PACKAGE FOR SUTURES

Abstract

A package for surgical sutures has a base member, an outer wall extending upwardly form the periphery of the base member, a plurality of pyramidal shaped standoff members arranged in an oval shape and a flat suture channel cover member having a plurality of precision holes to lock the cover member to the standoff members of the base member. The inner surface of the outer wall of the base member is a profiled surface and the outer periphery of the cover member has a profiled surface corresponding to the profiled surface of the outer wall of the base member. The profiled surface of the outer wall can consist of a plurality of D shaped vertical members extending from the top surface of the base member to the top of the outer wall.

Claims

1. A package (10) for surgical sutures (94), comprising a base member (12, 12.2, 12.3) having a top surface (20, 20.2, 20.3), a bottom surface, an outer periphery (22) and a longitudinal axis (24), an outer wall (30, 30.2) extending upwardly from the periphery (22) of said base member (12, 12.2, 12.3), said outer wall (30, 30.2) having an inner surface (32, 32.2), an outer surface (34) and a top (36), a plurality of pyramidal shaped standoff members (40) arranged in an oval shape that defines and captures the suture (94) extending from the inner surface (20, 20.2, 20.3) of the base member (12, 12.2, 12.3), each standoff member (40) having a top (44), a bottom and an outer surface (42), said standoff members (40) in conjunction with each other form a suture track area (16) to retain suture (94), a flat suture channel cover member (14) having a top surface (60), a bottom surface and an outer periphery (62), said cover member (14) having a plurality of precision holes (74) to lock said cover member (14) to the standoff members (40) of the base member (12), an opening (72) in the outer edge of the cover member (14) forming a suture port having a first end and a second end, needle park means (80, 80.2) located interior to the standoff members (40) and extending from the top surface (20, 20.2, 20.3) of the base member (12, 12.2, 12.3) wherein the inner surface (32, 32.2) of the outer wall (30, 30.2) of the base member (12, 12.2) is a profiled surface, the outer periphery (62) of the cover member (14) has a profiled surface (64) corresponding to the profiled surface of the outer wall (30, 30.2) of the base member (12, 12.2, 12.3).

2. The package according to claim 1 wherein the profiled surface (32, 32.2) of the outer wall (30, 30.2) consists of a plurality of bulges (38, 39) extending from the top surface (20, 20.2, 20.3) of the base member (12, 12.212.3) to the top (36) of the outer wall (30, 30.2).

3. The package according to claim 2 wherein the bulges (38, 39) are D shaped vertical members.

4. The package according to claim 3 wherein the D shaped vertical members (38, 39) protrude at least one millimetre from the outer wall (30, 30.2) of the base member (12, 12.2, 12.3).

5. The package according to claim 1 further comprising a plurality of air slots (50, 50.2) in the suture track area (16) of the base member (12, 12.2, 12.3).

6. The package according to claim 5 further comprising a plurality of lock members extending inward from the inner surface of the outer wall, each lock member having a top, a bottom and an outer surface.

7. The package according to claim 5 further comprising at least one tab member (120) extending outward from the outer surface (42) of the standoff member (40) and facing the inner surface (32) of the outer wall (30).

8. The package according to claim 1 further comprising at least one spacer (58) extending from the inner surface (20) of the base member (12), each spacer (58) having a top, a bottom and an outer surface, said spacers (58) being arranged between two standoff members (40).

9. The package according to claim 8 wherein said spacers in conjunction with each other and in conjunction with at least some of the standoff members (40) form an inner wall (46, 48) for the suture track area (16).

10. The package according to claim 1 wherein the standoff members (40) of the base member (12, 12.2, 12.3) are shaped like truncated pyramids.

11. The package according to claim 1 wherein the base member (12, 12.2, 12.3) is transparent.

12. The package according to claim 1 additionally comprising holes (76, 78) through the cover member (14) for receiving winding pins.

13. The package according to claim 1 further comprising a suture (94) wound into the winding channel (16), a surgical needle (92) mounted in the needle park means (80, 80.2).

14. The package according to claim 1 wherein the package (10) has an oval configuration.

15. The package according to claim 1 wherein the needle park member (80) comprises at least one cantilevered horizontal arm (82, 84, 86) extending from the top surface (20) of the base member (12) and a retaining feature (88, 90) for fixing the needle (92) under the at least one horizontal arm (82, 84, 86) of the needle park member (80).

16. The package according to claim 15 wherein the retaining feature comprises a concave area (88) at the bottom side of the at least one horizontal arm (82, 84, 86) and at least one snap (90) at the top surface (20) of the base member (12).

17. The package according to claim 1 wherein the needle park member (80.2) comprises at least one first web (100) and at least one second web (102) aligning each other the ends of the first web (100) and the second web (102), which are facing each other, are formed as a clamping device (106, 108, 110, 112).

18. The package according to claim 17 wherein the end of the first web (100), facing the second web (102), comprises a concave area (106) the end of the second web (102), facing the first web (100), comprises a convex area (108).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In the following text, the invention will be described and explained in greater detail using the exemplary embodiments which are shown in the drawings.

[0034] FIG. 1 is a top, plan view of a first embodiment of the package having a needle with suture mounted therein.

[0035] FIG. 2 is a top view of the base member of the package in FIG. 1.

[0036] FIG. 3 is a top view of the cover member of the package in FIG. 1.

[0037] FIG. 4 is an enlarged view of the base member of the package in FIG. 1 showing the needle park means.

[0038] FIG. 5 is a cross section through one of the needle park means of FIG. 4.

[0039] FIG. 6 is a cross section through one of the standoff members before the cover member has been fixed to it.

[0040] FIG. 7 is a cross section through the standoff member of FIG. 6 after the cover member has been fixed to it.

[0041] FIG. 8 is a top view of the base member of a second embodiment of the package.

[0042] FIG. 9 is an enlarged view of the base member in FIG. 8 showing the needle park means.

[0043] FIG. 10 is an enlarged perspective view of a part of the base member of a third embodiment of the package.

DESCRIPTION OF THE PREFERRED EMBODIMENT

[0044] The package 10 according to a first embodiment of the present invention is illustrated in FIGS. 1 to 7. As seen in FIGS. 1, 6, and 7, the package 10 has a base member 12 and a flat suture channel cover member 14.

[0045] Referring now in more detail to FIG. 2, the base member 12 is seen to have a top surface 20 and a bottom surface. The base member 12 is also seen to have an outer periphery 22. The base member 12 is seen to be a substantially flat and substantially oval shaped member having a longitudinal axis 24. However, although it is desired that the base member 12 along with the package 10 be oval shaped, other configurations can be used including circular, polygonal, square with rounded corner, and the like and combinations thereof and equivalents thereof.

[0046] Extending upwardly about the periphery 22 of the base member 12 is an outer wall 30. Outer wall 30 is seen to have a bottom, an inner surface 32, an outer surface 34 and a top 36. The inner surface 32 of the outer wall 30 is a profiled surface having a plurality of D shaped bulges 38 extending from the top surface 20 of the base member 12 to the top 36 of the outer wall 30. The D shaped bulges 38 protrude from the outer wall 30 at a minimum of one millimetre.

[0047] There can be optional notches at the top of the outer wall 30 of the base member 12. Theses notches are there to keep the base member 12 flat.

[0048] In FIG. 2 the standoff members 40 are seen to extend upward from the top surface 20 of the base member 12. According to FIG. 6 the standoff members 40 have a pyramidal shaped outer surface 42 and flat tops 44. The tops 44 of the standoff members 40 are preferably flush with the top 36 of the outer wall 30.

[0049] Extending through the bottom of the base member 12 is a plurality of air slots 50 (see FIG. 2). The air slots 50 are located between the outer wall 30 and the standoff members 40. Also extending through the bottom of the base member 12 are the circular winding drive pin locating hole 52 and the oval drive pin locating hole 54. The holes 52 and 54 are seen to be disposed along the longitudinal axis 24 and are at opposite ends of the base member 12. An optional slit in the bottom of the base member 12 interior to the outer wall 30 can form the tab lifting member 56.

[0050] Furthermore, there is a cantilevered spacer 58 positioned between two of the standoff members. The spacer 58 defines the position when the cover member 14 is pushed down onto the base member 12 to the lowest possible level. There can be one spacer 58 as shown in FIG. 2 or there can be more spacers 58 evenly spread on the top surface 20 of the base member 12.

[0051] Referring now to FIG. 3, the suture channel cover member 14 is seen to be illustrated. The suture channel cover member 14 has a top surface 60, a bottom surface, and a periphery 62. The D shaped bulges 38 of the outer wall 30 of the base member have a mirrored cut in the outer periphery 62 of the cover member 14. Those matching indentations 64 in the cover member 14 providewhen assembledan interlocking barrier that will contain sutures down to a size of 10/0 and keep them within the package 10.

[0052] The pin winding holes 66 and 68 are seen to be contained at opposite ends of the cover member 14. The pin winding holes 66 and 68 are seen to extend through the cover member 14 and to be disposed in the cover member 14 along its longitudinal axis 70, toward either end. They line up with the winding drive pin holes 52, 54 in the base member 12. Pin winding hole 66 is circular in shape, whereas pin winding hole 68 is of oval shape. However, other geometric shapes can be utilized.

[0053] The suture exit port 72 is seen to be contained in the cover member 14. Also seen to extend through the cover member 14 are precision holes 74 that mate up with the standoff members 40 of the base member 12. The diameter and shape of the precision holes 74 is determined by the shape of the standoff members 40. In order to lock the cover member 14 to the base member 12 the top 44 of the standoff members 40 are deformed by using ultrasonic sound, for example. This flattens and broadens the top 44 of the standoff members 40 (see FIG. 7). After this deformation of the top 40 of the standoff members 40, the precision holes 74 of the cover member cannot slip off the standoff members 40 so the cover member 14 is securely locked to the base member 12.

[0054] There is a multiplicity of suture winding pin holes 76 that extend through the cover member 14. The suture winding pin holes 76 are located between the outer periphery 62 and the precision holes 74. The preferred shape of the suture winding pin holes 76 is circular but other shapes can be utilized such as oval, octagonal, semi-circular, polygonal, triangular, combinations thereof and equivalents thereof and the like.

[0055] To maintain the control of the small needles a novel needle park 80 in the base member 12 is shown. The needle park 80 in FIGS. 4 and 5 is shown in its preferred configuration with three horizontal cantilevered arms 82, 84, 86. Each horizontal arm 82, 84, 86 has a concave area 88 at its bottom side (see FIG. 5). There are snaps 90 in the form of angled ramps on either side of the horizontal cantilevered arms 82, 84, 86 rising from the top surface 20 of the base member 12. These ramps 90 prevent the smaller needles from moving during transportation or from premature releasing.

[0056] The packages 10 of the present invention are assembled in the following manner. The needle 92 is placed into at least one of the horizontal cantilevered arms 82, 84, 86 of the needle park. Then, the suture 94 is threaded into the winding channel 16 of the base member 12 between the inner surface 32 of the outer wall 30 and the standoff members 40. During winding, negative pressure is applied through the air slots 50 in order to keep the suture 94 in the winding channel 16. Next, the suture channel cover member 12 is printed by conventional means and pin winding holes 66, 68 of the cover member 14 are aligned with winding drive pin locating holes 52, 54 of the base member 12. After the winding of the suture 94 is completed, the cover member 14 is pushed down onto the base member 12 until the precision holes 74 are in contact with the outer surface 42 of the standoff members 40. While still applying negative pressure, the tops 44 of the standoff members 40 are deformed in order to lock the cover member 14 to the base member 12.

[0057] The package 10 containing the wound suture 94 and the needle 92 may then be placed in a conventional pouch or package for conventional sterilization treatments such as gaseous sterilants, autoclaving, radiation and the like.

[0058] The base member 12.2 of a package according to a second embodiment of the present invention is illustrated in FIGS. 8 and 9. The base member 12.2 as seen in FIG. 8 can be combined with a cover member similar to the cover member 12 shown in FIG. 3.

[0059] The base member 12.2 is seen to have a top surface 20.2 and a bottom surface. The base member 12.2 is also seen to have an outer periphery 22.

[0060] The base member 12.2 is seen to be a substantially flat and substantially oval shaped member having a longitudinal axis 24.

[0061] Extending upwardly about the periphery 22 of the base member 12.2 is an outer wall 30.2. The inner surface 32.2 of the outer wall 30.2 is a profiled surface having a plurality of D shaped bulges 38, 39 extending from the top surface 20.2 of the base member 12.2 to the top 36 of the outer wall 30.2. The D shaped bulges 38, 39 protrude from the outer wall 30.2 at a minimum of one millimetre. The D shaped bulges 38 are approximately semi-circular in shape whereas the D shaped bulges 39 are much longer. In FIG. 8 the four D shaped bulges 39 are positioned in the transition region of the base member 12.2 between the straight middle section and the round end section. In contrast to that, it is possible to have more or less of the longer D shaped bulges 39 and they could be positioned at will.

[0062] In FIG. 8 the standoff members 40 are seen to extend upward from the top surface 20.2 of the base member 12.2. The standoff members 40 have a pyramidal shaped outer surface 42 and flat tops 44. The tops 44 of the standoff members 40 are preferably flush with the top 36 of the outer wall 30.2. Most of the standoff members 40 are part of an inner wall area 46.

[0063] The top of the inner wall area 46 lies beneath the top 36 of the outer wall 30.2 and also beneath the top 44 of the standoff members 40. Therefore, the inner wall area 46 can define the position when the cover member is pushed down onto the base member 12.2 to the lowest possible level. Furthermore, the inner wall area 46 can ease the withdrawal of the suture.

[0064] Extending through the bottom of the base member 12.2 is a plurality of air slots 50.2. The air slots 50.2 are located between the outer wall 30.2 and the inner wall area 46 with the standoff members 40. The air slots 50.2 are located in the suture track channel 16. Also extending through the bottom of the base member 12.2 are the circular winding drive pin locating hole 52 and the oval drive pin locating hole 54. The oval drive pin locating hole 54 also extends through the inner wall area 46 of the base member 12.2. The holes 52 and 54 are seen to be disposed along the longitudinal axis 24 and are at opposite ends of the base member 12.2. An optional slit in the bottom of the base member 12.2 interior to the inner wall area 46 can form the tab lifting member 56.

[0065] To facilitate the insertion of the needles a novel needle park 80.2 in the base member 12.2 is shown. The needle park 80.2 in FIG. 9 is shown in its preferred configuration with a first web 100, a second web 102, and a third web 104 aligning each other. The web 100 comprises a concave area 106 on the end facing the second web 102. The second web 102 comprises a convex area 108 on the end facing the first web 100 and a concave area 110 on the end facing the third web 104. The third web 104 comprises a convex area 112 on the end facing the second web 102. The convex areas 108, 112 of one web 102, 104 and the corresponding concave areas 106, 110 of the respective web 100, 102 form a clamping device for a needle 92. The needle 92 can be positioned between the concave area 106, 110 and the convex area 108, 112 in order to be fixed in the package.

[0066] It is possible to have a combination of the needle park 80 according to FIGS. 4 and 5 and the needle park 80.2 according to FIG. 9 in one base member. For example, the needle park 80.2 according to FIG. 9 could be combined with one horizontal cantilevered arm 86 and two angled ramps on either side of the horizontal cantilevered arm 86 according to FIG. 4.

[0067] The base member 12.3 of a package according to a third embodiment of the present invention is illustrated in FIG. 10. The base member 12.3 as seen in FIG. 10 can be combined with a cover member similar to the cover member 12 shown in FIG. 3.

[0068] The base member 12.3 is seen to have a top surface 20.3 and a bottom surface. The base member 12.3 is also seen to have an outer periphery 22. The base member 12.3 is seen to be a substantially flat and substantially oval shaped member having a longitudinal axis 24. Extending upwardly about the periphery 22 of the base member 12.3 is an outer wall 30. The outer wall 30 of the base member 12.3 is identical to the outer wall 30 of the base member 12 according to FIGS. 1 and 2. It would also be possible to combine the outer wall 30.2 of the base member 12.2 according to FIG. 8 with the base member 12.3 according to FIG. 10.

[0069] In FIG. 10 the standoff members 40 are seen to extend upward from the top surface 20.3 of the base member 12.3. The standoff members 40 have a pyramidal shaped outer surface 42 and flat tops 44. The tops 44 of the standoff members 40 are preferably flush with the top 36 of the outer wall 30. The standoff members 40 positioned at the round end section of the base member 12.3 are part of an inner wall 48. The top of the inner wall 48 lies beneath the top 36 of the outer wall 30.2 and also beneath the top 44 of the standoff members 40. Therefore, the inner wall 48 can define the position when the cover member is pushed down onto the base member 12.3 to the lowest possible level. Furthermore, the inner wall 48 can ease the withdrawal of the suture.

[0070] Extending through the bottom of the base member 12.3 is a plurality of air slots 50.2. The air slots 50.2 are located between the outer wall 30.2 and the inner wall 48 with the standoff members 40. The air slots 50.2 are located in the suture track channel 16. Extending outward from the outer surface 42 of the standoff members 40 are tab members 120. The tab members 120 are facing the inner surface 32 of the outer wall 30. The tab members 120 are positioned above the air slots 50.2 so the whole base member 12.3 may be produced in one mould. A cover member can be positioned above the tab members 120 in order to better define the distance between the cover member and the top surface 20.3 of the base member 12.3. Furthermore, those tab members 120 can prevent the suture from leaving the suture track area 16 once the cover member is removed.

[0071] In contrast to the embodiment shown in FIG. 10, those tab members 120 could also be combined with standoff members 40 without an inner wall 48 (as shown in FIGS. 1 and 2) or with standoff members 40 included in an inner wall area 46 (as shown in FIG. 8).

[0072] There could be lock members extending inward from the inner surface of the outer wall of the base member. Those lock members should also be positioned above the air slots of the base member so the whole base member may be produced in one mould. A cover member of the package can be positioned under those lock members in order to fasten the cover member to the base member. Those lock members could be combined with the tab members of the standoff members and they could also be combined with the different D shaped vertical members 38, 39 as shown in FIG. 8.

[0073] The base member 12 of the packages 10 of the present invention may be manufactured from conventional mouldable materials. It is especially preferred to use polyolefin materials such as polyethylene and polypropylene, other thermoplastic materials, and polyester materials such as nylon, and equivalents thereof. Preferably, the base members 12 of the present invention are injection moulded, however, the base members 12 may be formed by other conventional processes and equivalents thereof included thermo-forming. If desired, the packages 10 may be manufactured as individual assemblies or components which are then assembled.

[0074] The sutures and needles that can be packaged in the packages 10 of the present invention include conventional surgical needles and conventional bio-absorbable and non-absorbable surgical sutures and equivalents thereof. The packages 10 of the present invention are useful to package small diameter sutures which were previously difficult to package in tray packages because of removal or hang-up problems upon withdrawal of such sutures from the packages. These problems have been overcome using the packages 10 of the present invention.