Oval wrap suture package

Abstract: A molded two-piece (12, 14) suture package is disclosed which encloses and defines an oval channel (30) in which sutures (60) may be wound. The oval channel (30) has two semicircular end sections (32, 33) connected by straight side sections (34). An opening (38) in the channel (30) is provided at the juncture of a straight section (34) and an end section (33), permitting sutures (60) to be withdrawn from the channel (30) at the end of a straight section (34). In a preferred embodiment the interior wall of the channel (30) is formed by alternating engaging sections (32-36) formed in the respective package pieces (12, 14). To prevent the wrapped suture (60) from becoming entrapped when the two pieces (12, 14) are engaged, the top and bottom of the channel (30) is alternately raised (26', 30') and lowered (26'', 30'') in alignment with the alternating wall sections, causing the wound suture (60) to bridge those areas where it may become entrapped between the mating package pieces (12, 14). Entrapment of the suture (60) end at the outside of the channel (30) is prevented by alternately recessing the outer wall of the channel (30). Flexible molded needle (70) parks are also disclosed for the package.

Description: This invention relates to holders for needles and, in particular, to holders and packages which provide for the delivery of sutures containing attached needles. In the packaging of surgical needles including surgical needles to which there are attached sutures, it is important that the needle and its attached suture be easily removable from the package in one smooth motion. When the needle is grasped by a forceps and pulled, the needle should easily release from the package and the suture should withdraw from the package smoothly without binding or snagging in the package, and without becoming entangled. Also, suture materials, particularly monofilaments such as catgut, polydioxanone and the like, especially the heavier deniers, are known to take a set during storage; i.e., they tend to have a "memory" causing them to retain the shape of their position in the package after removal from the package. Hence the package should be designed so that any tight bends or curves required in order to package the suture be eliminated. It is further desirable for suture packages to be economical to manufacture in volume quantities. A manufacturing process directed toward this end is one in which the suture package is formed of two interlocking molded, stamped, or thermoformed polymeric members. Packages made in such a process enable the formation of projections useful for winding and capturing the suture in channels designed for that purpose. These packages also enable the maintenance of fine tolerances necessary in the formation of a precision design. Packages for armed sutures; i.e., sutures where the needle is attached, are disclosed, for example, in U.S. Pat. Nos. 4,135,623; 4,034,850; and 3,857,484. A molded package for armed sutures is disclosed in U.S. Pat. No. 4,424,898. EP-A-0091792 discloses a two-part suture package having an oval channel for retention of a suture. In accordance with the principles of the present invention, an improved suture package is described which forms an oval-shaped channel for retention of the suture. Such a package is defined in claim 1. It has been found that when a channelled suture package is formed of two interlocking pieces, mislocation of the suture toward an edge of the channel where the mating pieces come together will cause the suture to become pinched or entrapped between the mating pieces. In accordance with the present invention, the floor of the channel contains periodic projections toward the center of the channel. The suture will then "bridge" the surface of the channel intermediate these projections as it traverses the channel and hence can bridge the entrapping areas of the channel. The projections and corresponding wall areas also eliminate any continuous interlocking edges in the channel where the suture material can become entrapped as the two pieces of the package are interlocked together. In a preferred embodiment, one end of the suture exits the oval channel toward the center of the oval and is attached to a needle located in the center of the oval. The oval channel includes gently rounded end sections, eliminating any tight bends or curves which would induce undesirable suture "memory". In a preferred embodiment, the suture exits the oval at the juncture of a lesser arcuate side section of the channel and a rounded end section. This allows the suture to be withdrawn from the lesser arcuate side section rather than from the rounded end section, thereby minimizing resistance to withdrawal of the suture from the package. In the drawings: Figure 1 illustrates the assembly of a suture package; Figure 2 is a plan view of an oval suture package with a peel tab corner; Figure 3 is a plane view of an oval suture package with two long straight sides and two short straight sides; Figure 4 is a plan view of an oval suture package with a central depressed area at each end of the oval; Figure 5 is an enlarged view of the suture wrapping area of a suture package illustrating suture catching mating edges; Figure 5a is a cross-sectional view of the suture wrapping area of Figure 5; Figure 6 is an enlarged view of the suture wrapping area of a suture package in accordance with the present invention which eliminates the suture catching problem; Figures 6a and 6b are cross-sectional views of the suture wrapping area of Figure 6; FIGURES 7a-7d illustrate various views of a preferred oval suture package of the present invention; FIGURES 8a and 8b illustrate a molded needle holder; FIGURE 9 illustrates the periodically recessed outer wall of a suture wrapping channel in a suture package of the present invention; and FIGURES 10 and 10a illustrate in perspective and cross-sectional views a second molded needle holder. Referring first to FIGURE 1, an assembly drawing of an oval suture package is shown. The package is sealed in a foil overwrap which includes a mechanically formed bottom foil tray 10. A dish-like area 11 is formed in the center of the tray to hold the suture package. Sutures made of synthetic material such as Vicryl or polydioxanone have been found to degrade in the presence of excessive moisture over time. A sealed foil overwrap has been found to prevent moisture penetration of the package. Sutures made of natural materials such as catgut do not degrade in the presence of moisture and hence may be enclosed in moisture permeable overwraps, and may even be packaged in solution. Located within the dish-like area 11 of the foil tray 10 is a two-piece molded suture package including a top piece 14 and a bottom piece 12. Formed in the package bottom 12 are a number of molded straight and curved lugs 34, 33, and 32 which define the inner wall of a suture wrapping channel 30. The suture wrapping channel is also defined by the floor 31 of the bottom piece 12. The bottom piece 12 has an outer wall 22. At the top edge of the outer wall 22 is a sealing flange 13 which may be sealed to the overlying overwrap material. The top piece 14 of the suture package fits inside the bottom piece. The outer wall 28 of the package top fits inside the outer wall 22 of the package bottom and defines the outer wall of the suture wrapping channel 30. The package top 14 has an upper surface 26 inside of which is formed a depressed central area 24. The depressed central area 24 rests on the floor 31 of the package bottom when the two pieces are mated together. The outer wall of the central area 24 is molded in an irregular shape to fit around the lugs of the bottom piece. Wall sections 36 are recessed to fit inside of the lugs, and sections 35 project to extend between the lugs to form portions of the inner wall of the suture wrapping channel 30. At one end of the package the outer wall 28 and the upper surface 26 are cut away as shown at 38 to permit the suture to exit the suture wrap channel to the interior of the package. A small section 37 of the upper surface 26 is depressed to fit inside the depression of the lug 33, enabling the suture to pass to the interior of the package through the depression of the section 37. FIGURE 1 shows several types of overwraps which may be used with the suture package. One is a foil label 16 which overlies a major portion of the package when the package is to be enclosed in a single overwrap. The label 16 will leave the corner of the package where the suture exits the wrapping channel at 37 exposed. Optionally the package may be enclosed on the top by a peelable inner foil lid 18, which is sealed to the flange of the foil tray 10. When a double overwrap is used, an inner foil lid 20 is sealed to the flange of the foil tray 10 and the foil sealed package is then sealed inside a paper or paper and plastic overwrap (not shown). As yet another option, a peelable, breathable paper lid may be sealed to the tray flange and the sealed package enclosed in a clear plastic overwrap. An alternate form of the top and bottom package pieces 14 and 12 is shown in FIGURE 2. In this form one end of the oval channel is slightly flattened at 40 where the suture exits the channel 30 at the cutaway 38. The flattening of the oval at 40 leaves space at the corner of the package bottom flange 13 for a peel tab projection 41 which is molded in the flange. When the inner foil lid is sealed to the flange 13, it is sealed about the periphery of the channel 30, and in particular between the projection 41 and the flattened portion of the oval channel. An unsealed corner of the foil lid will then rest on the projection 41, raised above the surface of the flange 13 by this projection. The corner of the lid is thus visibly separated from the flange, enabling the user to easily identify the corner of the lid which is to be grasped when the lid is to be peeled off of the package. FIGURE 2 clearly shows the suture wrapping channel 30 defined by the outer wall 28 of the package top. The inner wall of the channel 30 is defined by the outer sides of the straight lugs 34 and the curved lugs 32 at the ends of the oval, which are molded to project from the bottom piece 12. The inner wall of the channel 30 is also defined by the projections 35 of the top piece 14, which extend between the lugs 32, 33, and 34. In the package of FIGURE 3 the suture wrapping channel has been enlarged to accommodate a longer suture. In the previously described packages the oval channel comprised two long, straight sides connected by semicircular ends. In the package of FIGURE 3 the suture wrapping channel comprises two long sides 74 and 76 at the top and bottom of the FIGURE and two shorter straight sides 42 and 44 at the ends of the oval. The two shorter straight sides 42 and 44 are connected to the longer straight sides 74 and 76 by quarter-circular channel corners 46. It may be seen that in this package the projections 45 extending from the top piece 14 between the curved lugs 32 define straight interior walls for the channel 30. In the package of FIGURE 4 the narrowest dimension of the oval suture wrapping channel is only defined at the ends of the oval by a circular and an oval lug pattern. A suture filament 60 is seen wound around these lug patterns in the channel and exits the channel at the cutout 38 in the top piece 14. The exiting end of the suture filament 60 is swaged to the bore of a curved needle 70. The needle 70 is retained in the depressed area 89 in the inside of the lugs at the suture-exiting end of the package in a needle park 72, formed by a piece of foam which is adhesively attached inside the depressed area 89. The top piece 14 of the package is attached to the bottom piece 12 where the depressed areas 87 and 89 of the top piece 14 contact the central area 31 of the bottom piece 12. The method of attachment may be by means of an adhesive, heat sealing or mechanical attachment. Between the depressed areas 87 and 89 the upper surface 86 of the package formed by the top piece is substantially coplanar with the flange 13 of the bottom piece 12. Thus, the narrowest dimension of the wrapping channel 30 is defined only at the oval ends of the package. At one end of the oval channel is a lug with a molded depression, similar to the depression molded in the curved lug 33 of FIGURE 1. A depression 84, similar to depressed section 37 in FIGURE 1, is formed in the top piece 14 just to the inside of the cutout 38, to enable the suture filament to exit the channel and enter the depressed central area 89 at a level below the top surface of the package. The package of FIGURE 4, unlike the previously described packages, does not have a continuous depressed central floor area 24 in the top piece 14 which contacts the surface of the depressed central floor 31 of the bottom piece 12. Instead, only the two areas 87 and 89, encircled by lugs 32, are depressed. The remainder of the top piece inside the channel and surrounding the areas 87 and 89 is raised to the level of the flange 13 of the bottom piece. Thus, there is a cavity between the top piece surface 25 and the central floor area 31 of the bottom piece which surrounds the depressed areas 87 and 89. This cavity may be used to enclose a suture filament which is wound around the two depressed areas in a figure-8 pattern instead of the oval winding pattern. The cross-over point of the figure-8 pattern will be within the cavity space between the two depressed areas. The suture filament may be wound around the lugs 32 prior to assembly of the two package pieces or, alternatively, the suture filament may be wound through the package after assembly by a filament-carrying stylus which is inserted into the channel 30 between the two pieces at the outer peripheral wall of the channel. If the stylus technique is used, it is necessary to form an opening across the center of the top piece surface 25 to enable traversal of the stylus across the interior of the package. Dashed lines 27 mark cut lines for removal of a section of the top surface 25, thereby enabling the stylus to traverse the central area of the package when winding a suture filament through the assembled package in a figure-8 pattern. FIGURE 5 is an enlarged view of the suture wrapping channel 30 of a suture package, and specifically an enlargement of the inner channel wall projection 35′ of FIGURE 3 and lugs 32 and 34 on either side of projection 35′. FIGURE 5 shows the planar floor 31 of the channel 30 and lugs 32 and 34, all of which are formed in the bottom piece 12 of the suture package. The inner wall of the channel is also formed by the mating projections 35′ and 35 of the top piece 14 of the suture package. The top of the channel 30 is defined by the upper surface 26 of the top piece 14, which extends from the top of the projections 35′ and 35 and over the lugs 32 and 34. It has been found that a problem can arise when mating the top and bottom pieces of the suture package in this manner. Before the two pieces are mated together, the suture filament is wound around the lugs in the package bottom piece 12 in its oval pattern. As an alternative and currently preferred method of winding the suture filament in the channel, the two package pieces are first mated together and the suture filament is wound through the channel by a stylus inserted into the bottom of the channel between the outer walls 22 and 28 of the mated package pieces. The winding of the suture in either case can result in location of the suture filament in contact with the lugs at the inside of the channel, particularly at the oval ends of the package. In the instance of the first technique, when the top piece is placed inside and over the bottom piece, the mating edges of the lugs with the top of the channel and the mating edges of the projections with the floor of the channel can catch and pinch the suture filament in these locations. The mating edges of the lugs and top of the channel are indicated at 52 and 56, and the mating edges of the projections and the floor of the channel are indicated at 50 and 54. The two package pieces are then adhesively attached in the center of the oval, leaving the suture filament pinched between these mating edges. When the suture filament is later pulled from the package for surgical use, the filament will pull and snag where it is pinched in these mating edges. In the case of both the stylus winding technique and the pre-closure winding technique, when the suture is pulled from the package a "capstan" phenomenon will occur as the suture filament tightens around the inner wall of the channel as it is pulled. The tightening of the suture filament against the inner wall of the channel will cause the filament to enter and bind between the mating edges. In accordance with the principles of the present invention, a solution to this suture catching problem is shown in FIGURE 6. The solution is to alternately raise and lower the top and bottom of the suture wrapping channel 30, which causes the wrapped suture filament to bridge the areas where it may become caught in the mating channel edges. The curved lug 32 and the straight lug 34 are seen to smoothly blend into raised channel floor areas 30′. On either side of these raised areas the channel floor is lowered as shown by areas 30′′. Similarly, the projections 35 and 35′ formed in the mating top piece 14 blend into lowered channel top areas 26′′. Where the upper surface 26 of the top piece overlies the lugs 32 and 34 to form the top of the channel, these portions of the channel top are raised as shown at 26′. These alternating raised and lowered areas cause the suture filament to bridge the mating edges where the filament can become entrapped between the two pieces of the package. While the depressed floor areas 30′′ in FIGURE 6 are shown as uniformly depressed across the width of the channel, it is preferable when using the aforementioned stylus winding technique to vary the depth of the depression across the width of the channel, as indicated by dashed line 30′′′. The depressed floor area 30′′ will then be level with the surrounding floor areas 30′ at the outer wall of the channel, and attain its maximum depression at the inner wall. This sloping of the depressed floor areas will provide a smooth floor at the outer periphery of the floor along which the stylus may smoothly travel during winding, while maintaining the depression at the inner wall which prevents the suture catching problem. This result can be more fully appreciated by referring to the cross-sectional views of the channel 30 shown in FIGURES 5a, 6a, and 6b. FIGURE 5a shows the top piece 14 of FIGURE 5, including the upper surface 26 and projections 35 and 35′, just as the top piece is about to mate with the bottom piece of the suture package. The interlocking bottom piece 12, including the lugs 32 and 34 and the channel floor 31, is shown below the top piece. The mating edge regions 50, 52, 54, and 56 where the suture filament may become pinched are clearly visible just before the two pieces interlock. FIGURE 6a shows the two package pieces of FIGURE 6 with the raised and lowered channel floor and top sections just before mating. The projections 35 and 35′ from the top piece 14 are seen to mate into the lowered floor sections 30′′, and the lugs 32 and 34 are seen to mate into the raised channel top sections 26′. Intermediate these sections the floor is alternately raised and the top is alternately lowered as shown at 30′ and 26′′, respectively. As FIGURE 6b illustrates, the alternately raised and lowered sections cause the suture filament 60 and 62 to bridge the areas 50-56 where the filament can become pinched between the mating pieces either during assembly of a pre-wound suture package or during suture withdrawal due to the capstan effect. It has been found that another suture catching problem can occur when using the suture packages of FIGURES 1 or 3. As the suture is pulled through the channel 30 and unwinds, the free end of the suture will straighten out and extend to the outer wall of the channel formed by the overlapping surfaces 28 and 22. It has been discovered that the end of the suture can become caught under the bottom edge of the wall surface 28 or between the outer surface of wall 28 and the inner surface of wall 22. The problem is especially acute when a substantial length of the end of the suture filament becomes caught along the straight lengthy side of the channel 30. In accordance with a further aspect of the present invention, the problem of suture catching along the overlapping outside walls of the channel is minimized by alternately recessing the outer walls of the top and bottom pieces of the suture package as illustrated in FIGURE 9. This FIGURE shows a section of the bottom piece 12 with its top outer flange 13 and floor 31 connected by the outer wall surface 22. Fitting within the wall surface 22 is the overlapping wall surface 28 of the top piece, which is joined at its upper edge to the upper surface 26 of the top piece. It may be seen that the two wall surfaces 22 and 28 are periodically recessed in tandem as indicated at 22′ and 28′. As the suture end slides along the outer wall, it may enter the small spaces 29 below the lower edge of the wall 28. However, because these entrapping spaces 29 do not continue in a straight line, but are interrupted where the outer wall is recessed at 28′ and 22′, the end of the suture is unable to become entrapped under a substantial length of the lower edge of the outer wall 28. The relatively short lengths of the projecting wall sections 28 are inadequate to trap the end of the suture with any substantial retentive force, and hence the suture filament will pull smoothly from the suture package. It has been found that, when a suture package with the alternately raised and lowered floor sections is wound with a suture from a suture-carrying stylus inserted between the outer walls 22 and 28, the stylus will bump up and down as it travels along the uneven floor of the channel. To prevent this occurrence in the embodiment of FIGURE 9, the outer wall 28, 28′ is modified by the addition of a lateral flange as shown in FIGURE 9a. In this FIGURE it may be seen that the outer wall 128 is not flush with the surface of outer wall 22, but is offset from wall 22 by a lateral flange 130. Similarly, the outer wall 128′ is offset from outer wall 22′ by a bottom lateral flange 124. The lateral flanges 130 and 124 are in the same plane, and extend continuously around the outer periphery of the channel 30. When the suture-carrying stylus is inserted between the walls 22, 128 or 22′, 128, it will track along the surface of the flanges 130, 124 as it travels around the periphery of the channel. The stylus will thus travel smoothly in the same plane about the channel. A preferred oval suture package constructed in accordance with the present invention is shown in FIGURES 7a-7d. FIGURE 7a illustrates a top plan view of the package, in which the suture filament 60 is seen wound in the channel 30. The channel 30 is surrounded by the sealing flange 13 of the bottom piece 12 extending outward from the channel and in a plane near the upper planar surface of the package. The central floor area 24 of the top piece 14 is recessed to contact the similarly recessed central area 31 of the bottom piece 12. The inner wall of the channel 30 is defined by the curved lugs 32, 32′, and 32′′ and the straight lugs 34 formed in the bottom piece 12. The projection 41 for the package peel tab is shown at the upper right corner of the package. The outer periphery of the top piece which forms the channel top is raised at 26′ where the lugs are located, and is depressed over channel areas 26′′ between the lugs. The section of the top piece between lugs 32′ and 32′′ is cut away at edges 68 and 66 to form an opening where the needle 70 attached to the suture 60 exits the channel 30. This exit area is shown more clearly in the enlarged view of FIGURE 7c, where the edge 68 is seen to retain the needle 70 in the center (i.e., from top to bottom) of the channel 30. The needle is held in place in the central area 24 of the package by the foam needle park 72. The needle may be held by the needle park 72 either by piercing the foam as indicated in FIGURE 7a, or by insertion in a slit cut into the foam. A plan view of the bottom of the suture package of FIGURE 7a is shown in FIGURE 7b. The central area 64 of the bottom of the package is in the same plane as the channel sections 30′′, which extend outward in alignment with the projections 35 of the top piece 14. The sections 30′′ of the bottom piece form the lowered floor sections of the channel 30, and the raised floor sections 30′ are in alignment with the lugs of the bottom piece. During use, the needle and suture are conventionally withdrawn from the suture package by grasping the body of the needle with a forceps. The needle is then pulled to withdraw the suture from the package as shown in FIGURE 7d. As FIGURE 7d shows, the cutaway 38 for the suture exit from the channel 30 is preferably located at the juncture of an oval end of the package with a straight section 74 of the oval channel. It may be seen that the suture is wound so that the suture will exit the channel 30 in a straight line with the long straight side 74 of the oval. By pulling the suture from a straight section of the oval rather than from a curved oval end of the channel, binding and frictional resistance of the suture as it unwinds from the channel 30 is minimized. In the embodiment of FIGURE 7d this is accomplished by locating the edge 68 of the cutaway opening 38 so that the suture is withdrawn in a straight line from the inside wall (32, 35) of the straight channel section 74 and through the opening 38. An alternate means for retaining the needle within the suture package, or needle "park", is illustrated in FIGURES 8a and 8b. This needle park comprises a molded projection or post 90 located in the depressed central area 24 of the top piece 14 of the package. Adjacent the post 90 is a molded rail 92 with end supports 94 and 96. Taking advantage of the precise tolerances which may be maintained by the molding process, the rail 92 is spaced apart from the post 90 by a distance which is slightly smaller than the diameter of the needle 70. The needle 70 is retained in place by contact on either side of the needle with the post and the rail. Because the rail is relatively thin and formed of the polymeric material of the package, it is resiliently flexible and will bend to accommodate placement of the needle between the post and rail. FIGURE 8a is a plan view of the needle 70 when placed between the post and rail, which causes the rail to flex slightly and hold the needle in place. FIGURE 8b is an enlarged view of the post 90, rail 92 and supports 94 and 96. While the needle park of FIGURES 8a and 8b is shown to be formed on a single molded surface such as the floor 24 of the suture package, portions of the needle park may be formed on both package pieces. The post 90 could be molded in the floor 31 of the bottom piece 12, and would extend through a hole cut in the floor 24 of the top piece 14. To enhance the flexibility of the rail 92, the bottom edge of the rail need not be connected to the underlying floor, but may be separated as by an opening formed beneath the rail as indicated at 93. To assure retention of the needle in the needle park, the opposing surfaces of the rail 92 and the post 90 may include a plurality of thinly formed ribs 98 as shown in FIGURE 8b. Another molded needle park is shown in FIGURES 10 and 10a. The needle park of FIGURE 10 is molded as a part extending upward from the depressed central area 24 of the top piece 14. The needle park comprises a platform 100 extending across the central area 24 of the top piece 14, between the inner walls of the channel in the location of the foam pad 72 of FIGURE 7a, discussed below. Attached to the top surface of the platform 100 are two string-like lengths 104 and 106 of the molded material. These strings are affixed at their ends to the top surface 102 of the platform. Formed in the bottom surfaces of the strings are tooth-like notches indicated at 105 and 107. The top 102 of the platform is open below the strings 104 and 106 as indicated at 110 and 112 to simplify the molding of the top piece. Needles are parked in the needle park of FIGURE 10 by insertion under the strings 104 and 106 and on top of the platform 100. The notches 105 and 107 prevent the inserted needles 70 from sliding in the direction of the length of the strings after insertion. The top 102 of the platform is recessed to a level below the upper surface 26 of the package top so that the top of the strings do not project above the level of the upper surface 26 after the needles have been inserted. Thus, the strings will not project upward to, or interfere with, the sealing of the overwrap across the top surface 26 of the suture package. Since the strings 104 and 106 are formed of the polymeric molding material, they are flexible so as to expand upward and back downward to hold the inserted needles securely in place. This needle park arrangement is capable of retaining needles of gages ranging from 0.2 mm (8 mils) to 1.1 mm (42 mils). Instead of inserting the points of the needles under the strings when they are parked, it may be easier to park them by sliding the central length of the needles under the strings from the ends of the strings. To enable this technique of needle insertion, an end of each needle is disconnected from the top surface 102 of the platform as indicated at 114. A needle is then parked by placing it on top of the platform surface 102 at the detached ends of the strings, then sliding the needle across the surface 102 and under the strings. A cross-sectional view of the needle park of FIGURE 10 is shown in FIGURE 10a. This view clearly shows the platform 100 extending upward from the depressed central area 24 of the top piece. The strings 104, 106 and their underlying open areas 110, 112 are also clearly shown in cross-section. Instead of forming the needle park of FIGURES 10 and 10a solely on the floor 24 of the top piece, the platform 100 can be molded on the floor 31 of the bottom piece and the strings 104, 106 can be molded in the top piece. The platform 100 extends through an opening formed in the overlying floor 24, and the strings are formed above this opening, stretching between the walls 36 of the channel. The needles may then be placed on the top surface 102 of the platform 100, and will be held in place when the top piece is mated with the bottom piece, which brings the extended strings down into contact with the needles. The suture package pieces 12 and 14 of the present invention may be formed by molding processes such as injection molding or thermoforming. The pieces may be made of any surgically compatible polymeric materials, such as polyester plastic, PET-G polyethylene, polyvinyl chloride (PVC), polypropylene, or polystyrene. The preferred technique for assembling the package is to first affix the top and bottom pieces together and attach the needle park if the foam-style needle park is employed. The preferred technique for winding the suture filament through the channel is to insert the end of the suture into a stylus which will travel through the channel between the overlapping outer walls of the top and bottom pieces. Prior to winding the suture the needle is inserted in the needle park. The suture filament is then wound around the channel starting from the end of the suture which is attached to the needle until the suture is fully wound within the channel. The present inventors have experimented with several winding techniques, including winding the end portion of the suture around the interior "capstan" of the channel first, and winding the suture portion which is closest to the point of attachment to the needle around the capstan first. It was found that, when the loop at the end of the suture was most interior in the channel (i.e., against the center capstan of the oval), and the loop at the point of needle attachment was the outermost loop of the wound suture, the suture would bind during withdrawal. This would occur as the outer loop being withdrawn first would tighten against the loops inside it, effectively pinning the underlying loops against the capstan in the center of the oval. To prevent this binding problem, the suture filament is wound through the channel so that the loop closest to the point of needle attachment (the loop which is withdrawn first from the suture package) is the most interior loop, located closest to the center of the channel. Loops of suture located progressively toward the free end of the suture are disposed sequentially toward the outer periphery of the channel, with the free end of the suture at the outside of the channel. Thus, when the suture is withdrawn from the package, the first loop withdrawn will dispense from the capstan. The next loop will then tighten toward the capstan and similarly be dispensed therefrom. With the loops progressively moving inward to the capstan as they are withdrawn, there will be no binding caused by the pinning of a loop of suture filament against the capstan by the loop being withdrawn. Loops to be subsequently withdrawn will move freely around the periphery of the channel as the loop being withdrawn is dispensed from the interior capstan. It may be appreciated that the oval wrapped suture package of the present invention imparts very little "set", or "memory" to the wound suture as compared, for instance, to a conventional figure-8 or other winding pattern with numerous loops and tight bends. The only curves to the winding pattern are the semicircular turns at the ends of the oval shape, which are made over almost the full width of the rectangular package. The sides of the oval channels may, in a modified embodiment, also be gradually curved outward as the suture filament passes from one end of the oval to the other in the shape of a "O". However, such a pattern may unacceptably widen the rectangular package or require a tighter curvature of the winding than the semicircular 180° end turns of the package of the preferred embodiment. It has been found that the oval shape with straight sides connecting the semicircular ends will result in a filament memory with straight filament segments between arcuate sections, an acceptable shape for a surgical filament. The preferred oval shape in a rectangular package is an optimal compromise of the objectives of minimal suture memory, smooth tangle-free withdrawal, and minimal package width for efficient packaging of a number of suture packages. Modifications may be made to the invention within the scope of the appendant claims. For example, the package of claim 1 may comprise package pieces which are molded from polymeric material. The oval channel may exhibit semicircular ends and straight sides interconnecting the semicircular ends. Alternatively, the oval channel may exhibit rounded ends of a smaller radius and sides of a larger radius interconnecting the rounded ends. Each of the package pieces may exhibit a length, a width, and a thickness which is aligned with the height of the channel. In particular, the first piece may be molded to form the bottom and an outer wall of the channel, and the second piece may be molded to form the top and an inner wall of the channel, with the second piece fitting on top of the first piece. The top of the channel may be alternately raised and lowered in alignment with the raised and lowered portions of the channel floor. In the package of claim 2, the first piece may further include a central planar area in the plane of the channel floor, and the second piece may further include a depressed central area, wherein the depressed central area of the second piece overlies the central planar area of the first piece when the package pieces are engaged. The projecting means of the first piece may comprise a plurality of spaced lugs arranged in an oval configuration, and the second piece may further include a plurality of projecting walls in the thickness dimension and spaced to engage between the lugs of the first piece when the pieces are engaged, with the lugs and the projecting walls defining the interior wall of the channel. The top of the channel thus formed by the second piece may extend from the projecting walls. The second piece may further include an outer oval wall extending from the outer periphery of the top of the channel in the thickness dimension and suitable for aligning within the outer wall of the first piece when the package pieces are engaged. The channel may include an aperture for passage of a suture from the channel to the central area of the package. The package may further include a suture with an attached needle located in the channel and means, located in the center of the oval channel, for retaining a needle, wherein the needle and attached suture exits the channel through the aperture and the needle is retained in the center of the oval channel by the retaining means. The channel may comprise opposing straight sides joined by two arcuate end sections, wherein the aperture is located at the juncture of a straight channel side and an arcuate end section. In the package of claim 3, the first package piece may include an outer overlapping surface of the outer wall, and the second package piece may include an inner overlapping surface of the outer wall, wherein the outer overlapping wall is connected to the floor of the channel and the inner overlapping wall is connected to the top of the channel. In the molded package of claim 4, the molded linear section may comprise a hollow molded rail having a length greater than its height, its height being in the dimension of the height of the molded projection, and the rail being supported by supporting projections at its linear ends. A portion of the molded linear section opposing the molded projection may be detached from the underlying floor of the space. The surface of the molded linear section opposing the projection may include at least one molded needle retention rib. The molded projection may comprise a rounded projecting post. The package of claim 5 may further include a flange extending from said one rounded end of the channel and underlying the peel tab, the flange including a projection extending from its surface to space the peel tab above the surface of the flange. The oval channel may include an aperture for enabling the suture to exit the channel, the aperture being located at the indented end of the channel. In the package of claim 6, the first projecting means may comprise a circular projection and the second projecting means may comprise an oval projection. The first projecting means may comprise a plurality of lugs arranged in a circle, and the second projecting means may comprise a plurality of lugs arranged in an oval configuration. The second piece may include a depression for engaging the center of one of the projecting means, and further including means, located in the depression, for holding a needle. The package may further include an aperture in the channel adjacent the projecting means engaged by the depression for enabling a suture with a needle to exit the channel, whereby the needle may be retained in the needle holding means. The floor of the first piece may extend across the oval channel between the first and second projecting means and the second piece may extend above the first piece extension to define a cavity within the package between the first and second projecting means. A portion of the second piece defining the top of the cavity may be cut away between the first and second projecting means, whereby a suture may be wound in the package channel and cavity around the first and second projecting means in a figure-8 pattern. In the arrangement of claim 7, the string-like length of material may be notched along its length on the side of the length which opposes the surface of the area. The needle retainer may further include a platform supporting the string-like length of material, the top of the platform being elevated above the surface of the area. The area of the package may be formed of molded material, and the string-like length of material and the platform may be formed of the same piece of molded material as the area. The package may be formed of molded material, the string-like length may be formed of a first piece of molded material, and the platform may be formed of a second piece of molded material. The arrangement may further comprise an opening located beneath the length of string-like material between the attached ends of the length. The arrangement may further include a continuous channel in which suture material may be wound, the channel including an opening permitting suture material to exit the channel, wherein the needle retainer area is surrounded by the closed channel. The channel may be located in the major plane of the package, the top and bottom of the channel may be parallel to the major plane and define the top and bottom of the package, and the length of the string-like material may be located substantially parallel to said major plane, wherein the length of string-like material is located between the top and bottom of the package when the needle retainer engages a needle. In the method of claim 9, the step of attaching the needle may comprise attaching the needle to a needle park location in the center of the oval channel. The step of winding may comprise attaching the filament to a stylus at a point in the proximity of its free end, then causing the stylus to travel through the channel to wind the filament through the channel.

Claims: A package for retaining a wound suture comprising first (12) and second (14) joined package pieces which define within the interior of the package an oval channel (30) in which a suture may be wound in an oval pattern, characterised in that the floor (31) of said channel (30) is alternately raised and lowered, and the interior wall of said channel (30) is at least partly defined by alternating wall sections (32, 33, 34, 35) formed in the first (12) and second (14) package pieces, wherein the wall sections formed in the first piece (12) are aligned with the raised floor areas and the wall sections formed in the second piece (14) are aligned with the lowered floor areas. A package according to claim 1, in which: said first package piece (12) is molded and has a length, a width, and a thickness, with an oval channel outer wall (22) formed in the piece (12) in the thickness dimension and an oval channel floor (31) formed adjacent and inside of said outer wall (22) in the plane of said length and width dimensions, and means (32, 33, 34) projecting from the plane of said floor (31) and spaced apart from said outer wall (22) to define portions of said wall sections; and said second package piece (14) is molded and suitable for engaging with said first piece (12) to form the top (26) of said channel (30) overlying said channel floor (31). A package according to claim 1, wherein said first (12) and second (14) package pieces include overlapping surfaces (27, 28) defining the outer wall of said channel (30), wherein said overlapping surfaces (27, 28) alternately project toward and away from the interior of said channel (30) along a length of said channel A package according to claim 1, including a space surrounded by said channel for retaining a needle comprising: a molded projection (90) formed within said space; and a flexible molded linear section (92) located adjacent said projection (90) and tangentially spaced apart from said projection (90) by less than the diameter of a needle, said linear section 92) undergoing flexure when said needle is emplaced between said projection (90) and said linear section (92). A package according to claim 1, said oval channel being sealed by an overlying sheet (18) of packaging material extending beyond the periphery of said channel (30), at one rounded end of said channel, and said oval pattern being indented at said one rounded end to delineate a peel tab of said overlying sheet. A package according to claim 2, wherein said means projecting from the plane of said floor of said piece comprises first and second means (32) respectively spaced apart from said outer wall at the oval ends of said channel to define part of the inner wall at the oval ends of said channel. A package according to claim 1, including a needle retainer comprising: a string-like length (104) of flexible material attached to a surface of said package at opposite ends of said length, whereby said needle may be retained by inserting the needle under the string-like length (104) of flexible material and on top of the area surrounding said length (104) of material. A package according to claim 1, including a needle retainer comprising: a string-like length (104) of flexible material attached at one end to extend across a surface of said package, whereby said needle may be retained by inserting the needle under the string-like length (104) of flexible material from the detached end of said string-like length (104) and on top of the area surrounding said length (104) of material. A method for substantially entirely winding a suture filament (60) in an oval channel (30) of a suture package according to claim 1, said suture filament (60) being attached to a needle (70) at one end and having a second, free end, comprising the steps of (a) winding said filament (60) through said channel (30) ending with its free end and (b) attaching the needle to a needle park location on the package, steps (a) and (b) being performed in either order.

Inventors: ALPERN MARVIN, CERWIN ROBERT JAMES, KALINSKI ROBERT J, ALPERN, MARVIN, CERWIN, ROBERT JAMES, KALINSKI, ROBERT J.
Applicants: ETHICON INC, ETHICON INC.
Application year: 1989
Main classification: A61B17
IPC codes: A61B17