets representing positioning information for one or more components of the automated suture fixture3270, one or more components of the suturing arm3280, and/or one or more additional components of the system3200for each respective step or stage of the suturing process.

The automated fixture assembly3270can include one or more components configured to articulate, to operate, and/or to position one or more motorized actuators3273to manipulate a target holder3271. This can be done to present a target device (e.g., a heart valve, suture target, etc.) in a desirable or suitable position for executing at least part of a procedure (e.g., suturing process) or an operation thereof in conjunction with the fixture/suturing arm3280. In certain embodiments, the automated suture fixture3270includes a plurality of motorized actuators3273that are mounted, attached, or connected to one another in a desirable configuration to provide a desirable range of motion for the automated fixture3270for the purpose of articulating a target device (e.g., an implant device) associated with or held by the automated fixture3270. In certain embodiments, the target holder component3271can be associated with, or connected to, one or more of the motorized actuators3273. Individual motorized actuators3273can include one or more rotating, translating, or otherwise articulating members driven by a motor, a piston, or the like. Examples of automated fixtures and associated components are described in greater detail herein with reference toFIGS.10,11,18-25,28-30, and33-35.

The motorized actuators3273can be configured to provide a number of degrees of freedom of movement for the target holder3271and, consequently, a target device held by the target holder3271. In some embodiments, the number of degrees of freedom is greater than or equal to 3, greater than or equal to 4, greater than or equal to 5, or greater than or equal to 6. The degrees of freedom can include positioning in any of the three spatial dimensions (e.g., movement in the x-axis, y-axis, and z-axis; horizontal movement, vertical movement, or a combination of horizontal and vertical movement), rotation (e.g., rotation about the x-axis, about the y-axis, and/or about the z-axis), and/or rotation of the target holder3271around a longitudinal axis of the target device (e.g., keeping the position and pointing direction of the target device fixed while rotating the target device around its longitudinal axis to expose a different portion of the target device to the fixture/suturing arm3280and/or targeting system3260).

The fixture/suturing arm3280can include one or more components configured to articulate, to operate, and/or to position one or more motorized actuators3283to manipulate one or more processing-device holders3281(generally referred to herein as needle holders, though other processing devices beyond needles can be held). This can be done to suture (e.g., perform one or more stitches) a target device (e.g., a heart valve or suture target) with a needle by performing an outside-to-inside stitch and/or an inside-to-outside stitch according to a suturing process in conjunction with the automated suture fixture3270. In certain embodiments, the suturing arm3280includes a plurality of motorized actuators3283that are mounted, attached, or connected to one another in a desirable configuration to provide a desirable range of motion for the suturing arm3280for the purpose of articulating a needle held by the suturing arm3280or grabbing a needle held by another suturing arm3280or by a needle transfer fixture3290. In certain embodiments, the needle holder3281can be associated with, or connected to, one or more of the motorized actuators3283. Individual motorized actuators3283can include one or more rotating, translating, or otherwise articulating members driven by a motor, a piston, or the like. Movement and operation of the suturing arm3280is similar to the movement and operation of the automated suture fixtures described in greater detail herein.

The motorized actuators3283can be configured to provide a number of degrees of freedom of movement for the one or more needle holders3281and, consequently, provide such freedom of movement to a needle held by a needle holder3281. In some embodiments, the number of degrees of freedom is greater than or equal to 3, greater than or equal to 4, greater than or equal to 5, or greater than or equal to 6. The degrees of freedom can include positioning in any of the three spatial dimensions (e.g., movement in the x-axis, y-axis, and z-axis; horizontal movement, vertical movement, or a combination of horizontal and vertical movement), rotation (e.g., rotation about the x-axis, about the y-axis, and/or about the z-axis), and/or rotation of the needle holder3281around a longitudinal axis of the needle (e.g., for thread management purposes).

It should be noted that the suturing arm3280can be a single suturing arm (e.g., a single multi-axis robotic arm) or it can be a plurality of robotic arms. In some embodiments, the suturing arm3280includes dual-coordinated, multi-axis robotic arms that are configured to pass the needle from one arm to the other when suturing the target device. In addition, the needle holder3281can be configured to operate with single-tipped and/or double-tipped needles.

The one or more needle holders3281can be configured to releasably secure a needle to the suturing arm3280. In some embodiments, at least one needle holder3281includes gripping appendages that are configured to open and close to alternately release and secure a needle. The needle holder3281can be rotated as well. This can be used to re-orient the needle in the needle holder3281while the needle is being secured by another suturing arm or another device or fixture (e.g., the needle transfer fixture3290). The needle holder3281can include one or more features configured to secure the needle in place during a suturing procedure. For example, the needle holder(s)3281can include gripping elements configured to secure the needle in place as it is pushed through a fabric of the implant device. In some embodiments, one or more of the needle holders3281can include an opening or aperture into which the needle can pass and then be secured (e.g., clamped, squeezed, etc.). In various embodiments, the needle holder(s)3281can include pliable material to secure the needle in the needle holder(s)3281. The needle holder(s)3281can also implement electromagnetic components, adhesive elements, components with high coefficients of friction, and the like to facilitate securing of a needle during a suturing procedure.

In certain embodiments, the controller3230can provide control signals for directing the positioning of the motorized actuators3273,3283based on a suture process script. Coordination of the movement of the motorized actuators3273,3283allows the automated suture fixture3270and the suturing arm (s)3280to work in concert to manufacture the implant device.

The system3200can include a targeting system3260that can be configured to provide feedback to the controller3230regarding the position and orientation of the needle holder3281(and/or the needle), the target holder3271(and/or the target device), the automated fixture3270, and/or the suturing arm3280. In some embodiments, the targeting system3260includes a camera or other imaging system, which can be configured to implement a variety of imaging capabilities for providing feedback regarding the suturing procedure being executed by the system3200. The targeting system3260can include one or more imaging devices or cameras, e.g., multiple imaging devices or cameras might be used to add dimensions or depth to the images. The targeting system3260can be configured to generate images that can be analyzed by the controller3230to determine whether sutures are correct and/or where to target the needle for the next suture to be placed. In addition, the targeting system3260can capture image data for quality control (e.g., similar to that described elsewhere herein) or other purposes at various stages of the suturing procedure.

The controller3230can be configured to communicate with an optional display system3250, such as an electronic computer display, or the like. The display system3250can be used to provide information on quality control, manufacturing or process status, manufacturing or process progress, or other visual indications to allow humans to monitor performance of the system3200. In some embodiments, the display system3250can be used to allow an operator to perform an inspection procedure using the automated fixture3270, as described herein. For example, an operator can view enlarged imaging of the target device during or after manufacture to inspect the device. In certain embodiments, the automated system3200can be configured to do automated quality control checks, for example, using inspection and/or recognition software (e.g., similar to facial-recognition software) as discussed above to identify or to help identify any quality control issues and/or whether the target has the required configuration after suturing or other processing.

In some implementations, the automated system3200can optionally include a needle transfer fixture3290configured to secure a needle while the needle is not secured by a needle holder3281. This can allow each suturing arm3280to adjust its grip on the needle in between stitches of the suturing procedure. This can be used to ensure proper or targeted alignment of the needle for the next stitch in the suturing procedure. This can also be used to correct any misalignment of the needle in the needle holder3281of a suturing arm3280. For example, a suturing arm3280can use the needle transfer fixture3290to secure the needle while the suturing arm3280changes its orientation in preparation for the next stitch or step in the suturing procedure. As another example, a suturing arm3280can use the needle transfer fixture3290to secure the needle to allow the suturing arm3280to adjust the grip of the needle holder3281on the needle. The needle transfer fixture3290can be configured for use with a single-tipped needle and/or a double-tipped needle.

In some embodiments, a needle may deflect while being secured by a needle holder3281during a suturing procedure. Deflection of the needle causes the needle to be in an unpredictable position after forming a suture (e.g., after passing from one suturing arm to another), resulting in difficulty in performing a subsequent suturing step. The needle transfer fixture3290allows the needle to be released from the suturing arm3280and secured in place while the suturing arm3280re-adjusts its needle holder3281to secure the needle in a desired location and/or orientation.

In some embodiments, the automated system3200is configured to perform a suturing procedure with a standard needle (e.g., a single-tipped needle). In such a procedure, a first suturing arm can be configured to pass the needle through a material of the target device (e.g., from a first side of the material to a second side such as from outside to inside the target device). Once the needle is at least partially inserted through the material of the target device, the first suturing arm can hand the needle off to the second suturing arm. After the second suturing arm receives the needle, it can pull the thread all the way through the material of the target device. The second suturing arm can then rotate the needle 180 degrees and push the needle back through the fabric and/or frame of the target device. Once the needle is at least partially through the material of the target device, the second suturing arm can hand the needle back off to the first suturing arm, which then pulls the needle the rest of the way through the fabric and rotates the needle 180 degrees. This can be repeated as part of a suturing procedure. In some embodiments, after the needle passes all the way through the fabric and/or the frame of the target device, the automated fixture3270can rotate and/or translate position of the target device so that the needle passes through a different portion of the target device to form the desired suture. In certain embodiments, the suturing arms3280adjust their position after the needle passes all the way through the fabric and/or frame of the target device so that the needle passes through a different portion of the target device to form the desired suture. In various embodiments, some combination of the automated suture fixture3270and the suturing arms3280move after the needle passes all the way through the fabric and/or frame of the target device so that the needle passes through a different portion of the target device to form the desired suture.

In some embodiments, the automated system3200is configured to perform a suturing procedure with a double-tipped needle. A difference between the procedure with the standard needle and the double-tipped needle is that once the second suturing arm grabs the needle and pulls it through the material of the target device, it does not need to rotate the needle 180 degrees. Instead, the target device is rotated or moved, or the second suturing arm adjusts its position to the next position, and the needle is pushed through the material of the target device. This procedure may advantageously save time and can facilitate management of the thread.

In some embodiments, the suturing procedure is designed so that the suturing arm3280performs the same stitch pattern each time while the automated suture fixture3270moves the target device to the correct location for the next needle puncture location. An example of such a procedure is illustrated inFIGS.34A-34Fusing a double-tipped needle. In some embodiments, the suturing procedure is designed so that both the suturing arm3280and the automated suture fixture3270move to perform the stitching. An example of such a procedure is illustrated inFIGS.35A-35Husing a standard needle.

FIG.33illustrates an example embodiment of a fully automated suturing system3300with an automated suture fixture3370and two additional automated fixtures configured as suturing arms3280a,3280b. The automated suture fixture3370includes a target holder3371configured to secure an implant device during suturing. The suturing arms include needle holders3381a,3381bto hold and transfer a needle during suturing. The automated suture fixture3370includes an articulating arm configured to adjust a position and orientation of the target holder3371. Similarly, each of the suturing arms3380a,3380binclude articulating arms to adjust a position and orientation of their respective needle holders3381a,3381b. The needle holders3381a,3381bcan be configured to open and close to release and secure a needle. The suturing arms3380a,3380bare mounted to a common base3382that supports each suturing arm3380a,3380b.

FIGS.34A-34Fillustrate an exemplary suturing procedure (or portion thereof) using a double-tipped needle wherein the suturing procedure uses an automated suture fixture3470to move a target device3410between stitches while the suturing arms3280a,3280bperform the same suturing movements for each suture. InFIG.34A, the automated suture fixture3470is illustrated securing the target device3410using a target holder3471. A first suturing arm3480ais illustrated securing a needle3485on an outside of the target device3410. A second suturing arm3480bis illustrated with a portion inside the target device3410, ready to receive the needle3485after it has been at least partially pushed through the material of the target device3410.

InFIG.34B, the first suturing arm3480ahas pushed the needle3485partially through the material of the target device3410and the needle holder3481bof the second suturing arm3480bhas gripped the needle3485. After the second needle holder3481bhas gripped the needle3485, the first needle holder3481areleases the needle3485.

InFIG.34C, the second suturing arm3480bpulls the needle3485into the inside of the target device3410. Once the needle3485is inside the target device3410, the automated suture fixture3470rotates and/or moves the target device3410into position for the next suture.

InFIG.34D, the second suturing arm3480bpushes the needle3485back out of the target device3410(without rotating the needle3485because the needle3485is double-tipped). Once the needle3485is partially pushed outside of the target device3410, the first suturing arm3480agrips the needle3485. After the first suturing arm3480agrips the needle3485, the second suturing arm releases the needle3485.

InFIG.34E, the first suturing arm3480afinishes pulling the needle3485through the cloth of the target device3410so that the needle is again outside of the target device3410.

InFIG.34F, the first suturing arm3480apushes the needle into a needle transfer fixture3490to allow the first suturing arm3480ato adjust its grip on the needle3485. After re-gripping the needle3485, the procedure repeats as described starting atFIG.34A.

FIGS.35A-35Hillustrate an exemplary suturing procedure (or portion thereof) using a standard, single-tipped needle3585wherein the suturing procedure uses an automated suture fixture3570to move a target device3510and an automated suturing arm3580to form the targeted sutures with the needle3585. InFIG.35A, the automated suture fixture3570secures the target device3510. A first needle transfer fixture3590asecures the needle3585that is partially penetrating into the target device3510. The suturing arm3580with a needle holder3581approaches the target device3510to grab the needle3585.

InFIG.35B, the suturing arm3580secures the needle3585. After the suturing arm3580secures the needle3585, the first needle transfer fixture3590areleases the needle3585.

InFIG.35C, the suturing arm3580delivers the needle3585to a second needle transfer fixture3590b. The second needle transfer fixture3590bsecures the needle3585while the suturing arm3580repositions itself to change the orientation of the needle3585relative to the needle holder3581.

InFIG.35D, the suturing arm3580grabs the needle3585with the new orientation and pushes the needle3585partially through the target device3510. Once the needle3585is partially inside the target device3510, the first needle transfer fixture3590asecures the needle3585. After the needle3585is secured by the first needle transfer fixture3590a, the suturing arm3580releases the needle3585.

InFIG.35E, the automated suture fixture3570moves relative to the needle3585being secured by the first needle transfer fixture3590ato pull the needle3585through the target device3510.

InFIG.35F, the suturing arm3580grabs the needle3585, after which the first needle transfer fixture3590areleases it.

InFIG.35G, the suturing arm3580delivers the needle3585to the second needle transfer fixture3590b. The second needle transfer fixture3590bsecures the needle3585while the suturing arm3580repositions itself to change the orientation of the needle3585relative to the needle holder3581.

InFIG.35H, the suturing arm3580delivers the needle3585to the first needle transfer fixture3590awhereupon it is secured by the first needle transfer fixture3590aand subsequently released by the suturing arm3580. To finish the suture, the automated suture fixture3570can return to its position illustrated inFIG.35Awhile the orientation and/or position of the target device3510has been changed relative to the first needle transfer fixture3590aby the automated suture fixture3570. The process then repeats as described starting inFIG.35A.

Multi-Tool Assistance

Certain embodiments disclosed herein provide for systems, devices, and methods for assisting in suturing procedures or other procedures, wherein an automated fixture or automated suture fixture and/or other system components are utilized in order to allow for execution of suturing operations or other operations by an operator using a single hand to operate, for example, a needle. In other words, in certain embodiments, the assist systems described herein may replace (or be used instead of) one of the operator's hands, thereby allowing the operator to perform operations or sutures with only one hand. Where only a single hand is required for executing suturing operations or other operations, systems, devices, and methods disclosed herein may allow for additional operations and functions to be performed by the operator using a free hand not required for holding the target or implant device being sutured or processed or operated on, which can advantageously instead be held by an articulation arm of the automated suture fixture, as described herein. For example, the free hand of the operator may be utilized for pre-drilling, pre-punching, or pre-dimpling of fabric or material, or the like, which may be executed using any suitable or desirable tool for such purposes, such as a mechanical tool, laser, or the like.

Furthermore, the free hand of the operator can be used for tensioning control or other operations. The free hand of the operator can be utilized to operate any type of hand tool, such as hand tools requiring only a simple trigger pull, for example. For example, a pistol-grip punch tool can be used by the operator with the operator's freehand. With the operator's free hand being used for other suture-related activities, stitch quality can be improved, and the precision of various operations of a suturing procedure can be improved.

Additional Embodiments

Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, may be added, merged, or left out altogether. Thus, in certain embodiments, not all described acts or events are necessary for the practice of the processes. Moreover, in certain embodiments, acts or events may be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or via multiple processors or processor cores, rather than sequentially.

While many of the specific examples and embodiments described herein focus on suturing assist systems, automated suture fixtures, suturing operations/steps/procedures, etc. the invention is not limited to suturing applications and the same or similar systems, fixtures, devices, features, components, principles, operations/steps/procedures, etc. to those discussed with respect to suturing can be used for other operations/steps/procedures/treatments, etc. For example, the system may be used to apply material to a frame using sputtering, electrospinning, rivets, staples, fasteners, fastener guns, clamps, or in other ways without involving suturing. While much of the discussion focuses on implant devices (e.g., human prosthetic heart valve implants) or other specific examples, the same or similar systems, fixtures, devices, features, components, principles, operations/steps/procedures, etc. to those discussed with respect to the examples above can be applied to other types of target devices.

Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain embodiments do include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous, are used in their ordinary sense, and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is understood with the context as used in general to convey that an item, term, element, etc. may be either X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y and at least one of Z to each be present.

It should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and/or described in a particular embodiment herein can be applied to or used with any other embodiment(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each embodiment. Thus, it is intended that the scope of the inventions herein disclosed and claimed below should not be limited by the particular embodiments described above but should be determined only by a fair reading of the claims that follow.

The schematic flow chart diagrams included herein are generally set forth as logical flow chart diagrams. As such, the depicted order and labeled steps are indicative of one embodiment of the presented method. Other steps and methods may be conceived that are equivalent in function, logic, or effect to one or more steps, or portions thereof, of the illustrated method. Additionally, the format and symbols employed are provided to explain the logical steps of the method and are understood not to limit the scope of the method. Although various arrow types and line types may be employed in the flow chart diagrams, they are understood not to limit the scope of the corresponding method. Indeed, some arrows or other connectors may be used to indicate only the logical flow of the method. For instance, an arrow may indicate a waiting or monitoring period of unspecified duration between enumerated steps of the depicted method. Additionally, the order in which a particular method occurs may or may not strictly adhere to the order of the corresponding steps shown.

Components, aspects, features, etc. of the systems, assemblies, devices, apparatuses, methods, etc. described herein may be implemented in hardware, software, or a combination of both. Where components, aspects, features, etc. of the systems, assemblies, devices, apparatuses, methods, etc. described herein are implemented in software, the software may be stored in an executable format on one or more non-transitory machine-readable mediums. Further, the software and related steps of the methods described above may be implemented in software as a set of data and instructions. A machine-readable medium includes any mechanism that provides (e.g., stores and/or transports) information in a form readable by a machine (e.g., a computer). For example, a machine-readable medium includes read only memory (ROM); random access memory (RAM); magnetic disk storage media; optical storage media; flash memory devices; DVD's, electrical, optical, acoustical or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, EPROMs, EEPROMs, FLASH, magnetic or optical cards, or any type of media suitable for storing electronic instructions. Information representing the units, systems, and/or methods stored on the machine-readable medium may be used in the process of creating the units, systems, and/or methods described herein. Hardware used to implement the invention may include integrated circuits, microprocessors, FPGAs, digital signal controllers, stream processors, and/or other components.