Systems and method for coating a suture with pharmaceutical ingredients

Abstract

A system for coating a suture with pharmaceutical ingredients includes a support frame, a suture-transport module operably coupled to the support frame and including a first spool of an uncoated suture rotatably supported on the support frame and a second spool rotatably supported on the support frame configured to receive a coated portion of the suture, a suture-coating module operably coupled to the support frame and including an applicator head removably coupled to the support frame, the applicator head defining a hollow interior portion configured to receive a coating solution forming a bath for coating the uncoated suture received within the applicator head and form a coated portion of the suture, and a suture-drying module operably coupled to the support frame configured to receive a heated gas, wherein the heated gas is configured to dry the coated portion of the suture.

Description

METHODS OF COATING PHARMACEUTICALS ONTO SUTURESBACKGROUNDTechnical Field

[0001] The disclosure relates to medical sutures, and in particular, to systems and methods for coating medical sutures with pharmaceutical ingredients.Description of Related Art

[0002] Sutures are commonly used to hold body tissues together and approximate wound edges. As can be appreciated, open wounds resulting from both injuries and surgical intervention increase susceptibility to infection and other diseases. In some circumstances, the presence of a foreign object within tissue may trigger foreign body reactions or suture-related pseudoinfections.

[0003] To minimize infections or foreign body reactions, antimicrobial or active pharmaceutical ingredients have been utilized as a coating on sutures. As can be appreciated, the pharmaceutical ingredients used to coat sutures can be expensive and the equipment used to coat the sutures with the pharmaceutical ingredients require frequent cleaning and sterilization. Additionally, undesired chemical reactions may occur when using a mixture of pharmaceutical ingredients. Open baths of pharmaceutical ingredients have the potential for significant waste. Open baths also result in continuous evaporation of the carrier solvents. This evaporation changes the active pharmaceutical concentrations in the bath, which in turn results inconsistencies during the suture coating run. To combat these issues, the volume of pharmaceutical ingredients contained within the bath is reduced and continuously replenished with new material, which consequently requires longer dwell times due to the reduced amount of suture submerged in the bath. As can be appreciated, longer dwell times result in increased manufacturing times and an increased potential for contamination, unwanted chemical reactions, and inconsistencies and / or flaws within the coating on the suture.SUMMARY

[0004] In accordance with the disclosure, a system for coating a suture with pharmaceutical ingredients includes a support frame, a suture-transport module operably coupled to the support frame, the suture-transport module including a first spool rotatably supported on the support frame, the first spool including an uncoated portion of a suture, and a second spool rotatably supported on the support frame, the second spool configured to receive a coated portion of the suture, asuture-coating module operably coupled to the support frame, the suture-coating module including an applicator head removably coupled to the support frame, the applicator head defining a hollow interior portion, wherein the hollow interior portion of the applicator head is configured to receive a coating solution forming a bath, wherein the applicator head is configured to slidably receive the uncoated portion of the suture, wherein the bath is configured to coat the uncoated portion of the suture with the coating solution and form a coated portion of the suture, and a suture-drying module operably coupled to the support frame, the suture-drying module configured to receive a heated gas, wherein the suture-drying module is configured to receive a portion of the suture exiting the applicator head, wherein the heated gas is configured to dry the coated portion of the suture received within the suture-drying module.

[0005] In aspects, the applicator head may be disposed in a U-shaped configuration.

[0006] In other aspects, the applicator head may be disposed in a linear configuration.

[0007] In certain aspects, the suture-coating module may include a mixing valve, the mixing valve configured to mix a first coating solution and a second coating solution and form a coating solution mixture, wherein an outlet of the mixing valve is in fluid communication with the hollow interior portion of the applicator head.

[0008] In other aspects, the suture-coating module may include a plurality of idler wheels, the plurality of idler wheels rotatably supported on the support frame, wherein eat least one idler wheel of the idler wheels is configured to guide the uncoated portion of the suture and at least one other idler wheel of the plurality of idler wheels is configured to guide the coated portion of the suture.

[0009] In aspects, the plurality of idler wheels is selectively removable from the support frame.

[0010] In other aspects, the suture-drying module may include a first pulley and a second pulley, the second pulley disposed in spaced relation to the first pulley, wherein the first pulley and the second pulley cooperate to rotatably support a loop of the coated portion of the suture within the suture-drying module.

[0011] In certain aspects, each of the first pulley and the second pulley may define a corresponding plurality of circumferential grooves, wherein each circumferential groove is configured to receive a portion of the coated portion of the suture to define a plurality of loops of the coated portion of the suture within the suture-drying module.

[0012] In aspects, the suture-coating module may include a coating solution pump, wherein the coating solution pump is in fluid communication with the coating solution and is in fluidcommunication with the hollow interior portion of the applicator head, wherein actuation of the pump effectuates a flow of coating solution through the hollow interior portion of the applicator head.

[0013] In other aspects, the suture-transport module may include an inspection module, the inspection module configured to receive the coated portion of the suture and analyze the coating disposed on the coated portion of the suture.

[0014] In other aspects, the coating systems provided herein may include a tension-control module configured to monitor and control an amount of tension applied to the suture. The tensioncontrol module including at least a tension sensor and a tension control wheel

[0015] In accordance with another aspect of the disclosure, a system for coating a suture includes an applicator head releasably coupled to a support surface, wherein the applicator head includes an inlet block, the inlet block defining a suture inlet and an opposite, suture outlet, wherein the suture inlet and the suture outlet cooperate to permit passage of a suture through the inlet block, an outlet block, the outlet block defining a suture inlet and an opposite, suture outlet, wherein the suture inlet of the outlet block and the suture outlet of the outlet block cooperate to permit passage of a suture through the outlet block, and a bath, the bath defining a hollow interior portion configured to receive a coating solution and the suture, wherein a first portion of the bath is operably coupled to the first inlet block and a second portion of the bath is operably coupled to the second inlet block.

[0016] In aspects, the bath may define a U-shaped configuration.

[0017] In certain aspects, the bath may define a linear configuration.

[0018] In other aspects, the inlet block, the outlet block, and the bath are in fluid communication to permit a flow of coating solution through each of the inlet block, the outlet block, and the bath.

[0019] In aspects, the applicator head may include a support block, the support block releasably coupled to the support surface and configured to releasably support the bath.

[0020] In aspects, the applicator head may include a homogenizer configured to control a flow of the coating solution through the outlet block to form a meniscus of the coating solution at or near the suture outlet where the suture exits the outlet block.

[0021] In accordance with another aspect of the disclosure a method of coating a suture with pharmaceutical ingredients includes drawing an uncoated portion of a suture into an inlet of anapplicator head, flooding a bath of the applicator head with a coating solution, drawing the uncoated portion of the suture through the bath to coat the uncoated portion of the suture with the coating solution, drawing the coated portion of the suture through an outlet of the applicator head and into an interior cavity of a suture-drying module, flooding the interior cavity of the suturedrying module with a heated gas, and drawing the coated portion of the suture through the interior cavity of the suture-drying module flooded with heated gas to dry the coated portion of the suture.

[0022] In aspects, flooding the bath of the applicator head with coating solution may include effectuating a continuous flow of coating solution through the bath to replenish the bath with fresh coating solution.

[0023] In aspects, drawing the coated portion of the suture through the outlet of the applicator head comprises avoiding contact with walls of the outlet.

[0024] In aspects, the method may further include homogenizing the coating solution at the outlet to control the flow of the solution to form a meniscus where the suture exits the coating solution.

[0025] In aspects, the method may further include monitoring and / or adjusting the tension on the suture throughout the coating process via a tension-control module. In other aspects, the method may include mixing a first coating solution with a second coating solution in a mixing valve to form a mixed coating solution, wherein flooding the bath of the applicator head with a coating solution may include drawing the mixed coating solution from an outlet of the mixing valve.

[0026] In certain aspects, drawing the coated portion of the suture through the interior cavity of the suture-drying module may include drawing the coated portion of the suture through the interior cavity of the suture-drying module to form multiple loops of the coated portion of the suture within the interior cavity of the suture-drying module.

[0027] In aspects, the method may include removing the applicator head from the support surface and replacing the removed applicator head with a clean applicator head.BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Various aspects and embodiments of the disclosure are described hereinbelow with references to the drawings, wherein:

[0029] FIG. 1 is a perspective view of a system for coating medical sutures with pharmaceutical ingredients in accordance with the disclosure;

[0030] FIG. 2 is a front elevation view of the system of FIG. 1;

[0031] FIG. 3 is a perspective view of another embodiment of a system for coating medical sutures with pharmaceutical ingredients in accordance with the disclosure;

[0032] FIG. 4 is a perspective view of a mixing valve of the system of FIG. 1;

[0033] FIG. 5 is a perspective view of an applicator head of the system of FIG. 1;

[0034] FIG. 6 is a front elevation view of another embodiment of the applicator head of FIG. 5 in accordance with the disclosure;

[0035] FIG. 7 is a front elevation view of another embodiment of an applicator head of the system of FIG. 1 in accordance with the disclosure illustrating a pharmaceutical ingredient received within a bath of the applicator head;

[0036] FIG. 8 is a front elevation view of the applicator head of FIG. 6 illustrating a pharmaceutical ingredient received within a bath of the applicator head;

[0037] FIG. 9A is a perspective view of another embodiment of an applicator head suitable for use in a system for coating in accordance with the disclosure;

[0038] FIG. 9B is a cross-sectional view of an outlet block of the applicator head of FIG. 9A;

[0039] FIG. 10 is a perspective view of a suture-drying module of the system of FIG. 1;

[0040] FIG. 11 is a schematic view of a tension control module of the system described herein;

[0041] FIG. 12 is a schematic view of a control module of the system of FIG. 1;

[0042] FIG. 13 A is a flow diagram of a method of coating a suture with pharmaceutical ingredients in accordance with the disclosure; and

[0043] FIG. 13B is a continuation of the flow diagram of FIG. 13 A.DETAILED DESCRIPTION

[0044] The disclosure is directed to a system and method for coating a suture with pharmaceutical ingredients. The system includes a support frame upon which a support surface is disposed. A suture-transport module, a suture-coating module, and a suture-drying module are disposed on the support surface. The suture-transport module includes a first spool retaining an uncoated suture thread, a second spool configured to receive and retain a coated portion of the suture thread, and one or more idler wheels releasably coupled to the support surface andconfigured to guide the suture thread through the suture-coating module and the suture-drying module. It is envisioned that the one or more idler wheels may be selectively removed from the support surface to more easily clean and / or sterilize the one or more idler wheels as compared to idler wheels that are fixedly coupled to the support surface. In embodiments, the second spool may be operably coupled to a drive motor, which when actuated, effectuates rotation of the second spool to draw the suture thread from the first spool towards the second spool. It is contemplated that the suture-transport module may include one or more inspection modules to inspect the coated portion of the suture and identify flaws or other inconsistencies within the coating.

[0045] The suture-coating module includes an applicator head releasably coupled to the support surface, a coating solution reservoir, and a coating solution pump. The applicator head includes an inlet block, and outlet block, and a bath interposed and operably coupled to each of the inlet block and the outlet block. The bath defines a generally hollow tubular configuration and is configured to slidably receive the suture thread and contain a volume of coating solution. The inlet block is fluidly coupled to the coating solution via the coating solution reservoir and / or the coating solution pump. In this manner, the coating solution is received within the inlet block and flows into bath. In embodiments, the coating solution pump may continuously or intermittently effectuate flow of the coating solution into the inlet block, through the bath, and out of the inlet block to replenish or otherwise refresh the bath with fresh coating solution. As can be appreciated, replenishing the bath with fresh coating solution minimizes or otherwise reduces potential for contamination or chemical reactions as compared to a large, static bath of coating solution. In embodiments, the suture-coating module may include a second coating solution reservoir retaining a second coating solution. The suture-coating module may include a mixing valve having a first inlet for receiving the first coating solution and a second inlet for receiving the second coating solution. In this manner, flow of the first coating solution and the second coating solution through the mixing valve causes the first and second coating solutions to intermix and be ejected from a single outlet that is fluidly coupled to the bath of the applicator head. As can be appreciated, mixing the first and second coating solutions in the mixing valve and delivering a single mixture of coating solution to the applicator head reduces the potential for chemical reactions and enables a fresh, adequately mixed coating solution to be delivered to the bath for coating the suture as compared to mixing coating solutions within the bath.

[0046] It is envisioned that the applicator head may define a U-shaped configuration, where the suture thread enters and exits the applicator head at the same side of the applicator head, or a linear configuration where the suture thread enters the applicator head at a first side and exits the applicator head at a second, opposite side. In this manner, the applicator head is disposed in a generally vertical orientation permitting gas or bubbles contained within the coating solution to escape (e. ., for example, degas the coating solution). As can be appreciated, the volume of the bath may be altered by changing an overall length of the bath, changing an interior dimension of the bath, or combinations thereof. The applicator head may be removed from the support surface and replaced with another, clean or sterilized, applicator head to continue coating an additional spool of uncoated suture thread while the previously used applicator head is being cleaned and / or sterilized.

[0047] The suture-drying module defines an interior cavity in which the coated, and still wet, suture thread is advanced through. The interior cavity of the suture-drying module is configured to receive a heated gas, which may be an inert gas such as for example, Nitrogen, which causes solvents or other carries of the coating solution to flash or otherwise vaporize, leaving the desired components of the coating solution on the coated portion of the suture. As can be appreciated, the heated gas may be pumped into, and out of, the interior cavity to replenish the interior cavity of the suture-drying module with fresh heated gas and generally maintain a desired temperature within the interior cavity. The suture-drying module includes a pair of pulleys rotatably supported within the interior cavity that are configured to support a loop of coated suture thread. In embodiments, an outer surface of each pulley of the pair of pulleys may define a plurality of circumferential grooves. Each groove of the plurality of circumferential grooves is configured to receive a loop of coated suture thread, enabling multiple loops of suture thread, and therefore, a longer portion of coated suture thread, to be disposed within the interior cavity and dried. As can be appreciated, multiple loops of coated suture thread disposed within the interior cavity enables a higher feedrate of suture thread as compared to only one loop of coated suture thread disposed within the interior cavity of the suture-drying module. As can be appreciated, the above processes may be automated or manually controlled. Although generally described with reference to sutures, it is envisioned that the systems and methods described herein may be used with any thread or elongated material without departing from the scope of the disclosure.

[0048] Turning now to FIG. 1 of the drawings, a system for coating a suture in accordance with the disclosure is illustrated and generally identified by reference numeral 10. As will be described in further detail hereinbelow, the system 10 is generally configured to transport sutures, coat sutures with a pharmaceutical coating, and dry the coated sutures.

[0049] The system 10 includes a support frame 12 upon which each of a suture-transport module 30, a suture-coating module 50, and a suture-drying module 100 are supported. The system 10 includes a control module 200 that may be remote from or disposed on the support frame 12, depending upon the design needs of the system 10. The support frame 12 includes a base 14 upon which a first support surface 16 and a second support surface 18 are supported. Although generally illustrated as approximating one another in a direction extending away from the base 14 to form an A-frame type configuration, it is envisioned that the first support surface 16 and the second support surface 18 may define any suitable arrangement relative to one another. The first support surface 16 is formed from one or more sub-plates 20. In one non-limiting embodiment, the first support surface 16 is formed from a plurality of sub-plates 20 and may be formed from any suitable material, such as for example, a metallic material, a polymer, a ceramic, and a composite without departing from the scope of the disclosure. As can be appreciated, the second support surface 18 may be the same as or different from the first support surface and the support frame 12 may include any number of support surfaces without departing from the scope of the disclosure. Although generally illustrated as including wheels or casters and adjustable feet, it is contemplated that the support frame may not include wheels or adjustable feet or may include any combination thereof.

[0050] Continuing with FIG. 1, and with additional reference to FIG. 2, the suture-transport module 30 includes one or more of a first spool 32 of an uncoated portion 34a of a suture 34, a second spool 36 for receiving a coated portion 34b of the suture 34, and a plurality of idler wheels 40. The first spool 32 is rotatably supported on the first support surface 16 using any suitable means. The second spool 36 is rotatably supported on the first support surface 16 using any suitable means and is disposed in spaced relation to the first spool 32. It is contemplated that the first spool 32 and / or the second spool 36 may be each be releasably coupled to the first support surface 16, fixedly coupled to the first support surface 16, or combinations thereof depending upon the design needs of the system 10. The second spool 36 is operably coupled to a drive motor (not shown) or other suitable device configured to effectuate rotation of the second spool 36 to draw the suture 34 from the first spool 32 towards the second spool 36, as will described in further detailhereinbelow. As can be appreciated, the operation and rotational speed of the first spool 32 is controlled by the control module 200, as will be described in further detail hereinbelow.

[0051] Each idler wheel of the plurality of idler wheels 40 is rotatably supported at various locations on the first support surface 16 to effectuate or maintain tension on the suture 34 as it is transported from the first spool 32 to the second spool 36, and to change direction of the path of the suture 34 to direct the suture 34 through each of the modules of the system 10. It is envisioned that one or more of the plurality of idler wheels 40 may be selectively removable from the first support surface 16 to permit cleaning and / or sterilization after use or on a predetermined cleaning schedule. In embodiments, idler wheels of the plurality of idler wheels 40 that are removed from the first support surface 16 may be replaced to enable the system 10 to continue coating sutures while the removed idler wheels are being cleaned and / or sterilized. It is contemplated that the plurality of idler wheels 40 may be selectively coupled to the first support plate 16 using any suitable means, such as for example, bolts or screws, detents, magnets, and keyholes. In embodiments, the suture-transport module 30 may include one or more inspections modules 42 disposed on the first support surface 16. It is contemplated that the one or more inspections modules 42 may be visual inspections cameras, measuring devices for determining dimensions of the suture 34 (such as, for example, after coating the suture, before coating the suture, and determining a difference in dimensions between the uncoated portion 34a of the suture and the coated portion 34b of the suture 34, a thickness of the coating disposed on the coated portion 34b of the suture 34, devices for detecting the presence of a suture 34, and devices for determining a chemical composition of the coating disposed on the coated portion 34b of the suture 34. It is envisioned that the suture-transport module 30 may include one or more calender rollers 44 through which the suture 34 traverses.

[0052] The suture-coating module 50 includes a coating reservoir 52, a coating pump 54, and an applicator head 70. The coating reservoir 52 is configured to store or otherwise retain a coating solution 56, such as for example, an antimicrobial composition (e.g., for example, a solvent system for transfer of solids, pharmaceutical ingredients, polymer(s) for adhesion, and a lubricating fatty acid excipient). It is envisioned that the coating reservoir 52 may be an open container, may be an enclosed container, or may include a selectively openable cover or cap, depending upon the design needs of the system 10. In embodiments, the coating reservoir 52 may be disposed on a portion of the support frame 12, although it is envisioned that the coating reservoir 52 may be disposedremote from the support frame 12 without departing from the scope of the present disclosure. The coating pump 54 is in fluid communication with the coating solution 56 disposed in the coating reservoir 52 and is configured to transport or otherwise pump the coating solution 56 from one location to another. It is contemplated that the coating pump 54 may be any suitable pump, such as for example, a diaphragm pump, a rotary pump, a piston pump, a syringe pump, and a peristaltic pump, and may be disposed at any suitable location, such as for example, submerged within the coating solution 56, disposed on the coating reservoir 52, disposed on the support frame 12, and disposed remote from the coating reservoir 52 and / or the support frame 12.

[0053] In embodiments, the suture-coating module 50 may include a second coating reservoir 58 containing a second coating solution 60. It is envisioned that the second coating solution 60 may be in fluid communication with the coating pump 54, in which the coating pump 54 draws or otherwise pulls both the coating solution 56 and the second coating solution 60 concomitantly, or individually via one or more valves configured to selectively permit and inhibit the flow of one or both of the coating solution 56 and the second coating solution 60. In embodiments, the coating solution 56 and the second coating solution 60 may be mixed downstream of the applicator head 70. In this manner, a mixture of the coating solution 56 and the second coating solution 60 is delivered to the applicator head 70 to coat the suture 34. As can be appreciated, the mixture may include equal or unequal parts of each of the coating solution 56 and the second coating solution 60. To form the mixture, the suture-coating module 50 includes a mixing valve 62 (FIG. 4) or other suitable device configured to intermix two or more liquids. In one non-limiting embodiment, the mixing valve 62 includes a first inlet 64 in fluid communication with the coating solution 56, a second inlet 66 in fluid communication with the second coating solution 60, and an outlet 68 in fluid communication with both of the first inlet 64 and the second inlet 66 to receive a mixture of the coating solution 56 and the second coating solution 60. The outlet 68 of the mixing valve 62 is in fluid communication with the applicator head 70 to permit the flow of the mixture of the coating solution 56 and the second coating solution 60 to the applicator head 70 and coat the suture 34. It is envisioned that the mixing valve 62 may be a static mixing valve, a proportioning valve, or may include one or more features or devices (such as, for example, mechanical valves, electromechanical valves, and unequal cross-sectional areas) configured to deliver an unequal mixture of coating solution 56 and the second coating solution 60 to the applicator head 70. In embodiments, the second coating solution 60 may be in fluid communication with a second coatingpump 62 that is separate from the coating pump 54. It is envisioned that the suture-coating module 50 may include any number of coating reservoirs and coating solutions without departing from the scope of the disclosure. Although generally described as being a separate component, it is envisioned that the suture-coating module 50 may include only a single coating reservoir divided into two or more separate cavities in which respective coating solutions may be retained.

[0054] With additional reference to FIGS. 5 and 6, the applicator head 70 is disposed on the first support surface 16 and includes an inlet block 72, an outlet block 74, and a bath 76 interposed between, and in fluid communication with, the inlet block 72 and the outlet block 74. It is envisioned that the applicator head 70 may be fixedly or selectively coupled to the first support surface 16 using any suitable means, depending upon the needs of the system 10. In one nonlimiting embodiment, the applicator head 70 is selectively coupled to the first support surface 16 to permit removal of one or more portions of the applicator head 70 for cleaning, replacement, or interchanging with one or more other embodiments of the applicator head 70, as will be described in further detail hereinbelow.

[0055] The inlet block 72 is in fluid communication with the coating reservoir 52, or in embodiments, with the outlet 68 of the mixing valve 62, permitting coating solution (e.g., for example, the coating solution 56, the second coating solution 60, or a mixture of coating solutions) to flow into an interior cavity (not shown) defined within the inlet block 72. It is envisioned that one or more of the coating solution 56, the second coating solution 60, or mixtures of the coating solution 56 and the second coating solution 60 may be continuously replenished. In this manner, the inlet block 72 includes an inlet port 78 fluidly coupled to the interior cavity of the inlet block 72 and fluidly coupled to the outlet 68 of the mixing valve 62. The inlet block 72 defines a suture inlet 80 and a suture outlet 82 disposed in juxtaposed relation to one another and defining a throughbore (not shown) therebetween. As can be appreciated, the suture inlet 80 and the suture outlet 82 cooperate to permit passage of the uncoated portion 34a of the suture 34 through the inlet block 72 and into the bath 76, as will be described in further detail hereinbelow.

[0056] Continuing with FIGS. 5 and 6, the outlet block 74 is substantially similar to the inlet block 72, having an outlet port 86, a suture inlet 88, and a suture outlet 90, and therefore, will not be described in further detail hereinbelow. As can be appreciated, the suture inlet 88 and the suture outlet 90 cooperate to permit passage of the coated portion 34b of the suture 34 through the outletblock 74 and out of the bath 76. The coated suture 34b avoids contact with walls of the suture inlet 88 and / or the suture outlet 90, particularly upon exit of the outlet block 74.

[0057] The bath 76 defines a generally hollow tubular configuration that is operably coupled to each of the inlet block 72 and the outlet block 74 at respective opposed end portions thereof. Although generally illustrated as defining a hollow tubular configuration, it is envisioned that the bath may define any suitable configuration without departing from the scope of the disclosure. The bath 76 is configured to retain coating solution (e.g., for example, the coating solution 56, the second coating solution 60, or a mixture of coating solutions) therewithin. In this manner, actuation of the coating pump 54 effectuates flow of the coating solution through the inlet block 72, through the bath 76, and through the outlet block 74. As shown, both the suture 34 and the coating solution 56, 60 move in a common direction (e.g., clock-wise) through the applicator head 70. However, it is envisioned that the suture and the coating solution may alternatively move in opposing directions relative to each other through the applicator head.

[0058] As can be appreciated, the flow of coating solution through the bath 76 enables the coating solution to be refreshed any suitable number of times depending upon the needs of the system 10. In this manner, fresh coating solution, or a fresh mix of coating solution, is continuously provided during the process of coating the suture 34 to increase the quality of the coating on the suture 34 as compared to a static bath of coating solution. In embodiments, the bath 76 may be retained or otherwise supported within a support block 92. The support block 92 is fixedly or selectively supported on the first support surface 16 using any suitable means. The support block 92 defines a channel 94 therein that is configured to receive and selectively retain the bath 76. Although generally illustrated as defining a U-shaped or horseshoe configuration, it is envisioned that the channel 94 may define any suitable configuration without departing from the scope of the disclosure. It is envisioned that the inlet block 72, the outlet block 74, and the support block 92 may be formed from any suitable material, and in embodiments, may be formed from the same or different materials. In one non-limiting embodiment, the inlet block 72, the outlet block 74, and the support block 92 are formed from a medical grade plastic.

[0059] As can be appreciated, the U-shaped configuration of the bath 76, having the inlet and outlet disposed above the crown, causes bubbles or any other gasses within the coating solution to rise and be removed from the coating solution contained in the bath 76. In this manner, the coating solution retained within the bath 76 is substantially free from bubbles or other gases, minimizing,reducing, or otherwise preventing uncoated spots or portions of the suture 34 advancing through the bath 76. It is envisioned that the bath 76 may include wipers, seals, and / or other features and / or devices for permitting the suture 34 to advance into the suture inlet 80 if the inlet block 72 and out of the suture outlet 90 of the inlet block to inhibit or otherwise prevent coating solution from overflowing and / or leaking out of the bath 76. In embodiments, the suture inlet 80 and the suture outlet 90 may be open to atmosphere. It is envisioned that the location of inlet block 72 and the outlet block 74 may be interchanged and the direction in which the suture 34 advanced through the bath 76 may be altered without departing from the scope of the present disclosure.

[0060] As can be appreciated, the internal volume of the bath 76 may be altered by changing an inner diameter of the bath 76 and / or the overall length of the bath 76. In this manner, the internal volume of the bath 76 may be customized or otherwise optimized for the type of suture 34 being coated and / or the type of coating solution being used. By adjusting the inner diameter and overall length of the bath 76, the soak time of the suture 34 within the coating solution can be optimized for the linear speed of the suture 34 being drawn through the system 10 while also minimizing the volume and waste of the coating solution being used to coat the suture 34.

[0061] With additional reference to FIGS. 7 and 8, it is envisioned that the applicator head 70 may include any suitable configuration, such as for example, curvate, curvilinear, and linear. In one non-limiting embodiment, the applicator head 70 defines a generally linear configuration, wherein the inlet block 72 is disposed above the outlet block 74 and the bath 76 extends generally linearly between the inlet block 72 and the outlet block 74. As can be appreciated, the location of the inlet block 72 may be interchanged with the location of the outlet block 74, where the inlet block 72 is disposed below the outlet block 74.

[0062] With additional reference to FIGS. 9A and 9B, in some embodiments, the applicator head 70, and particularly the outlet block 74, includes a homogenizer 96 designed to control the flow, and particularly the vertical flow, of the coating solution 56, 60. The homogenizer 96 may homogenize the coating solution to create an infinity pool-like or fountain-like configuration at the suture outlet 90. The coating solution 56, 60 may form a meniscus or dome-like configuration 93 at the suture outlet 90 so the coated suture 34b passes through the meniscus 93 upon exiting the coating solution 56, 60 and / or the outlet block 74. By controlling the flow of the coating solution 56, 60 (e.g., confining the vertical flow of the coating solution as shown) at the point where thecoated suture 34b exits the coating solution 56, 60, the homogenizer 96 (and / or applicator head 70) can better control the uniformity of the coating applied to the suture 34b upon exit.

[0063] Continuing with FIGS. 9A and 9B, in some embodiments, the homogenizer 96 includes a center bowl 98 in fluid communication with an overflow drain 99. The center bowl 98 is positioned between the suture inlet 88 and the suture outlet 90. The overflow drain 99 surrounds the center bowl 98 and connects the center bowl 98 to the solution outlet port 86. The homogenizer 96 is designed to pass the coating solution 56, 60 vertically through the bowl 98 and outwardly into the overflow drain 99 forming the meniscus 93 therebetween. The meniscus 93 of the solution 56, 60 is thus formed at or near the suture outlet 90 as the coated suture 34b exits the coating solution 56, 50 (and / or outlet block 74). The meniscus 93 may be concave or convex.

[0064] It is envisioned that the meniscus 93 of the solution 56, 60 improves the uniformity of the coating applied to the suture 34b by reducing and / or removing any applicable shear forces between the exiting coated suture 34b and the circulating or flowing coating solution 56, 60. The need to reduce shear force by confining the flow of the coating solution may be particularly useful when the movement of the suture and the coating solution are generally in the same vertical direction.

[0065] Returning to FIG. 2, and with additional reference to FIG. 10, the suture-drying module 100 includes a housing 102 operably supported on the first support surface 16. The housing 102 includes a baseplate 104 and a cover 106 that is hingedly coupled to the baseplate 104 defining a generally clamshell configuration. The baseplate 104 defines a generally rectangular configuration extending between a upper end portion 108 and an opposite, lower end portion 110, although it is contemplated that the baseplate 104 may define any suitable configuration, such as for example, oval, racetrack, and square, without departing from the scope of the disclosure. The suture-drying module 100 includes a first pulley 112 rotatably supported on the baseplate 104 adjacent the lower end portion 110 and a second pulley 114 rotatably supported on the baseplate 104 adjacent to the upper end portion 108. Although generally illustrated as being vertically aligned (e.g., for example, linearly aligned on a longitudinal axis defined through the upper end portion 108 and the lower end portion 110), it is envisioned that the first pulley 112 and the second pulley 114 may be disposed at any suitable location on the baseplate 104 without departing from the scope of the disclosure. The first pulley 112 defines a generally cylindrical profile having an outer surface 116. One or more circumferential grooves 118 are defined on the outer surface 118 and are configuredto selectively retain and support a portion of the coated portion 34b of the suture 34. In embodiments, one or more circumferential grooves 118 may support a portion of the uncoated portion 34a of the suture 34 (e.g., a portion of the suture 34 that has not yet been submerged within coating solution) to precondition or otherwise pre-heat the suture 34 before coating. As can be appreciated, heating the suture 34 causes the suture 34 to loosen or otherwise reduce the tightness of individual strands or threads of the suture 34 against one another and enable a greater surface area of the suture 34 to be coated as compared to an unheated suture 34. The second pulley 114 is substantially similar to the first pulley 112 and therefore, the second pulley 114 will not be described in detail herein in the interest of brevity. It is envisioned that the second pulley 114 may include the same or different number of circumferential grooves 118 as the first pulley 112 and may include the same or different outer dimension as the first pulley 112.

[0066] In embodiments where the first pulley 112 includes more than one circumferential groove 118, the coated portion 34b of the suture 34 may be wound about the first pulley 112 as many times as there are circumferential grooves 118. In this manner, if the first pulley 112 includes five circumferential grooves 118, the coated portion 34b of the suture 34 may be wound about the pulley 112 five times. As will be described in further detail hereinbelow, forming multiple loops of the coated portion 34b of the suture 34 about the first pulley 112 and the second pulley 114 increases the amount of time the coated portion 34b of the suture 34 is retained within the suturedrying module 100 without the need to slow down or otherwise decrease the feedrate of the suture 34, and reducing the overall dimensions of the suture-drying module 100 and therefore, reducing the overall dimensions of the system 10. As can be appreciated, the number of loops of the coated portion 34b of the suture 34 may be modified based upon the type of suture 34 being used, the type of coating solution being used, the feedrate of the suture 34, and / or the size constraints of the system 10.

[0067] The cover 106 defines a configuration that is substantially similar to the configuration of the baseplate 104, although it is contemplated that the cover 106 may define any suitable configuration without departing from the scope of the disclosure. The cover 106 defines an interior cavity 120 configured to receive the first pulley 112, the second pulley 114, and the coated portion 34b of the suture 34 supported on the first pulley 112 and the second pulley 114. In this manner, the overall shape and configuration of the interior cavity 120 mirrors the overall shape and configuration defined by the first pulley 112, the second pulley 114, and the coated portion 34b ofthe suture 34 supported on the first pulley 112 and the second pulley 114. As can be appreciated, interior cavity 120 may define any suitable shape and / or configuration depending upon the design needs of the system 10. In one non-limiting embodiment, the cover 106 includes a divider 122 disposed within a portion of the interior cavity 120 that is aligned with a gap 124 defined between the coated portion 34b of the suture 34 supported on the first pulley 112 and the second puller 114. In this manner, when closing or otherwise causing the cover 106 to approximate the baseplate 104, the divider 122 is received within the gap 124 to reduce or otherwise minimize the overall volume defined by the interior cavity 120.

[0068] The baseplate 104 includes an inlet 126 extending into the interior cavity 120 of the cover 106 when the cover 106 is placed in the closed position. The inlet 126 fluidly couples the interior cavity 120 to a heat source (not shown) to enable hot gas or other suitable medium to enter the interior cavity 120. As can be appreciated, the hot gas within the interior cavity heats the coating solution deposited on the coated portion 34b of the suture 34, causing solvents or other carriers of the coating solution to flash or otherwise vaporize, leaving the desired components of the coating solution on the coated portion 34b of the suture 34. In embodiments, the hot gas may be an inert gas, such as for example, Nitrogen, that eliminates or otherwise minimizes the presence of oxidizers and reduces or otherwise eliminates a fire risk associated with certain types of coating solutions. The hot gas is emitted from the inlet 126 into the interior cavity 120 of the cover 106, and escapes from openings or other apertures of the interior cavity 120 to enable a flow of the hot gas through the interior cavity 120. In this manner, fresh hot gas enters the interior cavity 120 and evacuates hot gas that has cooled from the interior cavity 120 to maintain a generally stable temperature within the interior cavity 120. In embodiments, the gas may be evacuated through an exhaust port 128 defined through the baseplate 104 adjacent the upper end portion 108. It is envisioned that the exhaust port 128 may be open to atmosphere or may be operably coupled to a vacuum source 130 (FIG. 3) to mechanically evacuate the gas from the interior cavity 120. It is envisioned that the suture-drying module 100 may be formed from any suitable material, and in embodiments, may be formed from a material resistant to the heat, chemicals, and gases used by the system 10 and that can be easily cleaned. In one non-limiting embodiment, one or more components of the suture-drying module 100 are formed of stainless steel.

[0069] With additional reference to Fig. 11, in some embodiments, the coating systems 10 described herein may further include a tension-control module 140 designed to monitor and controlthe amount of tension applied to the suture 34 before, during, and / or after the application of the coating to the suture 34. As a non-limiting example, the tension-control module 140 is shown upstream from the suture-coating module 50. However, the tension-control module 140 may be alternatively positioned downstream the suture-coating module 50 and / or between the suturecoating module 50 and the suture-drying module 100.

[0070] Continuing with Fig. 11, the tension-control module 140 includes at least one tension sensor 142 and at least one tension control wheel 144. The one or more tension sensors 142 communicate, either directly or via the control module 200, with the at least one tension control wheel 144 regarding the tension of the suture 34. The tension control wheel 144 may be operably coupled to a drive motor (not shown), which when actuated, effectuates rotation of the tension control wheel 144 to add or reduce tension to the suture 34 moving through the coating system 10. The tension control wheel 144 may replace or be combined with any of the idler wheels, pulleys and / or spools of the system described herein. Alternatively, the tension control wheel 144 may be added to the system independent of the idler wheels, pulleys, and / or spools of the system described herein.

[0071] Continuing further with Fig. 11, in some embodiments, the tension-control module 140 is particularly efficient in reducing and / or preventing frictional damage to the coating system 10 and / or to suture 34 along the suture-coating module 50. As shown, in some embodiments, the suture 34 is passed through a generally U-shaped bath 76 including a pair of opposing straight legs 77a, 77b connected via a curved central part 77c with a pair of opposing jags or notches 79a, 79b positioned therebetween. The suture 34 passes through the straight legs 77a, 77b without touching the straight inner walls 75a, 75b of the bath 76. The opposing jags 79a, 79b ensure the suture 34 also enters and exits the curved central part 77c without contacting the curved inner wall 75c. However, at least some part 34c of the suture 34 makes contact with curved inner wall 75c at or near the bottom or crown of the curved central part 77c. Because the U-shaped bath 76 is static, contact between the moving suture 34c and the central part 77c creates friction. The friction adds tension to the suture 34 and the bath 76, as well as other parts of the system 10 connected thereto. A sufficient amount of friction can damage to the suture 34 and / or cause wear to the system 10, particularly the bath 76 and / or applicator head 70. The tension control module 140 is particularly efficient in reducing and / or preventing frictional damage to the system 10 and / or suture 34 along the suture-coating module 50. The tension sensor 142 is designed to monitor the friction and / ortension applied to the suture 34 and the tension control wheel 144 is designed to adjust the tension (i.e., provide slack or tautness) on the suture 34 to prevent and / or reduce damage to the suture 34 and / or system 10, particularly along the coating module 50.

[0072] Turning to FIG. 12, the control module 200 may be a desktop computer or a tower configuration, may be a laptop computer, may be a programmable logic computer (PLC), or any other suitable computing device. The control module 200 includes a processor 202 which executes software stored in a memory 204. The memory 204 may store, for example, images or other data captured by the one or more inspection modules 42 during the coating process and images or other data relating to pre-coated sutures 34. In addition, the memory 204 may store one or more applications 206 to be executed on the processor 202. In embodiments, the control module 200 may include or be operably coupled to a display 208, which may be a touchscreen display, upon which a user interface 210 may be displayed. In one non-limiting embodiment, the user interface 210 may be one or more human machine interfaces operably coupled to one or more portions of the system 10, such as for example, any of the modules or components described herein. As can be appreciated, the software executed by the processor 202 causes or otherwise instruct the modules and / or components of the system 10 to perform functions according to the software stored on the memory 204.

[0073] A network interface 212 enables the control module 200 to communicate with a variety of other devices and systems via the Internet. The network interface 212 may connect the control module 200 to the Internet via a wired or wireless connection. Additionally, or alternatively, the communication may be via an ad-hoc Bluetooth® or wireless network enabling communication with a wide-area-network (WAN) and / or a local area network (LAN). The network interface 212 may connect to the Internet via one or more gateways, routers, and network address translation (NAT) devices. The network interface 212 may communicate with a cloud storage system 214, in which further data, such as for example, barb geometry and motion profiles, may be stored. The cloud storage system 214 may be remote from or on the premises of the manufacturing facility, such as for example, in a control room or an information technology room. An input module 216 receives inputs from an input device, such as for example, a keyboard, a mouse, or voice commands. An output module 218 connects the processor 202 and the memory 204 toa variety of output devices, such as for example, the display 208. In embodiments, the control module 200 may include its own display (not shown), which may be a touchscreen display. Although generallydescribed as having one control module 200, it is envisioned that the system 10 may include any suitable number of control modules 200 depending upon the design needs of the system 10.

[0074] With reference to FIGS. 1-12, in operation, a first spool 32 of an uncoated portion 34a of a suture 34 is loaded onto the first support surface 16 and a second spool 36 for receiving a coated portion 34b of the suture is loaded onto the first support surface 16 and operably coupled to the drive motor (not shown). The uncoated portion 34a of the suture 34 is threaded through or otherwise mounted to the suture-transport module 30, being supported and redirected by the plurality of idler wheels 40. The uncoated portion 34a of the suture 34 is advanced through the applicator head 70, into the suture-drying module 100 and about the first pulley 112 and the second pulley 114, through the one or more inspections modules 42, and operably coupled to the second spool 36, such that rotation of the drive motor effectuates a corresponding rotation of the second spool 36 and drawing of the suture 34 from the first spool 32 towards the second spool 36. As can be appreciated, the suture 34 may be wrapped or otherwise wound about the first pulley 112 and the second pulley 114 any number of times depending upon the needs of the system 10. In embodiments, the suture 34 exiting the applicator head 70 may bypass the first pulley 112 and initially engage the second pully 114. In this manner, the portion of the suture 34 exiting the applicator head 70 travels the longest possible distance within the suture-drying module 100 to minimize the risk of wet or otherwise not fully dried coating solution coating the suture 34 from being deposited on unwanted portions of the system 10. It is envisioned that the bath 76 of the applicator head 70 may be flooded or empty when the suture 34 is initially coupled to the suturetransport module 30 depending upon the needs of the system 10. In one non-limiting embodiment, the bath 76 is empty when the suture 34 is initially coupled to the suture-transport module 30 to minimize or otherwise avoid contamination of the coating solution and / or coated portion 34b of the suture 34 during initial installation.

[0075] With the suture 34 loaded into or otherwise coupled to the suture-transport module 30, the software stored on the memory 202 instructs the coating pump 54 to draw coating solution 56 from the coating reservoir 52 and flood the bath 76 of the applicator head 70 with the coating solution 56. In embodiments where a mixture of coating solutions is utilized, the software stored on the memory 202 effectuates pumping of the coating solution 56 from the coating reservoir 52 into the mixing valve 62 and pumping of the second coating solution 60 from the second coating reservoir 58 into the mixing valve 62, where the coating solution 56 and the second coatingsolution 60 are mixed and drawn into the bath 76 of the applicator head 70. With coating solution disposed within the bath 76 of the applicator head 70, the software stored on the memory 204 instructs the suture-drying module 100 to eject hot gas from the inlet 126 and into the interior cavity 120. At this point, the software stored on the memory 204 effectuates rotation of the drive motor, which in turn, effectuates rotation of the second spool 36 to begin drawing the uncoated portion 34a of the suture 34 through the bath 76 and the suture-drying module 100. As the uncoated portion 34a of the suture 34 is drawn through the bath 76, the coating solution disposed within the bath 76 is refreshed or otherwise replaced at a predetermined rate to maintain a continual fresh mix of coating solution within the bath 76. Continued drawing of the suture 34 causes the coated portion 34b of the suture 34 to exit the bath 76 and enter the suture-drying module 100, at which point the coated portion 34b of the suture 34 comes into contact with the hot gas within the interior cavity 120 of the suture-drying module 100 and cause solvents or other carriers of the coating solution to flash or otherwise vaporize before the coated portion 34b of the suture 34 contacts the remaining portions of the system 10.

[0076] Continued advancement of the suture 34 causes the coated portion 34b of the suture 34 exit the suture-drying module 100 and pass through one or more inspection modules 42, at which point the software stored on the memory 204 compares data captured by the one or more inspection modules 42 to predetermined data and / or predetermined thresholds. If the software stored on the memory 204 determines that the data captured by the one or more inspection modules 42 exceeds or falls below the predetermined thresholds, the software stored on the memory 204 issues an alarm, alert, or other indicator to inform the user that there is an issue with the coating disposed on the coated portion 34b of the suture 34 or a suture 34 is no longer being drawn through system 10. It is envisioned that the alarm, alert, or other indicator may be an audio alert, a visual alert, a haptic alert, and / or combinations thereof. In embodiments, the software stored on the memory 204 may instruct the drive motor to turn off and inhibit any further advancement of the suture 34 through the system 10.

[0077] In embodiments, the software stored on the memory 204 may alter the feedrate of the suture through the system 10, may alter the flowrate of hot gas flowing into the interior cavity 120 of the suture-drying module 100, and / or may alter the flowrate of one or both of the coating solution 56 and the second coating solution 60 to alter the characteristics of the coating disposed on the coated portion 34b of the suture 34. In this manner, the software stored on the memory 204reviews or otherwise analyzes the data collected by the inspection modules 42 and calculates whether one or more of the feedrate of the suture 34, flowrate of the hot gas, and / or flowrate of the one or both of the coating solution 56 and the second coating solution 60 should be altered to achieve the desired characteristics of the coated portion 34b of the suture 34. It is envisioned that the system 10 may automatically adjust these parameters or these parameters may be manually altered without departing from the scope of the disclosure.

[0078] At the completion of the coating process, such as for example, when the first spool 32 no longer retains any uncoated portion 34a of the suture 34, one or more of the idler wheels 40 and the applicator head 70 may be removed from the first support plate 16 for sterilization and / or cleaning. To minimize down-time, the removed idler wheels 40 and / or applicator head 70 may be replaced with new or clean and sterilized idler wheels 40 and applicator 70 and the above described process can be repeated using a new spool of uncoated suture 34. As can be appreciated, replacement of the idler wheels 40 and the idler head 70, in addition to other components of the system 10, reduces downtime and results in the manufacture of an increased amount of coated sutures as compared to a system that requires cleaning and sterilization without the removal and replacement of these components. It is envisioned that the above described process may be repeated as many times as necessary depending upon the design needs of the system 10.

[0079] With reference to FIGS. 13A and 13B, a method of coating a suture with pharmaceutical ingredients is illustrated and generally identified by reference numeral 300. Initially, in step 302, an uncoated suture is loaded or otherwise coupled to the suture-transport module. In step 304, the bath of the applicator head is flooded with coating solution. Optionally, in step 306, the bath of the applicator head may be flooded with a mixture of one or more coating solutions mixed in the mixing valve before flowing to the bath of the applicator head. In parallel with step 304, the interior cavity of the suture-drying module is flooded with hot gas in step 308. With the bath of the applicator head flooded with coating solution and the interior cavity of the suture-drying module flooded with hot gas, in step 310 the uncoated suture is drawn through the bath of the applicator head to coat the suture with coating solution. In step 312, the coated portion of the suture is drawn through the interior cavity of the suture-drying module to dry the coating solution. In step 314, the coated portion of the suture is drawn through the inspection module where the inspection module analyzes the coated portion of the suture. In step 316, it is determined whether the measurements obtained by the inspection module exceeds or falls below apredetermined threshold value. If it is determined that the measurements obtained by the inspection module exceeds or falls below the predetermined threshold value, in step 318, the software stored on the memory issues an alert or terminates the coating process and the process returns to step 302. If it is determined that the measurements obtained by the inspection module do not exceed or fall below the predetermined threshold value, in step 320, it is determined if the spool of uncoated material is empty. If it is determined that the spool of uncoated suture is not empty, the process returns to step 310. If it is determined that the spool of uncoated suture is empty, in step 322, the applicator head and / or one or more idler wheels are removed from the support surface for cleaning and / or sterilization. In step 324, it is determined coating another spool of uncoated suture is needed. If it is determined that coating another spool of uncoated material is needed, in step 326, a clean and / or sterilized applicator head and / or one or more idler wheels are coupled to the support surface and the method returns to step 302. If it is determined that coating another spool of uncoated suture is not needed, the method ends at step 328. As can be appreciated, the above-described method of coating a suture with pharmaceutical ingredients may be repeated as many times as necessary.

[0080] Although generally described hereinabove, it is envisioned that the memory 204 may include any non-transitory computer-readable storage media for storing data and / or software including instructions that are executable by the processor 202 and which control the operation of the control module 200. In an embodiment, the memory 204 may include one or more storage devices such as solid-state storage devices, e.g., flash memory chips. Alternatively, or in addition to the one or more solid-state storage-devices, the memory 204 may include one or more mass storage devices connected to the processor 202 through a mass storage controller (not shown) and a communications bus (not shown).

[0081] Although the description of computer-readable media contained herein refers to solid- state storage, it should be appreciated by those skilled in the art that computer-readable storage media can be any available media that can be accessed by the processor 202. That is, computer readable storage media may include non-transitory, volatile and non-volatile, removable and nonremovable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules, or other data. For example, computer-readable storage media may include RAM, ROM, EPROM, EEPROM, flash memory or other solid-state memory technology, CD-ROM, DVD, Blu-Ray or other optical storage,magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which may be used to store the desired information, and which may be accessed by the control module 200.

[0082] While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplification of embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

[0083] The invention may be further described by reference to the following numbered paragraphs:1. A system for coating a suture with pharmaceutical ingredients, comprising: a support frame; a suture-transport module operably coupled to the support frame, the suture-transport module comprising: a first spool rotatably supported on the support frame, the first spool including an uncoated portion of a suture; and a second spool rotatably supported on the support frame, the second spool configured to receive a coated portion of the suture; a suture-coating module operably coupled to the support frame, the suture-coating module comprising: an applicator head removably coupled to the support frame, the applicator head defining a hollow interior portion, wherein the hollow interior portion of the applicator head is configured to receive a coating solution forming a bath, wherein the applicator head is configured to slidably receive the uncoated portion of the suture, wherein the bath is configured to coat the uncoated portion of the suture with the coating solution and form a coated portion of the suture; and a suture-drying module operably coupled to the support frame, the suture-drying module configured to receive a heated gas, wherein the suture-drying module is configured to receive a coated portion of the suture exiting the applicator head, wherein the heated gas is configured to dry the coated portion of the suture received within the suture-drying module.2. The system according to paragraph 1, wherein the applicator head is disposed in aU-shaped configuration.3. The system according to paragraph 1, wherein the applicator head is disposed in a linear configuration.4. The system according to paragraph 1, wherein the suture-coating module comprises a mixing valve, the mixing valve configured to mix a first coating solution and a second coating solution and form a coating solution mixture, wherein an outlet of the mixing valve is in fluid communication with the hollow interior portion of the applicator head.5. The system according to paragraph 1, wherein the suture-coating module comprises a plurality of idler wheels, the plurality of idler wheels rotatably supported on the support frame, wherein at least one idler wheel of the plurality of idler wheels is configured to guide the uncoated portion of the suture and at least one other idler wheel of the plurality of idler wheels is configured to guide the coated portion of the suture.6. The system according to paragraph 5, wherein the plurality of idler wheels is selectively removable from the support frame.7. The system according to paragraph 1, wherein the suture-drying module comprises a first pulley and a second pulley, the second pulley disposed in spaced relation to the first pulley, wherein the first pulley and the second pulley cooperate to rotatably support a loop of the coated portion of the suture within the suture-drying module.8. The system according to paragraph 7, wherein each of the first pulley and the second pulley define a corresponding plurality of circumferential grooves, wherein each circumferential groove is configured to receive a portion of the coated portion of the suture to define a plurality of loops of the coated portion of the suture within the suture-drying module.9. The system according to paragraph 1, wherein the suture-coating module comprises a coating solution pump, wherein the coating solution pump is in fluid communication with the coating solution and is in fluid communication with the hollow interior portion of the applicator head, wherein actuation of the pump effectuates a flow of coating solution through the hollow interior portion of the applicator head.10. The system according to paragraph 1, wherein the suture-transport module comprises a inspection module, the inspection module configured to receive the coated portion of the suture and analyze the coating disposed on the coated portion of the suture.11. A system for coating a suture, comprising: an applicator head releasably coupled to a support surface, wherein the applicator head comprises: an inlet block, the inlet block defining a suture inlet and an opposite, suture outlet, wherein the suture inlet and the suture outlet cooperate to permit passage of a suture through the inlet block; an outlet block, the outlet block defining a suture inlet and an opposite, suture outlet, wherein the suture inlet of the outlet block and the suture outlet of the outlet block cooperate to permit passage of the suture through the outlet block; and a bath, the bath defining a hollow interior portion configured to receive a coating solution and the suture, wherein a first portion of the bath is operably coupled to the first inlet block and a second portion of the bath is operably coupled to the second inlet block.12. The system according to paragraph 11, wherein the bath defines a U-shaped configuration.13. The system according to paragraph 11, wherein the bath defines a linear configuration.14. The system according to paragraph 11, wherein the inlet block, the outlet block, and the bath are in fluid communication to permit a flow of coating solution through each of the inlet block, the outlet block, and the bath.15. The system according to paragraph 11, wherein the applicator head comprises a support block, the support block releasably coupled to the support surface and configured to releasably support the bath.16. A method of coating a suture with pharmaceutical ingredients, comprising: drawing an uncoated portion of a suture into an inlet of an applicator head; flooding a bath of the applicator head with a coating solution; drawing the uncoated portion of the suture through the bath to coat the uncoated portion of the suture with the coating solution; drawing the coated portion of the suture through an outlet of the applicator head and into an interior cavity of a suture-drying module; flooding the interior cavity of the suture-drying module with a heated gas; and drawing the coated portion of the suture through the interior cavity of the suture-drying module flooded with heated gas to dry the coated portion of the suture.17. The method according to paragraph 16, whereinflooding the bath of the applicator head with coating solution comprises effectuating a continuous flow of coating solution through the bath to replenish the bath with fresh coating solution.18. The method according to any of the preceding paragraphs, further comprising mixing a first coating solution with a second coating solution in a mixing valve to form a mixed coating solution, wherein flooding the bath of the applicator head with a coating solution comprises drawing the mixed coating solution from an outlet of the mixing valve.19. The method according to paragraph 16, wherein drawing the coated portion of the suture through the interior cavity of the suture-drying module comprises drawing the coatingportion of the suture through the interior cavity of the suture-drying module to form multiple loops of the coated portion of the suture within the interior cavity of the suture-drying module.20. The method according to any of the preceding paragraphs, further comprising removing the applicator head from the support surface and replacing the removed applicator head with a clean applicator head.

Claims

CLAIMSWhat is claimed is:

1. A system for coating a suture with pharmaceutical ingredients, comprising: a support frame; a suture-transport module operably coupled to the support frame, the suture-transport module comprising: a first spool rotatably supported on the support frame, the first spool including an uncoated portion of a suture; and a second spool rotatably supported on the support frame, the second spool configured to receive a coated portion of the suture; a suture-coating module operably coupled to the support frame, the suture-coating module comprising: an applicator head removably coupled to the support frame, the applicator head defining a hollow interior portion, wherein the hollow interior portion of the applicator head is configured to receive a coating solution forming a bath, wherein the applicator head is configured to slidably receive the uncoated portion of the suture, wherein the bath is configured to coat the uncoated portion of the suture with the coating solution and form a coated portion of the suture; and a suture-drying module operably coupled to the support frame, the suture-drying module configured to receive a heated gas, wherein the suture-drying module is configured to receive a coated portion of the suture exiting the applicator head, wherein the heated gas is configured to dry the coated portion of the suture received within the suture-drying module.

2. The system according to claim 1, wherein the applicator head is disposed in a U- shaped configuration.

3. The system according to claim 1, wherein the applicator head is disposed in a linear configuration.

4. The system according to any of the preceding claims, wherein the suture-coating module comprises a mixing valve, the mixing valve configured to mix a first coating solution and a second coating solution and form a coating solution mixture, wherein an outlet of the mixing valve is in fluid communication with the hollow interior portion of the applicator head.

5. The system according to any of the preceding claims, wherein the suture-coating module comprises a plurality of idler wheels, the plurality of idler wheels rotatably supported on the support frame, wherein at least one idler wheel of the plurality of idler wheels is configured to guide the uncoated portion of the suture and at least one other idler wheel of the plurality of idler wheels is configured to guide the coated portion of the suture.

6. The system according to claim 5, wherein the plurality of idler wheels is selectively removable from the support frame.

7. The system according to any of the preceding claims, wherein the suture-drying module comprises a first pulley and a second pulley, the second pulley disposed in spaced relation to the first pulley, wherein the first pulley and the second pulley cooperate to rotatably support a loop of the coated portion of the suture within the suture-drying module.

8. The system according to claim 7, wherein each of the first pulley and the second pulley define a corresponding plurality of circumferential grooves, wherein each circumferential groove is configured to receive a portion of the coated portion of the suture to define a plurality of loops of the coated portion of the suture within the suture-drying module.

9. The system according to any of the preceding claims, wherein the suture-coating module comprises a coating solution pump, wherein the coating solution pump is in fluid communication with the coating solution and is in fluid communication with the hollow interior portion of the applicator head, wherein actuation of the pump effectuates a flow of coating solution through the hollow interior portion of the applicator head.

10. The system according to claim 1-9 further comprising:an inspection module configured to receive the coated portion of the suture and analyze the coating disposed on the coated portion of the suture, the inspection module being part of the suture-transport module; or a tension-control module configured to monitor and control an amount of tension applied to the suture.

11. A system for coating a suture, comprising: an applicator head releasably coupled to a support surface, wherein the applicator head comprises: an inlet block, the inlet block defining a suture inlet and an opposite, suture outlet, wherein the suture inlet and the suture outlet cooperate to permit passage of a suture through the inlet block; an outlet block, the outlet block defining a suture inlet and an opposite, suture outlet, wherein the suture inlet of the outlet block and the suture outlet of the outlet block cooperate to permit passage of the suture through the outlet block; and a bath, the bath defining a hollow interior portion configured to receive a coating solution and the suture, wherein a first portion of the bath is operably coupled to the first inlet block and a second portion of the bath is operably coupled to the second inlet block.

12. The system according to claim 11, wherein: the bath defines a U-shaped configuration and the inlet block, the outlet block, and the bath are in fluid communication to permit a flow of coating solution through each of the inlet block, the outlet block, and the bath.

13. The system according to claims 11 or 12, wherein the applicator head further comprises: a support block, the support block releasably coupled to the support surface and configured to releasably support the bath; or a homogenizer configured to control a flow of the coating solution through the outlet block to form a meniscus of the coating solution at or near the suture outlet where the suture exits the coating solution.

14. A method of coating a suture with pharmaceutical ingredients, comprising: drawing an uncoated portion of a suture into an inlet of an applicator head; flooding a bath of the applicator head with a coating solution; drawing the uncoated portion of the suture through the bath to coat the uncoated portion of the suture with the coating solution; drawing the coated portion of the suture through an outlet of the applicator head and into an interior cavity of a suture-drying module; flooding the interior cavity of the suture-drying module with a heated gas; and drawing the coated portion of the suture through the interior cavity of the suture-drying module flooded with heated gas to dry the coated portion of the suture.

15. The method according to claim 14, wherein: flooding the bath of the applicator head with coating solution comprises effectuating a continuous flow of coating solution through the bath to replenish the bath with fresh coating solution; or, drawing the coated portion of the suture through the outlet of the applicator head comprises avoiding contact with walls of the outlet.

Images