Technical Field
This disclosure relates to suture packaging devises and methods for packing sutures. More particularly, this disclosure relates to foldable suture packages and methods for packaging sutures in foldable suture packages.
Description of the Related Art
Wound closure devices such as sutures, staples, and tacks have been widely used in surgical procedures in humans and animals for closing wounds, repairing traumatic injuries or defects, joining tissues together, attaching foreign elements to tissues, repositioning tissues to new anatomical locations and a myriad of other purposes.
Sutures are also often used as wound closure devices. Sutures typically consist of a filamentous suture thread attached to one or more needles with a sharp point. Suture threads can be made from a wide variety of materials including bioabsorbable (i.e., that break down completely in the body over time), or non-absorbable (permanent; non-degradable) materials. Absorbable sutures have been found to be particularly useful in situations where suture removal might jeopardize the repair, or where the natural healing process renders the support provided by the suture material unnecessary after wound healing has been completed; as in, for example, completing an uncomplicated skin closure. Non-degradable (non-absorbable) sutures are used in wounds where healing may be expected to be protracted or where the suture material is needed to provide physical support to the wound for long periods of time; as in, for example, deep tissue repairs, high tension wounds, many orthopedic repairs and some types of surgical anastomosis.
Like any long flexible filament, sutures may tangle during removal from their packaging, when preparing them for use, or during use. Because of the tendency for long flexible filaments to tangle, manufacturers and medical practitioners use great caution to prevent tangling during the packaging process and use of sutures. The handling of sutures and their attached needles also complicates the packaging and use of sutures.
Improperly packaged sutures may place the needles in a position where it is more likely to cause harm to medical practitioners, and some packaging device designs and methods for packaging may place the needles in less secure or less safe positions.
What is needed is a packaging device that safely and securely holds the suture and its needles and provides for its easy and safe removal. In addition, safe, easy, and efficient methods for loading and removing sutures from their packaging are also needed.
The present disclosure is directed towards an apparatus for holding a suture. The apparatus comprises a card including a base and a plurality of panels projecting outwardly from the base, the panels being adapted to fold to form the card into a box-shaped package. The base is adapted to mount on a fixture when the card is in an unfolded configuration for receiving the suture. The box-shaped package includes a plurality of walls enclosing an internal cavity for containing the suture. One of the plurality of panels includes a slit adapted to retain a portion of the suture proximate a needle while the suture is being placed in the apparatus. One of the plurality of panels includes a needle nest adapted to capture the needle after the remainder of the suture has been placed into the apparatus, and one of the plurality of panels is adapted to facilitate bending whereby a user can open a portion of the box-shaped package to access the needle and remove the needle and suture therefrom.
The present disclosure is also directed towards a method comprising the steps of: mounting a suture packaging card onto a mounting fixture with a portion of the mounting fixture passing through the suture packaging card, wrapping a suture into a coil around the portion of the mounting fixture that was passed through the suture packaging card, securing the suture coil to the suture packaging card, removing the suture packaging card from the mounting fixture, securing a suture needle to the suture packaging card, forming the suture packaging card into a box shape, and securing the suture packaging box
The present disclosure is also directed towards a system for packaging a suture. The system comprising a mounting fixture comprising a plurality of pins and a suture packaging card having a base comprising a plurality of apertures. The pins on the mounting fixture being configured to pass through the apertures in the base of the suture packaging card and to receive a coil of the suture material to be packaged within the suture packaging card. The suture packaging card comprising a plurality of panels projecting outwardly from the base. The panels being adapted to fold over the base to form the card into a box-shaped package for retaining the suture.
In the following description, certain specific details are set forth in order to provide a thorough understanding of various embodiments of the invention. However, one skilled in the art will understand that the invention may be practiced without these details. In other instances, well-known structures and steps associated with suture packaging have not been shown or described in detail to avoid unnecessarily obscuring descriptions of the embodiment of the invention.
The card 100 may be made from paper or other suitable materials. In some embodiments the card 100 is made from 9-point white surgical kraft paper.
The card 100 may include a base 110, which may include one or more fixture holes 111. The fixture holes 111 may be apertures cut, punched, or otherwise formed through the base 110. The fixture holes 111 allow one or more fixture pins, such as fixture pins 210, shown in
Although the embodiment shown in
In an unfolded position, as shown in
In some embodiments the fold indicators 102 and 103 are score lines. In some embodiments the score lines are formed by using an embossing tool, such as an embossing die, which applies a force along the fold indicator 102 and 103 to deform or create an indentation in the card 100 along the fold indicator 102 and 103. The deformation or indentation weakens the card 100 along the fold indicator 102 and 103 and facilitates folding a panel along the fold indicator 102 and 103.
In some embodiments, the fold indicators 102 and 103 are formed by making a shallow cut or line of perforations in the card 100. A shallow cut does not penetrate through the entire card 100, but penetrates less than all the way through the card 100 to weaken it along the fold indicators 102 and 103. A line of perforations, on the other hand, is a series of small holes or cuts through the card 100 along the fold indicators 102 and 103 to weaken it along the fold indicators 102 and 103. In some embodiments the fold indicators 102 and 103 may be a combination of deformations, indentations, cuts, and/or lines of perforations.
The walls 122, 132, 142, and 152 may have similar or different heights when formed. For example, wall 122 may have a height ‘A,’ while wall 132 may have a height ‘B.’ The difference in height of the walls 122, 132, 142, and 152 may account for potential differences caused by manufacturing tolerances, for the thickness of the packaged sutures, or for the additional thickness of each panel 120, 130, 140, and 150.
As discussed below, each panel is folded on top of each successive panel as the card 100 is formed into a box shape with an internal cavity, a top, a bottom, and a wall or walls extending between the top and bottom. To create a well-formed box, each wall should have a height that accounts for the material it covers such that it lays flat over the material. For example, in some embodiments, after positioning the sutures on the base 110, an operator may fold a first panel 130 over the sutures. In such an embodiment the height ‘B’ of wall 132 should account for the thickness of the sutures.
The operator may then fold a second panel 120 over the top of the first panel 130 and the sutures. In this case, the height ‘C’ of wall 122 should account for the thickness of the sutures and of the first panel 130. The height of the other walls would likewise account for the thickness of material over which a corresponding panel is folded.
In some embodiments, all wall heights are the same. In addition, in some embodiments the card 100 may not include any walls. In such embodiments, the card 100 may only include one fold indicator 102 or 103 for each panel 120, 130, 140, and 150 and the panels 120, 130, 140, and 150 may deform or bend to cover the packaged material or the other panels.
Each panel 120, 130, 140, and 150 may include one or more additional fold indicators. For example, the left panel 140 includes fold indicator 146. As discussed in more detail below, this fold indicator 146 may facilitate opening the package. For example, by creating a weak point in the panel 140, the fold indicator 146 may make it easier to bend or fold the panel and facilitate closing or opening the panel 140.
Each panel may include one or more lift tabs 148 to facilitate lifting a panel, such as panel 140 and opening the package 100.
Each panel may also include one or more cutouts. For example, the illustrated bottom panel 130 includes a cutout 136 to facilitate folding the panel 130 over a suture while the card 100 is loaded on a fixture, for example fixture 201 of
In some embodiments, the panels may have more than one cutout. In some embodiments, rather than removing a portion of a panel to create a cutout, the cutout may be a slit or slot through the panel that allows the panel to deform over a fixture pin or other obstruction when put in a closed or packed position.
Each panel may also include one or more suture holding tabs 134. The suture holding tabs 134 may hold the packaged suture in place during the packing operation.
Each panel may also include one or more locking slots. For example, the right panel 120 includes a locking slot 126. The illustrated locking slots 126 are D-shaped or in the shape of a semi-circle or half-moons as shown in
In some embodiments, the locking slots 126 may have a different shape. For example, the locking slots could have a rectangular or triangular shape. In some embodiments, the locking slots 126 could even be a slit.
Each panel and the base may also include one or more needle nests. For example, panel 120 includes a needle nest 127. The needle nest 127 is comprised of opposing and interleaved fingers 123 and 124 and one or more slits 125.
The needle nest 127 is adapted to hold one or more suture needles between the set of opposing fingers 123 and 124. The opposing fingers 123 and 124 are opened by bending the panel 120 along a line extending through the middle of the needle nest 127 and the slits 125. The slits 125 are similar to the fold indicators 102, 103, and 146 in that they facilitate the folding or bending of a panel. In particular, slits 125 facilitate the substantially elastic bending of the right panel 120 along a line running between the opposing fingers 123 and 124. This bending causes the fingers 123 and 124 to separate. The separation of the opposing fingers 123 and 124 creates a cavity into which an operator may place one or more suture needles.
After the operator places the needle or needles in the cavity they may remove the bending force. This may cause the opposing fingers 123 and 124 to close around the suture needle or needles, securing it in place.
Each panel may also include one or more suture positioning structures. For example, panel 120 includes suture positioning structure 128. A suture positioning structure 128 is a means for holding or positioning a suture while an operator is not using it. This allows the operator to place an end of the suture proximate to the needle into the positioning structure 128, which holds the suture while the operator parks the needle or needles in the needle nest 127. For example, in some embodiments, the card 100 holds more than one suture. In such embodiments, the operator may place one of the sutures in the positioning structure 128 and a corresponding needle in the needle nest and then proceed to load one or more additional sutures into the card.
The suture positioning structure may be comprised of one or more gates 129. For example, suture positioning structure 128 is comprised of four gates 129. Each gate 129 facilitates holding one or more sutures, but preferably only one suture.
Although panel 120 only shows a suture positioning structure 128 and its associated gates 129 along one edge of the panel 120, in other embodiments the panel 120 may include an additional corresponding or opposing suture positioning structure and associated gates along another edge, for example edge 121.
The card 100 may also include one or more wrapping slits. For example, panel 150 includes a wrapping slit 154. The wrapping slit is typically a cut or slot located along an edge of a panel. The wrapping slit 154 provides a place where an operator may secure the needle end of a suture during the wrapping and folding steps of a packaging procedure (see, for example,
When the operator places the needle end of a suture in the wrapping slit 154, the sides of the slit may deform and apply a holding force to the suture. This holding force acts against the suture and helps prevent the needle end of the suture from moving while the operator wraps the suture around the fixture pins 210 and when folding the panels 120, 130, 140, and 150 to close the card 100 around the suture.
The card 100 may also include one or more locking tabs, preferably at least two locking tabs. For example, panel 140 includes two locking tabs 144. As discussed above, each locking tab 144 engages with a corresponding locking slot 126 to releasably hold the panel 140 closed and substantially prevent the closed package 100 from opening.
The mounting post 240 includes indexes or flats 245 for coupling the wrapping fixture 201 to a fixture holder, not shown. The flats may interface with the fixture holder to aid in preventing the wrapping fixture from rotating while coupled to or held by the fixture holder.
The first and second couplers 250 and 260 couple the mounting plate 220 to the mounting post 240. The first coupler 260 may pass through an aperture 222 in mounting plate 220 and into a hole 242 in mounting post 240. The vertical hole 242 may be a blind and threaded hole as shown in
The second coupler 260 may provide an additional means to couple the mounting plate 220 to the mounting post 240. For example, mounting plate 220 and coupler 250 may include horizontal holes 224 and 270, respectively, through which the coupler 260, such as a machine screw, may pass. In such a configuration, the coupler 260 may prevent the mounting plate 220 from rotating relative to the coupler 250.
In some embodiments, for example, in the embodiment shown in
The mounting plate 220 may also include apertures 226 configured to receive pins 210. Pins 210 are configured and/or adapted to receive a suture packaging card, such as card 100 of
In
After the first suture 500 is wrapped, additional sutures (not shown) may be wrapped around the pins 410 while the additional needle ends 510 are secured in additional wrapping slits (not shown). In some embodiments, multiple needle ends 510 may be secured in a single wrapping slit 354.
In
The operator may also fold the bottom panel 330 up and over the top of the suture coil 520 as indicated by arrow E. During this step, the bottom panel 330 is bent along fold indicators 303 and 302, thus creating a first wall 332. The operator may then press the suture holding tabs 334 over the top of the suture coils 520. The cutout 336 may prevent the panel 330 and pins 410 from interfering with each other.
With the suture coils 520 held in place, the operator may remove the card 300 from the wrapping fixture 400 by sliding the card 300 up along the pins 410, as indicated by the arrow G.
Next, the operator may fold the right panel 320 up and over the top of the suture coil 520 and the bottom panel 330, as indicated by arrow H. During this step, the panel 320 is bent along fold indicators 303 and 302, thus creating a second wall 322.
Next, the operator may fold the top panel 350 up and over the top of the suture coil 520, the bottom panel 330, and the right panel 320, as indicated by arrow I. During this step, the panel 350 is bent along fold indicators 303 and 302, thus creating a third wall 352. During this process, the needle end 510 is removed from the wrapping slit 354 and placed over one of the positioning gates 329.
With the suture needle or needles 530 exposed and laying over the top of the right panel 320, the operator may bend the corner of the card 300 down and along line X, as indicated by arrows J, to separate the fingers 323 and 324 and open the needle nest 327. Aligning the slits 325 with the center of the needle nest 327, along axis X, facilitates folding the corner of the card 300 and opening the needle nest 327. With the needle nest 327 open, the operator may place the needle or needles 530 into the needle nest 327 with the needle facing towards the center of panel 320 and then release the bend on the card 300.
Finally, the operator may fold the left panel 340 over the top of the sutures 500 and the other folded panels 320, 330, and 350 to close the package. The panel 340 is folded along fold indicators 302 and 303, as indicated by arrows L and Y. During this step, a fourth wall 342 is created.
The operator securely closes package by inserting one or more locking tabs 344 into one or more respective locking slots 326.
After unfolding the left panel 340 along the fold indicator 346, the operator may unfold the top panel 350 as indicated by arrow N and then remove the needle or needles 530 from the needle nest 327 and the positioning gates 329 as shown by arrow 0. Finally, the operator may pull the entire suture 500 out from the package. Preferably, during the removal process the operator handles the needle 530 and sutures 500 with forceps.
The present disclosure provides the following exemplary embodiments:
The various embodiments described above can be combined to provide further embodiments. All of the U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications and non-patent publications referred to in this specification and/or listed in the Application Data Sheet are incorporated herein by reference, in their entirety. Aspects of the embodiments can be modified, if necessary to employ concepts of the various patents, applications and publications to provide yet further embodiments.
These and other changes can be made to the embodiments in light of the above-detailed description. In general, in the following claims, the terms used should not be construed to limit the claims to the specific embodiments disclosed in the specification and the claims, but should be construed to include all possible embodiments along with the full scope of equivalents to which such claims are entitled. Accordingly, the claims are not limited by the disclosure.
This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 61/952,660, filed Mar. 13, 2014, which application is hereby incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2015/020548 | 3/13/2015 | WO | 00 |
Number | Date | Country | |
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61952660 | Mar 2014 | US |