Suture winding apparatus and methods, devices and holders associated therewith

Abstract

The present disclosure relates to an apparatus and method for winding a surgical suture into a suture holder adapted to receive the suture therein.

Description

Cross-references to related applications

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 569,349, filed March 25, 2024, the entire contents of which are incorporated herein by reference. Background Technology 1. Technical Field This disclosure relates to apparatus and methods for winding surgical sutures into a suture retainer, and more specifically to a suture winding apparatus including a suture winding device for winding sutures into a suture retainer, a method for winding sutures into a suture retainer, and a suture retainer suitable for receiving sutures therein.

[0003] 2. Related Technologies Various systems and methods for winding sutures into suture retainers are known. While existing systems, methods, and retainers may be adequate for their intended use, winding and / or unwinding sutures into and / or from retainers remains laborious and costly. For example, many winding systems and methods utilize winding devices that require additional equipment, such as stylus needles or other rotatable suture guides, to attempt to prevent improper placement of the suture within the retainer. These additional devices can often be costly to develop, difficult to maintain, and may wear down over time, leading to improper suture placement within the retainer. Misplacement of the suture within the retainer can cause various problems, including, but not limited to, the suture being loaded in a tangled or crossed configuration, making extraction difficult due to increased friction between the crossed portions of the suture. This can result in damage to the suture during removal from the retainer, and when the suture cannot be completely removed, both the suture and the retainer must be discarded. Therefore, there remains a need for novel winding systems, methods, and suture retainers that provide sutures that are wound in an orderly, non-crossing, and / or vertically stacked manner during the winding process and while held inside the retainer, thereby facilitating removal. Summary of the Invention

[0004] This disclosure relates to suture winding devices and apparatuses for winding sutures into suture retainers, methods for winding sutures into suture retainers, and suture retainers suitable for receiving sutures therein, which are less costly, simpler in structure, and more efficient than existing devices, methods, and retainers.

[0005] This disclosure relates to a suture retainer, particularly a one-piece suture retainer, which includes at least a base, an outer wall, a plurality of spaced-apart inner wall segments, and a suture channel defined therein. The base extends between an inner base portion and an outer base portion. The outer base portion includes a plurality of alternating outer base portions and a base opening defined therethrough. The outer wall is positioned along the outer periphery of the base. A lower wall portion is attached to the outer portion of the base. The plurality of spaced-apart inner wall segments are positioned inward relative to the outer wall and are generally parallel to the outer wall. Each inner wall segment extends vertically between a lower segment portion and an upper segment portion. The lower segment portion is attached to a portion of the inner base portion, and the upper segment portion includes a tab extending radially from the upper segment portion toward the outer wall. Each inner wall segment is sandwiched between a first slit defined through the base and a second slit defined through the base. Each base opening communicates with both the first and second slits, thereby sandwiching each inner wall segment in the middle. The suture channel is located along the outer basal portion of the base and is defined between the outer wall, multiple spaced inner wall segments, the outer basal portion, and the flaps.

[0006] In some embodiments, the outer wall of the retainer is continuously positioned along the outer periphery of the base and includes a plurality of spaced-apart recessed protrusions extending inward from the upper wall portion of the outer wall.

[0007] In some embodiments, each tab and inner wall segment forms a generally L-shaped profile, and the tabs and inner wall segments are configured to be lifted into an open configuration by deflecting the inner basal portion, the lower segment portion, or a portion of both. The open configuration of the tabs and inner wall segments opens the top portion of the suture channel for loading sutures into the suture channel.

[0008] In some embodiments, the generally L-shaped profile of the tabs and inner wall segments remains unchanged in the open configuration and returns to the closed configuration covering the suture channel with the same generally L-shaped profile.

[0009] In some embodiments, each base opening extends along each inner wall segment, thereby separating each wall segment from the outer wall.

[0010] In some embodiments, the suture retainer includes a needle region inside the inner wall section. The needle region may further include a needle resting portion, particularly a sliding needle resting portion.

[0011] In some embodiments, the needle region further includes a first winding pin hole, and the suture channel further includes a second winding pin hole.

[0012] In some embodiments, the suture retainer further includes a needle region inside the inner wall, the needle region further including a cut in the base, a needle rest, a raised label groove, a wrapping pin hole, or any combination thereof. The needle region may include a first wrapping pin hole, and a second wrapping pin hole may be replaced in one of the first wall segments along the inner wall.

[0013] In some embodiments, the suture retainer further includes a suture needle assembly, wherein the sutures of the suture needle assembly are wound in an orderly or non-crossing configuration and stacked vertically in a central portion of the suture channel. The non-crossing vertical stacking configuration is maintained in the suture channel after loading is complete.

[0014] In some embodiments, the suture retainer defines an oval retainer external shape.

[0015] This disclosure also relates to suture wrapping devices comprising a wrapping base and a complementary wrapping cap. The wrapping devices can be adapted for use with any suture retainer, particularly with the suture retainers described herein.

[0016] The winding base includes a retainer cavity configured to receive a suture retainer therein. The retainer cavity defines the external shape of the cavity. The retainer cavity is defined by winding base sidewalls and a winding base plate. The winding base sidewalls include a beveled top edge defining a lower suture guide surface of the winding device. The suture guide surface is configured and / or angled to guide the suture into the winding device.

[0017] The wrapping cap is configured to cover a portion of the wrapping base while leaving a vertical gap between the wrapping cap and the wrapping base to allow the thread to pass through the gap into the wrapping device. The wrapping cap is configured to position and / or wrap the thread in a stacked configuration within the wrapping device. The wrapping cap includes a cap sidewall extending between a top side and a bottom side of the wrapping cap. The wrapping cap sidewall includes a beveled bottom edge that defines an upper thread guiding surface of the wrapping device. The thread guiding surface is configured and / or angled to guide the thread into the wrapping device.

[0018] The wrap cap defines an external shape that differs from the external shape of the retainer cavity (and / or the retainer external shape of the suture retainer). In some embodiments, the external shape of the cap is a dog-bone shape. In some embodiments, the dog-bone shape includes a pair of opposing parallel long sides of the wrap cap extending between substantially semi-circular rounded ends of the wrap cap, the opposing parallel long sides defining a central portion of the wrap cap that is narrower than the semi-circular rounded ends.

[0019] In some embodiments, the outer shape of the retainer and the outer shape of the cavity are oval, while the outer shape of the cover is dog bone shaped.

[0020] The wrapping cap further includes a first set of first winding beams that extend downward and / or vertically from the bottom side of the wrapping cap and are spaced apart along opposite long sides of the wrapping cap. The first set of winding beams includes a flat winding surface and defines a generally linear profile.

[0021] The wrapping cap further includes a second set of second wrapping beams that extend downward and / or vertically from the bottom side of the wrapping cap and are spaced apart along the rounded ends of the semicircular portion of the wrapping cap. The second set of wrapping beams includes a flat wrapping surface and defines a generally non-linear and / or curved profile. The flat wrapping surfaces of the first and second sets of wrapping beams are designed to wrap the stitching thread around the beams in a vertically stacked configuration.

[0022] The wrapping cap further includes a plurality of outwardly opening tab cavities, which are separated by one of a first wrapping beam or a second wrapping beam. A portion of the bottom side of the wrapping cap defines the top of each tab cavity. A first inner cavity sidewall and a second inner cavity sidewall extending downward from the bottom side of the wrapping cap define opposite sides of each tab cavity. A rear wall extending between and connecting the first and second inner cavity sidewalls defines the back side of each tab cavity.

[0023] In some embodiments, the underside of the cap further includes one or more pin openings defined therein. The pin openings are configured to receive the winding pins of the winding base when the cap is properly positioned on the winding base.

[0024] In some embodiments, the winding device does not have a contact needle or other rotatable suture guide.

[0025] This disclosure also relates to a suture winding apparatus, which includes at least a winding platform, a suture holder, and a suture winding device. The winding apparatus is suitable for use with any suture holder and any winding device, particularly with the suture holder and winding device described herein.

[0026] The winding platform extends along a central longitudinal axis between a proximal end portion and an opposing distal end portion. The platform also includes a platform channel defined therein. The platform channel extends longitudinally within the winding platform and, in some embodiments, is positioned offset from the central longitudinal axis of the platform.

[0027] The suture holder can move or slide longitudinally along and within the platform channel. The suture holder is configured to hold the suture under constant tension during winding and simultaneously move longitudinally closer to the winding device during winding.

[0028] The suture winding device includes: a winding base having a retainer cavity defined therein configured to receive a suture retainer; and a winding cover configured to cover the winding base while leaving a gap between the winding cover and the winding base to allow sutures to pass through the gap into the winding device. The retainer cavity of the winding base defines the external shape of the cavity. The winding cover defines the external shape of the cover, which differs from the external shape of the retainer cavity. The winding cover is configured to wind the sutures in a stacked configuration inside the winding device.

[0029] In some embodiments, the cavity retainer has an oval-shaped outer cavity and the cap has a dog-bone-shaped outer cap. The dog-bone shape includes a pair of opposing parallel long sides extending between substantially semi-circular rounded ends of the cap, the opposing parallel long sides defining a central portion of the cap that is narrower than the semi-circular rounded ends.

[0030] In some embodiments, the winding device further includes a suture lifting member positioned between the suture winding apparatus and the suture holder, channel, or both. The suture lifting member generates an approach angle for the suture to approach the winding apparatus. The approach angle can vary, and in some embodiments, is between 10 degrees and 45 degrees (including extreme values).

[0031] This disclosure also relates to methods for loading suture-needle assemblies into suture retainers. These methods are suitable for use with any suture retainer, winding device, and winding apparatus, particularly with the suture retainers, winding devices, and winding apparatuses described herein.

[0032] These methods include: if the winding base includes a base sidewall having a beveled top edge defining a lower suture guide surface configured to guide the suture into the winding base, then positioning a suture retainer in a retainer cavity; securing a needle of a suture-needle assembly to the suture retainer; securing a portion of the suture to a suture holder spaced apart from the suture winding device; covering the winding base and / or the suture retainer with a winding cap including a cap sidewall extending between a top side and a bottom side of the winding cap having a beveled bottom edge defining an upper suture guide surface configured to guide the suture into the winding device; and causing the winding device to spin to pull the suture through the gap between the winding cap and the winding base into the winding device (and / or the winding base, the suture retainer, and the suture channel of the suture retainer).

[0033] The suture-needle assembly includes a suture having a fixed end portion attached to the needle, a free end portion, and a central portion positioned between the fixed end portion and the free end portion.

[0034] The suture retainer defines the retainer's outer shape, and the retainer cavity defines the cavity's outer shape. The retainer's outer shape and the cavity's outer shape are the same outer shape. In some embodiments, both the retainer's outer shape and the cavity's outer shape are oval shapes.

[0035] The wrap-around cap defines an external shape that differs from the external shapes of the cavity and the retainer. In some embodiments, the external shapes of the retainer and the cavity are both oval, while the external shape of the cap is dog-bone shaped. In some embodiments, the dog-bone shaped wrap-around cap includes a pair of opposing parallel long sides extending between substantially semi-circular rounded ends of the wrap-around cap, the opposing parallel long sides defining a central portion of the wrap-around cap that is narrower than the semi-circular rounded ends.

[0036] In some embodiments, the method described herein further includes removing the wrapping cap after the suture has been loaded into the retainer. A label may be applied to the suture retainer via a label slot located on a raised area on the suture retainer.

[0037] The steps of loading the suture retainer, securing the needle to the retainer, and securing the suture to the suture retainer can occur in any order. Attached Figure Description

[0038] This document describes embodiments of the currently disclosed suture winding apparatus, device, method, and / or retainer with reference to the accompanying drawings, in which: Figure 1 This is a top view of the suture-needle assembly as described in at least one embodiment herein; Figure 2A This is a perspective view of the suture wound in a suture retainer as described in at least one embodiment of this document; Figure 2B As described in at least one embodiment herein Figure 2A A partial cross-sectional side view of a suture retainer, wherein the retainer is open to receive the suture; Figure 2C It is loaded as described in at least one embodiment of this document. Figure 2A A schematic top view of the suture in a suture retainer; Figures 2D to 2G As described in at least one embodiment herein Figure 2A A top view of the suture retainer; Figure 2HAs described in at least one embodiment herein Figure 2A An enlarged view of the needle resting section of the suture retainer shown; Figure 3A and Figure 3B This is a top view of various pin-holding sections as described in at least one embodiment of this document; Figure 4A and Figure 4B These are, respectively, a perspective view and a side view of the suture winding device as described in at least one embodiment of this document; Figure 5A This is a perspective view of the winding base and winding cap of the winding device as described in at least one embodiment of the present document, with a seam retainer between the winding base and the winding cap; Figure 5B As described in at least one embodiment herein Figure 5A A side view of the winding base and winding cap of the winding device, with a stitch retainer between the winding base and the winding cap; Figure 5C As described in at least one embodiment herein Figure 5A A bottom view of the wrapped cap; Figure 5D and Figure 5E As described in at least one embodiment herein Figures 5A to 5C Side cross-sectional views of various winding beams for the winding cap; Figures 6A to 7 This is a schematic representation of a method of wrapping sutures into a suture retainer as described in at least one embodiment of this document. Detailed Implementation

[0039] Embodiments of the currently disclosed suture winding apparatus, suture winding device, suture, retainer, and associated methods will now be described in detail with reference to the accompanying drawings, in which the same reference numerals denote the same or corresponding elements in each of the various views.

[0040] Any surgical suture, with or without a surgical needle, can be used with the devices, apparatus, retainers, and methods described herein. Figure 1 A suitable example is shown in which a suture 1 is equipped with at least one surgical needle 2 to form a surgical suture-needle assembly 3. The needle 2 is shown attached to a first end portion 1a of the suture 1, which extends a certain length to an opposite second end portion 1c, with a central portion 1b positioned between the first and second end portions. The needle 2 is a curved surgical needle, but it is conceivable that the needle 2 could alternatively be a straight needle or any other suitable shape of surgical needle.

[0041] The suture 1 can be a monofilament or multifilament suture. The suture 1 may also include barbs along its length and / or an end effector (i.e., an anchor or loop) or additional needle at its second end portion 1c. The suture 1 (and / or needle 2) can be made of any suitable biocompatible material, including but not limited to biodegradable materials (e.g., metals such as zinc or magnesium, or polymers such as polylactic acid, polyglycolic acid, polycaprolactone, polytrimethylene carbonate, or polydioxanone), non-biodegradable materials (e.g., metals such as stainless steel, or polymers such as polypropylene, polyethylene, or nylon), or combinations thereof. The suture 1 (and / or needle 2) can be formed using any suitable method known to those skilled in the art, including but not limited to extrusion, molding, solvent casting, pressing, spinning, and combinations thereof.

[0042] Figure 2A A suture retainer 10 is shown, in which a suture needle assembly 3 is loaded and / or wound in a vertically stacked configuration. The retainer 10 is shown as defining a one-piece, generally oval shape, including a generally planar base 12, having parallel long sides 15a, 15b, and substantially semi-circular rounded ends 16a, 16b. However, the retainer 10 is not intended to be limited to only a one-piece or oval shape, and may be defined as two or more pieces and / or any shape, including but not limited to circles, squares, triangles, rectangles, etc.

[0043] The base 12 includes the inner base portion 12 i and the outer base portion 12 o 12 outer base portions o Includes a plurality of outer base portions 13 and outer base openings 28 arranged alternately around the retainer 10. Inner base portion 12 i Includes needle area 34 and / or needle resting area 36.

[0044] The retainer 10 includes a retainer outer wall 18 that extends along the outer base portion 12. o The outer perimeter of the base 12 is positioned. The outer wall 18 of the retainer surrounds most (if not all) of the outer perimeter of the base 12. A plurality of intermittently (i.e., uniformly or non-uniformly) spaced wall segments 22 are located inside the outer wall 18 and are generally parallel to the outer wall, defining a discontinuous inner wall of the retainer. One or both of the outer wall 18 and the inner wall segments 22 may be a vertical retainer wall extending generally perpendicular to the base 12.

[0045] The wall section 22 surrounds the interior of the retainer 10, thereby defining the inner base portion 12. i The outer perimeter (and / or the outer portion 12) o (within the inner perimeter). Wall section 22 along the inner base portion 12i The outer perimeter is divided by space S. Space S consists of the width of the outer base portion 13 and the portion passing through the inner base portion 12. i A pair of slits 32a, 32b are defined within a portion of the wall segment 22. The first slit 32a is located on one side of the wall segment 22, and the second slit 32b is located on a second opposite side of the same wall segment 22. Each wall segment 22 is respectively sandwiched between the first slit 32a and the second slit 32b. The outer base portion 13 extends from the inner base portion 12. i The lower portion 18a of the base 12 extends radially to the outer wall 18 of the retainer. The outer portion 13 of the base 12 is positioned between adjacent wall sections 22 (and / or the first slit 32a of the first wall section 22 and the second slit 32b of the second adjacent wall section 22).

[0046] Each wall segment 22 extends generally vertically between the lower segment portion 22a and the upper segment portion 22b. Each lower segment portion 22a is attached to the inner base portion 12 along its inner circumference. i Each wall segment 22 is separate from (and / or not attached to) the outer wall 18 of the retainer. A portion of the base 12 does not extend outward beyond the lower segment portion 22a of the wall segment 22, thereby creating a base opening 28 between the lower segment portion 22a and the lower wall portion 18a of the outer wall 18. The base opening 28 connects to the first slit 32a and the second slit 32b.

[0047] The tabs 26 extend generally radially from each upper segment portion 22b of the wall section 22. The tabs 26 extend radially toward the outer wall 18, particularly the upper wall portion 18b, to a point near but not touching the outer wall 18 (and / or the dotted protrusions 29). The dotted protrusions 29 extend inward from the upper wall portion 18b of the outer wall 18 toward the tabs 26 without touching them. The tabs 26, with or without the dotted protrusions 29, are designed to prevent suture slippage after the suture is loaded and / or wound into the retainer 10 and / or suture channel 30. The dotted protrusions 29 are intermittently spaced around the outer wall 18 in a manner aligned with and / or centered on these tabs.

[0048] Typically, the outer base portion 13, outer wall 18, inner wall segment 22, and protrusion 26 are located along the outer base portion 12 of the retainer 10. o A suture channel 30 is defined. The suture channel 30 is configured to receive the suture 1 loaded / wound therein. More specifically, the outer base portion 13, the outer wall 18, the inner wall segment 22, and the tab 26 define the suture channel 30, which is open (or closed) along different (and / or alternating) portions of the top and bottom of the suture channel 30.

[0049] like Figure 2AAs depicted, the outer base portion 13 and the base opening 28 surround the outer base portion 12. o Alternating, thereby defining the alternating closed bottom portion and open bottom portion of the suture channel 30 respectively. For example... Figure 2A Further depiction shows that the outer basal portion 13 and the inner wall segment including the protrusion 26 extending therefrom also surround the outer basal portion 12. o Alternating, thereby defining alternating open or closed top portions of the suture channel 30, and alternating closed or open bottom portions of the suture channel 30. The suture channel 30 is open (or closed) along the alternating top and bottom portions of the suture channel.

[0050] Each base opening 28 is laterally positioned between the outer base portions 13 and vertically aligned with the tab 26 to define a lower retainer recess 46 therebetween. The lower retainer recess 46 is configured to wrap the suture around the base (see...). Figure 5A The lifting components are housed therein, as described in more detail below.

[0051] Each outer base portion 13 is laterally positioned between base openings 28 and is not covered by any tabs 26, thereby defining an upper retainer recess 44. The upper retainer recess 44 is configured to wrap around a suture (see [reference]). Figure 5A The winding of the retainer 10 (and / or the suture channel 30) is received therein by a beam, as described in more detail below. The upper retainer recess 44 and the lower retainer recess 46 alternate around the outer periphery of the retainer 10 (and / or the suture channel 30).

[0052] The base 12 may also include a pair of winding pin holes 40a, 40b defined therethrough for passing a winding pin during winding and / or loading of the suture 1 into the suture channel 30, as described in more detail below. One winding pin hole 40a is located on the inner base portion 12. i In the needle area 34, and another winding pin hole 40b is located in the outer base portion 22. o Above. (As shown) Figure 2A As shown, the first end portion 1a of the suture 1 passes over the needle region 34 around the first winding pin hole 40a and enters the suture channel 30 around the second winding pin hole 40b. A plurality of raised label slots 42 may also be positioned on the top of the base 12 and within the needle region 34. The raised label slots 42 are configured to attach a label (not shown), particularly a desiccant label, to at least a portion of the needle region 34, to at least cover the sharp end 2a of the needle 2 and / or the needle rest portion 36.

[0053] like Figure 2BAs shown, each retainer inner wall segment 22 is designed to pivot along segment 11 of the inner base portion 12i, causing the tab 26 to rise away from the top portion 30b of the suture channel 30. The first slit 32a and the second slit 32b allow the wall segment 22 to pivot via the inner base portion 12i. By pivoting along the inner base portion 12i, the initial configuration or angle between the tab 26 and the wall segment 22 can be adjusted in the closed configuration (…). Figure 2A ) and open configuration ( Figure 2B Both remain essentially unchanged without causing significant deformation of the tab 26. For example, in a closed configuration... Figure 2A The generally L-shaped combination of the wall section 22 (and / or the upper section portion 22b) and the protrusion 26 shown in the diagram Figure 2B It remains essentially unchanged in the open configuration and therefore returns to the same closed configuration after the suture is loaded into the suture channel.

[0054] Figure 2C The diagram schematically illustrates suture 1 wound and / or loaded into suture retainer 10 in a stacked configuration and spaced apart from outer wall 18 and inner wall segment 22. Needle 2 is not shown for clarity. It is conceivable that stacking the sutures in a configuration separate (and / or spaced apart) from any wall portion of the retainer allows for more efficient removal of the sutures from the retainer due to reduced friction between the overlapping sutures and / or, particularly, the inner wall segment 22.

[0055] The retainer 10 further includes a needle region 34 defined by an inner wall segment 22. The needle region 34 may include a needle rest 36 located therein. In some embodiments, as shown, the needle rest 36 is a sliding needle rest 36 configured to slide and / or move (i.e., change position) relative to the base 12 (and / or wall segment 22) to accommodate one or more needles of different sizes / designs. However, the retainer 10 may include any suitable needle rest, including but not limited to non-sliding needle rests such as a fixed needle rest 136, which may or may not be deformable, such as a foam needle rest 36a or a multi-pronged needle rest 36b, as... Figure 3A and Figure 3B As shown.

[0056] Figures 2D to 2F An example of a sliding needle rest 36 is depicted. Figures 2D to 2F A sliding needle rest portion 36 is depicted, which includes a needle rest portion body 56, which is configured to pass through the base 12 (e.g., through the inner base portion 12). iThe device slides within a parking opening 54 (defined approximately at the center of the portion) to park and / or release the parking pin. The parking body 56 is secured to the base 12 at a first end via a flexible leg 58 on a first longitudinal side of the parking opening 54. The flexible leg 58 allows the body 56 to slide relative to the base 12 through the opening 54. The parking body 56 is secured to a head 60 at a second opposite end via a flexible neck 61. The head 60 is positioned between corresponding first arms 55 and second arms 57 of the body 56. The first arms 55 and second arms 57 are fixed relative to each other. The flexible neck 61 allows the head 60 to slide within the parking opening 54 relative to the body 56 (and / or between arms 55, 57).

[0057] The head 60 includes an actuation aperture 62 defined therein and a first nose 64. The free end of a generally linear first arm 55 includes a stop member 86, and the free end of a second arm 57 includes a second nose 82. The second arm 57 also includes an elbow 59 that allows the second arm 57 to swing about the first nose 62.

[0058] The first contact member 70 is fixed to the base 12 on a first lateral side of the opening 54. A flexible wall 74 connects the head 60 and / or the eyelet 62 to the base 12 on the opposite second lateral side of the opening 54. The first contact member 70 and the second nose 82 are generally aligned, and a first needle space 66 is positioned between the first contact member and the second nose. The first contact member 70 and the second nose 82 are configured such that one or more needles are positioned therebetween in the first needle space 66a.

[0059] The first nose portion 64 and the second nose portion 82 are also generally aligned, and a second needle space is positioned between the first nose portion and the second nose portion. The first nose portion 64 and the second nose portion 82 are configured such that one or more needles are placed in the second needle space 66b therebetween.

[0060] The deflectable baffle 76 also extends across the needle rest opening 54 toward the head 60 and is secured to the base 12 on the second longitudinal side of the opening 54 opposite to the flexible leg 58. The base 12 is collinear or parallel to the deflectable baffle 76 and / or the body 56. The deflectable baffle 76 is located below a portion of any needle stored in the needle rest 36 to facilitate easy gripping and / or removal of needles and / or needle assemblies from the retainer 10.

[0061] Figures 2D to 2FA method for parking and / or releasing at least one needle and / or suture-needle assembly within a sliding needle parking portion 36 is also described. Parking and / or releasing can be performed manually, automatically, or in combination. A non-limiting example of automated loading includes placing the needle parking portion and / or suture retainer on a winding base and manipulating the needle parking portion via an insertable object (such as a tool pin). A non-limiting example of manual loading includes manipulating the needle parking portion and / or suture retainer using an insertable object (such as a human operator's finger) or via a handheld pin.

[0062] For the sake of brevity, pluggable objects designed to cover manual and / or automated processes will be used for description. Figures 2D to 2F The method. For clarity, the suture needle is not shown.

[0063] like Figure 2D As shown, initially, in the initial unloaded or empty configuration, the insertable object 96 is positioned within the actuation hole 62 of the needle resting part 36. In the initial configuration, the first needle space 66a and the second needle space 66b are in their narrowest states, that is, the first nose 64 is closest to the second nose 82 and the second nose 82 is closest to the first contact member 70, thereby forming a narrow or closed first needle space 66a and a second needle space 66b, respectively.

[0064] like Figure 2E As shown, the insertable object 96 is moved outward toward the outer wall 18 of the retainer 10 (i.e., slid laterally along the opening 54) to a first position, thereby causing the head 60 and body 56 to also move and / or slide away from the first contact member 70 within the parking opening 54, thereby widening the first needle space 66a between the second nose 82 and the first contact member 70. One or more needles can then be loaded into the first space 66a. Because the flexible neck 61 has greater stiffness or less flexibility than the flexible leg 58, the entire body 56 slides together with the head 60, such that the distance between the head 60 and the arms 55, 57 is initially kept approximately the same.

[0065] like Figure 2FAs shown, the insertable object 96 continues to move outward to the second position, thereby allowing the head 60 to continue to move outward and / or slide, while the first arm 55 and the second arm 57 are prevented from moving by the stop member 86. This widens the second needle space 66 between the first nose 64 and the second nose 82, while the first needle space 66a remains widened and unchanged. In the second position of the head 60, both the first needle space 66a and the second needle space 66b are configured to accommodate one or more needles. When the stop member 86 contacts the sidewall or thickness of the base 12, the stop member 86 prevents the first arm 55 from rotating further. Once the first arm 55 is locked and cannot move further outward, any additional force applied to the head 60 by the object 96 will cause the neck 61 to flex, thereby allowing the head 60 to continue to move outward, while the first arm 55 and the second arm 57 do not move outward. Because the first nose 64 continues to move away from the second nose 82, the second needle space 66b widens.

[0066] Figures 2G to 2H A retainer 10 is depicted, which has one or more needles 2a to 2c resting in a sliding needle resting portion 36. For clarity, Figures 2G to 2H The stitches are not shown.

[0067] like Figure 2G As shown, the sliding needle rest 36 is configured to rest a first needle 2a between the second nose 82 and the first contact member 70, a second needle 2b between the first nose 64 and the second nose 82, and / or a third needle 2c between the second nose 82 and the first contact member 70 and the second contact member 78. Each rested needle 2a to 2c extends at least partially over the deflectable tab 76 for easy removal.

[0068] Figure 2H Focusing on the first needle space 66a and the second needle space 66b. The first needle 2a is shown resting within the first needle space 66a, located between the second nose 82 and the contact fingers 71, 72 of the first contact member 70. The second needle 2b is shown resting within the second needle space 66b, located between the second nose 82 and the first nose 64.

[0069] The curved front surface 65 of the first nose 64 is configured to engage one or more needles thereon. The curved front surface 85 of the second nose 82 is also configured to engage one or more needles thereon. In some embodiments, the curved front surface 65 of the first nose 64 and / or the curved front surface 85 of the second nose 82 each include stepped recesses 69, 89 defined therein. Each stepped recess 69, 89 creates a needle cavity 67, 87 below the tip 64a, 82a of the first nose 64 and / or the second nose 82. Each tip 64a, 82a is configured to extend at least partially above the top of the needles 2b, 2a when the needles are respectively positioned in the first needle space 66a or the second needle space 66b.

[0070] The second nose portion 82 further includes a back surface 83, which includes a third contact member 84. The front surface 65 of the first nose portion 64 is separated from the third contact member 84 on the back surface 83 of the second nose portion 82 by a second needle space 66b. The third contact member 84 includes one or more contact points 84a, 84b. As shown, in some embodiments, the third contact member 84 includes two spaced-apart contact points separated by a concave back surface 83. The second nose portion 82 may also include a distal lug 92 extending along the opening 54 and configured to rest the needle on the distal lug when the needle is positioned in the second needle space 66b.

[0071] In some embodiments, after the two spaces are opened / widened by the head being in the second outermost position, one or more needles can be loaded into each of the first needle space or the second needle space simultaneously.

[0072] In some embodiments, after one or two spaces are opened / widened by positioning the head in a first outermost position or a second outermost position, one or more needles may be loaded into the first needle space or the second needle space in sequence.

[0073] Once one or more needles are positioned in the first needle space and / or the second needle space, the insertable object can either retract inward toward its initial position or retract directly from the eyelet. In either case, the memory properties of the flexible plastic components, particularly the flexible leg-like member 58, the flexible neck 61, and / or the flexible wall 74, will force the body 56 to move inward toward the first contact member 70, thereby narrowing and / or closing each of the first needle space 66a and the second needle space 66b where one or more needles are positioned.

[0074] Removing a needle from the needle rest described herein typically does not require much force. The sliding needle rest described herein, and in particular the flexible component described herein, is designed to have sufficient planar force to hold one or more needles laterally and / or horizontally between the nose and the contact member, while allowing the needle to be removed from the rest approximately vertically with the minimum force required to overcome the overhang of the nose tip.

[0075] Sliding needle resting part 36 in Figures 2G to 2H The image is shown in a loading configuration, i.e., comprising two or more needles of different sizes, diameters and / or shapes.

[0076] The retainer 10 (including the sliding needle rest 36) can be made of any suitable material (such as, but not limited to, polymeric materials, including but not limited to, polyethylene or polypropylene). As provided in more detail below, the polymeric material makes the inner base portion 12... i The wall segments 22 pivot and / or deflect along their junction, thereby causing the tab 26 to also rise upward and tilt inward, especially without causing the tab 26 to deflect significantly relative to the wall segments 22, fully opening the top portion 30b of the suture channel 30, thus allowing the suture 1 to be inserted therein, as... Figure 2B As shown. After loading and / or winding, the tabs 26 and the inner base portion 12 i The wall section 22 is essentially returned to its original position to close the top portion 30b of the suture channel 30.

[0077] The retainer 10 can be formed using any suitable method known to those skilled in the art, including but not limited to extrusion, molding, pressing, and combinations thereof. The retainer 10 is designed for use with the winding device 100, which is described in more detail below.

[0078] Figure 4A and Figure 4B A winding apparatus 100 is depicted, comprising a winding platform 102, a suture holder 106, a suture lifting member 108, and a winding device 110. The winding platform 102 is generally planar and extends along a central longitudinal axis A1 between correspondingly opposite first base end portions 102a and second base end portions 102b. A channel 104 is defined within the winding base 102, extending over a significant portion of the length of the base 102. In some embodiments, the channel 104 is offset from the central longitudinal axis A1.

[0079] When the suture 1 is wound into the suture retainer 10 positioned within the winding device 110, the suture retainer 106 is located in the channel 104 and travels and / or slides along the length of the channel 104 toward the winding device 110. The suture retainer 106 uses any suitable device to hold the second end portion 1c of the suture 1 (i.e., the free end portion of the suture). For example, the suture retainer 106 may include a mechanical gripper (such as a clamp or a pair of opposing jaw members) to grasp or hold the suture. Alternatively or in combination, the suture retainer 106 may include a vacuum port or vacuum tube attached to the suture retainer 106 for securing the suture 1 to the suture retainer. The vacuum port or vacuum tube is operatively coupled to a vacuum source, as known in the art.

[0080] The suture holder 106 maintains a constant tension on the suture 1 during the loading and / or winding process. During winding, the suture holder 106 also travels toward the winding device 110 (and / or the suture lifting member 108) while maintaining a constant tension on the suture 1.

[0081] The suture lifting member 108 is positioned between the suture holder 106 and the winding device 110, and its height h1 is greater than the height h2 of the winding base 112 of the winding device 110. Figure 6D The height of the suture retainer 106 is also considered. The suture lifting member 108 acts as a fulcrum on which the suture 1 rotates and / or changes direction, thereby creating an approach angle α2 for the suture 1 to approach the winding device 110. By entering the winding device 110 from the approach angle α2, rather than simply entering horizontally from the side, the suture 1 is more easily wound into the retainer, especially below the inclined tab 26 of the retainer 10 located in the winding device 110. However, the overall design of the winding device 100, and especially the winding device 112, allows the suture 1 to be wound from a horizontal direction or from any angle.

[0082] The height h1 of the suture lifting member 108 can be fixed or adjustable during the loading of the suture 1. For example, the suture lifting member 108 can be configured to extend or retract from the winding platform 102 to change the approach angle α2 as needed. The approach angle α2 can range between 1 degree and 85 degrees, more particularly between 5 degrees and 60 degrees, and more particularly between 10 degrees and 45 degrees (inclusive). In some embodiments, the approach angle ranges from 0 degrees to 30 degrees.

[0083] In some embodiments, the suture lifting member 108 is a block positioned longitudinally on the winding platform 102. The block defines any suitable shape, including but not limited to circular, elliptical, triangular, rectangular, etc. In some embodiments, as shown, the block is generally rectangular with rounded upper corners. The suture lifting member 108 can be made of any suitable material, as long as the material is strong enough to support the suture passing through it without damaging the suture. Some non-limiting examples include polymers (such as polypropylene, polyethylene, etc.) and / or metals (such as stainless steel, aluminum, etc.).

[0084] like Figure 4A and Figure 4B Further shown, the winding device 100 includes a suture winding apparatus 110, which includes a winding base 112 and a winding cap 114 configured to cover the winding base 112, with or without a suture retainer positioned between the winding base and the winding cap. The winding base 112 includes a lower suture guide surface 119, and the winding cap 114 includes an upper suture guide surface 129. When the winding cap 114 is properly positioned on the winding base 112, particularly when the suture retainer is positioned between the winding base and the winding cap, a gap 121 is positioned between the lower suture guide surface 119 and the upper suture guide surface 129 to allow the suture to pass through the gap and enter the winding apparatus 110, particularly into the suture retainer positioned inside the winding apparatus 110.

[0085] The gap 121 extends completely around the outer perimeter of the winding device 110. In some embodiments, the lower stitch guide surface 119 extends completely around the outer perimeter of the winding device 110, while the upper stitch guide surface 129 does not extend completely around the outer perimeter of the winding device 110. The winding device 110 is described and illustrated in more detail below.

[0086] like Figure 3AAs indicated by the arrows, the winding device 110, particularly the winding base 112, is configured to rotate horizontally (i.e., spin) about a center point C. Although depicted as rotating clockwise, the rotation of the winding device 110 can alternatively be performed counterclockwise. The rotation of the winding device 110, particularly the winding cap 114 including the winding beam 138, pulls the suture through the gap 121 into the winding device 110. As the suture is wound onto the winding device 110 and / or pulled into the suture holder positioned inside the winding device 110, the suture holder 106 slides longitudinally along the channel 104 in the direction of the winding device 110, while holding the free end portion 1c of the suture 1 under tension. The winding device 110 can be rotated manually or may include any suitable automated rotation device. In some embodiments, the winding device 110 is rotated via a motor (e.g., a servo motor). In some embodiments, the winding device 110 operates independently of the suture holder 106.

[0087] Figure 5A and Figure 5B A retainer 10 is depicted positioned between a winding base 112 and a winding cap 114 of a winding apparatus 110. The winding base 112 includes a retainer cavity 109 defined therein. The retainer cavity 109 is defined by a winding base sidewall 118 surrounding a winding base plate 120. The winding base sidewall 118 is typically a vertical wall having a chamfered or beveled top edge 118b. A chamfer or bevel means that the top edge 118b is angled inward from the lower vertical portion 118a of the sidewall 118. Although angled inward on the bevel, the top edge 118b may be generally smooth across the bevel. The chamfered top edge 118b forms a lower seam guide surface 119 around most (if not all) of the winding base 112. The lower suture guide surface 119 guides the suture to the gap 121 to enter the winding device 110 (and / or the suture retainer and / or suture channel located in the winding device 110), especially during spin.

[0088] The retainer cavity 109 may have an overall shape that matches the overall shape of the specific suture retainer to be placed in the retainer cavity. For example, the retainer cavity 1 may be oval-shaped to accommodate... Figure 2A The oval-shaped retainer 10. The winding base plate 120 can be generally planar. The depth of the retainer cavity 109 can be approximately equal to the height of the retainer, particularly the height of the outer wall 18 of the retainer 10.

[0089] During the spinning of the winding tool 110 and / or the loading of the suture therein, the winding base 112 holds the suture retainer in a fixed position within the retainer cavity 109. A pair of winding pins 122a, 122b extend from the base plate 120 outward from the retainer cavity 109. The winding pins 122a, 122b act as initial guides for correctly positioning (i.e., placing) the suture retainer within the cavity 109 and help maintain the retainer in a fixed position during spinning. At least one of the winding pins 122a, 122b also acts as an initial guide for correctly positioning (i.e., placing) the winding cap 114 onto the winding base 112 (with or without a suture retainer positioned between the winding cap and the winding base) and helps maintain the winding cap 114 in a fixed position relative to the winding base 112 during spinning.

[0090] The winding pins 122a and 122b are located inside the plurality of lifting pins 124. The lifting pins 124 are spaced apart intermittently around the outer perimeter of the retainer cavity 109. The winding pins 122a and 122b are configured to allow sutures to be wound around them. The winding pins 122a and 122b are not typically positioned or configured as tabs that lift the suture retainer. The lifting pins 124 are positioned and configured to lift the tabs 26 of the inner wall section 22, and are not typically positioned or configured to allow sutures to be wound around them. The lifting pins 124 include an inclined or beveled top edge 124a.

[0091] In some embodiments, and particularly useful for the suture retainer 10, the first winding pin 122a and the second winding pin 122b are positioned on the base plate 120 to be aligned with the first winding pin through hole 40a and the second winding pin through hole 40b, respectively. In some embodiments, and particularly useful for the suture retainer 10, the lifting pin 124 is positioned on the base plate 120 to be vertically aligned with the base opening 28 (and / or the lower recess 46) of the retainer 10. Figure 6A ).

[0092] In some embodiments, at least one of the winding pins 122a and 122b is in a fixed position relative to the winding base plate 120. In some embodiments, at least one of the winding pins 122a and 122b is retractable into and / or protrudes from the winding base plate 120. The lifting pin 124 is retractable into and / or protrudes from the winding base plate 120.

[0093] The winding pin 122b may further include a tapered extension 126, thereby making its length longer than that of the other winding pin 122a. The tapered extension 126 allows the winding pin 122b to interact with the bottom side 132 of the winding cap 114, particularly with the pin orifice 148 defined within the bottom side 132.

[0094] like Figures 5A to 5C As shown, the wrap cap 114 defines a shape different from that of the retainer 10 and / or the base cavity 109. For example, the wrap cap 114 defines a generally dog-bone shape including a pair of opposing parallel long sides 115a, 115b extending between substantially semi-circular rounded ends 116a, 116b, wherein the opposing parallel long sides 115 define a central portion 114c of the wrap cap 114, which is narrower than the semi-circular rounded ends 116, 116b.

[0095] The wrapping cap 114 includes a cap sidewall 128 extending between a cap top side 130 and a cap bottom side 132. The cap sidewall 128 is generally a vertical wall that may or may not include a beveled (i.e., chamfered or beveled) bottom edge 128a along its portion. A bevel means that the bottom edge 128a is angled inward from the upper vertical portion 128b of the sidewall 128. Although angled inward on the bevel, the bottom edge 128a may be generally smooth across the bevel. The beveled bottom edge 128a forms an upper suture guide surface 129 around the outer perimeter of the rounded ends 116a, 116b of the wrapping cap 114. The upper suture guide surface 129 guides the suture into the wrapping device 110 (and / or the suture retainer and / or suture channel positioned in the wrapping device 110), particularly during spin.

[0096] The wrapping cap 114 includes a plurality of wrapping beams 138, 139, which are designed to cause the thread to wrap around the wrapping beams inside the thread channel of the thread retainer. For example, a first set of wrapping beams 138 extends substantially perpendicularly from the bottom side 132 of the wrapping cap 114 along the opposite long sides 115a, 115b (and / or the center portion) of the wrapping cap 114. A second set of wrapping beams 139 also extends substantially perpendicularly from the bottom side 132 of the wrapping cap 114 along the rounded ends 116a, 116b of the wrapping cap 114.

[0097] like Figure 5D and Figure 5E As shown, the first winding beam 138 and the second winding beam 139 each include winding surfaces 140 and 141, configured to wind the suture 1 around it in a vertically stacked configuration (i.e., one directly on top of the other). The two winding surfaces 140 and 141 are generally flat and / or perpendicular to the bottom side 132, thereby defining a vertically flat geometry that the suture 1 wound on it will simulate. After the winding beams 138 and 139 are removed, the vertically stacked configuration of the suture 1 is maintained inside the retainer. Figure 2A ).

[0098] The difference between the first winding beam 138 and the second winding beam 139 is that the first winding beam 138 defines a linear profile, while the second winding beam 139 defines a curved (and / or non-linear) profile. The linear profile of the first winding beam 138 follows the linear nature of the opposing long sides 115a, 115b of the cover 114. The curved profile of the second winding beam 139 follows the rounded nature of the opposing rounded end portions 116a, 116b of the cover 114.

[0099] In some embodiments, the cover sidewall 128 includes a beveled bottom edge 128a along the rounded end portions 116a, 116b of the cover 114, and the cover sidewall 128 has no bottom edge along the opposing long sides 115a, 155b of the cover 114. The beveled bottom edge 128a provides additional guidance for properly loading the stitches along the rounded ends 116a, 116b onto the winding beam 139, while the absence of overhanging beveled bottom edges on the opposing long sides 115a, 115b provides enhanced visibility of the stitch configuration wound on the winding beam 138.

[0100] like Figure 5C As further shown, the cover 114 includes a plurality of cavities 142. Each cavity 142 is configured to be sufficiently large to receive at least an elevating or tilting tab, such that the tab rises above the upper suture guide surface 129. Figure 6F Each cavity 142 may also have sufficient size or dimensions to receive at least the tab and the upper section portion attached to the tab when the tab and the inner wall section are lifted or tilted into an open configuration. Figure 6F ).

[0101] Each tab cavity 142 is open to the outside and is defined at the top by a portion 132a of the bottom side 132, laterally by opposing inner cavity sidewalls 134a, 134b, and rearward and / or inward by a rear wall 136 extending between opposing sidewalls 124a, 134b.

[0102] The bottom side 132 may also include pin openings 148a and 148b defined therein. The pin openings 148a and 148b are each positioned and configured to receive a winding pin 122a and 122b (with or without a tapered extension) therein when the winding cap 114 is properly placed on the winding base 112 to form the winding device 110.

[0103] When the cap 114 is properly positioned on the base 112, the upper and lower suture guide surfaces 129 can guide the free end of the suture into the gap 121 as the suture is released from the suture holder 106. In some embodiments, the winding device 100 or winding apparatus 110 further includes a vacuum port or vacuum tube that, with the assistance of the suture guide surfaces 119, 129, can guide or pull the free end portion of the suture through the gap 121 into the winding apparatus. The vacuum port or vacuum tube can be positioned in the base plate 120 and aligned with the base opening 28. Alternatively, the vacuum port or vacuum tube can be integrated into the lifting pin 124 and activated whenever the lifting pin 124 is in an extended configuration. Alternatively, or in combination with the use of vacuum, the winding system may further include a blower system designed to blow air (air, nitrogen, etc.) toward the winding device, thereby blowing the free end portion of the thread from the thread holder toward the winding device.

[0104] In some embodiments, the winding device 100 or winding apparatus 110 further includes a stylus or suture guide attached thereto for manipulating at least the free end of the suture after it has been released from the suture holder 106. In some embodiments, the winding device 100 or winding apparatus 110 does not have any kind of stylus or additional suture guide attached thereto.

[0105] The winding device 110 and / or winding equipment 100 can be operated manually or automatically, at least partially (if not completely).

[0106] Figures 6A to 7 Various methods of loading a suture-needle assembly into a suture retainer are schematically depicted and described. Although the suture-needle assembly 3 and the suture retainer 10 are specifically depicted, the methods, devices, and apparatuses described herein can be used with any suitable suture, needle, and / or retainer.

[0107] Generally, the method described herein may include the following steps: loading a suture retainer defining the external shape of a retainer into a retainer cavity of a winding base, the retainer cavity defining an external shape of a cavity S1; securing a suture-needle assembly to the suture retainer and the suture holder S2; covering the winding base with a winding cap configured to leave a gap between the winding base and the winding cap, the winding cap defining a cap external shape S3 different from at least one of the external shape of the retainer or the external shape of the cavity; and causing the winding device to spin to pull the suture through the gap into the winding device and / or the suture retainer in a vertically stacked configuration S4.

[0108] like Figure 6AAs shown, a suture retainer 10 can be loaded into a retainer cavity 109 of a winding base 112 (S1). The retainer cavity 109 is defined by a base sidewall 118. In some embodiments, the retainer 10 is loaded into a winding base 112 that includes a first suture guide surface 119 on top of the base sidewall 118. The first external shape of the retainer 10 and the second external shape of the retainer cavity 109 may be the same shape. In a non-limiting example, the retainer 10 defines an oval first external shape, and the retainer cavity 109 defines an oval second external shape.

[0109] In some embodiments, the step of loading the retainer 10 further includes passing the winding pins 122a, 122b of the base 112 through the winding pin through holes 40a, 40b of the retainer 10 to secure the retainer 10 in the cavity 109. The lifting pin 124 of the base 112 may also pass through the base opening 28 of the retainer 10 and be vertically aligned with the tab 26. Unlike the winding pins 122a, 122b, the lifting pin 124 is in a retracted configuration.

[0110] When the retainer 10 is correctly positioned in the winding base 112 ( Figure 6A When the winding pin 124 is positioned in the lower retainer recess 46, the winding pin is used to position the retainer. Figure 2A The method is to place the winding pin 124 below the tab and closer to the inner wall section 22 of the retainer 10 than any of the winding beams 138, 139.

[0111] like Figure 6B and Figure 6C As shown, the suture-needle assembly 3, particularly the needle 2, can be secured to the retainer 10, and the free end portion 1c of the suture 1 can be secured to the suture holder 106 (S2). In some embodiments, the needle 2 of the suture-needle assembly 3 is placed in the needle holding portion 36 of the retainer 10. In some embodiments, the proximal or fixed end portion 1a of the suture 1 is wound around the needle crossing region 34 and the suture channel 30 on the winding pins 122a, 122b, wherein the suture 1 extends away from the retainer 10 toward the suture holder 106.

[0112] Additionally, in some embodiments, the loading method further includes placing the central portion 1b of the suture 1 on the suture lifting member 108 between the suture holder 106 and the winding base 112, thereby creating a suture approach angle α2. Figure 6D ).

[0113] In some embodiments, the suture retainer is loaded into the winding base before the needle is secured to the retainer or the suture is secured to the suture retainer. In some embodiments, the needle is secured to the suture retainer before the retainer is loaded into the winding device or the suture is secured to the suture retainer. In yet other embodiments, the suture is secured to the suture retainer before the suture retainer is loaded into the winding base or the needle is secured to the suture retainer.

[0114] like Figure 6E As shown, a wrapping cap 114 covers a wrapping base 112 and a suture retainer 10 including a suture-needle assembly 3, with a gap 121 positioned between the wrapping base 112 and the cap 114 (S3). The base 112 includes a first lower suture guiding surface 119, and the cap 114 includes a second upper suture guiding surface 129, with the gap 121 between the two surfaces. The wrapping cap 114 defines a third external shape different from at least one of a first external shape of the retainer 10 or a second external shape of the wrapping base 112 (S3). In a non-limiting example, the retainer 10 defines an oval first external shape, the retainer cavity 109 defines an oval second external shape, and the wrapping cap 114 defines a third external shape resembling a dog bone.

[0115] When the cover 114 is properly positioned over the wrapping base 112 and the seam retainer 10 ( Figure 6E When the winding beams 138 and 139 are positioned in the upper retainer recess 44, the winding beams are positioned in the recess 44. Figure 2A Within the retainer 10, the winding beams 138 and 139 (and winding surfaces 140 and 141) are positioned closer to the outer wall 18 of the retainer 10 than the lifting pin 124. The winding beams 138 and 139 are centered within the seam channel 30 of the retainer 10 and are equidistant between the outer wall 18 and the inner wall section 22.

[0116] When the cover 114 is properly positioned over the wrapping base 112 and the seam retainer 10 ( Figure 6E When the suture retainer 10 (and / or the wrapping base 112) is in place, the outer portion of the suture retainer 10 (and / or the wrapping base 112) will remain uncovered by the cover 114 along the opposite long sides 115a, 115b.

[0117] The lifting pin 124 can be retracted from the configuration ( Figures 6A to 6B ) transforms into an extended configuration ( Figure 6F In the extended configuration, the lifting pin 124 lifts and tilts the tabs 26 inward into the tab cavities 142 defined within the bottom side 132 of the cover 114. Each tab 26 is raised a sufficient distance above the gap 121 while remaining at or below the upper suture guide surface 129.

[0118] In some embodiments, the lifting pins 124 are configured to lift and / or lower each tab 26 individually (or in a smaller group relative to the total number of lifting pins) as needed when the suture 1 is wound around the winding device 110. In some embodiments, the lifting pins 124 are configured to lift and / or lower each tab 26 together before and / or after the suture 1 is fully wound around the winding device 110.

[0119] Once the covering is complete, the wrapping base 112 (including the retainer 10) and the cap 114 can be rotated around their center to wrap the suture 1 around the wrapping beams 138, 139 positioned within the suture channel 30 of the retainer 10. For example... Figure 4A As indicated by the arrow, the spin of the winding device 110 (left arrow) pulls the central portion 1b of the suture 1 into the winding device 110, while the free end portion 1c of the suture 1 remains fixed to the slidable suture holder 106. As the central portion 1b of the suture 1 winds into the holder 10 within the spinning winding base 112, the suture holder 106 slides or moves longitudinally toward the winding device 110 along the channel 104 (right arrow), thereby reducing the distance between the winding device 110 and the suture holder 106. The suture holder 106 maintains tension on the suture 1 until it reaches the end portion 104b of the channel 104, spaced apart from the winding device 110 and the suture lifting member 108.

[0120] In some embodiments, the method described herein further includes releasing the suture 1 from the suture holder 106 while the winding base 112 continues to spin. It is conceivable that when the suture holder 106 releases the free end portion 1c of the suture 1, the free end portion 1c can continue to be pulled toward the device 110, and due to the lack of tension, the free end portion may or may not vertically displace from the approach angle α1. The pair of suture guide surfaces 119, 129 have sufficient thickness to accommodate the vertical displacement of the free end portion 1c of the suture 1 and redirect the free end portion 1c back to the gap 121.

[0121] Once the free end portion 1c of the suture 1 is wound into the retainer 10, the lifting pin 124 can be retracted toward the base plate 120, allowing the tab 26 to lower and return to its position as a cover portion of the suture channel 30. In some embodiments, a generally L-shaped configuration between the upper section portion 22b and the tab 26 is maintained during the lifting and lowering of the tab 26 via the lifting pin 124. The cap 114 can then be removed from the base 112, and a label or desiccant label can be attached to the retainer via the raised label slot 42 using any suitable method. The retainer and suture-needle assembly can then be sterilized and / or further packaged using any suitable method.

[0122] While several embodiments of this disclosure are shown in the accompanying drawings, they are not intended to limit the disclosure thereto, as the aim is to make the scope of the disclosure as broad as is permitted in the art, and this specification should be read in the same manner. Therefore, the above description should not be construed as restrictive, but merely as examples of embodiments. Other modifications within the scope and spirit of the appended claims will be contemplated by those skilled in the art.

[0123] The invention can be further described with reference to the following numbered paragraphs: 1. A one-piece suture retainer, comprising: a base extending between the inner base portion and the outer base portion, the outer base portion including a plurality of alternating outer base portions and base openings defined therein; an outer wall positioned along an outer periphery of the outer base portion; a plurality of spaced-apart inner wall segments positioned inward and substantially parallel to the outer wall relative to the outer wall, each inner wall segment extending vertically between a lower segment portion and an upper segment portion, the lower segment portion being attached to... A portion of the inner base portion, and the upper section portion including tabs extending radially from the upper section portion toward the outer wall, wherein each inner wall segment is sandwiched between a first slit defined by the base and a second slit defined by the base, each base opening communicating with both the first slit and the second slit, thereby sandwiching each inner wall segment in the middle; and a suture channel positioned along the outer base portion of the base and defined between the outer wall, the plurality of spaced inner wall segments, the outer base portion and the tabs.

[0124] 2. The suture retainer according to paragraph 1, wherein the tab and the inner wall section form a generally L-shaped profile, and the tab and the inner wall section are configured to be lifted into an open configuration by deflecting the inner base portion, the lower section portion, or a portion of both.

[0125] 3. The suture retainer according to paragraph 1 or 2, wherein the generally L-shaped profile of the tab and the inner wall section remains unchanged in the open configuration and returns to the closed configuration covering the suture channel with the same generally L-shaped profile.

[0126] 4. The suture retainer according to any one of paragraphs 1 to 3, wherein the outer wall is continuously positioned along the outer periphery of the base and includes a plurality of spaced-apart recessed protrusions extending inwardly from the upper wall portion of the outer wall.

[0127] 5. The suture retainer according to any one of paragraphs 1 to 4, wherein each base opening extends along each inner wall segment, thereby separating each wall segment from the outer wall.

[0128] 6. The suture retainer according to any one of paragraphs 1 to 5, further comprising a needle region inside the inner wall sections, the needle region further comprising a needle resting portion.

[0129] 7. The suture retainer according to paragraph 6, wherein the needle resting part is a sliding needle resting part.

[0130] 8. The suture retainer according to paragraph 7, wherein the needle region includes a first winding pin hole, and the suture channel includes a second winding pin hole.

[0131] 9. The suture retainer according to any one of paragraphs 1 to 8, further comprising a suture needle assembly, wherein the suture of the suture needle assembly is centrally wound in the suture channel in a vertically stacked configuration.

[0132] 10. A suture winding device, comprising: a winding base including a retainer cavity configured to receive a suture retainer therein, the retainer cavity defining an external shape of the cavity; and a winding cap configured to cover the winding base while leaving a gap between the winding cap and the winding base to allow a suture to pass through the gap into the winding device, wherein the winding cap is configured to position the suture in a stacked configuration within the winding device, and the winding cap defines a cap external shape different from the external shape of the cavity.

[0133] 11. The suture winding device according to paragraph 10, wherein the outer shape of the cavity of the cavity retainer is oval, and the outer shape of the winding cap is dog bone shaped.

[0134] 12. The suture wrapping device according to paragraph 11, wherein the dog bone shape includes a pair of opposing parallel long sides extending between the substantially semi-circular rounded ends of the wrapping cap, the opposing parallel long sides defining a central portion of the wrapping cap that is narrower than the semi-circular rounded ends.

[0135] 13. The suture winding device according to paragraph 12, wherein: the retainer cavity is defined by a winding base sidewall and a winding base plate, and the winding base sidewall includes a beveled top edge defining a lower suture guiding surface configured to guide the suture into the winding device; and the winding cap includes a cap sidewall extending between a top side and a bottom side of the winding cap, the cap sidewall having a beveled bottom edge around the outer perimeter of a semi-circular rounded end of the winding cap, the beveled bottom edge defining a higher suture guiding surface configured to guide the suture into the winding device, wherein the opposite long side of the winding cap does not have the beveled bottom edge.

[0136] 14. The stitch wrapping apparatus according to paragraph 13, wherein the wrapping cap further comprises: a first set of first wrapping beams extending vertically from the bottom side of the wrapping cap and spaced apart along opposite long sides of the wrapping cap, the first set of wrapping beams including a flat wrapping surface and defining a generally linear profile; and a second set of second wrapping beams extending vertically from the bottom side of the wrapping cap and spaced apart along a semi-circular rounded end of the wrapping cap, the second set of wrapping beams including a flat wrapping surface and defining a generally curved profile.

[0137] 15. The stitch wrapping device according to paragraph 14, wherein the cover further includes a plurality of outwardly opening tab cavities separated by one of the first wrapping beams or the second wrapping beams, wherein each tab cavity is defined along its top by a portion of the bottom side of the wrapping cover; along its opposite sides by a first inner cavity sidewall extending downward from the bottom side of the wrapping cover and a second inner cavity sidewall extending downward from the bottom side of the wrapping cover; and along its back side by a rear wall extending between and connecting the first inner cavity sidewall and the second inner cavity sidewall.

[0138] 16. The stitch wrapping device according to any one of paragraphs 13 to 15, wherein the bottom side further includes at least one pin opening, the at least one pin opening being configured to receive a wrapping pin in the pin opening when the wrapping cap is properly placed on the wrapping base.

[0139] 17. The thread winding device according to any one of paragraphs 10 to 16, wherein the winding base further includes a plurality of lifting pins spaced apart intermittently around an outer portion of the winding base plate and a plurality of winding pins spaced inwardly from the lifting pins, wherein the lifting pins are not configured to wind thread onto the lifting pins.

[0140] 18. The thread winding device according to paragraph 17, wherein the plurality of winding pins includes a first winding pin and a second winding pin, wherein at least one of the first winding pin or the second winding pin includes a tapered extension.

[0141] 19. The thread winding device according to any one of paragraphs 10 to 18, wherein the winding device has no contact needle.

[0142] 20. A suture winding apparatus comprising: a winding platform extending along a central longitudinal axis between a proximal end portion and an opposing distal end portion; a platform channel defined within the winding platform; a suture holder longitudinally movable along and within the platform channel, the suture holder configured to maintain a suture under constant tension during winding; and a suture winding device comprising: a winding base having a retainer cavity defined therein configured to receive a suture retainer; and a winding cap configured to cover the winding base while leaving a gap between the winding cap and the winding base to allow a suture to pass through the gap into the winding device, wherein: the retainer cavity defines an external shape of the cavity; the winding cap defines an external shape of the cap that differs from the external shape of the retainer cavity; and the winding cap is configured to wind the suture in a stacked configuration within the winding device.

[0143] 21. The suture winding device according to paragraph 20, wherein the outer shape of the cavity of the cavity retainer is oval, and the outer shape of the winding cap is dog bone shaped.

[0144] 22. The suture wrapping device according to paragraph 21, wherein the dog bone shape includes a pair of opposing parallel long sides extending between substantially semi-circular rounded ends of the wrapping cap, the opposing parallel long sides defining a central portion of the wrapping cap that is narrower than the semi-circular rounded ends.

[0145] 23. A method of loading a suture-needle assembly into a suture retainer, comprising: positioning the suture retainer in a retainer cavity of a winding base, the winding base including base sidewalls including a beveled top edge defining a lower suture guide surface configured to guide suture into the winding device, wherein the suture retainer defines a retainer outer shape, the retainer cavity defines a cavity outer shape, and the retainer outer shape and the cavity outer shape are identical outer shapes; securing a needle of the suture-needle assembly to the suture retainer, the suture-needle assembly including suture having a fixed end portion attached to the needle, a free end portion, and a central portion positioned between the fixed end portion and the free end portion; and securing the free end portion of the suture to a location spaced apart from the suture winding device. A suture retainer is positioned at a certain distance, and a wrapping cap is used to cover the suture retainer. The wrapping cap includes a cap sidewall extending between the top and bottom sides of the wrapping cap. The cap sidewall has a beveled bottom edge defining an upper suture guide surface configured to guide the suture into the wrapping device. The wrapping cap is configured to cover the wrapping base while leaving a gap between the upper and lower suture guide surfaces to allow the suture to pass through the gap into the wrapping device. The wrapping cap defines an outer shape that differs from the outer shape of the retainer or the outer shape of the cavity. The wrapping device is also rotated to pull at least the central portion of the suture through the gap into the suture retainer positioned within the wrapping device in a vertically stacked configuration, and to reduce the distance between the wrapping device and the suture retainer.

[0146] 24. The method according to paragraph 23, wherein the external shape of the cavity retainer is oval and the external shape of the cover of the wrapping cap is dog bone shaped.

[0147] 25. The method according to paragraph 24, wherein the dog bone-shaped wrap cap includes a pair of opposing parallel long sides extending between substantially semi-circular rounded ends of the wrap cap, the opposing parallel long sides defining a central portion of the wrap cap that is narrower than the semi-circular rounded ends.

[0148] 26. The method according to paragraph 25, wherein the wrapping cap further comprises: a first set of first wrapping beams extending vertically from the bottom side of the wrapping cap and spaced apart along opposite long sides of the wrapping cap, the first set of wrapping beams including a flat wrapping surface and defining a generally linear profile; and a second set of second wrapping beams extending vertically from the bottom side of the wrapping cap and spaced apart along a semi-circular rounded end of the wrapping cap, the second set of wrapping beams including a flat wrapping surface and defining a generally curved profile.

[0149] 27. The method according to any one of paragraphs 23 to 26, wherein securing the needle of the suture-needle assembly to the suture retainer includes securing the needle to the sliding needle rest.

[0150] 28. The method according to any one of paragraphs 23 to 27 further includes positioning the central portion of the suture above a suture lifting member before the winding device is spun, the suture lifting member being spaced apart from the winding device and located between the winding device and the suture holder, the height of the suture lifting member being greater than the height of the winding base.

[0151] 29. The method according to any one of paragraphs 23 to 28, further comprising releasing the free end portion of the suture from the suture holder when the suture holder approaches the suture lifting member; and continuing to spin the winding device to wind the free end portion of the suture through the gap into the suture retainer, wherein the upper suture guide surface and the lower suture guide surface are configured to redirect the free end portion of the suture toward the gap.

[0152] 30. The method according to any one of paragraphs 23 to 29, wherein the winding base further includes a vacuum source for applying a vacuum near the gap to assist in pulling the free end portion of the suture into the retainer.

[0153] 31. The method according to any one of paragraphs 23 to 30 further includes removing the wrapping cap after the suture is wound in the vertical stack configuration and applying a label to the suture retainer via a raised label groove located on the suture retainer.

[0154] 32. The method according to paragraph 26 further includes extending one or more lifting pins from the base plate of the winding base to lift one or more tabs, thereby providing access to the suture channel.

[0155] 33. The method according to paragraph 32, wherein the one or more lifting pins are positioned further away from the outer wall than the positioning of the first set of winding beams and the second set of winding beams relative to the outer wall, so that the suture is wound around the winding beams rather than the lifting pins in the suture channel.

[0156] 34. The method according to any one of paragraphs 23 to 33, wherein the steps of positioning the suture retainer in the retainer cavity, securing the needle to the suture retainer, and securing the free end portion of the suture to the suture retainer can occur in any temporal sequence.

Claims

1. A one-piece suture retainer, comprising: A base extending between an inner base portion and an outer base portion, the outer base portion including a plurality of alternating outer base portions and base openings defined therein; The outer wall is positioned along the outer periphery of the outer base portion; Multiple spaced-apart inner wall segments are positioned inside and generally parallel to the outer wall relative to it. Each inner wall segment extends vertically between a lower segment portion and an upper segment portion, the lower segment portion being attached to a portion of the inner base portion, and the upper segment portion including a tab extending radially from the upper segment portion toward the outer wall. Each inner wall segment is sandwiched between a first slit defined by the base and a second slit defined by the base, and each base opening communicates with both the first slit and the second slit, thereby sandwiching each inner wall segment in the middle. as well as A suture channel is positioned along the outer base portion of the base and is defined between the outer wall, the plurality of spaced inner wall segments, the outer base portion, and the tabs.

2. The suture retainer according to claim 1, wherein, The tab and the inner wall section form a generally L-shaped profile, and the tab and the inner wall section are configured to be lifted into an open configuration by deflecting the inner base portion, the lower section portion, or a portion of both.

3. The suture retainer according to claim 2, wherein, The generally L-shaped outline of the tab and the inner wall segment remains unchanged in the open configuration and returns to the closed configuration covering the suture channel with the same generally L-shaped outline.

4. The suture retainer according to any one of the preceding claims, wherein, The outer wall is continuously positioned along the outer periphery of the base and includes a plurality of spaced-apart recessed protrusions extending inward from the upper wall portion of the outer wall.

5. The suture retainer according to any one of the preceding claims, wherein, Each base opening extends along each inner wall segment, thereby separating each wall segment from the outer wall.

6. The suture retainer according to any one of the preceding claims further includes a needle region inside the inner wall sections, the needle region further including a needle resting portion.

7. The suture retainer according to claim 6, wherein, The needle resting part is a sliding needle resting part.

8. The suture retainer according to claim 7, wherein, The needle area includes a first winding pin hole, and the suture channel includes a second winding pin hole.

9. The suture retainer according to any one of the preceding claims, further comprising a suture needle assembly, wherein, The sutures of the suture needle assembly are centrally wound in the suture channel in a vertically stacked configuration.

10. A thread wrapping device, comprising: A winding base, the winding base including a retainer cavity configured to receive a suture retainer therein, the retainer cavity defining an external shape of the cavity; and A wrapping cap is configured to cover the wrapping base while leaving a gap between the wrapping cap and the wrapping base to allow the thread to pass through the gap into the wrapping device, wherein the wrapping cap is configured to position the thread in a stacked configuration inside the wrapping device, and the wrapping cap defines an outer shape of the cap that is different from the outer shape of the cavity.

11. The thread winding device according to claim 10, wherein, The cavity retainer has an oval-shaped outer cavity, and the wrapping cap has a dog-bone-shaped outer cap.

12. The thread winding device according to claim 11, wherein, The dog bone shape includes a pair of opposing parallel long sides extending between the generally semi-circular rounded ends of the wrap cap, which define a central portion of the wrap cap that is narrower than the semi-circular rounded ends.

13. The suture winding device according to claim 12, wherein: The retainer cavity is defined by the winding base sidewall and the winding base plate of the winding base, and the winding base sidewall includes a beveled top edge that defines a lower thread guide surface configured to guide the thread into the winding device. and The wrapping cap includes a cap sidewall extending between the top and bottom sides of the wrapping cap, the cap sidewall having a beveled bottom edge around the outer perimeter of the rounded end of the semicircular portion of the wrapping cap, the beveled bottom edge defining an upper thread guide surface configured to guide the thread into the wrapping device, wherein the opposite long side of the wrapping cap does not have the beveled bottom edge.

14. A suture winding device, comprising: A winding platform that extends along a central longitudinal axis between a proximal end portion and an opposing distal end portion; A platform channel, which is confined within the winding platform; A suture holder that can move longitudinally along and within the platform channel, the suture holder being configured to maintain the suture under constant tension during winding. as well as A suture winding device includes: a winding base having a retainer cavity defined therein configured to receive a suture retainer; and a winding cover configured to cover the winding base while leaving a gap between the winding cover and the winding base to allow suture to pass through the gap into the winding device, wherein: The retainer cavity defines the external shape of the cavity; The wrapping cap defines the outer shape of the cap, which differs from the outer shape of the retainer cavity; and The wrapping cap is configured to wrap the seam in a stacked configuration inside the wrapping device.

15. A method of loading a suture-needle assembly into a suture retainer, comprising: A suture retainer is positioned in a retainer cavity of a winding base, the winding base including a base sidewall including a beveled top edge defining a lower suture guide surface configured to guide the suture into the winding device, wherein the suture retainer defines a retainer outer shape, the retainer cavity defines a cavity outer shape, and the retainer outer shape and the cavity outer shape are the same outer shape; The needle of the suture-needle assembly is secured to the suture retainer. The suture-needle assembly includes a suture having a fixed end portion attached to the needle, a free end portion, and a central portion positioned between the fixed end portion and the free end portion. The free end portion of the suture is fixed to a suture holder that is spaced a certain distance from the suture winding device; The suture retainer is covered with a wrapping cap, the wrapping cap including a cap sidewall extending between the top and bottom sides of the wrapping cap, the cap sidewall having a beveled bottom edge defining an upper suture guide surface configured to guide the suture into the wrapping device, the wrapping cap being configured to cover the wrapping base while leaving a gap between the upper and lower suture guide surfaces to allow the suture to pass through the gap into the wrapping device, wherein the wrapping cap defines a cap exterior shape that differs from the exterior shape of the retainer or the exterior shape of the cavity; The winding device is spun to pull at least the central portion of the suture through the gap into the suture holder located within the winding device in a vertically stacked configuration, and to reduce the distance between the winding device and the suture holder.

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