EP1504829B1 - Verfahren zur Herstellung einer medizinischen Nadel - Google Patents

Verfahren zur Herstellung einer medizinischen Nadel Download PDF

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Publication number
EP1504829B1
EP1504829B1 EP03017883A EP03017883A EP1504829B1 EP 1504829 B1 EP1504829 B1 EP 1504829B1 EP 03017883 A EP03017883 A EP 03017883A EP 03017883 A EP03017883 A EP 03017883A EP 1504829 B1 EP1504829 B1 EP 1504829B1
Authority
EP
European Patent Office
Prior art keywords
needle
portions
laser beam
plane
dimensions
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP03017883A
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English (en)
French (fr)
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EP1504829A1 (de
Inventor
Adrian Fiechter
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lasag AG
Original Assignee
Lasag AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lasag AG filed Critical Lasag AG
Priority to EP03017883A priority Critical patent/EP1504829B1/de
Priority to DE60305912T priority patent/DE60305912T2/de
Priority to AT03017883T priority patent/ATE328686T1/de
Priority to TW093123105A priority patent/TWI311084B/zh
Priority to CNB2004100766089A priority patent/CN100364690C/zh
Priority to JP2004229069A priority patent/JP2005052654A/ja
Priority to US10/911,508 priority patent/US7557325B2/en
Publication of EP1504829A1 publication Critical patent/EP1504829A1/de
Priority to HK05106894A priority patent/HK1074597A1/xx
Application granted granted Critical
Publication of EP1504829B1 publication Critical patent/EP1504829B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21G—MAKING NEEDLES, PINS OR NAILS OF METAL
    • B21G1/00—Making needles used for performing operations
    • B21G1/08—Making needles used for performing operations of hollow needles or needles with hollow end, e.g. hypodermic needles, larding-needles

Definitions

  • the present invention relates to a method of manufacturing a medical metal needle of the type generally used to make sutures.
  • the tubular portion arranged at the non-pointed end of the needle is intended to ensure the subsequent attachment of the suture to the needle.
  • current medical needles are typically made from a single metal portion with one end pointed while the second end is substantially flat.
  • a blind hole is then formed in the second end to subsequently secure the fixation of a suture.
  • the blind hole is made by a laser or drill drilling method according to the desired dimensions.
  • Another disadvantage of this type of process is related to the fact that if the blind hole is poorly positioned or dimensioned, it is possible that its walls are too thin to withstand the mechanical stresses subsequently suffered during the production of a suture.
  • An object of the present invention is to overcome the aforementioned drawbacks of the prior art by providing a method for manufacturing medical needles fast, inexpensive and having a good yield, that is to say, a good reproducibility of quality needles obtained.
  • the present invention relates to a manufacturing method of the type indicated above, characterized in that the speed of the relative rotational movement and the duration of the pulses of the laser are adjusted relative to each other such way that at least one rotation rotation is performed during the duration of a pulse of the laser beam.
  • the weld obtained is continuous and of uniform quality over the entire periphery of the needle. Since the tube welded to the main portion of the needle is manufactured by a conventional and proven method, its dimensions are relatively accurately guaranteed. Thus, the dimensions of the blind hole of the needle obtained by the method according to the present invention are not subject to fluctuations, from one needle to another, as is the case for the needles of the prior art .
  • the first portion of the needle has a substantially cylindrical shape in the region of its second end, preferably of the same dimensions as the second needle portion. In this way, the passage from one portion to another is not discontinuous when the needle is assembled.
  • the two needle portions are applied against each other with a certain pressure force prior to the welding operation.
  • the chamfer is made by material removal by laser heating and so as to have a circular arc-shaped cross section.
  • the presence of such a chamfer facilitates the subsequent insertion of the suture within the blind hole of the needle.
  • the chamfer can be advantageously made after the welding operation of the two needle portions, using the same laser machining head and the same relative rotational movement between the formed needle and the laser beam incident. Indeed, currently the chamfer is typically realized by the use of two laser beams of respective opposite angles of incidence and each of which makes it possible to achieve half of the chamfer.
  • a preferred embodiment of the present invention provides to arrange the two needle portions stationary on a workpiece holder. fixed while the laser beam is rotated around the axis X2 of the tubular portion. A rapid movement of the two portions that must remain fixed relative to each other is indeed difficult to implement without affecting the accuracy of the welding.
  • Figure 1 shows a medical needle 100 of the type currently used and described above, in partial section.
  • This needle is typically made in one piece between a first pointed end 101 and a second end 102 whose section is substantially flat.
  • the needle 100 is only partially shown, its middle part not being visible, the first end 101 being shown in perspective while the region of the second end is shown in section.
  • the median portion may have a rectilinear or curvilinear shape.
  • a blind hole 103 is made in the region of the second end 102 for the purpose of securing a suture (not shown) in a subsequent manufacturing step.
  • the blind hole 103 is made by a laser drilling method.
  • this laser drilling method has a significant disadvantage which concerns the accuracy of the positioning of the hole 103 relative to the needle and the accuracy of the dimensioning of the hole obtained.
  • a wrong sizing of the hole 103 may result in a poor hold of the suture (not shown) which is intended to be threaded thereon, as well as an irregular shape of the hole 103.
  • the Applicant has developed the method of manufacturing medical needles according to the present invention.
  • FIG. 2 shows a medical needle 1 obtained by a method according to the present invention, in a view similar to the view of FIG. 1.
  • the needle 1 comprises two portions, a first main portion 2, partially shown, and a second portion 3 of tubular shape.
  • the first main portion 2 comprises a first pointed end 4 and a second end 5 contained in a plane P1.
  • the middle portion of the first main portion 2, which is not shown, may have any shape, that is to say it may be rectilinear or curvilinear without its shape affecting the manufacturing method according to the present invention.
  • the second portion 3 preferably has an axial symmetry axis X2 and comprises a first end 6 intended to be welded to the first portion 2, contained in a plane P2 substantially perpendicular to the axis X2.
  • the second portion 3 further comprises a second end 7 through which it is intended to insert a suture in a subsequent manufacturing step to bond the latter to the needle 1.
  • the suture must eventually be housed inside the blind hole 8 formed by the meeting of the first 2 and second 3 portions of the needle 1.
  • a chamfer 10 preferably has a substantially arcuate section of circle, with a radius of curvature of the order of a few tens or hundreds of micrometers, preferably between 10 and 200 microns, and ensures a guide function of the suture when it is threaded into the needle. This measure makes it possible to appreciably soften the insertion conditions of the suture and results in a significant time saving in the operation of assembling the yarn and the needle, which is typically automated with a cadence. of high operation of the order of several assemblies per second.
  • Figure 2 also shows a structural detail of the needle 1, directly related to its manufacturing process. Indeed, there is the presence of a weld 11 at the interface between the first 2 and second 3 portions of the needle. Preferably, the weld extends over the entire thickness of the wall of the second tubular portion, as shown in Figure 2, so as to ensure optimum rigidity of the connection between the two portions of the needle.
  • the manufacturing method according to the present invention allows to form a continuous weld 11 over the entire periphery of the second portion 3 and of excellent quality both mechanically and visually.
  • the first 2 and second 3 portions of the needle have been shown here with identical dimensions in the regions of their respective ends intended to be welded together.
  • the needle 1 has an envelope without irregularity of its surface from its pointed end 4 to its end 7 for securing the suture.
  • this characteristic which corresponds to a preferred variant is not limiting.
  • Those skilled in the art can adapt the relative dimensions of the first and second needle portions according to their own needs without particular difficulty and without departing from the scope of the present invention.
  • the transverse dimensions of the second needle portion be smaller or smaller. equal to those of the first portion.
  • FIGS 3 and 4 show two examples of implementation of the method according to the present invention, with different welding devices.
  • FIG. 3 schematically represents a first embodiment of the method according to the invention, in which the first 2 and second 3 portions of the needle 1 are rotated opposite an immobile incident laser beam.
  • a work table 30 whose inclination of the working surface 31 is preferably capable of being adjusted according to at least an axis of rotation, as indicated by the arrow F1, to be able to adjust the angle of incidence of the laser beam on the welding region if necessary.
  • a motor 32 is secured to the working surface 31 and drives a shaft 33 in rotation.
  • the shaft 33 carries a workpiece tool 34, which is rigidly attached thereto, for supporting a needle 1 during the welding operation.
  • the workpiece tool 34 is provided with conventional means for maintaining the needle 1.
  • the device for carrying out the method according to the embodiment of FIG. 3 comprises a laser source 35 emitting a laser beam 36 of optical characteristics adapted to the operating conditions envisaged, in particular in terms of power and frequency of operation. pulses.
  • the device of FIG. 3 comprises conventional optical means for modulating the shape of the laser beam 36, such as lenses 37, 38 and 39, as well as optical means for modifying the direction of the laser beam 36, as the case may be , such as a mirror 40.
  • optical means for modulating the shape of the laser beam 36 such as lenses 37, 38 and 39
  • optical means for modifying the direction of the laser beam 36 such as a mirror 40.
  • the workpiece tool 34 is rotated on itself, in the direction indicated by the arrow F2, so that the needle rotates on itself, the interface between its two portions remaining facing the incident laser beam 41.
  • An important parameter of the method according to the present invention then consists in adjusting the values of the duration of the pulses of the laser beam 36 and the speed of rotation of the workpiece tool 34 relative to each other, such that during the duration of a full pulse of the laser beam, the workpiece tool 34 performs at least one complete whole on itself.
  • the welding of the first and second needle portions is carried out in two steps.
  • a sleeve 42 of the type shown in FIG. 3 for illustrative and nonlimiting purposes.
  • the sleeve 42 has a shape generally cylindrical and comprises a bearing surface 43 against which is disposed the second portion 3 of needle 1.
  • the sleeve 42 is then threaded onto the end 5 of the first portion 2 needle carried by the workpiece tool 34 such that the first and second needle portions are abutted against each other.
  • the sleeve further has a plurality of openings 44 regularly distributed around its periphery and located opposite the interface region between the first and second needle portions.
  • the sleeve 42 shown comprises 3 openings 44 arranged at 120 ° from each other.
  • the incident beam 41 irradiates the interface regions between the first and second needle portions located opposite the openings 44 to form small weld spots.
  • the sleeve 42 is removed and the workpiece tool 34 is rotated again to perform the continuous welding, as mentioned above.
  • the method for manufacturing medical needles according to the present embodiment of the invention is applicable to needles whose section is not circular.
  • the application of this method to the realization of needles of different shapes leads to much lower results in terms of production speed, insofar as the use of support means of the robotic arm type are required. Indeed, the movements made by a robotic arm in this case are more complex, so the welding process is generally slower.
  • Figure 4 shows a preferred embodiment of the method according to the present invention schematically.
  • a needle of curvilinear type has been intentionally represented for illustrative purposes, the shape of the needle having no effect on the method according to the present invention, as mentioned above.
  • the first 2 'and second 3' portions of the needle 1 ' are held in a fixed position during the welding operation. while the incident laser beam is driven in a rotational movement.
  • the present embodiment is therefore more favorable from the point of view of the stability of the relative position of the two parts to be welded together, as well as from the point of view of their positioning with respect to the incident laser beam.
  • a laser source 50 emitting a laser beam 51 through a mechanical system 52 comprising conventional optical means for adjusting the characteristics of the incident laser beam 53.
  • the system 52 also comprises a reflecting surface 54 as well as mechanical means (not shown) for rotating the reflecting surface 54 in the direction indicated by the arrow F3 in FIG.
  • the laser beam is then deflected towards a second reflecting surface 55 of annular overall shape and having a concave cross-sectional shape, as shown in FIG. 4.
  • the incident laser beam 53 is then emitted from the second reflecting surface 55, in the direction of the needle 1, with a certain angle of incidence adjustable through the mechanical means of the system 52.
  • the needle 1 is disposed in a workpiece holder 56, the relative positioning of the system 52 and the needle being adjusted so that the incident laser beam has its focal point substantially in the region of the interface between the first 2 and second 3 portions of the needle 1.
  • the laser beam is emitted and driven in a rotational movement by the rotation of the reflecting surface 54, so that the incident laser beam travels the periphery of the needle at the level of the needle. of the interface between the two portions of the latter.
  • the values of the speed of rotation of the reflecting surface 54 and the duration of the pulses of the laser beam 51 are adjusted relative to each other, so that During the duration of a complete pulse of the laser beam, the reflective surface 54 performs at least one complete whole on itself.
  • the method according to the present invention comprises an additional step of polishing the casing of the needle 1 obtained after completion of the welding.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Surgical Instruments (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Laser Beam Processing (AREA)

Claims (13)

  1. Verfahren zum Herstellen einer metallischen medizinischen Nadel (1), das die folgenden Schritte umfasst:
    a) Vorsehen eines ersten Hauptabschnitts (2) der Nadel (1), der ein zugespitztes erstes Ende (4) und ein zweites Ende (5), dessen Umfang in einer Ebene P1 enthalten ist, aufweist,
    b) Vorsehen eines zweiten Abschnitts (3) der Nadel (1) in Form eines Rohrs mit Längsachse X2, wovon wenigstens ein erstes Ende (6) einen Umfang aufweist, der in einer Ebene P2 enthalten ist, die zu der Achse X2 im Wesentlichen senkrecht ist, wobei die Abmessungen des zweiten Abschnitts (3) der Nadel in der Ebene P2 kleiner oder gleich den Abmessungen des ersten Abschnitts (2) in der Ebene P1 sind,
    c) Anordnen des ersten Abschnitts (2) und des zweiten Abschnitts (3) der Nadel (1) Ende an Ende, derart, dass die Ebenen P1 und P2 zusammenfallen und dabei eine Grenzfläche zwischen den zwei Nadelabschnitten bilden,
    d) Ausführen eines Verschweißens des ersten Abschnitts (2) und des zweiten Abschnitts (3) der Nadel (1) durch Einwirkung eines gepulsten Laserstrahls (41), der auf einen Schweißbereich (11) auftrifft, der sich auf Höhe der Grenzfläche befindet, und
    während des Schrittes d) Einführen einer relativen Drehbewegung zwischen den zwei Abschnitten (2; 3) der Nadel (1) einerseits und dem auftreffenden Laserstrahl (41) andererseits, wobei das Verfahren dadurch gekennzeichnet ist, dass die Geschwindigkeit der relativen Drehbewegung und die Dauer der Impulse des Lasers relativ zueinander in der Weise eingestellt werden, dass wenigstens eine relative Umdrehung während der Dauer eines Impulses des Laserstrahls (41) erfolgt.
  2. Verfahren nach Anspruch 1, dadurch gekennzeichnet, dass der erste Abschnitt (2) der Nadel (1) im Bereich seines zweiten Endes (7) im Wesentlichen zylindrisch ist.
  3. Verfahren nach Anspruch 2, dadurch gekennzeichnet, dass die Abmessungen des zweiten Abschnitts (3) der Nadel (1) in der Ebene P2 im Wesentlichen gleich den Abmessungen des ersten Abschnitts (2) in der Ebene P1 sind.
  4. Verfahren nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass im Schritt c) von Anspruch 1 außerdem auf den ersten Abschnitt (2) und auf den zweiten Abschnitt (3) der Nadel (1) eine Druckkraft ausgeübt wird, um sie gegeneinander zu pressen.
  5. Verfahren nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass es einen zusätzlichen Schritt der Ausbildung einer Fase (10) zwischen dem zweiten Ende (7) des zweiten Abschnitts (3) der Nadel (1) und seiner inneren Oberfläche (9) umfasst.
  6. Verfahren nach Anspruch 5, dadurch gekennzeichnet, dass die Fase (10) einen kreisbogenförmigen Querschnitt aufweist.
  7. Verfahren nach Anspruch 6, dadurch gekennzeichnet, dass der Kreisbogen einen Radius im Bereich von 10 bis 200 Mikrometern aufweist.
  8. Verfahren nach einem der Ansprüche 5 bis 7, dadurch gekennzeichnet, dass ein gleicher Laser-Bearbeitungskopf im Schritt d) von Anspruch 1 und für die Ausbildung der Fase (10) verwendet wird.
  9. Verfahren nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die zwei Abschnitte (2; 3) der Nadel (1) an einer festen Werkstückauflage (56) unbeweglich angeordnet sind, während der auftreffende Laserstrahl (41) zu einer Drehbewegung um die Achse X2 angetrieben wird.
  10. Verfahren nach Anspruch 9, dadurch gekennzeichnet, dass die Drehbewegung des auftreffenden Laserstrahls (41) durch Betreiben einer optischen Vorrichtung verwirklicht wird, die insbesondere eine rotierende reflektierende Oberfläche (54, 55) aufweist.
  11. Verfahren nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der Schritt d) von Anspruch 1 zweimal nacheinander ausgeführt wird, wobei an der Nadel (1) bei der ersten Ausführung eine Muffe (42) angeordnet wird, die vor der zweiten Ausführung abgezogen wird, wobei die Muffe (42) Öffnungen (44) aufweist, die sich gegenüber der Grenzfläche zwischen dem ersten Abschnitt (2) und dem zweiten Abschnitt (3) der Nadel (1) befinden.
  12. Verfahren nach Anspruch 11, dadurch gekennzeichnet, dass die Muffe (42) drei Öffnungen (44) aufweist, die voneinander in Umfangsrichtung der Muffe (42) um 120° beabstandet sind.
  13. Verfahren nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass nach dem Schritt d) von Anspruch 1 außerdem ein Polierschritt vorgesehen ist.
EP03017883A 2003-08-05 2003-08-05 Verfahren zur Herstellung einer medizinischen Nadel Expired - Lifetime EP1504829B1 (de)

Priority Applications (8)

Application Number Priority Date Filing Date Title
EP03017883A EP1504829B1 (de) 2003-08-05 2003-08-05 Verfahren zur Herstellung einer medizinischen Nadel
DE60305912T DE60305912T2 (de) 2003-08-05 2003-08-05 Verfahren zur Herstellung einer medizinischen Nadel
AT03017883T ATE328686T1 (de) 2003-08-05 2003-08-05 Verfahren zur herstellung einer medizinischen nadel
TW093123105A TWI311084B (en) 2003-08-05 2004-08-02 Method for manufacturing a medical needle
CNB2004100766089A CN100364690C (zh) 2003-08-05 2004-08-04 医用针的加工方法
JP2004229069A JP2005052654A (ja) 2003-08-05 2004-08-05 医療用針の製造方法
US10/911,508 US7557325B2 (en) 2003-08-05 2004-08-05 Method for manufacturing a medical needle
HK05106894A HK1074597A1 (en) 2003-08-05 2005-08-10 Method for manufacturing a medical needle

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP03017883A EP1504829B1 (de) 2003-08-05 2003-08-05 Verfahren zur Herstellung einer medizinischen Nadel

Publications (2)

Publication Number Publication Date
EP1504829A1 EP1504829A1 (de) 2005-02-09
EP1504829B1 true EP1504829B1 (de) 2006-06-07

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Application Number Title Priority Date Filing Date
EP03017883A Expired - Lifetime EP1504829B1 (de) 2003-08-05 2003-08-05 Verfahren zur Herstellung einer medizinischen Nadel

Country Status (8)

Country Link
US (1) US7557325B2 (de)
EP (1) EP1504829B1 (de)
JP (1) JP2005052654A (de)
CN (1) CN100364690C (de)
AT (1) ATE328686T1 (de)
DE (1) DE60305912T2 (de)
HK (1) HK1074597A1 (de)
TW (1) TWI311084B (de)

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CN104874911B (zh) * 2015-05-27 2016-10-12 四川大学 一种微探针尖端成形激光加工系统

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Also Published As

Publication number Publication date
HK1074597A1 (en) 2005-11-18
EP1504829A1 (de) 2005-02-09
US20050049639A1 (en) 2005-03-03
DE60305912T2 (de) 2007-02-01
JP2005052654A (ja) 2005-03-03
US7557325B2 (en) 2009-07-07
TWI311084B (en) 2009-06-21
ATE328686T1 (de) 2006-06-15
CN100364690C (zh) 2008-01-30
TW200518857A (en) 2005-06-16
DE60305912D1 (de) 2006-07-20
CN1579666A (zh) 2005-02-16

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