Abstract:
System and method for coating a suture line are disclosed. The system includes a first guide positioned to orient the suture line for entry into a coating tube. The system also includes a coating tube having an inlet opening to admit the suture line and an outlet opening through which the suture line exits the coating tube. The coating tube includes a fill opening through which a coating composition is introduced into the coating tube to a level sufficient to submerge a portion of the suture line. The system further includes a second guide positioned to orient the suture line exiting from the dryer.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]     The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 60/752,685 filed on Dec. 20, 2005, the entire disclosure of which is incorporated by reference herein. 
     
    
     BACKGROUND  
       [0002]     1. Technical Field  
         [0003]     The present disclosure relates generally to filament coating systems and methods, more specifically to systems and methods for coating sutures.  
         [0004]     2. Background of Related Art  
         [0005]     Surgical sutures are primarily used during surgery to stitch together sections of tissue to aid in post-surgical healing. Sutures are often coated with various substances to improve their knot tie-down characteristics. In addition, coating increases suture&#39;s surface lubricity which reduces the friction associated with passing of the suture through the tissue, thereby reducing tissue trauma. Conventionally, suture coatings have been applied by dipping, bushing, wiping, spraying or drip coating. Dip coating involves submergence of a suture line into a coating composition contained in a vessel. Typically, dip coating involves the use of multiple guiding means (e.g., rollers) to pass the suture through the coating composition. For instance, a horizontally passing suture needs to be directed downward into and upward out of the vessel containing the coating composition. Thus, at least one of the guiding roller(s) is positioned within the coating vessel, in contact with the suture before the line is dried. This contact by the roller frequently removes coating material from the suture, thereby reducing the effectiveness of the coating.  
         [0006]     Coating has also been accomplished using filling heads. This method involves passing a suture line through a V-shaped notch. Coating composition injected into the notch contacts and coats the suture line. The suture line does not come in contact with guiding rollers until after the coating dries. Although the coating system using filling heads provides more consistent coating for the suture line, the contact time for coating solution to penetrate into suture is significantly less (e.g., less that 0.1 second) than that provided by the conventional dipping coating mechanisms.  
         [0007]     Therefore, there is a need for a coating system which allows for more consistent coating at high contact time.  
       SUMMARY  
       [0008]     A system and method for coating a suture line are disclosed. The system includes an elongated coating tube having coater heads disposed at both ends thereof. The suture line is fed into the coating tube through an opening in one of the coater heads and exits the coating tube through an opening in the other coater head. Guide rollers that contact the un-coated suture ensure alignment of the suture line as it enters the coating tube. The coating tube is filled with a coating composition to a level above the entry point of the suture line. The composition pours through the openings of the coating tube and is collected by the coater heads so that it is circulated during the coating process to ensure proper ratio of coating agent to solvent. After exiting the coating tube, the suture line passes through a dryer and then is guided by a set of rollers to a winding roll. Then, the suture contacts guide rollers only after exiting the dryer, thereby helping to ensure a uniform coating.  
         [0009]     According to one embodiment of the present disclosure, a system for coating a suture line is disclosed. The system includes a first guide positioned to orient the suture line for entry into a coating tube. The system also includes a coating tube having an inlet opening to admit the suture line and an outlet opening through which the suture line exits the coating tube. The coating tube includes a fill opening through which a coating composition is introduced into the coating tube to a level sufficient to submerge a portion of the suture line. The system further includes a second guide positioned to orient the suture line exiting from the dryer.  
         [0010]     According to another embodiment of the present disclosure, a method for coating at least one suture line is disclosed. The method includes the step of orienting the suture line through a first guide for entry into a coating tube. The coating tube includes an inlet opening to admit the suture line and an outlet opening through which the suture line exits the coating tube. The coating tube further includes one or more fill openings through which a coating composition is introduced into the coating tube a level sufficient to submerge a portion of the suture line. The method also includes the steps of submerging the suture line in the coating composition filling the coating tube as well as orienting the suture line exiting from the dryer through a second guide.  
         [0011]     According to a further embodiment of the present disclosure, a system for coating at least one suture line is disclosed. The system includes a first guide positioned to orient the suture line for entry into a coating tube having an inlet opening to admit the suture line passing through the first guide and an outlet opening through which the suture line exits the coating tube. The coating tube also includes at least one fill opening through which a coating composition is introduced into the coating tube to at least a level sufficient to submerge at least one portion of the suture line, such that the coating composition flows out through at least one of the inlet and outlet openings. The system also includes at least one coater head disposed at each of end of the coating tube, the first and second coater head configured to collect the coating composition flowing through the inlet and outlet openings and a second guide positioned to orient the suture line exiting the coating tube. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0012]     The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:  
         [0013]      FIG. 1  is a schematic diagram of a dip suture coating system according to one embodiment of the present disclosure;  
         [0014]      FIG. 2  is a schematic diagram of a dip coater according to the present disclosure;  
         [0015]      FIG. 3  is a schematic diagram of a distal coater head useful in embodiments of coating systems according to the present disclosure;  
         [0016]      FIG. 4  is a sectional view of a dip coating tube according to the present disclosure; and  
         [0017]      FIG. 5  is a flow diagram of a method for coating a suture line according to the present disclosure.  
     
    
     DETAILED DESCRIPTION  
       [0018]     Preferred embodiments of the present disclosure will be described herein below with reference to the accompanying drawings. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.  
         [0019]     The present disclosure provides for a horizontal dip coating system. The system includes one or more input winders inputting a suture line into a dip coater using a first set of one or more guiding rollers. The dip coater includes a coating tube positioned horizontally with a coater head disposed at proximal and distal ends thereof. The coating tube and the coater heads include openings through its centers to allow for the suture line to pass horizontally therethrough. A coating composition fills the coating tube above the openings of the coating tube through which the suture line passes to coat the line. Any coating composition that leaks out of the coating tube is collected by the coater heads. The coating composition is injected at a higher rate than it leaks out to maintain the composition level therein. In addition, the coating composition collected by the coater heads is circulated throughout the dip coater. In some embodiments, where the coating composition includes solvent carrier and coating agent, solvent content of the coating composition is-monitored and adjusted to ensure that a predetermined ratio of coating agent to solvent is maintained. Upon coating, the suture line is dried and thereafter the line is guided by a second set of one or more rollers to winding rolls.  
         [0020]      FIG. 1  shows a horizontal dip coating system  1  according to the present disclosure for coating a plurality of suture lines simultaneously. The coating system  1  includes at least one input winder  2  for passing at least one suture line  10  through a dip coater  3 , an air wiper  5 , a dryer  6 , and an air cooler  7 . Thereafter the line  10  is wound by at least one take-up winder  8 , which may be part of a pull-over loading station  9 . It is envisioned that the pull-over loading station pulls the line  10  through the coating system  1 . As the line  10  passes through the dip coater  3  it is submerged in a coating composition in order to absorb coating materials. As will be appreciated by those skilled in the art, the coating system shown in  FIG. 1  includes multiple input winders and multiple take-up winders. Also, it is contemplated that each input winder and/or take-up winder may handle one or more than one suture lines (e.g., in  FIG. 1  each winder handles two suture lines).  
         [0021]     The input winder(s)  2  disperses the line  10  which may be a monofilament or a multifilament braided suture. Prior to dispersing, the line  10  may be prepared for coating which may involve calendaring the line  10  to facilitate penetration of the coating composition into the interstices of the braid suture, especially where the present system is used to apply a second or third composition to the suture line. An example of a calendaring apparatus and method thereof is disclosed by commonly owned U.S. Pat. No. 5,312,642 entitled “Method and Apparatus for Calendering and Coating/Filling Sutures” which is hereby incorporated by reference in its entirety herein.  
         [0022]     The system  1  also includes the air wiper  5  and the air cooler  7 . The air wiper  5  is positioned between the dip coater  3  and the dryer  6  and is configured to blow gas (e.g., air, nitrogen, etc.) on the passing line  10  to blow off excess composition. The air cooler  7  is positioned between the dryer  6  and the take-up winder  8  and is configured to blow cool air on the line  10  to provide cooling for the dried line.  
         [0023]      FIG. 2  shows in more detail a dip coater  3  and the dryer  6  in accordance with an embodiment of the present disclosure. The line  10  is passed through the dip coater  3  so that it is immersed in a coating composition. The line  10  is guided into the dip coater  3  around a first set of rollers  13  (e.g., rollers  12  and  14 ) and passed horizontally through a coating tube  24  which is filled with a coating composition  31  containing the dissolved coating agent. It is envisioned that the dip coater  3  may be configured to coat a plurality of lines  10 . For example, the dip coater  3  may have a plurality of coating tubes  24  corresponding to the number of lines  10 . Alternatively, the coating tube  4  may be substituted by a container configured to coat multiple lines  10 .  
         [0024]     As the line  10  is passed horizontally through the coating tube  24 , coating composition is applied to the line  10 . The coating tube  24  is positioned horizontally and may have a cylindrical shape and may be approximately 1′ to 10′ in length. Typically, the coating tube is 3′ to 5′ long. In addition, the coating tube  24  is preferably manufactured from stainless steel material that does not react with the coating composition. For example, the coating tube may be glass or glass-lined. In addition, if a metal tube is used, it may be desirable to passivate the tube to reduce its reactivity. Passivation methods and materials are within the purview of those skilled in the art. The outer diameter of tube can vary depending on a number of factors such as the number of filaments being treated, the particular coating composition being applied and the desired contact time between the composition and the suture line. Those skilled in the art will appreciate that the cylindrical shape is merely only one embodiment of the coating tube  24  and that it may have a variety of shapes (e.g., rectangular, triangular, or hexagonal cross-sectional shapes, etc.).  
         [0025]     The line  10  enters the coating tube  24  through a proximal coater head  18  which is discussed in more detail below with reference to a distal coater head  20 , both of which have a circular cross section. It is envisioned that the line  10  passes through dip coater  3  through an opening  91  of the proximal coater head  18 , an opening  92  of the coating tube  24 , an opening  93  of the coating tube  24  and an opening  94  of the distal coater head  20 . The openings  91 ,  92 ,  93 ,  94  are preferably drilled through the center of surfaces  95 ,  96 ,  97 ,  98  respectively, of ceramic eyelets disposed within the proximal and distal coater heads  18 ,  20  and the coating tube  24  as shown in  FIG. 3  and discussed in more detail below. The openings may be drilled in a plurality of ways (e.g., a laser) to achieve a straight path for the line  10  through the dip coater  3 .  
         [0026]     The coating tube  24  is filled with a coating composition  31  through a supply tube  56  which is connected thereto via adapter  60  having a male national pipe thread (MNPT) or another type of connecting means. The adapter  60  may be coupled to the coating tube  24  at an angle (e.g., a 135° angle) with the longitudinal axis of the coating tube  24  at the top portion thereof. Those skilled in the art will appreciate that the tubing used to interconnect the components of the dip coater  3  (e.g., the supply tube  56  and other tubing discussed below) may be manufactured from any materials allowing the tubing to be flexible as well as chemically inert to a variety of organic solvents. In one embodiment, the supply tube  56  is made from PTFE and has a ⅜″ diameter. The coating composition  31  is carried into the coating tube  24  via a circulating pump  34  which withdraws the composition  31  from a tank  28  through a tube  58 . The tank  28  preferably includes a stirring device, such as a magnetic stirrer driver  26  positioned thereunder, to prevent settling or other separation of the components of the coating composition.  
         [0027]      FIG. 3  shows a cross sectional view of the distal coater head  20  along the vertical axis of the coating tube  24 . The coating tube  24  is filled with the composition  31  to a level which is at least above the line  10  (e.g., above the center of the coating tube  24 ) to ensure that the line  10  is immersed in the composition  31  as the line  10  passes through the coating tube  24 . Since the composition  31  fills the coating tube  24  above the opening  93 , composition  31  may leak therethrough and be collected in the proximal and distal coater heads  18 ,  20 . As a result of composition  31  leaking out of the coating tube  24 , the in-flow must equal or exceed out-flow. Therefore, the composition  31  will be circulated (e.g., continually supplied into the coating tube  24 ) to maintain a steady state, where the level of the composition  31  is continuously above the openings  92 ,  93 .  
         [0028]     The assembly  20  includes a removable reducing tee  80  configured to drain leaking composition  31 . The reducing tee  80  can advantageously have an outer diameter larger than the outer diameter of the coating tube  24  so that the tee  80  fits over the coating tube  24 . The return adapter  22  is the reducing portion of the reducing tee  80  and preferably includes an MNPT connection.  
         [0029]     The removable tee  80  is connected to the coating tube  24 . The distal coater head  20  includes two ceramic eyelets  72 ,  74 . The ceramic eyelet  72  is positioned at the distal end of the coating tube  24  within the reducing tee  80  and the ceramic eyelet  74  is attached at the distal end of the reducing tee  80 . The ceramic eyelets  72 ,  74  are designed to optimize alignment of the openings  93 ,  94  while minimizing the solvent lost during the coating process as discussed in more detail below. Those skilled in the art will appreciate that the proximal coater head  18  includes the same components (e.g., ceramic eyelet, o-ring, etc.) assembled in the same manner as discussed above with regard to the distal coater head  20 .  
         [0030]     With reference to  FIG. 2 , the composition  31  out-flows through return adapters  21 ,  22  coupled to the bottom portion of the proximal and distal coater heads  18 ,  20  respectively and return tubes  45 ,  42  to a return tank  32 . In addition, the return tank  32  collects any excess composition  31  present in the coating tube  24  through an overflow adapter  40  which is coupled to the upper portion thereof. Upon reaching the overflow adapter  40 , the excess coating composition  31  flows through a return tube  44  to the return tank  32  and mixes with return composition  33 . The outlet of overflow adapter  40  is also used to determine when the composition  31  filled the coating tube  24  to the desired level. The overflow adapter  40  is positioned above the openings  91 ,  92 ,  93 ,  94  hence when composition  31  reaches the overflow adapter  40  and flows therethrough and into the return tank  32 . This ensures that the suture line  10  is submerged inside the coating tube  24 . There can be multiple overflow adapters  40  positioned along the coating tube  24  for higher recirculation rate.  
         [0031]      FIG. 4  shows a cross sectional view along the section line  4  of the coating tube  24 . Adapter  60  and adapter  54  are shown positioned on the upper portion of the coating tube  24  while the drain valve  46  is positioned on the bottom portion thereof. In addition, the overflow adapter  40  is positioned on the upper portion of the coating tube  24  as well, slightly below the adapters  54 ,  60 . The drain valve  46  may be used to empty coating tube  24  of the coating composition  31  upon shut down of the coating system  1  for maintenance or once the coating process is finished.  
         [0032]     It is also envisioned that the return composition  33  may be recycled during the coating process. Typically, a portion of any volatile solvent in the coating composition may evaporate during the coating process before excess composition  31  flows to the return tank  32 . The return composition  33  is contained within the coating system  1  by a plurality of tubes and adapters discussed above to contain the return composition  33  and to minimize solvent loss and vapor escape. Some vapor which does escape is vented through vent headers (not shown) installed above the coating tube  24 .  
         [0033]     In order for the return composition  33  to be recycled, it must be verified that the desired coating agent composition is maintained. With reference to  FIG. 2 , a controller  48  can be connected to the return tank  32  and configured to test the density and/or viscosity of the return composition  33  using, e.g., a mass flow meter. If the density/viscosity of the return composition  33  exceeds a predetermined level (e.g., density of the original composition  31 ) then the controller  48  signals that the composition needs to be adjusted e.g., by injecting additional solvent carrier  35  directly into the coating tube  24  or into the return tank  32 .  
         [0034]     In one embodiment, the controller  48  is electrically connected to a solvent pump  96  (e.g., solvent supply means) which injects solvent  35  into the coating tube  24  and a control valve  50  adjusts the flow of the solvent  35  into the return tank  32 . The solvent  35  can be injected into the coating tube  24  through the solvent adapter  54  connected to the solvent tank  36  through a tube  52 . The solvent adapter  54  is positioned at an angle (e.g., a 45° angle) with the longitudinal axis of the coating tube  24  at the top portion thereof while the drain valve  46  is positioned on the bottom portion thereof. In addition, the return tank  32  includes a magnetic stirrer driver  30  to maintain uniformity of the coating composition throughout the return composition  33  and to mix any added solvent  35 . Furthermore, return tank  32  supplies the return composition  33  to tank  28  where it is recycled and continually pumped into the coating tube  24 .  
         [0035]      FIG. 5  shows a method for coating the suture line  10  using the coating system  1  of the present disclosure. In step  150  the coating tube  24  is filled with the composition  31  above the openings  92 ,  93  to ensure that as the line  10  is submerged in the composition  31 . The composition  31  is continually fed into the coating tube  24  at a rate which is equal to or slightly exceeds the rate at which the composition  31  leaks through the openings  92 ,  93 . This allows the level of the composition  31  to stay above the openings  92 ,  93  despite the loss of the composition  31 . Thus, only the level of the composition  31  must be controlled during the coating process, whereas, conventional coating techniques, which depend on point coating, require precise control of the flow rate of the coating composition.  
         [0036]     In step  152 , excess composition  31  is collected. This is accomplished by collecting the composition  31  from the proximal and distal coater heads  18 ,  20  which are configured to catch excess liquid and from the overflow adapter  40  which prevents overfilling of the coating tube  24  by providing a flow path for any excess composition  31 . The excess composition  31  flows to the return tank  32 .  
         [0037]     Since the coating system  1  relies on constant supply of the composition  31  to the coating tube  24  the composition  31  must be circulated. As discussed above, in some embodiments the coating process involves application of coating agent dissolved in a volatile organic solvent. Therefore, solvent may need to be replenished to maintain the desired coating agent levels within the composition  31 . In step  154 , the controller  48  analyzes the density/viscosity of return composition  33  to determine whether additional solvent  35  needs to be added. If the density is above the desired limit (e.g., the coating agent to solvent ratio within the return composition  33  is larger than that ratio within the composition  31 ) then in step  156 , the controller  48  adjusts the solvent content. Adjustment of solvent level can be accomplished by signaling the solvent pump  96  which injects the solvent  35  into the coating tube  24  and/or opening the control valve  50  to add solvent  35  into the return composition  33 . The return composition  33  is then added into tank  28  from where it is continuously injected into coating tube  24 .  
         [0038]     Each portion of the suture line  10  should reside within the coating tube  24  approximately between 0.5 second to 10 minutes, preferably the residence time is about 1 minute. As the line  10  the dip coater  3  the line  10  enters the dryer  6  and in step  158 , the line  10  is dried. The drying temperature depends on the coating composition used and may range approximately between the ambient room temperature (e.g., 25° C.) at the low extreme and above 100° C. at the upper extreme. It is also envisioned that the dryer  6  uses heated gas (e.g., air, nitrogen, etc.) to dry the line  10 . In step  160 , the line  10  is cooled by the air cooler  7 , which blows cool air onto the dried line  10  and thereafter the line  10  is guided by a second set of rollers  39  (e.g., a roller  38 ) into the winder  8  where it is wound.  
         [0039]     The present disclosure allows the line  10  to avoid physical contact with various machine parts during the coating process (e.g., guiding rollers). The line  10  comes in contact only with the coating composition between the time it is fed into the dip coater  3  and the time it is wound on the winder  8 . This is due to the horizontal positioning of the coating tube  24  and the horizontal orientation of the line  10  therethrough, which allows the line  10  to avoid physical contact with components by using a minimal amount of guiding mechanisms (e.g., guiding rollers  13 ,  39 )  
         [0040]     Any coating composition known to be useful for coating medical devices may be applied to a medical device using the present methods and apparatus. The coating composition can be a solution, dispersion, emulsion containing, for example, one or more polymeric materials and/or one or more bioactive agents.  
         [0041]     In some embodiments, the coating composition includes a polymer, or a combination of polymers. The polymer is most suitably biocompatible, including polymers that are non-toxic, non-inflammatory, chemically inert, and substantially non-immunogenic in the applied amounts. The polymer may be either bioabsorbable or biostable. A bioabsorbable polymer breaks down in the body. Bioabsorbable polymers are gradually absorbed or eliminated by the body by hydrolysis, metabolic process, bulk, or surface erosion. Examples of bioabsorbable materials include but are not limited to polycaprolactone (PCL), poly-D, L-lactic acid (DL-PLA), poly-L-lactic acid (L-PLA), poly(lactide-co-glycolide), poly(hydroxybutyrate), poly(hydroxybutyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride, poly(glycolic acid), poly(glycolic acid-cotrimethylene carbonate), polyphosphoester, polyphosphoester urethane, poly (amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), copoly(ether-esters), polyalkylene oxalates, polyphosphazenes, polyiminocarbonates, and aliphatic polycarbonates. Biomolecules such as heparin, fibrin, fibrinogen, cellulose, starch, and collagen are typically also suitable. A biostable polymer does not break down in the body, and thus a biostable polymer is present in the body for a substantial amount of time after implantation. Examples of biostable polymers include PARYLENE™, PARYLAST™, polyurethane (for example, segmented polyurethanes such as BIOSPAN™), polyethylene, polyethlyene teraphthalate, ethylene vinyl acetate, silicone, polyethylene oxide, and polytetrafluoroethylene (PTFE).  
         [0042]     In some embodiments, the coating compositions of the present disclosure may also include a fatty acid component that contains a fatty acid or a fatty acid salt or a salt of a fatty acid ester. Suitable fatty acids may be saturated or unsaturated, and include higher fatty acids having more than about 12 carbon atoms. Suitable saturated fatty acids include, for example, stearic acid, palmitic acid, myristic acid and lauric acid. Suitable unsaturated fatty acids include oleic acid, linoleic acid, and linolenic acid. In addition, an ester of fatty acids, such as sorbitan tristearate or hydrogenated castor oil, may be used.  
         [0043]     Suitable fatty acid salts include the polyvalent metal ion salts of C6 and higher fatty acids, particularly those having from about 12 to 22 carbon atoms, and mixtures thereof. Fatty acid salts including the calcium, magnesium, barium, aluminum, and zinc salts of stearic, palmitic and oleic acids may be useful in some embodiments of the present disclosure. Particularly useful salts include commercial “food grade” calcium stearate which consists of a mixture of about one-third C16 and two-thirds C18 fatty acids, with small amounts of the C14 and C22 fatty acids.  
         [0044]     Suitable salts of fatty acid esters which may be included in the coating compositions applied in accordance with the present disclosure include calcium, magnesium, aluminum, barium, or zinc stearoyl lactylate; calcium, magnesium, aluminum, barium, or zinc palmityl lactylate; calcium, magnesium, aluminum, barium, or zinc olelyl lactylate; with calcium stearoyl-2-lactylate (such as the calcium stearoyl-2-lactylate commercially available under the tradename VERV from American Ingredients Co., Kansas City, MO.) being particularly useful. Other fatty acid ester salts which may be utilized include those selected from the group consisting of lithium stearoyl lactylate, potassium stearoyl lactylate, rubidium stearoyl lactylate, cesium stearoyl lactylate, francium stearoyl lactylate, sodium palmityl lactylate, lithium palmityl lactylate, potassium palmityl lactylate, rubidium palmityl lactylate, cesium palmityl lactylate, francium palmityl lactylate, sodium olelyl lactylate, lithium olelyl lactylate, potassium olelyl lactylate, rubidium olelyl lactylate, cesium olelyl lactylate, and francium olelyl lactylate.  
         [0045]     Where utilized, the amount of fatty acid component can range in an amount from about 5 percent to about 50 percent by weight of the total coating composition. Typically, the fatty acid component may be present in an amount from about 10 percent to about 20 percent by weight of the total coating compositions.  
         [0046]     In some embodiments, the coating composition contains one or more bioactive agents. The term “bioactive agent”, as used herein, is used in its broadest sense and includes any substance or mixture of substances that have clinical use. Consequently, bioactive agents may or may not have pharmacological activity per se, e.g., a dye. Alternatively a bioactive agent could be any agent which provides a therapeutic or prophylactic effect, a compound that affects or participates in tissue growth, cell growth, cell differentiation, a compound that may be able to invoke a biological action such as an immune response, or could play any other role in one or more biological processes.  
         [0047]     Examples of classes of bioactive agents which may be utilized in accordance with the present disclosure include antimicrobials, analgesics, antipyretics, anesthetics, antiepileptics, antihistamines, anti-inflammatories, cardiovascular drugs, diagnostic agents, sympathomimetics, cholinomimetics, antimuscarinics, antispasmodics, hormones, growth factors, muscle relaxants, adrenergic neuron blockers, antineoplastics, immunogenic agents, immunosuppressants, gastrointestinal drugs, diuretics, steroids, lipids, lipopolysaccharides, polysaccharides, and enzymes. It is also intended that combinations of bioactive agents may be used.  
         [0048]     Suitable antimicrobial agents which may be included as a bioactive agent in the bioactive coating of the present disclosure include triclosan, also known as 2,4,4′-trichloro-2′-hydroxydiphenyl ether, chlorhexidine and its salts, including chlorhexidine acetate, chlorhexidine gluconate, chlorhexidine hydrochloride, and chlorhexidine sulfate, silver and its salts, including silver acetate, silver benzoate, silver carbonate, silver citrate, silver iodate, silver iodide, silver lactate, silver laurate, silver nitrate, silver oxide, silver palmitate, silver protein, and silver sulfadiazine, polymyxin, tetracycline, aminoglycosides, such as tobramycin and gentamicin, rifampicin, bacitracin, neomycin, chloramphenicol, miconazole, quinolones such as oxolinic acid, norfloxacin, nalidixic acid, pefloxacin, enoxacin and ciprofloxacin, penicillins such as oxacillin and pipracil, nonoxynol 9, fusidic acid, cephalosporins, and combinations thereof. In addition, antimicrobial proteins and peptides such as bovine lactoferrin and lactoferricin B may be included as a bioactive agent in the bioactive coating of the present disclosure.  
         [0049]     Other bioactive agents which may be included as a bioactive agent in the coating composition applied in accordance with the present disclosure include: local anesthetics; non-steroidal antifertility agents; parasympathomimetic agents; psychotherapeutic agents; tranquilizers; decongestants; sedative hypnotics; steroids; sulfonamides; sympathomimetic agents; vaccines; vitamins; antimalarials; anti-migraine agents; anti-parkinson agents such as L-dopa; anti-spasmodics; anticholinergic agents (e.g. oxybutynin); antitussives; bronchodilators; cardiovascular agents such as coronary vasodilators and nitroglycerin; alkaloids; analgesics; narcotics such as codeine, dihydrocodeinone, meperidine, morphine and the like; non-narcotics such as salicylates, aspirin, acetaminophen, d-propoxyphene and the like; opioid receptor antagonists, such as naltrexone and naloxone; anti-cancer agents; anti-convulsants; anti-emetics; antihistamines; anti-inflammatory agents such as hormonal agents, hydrocortisone, prednisolone, prednisone, non-hormonal agents, allopurinol, indomethacin, phenylbutazone and the like; prostaglandins and cytotoxic drugs; estrogens; antibacterials; antibiotics; anti-fungals; anti-virals; anticoagulants; anticonvulsants; antidepressants; antihistamines; and immunological agents.  
         [0050]     Other examples of suitable bioactive agents which may be included in the coating composition include viruses and cells, peptides, polypeptides and proteins, analogs, muteins, and active fragments thereof, such as immunoglobulins, antibodies, cytokines (e.g. lymphokines, monokines, chemokines), blood clotting factors, hemopoietic factors, interleukins (IL-2, IL-3, IL-4, IL-6), interferons (β-IFN, (α-IFN and γ-MN), erythropoietin, nucleases, tumor necrosis factor, colony stimulating factors (e.g., GCSF, GM-CSF, MCSF), insulin, anti-tumor agents and tumor suppressors, blood proteins, gonadotropins (e.g., FSH, LH, CG, etc.), hormones and hormone analogs (e.g., growth hormone), vaccines (e.g., tumoral, bacterial and viral antigens); somatostatin; antigens; blood coagulation factors; growth factors (e.g., nerve growth factor, insulin-like growth factor); protein inhibitors, protein antagonists, and protein agonists; nucleic acids, such as antisense molecules, DNA and RNA; oligonucleotides; and ribozymes.  
         [0051]     A single bioactive agent may be utilized to form the coating composition or, in alternate embodiments, any combination of bioactive agents may be utilized to form the coating composition applied in accordance with the present disclosure.  
         [0052]     The amounts of bioabsorbable coating composition to be applied to the suture vary depending upon the specific construction of the suture, the size and the material of this construction. In general, the coating composition applied to an unfilled suture will constitute from about 1.0 to about 3.0 percent by weight of the coated suture, but the amount of coating composition on may range from as little as about 0.5 percent, by weight, to as much as 4.0 percent or higher. For a preferred filled (i.e., containing a storage stabilizing agent) braided suture, amounts of coating composition will generally vary from about 0.5% to 2.0% with as little as 0.2% to as much as 3.0%. As a practical matter and for reasons of economy and general performance, it is generally preferred to apply the minimum amount of coating composition consistent with good surface lubricity and/or knot tie-down characteristics and this level of coating add on is readily determined experimentally for any particular suture.  
         [0053]     The described embodiments of the present disclosure are intended to be illustrative rather than restrictive, and are not intended to represent every embodiment of the present disclosure. Various modifications and variations can be made without departing from the spirit or scope of the disclosure as set forth in the following claims both literally and in equivalents recognized in law.