Patent Application
20240024974
The invention relates to a method for producing a surgical instrument for grasping and/or holding and/or guiding a needle, in particular a surgical needle.
Special surgical instruments, in particular surgical needle holders, are used for grasping, holding and guiding a surgical needle.
Surgical needle holders have two arm parts which are mirror images of one another and which are pivotably mounted relative to one another at an articulation or articulation point. Usually, the arm parts each have a distal holding or clamping jaw containing a hard metal insert. The hard metal inserts are inserted into recesses in the holding or clamping jaws. Owing to the hard metal inserts, it is advantageously possible to slow down the occurrence of profile wear. To hold needles without any slipping or tilting, the hard metal inserts can have a cross-shaped profile, it being possible for the profile to be pressed in the form of pyramids or ground in a pyramidal checkered pattern with diamond tools.
Usually, the hard metal inserts are connected to hardened arm parts intended for production of surgical needle holders, in a so-called brazing process using a silver solder. A disadvantage here, however, is that brazing requires temperatures which are problematic with respect to microstructure transformations and, accordingly, also with respect to corrosion resistance. This is especially the case when the arm parts are made of a martensitic material. Another disadvantage is that silver hard solders themselves can exhibit black discoloration over time owing to reprocessing of the instruments.
Alternatively, the hard metal inserts can be connected to arm parts intended for production of surgical needle holders, in a so-called high-temperature vacuum soldering process during a hardening process. A disadvantage here, however, is that the different coefficients of thermal expansion for a base or carrier material used for the arm parts (generally stainless steel) and for a hard metal used for the hard metal inserts have a significant effect owing to the large temperature differences during the hardening process, and so relative movements in a hardening furnace can occur even with correct positioning of the hard metal inserts into the recesses in the holding and clamping jaws.
It is an object of the invention to provide a method for producing a surgical instrument for grasping and/or holding and/or guiding a needle, in particular a surgical needle, by means of which disadvantages occurring in methods of the type in question are partially or completely avoided and which especially results in a surgical instrument for grasping and/or holding and/or guiding a needle, in particular a surgical needle, having increased stability and corrosion resistance.
This object is achieved by a method having the features as claimed in independent claim 1. Preferred embodiments of the invention are subject matter of dependent claims 2 to 13. The wording of all the claims is hereby incorporated in the content of the present description by express reference.
The invention relates to a method for producing a surgical instrument for guiding and/or holding and/or grasping a needle, in particular a surgical needle. The surgical instrument is preferably a surgical needle holder or surgical tweezers. The method comprises, especially in chronological order, the following steps:
The expression “solder depot” is to be understood in the context of the present invention to mean a depot, i.e., a storing or storage mechanism, designed or configured to be filled with a solder and to keep or store the solder after filling, i.e., to have it available.
In the context of the present invention, the expression “distal” is intended to mean pointing away from a center of a human or animal body or located further away from a center of a human or animal body.
In the context of the present invention, the expression “proximal” is intended to mean pointing to a center of a human or animal body or located closer to a center of a human or animal body.
The invention is especially distinguished by the following advantages:
The metering of the amount of solder can advantageously be defined via a volume of the solder depot. The control of the flow of solder is preferably based on capillary action, by means of which the solder can be drawn into a solder gap present between the inserted hard metal inserts and the distal holding jaws, the capillary effect breaking at the end of the solder gap and there being no further flow of the solder. As a result, the problems described in the introduction in connection with an excess of solder and an uncontrolled flow of solder can be avoided with particular advantage.
For example, there is no need to grind off excess solder and/or protruding hard metal inserts. Instead, any grinding process subsequent to the soldering process can, for example, be limited to dimensional adjustment between the hard metal inserts and the distal holding jaws and to the removal of any solder residues present. As a result, the amount of costly hard metal used can be reduced.
The method according to the invention is thus distinguished overall by improved process reliability and, in particular, by a reduction in manual work steps. As a result, higher product quality is achievable.
Moreover, by avoiding scrap and reducing the work required, the production costs can be reduced.
Lastly, it is advantageous that more stable surgical instruments for grasping and/or holding and/or guiding a needle can be produced by means of the method according to the invention, by the method making it possible to reduce stress peaks and to thus reduce the risk of breakage.
The expression “hard metal insert” is to be understood in the context of the present invention to mean an insert which comprises a hard metal, in particular as the main component, or consists of a hard metal.
The expression “hard metal” is to be understood in the context of the present invention to mean a metal-matrix composite material in which hard materials present as small particles are held together by a matrix composed of metal or an alloy. As a result, hard metals are somewhat less hard than pure hard materials, but distinctly tougher. On the other hand, they are harder than pure metals, alloys and hardened steel.
Preferably, the first arm part and the second arm part are mirror images of one another. Preferably, the first arm part has a first grip part, in particular a first finger opening, at a proximal end, and the second arm part has a second grip part, in particular a second finger opening, at a proximal end.
Preferably, the first arm part and the second arm part each comprise a stainless steel as base or carrier material. In particular, the first arm part and the second arm part can each consist largely or entirely of a stainless steel. The stainless steel is preferably a corrosion-resistant stainless steel, preferably a corrosion-resistant, martensitic stainless steel, particularly preferably a corrosion-resistant, martensitic stainless steel having the material number 1.4021.
Hard metal inserts preferably used are hard metal inserts which comprise a metal matrix composed of cobalt and/or nickel and a hard material selected from the group consisting of tungsten carbide (WC), titanium carbide (TiC), titanium nitride (TiN), niobium carbide, tantalum carbide, vanadium carbide and mixtures thereof. In particular, the hard metal inserts can each have a nickel content of 8% by weight to 20% by weight and a metal carbide content, in particular tungsten carbide content, of 80% by weight to 92% by weight, based on the total weight of a particular hard metal insert.
Preferably, the hard metal inserts also have a profiled, in particular serrated or toothed, surface, preferably a surface having a cross-shaped profile and/or pyramidal checkered pattern. As a result, gripping and/or holding and/or guiding of a needle without any tilting and/or slipping is achievable with particular advantage.
Furthermore, the hard metal inserts can have an encircling chamfer.
Particularly preferably, the hard metal inserts, for example having a toothed profile, an encircling chamfer and a shape complementary to the shapes of the recesses in the distal holding jaws, are produced by a near-net-shape forming process.
The surgical instrument produced by means of the method according to the invention can comprise a locking mechanism (lock) in the form of locking arms having latching hooks, which locking arms extend away in the vicinity of the abovementioned grip parts and point toward one another. When the distal holding jaws are in the closed state, said latching hooks of the locking arms can form-fittingly latch with one another, such that a thread between the distal holding jaws, or a corresponding needle, automatically remains firmly held. This locking (lock) can be released by a user operating the surgical instrument as a result of the grip parts being further pressed together and being moved slightly apart along the plane of the holding jaws. The surgical instrument and the distal holding jaws can then be opened.
In one embodiment of the invention, when carrying out step b), the hard metal inserts are form-fittingly inserted into the recesses in the distal holding jaws. As a result, a high degree of accuracy in fitting and positioning is achievable. In particular, displacements of the hard metal inserts can in this way be avoided completely or at least to a large extent.
In a further embodiment of the invention, when carrying out step b), a nose shaped form-fitting section of the hard metal inserts is inserted into a complementary (i.e., shape-complementary) region of the recess in the distal holding jaws and form-fittingly held thereby. The nose shaped form-fitting section allows, in principle, displacement between hard metal insert and arm part or distal holding jaw while carrying out step e) (owing to differing material expansion of the hard metal and of a base or carrier material, preferably stainless steel, of the arm parts). Nevertheless, the nose shaped form-fitting section can ensure, with particular advantage, correct alignment, in particular centering, of the hard metal inserts.
In a further embodiment of the invention, the solder depots are each in the form of a cavity, in particular in the form of an elongate or elongated, in particular channel-shaped, cavity. Particularly preferably, the cavity extends in the axial direction of the distal holding jaw. The cavity can, in principle, have a polygonal, in particular triangular, quadrangular, pentagonal or hexagonal, cross-section. Preferably, however, the cavity has a cornerless, in particular circular, oval or elliptical, cross-section. A particularly specific control of flow of solder when carrying out step e) is advantageously achievable especially by an elongate or elongated design of the cavity.
In a further embodiment of the invention, the cavity has an inner diameter of 0.3 mm to 2 mm, preferably 0.8 mm to 1.2 mm, and/or a length of 4 mm to 15 mm, preferably 7 mm to 12 mm. The amount of solder for carrying out step e) can be controlled with particular advantage via the inner diameter and/or the length of the cavity. Apart from that, the advantage mentioned in the preceding paragraph applies mutatis mutandis.
In a further embodiment of the invention, step c) is carried out between steps b) and e), in particular between steps b) and d).
To carry out step c), the first arm part and the second arm part can, for example, be screwed together at the articulation or articulation point with the aid of a screw, in particular a locking screw.
In a further embodiment of the invention, when carrying out step d), the solder depots are each filled with the solder via an inlet opening formed on the end face at the free end of the distal holding jaws. The solder depots can, for example, be filled with the solder with the aid of a metering aid, in particular a syringe.
In a further embodiment of the invention, step d) is carried out between steps b) and e), in particular between steps c) and e).
In a further embodiment of the invention, the solder used is a nickel solder, i.e., a nickel alloy or nickel-containing alloy (according to EN ISO 17672), in particular selected from the group consisting of Ni600, Ni610, Ni612, Ni620, Ni630, Ni631, Ni650, Ni700, Ni710, Ni720, Ni800 and mixtures thereof.
The nickel solder Ni600 is preferably a nickel alloy having a melting temperature range from 980° C. to 1060° C., the nickel alloy consisting of the following constituents:
The nickel solder Ni610 is preferably a nickel alloy having a melting temperature range from 980° C. to 1070° C. and consisting of the following constituents:
The nickel solder Ni612 is preferably a nickel alloy having a melting temperature of 1055° C. and consisting of the following constituents:
The nickel solder Ni620 is preferably a nickel alloy having a melting temperature range from 970° C. to 1000° C. and consisting of the following constituents:
The nickel solder Ni630 is preferably a nickel alloy having a melting temperature range from 980° C. to 1040° C. and consisting of the following constituents:
The nickel solder Ni631 is preferably a nickel alloy having a melting temperature range from 980° C. to 1070° C. and consisting of the following constituents:
The nickel solder Ni650 is preferably a nickel alloy having a melting temperature range from 1080° C. to 1135° C. and consisting of the following constituents:
The nickel solder Ni700 is preferably a nickel alloy having a melting temperature of 875° C. and consisting of the following constituents:
The nickel solder Ni710 is preferably a nickel alloy having a melting point of 890° C. and consisting of the following constituents:
The nickel solder Ni720 is preferably a nickel alloy having a melting temperature range from 880° C. to 950° C. and consisting of the following constituents:
The nickel solder Ni800 is preferably a nickel alloy having a melting temperature range from 980° C. to 1010° C. and consisting of the following components:
The aforementioned nickel solders are particularly preferred according to the invention, since the melting temperature ranges or melting temperatures thereof are compatible with the temperatures required for hardening of the arm parts, in particular joined arm parts. As a result, when carrying out step e), hardening of the arm parts, in particular joined arm parts, is also achievable at the same time with particular advantage.
In a further embodiment of the invention, when carrying out step e), the solder exits in each case from an outlet opening in the solder depot, which outlet opening opens into a bottom of the recess in the distal holding jaws. Preferably, when carrying out step e), the solder passes from the solder depots into the bottom of the recess in the distal holding jaws under the action of a capillary force. This in turn means that the solder from the solder depot can spread uniformly in solder gaps formed between the hard metal inserts and the distal holding jaws, without escaping from the solder gaps. Furthermore, soldering of the distal holding jaws to one another while step e) is being carried out can be avoided.
In a further embodiment of the invention, the inlet opening and the outlet opening are arranged acute-angledly or perpendicularly to one another.
Preferably, to carry out step e), the arm parts, in particular joined arm parts, are clamped or suspended by means of a suspension device in such a way that the free ends of the distal holding jaws with the solder depots are oriented upwards. As a result, when carrying out step e), the solder can spread particularly well in solder gaps formed between the hard metal inserts and the distal holding jaws, owing to liquefaction of said solder and with the assistance of gravity and preferably capillary action.
Further preferably, step e) is carried out in a vacuum furnace or protective gas furnace, for example with a hydrogen or argon atmosphere.
Particularly preferably, step e) is carried out in a high-temperature soldering process, in particular in accordance with DIN 8593-7.
Especially through step e), hardening of the arm parts is also achievable with particular advantage. In particular, the arm parts, or the surgical instrument produced by means of the method according to the invention, can achieve here an HRC hardness (Rockwell hardness) of 42 HRC to 50 HRC. An independent hardening step, in particular before carrying out step e), is therefore not necessary. This is a (further) simplification of the process flow, meaning that time and costs in particular can be saved.
In a further embodiment of the invention, after step e) has been carried out, the method further comprises a step f) removing the solder depots.
In a further embodiment of the invention, when carrying out step f), the solder depots are each removed by breaking a predetermined breaking line or predetermined breaking point/thin spot. The predetermined breaking lines or predetermined breaking points/thin spots each preferably extend in the circumferential direction of the distal holding jaws. Especially preferably, the predetermined breaking lines or predetermined breaking points/thin spots are each formed between the free end of the distal holding jaws that comprises the solder depot, and a solder depot-free section of the distal holding jaws that adjoins the free end of the distal holding jaws. The predetermined breaking lines or predetermined breaking points/thin spots can, for example, be in the form of perforations, notches or scratches. The predetermined breaking lines or predetermined breaking points/thin spots advantageously allow simple manual removal of the (external) solder depots by means of breaking, in particular without the use of additional tools and in particular without the risk of damaging the arm parts and therefore the surgical instrument to be produced.
Alternatively, when carrying out step f), the free ends of the distal holding jaws can be ground off as far as the predetermined breaking lines or predetermined breaking points/thin spots.
Furthermore, after step e), in particular after step f), the method can comprise a further step g) grinding the hard metal inserts used and/or the distal holding jaws. As a result, tolerance differences between the hard metal inserts and the arm parts/distal holding jaws can be leveled out with particular advantage and, in particular, any residual solder can be removed.
Further advantages and aspects of the invention will become apparent from the claims and from the following description of preferred exemplary embodiments of the invention, which are explained on the basis of a production example and on the basis of figures and associated descriptions thereof.
The following is depicted schematically in the figures:
The surgical instrument 1 depicted schematically in
The surgical needle holder has a first arm part 10 and a second arm part 10′ which are pivotably mounted relative to one another at an articulation point 20. Preferably, the first arm part 10 and the second arm part 10′ are mirror images of one another.
Both the distal end of the first arm part 10 and the distal end of the second arm part 10′ each have a holding jaw 30, 30′ (so-called distal holding jaws). The distal holding jaws 30, 30′ each have a hard metal insert 40, 40′. The hard metal inserts 40, 40′ are each form-fittingly inserted in a recess in the distal holding jaws 30, 30′.
The proximal ends of the arm parts 10 and 10′ each have a grip part 50, 50′ in the form of a finger opening.
Located between the distal holding jaws 30, 30′ and the two grip parts 50, 50′ is a locking mechanism 60 which is formed by two locking arms 62, 64. The first locking arm 62 protrudes from the first arm part 10 toward the second arm part 10′. The second locking arm 64 protrudes from the second arm part 10′ toward the first arm part 10, and so, by means of latching hooks (not depicted) attached to the first locking arm 62 and latching hooks 65 attached to the second locking arm 64, it is possible to latch or lock the two locking arms 62 and 64 and hence the surgical needle holder 1. The latching hooks of the first locking arm 62 and the latching hooks 65 of the second locking arm 64 are designed in such a way that form-fitting locking is achieved when the grip parts 50, 50′ are pressed together. The latching hooks can, for example, be shark tooth-shaped.
The hard metal insert 40 is preferably planar and preferably has a cross-shaped profile 41. Furthermore, the hard metal insert 40 has a nose shaped form-fitting section 43.
The distal holding jaw 30 has a recess 31 complementary to the shape of the hard metal insert 40. Formed in the free end 33 of the distal holding jaw 30 is a hollow solder depot 35 (see
The solder depot 35 is preferably in the form of an elongate or channel-shaped cavity which extends in the axial direction of the distal holding jaw 30. On the end face 34 of the free end 33 of the distal holding jaw 30, the solder depot 35 has an inlet opening 37 for filling the solder depot 35 with a solder.
With regard to further features and advantages of the hard metal insert 40 and the distal holding jaw 30, full reference is made to the description relating to
Lastly, the advantages of the method according to the invention shall be summarized again as follows: by means of a near-net-shape forming process, it is possible for the hard metal inserts to be already produced with a matching outer shape and an encircling chamfer in a tool-dependent manner.
The arm parts of the surgical needle holder were produced from a sheet of stainless steel (1.4021) having a thickness of 5.5 mm. Thereafter, milling was carried out to produce a recess for an articulation closure and also one recess each in the region of the distal holding jaws of the arm parts. Furthermore, drilling was carried out to create hollow solder depots in the free ends of the distal holding jaws.
The hard metal inserts to be inserted into the recesses in the distal holding jaws were produced by means of a near-net-shape forming process. The hard metal inserts thus produced each had a toothed profile, an encircling chamfer on the toothed profile, and a matching outer shape for insertion into the recesses in the distal holding jaws. It was possible to produce relevant hard metal inserts by means of pressing or MIM (metal injection molding), for example. The hard metal inserts thus produced were then sintered.
The hard metal inserts were then form-fittingly inserted into the recesses in the distal holding jaws. Thereafter, the arm parts were fixed with a rivet pin and locked by means of a locking mechanism.
To solder the hard metal inserts to the arm parts, the solder depots were filled to the top edge with a high-temperature nickel-based solder in accordance with EN ISO 17672 by means of a metering device or a syringe. Any excess solder was removed.
The surgical needle holder was then suspended in a suspension device, specifically in such a way that the free ends of the distal holding jaws of the arm parts were oriented upwards. The needle holder thus suspended was placed in a hardening furnace.
A high-temperature vacuum soldering process was then carried out in accordance with DIN 8593-7. As a result, what occurred here was not only soldering of the hard metal inserts to the arm parts of the surgical needle holder, but also, at the same time, hardening of the base or carrier material (stainless steel) of the instrument. The base or carrier material achieved a hardness of 42 HRC to 50 HRC.
The solder depot-containing free ends of the distal holding jaws were then removed. Said ends were removed by breaking predetermined breaking lines, which were formed in the circumferential direction of the distal holding jaws and between the solder depot-containing free ends and adjoining solder depot-free holding jaw sections.
Thereafter, the surgical needle holder was ground to level out tolerance differences between the hard metal inserts and the base or carrier material of the needle holder and to remove any residual solder.
Lastly, the surface of the surgical needle holder was subjected to a surface finish.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10 2020 210 664.9 | Aug 2020 | DE | national |
This application is the United States national stage entry of International Application No. PCT/EP2021/073062, filed Aug. 19, 2021, and claims priority to German Application No. 10 2020 210 664.9, filed Aug. 21, 2020. The contents of International Application No. PCT/EP2021/073062 and German Application No. 10 2020 210 664.9 are incorporated by reference herein in their entireties.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2021/073062 | 8/19/2021 | WO |
