Patent ID: 12207635

DETAILED DESCRIPTION

FIG.1shows a schematic view of an article comprising a knotting device1, a thread2, which in the embodiment shown is a surgical suture, and a surgical tool in the form of a surgical needle3. The knotting device1is folded from a cutout of a flat material. A base section4of the knotting device1has two parts which in the depiction ofFIG.1form a top section5and a bottom section6. The top section5and the bottom section6may be folded onto each other along a base folding line7to close the knotting device1.

On the bottom section6of the base section4, thread storage section, which in the embodiment shown is a suture storage section8, is provided. In the embodiment ofFIG.1, the suture storage section8comprises an envelope-like structure which, as may be seen inFIG.1, is configured to hold a length of the suture2.

On the top section5of the base section4, a knot support element9is arranged. The knot support element9comprises two flaps10a,10bfolded or rolled up into a frustoconical shape11. The flaps10a,10bare formed out of the cutout and connected thereto at a base end of the frustoconical shape11. The base shape of the frustoconical shape11approximates a circle. However, due to the connection to the rest of the cutout and the nature of the process of folding or rolling, the circle is deformed with a flattened section at the point of connection with the rest of the cutout and kinks along its circumference where the frustoconical shape11has creases caused by folding or rolling. Further, the cross-sectional shape of the frustoconical shape11varies along its height. The frustoconical shape has a slit12formed by a distance between edges of the flaps10a,10b. As can be seen inFIG.1, the width of the slit12varies along the height of the frustoconical shape11due to the shape of the flaps10a,10b.

The needle3is connected to an extreme end of a first end13of the suture2. The first end13of the suture2is stored in the suture storage section8. In particular, most of the first end13of the suture2is arranged in the envelope-like structure of the suture storage section8.

A second end14of the suture2forms an open, non-tightened knot by being arranged in a plurality of windings15. The plurality of windings15are placed on the outer surface of the frustoconical shape11. Thereby, the plurality of windings15are held open by the frustoconical shape11. Further, the elasticity of the flaps10a,10bleads to a force expanding the frustoconical shape11, thereby keeping the plurality of windings15under tension. An extreme end of the second end14of the suture2is led back to the storage section8and stored in the envelope-like structure of the storage section8.

The plurality of windings15are kept form sliding off the base end of the frustoconical shape11both by the widening of the frustoconical shape11towards the base end and by the much wider configuration of the rest of the cutout to which the flaps10a,10bare connected at the base end of the frustoconical shape11. The plurality of windings15are kept from sliding off the tip end of the frustoconical shape11by a security flap16. The security flap16is integral with the rest of the cutout and connected thereto along a fold line. A smaller securing section17of the security flap16is placed on the tip end of the frustoconical shape11, thereby keeping the tip end in place and preventing the plurality of windings15from sliding off the tip end. A larger actuating section18of the security flap16is arranged opposite the fold line from the securing section17. Due to such placement, exerting a pressure on the actuating section18in the direction into the drawing plane ofFIG.1causes the security flap16to pivot around the fold line, lifting the securing section17off the tip end of the frustoconical shape and thereby releasing the tip end. With the tip end released, the plurality of windings15can slide off the tip end of the frustoconical shape11.

The needle3is held in place by a surgical tool support element19which, in the example ofFIG.1, is a piece of adhesive tape placed on the needle3and the knotting device1fixing the needle3to the knotting device1.

FIG.2shows a schematic view of a knotting device1. In comparison to the knotting device1ofFIG.1, the surgical tool support element19of the knotting device1ofFIG.2is a foam block glued to the cutout of the knotting device1. A surgical tool, in particular a needle3, may pierce the foam block, thereby fixing the surgical tool to the knotting device1.

FIG.3shows a cutout for forming a knotting device1. In the example shown, the cutout is cut from a sheet of a flat material using punching and allows forming a complete knotting device1with the exception of a surgical tool support element19which may be attached to the knotting device1once it has been folded from the cutout.

The cutout comprises a base section4with a top section5and a bottom section6. The top section5comprises a flap forming a subsection (on the left side inFIG.3) to which flaps10a,10bare connected from which the frustoconical shape11of a knot support element9is to be folded or rolled. The top section further comprises a security flap16with a securing section17and an actuating section18which may be pivoted by folding along a demarcated fold line of the top section5. The bottom section6comprises elements which are to be folded into a suture storage section8. Two storage flaps20a,20bmay be folded up for winding a suture2around such storage flaps20a,20b. Further storage flaps21a,21b,21c,21dare adapted to be folded into an envelope-like structure for storing the suture2wrapped around the storage flaps20a,20b; the folding motion depicted by arrows inFIG.4B.

For fixing the top section5and the bottom section6in a folded position after the knotting device1has been formed from the cutout, tabs22and corresponding slits23are provided. The tabs22may each be inserted into a corresponding slit23to secure a flap provided with the tab22in position.

FIGS.4A to4Dillustrate producing an article comprising a knotting device1, a thread provided as a surgical suture2and a surgical tool which is a needle3in the example shown.

According toFIG.4A, a knotting device1is provided. A frustoconical shape11formed from flaps10a,10bof a knot support element9is provided on a top section5of a cutout from which the knotting device1is formed. The tip end of the frustoconical shape11is free. A thread or suture storage section8provided on a bottom section6is completely unfolded.

As shown inFIG.4B, for producing an article, a plurality of windings15is formed in second end14of a suture. The plurality of windings15is placed on the outer surface of the frustoconical shape11. Following, the tip end of the frustoconical shape11is placed under a securing section17of a security flap18(as shown inFIG.4C). Thereby, the tip end of the frustoconical shape11is fixed in place and the plurality of windings15are prevented from sliding off the tip end of the frustoconical shape11. In alternative embodiments, only one or any number of windings of the plurality of windings15may be placed on the outer surface of the frustoconical shape11, as long as safe storage of a non-tightened knot provided by the plurality of windings15is ensured.

Storage flaps20a,20bof the suture storage section8are folded up and a first end13of the suture2is wound around the storage flaps20a,20bin a figure-8 shape. Following, storage flaps21a,21band21dare folded onto the wound first end13of the suture2, forming an envelope-like structure enclosing the first end of the suture13(as shown inFIG.4C).

FIG.4Cshows a step of closing the suture storage section8by folding a storage flap21cover the envelope-like structure; the folding motion depicted by an arrow. At the same time, a needle3attached to the extreme end of the first end13of the suture2is moved out of the suture storage section8along with part of the first end13of the suture2. The storage flap21cis fixed in the folded-over position by inserting a tab22into a corresponding slit23. It is to be noted that a flap of the top section5has accordingly been fixed in place by inserting tabs22into corresponding slits23as can be seen on the left side ofFIG.4C.

Finally, as shown inFIG.4D, the needle is fixed to a surgical tool support element19provided with a foam block by piercing the foam block with the needle3. For packaging the article, the knotting device1may be folded in half along a base fold line7, arranging the top section5on the bottom section6and thereby the knot support element9on the suture storage section8. The knotting device1may thus provide at least part of the packaging of the article, improving handling of the article and protecting the needle while allowing suture delivery from a sterilizable and discardable material from which the knotting device1is formed.

FIGS.5A to5Eshow a use of an article comprising a knotting device1, a thread2and a surgical tool which is a needle3in the example shown. The use shown inFIGS.5A to5Eis with regard to placing a knot at a surgical site. However, the article may be used in different scenarios, for example model building, in which a thread, which may be any desired thread, has to be knotted at a site that is hard to reach or/and at which there is little space for forming, placing and tightening the knot.

As shown inFIG.5A, the knotting device1is opened and the needle3is grasped, in the example shown using a surgical needle holder, and removed from a surgical tool support element19on the knotting device1. The needle3is then pulled away from the knotting device1, thereby pulling and removing a first end13of a suture2, to which the needle3is attached and which was placed in a suture storage section8of the knotting device1, from the suture storage section8, as shown inFIG.5B. The needle and the first end13of the suture2are then free to use. In particular, stitches may be placed at a surgical site using the needle3, for example closing a cut using the first end13of the suture2.

After the needle3and the first end13of the suture have been used and a knot is to be places, as illustrated inFIG.5C, the needle3is inserted into an open tip end of a frustoconical shape11of a knot support element9of the knotting device. The needle3is guided through the hollow frustoconical shape11and out of an open base end of the frustoconical shape11. Thereby, the needle is also guided through a plurality of windings15or loops of a knot formed in a second end14of the suture2, placed on and held open by the outer surface of the frustoconical shape11. The needle3is then pulled away from the knot support element9, pulling the first end13of the suture2along. Thereby, the first end13of the suture2is guided through the plurality of windings15of the knot, as well.

After first guiding the needle3through the frustoconical shape11and before pulling the needle3away from the knot support element9, it is usually necessary to change the grip on the needle3. For changing the grip, flaps10a,10bof the knot support element9forming the frustoconical shape11may also serve to hold the needle3in place while the grip is released. To achieve this, pressure may be exerted on the frustoconical shape11, in particular on the flaps10a,10bwhile the needle3is at least partially placed inside the frustoconical shape. The needle3is thus fixated and a user may momentarily let go of needle3to change their grip of the needle3.

InFIG.5D, it can be seen that the plurality of windings15of the knot may be released from the knot support element9by pushing on an actuation section18of a security flap16. Pushing on the actuation section18causes the security flap16to pivot around a fold line, thereby moving a securing section17of the security flap16, which was previously placed on a tip end of the frustoconical shape11, fixing the tip end in place, away from the tip end of the frustoconical shape11. The tip end is thereby released and the plurality of windings15of the knot are free to slide off the frustoconical shape11.

FIG.5Eillustrates tightening the knot. To tighten the knot, the plurality of windings15are slid along the length of the suture2towards the desired location of the knot. There, the knot is tightened by pulling on both the first end13and the second end14of the suture2. The suture2may then be trimmed at the knot and the knotting device1, the needle3and the trimmed sections of the suture2may be discarded.

As outlined above, the article according to the disclosure may be used in non-surgical contexts. In particular, the article may be used in any context in which it is desirable to form a knot in a thread2at a distance from the site of final placement of the knot by forming the knot at the knotting device1as outlined above and then moving it to the site of final placement along the thread2.

Although the invention has been illustrated and described in greater detail with reference to the exemplary embodiment, the invention is not limited to the examples disclosed, and further variations can be inferred by a person skilled in the art, without departing from the scope of protection of the invention.

For the sake of clarity, it is to be understood that the use of “a” or “an” throughout this application does not exclude a plurality, and “comprising” does not exclude other steps or elements.