Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/064—Surgical staples, i.e. penetrating the tissue
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
  • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
  • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
  • A61B2017/00588—Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
  • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
  • A61B2017/0061—Implements located only on one side of the opening
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
  • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
  • A61B2017/00623—Introducing or retrieving devices therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
  • A61B2017/0419—H-fasteners
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/064—Surgical staples, i.e. penetrating the tissue
  • A61B2017/0649—Coils or spirals

Definitions

• the present invention relates to a device for occluding an opening existing in a body wall, which can be implanted. by minimally invasive non-surgical route, that is to say by passing through bodily conduits.
• the invention also relates to an assembly for installing this device.
• the invention is in particular applicable to the occlusion of septal defects between the right atrium and the left atrium or the right ventricle and the left ventricle of a heart.
• the document EP 1 046 375 A1 describes a similar device, with two discs connected to each other. These discs have a diameter slightly greater than the diameter of the communication to be treated and are connected by an elastic wire, this wire making it possible, after implantation, to keep the discs pressed against the respective faces of the body wall treated.
• the present invention aims to provide a device easier to implant than that according to this prior document, less bulky, and more securely held on said body wall.
• Document WO 01/30267 describes devices for closing or excluding a cavity, comprising an occlusion disc and a structure for anchoring this disc to the body walls forming this cavity.
• the device according to this document is not suitable for producing the occlusion of an opening or communication existing in a body wall, in particular in the interauricular septum of a heart, by a minimally invasive route.
• the present invention aims to provide a device for occluding an opening or communication existing in a body wall, overcoming the drawbacks of existing devices.
• the object of the invention is in particular to provide a space-saving device, the implantation of which is very minimally invasive and which is fixed in a particularly reliable manner to the body wall treated.
• the device comprises: - a single disc, of diameter greater than the diameter of the opening to be treated, formed by a deformable peripheral wire made of shape memory material and by a flexible wall made of a biocompatible material connected to this wire, this disc being deformable between a normal state of deployment, in which it can be applied against said body wall and come to cover the whole of the opening to be treated, extending beyond the latter, and a state of contraction, in which it can be inserted into a sheath enabling it to be conveyed towards said body wall with a view to its establishment, the disc further comprising means for its removable connection with a rod of manipulation, making it possible to put this disc in place and to keep it applied against said body wall; and
• the device installation assembly includes:
• - Said sheath adapted to receive the disc in said state of contraction of this disc and to contain said manipulation rod;
• At least one catheter containing said hollow needle this needle being of a shape memory material and being deformable between a substantially rectilinear shape, which it takes when it is inserted into the catheter, and a shape in which its portion of the free end is offset laterally relative to its other end portion, the shape which it takes when it is pushed out of the catheter, this offset being such that it allows said free end portion to come opposite the area of said body wall covered by said flexible wall of the disc and to pass through this area when the needle is pushed out of the catheter; and
• a control rod engaged in the catheter and removably connected to said attachment, making it possible to control the sliding of this attachment through said needle.
• the disc connected to the manipulation rod, can thus be routed towards the body wall to be treated by means of said sheath then be deployed by withdrawal of this sheath and be pressed against the body wall by means of the manipulation rod.
• the hollow needle is then pushed out of the catheter which contains it so as to offset its free end portion and then push it through said zone of the body wall covered by the flexible wall of the disc.
• the fastener is then pushed through the needle by means of said control rod bringing its connection zones into engagement respectively with the disc and with the body wall.
• This assembly allows the device to be put in place in a very minimally invasive manner, avoiding the use of additional imaging devices and above all allowing the positioning of the needle or needles to be perfectly controlled relative to the disc and therefore relative to the communication to be closed, this positioning being determined by the shape of the needle or needles in the deployed state.
• Fasteners can be placed over the entire periphery of the disc, so as to hold this disc against the body wall and to achieve a permanent occlusion of the opening that this wall comprises, or one or more fasteners can be put in place on a marginal sector of this periphery, so that the disc does not permanently occlude the opening to be treated and can function like a valve.
• This second mode of implantation can be extremely interesting in patients with pulmonary arterial hypertension.
• the means for the removable connection of the disc with the handling rod may comprise a radial wire integral with said peripheral wire of the disc, comprising, at the center of the disc, a threaded sleeve, said manipulation rod comprising a threaded end which can be screwed into this socket.
• the flexible wall of the disc can be made of PTFE (polytetrafluoroetylene) or pericardium, and the peripheral wire can be made of a nickel-titanium alloy known under the name "nitinol”.
• Said connecting zones which each fastener comprises may be in the form of two deployable distant bearing surfaces, separated from each other by a tapered intermediate portion of length corresponding substantially to the added thickness of said body wall and said flexible wall of the disc, one of said support surfaces of the fastener being intended to bear against said flexible wall of the disc and the other support surface of this fastener being intended to bear against said body wall, side of this wall opposite the disc, said tapered intermediate portion being intended to pass through said body wall.
• the bearing surfaces that the fastener comprises may be in the form of spirals formed by a wire constituting the fastener, or in the form of branches or radial fins.
• This fastener can also be made of a nickel-titanium alloy known by the name "nitinol”.
• the catheter can be integral with the manipulation rod, or can slide along the latter.
• the manipulation rod comprises a stop allowing the catheter to be positioned axially with respect to the disc so as to achieve the adequate offset of said free end portion of the needle.
• the axial position of the catheter relative to the manipulation rod, therefore relative to the disc, at the time of deployment of the needle is precisely determined, either by the connection from this catheter to the manipulation rod, either by said stop.
• This position has been determined as a function of the shape of the needle in the deployed state, and makes it possible to perfectly control the positioning of the needle relative to the disc and therefore relative to the communication to be closed.
• the sliding mounting of the catheter relative to the manipulation rod has the advantage of reducing the size of the vascular access required, each element of the occlusion device being brought one after the other at the implantation site.
• the catheter can also be pivotally mounted around the manipulation rod.
• a single catheter can then be used for the placement of several attachments at different locations on the periphery of the disc, by pivoting the catheter around the manipulation rod.
• the catheter and the manipulation rod can then respectively comprise a mark and a graduation making it possible to position the catheter angularly with respect to the manipulation rod.
• the assembly according to the invention may also include several catheters arranged angularly according to the different implantations of the fasteners to be produced.
• the needle can also be made of a nickel-titanium alloy known by the name "nitinol”.
• the removable connection means the control rod and the fastener can also be in the form of a threaded socket and of threaded end that can be screwed into this socket.
• Figures 1 and 2 are views, respectively in plan and side, of a disc that includes this device;
• Figures 3a to 3c are perspective views of three embodiments of a fastener that includes the device;
• Figure 4 is a side view of a handling rod that includes said assembly;
• FIGS. 5a to 5e and 6a to 6e are views, respectively at the end and from the side, of different variants of a guide sheath and of catheters that said assembly comprises;
• Figure 7 is a side view of a hollow needle that includes this assembly;
• Figure 8 is an enlarged view of the free end of this needle;
• Figures 9 to 15 are views of different successive stages of positioning the device on a right atrium of a heart;
• FIG. 16a and 16b are end views of two variants of another guide sheath and of catheters that said assembly comprises, and Figures 17 and 18 are side views of a disc that the device comprises, after implantation by means of the sheath and catheters according to one of Figures 16a or 16b, in two operating positions.
• Figures 1 and 2 show a disc 1 allowing, as shown in Figure 15, to occlude an opening or communication 2 that comprises a body wall 3, in this case the interauricular septum of a heart.
• the disc 1 comprises a flexible wall 5 made of PTFE (polytetrafluoroethylene) connected to a peripheral wire 6 made of nickel-titanium alloy known under the name "nitinol”, and a radial wire 7 comprising, at the center of the disc 1, a threaded socket 8, axially oriented.
• PTFE polytetrafluoroethylene
• the disc 1 has a diameter greater than the diameter of the opening 2 to be treated.
• This disc 1 can be deformed in order to be able to be engaged in a sheath 10 allowing its routing to the implantation site, by using a vascular duct 11, as shown in FIG. 9.
• the disc 1 is fixed to the body wall 3 by means of fasteners 15, more particularly visible in FIGS. 3a to 3c.
• Each fastener 15 comprises two deployable remote bearing surfaces 16, separated from each other by a tapered intermediate portion 17 of length corresponding substantially to the added thickness of the body wall 3 and the wall 5 of the disc 1.
• Each fastener 15 is made of "nitinol" and can be deformed so as to be able to be engaged in a hollow needle 28 described below.
• the bearing surfaces In the case of the fastener 15 shown in FIG. 3a, the bearing surfaces
• each fastener 15 further comprises a threaded socket 18 which allows its removable connection with a control rod 20, visible in Figures 13 and 14, the latter having a corresponding threaded end.
• the implantation of the disc 1 is carried out by means of an assembly comprising, in addition to the aforementioned sheath 10, the manipulation rod 25 shown in FIG. 4, the guide sheath 26 and the catheter (s) 27 shown in FIGS. 5a to 6th, and one or more needles 28, one of which is shown in FIG. 7.
• These rod 25, sheath 26 and catheters 27 have lengths such that they can be manipulated from outside the patient's body when the disc 1 is level with the wall 3, and have flexibilities allowing them to cross the elbows that can form the vascular duct 11 used for their introduction.
• the handling rod 25 comprises a threaded end 30 which can be screwed into the socket 8 and thus ensure a removable connection of the disc 1 to it, and comprises a stop 31 secured to it, located in a determined location, explained below.
• the guide sheath 26 has a diameter such that it can be slidably engaged on the rod 25 until it comes against the stop 31. It can comprise from one to six catheters 27, the latter being regularly distributed around its periphery.
• Each catheter 27 is connected to the sheath 26 and can slidingly receive a needle 28.
• Each catheter 27 has a proximal tip 32 allowing it to be connected to a syringe for injecting an appropriate liquid, so that its light can be purged for avoid embolism.
• Each needle 28 is made of a nickel-titanium alloy known under the name "nitinol”, and is deformable between a substantially rectilinear shape, which it takes when it is inserted into the catheter 27, and the deflected shape shown in FIG. 7, that it takes when it is pushed out of the catheter 27.
• this deflected form it has a double curvature dividing it into a free end portion 28a, an oblique intermediate portion 28b and its other end portion 28c, said free end portion 28a being offset laterally relative to this other end portion 28c. This offset is such that it allows said free end portion 28a to come opposite the zone of the body wall 3 covered by the wall 5 of the disc 1 and to pass through this zone when the needle 28 is pushed further out of the catheter 27, as shown in FIGS. 12 and 13.
• the needle 28 is bevelled at its free end, as shown in FIG. 8, to facilitate its penetration through the walls 3 and 5, and is connected by its other end to a catheter 35 opening onto the outside of the patient, this catheter capable of slidingly receiving a clip 15 connected to a control rod 20.
• the disk 1 connected to the rod 25 is routed to the wall 3, this disk and this rod being contained in the sheath 10, which keeps the disk in the contracted state (FIG. 9), through the opening 2; the sheath 10 is then removed to allow the deployment of the disc 1 (FIG. 10), then the guide sheath 26 is engaged on the rod 25 until it comes against the stop 31, and the needles 28 and catheter 35 are engaged in the catheters 27 ( Figure 11); the needles 28 are then partially pushed out of the catheters 27 so as to carry out the abovementioned offset from their free ends 28a (left needle in FIG. 12) then their insertion through the walls 3 and 5 (right needle in FIG.
• Figures 16a and 16b show that the sheath 26 may include catheters 27 only on a marginal sector of its periphery; fasteners 15 can be put in place using the assembly comprising such a sheath and such catheters as on a corresponding marginal sector of the disc 1, so that this disc 1 does not achieve permanent occlusion of the opening 2 to be treated and can operate in the manner of a valve, as shown in FIGS. 17 and 18.
• This second embodiment can be extremely interesting in patients with pulmonary arterial hypertension.
• the invention thus provides a device for occluding an opening existing in a body wall, which can be implanted by a minimally invasive route, that is to say by passing through bodily conduits, and having the determining advantages of being little bulky, relatively easy to implant and securely held on said body wall.
• the invention also provides a set of installation of this device allowing a positioning of the device in a very minimally invasive manner, by avoiding the use of additional imaging devices and above all by allowing to perfectly control the positioning of the or needles in relation to the disc and therefore in relation to the communication to be closed.
• the catheter (s) 27 may be integral with the manipulation rod 25, the axial position of this or these catheters relative to this rod being then determined by the connection of this or these catheters to this rod, instead of the stop 31.
• the needle 28 can be through at its distal end, as shown in FIGS. 7 and 8, or can comprise a lateral slit at this distal end and be equipped with a removable means for concealing the this slot.
• This removable means can in particular be a flexible tube sliding in the needle. The fastener 15 is then deployed through this lateral slot, the latter being concealed by retraction of the sliding tube.
• the distal end of the needle may, in this case, be full, forming a dead end.
• the fastener may have, in particular for use with a needle comprising such a lateral slit, the shape of a staple, that is to say comprise two end branches, forming said connecting zones, and an intermediate branch , said end branches coming, in the deployed state of the fastener, in a position perpendicular to the intermediate branch.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Surgery (AREA)
• Molecular Biology (AREA)
• General Health & Medical Sciences (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Medical Informatics (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Animal Behavior & Ethology (AREA)
• Engineering & Computer Science (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Cardiology (AREA)
• Surgical Instruments (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Prostheses (AREA)

Applications Claiming Priority (3)

Publications (1)

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ID=30129613

Family Applications (1)

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• 2002
  • 2002-08-01 FR FR0209807A patent/FR2843012B1/fr not_active Expired - Fee Related
• 2003
  • 2003-07-28 CA CA002494733A patent/CA2494733A1/fr not_active Abandoned
  • 2003-07-28 US US10/522,898 patent/US7273489B2/en not_active Expired - Fee Related
  • 2003-07-28 AU AU2003269071A patent/AU2003269071A1/en not_active Abandoned
  • 2003-07-28 EP EP03750855A patent/EP1531735A2/fr not_active Withdrawn
  • 2003-07-28 WO PCT/FR2003/002386 patent/WO2004012572A2/fr active Application Filing
  • 2003-07-28 JP JP2004525481A patent/JP2005534394A/ja active Pending

Non-Patent Citations (1)

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