Crane arm pulley system over the horizontal manufacturing plane for microfluidic extrusion

Abstract

Methods and systems for producing a collagen biopolymer fiber dissolve clinical-grade collagen in an acid solution to form a collagen solution and extrude the collagen solution into a formation buffer bath to form a plurality of sub-fibers at a fiber formation speed. The sub-fibers are combined together to form a starting end of a collagen fiber that is attached to a pulley arm positioned above a horizontal processing facility. The pulley arm feeds the collagen fiber into the horizontal processing facility by moving across the horizontal processing facility at a fiber feeding speed equal to the fiber formation speed.

Description

CRANE ARM PULLEY SYSTEM OVER THE HORIZONTAL MANUFACTURING PLANE FOR MICROFLUIDIC EXTRUSIONCLAIM OF PRIORITY

[0001] This application claims the benefit of U.S. Provisional Patent Application SerialNo. 63 / 494,923, filed on April 7, 2023, the benefit of priority of which is claimed hereby, and which is incorporated by reference herein in its entirety.STATEMENT REGARDING GOVERNMENTAL SUPPORT

[0002] The data presented in this application was supported at least in part by DARPA SBIR 140D0420C0005. The US government has certain rights in the invention.BACKGROUND OF THE INVENTION1. Field of the Disclosure

[0003] The present disclosure relates to a method and a system for manufacturing collagen fibers. In particular, the disclosure relates the use of a crane arm pulley in a method for extruding collagen fibers having superior mechanical strength, biocompatibility and immunological properties.2. Description of Related Art

[0004] Collagen is a fibrous insoluble protein consisting of bundles of tiny reticular fibrils. Collagen protein molecules combine to form white, glistening, inelastic fibers of the tendons, the ligaments, and the fascia. Collagen is found in connective tissue, including skin, bone, ligaments, and cartilage.

[0005] In particular, collagen fibrils combine to form tough connective tissue such as ligaments and tendons. Many efforts have been made to manufacture collagen-containing tissue for use in the body to replace damaged collagen body parts, including, in particular, ligaments and tendons. Such implantable devices may replace the damaged part directly or may serve to provide a scaffold to facilitate repair of, and eventually replace, damaged soft tissues such as tendons and ligaments.

[0006] Such products must function in a variety of challenging biomechanical environments in which multiple functional parameters must be addressed. These parameters include, for example, compatibility with bodily tissue and fluids, strength, flexibility, and biodegradability.

[0007] There is a need in the art for a system and method that addresses the shortcomings of the prior art discussed above.SUMMARY OF THE INVENTION

[0008] In one aspect, the disclosure is directed to a method of producing a collagen biopolymer fiber that includes the steps of dissolving collagen, including clinical-grade and non- clinical-grade collagen in an acid solution to form a collagen solution, extruding the collagen solution into a formation buffer bath to form a plurality of sub-fibers at a fiber formation speed, combining the plurality of sub-fibers together to form a starting end of a collagen fiber, attaching the starting end to a pulley arm positioned above a horizontal processing facility, and feeding the collagen fiber into the horizontal processing facility by moving the pulley arm across the horizontal processing facility at a fiber feeding speed equal to the fiber formation speed.

[0009] In one aspect the disclosure is directed to a method of producing collagen biopolymer fibers that includes the steps of dissolving collagen in an acid solution to form a collagen solution; extruding the collagen solution into at least one formation buffer bath to form a plurality of groups of sub-fibers at a fiber formation speed, combining the sub-fibers in each group of sub-fibers together to form starting ends for each one of a plurality of collagen fibers, attaching each starting end in a set of starting ends to each one of a plurality of pulley arms positioned above a horizontal processing facility, and feeding the collagen fiber for each starting end in the set of starting ends into the horizontal processing facility by moving the plurality of pulley arms across the horizontal processing facility at a fiber feeding speed equal to the fiber formation speed.

[0010] In one aspect the disclosure is directed to a crane arm pulley system for use in producing collagen biopolymer fibers. The crane arm pulley system includes a fixed frame positioned above a horizontal processing facility for processing collagen fibers formed at a fiber formation speed by combining groups of sub-fibers created by extruding collagen that was in anacid solution to form a collagen solution into a formation buffer bath. An adjustable assembly is mounted to the fixed frame and includes a moveable crane arm. The adjustable assembly is moveable within the fixed frame to position the moveable crane arm in three dimensions with respect to the horizontal processing facility. A pulley arm is connected to the moveable crane arm at an attachment point and is rotatable with respect to the moveable crane arm around the attachment point in a plane that is perpendicular to the horizontal processing facility. The pulley arm includes a driven pulley rotatably attached to the pulley arm on an end opposite the attachment point and a drive pulley in communication with the driven pulley to rotate the driven pulley.

[0011] Other systems, methods, features, and advantages of the invention will be, or will become, apparent to one of ordinary skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description and this summary, be within the scope of the invention, and be protected by the following claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The invention can be better understood with reference to the following drawings and description. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. Moreover, in the figures, like reference numerals designate corresponding parts throughout the different views.

[0013] FIG. 1 is a schematic flow diagram of an embodiment of producing a biopolymer collagen fiber;

[0014] FIG. 2 is an illustration of an embodiment of an apparatus for manufacturing biopolymer collagen fibers that includes a crane arm pulley system;

[0015] FIG. 3 is an illustration of an embodiment of the pulley arms of the crane arm pulley system positioned above a horizontal processing facility;

[0016] FIG. 4 is an illustration of an embodiment of a pulley arm being rotated from a raised position to a lowered position;

[0017] FIG. 5 is a flow chart illustrating an embodiment of method for producing biopolymer collagen fibers;

[0018] FIG. 6 is an illustration of an embodiment of an adjustable assembly being positioned with respect to a horizontal processing facility;

[0019] FIG. 7 is an illustration of an embodiment of a collagen fiber being attached to the driven pulley of a pulley arm;

[0020] FIG. 8 is a schematic representation of an embodiment of a driven pulley being rotated to attached a length of collagen fiber;

[0021] FIG. 9 is an illustration of an embodiment of a pulley arm with attached collagen fiber being lowered into a horizontal formation buffer section for feeding through the horizontal buffer section;

[0022] FIG. 10 is an illustration of an embodiment of a pulley arm with attached collagen fiber feeding the collagen fiber through an ethanol bath section;

[0023] FIG. 11 is an illustration of an embodiment of a pulley arm with attached collagen fiber feeding the collagen fiber through a forced air drying box section;

[0024] FIG. 12 is an illustration of an embodiment of a pulley arm with attached collagen fiber having feed the collagen fiber through a fiber integrity monitoring system and removed the collagen fiber from the driven pulley;

[0025] FIG. 13 is an illustration of an illustration of an embodiment of the collagen fiber being attached to a collagen fiber spool; and

[0026] FIG. 14 is an illustration of an embodiment of collagen fiber being collected on a collagen fiber spool during the collagen fiber formation process.DETAILED DESCRIPTION

[0027] The embodiments provide systems and methods for producing a biopolymer fiber. Exemplary methods for producing biopolymer fiber are described in further detail in U.S. Patent No. 11,020,509 issued on June 1, 2021 and titled “Microfluidic Extrusion” to Francis, et al., the disclosure of which is incorporated by reference herein in its entirety. In general, biopolymer fiber is typically formed of collagen. In particular, telocollagen is obtained from any source (human, bovine, recombinants, jelly fish, etc.). Bio-acceptable polymer, such as silk fibroin; other types of collagen such as type II collagen; fibrin / fibrinogen; basement membrane proteins; hyaluronic acid, poly ethylene oxide, poly ethylene glycol, poly caprolactone, polyethylene,polyhydroxybutyrate, PDLA; PDLLA and high molecular weight PDLLA; PLGA; and blends thereof, may be blended with collagen to form biopolymer fiber.

[0028] In one embodiment, the formation buffer of the disclosed embodiments is configured as an elongated vertical tank, and filaments containing the collagen emerge from apertures arranged near or at the bottom of the vertical tank. As the filaments emerge, they are immersed in the formation buffer and progress through a reaction zone at speeds that provide a time in the formation buffer sufficient to form collagen sub-fibers, which are referred to herein more simply as “sub-fibers”. The greater buoyancy of the emerging filaments and subsequent sub-fibers relative to the surrounding formation buffer causes the sub-fibers to float naturally upward to the top of the elongated vertical tank. These resultant sub-fibers are then collected together at the top of the vertical tank and progress out of the vertical tank and formation buffer. A given set of sub-fibers is collectively joined to form a single collagen fiber. This single collagen fiber is then cross-linked and dried. In one example, each resulting cross-linked and dried collagen fiber is wound onto a rotating collagen fiber spool that articulates in a vertical direction. In one embodiment, the collagen fiber spool is rotated at a spool rotational speed matching the fiber formation speed spool. In one embodiment, the collagen fiber spool is rotated at a speed is from about 2 to about 10 times faster than the injection speed of the collagen solution into the formation buffer to increase molecular alignment and reduce the diameter of the fiber.

[0029] In various embodiments of the disclosure, collagen or collagen combined with other suitable biopolymers is made into biopolymer or collagen fiber. For purposes of illustration, the embodiments are described using collagen. However, these embodiments are also applicable to collagen blended or combined with suitable biopolymers in various combinations and proportions to obtain fibers of the type disclosed herein. In addition, throughout the specification, steps that might be taken together during a typical manufacturing process, such as washing and drying or soaking and drying, may be carried out or repeated as appropriate to achieve a desired result. For example, in an embodiment, a composition may be washed and dried before advancing to the next step. In some embodiments, the material may be passed through a vertical tank of formation buffer a second time before advancing to the next processing step. In other embodiments, a first washing or drying step may be made optional.Thus, a material typically washed and then dried may go directly to the drying step and then move to the next processing step. The skilled practitioner can recognize circumstances under which steps may be repeated or eliminated.

[0030] In different embodiments, constructs made from the collagen fibers, for example, scaffolds, allow cellular ingrowth. Therefore, various types of cells from the animal into which the collagen fiber (or devices made from the collagen fiber) is implanted grow into the pores of the scaffold and are preferably aligned with the fibers in the scaffold. Constructs and scaffolds include single layer and multi-layer articles used as a substitute for a known repair feature, for example, sutures used to re-attach opposing ends of a ruptured Achilles tendon. In addition to providing supporting structures for repairing torn or damaged tendons, collagen fibers produced in accordance with exemplary embodiments of the method disclosed herein are also suitable for use in ligament repair. Ligaments for which the scaffolds made from the collagen fiber may be used to provide support include the ACL, MCL, PCL, UCL, and other human and animal ligaments. The collagen fiber produced in accordance with the exemplary methods disclosed herein can be used in other surgeries including superior capsular reconstruction as a treatment option for superior rotator cuff tears that are otherwise irreparable or difficult to repair partial or full tears. In addition, a multi-layered sheet containing the collagen fiber can be used to overlap and strengthen a repair.

[0031] Multiple collagen fibers can be twisted, bundled, braided, interwoven, or otherwise arranged to improve a form factor. This improved form factor produces a collagen fiber that is easier to work with and to manipulate than a single fiber, for example during surgery. The improved form facts also make locating a fiber or platform accurately easier. Specific form factors may be constructed to serve as a reinforcement or internal brace for a torn natural body part. A brace connects from one bone to another bone to support a joint and typically forms an isometric joint with restored biomechanics and the isometry of the native joint.

[0032] Referring initially to FIG. 1 , an embodiment of a system and method for manufacturing collagen fiber 100 is illustrated. As illustrated, the system includes four sections or manufacturing areas. The four sections include a first collagen solution preparation section, and second collagen fiber formation section. The other two sections are a third collagen fiber treatment process section, and a fourth collagen fiber collection section. As illustrated in Fig. 1,the four sections of the system are associated with one or more steps in the method as follows:Section Name Steps Included1 Preparing Collagen Solution 105-1202 Forming Collagen Fiber 125-1303 Post-Treatment or End Treatment 135-1404 Collecting Collagen Fiber 145- 150

[0033] To prepare the collagen solution, collagen is combined with an acidic solution 105 and the combined collagen and acidic solution is stirred thoroughly 110. In one embodiment, the acid is between about 0.01 M and about 0.50 M acetic acid. Alternatively, the acid is between about 0.01 M and about 0.50 M hydrochloric acid. The resulting stirred collagen and acidic solution is degassed 115 and centrifuged 120 to remove residual bubbles.

[0034] To form collagen fiber, the resultant collagen solution is injected into a bath of formation buffer solution as a stream of filaments to form a plurality of sub-fibers 125. The resultant sub-fibers 130 may incorporate a coaxial sheath (shown in cross-section surrounding or encasing the filament) 130. This resultant product is a formed collagen sub-fiber, and a plurality of collagen sub-fibers are joined together to produce a collagen fiber.

[0035] The resulting collagen fiber is then passed through one or more collagen fiber treatment processes. These collagen fiber treatment processes include, for example, postprocessing, post-treatment or end of treatment processes that yield wet or dry collagen fiber. As illustrated, the collagen fiber continues through and emerges from the formation buffer solution 135. After emerging from the formation buffer solution, the collagen fiber passes through one or more drying or dehydrating steps 140. These drying and dehydrating steps include an ethanol bath and a forced air drying box. Following the collagen fiber treatment processes, the collagen fiber is wound onto a collagen fiber spool 145 or mandrel. The resulting spool of collagen fiber is then air-dried 150.

[0036] In one embodiment as illustrated and described herein, the collagen fiber treatment processes include a series of processes for drying and dehydrating the collagen fibers. These treatment processes include an alcohol immersion bath and an air drying section.Therefore, the collagen fiber is initially passed through the alcohol immersion bath. Preferably, the alcohol immersion bath is an ethanol bath. As the collagen fiber passes through the ethanol bath, the collagen fiber is immersed in ethanol. The ethanol penetrates the collagen fiber, which dehydrates the collagen fiber. Dehydration removes residual water from the collagen fiber.

[0037] The collagen fiber emerges from the alcohol immersion bath and enters the air drying section. In one embodiment, the air drying section is a forced air drying box containing a plurality of fans or other air moving devices that direct a flow of air, or other gas across the collagen fiber in a direction perpendicular to the direction of propagation of the collagen fiber. The plurality of fans is arranged in series along a length of the forced air drying box. In one embodiment, one or more fans can also direct a flow of air along the length of the collagen fiber. The air drying section removes residual moisture from the collagen fiber.

[0038] The collagen fiber spool is rotated to wind the collagen fiber onto the collagen fiber spool. In one embodiment, the collagen fiber spool is rotated at a speed that maintains a desired residual stress along the length of the collagen fiber as it passes through the collagen fiber treatment processes. Therefore, as the collagen fiber progresses towards collagen fiber spool, the collagen fiber becomes stronger as a result of the residual stress imposed by the collagen fiber spool and the dehydration and drying processes that remove water and moisture content from the collagen fiber.

[0039] FIG. 1 provides a generalized view of a system and method for carrying out methods for forming the collagen fiber. When running, the method relies on the buoyancy of the collagen sub-fibers to propagate the sub-fibers through the vertical buffer tanks. Suitable arrangements and operation of vertical buffer tanks are described in (172-MBDY-037), the entire disclosure of which is incorporated herein by reference. Once the collagen fiber is attached to rotating collagen fiber spool and the spool is rotated, the sub-fibers and collagen fiber form a continuous strand that passes through all of the sections of the system for forming a long, continuous collagen fiber. While buoyancy is used to initially pass or feed the sub-fibers through the vertical buffer tank, the resulting collagen fiber also needs to be routed initially through all of the subsequent treatment processes and attached to the collagen collection spool. This initial routing and attachment is preferably conducted to maintain the desired speed of collection fiber production. In addition, a desired tension is maintained in the collagen fiber, and the collagenfiber is rotated through and exposed to the collagen fiber treatment processes during the initial routing.

[0040] Exemplary embodiments provide an apparatus and a method for making collagen fiber that achieves the desired initial routing of the collagen fiber through all the collagen fiber treatment processes. In one embodiment, a collagen fiber feeder system is provided in the apparatus for making the collagen fiber. The collagen fiber feeder system includes at least one fiber attachment mechanism for releasably attaching the starting end of a collagen fiber to the collagen fiber feeder system. In one embodiment, the collagen fiber feeder system includes a plurality of fiber attachment mechanisms. Any structure that provides for releasably securing a fiber can be used. Suitable fiber attachment mechanisms include, but are not limited to, clamps, hooks, spindles, wheels, pulleys, and slits. At least one collagen fiber is attached to the collagen fiber feeder system. Preferably, a plurality of collagen fibers is attached to the collagen fiber feeder assembly to provide for simultaneous feeding of the plurality of fibers from collagen fiber formation, through each collagen fiber treatment process and to collagen fiber collection.

[0041] The collagen fiber feeder system includes support structure that supports all the elements of the collagen fiber feeder system in the desired location with respect to the collagen fiber formation, collagen fiber treatment and collagen fiber collection sections. Positioning structure is provided in the collagen fiber feeder system. The positioning structure is moveably attached to and supported by the support structure. The fiber attachment mechanism is connected to the positioning structure. Therefore, movement of the positioning structure with respect to the support structure provides for movement of the fiber attachment mechanism and therefore any attached collagen fiber with respect to the collagen fiber formation, collagen fiber treatment and collagen fiber collection sections. In one embodiment, the fiber attachment mechanism is moveable in two dimensions with respect to the collagen fiber formation, collagen fiber treatment and collagen fiber collection sections. Alternatively, the fiber attachment mechanism is moveable in three dimensions with respect to the collagen fiber formation, collagen fiber treatment and collagen fiber collection sections.

[0042] To provide for the desired movement, the positioning structure includes, for example, motors, braces, wheels, pulleys, belts, cables, framing, and telescoping members. In one embodiment, the positioning structure also includes the wiring and control systems formoving the positioning structure. In one embodiment, the control system is integrated into the control system for the apparatus for making the collagen fiber. Alternatively, the control system is a separate control system. In one embodiment, the control system provides for wireless control of the positioning structure. In one embodiment, the collagen fiber feeder system includes a handheld device for wireless communication and control of the positioning structure.

[0043] Referring now to FIG. 2 an embodiment of a collagen fiber manufacturing apparatus 200 is illustrated. As illustrated, the collagen fiber manufacturing apparatus 200 includes the various interconnected sections or systems described above that are used to form the collagen fiber. A given arrangement of sections interconnected and arranged in series is used to produce a single collagen fiber. These sections include the fiber formation section 210, a collagen fiber treatment section 230, and a collagen fiber collection section 250. As illustrated, multiple arrangements of these sections are arranged in parallel. Therefore, the collagen fiber manufacturing apparatus produces a plurality of collagen fibers simultaneously in parallel. The collagen fiber manufacturing apparatus includes a framework 251 to support all of the components of the fiber formation section 210, collagen fiber treatment section 230, and a collagen fiber collection section 240.

[0044] As illustrated, the fiber formation section 210 includes the vertical buffer tanks 212 for forming the collagen sub-fibers. The fiber treatment section 230 is arranged as a horizontal processing facility that includes a plurality of collagen fiber treatment processes for processing collagen fibers formed at a fiber formation speed. As illustrated, these collagen fiber treatment processes include a horizontal formation buffer extension section 214, an ethanol bath section 216, a forced air drying box section 274, and a fiber integrity monitoring section 218. Suitable forced air drying box sections are described in (172-MBDY-039), the entire disclosure of which is incorporated herein by reference. Each collagen fiber treatment process is open on the top or can be opened on the top to facilitate initial insertion of a collagen fiber into the collagen fiber treatment process. The collagen fiber collection section 250 includes one or more collagen fibers spools 220.

[0045] The collagen fiber manufacturing apparatus 200 also includes a collagen fiber feeder system configured as a crane arm pulley system that is used in the production of the collagen biopolymer fibers. In this embodiment, the crane arm pulley system includes a supportstructure arranged as a fixed frame 222 positioned above the horizontal processing facility. The fixed frame does not move with respect to the horizontal processing facility and includes all the horizontal and vertical support members that are needed to support the other components of the crane arm pulley system.

[0046] The crane arm pulley system includes as the positioning structure an adjustable assembly 224 mounted to the fixed frame. The adjustable assembly engages two parallel top support members 228 of the fixed frame 222. In particular, the adjustable assembly engages the top surface 230 of each top support member. The adjustable assembly is moveable with respect to the fixed frame. In one embodiment, the adjustable assembly is moveable or slideable along the top surfaces of the top support members. This provides movement of the adjustable assembly, and all components of the adjustable assembly, in a first dimension as indicated by arrow A. This first dimension is parallel to the horizontal support facility between the fiber formation section 210, and the collagen fiber collection section 250.

[0047] The adjustable assembly includes a moveable crane arm 226. The moveable crane arm extends downward from the top support members toward the horizontal processing facility. The moveable crane arm includes at least one vertical assembly 232 and a horizontal support member 234 attached to one end of the vertical assembly. In one embodiment, the vertical assembly is an extensible or telescoping assembly. This provides movement of the moveable crane arm and elements attached to the moveable crane arm in the direction of arrow C. The moveable crane arm is also moveable between the top support members in the direction of arrow B. Therefore, the adjustable assembly is moveable within the fixed frame to position the moveable crane arm in three dimensions with respect to the horizontal processing facility.

[0048] In one embodiment, the adjustable assembly includes one or more motors 236 or actuators that provide the desired movement of the adjustable assembly. These motors are attached to power and control electronics (not shown) to provide for actuation and control of the motors for positioning and movement of the adjustable assembly. In one embodiment, the adjustable assembly provides for wireless communication and control. Therefore, the collagen fiber manufacturing apparatus 200 includes a handheld device 238 or remote control for wireless control of the adjustable assembly.

[0049] The adjustable assembly includes at least one fiber attachment mechanismarranged as a pulley arm 240. In one embodiment, the adjustable assembly includes a plurality of pulley arms 240. In one embodiment, the adjustable assembly includes a number of pulley arms equal to the number of parallel collagen treatment processes in the horizontal processing facility. Alternatively, the number of pulley arms is less than the number of collagen treatment processes. As illustrated, the adjustable assembly includes four pulley arms. Referring now to Fig. 3, each pulley arm 240 is connected the horizontal support member 234 of the moveable crane arm 226. Therefore, the pulley arms extend in a line parallel to the horizontal processing facility 230. Each pulley arm includes an arm portion 246 that is rotatably attached to the horizontal support member 234. In addition, each pulley arm includes a driven pulley 244 rotatably attached to the pulley arm on an end opposite the attachment point with the horizontal support member, e.g., a distal end. In one embodiment, each pulley arm includes a motor 242 in communication with the driven pulley to rotate the driven pulley.

[0050] As illustrated, the pulley arms are in a raised position with the driven pulleys located above the horizontal support member. Referring now to Fig. 4, each pulley arm is attached to the horizontal support member 234 at an attachment point 252. The pulley arm is rotatable with respect to the moveable crane arm and horizontal support member as indicated by arrow D. In particular, each pulley arm is rotatable around the attachment point in a plane that is perpendicular to the horizontal processing facility. Therefore, each pulley arm can be rotated down toward the horizontal processing facility and up away from the horizontal processing facility in the direction of arrow D. In one embodiment, each pulley arm is independently rotated manually between the raised and lowered or down position. In the lowered position, the driven pulley is located between the horizontal support member and the horizontal processing facility. Each drive pulley includes a fiber contact surface 248 and a pulley driving surface 253. The fiber contact surface is used for attachment of a length of the collagen fiber to the driven pulley and therefore the crane arm pulley system. The pulley driving surface is attached to a cable or belt 254 that is also attached to a driven pulley 256 that is driven by the pulley motor 242. Therefore, the pulley motor can selectively rotate the driven pulley in the direction of arrow E.

[0051] Referring now to Fig. 5, an exemplary embodiment of a method for using the collagen fiber manufacturing apparatus with the crane arm pulley system to manufacture collagen fiber 300 is illustrated. The formation of a stream of filaments is initiated in a vertical buffer tank302. At least one of the pulley arms is rotated down from the raised position 304, and the adjustable assembly is used to more the pulley arm to a position a driven pulley adjacent and above the top of one of the vertical buffer tanks 306. The tops of the collagen treatment processes that are not open are then opened 308.

[0052] As the sub-fibers emerge from the top of the vertical buffer tank, those sub-fibers are formed into a collagen fiber 310. In one embodiment, the sub-fibers are manually formed into the collagen fiber. The starting end of the collagen fiber is placed on the fiber contact surface of the driven pulley 312. In one embodiment, the starting end of the collagen fiber is manually placed on the fiber contact surface. The pulley motor is activated to rotate the driven pulley 314 in a desired direction of rotation. The driven pulley is rotated a sufficient number of times to attach and secure the collagen fiber to the driven pulley. Once the collagen fiber is adequately attached, rotation of the driven pulley is stopped 316. The driven pulley is then lowered into the a collagen fiber treatment process 318. In one embodiment, this first collagen fiber treatment process is the horizontal formation buffer extension section. Preferably, the driven pulley is lowered a sufficient distance so that the collagen fiber extending from the pulley is completely immersed or engaged in the first collagen fiber treatment process. If necessary, the driven pulley is moved to be aligned with the path through the collagen fiber treatment processes.

[0053] The driven pulley is moved through each one of the collagen fiber treatment processes in series 320. The driven pulley is adjusted up or down vertically as needed to pass between adjacent collagen fiber treatment processes while keeping the collagen fiber engaged in each treatment process. After the driven pulley passes the final collagen fiber treatment process, the collagen fiber is removed from the driven pulley 322. In one embodiment, the collagen fiber is manually removed from the driven pulley. In one embodiment, the driven pulley is rotated to unwind the collagen fiber. The collagen fiber is then attached to the collagen fiber spool 324, and the tops of the collagen fiber treatment processes are closed 326.

[0054] The collagen fiber manufacturing apparatus can continue to operate to produce collagen fiber until a desired length of collagen fiber. The pulley arm is them moved up and away from the horizontal processing facility and is manually rotated to the raised position. The collagen fiber manufacturing apparatus is then operated to produce collagen fiber that is collected on the collagen fiber spool. In one embodiment, a remote control is used to control the movementof the pulley arm and the rotation of the driven pulley.

[0055] An exemplary method of producing a collagen biopolymer fiber is illustrated with respect to an embodiment of the collagen fiber manufacturing apparatus with the crane arm pulley system. As described herein, collagen including clinical-grade and non-clinical-grade collagen, is dissolved in an acid solution to form a collagen solution. The collagen solution is extruded into a formation buffer bath, for example, in a vertical buffer tank. Referring now to Fig. 6, the adjustable assembly 224 moves at least one pulley arm 240, which is in the raised position with respect to the horizontal support member 234 over the horizontal processing facility as indicated by arrows A and B. This moves the pulley arm towards the top of the vertical buffer tank. In one embodiment, the adjustable assembly moves all of the pulley arms that are attached to the horizontal support member simultaneously.

[0056] Referring now to Fig. 7, a given pulley arm 240 is rotated about the point of attachment 252 to the horizontal support member so that the driven pulley 244 is disposed between the horizontal support member and the horizontal processing facility 230. The adjustable assembly continues to move the pulley arm 244 in the direction of arrows A, B and C to position the driven pulley 244 over the horizontal formation buffer extension section 214 and adjacent the top of the vertical buffer tank 260.

[0057] The plurality of sub-fibers 262 is formed at a fiber formation speed. As the subfibers emerge from the top of the buffer solution 268, those sub-fibers are combined together to form a starting end 266 of a collagen fiber 264. The starting end is then attached to the pulley arm by attaching the starting end to fiber contact surface 248 of the driven pulley 244.

[0058] Referring now to Fig. 8, initially at (a) the starting end 404 of the collagen fiber is attached to the driven pulley 402 that is rotatably attached to the arm portion 400 of the pulley arm 406. The driven pulley is then rotated in the direction of arrow E. In one embodiment, a remote control is used to control the motor for rotating the driven pulley. At (b), a first rotation of the driven pulley draws a length of collagen fiber onto the drive pulley that is at least equal to the circumference of the fiber contact surface 408 of the driven pulley. A (c) a second rotation of the driven pulley draws another length of collagen fiber onto the driven pulley that is equal to the circumference of the fiber contact surface of the driven pulley. Each rotation attaches a length of collagen fiber equal to a circumference of the fiber contact surface, and the driven pulley isrotated to draw one or more windings of the collagen fiber onto the fiber contact surface. In general, the driven pulley is rotated through a plurality of rotations sufficient to secure the collagen fiber to the driven pulley, and therefore, the pulley arm. In one embodiment, the driven pulley is rotated at a pulley rotational speed matching the fiber formation speed. As described herein, a drive pulley attached to the pulley arm and in contact with the driven pulley is used to rotate the driven pulley.

[0059] The driven pulley is rotated so that the collagen fiber extends tangentially from the driven pulley. Once a sufficient amount of collagen fiber is wrapped onto the driven pulley, rotation of the driven pulley is stopped before feeding the collagen fiber into the horizontal processing facility and through the collagen fiber treatment processes. Referring now to Fig. 9, the collagen fiber 264 extends tangentially from the driven pulley 244 toward the vertical buffer tank 260. This places the collagen fiber between the driven pulley and the horizontal processing facility 230 and facilitates extending the collagen fiber along and through the collagen fiber treatment processes. The pulley arm 240 is moved downward in the direction of arrow C until the collagen fiber and at least a portion of the driven pulley is at located below the level of buffer solution 268 within the horizontal formation buffer extension section 214. In one embodiment, this maintains the collagen fiber within the buffer solution and therefore continues the processing of the collagen fiber. The pulley arm 240 is then moved by the adjustable assembly relative to the horizontal processing facility in the direction or arrow A. In one embodiment, the pulley arm is moved simultaneously in the direction of both arrow A and arrow C. In one embodiment, the pulley arm is moved manually using a remote control. Alternatively, the pulley arm is moved in accordance with a programmed movement that is initiated, for example, by a remote control. The programmed movement includes the path and speed of the pulley arm.

[0060] Referring now to Fig. 10, the horizontal processing facility includes at least one and preferably a plurality of collagen fiber treatment process extending across the horizontal processing facility. The pulley arm and adjustable assembly continue feeding the collagen fiber into the horizontal processing facility by moving the pulley arm across the horizontal processing facility in the direction of arrow A at a fiber feeding speed equal to the fiber formation speed. The pulley arm is moved with respect to the horizontal processing facility to engage the collagen fiber extending from the driven pulley in each collagen fiber treatment processes in series. In oneembodiment, movement of the pulley arm is controlled manually, for example, using a remote control. Alternatively, the pulley arm moves in accordance with programmed movement that can be initiated by remote control.

[0061] After the horizontal formation buffer extension section 214, the pulley arm 240 and driven pulley 244 draw the collagen fiber through the ethanol bath section 216. The lid 276 of the ethanol bath section was opened to facilitate passage of the pulley arm and driven pulley through the ethanal bath section. In addition, the pulley arm and driven pulley are moved vertically in the direction of arrow C while propagating through the collagen fiber treatment processes. This allows the collagen fiber to be lifted over support members 270 located at the ends of each section. Suitable support members include glass, stainless steel, or plastic rods that support the collagen fiber as it transitions out of one section and into the next section. Having cleared the support members, the pulley arm 240 and driven pulley 244 are then lowered so that at least the collage fiber extending from the driven pulley is below the level of ethanol 272 in the ethanol bath section.

[0062] Referring now to Fig. 11, the pulley arm 240 and driven pulley 244 emerge from and move past the ethanol bath section, and the collagen fiber is drawn through the forced air drying box section 274. The top 282 of the forced air drying box section was opened to accommodate passage of the pulley arm 240 and driven pulley through the forced air drying box section. Forced air for drying is provided by a plurality of fans 280 located along the length of the forced air drying box section. The pulley arm 240 and driven pulley 244 are positioned vertically within the forced air drying box section so the collagen fiber 264 is located within the flow of forced air.

[0063] Referring now to Fig. 12, after passing through the forced air drying box section 274, the pulley arm 240 and driven pulley 244 draw the collagen fiber through the fiber integrity monitoring section 218. The top 284 of a given fiber integrity monitor 219 is opened to facility passage of the pulley arm 240 and driven pulley 244 and feeding of the collagen fiber 264 into the fiber integrity monitor.

[0064] The pulley arm 240 and driven pulley 244 continue moving in the direction of arrow A, until the pulley arm 240 and driven pulley 244 clear the fiber integrity monitoring system 218 and are positioned adjacent a collagen fiber spool 220. Movement of the pulley arm240 and driven pulley 244 is stopped, and the starting end 266 of the collagen fiber 264 is removed or detached from the driven pulley of the pulley arm. Therefore, the collagen fiber is detached after the collagen fiber is feed completely through the horizontal processing facility.

[0065] Referring to Fig. 13, the starting end of the collagen fiber 264 is attached to the collagen fiber spool 220, and the collagen fiber spoil is rotated at the desired speed for the collagen fiber formation process. All lids of the collagen fiber treatment processes are closed, and the pulley arm 240 and driven pulley 244 are moved vertically up from the horizontal treatment facility in the direction of arrow C. The adjustable assembly is ultimately returned to an initial position as illustrated for example, in Fig. 3. If desired, the adjustable assembly can be moved into position to feed one or more additional collagen fibers through the collagen fiber treatment processes. Therefore, the process steps are repeated for each collagen fiber to be feed through the collagen fiber treatment processes.

[0066] Referring to Fig. 14, the collagen fiber spool 220 rotates at the desired rotational speed and moves vertically to accumulate a plurality of windings 290 of the collagen fiber 264 on the collagen fiber spool. The collagen fiber spool continues to rotate and move vertically until the desired length of collagen fiber is produced by the collagen fiber formation process and collected on the spool.

[0067] Exemplary embodiments are also directed to producing collagen biopolymer fibers using the collagen fiber manufacturing apparatus with the crane arm pulley system to feed a plurality of collagen fibers simultaneously through a plurality of collagen fiber treatment processes arrangement in parallel. Overall, this method provides for the simultaneous feeding of a plurality of separate collagen fibers. The steps discussed above for single fiber are performed for each fiber in the plurality of fibers. In one embodiment, each one of a plurality of pulley arms in lowered and positioned next to the top of one of a plurality of vertical buffer tanks, and the starting end of one collagen fiber is attached to that pulley arm. The process is repeated until a plurality of collage fibers are attached to a plurality of pulley arms. Then all of the pulley arms are moved simultaneously and in a line through the collagen fiber treatment processes.

[0068] In general for this exemplary method, collagen is dissolved in an acid solution to form a collagen solution, which is extruded at a fiber formation speed into at least one formation buffer bath to form a plurality of groups of sub-fibers. Preferably, the collagen solution isextruded into a plurality of formation buffer baths to form a groups of sub-fibers in each formation bath.

[0069] The sub-fibers in each group of sub-fibers are combined together to form starting ends for each one of a plurality of collagen fibers. Each pulley arm in a plurality of pulleys is pivotally attached to a moveable crane arm supported above a horizontal processing facility containing a plurality of collagen fiber treatment processes arranged in series. An adjustable assembly including the moveable crane arm is used to move each pulley arm in three dimensions with respect to the horizontal processing facility. The adjustable assembly and moveable crane arm position the plurality of pulley arms and driven pulleys adjacent a formation buffer bath.

[0070] Each starting end in a set of starting ends is attached to each one of a plurality of pulley arms positioned above the horizontal processing facility. In one embodiment, the set of starting ends are associated with a number of collagen fibers that is less than the plurality of collagen fibers formed by the extrusion process. Alternatively, the set of starting ends are for all of the collagen fibers in the plurality of collagen fibers. In one embodiment, each starting end is attached to each pulley arm by placing each starting end on a fiber contact surface of a driven pulley rotatably attached to each pulley arm. The driven pulley is rotated to draw one or more windings of each collagen fiber onto each fiber contact surface.

[0071] The adjustable assembly and moveable crane arm move all of the pulley arms and driven pulleys across the horizontal processing facility. The pulley arms and driven pulleys feed the collagen fiber for each starting end in the set of starting ends into the horizontal processing facility by moving the plurality of pulley arms across the horizontal processing facility at a fiber feeding speed equal to the fiber formation speed. The plurality of pulley arms moves across the horizontal processing facility simultaneously so that the plurality of collagen fibers are simultaneously feed through the collage fiber treatment processes. This engages the collagen fiber attached each pulley arm in each collagen fiber treatment process. Each collagen fiber is simultaneously drawn in series through each collagen fiber treatment process.

[0072] Once the plurality of collagen fibers pass through all of the collagen fiber treatment processes, each collagen fiber is detached from each pulley arm. Each starting end in the set of starting ends is attached to each one of a plurality of collagen fiber spools operated at a spool rotational speed matching the fiber formation speed.

[0073] While various embodiments of the invention have been described, the description is intended to be exemplary, rather than limiting and it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible that are within the scope of the invention. Accordingly, the invention is not to be restricted except in light of the attached claims and their equivalents. Also, various modifications and changes may be made within the scope of the attached claims.

Claims

WHAT IS CLAIMED IS:

1. A method of producing a collagen biopolymer fiber, comprising the steps of: dissolving collagen in an acid solution to form a collagen solution; extruding the collagen solution into a formation buffer bath to form a plurality of sub-fibers at a fiber formation speed; combining the plurality of sub-fibers together to form a starting end of a collagen fiber; attaching the starting end to a pulley arm positioned above a horizontal processing facility; and feeding the collagen fiber into the horizontal processing facility by moving the pulley arm across the horizontal processing facility at a fiber feeding speed equal to the fiber formation speed.

2. The method of claim 1, wherein attaching the starting end to the pulley arm comprises: placing the starting end on a fiber contact surface of a driven pulley rotatably attached to the pulley arm; and rotating the driven pulley to draw one or more windings of the collagen fiber onto the fiber contact surface.

3. The method of claim 2, wherein rotating the driven pulley further comprises rotating the driven pulley through a plurality of rotations, the plurality of rotations sufficient to secure the collagen fiber to the driven pulley, each rotation attaching a length of collagen fiber equal to a circumference of the fiber contact surface.

4. The method of claim 2, wherein rotating the driven pulley further comprises rotating the driven pulley at a pulley rotational speed matching the fiber formation speed.

5. The method of claim 2, wherein rotating the driven pulley comprises rotating the driven pulley so that the collagen fiber extends tangentially from the driven pulley between the driven pulley and the horizontal processing facility.

6. The method of claim 2, wherein rotating the driven pulley comprises using a drive pulley attached to the pulley arm and in contact with the driven pulley to rotate the driven pulley.

7. The method of claim 2, further comprising stopping rotation of the driven pulley before feeding the collagen fiber into the horizontal processing facility.

8. The method of claim 2, wherein: the horizontal processing facility comprises at least one collagen fiber treatment process extending across the horizontal processing facility; the collagen fiber comprises clinical-grade collagen fiber; the method further comprises moving the pulley arm with respect to the horizontal processing facility to engage the collagen fiber extending from the driven pulley in each collagen fiber treatment process; and feeding the collagen fiber into the horizontal processing facility comprises drawing the collagen fiber in series through each collagen fiber treatment process.

9. The method of claim 1 , wherein: the pulley arm is pivotally attached to a moveable crane arm supported above the horizontal processing facility; and the method further comprises using the moveable crane arm to move the pulley arm in two dimensions with respect to the horizontal processing facility.

10. The method of claim 9, wherein the moveable crane arm is used to move the pulley arm in three dimensions with respect to the horizontal processing facility.

11. The method of claim 1, wherein the method further comprises: detaching the collagen fiber from the pulley arm after the collagen fiber is feed into the horizontal processing facility; and attaching the starting end to a collagen fiber spool operated at a spool rotational speed matching the fiber formation speed.

12. A method of producing collagen biopolymer fibers, comprising the steps of: dissolving collagen in an acid solution to form a collagen solution; extruding the collagen solution into at least one formation buffer bath to form a plurality of groups of sub-fibers at a fiber formation speed; combining the sub-fibers in each group of sub-fibers together to form starting ends for each one of a plurality of collagen fibers; attaching each starting end in a set of starting ends to each one of a plurality of pulley arms positioned above a horizontal processing facility; and feeding the collagen fiber for each starting end in the set of starting ends into the horizontal processing facility by moving the plurality of pulley arms across the horizontal processing facility at a fiber feeding speed equal to the fiber formation speed.

13. The method of claim 12, wherein the set of starting ends are associated with a number of collagen fibers that is less than the plurality of collagen fibers.

14. The method of claim 12, wherein moving the plurality of pulley arms across the horizontal processing facility comprises simultaneously moving the plurality of pulley arms across the horizontal processing facility.

15. The method of claim 12, wherein attaching each starting end to each pulley arm comprises: placing each starting end on a fiber contact surface of a driven pulley rotatably attached to each pulley arm; and rotating the driven pulley to draw one or more windings of each collagen fiber onto each fiber contact surface.

16. The method of claim 12, wherein: the horizontal processing facility comprises at least one collagen fiber treatment process extending across the horizontal processing facility; the method further comprises moving each pulley arm with respect to the horizontal 1processing facility to engage the collagen fiber attached each pulley arm in each collagen fiber treatment process; and feeding each collagen fiber into the horizontal processing facility comprises simultaneously drawing each collagen fiber in series through each collagen fiber treatment process.

17. The method of claim 12, wherein: each pulley arm is pivotally attached to a moveable crane arm supported above the horizontal processing facility; and the method further comprises using the moveable crane arm to move each pulley arm in three dimensions with respect to the horizontal processing facility.

18. The method of claim 12, wherein the method further comprises: detaching each collagen fiber from each pulley arm after each collagen fiber is feed into the horizontal processing facility; and attaching each starting end in the set of starting ends to each one of a plurality of collagen fiber spools operated at a spool rotational speed matching the fiber formation speed.

19. A crane arm pulley system for use in producing collagen biopolymer fibers, the crane arm pulley system comprising: a fixed frame positioned above a horizontal processing facility for processing collagen fibers formed at a fiber formation speed by combining groups of sub-fibers created by extruding collagen that was in an acid solution to form a collagen solution into a formation buffer bath; an adjustable assembly mounted to the fixed frame and comprising a moveable crane arm, the adjustable assembly moveable within the fixed frame to position the moveable crane arm in three dimensions with respect to the horizontal processing facility; and a pulley arm connected to the moveable crane arm at an attachment point and rotatable with respect to the moveable crane arm around the attachment point in a plane that is perpendicular to the horizontal processing facility, the pulley arm comprising: a driven pulley rotatably attached to the pulley arm on an end opposite the attachment point; anda drive pulley in communication with the driven pulley to rotate the driven pulley.

20. The crane arm pulley system of claim 19, further comprising a plurality of pulley arms attached to the adjustable frame and extending in a line parallel to the horizontal processing facility and perpendicular to the plane through which each pulley arm rotates, wherein the collagen fiber comprises clinical-grade collagen fiber.

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