EP1965708A1 - Dispositif de fermeture d'une ouverture presente dans une cloison cardiaque - Google Patents

Dispositif de fermeture d'une ouverture presente dans une cloison cardiaque

Info

Publication number
EP1965708A1
EP1965708A1 EP06841103A EP06841103A EP1965708A1 EP 1965708 A1 EP1965708 A1 EP 1965708A1 EP 06841103 A EP06841103 A EP 06841103A EP 06841103 A EP06841103 A EP 06841103A EP 1965708 A1 EP1965708 A1 EP 1965708A1
Authority
EP
European Patent Office
Prior art keywords
opening
catheter
traction means
screw
heart
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.)
Withdrawn
Application number
EP06841103A
Other languages
German (de)
English (en)
Inventor
Peter Osypka
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP1965708A1 publication Critical patent/EP1965708A1/fr
Withdrawn legal-status Critical Current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
    • A61B17/0057—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
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482—Needle or suture guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00349—Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • 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
    • A61B2017/00646—Type of implements
    • A61B2017/00663—Type of implements the implement being a suture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409—Instruments for applying suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417—T-fasteners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0458—Longitudinal through hole, e.g. suture blocked by a distal suture knot
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0461—Means for attaching and blocking the suture in the suture anchor with features cooperating with special features on the suture, e.g. protrusions on the suture
    • A61B2017/0462—One way system, i.e. also tensioning the suture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0472—Multiple-needled, e.g. double-needled, instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B2017/06052—Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • A61B2017/06176—Sutures with protrusions, e.g. barbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/30—Surgical pincettes, i.e. surgical tweezers without pivotal connections
    • A61B2017/306—Surgical pincettes, i.e. surgical tweezers without pivotal connections holding by means of suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3407—Needle locating or guiding means using mechanical guide means including a base for support on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
    • A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
    • A61B2017/3488—Fixation to inner organ or inner body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00392—Transmyocardial revascularisation

Definitions

  • the invention relates to a device for closing an opening in a partition located in the heart between two heart chambers, in particular between the right atrium and the left atrium, with a closure element, with a delivery catheter for transvenously inserting the closure element m inside the heart and with a punk tion cannula and with a tool or stylet for pushing out the closure element from the distal end of the puncture cannula according to the passage through the edge or neighboring area of the m the heart separation wall opening, wherein at least two individual elements are provided as closure elements, the traction means or threads, which for Closing the opening m use position contractible, connectable and / or knotty.
  • Such a device is known from US-A-6056760.
  • the edge region of the opening in the heart separation wall is pierced and then an anchoring element with an anchor pin arranged transversely to the traction means is fixed through the inner longitudinal cavity of the puncturing cannula, so that the traction means are knotted together and thereby the opening edges are contracted and closed can.
  • the heart activity of the heart separation wall in the region of an opening is so yielding that even a very sharpened puncture cannula deflects this edge region of the heart separation wall rather than piercing it.
  • this prior art device is unsuitable for closing a mouth formed by two overlapping tissue flaps in a heart separation wall.
  • the invention is therefore based on the object to provide a device of the type mentioned, with which designed as individual elements closure elements in the form of pin-shaped anchor at the Mittei Scheme a traction means or
  • Thread or possibly a wire or cord is attached to create, with which this anchor can be securely fastened in the edge region of an opening of a cardiac partition.
  • the device defined at the outset has at least one screw-in catheter provided with an inner feed channel, which can be inserted into the guide catheter, at the distal end of which at least one screw-in helix which can be screwed into the edge region of the opening m of the cardiac partition wall is provided, the lumen or the free internal cross-section the screw catheter and the helical or helical coil is chosen so large that the puncture cannula is displaceable with the contained therein, belonging to the closure element anchor relative thereto and through this inner cross section and through the helical or helical spirals.
  • the helical coil can serve as a counter-holder when the puncture cannula is inserted into this edge region, so that the edge region of the opening of the cardiac partition can not escape during this puncturing of the puncture cannula or the anchor.
  • the closure element can thus at least substantially consist of two in particular on opposite or opposite edges of the opening to be fired anchors whose traction means m use position are interconnected and contracted, so that thereby the edges of the opening to each other or optionally also something above the other are pulled, whereby the opening is closed and can grow.
  • the heart separation wall can be prevented from escaping by the helical screw or screw helices of the screw catheter during this grooving with the puncture cannula and / or the anchor pin.
  • the helical coil thus forms an abutment practically on the heart separation wall for receiving the forces occurring during piercing m the cardiac partition.
  • the screw catheter m use position at its proximal end can be fixed or detected and the helical (s) - as already mentioned - serves as a counter-holder and for receiving the force that puncture cannula when piercing the edge region of the opening in the cardiac partition to exercise this.
  • the anchor pin penetrates the cardiac separation wall when pushed out of a corresponding cannula.
  • the screw catheter can therefore in Use position relatxv to the delivery catheter or fixed after it has been previously moved relative to this supply catheter by this in its position of use.
  • two guide catheter and screw with screw spirals can be provided for the attachment of at least two anchors also expediently two guide catheter and screw with screw spirals can be provided.
  • the helical coil (s) can (at least) have at least one or two, in particular about one and a half turn and engage in the position of use the point to be punctured next to the opening of the heart separation wall. By at least one turn or something more is ensured that the entire area to be punctured or pierced, is detected at its periphery by the helical, so that the holding forces of
  • Helical be transferred to this area to be pierced largely uniformly and not a portion of the puncture forces can escape, which would be conceivable with less than one turn of the helical.
  • the pitch of the helical coil (s) can be selected so that their tip (s) in the position of use protrudes therefrom on the side of the cardiac separation wall facing away from the delivery catheter. This ensures that the entire thickness of the cardiac partition is used for anchoring the helical coil and for receiving the counter forces to be absorbed by this.
  • the screwing force transmitting shaft of the screw catheter can be flexible, but not or only slightly stretchable.
  • the screw catheter can adapt well to changing directions when it is being delivered, while still transferring the counterforce that occurs during puncturing.
  • the wall of the screw catheter or a formed from one or more wires, in particular closed coil can, on the one hand, transmit sufficient axial force and, on the other hand, have the flexibility and flexibility required for delivery through blood vessels into the interior of a heart.
  • a conical reduction or an abutment may be provided in front of the screwdriver as a retention instrument for the puncturing instrument, this stop limiting the exit length of the puncture instrument from the screw catheter and relative to the helical coil. This ensures even better that the puncturing instrument does not reach and injure the cardiac wall opposite this when piercing the cardiac partition wall or the septum. Since the puncturing instrument can be a ground cannula or a pointed stylet or a puncture needle, the danger is avoided that the heart wall, for example the atrial wall in the left atrium, which is opposite the septum or the heart separation wall, will be injured if the entire device is used wisely.
  • At the puncture instrument can be arranged at a distance from its tip, a counter-stop, which limits in the position of use with the retention mechanism or stop together the exit length of the puncture instrument from the screw.
  • At least two anchors provided with traction means can be attached at a distance from one another in the edge region of the opening of the cardiac separation wall by means of a puncture cannula and their traction means knotted or knotted together in the use position.
  • a modified expedient embodiment of the device according to the invention which is suitable primarily for closing an opening formed by two overlapping tissue flaps in the heart, may have a second screwing catheter which fits the first screwing catheter and is rotatable therethrough and relatively rotatable therethrough wherein the first screw with its at least one helical screw in a guide flap closer tissue flap screwed and then the second screw through this and the first tissue flap m the second tissue flap is screwed, wherein the lumen or the free inner cross section of the second screw and its at least one Screw is chosen so large that the puncture instrument with it, belonging to the closure device anchor relative thereto and through this inner cross section and through the second (s) helical (s) m the Bere I can move behind the second fabric flap.
  • the embodiment with two screw catheters arranged relative to one another and one another also makes it possible to close an opening in the heart in which two tissue flaps of the cardiac partition lie behind or one above the other, but are not grown together or connected.
  • a PFO closure permanent foramen ovalis
  • the tissue flap located away from the guide catheter can be pulled against the tissue flap closer to the guide catheter with the aid of the second helical screw, so that both tissue flaps can already be firmly attached to one another during the attachment of the closure element or anchor.
  • the second screw at its proximal end can be fixed or detected and its helical (n) serves as a counter-holder for receiving the force that the puncture cannula upon puncturing the rear - the guide catheter further lying - tissue flap on this exercises.
  • a modified embodiment of the device in particular for closing an opening formed by two tissue lobes arranged one above the other or one behind the other in the heart, may be characterized in that a suction tube or tube is provided which can be inserted through the screwing catheter and its helical coil (s) and a puncture opening in the Guide flap facing first tissue flap to which these overlapping second tissue flap is displaceable and connectable with its proximal end to a vacuum source.
  • a suction tube or tube can thus be provided, with the aid of which a vacuum or negative pressure is applied to the screwdriver. action direction rear tissue flap can be exercised in order to transmit the counterforce when puncturing or puncturing using an anchor can.
  • the suction tube or the suction hose can have an internal cross section through which the puncture instrument or the puncture cannula with the contained therein, belonging to the closure device anchor relative thereto and through this mecanicquerschmtt and through the second tissue flap is displaceable.
  • the suction tube or the suction hose can be fixed or detectable at its proximal end and, because of the negative pressure applied in it, serve as an anvil and for absorbing the force which the puncture cannula exerts on piercing the rear tissue flap.
  • At least two anchors with traction means adjacent to one another and attachable ends facing away from their anchors can also be connectable and / or knotted as closure or closure element.
  • the anchors are pin-shaped and pierceable or passable through the cardiac partition, as a point of attack for a tool or stiletto deformation at the pierceable or feasible tip opposite end arranged deformation, in particular, have an open end opposite the tip and a recess terminating in the interior of the pin-like armature, which can be releasably coupled to the tool, the tool or stiletto in particular m m this recess, the traction means in each case between the both ends of the pin-like anchor attacks approximately in the middle.
  • the respective anchor In the position of use, therefore, the respective anchor can form a T-shape with its tension element or traction means, because the pin-like anchor is pivotable relative to the traction means.
  • the armature can first be completely moved through the heart tissue by means of the tool or stylet and then supported on the side facing away from the feed side by pivoting back relative to the traction means, while the traction means or the thread runs back through the opening, by the piercing or Piercing has arisen.
  • the entire length of the pin-like anchor m position of use is available as anchoring and abutment surface, so that this anchor can be correspondingly small, whereby at the same time the risk of a possible embolism is practically excluded.
  • the respective armature may be bendable or foldable relative to the point of engagement of the traction means against its insertion direction.
  • this anchor can be pushed through the puncture cannula and the heart tissue, wherein the both sides of the point of attack of the traction means located areas are bent or folded to each other. Once the heart tissue has passed through, these two areas can unfold and rest on the tissue in the sense of anchoring.
  • ASD closures and PFO closures can be mastered, in which the helical coils used are adapted or supplemented accordingly.
  • ASD means Atrial Septal Defect.
  • PFO Permanent Foramen Ovalis.
  • the puncture cannula accommodating the tool and the armature receives the armature in whole or in part, with the tension element or the thread exiting within the puncture cannula at its distal end in the arrangement of the armature and is disposed on the outside of the puncture cannula.
  • the respective anchor can therefore be at least partially inserted at the distal end of the puncture cannula, while its traction means or tension element remains on the outside of this puncture cannula.
  • the latter can be displaced through the delivery catheter m to its point of use, where the anchor is then pierced and pushed through the edge of the opening of the cardiac separation wall with the aid of the tool or stylet directly from the distal end of the puncture cannula or puncture cannula penetrating the cardiac separation wall from the guide catheter Seen from behind this heart partition can be transported.
  • the puncture cannula the first held by her anchor with its tip - initially - surmounted so that they can puncture or punch the partition in the heart at the edge of the opening to be closed or on a tissue flap, where then the anchor pierced or pushed or pushed , Thereafter, this anchor can be pushed out of the puncture cannula with the tool or the puncture cannula can be withdrawn while fixing the anchor with the aid of the tool relative thereto.
  • the use of the device or of the kit formed from the mentioned individual parts and above all the attachment of the anchor by means of imaging methods can also be observed directly.
  • a particularly expedient embodiment of the device according to the invention or of the kit forming this device can consist in that the armature and the traction means consist of non-metallic material, in particular of plastic or of biocompatible material. Particularly favorable is the use of biocompatible plastic.
  • At least three or four anchor and traction means may be provided whereby the device is applicable as an ASD or PFO closure.
  • the closure device has at least two anchors with each acting on these traction means and at least one closure plate or utn- summarizes, in its edge region perforations for has the passage of the traction means and through which the traction means or threads on the back of the closure opening facing away from the back of the closure plate in use position, where they are connected or connectable or knotted or knotted.
  • the opening to be closed is so large that a contraction of the edges is not sufficient for their closure, may belong to the device or the device forming the kit the mentioned closure plate, the mutual approach of the Opening edges no longer required or reduces the degree of approach of these edges.
  • the closure plate may consist of biocompatible and / or non-metallic material.
  • closure plate and a plurality of anchors are provided with traction devices as a closure device and in each case two anchors and their traction means in the position of use are connected to each other or connected or knotted or knotted.
  • the respective anchor can also be a flexible, approximately angled or hook-shaped part relative to the traction means or thread at a tensile force against the insertion direction is erected or spread and / or retraction of the traction device or thread through a perforation or a heart wall area locks.
  • a device or a kit for closing an opening in a heart located in the partition as ASD or PDF closure in which the actual Verschmirroredemheit consists of very few parts with little material whereby the use of metal in the parts remaining in the heart can even be completely avoided.
  • the risk of embolism which can arise from such a closure or a corresponding closure, can be considerably reduced.
  • the anchors can be relatively small parts with their traction means, they can be brought conveniently in succession with one or more puncture cannulas each through a catheter and the or the screw m their respective position of use.
  • FIG. 1 shows a side view of a device according to the invention with a delivery catheter and a screw catheter arranged therein and displaceable by it, the proximal end of which protrudes from the guide catheter to the rear and has a handle for shifting and twisting, while on the distal end of the screwing catheter a helical coil is arranged, which protrudes in the position shown from the delivery catheter,
  • Fig. 2 is a belonging to the device according to the invention, by the delivery catheter and the screw located therein slidable puncture cannula, which contains one of at least two at the distal end of each individually arranged anchors, which anchor on the outside of the
  • Puncture cannula extending traction means or tension element and with a tool with which the anchor from the puncture cannula pushed out and hm doctorschiebbar in the edge region of an opening to be closed,
  • FIG. 4 shows an associated with the device according to the invention or a kit according to the invention anchor with its tension element or traction device
  • FIG. 5 shows a section through a heart and the left and the right atrium, wherein the guide catheter with the screw catheter is inserted transvenously into the right atrium and is approximated with its mouth to the septum such that the helical screw is screwed therein or already screwed into it,
  • Fig. 6 is a representation corresponding to FIG. 5 after additional advancement of the puncture cannula through the screw catheter and after piercing the septum, with an anchor already pushed through the puncture cannula through the edge of the opening and transverse to its traction means, while the same or a second puncture cannula in the opposite edge to be closed Opening between the left and right atrial chamber is pierced, the anchor still shortly after its expulsion m direction of the
  • FIG. 7 shows, on an enlarged scale, the distal end of the delivery catheter and the screw catheter m of the situation according to FIG. 5, wherein the distal end of the delivery catheter and the screw catheter inserted therein are shown after screwing in the helical screw m the septum, FIG.
  • FIG. 8 shows a representation corresponding to FIG. 7 after advancing the puncture instrument or the puncture cannula through the screw catheter and FIG.
  • Point of the puncture cannula is chosen sufficiently large to the still located within the puncture cannula anchor behind the partition wall of the heart to be able to bring, wherein the delivery catheter is shown in longitudinal section,
  • FIG. 9 is a representation corresponding to FIG. 8 after pushing out the armature into that shown in FIG.
  • Fig. 10 is a representation corresponding to FIG. 9 after the withdrawal of serving for pushing out of the armature
  • FIG. 11 shows a simplified representation analogous to FIG. 8, with only the puncturing instrument and an armature, which is modified therewith and consisting of two foldable parts, being shown with traction means, FIG.
  • Fig. 12 is a representation corresponding to FIG. 11 after the
  • FIG. 13 shows a representation corresponding to FIGS. 11 and 12 after the retraction of the puncture cannula and the application of the anchor to the heart wall, through which the traction means travels
  • FIG. 14 is a schematic representation of a cross section of the edges of the opening m of the heart partition wall after the attachment of at least two or optionally three or four or more anchors, wherein the traction means run back from the anchors through the partition wall of the heart,
  • Fig. 15 is a view of the opening m of the cardiac partition of the the anchors facing away with four traction devices
  • FIG. 16 shows a representation corresponding to FIG. 14, after anchors attached to opposite opening edges are pulled together with the aid of their traction means and these are knotted so that the edges of the opening are closely approximated to one another,
  • FIG. 17 shows a view corresponding to FIG. 16 after the connection and contraction of the tension elements or traction means of the anchors, whereby the opening is practically completely closed and / or can grow, FIG.
  • Fig. 18 is a of Fig. 6 approximately corresponding representation of the heart, wherein at opposite edges of the
  • Opening in the partition wall of the heart are each arranged at least two anchors before the opening is closed,
  • Fig. 19 is a representation corresponding to FIG. 14, wherein the closure element in addition to the anchors provided with tension elements or traction means still has a closure plate which has perforations to be moved over the tension elements in the use position, where they m Fig. 19 still one
  • FIG. 20 shows a view corresponding to FIG. 15 of the opening m of the partition wall of the heart, with four anchors already attached and a closure plate being displaced close to the opening
  • FIG. 21 shows a representation corresponding to FIG. 19 after the closure plate has been displaced until it contacts the edges of the opening and after the mutual connection and knotting of the traction means of the armature on the side facing away from the opening
  • FIG. 22 shows a representation corresponding to FIG. 20 after fastening the closure plate in the position of use by means of the traction means passing through it, FIG.
  • FIG. 23 shows a representation corresponding to FIG. 19, in which only two anchors are attached to mutually opposite edges of the opening m of the cardiac partition wall, while two further anchors are attached directly to the cardiac partition wall
  • FIG. 24 shows a representation corresponding to FIG. 20, in which the closure plate is still at a distance from the opening m of the heart separation wall
  • FIG. 25 shows a representation corresponding to FIG. 21 after the closure plate has been displaced up to its contact with the opening edges and after the mutual connection and knotting of the traction means, respectively, of an armature engaging the closure plate and an armature engaging on the cardiac partition on the opening Side of the closure plate,
  • FIG. 26 shows a representation corresponding to FIG. 22 after fastening the closure plate according to FIGS. 23 to 25 in the position of use with the aid of the traction means passing through it
  • FIG. 27 shows a representation corresponding approximately to FIG. 14 or 19, in which a closure plate is still arranged at a distance from the opening in the cardiac separation wall on the traction means of anchors, the traction means having barb-like holders on the side of the cardiac separation wall facing away from the anchors,
  • FIG. 28 shows a representation corresponding to FIG. 27 after the closure plate has been moved to its position of use, in which it touches the edges of the opening m of the cardiac separation wall, being fixed by the barb-like holding elements nearest this partition, FIG.
  • Fig. 29 is a side view
  • FIG. 30 shows a top view of a closure plate with predefined and predefined locations for attaching perforations for tension elements, which are pierceable as needed, the closure plate having an oval outline,
  • FIGS. 29 and 30 shows the illustration of a closure plate according to FIGS. 29 and 30, wherein the closure plate has a rectangular or square outline
  • FIGS. 33 to 37 show the use of a modified exemplary embodiment of a device according to the invention for closing a tissue flap in the heart which is arranged above or behind one another formed opening and thereby the distal end of the delivery catheter and the therein advanced SSkatheter after screwing his helical screw in the guide catheter closer tissue flap,
  • FIG. 34 shows a representation corresponding to FIG. 33 after puncturing and dilating and after the insertion of a second screw catheter through the first tissue flap and after screwing in its helical coil into the rear tissue flap in the direction of insertion, FIG.
  • FIGS. 33 and 34 shows a representation corresponding to FIGS. 33 and 34 during the insertion of a puncture instrument or a puncture cannula through the inner lumen of the second screw catheter and its helical coil and thus through the rear tissue flap in the direction of insertion,
  • FIG. 36 is a representation corresponding to FIG. 35 after pushing out the armature and its traction means and
  • FIG. 38 shows a representation corresponding to FIG. 34, wherein, instead of a second screw catheter, a suction tube or tube is inserted through the screw catheter and the helical screw according to FIG Insertion direction is pushed rear tissue flap and prevents him by suppressing against evasion of the anterior tissue flap,
  • FIG. 39 shows a representation corresponding to FIG. 35, in which a puncturing instrument with an anchor contained in it is pierced through the rear tissue flap in the feed direction, wherein the suction tube holds this tissue flap against the piercing force, as well as FIG. 39
  • FIG. 40 shows a representation corresponding to FIG. 36 after pushing out the armature, which thereafter serves analogously to FIG. 37 for closing the opening.
  • a designated as a whole with 1 device which can also be regarded as a kit used to close an opening 2 in a heart 3 between two chambers, especially between the right atrium and the left atrium, located partition 4 with a detail of the Embodiments closer to be explained closure element.
  • the device 1 is embodied as an ASD closure device according to FIGS. 1 to 32 and as a PFO closure device according to FIGS. 33 to 40, wherein in these differently configured devices 1, however, parts matching in their function correspond to corresponding reference numbers receive.
  • a delivery catheter 5 for the transvenous insertion of the respective closure element into the interior of the heart 3 belongs to the respective device 1 or to the kit forming it.
  • the respective device 1 has a puncture cannula 6 and a tool 7 or stiletto for pushing out the closure element to be explained in more detail from the distal end of the puncturing cannula 6 according to its passage through the edge or neighboring area of the opening 2 located in the heart separation wall 4, wherein at least two individual elements are provided as the closure element, the traction means 8 or threads, hereinafter also referred to as "tension elements", which, according to FIG. 16, 17, 21, 22 or 25 and 26, can be contracted, connected and / or knotted to close the opening 2 in the position of use.
  • the respective device 1 which may also be referred to as a kit
  • at least one provided with an inner feed channel 9, in the Zuzhoukatheter 5 insertable screw 10, at the distal end in the edge region of the opening 2 in the heart separation wall 4th rotatable helical coil 11 is provided, wherein the lumen or the free inner cross section of the screw 10 and its helical coil 11 is chosen so large that the puncture cannula 6 together with the first contained therein, belonging to the closure element armature 12 relative thereto and through this inner cross section and therethrough is displaceable by the helical coil 11. It could also be several, preferably two matching, circumferentially offset from each other helical coils 11 may be provided, so that the tissue can be detected even more effective.
  • An essential part of the device 1 is thus the inner feed channel 9 having, in the delivery catheter or Guide catheter 5 insertable and slidable through this screw 10, which can be seen in Fig. 1 with its two over the guide catheter 5 protruding ends. Furthermore, the distal end of this screw catheter 10 and its helical coil 11 is shown in side view in Fig. 7 and in longitudinal section, for example m Figs. 8 to 10 for one embodiment and in Fig. 33 to 40 for two further embodiments. It can also be seen that the helical screw 11 provided at this distal end of the screw catheter 10 and screwable into the septum or cardiac partition wall 4 has a sharp tip 11a at its distal end, so that it can easily m with appropriate axial axial feed motion the heart partition wall 4 can penetrate.
  • the relation of the lumen or the free inner cross-section of the screw catheter 10 to the puncture cannula 6 can be seen particularly well in FIGS. 8 to 10 for the first embodiment and in FIGS. 35 and 36 and 39 and 40 for the second and third embodiments
  • the tip 6a of the puncturing instrument 6 can thus be pushed freely through the area of the heart separation wall 4 enclosed by the respective helical coil 11 in the position of use, in order to reach the position illustrated, for example, in FIG.
  • the screwed catheter 10 can be fixed on its proximal end opposite the delivery catheter 5 or can be grasped on a handle 13, with which it can be manipulated, ie advanced through the delivery catheter 5 and also twisted, around the helical coil 11 into the septum or the cardiac separation wall 4 screw in and screw. Furthermore, this screwing catheter 10 and thereby also his handle 13 for receiving the force exerted by the puncture cannula 6 when piercing the edge region of the opening 2 in the cardiac partition 4 on this. Thus, an undesirable or too strong deflection of this edge region during insertion of the puncture cannula 6 can be prevented. The user can thus on the one hand puncture the puncture cannula 6 through the heart separation wall 4 and on the other hand with similar force the cardiac partition 4 on the helical coil 11 and the screw catheter 10 on the handle 13 to hold back and set.
  • the helical coil 11 has approximately one and a half or two turns, which according to FIGS. 7 to 10 or 33 to 36 and 38 to 40 engage in the position of the heart separation wall 4 to be punctured or punctured in the position of use.
  • the pitch of the respective helical coil 11 and also to be described with reference to FIGS. 33 to 40 to be described second helical 111 is chosen so that its tip 11 a or 111 a in the position of use on the side facing away from the feeding catheter 5 of the heart separation wall 4 protrudes from this or until the supply catheter 5 facing away from the surface of this cardiac partition 4 extends.
  • the cardiac partition 4 is m and its interior, with a supernatant of the helical coil 11 or 111 also detected and overlapped on the outside, so that the retaining force, which is transmitted via the handle 13 and the screw 10, well into the cardiac partition 4 can be initiated.
  • the shaft of the respective screw catheter 10 or 110 which transmits the screwing force is flexible but not or only slightly expandable, its wall according to FIG. 7 being able to be formed from one or more wires which, as a closed coil, provide the required flexibility and at the same time good axial strength ,
  • at least two armatures 12 provided with traction means 8 can be attached by means of a puncture cannula 6 at a distance from one another in the edge region of the opening 2 of the cardiac partition 4 and their traction means 8 are in the position of use according to FIGS. 16, 17, 21, 22 or 25 and 26 and 37 knotted together, whereby an ASD closure or according to FIG. 37, a PDF-closure can be produced.
  • FIGS. 33 to 40 show an arrangement in which the opening 2 in the cardiac partition 4 each overlapping tissue flap 14th and 15, which can be brought by the closure device in the mutual contact position shown in FIG. 37, whereby the distance between them and thus the opening 2 can be closed.
  • a puncture cannula 6 a tool 7 and anchors 12 with traction means 8 shown in FIGS. 34 to 36 already mentioned second screwing catheter 110 which m fits the first screwing catheter 10, which in turn is displaceable through the supply channel 9 of the delivery catheter 5.
  • this second screwing catheter 110 is shown in the position of use and it is clear that it is not only by the first screw 10 hin tellschiebbar, but also relatively rotatable, the first screw 10 with its helical coil 11 in the Guide catheter 5 closer
  • the tissue flap 14 can be screwed in and then the second screw catheter 110 can be screwed through this and the first tissue flap 14 into the second tissue flap 15, after the tissue flap 14 has been punctured and dilated, if necessary, in a manner not shown within the screw coil.
  • the lumen or the free inner cross section of the second screw catheter 110 and its helical screw 111 is again chosen to be large enough that the puncture cannula 6 contains the armature 12 and the tool 12 used to actuate the armature 12, which is included in this closure device 1 7 relative thereto and through this inner cross section and also by the second helical coil 111 in the area behind the second tissue flap 15 is displaceable.
  • the individual steps for the production of a PDF shutter with this modified device 1 can be seen m the Figs. 33 to 37th
  • the second screw 110 can be fixed or detectable at its proximal end and its helical 111 can serve as an anvil and to absorb the force exerted by the puncture cannula 6 when piercing the rear tissue flap 15 on this, to him to evade and retreat to prevent.
  • the screw catheter 110 could have two or more m parallel m circumferentially offset helices 111.
  • FIGS. 38 to 40 show a third embodiment which likewise serves to approach and connect two tissue flaps 14 and 15, wherein FIGS. 33 and 37 m also belong to this embodiment in the same way.
  • a suction tube or tube 16 is provided by the - first screw 10 and its helical coil 11 and a not shown puncture opening in which the supply catheter 5 facing first tissue flap 14 to which these overlapping second tissue flap 15 is slidably connected and with its proximal end to a vacuum source.
  • FIG. 38 The corresponding situation is shown in FIG. 38.
  • the screw catheter 10 is then brought into position with its helical coil 11 and anchored to the tissue flap 14 that is closer to the delivery catheter 5. Thereafter, this tissue flap is punctured 14 m not shown manner and expanded with a dilator at the dotted point extent that the suction tube 16 can be moved through until its mouth of FIG. 38 has reached the rear tissue flap 15. By negative pressure, this can be prevented from dodging when a force is exerted on these rear tissue flap 15.
  • the suction tube or suction tube 16 has an internal cross section through which the puncture cannula 6 with the armature 12 belonging to the closure device 1 relative thereto and through this inner cross section and through the second tissue flap 15 is displaceable. Also in this case, therefore, with the help of the puncture cannula 6, an armature 12 can be introduced into the cardiac partition 4, at the traction means 8, in turn, the actual anchoring force is applied. When piercing the puncturing cannula m the tissue flap 15 of this is prevented by the suction tube and the vacuum applied thereto to a dodge or retreat.
  • the suction tube 16 can be fixed at its proximal end in a manner not shown or detectable and due to the applied negative pressure as a counter-holder and serve to absorb the force that the puncturing cannula 6 exerts on piercing the posterior tissue flap 15.
  • the armatures 12 are pin-shaped and can be moved and pierced with the help of the puncture cannula 6 through the heart separation wall 4 and have as a point of attack for the already mentioned tool 7, for example a stylet, a deformation on the pierceable or feasible Tip 12a opposite end disposed deformation, which is detachably coupled with the tool 7.
  • the operating handle 7a of the tool 7 can be seen m Fig. 2 and 3. 4, the traction means 8 engages between the two ends of the pin-like armature 12 approximately at its center at this.
  • FIGS. 11 to 13 A modified embodiment of the armature 12 is shown in FIGS. 11 to 13.
  • the respective armature 12 shown there is bendable or foldable relative to the point of engagement of the traction means 8 against its insertion direction and thus can initially be accommodated well within the puncture cannula 6 according to FIG and then ejected as shown in FIG. 12, whereby it already partially unfolds.
  • this modified armature 12, according to FIG. 13, then lies flat against the heart wall 4 and can transmit corresponding anchoring forces.
  • the puncture cannula 6 projects beyond the armature 12 held by it with its tip 6a, so that when the armature 12 is inserted, the tip 6a punctures and punctures the partition wall 4 adjacent to the opening 2 to be closed, so that the insertion of the armature 12 is correspondingly punctured is relieved.
  • the armature 12 is moved out of the puncture cannula 6 and thus also from the delivery catheter 5 and brought into its position of use.
  • the dimension of the inner cavity of the puncture cannula 6 according to FIG. 2, 35 or 39 corresponds at least in its outer or distal end region approximately to the outer cross section of the armature 12 and therefore completely absorbs it.
  • the axial position of the armature 12 can be determined by the tool 7.
  • the armature 12 and the traction means 8 may be made of non-metallic material, in particular of plastic.
  • 2 traction means or threads 8 according to FIGS. 16 and 17 can be knotted together and pulled together, whereby one another opposite edge regions of the opening 2 as shown in FIG. 7 and 8 approach each other and thereby the opening 2 is closed so far that they can grow.
  • This position can be fixed by the connection of the traction means 8 by means of nodes 8a, so that the opening 2 remains closed until it is overgrown.
  • the knotting of the traction means 8 can be done by conventional surgical means and methods.
  • the device or the kit 1 as part of the closure element can comprise or comprise at least two anchors 12 with the tension elements or threads 12 arranged on them in the already described manner and at least one closure plate 18 which at least in FIG their marginal perforations 19 for the passage of the traction means 8 and through which the traction means 8 or threads on the opening to be closed 2 facing away from back of the closure plate 18, where they are connected or knotted together in the use position.
  • the device 1 may additionally comprise, in addition to the anchors 12, the illustrated closure plate 18 which can be guided in its position of use by means of the traction means or threads 8 of the previously attached anchor 12, as indicated in FIGS. 19 and 20.
  • the anchors 12 - in the exemplary embodiment a total of four anchors 12 - can be placed one after the other with the help of the puncture cannula 6 or with the aid of several puncture cannulas 6 in the edge region of the opening 2 m of the partition wall 4, after which the closure plate 18 with its Holes 19 pushed over the traction means 8 and thereby can be guided until it abuts the edge region of the opening 2 and the opening 2 of FIG. 22 covers and closes.
  • at least three or according to FIG. 20 four armatures 12 and knots 8a forming traction means 8 as well as at least one closure plate 18 can be provided as closure element.
  • the closure plate 18 is made of non-metallic material and like the armature 12 and the traction means 8 made of biocompatible material or plastic. As a result, metallic parts are avoided and reduced Emboliegefahr or excluded.
  • FIG. 29 to 32 A modified embodiment of the closure plate 18 is shown in Figs. 29 to 32.
  • the closure plate 18 has m this case initially no holes 19, but prepared reinforced areas 19a, where optionally 19 holes can be attached as needed.
  • FIGS. 23 to 26 show a modification to the effect that in each case two armatures 12 are arranged in the edge region of the opening 2 m of the heart separation wall 4 and two further anchors 12 in the edge region of the closure plate 18, wherein each position of use is a traction means 8 of a voltage applied to the heart separation wall Anchor 12 with a cooperating on the closure plate 18 anchor 12 is knotted or knotted.
  • FIGS. 27 and 28 likewise show a possibility of being able to fix a closure plate 18 with only two anchors 12, but in turn more than two anchors 12 could also be used. It can be seen in this embodiment shown in FIG. 27 and 28, that at the traction means 8 spaced from the armature 12 at least one, in the embodiment, several bendable or barb-like projections 20 are provided, via which the holes 19 of the closure plate 18 m direction to the respective armature 12 towards slidably, but can be fixed in the opposite direction of displacement.
  • Fig. 27 shows the closure plate 18 still at a distance from the heart separation wall 4 and the opening 2, wherein just a first pair of barb-like projections 20 is folded together to enter the respective perforation 19 of the closure plate 18.
  • the closure plate 18 has reached its position of use and is determined by the cardiac partition 4 and the opening 2 closest pair of barb-like projections 20 which rest on the side facing away from the heart separation wall 4 of the closure plate 18.
  • a device 1 or a kit with which an opening 2 m of a cardiac partition 4 can be closed effectively and with few individual parts.
  • the anchor 12, which is important for the closure in each case, can be moved through the respective region of the dividing wall 4 with the aid of puncture cannulas 6, without this region of the cardiac dividing wall 4 being able to escape because it is made with the aid of a helical coil 11 or 111 or with the aid of a suction tube or hose 16 can be held.
  • a device or a kit 1 serves to close an opening 2 m of a partition wall 4 located in the heart 3 between two heart chambers with a multipart closure element.
  • a delivery catheter 5 for transvenous insertion of the closure element into the interior of the heart 3 and a puncture cannula 6 and a tool 7 or stiletto for pushing out at least an important part of the closure element from the distal end of the puncture cannula 6 after the puncture by the edge or adjacent area of the m the cardiac partition 4 located opening 2, wherein at least two individual elements are provided as a closure element, the traction means 8 or threads which are contractible for closing the opening 2 in the use position, connectable and / or knotty.
  • the device 1 in this case has at least one insertable into the feed catheter 5 and by him forward movable screw catheter 10, at its distal end at least one screwed into the edge region of the opening 2 in the heart separation wall 4 , ring Listel 11 is provided, wherein the puncturing cannula 6 with a to the Closure belonging armature 12 through the inner cross section of the screw 10 and the helical screw 11 is slidable. If the edges of the opening 2 overlap, the lobe 15 facing away from the delivery catheter 5 can be provided with at least one second helical coil 111 or a suction tube 16 against the force of the puncture cannula 6 during insertion and placement of the armature 12.

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Abstract

L'invention concerne un dispositif ou un module (1) qui sert à fermer une ouverture (2) dans une cloison (4) située entre deux chambres cardiaques à l'aide d'un élément de fermeture en plusieurs pièces. Des éléments importants en sont un cathéter d'amenée (5) qui permet d'insérer par l'intermédiaire d'une veine l'élément de fermeture à l'intérieur du coeur (3) et une canule de ponction (6) ainsi qu'un outil (7) ou stylet qui permet d'expulser au moins une partie importante de l'élément de fermeture hors de l'extrémité distale de la canule de ponction (6) après qu'elle a perforé le bord ou le voisinage de l'ouverture (2) située dans la cloison cardiaque (4). Au moins deux éléments différents sont prévus pour former l'élément de fermeture et ils présentent des moyens de traction (8) ou des fils qui, en position d'utilisation, peuvent être rapprochés, reliés et/ou noués pour fermer l'ouverture (2). Le dispositif (1) présente au moins un cathéter fileté (10) qui peut être inséré dans le cathéter d'amenée (5) et déplacé vers l'avant par ce dernier et à l'extrémité distale duquel au moins un filet (11) qui peut être inséré dans la bordure de l'ouverture (2) présente dans la cloison cardiaque (4) est prévu. La canule de ponction (6) peut être déplacée avec un ancrage (12) qui fait partie de la fermeture dans la section transversale intérieure du cathéter fileté (10) et du filet (11). Si les bords de l'ouverture (2) se superposent, la patte (15) non tournée vers le cathéter d'amenée (5) peut être dotée d'au moins un deuxième filet (111) ou d'un tube d'aspiration (16) qui résiste à la force exercée par la canule pour ponction (6) lors de la perforation et du placement de l'ancrage (12).
EP06841103A 2005-12-28 2006-12-21 Dispositif de fermeture d'une ouverture presente dans une cloison cardiaque Withdrawn EP1965708A1 (fr)

Applications Claiming Priority (2)

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DE102005062657A DE102005062657A1 (de) 2005-12-28 2005-12-28 Vorrichtung zum Verschliessen einer in einer Herztrennwand befindlichen Öffnung
PCT/EP2006/012413 WO2007079952A1 (fr) 2005-12-28 2006-12-21 Dispositif pour fermer une ouverture dans une cloison cardiaque

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EP (1) EP1965708A1 (fr)
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US20090012557A1 (en) 2009-01-08
US8172872B2 (en) 2012-05-08
WO2007079952A1 (fr) 2007-07-19

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