Patent ID: 12186039

DETAILED DESCRIPTION

The following description teaches the best mode of the invention through various embodiments. For the purpose of teaching inventive principles, some conventional aspects of the following embodiments may be simplified or omitted. Further, those skilled in the art will appreciate that the features described below can be substituted and/or combined in various ways to form multiple variations of the inventive embodiments. As a result, the invention is not limited to the specific examples and embodiments described below.

As a brief introduction, in order to achieve a large range of working positions, the positioning system may employ a number of actuators in a given configuration. The actuators may be individually or jointly actuated in order to position a component used to hold a workpiece. The actuators may use a gear system to transform the motion of the actuators in various ways. The number of actuators, the chosen configuration, and the presence of any additional components, such as the gear system, may affect the degree of maneuverability.

Complex actuator systems, however, often have relatively large aggregated (movement) error tolerances, leading to reduced positional precision, reduced stability, and/or other effects. Typical prior art positioning systems employing complex actuator systems in an effort to obtain higher degrees of maneuverability often suffer from such reduced precision and reduced stability. Current positioning systems also often lack a required level of rigidity. For example, smaller systems are often not rigid enough to maintain a desired (e.g., workpiece) position when force is applied to the workpiece (e.g., when a user is manipulating the workpiece as part of a manufacturing process). Larger systems may have the requisite rigidity, but the larger motors and added mass make these larger systems difficult or impossible to use in smaller scale applications (e.g., for manufacturing medical devices, etc.).

As such, typical prior art positioning systems are generally unsuitable for more sensitive applications or applications that require precise positioning on a small scale. This is more pronounced where the maneuverability and precise positioning must be repeatable, reliable, and consistent. One example of a relatively sensitive application involves the manufacture and assembly of medical devices. The acceptable range of error in manufacturing a medical device is narrow given the consequences of the presence of any flaws in such products. This is especially true for surgical implants and/or other products. As a result, the manufacture of surgical implants is often regulated by rigorous quality control standards and involves complex assembly procedures and considerations.

As one example, the manufacture of fabric-covered medical devices, including but not limited to, heart valves or Abdominal Aortic Aneurysm (AAA) Vascular Grafts, is known to be an intricate process requiring precision and consistency with a low acceptable range of error. Conventionally, the manufacture of cloth-covered medical devices like AAA devices is accomplished using manual labor, by hand-sewing (with needle and thread) the cloth and/or animal tissue onto a metal stent. The typical assembly procedure for a fabric-covered medical device occurs in two stages. During the first stage, intermittent stitches are placed to secure the fabric in its gross position around a support component, such as a stent. In the second stage, a closely-spaced line of stitches is applied to complete the seam, all while maintaining a certain degree of tension on the fabric. The procedure requires the needle and thread to pass through multiple layers of fabric, and sometimes biological tissue, with precision and consistency. This procedure is manually intensive for operators, and may induce high levels of stress and/or injury (e.g., carpel tunnel related injuries) in the operators. The hand sewing procedure is repetitive, and thus, operators frequently experience repetitive motion injuries (thus resulting in increased costs associated with treatment of such injuries for their employers). The fabric is typically tightly fitted around the support component and stitches are placed individually. The unusual shape of the medical device, and varying dimensions, contributes to the difficulty of assembly. Typical prior art positioning systems do not provide the precision and stability necessary to meaningfully assist in this and other assembly procedures.

There is a need for an improved positioning system that is suitable for force and dimensionally sensitive applications, including assisting with the assembly of heart valves and/or other medical devices in a manner that reduces time and effort required to manufacturing a device, and reduces stress and potential for injury in operators, while maintaining or enhancing quality and reliability of the manufacturing process and or the device.

FIG.1shows an exemplary positioning apparatus10. Apparatus10is an improved positioning apparatus that is suitable for force and dimensionally sensitive applications, including assisting with the assembly of heart valves and/or other medical devices in a manner that reduces time and effort required to manufacturing a device, and reduces stress and potential for injury in operators, while maintain or enhancing quality and reliability of the manufacturing process and or the device. In apparatus10, the inclusion and/or novel arrangement of the various components described herein facilitate precision movement and stability and also help reduce the stress and potential for injury in operators.

Apparatus10includes a support frame20. Support frame20comprises a frame base22, a frame cover24, a first set of frame posts26, a second set of frame posts28, and/or other components. In some embodiments, support frame20may be an independent structure, allowing positioning apparatus10to be a self-contained unit. In some embodiments, support frame20may be embedded into another structure or surface, such as a tabletop, bench, or wall, or positioning apparatus10may be built directly into such structures and surfaces. In some embodiments, a vacuum (not shown inFIG.1) may be integrated within frame20to facilitate suctioning and/or containment of particulates or noxious fumes, for example, that are emitted during a manufacturing process. Such a vacuum system may facilitate a clean and sanitary working environment, which is desirable in sensitive applications and those involving human operators. In some embodiments, frame20may surround and/or enclose other components of apparatus10. In some embodiments, frame20may provide an anchor point and/or other attachment points for fixed or removable coupling of other components of apparatus10.

In some embodiments, frame20may include brackets, nuts, bolts, screws, and/or other components configured to couple the various components of frame20. Frame20may be formed from metal (e.g., aluminum, steel, etc.), polymers, ceramics, and/or other materials. For example, in some embodiments, base22, cover24, posts26, posts28, and/or other components of frame20may be formed from aluminum, steel, and/or other materials. As another example, individual components may have oxide layers, polymer and/or other coatings, and/or other features. In some embodiments, frame20may have a generally rectangular shape and/or other shapes. In some embodiments, frame20may have a length21. In some embodiments, frame20may have a height23. In some embodiments, a material, a shape, a size, and/or other characteristics of frame20and/or components of frame20may be configured to enhance a weight and/or a stability of frame20.

Fixedly attached to the support frame20is a plurality of linear actuators30, as illustrated inFIG.2. A linear actuator30may be and/or include a Toothed Belt Axis ECG-50-TB-KF linear actuator from Pesto Corporation and/or other components, for example. The plurality of linear actuators30may be fixed between the first set of frame posts26and the second set of frame posts28, attached to the frame base22, and/or positioned in any other manner that secures the plurality of linear actuators30within the support frame20. The plurality of linear actuators30includes a plurality of slide tracks32and a plurality of slidable bases34that move along the plurality of slide tracks32. It should be understood that any suitable type of linear actuator may be utilized. The plurality of linear actuators30can be actuated by any means (pneumatically, electrically, hydraulically, by servo drive, etc.). In some embodiments, apparatus10includes a pair of slidable bases34with a first slidable base39located toward a first end41of frame20, and a second slidable base43located toward a second end45of frame20. In some embodiments, bases39and43are positioned on opposite sides of workpiece holding unit70along an x-axis47of apparatus10that extends from end41to end45.

As seen inFIG.3, the plurality of slidable bases34have at least one movable platform receiving groove36, which allows connecting portions (e.g., wheels63and/or other connecting portions as shown in the example inFIG.3) of the movable platform40to travel on a course defined by the at least one movable platform receiving groove36. Grooves36may be formed in or by angled portions35of slidable bases34. In some embodiments, an individual slidable base34includes two angled portions35formed on opposite sides of an individual base34. For example, as shown inFIG.3, a slidable base34, includes an angled portion35located toward a side51of frame20and another angled portion35located toward an opposite side53of frame20(along a y-axis61of apparatus10). In some embodiments, apparatus10comprises four grooves36, with one groove36formed in each of four individual angled portions35of slidable bases34. In some embodiments, grooves36extend along angled portions35from a location of an angled portion35located toward base plate22in a direction away from base plate22toward end41(base39) or45(base43) along x-axis47, and along a z-axis49. In some embodiments, angled portions35and/or grooves36may form an angle37relative to base plate22.

The positioning apparatus10can be used to hold, position, orient, and/or move a workpiece90by manipulating the position and orientation of the workpiece holding unit70. The plurality of linear actuators30can be actuated to raise or lower (in combination with grooves36) the workpiece holding unit70(i.e., to translate the workpiece holding unit70along z-axis49), generating one degree of freedom. The linear actuators30can also be actuated to move the workpiece holding unit70from side to side (i.e., to translate the workpiece holding unit70along x-axis47) adding an additional degree of freedom, combining to two degrees of freedom.

For example, one embodiment of the positioning apparatus10can be set at what may be referred to as a neutral position, where the workpiece holding unit70is centered along the Z (49) and X (47) axes. The two slidable bases34, each with two movable platform receiving grooves36can be used as described above. The movable platform receiving grooves36of the slidable base34that is closer to the first set of frame posts26(e.g., end45) can be angled (e.g., as described above) to set a course that travels away from frame cover24(FIG.1) toward the frame base22(e.g., along z-axis49) as it travels away from the first set of frame posts26(end45) toward the second set of frame posts28(e.g., along x-axis47toward end41). The movable platform receiving grooves36of the slidable base34that is closer to the second set of frame posts28(e.g., end41) can be angled to set a course that travels away from frame cover24toward the frame base22(e.g., along z-axis49) as it travels away from the second set of frame posts28(end41) toward the first set of frame posts26(e.g., along x-axis47toward end45). In this configuration, illustrated inFIG.3, the workpiece holding unit70can be raised along z-axis49by actuating the plurality of linear actuators30toward each other, such that the movable platform40travels along the course set by the movable platform receiving grooves36toward the frame cover24. The workpiece holding unit70can be lowered along z-axis49by actuating the plurality of linear actuators30away from each other, such that the movable platform40travels along the course set by the movable platform receiving grooves36toward the frame base22. In some embodiments, a typical translation along z-axis49may be on the order of millimeters, centimeters, or more. The workpiece holding unit70can be translated along x-axis47by actuating the plurality of linear actuators30in the same direction, such that the movable platform40does not travel along the course set by the movable platform receiving grooves36.

It is to be understood that different embodiments may vary in the types, number, and/or the orientation of the components (e.g., actuators, slide tracks, slidable bases, moveable platform receiving grooves) used. Although the exemplary positioning apparatus10shown inFIG.3uses two linear actuators, two slide tracks, two slidable bases, and the given groove orientation, it should be understood that this configuration is illustrated for exemplary purposes only and any suitable type, number, and/or orientation of these components may be used.

FIGS.4and5illustrate a gear system50configured to facilitate further manipulation of the position and orientation of the workpiece holding unit70. The gear system50includes a plurality of gear chains55. A (e.g., each) gear chain55may include a rotary actuator60that is attached to the movable platform40. Rotary actuator60may be and/or include Rotary Drive ERMO-12-ST-E from Pesto Corporation, for example, and/or other components. Rotary actuator60may be and/or include one more of a metal gear with a 20 degree pressure angle round bore (48 pitch, 18 teeth—McMaster Carr part number 7880K190), for example, and/or other components. It should be understood that any suitable type of rotary actuator may be utilized. The rotary actuator60may then rotate (drive) one end of a gear shaft62, which may have a worm wheel64located on the opposite end. A gear shaft62may be and/or include a linear motion shaft, 1055 carbon steel, 8 mm diameter, 200 mm length (McMaster Carr part number 6l 12K44), for example, and/or other components. A worm wheel64may be and/or include a W Worm, Kyouiku Gear, W80SURI+B from Misumi USA, for example, and/or other components. An individual gear shaft62may include a gear71configured to engage a rotary actuator60. Gear(s)71may be located at or near an end of a gear shaft62toward moveable platform40. A gear71may be and/or include a metal gear with a 20 degree pressure angle round bore (48 pitch, 24 teeth-McMaster Carr part number 7880K210), for example, and/or other components. An individual gear shaft62may be positioned along z-axis49and extend from moveable platform40in a direction along z-axis49away from base plate22. As a gear shaft62is rotated, the worm wheel64spins, which in tum may drive a worm gear66. A worm gear66may be and/or include Worm Wheels, G Series, Kyouiku Gear, G80A20+Rl from Misumi USA, for example, and/or other components. Coupled to individual worm gears66may be bevel gears68(with an individual bevel gear68engaged with an individual worm gear66), which rotate as the worm gears66are driven. A bevel gear68may be and/or include a Ground Tooth Spiral Miter SMSG 1-20RJ6 from Misumi USA, for example, and/or other components. It should be understood that the gear chains55may be any combination and configuration of components and gears that ultimately drives the bevel gear68of the gear chain55. The gear system50may further include a workpiece holding unit bevel gear72that couples with the bevel gear68of each of the plurality of gear chains55. A bevel gear72may be and/or include a Ground Tooth Spiral Miter SMSG 1-20LJ6 from Misumi USA, for example, and/or other components.

As shown inFIG.5, in some embodiments, worm wheel(s)64may be positioned along z-axis49, substantially parallel to gear shaft(s)62. Worm gear(s)66, bevel gears68, and/or other components may be positioned along y-axis61substantially perpendicular to gear shaft(s)62. Bevel gear72, workpiece holding unit70, workpiece90, and/or other components may be positioned along x-axis47, substantially perpendicular to both gear shaft(s)62and bevel gear68and worm gears66. It should be noted that these components are configured to rotate in various directions and the arrangement and position shown inFIG.5is an example only.

FIG.6illustrates one possible arrangement of the worm wheel(s)64, worm gear66, and bevel gear68components of the plurality of gear chains55and the coupled workpiece holding unit bevel gear72. By driving the plurality of gear chains55such that the bevel gears68rotate in the same direction, rotation of the workpiece holding unit70about an x-axis47(in this example) is achieved, as the workpiece holding unit bevel gear72, which is coupled to the bevel gears68, orbits around the x-axis in a course determined by the rotation of the bevel gears68. This adds an additional degree of freedom, to a total of three degrees of freedom. By driving the plurality of gear chains55such that the bevel gears68rotate in opposite directions (e.g., one clockwise and the other counter-clockwise), rotation of the workpiece holding unit70about an axis defined by a line that is perpendicular to the x-axis and that travels through the center of the workpiece holding unit bevel gear72is achieved, as the workpiece holding unit bevel gear72, which is coupled to the bevel gears68, spins in place with respect to the x-axis. This adds yet another degree of freedom, to a total of four degrees of freedom.

It is to be understood that alternative embodiments may vary in the types and numbers of gears used, as well as their configuration, as needed. For example, in alternative embodiments, the gears may be bevel gears, planetary gears, or other similar types of gears. The plurality of gear chains and its rotary actuators may be selectively actuated by an external controller. The controller may be any suitable type of controller, such as, for one example, a programmable logic controller. In some embodiments, the gears may be replaced by one or more (e.g., miniature) drive belts, (e.g., precision) chains, sprockets, and/or other components. Using these alternatives, or a combination of gears and these alternatives, may provide more optimal use of power and resulting torque in the system.

Returning toFIG.1, various embodiments of the positioning apparatus10may be configured to perform different applications. Any industry requiring precise and consistent manufacturing processes, and/or reduced stress and potential for injury in operators, may employ the positioning apparatus10to provide high degrees of maneuverability and precise contact points. In the health industry, for example, the positioning apparatus10may be used to manufacture and produce medical devices (e.g., as described herein). In various fields, the positioning apparatus10may be used to manufacture and produce mechanical or electronic products and components. In the fashion industry, the positioning apparatus10may be used to manufacture and produce fine jewelry. The positioning apparatus10may be used in processes requiring precise soldering, cutting, assembly, painting, and the like. The foregoing applications are not inclusive and embodiments of the positioning apparatus10may be used in many other applications not expressly described. Embodiments of the present apparatus may be of varying size depending on the scale required by the particular application.

The positioning apparatus10may include a tool80, mounted in a location that allows the tool80to interact with the workpiece90in the various working positions and orientations achieved. Apparatus10includes a tool rotary actuator182. It should be understood that any suitable type of rotary actuator may be utilized. The tool rotary actuator182can be actuated to rotate the tool80about y-axis61(FIG.2,3), resulting in various possible angles of contact between the tool80and the workpiece90. Although this does not generate an additional degree of freedom of movement between the workpiece90and the tool80, rotating the tool80may allow for angles of contact unobtainable by solely tilting, rotating, or otherwise moving the workpiece holding unit70. The tool80may include additional components as desired for the specific application. For the specific application of manufacturing prosthetic heart valves, for example, the tool may be a needle guide that positions and orients the needle to the correct point and angle of entry for the desired stitch as shown inFIGS.7and8, which will be discussed in further detail below.

The positioning apparatus10and its various actuators may be selectively actuated by an external controller and/or other components. The controller may be any suitable type of controller, such as, for one example, a programmable logic controller. The positioning apparatus10may comprise a coordinate system, facilitating positioning and orientation of the workpiece90and the tool80according to defined coordinates.

It is to be understood that various embodiments of the invention may vary in the orientation (e.g., horizontal, vertical, etc.) of the positioning apparatus and its various components (e.g., the linear actuators, the gear system, the workpiece holding unit, the workpiece, the tool) and that any suitable orientation may be used. For example, one embodiment may achieve a horizontal orientation with components installed horizontally into a reoriented outer casing or directly into a wall or other structure. The orientation of the X, Y, and Z axes referenced herein may be adjusted as desired and necessary.

For applications that require human supervision, the positioning apparatus10may include a video camera (not shown inFIG.1) for monitoring the work. The video camera may be any suitable type of video camera and may provide enhanced visibility for the operator. The camera may also be configured to provide remote viewing by an off-site supervisor, for example, through a coupled computer via either a wired or wireless connection.

In some embodiments, as described herein, the positioning apparatus10may be used to manufacture medical devices. In some embodiments, as shown inFIGS.7-9, apparatus10may be and/or be included in a robotic positioning apparatus100. During the manufacture of medical devices, for example, apparatus10and/or100may facilitate a semi-automatic method of stitching materials onto a prosthetic heart valve, and/or other medical devices. It is to be understood that the assembly of a fabric-covered prosthetic heart valve is an example of an application of the present apparatus, but the present apparatus is not to be limited to this example. The present apparatus may be used to attach any desired material to a prosthetic heart valve and can further be used for applications beyond prosthetic heart valve assembly.

In this example (where numerals inFIG.7-9(e.g., lxx) correspond to like numerals inFIG.1-6(e.g., xx)), apparatus10(FIG.1-6) and/or apparatus100(FIG.7-9) may be configured such that an operator may begin manufacturing a prosthetic heart valve using apparatus100by attaching a valve base structure or scaffolding190to the valve holding unit170of the robotic positioning apparatus100and holding a tubular biocompatible fabric around the valve base structure190, applying tension to the fabric as necessary to ensure that the stitches are properly made. The robotic positioning apparatus100may establish a coordinate system. The robotic positioning apparatus100may place the valve base structure190in the proper position and orientation according to the coordinate system, as well as position and orient a needle guide180(e.g., an example of a tool80shown inFIG.1) such that a stitching needle186is aligned to an entry point for penetration according to the coordinate system. The needle guide180may also be oriented to a specific angle of contact relative to the valve base structure190to provide precise positioning and orientation for a desired stitch.

This positioning process is performed by apparatus100by selectively actuating the various actuators of the robotic positioning apparatus100(e.g., as part of apparatus10shown inFIG.1-6). The robotic positioning apparatus100and its various actuators may be selectively actuated by an external controller and/or other components. The controller may be any suitable type of controller, such as, for one example, a programmable logic controller. The controller may selectively actuate the various actuators in response to various inputs by the operator. The controller may further be programmed to automatically place the valve base structure190in a number of predetermined positions and orientations or to follow a template defining a standardized stitching position order. Such a template may be created by programming the controller to locate a progressive series of discreet entry points and angles of contact.

Once the positioning process is complete, apparatus100is configured such that an operator may pull (push, and/or otherwise move) a stitching needle186through a needle guide180to a defined penetration point. The needle guide180is configured to reduce stress on an operator at least because needle guide180is configured such that an operator need only move stitching needle186in an axial direction, and not in lateral directions. As the operator does so, apparatus TOO is configured such that the stitching needle186releases the needle guide180, allowing the operator to tension the stitch. The needle guide180may be configured to provide tensioning to the suture as needed during a stitch. After a stitch is complete, apparatus TOO is configured such that the operator may return the stitching needle186to the needle guide180and the robotic positioning apparatus100may proceed to the next stitch position to prepare for the next stitch. The needle guide180may continue to provide tension to the suture as necessary. Once the repositioning process is complete, the operator may complete the next stitch, and the process is repeated as needed until the stitching process is complete.

Needle guide180is configured to ensure needle penetration in a prescribed location. Needle guide180is configured to reduce operator fatigue during a stitching process because, using needle guide180, an operator need only provide a linear or axial push to needle186to complete a stitch. An operator need not grasp and squeeze needle186, for example, or manually determine angular or lateral movement. Needle guide180includes rollers configured to reduce friction and/or drag and, together with tensioning device187(described below), facilitates accurate stitch placement and thread tension. Needle guide180is configured such that needle186is not permanently attached to a moving head (e.g., such as a sewing machine), or used only manually. Needle guide180and needle186are configured such that needle186may repeatedly pass completely through a manufacturing (e.g., heart valve) assembly and be retrieved for a next stitch. By way of a contrasting example, a sewing machine is not configured in this way unless a bobbin apparatus is incorporated (which would not be feasible in this heart valve and other examples).

The needle guide180has a needle guide rotary actuator182. It is understood that any suitable type of rotary actuator may be utilized. The needle guide rotary actuator182can be actuated to rotate the needle guide180and the stitching needle186about the y-axis61, resulting in various possible angles of contact between the stitching needle186and the valve base structure190. The needle guide180includes a guidance structure184to direct the stitching needle186. The guidance structure184may be a rail, a track, guide rollers, guide wheels, a tube, or any other suitable mechanism. The guidance structure184may secure the stitching needle186until use by the operator through friction, a lock, or any other suitable mechanism.

A tensioning device187incorporating a suture catch and release mechanism may be provided to hold a thread substantially still and taut, or with a desired amount of tension depending on the application, which may assist in creating stitches and avoiding entanglement of the thread, among other advantages. The tensioning device187may be, for example, a magnetic assembly, a spring assembly, and/or other assemblies. In some embodiments, the tensioning device187comprises a tensioning device base188and a magnetic head189. Base188and head189may be configured such that the tensioning device187is used by placing a section of thread behind the tensioning device187(relative to the valve base structure190), inserting the section of thread between the tensioning device base188and magnetic head189, and tautening the thread. The thread may be tautened in any suitable manner, including manually, such as pulling on the thread directly, by winding a spool or the source of the thread, and by moving the stitching needle186, including by using the needle guide180, needle guide rotary actuator182, and guidance structure184. The operator may release the tension on the thread whenever desired by pulling on the thread with enough force to allow the thread to move between the tensioning device base188and magnetic head189to the other side of the tensioning device187. The magnetic strength of magnetic head189can be adjusted to determine the amount of force needed to allow the thread to move in such a manner, allowing the operator to obtain various levels of tension. The magnetic head189can be kept in correct position (i.e., in a position where the magnetic head189maintains a magnetic connection to an appropriate portion of the tensioning device base188instead of being displaced to a location that renders the tensioning device187inoperable) by any number of suitable means, including a displacement prevention lip on the tensioning device base188or a displacement prevention chamber that allows the magnetic head189sufficient range of movement for the thread to pass between the magnetic head189and the tensioning device base188but restricts the range of movement such that the magnetic head189cannot fully exit the displacement prevention chamber. The structural arrangement of the tensioning device187facilitates efficient and accurate tensioning required for the specific stitch or suture.

In some embodiments, the tensioning device187may be any other device configured to control tensioning during sewing (e.g., compared to prior devices which require an operator to manually control tensioning). In some embodiments, as described above, the tensioning device187may be a spring assembly.

In some embodiments, needle guide180and tensioning device187are coupled to frame20on frame cover24via a block191configured to support needle guide180and tensioning device180. For example, frame cover24and block191may include corresponding through holes193(e.g., which form a hole pattern) and195. Bolts, screws, nuts, and/or other coupling devices may be used in conjunction with holes193and195to couple block191to frame cover24. In some embodiments, a plate197may be coupled to block191and components of needle guide180and/or tensioning device187may be coupled to plate197. Plate197and block191may be positioned on a side of valve base structure190(or another workpiece90—FIG.1) toward side51of apparatus100(but this is not intended to be limiting). In some embodiments, components of needle guide180(e.g., rotary actuator182, guidance structure184) and/or tensioning device187(e.g., tensioning device base188, magnetic head189, etc.) may extend away from plate197toward valve base structure190(e.g., or another workpiece90).

In some embodiments, for example, tensioning device base188may extend away from plate197and magnetic head189may be located at an end of tensioning device base188at or near valve base structure190. In some embodiments, the tensioning device187comprises a suture tensioning arm (base)188that has a magnetic end (magnetic head189) which may or may not be electrically energized. The electrically energized portion may allow for the option of using an electrical magnet, which may allow the user to adjust the magnitude of magnetic force whenever a change in suture tension is desired. A permanent magnet may also be used. A metal disc may be magnetically attached or attachable to the magnetic end and configured to allow for the suture to catch with an adjustable specified tension.

FIG.10is a schematic illustration of apparatus10,100. As shown inFIG.10, apparatus10,100may include a video camera202for monitoring the work (not shown inFIG.7-9). The video camera202may be any suitable type of video camera. As each stitch may be inspected, the camera202may also function as a magnifier and provide enhanced visibility for the operator. If any stitch should be unsatisfactory, the operator may undo the stitch and program or position the robotic positioning apparatus10,100to redo the unsatisfactory stitch before proceeding. The camera202may also be configured to provide remote viewing by an off-site supervisor, for example, through a coupled computer.

In some embodiments, as shown inFIG.10(andFIG.9), apparatus10,100may include a user interface199. User interface199may be configured to provide an interface between apparatus10,100and an operator (e.g., a technician, etc.) through which the operator may provide information to and receive information from apparatus10,100. This enables data, cues, results, and/or instructions and any other communicable items, collectively referred to as “information,” to be communicated between the operator and apparatus10,100. Examples of interface devices suitable for inclusion in user interface199include a touch screen, a keypad, buttons, switches, a keyboard, knobs, levers, a display, speakers, a microphone, an indicator light, an audible alarm, a printer, and/or other interface devices. In some embodiments, user interface199includes a plurality of separate interfaces. In some embodiments, user interface199includes at least one interface that is provided integrally with frame20. It is to be understood that other communication techniques, either hard-wired or wireless, are also contemplated by the present disclosure as user interface199. For example, the present disclosure contemplates that user interface199may be integrated with a removable storage interface. In this example, information may be loaded into apparatus10,100from removable storage (e.g., a smart card, a flash drive, a removable disk) that enables the operator to customize the implementation of apparatus10,100. Other exemplary input devices and techniques adapted for use as user interface199include, but are not limited to, an RS-232 port, RF link, an IR link, modem (telephone, cable or other). In short, any technique for communicating information with apparatus10,100is contemplated by the present disclosure as user interface199. By way of a non-limiting example, user interface199may be configured to display control fields, spatial information, video information, manufacturing instructions, quality control information, and/or other information.

In some embodiments, apparatus10,100may include one or more processors204, electronic storage206, and/or other components. The one or more processors204may be configured to provide information-processing capabilities in apparatus10,100. As such, a processor204may comprise one or more of a digital processor, an analog processor, a digital circuit designed to process information, an analog circuit designed to process information, a state machine, and/or other mechanisms for electronically processing information. A processor204may be a single entity, or a processor204may comprise a plurality of processing units. These processing units may be physically located within the same device (e.g., apparatus10,100), or a processor204may represent processing functionality of a plurality of devices operating in coordination (e.g., a processor included in a remote server, etc.). The one or more processors204, may run one or more electronic applications having graphical user interfaces configured to facilitate operator interaction with apparatus10,100, control the actuators, gears, and/or other mechanisms described herein, and/or perform other operations.

The electronic storage206may include electronic storage media that electronically stores information. The electronic storage media may include one or both of system storage that is provided integrally (i.e., substantially non-removable) with apparatus10,100and/or removable storage that is removably connectable to apparatus10,100via, for example, a port (e.g., a USB port, a firewire port) or a drive (e.g., a disk drive). The electronic storage206may include one or more of optically readable storage media (e.g., optical disks), magnetically readable storage media (e.g., magnetic tape, magnetic hard drive, floppy drive), electrical charge-based storage media (e.g., EEPROM, RAM), solid-state storage media (e.g., flash drive), and/or other electronically readable storage media. The electronic storage206may include one or more virtual storage resources (e.g., cloud storage, a virtual private network, and/or other virtual storage resources). The electronic storage206may store software algorithms, information determined by a processor (e.g., processor204), information received from external resources, information entered and/or selected via user interface199, and/or other information that enables apparatus TO, TOO to function as described herein.

Using the robotic positioning apparatus10,100and this semi-automatic method of stitching materials onto a prosthetic heart valve (for example) may provide increased precision, consistency, and efficiency while decreasing the amount of errors made and repetitive stress injuries suffered by operators. In some embodiments, the amount of time required to train an operator to become proficient in prosthetic heart valve production may also be decreased.

FIG.11illustrates a method300for assembling a semi-automatic precision positioning robot apparatus and/or using the semi-automatic precision positioning robot apparatus. In some embodiments, method300may include operations related to using the semi-automatic precision positioning robot apparatus for heart valve stitching and/or other manufacturing activities. The operations of method300presented below are intended to be illustrative. In some embodiments, method300may be accomplished with one or more additional operations not described, and/or without one or more of the operations discussed. Additionally, the order in which the operations of method300are illustrated inFIG.11and described below is not intended to be limiting.

At an operation302, a gear system may be assembled. In some embodiments, assembling the gear system may comprise assembling a plurality of gear chains, coupling a workpiece holding unit gear to the plurality of gear chains, and/or other operations. Assembling the plurality of gear chains may comprise, for an individual gear chain: providing a rotary actuator, coupling a gear shaft to the rotary actuator, coupling a worm wheel to the gear shaft, coupling a worm gear to the worm wheel, coupling an end gear to the worm gear, and/or other operations. In some embodiments, the workpiece holding unit gear may coupled to the end gear of each of the plurality of gear chains. In some embodiments, the end gear of each of the plurality of gear chains is a bevel gear. In some embodiments, the workpiece holding unit gear may be a bevel gear. In some embodiments, operation302may be performed with a gear system similar to or the same as gear system50(shown inFIGS.5and6, and described herein).

At an operation304, a workpiece holding unit may be coupled. The workpiece holding unit may be coupled to the workpiece holding unit gear and/or other components. In some embodiments, the gear system is configured to position a workpiece, by positioning the workpiece holding unit, relative to a tool. The tool may be configured to facilitate performance of a manufacturing operation on the workpiece. In some embodiments, operation304may be performed with a workpiece holding unit and/or a workpiece holding unit gear similar to or the same as workpiece holding unit70and/or bevel gear72(shown inFIGS.5and6, and described herein).

In some embodiments, operation302and/or operation304may include assembling a support frame. Assembling the support frame may comprise providing a frame base, coupling frame posts to the frame base, coupling a frame cover coupled to the frame posts, and/or other operations. In some embodiments, operation302and/or304may include providing a plurality of linear actuators. An individual linear actuator may comprise at least one slide track, and/or other components. In some embodiments, operation302and/or304may include fixedly coupling the at least one slide track to the support frame, and coupling a slidable base to the at least one slide track. The slidable base may be configured to be actuated to move along the at least one slide track. The slidable base may have at least one movable platform receiving groove. The at least one moveable platform receiving groove may extend within the slidable base, for example, in an angled direction away from the slide track. In some embodiments, operation302and/or304may include coupling a moveable platform to the plurality of linear actuators; and coupling the gear system to the moveable platform.

At an operation306, a tool may be assembled. Assembling the tool may comprise coupling a needle guide, a tensioning device, and/or other components to the semi-automatic precision positioning robot apparatus. The needle guide and the tensioning device may be configured to facilitate stitching in various applications, for one example, stitching associated with a medical device like a heart valve. In some embodiments, assembling the needle guide may comprise coupling a rotary actuator to the semi-automatic precision positioning robot apparatus. The rotary actuator may be configured to rotate the needle guide relative to the workpiece holding unit. Assembling the needle guide may comprise coupling a guidance structure to the rotary actuator. The guidance structure may be configured to removably receive and guide a stitching needle to a predetermined location on the medical device. In some embodiments, assembling the tensioning device comprises coupling a magnetic head to a base, and coupling the base to the semi-automatic precision positioning robot. The magnetic head may be configured to removably couple with a stitching thread. The base may be configured to position the magnetic head in proximity to the needle guide and the workpiece holding unit. In some embodiments, operation306may be performed with a needle guide and a tensioning device similar to or the same as needle guide180and tensioning device187(shown inFIGS.7and8, and described herein).

At an operation308, the semi-automatic precision positioning robot apparatus may be used for heart valve stitching and/or other operations. Operation308may include providing a guidance structure as part of the needle guide, and positioning the workpiece (e.g., valve) holding unit relative to the needle guide by actuating the plurality of gear chains to tum or move the workpiece (valve) holding unit (bevel) gear. Operation308may include aligning, by actuating the plurality of gear chains, a needle held by the needle guide to a stitch point on a heart valve held by the workpiece (valve) holding unit; and guiding, with the needle guide, completion of a stitch for the heart valve. Operation308may include positioning the workpiece (valve) holding unit by actuating at least one of the plurality of linear actuators such that at least one of the plurality of slidable bases moves in a direction along the slide track to position the workpiece (valve) holding unit. Operation308may include tensioning a stitching thread with the tensioning device of the semi-automatic precision positioning robot apparatus such that the thread has a desired amount of tension. In some embodiments, operation308may comprise determining a coordinate system, and one or both of: (1) positioning the workpiece (valve) holding unit relative to the needle guide by actuating the plurality of gear chains to tum or move the workpiece (valve) holding unit (bevel) gear based on the coordinate system; and (2) aligning, by actuating the plurality of gear chains, the needle held by the needle guide to the stitch point on the heart valve held by the workpiece (valve) holding unit based on the coordinate system. In some embodiments, operation308comprises displaying one or more images of the stitch point and/or other locations on the heart valve (or any other workpiece) on a display of the semi-automatic precision positioning robot apparatus. In some embodiments, operation308may be performed a system similar to or the same as system10and/or system100(shown inFIG.1-10and described herein).

FIG.12Aillustrates a perspective view of an embodiment of the robotic positioning apparatus10,100.FIG.12Billustrates a top view of this embodiment of the robotic positioning apparatus10,100.FIGS.12A and12Bare presented to compliment the previous figures described herein.FIG.12Aand/orFIG.12Billustrate various components of apparatus10,100including support frame20, frame base22, frame cover24, frame posts26,28, linear actuators30, slide tracks32, slideable bases34and/or other components.FIG.12A and/or12Billustrate the relative positions of gear system50, gear chains55, rotary actuator60, gear shaft62, worm wheels64, worm gears66, bevel gears68, work piece holding unit70, bevel gear72, and/or other components.FIGS.12A and12Balso illustrate ends41,45,51, and53.

It will be appreciated that various of the above-disclosed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. Also, various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art, and are also intended to be encompassed by the following claims.

While the description above refers to particular embodiments, it will be understood that many modifications may be made without departing from the spirit thereof. The accompanying claims are intended to cover such modifications as would fall within the scope and sprit of embodiments herein.

The presently disclosed embodiments are, therefore, to be considered in all respects as illustrative and not restrictive. All changes that come within the meaning of and range of equivalency of the claims are intended to be embraced therein.

The present techniques will be better understood with reference to the following enumerated embodiments:

1. A semi-automatic precision positioning robot apparatus, comprising: a gear system, the gear system comprising: a plurality of gear chains; a workpiece holding unit gear, wherein the workpiece holding unit gear is coupled to the plurality of gear chains; and a workpiece holding unit, wherein the workpiece holding unit is coupled to the workpiece holding unit gear; wherein the gear system is configured to position a workpiece, by positioning the workpiece holding unit, relative to a tool, the tool configured to facilitate performance of a manufacturing operation on the workpiece.
2. The apparatus of embodiment 1, further comprising the tool, the tool comprising a needle guide and a tensioning device configured to facilitate stitching.
3. The apparatus of embodiment 2, wherein the tool is configured to facilitate stitching associated with a medical device.
4. The apparatus of embodiment 2 or 3, wherein the needle guide comprises: a rotary actuator configured to rotate the needle guide relative to the workpiece holding unit; and a guidance structure configured to removably receive and guide a stitching needle to a predetermined location on the medical device; and wherein the tensioning device comprises: a magnetic head configured to removably couple with a stitching thread; and a base configured to position the magnetic head in proximity to the needle guide and the workpiece holding unit.
5. The apparatus of any of embodiments 1-4, wherein the plurality of gear chains individually comprise: a rotary actuator, a gear shaft, wherein the gear shaft is coupled to the rotary actuator, a worm wheel, wherein the worm wheel is coupled to the gear shaft, a worm gear, wherein the worm gear is coupled to the worm wheel, and an end gear, wherein the end gear is coupled to the worm gear; wherein the workpiece holding unit gear is coupled to the end gear of each of the plurality of gear chains.
6. The apparatus of embodiment 5, wherein the end gear further comprises a bevel gear.
7. The apparatus of any of embodiments 1-6, wherein the workpiece holding unit gear further comprises a bevel gear.
8. The apparatus of any of embodiments 1-7, further comprising: a support frame, wherein the support frame further comprises: a frame base, frame posts coupled to the frame base, and a frame cover coupled to the frame posts; a plurality of linear actuators, wherein an individual linear actuator comprises: at least one slide track, wherein the at least one slide track is fixedly coupled to the support frame; and a slidable base configured to be actuated to move along the at least one slide track, wherein the slidable base has at least one movable platform receiving groove, the at least one moveable platform receiving groove extending within the slidable base in an angled direction away from the slide track; and a moveable platform coupled to the plurality of linear actuators, wherein the gear system is coupled to the moveable platform.
9. A method for assembling a semi-automatic precision positioning robot apparatus, the method comprising: assembling a gear system, assembling the gear system comprising: assembling a plurality of gear chains; and coupling a workpiece holding unit gear to the plurality of gear chains; and coupling a workpiece holding unit to the workpiece holding unit gear; wherein the gear system is configured to position a workpiece, by positioning the workpiece holding unit, relative to a tool, the tool configured to facilitate performance of a manufacturing operation on the workpiece.
10. The method of embodiment 9, further comprising assembling the tool, assembling the tool comprising assembling a needle guide and a tensioning device, and coupling the needle guide and the tensioning device to the semi-automatic precision positioning robot apparatus,
11. The method of embodiment TO, wherein the needle guide and the tensioning device are configured to facilitate stitching associated with a medical device.
12. The method of embodiment 10 or 11, further comprising assembling the needle guide and the tensioning device, wherein assembling the needle guide comprises: coupling a rotary actuator to the semi-automatic precision positioning robot apparatus, the rotary actuator configured to rotate the needle guide relative to the workpiece holding unit; and coupling a guidance structure to the rotary actuator, the guidance structure configured to removably receive and guide a stitching needle to a predetermined location on the medical device; and wherein assembling the tensioning device comprises: coupling a magnetic head to a base, and coupling the base to the semi-automatic precision positioning robot, the magnetic head configured to removably couple with a stitching thread; and the base configured to position the magnetic head in proximity to the needle guide and the workpiece holding unit.
13. The method of any of embodiments 9-12, wherein assembling the plurality of gear chains comprises, for an individual gear chain: providing a rotary actuator, coupling a gear shaft to the rotary actuator, coupling a worm wheel to the gear shaft, coupling a worm gear to the worm wheel, and coupling an end gear to the worm gear; wherein the workpiece holding unit gear is coupled to the end gear of each of the plurality of gear chains.
14. The method of embodiment 13, wherein the end gear comprises a bevel gear.
15. The method of any of embodiments 9-14, wherein the workpiece holding unit gear further comprises a bevel gear.
16. The method of any of embodiments 9-15, further comprising: assembling a support frame, wherein assembling the support frame comprises: providing a frame base, coupling frame posts to the frame base, and coupling a frame cover to the frame posts; providing a plurality of linear actuators, wherein an individual linear actuator comprises: at least one slide track; fixedly coupling the at least one slide track to the support frame; coupling a slidable base to the at least one slide track, the slidable base configured to be actuated to move along the at least one slide track, wherein the slidable base has at least one movable platform receiving groove, the at least one moveable platform receiving groove extending within the slidable base in an angled direction away from the slide track; coupling a moveable platform to the plurality of linear actuators; and coupling the gear system to the moveable platform.
17. A method of using a semi-automatic precision positioning robot apparatus for heart valve stitching, comprising: providing a semi-automatic precision positioning robot apparatus comprising a gear system, wherein the gear system comprises: a plurality of gear chains, and a valve holding unit bevel gear, wherein the valve holding unit bevel gear is coupled to the plurality of gear chains; coupling a valve holding unit to the valve holding unit bevel gear; providing a needle guide, wherein the needle guide includes a needle guide rotary actuator and a guidance structure; positioning the valve holding unit relative to the needle guide by actuating the plurality of gear chains to tum or move the valve holding unit bevel gear; aligning, by actuating the plurality of gear chains, a needle held by the needle guide to a stitch point on a heart valve held by the valve holding unit; and guiding, with the needle guide, completion of a stitch for the heart valve.
18. The method of embodiment 17, wherein the semi-automatic precision positioning robot apparatus comprises: a support frame, wherein the support frame further comprises: a frame base, frame posts coupled to the frame base, and a frame cover coupled to the frame posts; a plurality of linear actuators, wherein the plurality of linear actuators further comprises: a slide track, wherein the slide track is fixedly attached to the support frame and a plurality of slidable bases that can be actuated to move along the slide track wherein the plurality of slidable bases has at least one movable platform receiving groove; and a moveable platform with at least one connecting portion that is received by the at least one movable platform receiving groove, wherein the gear system is mounted on the moveable platform; wherein the method further comprises: positioning the valve holding unit by actuating at least one of the plurality of linear actuators, wherein at least one of the plurality of slidable bases moves in a direction along the slide track to position the valve holding unit; and coupling the needle guide to the support frame.
19. The method of any of embodiments 17-18, further comprising: tensioning a stitching thread with a tensioning device of the semi-automatic precision positioning robot apparatus such that the thread has a desired amount of tension.
20. The method of embodiment 19, wherein the tensioning device comprises: a suture tensioning arm with a magnetic end; and a metal disc magnetically attachable to the magnetic end.
21. The method of any of embodiments 17-20, further comprising determining a coordinate system, and one or both of: (1) positioning the valve holding unit relative to the needle guide by actuating the plurality of gear chains to turn or move the valve holding unit bevel gear based on the coordinate system; and (2) aligning, by actuating the plurality of gear chains, the needle held by the needle guide to the stitch point on the heart valve held by the valve holding unit based on the coordinate system.
22. The method of any of embodiments 17-21, further comprising displaying one or more images of the stitch point on the heart valve on a display of the semi-automatic precision positioning robot apparatus.