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WO2011117725A1 - Dispositif auxiliaire automatisé à des fins d'insertion et de fixation d'un corps annulaire au moyen d'agrafes - Google Patents

Dispositif auxiliaire automatisé à des fins d'insertion et de fixation d'un corps annulaire au moyen d'agrafes Download PDF

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Publication number
WO2011117725A1
WO2011117725A1 PCT/IB2011/000778 IB2011000778W WO2011117725A1 WO 2011117725 A1 WO2011117725 A1 WO 2011117725A1 IB 2011000778 W IB2011000778 W IB 2011000778W WO 2011117725 A1 WO2011117725 A1 WO 2011117725A1
Authority
WO
WIPO (PCT)
Prior art keywords
clips
ancillary device
clip
shape
legs
Prior art date
Application number
PCT/IB2011/000778
Other languages
English (en)
Inventor
Sidney Chocron
Original Assignee
Universite De Franche-Comte
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 Universite De Franche-Comte filed Critical Universite De Franche-Comte
Publication of WO2011117725A1 publication Critical patent/WO2011117725A1/fr

Links

Classifications

    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect

Definitions

  • the invention relates to an automated ancillary device for 5 inserting and fixing, by means of clips, an annular body, namely a prosthetic heart valve.
  • the present invention is related to the field of the surgery tools.
  • the invention relates more particularly to an automated
  • a prosthetic heart valve is a prosthesis with a circular or annular shape, which is implanted instead of a patient's heart valve, in particular an aortic valve or a mitral valve.
  • the invention thus proposes to put at the disposal of the heart-surgery practitioners an ancillary device, which permits
  • a prosthetic heart valve is fixed by suture.
  • the suture of the prosthetic valve is performed by means of separated suture stitches between the prosthetic valve and
  • the ring essentially according to two usual methods, i.e. the insertion at simple separate points, and the insertion at separate points in the form of a U on a felt.
  • US2001/0031972 in turn, describes an apparatus for placing a prosthetic valve through fastening with clips, which is designed so as to unfold the clips radially with respect to the axis of the patient's ring.
  • These clips include, each, two tapping ends. The first one is straight and is designed capable of perforating a collar the prosthetic valve includes, after radial extension of a clip holder. The other tapping end is bent and is designed capable of separating the tissues during the radial extension of the clip holder, then of perforating same during its deformation towards a closing position enclosing the tissues in the vicinity of said collar, under the action of the translation of a tube inserted into the tissues.
  • a device for repairing a heart valve, namely the mitral valve, through fixing an implant by means of clips comprising a clip-holding element associated with pushing means permitting to eject shape-memory clips in the front portion of the patient's ring.
  • the clip- holder includes a multiplicity of supporting elements arranged according to an arch of a circle, each comprising a pair of parallel tubular guides each aimed at accommodating the leg of a clip.
  • the tubular guides are previously inserted into the peripheral edge of the implant, while pistons, each integrated in a supporting element, push back, under the action of said pushing means, the clip in the tubular guides, in order to cause it to pass through the patient's ring.
  • Such a device has the drawback that the separation of the clips and the clip-holder occurs by force by removing the latter after the legs of said clips are closed.
  • the tubular guides create in the implant wider holes than what is necessary for the clips.
  • the purpose of the present invention is to permit to reduce the operational time while coping with the various above- mentioned drawbacks, and while permitting the placing of an already existing and evaluated prosthetic heart valve, irrespective of its type, biological or mechanical type, and irrespective of its origin, i.e. its manufacturer.
  • the automated ancillary device for inserting and fixing by means of clips an annular body, namely a prosthetic heart valve, on a substantially annular resilient volume, including an opening includes, coaxially fitted about a longitudinal axis, means for receiving and supporting said annular body designed capable of receiving the latter coaxially to its axis of rotation, and is essentially characterized in that it includes, on the one hand, means for longitudinally pushing about said longitudinal axis, which consist of means for pushing by percussion under the action of springy restoring means and, on the other hand, clip- supporting means designed capable of bearing clips made out of shape-memory material, of nitinol or the like, said clips including two legs connected by a heel, and designed so that at least one of said legs passes through both a thickness of a material belonging to said annular body and a thickness of a material belonging to said substantially annular resilient volume, under the action of said longitudinal pushing means.
  • the springy restoring means are formed by at least one spring or the like.
  • the springy restoring means are formed by pneumatic means, like a compressed air cartridge.
  • the clip- supporting means are substantially annular and include means for the passing through of fluids.
  • the clip- supporting means include recesses designed capable of receiving said clips in a pre- stressed position, in which both legs of each clip are parallel. or substantially parallel, to said longitudinal direction of insertion.
  • each recess is oriented according to a plane radial to the main axis of the ancillary device.
  • the clip- supporting means are shaped so that each of its recesses can hold one clip the leg of which arranged on the internal side is longer than that arranged on the external side.
  • each recess is oriented according to a plane tangent to the clip- supporting means.
  • the ancillary device includes, extending beyond the bearing means, an axial extension containing means that radially unfold in a reversible way, designed capable of forming counter- resting means during the operation of fixing by means of clips.
  • the invention relates to a surgical device including such an ancillary device and a set of such clips, characterized in that each clip has, at a first temperature lower than that of an animal body, a U- or V- shape and, at a second temperature corresponding to that of the animal body on which said clip is aimed at being implanted, a gamma- shape when closed and a omega- shape when open.
  • FIG. 1 represents a schematic and perspective view of a first embodiment of the ancillary device according to the invention .
  • FIGS. 2a and 2b represent schematic and cross- sectional views according to a median longitudinal plane of the same ancillary device, in two different positions of use.
  • - figure 3 represents a schematic perspective and exploded view of part of the same ancillary device.
  • FIG. 4a and 4b represent schematic perspective and partially exploded views of the same ancillary device in different phases of use.
  • FIG. 5 and 6 each represent a schematic, partial and perspective view of a prosthetic heart valve placed by means of the ancillary device according to the invention.
  • figure 7 represents a schematic profile view of a portion of a second embodiment of the ancillary device according to the invention.
  • FIG. 8 represents a schematic plan view of an end of the same second embodiment.
  • figure 9 represents a schematic plan view of a clip utilizable with the second embodiment, shown in two configurations .
  • the invention relates to an automated ancillary device 1 for inserting and fixing an annular body 2, namely, in a preferred application, a prosthetic heart valve, on a substantially annular resilient volume 3 and including an opening.
  • this resilient volume when it is formed by the patient's ring, generally has a triangular cross -section with rounded angles.
  • This volume 3 after a preparation by the surgeon to remove very hard areas, is shaped and a cylindrical tool, called phantom, is passed through it, which permits to define the diameter of the prosthesis, the latter being generally circular.
  • an ancillary device 1 When referring to figures 1 and 2a, one can see an ancillary device 1 according to the invention. It mainly includes a cylindrical hand grip 10 axially extended by a tube 11 provided at its free end with clip- supporting means 4 that is in the form of a cup 40, which will be described below. On the tube 11 can slide an ejector body 5 including, on the one hand, on the side of the cup 40, a cup 50 dimensioned so as to cover the cup 40 and, on the other hand, on the side of the hand grip 10, an annular element 51 forming a stop for a spring 12 inserted onto the tube 11, the hand grip 10 forming the other stop, and incorporating means for blocking the ejector body 5 in stand-by position when the spring 12 is compressed.
  • the cup 40 includes a tubular peripheral wall 41 provided at its free end with an annular element 42 defining a bearing surface 43.
  • annular element 42 In the tubular wall 41 are provided for, distributed over the periphery, recesses 44 extending in the annular element 42, each aimed at containing and holding a clip 6, comprising two legs 60 and 61 connected by a heel 62, the legs 60 and 61 being oriented parallel to the main axis of the ancillary device 1.
  • the recesses 44 are designed so that each clip 6 is in a plane radial to the cup 40, knowing that it is perfectly possible, according to another embodiment, not shown, to contemplate recesses 44 that are arranged in a different way, for example so that the clips 6 are in tangent planes.
  • the legs 60 and 61 are, preferably and advantageously, not of a same length, thus the leg 60, arranged on the internal side of the cup 40, is longer than the leg 61 arranged on the external side.
  • the recesses 44 are configured in the tubular peripheral wall 41 so as to be capable of holding such clips 6, thus, in the embodiment shown, the annular element 42 in which the recesses 44 extend has a sufficient height to permit to contain the ends of the legs 61 and to compensate for the difference in length of the latter.
  • the clips 6 are made out of shape-memory material, of nitinol or the like, and are designed so as to have, at a first temperature lower than that of an animal body, a shape permitting that the legs pass through an element, for example by being parallel or substantially parallel, and, at a second temperature corresponding to that of the animal body on which the clips 6 are aimed at being implanted, a shape in which the legs are folded, in order to impede their extraction, for example gamma- shaped.
  • the cup 50 of the ejector body 5 includes a tubular wall 52 having an inner diameter larger than the outer diameter of the tubular wall 41 of the cup 40, and its free outermost end is provided with teeth 53, in the number equal to the recesses 44 and distributed in a similar angular way, each aimed at cooperating with a recess 44 and at entering into contact with the heel 62 of the clip 6 contained in this recess 44.
  • the ancillary device 1 comprises blocking and releasing means permitting maintaining and releasing the ejector body 5.
  • the annular element 51 of the ejector body 5 includes radial bores 54 each containing a pin 55 restored towards the axis of the ancillary device 1, through springy restoring means such as a spring 56.
  • the tube 11 is drilled with holes 13, into each of which can insert a pin 55 when the holes 13 are in front of the bores 54, i.e. when the ejector body 5 is in a stand-by position, the spring 12 being compressed.
  • the release of the ejector body 5 requires the withdrawal of the pins 55 into their bore 54, which is achieved through control means comprising a piston 14, axially movable in the tube 11, and the conical surface 15 of which can, depending on the positioning of the piston 14 in the tube 11, push the pins 55 into their bore 54, the pins advantageously having a conical free end.
  • the piston 14 is integral with the end of a rod 16 movable through axially sliding in the hand grip 10, and provided at its other end with a button 17 pushed away from the hand grip 10 by a spring 18.
  • the button 17 In stand-by position, the button 17 is separated from the hand grip 10, and when the button is pressed 17, the piston 14 slides in the tube 11, its conical surface 15 pushes the pins 55 outwardly, which releases the ejector body 5, which under the action of the spring 12 moves towards the cup 40 and releases the clips 6.
  • the ancillary device 1 is provided with a safety system permitting, when it is in stand-by position, to avoid an unexpected triggering.
  • this safety system consists, non-restrictively, of a spacer 19 intercalated between the button 17 and the hand grip 10.
  • the ejector body 5 can be push back by pneumatic means, replacing the spring 12, which are a cartridge of compressed air, for example.
  • the annular body 2 consists, in this case, of a prosthetic heart valve that includes a peripheral ring 20 made out of « Dacron » aimed at being crossed by the clips 6.
  • the portion of the legs 60 that protrudes beyond the bearing surface 43 has a length smaller than the thickness of the peripheral ring 20, so as not to protrude out of it when the annular body is secured to the ancillary device 1.
  • the diameter of the peripheral ring 20 varies between that of the circle containing the legs 60 and that of the circle containing the legs 61, so that the latter are not aimed at passing through the peripheral ring 20, but only at pricking and drilling the resilient body so as to protrude out of same, formed by the patient's ring in heart surgery.
  • the two legs having the same length are both aimed at passing through the Dacron of the prosthetic valve.
  • the following operation consists in injecting through the aorta or through the ancillary device 1, which can to this end be provided with means permitting a flow, a serum, or the like, at a temperature preferably higher than 30°C and close to the normal temperature of the animal body involved.
  • the clips 6 then close inwardly and adopt a gamma- shape, each forming a loop that ties the prosthetic heart valve 2 to the patient's ring 31, as can be seen in figures 5 and 6.
  • the user can then remove the ancillary device 1 from the aorta 30.
  • the shape-memory clips can never reach their closed resting position, because of the hardness of the tissues. Therefore, a dynamic tension remains at the level of the clips, which exerts an elastic restoring of the prosthetic valve onto the patient's ring. This elastic restoring permits that both structures - prosthetic valve and patient's ring - remain integral with each other despite the pressure changes exerted during the heat cycle.
  • the clips 6 are aimed at being implanted, not according to radial planes, but according to tangent planes, as has already be evoked.
  • This configuration has an advantage over that of the preceding embodiment, namely that of permitting to reduce the diameter of the active end of the ancillary device, so that its size is equal to that of the prosthesis, and not larger, as in the first embodiment.
  • the ancillary device 1 includes, at its distal end, an extension 7, which extends beyond the clip- supporting means 4.
  • This extension 7, which can also be provided for in the embodiment shown in figures 1, 2a, 2b, 3, 4a and 4b, consists of a counter-resting means aimed at facilitating the operation of fixing by means of clips .
  • This counter-resting means comprises an axial tubular portion 70, extending the tube 11, not visible, which it is integral with, in which slots 71 are cut according to generating lines, and which contains arms 72 movably, pivotally mounted so that each of them can pass from a folded position inside the tubular portion 70 into a radially unfolded position while passing through a slot 71, so that all the arms 72 form together a star- shaped bearing surface.
  • the arms 72 are unfolded, after positioning the peripheral ring 20 of the prosthetic heart valve 2, against the patient's ring 31, and that after fixing by means of clips they are folded back, in order to permit the removal of the ancillary device 1.
  • This clip 6 includes a heel 62 and two legs 63 and 64 of the same length, and they are also made out of a shape-memory material, of nitinol or the like, they are designed so as to have, at a first temperature lower than that of an animal body, a shape permitting the legs to pass through an element, while being for example parallel or substantially parallel, as shown in interrupted lines, and, at a second temperature corresponding to that of the animal body on which the clips 6 are aimed at being implanted, a shape in which the legs 62 and 63 are separated and bent so as to adopt a substantially omega-shape, so that, after having passed through the annular body 2 of the prosthesis and the patient's ring 31, their tips 65 and 66, respectively, enter into contact with the ring 31, until they penetrate into same, so as to form two addition fixing points.

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

Abstract

L'invention concerne un dispositif auxiliaire automatisé (1) servant à insérer et fixer un corps annulaire au moyen d'agrafes (6), à savoir une valvule cardiaque prothétique (42), sur un volume élastique sensiblement annulaire, comprenant une ouverture, comprenant, installé de manière coaxiale autour d'un axe longitudinal, un moyen permettant de recevoir et de supporter ledit corps annulaire conçu pour être en mesure de recevoir ce dernier de manière coaxiale par rapport à son axe de rotation. Il comprend, d'une part, un moyen permettant de pousser de manière longitudinale autour dudit axe longitudinal, qui consiste en un moyen permettant de pousser par percussion sous l'action d'un moyen de rappel élastique, et d'autre part, un moyen de support d'agrafes conçu pour porter des agrafes en un matériau à mémoire de forme, de nitinol ou similaire, lesdites agrafes comprenant deux branches rattachées par un pied, et conçues de sorte qu'au moins l'une desdites branches passe au travers à la fois d'une épaisseur d'un matériau appartenant audit corps annulaire et d'une épaisseur d'un matériau appartenant audit volume élastique sensiblement annulaire, sous l'action dudit moyen de poussée dans le sens longitudinal.
PCT/IB2011/000778 2010-03-22 2011-03-22 Dispositif auxiliaire automatisé à des fins d'insertion et de fixation d'un corps annulaire au moyen d'agrafes WO2011117725A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/IB2010/001196 WO2011117665A1 (fr) 2010-03-22 2010-03-22 Ancillaire automatisé pour la pose et la fixation d'un corps annulaire à l'aide de pinces
IBPCT/IB2010/001196 2010-03-22

Publications (1)

Publication Number Publication Date
WO2011117725A1 true WO2011117725A1 (fr) 2011-09-29

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Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/IB2010/001196 WO2011117665A1 (fr) 2010-03-22 2010-03-22 Ancillaire automatisé pour la pose et la fixation d'un corps annulaire à l'aide de pinces
PCT/IB2011/000778 WO2011117725A1 (fr) 2010-03-22 2011-03-22 Dispositif auxiliaire automatisé à des fins d'insertion et de fixation d'un corps annulaire au moyen d'agrafes

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/IB2010/001196 WO2011117665A1 (fr) 2010-03-22 2010-03-22 Ancillaire automatisé pour la pose et la fixation d'un corps annulaire à l'aide de pinces

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Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110002729B (zh) * 2019-05-21 2024-03-19 河北陆源科技有限公司 制瓶机无连杆式自定心夹头

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997030659A1 (fr) * 1996-02-23 1997-08-28 Williamson Warren P Iv Moyens et technique de remplacement de valvule cardiaque de la façon la moins invasive qui soit
WO1999053845A1 (fr) * 1998-04-20 1999-10-28 St. Jude Medical, Inc. Outil d'entrainement pour fixations prothetiques de valvule cardiaque
US20010031972A1 (en) 1998-09-15 2001-10-18 United States Surgical Stapling apparatus and method for heart valve replacement
US6413274B1 (en) 1998-01-27 2002-07-02 United States Surgical Corporation Stapling apparatus and method for heart valve replacement
US20050107871A1 (en) 2003-03-30 2005-05-19 Fidel Realyvasquez Apparatus and methods for valve repair
US20090171363A1 (en) * 2007-12-28 2009-07-02 Universite De Franche-Comte Automated insertion device for heart valve prosthesis

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997030659A1 (fr) * 1996-02-23 1997-08-28 Williamson Warren P Iv Moyens et technique de remplacement de valvule cardiaque de la façon la moins invasive qui soit
US6413274B1 (en) 1998-01-27 2002-07-02 United States Surgical Corporation Stapling apparatus and method for heart valve replacement
WO1999053845A1 (fr) * 1998-04-20 1999-10-28 St. Jude Medical, Inc. Outil d'entrainement pour fixations prothetiques de valvule cardiaque
US20010031972A1 (en) 1998-09-15 2001-10-18 United States Surgical Stapling apparatus and method for heart valve replacement
US20050107871A1 (en) 2003-03-30 2005-05-19 Fidel Realyvasquez Apparatus and methods for valve repair
US20090171363A1 (en) * 2007-12-28 2009-07-02 Universite De Franche-Comte Automated insertion device for heart valve prosthesis

Also Published As

Publication number Publication date
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