Surgical assembly, method for manufacturing a surgical assembly, and apparatus for manufacturing a surgical

Abstract

The present invention relates to a surgical assembly (1), in particular in the form of a surgical needle-suture or surgical anchor-suture assembly, comprising:-a first element (10) having a proximal end portion (11) and a distal end portion (12), and-a second element (20) having a proximal end portion (21) and a distal end portion (22), the distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20) are joined to each other via a third element (30) covering the distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20) and attached to the distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20). The invention also relates to a method and an apparatus for manufacturing a surgical assembly.

Description

Technical Field

[0001] The present invention relates to a surgical assembly, a method for manufacturing a surgical assembly and an apparatus for manufacturing a surgical assembly. Background Art

[0002] The attachment end portion of a surgical needle can have four different configurations: closed eye, French eye (split or flexible), U-channel, or swaged (commonly referred to as eyeless).

[0003] Closed eye needles are very similar to ordinary or household sewing needles, although the shape of the eye can be round, square or oblong. The disadvantage of closed eye needles is that the suture must be tied through the eye, thereby increasing the bulk of the suture that must be passed through the tissue. In addition, tying the suture on the needle is a tedious and time-consuming process.

[0004] The French eye needle has a slit from the inside of the eye to the distal end portion of the needle. Typically, the slit is provided with ridges to hold the suture in place. An advantage of the French eye needle is that the suture can be easily inserted into or removed from the eye, thereby simplifying suture attachment. However, during surgery, the needle has the potential to become detached from the suture and may be lost within a deep wound.

[0005] Therefore, French eye or closed eye needles are rarely used in most surgical procedures, although they are still used in veterinary surgeries that employ larger gauge sutures.

[0006] Virtually all surgical needles used in modern surgery are either swaged or channel needles, in which the suture is crimped to form a continuous unit, although the security of suture attachment does vary with suture size and needle diameter. Swaged or channel needles have the great advantage that the suture is supplied with the needle in sterile packaging, making immediate suturing of tissue possible while greatly reducing the risk of needle or suture contamination. Most sutures are applied in combination swaged needles, which are considered more reliable in terms of bond strength and less traumatic to tissue.

[0007] During the manufacture of the swaged needle, a blind hole is drilled in the proximal end portion of the needle. To make a channel needle for micro sutures, a U-shaped channel is cut at the proximal end portion of the needle, and after suture placement, the walls of the channel are closed around the suture to hold it securely in place. Typically, the pull-out force for separating the suture from the needle is between 30% and 80% of the breaking load of the suture itself.

[0008] Recently, eyeless needles have also been manufactured by laser drilling a hole parallel to the axis of the needle in the proximal end portion of the needle body. Compared to channel needles, eyeless needles have a smoother outer periphery while the length of the drilled hole is shorter than that required at the end of the channel. These are significant advantages, especially the latter, as it allows the surgeon to hold the needle closer to the distal end portion.

[0009] Eyeless needles were quickly accepted by surgeons because the difference in size between the needle and suture (in other words, the ratio between the needle diameter and the suture diameter) is smaller than with conventional channel needles. This reduction in the difference between the needle and suture diameter facilitates surgical suturing and helps wound healing. The pull-out force for separating the suture from the needle is the same or slightly higher for a full needle than for a channel crimp.

[0010] The significant advantages of eyeless needles over channel needles have resulted in the current market being dominated by sutures with eyeless needles, and the use of channel needles has retreated to extremely small suture sizes, primarily for assembling sutures with thread diameters thinner than 50 μm.

[0011]

[0004] Despite the significant advances made regarding assemblies including surgical sutures and surgical needles or other surgical devices suitable for introducing surgical sutures into biological tissue, there remains a continuing need for further improved surgical assemblies. Summary of the invention

[0012] In view of the above, it is therefore an object of the present invention to provide a surgical assembly, a method for producing a surgical assembly and a device for producing a surgical assembly which exhibit further improved properties, in particular compared to surgical needle-suture assemblies known from the prior art.

[0013] This object is achieved by a surgical assembly according to independent claim 1, a method for producing a surgical assembly according to claim 12 and a device for producing a surgical assembly according to claim 15. Preferred embodiments of the invention are defined in the dependent claims and in the present description. The subject matter and wording of all claims are respectively incorporated into the description by explicit reference.

[0014] According to a first aspect, the present invention relates to a surgical assembly, in particular in the form of a surgical device-suture assembly, preferably a surgical needle-suture assembly or a surgical anchor-suture assembly.

[0015] The components include the following: - a first element having a proximal end portion and a distal end portion, and - A second element having a proximal end portion and a distal end portion.

[0016] The distal end portion of the first element and the proximal end portion of the second element are linked or connected to each other via a third element. More specifically, the distal end portion of the first element and the proximal end portion of the second element can be linked or connected to each other directly or indirectly via a third element.

[0017] The third element in particular only covers or coats the distal end portion of the first element, and in particular only covers or coats the proximal end portion of the second element. More specifically, the third element may completely or only partially, preferably completely, cover or coat the distal end portion of the first element and the proximal end portion of the second element.

[0018] Furthermore, the third element may cover or coat the distal end portion of the first element and the proximal end portion of the second element directly or indirectly, preferably directly.

[0019] Furthermore, the third element is attached or connected (particularly bonded) to the distal end portion of the first element and the proximal end portion of the second element. More specifically, the third element may be directly or indirectly, preferably directly, attached or connected (particularly bonded) to the distal end portion of the first element and the proximal end portion of the second element.

[0020] The present invention is based on the surprising discovery that the ratio between the diameter of a surgical needle or another surgical device (such as a surgical anchor) suitable for introducing a surgical suture into biological (particularly human or non-human) tissue and the diameter of the surgical suture can be significantly reduced by a surgical assembly as defined according to the present invention. Thus, the risk of tissue trauma can be advantageously reduced and wound healing can thus be facilitated. In addition, an eye, French eye, channel or hole at the proximal end portion of the surgical needle is not necessary, thereby simplifying the manufacturing method of the surgical assembly of the present invention and additionally increasing the safety of the patient.

[0021] The term "surgical assembly" as used according to the present invention may also be denoted as a surgical combination, in particular a surgical device-suture combination, preferably a surgical needle-suture combination or a surgical anchor-suture combination.

[0022] The term "proximal end portion" as used in accordance with the present invention (particularly with respect to the first element and the second element) refers to an end portion (particularly the end portion of the first element and the second element) which is arranged closer to the center or central axis of the body or organ of a user or practitioner (particularly a doctor or medical staff, preferably a surgeon or surgical staff).

[0023] The term "distal end portion" as used in accordance with the present invention (particularly with respect to the first element and the second element) refers to an end portion (particularly the end portion of the first element and the second element) which is arranged further away from the center or central axis of the body or organ of a user or practitioner (particularly a doctor or medical staff, preferably a surgeon or surgical staff).

[0024] In an embodiment of the present invention, the third element is adhesively (i.e., materially) attached or connected (particularly covalently or non-covalently bonded, particularly via van der Waals forces, hydrogen bonding, ionic interactions, coordinate bonding, or a combination of at least two of the aforementioned non-covalent bonding) to the distal end portion of the first element and / or the proximal end portion of the second element. Preferably, the third element is adhesively attached or connected to the distal end portion of the first element and the proximal end portion of the second element.

[0025] In a further embodiment of the invention, the third element is mechanically, in particular positively and / or frictionally attached or connected to the distal end portion of the first element and / or the proximal end portion of the second element. In particular, the third element can be mechanically attached or connected to the distal end portion of the first element and the proximal end portion of the second element.

[0026] Furthermore, the third element may be adhesively attached or connected to the distal end portion of the first element and mechanically attached or connected to the proximal end portion of the second element, or vice versa. With regard to further features in terms of adhesive attachment / connection and mechanical attachment / connection, reference is made to the previous two paragraphs. The features described therein in terms of adhesive attachment / connection and mechanical attachment / connection do apply mutatis mutandis.

[0027] In another embodiment of the present invention, the third element is molded on the distal end portion of the first element and / or the proximal end portion of the second element. Preferably, the third element is molded on the distal end portion of the first element and the proximal end portion of the second element. More preferably, the third element is overmolded around the distal end portion of the first element and / or the proximal end portion of the second element. Particularly preferably, the third element is overmolded around the distal end portion of the first element and the proximal end portion of the second element. Therefore, it is particularly preferred according to the present invention that the third element is in the form of an overmolded member or an overmolded part. Advantageously, this embodiment of the present invention can be realized at low cost and in a reliable and particularly customized manner. In addition, this embodiment of the present invention results in a particularly firm attachment or connection, particularly bonding, of the third element on the distal end portion of the first element and the proximal end portion of the second element. Therefore, the risk of detachment can be particularly reduced.

[0028] In a further embodiment of the invention, the third element comprises or consists of a meltable, in particular injection-moldable material, preferably a polymer, more preferably a synthetic polymer. Preferably, the polymer is selected from the group consisting of polyolefins, polyvinyl alcohols, polyamides, polyimides, polyesters, polyurethanes (in particular thermoplastic polyurethanes), polyhydroxyalkanoates, copolymers of at least two of the aforementioned polymers, and mixtures of at least two of the aforementioned polymers.

[0029] In a further embodiment of the invention, the proximal end portion of the second element has a cross section, in particular an orthogonal or vertical cross section, which is equal to a cross section, in particular an orthogonal or vertical cross section, of the distal end portion of the first element.

[0030] In a further embodiment of the invention, the proximal end portion of the second element has a cross-section, in particular an orthogonal or vertical cross-section, which is at most 30% larger than the cross-section, in particular an orthogonal or vertical cross-section, of the distal end portion of the first element, i.e. >0% to 30%.

[0031] In a further embodiment of the invention, the distal end portion of the first element and the proximal end portion of the second element abut against each other, in particular directly or indirectly. Preferably, the distal end portion of the first element and the proximal end portion of the second element abut against each other directly, i.e. preferably there is no gap or space between the distal end portion of the first element and the proximal end portion of the second element.

[0032] In a further embodiment of the present invention, the distal end portion of the first element and the proximal end portion of the second element are not directly connected to each other via a third element, and the third element is additionally formed between the distal end portion of the first element and the proximal end portion of the second element.

[0033] In another embodiment of the present invention, the third element has a thickness of 0.001mm to 10mm, in particular 0.005mm to 5mm, preferably 0.01mm to 0.5mm, in particular a layer or wall thickness. The thickness may also be in the form of a constant or variable thickness. For example, the portion of the third element covering or coating the distal end portion of the first element may have a thickness that is different from the thickness of the portion of the third element covering or coating the proximal end portion of the second element and / or different from the thickness of the portion of the third element formed between the distal end portion of the first element and the proximal end portion of the second element. Alternatively, the portion of the third element covering or coating the proximal end portion of the second element may have a thickness that is different from the thickness of the portion of the third element covering or coating the distal end portion of the first element and / or different from the thickness of the portion of the third element formed between the distal end portion of the first element and the proximal end portion of the second element. Alternatively, the portion of the third element covering or coating the distal end portion of the first element may have a thickness that is equal to the thickness of the portion of the third element covering or coating the proximal end portion of the second element, in particular but different from the thickness of the portion of the third element formed between the distal end portion of the first element and the proximal end portion of the second element. Alternatively, the portion of the third element covering or coating the distal end portion of the first element may have a thickness that is equal to the thickness of the portion of the third element formed between the distal end portion of the first element and the proximal end portion of the second element, in particular but different from the thickness of the portion of the third element covering or coating the proximal end portion of the second element. Alternatively, the portion of the third element covering or coating the proximal end portion of the second element may have a thickness that is equal to the thickness of the portion of the third element formed between the distal end portion of the first element and the proximal end portion of the second element, in particular but different from the thickness of the portion of the third element covering or coating the distal end portion of the first element. Alternatively, the portion of the third element covering or coating the distal end portion of the first element may have a thickness that is equal to the thickness of the portion of the third element covering or coating the proximal end portion of the second element, and equal to the thickness of the portion of the third element formed between the distal end portion of the first element and the proximal end portion of the second element.

[0034] More specifically, when covering or coating the distal end portion of the first element, the third element may have a thickness of 0.001 mm to 10 mm, particularly 0.005 mm to 5 mm, preferably 0.01 mm to 0.5 mm. Furthermore, when covering the proximal end portion of the second element, the third element may have a thickness of 0.001 mm to 10 mm, particularly 0.005 mm to 5 mm, preferably 0.01 mm to 0.5 mm. Furthermore, when formed between the distal end portion of the first element and the proximal end portion of the second element, the third element may have a thickness of 0.001 mm to 10 mm, particularly 0.005 mm to 5 mm, preferably 0.01 mm to 0.5 mm.

[0035] In a further embodiment of the invention, the third element is in the form of a cover, preferably a sleeve, in particular a tubular sleeve.

[0036] Furthermore, the third element may have a length of from 0.1 mm to 100 mm, in particular from 0.5 mm to 50 mm, preferably from 0.75 mm to 5 mm.

[0037] In a further embodiment of the invention, at least the distal end portion of the first element (particularly only the distal end portion of the first element or the entire first element) comprises or consists of a thermally unstable or thermosensitive (particularly thermoplastic) material. Alternatively or in combination, at least the proximal end portion of the second element (particularly only the proximal end portion of the second element or the entire second element) may comprise or consist of a thermally unstable or thermosensitive (particularly thermoplastic) material.

[0038] The terms "thermally unstable material" and "thermosensitive material" as used according to the present invention refer to materials which undergo changes (particularly degradation) and / or become viscous (particularly due to melting), respectively, when exposed to defined elevated temperatures.

[0039] In particular, thermally unstable or heat sensitive (particularly thermoplastic) materials may have a degradation profile or degradation temperature of 30°C to 400°C, in particular 36°C to 250°C.

[0040] Furthermore, the thermally unstable or thermosensitive, in particular thermoplastic material is preferably selected from the group consisting of polyolefins, polyvinyl alcohols, polyamides, polyimides, polyesters, polyurethanes (in particular thermoplastic polyurethanes), polyhydroxyalkanoates, copolymers of at least two of the aforementioned polymers (in particular synthetic polymers), and mixtures of at least two of the aforementioned polymers (in particular synthetic polymers).

[0041] In another embodiment of the present invention, at least the proximal end portion of the second element, in particular only the proximal end portion of the second element or the entire second element comprises a metal material or consists of a metal material. Alternatively or in combination, at least the distal end portion of the first element, in particular only the distal end portion of the first element or the entire first element may comprise a metal material or consist of a metal material.

[0042] The term "metallic material" as used in accordance with the present invention refers to any material characterized by metallic bonding and / or consisting of metal ions.

[0043] Preferably, the metal material is selected from the group consisting of steel, stainless steel, nickel-titanium (NiTi) alloy, cobalt-chromium (CoCr) alloy, tungsten-rhenium (W—Re) alloy and a mixture of at least two of the aforementioned metal materials, in particular an alloy.

[0044] Preferably, the first element and / or the second element, in particular the first element and the second element, have an elongated form or are in an elongated form.

[0045] In addition, the first element or at least the distal end portion of the first element may have a cornerless (i.e., circular) cross-section. For example, the first element or at least the distal end portion of the first element may have a circular, oval or elliptical cross-section. Alternatively, the first element or at least the distal end portion of the first element may have a polygonal cross-section, in particular a triangle, an oblong, a square, a pentagon, a hexagon, a heptagon, an octagon, a nonagon, a decagon or a star-shaped cross-section.

[0046] In addition, the second element or at least the proximal end portion of the second element may have a cornerless (i.e., circular) cross section. For example, the second element or at least the proximal end portion of the second element may have a circular, oval or elliptical cross section. Alternatively, the second element or at least the proximal end portion of the second element may have a polygonal cross section, particularly a triangle, an oblong, a square, a pentagon, a hexagon, a heptagon, an octagon, an enneagon, a decagon or a star-shaped cross section.

[0047] In another embodiment of the present invention, the first element is in the form of a surgical suture, and the second element is in the form of a surgical device suitable for introducing the surgical suture into or through a biological (particularly human or non-human) tissue. The surgical suture can be in the form of a monofilament, a pseudo-monofilament or a multifilament, particularly a braided or twisted multifilament. In addition, the surgical suture can have a diameter of 0.015mm to 2mm, particularly 0.03mm to 1.2mm, preferably 0.04mm to 1mm. Preferably, the surgical device suitable for introducing the surgical suture into or through a biological (particularly human or non-human) tissue is in the form of a surgical needle or a surgical anchor. The term "surgical anchor" as used according to the present invention refers to any component that can hold a biological (particularly human or non-human) tissue. The surgical needle can, for example, have a straight shape, a 1 / 4 circle shape, a 3 / 8 circle shape, a 1 / 2 circle shape, a 5 / 8 circle shape, a compound curve, a semi-bent shape (also referred to as a sled needle) or a semi-bent (also referred to as a canoe needle) at both ends of a straight section. Furthermore, the surgical needle may have a taper point (the needle body is round and tapers smoothly to a point), a cutting point (the needle body is triangular and has a sharp cutting edge on the inside curve), a reverse cutting point (having a cutting edge on the outside), a trocar point or taper cut point (the needle body is round and tapers, but ends in a small triangular, positive point), a trocar point (for suturing fragile tissues), or a sidecutting or spatula point (flat on the top and bottom, with a cutting edge along the front to one side). Furthermore, the needle may be in the form of an atraumatic needle. In principle, the surgical needle may have a closed eye or a French eye at its proximal end portion. Alternatively, the needle may be primarily in the form of an eyeless needle, in particular a swaged needle or a channel needle. However, more preferably, the surgical needle, in particular the proximal end portion of the surgical needle, is free of any attachment element, in particular an eye, channel or hole, for attaching a surgical suture. Furthermore, the surgical device, in particular a surgical needle or a surgical anchor, suitable for introducing a surgical suture into or through biological (in particular human or non-human) tissue may have a diameter of 0.02 mm to 2 mm, in particular 0.03 mm to 1.8 mm, preferably 0.05 mm to 1.68 mm. Furthermore, the surgical assembly may have a ratio of the diameter of the surgical suture to the diameter of the surgical device, in particular the diameter of the surgical needle or the surgical anchor, of 0.5 to 2, in particular 0.75 to 1.5, preferably 0.9 to 1.1.

[0048] Particularly preferably, the first element is in the form of a surgical suture and the second element is in the form of a surgical needle. With regard to further features and advantages of surgical sutures and surgical needles, reference is made in particular to the preceding paragraph as a whole. The advantages and features described therein with regard to surgical sutures and surgical needles do apply mutatis mutandis.

[0049] In another embodiment of the present invention, the third element is formed or produced by means of injection overmolding (i.e., by means of injection molding the third element on or around the distal end portion of the first element and the proximal end portion of the second element). In this regard, the third element may also be referred to as an "overmolded connector" according to the present invention. Particularly preferably, the third element is formed or produced by means of ultrasonic injection overmolding (i.e., by means of ultrasonic injection molding the third element on or around the distal end portion of the first element and the proximal end portion of the second element, in particular applying an ultrasonic frequency of 20kHz to 60kHz, in particular 25kHz to 35kHz, preferably 29kHz to 31kHz and / or a time period of 0.1s to 30s, in particular 1s to 10s, preferably 4s to 6s). By using ultrasonic injection overmolding, the meltable material used to produce the third element is heated to its melting point by applying ultrasonic energy. Therefore, more delicate structures can be advantageously molded. Another advantage is that injection molding can be performed by applying a lower temperature to the mold, which is particularly beneficial when, for example, injecting absorbable polymers to avoid their thermal degradation.

[0050] According to a second aspect, the present invention relates to a method for manufacturing a surgical assembly, in particular according to the first aspect of the invention.

[0051] The method comprises the following steps: a) forming, in particular directly or indirectly, a third element on a distal end portion of the first element, in particular only on the distal end portion, and on a proximal end portion of the second element, in particular only on the proximal end portion, so that the distal end portion of the first element and the proximal end portion of the second element are linked or connected to each other via the third element, in particular directly or indirectly, and the third element covers or coats, in particular directly or indirectly covers or coats, the distal end portion of the first element and the proximal end portion of the second element, and is in particular directly or indirectly attached or connected, in particular bonded to, the distal end portion of the first element and the proximal end portion of the second element.

[0052] Preferably, the distal end portion of the first element and / or the proximal end portion of the second element, in particular the distal end portion of the first element and the proximal end portion of the second element, is subjected to a surface treatment, in particular a mechanical surface treatment and / or a chemical surface treatment. Thus, the strength of the attachment or connection of the third element to the distal end portion of the first element and / or the proximal end portion of the second element can be advantageously increased. The mechanical surface treatment may be selected from the group consisting of abrasive blasting, sandblasting, polishing, grinding, honing, batch finishing, industrial etching, laser ablation, laser engraving, and a combination of at least two of the aforementioned mechanical surface treatments. The chemical surface treatment may be selected from the group consisting of chemical vapor deposition (CVD), physical vapor deposition (PVD), plasma spraying, powder coating, thin film deposition, electroplating, electrophoretic deposition, galvanizing, mechanical plating, sputtering deposition, passivation, plasma activation, flame activation, and a combination of at least two of the aforementioned chemical surface treatments.

[0053] In addition, before or during step a), the distal end portion of the first element and the proximal end portion of the second element are preferably in abutment with each other. Thus, a particularly strong bond or connection between the distal end portion of the first element and the proximal end portion of the second element via the third element can be achieved.

[0054] Alternatively, before or during step a), the distal end portion of the first element and the proximal end portion of the second element are approached to a defined distance, in particular a distance of 5 to 10 mm, preferably 1 to 2 mm.

[0055] In a further embodiment of the present invention, step a) is performed by applying a molten material on the distal end portion of the first element and the proximal end portion of the second element and then cooling the molten material applied on the distal end portion of the first element and the proximal end portion of the second element to solidify to the third element. Preferably, the molten material is provided by heating the meltable material at a temperature of 100°C to 350°C, in particular 120°C to 300°C, preferably 200°C to 260°C. In addition, the meltable material may be heated for a time period of 0.1s to 20s, in particular 0.5s to 10s, preferably 0.75s to 5s. In addition, after having been applied on the distal end portion of the first element and the proximal end portion of the second element, the molten material is preferably cooled at a temperature of 10°C to 60°C, in particular 15°C to 40°C, preferably 20°C to 30°C. In addition, the molten material may be cooled for a time period of 0.5s to 600s, in particular 0.75s to 300s, preferably 3s to 30s.

[0056] In a further embodiment of the invention, the molten material is applied to the distal end portion of the first element transversely (i.e. with a straight slope or with a curved slope (at an acute angle, i.e. an angle between 0° and 90°)) relative to the longitudinal axis of the first element, in particular such that the distal end portion of the first element is pulled or dragged in the direction of the proximal end portion of the second element, preferably such that the distal end portion of the first element and the proximal end portion of the second element abut against each other, in particular directly or indirectly, or are spaced apart from each other at a defined distance, in particular at a distance of 0.05 mm to 5 mm, preferably 1 mm to 2 mm. With regard to further features and advantages of the processing of the meltable material, reference is made to the previous paragraph. The features and advantages described in the previous paragraph do also apply mutatis mutandis to the embodiments described in this paragraph.

[0057] In a further embodiment of the invention, step a) is performed by injection overmolding, ie by injection molding the third element on or around a distal end portion of the first element and a proximal end portion of the second element.

[0058] Preferably, step a) is carried out by ultrasonic injection overmolding, i.e., ultrasonic injection molding the third element on or around the distal end portion of the first element and the proximal end portion of the second element. For example, an ultrasonic frequency of 20kHz to 60kHz, particularly 25kHz to 35kHz, preferably 29kHz to 31kHz, particularly 0.1s to 30s, particularly 1s to 10s, preferably 4s to 6s, and / or 0.1s to 30s, particularly 1s to 10s, preferably 4s to 6s can be applied. By using ultrasonic injection overmolding, the meltable material for forming the third element is heated to its melting point by applying ultrasonic energy. Therefore, as previously mentioned, more delicate structures can be advantageously molded. Another advantage is that injection molding can be carried out by applying a lower temperature to the mold, which is particularly beneficial when, for example, injecting absorbable polymers to avoid their thermal degradation.

[0059] With regard to the further features and advantages of the method, in particular with regard to the first, second and third elements, reference is made as a whole to the embodiments described under the first aspect of the invention. The features and advantages described under the first aspect of the invention also apply mutatis mutandis to the method according to the second aspect of the invention.

[0060] According to a third aspect, the invention relates to a device for manufacturing a surgical assembly, in particular according to the first aspect of the invention.

[0061] The device comprises a mold, which comprises: - a first mould cavity adapted to receive a first element, wherein the first element has a proximal end portion and a distal end portion, - a second mould cavity adapted to receive a second element, wherein the second element has a proximal end portion and a distal end portion, - at least one positioning element adapted to position a distal end portion of the first element inside the first mould cavity, - at least one positioning element adapted to position a proximal end portion of the second element inside the second mould cavity, and - At least one inlet channel adapted to guide molten material into the first mould cavity and / or the second mould cavity, in particular for forming the third element on a distal end portion of the first element and a proximal end portion of the second element.

[0062] The term "at least one positioning element" as used according to the present invention may mean only one positioning element or a plurality of positioning elements, ie two or more positioning elements.

[0063] Furthermore, the term "at least one inlet channel" as used according to the present invention may mean only one inlet channel or a plurality of inlet channels, ie two or more inlet channels.

[0064] Preferably, the first mould cavity and the second mould cavity are fluidly connected to each other.

[0065] Furthermore, the first mould cavity preferably has a cross section which is larger than a cross section of the first element or of a distal end portion of the first element.

[0066] Furthermore, the first mould cavity is preferably adapted to receive the first element such that a first tubular gap or space is defined between an inner surface or contour of the first mould cavity and an outer surface or contour of the first element or a distal end portion of the first element.

[0067] The first tubular gap can have a thickness of from 0.001 mm to 10 mm, in particular 0.005 mm to 5 mm, preferably 0.01 mm to 0.5 mm, in particular a constant or variable thickness. In addition, the first tubular gap can have a length of from 0.1 mm to 50 mm, in particular 0.5 mm to 50 mm, preferably 0.75 mm to 2.5 mm.

[0068] Furthermore, the second mould cavity preferably has a cross section which is larger than a cross section of the second element or a proximal end portion of the second element.

[0069] Furthermore, the second mould cavity is preferably adapted to receive the second element such that a second tubular gap is defined between an inner surface or contour of the second mould cavity and an outer surface or contour of the second element or a proximal end portion of the second element.

[0070] In addition, the second tubular gap can have a thickness of 0.001mm to 10mm, in particular 0.005mm to 5mm, preferably 0.01mm to 0.5mm, in particular a constant or variable thickness. In addition, the second tubular gap can have a length from 0.1mm to 50mm, in particular 0.5mm to 50mm, preferably 0.75mm to 2.5mm.

[0071] Furthermore, the mold is preferably separable or detachable into two mold members, wherein the mold members form a first mold cavity and a second mold cavity when joined together or coupled.

[0072] Furthermore, the at least one inlet channel is preferably part of the first mould member and in particular extends through the wall of the first mould member transversely (i.e. with a straight slope or with a curved slope (at an acute angle, i.e. between 0° and 90°)) relative to the longitudinal axis of the first mould member or the first mould cavity.

[0073] Furthermore, the at least one positioning element adapted to position the distal end portion of the first element inside the first mould cavity preferably extends from an inner surface or contour of the first mould cavity, in particular inwardly.

[0074] Preferably, the at least one positioning element adapted to position the distal end portion of the first element inside the first mould cavity is in the form of two positioning elements extending, in particular from opposite sides of the inner surface or contour of the first mould cavity, preferably inwardly.

[0075] More preferably, the at least one further positioning element adapted to receive the distal end portion of the first element inside the first mould cavity is in the form of at least one lug, i.e. only one lug or a plurality of lugs, i.e. two or more lugs. Particularly preferably, the at least one positioning element adapted to receive the distal end portion of the first element inside the first mould cavity is in the form of two lugs, which extend preferably inwardly, in particular from opposite sides of the inner surface or contour of the first mould cavity.

[0076] Furthermore, the at least one positioning element adapted for positioning the proximal end portion of the second element inside the second mould cavity preferably extends from an inner surface or contour of the second mould cavity, in particular inwardly.

[0077] Preferably, the at least one positioning element adapted to position the proximal end portion of the second element inside the second mould cavity is in the form of two positioning elements extending, in particular from opposite sides of the inner surface or contour of the second mould cavity, preferably inwardly.

[0078] More preferably, the at least one further positioning element adapted to receive the proximal end portion of the second element inside the second mould cavity is in the form of at least one lug, i.e. only one lug or a plurality of lugs, i.e. two or more lugs. Particularly preferably, the at least one positioning element adapted to receive the proximal end portion of the second element inside the second mould cavity is in the form of two lugs, which extend preferably inwardly, in particular from opposite sides of the inner surface or contour of the second mould cavity.

[0079] Furthermore, the device may further comprise a guide element adapted to guide the first element inside the first mould cavity. The guide element may in particular comprise or be in the form of a channel or an elongated recess. Furthermore, the guide element may be in the form of an insert comprising a guide channel or an elongated recess. The channel or the elongated recess may have a length of 1 mm to 150 mm, in particular 3 mm to 50 mm, preferably 5 mm to 30 mm. Thus, a correct positioning of the first element inside the first mould cavity may advantageously be facilitated.

[0080] With regard to further features and advantages of the device, in particular with respect to the first, second and third elements, reference is made in its entirety to the previous description, in particular to the embodiments described under the first aspect of the invention. The features and advantages described in the previous description, in particular with respect to the first aspect of the invention, in particular with respect to the first, second and third elements, do also apply mutatis mutandis to the device according to the third aspect of the invention.

[0081] Other features and advantages of the present invention will become clear from the following drawings, their descriptions and examples of the subject matter of the dependent claims. Each feature can be implemented individually or in several combinations in one embodiment of the present invention. The preferred embodiments are only used to illustrate and better understand the present invention, and should not be understood as limiting the present invention in any way. BRIEF DESCRIPTION OF THE DRAWINGS

[0082] In the accompanying drawings, the following is schematically shown:

[0083] Figure 1 : According to an embodiment of the surgical assembly of the present invention,

[0084] Figure 2a : a longitudinal cross-sectional view of an embodiment of the device according to the invention, and

[0085] Figure 2b :like Figure 2a Exploded view of the device shown in . DETAILED DESCRIPTION

[0086] Figure 1 A surgical assembly 1 according to the invention is schematically shown.

[0087] The surgical assembly 1 includes a first element 10 having a proximal end portion 11 and a distal end portion 12 and a second element 20 having a proximal end portion 21 and a distal end portion 22 .

[0088] Furthermore, the surgical assembly 1 comprises a third element 30. The distal end portion 12 of the first element 10 and the proximal end portion 21 of the second element 20 are coupled to each other via the third element 30.

[0089] In particular, the proximal end portion 21 of the second element 20 has a cross section, in particular an orthogonal or vertical cross section, which is at most 30% larger than a cross section, in particular an orthogonal or vertical cross section, of the distal end portion 12 of the first element 10 .

[0090] The third element 30 in particular completely covers the distal end portion 12 of the first element 10 and the proximal end portion 21 of the second element 20 .

[0091] Furthermore, the third element 30 is attached to, in particular bonded to, the distal end portion 12 of the first element 10 and the proximal end portion 21 of the second element 20. For example, the third element 30 may be attached to, in particular bonded to, the distal end portion 12 of the first element 10 and the proximal end portion 21 of the second element 20 mechanically or chemically, in particular covalently or non-covalently, in particular via van der Waals forces.

[0092] Preferably, the distal end portion 12 of the first element 10 and the proximal end portion 21 of the second element 20 abut directly against each other.

[0093] Alternatively, the distal end portion 12 of the first element 10 and the proximal end portion 21 of the second element 20 may be spaced apart from each other. In this case, the third element 30 is also preferably formed between the distal end portion 12 and the proximal end portion 21.

[0094] Furthermore, the third element 30 is preferably overmolded around the distal end portion 12 of the first element 10 and the proximal end portion 21 of the second element 20. In other words, the third element 30 is preferably in the form of an overmolded member or an overmolded component.

[0095] Particularly preferably, the third element 30 is overmolded around the distal end portion 12 of the first element 10 and the proximal end portion 21 of the second element 20 by means of ultrasonic injection molding, in particular applying an ultrasonic frequency of 20kHz to 60kHz, in particular 25kHz to 35kHz, preferably 29kHz to 31kHz and / or a time period of 0.1s to 30s, in particular 1s to 10s, preferably 4s to 6s.

[0096] Preferably, the third element 30 comprises or consists of a meltable, in particular injection-moldable material. Preferably, the material is selected from the group consisting of polyolefins, polyvinyl alcohols, polyamides, polyimides, polyesters, polyurethanes (in particular thermoplastic polyurethanes), polyhydroxyalkanoates, copolymers of at least two of the aforementioned polymers (in particular synthetic polymers), and mixtures of at least two of the aforementioned polymers (in particular synthetic polymers).

[0097] Furthermore, the third element 30 may have a thickness of from 0.001 mm to 10 mm, particularly 0.005 mm to 5 mm, preferably 0.01 mm to 0.5 mm. Furthermore, the third element 30 may have a length of from 0.1 mm to 100 mm, particularly 0.5 mm to 50 mm, preferably 0.75 mm to 5 mm.

[0098] Furthermore, the third element 30 is preferably in the form of a cover, in particular a sleeve, preferably a tubular sleeve.

[0099] Furthermore, at least the distal end portion 12 of the first element 10 (in particular only the distal end portion 12 of the first element 10 or the entire first element 10) preferably comprises or consists of a thermally unstable, in particular thermoplastic material. The material may have a degradation temperature or profile of 30° C. to 240° C. Furthermore, the material may be selected from the group consisting of polyolefins, polyvinyl alcohols, polyamides, polyimides, polyesters, polyurethanes (in particular thermoplastic polyurethanes), polyhydroxyalkanoates, copolymers of at least two of the aforementioned polymers (in particular synthetic polymers), and mixtures of at least two of the aforementioned polymers (in particular synthetic polymers).

[0100] Furthermore, the first element 10 is in the form of a surgical suture. The surgical suture may be in the form of a monofilament, a pseudo-monofilament or a multifilament, such as a twisted or braided multifilament.

[0101] In addition, at least the proximal end portion 21 of the second element 20, in particular only the proximal end portion 21 of the second element 20 or the entire second element 20 preferably includes a metal material or consists of a metal material, which metal material is particularly selected from the group consisting of: steel, stainless steel, nickel-titanium (NiTi) alloy, cobalt-chromium (CoCr) alloy, tungsten-rhenium (W-Re) alloy and a mixture of at least two of the aforementioned metal materials, in particular an alloy.

[0102] The second element 20 is in the form of a surgical needle or a surgical anchor.

[0103] In other words, the surgical assembly 1 is in the form of a surgical needle-suture assembly or combination, or in the form of a surgical anchor-suture assembly or combination.

[0104] The surgical assembly 1 advantageously facilitates a reduction in the ratio between the diameter of the second element (i.e., a surgical needle or surgical anchor) 20 and the diameter of the first element (i.e., a surgical suture) 10, and an improvement in the reliability of the bond or connection between the distal end portion 12 of the first element 10 and the proximal end portion 21 of the second element 20 via the third element 30.

[0105] Figure 2a and Figure 2b A device 100 for producing a surgical assembly according to the invention, in particular by means of injection overmolding, preferably ultrasonic injection overmolding, is schematically shown.

[0106] The device 100 comprises a mold 105. The mold 105 comprises a first mold cavity 110 adapted to receive a first element 10 having a proximal end portion 11 and a distal end portion 12. Furthermore, the mold 105 comprises a second mold cavity 120 adapted to receive a second element 20 having a proximal end portion 21 and a distal end portion 22. Furthermore, the mold 105 comprises at least one positioning element 116 adapted to position the distal end portion 12 of the first element 10 inside the first mold cavity 110. Furthermore, the mold 105 comprises at least one positioning element 126 adapted to position the proximal end portion 21 of the second element 20 inside the second mold cavity 120. Furthermore, the mold 105 comprises at least one inlet channel 130 adapted to guide molten material into the first mold cavity 110.

[0107] The mold 105 is preferably separable or detachable into a first mold member 103 and a second mold member 107. According to the present invention, the first mold member 103 may also be referred to as a demolding cavity plate, and the second mold member 107 may also be referred to as an injection cavity plate. Preferably, when spliced ​​together or coupled, the first mold member 103 and the second mold member 107 form a first mold cavity 110 and a second mold cavity 120. Advantageously, the first mold cavity 110 and the second mold cavity 120 are fluidly connected to each other.

[0108] In addition, the first mold cavity 110 has a cross-section that is larger than the cross-section of the first element 10 or the distal end portion 12 of the first element 10, in particular so that a first tubular gap is defined between the inner surface of the first mold cavity 110 and the outer surface of the first element 10 or the distal end portion 12 of the first element 10.

[0109] In addition, the second mold cavity 120 has a cross-section that is larger than the cross-section of the second element 20 or the proximal end portion 21 of the second element 20, and in particular, a second tubular gap is defined between the inner surface of the second mold cavity 120 and the outer surface of the second element 20 or the proximal end portion 21 of the second element 20.

[0110] Furthermore, the at least one positioning element 116 adapted to position the distal end portion 12 of the first element 10 inside the first mold cavity 110 is in the form of two lugs extending inwardly and oppositely from the inner surface of the first mold cavity 110. Furthermore, the at least one positioning element 126 adapted to position the proximal end portion 21 of the second element 20 inside the second mold cavity 120 is in the form of two lugs extending inwardly and oppositely from the inner surface of the second mold cavity 120. Therefore, both the distal end portion 12 and the proximal end portion 21 can be advantageously maintained in place within the first mold cavity 110 and the second mold cavity 120.

[0111] The at least one inlet channel 130 is preferably part of the first mold member 103. Furthermore, the at least one inlet channel 130 preferably extends through the wall of the first mold member 103 transversely (i.e. at an acute angle (angle between 0° and 90°)) relative to the longitudinal axis L of the first mold cavity 110. Thus, molten material for forming, in particular overmolding, the third element around the distal end portion 12 of the first element 10 and the proximal end portion 21 of the second element 20 can be guided into the first mold cavity 110 so that the molten material flows towards (in the direction of) the second mold cavity 120 and thereby exerts a drag force on the outer surface of the distal end portion 12 of the first element 10. This helps the distal end portion 12 of the first element 10 and the proximal end portion 21 of the second element 20 to directly abut or approach each other to a defined distance, for example a distance of 0.5 mm to 2 mm, during their joining or connection via the third element 30.

[0112] Furthermore, the device 100 may further comprise a guide element 140 adapted to guide the first element 10, in particular its distal end portion 12, inside the first mould cavity 110. The guide element 140 may in particular be in the form of an insert having a guide channel 142.

[0113] Furthermore, the apparatus 100 , in particular the first mold member 103 and / or the second mold member 107 , may include a runner 150 and a gate 160 .

[0114] Preferably, the runner 150 is in the form of a channel. The runner 150 may be machined directly into the first mold member 103 and / or the second mold member 107. Furthermore, the runner 150 is preferably adapted to direct the flow of the molten material toward the first mold cavity 110 and / or the second mold cavity 120.

[0115] The gate 160 is preferably in the form of an opening, in particular a small opening, in the mold 105, through which the molten material supplied by the runner 150 fills the first mold cavity 110 and / or the second mold cavity 120. In particular, the gate and the opening 160, respectively, may be in the form of a drilled circular hole, or may have a rectangular or oblong shape, in particular may be milled to produce a rectangular or oblong shape.

[0116] about Figure 1 , Figure 2a and Figure 2b For further features and advantages of the embodiments shown in , reference is made to the general description as a whole.

[0117] Example section A second element in the form of a straight cylindrical needle made of AISI 302 stainless steel was attached to a first element in the form of a surgical wire made of 95% polypropylene and 5% polyethylene by means of a third element in the form of an overmoulded sleeve made of pure polypropylene.

[0118] The surface of the needle is finely polished to Ra 0.4 and plasma activated during 4 seconds before being placed in the steel mold. The needle and surgical wire are positioned against each other with no gap between them. During the injection process, the two elements are held in place by sets of hardened steel lugs.

[0119] The third element was overmolded by ultrasonic injection with the following process parameters: Mold temperature: 75℃ Injection chamber temperature: 260°C Injection speed: 16mm / s Sonotrode frequency: 29kHz Ultrasonic time: 4s Compacting force: 14000N Cooling time: 5s

[0120] After the ultrasonic injection molding step, the sprues are precisely cut from the resulting component with the aid of a small custom-made guillotine-like device with a 0.2 mm thick AISI 420 steel blade. The resulting surgical component does not require any additional finishing steps, such as deburring or polishing of the parting line.

Claims

1. A surgical assembly (1), comprising: - a first element (10) having a proximal end portion (11) and a distal end portion (12), and - a second element (20) having a proximal end portion (21) and a distal end portion (22), wherein the distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20) are connected to each other via a third element (30), the third element (30) covering the distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20) and being attached to the distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20), wherein the first element (10) is in the form of a surgical suture and the second element (20) is in the form of a surgical needle or a surgical anchor.

2. The surgical assembly (1) according to claim 1, wherein: The third element (30) is adhesively or mechanically attached to the distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20).

3. The surgical assembly (1) according to claim 1 or 2, wherein: The third element (30) is molded on the distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20), and in particular is overmolded around the distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20).

4. The surgical assembly (1) according to any one of the preceding claims, wherein: The third element (30) comprises or consists of a meltable material, in particular an injection-mouldable material, and the meltable material is preferably selected from the group consisting of polyolefins, polyvinyl alcohols, polyamides, polyimides, polyesters, polyurethanes, in particular thermoplastic polyurethanes, polyhydroxyalkanoates, copolymers of at least two of the aforementioned polymers, in particular synthetic polymers, and mixtures of at least two of the aforementioned polymers, in particular synthetic polymers.

5. The surgical assembly (1) according to any one of the preceding claims, wherein: The proximal end portion (21) of the second element (20) has a cross-section, in particular an orthogonal cross-section, which is equal to the cross-section, in particular an orthogonal cross-section, of the distal end portion (12) of the first element (10), or is at most 30% larger than the cross-section, in particular an orthogonal cross-section, of the distal end portion (12) of the first element (10).

6. The surgical assembly (1) according to any one of the preceding claims, wherein: The distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20) directly abut against each other.

7. The surgical assembly (1) according to any one of claims 1 to 5, wherein: The distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20) are not directly connected to each other via the third element (30), and the third element (30) is additionally formed between the distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20).

8. The surgical assembly (1) according to any one of the preceding claims, wherein: The third element (30) is in the form of a cover, preferably a sleeve.

9. The surgical assembly (1) according to any one of the preceding claims, wherein: At least the distal end portion (12) of the first element (10) comprises or consists of a thermally unstable material, in particular having a degradation distribution of 30°C to 400°C, and / or is selected from the group consisting of: polyolefins, polyvinyl alcohols, polyamides, polyimides, polyesters, polyurethanes, in particular thermoplastic polyurethanes, polyhydroxyalkanoates, copolymers of at least two of the aforementioned polymers, in particular synthetic polymers, and mixtures of at least two of the aforementioned polymers, in particular synthetic polymers.

10. The surgical assembly (1) according to any one of the preceding claims, wherein: At least the proximal end portion (21) of the second element (20) comprises or consists of a metal material, which is particularly selected from the group consisting of: stainless steel, nickel-titanium (NiTi) alloy, cobalt-chromium (CoCr) alloy, tungsten-rhenium (W-Re) alloy and a mixture of at least two of the aforementioned metal materials.

11. The surgical assembly (1) according to any one of the preceding claims, wherein: Said third element (30) is formed by means of injection overmolding, preferably ultrasonic injection overmolding.

12. A method for manufacturing a surgical assembly (1) according to any one of the preceding claims, comprising the steps of: a) forming a third element (30) on a distal end portion (12) of a first element (10) and a proximal end portion (21) of a second element (20), so that the distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20) are coupled to each other via the third element (30), and the third element (30) covers the distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20) and is attached to the distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20).

13. The method according to claim 12, wherein: Step a) is performed by applying molten material on the distal end portion (12) of the first element (10) transversely relative to the longitudinal axis L of the first element (10), so that the distal end portion (12) of the first element (10) is pulled in the direction of the second element (20), in particular, so that the distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20) are abutted against each other or spaced apart from each other at a defined distance.

14. The method according to claim 12 or 13, wherein: Step a) is carried out by injection overmolding, in particular ultrasonic injection overmolding.

15. A device (100) for manufacturing a surgical assembly (1) according to any one of claims 1 to 11, the device (100) comprising a mold (105), the mold (105) comprising: - a first mould cavity (110) adapted to receive a first element (10) having a proximal end portion (11) and a distal end portion (12), and - a second mould cavity (120) adapted to receive a second element (20) having a proximal end portion (21) and a distal end portion (22), at least one positioning element (116) adapted to position the distal end portion (12) of the first element (10) inside the first mould cavity (110), at least one positioning element (126) adapted to position said proximal end portion (21) of said second element (20) inside said second mould cavity (120), and - at least one inlet channel (130), the at least one inlet channel (130) being suitable for guiding molten material into the first mold cavity (110) and / or the second mold cavity (120) to form a third element (30) on the distal end portion (12) of the first element (10) and the proximal end portion (21) of the second element (20).

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