Article, method of producing a knotting device for an article, method of producing an article, and method of forming and tightening a knot

Abstract

According to the present disclosure, an article is provided that supports a user in providing and tightening a knot. The article comprises a knotting device (1) and a suture (2). The knotting device (1) comprises a base section (4), a suture storage section (8) provided thereon, and a knot support element (9) comprising at least one flap (10a, 10b) of flat material folded into a truncated cone shape (11), the truncated cone shape (11) being hollow and open on a base end and a tip end of the truncated cone shape (11), the suture (2) comprising a first end (13) along a length of the suture (2) and a second end (14) opposite the first end. The first end (13) of the suture (2) is arranged in the suture storage section (8), and the second end (14) of the suture (2) forms a plurality of windings (15) of the suture (2) that are not tightened, at least one winding being arranged on and around an outer surface of the truncated cone shape (11) of the knot support element (9), the knot support element (9) thereby supporting the knot that is not tightened and keeping it open. Furthermore, a method of producing a knotting device, a method of producing an article, and a method of forming and tightening a knot are disclosed.

Description

Technical Field

[0001] The present invention relates to an article, a method for producing a knotting device for said article, a method for producing an article, and a method for forming and tightening a knot. Background Technology

[0002] Knotting is a complex task, and in some applications, tying knots that meet specific requirements, particularly in terms of strength and durability, can be tedious or impossible. For example, in model building, it may be necessary to place complex knots in tiny details of the model being built, which can be difficult to access, such as in the case of a boat in a bottle.

[0003] In the medical field, knot-tying in restricted access or minimally invasive surgeries (e.g., single-port laparoscopic surgery (LESS)) is technically difficult and time-consuming. However, minimally invasive surgery is widely accepted due to its significant advantages over open surgery in terms of patient outcomes and care costs. Patient benefits include reduced pain and scarring, shorter anesthesia time, shorter recovery and hospital stays, and faster return to normal activities, while economic benefits include lower postoperative complication rates, shorter hospital stays, and lower cumulative treatment costs.

[0004] Minimally invasive procedures are performed through tiny incisions in the body, using slender instruments to carry out the surgery. Another incision can be used for a camera, providing the surgeon with a limited, often two-dimensional, view of the workspace. The extreme constraints on space and movement make tying surgical knots to secure tissues, organs, or close internal wounds a complex technical challenge. This is time-consuming, requires extensive practice, and is difficult to guarantee consistently reliable results. Improperly tied knots after surgery can loosen, leading to serious complications and / or repeat surgeries.

[0005] Patient demand for minimally invasive surgery is increasing, but its adoption is hampered by procedural costs and a lack of technical skills. Suturing, especially knot tying, in minimally invasive surgery presents significant technical challenges. For these reasons, some surgeons may opt for open surgery.

[0006] Current suture aids and alternative surgical closure solutions include, for example, adhesives, strips, suture devices, and mechanical suturing devices. Some devices are suited to specific use cases, such as barbed sutures for soft tissue approximation or prefabricated sling knots for laparoscopic ligation, while other solutions use costly and complex mechanical devices.

[0007] Suture aids and laparoscopic closure devices are known, for example, from documents WO 96 / 02194A1 and US 2018 / 0206841A1. Such devices are mechanically complex and relatively expensive per patient.

[0008] Other comparable products include the so-called lasso knot, which does not offer a locking mechanism and requires manual knotting, and barbed sutures that provide low-tension fixation without knotting but do not offer strong fixation.

[0009] Conventional suture kits, consisting of needles attached to the suture, are the least expensive and most complex, and remain the most widely used surgical closure solution today. Examples of such suture kits are known from documents DE 2 044 486A1, US5,127,518A, US 5,174,087 A, and US 5,566,821 A.

[0010] Document WO 2019 / 106189 A1 discloses an insert retainer and a suture retainer for attaching a suture to an insert for insertion into bone. The insert retainer and suture retainer may be composed of flat sheet material.

[0011] Document WO 2016 / 005118A1 describes a device for tying knots. The device includes a thread having a functional end and a pull end. A body is provided, and the thread is placed around the body in the form of a pre-prepared, still-open knot, such that due to the pull end, the thread moves along the lateral surface and forms a closed knot. Summary of the Invention

[0012] The purpose of this disclosure is to provide improved techniques to support users in providing and tightening knots, particularly improving operation and safety compared to existing knot-tying aids.

[0013] To achieve the objectives, an article of manufacture according to the independent claim is provided, a method for producing a knotting device for said article of manufacture, a method for producing the article of manufacture, and a method for forming and tightening a knot are provided. Embodiments are disclosed in the dependent claims.

[0014] According to one aspect, an article is provided for supporting a user in providing and tightening a knot. The article includes a knotting device comprising a base section, a thread storage section disposed on the base section, and a knot support element. The knot support element includes at least one flap of a flat material folded into a frustoconical shape. The frustoconical shape is hollow and open at both its base and tip ends. The article also includes a thread comprising a first end along its length and a second end opposite to the first end. The first end of the thread is disposed in the thread storage section, and the second end of the thread forms a plurality of loops of an untightened knot. At least one of the loops is disposed on and around the outer surface of the frustoconical shape of the knot support element, thereby supporting the untightened knot and keeping it open.

[0015] According to another aspect, a method for a knotting apparatus for producing an article is provided. The method includes the steps of: providing a base segment; forming a thread storage segment on the base segment, the thread storage segment being configured to retain the length of the thread; and forming a knot support element. Forming the knot support element includes folding at least one flap of a flat material into a hollow frustoconical shape, the hollow frustoconical shape being open at both its base and tip ends, and the knot support element being configured to support and open an untightened knot by at least one of a plurality of windings supporting the thread forming an untightened knot, such that at least one of the plurality of windings rests on and around the outer surface of the frustoconical shape.

[0016] According to another aspect, a method for producing an article is provided. The method for producing an article includes the steps of: providing a knotting device by performing the method described herein; arranging a first end of a thread in a thread storage section; forming a plurality of untightened knots in a second end of the thread; and arranging at least one of the plurality of knots on and around the frustoconical outer surface of a knot support element.

[0017] According to another aspect, a method for forming and tightening a knot is provided, the method comprising the steps of: providing an article as described herein; passing a first end of a suture first through an open tip section of a truncated cone shape, then through a hollow truncated cone shape, then through another hollow truncated cone shape, and then through an open base section of a truncated cone shape; causing at least one of a plurality of untightened sutures to slip off from the tip end of the truncated cone shape; and tightening the knot by pulling on the first and second ends of the suture. The method for forming and collecting a knot does not involve any steps of treating a human or animal body through surgery or therapy, particularly any steps of surgical intervention on a human body. Therefore, the method is non-surgical. Also provided is an article as described herein, using an article for surgical purposes by: passing a first end of a suture, in this case a surgical suture, first through an open tip section of a truncated cone shape, then through a hollow truncated cone shape, and then through an open base section of a truncated cone shape, thereby causing at least one of a plurality of untightened sutures to slip off from the tip end of the truncated cone shape and tightening the knot by pulling on the first and second ends of the suture.

[0018] The truncated cone shape can take the form of a street cone with any base shape having a vertebral base. Specifically, the base shape can be a rounded shape, such as a circle or an ellipse. Alternatively, the base shape can have different types of shapes, such as ellipses or polygons, such as rectangles or trapezoids, optionally with rounded corners. Specifically, the truncated cone shape can be the shape of a truncated cone, a pyramid being a specific type of cone, i.e., a cone with a polygonal base shape. Regarding all base shapes including rounded base shapes, the truncated cone shape can include, in particular, crease lines resulting from folding at least one flap into a truncated cone shape, causing the base shape to exhibit a deviation from the nominal shape, such as a corner-like deviation at the crease endpoints. Regarding the ends of the truncated cone shape, the base end is the end where the truncated cone of the truncated cone shape is located, and the apical end of the truncated cone shape is the end oriented opposite to the base end along the guide of the truncated cone towards the apex of the (imaginary) vertices of the truncated cone shape. Compared to the base end of a truncated cone shape, the tip end of a truncated cone shape can be closer to the edge of the knotting device, especially closer to the edge of the base segment.

[0019] The truncated cone shape can vary along the height of the truncated cone. For example, the truncated cone shape can be a shape consisting of more than one truncated cone stacked on top of each other. This can cause the outer surface of the truncated cone shape to vary at an angle along its height from the base end to the tip end. Alternatively or additionally, the truncated cone shape can be rounded along the height of the truncated cone, for example, thus producing a bottle-shaped shape. Generally, the truncated cone shape of the knot support element tapers towards the tip end. In particular, the knot support element can vary along its radius to prevent movement of the sutures resting on it. The plane and / or tapering of the truncated cone shape can be configured such that the radius of the multiple sutures resting on it is increased at least to reduce or prevent twisting or other shapes (memory effect) imprinted on such sutures due to storage around the knot support element.

[0020] Within the meaning of this disclosure, a flat material is a material that extends far less in one spatial dimension than in the other two. In this sense, a flat material can be substantially two-dimensional. For example, the thickness of a flat material can be less than at least an order of magnitude less than both its length and width. Flat materials can include paper materials. Alternatively or additionally, flat materials can include paper-like materials, plastic materials, metallic materials, or combinations thereof. Flat materials can be sterilizable materials.

[0021] Folding at least one flap of a flat material into a hollow truncated cone shape may include rolling the flap into the truncated cone shape. Within the meaning of this disclosure, a flap folded into a particular shape, particularly a truncated cone shape, may be a flap rolled into such a form.

[0022] Regarding the arrangement of at least one of a plurality of windings on and around the outer surface of the frustoconical shape, the arrangement may be exactly one of a plurality of windings, all of the plurality of windings, or any desired number of windings. In particular, the number of windings among the plurality of windings forming the uncoiled knot can be selected to ensure the safe storage of the uncoiled knot in the knotting device by the knot support element.

[0023] The knot support element comprises two flaps of flat material or another flat material folded into a frustoconical shape. In alternative embodiments, the knot support element may include more than two flaps. In embodiments where the knot support element includes more than one flap, the flaps may be folded and arranged relative to each other to form a frustoconical outer surface, wherein portions of the flaps provide portions of the outer periphery while other portions of the flaps may not form part of the outer periphery of the frustoconical shape but may be arranged, for example, inside the frustoconical shape. The flaps may be folded from the outside of the frustoconical shape to the inside of the frustoconical shape, from the inside of the frustoconical shape to the outside of the frustoconical shape, or different flaps may be folded in different directions.

[0024] The support element may include a slit disposed within a frustoconical shape and extending from the base end of the frustoconical shape to its apex end. In an embodiment, two flaps may form a slit by providing a distance between such flaps in a segment of the flaps forming a portion of the outer periphery of the frustoconical shape. In this case, the flaps may be folded inward relative to the edge forming the slit, particularly the rounded edge.

[0025] The base segment can be formed from a block of flat material or another flat material. The block can be cut from the flat material or another flat material using any known method, such as mechanical cutting including die cutting, laser cutting, and / or waterjet cutting. Alternatively, the block can be formed without cutting, but can be any shape with the appearance of a pre-cut shape. For example, the block can be formed by additive manufacturing such as 3D printing, especially if it is already in its desired shape. By using blocks of flat material to form the knotting device, the volume of the knotting device can be minimized. At least the base segment of the knotting device formed from blocks of flat material can provide a disposable and / or sterilizable knotting device. Furthermore, manufacturing and logistical costs can be reduced by using blocks of flat material to form the knotting device.

[0026] In one embodiment, while the support element comprises at least one flap of flat material folded into a frustoconical shape, the base segment may be formed from a cut of another flat material. In such embodiments, the flat material of at least one flap is fixed to the cut of the other flat material, for example, by gluing, welding, and / or sewing. In particular, the other flat material may be fixed to the base segment. Embodiments concerning the flat material are applicable accordingly.

[0027] The cut of flat material may include at least one flap as a support element. For example, at least one flap may be a segment of the cut that is directly or indirectly attached to a base segment. In another example, at least one flap may be provided by a cut in the base segment itself, and the truncated cone shape may be formed by folding at least one flap out from the base segment.

[0028] Generally, knotting devices can be formed from single-piece cuts. For example, a cut can be made from a flat material cut into a single shape without assembling several parts. The cut can include segments that provide all the supporting components when folded, for example, in the form of winglets. By using single-piece cuts, knotting devices can be manufactured from a single part or a small number of parts.

[0029] In alternative embodiments, the base segment may not be formed from a block of flat material. For example, the base segment may be formed as a box or container that can be formed, for example, using a casting method or additive manufacturing. In such embodiments, the flat material forming at least one flap of the knot support element may be formed as a flat segment of the same material as the base segment, or the flat material forming at least one flap of the knot support element may be fixed to the base segment, for example, by gluing, welding, and / or sewing.

[0030] At least one segment of the base end of the truncated cone shape may be configured to prevent one or more untightened strands arranged on and around the outer surface of the truncated cone shape from moving away from the base end. For example, a cut of flat material may include at least one flap, and the base end of the flap may be directly or indirectly connected to the base segment in the cut. The base segment may widen the truncated cone shape at the base end, thereby preventing untightened strands arranged on and around the outer surface of the truncated cone shape from moving off the base end.

[0031] The knotting device may include a safety flap formed adjacent to the knot support element and configured to be disposed on the tip of a truncated cone shape, such that one or more windings of an untightened knot disposed on and around the outer surface of the truncated cone shape are prevented from moving off the tip and are movable relative to the tip of the truncated cone shape, such that the safety flap is movable away from the tip of the truncated cone shape, making it possible to remove one or more windings of an untightened knot disposed on and around the outer surface of the truncated cone shape from the tip. In the example, the safety flap can be pivotally connected to the base segment by being formed continuous with the base segment and pivotable by folding relative to the base segment, and includes a first safety flap segment and a second safety flap segment. The first safety flap segment is configured to be disposed at the pointed end of a frustum shape, and the second safety flap segment is configured to be disposed on the opposite side of the pivot point or line of the safety flap relative to the first safety flap segment, such that pressing the second safety flap segment pivots the first safety flap away from the pointed end of the frustum shape, thereby releasing the untightened knot of the winding disposed on and around the outer surface of the frustum shape. In the example, a cut of flat material may include the safety flap. In particular, the knotting device including the safety flap may be formed from a cut that is configured as a single piece.

[0032] The safety flap can be secured in its position at the pointed end of a truncated cone shape by a retaining element. The retaining element can be a retaining tab or flap, beneath which the safety flap can slide and thus be held in place. The retaining tab or flap can be a small tab or flap, such that the retaining tab or flap has high rigidity to support and hold the safety flap in place. Alternatively, the retaining element can be a clip, adhesive point, magnet, or hook and ring fixing device.

[0033] The safety flap can be configured to release multiple windings by applying a limiting force. The limiting force can be applied to the safety flap itself, a knot support element, and / or the stitching forming the multiple windings, at least one of which is in a frustoconical shape and arranged around the frustoconical shape. A retaining element can be sized such that the limiting force causes the safety flap to release from the retaining element.

[0034] A suture storage section may be arranged adjacent to a first end of a base section on the base section, and a knot support element may be arranged adjacent to a second end of the base section opposite to the first end on the base section, such that when the base section is folded onto itself along a base fold line extending between the suture storage section and the knot support element, from a third end of the base section adjacent to the first and second ends and a fourth end of the base section opposite to the third end and adjacent to the first and second ends, the knot support element rests on the suture storage section. In this embodiment, the base section, which may be formed from a cut, may include a section covering half of the suture storage section and the other half of the knot support element, and the first half may be folded onto the second half along a middle fold cut. This arrangement may be particularly suitable in embodiments where the cut of flat material includes at least one flap of the knot support element. Thus, the knotting device can both support the user in providing and tightening knots and package such a knotting device by enclosing the thread storage section and knot support element when the knotting device, particularly the cut piece, is folded in half. The function of the knotting device as packaging can include protecting the elements arranged in the packaged knotting device, particularly the thread, and more specifically, the thread wrapping that forms an untightened knot and / or other wrappings of such thread, such as wrappings for tight storage of the thread. In different embodiments, the knotting device, particularly the cut piece forming the knotting device, may include additional sections and / or flaps. In such embodiments, the section covering the knot support element can still be folded over the section covering the thread storage, thereby providing packaging of the knotting device itself.

[0035] The base section may include creases along the base fold line. The creases may be pre-formed to facilitate folding along the fold line or may be formed when the base section is first folded along the fold line.

[0036] Generally, the suture can be a surgical suture. Specifically, a knotting device can be configured for use with the surgical suture. In this case, the suture storage section is configured to maintain the length of the surgical suture, and the knot support element supports an untightened knot and keeps it open by supporting multiple loops of the surgical suture. In such embodiments, the surgical suture can be any desired surgical suture, such as monofilament sutures, multifilament sutures, braided sutures, sutures made of natural materials, and / or sutures made of synthetic materials.

[0037] The knotting device may include a surgical tool support element formed on or adjacent to a suture storage segment. In an alternative embodiment, the knotting device may include a surgical tool support element not formed on or adjacent to a suture storage segment, such as a surgical tool support element formed adjacent to a knot support element. The surgical tool support element may be configured to secure a surgical tool to the knotting device. The article may include a surgical tool. In embodiments where the knotting device of the article includes a surgical tool support element, the article may include a surgical tool secured to the surgical tool support element. In such embodiments, the suture may be a surgical suture. The surgical tool may be secured to the suture, and in particular, secured within the article, the surgical tool may be secured to a first end of the suture.

[0038] Surgical instruments can be any tool used to perform functions in conjunction with surgical sutures during surgery. Specifically, a surgical instrument can be a surgical needle. Such a needle can be used to puncture and guide surgical sutures through tissue to perform suturing at the surgical site. Alternatively, a surgical instrument can be a fixation tool. For example, a surgical instrument can be a surgical anchor or suture anchor. Such an anchor or suture anchor can be used to anchor a surgical suture at the surgical site. For example, a surgical suture can be anchored by securing a surgical anchor or suture anchor to bone. For example, a surgical anchor or suture anchor can be secured by screwing a surgical anchor or suture anchor into a receiving structure such as bone at the surgical site.

[0039] The surgical tool support element may be made of a material that can be pierced by a surgical tool, such as a soft material, for example, a surgical needle used to hold a needle in place. For example, the surgical tool support element may be a foam block, a wax block, and / or a kneading compound. Alternatively, the surgical tool support element may be provided by the material of the knotting device itself, particularly by a cut of flat material. For example, the surgical tool support element may be an area of ​​the cut in which the paper material can be pierced by a surgical tool, such as a wing. Alternatively, the surgical tool support element may be provided as a magnet, a clamp for holding the surgical tool, at least one pressing tab, a locking mechanism such as a bayonet base, tape, or glue. The surgical tool support element may be adapted to repeatedly secure and suit surgical tools. In embodiments, the knotting device may be formed from a cut that is configured to include a single piece of the surgical tool support element. For example, the surgical tool support element may be a wing of the cut. In other embodiments, the knotting device may be formed from a cut that is configured to not include a surgical tool support element, as described herein. In such embodiments, surgical tool support elements, such as foam blocks, may be attached to the cut before, after, or during the formation of the knotting device from the cut.

[0040] The knotting device may include at least one storage wing disposed in a suture storage segment and configured to receive suture, for example, the length of the suture. Specifically, the at least one storage wing may receive multiple non-knotted loops of the suture for storing the length of the suture wound around the at least one storage wing. A first end of the suture may be wound around the at least one storage wing such that the suture is not biased toward the shape in which it is stored, and for example, a figure-eight or O-shaped storage segment. The at least one storage wing may be movable from a first position in which the first segment of the suture is about the at least one storage wing to a second position in which the at least one storage wing is not engaged with the first segment of the suture and the first segment of the suture is free to move from the storage segment.

[0041] Alternatively, at least one storage flap may be folded into a sac-like structure for sealing the length of the suture. A first end of the suture may be arranged in the sac-like structure, for example, in a loop of thread without a knot. To form the sac-like structure, at least one storage flap may be configured, in particular with respect to its size, to form one or more sac-like segments of a cut piece of flat material.

[0042] The knotting device may include a plurality of storage flaps, wherein at least one of the storage flaps receives a plurality of unknotted strands of suture for storing the length of the suture wrapped around at least one of the storage flaps, and at least another of the storage flaps is folded into a sealing-like structure to seal the length of the suture. A first end of the suture may be wrapped around at least one of the storage flaps and may be simultaneously arranged in a sealing-like structure provided by at least another of the storage flaps.

[0043] The cut piece of flat material or another flat material may include at least one storage wing. In particular, the knotting device may be formed from a cut piece configured as a single piece, or it may be formed from a cut piece configured as a single piece without a surgical tool support element.

[0044] The storage section may include a hole configured to receive a pin around which a thread is wrapped. Specifically, the pin may be placed in the hole for producing an article. The pin may be removed from the hole after the first section of the thread has wrapped around the pin, and the finished article may not include the pin. The first section of the thread may wrap around the pin such that the thread is not biased toward the shape in which it is stored in the storage section. For example, the first section of the thread may wrap around the pin in a figure-eight or O-shape.

[0045] The first and second ends of the suture may each have any length. In particular, the first and second ends may be directly adjacent to each other, and the suture may consist entirely of the first and second ends. Alternatively, the suture may include an intermediate segment located between the first and second ends.

[0046] The knots used can be of any type. Multiple knots may be provided at the second end of the thread. For example, multiple knots may be provided with multiple loops, at least one of which will be arranged on and around the frustum shape.

[0047] Articles may include encapsulating knotting devices, sutures, particularly surgical sutures, and sterile or sterilizable packaging of surgical instruments in articles including surgical instruments. Articles may be disposable or single-use. Components of the article may be discarded individually. For example, packaging may be discarded after the knotting device, sutures, and, in embodiments of articles including surgical instruments, the surgical instruments have been removed from the packaging. The knotting device may be discarded after the sutures have been removed from the knotting device. A portion of the suture may be discarded after the knot has been formed and tightened. In particular, portions of surgical instruments and sutures used as surgical sutures may be discarded after suturing has been completed at the surgical site. The portion of the suture still located at the surgical site may be removed and discarded after sufficient healing, or may be left at the surgical site.

[0048] The article may include more than one knotting device, suture, and optionally a surgical instrument in a sterile or sterilizable package. The above embodiments are applicable to each combination of knotting device, suture, and, if applicable, surgical instrument. Thus, more than one knotting device combined with suture and optional surgical instrument can be provided in a single sterile or sterilizable package. For example, five knotting devices, each having a corresponding suture and a corresponding surgical instrument, can be provided in a single sterile or sterilizable package.

[0049] The knotting device may include a pull-end fixing element for securing the pull end of the thread. In the article, the pull end of the thread may be the end of a second segment of the thread. The pull end can be used to tighten the knot after at least one of a plurality of threads has been removed from the support element by pulling the pull end. The pull-end fixing element may be configured as a tab or wing, a clamp, an adhesive point, or a similar structure for securing the pull end. Alternatively, the pull end may extend on a track, and access to the pull end may be provided by a recess in the outer side of the track. For example, the track may be formed by a track wing of the knotting device, with the pull end arranged longitudinally below the track wing, and the track disc may be provided with an opening or recess, which may be configured, for example, as a hole cut into the track wing, through which the pull end can be accessed.

[0050] The knot-tying device may include interactive points that a user can interact with when using the device. The device may be marked with usage instructions. For example, the interactive points may be visually marked or provide tactile cues. The interactive points may include, with respect to the knot-tying device and / or the article, any or all of the following: surgical instruments, surgical instrument support elements, safety wings, traction end fixing elements, and gripping areas for holding the knot-tying device. The gripping area may have a surface with tactile or visual indications for better handling. The knot-tying device may also include alphanumeric markings and / or symbols. For example, alphanumeric markings and / or symbols may indicate a sequence of operating steps for using the knot-tying device and / or for using the article.

[0051] The knotting device can maintain its desired shape after folding without additional fastening devices such as glue or nails. For example, the cut piece can be provided with additional tabs or flaps and corresponding slits, such that during folding, the tabs or flaps are inserted into the corresponding slits. Thus, the section of the cut piece can be fixed in place and the knotting device can maintain its desired shape.

[0052] Methods for forming and tightening knots can be used, for example, for model building. For instance, a method can be used to construct a so-called boat in a bottle by: placing the article outside the bottle; inserting a first end of a thread into the bottle; and passing it through a loop or similar structure of a boat model placed inside the bottle and transferring the first end out of the bottle. The first end can then pass through a truncated cone shape, at least one of a plurality of threads can slide off the truncated cone shape, and the knot can be transferred into the bottle and onto the boat model by pulling the first and second ends to tighten the knot.

[0053] The knot can be closed at the desired time by guiding a first end of the suture through a plurality of loops, guiding at least one of the loops away from the truncated cone shape, and tightening the knot. Guiding the first end through the plurality of loops can occur before or after at least one loop has slipped (at least partially) away from the truncated cone shape. Alternatively or additionally, guiding the first end through the plurality of loops can occur during at least partial slippage of at least one loop from the truncated cone shape. For example, a first portion of the first end may be guided through the plurality of loops, and a second portion of the first end may not yet have been guided through the plurality of loops. Then, at least one loop is guided away from the truncated cone shape and over the first end, thereby guiding the second portion of the first end through the plurality of loops. In embodiments including surgical instruments, the embodiments outlined above regarding the first end passing through the plurality of loops can be correspondingly applied to guiding the surgical instrument through the plurality of loops.

[0054] According to this disclosure, a cut block for forming a knotting device is provided. The cut block is made of a flat material. In particular, the cut block can be a shaped cut from a flat material. The cut block can be cut from the flat material using any known method, such as mechanical cutting including die cutting, laser cutting, and / or waterjet cutting. Alternatively, the cut block can be formed without cutting, but can be any shape with the appearance of a pre-cut shape. For example, the cut block can be formed by additive manufacturing such as 3D printing, especially if it is already in its desired shape. The cut block can be configured as a sterile cut block. The cut block can be manufactured as a single piece. For example, the cut block can be cut from a flat material into a single shape without assembling several parts. The cut block can include segments that provide all parts of the knotting device when folded. By configuring the cut block as a single piece, the knotting device can be manufactured from a single part or a small number of parts.

[0055] The cut block can be configured to fold into the knotting device described herein. For this purpose, the cut block includes different segments that can be folded relative to each other. The segments may include segments that are adjacent to each other and separate from each other but connected to each other as part of the cut block. Alternatively or additionally, the segments may include a first segment and a second segment, the second segment being disposed within the first segment and spaced apart from the first segment by a cut that does not form a closed curve, such that the second segment is coupled to the first segment and can be folded relative to the first segment. Additional segments disposed within other segments may be provided accordingly.

[0056] By utilizing materials and methods for forming and tightening knots, faster and easier knot-tying can be achieved, for example, in minimally invasive surgery, compared to manual knot-tying. In particular, reliable knot-tying and therefore relatively higher patient safety can be achieved compared to manual surgical knot-tying, which is a standard of care and depends on the expertise of the surgeon performing the knot, in contrast to the average surgical manual knot formation. Compared to known surgical suture devices, the cost and / or complexity of use can be reduced. Therefore, a wider range of applications are available compared to known devices.

[0057] The embodiments described above regarding the knotting device can be applied accordingly to articles, methods for producing knotting devices, methods for producing articles, and / or methods for forming and tightening knots, and vice versa. Attached Figure Description

[0058] Embodiments are described by way of example with reference to the accompanying drawings. The drawings show:

[0059] Figure 1 This is a schematic diagram of an article containing a knotting device, sutures, and surgical tools;

[0060] Figure 2 This is a schematic diagram of a knotting device with a surgical tool support element;

[0061] Figure 3These are cut pieces used to form knotting devices;

[0062] Figures 4A to 4D It is a schematic diagram showing the steps involved in producing an article including a knotting device, sutures, and surgical instruments;

[0063] Figures 5A to 5E This is a schematic diagram illustrating the use of knotting devices, sutures, and Vico International's products. Detailed Implementation

[0064] Figure 1 A schematic diagram is shown of a surgical instrument comprising a knotting device 1, a suture 2 shown as a surgical suture in an embodiment, and a surgical needle 3. The knotting device 1 is folded from a piece of flat material. The base segment 4 of the knotting device 1 has... Figure 1 The depiction forms two parts: a top section 5 and a bottom section 6. The top section 5 and the bottom section 6 can be folded onto each other along the base fold line 7 to close the knotting device 1.

[0065] A suture storage section, shown as suture storage section 8 in the embodiment, is provided on the bottom section 6 of the base section 4. Figure 1 In one embodiment, the suture storage segment 8 includes, as shown below: Figure 1 The visible structure is a suffocating structure configured to maintain the length of suture 2.

[0066] A knot support element 9 is arranged on the top section 5 of the base section 4. The knot support element 9 includes two flaps 10a and 10b folded or rolled into a frustoconical shape 11. The flaps 10a and 10b are formed from a cut piece and are connected to the cut piece at the base end of the frustoconical shape 11. The base shape of the frustoconical shape 11 approximates a circle. However, due to the nature of the connection to the rest of the cut piece and the folding or rolling process, the circle and the flattened section at the connection point, as well as the rest of the cut piece and the twisting deformation along its circumference, result in creases in the frustoconical shape 11 caused by folding or rolling. Furthermore, the cross-sectional shape of the frustoconical shape 11 varies along its height. The frustoconical shape has a slit 12 formed by the distance between the edges of the flaps 10a and 10b. Figure 1 It can be seen that the width of the slit 12 varies along the height of the truncated cone shape 11 due to the shape of the blades 10a and 10b.

[0067] The needle 3 is attached to the end of the first end 13 of the suture 2. The first end 13 of the suture 2 is stored in the suture storage section 8. In particular, most of the first end 13 of the first suture 2 is arranged in a suffix-like structure of the suture section 8.

[0068] The second end 14 of the suture 2 forms an open, untight knot by arranging a plurality of windings 15. The plurality of windings 15 are placed on the outer surface of the frustoconical shape 11. Thus, the plurality of windings 15 are kept open by the frustoconical shape 11. Furthermore, the elasticity of the flaps 10a and 10b generates a force that expands the frustoconical shape 11, thereby placing the plurality of windings 15 under tension. The end of the second end 14 of the suture 2 is led back to the storage section 8 and is contained within the encapsulation-like structure of the storage section 8.

[0069] The widening of the truncated conical shape 11 toward its base end and the wider configuration of the remaining portion of the cut block connected at the base end of the truncated conical shape 11 by the flaps 10a and 10b retain the plurality of windings 15 from slipping off the base end of the truncated conical shape 11. The safety flap 16 retains the plurality of windings 15 from slipping off the tip end of the truncated conical shape 11. The safety flap 16 is integral with the remaining portion of the cut block and is connected to the remaining portion of the cut block along the fold line. The smaller fixing section 17 of the safety flap 16 is placed on the tip end of the truncated conical shape 11, thereby holding the tip end in place and preventing the plurality of windings 15 from slipping off the tip end. The larger actuating section 18 of the safety flap 16 is arranged opposite to the fixing section 17 with respect to the fold line. Due to this arrangement, the windings 15 enter along the actuating section 18. Figure 1 Applying pressure in the direction of the drawing causes the safety flap 16 to pivot around the fold line, thereby lifting the fixing section 17 away from the tip of the truncated cone shape and releasing the tip. With the tip released, the plurality of windings 15 can slide away from the tip of the truncated cone shape 11.

[0070] Needle 3 is held in place by surgical tool support element 19. Figure 1 In the example, the surgical tool support element 19 is an adhesive tape sheet placed on the needle 3 and the knotting device 1 to secure the needle 3 to the knotting device 1.

[0071] Figure 2 A schematic diagram of the knotting device 1 is shown. (and...) Figure 1 Compared to the knotting device 1, Figure 2 The surgical tool support element 19 of the knotting device 1 is a foam block glued to the cut piece of the knotting device 1. A surgical tool (specifically, a needle 3) can pierce the foam block, thereby securing the surgical tool to the knotting device 1.

[0072] Figure 3 A cut piece for forming the knotting device 1 is shown. In the example shown, the cut piece is cut from a flat sheet of material using a stamping process and allows the formation of a complete knotting device 1 excluding the surgical tool support element 19, which can be attached to the knotting device 1 once folded from the cut piece.

[0073] The cut segment includes a base segment 4 having a top segment 5 and a bottom segment 6. The top segment 5 includes segments forming sub-segments (in... Figure 3 The left-hand side of the top section 5 has flaps 10a and 10b connected to the sub-section, and the truncated cone shape 11 of the support element 9 is folded or rolled up onto the flaps 10a and 10b. The top section also includes a safety flap 16 with a fixing section 17 and an actuating section 18 that can be pivoted by folding along a marked fold line of the top section 5. The bottom section 6 includes elements to be folded into the suture storage section 8. Two storage flaps 20a and 20b are foldable for wrapping the suture 2 around such storage flaps 20a and 20b. Additional storage flaps 21a, 21b, 21c, and 21d are adapted to fold into a sachet-like structure for storing the suture 2 wrapped around the storage flaps 20a and 20b.

[0074] In order to secure the top section 5 and the bottom section 6 in the folded position after the knotting device 1 has been formed from the cut pieces, tabs 22 and corresponding slits 23 are provided. The tabs 22 can be inserted into the corresponding slits 23 to secure the flaps with the tabs 22 in place.

[0075] Figures 4A to 4D The invention depicts a surgical tool comprising a knotting device 1, a suture configured as a surgical suture 2, and a needle 3 in the example shown.

[0076] according to Figure 4A A knotting device 1 is provided. A frustoconical shape 11 formed by the flaps 10a and 10b of the knot support element 9 is provided on the top section 5 of the cut block forming the knotting device 1. The pointed end of the frustoconical shape 11 is free. The suture or stitch storage section 8 provided on the bottom section 6 is completely unfolded.

[0077] like Figure 4B As shown, to produce the article, a plurality of loops 15 are formed in the second end 14 of the suture. The plurality of loops 15 are placed on the outer surface of the frustoconical shape 11. Then, the pointed end of the frustoconical shape 11 is placed below the fixing section 17 of the safety flap 18 (as shown). Figure 4C (As shown). This secures the tip of the frustum shape 11 in place and prevents the multiple windings 15 from slipping off the tip of the frustum shape 11. In an alternative embodiment, only one or any number of the multiple windings 15 are placed on the outer surface of the frustum shape 11, ensuring safe storage of any loose knots provided by the multiple windings 15.

[0078] The storage flaps 20a and 20b of the suture storage section 8 are folded and wrapped around the first end 13 of the suture 2 in a figure-eight shape. Then, the storage flaps 21a, 21b, and 21d are folded onto the first end 13 of the wrapped suture 2, thereby forming a suffix-like structure enclosing the first end of the suture 13 (e.g., ...). Figure 4C (As shown).

[0079] Figure 4C The steps are shown to close the suture storage section 8 by folding the storage flap 21c over the sachet-like structure. Simultaneously, the needle 3, attached to the end of the first end 13 of the suture 2, along with a portion of the first end 13 of the suture 2, is removed from the suture storage section 8. The storage flap 21c is secured in the folded position by inserting the tab 22 into the corresponding slit 23. It should be noted that the flap of the top section 5 has been secured in place by inserting the tab 22 into the corresponding slit 23, as... Figure 4C It is visible on the left.

[0080] Finally, as Figure 4D As shown, the needle is secured to the surgical tool support element 19, which is provided with foam, by piercing the foam block with the needle 3. For packaging the article, the knotting device 1 can be folded in half along the base fold line 7, thereby placing the top section 5 on the bottom section 6 and thus placing the knot support element 9 on the suture storage section 8. Therefore, the knotting device 1 can provide at least a portion of the packaging for the article, thereby improving the handling of the article and protecting the needle while simultaneously enabling suture delivery from the sterile and disposable material forming the knotting device 1.

[0081] Figures 5A to 5E The use of an article of surgical tools, including a knotting device 1, a suture 2, and a needle 3 in the example shown, is illustrated. Figures 5A to 5E The application shown pertains to placing a knot at a surgical site. However, the product can be used in various situations, such as in model constructions where any desired suture must be knotted at a site that is difficult to reach and / or where there is little space available for forming, preventing, and tightening the knot.

[0082] like Figure 5A As shown in the example using the surgical needle holder, the knotting device 1 is opened, and the needle 3 is held and removed from the surgical tool support element 19 of the knotting device 1. Then, the needle 3 is pulled away from the knotting device 1, thereby pulling the first end 13 of the suture 2, to which the needle 3 is attached and placed in the suture storage section 8 of the knotting device 1, and removing it from the suture storage section 8, as shown. Figure 5B As shown. Then the first end 13 of the needle and suture 2 is used freely. In particular, the needle 3 is placed at the surgical site, for example, the first end 13 of the suture 2 is used to close the incision.

[0083] After using needle 3 and the first end 13 of the suture thread and preventing knots, as Figure 5C As shown, the needle 3 is inserted into the open tip of the truncated cone shape 11 of the knot support element 9 of the knot-tying device. The needle 3 is guided through the hollow truncated cone shape 11 and out from the open base end of the truncated cone shape 11. This also guides the needle through the plurality of loops 15 or loops formed on the outer surface of the truncated cone shape 11 and held open by it in the second end 14 of the suture 2. Then, the needle 3 is pulled away from the knot support element 9, thereby pulling along the first end 13 of the suture 2. This also guides the first end 13 of the suture 2 through the plurality of loops 15 of the knot.

[0084] After the needle 3 is first guided through the truncated cone shape 11 and before being pulled away from the knot support element 9, it is usually necessary to change the gripping force on the needle 3. To change the gripping force, the flaps 10a, 10b of the knot support element 9 forming the truncated cone shape 11 can also be used to hold the needle 3 in place while releasing the tensioner. To achieve this, pressure can be applied to the truncated cone shape 11, particularly to the flaps 10a, 10b, while the needle 3 is at least partially positioned inside the truncated cone shape. Thus, the needle 3 is secured and the user can temporarily release the needle 3 to change the gripping force.

[0085] exist Figure 5D As can be seen, the multiple windings 15 properly knotted from the knot support element 9 can be disengaged by pushing the actuating section 18 of the safety flap 16. Pushing the actuating section 18 causes the safety flap 16 to pivot about the fold line, thereby moving the fixing section 17, which was previously placed on the tip of the frustum shape 11 and thus fixed in place, away from the tip of the frustum shape 11. The tip is thus released and the multiple windings 15 of the knot freely slide away from the frustum shape 11.

[0086] Figure 5E The tightening knot is shown. To tighten the knot, multiple loops 15 are slid along the length of the suture 2 toward the desired position of the knot. There, the knot is tightened by pulling on both the first end 13 and the second end 14 of the suture 2. The suture 2 can then be trimmed at the knot, and the trimmed portion of the knotting device 1, needle 3, and suture 2 can be discarded.

[0087] As outlined above, the article of manufacture according to this disclosure can be used in non-surgical contexts. In particular, the article of manufacture can be used in any context in which it is desired to form a knot of suture 2 at a distance from the site of the final layout of the knot by forming a knot at the knotting device 1 as outlined above and then moving it along the suture 2 to the site of the final layout.

[0088] The features disclosed in this specification, drawings and / or claims may be material for implementing various embodiments, individually or in various combinations thereof.

Claims

1. An article for supporting a user in providing and tightening a knot, comprising: - Knotting device (1), which includes - Base segment (4); - A suture storage section (8), said suture storage section (8) being disposed on the base section (4); and - A knot support element (9), the knot support element (9) comprising at least one flap (10a, 10b) of a flat material folded into a frustoconical shape (11), the frustoconical shape (11) being hollow and open at its base end and tip end; and - A suture (2), the suture (2) comprising a first end (13) along the length of the suture (2) and a second end (14) opposite to the first end. in - The first end (13) of the suture (2) is disposed in the suture storage section (8); and - The second end (14) of the suture (2) forms a plurality of untightened loops (15), at least one of which is arranged on and around the outer surface of the frustoconical shape (11) of the knot support element (9), thereby supporting the untightened knot and keeping it open.

2. The article of claim 1, wherein the knot support element (9) comprises two flaps (10a, 10b) folded into the truncated cone shape (11).

3. The article of claim 1 or 2, wherein the knot support element (9) includes a slit (12) configured in a frustum shape (11) and extending from the base end of the frustum shape to the tip end of the frustum shape (11).

4. The article of claim 1 or 2, wherein the base portion is formed from a piece of the flat material or another flat material.

5. The article of claim 4, wherein the cut comprises at least one flap (10a, 10b) of the knot support element (9).

6. The article of claim 1 or 2, wherein at least one segment of the base end of the truncated cone shape (11) is formed to be continuous with the base segment (4) such that one or more untightly wounds (15) arranged on and around the outer surface of the truncated cone shape (11) are prevented from moving away from the base end.

7. The article of claim 1 or 2, wherein the knotting device (1) comprises a safety wing (16), the safety wing (16) - Formed adjacent to the junction support element (9); - Configured to be arranged on the tip of the truncated cone shape (11) such that one or more untightly wound wires (15) arranged on and around the outer surface of the truncated cone shape (11) are prevented from dislodging from the tip; and - It is possible to move relative to the tip end of the truncated cone shape (11) such that the safety flap (16) can be moved away from the tip end of the truncated cone shape (11), making it possible for one or more untightened strands (15) arranged on and around the outer surface of the truncated cone shape (11) to be removed from the tip end.

8. The article of claim 1 or 2, wherein the suture storage section (8) is disposed on the base section (4) adjacent to a first end of the base section (4), and the knot support element (9) is disposed on the base section (4) adjacent to a second end of the base section (4) opposite to the first end, such that when the base section (4) folds itself over itself along a base fold line (7) extending between the suture storage section (8) and the knot support element (9), from a third end of the base section (4) adjacent to the first and second ends and a fourth end of the base section (4) opposite to the third end and adjacent to the first and second ends.

9. The article of claim 8, wherein the base segment (4) includes a crease along the base fold line (7).

10. The article of claim 1 or 2, wherein the knotting device (1) includes a surgical tool support element (19) formed on or adjacent to the suture storage section (8).

11. The article of claim 1 or 2, wherein the knotting device comprises at least one storage flap (20a, 20b, 21a, 21b, 21c, 21d) disposed on the suture storage section (8) and configured to receive the length of the suture (2).

12. The article of claim 11, wherein the base segment is formed from a cut of the flat material or another flat material, the cut of the flat material including the at least one storage flap (20a, 20b, 21a, 21b, 21c, 21d).

13. A method for producing a knotting device (1) for any article of claims 1-12, comprising the following steps: - Provide base section (4); - A suture storage section (8) is formed on the base section (4), the suture storage section (8) being configured to retain the length of the suture (2); as well as - Forming a knot support element (9) includes folding at least one flap (10a, 10b) of a flat material into a hollow frustoconical shape (11), the hollow frustoconical shape (11) being open at its base end and tip end, the knot support element (9) being configured to support and open the untightened knot by at least one of a plurality of windings (15) forming an untightened knot that support the stitch (2), such that the at least one of the plurality of windings (15) rests on and around the outer surface of the frustoconical shape (11).

14. A method for producing an article of articles, comprising the following steps: - The knotting device (1) is provided by performing the method as described in claim 13; - Arrange the first end (13) of the suture (2) in the suture storage section (8); - A plurality of loosely knotted loops (15) are formed in the second end (14) of the suture (2); and - At least one of the plurality of windings (15) is arranged on the outer surface of the truncated cone shape (11) of the knot support element (9) and around the outer surface.

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