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WO2015000560A1 - Agrafe médicale - Google Patents

Agrafe médicale Download PDF

Info

Publication number
WO2015000560A1
WO2015000560A1 PCT/EP2014/001720 EP2014001720W WO2015000560A1 WO 2015000560 A1 WO2015000560 A1 WO 2015000560A1 EP 2014001720 W EP2014001720 W EP 2014001720W WO 2015000560 A1 WO2015000560 A1 WO 2015000560A1
Authority
WO
WIPO (PCT)
Prior art keywords
legs
clip
actuating
leg
control part
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/EP2014/001720
Other languages
German (de)
English (en)
Inventor
Christian Hummel
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.)
Carl Stahl GmbH
Fujifilm Medwork GmbH
Original Assignee
Carl Stahl GmbH
Medwork GmbH
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
Priority claimed from DE102013011191.9A external-priority patent/DE102013011191A1/de
Priority claimed from DE102013011192.7A external-priority patent/DE102013011192A1/de
Priority claimed from DE102013011199.4A external-priority patent/DE102013011199A1/de
Application filed by Carl Stahl GmbH, Medwork GmbH filed Critical Carl Stahl GmbH
Priority to DE112014003129.1T priority Critical patent/DE112014003129A5/de
Publication of WO2015000560A1 publication Critical patent/WO2015000560A1/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
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A61B17/1227—Spring clips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/128—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for applying or removing clamps or clips
    • A61B17/1285—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for applying or removing clamps or clips for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B2017/12004—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for haemostasis, for prevention of bleeding

Definitions

  • the invention relates to a medical clip, in particular provided for endoscopic application in the body of a living being, preferably for the breastfeeding of internal bleeding, with at least two legs, which occupy each other by means of an operating part of different spreading angle, which is arranged for this relative to a control part movable.
  • the invention relates to a clip part for such a clip and to a device for endoscopic application of such clips.
  • various methods are known for the treatment of internal bleeding, for example in the upper or lower gastrointestinal tract, such as variceal bleeding, bleeding after polypectomy or ulcer bleeding, with the aid of flexible endoscopes. Examples which may be mentioned are coagulation, sclerotherapy, ligature or the application of self-closing clips.
  • a self-closing medical clip of the type mentioned is known from document WO 2005/009254 AI.
  • the known clip is composed of a first clip part with the expandable legs and the associated actuating part and a second, provided as a control part for the actuating part second clip part.
  • the second clip part has the form of a receiving sleeve in which the actuating part for the control of the leg movements is axially movable.
  • the invention has the object to provide a medical clip available that can be applied endoscopically in a particularly secure manner.
  • the invention provides that the control part has a positioning device which cooperates with the movable actuating part in such a way that it opposes a specific resistance value in predeterminable, discrete positions to the actuating part to be traversed, wherein the respective resistance value has a defined spread angle the leg is assigned.
  • a mechanical feedback can be generated, which provides the surgeon information about each of the leg movement reached stage and thus on the progress of the Appliziervorgangs.
  • the positioning can be designed such that in a first position of the spread angle of the leg is large, preferably largest, and that in at least one further, seen in the direction of the operating part following second position of the spread angle of the legs is smaller. This means that the application process for the secure detection of body material at the treatment site is carried out with widely opened legs which move in the closing direction during the transition to the next, second position.
  • the arrangement is such that the respective positions of the positioning a defined predeterminable Friedsp Dahlwinkel the legs can be assigned and the assumption of subsequent third positions by the operating part in the application depends on the enclosed between the spread legs cell quantity of body material, then determined this with the smallest possible Fatsp Dretzwinkel between the legs with.
  • the spread angle of the legs in one of the third positions goes against very small angles, preferably towards zero.
  • the positioning device has at least one further fourth position, which forms a counter-holding surface for an abutment with parts of at least one leg in order to prevent further relative movement between the control part and the actuating part beyond the widest possible closed state of the legs , In the fourth position, therefore, the resistance value of a blockage that clearly signals the completion of the application process.
  • the actuating member is movable by means of an actuating device whose operating device is preferably arranged outside the body, wherein the value of the force exerted by the positioning of the control part on the operating member to be moved resistance a tactile feedback of the occupied by the legs Aufsp Auswinkel to a Be - Serving the operator device and thus a particularly secure setting of the clip allows.
  • control part at least one contact surface and / or a step-shaped first grid have on or in which the movable actuating part with at least one partially elastically resetting latching part on or intervenes.
  • the step-shaped grid can have individual notches whose resistance acts on the actuating part in the direction of the leg to be actuated, which is to be spread with different spreading angles.
  • control part in the form of a receiving sleeve having a continuous inner recess which is bounded by an inner wall which forms the at least one contact surface and / or the step-shaped grid, wherein the individual notches by tapered annular recesses in the inner wall of the receiving sleeve are formed.
  • the screening can be advantageously designed such that it forms a kind of sawtooth shape such that in the Locking with the actuating part of this is secured against a movement in the direction of the legs out practically positively.
  • the arrangement may advantageously be such that the first position of the positioning device of the respective second and third positions has an axial distance in the possible direction of travel of the actuating part that the respective second and third positions in the same Training in this direction of travel are arranged directly successive and that the fourth position the other positions axially upstream of the front end of the control part is arranged, which faces the free ends of the legs.
  • the actuating part is formed from an actuating plate, wherein the respective, at least partially elastically restoring detent part is formed from the respective opposite ends of the actuator plate and wherein the actuator plate is an integral part of the respective leg and has a possibility of attack for the actuator of the operator device ,
  • the subject of the invention is also a clip part for a clip according to one of claims 1 to 1 1, wherein the clip part at its two adjacent, partially abutting legs each have a distance of the legs magnifying first kink to the outside and a adjoining this, the free leg ends closer second kink has to the outside, which forms the point of mutual support of the legs, wherein the clip part is characterized in that each leg of the clip part starting from the second kink starting towards the free end of the respective leg, in particular in the area of the first fifth of the respective vision kels in the direction of the second kink, a third kink, which protrudes outward like the first kink.
  • the subject of the invention is a device for endoscopic application of at least one closing medical clip according to one of the claims 1 to 1 2, wherein the device has the features of claim 13 in its entirety.
  • the device according to the invention can be designed such that a plurality of clips are combined to form a kind of magazine in the catheter tube and are accommodated in the catheter tube so as to be controllable by only one actuating device. This allows more than one clip to be placed without having to remove the catheter tube from the body after each application.
  • a catheter tube is in the application part of a Endkoskops.
  • Fig. 1 shows a relation to the natural size drawn on an enlarged scale longitudinal section only of the free
  • FIG. 2 shows an oblique view of an exemplary embodiment of the front clip part of a clip according to the invention in perspective and on an even larger scale
  • FIG. Fig. 3 is a scale enlarged in Fig. 2 drawn
  • 9a and 9b are sectional views corresponding to Figs. 4 and 4b showing successive positions in the course of the opening and closing cycle of the clip;
  • FIG. 1 1 to 1 3 of Fig. 10 corresponding representations, wherein successive positions in the opening and closing cycle are shown.
  • FIG. 1 shows the front, free end section of a catheter tube 1 as part of a device for setting clips according to the invention.
  • the catheter tube 1 is part of a flexible
  • Instruments that can be of conventional design in medical technology and introduced into an inner working space for an endoscope device including lighting and / or other purposes (for example suction).
  • the rear end, not shown, of the catheter tube 1 is in functional connection with a handling and operating device located at the relevant end.
  • the outer diameter of the catheter tube 1 is 2.7 mm.
  • the medical clips to be applied belong to the category of self-closing clips, as are known from the document WO 2005 / 009254A1 already mentioned above.
  • Medical clips of this construction are made of a standard medical grade material, such as stainless steel.
  • a clip pushed out of the front end of the catheter tube 1 can be actuated by axially displacing a front clip part 3 relative to a second rear clip part 5 serving as the control part.
  • a pull cable loop 7 is provided as part of the associated actuator for this axial movement.
  • a sliding tube 9 which is shown only in FIG.
  • FIG. 1 is provided, by means of which the clip 3, 5 to be applied can be pushed out of the catheter tube 1.
  • a plurality of clips 3, 5 are arranged one behind the other in the catheter tube 1 and pushed out successively for application.
  • two clips 3, 5 are arranged in the catheter tube 1. It will be appreciated that more or fewer clips could be arranged in the catheter tube 1 for sequential application.
  • Fig. 2 shows of an embodiment of the clip according to the invention only the front clip part 3 with two legs 1 1, which, without crossing over, juxtaposed and to the free Leg ends 14 are bent towards each other.
  • end plate 1 3 At the leg ends 14 opposite end of the legs 1 1 are connected by an integral with them end plate 1 3. This serves as an actuating part, which causes the movements of the legs 1 1 during the opening-closing cycle.
  • each leg 1 1 Offset from the end plate 1 3 against the free leg ends 14, each leg 1 1 has an outwardly bulging first crease 19 and, further offset against the leg ends 14, a second crease 21, the latter together a support point for the mutual abutment of the legs 1 1 form.
  • the effect of the kinks 19 against each other oppressive force F as indicated in Fig.
  • Fig. 2 shows a partially spread state of the legs 1 1, as it is caused by the action of the forces F. From the respective second kink 21 of the legs 1 1 offset forward, a third bend 22 is formed in the form of a slight bulge to the outside.
  • FIG. 3 shows the second clip part 5 in the form of a receiving sleeve 5 which has an axial inner passage and acts as a control part for the actuating part of the first clip part 3 formed by the end plate 1 3, when this is inserted into the receiving sleeve 5 by means of the cable loop 7 pulled and moved axially therein.
  • two juxtaposed Seilöffnun- gen 1 5 are provided in the end plate 13 through which one strand of the cable loop 7 is guided.
  • There is a bridge 1 7 greatly reduced material thickness between the rope openings 1 5, so that the bridge 1 7 forms a predetermined breaking point, which allows the detachment of the pull cable loop 7 to release the clip 3, 5 after the application.
  • FIGS. 4a, 4b show an initial state in which the clip 3, 5 with his Kink 19 is already retracted after entering an opening cone 25 serving as a control part receiving sleeve 5 in a narrower cylindrical part 23 of the receiving sleeve 5, so that the state of the complete opening of the legs 1 1 due to the exerted by the inner wall of the cylinder part 23 compressive forces F ( Fig. 2) is reached.
  • the cylinder part 23 is part of a positioning device formed by the inside of the receiving sleeve 5.
  • 5a, 5b illustrate a state in which start by further retraction of the clip part 3 in the receiving sleeve 5, the legs 1 1 at the edge 41 of the opening cone 25 of the receiving sleeve 5, while the legs 1 1 are still in fully spread position. If starting from this state, the clip part 3 in the
  • Receiving sleeve 5 is further retracted, as shown in Fig. 6a, 6b, then reached by the end plate 1 3 formed actuating member reaches the first, defined by the positioning position, wherein the end plate at a stage 26 (see FIG. 2) starts to which an elevated step surface 27 connects.
  • the achievement of the first position is therefore associated with a sudden increase in the resistance value, which counteracts the pulling-in movement of the clip part.
  • the legs 1 1 By starting the legs 1 1 in a located between the second bend 21 and a slightly outwardly curved third bend 22 located on the area formed by the opening cone 25 control surface, the legs 1 1 begin to approach each other simultaneously to reduce the closing angle.
  • FIGS. 7 a, 7 b illustrate the second position defined by the positioning device, in which the end plate 13 serving as the actuating part has accumulated on the step surface 27.
  • the spread angle of the legs 1 1 is reduced by their tarnishing at the control surface formed by the opening cone 25, wherein the resistance decreases from the first position again.
  • the positioning device formed by the inside of the receiving sleeve 5 provides as third positions locking the serving as an actuating part end plate 1 3 before.
  • 8a, 8b show such a detent position shortly after overflow of the step surface 27.
  • the reaching of a third position or detent position is accompanied by a further closing movement of the legs 11.
  • Figures 9a, 9b show the achievement of a fourth position in which, for the completion of an application process, the legs 11 are closed except for a spread angle which depends on the dimension of an amount of body material grasped by the leg ends 14, failing to capture Body material, the legs 1 1 are completely closed.
  • This fourth position is an end position insofar as the clip part 3 is secured against further retraction into the receiving sleeve 5 by forming abutment surfaces 43 on the lateral wing parts 45 of the legs 11, which interact with the edge 41 of the opening cone 25 as a counter-holding surface to block another pull-in movement.
  • the wing parts 45 have the shape of ribs whose height decreases steadily from the rear abutment surface 43 toward the front in the direction of the leg ends 14.
  • the achievement of the third positions as locking positions and the achievement of the fourth position as an end position is accompanied in each case by a change in the resistance value, which counteracts the axial movement relative to the receiving sleeve 5.
  • a change in the resistance value which counteracts the axial movement relative to the receiving sleeve 5.
  • FIG. 10 to 13 show an enlarged view of the details of the positioning device in cooperation with serving as an actuating part end plate 13 of the clip part 3.
  • FIG. 10 shows the position shortly before reaching the step 26 at the transition to the step surface 27.
  • the end plate 1 3 undeformed, so that on the end plate 1 3 laterally projecting locking parts 31 with the remaining part of the end plate 1 3 lie in the same plane.
  • Fig. 1 1 shows that on further retraction, the lateral locking parts 31 of the end plate 1 3 for running onto the step surface 27 begin to deform and then, see Fig. 12, upon further axial movement in a deformed state, the step surface 27 overflow.
  • the fourth position is reached as the end position, in which the further axial movement is prevented by abutment between serving as a counter-surface edge 41 on the opening cone 25 with the contact surfaces 43 of the legs 1 1 further axial movement, ie, the maximum resistance is reached.
  • the tapered annular recesses in the inner wall of the receiving sleeve 5 form a step-like ridge in the form of the sawtooth toothing 29, see in particular Fig. 3.
  • the opening cone 25 facing locking surfaces 33 are steeper, in the limit even perpendicular to the longitudinal axis formed as the back surfaces.
  • a limiter device 41, 43 which defines an end position for the respective clip 3 in the actuation sleeve 5 as a sleeve-shaped control part caused by the actuation device.
  • the limiting device has at least one stop surface 41 on or in the sleeve-shaped control part 5 and at least one associated contact surface 43 on the clip 3.
  • the abutment surface is formed on the edge 41 or within an opening cone 25 at the distal end of the sleeve-shaped control part 5.
  • a contact surface 43 projecting from the limb 1 1 transversely to its longitudinal extent is provided.
  • a contact surface 43 is preferably formed on both legs 1 1 of the clip 3, which project opposite to each other on both sides of each leg 1 1 to the outside in the direction of the environment.
  • a rib 45 extending in the longitudinal direction is provided, the height of which preferably decreases toward the leg end 14 and forms the abutment surface 43 at its end facing the control part.
  • the figures show in detail the shape of the legs 1 1 laterally projecting ribs 45.
  • the ribs 45 on the contact surface 43, the greatest height, against the leg end 14 decreases steadily.
  • the clip 3 is supported on four abutting bearing surfaces 43 in pairs, on which the stop surfaces forming the opening edge 41 or the inner surface of the opening cone 25 of the control part 5.
  • the rib 45 may have a rectangular shape at least at the transition point to the actual clip body.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

Agrafe médicale (3, 5), prévue en particulier pour la pose endoscopique dans le corps d'un être vivant, de préférence pour stopper des hémorragies internes, et pourvue d'au moins deux branches (11) qui peuvent être placées à des angles d'écartement de différentes grandeurs au moyen d'une partie d'actionnement (13) disposée mobile à cet effet par rapport à une partie de commande (5). Ladite agrafe est caractérisée en ce que la partie de commande (5) comporte un dispositif de positionnement (26, 27, 29, 41) qui coopère avec la partie d'actionnement (13) mobile de manière telle qu'il oppose, dans des positions distinctes prédéfinies, à la partie d'actionnement mobile (13) une valeur de résistance concrète à laquelle est associé un angle d'écartement défini des branches (11).
PCT/EP2014/001720 2013-07-04 2014-06-25 Agrafe médicale Ceased WO2015000560A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE112014003129.1T DE112014003129A5 (de) 2013-07-04 2014-06-25 Medizinischer Clip

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
DE102013011191.9 2013-07-04
DE102013011191.9A DE102013011191A1 (de) 2013-07-04 2013-07-04 Vorrichtung zur endoskopischen Applizierung von sich schließenden medizinischen Clips
DE102013011192.7 2013-07-04
DE102013011192.7A DE102013011192A1 (de) 2013-07-04 2013-07-04 Vorrichtung zur endoskopischen Applizierung mindestens eines sich schließenden medizinischen Clip
DE102013011199.4 2013-07-04
DE102013011199.4A DE102013011199A1 (de) 2013-07-04 2013-07-04 Medizinischer Clip

Publications (1)

Publication Number Publication Date
WO2015000560A1 true WO2015000560A1 (fr) 2015-01-08

Family

ID=51136414

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/EP2014/001721 Ceased WO2015000561A1 (fr) 2013-07-04 2014-06-25 Procédé de pose endoscopique d'agrafes médicales se refermant
PCT/EP2014/001720 Ceased WO2015000560A1 (fr) 2013-07-04 2014-06-25 Agrafe médicale

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/EP2014/001721 Ceased WO2015000561A1 (fr) 2013-07-04 2014-06-25 Procédé de pose endoscopique d'agrafes médicales se refermant

Country Status (2)

Country Link
DE (2) DE112014003090A5 (fr)
WO (2) WO2015000561A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20240398423A1 (en) * 2021-09-18 2024-12-05 Hangzhou Ags Medtech Co., Ltd. Clip apparatus

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020177861A1 (en) * 2001-05-23 2002-11-28 Asahi Kogaku Kogyo Kabushiki Kaisha Clip device of endoscope
WO2005009254A1 (fr) 2003-07-26 2005-02-03 Carl Stahl Gmbh Procede et dispositif de mise en place endoscopique de clips medicaux se refermant automatiquement
WO2012126477A1 (fr) * 2011-03-22 2012-09-27 Herlev Hospital Dispositif de fixation, outils et procédés associés

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19752331C1 (de) * 1997-11-26 1999-09-30 Aesculap Ag & Co Kg Magazin für ein chirurgisches Clipanlegegerät
JP4578708B2 (ja) * 2001-03-26 2010-11-10 オリンパス株式会社 生体組織のクリップ装置
JP2008307168A (ja) * 2007-06-13 2008-12-25 Hoya Corp 内視鏡用クリップ装置
JP2010136819A (ja) * 2008-12-10 2010-06-24 Fujifilm Corp 連結クリップパッケージ

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020177861A1 (en) * 2001-05-23 2002-11-28 Asahi Kogaku Kogyo Kabushiki Kaisha Clip device of endoscope
WO2005009254A1 (fr) 2003-07-26 2005-02-03 Carl Stahl Gmbh Procede et dispositif de mise en place endoscopique de clips medicaux se refermant automatiquement
WO2012126477A1 (fr) * 2011-03-22 2012-09-27 Herlev Hospital Dispositif de fixation, outils et procédés associés

Also Published As

Publication number Publication date
DE112014003090A5 (de) 2016-03-31
WO2015000561A1 (fr) 2015-01-08
DE112014003129A5 (de) 2016-04-21

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