Automated sewing and thread management

Abstract

The present disclosure relates to automated systems, devices, and methods for sewing a target device, such as a prosthetic implant device. The systems and methods include forming a stitch on the target device, adjusting a thread coupled to a needle used to form the stitch so that the thread is clear of (e.g., does not interfere with) the needle path, and applying a target tension to the thread to tension the stitch on the target device. The suturing process can also include providing different target tensions during stitch formation. The suturing process can also include providing different target tensions at different stages of stitch formation to assist in stitch formation, clear the thread from the needle path, and / or hold the stitch in place in preparation for the next stitch.

Description

[[Background Art]]

[0001] Medical devices, artificial implants, artificial heart valves, and the like may sometimes require sewing, processing, inspection, and the like of several portions and / or components thereof. Accuracy and / or efficiency in performing suturing or other operations for such devices and other devices can be important. Furthermore, some suturing or other operations can be time-consuming and difficult. [[Prior Art Document]] [[Patent Document]]

[0002] [[Patent Document 1]] International Publication No. 2015 / 070249 pamphlet [[Summary of the Invention]] [[Means for Solving the Problem]]

[0003] This summary is meant to provide several examples and is in no way intended to limit the scope of the disclosed subject matter. For example, any feature included in an example of this summary is not required by the claims unless the claims explicitly recite that feature. Furthermore, the features, steps, concepts, and the like described in examples in this summary and elsewhere in this disclosure can be combined in various ways. The description herein relates to devices, apparatuses, systems, assemblies, methods, combinations, and the like that can be used for manufacturing and processing heart valves and / or related or associated components, devices, apparatuses, and the like.

[0004] In some implementations, this disclosure relates to an automated method for manufacturing (e.g., sewing or suturing) a target device or component, such as an artificial implant device (e.g., an artificial human implant device, an artificial heart valve, etc.). The method includes the steps of forming a stitch on the target device, adjusting a thread attached to a needle used to form the stitch so that the thread is removed from the needle's path (e.g., the thread does not interfere with the needle's path), and applying a target tension to the thread to tension the stitch on the target device. This method can be automated.

[0005] In some implementations, this method also includes a step of providing multiple target tensions during stitch formation. For example, this method may include a step of providing target tensions that vary as a function of time and / or as the stitch formation progresses. Multiple target tensions can be applied at different stages of stitch formation to help remove the thread from the needle path and / or to hold the stitch in place for the next stitch. The tension can be substantially released from the thread at one or more stages of stitch formation.

[0006] In some implementations, a method for sewing an implant device includes the steps of: passing a threaded needle from a first needle gripper to a second needle gripper to form a first portion of a stitch on the implant device; returning the threaded needle from the second needle gripper to the first needle gripper to form a second portion of a stitch on the implant device; moving the thread along or outside the needle path; and applying tension to the thread. The first and second needle grippers and their movements can be automated. In some embodiments, the needle path can be a fixed linear path (e.g., a path along a line or along an axis), and the method can include the step of moving the needle back and forth along the fixed linear path. As described herein, the tension of the thread can be changed over time and / or during the stages of stitch formation, and the tension can be removed at one or more points during stitch formation.

[0007] In some embodiments, the step of applying tension to the suture includes applying a number of different tensions at different times to form and / or secure the suture. The step of removing the suture from the needle path may include moving a portion of the suture between the implant device and the first needle gripper in a direction perpendicular to the needle path.

[0008] In some implementations, the suturing system includes one or more automated fixtures or systems. For example, the suturing system includes a first automated fixture which includes a plurality of actuator devices and a holder or target device holder. The first automated fixture is configured to move or rotate a target device (e.g., a heart valve, a component of a heart valve, etc.) when the target device is mounted on the holder or target device holder. The suturing system includes a second automated fixture which includes one or more needle grippers and a plurality of actuator devices. The second automated fixture is configured to pass a needle back and forth through the surface of the target device to form a stitch or suture on the target device. The suturing system includes an automated thread management system for moving the thread and providing tension to the thread. The automated thread management system includes a tension device which can provide a target tension to the suture when forming a suture on the target device. The automated thread management system also includes a thread moving device which moves the thread along or outside the needle path defined by the second automated fixture. The needle path can be a fixed linear path, for example, a path along an axis or along a line.

[0009] In some implementations, the automated thread management system provides increasing tension during the first stage of the suturing process and a target tension during the second stage of the suturing process. In some implementations, the automated thread management system transitions to the target tension in response to exceeding a tension threshold during the first stage of the suturing process. In some implementations, the automated thread management system removes the tension during the third stage of the suturing process.

[0010] In some embodiments, the needle is a double-ended needle with a hole near the center. In such embodiments, the second automatic fixture can be configured to maintain the orientation of the needle as it passes back and forth through the surface of the target device (for example, the needle does not rotate 180 degrees while forming a stitch).

[0011] In some embodiments, a second automatic fixture is configured to move the needle along a fixation path. In such embodiments, the first automatic fixture is configured to adjust the position and / or orientation of the target device during suture formation so that a suture is made at a target location on the target device. In further embodiments, the fixation path is a straight path, or a path along an axis or a straight line. In some embodiments, the fixation path may be curved, or a combination of straight and curved portions.

[0012] In some embodiments, a first and second automatic fixture of the system are positioned relative to each other and configured such that the first automatic fixture can move a target device in three dimensions to position and orient the target device along the needle path. This suturing system and its components or fixtures can be configured to implement a predetermined suture pattern on a target device. In some embodiments, the first automatic fixture includes a first controller configured to instruct the first automatic fixture how to position the target device. In some embodiments, the second automatic fixture includes a second controller configured to instruct the second automatic fixture when to move the needle to implement the suture pattern.

[0013] In some embodiments, the automated thread management system includes a third controller configured to instruct a thread moving device to move the thread outside the needle path. The third controller may also be configured to instruct a tension device to apply tension to the thread. The third controller may also be configured to change the tension applied to the thread. In some embodiments, two or more functionalities of the first, second, and third controllers are combined into a controller for the suturing system. The needle path may be a fixed straight path, e.g., a path along an axis or a straight line; a fixed curved path, e.g., a path along a curve; or a fixed path that is a combination of straight and curved paths, e.g., a path with one or more straight sections and one or more curved sections. The needle path may be a path that is repeatedly crossed when forming a stitch on a target device. A suture pattern can be achieved on a target device using a fixed needle path by adjusting the position and / or orientation of the target device during and / or between stitches.

[0014] In several implementations, a thread management system is provided that includes a thread movement device configured to move the thread so that it is removed from the needle path for an automated suturing system. The thread movement can be in a direction perpendicular to the needle path. The thread management system may also include a tension device configured to apply a target tension to the thread to form a stitch on a target device.

[0015] In some implementations, the tension device is configured to provide increasing tension until a tension threshold is reached, and then to provide steady-state tension after the increasing tension exceeds the tension threshold. In some implementations, the tension device is configured to provide different tension stages while forming a stitch, the different tension stages include an increasing tension stage, a decreasing tension stage, a steady-state tension stage, and a tension release stage. In further implementations, when the tension increases beyond a threshold, the increasing tension stage can proceed to a decreasing tension stage. When the decreasing tension reaches a steady-state tension that is less than the threshold tension, the decreasing tension stage can proceed to a steady-state tension stage. The steady-state tension stage can proceed to a tension release stage at a specific stage during stitch formation. The tension stages can be repeated in conjunction with the movement of the needle to form a stitch on the target device.

[0016] The thread management system can be used in an automated suturing system as described above or elsewhere in this specification. For example, the thread management system can be used with, or be part of, an automated suturing system which includes a first automated fixture having a holder and configured to adjust the orientation of a target device when held by the holder, and a second automated fixture having a first needle gripper and a second needle gripper configured to pass a needle back and forth through the surface of a target device to form a suture.

[0017] In some implementations, a method for suturing or sewing a target device includes the step of operating an automated suturing system to suturing or sewing a target device, the automated suturing system being programmed to perform programmed steps. In some embodiments, the programmed steps include: passing a needle through the surface of a target device using a first needle gripper and a second needle gripper, wherein the first needle gripper moves toward the target device along a needle path (e.g., a fixed path, a fixed straight path, a path along an axis or straight line, a curved path, etc.); and adjusting the position of the target device. In some embodiments, the programmed steps include returning the needle through the surface of the target device using the first and second needle grippers. The first needle gripper can be programmed to move with the needle toward the target device toward the target device along the needle path. In some embodiments, the programmed steps also include moving a thread attached to the needle so that the thread is removed from the needle path; and applying a target tension to the thread.

[0018] The step of applying a target tension may include the steps of applying increasing tension until it exceeds a tension threshold, and then applying a steady-state tension after the tension threshold has been exceeded. In some embodiments, the tension threshold is approximately 0.4 N or greater. In some embodiments, the steady-state tension is approximately 0.3 N or less. In some embodiments, the programmed step further includes releasing the tension in the yarn after the steady-state tension has been applied to the yarn.

[0019] The step of moving the thread so that it is removed from the needle path may include the step of moving the thread perpendicular to the needle path. The step of adjusting the position of the target device may include the step of rotating the target device. Alternatively, the step of adjusting the position of the target device may include the step of moving the target device perpendicular to the needle path.

[0020] The step of operating an automated suturing system to suture a target device includes the step of causing the automated suturing system to perform programmed steps (for example, any and / or all of the programmed steps).

[0021] In some implementations, a method for suturing a target device includes a step of operating an automated suturing system, which is programmed to perform a plurality of suturing steps. In some embodiments, the automated suturing system is programmed to adjust the position of a target device using a first needle gripper and a second needle gripper, which move toward the target device along the needle path, so as to pass the needle through the surface of the target device, and to return the needle through the surface of the target device using the first and second needle grippers. The first needle gripper can be programmed to move away from the target device along the needle path.

[0022] In some embodiments, the automated suturing system is programmed to move the thread attached to the needle so that the thread is removed from the needle path. In some embodiments, the automated suturing system is programmed to apply a target tension to the thread.

[0023] In several implementations, the automated suturing system is programmed to pass a needle through the surface of a target device using a first needle gripper and a second needle gripper, with the first needle gripper moving toward the target device along a needle path (e.g., a fixed path, a fixed straight path, a path along an axis or straight line, a curved path, etc.). The automated suturing system can also be programmed to adjust the position of the target device and return the needle through the surface of the target device using the first and second needle grippers. The first needle gripper can also be programmed to move away from the target device along the needle path.

[0024] In some embodiments, the automated suturing system is also programmed to move the thread attached to the needle so that it is removed from the needle path, and to apply a target tension to the thread. The automated suturing system can be programmed to apply the target tension such that an increasing tension is applied for a certain period, and then a steady-state tension is applied after the increasing tension exceeds a tension threshold. In some implementations, the tension threshold can be about 0.4 N or higher. In various implementations, the steady-state tension can be about 0.3 N or lower. The automated suturing system can be further programmed to release the tension in the thread after applying the target tension.

[0025] An automated suturing system can be programmed to move the thread so that it is removed from the needle path. For example, the thread can be moved perpendicular to the needle path to remove it from the needle's path. An automated suturing system can also be programmed to adjust the position of a target device. For example, the target device can be rotated and / or moved perpendicular to the needle path.

[0026] Other steps, features, and components, which are not specifically mentioned in these examples but are described elsewhere in this specification or are otherwise known, are also included and / or can be used in conjunction with the examples described herein.

[0027] Various embodiments are depicted in the accompanying drawings for illustrative purposes, and should in no way be construed as limiting the scope of any invention disclosed in the present specification. In addition, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between reference elements. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] [Figure 1] Figure is a diagram showing an example of an implantable artificial valve device. [Figure 2] Figure is a perspective view showing an example of another artificial heart valve. [Figure 3A] Figure is a diagram showing a frame for a support stent for an example surgical valve. [Figure 3B] Figure is a diagram showing the frame of Figure 3A covered with fabric. [Figure 4] Figure is a diagram showing an example of an operator performing an operation on an implant device. [Figure 5] Figure is an enlarged view showing a heart valve implant device being sutured using manual holding and suturing. [Figure 6] Figure is an enlarged view showing a fabric that can be associated with an implant device. [Figure 7] Figure is a block diagram showing an example automatic suturing system. [Figure 8] Figure is a diagram showing an example embodiment of an automatic suturing system including an automatic thread management system. [Figure 9A] Figure is a diagram showing the functionality of an automatic fixture holder of the automatic suturing system of Figure 8. [Figure 9B] Figure is a diagram showing an example automatic fixture holder having an articulated arm and a target device holder. [Figure 10A]Figure 8 shows a portion of an example suturing process performed by several components of an example automated suturing system. [Figure 10B] Figure 8 shows a portion of an example suturing process performed by several components of an example automated suturing system. [Figure 10C] Figure 8 shows a portion of an example suturing process performed by several components of an example automated suturing system. [Figure 10D] Figure 8 shows a portion of an example suturing process performed by several components of an example automated suturing system. [Figure 10E] Figure 8 shows a portion of an example suturing process performed by several components of an example automated suturing system. [Figure 11A] This figure shows an example of how the tension of a string changes over time. [Figure 11B] This figure shows an example of how the tension of a string changes over time. [Figure 12] This figure shows a block diagram of an example control system for controlling an automated suturing system. [Figure 13] This figure shows the distal portion of the articulated arm of an automatic fixture holder, to which the target device is fixed in the target device holder. [Figure 14] This figure shows a flowchart illustrating an example of a method for forming sutures on an implant device using an automated suture management system. [Modes for carrying out the invention]

[0029] While several preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as their modifications and equivalents. Therefore, the scope of claims that may arise therefrom is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the actions or operations of that method or process can be performed in any suitable order and are not necessarily limited to any particular disclosed order. Furthermore, one or more steps disclosed with respect to one method can be incorporated into other methods disclosed herein. While various operations can be described sequentially as multiple distinct operations in a manner that may be helpful in understanding some embodiments, the order of description should not be interpreted as meaning that these operations are order-dependent. In addition, the structures, systems, and / or devices described herein can be implemented as integrated components or as separate components. For the purpose of comparing various embodiments, some aspects and advantages of these embodiments are described below. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Therefore, various embodiments can be implemented, for example, in a way that achieves or optimizes one or more advantages as taught herein, without necessarily achieving other embodiments or advantages, which may also be taught or suggested herein. Features described in relation to one exemplary embodiment can be incorporated into other embodiments disclosed herein, even if they are not specifically described in relation to that embodiment.

[0030] overview Artificial heart valve implants, as well as many other types of artificial implant devices and other types of devices, can include various sutured components and / or parts. For example, sealing portions, skirts, etc., can be sutured to the frame of the artificial heart valve to help prevent blood from leaking to the outer edge or periphery of the artificial heart valve. Performing sutures or stitches by human operators can be relatively difficult and / or cumbersome in some situations. For example, when small stitches must be made with high precision, the complexity and / or associated operator burden can result in discomfort and / or an undesirable decrease in product quality. Furthermore, some heart valve implant devices may require hundreds of sutures, which can involve a substantially labor-intensive and error-prone suturing procedure. Therefore, adding automation to the suturing of implants may be desirable to help improve the quality and speed of manufacturing and / or prevent problems associated with human operators.

[0031] Some embodiments disclosed herein provide automated heart valve suturing systems, devices, and / or methods for performing a suturing procedure involving the physical manipulation and / or placement of one or more automated mechanical articulation fixtures, components, and / or subassemblies, by manipulating a needle using an automated needle gripper to form a suture or stitch on a target heart valve, and by applying tension to the suture and moving the thread out of the needle's path using an automated mechanical system. Such articulation fixtures or components may be configured to hold or fix an artificial human heart valve implant device, or other suture target or implant device having one or more components or parts that can be advantageously sutured together. Such automated needle grippers may be configured to pass a needle back and forth through the surface or material of a target heart valve to form a suture. Such automated mechanical systems may be configured to move the thread out of the needle's path and / or to apply tension to the thread to form a suture. Various embodiments relating to heart valve suturing presented herein may be applicable to heart valves having any kind of suture and / or structural configuration or pattern. Examples of cardiac valve structures and cardiac valve suturing techniques that may be applicable to some embodiments presented herein are disclosed in Patent Document 1, the entire contents of which are expressly incorporated herein by reference.

[0032] Figure 1 shows an example of an implantable artificial human valve device 110 according to one or more embodiments, but various other variations and designs of the valve device are also possible. The features of the valve 110 described herein can be applied to other valves, including other valves or target devices described elsewhere herein. The valve 110 may be, for example, a transcatheter heart valve (THV), a balloon-expandable heart valve, and / or a mechanically expandable heart valve. The valve 110 in the illustrated embodiment may generally include a frame or stent 112, a lobular structure 193 supported by the frame 112, and a sealing member or skirt 116 fixed (e.g., sutured or stitched) to the outer surface of the lobular structure 193. In some embodiments, the valve 110 is configured to be implanted in the ring of a natural human heart valve, such as an aortic valve. However, the valve 110 can also be adapted to be implanted, or instead, in other natural valves of the heart, or in various other vascular structures, tubes, or orifices of the body, or in implanted grafts, docking stents, docking stations, rings, etc. In the orientation shown, the lower end 180 of the valve 110 represents the inlet end, while the upper end 182 of the valve 110 represents the outlet end.

[0033] The valve 110 and frame 112 can be configured to be radially foldable into a folded or retracted state or configuration for introduction into the body using a delivery catheter, and can be further configured to be radially expandable into an expanded state or configuration for implantation of the valve at a desired location in the body (e.g., a natural aortic valve). In some embodiments, the frame 112 includes a plastic, polymer, shape memory material, or metal expandable material that allows the valve to be retracted to a smaller external shape for delivery and expansion of the valve 110. In some implementations, the valve can be expanded or assisted in expanding the valve using an expansion device such as a balloon catheter balloon or a tool for mechanical expansion. In some embodiments, the valve 110 is a self-expanding valve, and the frame is made of a self-expanding material such as a shape memory material or a metal (e.g., nitinol). The self-expanding valve can be retracted to a smaller external shape and can be held in the retracted state by a restraint device such as a sheath covering the valve. Once the valve is positioned at or near the target site, the restraint device can be removed or retracted, allowing the valve to self-extend to its expanded functional size or deployed configuration.

[0034] The sealing portion or skirt 116 may include a single or multiple pieces with both ends or a material (e.g., cloth, polymer, etc.) that are fixed together to form an annular shape as shown in Figure 1, or that extend around the valve. In some embodiments, the upper edge of the sealing portion or skirt 116 has a wavy shape that generally follows the shape of the struts of the frame 112. In this way, the upper edge of the sealing portion or skirt 116 can be securely fastened to each strut with sutures 156. The sealing portion or skirt 116 may be positioned outside or inside the frame 112 (as shown), and the upper edge of the sealing portion or skirt 116 can be wrapped around the upper surface of the frame struts and fastened in place with sutures. The sutures 156 provide a durable attachment of the sealing portion or skirt 116 to the frame 112.

[0035] The lobular structure 193 may, in some embodiments, include three lobules (as shown in Figure 1), which may be arranged to fold into a tricuspid configuration. Although a three-lobular embodiment is shown, it should be understood that a valve implant sutured according to the embodiments disclosed herein may have any number of lobules, such as two or four. The lobules 193 may be formed from separate flaps of material or tissue, or all three lobules may be obtained from a single material. The lower edge of the lobular structure 193 may have a variety of shapes. In some embodiments, the lower edge of the lobular structure 193 may have a wavy, curved, and / or scalloped shape that can be sutured to the frame 112. The lobules 193 may be fixed to each other on their adjacent sides to form a commissure 184 of the lobular structure, where the edges of the lobules become one. The lobular structure 193 may be fixed to the frame 112 using any suitable technique and / or mechanism. For example, the commissural lobular structures 184 can be aligned with and fixed to the support posts 118 using, for example, sutures, adhesives, fastening parts, crimping, and / or other mounting means. In some implementations, the attachment points of the lobes 193 to the posts 118 can be reinforced with, for example, bars made of a more rigid material or stainless steel.

[0036] Figure 2 shows a perspective view of an example artificial human heart valve 210 according to one or more embodiments. The heart valve 210 may include a peripheral sealing ring structure 291 configured to provide support for nesting the heart valve 210 into the heart valve cavity and / or for placing or mounting it on the heart ring or other structure. The valve 210 may further include a frame member 292, such as a metal frame, which can provide support for a plurality of flexible lobules 293 and define three upright commissure posts 294, which can support the lobules 293 between the commissure posts 294. In some implementations, as shown in Figure 2, the sealing ring 291 may be attached around the frame member 292 at the inlet end of the valve 210, with the commissure posts 294 protruding in the outlet direction.

[0037] The lobules 293 can be formed from separate flaps of material or tissue, or all three lobules can be obtained from a single material. The lobules 293 can be fixed and supported by commissure posts 294 and along the arched tips of frame members 292 between the commissure posts 294.

[0038] Figure 3A shows a frame 392 for a support stent for a surgical heart valve, such as the valve 210 in Figure 2. The frame 392 may include multiple apex curved toward the axial inlet end, alternating with multiple commissures 322 projecting toward the axial outlet end, and the support stent 392 defines a wavy outlet edge. The support stent 392 may include a wireform 320 having three upright commissures 322 alternating with three apex 324 that generally surround the perimeter. A stiffening band 326 may be positioned inside or outside the wireform 320. The inlet edge of the band 326 may fit or at least partially fit the apex 324 of the wireform 320, and may be curved in the outlet direction between the wireform commissures 322, for example, as shown in Figure 3A. In some embodiments, the support stent 392 provides a support structure for a unidirectional artificial heart valve, one example being the valve 210 described herein with reference to Figure 2.

[0039] Figure 3B shows the frame of Figure 3A covered with fabric 340, and the fabric 340 can be sewn in one or more sections to secure the fabric 340 as a covering for the frame 392. The fabric-covered support stent 342 may be generally tubular and may include multiple points 344 that curve toward the axial inlet end, alternating with multiple cross 346 that project toward the axial outlet end. The support stent 342 may include a wavy outlet edge around which the fabric 340 is fixedly held. In some embodiments, a seam 350 is sewn adjacent to the inlet edge 352 that secures the fabric 340 around the support stent 342. The seam 350 is shown slightly axially above the inlet edge 352 for clarity, but can be located directly at the inlet end or even inside the support stent 342. In some implementations, one or more seams can be located at other positions along the fabric 340. The suturing of the support stent 342 can be performed or added in multiple ways, such as by using the devices and systems disclosed herein. Furthermore, although some sutures are shown in Figure 3B, the support stent 342 and / or the valve implant 210 in Figure 2 may include any type or number of sutures or stitches. For example, lobules and / or other materials can also be sutured to one or more other components of the support stent 342 and / or associated implant device.

[0040] The suturing of artificial heart valve devices and / or other implant devices, such as those described above, can be performed in a variety of ways. For example, several handheld processes may be performed for suturing artificial human implant devices, in which the operator uses both hands to hold, secure, and / or suture the implant device. Figure 4 shows an operator 405 performing an operation on an artificial human implant device 410. For example, the operator 405 may suture the outer wire frame of the device 410 to the inner skirt or fabric, as described above, where the implant device 410 is a transcatheter heart valve device. Alternatively, the implant device 410 may be a surgical valve device or other type of implant device. The implant device 410 may be the same as or similar to one of the valves described herein, or it may be a different type of valve or implant device.

[0041] As shown in Figure 4, in some processes, the operator 405 may need to use both hands to perform the suturing actions involved. For example, the first hand 406 can be used to hold and / or secure the implant device 410, and the second hand 407 can be used to manipulate the suture needle or the like.

[0042] For the operator 405 to effectively perform the suturing motions involved with the implant device 410, it may be necessary or desirable to somehow magnify or enhance the appearance of the implant device 410. For example, as shown, the operator may further utilize a magnification system 460 such as a microscope, which may include an eyepiece component 461 as well as one or more lenses and / or refractive elements 463. In some embodiments, the magnification system 460 is designed so that the operator 405 can have a line of sight 409 at a first angle, and the magnification system 460 is configured to focus on a lower target focal plane by at least partially reflecting the light inside at a downward angle 408.

[0043] Figure 5 shows a magnified view of the artificial human implant device 510 being sutured using hand-holding and suturing, as described above. As shown in the figure, in the hand-holding suturing solution, the first hand 506 may be required to hold the target implant device 510, while the second hand 507 may be required to manipulate the suture needle 509, etc. According to some processes, the operator may be required to hold one or more hands at a substantially constant focal point of the microscope for an extended period of time. Furthermore, the operator may be required to compress, push, pull, or otherwise apply force to one or more parts of the target implant device 510 and / or the suture needle 509.

[0044] Figure 6 shows a magnified view of a fabric associated with an implant device according to one or more embodiments. Such a fabric may include woven strands forming ribs 625 with relatively small gaps between them. For example, each rib 625 in the fabric area to be sutured may have a thickness, t, of about 0.2 mm or less. In some processes, it is necessary or desirable to position and sew such a fabric within the precision of one rib. Therefore, precise positioning and alignment of the suture components and targets are desirable.

[0045] To address the issues identified above and to meet the requirements for heart valves and other implants, automating the suturing process could be beneficial to manufacturing, for example, by improving manufacturing quality, increasing manufacturing efficiency, reducing human error, and lowering costs.

[0046] The automated suturing system with thread management Some embodiments disclosed herein provide systems and processes for the automated suturing of a target device (e.g., an artificial implant device or its components) using one or more coordinating systems (e.g., a target device holder, a needle gripper, a tension device, a thread transfer device, etc.). Such systems can be configured to articulate the target device (e.g., an implant device such as a human artificial heart valve device or a part thereof), and the precise placement and orientation of the components or devices may enable necessary or desired suturing operations performed by the automated sewing or suturing subsystem. Furthermore, the system can be further configured to provide a target tension to the thread forming the suture during the suturing process. The system can also be further configured to remove the thread from the needle path of the automated suturing subsystem.

[0047] Suturing implant devices, heart valves, and / or heart valve components may require suture accuracy of millimeters, half a millimeter, or less, but the suture location can easily be lost between ribs or threads, especially due to operator error (e.g., when performing manual suturing procedures). Embodiments of the present disclosure can improve accuracy and help reduce or eliminate human error by using an automated sewing procedure that provides thread management capabilities.

[0048] Embodiments disclosed herein provide systems, devices, and methods for managing sutures in automated suturing systems used to suture artificial implant devices for humans (e.g., artificial heart valves) and / or other types of devices or components. The disclosed systems, devices, and methods may include one or more automated fixtures. For example, a first automated fixture (which may be the same as or similar to the various automated fixtures or automated suturing fixtures described and illustrated herein) may be used to articulate and move the implant device to various desired positions and orientations for processing operations or steps (e.g., suturing, treatment, application, etc.), while a second automated fixture or device may be used to perform processing operations or steps at various desired positions (e.g., forming a suture on a target device). As an example, the second automated fixture may be an automated suturing subsystem or device that moves a needle back and forth through a material or surface to add a suture to a target device (e.g., this can be done along a straight path or other suitable path) while the first automated fixture moves the target device to the correct position so that it receives the desired suture at the correct location on the target device. The disclosed system can be programmed with a specified or defined suture pattern at the tip of an implant or heart valve. Suture tension control can also be used to apply and / or maintain a target tension in the suture to form the suture. Suture control can also be used to remove the suture from the needle path to reduce or eliminate knotting or entanglement of the suture during the automated suturing process.

[0049] In some implementations, an automated suturing process for one or more suturing operations may include two subsystems or automated fixtures, one subsystem or automated fixture configured to suture or sew a pattern by converting the movement of a needle, while the other subsystem or automated fixture can cooperate or synchronize with it, using a multi-axis articulated arm (e.g., a 5-axis robotic arm) to grasp and move a target implant as desired for suturing. The suturing subsystem or automated fixture may include a thread management device configured to provide target tension to the suture or thread attached to the needle to form a suture, and / or to reduce or eliminate problems associated with slack in the suture or thread line (e.g., the risk of entanglement, knotting, etc.). The implant holding subsystem or automated fixture may include a gripper that does not damage the implant and may be configured to precisely position a target device holder and the implant held thereby to receive the suture at the target location.

[0050] As used herein, the terms target device or target suture device include devices such as valves 110, 210 and implant devices 410, 510 and other similar implantable devices. Therefore, the automated suturing system described herein can be used to suture valves and other similar implant devices or parts of their components. The terms target device or target suture device may also include any other suitable implant device that includes one or more components to be sutured or sewn.

[0051] Figure 7 shows a block diagram of an example automated suturing system 700. One or more components of system 700 can be used to suture heart valve devices or other implant devices as described herein. The depiction of system 700 is illustrative and not limiting, so that various components shown in Figure 7 can be omitted from system 700, and other components not shown in Figure 7 can be added to system 700.

[0052] The system 700 includes one or more power inputs 702, a first automatic fixture 710 (e.g., a suturing subsystem, a suturing device, etc.), a second automatic fixture 720 (e.g., a movable target device fixture, etc.), a thread management system 730, and a feedback microcontroller unit (MCU) 740, etc. In some embodiments, the power input 702 is outlet power (e.g., 110 volts) which can be configured to power one or both of the automatic fixtures (e.g., one or both of an articulated arm and a suturing subsystem, etc.) and the thread management system 730, but other power inputs are also possible. The system 700 also includes a module 750 which integrates the automatic mechanisms 710, 720, and 730 based on information or feedback from the feedback MCU 740. The module 750 may include one or more processors, memory, data storage, etc., as typically found in a dedicated or general-purpose computer.

[0053] In some implementations, the first automatic fixture 710 includes a controller (e.g., a microcontroller), one or more actuators, and a suturing device, all configured together to move a threaded needle to form a suture on a target device. The first automatic fixture 710 also includes programming, one or more needle holders or needle grippers, circuitry, gripper movement components (e.g., magnetic actuators, pneumatic actuators, linear motion drivers, motors, servo motors, etc.), and / or other components. The first automatic fixture 710 uses the actuators, needle grippers, and gripper movement components (e.g., motors, pneumatic actuators, linear motion drivers, and / or servo motors) to move the needle and, in conjunction with the second automatic fixture 720, coordinate the needle's movement back and forth across the surface of the target device to form a suture on the target device.

[0054] In some embodiments, the first automatic fixture 710 includes two needle grippers. In various implementations, the two needle grippers pass the needle back and forth through the surface of the target device to form a suture. For example, the two needle grippers may include an inner gripper and an outer gripper that pass the needle from the outside of the target device to the inside of the target device through the material of the target device (e.g., fabric) and then back to the outside of the target device to form a suture. The needle grippers can use any suitable combination of gripper movement components (e.g., magnetic actuators, motors, pneumatics, linear motion drivers, servo motors, etc.) that adjust the back and forth movement of the needle grippers during the suturing process. Programming can be configured to coordinate the movement of the needle with the process being performed by the second automatic fixture 720 and the thread management system 730, and this coordination is supported by the feedback MCU 740 and / or integration module 750.

[0055] The second automated fixture 720 may include a controller (e.g., a microcontroller), one or more actuators, and an articulated arm, configured together to position and orient a target device in space for suturing. The second automated fixture 720 may also include fixture movement components (e.g., fixture grippers, fixture actuators), programming, circuitry, one or more sensors, and / or other components. The second automated fixture 720 uses the actuators, fixture movement components, and one or more sensors to work in conjunction with the first automated fixture 710 to adjust the position and / or orientation of the target device for each suture. The programming can be configured to coordinate the movement of the fixture movement components with the processes performed by the first automated fixture 710 and the thread management system 730, and this coordination is supported by the feedback MCU 740 and / or the integration module 750.

[0056] The thread management system 730 may include a controller (e.g., a microcontroller), one or more actuators, and a thread management device configured together to remove the thread from the needle path and to apply a target tension to the thread during the suturing process. The thread management system 730 also includes a thread moving device, a tensioning device, circuitry, programming, and / or other components. The thread management system 730 uses the actuators and thread moving device to move the thread during the suturing process so that the thread is removed from the needle path provided by the first automatic fixture 710. The thread management system 730 uses the actuators and tensioning device to provide a target tension during the suturing process, and the target tension can be changed at various points in the process. In some embodiments, the thread moving device and the tensioning device can be integrated into a single device.

[0057] The first automatic fixture 710, the second automatic fixture 720, and the thread management system 730 can be integrated and synchronized to form a suture on a target device. To form a suture on the target device, the first automatic fixture 710 (e.g., a suturing device) adjusts the movement of the needle gripper so that the needle, with the thread attached, passes back and forth through the surface of the target device, which is held by the second automatic fixture 720 (e.g., a multi-axis robot arm, an articulated fixture, or other fixture) and moved to a desired position, while the thread management system 730 provides tension to the thread and removes it from the needle path.

[0058] In some embodiments, one or more of the System 700 and / or automatic fixtures include one or more controllers (e.g., microcontrollers) configured to direct one or more components of the automatic fixture and / or other components according to a predefined or programmed suturing process. The controllers may include one or more hardware and / or software components designed to generate and / or provide fixture control signals (e.g., suturing fixture control signals) and / or data related to one or more steps of the suturing process. For example, the controllers may include one or more data storage devices or components, including a computing device including one or more processors, and volatile and / or nonvolatile data storage media. In some embodiments, the data storage may be configured to store process script data (e.g., suturing process script data), which may include data indicating the placement of one or more components and / or fixtures of the System 700 for various steps and / or stages of the suturing process. A process including multiple steps may be represented at least partially by numerical or other datasets representing positional information for one or more components of the automatic fixture and / or one or more additional components of the System 700 for each step or stage of the process. For example, a suturing process that includes multiple suturing steps may be represented, at least partially, by numerical or other datasets representing positional information for one or more components and / or fixtures of the system 700, for each step or stage of the suturing process.

[0059] The first automatic fixture 710 can be configured to operate a needle. Various needles can be used. In several implementations, non-corrosive double-ended needles are used, including one or more of the following: NiTi / nitinol, Delrin, cobalt-chromium, ABS plastic, PEEK plastic, and strong plastics with a polycarbonate base. The needle can be double-ended, with a hole near the center through which the thread passes, and both ends of the needle are configured to penetrate fabric or other material (e.g., cover, seal, leaflet, etc.) sewn to the stent or frame of the target device. Conveniently, this allows the first automatic fixture 710 to pass the needle back and forth through the surface of the target device without the need to rotate the needle between stitches or sutures. However, single-ended needles can also be used. Such needles may have a hole opposite the penetrating end of the needle, or between the end and another point along the needle, for example, in the center of the needle.

[0060] The first automatic fixture 710 includes a needle holder (e.g., a needle gripper or needle gripping mechanism) configured to hold a needle during the suturing process. The needle holder or gripper can be configured in a variety of ways. For example, a needle gripper can grip a needle in a manner similar to a drill chuck tool holder or any of the various mechanical methods. Other examples of gripping mechanisms include magnetic, pneumatic, hydraulic, and vacuum pressure mechanisms.

[0061] In some embodiments, the second automatic fixture 720 includes one or more components configured to articulate, rotate, operate, and / or position one or more actuators to present a target device (e.g., a heart valve, implant, or other suture target) to a desired or appropriate position or presentation for engagement or interaction with it by another fixture performing at least part of a process (e.g., a suturing process). In some embodiments, the second automatic fixture 720 may be configured to provide limited motion, such as rotation without translation or rotation combined with translation along a single axis. In some embodiments, the second automatic fixture 720 may be configured to provide a wide range of motion, such as rotation around multiple axes and motion along multiple axes (e.g., two or more axes).

[0062] In some embodiments, the second automatic fixture 720 includes a plurality of actuators mounted, attached, or connected to one another in a configuration that provides a desired range of motion for a target device associated with or held by the automatic fixture (e.g., a suture target). In some embodiments, a target holder component or assembly can be associated with or connected to one or more of the actuators. Each actuator may include one or more rotational or other articulating members driven by a motor, pneumatics, magnets, a driver, etc.

[0063] The second automatic fixture 720 may include a holder or holder assembly (e.g., a gripper or gripping fixture) configured to hold the target device while sewing is being performed. For example, a holder formed as a gripper may be a multi-protruding gripper (e.g., a two- or three-protruding gripper) configured to hold the target device while sewing is being performed. Other examples of grippers include, but are not limited to, internal bellow grippers, protruding grippers, 3D-printed grippers, caged grippers, or other types of grippers. In some embodiments, a target holder assembly configured to hold or fix the target device (e.g., an artificial implant device) may be similar to the target holder assembly shown in Figure 13.

[0064] The first automatic fixture 710, the second automatic fixture 720, and / or the thread management system 730 may also include a variety of sensors, such as a vision camera. For example, the second automatic fixture 720 may include a sensor that detects the position and orientation of a target holder during a suturing or sewing process, and / or a sensor that detects the forces associated with the process. For example, the second automatic fixture 720 may also include a gripping force sensor, which may be configured to relay the force that the gripper applies to the target device. The second automatic fixture 720 may also include a gyroscope sensor, which may be configured to measure the rotation of the second automatic fixture 720, its end actuator, its articulated arm, its fixture holder, etc. The second automatic fixture 720 may also include an accelerometer sensor, which may be configured to measure the position of the automatic fixture 720, its end actuator, its articulated arm, its fixture holder, etc. The yarn management system 730 may include one or more sensors that determine the position and / or orientation of various components, and / or the force or tension applied to the yarn.

[0065] In some embodiments, the second automatic fixture 720 is configured to move, rotate, etc., a target device as the first automatic fixture 710 moves the needle along the fixation path to create a desired suture pattern. The movement of the target device can be performed in three spatial dimensions and may include rotational movement around any axis or combination of axes in the three spatial dimensions. The automatic fixtures 710, 720 and the thread management system 730 can be programmed, coordinated, or synchronized to work together to achieve various desired suture patterns on various implants. Coordination can be achieved by using the integration module 750 in conjunction with the feedback MCU 740.

[0066] In some embodiments, the automatic fixtures 710, 720 and / or suture management systems 730 (collectively referred to as automatic suture fixtures) include one or more actuators (e.g., servo actuators, motors, magnetic actuators, drivers, pneumatics, etc.) that are physically coupled to one another. By constructing the automatic suture fixtures 710, 720, 730 using one or more actuator devices (e.g., servo motor components), the system 700 can provide an enhanced range of motion, as well as multiple axes of rotation, relatively inexpensive and / or advantageously. In some embodiments, one or more of the automatic suture fixtures 710, 720, 730 include multiple actuator devices (e.g., servo actuator devices) that are daisy-chained together and implemented using software scripts, providing collaborative functionality for the purpose of positioning target implant devices. For example, the actuator devices or servo actuator devices (e.g., servo motor devices) can be mounted or configured to be mounted horizontally, vertically, or at an angle, and can articulate in any direction.

[0067] In some embodiments, the microcontroller provides control signals to instruct the placement and / or operation of the automatic suture fixtures 710, 720, 730 (or actuators of the fixtures) based on placement scripts, suture process scripts, and / or user inputs provided by the operator. For example, system 700 (or system 1700 as described herein with reference to Figure 12) may include a user input device (not shown) which can be used by the operator to provide inputs to initiate or instruct the operation of the controller and / or the automatic suture fixture assembly. For example, the user input device may include any suitable user input interface, such as a mechanism for user input related to a graphic user interface related to an electronic display, through which the operator can provide inputs through interaction with the interface.

[0068] In some embodiments, the actuator device is implemented using piezoelectric control with analog voltage signals. In some embodiments, one or more components of the automatic suture fixtures 710, 720, 730 are controlled using pulse-width modulated control signals, such as control signals spaced between 0 and 2 μs. In some embodiments, multiple actuator components (e.g., multiple servo motor components) of the automatic suture fixtures 710, 720, 730 share one or more common leads with multiplexed signals, such as a three-lead connection. In some embodiments, the automatic suture fixtures 710, 720, 730 include four or five or more actuator devices. The devices and fixtures disclosed herein may be remotely controllable or partially remotely controllable.

[0069] The automated suturing system with thread management Figure 8 shows an example embodiment of an automated suturing system 800 equipped with an automated thread management system. The thread management system includes a thread support component 820 and a tension component 830. The suturing system 800 also includes a sewing device 840 and an automated fixture holder 805 of an automated fixture configured to hold and operate a target device 810. The suturing system 800 is configured to avoid entanglement or knotting of the thread 846 used to form the stitch while coordinating the movement of its various components (including the thread management system, the sewing device 840, and the fixture holder 805) to form a stitch at a target location on the target device 810.

[0070] The thread support component 820 includes a support bracket 821 and support pins 822, 824 coupled to the support bracket 821. The support pins 822, 824 are configured to support the thread 846 used to form a stitch on the target device 810 during various stages of the suturing process (for example, while tension is being applied to the thread). The tension component 830 includes a tension bracket 831 and a tension pin 832 fixed to the tension bracket 831. The tension pin 832 is configured to apply tension to the thread 846 used to form a stitch on the target device 810 during various stages of the suturing process. As described herein, the thread movement component 820 may also be configured to adjust the direction of tension on the thread 846.

[0071] Figure 9A illustrates the functionality of the automatic fixture holder 805 of the automatic fixture of the automatic suturing system, for example, in the automatic suturing system 800 of Figure 8. The automatic fixture holder 805 is configured to move and orient the target device 810. The automatic fixture holder 805 is configured to move the target device 810 with many degrees of freedom. This can include, for example, positioning, rotation, and / or rotation of the target device 810 about its longitudinal axis in one or more (e.g., all) of the three spatial dimensions (e.g., rotating the target device 810 about its longitudinal axis while keeping its position and orientation fixed).

[0072] Figure 9B shows an example of an auto-fixture and / or auto-fixture holder 905 having an articulated arm 909 and a target device holder 907. The articulated arm 909 has a crane-like configuration and is configured to substantially enclose multiple actuators within one or more housings. The articulated arm 909 secures a target assembly 907, which is configured to secure a target device 910, such as a heart valve implant. The articulated arm 909 can be configured to move and manipulate the target assembly 907, which in turn moves and orients the target device 910. The combination of the articulated arm 909 and the target assembly 907 moves the target device 910 in any of the three spatial dimensions (for example, translation, horizontal translation, vertical translation, or a combination of horizontal and vertical translation along the x, y, and z axes), rotates the target device 910 (for example, rotation around the x, y, and / or z axis), and / or rotates the target assembly 907 around the longitudinal axis of the target device 910 (for example, rotating the target device 910 around its longitudinal axis while keeping the position and direction of the target device 910 fixed).

[0073] Figures 10A–10E illustrate an example of a suturing process as performed by the automatic fixture and / or sewing device 840 of the automatic suturing system 800 of Figure 8. These figures illustrate the process using simplified diagrams of the system 800 and its associated components for simplification and clarity. The sewing device 840 includes a first or outer needle gripper 842 and a second or inner needle gripper 844 configured to pass a needle 841 back and forth through the surface of a target device 810. The outer needle gripper 842 traverses a fixed straight path outside the target device 810 and approaches the target device as shown in Figure 10A. The outer needle gripper 842 moves toward the target device 810, passing the needle through the surface of the target device 810, which is then received by the inner needle gripper 844 as shown in Figure 10B. The inner needle gripper 844 moves the needle 841 inward so that it passes completely through the surface of the target device 810, in which case the target device 810 rotates or moves in any other way, as shown in Figure 10C. After the target device 810 has adjusted to its next position, the inner needle gripper 844 returns the needle 841 through the surface of the target device 810, which is then received by the outer needle gripper 842, as shown in Figure 10D. The outer needle gripper 842 then returns to its original starting position in preparation for the next stitch, as shown in Figure 10E. Before forming the next stitch, the target device 810 may move and / or rotate again, as shown in Figure 10E, so that the fixed path of the needle 841 intersects with the surface of the target device 810 at the location of the next stitch.

[0074] As used herein, the term “stitch” refers to a single stitch formed by passing a needle 841 equipped with thread 846 over the surface of a target device 810 twice. For example, if the target device 810 is substantially cylindrical, a single stitch is formed by passing the needle 841 over its surface from the outside of the target device 810 to the inside of the target device 810, and then back over from the inside of the target device 810 to the outside. The target device 810 does not need to have an inside or outside, in which case a single stitch can also be formed by passing the needle 841 over the surface of the target device 810 from a first side to a second side, and then back over the surface to the first side.

[0075] Returning to Figure 8, forming a stitch involves using needle grippers 842, 844 to guide the needle 841 across a fixed needle path to form a stitch on the target device 810. The thread management system is configured to move the thread 846 coupled to the needle 841 out of the needle path and to apply tension to the thread 846. The automatic fixture holder 805 is configured to adjust the position and / or orientation of the target device 810 so that the needle 841 passes through the target location on the target device 810 as the needle 841 crosses the fixed needle path.

[0076] Tension is applied to the thread 846 using a combination of tension pin 832 and support pins 822 and 824. For example, tension pin 832 can push the thread 846 downward, and support pins 822 and 824 redirect the path of the thread 846 from the needle 841 to the target device 810. The tension can be configured to be sufficient to hold the suture in place and to keep the thread 846 outside the needle path. In this way, entanglement between the thread 846 and the needle 841 can be avoided or eliminated.

[0077] In some embodiments, the support pins 822, 824 can be positioned to provide a target direction for the tension of the thread 846. For example, the support pin 824 can be configured to support the thread 846 so that, as tension is applied by the tension pin 832, the support pin 824 is pulled in a direction substantially perpendicular to the surface of the target device 810 on which the stitch is being formed. In some implementations, the support pins 822, 824 can be positioned such that applying tension to the thread 846 generates a substantially horizontal force on the needle 841 and the target device 810 (for example, by pulling the newly formed stitch) (for example, reducing or eliminating a vertical force). Advantageously, the direction of the tension can be configured to reduce the bending or deformation of the needle 841 when it is gripped by the outer needle gripper, or to reduce the possibility of the needle 841 moving or coming loose from the outer needle gripper. Similarly, this may be advantageous in reducing deformation of the fabric or stent of the target device 810, reducing the likelihood of the target device 810 moving or becoming dislodged within the target holder, increasing undesirable spaces between the ribs of the fabric of the target device 810 (e.g., creating holes in the material), or otherwise damaging the target device 810.

[0078] In some embodiments, the thread 846 can be released from one or more of the support pins 822, 824 or tension pins 832 between one or more portions forming the stitch. Releasing the thread 846 during the stitch-forming process can help reduce or eliminate entanglement of the thread 846. During stitch formation, the tension pins 832 can be configured to apply tension to the thread 846, and / or to pull the slack portion of the thread 846 through the surface of the target device 810, so as to move the thread 846 in a direction substantially perpendicular to the needle path so as to be removed from the needle path. For example, applying tension to the thread 846 pulls the slack portion of the thread 846 through the surface of the target device 810 (e.g., fabric), completing the newly formed stitch.

[0079] In some embodiments, different tensions can be applied at different points in the process of forming a single stitch. Figures 11A and 11B show graphs 1100a and 1100b of examples of tensions 1101a and 1101b applied over the process of forming a single stitch. This process can be repeated to form multiple stitches on the target device 810.

[0080] In graph 1100a of Figure 11A, the tension 1101a applied to the thread can be a steady-state tension during part of the stitch-forming process, and the steady-state tension is configured to hold the stitch in place and keep the thread away from the needle path. Between finishing a stitch and starting a new stitch, the tension applied to the thread may exceed the steady-state tension, at least temporarily. For example, tension can be applied to the thread until it reaches a threshold tension greater than the steady-state tension. Once the threshold tension is reached, the tension is reduced to the steady-state tension. The threshold tension is configured to be large enough to pull the thread to finish the stitch, eliminate any potential snags or entanglements in the thread, and ensure that the finished stitch is level with the surface of the target device (e.g., fabric or other material). The steady-state tension is configured to keep the stitch in a restrained state so that the next needle penetration does not penetrate the previous stitch as well. The steady-state tension can be less than the threshold tension to reduce the stress on the needle, needle gripper, target device, and / or fixture holder. In some embodiments, the tension threshold is at least about 35 g (or about 0.34 N) and / or less than or equal to about 50 g (or about 0.49 N), for example, about 40 g (or about 0.39 N). In some embodiments, the steady-state tension is at least about 20 g (or about 0.2 N) and / or less than or equal to about 35 g (or about 0.34 N), for example, about 29 g (or about 0.28 N).

[0081] Graph 1100b in Figure 11B shows that, in some embodiments, the tension 1101b of the thread can be released during part of the stitch-forming process. As shown in Graph 1100a, a steady-state tension can be applied to the thread to hold it out of the needle path. This can be done as the needle passes through the surface of the target device from a first side to a second side of the target device. As the needle returns from the second side to the first side, the tension can be released, allowing the needle to return to its starting position, and / or resetting the tension and thread placement components. The tension can then be reapplied up to a threshold tension to pull the remaining slack thread through the surface of the target device to form a stitch. Once the threshold tension is achieved, the tension can be returned to a steady-state tension to hold the stitch in place when the process restarts and a new stitch is formed. As described herein, the threshold tension can be configured to be high enough to prevent or reduce tangling or knotting of the thread as the thread is pulled through the surface of the target device, and to finish the stitch. The steady-state tension can be configured to be sufficient to hold down the formed stitch during the suturing process.

[0082] Example control system for an automated suturing system Figure 12 shows a block diagram of an example control system 1760 for controlling the automated suturing system 1700. The automated suturing system 1700 can include various components, features, systems, automated fixtures, and combinations thereof. In some implementations, the automated suturing system 1700 includes a first automated fixture or automated suturing device 1740, a second automated fixture or automated suturing fixture 1705, and a thread management system 1750. Additional automated fixtures may also be used. Furthermore, the systems described herein can include multiple combinations of these components and fixtures to control and operate multiple suturing operations on multiple target devices simultaneously, for example.

[0083] The controller 1760, also known as the control system 1760, provides input to various components and devices and receives feedback from these components and devices to adjust the operation of the automated suturing system 1700.

[0084] A first automatic fixture or automatic suturing device 1740 is configured to manipulate the needle to form a stitch on a target device. A second automatic fixture or automatic suturing fixture 1705 is configured to articulate the target device (e.g., an artificial human heart valve implant) to the desired suture position. A thread management system 1750 is configured to move the thread out of the needle path and to apply tension to the thread.

[0085] The first automatic fixture or automatic suturing device 1740 (which may represent any or all of the automatic suturing devices described herein), the second automatic fixture or automatic suturing fixture 1705 (which may represent any or all of the automatic fixtures that move the target device described herein, and may be the same or similar thereto), and the thread management system 1750 (which may represent any or all of the thread management systems described herein, and may be the same or similar thereto) are each configured to receive control signals from the controller module 1760. The controller module 1760 may include a combination of software and / or hardware components configured to generate control signals to at least partially instruct the operation of the automatic suturing fixture 1705, the automatic suturing device 1740, the thread management system 1750, and / or one or more of these components.

[0086] In some embodiments, the controller 1760 includes one or more processors and / or controller circuits configured to access suture script information 1764 or other script or program information maintained by the controller in its data storage or otherwise accessed by the controller 1760. The controller 1760 may include a placement control circuit 1762 designed to interpret the suture script information or other script or program information and generate control signals for controlling a first automatic fixture or automatic suture device 1740, a second automatic fixture or automatic suture fixture 1705, and a thread management system 1750, at least in part thereto.

[0087] The suture script information 1764 or other script or program information may include sequential placement information for one or more automatic fixtures (e.g., automatic suture fixture 1705, automatic suture device 1740, and / or any additional automatic fixtures used) related to one or more suturing processes or other processes designed to be implemented by the controller 1760, as well as for one or more components of the thread management system 1750. For example, in some embodiments, the placement control circuit 1762 is configured to provide sequential position information for each step of the suturing process. Advancement from one position step to another can be instructed by the controller 1760 based on a timer, feedback from one or more components, and / or user input.

[0088] The automatic suturing fixture 1705 may include multiple electric actuators 1702, which can be communicatively coupled to the controller 1760. In some embodiments, the electric actuators 1702 are coupled to each other in a daisy-chain configuration, and two or more electric actuators are coupled or wired together in sequence. Although the electric actuators 1702 are described in detail with respect to Figure 12, it should be understood that any suitable combination of actuators and / or drivers can be used with the automatic suturing fixture 1705 and, in association, with the automatic suturing device 1740 and the thread management system 1750.

[0089] Each of the electric actuators 1702 may include a motor 1704, such as a DC, AC, or brushless DC motor. The motor 1704 may be a servo motor. In some embodiments, the motor 1704 is controlled using pulse-coded modulation (PCM) as directed by a motor control circuit 1708. For example, the motor control circuit 1708 may apply pulses for a certain period of time, and the angular arrangement of the rotor component 1703 is determined at least partially by the length of the pulses. The amount of force applied to the motor 1704 may be proportional to the rotational distance of the rotor 1703.

[0090] In some embodiments, the electric actuator 1702 is a servo actuator device that includes one or more servo feedback components 1706, such as position sensors (e.g., digital encoders, magnetic encoders, lasers, etc.). The use of servo feedback components 1706 may be desired to achieve a desired level of reliability that the electric actuator 1702 is positioned to be directed by the controller 1760 with an acceptable degree of accuracy. The servo feedback components 1706 can provide the motor control circuit 1708 with signals (e.g., analog or digital signals) indicating the position and / or velocity of the rotor 1703, which may advantageously enable relatively precise control of the position to achieve a stable and accurate rotor position more quickly. Relatively precise positioning of the implant device may be required or desired, at least in part, due to the dimensions of the material or fabric of the heart valve or other implant device being sutured in an implant suturing operation using the automatic suture fixture 1705. For example, the fabric or other material being sutured may include woven strands that form ribs with relatively small gaps between them. In some embodiments, the automatic suturing fixture 1705 can be configured to articulate the suture target artificial human implant device within an accuracy of 0.2 mm, while others may operate with higher or lower accuracy. Although servo motor devices and components are described, in some embodiments, one or more electric actuators may include stepper motors or other types of motor subsystems.

[0091] The electric actuator 1702 may include a motor control circuit 1708, which can drive the motor 1704 according to a control signal received from the controller 1760. In some embodiments, the motor 1704 can be advantageously configured in combination with a servo feedback mechanism 1706 and / or the motor control circuit 1708 to hold the rotor 1703 and / or the attached support member in a set position for a desired period of time. The motor 1704 can provide relatively smooth turning and / or precise positioning of the associated rotor 1703. The motor 1704 can be relatively powerful for its size and can draw a force proportional to the mechanical load present in the rotor 1703 and / or the associated support member.

[0092] In some embodiments, the servo feedback component 1706 includes a potentiometer connected to the rotor 1703, which may be an output device of the electric actuator 1702. The rotor 1703 can be linked to the potentiometer and the control circuit 1708, and the potentiometer is coupled with a signal from the control circuit to control the angle of the rotor 1703 (and associated support members) over a rotation range, for example, between 0° and 180° or more. In some embodiments, the rotation range of the rotor 1703 is limited by one or more mechanical stops, which may be incorporated within an associated gear mechanism. The potentiometer (or other servo mechanism such as an internal rotary encoder) allows the control circuit 1708 to monitor the current angle of the motor or rotor. When the rotor 1703 is at the correct angle, the motor 1704 can idle until the next positioning signal is received from the controller 1760.

[0093] The automated suturing fixture 1705 may further include a suture target holder device or assembly 1707 (referred to herein as a suture target holder or assembly, which may be other types of target holder devices, grippers, or assemblies that hold a target device or component for other procedures). The suture target holder 1707 may be physically coupled to one of the motorized actuators 1702, such as a distal extension arm actuator device of multiple actuators. The suture target holder 1707 may be configured to hold or attach to an artificial heart valve device or other artificial human implant device that is to be sutured. The suture target holder 1707 may have any suitable or desired shape, configuration and / or dimensions and may be configured to hold or fix the target device or implant device in a variety of different ways. An example embodiment of the suture target holder device or assembly is described herein with reference to Figure 13. However, it should be understood that such embodiments are provided merely as examples and other types of suture target holders may be implemented in the disclosed system.

[0094] Figure 13 shows the distal portion of the articulated arm 1878 of an automated fixture holder 1878, with the target device 1810 fixed to the target device holder 1880. The articulated arm 1878 may include one or more actuators coupled to the holder component 1880. In some embodiments, the holder component 1880 is fixed or anchored to the distal articulated arm 1878 or end actuator of the automated suture fixture for the purpose of providing a boundary for fixing the implant device or other target form or device. The holder component or assembly 1880 may be designed or configured to hold or fix the implant device or other target device, or a portion thereof, for the purpose of enabling its suturing according to any process or embodiment disclosed herein. The holder component 1880 may be configured to fix or otherwise include a cylindrical form 1885, which may be sized or dimensional to pull on the target device or implant (e.g., a fabric-covered support stent for a surgical valve implant device 1810). For example, the valve implant device 1810 may include multiple commissure post portions 1892, as shown in the figure, which can be positioned to face toward the holder component 1880, so that a seam 1818 can be stitched over what will ultimately represent the inlet end of the implant device 1810. A cylindrical form or component 1885 may be designed in a similar manner to a handheld implant device holder, which in some embodiments can be used when performing the suturing procedure without the assistance of the articulating arm 1878 and associated components. A cloth 1825 may be placed around a rigid wire frame structure, and the stitch of stitch 1818 is performed to substantially cover the wire frame with the cloth 1825. The seam 1818 can secure the cloth 1825 around a stiffening band, as shown and described in Figure 3A.

[0095] The holder component 1880 can be designed for specific applications such as transcatheter heart valve suturing applications, surgical heart valve suturing operations, or other implant suturing procedures. The valve may be for animals (e.g., humans). While a surgical valve configuration is shown in Figure 13, it should be understood that the holder device 1880 and / or other components in Figure 13 can be designed or configured to support suturing processes and / or other processes for transcatheter heart valves or other valves or devices. For example, the diagram in Figure 13 shows a cylindrical form 1885 designed to hold an implant device 1810 in a desired position, but such a cylindrical form may not be necessary with respect to transcatheter heart valves. For example, instead of the cylindrical form 1885, the holder 1880 can instead be configured to secure a rigid cylindrical wire frame of a transcatheter heart valve, one embodiment of which is illustrated and described above in relation to Figure 1.

[0096] The specific type of holder used for a particular procedure or application (e.g., suturing assistance) can be determined on a process-by-process basis. That is, a particular adapter may be appropriate or desired for each of separate actions or procedures, or for different types of valves or other targets. In some embodiments, a single suturing procedure for an implant device may involve the use of multiple different types of holder devices.

[0097] Returning to Figure 12, the automatic suturing device 1740 includes one or more needle grippers 1742 and corresponding gripper actuators 1748. The needle grippers 1742 can be configured to fix and release the needle during the suturing process. The gripper actuators 1748 can be configured to move the needle grippers 1742 according to the suturing process. The controller 1760 can provide the automatic suturing device 1740 with control signals that coordinate the operation of the needle grippers 1742 and gripper actuators 1748 with the automatic suturing fixture 1705 and the thread management system 1750. The gripper actuators 1748 can operate in a similar manner to the electric actuators 1702 and / or motors 1704 of the automatic suturing fixture 1705, and the descriptions of these components as well as the rotor, servo feedback, and motor control circuits can be similarly applied to the automatic suturing device 1740.

[0098] The thread management system 1750 includes a tension device 1730 and a thread transfer device 1720 configured together to remove thread from the needle path and to apply one or more target tensions to the thread during suturing. A controller 1760 can provide the thread management system 1750 with control signals to coordinate the operation of the tension device 1730 and the thread transfer device 1720 with the automatic suturing fixture 1705 and the automatic suturing device 1740. The tension device 1730 and / or the thread transfer device 1720 may include actuators that operate components of each device. In some embodiments, the actuators include electric actuators that can operate in a similar manner to the electric actuator 1702 and / or motor 1704 of the automatic suturing fixture 1705, and the descriptions of these components as well as the rotor, servo feedback, and motor control circuits can similarly apply to the thread management system 1750.

[0099] A suturing system can execute suturing procedures after they have been programmed with specific steps, programs, or scripts. One or more computer components, such as one or more processors and / or memory devices, can be used to store and execute the procedure instruction scripts or programs, allowing operators to replay the procedure scripts or programs on demand.

[0100] This procedure involves loading a suturing process script or program, which can be pre-programmed. The desired script or program can be loaded in various ways, for example, by providing input to the system or the system's computer to load the desired script or program from storage or memory.

[0101] This procedure may involve inducing the placement of the automatic suture fixture (or automatic fixture) 1705 and / or performing a suturing operation or other operation or step.

[0102] Once a suturing action or other action or step is performed, the process can terminate if the suturing action or other action or step represents the final action or step of the suturing procedure or other procedure. However, if there are additional steps remaining in the suturing action or procedure or other action or procedure, the process can repeat the trigger, placement, or execution steps, which can trigger subsequent steps in the suturing process or procedure, and thus the process can culminate in the completion of those subsequent steps.

[0103] A method for forming a suture Figure 14 shows a flowchart of Method 1400, an example of forming a suture on an implant device using an automated suturing system with a thread management system. Any of the automated suturing systems described herein can be used to perform Method 1400. For ease of explanation, Method 1400 will be described as being performed by an automated suturing system. However, it should be understood that any part of an automated suturing system and / or any combination of components of an automated suturing system can perform any step, part of a step, or combination of steps of Method 1400. Additional steps beyond those highlighted herein are also possible, including steps described elsewhere herein, such as those relating to tension and thread management.

[0104] In block 1405, the automatic suturing system passes a needle through the surface of a target device, and the needle is coupled to a thread that will form a stitch on the target device. The needle can pass from a first needle gripper to a second needle gripper or any other suitable combination of needle gripping mechanisms. The path from the first needle gripper to the target device defines the needle path. In some embodiments, the needle path is a fixed straight path. The needle path can be a fixed straight path, a fixed curved path, or a fixed path with any combination of linear and curved portions.

[0105] In block 1410, the automated suturing system adjusts the position of the implant device to form a stitch. The position can be adjusted by rotating and / or moving the target device.

[0106] In block 1415, the automated suturing system returns the needle through the surface of the target device. In some embodiments, the first needle gripper can return to the starting position along the same needle path.

[0107] In block 1420, the automated suturing system removes the thread from the needle path. In some embodiments, the thread is removed from the needle path by moving a portion of the thread between the target device and the needle perpendicular to the needle path.

[0108] In block 1425, the automated suturing system applies a target tension to the thread. In some embodiments, the target tension changes during the course of the suturing procedure. In some embodiments, the target tension differs between different parts of method 1400. In some embodiments, the target tension includes providing a tension that increases until a threshold tension is reached, and then decreasing that tension to a steady state or reduced tension. Applying a target tension to the thread may include providing tension to the thread to keep the stitch in a restrained position while the outer needle gripper approaches the target device, in order to prevent the needle from penetrating the previously formed stitch. The steps in block 1425 can be performed in various ways described and / or illustrated herein. For example, the target tension can be applied as described herein with reference to Figures 11A and 11B. Therefore, a first target tension can be applied during the steps of blocks 1405 and 1410 (e.g., steady-state tension), a second target tension can be applied during the step of block 1415 (e.g., steady-state tension or no tension), and a third target tension can be applied during the step of block 1420 (e.g., a tension that increases until it reaches a threshold tension and then returns to steady-state tension).

[0109] Terminology and Additional Embodiments As used herein, the terms suture and stitch are interchangeable and include, for example, a portion of thread passing through a fabric, which is typically used, for example, not limited to, to attach a fabric to a structure, to join parts of a fabric together, and / or to repair a fabric. As used herein, the terms suture and stitch are interchangeable and include, for example, not limited to, the process of forming a stitch or suture on a target device. As used herein, the term target device is generally used to refer to any implantable device or its components, including, for example, not limited to, artificial implants, artificial human implant devices, artificial heart valves, artificial human heart valves, etc. As used herein, for a target device that is, for example, substantially cylindrical or otherwise forms a lumen, a reference to “inside the device” or “inside portion of the device” refers to a location within a lumen enclosed and / or surrounded by the surface or structure of the device, or formed by the surface or structure of the device. Similarly, as used herein, references to the “outside of the device” or “outside portion of the device” refer to locations that are not inside the device (for example, outside or not enclosed within the surface or structure of the device, or not within a lumen formed by the surface or structure of the device).

[0110] Depending on the embodiment, some actions, events, or functions of any of the processes or algorithms described herein may be performed in a different order, and may be added, merged, or omitted entirely. Therefore, in some embodiments, not all described actions or events are necessary for the process to function. Also, in some embodiments, actions or events may be performed simultaneously rather than sequentially. For example, multithreading, interrupt handling, and / or more processors or processor cores may be used.

[0111] Conditional language used herein, such as in particular "can," "could," "might," "may," and "eg," is intended in its ordinary sense unless otherwise specifically stated or understood in the context in which it is used, and is generally intended to convey that some embodiments include certain features, elements, and / or steps, while others do not. Therefore, such conditional language is not generally intended to mean that features, elements, and / or steps are required in any way to one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without input or prompting, whether these features, elements, and / or steps are included in or should be performed in any particular embodiment. Terms such as "comprising," "including," and "having" are synonyms and are used in their ordinary sense, in an open-ended and comprehensive manner, without excluding additional elements, features, actions, or behaviors. Furthermore, the term "or" is used in its inclusive sense (rather than its exclusive sense), for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in that list. Conjunctions such as the phrase "at least one of X, Y, and Z" are understood in the context in which they are used, unless specifically described otherwise, to generally convey that a certain article, term, element, etc., can be any of X, Y, or Z. Thus, such conjunctions are not generally intended to mean that certain embodiments require the presence of at least one X, at least one Y, and at least one Z, respectively.

[0112] In the above description of embodiments, it should be understood that various features may be grouped together in a single embodiment, figure, or description for the purpose of simplifying the disclosure and aiding in the understanding of one or more of the various aspects of the invention. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than those explicitly specified in that claim. Furthermore, any component, feature, or step illustrated and / or described in a particular embodiment of this specification can be applied to or used in any other embodiment. Moreover, none of the components, features, steps, or groups of components, features, or steps are required or essential to each embodiment. Accordingly, the scope of the invention disclosed herein and in the following claims is not intended to be limited by the particular embodiments described above, but should be determined solely by a fair interpretation of the following claims.

[0113] The methods described herein include steps illustrating one or more embodiments of the presented methods. Other steps and methods may be considered to be equivalent in function, logic, or effect to one or more steps or parts thereof of the procedures or methods described herein. In addition, the order in which the steps of a particular method occur may or may not strictly follow the order of the corresponding steps described herein. Components, features, steps, etc., described in reference to one embodiment of this specification may be combined with or included in other embodiments described elsewhere in this specification.

[0114] The components, aspects, features, etc., of the systems, assemblies, devices, apparatus, methods, etc., described herein can be implemented in hardware, software, or a combination of both. When the components, aspects, features, etc., of the systems, assemblies, devices, apparatus, methods, etc., described herein are implemented in software (e.g., scripts), this software can be stored in an executable format on one or more non-temporary machine-readable media. Furthermore, the relevant steps of this software and the methods described above can be implemented in software as a set of data and instructions. Machine-readable media includes any mechanism that provides (e.g., stores and / or transfers) information in a form readable by a machine (e.g., a computer). For example, machine-readable media include read-only memory (ROM), random access memory (RAM), magnetic disk storage media, optical storage media, flash memory devices, DVDs, electrically, optically, acoustically or otherwise propagated signals (e.g., carrier waves, infrared signals, digital signals), EPROM, EEPROM, FLASH®, magnetic or optical cards, or any type of media suitable for storing electronic instructions. Information representing a unit, system, and / or method stored in a machine-readable medium can be used in the process of creating the unit, system, and / or method described herein. Hardware used to implement the present invention may include integrated circuits, microprocessors, FPGAs, digital signal controllers, stream processors, and / or other components. [Explanation of Symbols]

[0115] 110 valves 112 frames 116 Skirt 118 Support Posts 156 Sutures 180 bottom end 182 Top 184 commissure 193 Lobules 210 valves 291 Sealing ring 292 Frame members 293 Lobules 294 Intercom Post 320 Wire Form 322 commissure 324 Apex 326 Reinforcement band 340 fabrics 342 Support Stent 344 Apex 346 commissure 350 stitches 352 Inlet edge 392 Support Stent 405 Operator 406 First Move 407 The second hand 408 Downward angle 409 line of sight 410 Implant Devices 460 Expansion System 461 Eyepiece Components 463 Refraction elements 506 First Move 507 The second move 509 Suture needle 510 Implant Devices 700 Automatic Suturing System 702 Power Input 710 First automatic fixture, automatic suture fixture 720 Second automatic fixture, automatic suture fixture 730 thread management system, automatic suture fixture 740 Feedback Microcontroller Unit 750 modules 800 Automatic Suturing System 805 Automatic Fixture Holder 810 Target Devices 820 Thread support component 821 Support bracket 822 Support pin 824 Support pin 830 Tension Components 831 Tension Bracket 832 Tension Pin 840 Sewing device 841 needle 842 Outer Needle Gripper 844 Inner Needle Gripper 846 thread 905 Automatic Fixture Holder 907 Target Assembly 909 Joint Arm 910 Target Device 1700 Automatic Suturing System 1702 Electric Actuator 1703 Rotor 1704 Motor 1705 Automatic Suturing Fixture 1706 Servo Feedback Component 1707 Suture Target Holder 1708 Motor control circuit 1720 Thread Transfer Device 1730 Tension Devices 1740 Automatic suturing device 1742 Needle Gripper 1748 Gripper Actuator 1750 Thread Management System 1760 Control System 1762 Placement control circuit 1764 Suture Script Information 1810 Target devices, implantable devices 1818 stitches 1825 cloth 1878 Articulated Arm 1880 Target device holder, holder component 1885 Cylindrical Form 1892 Interconnection post section

Claims

1. A method for suturing an implant device, A step of passing a needle through the surface of the implant device using a first needle gripper and a second needle gripper, wherein the first needle gripper moves toward the implant device along a needle path from the first needle gripper toward the implant device. The steps include adjusting the position of the implant device, A step of returning the needle through the surface of the implant device using the first needle gripper and the second needle gripper, wherein the first needle gripper moves away from the implant device along the needle path, The steps include applying a target tension to the thread by moving the thread attached to the needle in a direction perpendicular to the needle path at a position along the needle path so that the thread deviates from the needle path, Methods that include...

2. The method according to claim 1, wherein the step of applying the target tension includes the step of applying an increasing tension during part of the method, and the step of applying a steady-state tension after the increasing tension exceeds a tension threshold.

3. The method according to claim 2, wherein the tension threshold is approximately 0.4 N or more.

4. The method according to claim 2 or 3, wherein the steady-state tension is approximately 0.3 N or less.

5. The method according to any one of claims 1 to 4, wherein the step of adjusting the position of the implant device includes the step of moving the implant device so as to be perpendicular to the needle path.

6. A first automatic fixture comprising a plurality of actuator devices and holders, the first automatic fixture configured to adjust the orientation of a target device when mounted on the holders, A second automatic fixture comprising a first needle gripper and a second needle gripper configured to pass a needle back and forth through the surface of the target device and form a suture with a thread attached to the needle, wherein the first needle gripper is configured to track the needle path from the first needle gripper to the target device, A thread management system configured to move the thread in a direction perpendicular to the needle path at a position along the needle path and to apply a target tension to the thread, An automated suturing system including...

7. The automated suturing system according to claim 6, wherein the target device is a heart valve or a component of a heart valve.

8. The automatic suturing system according to claim 6 or 7, wherein the thread management system includes a tension pin configured to apply tension to the thread.

9. The automatic suturing system according to any one of claims 6 to 8, wherein the automatic suturing system is configured to repeatedly execute a suturing pattern to continuously form a suture on the target device.

10. The automatic suturing system according to claim 9, wherein the thread management system is configured to provide increasing tension during a portion of the suturing pattern, and to provide steady-state tension after the increasing tension exceeds a tension threshold.

11. The automatic suturing system according to claim 10, wherein the tension threshold is at least about 0.4 N.

12. The automatic suturing system according to claim 11, wherein the steady-state tension is approximately 0.3 N or less.

13. A method for suturing a target device, The steps include operating an automated suturing system to suture a target device, The aforementioned automatic suturing system is programmed to perform programmed steps, The programmed steps are: A step of passing a needle through the surface of the target device using a first needle gripper and a second needle gripper, wherein the first needle gripper moves toward the target device along a needle path from the first needle gripper toward the target device. The steps include adjusting the position of the target device, A step of returning the needle through the surface of the target device using the first needle gripper and the second needle gripper, wherein the first needle gripper moves away from the target device along the needle path, The steps include applying a target tension to the thread by moving the thread attached to the needle in a direction perpendicular to the needle path at a position along the needle path so that the thread deviates from the needle path, Methods that include...

14. The method according to claim 13, wherein the step of applying the target tension includes the step of applying a tension that increases until it exceeds a tension threshold, and then the step of applying a steady-state tension after it has exceeded the tension threshold.

15. The method according to claim 14, wherein the tension threshold is approximately 0.4 N or more.

16. The method according to claim 14 or 15, wherein the steady-state tension is approximately 0.3 N or less.

17. The method according to any one of claims 13 to 16, wherein the step of adjusting the position of the target device includes the step of moving the target device so as to be perpendicular to the needle path.

18. The method according to any one of claims 13 to 17, wherein the needle path is a fixed straight path.

19. The method according to any one of claims 13 to 18, wherein the programmed step further includes the step of releasing the thread while the first needle gripper moves away from the target device along the needle path.

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