WO2020036325A1 - Pince de ligature chirurgicale constituée d'un matériau polymère et ayant une force de ligature fortement uniforme - Google Patents

Pince de ligature chirurgicale constituée d'un matériau polymère et ayant une force de ligature fortement uniforme Download PDF

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Publication number
WO2020036325A1
WO2020036325A1 PCT/KR2019/008989 KR2019008989W WO2020036325A1 WO 2020036325 A1 WO2020036325 A1 WO 2020036325A1 KR 2019008989 W KR2019008989 W KR 2019008989W WO 2020036325 A1 WO2020036325 A1 WO 2020036325A1
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WIPO (PCT)
Prior art keywords
ligation
leg
clip
male
protrusion
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PCT/KR2019/008989
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English (en)
Korean (ko)
Inventor
강성욱
한성호
신현석
최복록
박한솔
이예철
박재형
Original Assignee
(주)유원메디텍
강릉원주대학교산학협력단
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Publication of WO2020036325A1 publication Critical patent/WO2020036325A1/fr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122Clamps or clips, e.g. for the umbilical cord
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/083Clips, e.g. resilient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B2017/12004Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding

Definitions

  • the present invention relates to a clip for ligation of tissues such as blood vessels or other conduits, and more specifically, to bleed tissues such as blood vessels temporarily or permanently during surgical operation, so that fluids such as blood are not leaked.
  • the present invention relates to a structure of a surgical surgical ligation clip made of a polymer for preventing detachment from a blood vessel or a conduit during a postoperative recovery.
  • the vessels should be ligated to prevent excessive bleeding of the patient to maintain the surgical field and to reduce the incidence of other complications.
  • specific blood vessels must be ligated before separating the tissue.
  • ligation clips there is a metal hemostatic clip formed in a narrow U-shaped or V-shaped made of tantalum (titanium) or titanium (titanium) material.
  • the metallic hemostatic clip remains in the human body after ligation of blood vessels, and has been widely used because it does no harm to biological tissues, but the material itself is used as a metallic ligation cream by deforming (process hardening) the bar.
  • the metallic hemostatic clip of which the inlet is open is limited in ligation force by one deformation, so that the tension cannot be maintained continuously, and there is a problem that the metallic hemostatic clip can be released from the blood vessel during surgery and recovery.
  • FIG. 1 is one example of the present invention. Is a perspective view of a surgical clip disclosed by -0115163.
  • the polymer ligation clip corresponds to the first leg member 100 to be folded about the first leg member 100 and the hinge part 300 having a gentle inner surface.
  • the second leg member 200 having a shape to be formed, the first locking member 140 formed at the end of the first leg member 100, and the second locking member 240 formed at the end of the second leg member 200.
  • the hinge part 300 includes an inner connection part having slits 33 and 300 therebetween so that the clip action of the first leg member 100 and the second leg member 200 can be flexibly performed.
  • 310 and the outer connection portion 320 are provided on the inner surfaces 110 and 210 of the first leg member 100 and the second leg member 200 to prevent the ligated blood vessel from sliding.
  • the polymer ligation clip is used to be mounted on a dedicated tool called an applier, and when ligation of blood vessels, the first leg member 100 and the second locking member 240 having a male and female structure are locked while the first leg member 100 is locked. And the second leg member 200 pressurizes the blood vessel to prevent leakage of body fluid therein.
  • the ligation clip is inserted into the applier to access the blood vessel between the first and second leg members 100 and 200 of the clip, and then the ligation is performed by pulling the applier, wherein the polymer ligation clip is hinged. Deformation starts at 300 and the blood vessel is pressed between the first and second leg members 100 and 200 and elastically locked by the male and female structures of the first and second locking members 140 and 240.
  • the deformation start point of the polymer ligation clip starts at the Hanji portion 300, but more specifically, at the inner connection portion 310 and the deformation is led to each leg member 100,200, and then the first and second locking members 140,240. Is locked by).
  • the inner connecting portion 310 is deformed at the same time as the ligation by the structural characteristics of each of the leg members 100 and 200 having a curved shape, the deformation direction of the inner connecting portion 310 sags downward.
  • the polymer clip uses the physical properties of plastics by injection molding, since the hinge structure is formed at the end of the bow shape, when the pressure is applied from the outside, the deformation direction of the inner hinge proceeds downward. That is, since the deformation of the inner connection portion proceeds between the slits by the thickness and stops, the circumference of the hinge portion causes unstable ligation compared to the male and female head portions.
  • the protrusions 410 and 420 are provided so that the blood vessels ligated between the first and second leg members 100 and 200 are not slid, the end sides of the protrusions 410 and 420 constraining the left and right directions of the blood vessels are formed vertically. When the blood vessel is pulled in any one direction, the restraint is easily released and the ligation force is weakened.
  • the present invention can improve the ligation force by inducing a uniform force distribution over the entire inside of the leg so that when the legs of the ligation clip is locked, the part that does not sufficiently bleed blood vessels between the legs does not occur, ensuring the stability of the ligation
  • the purpose is to provide a surgical clip ligation clip excellent in manufacturability while having a structure that does not slip in the horizontal direction.
  • the female head and the male head provided at each end of the upwardly convex female legs and the upwardly convex male legs corresponding to each rear end is connected by the hinge is elastically fastened
  • the hinge is the inner hinge portion and the outer hinge portion between the slit, and the folding surface of the inner hinge portion is the pressing means of the outer hinge portion
  • a surgical ligation clip having a uniformity of high ligation force, characterized in that it consists of deformation-induced and additional deformation-proof protrusion structure.
  • the folding surface pressing means may be composed of a pressing projection protruding toward the slit from the outer hinge portion, the pressing projection should be located on the side of the cart with respect to the longitudinal center line of the hinge, most preferably the terminal center line and the slit Position it below the center between the carteg's ends of it.
  • each inner surface of the female leg and the male leg of the ligation clip is provided with a pair of ligation protrusions are formed to protrude in the width direction, the pair of ligation protrusions of the inner surface of each leg
  • a surgical ligation clip having uniformity of high ligation force, characterized in that the ligation protrusion of the female leg and the ligation protrusion of the male leg is positioned to be offset to the left and right with respect to the longitudinal center virtual line.
  • the outer end surface of the ligation protrusion may be configured as a history surface to exhibit a higher ligation force.
  • the pressure applied to the blood vessel by the ligation clip is uniformly made when ligation of the blood vessel, the uniform ligation force is achieved regardless of the position of the blood vessel placed inside the ligation clip.
  • the operation time can be shortened, and by exerting a high binding force, the ligation state can be stably maintained without the blood vessel slipping in the horizontal direction, thereby reducing side effects of the surgery.
  • FIG. 1 is a perspective view of a ligation clip according to the prior art.
  • GAP malocclusion
  • FIG 3 is a perspective view of the ligation clip according to an embodiment of the present invention.
  • Figure 4 is an enlarged cross-sectional view of the hinge portion of the ligation clip of the present invention.
  • FIG. 5 is an enlarged plan view and a cross-sectional view of the ligation protrusion part of the ligation clip of the present invention.
  • FIG. 6 is a front view showing the operating relationship of the present invention folded surface pressing means.
  • Figure 12 is a photograph of each of the initial setting step and the step of calculating the measurement of the final result during the experiment of the test subject of the present invention.
  • Figure 3 is a perspective view showing the overall shape of the ligation clip according to an embodiment of the present invention
  • Figure 4 is an enlarged cross-sectional view of the hinge 30 portion of the ligation clip
  • Figure 5 is the ligation projection 50 of the ligation clip
  • Each is an enlarged plan view and an AA cross section for the part.
  • the ligation clip of the present invention is made of a polymer material, and each end of the female leg 11 and the male leg 21 and the female leg 11 and the female leg 21 for ligation of blood vessels.
  • the arm head 12 and the male head 22 and the rear end of the female leg 11 and the male leg 21 which lock the female leg 11 and the male leg 21 in a state in which the blood vessels are ligated. It consists of a hinge 30 to enable relative rotation of these arm legs 11 and the male leg 21 while connecting integrally.
  • the arm leg 11 is formed in an upwardly convex shape
  • the male leg 21 is also formed in an upwardly convex shape corresponding to the shape of the arm leg 11 to form a blood vessel placed between these arm legs 11 and the male leg 21. Ligation with elastic force.
  • Each inner surface of the arm leg 11 and the male leg 21 is ligated by preventing the outer wall of the blood vessel from slipping in the forward direction during ligation and preventing the ligation clip from slipping down in the horizontal direction from the ligation vessel.
  • the hinge 30 connecting the female legs 11 and the male legs 21 has an inner hinge portion 31 and an outer hinge portion 32 so that the female legs 11 and the male legs 21 can be easily rotated. It is similar to the prior art in that it consists of a slit 33 therebetween, but in the present invention, in addition to the folded surface pressing means of the inner hinge portion 31, for example, the projected structure for the intended deformation induction and further prevention of further deformation There is a significant technical difference in that the means are further provided.
  • the folded surface 34 of the inner hinge portion 31 means a portion to which the inner legs of the female legs 11 and the male legs 21 opposite to the slits 33 of the inner hinge portion 31 are connected. .
  • the inner hinge portion 31 sags downward, and an abnormal large gap (gap) in the folded surface 34 of the inner hinge portion 31 is observed. ) Is formed, and this causes the malocclusion between the female legs 11 and the male legs 21 around the entire hinge portion 30, and the folding surface pressing means sags downward as shown in FIG. By pressing the lower side of the inner hinge portion 31 upward to increase the surface pressure so that the above-mentioned voids to have a malocclusion on the folded surface 34 is not formed.
  • FIG. 7 shows the results of structural analysis regarding the surface pressure distribution of the inner hinge portion 31 comparing the case where the folded surface pressing means is not provided with the case where the folding surface pressing means is provided.
  • (B) shows the latter surface pressure distribution.
  • the surface pressure distributed by the inner hinge portion 31 is 1.621e-01, and the folding surface pressing means is provided (b). ) Indicates that the surface pressure distributed to the inner hinge portion 31 is increased by about 13.57% to 1.841e-01.
  • the folding surface pressing means is sufficient as long as the female legs 11 and the male legs 21 can be precisely engaged at the folding surface 34 while preventing the inner hinge portion 31 from sagging downward.
  • the pressing protrusion 40 protrudes from the outer hinge portion 32 toward the slit 33.
  • the folding surface pressing means consisting of the pressing projection 40 is simple in its configuration to facilitate the production of the ligation clip and to have an accurate pressing force.
  • the pressing protrusion 40 provided on the outer hinge part 32 is to pressurize the lower side of the inner hinge part 31 upwards, and the position thereof is lower based on the terminal center line OO of the hinge 30. That is, it should be located on the side of the cart 21, most preferably located below the center between the terminal center line (OO) and the end of the cart 21 side of the slit (33).
  • the pressing projection 40 may have a variety of shapes, but preferably configured in a semi-circular shape when the degree of pressing against the inner hinge portion 31 gradually increases, the inner hinge portion 31 is in the central axis direction To induce deformation and to prevent further deformation downwards.
  • the width of the slit 33 toward the inner hinge portion 31 is reduced by about 70 to 80%. Therefore, the semicircular midpoint Q of the pressing protrusion 40 is positioned on the line of the arc h formed by the inner surface of the outer hinge portion 32, and the radius R thereof is the slit located at the midpoint Q. It is preferable to configure 0.3 to 0.6 times the initial width of (33). For example, when the radius is less than 0.3 times, the pressing on the inner hinge portion 31 may not be performed at all or the degree of the pressing may be insignificant. When it exceeds 0.6 times, there exists a possibility that the deformation which is not required for the hinge 30 may generate
  • the pressing protrusion 40 of the present invention directly increases the surface pressure at the folding surface 34 at the rear end of the legs 11 and 21 by pressing the inner hinge portion 31 upwardly.
  • the pressing force exerts an additional effect of increasing the ligation force of the ligation clip by affecting the arm legs 11 and the entire leg 21 and has a complementary relationship to the shape of the teeth described later. This will be described later through an experimental example.
  • each inner surface of the arm leg 11 and the male leg 21 is provided with a ligation protrusion 50 to prevent slipping in the horizontal direction in the ligated blood vessel to have a high ligation force.
  • the ligation protrusion 50 is formed to protrude in the horizontal direction from each of the inner surface of the female leg 11 and the male leg 21, as shown in Figure 5 (a) of the inner surface of each leg (11, 21)
  • the pair of protrusions 50 of the female leg 11 and the ligation protrusion 50 of the male leg 21 are installed to be engaged with each other while the pair is positioned to the left and right on the basis of the longitudinal center virtual line K.
  • the ligation protrusion 50 may have a higher anti-slip force by configuring the outer end surface as the inverse surface 51 as shown in FIG.
  • FIG. 8 to 11 shows the surface pressure of blood vessels located at the engaging portion with the outer end surface of the ligation protrusion 50 when the ligated blood vessel is contracted during the postoperative recovery period or the ligation force of the ligation clip is reduced and pulled in the horizontal direction.
  • FIG. 8 shows the virtual vertical plane length L1 of the outer end face and the length of the inner end face from the lower face when the inverse surface 51 is not formed.
  • FIG. 10 shows the virtual vertical plane length L1 of the outer end face and the length L2 entered inwardly from the lower face 20: 4.
  • the case where the ratio of the vertical surface length L1 and the length L2 which went inwardly from the lower surface is 20: 5 is shown, respectively.
  • the stress generated in the blood vessel is 6.351e-01, but in FIG. 9, 6.657e-01, FIG. 10, 6.701-e01, and FIG. 11, 6.884e-01 are shown. It can be seen that the angle ⁇ of the inverse surface 51 increases as the angle increases.
  • the outer end surface of the ligation protrusion 50 is constituted by the history surface 51, and the larger the angle ⁇ of the history surface 51, the ability of the blood vessel to resist slip increases.
  • the angle ⁇ of the inclined surface 51 is too large, the stress generated in the blood vessel exceeds the allowable stress, so that the blood vessel may be torn. Therefore, it is preferable to set the angle (alpha) of the inversion surface 51 so that the ratio of the virtual vertical surface length L1 of an outer end surface and the length L2 which went inwardly from the lower surface may not exceed 20: 5.
  • the ligation clip of the present invention has an overall uniform and high ligation force by the shape of the folding surface pressing means formed on the hinge 30 and the binding protrusions formed on the inner surfaces of the legs 11 and 21.
  • the folding surface pressurizing means increases the ligation force of the ligation clip by affecting the entirety of the arm leg 11 and the male leg 21.
  • the pressing projection 40 is formed in the outer hinge portion 32, the position of the center line (OO) of the hinge 30 and the male legs of the slit 33
  • the pressing protrusion 40 is formed in the center between the end portions 21, and the radius of the pressing protrusion 40 is 0.45 mm and 0.40 mm in consideration of the fact that the initial width of the slit 33 is usually 0.7 to 0.8 mm. , 0,35mm and 0.3mm, respectively, and the inclined surface 51 of the binding protrusion has no inclination angle and the ratio of L1: L2 of 20: 3, 20: 4, and 20: 5 is sequentially applied to the pressing protrusion 40 ) To correspond to the scale.
  • the test method was: 1 Fix the top of the 5cm PVC tube to the upper jig of the PUSH-PULL gauge (IMADA, JAPEN) ⁇ 2 Ligation the ligation clip to about 5mm at the bottom of the PVC tube ⁇ 3 PVC ligation at the speed of 2000pps (1mm / s) Pull out the PUSH-PULL gauge until it is completely removed from the tube ⁇ 4 Insert the ligation ligation clip into the bottom of the jig so that the armleg (11) and the wagon (21) parts are caught by the jig (the lower jig is made of PVC) Slip enough to take only the leg part of the ligation clip without applying force to the tube.) 5 After the ligation clip is completely removed from the PVC tube, the slip resistance of each specimen is measured by measuring the peak value of the PUSH-PULL gauge. Was measured, and the results are shown in Table 1 below. 12 is a photograph of each of the initial setting step and the step of calculating the measurement of the
  • Test Subject 1 (Control W Company) Subject 2 (R 0.45, 20: 0)) Test Subject 3 (R 0.40, 20: 3) Test Subject 4 (R 0.35, 20: 4) Test Subject 5 (R 0.30, 20: 5) One 16.7 29.8 33.9 26.0 23.7 2 23.3 38.7 23.5 37.3 22.5 3 22.4 26.7 36.0 27.1 25.8 4 24.4 24.9 28.3 28.9 30.1 5 24.0 22.4 35.2 42.5 24.0 6 24.2 43.8 33.8 32.0 24.7 7 21.8 41.0 31.3 40.9 22.4 8 24.7 43.9 27.6 27.3 31.0 9 23.6 42.1 26.9 37.0 39.1 10 24.9 34.4 29.7 22.1 39.9 Avg 23.0 34.8 30.6 32.1 28.3
  • the size of the slip resistance is inclined angle ⁇ of the history surface 51 of the ligation protrusion 50. It is shown that it is controlled by the standard of the pressurization protrusion 40 rather. That is, the larger radius of the pressing protrusion 40 has a larger ligation force than the larger angle of the inlet surface 51 of the ligation protrusion 50.
  • the present invention having a folding surface pressing means such as the pressing protrusion 40 has a uniform and high ligation force with respect to the entire legs 11 and 21 including the hinge 30, regardless of the ligation position of the blood vessel.
  • the ligation state can be maintained stably, and the size of the ligation force can be further increased by adjusting the angle ⁇ of the back surface 51 of the ligation protrusion 50.
  • the present invention relates to the ligation performance according to the structure of the ligation clip for surgical surgery using the intended deformation characteristics of the polymer material to prevent the leakage of body fluids such as blood by ligation of tissues such as blood vessels temporarily or permanently during surgical operation
  • the ligation clip is connected to each rear end by a hinge
  • the female head and male head provided at each end of the upwardly convex female leg and the upwardly convex male leg corresponding to each other are fastened by elasticity and eccentricity between the female leg and the male leg
  • the hinge is deformed in the slit space when the inner hinge portion and the outer hinge portion between the slits and the inner hinge portion collinear with the inner blood vessel contact surface of the ligation clip are ligated.
  • the present invention relates to a clip for ligation of tissues such as blood vessels or other conduits, and more specifically, to bleed tissues such as blood vessels temporarily or permanently during surgical operation, so that fluids such as blood are not leaked.
  • the invention relates to the structure of the ligation clip for surgical surgery made of a polymer material for preventing detachment from blood vessels or conduits in the postoperative recovery process.

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Abstract

La présente invention concerne les performances de ligature qui accompagnent la structure d'une pince de ligature chirurgicale pour la ligature temporaire ou permanente d'un tissu, tel que des vaisseaux sanguins, lors d'une opération chirurgicale, empêchant ainsi des fluides corporels tels que le sang de s'écouler, la pince de ligature utilisant la propriété de déformation intentionnelle d'un matériau polymère. La pince de ligature est une pince de ligature polymère dans laquelle une patte femelle fait saillie vers le haut, et une patte mâle fait saillie vers le haut pour correspondre à la patte femelle, les extrémités arrière respectives des pattes femelle et mâle étant reliées par une charnière. Un vaisseau sanguin placé entre la patte femelle et la patte mâle est ligaturé lorsqu'une tête femelle et une tête mâle respectivement disposées sur les pointes des pattes sont fixées par élasticité et récupération. La charnière est composée d'une partie de charnière interne et d'une partie de charnière externe avec une fente entre celles-ci. Une partie en saillie sur la partie de charnière externe sert de moyen de pression pour le pliage par déformation lorsque la partie de charnière interne colinéaire avec une surface de contact de vaisseau sanguin interne de la pince de ligature se déforme dans l'espace de fente pendant la ligature.
PCT/KR2019/008989 2018-08-14 2019-07-19 Pince de ligature chirurgicale constituée d'un matériau polymère et ayant une force de ligature fortement uniforme WO2020036325A1 (fr)

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KR10-2018-0094969 2018-08-14
KR1020180094969A KR102031783B1 (ko) 2018-08-14 2018-08-14 높은 결찰력의 균일성을 가진 폴리머 재질의 외과 수술용 결찰클립

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2593977A (en) * 2020-03-11 2021-10-13 Robinson Healthcare Ltd An umbilical cord clamp
FR3118573A1 (fr) * 2021-01-07 2022-07-08 Peters Surgical agrafe chirurgicale pour pincer un tissu biologique
FR3118571A1 (fr) * 2021-01-07 2022-07-08 Peters Surgical agrafe chirurgicale pour pincer un tissu biologique
FR3118572A1 (fr) * 2021-01-07 2022-07-08 Peters Surgical Agrafe chirurgicale pour pincer un tissu biologique

Families Citing this family (1)

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Publication number Priority date Publication date Assignee Title
CN112494091A (zh) * 2020-12-15 2021-03-16 福建省立医院 一种肌腱减张吻合器

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Publication number Priority date Publication date Assignee Title
US20110224700A1 (en) * 2010-03-09 2011-09-15 Teleflex Medical Incorporated Narrow Profile Surgical Ligation Clip
KR101377429B1 (ko) * 2013-02-20 2014-03-26 (주)유원메디텍 외과 수술용 결찰클립
KR20160030973A (ko) * 2013-07-12 2016-03-21 프라이스 인베나 에이피에스 절단 장치에 사용하기 위한 개선된 클램프
KR20160036027A (ko) * 2016-03-18 2016-04-01 한희상 헤모클립
KR20180074398A (ko) * 2016-12-23 2018-07-03 주식회사 삼양바이오팜 혈관 결찰을 위한 외과용 클립

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Publication number Priority date Publication date Assignee Title
KR102365594B1 (ko) 2015-03-26 2022-02-22 주식회사 메타바이오메드 외과용 클립

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110224700A1 (en) * 2010-03-09 2011-09-15 Teleflex Medical Incorporated Narrow Profile Surgical Ligation Clip
KR101377429B1 (ko) * 2013-02-20 2014-03-26 (주)유원메디텍 외과 수술용 결찰클립
KR20160030973A (ko) * 2013-07-12 2016-03-21 프라이스 인베나 에이피에스 절단 장치에 사용하기 위한 개선된 클램프
KR20160036027A (ko) * 2016-03-18 2016-04-01 한희상 헤모클립
KR20180074398A (ko) * 2016-12-23 2018-07-03 주식회사 삼양바이오팜 혈관 결찰을 위한 외과용 클립

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2593977A (en) * 2020-03-11 2021-10-13 Robinson Healthcare Ltd An umbilical cord clamp
FR3118573A1 (fr) * 2021-01-07 2022-07-08 Peters Surgical agrafe chirurgicale pour pincer un tissu biologique
FR3118571A1 (fr) * 2021-01-07 2022-07-08 Peters Surgical agrafe chirurgicale pour pincer un tissu biologique
FR3118572A1 (fr) * 2021-01-07 2022-07-08 Peters Surgical Agrafe chirurgicale pour pincer un tissu biologique
WO2022148939A1 (fr) * 2021-01-07 2022-07-14 Peters Surgical Agrafe chirurgicale pour pincer un tissu biologique

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