Article, method for making a knot-forming apparatus for the article, method for making an article, and method for forming and tightly tying a knot.

Abstract

An article for assisting a user in tying and securing knots is provided. The article includes a knot tying device (1) and a line (2). The knot tying device (1) includes a base section (4), a line storage section (8) disposed on the base section (4), and a knot support element (9) including at least one flap (10a, 10b) of flat material folded into a frustum shape (11), the frustum shape (11) being hollow and open at a proximal end and a distal end of the frustum shape (11). The line (2) includes a first end (13) and a second end (14) opposite the first end along the length of the line (2). The first end (13) of the thread (2) is disposed within the thread storage section (8), and the second end (14) of the thread (2) forms a plurality of turns (15) of a loose knot, at least one turn (15) of the plurality of turns (15) being disposed on and around the outer surface of the frustum shape (11) of the knot support element (9), whereby the knot support element (9) supports the loose knot and holds the loose knot open. Additionally, methods of making a knot tying device, methods of making an article, and methods for forming and tying knots are disclosed.

Description

Detailed Description of the Invention

[0001] The present invention relates to an article, a method for manufacturing a knotting device for said article, a method for manufacturing the article, and a method for forming and tightly tying a knot.

[0002] [Background] Forming a knot is a complex operation. Forming a knot that meets specific requirements, particularly those relating to strength and durability, can be difficult or impossible in certain application scenarios. For example, in the model making of bottle ships and the like, it may be necessary to arrange complex knots at tiny details of the model to be manufactured that are difficult to reach (located in hard-to-reach areas).

[0003] In the medical field, knot formation in surgically accessed-restricted or minimally invasive surgery (for example, Laparo-Endoscopic Single-Site Surgery (LESS)) is technically difficult and time-consuming. At the same time, minimally invasive surgery is widely accepted as having greater advantages over open laparotomy in terms of both patient outcomes and treatment costs. Patient benefits include, in particular, reduced pain and scarring, reduced anesthesia time, shorter recovery and hospital stay, and faster return to normal activities; economic benefits include reduced postoperative complication rate, shorter hospital stay, and reduced total treatment costs.

[0004] Minimally invasive procedures are performed through very small incisions made in the body, and slender instruments are used to carry out the surgery. A separate incision may be used for a camera. This gives the surgeon a limited, usually two-dimensional, view of the working space. The extreme limitations of space and movement make creating surgical knots to fix tissues, organs, or close internal wounds a complex technical challenge. It is time-consuming and requires extensive practice. Guaranteeing consistently reliable results is difficult. Improperly made knots can loosen after surgery, resulting in serious complications and / or the need for reoperation.

[0005] While patient demand for minimally invasive surgical procedures is increasing, the cost of these procedures and a lack of technical skills are hindering their adoption. Suturing, and especially knot formation, during minimally invasive surgery presents significant technical challenges. For these reasons, some surgeons may opt for open surgery as an alternative.

[0006] Examples of suture-assisted devices and alternative surgical closure solutions used today include adhesives, strips, staplers, and mechanical suture devices. Some devices are adapted to specific use cases (e.g., barbed sutures for soft tissue approximation, or pre-made lasso knots for laparoscopic ligation). Other solutions, on the other hand, are mechanically complex devices that are costly to use.

[0007] Suture assist devices and laparoscopic closure devices are known, for example, from references WO 96 / 02194 A1 and US 2018 / 0206841 A1. Such devices are mechanically complex and have a relatively high cost per patient use.

[0008] Other comparable products include the so-called loop knot, which lacks a locking mechanism and requires a manually made security knot, and barbed sutures, which provide low-tension fixation without the need for knot formation, but do not provide strong fixation.

[0009] Conventional suture kits, consisting of needles attached to sutures, remain the most cost-effective, least complex, and most widely used solution for surgical closure today. Examples of such suture kits are known from references DE 2 044 486 A1, US 5,127,518 A, US 5,174,087 A, and US 5,566,821 A.

[0010] Reference US 3,869,044 discloses a device in which a needle-tipped, very fine surgical suture is wound from a needle-tipped end on a printed reel-label. This suture is cut from a single piece of label stock so that it is wound over a folded edge rather than a cut edge, preventing the very fine suture from fraying due to the cut edge of the label stock. The suture on the reel-label is contained within a protective envelope, for example, a peelable outer envelope.

[0011] Reference FR 2 331 638 A1 describes a holder for needles of sutures, such as surgical sutures. The holder consists of an envelope-like structure with a flap. It is formed of thin parallel plates partially attached along its edges by side walls having outward-facing recessed sections for winding the suture. A narrow slit for the end of the needle is provided in one plate, and there is an open groove for trapping the end of the suture. The flap covers the needle.

[0012] Reference US 3,876,068 relates to suture reel label packaging in which surgical sutures (including ligatures) are wound from either a needleed end or a free end on a printed reel label. The reel label is created from sealed thickness of a rigid, inert, sterilizable label stock by means of an aperture or grommet, and acts as a notable axis that allows it to be held between the fingers and thumb for unwinding. The needle, if attached, is held in a pocket between the thicknesses with the arm portion of the needle protected. Friction between the thicknesses and the suture allows the suture to be held in place during storage and unwound from either end. The suture reel assembly is housed in a sterile envelope that can be completely dried.

[0013] Reference WO 2019 / 106189 A1 discloses an insert retainer and a suture retainer used for connecting sutures to an insert for insertion into bone. The insert retainer and suture retainer may consist of a flat sheet of material.

[0014] Reference WO 2016 / 005118 A1 describes a device for making knots. The device includes a thread having a functional end and a pulling end. A main body is provided, and the thread is positioned around the outer surface of the main body in the form of a prepared open knot, such that when the pulling end is pulled, the thread slides along the lateral surface to form a closed knot.

[0015] 〔overview〕 The purpose of this disclosure is to provide an improved technology to assist users in tying knots and securing them tightly, in particular, to improve handling and enhance safety compared to existing knot-making aids.

[0016] To achieve the above objectives, an article, a method for making a knot-forming apparatus for the article, a method for making an article, and a method for forming and securing a knot are provided according to the independent claim. Embodiments are disclosed in the dependent claims.

[0017] According to one embodiment, an article is provided for assisting a user in forming and tying a knot. The article includes a knot-forming device. The knot-forming device includes a base section, a yarn storage section provided on the base section, and a knot-supporting element. The knot-supporting element includes at least one flap of flat material folded into a frustoconical shape. The frustoconical shape is hollow and open at the base end and the tip end of the frustoconical shape. Furthermore, the article includes a yarn. The yarn includes a first end and a second end located along the length of the yarn, opposite to the first end. The first end of the yarn is located within the yarn storage section, and the second end of the yarn forms a plurality of wraps of an untied knot. At least one of the multiple windings is positioned on and around the frustoconical outer surface of the knot support element, thereby allowing the knot support element to support the loosely tied knot and hold the loosely tied knot in an open state.

[0018] In another embodiment, a method for creating a knot-forming apparatus for the article is provided. The method includes the steps of providing a base section, forming a yarn storage section on the base section configured to hold a certain length of yarn, and forming a knot support element. The step of forming the knot support element includes folding at least one flap of a flat material into a frustoconical shape, the frustoconical shape being hollow and open at the base and tip of the frustoconical shape, and the knot support element is configured to support and hold the unknotted knot in an open state by supporting at least one of a plurality of windings that form an unknotted knot so that the winding remains on and around the outer surface of the frustoconical shape.

[0019] In a further embodiment, a method for producing an article is provided. The method for producing an article, by performing the method described herein, includes the steps of: providing a knot-forming device; placing a first end of a thread in the thread storage section; forming a plurality of loosely knotted knots at a second end of the thread; and placing at least one of the plurality of windings on and around the frustoconical outer surface of the knot-supporting element.

[0020] In an additional embodiment, a method is provided for forming and securing a knot. The method includes the steps of: providing the article described herein; passing the first end of the thread first through the open tip section of the frustum, then through the hollow frustum, and then through the open base section of the frustum; sliding at least one of the multiple turns of the unsecured knot away from the tip section of the frustum; and securing the knot by pulling the first end and the second end of the thread. The method for forming and securing a knot does not involve any steps of treatment of the human or animal body by surgery or therapy, and in particular does not involve any steps of surgical intervention on the human body. Thus, the method is non-surgical. Also provided is an article of the Specified Specification for use in surgery, comprising the steps of: passing the first end of the thread (in this case, a surgical suture) through the open tip section of the frustum, then through the hollow frustum, then through the open base section of the frustum; sliding at least one of the multiple wraps of the loosely tied knot away from the tip of the frustum; and tightening the knot by pulling the first and second ends of the suture.

[0021] The frustum shape may be a form of a frustum having any base shape of the base of the cone. In particular, the base shape may be a rounded shape (e.g., circular or elliptical). Alternatively, the base shape may have various types of shapes, such as elliptical or polygonal. The base shape may be, for example, rectangular or trapezoidal, and optionally may have rounded corners. In particular, the frustum shape may be a pyramidal frustum. Here, pyramidal is a specific type of cone, namely a cone having a polygonal base shape. With respect to all base shapes, including rounded base shapes, the frustum shape may include a fold line. The fold line is, in particular, the result of folding at least one of the flaps into the frustum shape. As a result, the base shape exhibits a deviation from the nominal shape, for example, a angular deviation at the endpoint of the fold in a rounded base shape. With respect to the ends of the frustum shape, the base end is the end of the frustum shape where the base of the frustum is located, and the tip of the frustum shape is the end that is on the opposite side of the base end along the height direction of the frustum and faces toward the apex of the (virtual) cone, which is the frustum of the (virtual) cone. The tip of the frustum shape may be closer to the edge of the knot-forming device than the base end of the frustum shape, and in particular, it may be closer to the edge of the base section.

[0022] The frustum shape may vary along the height direction of the frustum. For example, the frustum shape may consist of two or more frustums stacked on top of each other. As a result, the angle of the outer surface of the frustum shape may vary along the height direction of the frustum shape from the base to the tip. Alternatively or additionally, the frustum shape may be rounded along the height direction of the frustum, for example, resulting in a bottle-like shape. Generally, the frustum shape of the knot support element tapers towards the tip. In particular, the radius of the knot support element may vary to avoid movement of the suture windings that remain on the knot support element. The cross section and / or taper of the frustum shape may be provided such that the radius of multiple windings of suture remaining on the knot support element increases to a value that reduces or prevents twists or other shapes (memory effect) that would be left on the suture by being stored around the knot support element.

[0023] In the sense of this disclosure, a flat material is a material that extends substantially shorter in one spatial dimension than in two other spatial dimensions. In this sense, the flat material may be substantially two-dimensional. For example, the thickness of the flat material may be at least an order of magnitude smaller than both its length and width. The flat material may include paper materials. Alternatively or additionally, the flat material may include paper-like materials, plastic materials, metallic materials, or a combination thereof. The flat material may be a sterilizable material.

[0024] Folding at least one of the flaps of the flat material into the hollow frustum shape may include rolling the flap into the frustum shape. In the sense of this disclosure, a flap folded into a particular shape (in particular, a frustum shape) may be a flap rolled into such a shape.

[0025] With respect to arranging at least one of the multiple windings on and around the outer surface of the frustoconical shape, exactly one of the multiple windings, all of the multiple windings, or any desired number of the multiple windings may be arranged on and around the outer surface of the frustoconical shape. In particular, the number of windings of the multiple windings of thread that form the loosely tied knot may be selected so as to ensure that the loosely tied knot is securely held in place by the knot support element in the knot-forming device.

[0026] The knot support element may include two flaps of flat material or further flat material folded into the frustoconstrictor. In an alternative embodiment, the knot support element may include three or more flaps. In an embodiment in which the knot support element includes two or more flaps, the flaps may be folded and arranged toward each other (to the other) so that sections of the flaps provide an outer section, thereby forming the outer perimeter of the frustoconstrictor. On the other hand, other sections of the flaps may not form part of the outer perimeter of the frustoconstrictor and may be located, for example, inside the frustoconstrictor. The flaps may be folded from the outside of the frustoconstrictor toward the inside, or from the inside of the frustoconstrictor toward the outside, or the flaps may be folded in various directions.

[0027] The knot support element may include a slit provided in the frustoconical shape, extending from the base end to the tip end of the frustoconical shape. In some embodiments, the two flaps may form the slit by providing distance between the flaps in multiple sections of the flaps that form part of the outer circumference of the frustoconical shape. In this case, the flaps may fold inward with respect to the frustoconical shape, forming an edge of the slit (particularly a rounded edge).

[0028] Said base section may be formed from said cutout of flat material or from a further cutout of flat material. Said cutout may be cut from said flat material or said further flat material using any known method, for example mechanical cutting including punching and die cutting, laser cutting and / or water jet cutting. Alternatively, said cutout does not have to be formed by cutting, and may be any shape having the appearance of a cut-out shape. For example, said cutout may be formed by additive manufacturing, for example 3D printing, particularly in a desired shape that has been pre-formed. Forming the knot forming device using a cutout of flat material can minimize the volume of the knot forming device. Forming at least the base section of the knot forming device from a cutout of flat material may provide a distributable and / or sterilisable knot forming device. Furthermore, forming the knot forming device using a cutout of flat material may reduce manufacturing costs and logistics costs.

[0029] In a plurality of embodiments, said knot support element comprises at least one said flap of said flat material folded into said frustum shape, wherein said base section may be formed from a further cutout of flat material. In such embodiments, said flat material of at least one said flap is fixed to said cutout of said further flat material, for example by gluing, welding and / or stapling. In particular, said further flat material may be fixed to said base section. With respect to said further flat material, the embodiments described with respect to said flat material apply mutatis mutandis.

[0030] The cutout of said flat material may comprise at least one said flap of the knot support element. For example, at least one said flap may be a section of said cutout directly or indirectly attached to said base section. In another embodiment, at least one said flap may be provided by a cut in said base section itself, and the frustoconical shape may be formed by folding at least one said flap from said base section.

[0031] In general, the knot forming device may be formed from a cutout provided as a single (integral) piece. For example, said cutout may be cut from said flat material as a single shape, without the need to assemble multiple pieces. Said cutout may comprise a plurality of sections, for example in the form of flaps, that provide all parts of the support member when folded. By using a single-piece cutout, said knot forming device may be manufactured from a single component (part) or a small number of components.

[0032] In an alternative embodiment, said base section may not be formed from a cutout of flat material. For example, said base section may be formed by a box or a cartridge, which may for example be formed using a casting method or additive manufacturing. In such embodiments, said flat material forming at least one said flap of the knot support element may be formed as a flat section of the same material as said base section, or said flat material forming at least one said flap of the knot support element may be fixed to said base section, for example by gluing, welding and / or stapling.

[0033] At least one section of the base end of the frustum shape may be formed continuously (without break) with the base section so as to prevent one or more turns of the loosely tied knots located on and around the outer surface of the frustum shape from moving away from the base end. For example, the cutout of the flat material may include at least one flap, the base end of which may be directly or indirectly connected to the base section in the cutout. The base section may be wider at the base end than the base end of the frustum shape so as to prevent the turns of the loosely tied knots located on and around the outer surface of the frustum shape from moving away from the base end.

[0034] The knot-forming apparatus includes a security flap, which is formed adjacent to the knot support element and is configured to be positioned on the tip of the frustoconstrictor such as to prevent one or more turns of the loosely knotted knots located on and around the outer surface of the frustoconstrictor from moving away from the tip, and is movable relative to the tip of the frustoconstrictor such as to allow one or more turns of the loosely knotted knots located on and around the outer surface of the frustoconstrictor to move away from the tip. In one embodiment, the security flap may be pivotably connected to the base section. For example, the security flap may be formed continuously (without breaks) with the base section and be pivotably foldable relative to the base section. The security flap comprises a first security flap section configured to be positioned on the tip of the frustoconstrictor, and a second security flap section positioned opposite the pivot point or pivot line of the security flap relative to the first security flap section. This allows the first security flap section to pivot away from the tip of the frustoconstrictor by pressing the second security flap section, thereby releasing the loosely tied knots positioned on and around the outer surface of the frustoconstrictor. In some embodiments, the cutout of the flat material may include the security flap. In particular, the knot-forming device including the security flap may be formed from a cutout provided as a single piece.

[0035] The security flap may be secured by a retaining element in a position where it is positioned on the tip of the frustoconical shape. The retaining element may be a retaining tab or a retaining flap, and the security flap may slide beneath the retaining tab or flap, thereby being held in place. The retaining tab or flap may be a small tab or flap so as to have high rigidity to help hold the security flap in place. Alternatively, the retaining element may be a clip, adhesive point, magnet, or hook-and-loop fastening means.

[0036] The security flap may be configured to release the plurality of windings by applying a predetermined force. The predetermined force may be applied to the security flap itself. Here, the knot support element and / or the thread form a plurality of windings, and at least one of the plurality of windings is located on and around the frustum. The retaining element may be sized such that the predetermined force causes the security flap to be released from the retaining element.

[0037] The yarn storage section may be positioned on the base section adjacent to the first end, and the knot support element may be positioned on the base section adjacent to the second end, such that when the base section is folded over itself along a base fold line running between the yarn storage section and the knot support element, the knot support element will come into contact with the yarn storage section, and the knot support element may be positioned on the base section adjacent to the second end opposite to the first end. In this specification, the base section (which in some embodiments may be formed from a cutout) may include one half containing the yarn storage section and another half containing the knot support element. The first half may be folded over the second half by folding the cutout in the middle. In particular, such configuration may be provided in embodiments in which the cutout of the flat material includes at least one of the flaps of the knot support element. This may provide both a knot-forming device for assisting the user in forming and tying knots, and packaging for the knot-forming device, by enclosing (retaining) the thread storage section and the knot support element when the knot-forming device, particularly the cutout, is folded in half. The function of the knot-forming device as packaging may include protecting elements placed within the packaged knot-forming device, in particular the thread, more specifically, the winding of such thread that forms a knot that is not tightly tied, and / or the protection of other windings of such thread (e.g., windings provided for compact storage of the thread). In various embodiments, the knot-forming device, particularly the cutout from which the knot-forming device is formed, may include additional sections and / or additional flaps. In such embodiments, the section including the knot support element may still be folded onto the section including the thread storage section, thereby providing packaging for the knot-forming device by the knot-forming device itself.

[0038] The base section may include a fold along the base fold line. The fold may be pre-formed to facilitate folding along the fold line, or the fold may be formed when the base section is first folded along the fold line.

[0039] In general, the thread may be a suture. In particular, the knot-forming device may be configured for use with surgical sutures. In this case, the thread storage section is configured to hold a certain length of surgical suture, and the knot-supporting element supports an untied knot by supporting multiple turns of the surgical suture, and holds the untied knot in an open state. In such embodiments, the surgical suture may be any desired surgical suture, such as monofilament sutures, multifilament sutures, braided sutures, sutures made from natural materials, and / or sutures made from synthetic materials.

[0040] The knot-forming device may include a surgical instrument support element formed on the suture storage section, or a surgical instrument support element formed adjacent to the suture storage section. In an alternative embodiment, the knot-forming device may include a surgical instrument support element not formed on the suture storage section, or a surgical instrument support element not formed adjacent to the suture storage section. For example, the knot-forming device may include a surgical instrument support element formed adjacent to the knot support element. The surgical instrument support element may be configured to fix the surgical instrument to the knot-forming device. The article may comprise a surgical instrument. In an embodiment in which the knot-forming device of the article comprises a surgical instrument support element, the article may comprise a surgical instrument fixed to the surgical instrument support element. In such an embodiment, the suture may be a surgical suture. The surgical instrument may be fixed to the suture, and in particular, in the article, the surgical instrument may be fixed to the first end of the suture.

[0041] The surgical instrument may be any instrument used to perform functions related to surgical sutures during surgery. In particular, the surgical instrument may be a surgical needle. Such a surgical needle may be used to pierce tissue at the surgical site for suturing and to guide the surgical suture through the tissue. Alternatively, the surgical instrument may be a fixation device. For example, the surgical instrument may be a surgical anchor (fixation device) or a suture anchor. Such a surgical anchor or suture anchor may be used to fix the surgical suture to the surgical site. For example, the surgical suture may be fixed by fixing the surgical anchor or suture anchor to bone. For example, the surgical anchor or suture anchor may be fixed by screwing the surgical anchor or suture anchor into a receptive structure such as bone at the surgical site.

[0042] The surgical instrument support element may be made of a material through which the surgical instrument can be pierced. For example, the surgical instrument support element may be made of a material (e.g., a soft material) through which a surgical needle can be pierced so that the surgical needle is fixed in place. For example, the surgical instrument support element may be provided as a foam block, a wax block and / or a compound. Alternatively, the surgical instrument support element may be provided by the material of the knot-forming device itself, in particular by the cutout of the flat material. For example, the surgical instrument support element may be the cutout (e.g., a flap) of a certain area through which the surgical instrument can be pierced. Alternatively, the surgical instrument support element may be provided as a magnet, a clip for clipping the surgical instrument, at least one press-on tab, a locking mechanism (bayonet mount, tape or adhesive, etc.). The surgical instrument support element may be adapted to repeatedly fix and release the surgical instrument.

[0043] In several embodiments, the knot-forming device may be formed from a cutout provided as a single piece, including the surgical instrument support element. For example, the surgical instrument support element may be a flap of the cutout. In other embodiments, the knot-forming device may be formed from a cutout provided as a single piece, excluding the surgical instrument support element, as described herein. In such embodiments, the surgical instrument support element (e.g., a foam block) may be fixed to the cutout before forming the knot-forming device from the cutout, after forming the knot-forming device from the cutout, or while forming the knot-forming device from the cutout.

[0044] The knot-forming device may include at least one storage flap provided in the suture storage section and configured to receive a certain length of thread (e.g., suture). In particular, at least one of the storage flaps may receive multiple unknotted windings of the thread such that a length of the thread is wound around and stored around at least one of the storage flaps. The first end of the thread may be wound around at least one of the storage flaps, for example, in a figure-eight or O-shape, so that the thread is not biased into the shape stored in the storage section. At least one of the storage flaps may be movable from a first position (in the first position, the first section of the thread may be wound around at least one of the storage flaps) to a second position (in the second position, at least one of the storage flaps does not engage with the first section of the thread, and the first section of the thread is freely removable from the storage section).

[0045] Alternatively, at least one of the storage flaps may be folded into an envelope-like structure for enclosing (containing) a thread of a certain length. The first end of the thread may be placed within the envelope-like structure, for example, in a wound state without forming a knot. To form the envelope-like structure, at least one of the storage flaps may be configured to form one or more envelope sections of the cutout of the flat material, particularly in terms of its size.

[0046] The knot-forming device may include a plurality of storage flaps, where at least one of the plurality of storage flaps receives a plurality of windings of a thread that does not form a knot, such that the thread is wound around and stored for a length of time around at least one of the plurality of storage flaps. At least one other storage flap of the plurality of storage flaps folds into an envelope-like structure to enclose a certain length of thread. The first end of the thread may be wound around at least one of the plurality of storage flaps and at the same time may be placed within the envelope-like structure provided by at least one other storage flap of the plurality of storage flaps.

[0047] The cutout of the flat material or the cutout of the further flat material may include at least one of the storage flaps. In particular, the knot-forming device may be formed from a cutout provided as a single piece, or from a cutout provided as a single piece, except for the surgical instrument support element.

[0048] The storage section may include a hole configured to receive a pin around which the thread can be wound. In particular, the pin may be placed in the hole for creating the article. The pin may be removed from the hole after the first section of the thread has been wound around the pin, and the finished article may not contain the pin. The first section of the thread may be wound around the pin in such a way that the thread is not biased into the shape stored in the storage section. For example, the first section of the thread may be wound around the pin in the shape of an eight or an O as shown in the figure.

[0049] The first and second ends of the yarn may each have any length. In particular, the first and second ends may be directly adjacent to each other, and the yarn as a whole may consist of the first and second ends. Alternatively, the yarn may include an intermediate portion between the first and second ends.

[0050] The knot used may be of any type. The second end of the thread may have multiple knots. For example, the multiple knots may have multiple windings, where at least one of the windings is located on and around the frustum.

[0051] The article may include sterile or sterilizable packaging that encloses (contains) the knot-forming device, the thread (particularly surgical suture), and, in the case of an article including a surgical instrument, the surgical instrument. The article may be a disposable or single-use article. The components of the article may be disposable separately. For example, the packaging may be disposed of after the knot-forming device, the thread, and, in the embodiment of the article including a surgical instrument, the surgical instrument, have been removed from the packaging. The knot-forming device may be disposed of after the thread has been removed from the knot-forming device. Part of the thread may be disposed of after the knot has been formed and secured. In particular, the surgical instrument and part of the thread provided as surgical suture may be disposed of after suturing at the surgical site is completed. Part of the suture remaining at the surgical site may be removed and disposed of after sufficient healing, or may be left at the surgical site.

[0052] The articles may include two or more of the knot-forming devices, the sutures, and optionally the surgical instruments, in sterile or sterilizable packaging. The embodiments described above may be applied to each combination of knot-forming devices, sutures, and, where applicable, surgical instruments. Thus, two or more knot-forming devices combined with sutures and optionally surgical instruments may be provided in a single sterile or sterilizable package. For example, five knot-forming devices, each having a corresponding suture and a corresponding surgical instrument, may be provided in a single sterile or sterilizable package.

[0053] The knot-forming device may include a towing end fixing element for securing the towing end of a thread. In the article, the towing end of the thread may be the end of the second section of the thread. The towing end may act to tightly tie the knot after, by pulling the towing end, at least one of the multiple windings moves away from the knot support element. The towing end fixing element may be provided as a tab or flap, a clip, an adhesive point, or a similar structure for securing the towing end. Alternatively, the towing end may run within a rail, and access to the towing end may be provided by a recess outside the rail. For example, the rail may be formed by a rail flap of the knot-forming device, with the towing end positioned longitudinally below the rail flap of the knot-forming device. The rail flap may also be provided with an opening or recess, which may be provided, for example, as a hole cut into the rail flap that the towing end can access.

[0054] The knot-forming device may include interaction points that a user of the knot-forming device can interact with when using the device. The knot-forming device may be marked for indication of use. For example, the interaction points may be visually marked or may have tactile cues. With respect to the knot-forming device and / or the article, the interaction points may include any or all of the surgical instruments, the surgical instrument support elements, the security flaps, the traction end fixing elements, and the grip zones for holding the knot-forming device. The grip zones may have surfaces with tactile or visual markings for better handling. The knot-forming device may further include alphanumeric characters and / or symbols. For example, the alphanumeric characters and / or symbols may indicate a set of operating steps for using the knot-forming device and / or a set of operating steps for using the article.

[0055] The knot-forming device may retain its desired shape after folding without requiring additional fastening means such as adhesive or staples. For example, the cutout may be provided with additional tabs or flaps and their respective slots, such that each tab or flap is inserted into its respective slot during folding. Thereafter, the section of the cutout may be fixed in place, and the knot-forming device may retain its desired shape.

[0056] The method for forming and securing a knot may be used, for example, for model making. For example, the method may be used when assembling a so-called bottle ship by placing the article outside the bottle, inserting the first end of the thread into the bottle, passing it through a loop or similar structure of a ship model placed inside the bottle, and bringing the first end out of the bottle. The first end may then be passed through the frustum, or at least one of the multiple windings may be slid away from the frustum, and the knot may be passed through the bottle and onto the ship model by pulling the first and second ends together to secure the knot.

[0057] The knot may be closed at any time by guiding the first end of the thread through a plurality of the windings, guiding at least one of the plurality of windings away from the frustoconstriction, and tying the knot tightly. Guiding the first end through the plurality of windings may be done (at least partially) before or after guiding at least one of the windings away from the frustoconstriction. Alternatively or additionally, guiding the first end through the plurality of windings may be done at least partially during guiding at least one of the windings away from the frustoconstriction. For example, a first portion of the first end may be guided through the plurality of windings, but a second portion of the first end does not have to be guided through the plurality of windings. Then, at least one of the windings may be guided away from the frustoconstriction and beyond the first end, thereby guiding the second portion of the first end through the plurality of windings. In embodiments including a surgical instrument, the embodiments outlined above with respect to passing the first end through the plurality of windings may be applied mutatis mutandis to passing the surgical instrument through the plurality of windings.

[0058] The present disclosure provides cutouts for forming the knot-forming apparatus. The cutouts are made from a flat material. In particular, the cutouts may be shapes cut out from the flat material. The cutouts may be cut out from the flat material using any known method (e.g., mechanical cutting (including punching and die-cutting), laser cutting and / or waterjet cutting). Alternatively, the cutouts may be any shape that has the appearance of a cutout shape but is not formed by cutting. For example, the cutouts may be formed by additive manufacturing (e.g., 3D printing), particularly when they are already in their desired shape. The cutouts may be provided as sterile cutouts. The cutouts may be manufactured as single pieces. For example, the cutouts may be cut out from the flat material as a single shape without the need to assemble multiple pieces. The cutouts may include multiple sections that provide all parts of the knot-forming apparatus when folded. By providing the cutout as a single piece, the knot-forming apparatus may be manufactured from a single part or a small number of parts.

[0059] The cutout is configured to fold into the knot-forming apparatus described herein. For this purpose, the cutout includes various sections that can be folded toward each other. The plurality of sections may include a plurality of sections that are adjacent to each other and separated from each other as part of the cutout, and which are connected to each other. Alternatively or additionally, the plurality of sections may include a first section and a second section located within the first section and separated from the first section by a cut that does not form a closed curve, such that the second section is connected to and foldable toward the first section. Further sections located within other sections may be provided accordingly.

[0060] With respect to the articles and methods for forming and securing knots, faster and easier knot formation can be provided compared to making knots by hand, for example, in minimally invasive surgery with respect to the articles. In particular, compared to making surgical knots by hand, which is the medical standard, and depending on the expertise of the surgeon performing the knot formation, reliable knot formation, and therefore relatively higher patient safety, may be possible compared to manual knot formation in average surgery. Compared to known surgical suturing devices, the cost and / or complexity of use may be reduced. As a result, it may be more widely applicable than known devices.

[0061] The embodiments described above with respect to the knot-forming apparatus may also be applied mutatis mutandis to the article, the method for making the knot-forming apparatus, the method for making the article, and / or the method for forming and tightly tying a knot, and vice versa.

[0062] [Further description of embodiments] The following describes an embodiment using drawings as an example. The contents of the drawings are as follows: Figure 1 is a schematic diagram of an article comprising a knot-forming device, sutures, and surgical instruments.

[0063] Figure 2 is a schematic diagram of a knot-forming device having a surgical instrument support element.

[0064] Figure 3 shows the cutout for forming the knot-forming device.

[0065] Figures 4A to 4D are schematic diagrams of the process for creating an article that includes a knot-forming device, sutures, and surgical instruments.

[0066] Figures 5A to 5E are schematic diagrams illustrating the use of an article including a knot-forming device, sutures, and surgical instruments.

[0067] Figure 1 shows a schematic diagram of an article comprising surgical instruments in the form of a knot-forming device 1, thread 2 (in this embodiment, surgical suture is shown), and a surgical needle 3. The knot-forming device 1 is folded from a cutout of flat material. The base section 4 of the knot-forming device 1 has two parts. In the depiction of Figure 1, these two parts form the top section 5 and the bottom section 6. The top section 5 and the bottom section 6 may be folded toward each other along the base fold line 7 so that the knot-forming device 1 is closed.

[0068] A thread storage section (in this embodiment, a suture storage section 8) is provided on the bottom section 6 of the base section 4. In the embodiment of Figure 1, the suture storage section 8 includes an envelope-like structure configured to hold a certain length of suture thread 2, as can be seen in Figure 1.

[0069] A knot support element 9 is positioned on the top section 5 of the base section 4. The knot support element 9 includes two flaps 10a and 10b. These two flaps 10a and 10b are folded into or rolled up into a frustoconstrictor 11. The flaps 10a and 10b are formed from cutouts and are connected to the base end of the frustoconstrictor 11. The base shape of the frustoconstrictor 11 approximates a circle. However, due to the connection to the rest of the cutout and the nature of the folding or rolling process, the circle is deformed to have a flattened section at the connection point with the rest of the cutout, and the circle is twisted along its circumference, which has creases (wrinkles) created by the folding or rolling. Furthermore, the cross-sectional shape of the frustoconstrictor 11 changes along its height direction. The frustoconstrictor has a slit 12 formed by the separation between the edges of the flaps 10a and 10b. As can be seen in Figure 1, the width of the slit 12 changes along the height direction of the frustum 11, depending on the shape of the flaps 10a and 10b.

[0070] The needle 3 is connected to the end of the first end 13 of the suture thread 2. The first end 13 of the suture thread 2 is stored in the suture thread storage section 8. In particular, most of the first end 13 of the suture thread 2 is located within the envelope-like structure of the suture thread storage section 8.

[0071] The second end 14 of the suture 2 is arranged in a state of multiple wraps 15, forming an open, loosely tied knot. The multiple wraps 15 are arranged on the outer surface of the frustoconical shape 11. Thus, the multiple wraps 15 are held open by the frustoconical shape 11. Furthermore, the elasticity of the flaps 10a and 10b provides a force that expands the frustoconical shape 11, thereby keeping the multiple wraps 15 taut. The end portion of the second end 14 of the suture 2 is returned to the storage section 8 and stored in the envelope-like structure of the storage section 8.

[0072] The multiple windings 15 are held in place by the frustum 11 widening toward the base, and by the very wide configuration of the remaining cutout to which the flaps 10a, 10b are connected at the base of the frustum 11. The multiple windings 15 are held in place by a security flap 16 to prevent them from sliding away from the tip of the frustum 11. The security flap 16 is integral with the remaining cutout and connected to it along the fold line. A smaller fixed section 17 of the security flap 16 is positioned on the tip of the frustum 11, thereby keeping the tip in place and preventing the multiple windings 15 from sliding away from the tip. A larger working section 18 of the security flap 16 is positioned opposite the fold line from the fixed section 17. Due to this arrangement, applying pressure to the operating section 18 in the direction toward the drawing plane of Figure 1 causes the security flap 16 to pivot around the folding line, lifting the fixed section 17 away from the tip of the frustoconical shape, thereby releasing the tip. With the tip released, the multiple windings 15 can slide away from the tip of the frustoconical shape 11.

[0073] The needle 3 is held in place by a surgical instrument support element 19 (in the embodiment shown in Figure 1, a piece of adhesive tape placed on the needle 3 and the knot-forming device 1, which secures the needle 3 to the knot-forming device 1).

[0074] Figure 2 shows a schematic diagram of the knot-forming device 1. Compared to the knot-forming device 1 in Figure 1, the surgical instrument support element 19 of the knot-forming device 1 in Figure 2 is a foam block bonded to a cutout in the knot-forming device 1. A surgical instrument, particularly a needle 3, may be pierced through the foam block, thereby fixing the surgical instrument to the knot-forming device 1.

[0075] Figure 3 shows a cutout for forming the knot-forming device 1. In the illustrated embodiment, the cutout is cut from a sheet of flat material using punching. The cutout allows for the formation of the complete knot-forming device 1, except for the surgical instrument support element 19 (which can be attached to the knot-forming device 1 once the knot-forming device 1 is folded from the cutout).

[0076] The cutout includes a base section 4. The base section 4 has a top section 5 and a bottom section 6. The top section 5 includes flaps that form a subsection (on the left side in Figure 3) to which flaps 10a, 10b are connected. The frustoconical shape 11 of the knot support element 9 is formed by folding from or winding from the flaps forming the subsection. The top section further includes a security flap 16 having a fixed section 17 and an actuation section 18. The security flap 16 can be pivoted by folding along a defined fold line of the top section 5. The bottom section 6 includes an element that will fold into a suture storage section 8. Two storage flaps 20a, 20b may be folded up to wind the suture 2 around such storage flaps 20a, 20b. Further retractable flaps 21a, 21b, 21c, and 21d are adapted to fold into an envelope-like structure for storing sutures 2 wrapped around retractable flaps 20a and 20b.

[0077] After the knot-forming device 1 is formed from the cutout, a plurality of tabs 22 and a plurality of corresponding slits 23 are provided to secure the top section 5 and bottom section 6 in the folded position. Each of the plurality of tabs 22 may be inserted into the corresponding slit 23 so that the flap on which the tab 22 is provided is secured in place.

[0078] Figures 4A to 4D illustrate the creation of an article comprising a knot-forming device 1, thread (provided as surgical suture 2), and a surgical instrument (needle 3 in the illustrated embodiment).

[0079] According to Figure 4A, a knot-forming device 1 is provided. The frustum 11 formed from the flaps 10a and 10b of the knot support element 9 is provided on the top section 5 of the cutout from which the knot-forming device 1 is formed. The tip of the frustum 11 is free (not fixed). The thread storage section or suture storage section 8 provided on the bottom section 6 is fully extended.

[0080] As shown in Figure 4B, multiple wraps 15 are formed at the second end 14 of the suture to create the article. The multiple wraps 15 are positioned on the outer surface of the frustoconstrictor 11. Subsequently, the tip of the frustoconstrictor 11 is positioned under the fixing section 17 of the security flap 18 (as shown in Figure 4C). This secures the tip of the frustoconstrictor 11 in place and prevents the multiple wraps 15 from sliding away from the tip of the frustoconstrictor 11. In an alternative embodiment, only one or any number of the multiple wraps 15 may be positioned on the outer surface of the frustoconstrictor 11, as long as the secure storage of the loosely knotted knot provided by the multiple wraps 15 is ensured.

[0081] The storage flaps 20a and 20b of the suture storage section 8 are folded up, and the first end 13 of the suture 2 is wrapped around the storage flaps 20a and 20b in the figure-eight shape shown in the figure. Subsequently, the storage flaps 21a, 21b and 21d are folded over the wrapped first end 13 of the suture 2, forming an envelope-like structure surrounding the first end 13 of the suture (as shown in Figure 4C).

[0082] Figure 4C shows the process of closing the suture storage section 8 by folding the storage flap 21c over the envelope-like structure. At the same time, the needle 3 attached to the end of the first end 13 of the suture 2 is moved out of the suture storage section 8 along with a portion of the first end 13 of the suture 2. The storage flap 21c is fixed in the folded position by inserting the tab 22 into the corresponding slit 23. Note that, correspondingly, as can be seen on the left side of Figure 4C, the flap of the top section 5 is fixed in place by inserting the tab 22 into the corresponding slit 23.

[0083] Finally, as shown in Figure 4D, the needle is secured to the surgical instrument support element 19 on which the foam block is provided by piercing the needle 3 through the foam block. To package an article, the knot-forming device 1 may be folded in half along the base fold line 7, with the top section 5 positioned on the bottom section 6, thereby positioning the knot support element 9 on the suture storage section 8. This provides at least part of the packaging of the article, improving the handling of the article and protecting the needle, while allowing the knot-forming device 1 to be supplied with suture from a sterilizable and disposable material from which the suture is formed, thereby improving the handling of the article.

[0084] Figures 5A to 5E illustrate the use of an article comprising a knot-forming device 1, a thread 2, and a surgical instrument (a needle 3 in the illustrated embodiment). The use shown in Figures 5A to 5E relates to placing a knot at a surgical site. However, this article may also be used in various situations (e.g., model making) where it is necessary to form a knot in a thread in a place that is difficult to reach and / or where there is little space to form, place, and tightly tie a knot.

[0085] As shown in Figure 5A, the knot-forming device 1 is opened, the needle 3 is grasped (using a surgical needle holder in the illustrated embodiment) and removed from the surgical instrument support element 19 on the knot-forming device 1. Next, as shown in Figure 5B, the needle 3 is pulled away from the knot-forming device 1, thereby pulling out the first end 13 of the suture 2 to which the needle 3 is attached, which is located in the suture storage section 8 of the knot-forming device 1. The needle and the first end 13 of the suture 2 are then made available for use. In particular, the needle 3 may be used to suture the surgical site, or, for example, the first end 13 of the suture 2 may be used to close an incision.

[0086] As shown in Figure 5C, after the needle 3 and the first end 13 of the suture are used and the knot is to be formed, the needle 3 is inserted into the open tip of the frustoconical shape 11 of the knot-forming device's knot support element 9. The needle 3 is guided through the hollow frustoconical shape 11 and exits through the open base end of the frustoconical shape 11. As a result, the needle is also guided through the multiple turns 15 or loops of the knot formed on the second end 14 of the suture 2, which is positioned on the outer surface of the frustoconical shape 11 and held open by the outer surface of the frustoconical shape 11. The needle 3 is then pulled away from the knot support element 9, and the first end 13 of the suture 2 is pulled accordingly. As a result, the first end 13 of the suture 2 is also guided through the multiple turns 15 of the knot.

[0087] After initially guiding the needle 3 through the frustoconstrictor 11, it is usually necessary to change the grip on the needle 3 before pulling it away from the knot support element 9. To change the grip, the flaps 10a and 10b of the knot support element 9 forming the frustoconstrictor 11 can serve to hold the needle 3 in place while the grip is released. To achieve this, pressure may be applied to the frustoconstrictor 11, and especially to the flaps 10a and 10b, while the needle 3 is positioned at least partially inside the frustoconstrictor. This fixes the needle 3 in place, allowing the user to release the needle 3 for a short time to change the grip.

[0088] In Figure 5D, it can be seen that the multiple turns 15 of the knot may be released from the knot support element 9 by pressing the actuation section 18 of the security flap 16. When the actuation section 18 is pressed, the security flap 16 pivots around the fold line. As a result, the fixing section 17 of the security flap 16, which is pre-positioned on the tip of the frustoconstrictor 11 and secures the tip in place, moves away from the tip of the frustoconstrictor 11. This releases the tip, allowing the multiple turns 15 of the knot to slide freely away from the frustoconstrictor 11.

[0089] Figure 5E shows how the knot is tied tightly. To tie the knot tightly, multiple wraps 15 are slid along the length of the suture 2 toward the desired position of the knot. The knot is then tied tightly by pulling both the first end 13 and the second end 14 of the suture 2. The suture 2 may then be cut at the knot, and the knot-forming device 1, the needle 3, and the trimmed portion of the suture 2 may be discarded.

[0090] As described above, the articles of this disclosure may be used in non-surgical situations. In particular, the articles may be used in any situation in which it is desirable to form a knot in the knot-forming device 1 as described above, and then move along the thread 2 to the final location where the knot will be placed, thereby forming a knot on the thread 2 at a distance from the final location where the knot will be placed.

[0091] Multiple configurations disclosed herein, in drawings and / or claims may be used individually or in various combinations to realize various embodiments. [Brief explanation of the drawing]

[0092] [Figure 1] This is a schematic diagram of an article comprising a knot-forming device, sutures, and surgical instruments. [Figure 2] This is a schematic diagram of a knot-forming device with a surgical instrument support element. [Figure 3] This is a cutout for forming a knot-forming device. [Figure 4A] This is a schematic diagram of the process for creating an article that includes a knot-forming device, sutures, and surgical instruments. [Figure 4B] This is a schematic diagram of the process for creating an article that includes a knot-forming device, sutures, and surgical instruments. [Figure 4C] This is a schematic diagram of the process for creating an article that includes a knot-forming device, sutures, and surgical instruments. [Figure 4D] This is a schematic diagram of the process for creating an article that includes a knot-forming device, sutures, and surgical instruments. [Figure 5A] This is a schematic diagram illustrating the use of an article including a knot-forming device, sutures, and surgical instruments. [Figure 5B] This is a schematic diagram illustrating the use of an article including a knot-forming device, sutures, and surgical instruments. [Figure 5C] This is a schematic diagram illustrating the use of an article including a knot-forming device, sutures, and surgical instruments. [Figure 5D] This is a schematic diagram illustrating the use of an article including a knot-forming device, sutures, and surgical instruments. [Figure 5E] This is a schematic diagram illustrating the use of an article including a knot-forming device, sutures, and surgical instruments.

Claims

1. An item for assisting the user when making a knot and tying it tightly, Base section (4), A thread storage section (8) is provided on the base section (4), A knot support element (9) comprising at least one flap (10a, 10b) of a flat material folded into a frustoconical shape (11), wherein the frustoconical shape (11) is hollow and has openings at the base and tip of the frustoconical shape (11), A knot-forming device (1) including, The first end (13) and Along the length of the thread (2), the second end (14) is on the opposite side from the first end, The yarn (2) includes, Includes, At least a portion of the first end (13) of the thread (2) is located within the thread storage section (8), The second end (14) of the thread (2) forms a plurality of wraps (15) for a knot that is not tightly tied. At least one of the multiple windings (15) is arranged on and around the outer surface of the frustoconical shape (11) of the knot support element (9), An article wherein the knot support element (9) is configured to support the loosely tied knot and to hold the loosely tied knot in an open state.

2. The article according to claim 1, wherein the knot support element (9) includes two flaps (10a, 10b) of the flat material that are folded into the frustoconical shape (11).

3. The article according to claim 1 or 2, wherein the knot support element (9) is a slit (12) provided in the frustoconical shape (11), and the slit (12) extends from the base end of the frustoconical shape (11) to the tip of the frustoconical shape (11).

4. The article according to any one of claims 1 to 3, wherein the base section is formed from a cutout of the flat material or a cutout of a further flat material.

5. The article according to claim 4, wherein the cutout includes at least one of the flaps (10a, 10b) of the knot support element (9).

6. The article according to any one of claims 1 to 5, wherein at least one section of the base end of the frustoconstrictor (11) is formed in continuity with the base section (4) so ​​as to prevent one or more turns (15) for a loosely tied knot, which are located on and around the outer surface of the frustoconstrictor (11), from moving away from the base end.

7. The knot-forming device (1) includes a security flap (16), The security flap (16) is It is formed adjacent to the knot support element (9), The one or more wraps (15) for a tightly knotted knot, which are arranged on and around the outer surface of the frustoconstrictor (11), are configured to be positioned on the tip of the frustoconstrictor (11) so as not to move away from the tip, and The article according to any one of claims 1 to 6, wherein the security flap (16) is movable relative to the tip of the frustoconstrictor (11) so that one or more wraps (15) for a tightly tied knot, which are arranged on and around the outer surface of the frustoconstrictor (11), can move away from the tip.

8. The article according to any one of claims 1 to 7, wherein the yarn storage section (8) is positioned on the base section (4) adjacent to the first end, and the knot support element (9) when the base section (4) is folded on itself along a base folding line (7) running between the yarn storage section (8) and the knot support element (9), from the first end of the base section (4) to the third end of the base section (4) adjacent to the first end of the base section (4) and the fourth end of the base section (4) opposite to the third end and adjacent to the first end and the second end, the knot support element (9) comes into contact with the yarn storage section (8), and the knot support element (9) is positioned on the base section (4) adjacent to the second end opposite to the first end.

9. The article according to claim 8, wherein the base section (4) includes a fold along the base fold line (7).

10. The article according to any one of claims 1 to 9, wherein the knot-forming device (1) includes a surgical instrument support element (19) formed on the thread storage section (8), or a surgical instrument support element (19) formed adjacent to the thread storage section (8).

11. The knot-forming device comprises at least one storage flap (20a, 20b, 21a, 21b, 21c, 21d) provided in the thread storage section (8) and configured to receive a thread (2) of a certain length, according to any one of claims 1 to 10.

12. The knot-forming device includes at least one storage flap (20a, 20b, 21a, 21b, 21c, 21d) provided in the thread storage section (8) and configured to receive a thread (2) of a certain length. The article according to claim 4, wherein the cutout of the flat material includes at least one of the storage flaps (20a, 20b, 21a, 21b, 21c, 21d).

13. A method for making a knot-forming device (1) for an article according to any one of claims 1 to 12, The process of providing the base section (4), The steps include forming a yarn storage section (8) on the base section (4) that is configured to hold a yarn (2) of a certain length, The process of forming the knot support element (9), Includes, The step of forming the knot support element (9) includes folding at least one flap (10a, 10b) of a flat material into a frustoconical shape (11), The frustum shape (11) is hollow and has openings at its base and tip. A method wherein the knot support element (9) is configured to support the loosely tied knot and hold the loosely tied knot open by supporting at least one of the multiple windings (15) of the thread (2) for the loosely tied knot so that the winding (15) remains on and around the outer surface of the frustoconical shape (11).

14. A method for creating an article, The method according to claim 13 provides a knot-forming device (1), and A step of placing at least a portion of the first end (13) of the thread (2) into the thread storage section (8), The process of forming multiple windings (15) for a knot that is not tightly tied at the second end (14) of the thread (2), A step of arranging at least one of the multiple windings (15) on and around the outer surface of the frustoconical shape (11) of the knot support element (9), Methods that include...

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