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WO1995008296A1 - Aiguille de suture destinee a etre utilisee dans les operations endoscopiques et son procede de fabrication - Google Patents

Aiguille de suture destinee a etre utilisee dans les operations endoscopiques et son procede de fabrication Download PDF

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Publication number
WO1995008296A1
WO1995008296A1 PCT/KR1994/000128 KR9400128W WO9508296A1 WO 1995008296 A1 WO1995008296 A1 WO 1995008296A1 KR 9400128 W KR9400128 W KR 9400128W WO 9508296 A1 WO9508296 A1 WO 9508296A1
Authority
WO
WIPO (PCT)
Prior art keywords
suture needle
needle
shape memory
straight
curved
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.)
Ceased
Application number
PCT/KR1994/000128
Other languages
English (en)
Inventor
Young Kon Kim
Jae Kyun Doo
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of WO1995008296A1 publication Critical patent/WO1995008296A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • C—CHEMISTRY; METALLURGY
    • C21—METALLURGY OF IRON
    • C21D—MODIFYING THE PHYSICAL STRUCTURE OF FERROUS METALS; GENERAL DEVICES FOR HEAT TREATMENT OF FERROUS OR NON-FERROUS METALS OR ALLOYS; MAKING METAL MALLEABLE, e.g. BY DECARBURISATION OR TEMPERING
    • C21D9/00—Heat treatment, e.g. annealing, hardening, quenching or tempering, adapted for particular articles; Furnaces therefor
    • C21D9/26—Heat treatment, e.g. annealing, hardening, quenching or tempering, adapted for particular articles; Furnaces therefor for needles; for teeth for card-clothing
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
    • C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
    • C22F1/006—Resulting in heat recoverable alloys with a memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30092—Properties of materials and coating materials using shape memory or superelastic materials, e.g. nitinol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A61F2210/0019—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
    • C—CHEMISTRY; METALLURGY
    • C21—METALLURGY OF IRON
    • C21D—MODIFYING THE PHYSICAL STRUCTURE OF FERROUS METALS; GENERAL DEVICES FOR HEAT TREATMENT OF FERROUS OR NON-FERROUS METALS OR ALLOYS; MAKING METAL MALLEABLE, e.g. BY DECARBURISATION OR TEMPERING
    • C21D2201/00—Treatment for obtaining particular effects
    • C21D2201/01—Shape memory effect

Definitions

  • This invention relates to a suture needle for use in endoscopic operations and its method of manufacture.
  • endoscopes and slender tubes are used in order to minimize the patient's external incised sections.
  • a surgeon removes patient's focuses using medical appliances which are supplied into the abdomen of the patient through tubes and seeing through an endoscope.
  • Incised sections from which focuses have been removed are brought into contact and sutured together, by the manipulation of a suture needle and other surgical instruments which are inserted through tubes.
  • Such a straight or ski-shaped suture needle can easily pass through a slender tube, but it has a difficulty in stitching incised sections. Since such stitching should be carried out within a extremely small space, very skillful manipulation is required, and it is not easy to stitch precisely. The time needed for stitching is also very long.
  • An object of the invention is to provide a suture needle for use in endoscopic operations which can easily pass through a slender tube and easily stitch interior incised sections.
  • Another object of the invention is to provide a method for manufacturing a suture needle which can easily pass through a slender tube and easily stitch interior incised sections in endoscopic operations.
  • a suture needle made of shape memory alloy for use in endoscopic operations consists of a sharp end, a needle eyehole at the other end, and a long slender body extending between the sharp end and the needle eyehole such that it remains straight at a normal temperature and at least its body is curved at a temperature in the range of 25°C to 40°C through a shape memory transformation.
  • a method for manufacturing a suture needle for use in endoscopic operations comprises the steps of: forming a straight suture needle from a wire rod made of a shape memory alloy; bending the suture needle into a curved shape; installing the curved needle in a die and subjecting the needle to a heat cycle in order to endow the needle with a property of reverting to the curved shape in the temperature range of 25°C to 40°C through a shape memory transformation; and stretching the curved suture needle into a straight shape.
  • normal temperature means a temperature within the range Of 0°C to 24°C .
  • Figures 1A and IB show a straight suture needle and a curved suture needle, respectively, conventionally used in endoscopic operations;
  • Figures 2A and 2B show a suture needle according to the invention, wherein Figure 2A shows the needle at a normal temperature and Figure 2B shows the needle at the body temperature; and
  • Figure 3 shows the changes in the configurations of a suture needle during the following steps of a process for manufacturing a suture needle according to the invention:
  • A preparing a shape memory alloy wire rod;
  • B manufacturing a straight suture needle from the wire rod.
  • C bending the straight suture needle into a curved shape;
  • D placing the curved suture needle in a mold and subjecting it to a shape memory heat treatment (In this figure, the mold is illustrated as though it were transparent.);
  • E ejecting the curved suture needle from the mold;
  • F stretching the curved suture needle into a straight shape;
  • G placing the needle in a mold and subjecting it to a shape memory heat treatment (Again, the mold is illustrated as though it were transparent.); and
  • H ejecting the two way shape memory suture needle from the mold.
  • the suture needle of the present invention consists of a sharp end, a needle eyehole at the other end, and a long slender body extending between the two ends.
  • the suture needle is straight at a normal temperature as shown in Figure 2A, and at least the body portion changes into a curved shape at a temperature within the range of 25°C to 40°C through a shape memory transformation as shown in Figure 2B.
  • the suture needle of the invention is manufactured by carrying out the following procedures: preparing a wire rod 1 made of a shape memory alloy; forming a straight suture needle 2 from the wire rod by sharpening one end of the wire rod and by providing a needle eyehole at the other end of the wire rod; bending at least the body of the suture needle into a curved suture needle 3; fixing the curved suture needle 3 in a mold 4 and subjecting the suture needle 3 to an appropriate heat treatment in order to endow the needle with the property of changing into the curved shape at a temperature within the temperature range of 25°C to 40°C through a shape memory transformation; and stretching the suture needle into a straight shape at a normal temperature.
  • the suture needle is then put into a straight stainless tube or other container (not shown) which will keep the suture needle straight under hygienic conditions.
  • the suture needle made by the above process has a one ⁇ way shape memory property. That is, the suture needle, which is always kept straight at a normal temperature, is changed to the curved shape upon being exposed in the temperature range of 25°C to 40°C through a shape memory transformation.
  • the one-way shape memory suture needle may lose its straight shape before it is used in an endoscopic operation. That is, if hot sterilization of the suture needle should be made before its use, the action brings about the shape memory transformation of the suture needle because the needle is exposed in the temperature range of 25°C to 40°C, and thus the suture needle is changed from straight to curve shape. In this case, even if the suture needle is cooled below the transformation temperature by being immersed into cold water after the hot sterilization, the needle may not revert to the desired straight shape. Therefore, the extra step of straightening the needle is needed before the sterilized needle can be used.
  • the present invention further proposes a suture needle having two-way shape memory property.
  • the two-way shape memory property can be obtained by fixing the one-way suture needle in a straight form in a mold and subjecting the straight needle to a heat treatment thereby endowing the needle with the property of being able to revert to its straight form through another shape memory transformation at the normal temperature.
  • the suture needle has two-way shape memory property, that is, a cold shape memory transformation of reverting into the straight shape is carried out at a normal temperature and a hot shape memory transformation of changing to the curved shape occurs at the temperature within the range of 25°C to 40°C.
  • a cold shape memory transformation of reverting into the straight shape is carried out at a normal temperature
  • a hot shape memory transformation of changing to the curved shape occurs at the temperature within the range of 25°C to 40°C.
  • Figure 3 depicts the process of manufacturing a suture needle of the invention. It will be appreciated, in the drawing, that the suture needle carried just to step (F) has one-way shape memory capability and the needle carried to step (H) has two-way shape memory capability. Although it is not shown in Figure 3, it is preferable to pack the suture needle product in a container such as a straight stainless tube in order to keep it straight and sanitary.
  • Shape memory alloys such as Ni-Ti based alloys, Cu-Al-
  • Ni based alloys Cu-Al-(one element from among Si, Sn, and
  • the shape memory transformation temperature can be adjusted by changing the shape memory heat treatment, the amount of plastic deformation, or the chemical composition of the shape memory alloys.
  • alloy 1s are especially preferred as materials for the suture needle of the present invention:
  • Cu-Sn alloys containing 0.0-15.0 Sn and the balance of Cu in at. %; (8) Cu-Zn alloys containing 38.5-41.5 Zn and the balance of Cu in wt. %; (9) Cu-Zn-X (X Si, Sn, Al, Gi) alloys containing 38.5-41.5 Zn, 0.0-5.0 X and the balance of Cu in wt. %; (10) In-Tl alloys containing 18.0- 23.0 TI and the balance of In in at. %; (11) Ni-Al alloys containing 36.0-38.0 Al and the balance of Ni in at. %; (12) Fe-Pt alloys containing 0.0-25.0 Pt and the balance of Fe in at.
  • Fe-Pd alloys containing 0.0-30.0 Pd and the balance of Fe in wt. % (14) Fe-Ni-Co-Ti alloys containing 33.0 Ni, 10.0 Co, 4.0 Ti and the balance of Fe in at. %; and (15) Mn-Cu alloys containing 5.0-35.0 Cu and the balance of Mn in at. %.
  • the greater plastic deformation (that is, above 8%) the higher the shape memory transformation temperature.
  • the shape memory transformation temperature also depends on the duration of the shape memory heat treatment at a specific temperature.
  • the suture needle according to the invention can easily pass through slender tubes in endoscopic operations because it remains straight at normal temperatures.
  • the suture needle changes to a curved shape inside the abdominal cavity of a human body where the temperature is about 36°C. Therefore, a suturing operation can be performed more easily and precisely.
  • the curved suture needle can easily be extracted from the human body because the curved needle body is somewhat straightened when passed through the tube by being pulled up forcefully.

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  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Organic Chemistry (AREA)
  • Metallurgy (AREA)
  • Materials Engineering (AREA)
  • Mechanical Engineering (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Thermal Sciences (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne une aiguille de suture destinée à être utilisée dans des opérations endoscopiques ainsi que son procédé de fabrication. L'aiguille de suture selon l'invention qui est fabriquée dans un alliage à mémoire de forme reste droite à des températures normales et se courbe à des températures variant de 25 °C à 40 °C par un phénomène de transformation par mémoire de forme. On fabrique cette aiguille de suture de la manière suivante: on forme une tige (1) en alliage à mémoire de forme; on forme ensuite une aiguille de suture droite (2) en affilant une extrémité de ladite tige et en créant un chas à l'autre extrémité; on courbe au moins le corps de l'aiguille de suture pour lui donner une forme courbe (3); on place ladite aiguille de suture courbe dans un moule dans lequel elle est soumise à un traitement thermique destiné à lui conférer la propriété de se courber à une température comprise entre 25 °C et 40 °C par un phénomène de transformation par mémoire de forme; on étire ensuite ladite aiguille de suture de sorte qu'elle soit droite à une température normale. On peut utiliser ainsi plus facilement et avec plus de précision ladite aiguille de suture dans des opérations endoscopiques.
PCT/KR1994/000128 1993-09-25 1994-09-23 Aiguille de suture destinee a etre utilisee dans les operations endoscopiques et son procede de fabrication Ceased WO1995008296A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1019930019826A KR950007802A (ko) 1993-09-25 1993-09-25 복강경 수술용 봉합침
KR1993/19826 1993-09-25

Publications (1)

Publication Number Publication Date
WO1995008296A1 true WO1995008296A1 (fr) 1995-03-30

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR1994/000128 Ceased WO1995008296A1 (fr) 1993-09-25 1994-09-23 Aiguille de suture destinee a etre utilisee dans les operations endoscopiques et son procede de fabrication

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Country Link
KR (1) KR950007802A (fr)
WO (1) WO1995008296A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001056478A1 (fr) * 2000-02-04 2001-08-09 Soprane S.A. Aiguille hyper-elastique
FR2881353A1 (fr) 2005-02-03 2006-08-04 Vygon Sa Perfectionnement aux embouts de ponction et aux tubes catheters
EP2189120A1 (fr) 2008-11-19 2010-05-26 Université Libre de Bruxelles Aiguille chirurgicale à mémoire de forme
DE102009019062A1 (de) 2009-04-27 2010-11-04 Haindl, Hans, Dr. Chirurgische Klammer und Applikator
WO2017159427A1 (fr) * 2016-03-17 2017-09-21 株式会社吉見製作所 Aiguille de suture
CN110301950A (zh) * 2019-07-19 2019-10-08 刘奇为 用于微创手术的自动缝合机构及其使用方法
US11229430B2 (en) 2019-08-08 2022-01-25 Ethicon, Inc. Systems, devices and methods of using needle sheaths for passing curved, superelastic suture needles through trocars
US12011161B2 (en) 2021-01-21 2024-06-18 Ethicon, Inc. Suture needle adaptors for delivering suture needles through cannulas while simultaneously visualizing the delivery of the suture needles through the cannulas

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20190078070A (ko) 2017-12-26 2019-07-04 연세대학교 산학협력단 복강경 수술용 조직 견인기구
KR102422653B1 (ko) * 2021-03-26 2022-07-18 김연희 균일한 높이를 갖도록 제본된 요철인쇄 책자

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4926860A (en) * 1988-02-05 1990-05-22 Flexmedics Corporation ARthroscopic instrumentation and method
US4984581A (en) * 1988-10-12 1991-01-15 Flexmedics Corporation Flexible guide having two-way shape memory alloy
WO1991012771A1 (fr) * 1990-02-22 1991-09-05 Raychem Corporation Sutures en alliages a effet memoire
EP0529675A2 (fr) * 1991-08-29 1993-03-03 Ethicon, Inc. Aiguilles chirurgicales à effet de mémoire de forme

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4926860A (en) * 1988-02-05 1990-05-22 Flexmedics Corporation ARthroscopic instrumentation and method
US4984581A (en) * 1988-10-12 1991-01-15 Flexmedics Corporation Flexible guide having two-way shape memory alloy
WO1991012771A1 (fr) * 1990-02-22 1991-09-05 Raychem Corporation Sutures en alliages a effet memoire
EP0529675A2 (fr) * 1991-08-29 1993-03-03 Ethicon, Inc. Aiguilles chirurgicales à effet de mémoire de forme

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8308764B2 (en) 2000-02-04 2012-11-13 Soprane S.A. Hyper-elastic needle
FR2804597A1 (fr) * 2000-02-04 2001-08-10 Soprane Sa Aiguille hyper-elastique
US7727257B2 (en) 2000-02-04 2010-06-01 Soprane S.A. Hyper-elastic needle
WO2001056478A1 (fr) * 2000-02-04 2001-08-09 Soprane S.A. Aiguille hyper-elastique
FR2881353A1 (fr) 2005-02-03 2006-08-04 Vygon Sa Perfectionnement aux embouts de ponction et aux tubes catheters
WO2006082314A1 (fr) * 2005-02-03 2006-08-10 Vygon Perfectionnements aux embouts de ponction et aux tubes catheters
EP2189120A1 (fr) 2008-11-19 2010-05-26 Université Libre de Bruxelles Aiguille chirurgicale à mémoire de forme
DE102009019062A1 (de) 2009-04-27 2010-11-04 Haindl, Hans, Dr. Chirurgische Klammer und Applikator
DE202009018081U1 (de) 2009-04-27 2010-12-30 Haindl, Hans, Dr. Chirurgische Klammer und Applikator
WO2017159427A1 (fr) * 2016-03-17 2017-09-21 株式会社吉見製作所 Aiguille de suture
CN110301950A (zh) * 2019-07-19 2019-10-08 刘奇为 用于微创手术的自动缝合机构及其使用方法
CN110301950B (zh) * 2019-07-19 2024-03-15 刘奇为 用于微创手术的自动缝合机构及内窥镜
US11229430B2 (en) 2019-08-08 2022-01-25 Ethicon, Inc. Systems, devices and methods of using needle sheaths for passing curved, superelastic suture needles through trocars
US12011161B2 (en) 2021-01-21 2024-06-18 Ethicon, Inc. Suture needle adaptors for delivering suture needles through cannulas while simultaneously visualizing the delivery of the suture needles through the cannulas

Also Published As

Publication number Publication date
KR950007802A (ko) 1995-04-15

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