Patent Description:
The present embodiments relate generally to positioning systems that are used to hold and position a workpiece. While the present embodiments may be used in a broad range of applications in various industries, a particular embodiment relates to an apparatus that assists in the assembly of components of a fabric-covered prosthetic heart valve, and associated methodology.

Manufacturing processes involving human participation often suffer from quality control problems due to human error. Manufacturing processes involving human participation also often cause operator stress and even injury. These quality control, stress, and/or injury problems are pronounced in manufacturing processes requiring sustained focus and manual dexterity due to fatigue. Consequently, there is often a desire to reduce human involvement and automate manufacturing processes. Automation of many manufacturing processes is not easy. For example, mechanical positioning systems used to hold and position a workpiece are utilized in various fields for a number of applications, such as manufacturing, machining, and assembly. Such positioning systems typically require a considerable degree of maneuverability and highly precise positioning of the workpiece in order to obtain the level of quality desired for each workpiece.

<CIT> relates to a robot arm which includes a first holder and a second holder. The first holder includes a first base portion and a first distal portion. The first distal portion has a first distal thickness smaller than a thickness of the first base portion. The second holder includes a second base and a second distal portion. The second distal portion has a second distal thickness smaller than a thickness of the second base portion. A first rotator is supported by the first distal portion and the second distal portion. A second rotator is supported by the first rotator. A first bevel gear is provided in the first distal portion. Another first bevel gear is provided in the second distal portion. A second bevel gear engages with the first bevel gear and the another first bevel gear.

<CIT> relates to an apparatus which has a three dimensional form with a peripheral surface which generally corresponds to the contour of the article to be formed. Pattern pieces are picked up and positioned on the form by a manipulator which has an articulated arm carrying a pickup device and which operates in response to signals from a programmable controller. A seaming tool carried by another manipulator moves in working relation to pattern pieces spread on the form to join the pattern pieces along seams which generally follow the contour of the form in response to signals from the controller. Another manipulator moves a pressing head in pressing relation to pattern pieces spread on the form in response to signals from the controller to press the pattern pieces or the article made from the pattern pieces to remove wrinkles therefrom.

<CIT> relates to a redundant parallel positioning table device for a precise positioning of heavy load samples, instrument and/or apparatus e.g. in the context of diffractometer machines for synchrotron facilities.

<CIT> relates to a system and method for assembling a prosthetic heart valve, including a procedure for sewing fabric around a heart valve support stent. The system includes a support stent handling component that works in conjunction with a sewing machine component. The sewing machine has a bobbin, and the system includes a non-contact sensor to monitor the passage of a needle thread loop over the bobbin. The sensor may be a monitoring laser, and a controlling processor receives information therefrom for <NUM>% real-time inspection of each stitch. The occurrence of an unsuccessful stitch may prompt the processor to repeat the stitch at a slower speed.

<CIT> relates to three-dimensional positioning table which has a thin and simple structure and can make a high-precision positioning, and which comprises a base table, an elevating device installed on the base table, a support plate fixed to the upper part of the elevating device, a table plate disposed on the support plate, and at least three direct-acting drive devices disposed around the elevating device on the base table and provided with drive shafts respectively connected with the table plate via connectors, wherein each of the above connectors comprises, linked in an arbitrary sequence, a first linear bearing consisting of a rail and a slider disposed vertically to the table plate, a second linear bearing consisting of a rail and a slider disposed vertically to the table plate, a second linear bearing consisting of a rail and a slider disposed in a direction perpendicular to the rail of the first bearing, and a swinging unit provided with a movable unit capable of swinging with a direction vertical to the table plate as an axis, wherein the rails of the second linear bearings of at least two connectors out of the above three connectors are disposed to be coaxial or parallel with each other, and are disposed in a direction perpendicular to the rail of the second linear bearing of the remaining connector.

One aspect of the present disclosure useful for understanding the presently claimed invention relates to a semi-automatic precision positioning robot apparatus and method for use to hold, position, orient and/or move a workpiece. The positioning apparatus includes a support frame or casing, which can be an independent structure, allowing the positioning apparatus to be a self-contained unit, or the casing may be embedded into another structure or surface. In some embodiments, a vacuum may be integrated into the casing to help suction and contain any particulates or noxious fumes that are emitted during the manufacturing or work process.

Embodiments of the positioning apparatus utilize a plurality of linear actuators to position and orient the workpiece. The plurality of linear actuators may be attached to the support frame or casing in any suitable manner, including fixing the plurality of actuators between frame posts and/or to a frame base. The plurality of linear actuators includes a plurality of slide tracks and a plurality of slidable bases that move along the plurality of slide tracks. The plurality of slidable bases may have at least one movable platform receiving groove, which allows connecting portions of a movable platform to travel on a course defined by the groove. The plurality of linear actuators may be actuated to hold, position, orient, and move the workpiece by manipulating the position and orientation of a workpiece holding unit. The plurality of linear actuators can be actuated, alone or in conjunction with each other, to raise or lower the workpiece holding unit, as well as to move the workpiece holding unit side to side. Various embodiments may vary in the types and numbers of actuators used.

The positioning apparatus may include a gear system that allows for further manipulation of the position and orientation of the workpiece holding unit. The gear system includes a plurality of gear chains. A gear chain may include a rotary actuator coupled to the movable platform. The rotary actuator may rotate a gear shaft, which may, in embodiments, have a worm wheel on the end. As the gear shaft is rotated, the worm wheel spins, which in turn may drive a worm gear. Coupled to each worm gear may be a bevel gear, which rotates as the worm gear is driven. The gear system may include a workpiece holding unit bevel gear that couples with the bevel gear of individual ones of the plurality of gear chains. The plurality of gear chains can be driven such that the bevel gears rotate in the same direction, rotating the workpiece holding unit about an axis as the workpiece holding unit bevel gear, which is coupled to the bevel gears, orbits around the axis in a course determined by the rotation of the bevel gears. The plurality of gear chains can also be driven such that the bevel gears rotate in opposite directions (e.g., one clockwise and the other counter-clockwise), rotating the workpiece holding unit about an axis defined by a line that is perpendicular to the axis and that travels through the center of the workpiece holding unit bevel gear, as the workpiece holding unit bevel gear, which is coupled to the bevel gears, spins in place with respect to the axis. Various embodiments may vary in the types and numbers of components used, as well as their configuration, as needed. For example, in some embodiments, the gears may be bevel gears, planetary gears, or other similar types of gears. In some embodiments, the system may include (e.g., miniature) drive belts, (e.g., precision) chains, sprockets, and/or other components.

The positioning apparatus may include a tool, mounted in a location that allows the tool to interact with the workpiece. The tool includes a tool rotary actuator, which is configured to facilitate various possible angles of contact between the tool and the workpiece.

The positioning apparatus may establish a coordinate system, facilitating positioning and orientation of the workpiece and the tool according to defined coordinates.

For applications that require human supervision and/or other applications, the positioning apparatus may include a video camera for monitoring the work, which may also be configured for remote viewing by an off-site supervisor, for example, through an operatively coupled computer.

The various components of the positioning apparatus may be selectively controlled by an external controller.

The positioning apparatus may be used in a number of different applications, such as the manufacture of various mechanical and electronic products and components, manufacture and production of fine jewelry, and soldering, cutting, and assembly processes. Specific embodiments of the positioning apparatus may be fitted for the manufacture of medical devices, such as for example, including stitching materials onto prosthetic valves.

For embodiments of the positioning apparatus used to manufacture medical devices, including stitching materials onto prosthetic valves, the positioning apparatus may use a needle guide as the tool, including a needle guide rotary actuator, a guidance structure, and a stitching needle. A tensioning device incorporating a suture catch and release may also be provided to hold the thread (substantially) still and taut, or with the desired amount of tension, which can assist in creating proper stitches and avoiding entanglement of the thread. The tensioning device may be a magnetic assembly, for example, a spring assembly, and/or include other devices. In some embodiments, the tensioning device comprises a tensioning device base and a magnetic head. The operator may utilize the tensioning device by placing a section of thread behind the tensioning device (relative to the valve base structure), inserting the section of thread between the tensioning device base and magnetic head, and tautening the thread. 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 base and magnetic head to the other side of the tensioning device. The magnetic strength of the magnetic head can 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 head can be kept in correct position (i.e., in a position where the magnetic head maintains a magnetic connection to an appropriate portion of the tensioning device base instead of being displaced to a location that renders the tensioning device inoperable) by any number of suitable means, including a displacement prevention lip on the tensioning device base or a displacement prevention chamber that allows the magnetic head sufficient range of movement for the thread to pass between the magnetic head and the tensioning device base but restricts the range of movement such that the magnetic head cannot fully exit the displacement prevention chamber. The structural arrangement of the tensioning device facilitates efficient and accurate tensioning required for the specific stitch or suture.

These and other objects, features, and characteristics of the apparatus or method disclosed herein, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the disclosure. As used in the specification and in the claims, the singular form of "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

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> shows an exemplary positioning apparatus <NUM>. Apparatus <NUM> is 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 apparatus <NUM>, 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.

Apparatus <NUM> includes a support frame <NUM>. Support frame <NUM> comprises a frame base <NUM>, a frame cover <NUM>, a first set of frame posts <NUM>, a second set of frame posts <NUM>, and/or other components. In some embodiments, support frame <NUM> may be an independent structure, allowing positioning apparatus <NUM> to be a self-contained unit. In some embodiments, support frame <NUM> may be embedded into another structure or surface, such as a tabletop, bench, or wall, or positioning apparatus <NUM> may be built directly into such structures and surfaces. In some embodiments, a vacuum (not shown in <FIG>) may be integrated within frame <NUM> to 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, frame <NUM> may surround and/or enclose other components of apparatus <NUM>. In some embodiments, frame <NUM> may provide an anchor point and/or other attachment points for fixed or removable coupling of other components of apparatus <NUM>.

In some embodiments, frame <NUM> may include brackets, nuts, bolts, screws, and/or other components configured to couple the various components of frame <NUM>. Frame <NUM> may be formed from metal (e.g., aluminum, steel, etc.), polymers, ceramics, and/or other materials. For example, in some embodiments, base <NUM>, cover <NUM>, posts <NUM>, posts <NUM>, and/or other components of frame <NUM> may 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, frame <NUM> may have a generally rectangular shape and/or other shapes. In some embodiments, frame <NUM> may have a length <NUM>. In some embodiments, frame <NUM> may have a height <NUM>. In some embodiments, a material, a shape, a size, and/or other characteristics of frame <NUM> and/or components of frame <NUM> may be configured to enhance a weight and/or a stability of frame <NUM>.

Fixedly attached to the support frame <NUM> is a plurality of linear actuators <NUM>, as illustrated in <FIG>. A linear actuator <NUM> may be and/or include a Toothed Belt Axis ECG-<NUM>-TB-KF linear actuator from Festo Corporation and/or other components, for example. The plurality of linear actuators <NUM> may be fixed between the first set of frame posts <NUM> and the second set of frame posts <NUM>, attached to the frame base <NUM>, and/or positioned in any other manner that secures the plurality of linear actuators <NUM> within the support frame <NUM>. The plurality of linear actuators <NUM> includes a plurality of slide tracks <NUM> and a plurality of slidable bases <NUM> that move along the plurality of slide tracks <NUM>. It should be understood that any suitable type of linear actuator may be utilized. The plurality of linear actuators <NUM> can be actuated by any means (pneumatically, electrically, hydraulically, by servo drive, etc.). In some embodiments, apparatus <NUM> includes a pair of slidable bases <NUM> with a first slidable base <NUM> located toward a first end <NUM> of frame <NUM>, and a second slidable base <NUM> located toward a second end <NUM> of frame <NUM>. In some embodiments, bases <NUM> and <NUM> are positioned on opposite sides of workpiece holding unit <NUM> along an x-axis <NUM> of apparatus <NUM> that extends from end <NUM> to end <NUM>.

As seen in <FIG>, the plurality of slidable bases <NUM> have at least one movable platform receiving groove <NUM>, which allows connecting portions (e.g., wheels <NUM> and/or other connecting portions as shown in the example in <FIG>) of the movable platform <NUM> to travel on a course defined by the at least one movable platform receiving groove <NUM>. Grooves <NUM> may be formed in or by angled portions <NUM> of slidable bases <NUM>. In some embodiments, an individual slidable base <NUM> includes two angled portions <NUM> formed on opposite sides of an individual base <NUM>. For example, as shown in <FIG>, a slidable base <NUM>, includes an angled portion <NUM> located toward a side <NUM> of frame <NUM> and another angled portion <NUM> located toward an opposite side <NUM> of frame <NUM> (along a y-axis <NUM> of apparatus <NUM>). In some embodiments, apparatus <NUM> comprises four grooves <NUM>, with one groove <NUM> formed in each of four individual angled portions <NUM> of slidable bases <NUM>. In some embodiments, grooves <NUM> extend along angled portions <NUM> from a location of an angled portion <NUM> located toward base plate <NUM> in a direction away from base plate <NUM> toward end <NUM> (base <NUM>) or <NUM> (base <NUM>) along x-axis <NUM>, and along a z-axis <NUM>. In some embodiments, angled portions <NUM> and/or grooves <NUM> may form an angle <NUM> relative to base plate <NUM>.

The positioning apparatus <NUM> can be used to hold, position, orient, and/or move a workpiece <NUM> by manipulating the position and orientation of the workpiece holding unit <NUM>. The plurality of linear actuators <NUM> can be actuated to raise or lower (in combination with grooves <NUM>) the workpiece holding unit <NUM> (i.e., to translate the workpiece holding unit <NUM> along z-axis <NUM>), generating one degree of freedom. The linear actuators <NUM> can also be actuated to move the workpiece holding unit <NUM> from side to side (i.e., to translate the workpiece holding unit <NUM> along x-axis <NUM>) adding an additional degree of freedom, combining to two degrees of freedom.

For example, one embodiment of the positioning apparatus <NUM> can be set at what may be referred to as a neutral position, where the workpiece holding unit <NUM> is centered along the Z (<NUM>) and X (<NUM>) axes. The two slidable bases <NUM>, each with two movable platform receiving grooves <NUM> can be used as described above. The movable platform receiving grooves <NUM> of the slidable base <NUM> that is closer to the first set of frame posts <NUM> (e.g., end <NUM>) can be angled (e.g., as described above) to set a course that travels away from frame cover <NUM> (<FIG>) toward the frame base <NUM> (e.g., along z-axis <NUM>) as it travels away from the first set of frame posts <NUM> (end <NUM>) toward the second set of frame posts <NUM> (e.g., along x-axis <NUM> toward end <NUM>). The movable platform receiving grooves <NUM> of the slidable base <NUM> that is closer to the second set of frame posts <NUM> (e.g., end <NUM>) can be angled to set a course that travels away from frame cover <NUM> toward the frame base <NUM> (e.g., along z-axis <NUM>) as it travels away from the second set of frame posts <NUM> (end <NUM>) toward the first set of frame posts <NUM> (e.g., along x-axis <NUM> toward end <NUM>). In this configuration, illustrated in <FIG>, the workpiece holding unit <NUM> can be raised along z-axis <NUM> by actuating the plurality of linear actuators <NUM> toward each other, such that the movable platform <NUM> travels along the course set by the movable platform receiving grooves <NUM> toward the frame cover <NUM>. The workpiece holding unit <NUM> can be lowered along z-axis <NUM> by actuating the plurality of linear actuators <NUM> away from each other, such that the movable platform <NUM> travels along the course set by the movable platform receiving grooves <NUM> toward the frame base <NUM>. In some embodiments, a typical translation along z-axis <NUM> may be on the order of millimeters, centimeters, or more. The workpiece holding unit <NUM> can be translated along x-axis <NUM> by actuating the plurality of linear actuators <NUM> in the same direction, such that the movable platform <NUM> does not travel along the course set by the movable platform receiving grooves <NUM>.

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 apparatus <NUM> shown in <FIG> uses 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.

<FIG> and <FIG> illustrate a gear system <NUM> configured to facilitate further manipulation of the position and orientation of the workpiece holding unit <NUM>. The gear system <NUM> includes a plurality of gear chains <NUM>. A (e.g., each) gear chain <NUM> may include a rotary actuator <NUM> that is attached to the movable platform <NUM>. Rotary actuator <NUM> may be and/or include Rotary Drive ERMO-<NUM>-ST-E from Festo Corporation, for example, and/or other components. Rotary actuator <NUM> may be and/or include one more of a metal gear with a <NUM> degree pressure angle round bore (<NUM> pitch, <NUM> 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 actuator <NUM> may then rotate (drive) one end of a gear shaft <NUM>, which may have a worm wheel <NUM> located on the opposite end. A gear shaft <NUM> may be and/or include a linear motion shaft, <NUM> carbon steel, <NUM> diameter, <NUM> length (McMaster Carr part number 6112K44), for example, and/or other components. A worm wheel <NUM> may be and/or include a W Worm, Kyouiku Gear, W80SUR1+B from Misumi USA, for example, and/or other components. An individual gear shaft <NUM> may include a gear <NUM> configured to engage a rotary actuator <NUM>. Gear(s) <NUM> may be located at or near an end of a gear shaft <NUM> toward moveable platform <NUM>. A gear <NUM> may be and/or include a metal gear with a <NUM> degree pressure angle round bore (<NUM> pitch, <NUM> teeth - McMaster Carr part number 7880K210), for example, and/or other components. An individual gear shaft <NUM> may be positioned along z-axis <NUM> and extend from moveable platform <NUM> in a direction along z-axis <NUM> away from base plate <NUM>. As a gear shaft <NUM> is rotated, the worm wheel <NUM> spins, which in turn may drive a worm gear <NUM>. A worm gear <NUM> may be and/or include Worm Wheels, G Series, Kyouiku Gear, G80A20+R1 from Misumi USA, for example, and/or other components. Coupled to individual worm gears <NUM> may be bevel gears <NUM> (with an individual bevel gear <NUM> engaged with an individual worm gear <NUM>), which rotate as the worm gears <NUM> are driven. A bevel gear <NUM> may be and/or include a Ground Tooth Spiral Miter SMSG1-20RJ6 from Misumi USA, for example, and/or other components. It should be understood that the gear chains <NUM> may be any combination and configuration of components and gears that ultimately drives the bevel gear <NUM> of the gear chain <NUM>. The gear system <NUM> may further include a workpiece holding unit bevel gear <NUM> that couples with the bevel gear <NUM> of each of the plurality of gear chains <NUM>. A bevel gear <NUM> may be and/or include a Ground Tooth Spiral Miter SMSG1-20LJ6 from Misumi USA, for example, and/or other components.

As shown in <FIG>, in some embodiments, worm wheel(s) <NUM> may be positioned along z-axis <NUM>, substantially parallel to gear shaft(s) <NUM>. Worm gear(s) <NUM>, bevel gears <NUM>, and/or other components may be positioned along y-axis <NUM> substantially perpendicular to gear shaft(s) <NUM>. Bevel gear <NUM>, workpiece holding unit <NUM>, workpiece <NUM>, and/or other components may be positioned along x-axis <NUM>, substantially perpendicular to both gear shaft(s) <NUM> and bevel gear <NUM> and worm gears <NUM>. It should be noted that these components are configured to rotate in various directions and the arrangement and position shown in <FIG> is an example only.

<FIG> illustrates one possible arrangement of the worm wheel(s) <NUM>, worm gear <NUM>, and bevel gear <NUM> components of the plurality of gear chains <NUM> and the coupled workpiece holding unit bevel gear <NUM>. By driving the plurality of gear chains <NUM> such that the bevel gears <NUM> rotate in the same direction, rotation of the workpiece holding unit <NUM> about an x-axis <NUM> (in this example) is achieved, as the workpiece holding unit bevel gear <NUM>, which is coupled to the bevel gears <NUM>, orbits around the x-axis in a course determined by the rotation of the bevel gears <NUM>. This adds an additional degree of freedom, to a total of three degrees of freedom. By driving the plurality of gear chains <NUM> such that the bevel gears <NUM> rotate in opposite directions (e.g., one clockwise and the other counter-clockwise), rotation of the workpiece holding unit <NUM> about 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 gear <NUM> is achieved, as the workpiece holding unit bevel gear <NUM>, which is coupled to the bevel gears <NUM>, 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 to <FIG>, various embodiments of the positioning apparatus <NUM> may 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 apparatus <NUM> to provide high degrees of maneuverability and precise contact points. In the health industry, for example, the positioning apparatus <NUM> may be used to manufacture and produce medical devices (e.g., as described herein). In various fields, the positioning apparatus <NUM> may be used to manufacture and produce mechanical or electronic products and components. In the fashion industry, the positioning apparatus <NUM> may be used to manufacture and produce fine jewelry. The positioning apparatus <NUM> may be used in processes requiring precise soldering, cutting, assembly, painting, and the like. The foregoing applications are not inclusive and embodiments of the positioning apparatus <NUM> may 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 apparatus <NUM> may include a tool <NUM>, mounted in a location that allows the tool <NUM> to interact with the workpiece <NUM> in the various working positions and orientations achieved. Apparatus <NUM> includes a tool rotary actuator <NUM>. It should be understood that any suitable type of rotary actuator may be utilized. The tool rotary actuator <NUM> can be actuated to rotate the tool <NUM> about y-axis <NUM> (<FIG>, <FIG>), resulting in various possible angles of contact between the tool <NUM> and the workpiece <NUM>. Although this does not generate an additional degree of freedom of movement between the workpiece <NUM> and the tool <NUM>, rotating the tool <NUM> may allow for angles of contact unobtainable by solely tilting, rotating, or otherwise moving the workpiece holding unit <NUM>. The tool <NUM> may 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 in <FIG> and <FIG>, which will be discussed in further detail below.

The positioning apparatus <NUM> and 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 apparatus <NUM> may comprise a coordinate system, facilitating positioning and orientation of the workpiece <NUM> and the tool <NUM> according 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 apparatus <NUM> may include a video camera (not shown in <FIG>) 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 apparatus <NUM> may be used to manufacture medical devices. In some embodiments, as shown in <FIG>, apparatus <NUM> may be and/or be included in a robotic positioning apparatus <NUM>. During the manufacture of medical devices, for example, apparatus <NUM> and/or <NUM> may 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 in <FIG> (e.g., 1xx) correspond to like numerals in <FIG> (e.g., xx)), apparatus <NUM> (<FIG>) and/or apparatus <NUM> (<FIG>) may be configured such that an operator may begin manufacturing a prosthetic heart valve using apparatus <NUM> by attaching a valve base structure or scaffolding <NUM> to the valve holding unit <NUM> of the robotic positioning apparatus <NUM> and holding a tubular biocompatible fabric around the valve base structure <NUM>, applying tension to the fabric as necessary to ensure that the stitches are properly made. The robotic positioning apparatus <NUM> may establish a coordinate system. The robotic positioning apparatus <NUM> may place the valve base structure <NUM> in the proper position and orientation according to the coordinate system, as well as position and orient a needle guide <NUM> (e.g., an example of a tool <NUM> shown in <FIG>) such that a stitching needle <NUM> is aligned to an entry point for penetration according to the coordinate system. The needle guide <NUM> may also be oriented to a specific angle of contact relative to the valve base structure <NUM> to provide precise positioning and orientation for a desired stitch.

This positioning process is performed by apparatus <NUM> by selectively actuating the various actuators of the robotic positioning apparatus <NUM> (e.g., as part of apparatus <NUM> shown in <FIG>). The robotic positioning apparatus <NUM> and 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 structure <NUM> in 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, apparatus <NUM> is configured such that an operator may pull (push, and/or otherwise move) a stitching needle <NUM> through a needle guide <NUM> to a defined penetration point. The needle guide <NUM> is configured to reduce stress on an operator at least because needle guide <NUM> is configured such that an operator need only move stitching needle <NUM> in an axial direction, and not in lateral directions. As the operator does so, apparatus <NUM> is configured such that the stitching needle <NUM> releases the needle guide <NUM>, allowing the operator to tension the stitch. The needle guide <NUM> may be configured to provide tensioning to the suture as needed during a stitch. After a stitch is complete, apparatus <NUM> is configured such that the operator may return the stitching needle <NUM> to the needle guide <NUM> and the robotic positioning apparatus <NUM> may proceed to the next stitch position to prepare for the next stitch. The needle guide <NUM> may 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 guide <NUM> is configured to ensure needle penetration in a prescribed location. Needle guide <NUM> is configured to reduce operator fatigue during a stitching process because, using needle guide <NUM>, an operator need only provide a linear or axial push to needle <NUM> to complete a stitch. An operator need not grasp and squeeze needle <NUM>, for example, or manually determine angular or lateral movement. Needle guide <NUM> includes rollers configured to reduce friction and/or drag and, together with tensioning device <NUM> (described below), facilitates accurate stitch placement and thread tension. Needle guide <NUM> is configured such that needle <NUM> is not permanently attached to a moving head (e.g., such as a sewing machine), or used only manually. Needle guide <NUM> and needle <NUM> are configured such that needle <NUM> may 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 guide <NUM> has a needle guide rotary actuator <NUM>. It is understood that any suitable type of rotary actuator may be utilized. The needle guide rotary actuator <NUM> can be actuated to rotate the needle guide <NUM> and the stitching needle <NUM> about the y-axis <NUM>, resulting in various possible angles of contact between the stitching needle <NUM> and the valve base structure <NUM>. The needle guide <NUM> includes a guidance structure <NUM> to direct the stitching needle <NUM>. The guidance structure <NUM> may be a rail, a track, guide rollers, guide wheels, a tube, or any other suitable mechanism. The guidance structure <NUM> may secure the stitching needle <NUM> until use by the operator through friction, a lock, or any other suitable mechanism.

A tensioning device <NUM> incorporating 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 device <NUM> may be, for example, a magnetic assembly, a spring assembly, and/or other assemblies. In some embodiments, the tensioning device <NUM> comprises a tensioning device base <NUM> and a magnetic head <NUM>. Base <NUM> and head <NUM> may be configured such that the tensioning device <NUM> is used by placing a section of thread behind the tensioning device <NUM> (relative to the valve base structure <NUM>), inserting the section of thread between the tensioning device base <NUM> and magnetic head <NUM>, 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 needle <NUM>, including by using the needle guide <NUM>, needle guide rotary actuator <NUM>, and guidance structure <NUM>. 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 base <NUM> and magnetic head <NUM> to the other side of the tensioning device <NUM>. The magnetic strength of magnetic head <NUM> can 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 head <NUM> can be kept in correct position (i.e., in a position where the magnetic head <NUM> maintains a magnetic connection to an appropriate portion of the tensioning device base <NUM> instead of being displaced to a location that renders the tensioning device <NUM> inoperable) by any number of suitable means, including a displacement prevention lip on the tensioning device base <NUM> or a displacement prevention chamber that allows the magnetic head <NUM> sufficient range of movement for the thread to pass between the magnetic head <NUM> and the tensioning device base <NUM> but restricts the range of movement such that the magnetic head <NUM> cannot fully exit the displacement prevention chamber. The structural arrangement of the tensioning device <NUM> facilitates efficient and accurate tensioning required for the specific stitch or suture.

In some embodiments, the tensioning device <NUM> may 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 device <NUM> may be a spring assembly.

In some embodiments, needle guide <NUM> and tensioning device <NUM> are coupled to frame <NUM> on frame cover <NUM> via a block <NUM> configured to support needle guide <NUM> and tensioning device <NUM>. For example, frame cover <NUM> and block <NUM> may include corresponding through holes <NUM> (e.g., which form a hole pattern) and <NUM>. Bolts, screws, nuts, and/or other coupling devices may be used in conjunction with holes <NUM> and <NUM> to couple block <NUM> to frame cover <NUM>. In some embodiments, a plate <NUM> may be coupled to block <NUM> and components of needle guide <NUM> and/or tensioning device <NUM> may be coupled to plate <NUM>. Plate <NUM> and block <NUM> may be positioned on a side of valve base structure <NUM> (or another workpiece <NUM> - <FIG>) toward side <NUM> of apparatus <NUM> (but this is not intended to be limiting). In some embodiments, components of needle guide <NUM> (e.g., rotary actuator <NUM>, guidance structure <NUM>) and/or tensioning device <NUM> (e.g., tensioning device base <NUM>, magnetic head <NUM>, etc.) may extend away from plate <NUM> toward valve base structure <NUM> (e.g., or another workpiece <NUM>).

In some embodiments, for example, tensioning device base <NUM> may extend away from plate <NUM> and magnetic head <NUM> may be located at an end of tensioning device base <NUM> at or near valve base structure <NUM>. In some embodiments, the tensioning device <NUM> comprises a suture tensioning arm (base) <NUM> that has a magnetic end (magnetic head <NUM>) 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> is a schematic illustration of apparatus <NUM>, <NUM>. As shown in <FIG>, apparatus <NUM>, <NUM> may include a video camera <NUM> for monitoring the work (not shown in <FIG>). The video camera <NUM> may be any suitable type of video camera. As each stitch may be inspected, the camera <NUM> may 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 apparatus <NUM>, <NUM> to redo the unsatisfactory stitch before proceeding. The camera <NUM> may also be configured to provide remote viewing by an off-site supervisor, for example, through a coupled computer.

In some embodiments, as shown in <FIG> (and <FIG>), apparatus <NUM>, <NUM> may include a user interface <NUM>. User interface <NUM> may be configured to provide an interface between apparatus <NUM>, <NUM> and an operator (e.g., a technician, etc.) through which the operator may provide information to and receive information from apparatus <NUM>, <NUM>. 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 apparatus <NUM>, <NUM>. Examples of interface devices suitable for inclusion in user interface <NUM> include 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 interface <NUM> includes a plurality of separate interfaces. In some embodiments, user interface <NUM> includes at least one interface that is provided integrally with frame <NUM>. It is to be understood that other communication techniques, either hard-wired or wireless, are also contemplated by the present disclosure as user interface <NUM>. For example, the present disclosure contemplates that user interface <NUM> may be integrated with a removable storage interface. In this example, information may be loaded into apparatus <NUM>, <NUM> from removable storage (e.g., a smart card, a flash drive, a removable disk) that enables the operator to customize the implementation of apparatus <NUM>, <NUM>. Other exemplary input devices and techniques adapted for use as user interface <NUM> include, but are not limited to, an RS-<NUM> port, RF link, an IR link, modem (telephone, cable or other). In short, any technique for communicating information with apparatus <NUM>, <NUM> is contemplated by the present disclosure as user interface <NUM>. By way of a non-limiting example, user interface <NUM> may be configured to display control fields, spatial information, video information, manufacturing instructions, quality control information, and/or other information.

In some embodiments, apparatus <NUM>, <NUM> may include one or more processors <NUM>, electronic storage <NUM>, and/or other components. The one or more processors <NUM> may be configured to provide information-processing capabilities in apparatus <NUM>, <NUM>. As such, a processor <NUM> may 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 processor <NUM> may be a single entity, or a processor <NUM> may comprise a plurality of processing units. These processing units may be physically located within the same device (e.g., apparatus <NUM>, <NUM>), or a processor <NUM> may 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 processors <NUM>, may run one or more electronic applications having graphical user interfaces configured to facilitate operator interaction with apparatus <NUM>, <NUM>, control the actuators, gears, and/or other mechanisms described herein, and/or perform other operations.

The electronic storage <NUM> may 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 apparatus <NUM>, <NUM> and/or removable storage that is removably connectable to apparatus <NUM>, <NUM> via, for example, a port (e.g., a USB port, a firewire port) or a drive (e.g., a disk drive). The electronic storage <NUM> may 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 storage <NUM> may include one or more virtual storage resources (e.g., cloud storage, a virtual private network, and/or other virtual storage resources). The electronic storage <NUM> may store software algorithms, information determined by a processor (e.g., processor <NUM>), information received from external resources, information entered and/or selected via user interface <NUM>, and/or other information that enables apparatus <NUM>, <NUM> to function as described herein.

Using the robotic positioning apparatus <NUM>, <NUM> and 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> illustrates a method <NUM> for assembling a semi-automatic precision positioning robot apparatus and/or using the semi-automatic precision positioning robot apparatus. In some embodiments, method <NUM> may include operations related to using the semi-automatic precision positioning robot apparatus for heart valve stitching and/or other manufacturing activities. The operations of method <NUM> presented below are intended to be illustrative. In some embodiments, method <NUM> may 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 method <NUM> are illustrated in <FIG> and described below is not intended to be limiting.

At an operation <NUM>, 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, operation <NUM> may be performed with a gear system similar to or the same as gear system <NUM> (shown in <FIG> and <FIG>, and described herein).

At an operation <NUM>, 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, operation <NUM> may be performed with a workpiece holding unit and/or a workpiece holding unit gear similar to or the same as workpiece holding unit <NUM> and/or bevel gear <NUM> (shown in <FIG> and <FIG>, and described herein).

In some embodiments, operation <NUM> and/or operation <NUM> may 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, operation <NUM> and/or <NUM> may 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, operation <NUM> and/or <NUM> may 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, operation <NUM> and/or <NUM> may include coupling a moveable platform to the plurality of linear actuators; and coupling the gear system to the moveable platform.

At an operation <NUM>, 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, operation <NUM> may be performed with a needle guide and a tensioning device similar to or the same as needle guide <NUM> and tensioning device <NUM> (shown in <FIG> and <FIG>, and described herein).

At an operation <NUM>, the semi-automatic precision positioning robot apparatus may be used for heart valve stitching and/or other operations. Operation <NUM> may 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 turn or move the workpiece (valve) holding unit (bevel) gear. Operation <NUM> may include aligning, by actuating the plurality of gear chains, a needle held by the needle guide to a stich 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. Operation <NUM> may 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. Operation <NUM> may 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, operation <NUM> may comprise determining a coordinate system, and one or both of: (<NUM>) positioning the workpiece (valve) holding unit relative to the needle guide by actuating the plurality of gear chains to turn or move the workpiece (valve) holding unit (bevel) gear based on the coordinate system; and (<NUM>) aligning, by actuating the plurality of gear chains, the needle held by the needle guide to the stich point on the heart valve held by the workpiece (valve) holding unit based on the coordinate system. In some embodiments, operation <NUM> comprises 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, operation <NUM> may be performed a system similar to or the same as system <NUM> and/or system <NUM> (shown in <FIG> and described herein).

Claim 1:
A semi-automatic precision positioning robot apparatus (<NUM>), comprising:
a gear system (<NUM>), the gear system (<NUM>) comprising:
a plurality of gear chains (<NUM>); and
a workpiece holding unit gear (<NUM>), wherein the workpiece holding unit gear (<NUM>) is coupled to the plurality of gear chains (<NUM>);
a workpiece holding unit (<NUM>), wherein the workpiece holding unit (<NUM>) is coupled to the workpiece holding unit gear (<NUM>); and
a tool (<NUM>) configured to facilitate performance of a manufacturing operation on a workpiece (<NUM>);
wherein the gear chains (<NUM>) are selectively actuatable to position the workpiece (<NUM>) relative to the tool (<NUM>) by positioning the workpiece holding unit (<NUM>), relative to the tool (<NUM>);
wherein the tool (<NUM>) further comprises a needle guide (<NUM>) and a tensioning device (<NUM>) configured to facilitate stitching, wherein the tensioning device (<NUM>) is configured to tension a stitching thread;
wherein the tool (<NUM>) is configured to facilitate a semi-automatic method of stitching materials onto a medical device; and
wherein the needle guide (<NUM>) comprises a guidance structure (<NUM>) configured to removably receive and guide a stitching needle (<NUM>) to a predetermined location on the medical device.