WO2001019269A1 - Stent d'ablation de veine pulmonaire et procede de traitement associe - Google Patents

Stent d'ablation de veine pulmonaire et procede de traitement associe Download PDF

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Publication number
WO2001019269A1
WO2001019269A1 PCT/US2000/024835 US0024835W WO0119269A1 WO 2001019269 A1 WO2001019269 A1 WO 2001019269A1 US 0024835 W US0024835 W US 0024835W WO 0119269 A1 WO0119269 A1 WO 0119269A1
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WO
WIPO (PCT)
Prior art keywords
stent
pulmonary vein
catheter
vein
ablation
Prior art date
Application number
PCT/US2000/024835
Other languages
English (en)
Inventor
David Keane
Original Assignee
The General Hospital Corporation D.B.A Massachusetts General Hospital
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US09/396,959 external-priority patent/US6607520B2/en
Priority claimed from US09/539,056 external-priority patent/US6632223B1/en
Application filed by The General Hospital Corporation D.B.A Massachusetts General Hospital filed Critical The General Hospital Corporation D.B.A Massachusetts General Hospital
Publication of WO2001019269A1 publication Critical patent/WO2001019269A1/fr

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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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • 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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • 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
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00071—Electrical conductivity
    • A61B2018/00083—Electrical conductivity low, i.e. electrically insulating
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00107—Coatings on the energy applicator
    • A61B2018/00136—Coatings on the energy applicator with polymer
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • 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
    • A61B2018/00375—Ostium, e.g. ostium of pulmonary vein or artery
    • 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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1435—Spiral
    • 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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1497—Electrodes covering only part of the probe circumference
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/821—Ostial stents

Definitions

  • the present invention relates to cardiac treatment, and particularly relates to methods and devices for treating cardiac conditions such as atrial fibrillation.
  • Atrial fibrillation is a common cardiac rhythm disorder which can affect the quality of a patient's life and may be associated with significant morbidity.
  • Atrial fibrillation is characterized by a rapid disorganized rhythm of the upper chambers of the heart (the atria). Instead of a single wavefront of electrical activation during regular rhythm, atria fibrillation consists of multiple coexistent wavefronts with random reentry. The condition may arise following cardiac surgery, or after infection. Its etiology is varied and has even been hypothesized in some cases to have a genetic component. While medication is effective to control fibrillation in some patients, endocardial ablation or surgical intervention is often necessary for effective treatment.
  • Endovascular approaches may be used to create lesions using an ablation catheter to block intraatrial conduction.
  • Surgical procedures such as Cox's maze have been used to address the problem. This procedure creates surgical lines to compartmentalize the tissue of the cardiac wall into a plurality of regions which are each too small to support a depolarization/repolarization cycle.
  • the results of early clinical trials of ablation to treat atrial fibrillation indicate that in a significant proportion of patients with atrial fibrillation, the cause lies in the pulmonary veins.
  • the pulmonary veins contain a sleeve of heart muscle in their proximal extension from the left atrium, and episodes of atrial fibrillation are often triggered by rapidly discharging foci in this region of the pulmonary veins. Such rapidly discharging foci may be located as far as several centimeters up a pulmonary vein. Catheter ablation of focal triggers in the pulmonary veins has been reported to prevent the recurrence of atrial fibrillation in some patients.
  • treatment of atrial fibrillation in this set of patients by extracardiac ablation may require close follow up and secondary treatment to avoid complications.
  • a self-expanding stent configured to lodge in a pulmonary vein and having an exposed conductive region forming a loop.
  • the stent is delivered via a flexibly deflectable endo vascular delivery catheter, which is inserted in a femoral vein and follows a transseptal path to carry the stent in a compact form through the left atrium and deliver it to the pulmonary vein.
  • the stent is then at least partially released or ejected from the catheter and expands into position such that the exposed conductive loop contacts the pulmonary vein around the vessel interior circumference.
  • the stent remains electrically attached to the catheter, which carries an energy supply line, such as an RF cable or other energy conductor, or a cryogenic system, for supplying ablation energy or cryothermy to the stent.
  • This line is then energized to form a lesion in that portion of the vessel contacting the exposed loop, after which the stent is detached from the catheter and remains positioned in the vein to maintain vessel patency.
  • the ablation potion may include a proximal loop sized and positioned to contact the posterior left atrial wall outside the os of the pulmonary vein and to ablate a blocking lesion in the wall.
  • the stent has the shape of a simple wire or ribbon helix with one or more full circumferential turns or windings of the helix exposed to operate as an ablation electrode and form the ablation lesion.
  • the remaining turns of the helix may be covered by electrical insulation, so that the ablation energy is selectively placed in a circumferential line or band at the os.
  • the coil forms a closed loop which zig-zags around a ring-like contour such that when expanded it subtends a circumferential cylindrical band around the axis of the vessel.
  • the stent has a proximal coil or loop that is larger than, or expandable to be larger than, the distal portion of its body, which may be formed of coils, loops or other know stenting structures.
  • the proximal portion lies against the endocardial surface of the posterior left atrium, while the distal portion anchors the stent within the pulmonary vein.
  • the proximal portion may be configured to ablate a circumferential lesion outside the pulmonary vein, which may further reduce the risk of inducing pulmonary vein stenosis.
  • Other known stent shapes and structures may be used, which contain, or which are augmented to contain, or which are selectively insulated so as to expose or leave exposed, a conductive loop positioned for defining a blocking lesion at the vessel entrance.
  • the stent may also be used to prevent or treat pulmonary vein stenosis following ablation of the pulmonary vein or adjacent atrium by any other form of ablative energy system, such as cryothermy, laser, ultrasound, microwave or rf energy treatment, among others.
  • ablative energy system such as cryothermy, laser, ultrasound, microwave or rf energy treatment, among others.
  • the proximal portion expands to a size larger than the pulmonary vein os.
  • the stent may be formed of a material such as a shape memory alloy (e.g., nitinol wire or a titanium or other such alloy), or such as a superelastic alloy.
  • a shape memory alloy e.g., nitinol wire or a titanium or other such alloy
  • the wire or structural material of the stent may, moreover, be of light construction since it need only possess sufficient structural resilient force to counteract venous recoil and prevent stenosis.
  • the ablation energy utilized in a stent of the present invention may take several forms.
  • a radio-frequency signal may be applied to an exposed conductor, and optionally irrigation through the conductor or via an ancillary structure, may be provided to cool the surface, vary electrical conduction or otherwise modulate the lesion characteristics.
  • ablation may be effected by laser, ultrasound, microwave or cryothermal ablation.
  • the illustrated structures shall be generally described and referred to simply as rf or electrical ablation structures.
  • the catheter need carry no balloon or other expansion mechanism, and does not actively effect stent expansion, so the delivery system can be quite small. It thus avoids the risk of balloon injury to the venous wall, and avoids the transient pulmonary vein occlusion that occurs with balloon delivery systems.
  • the stent Once deployed, however, the stent may be further expanded, or an anchor mechanism may be set, by balloon inflation if necessary.
  • the electrical connection between catheter and stent may be effected by a fusible link, by a removable ribbon or wire attached with conductive adhesive, or by temporary capture of the stent between, or electrical contact with, conductive components of the stent delivery mechanism.
  • the stent functions as a wall support in the pulmonary vein and thus may reduce wall stress and stretching that occurs, for example, in the presence of left ventricular diastolic dysfunction, mitral stenosis or regurgitation, or other conditions of left atrial hypertension.
  • This further therapeutic support is therefore believed to contribute generally to the integrity of the vessel wall and the health of the subtended lung, and to remove a potential contribution to the development of automaticity in the pulmonary vein myocytes.
  • Figure 1 is a flow chart illustrating steps of the treatment procedure of the present invention
  • Figure 1A illustrates catheter placement of the ablation stent in a pulmonary vein
  • Figure 2 illustrates a pulmonary vein ablation stent delivery catheter in accordance with one embodiment of the invention
  • Figure 3 illustrates a second embodiment of the pulmonary vein ablation stent
  • Figure 4, and 4A-C illustrate a third embodiment of the stent and a method of deployment
  • Figure 4D illustrates another stent embodiment.
  • Figure 1 illustrates basic steps in a method in accordance with the present invention.
  • the method is broadly applicable to block occult trigger signals from reaching the cardiac wall and is applied when one has, as an initial matter, determined that an arrhythmia is initiated or sustained by triggering signals located in a pulmonary vein.
  • a special catheter configured to deliver a stent is employed to access the pulmonary vein.
  • the catheter is inserted percutaneously to the femoral vein and is navigated along the venous system to the right atrium of the heart, through the atrial septum and into the left atrium.
  • the catheter may be of any suitable design which is sufficiently steerable or deflectable for transseptal access and use.
  • the insertion procedure may involve a preliminary procedure for inserting a guide wire, penetrating the atrial septum and positioning the guide wire to guide the catheter to the intended locus.
  • the catheter is then guided, for example to one of the pulmonary veins in the left atrium, and, with its tip positioned just past the ostium, is actuated to deploy the stent carried in the catheter tip at a proximal site within the pulmonary vein.
  • Ablation energy is then provided to form a blocking lesion.
  • FIG. 2 illustrates in schematic form the stent and the catheter tip of one system in accordance with the present invention.
  • the stent 10 is carried within the catheter 5 and is ejected at the time of deployment such that it self-expands to a contour generally larger than that in its stored state, and large enough to exert an outward elastic retaining and supporting force against the wall of the vessel in which it is placed.
  • the illustrated stent 10 is shown as a simple helical winding of diameter larger than the intended vessel inner diameter.
  • Such a stent may be formed of a superelastic material that springs back to a greatly expanded shape, or may be formed of a shape memory alloy (SMA) which reassumes a pre-set larger shape as microstructure of its material composition changes state.
  • SMA shape memory alloy
  • Suitable shape memory alloys include Nitinol and various titanium alloys, for which the properties may be varied by suitable selection of the alloy components in a manner known in the art.
  • the shape of the stent is subject to two constraints, namely that it be self-expanding to form a self-anchoring venous stent when deployed, and that it contain an ablation portion, such as an exposed conductive portion, effective to ablate a blocking line in the vessel at or near the os.
  • this conductive loop or ablation portion is located at the proximal end, so that any extreme current or heating of the stent is restricted to a small initial length that does not contribute substantially to the overall function of supporting the vessel wall.
  • the proximal location assures that the lesion formed by the stent will block substantially all trigger signals originating in the vein.
  • the stent alloy or material may be selected to be compatible with operation at the ablation temperature, or the exposed ablation band may be implemented with a hybrid structure, by a construction with a suitable conductor separately carried by the self-expanding stent.
  • the illustrated stent 10 includes a number of circumferential windings 12a, 12b, 12c... At least one winding, illustratively winding 12b, is located close to the proximal end of the stent and has an exposed conductive surface that directly contacts the surrounding inner wall of the vessel. Other windings illustratively 12a, 12c have insulating material 14 thereabout.
  • Delivery of the stent from the catheter tip and its deployment in the pulmonary vein may be accomplished by any of a number of known mechanisms, such as by having the stent tightly wound or compacted within an outer sheath that is withdrawn to release the stent for radial expansion; or by having a cylindrical sleeve and an inner plunger within the catheter tip that pushes the stent outwardly therefrom, or grips the stent distal end and pulls it, to deploy it in the vessel.
  • the tip assembly further includes a means for energizing the stent after such deployment.
  • the proximal end of stent 10 when initially deployed from the tip remains close to or within the catheter.
  • this end of the stent is electrically connected to an energy delivery line 18 such as an electrically conductive lead, wire or cable that is energized with a suitable RF or other electrical signal.
  • an energy delivery line 18 such as an electrically conductive lead, wire or cable that is energized with a suitable RF or other electrical signal.
  • this RF line is activated so that the conductive loop 12b ( Figure 2) contacting the vessel interior ablates a blocking lesion in an arc around the inner vessel wall along its line of contact between the vessel wall and the exposed stent.
  • the stent is then disconnected from the catheter so that it resides as a separate stent remaining in the pulmonary vessel, and the catheter is withdrawn from the patient.
  • the manner of forming an electrical connection between the energy supply line 18 and the stent 10 may take several forms.
  • One suitable mechanism for connecting the stent and delivery line is to form a fusible link at the junction of the delivery line 18 and the stent 10, with the link having a composition and size that is intended to pass sufficient current for ablating the inner vessel wall, yet to fuse when a short pulse of higher current is applied, thereby causing the two conductive structures to separate.
  • a ground shunt wire within the catheter may be provided to momentarily contact a conductor and cause the link to fuse.
  • Another suitable method of connecting the energy line to the stent is to provide a conductive cylinder or piston at the catheter distal tip which operates as the stent ejection mechanism and which is also connected to the energy supply line. This mechanism captures the proximal end of the stent between or against a structure such as the surrounding sleeve or catheter body (not numbered) . The stent then remains electrically connected to the energy source so long as a portion of the distal stent end has not been fully ejected from the catheter. Once the ablation energy has been applied, the cylinder or piston is then advanced (or retracted) to the end of its travel to release the stent entirely and electrically disconnect it.
  • a third suitable method of connection is to provide a pigtail connection that may be broken off or severed, or is attached by conductive adhesive and may be peeled back by a simple low-tension pull.
  • Conductive gel or the like may also be used to effect or improve a temporary conductive coupling between parts of the tip assembly and the stent.
  • the stent of Figure 2 is a simple open helical coil. However, applicant contemplates that other forms of expandable or self-expanding stent may be employed or adapted for the intended application.
  • the shape of the stent may take any of a number of forms, such as a serpentine wire or ribbon configuration, a bent-corner zig-zag configuration or other coil configuration compatible with SMA or superelastic expansion or re-shaping for deployment.
  • a stent may be formed in a closed loop that extends in a narrow zigzag band around a generally circumferential direction as illustrated in Figure 3 in a side view.
  • the stent 20 is formed of a single strand of material which zig-zags back and forth over a width W in the axial direction, and forms a closed loop so as to provide a springy structure which self-expands to a much greater diameter and provides radial support of the vessel wall.
  • the entire stent length may operate as an exposed conductor ablation wire.
  • a superelastic or shape memory alloy material may be employed to form the stent and cause it to self-expand without requiring a balloon or other external source of pressure or mechanical expansion force.
  • the self-expanding stent have sufficient outwardly directed force to resist the elastic recoil of the vein, which is rather small in magnitude, and to guard against stenotic narrowing of the vessel following ablation.
  • the ablative operation of the stent may be essentially a unipolar ablation, and carried out by applying RF energy to the conductive contacting portion of the stent while, for example, providing a return path through a large area surface electrode or ground electrode located on the patient's skin.
  • the ground electrode may be positioned so as to minimize the possibility of current paths extending through the heart itself.
  • the ablating loop may carry multiple electrode elements to allow either unipolar or bipolar RF energy delivery as well as cardiac signal recording.
  • Figure 4 shows a third embodiment 30 of the pulmonary vein stent of the present invention configured for delivery by a catheter 5.
  • the proximal portion of the stent 30 includes a loop 34 that is substantially larger in diameter than the pulmonary vein and remains outside the vein, and a distal portion 32 that extends into and anchors within the vein.
  • the proximal portion may be the ablation portion, deployed to lie against the endocardial surface of the posterior left atrium and ablate a circumferential lesion outside of and entirely surrounding the pulmonary vein os.
  • Figures 4A-4C illustrate installation and operation of this stent with one delivery catheter 5.
  • the stent 30 may be delivered by a catheter delivery system wherein an axially-moved member 37 engages the distal end 32 of the stent and advances to pull the coiled stent into the pulmonary vein, while the proximal loop 34 remains connected via a catheter 5 to a source of ablation energy. This tensile pulling may reduce the diameter of the coils 32, allowing clearance for the stent to travel up the pulmonary vein to an anchoring site.
  • the puller is then disengaged and may be retracted into the catheter, while the proximal loop 34 elastically bears against the endocardial surface of the posterior left atrium along a path that substantially surrounds the os, while remaining connected to the ablation energy source by connecting portion 38.
  • the proximal loop 34 is configured to apply the ablation energy, while the distal portion 32 operates as a stent to anchor the assembly and prevent stenosis.
  • the ablation lesion, corresponding to position of the proximal loop or loops 34 in Figure 4C is thus entirely outside the pulmonary vein.
  • both the distal and proximal portions may be energized.
  • a stent shaped as in Figure 4 may also be constructed, or used, as a pulmonary vein stent without ablation, to assure patency of the vessel after treatment or ablation has been effected with some other or a conventional ablation catheter.
  • Such a stent may be implemented with spaced-apart loops rather than a helical structure, and may include longitudinal struts to provide further wall support and prevent intercoil recoil, as shown in Figure 4D.
  • various other forms of stent either proposed in the literature or existing as commercial products may be readily adapted for the practice of the present invention, and in this case the electrical driving current or other ablation energy and the delivery mechanisms may be modified as appropriate for allowing deployment while connected, and then severing the catheter ablation energy connection.
  • Stents such as flexstent-type, wallstent-type, Gianturco-type stents or Palmaz-type stents may be constructed and configured for the practice of the invention by applying insulation over the distal ends and providing an energy connection in the tip assembly.
  • An expansion balloon may be further provided if needed, dimensions permitting, and the stent itself may be configured with projecting barbs, or treated to assure effective anchoring.
  • Known RF and other ablation consoles may be adjusted or programmed to apply suitable levels of RF ablation or treatment energy through the exposed portion of the stent.
  • suitable levels of RF ablation or treatment energy through the exposed portion of the stent.
  • impedance matching elements may be employed to more closely achieve the desired circuit characteristics for the described ablation procedure.
  • the conductive portions (12b in Figure 2, 34 in Figure 4 or the entire stent in Figure 3) need not entirely circumscribe the vessel, but are preferably to extend substantially entirely around a full arc and define a blocking lesion of a contour that effectively isolates the distal vessel wall from conduction to and across the ostium into the atrial wall.
  • the spiral configuration of the stent shown in Figure 2 may not entirely disconnect the vessel from the cardiac wall, but may leave a narrow region between successive turns in which, although signals may still be propagated, the length and geometry of the unblocked region effectively prevents trigger signal leakage to the heart.
  • the embodiment of Figure 3 forms a completely circumferential blocking lesion, and that of Figure 4 may employ partial or multiple turns in the enlarged initial winding 34 to achieve either form of such blocking lesion.
  • the latter stent and its delivery catheter may also be configured so that the ablation loop 34 detaches from the distal installed stent portion 32 and is simply retracted into the catheter following ablation.
  • This embodiment may be viewed as a specialized ablation catheter similar to the ablation catheter of the above mentioned United States patent application, having an ablation electrode winding that extends in a broad loop or arc in a plane generally transverse or perpendicular to the axis of the catheter, and with a pulmonary vein stent structure further integrated with the ablation electrode.

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Abstract

Un système de traitement de la fibrillation auriculaire comprend un stent (10) et un cathéter de guidage (5) qui achemine le stent (10) jusqu'à un site de traitement. Le stent est auto-expansible et réalisé par exemple dans un alliage à mémoire de forme et sa configuration est telle qu'il peut porter contre la paroi intérieure d'une veine pulmonaire. Le stent (10) peut se présenter sous forme de boucle (34), d'hélice (32), d'hélice à enroulement progressif ou bien d'une autre forme appropriée et dans une forme de réalisation ledit stent comporte une partie proximale exposée incluant une région d'ablation qui est en contact et se trouve dessous et à proximité d'un pourtour de la veine ou qui se trouve en contact avec le tissu de la paroi endocardique sur une longueur circonférentielle au niveau de l'ostium. La partie proximale (18) est reliée à une ligne de distribution d'énergie présente dans le cathéter (5) pour alimenter le stent (10) en énergie et le mettre sous tension et pratiquer l'ablation du tissu dans la région circonférentielle, ceci formant une lésion qui bloque la conduction au niveau de l'ostium ou qui empêche des signaux de déclenchement provenant de la veine pulmonaire d'amorcer ou d'assurer la fibrillation dans l'oreillette. Le stent (10) soutient également la paroi du vaisseau et réduit ainsi la probabilité que se développe une sténose de la veine pulmonaire. Le stent (10) peut également être déployé sans pratiquer d'ablation concurrente ou concomitante, pour prévenir ou traiter une sténose de la veine pulmonaire primaire ou secondaire.
PCT/US2000/024835 1999-09-15 2000-09-11 Stent d'ablation de veine pulmonaire et procede de traitement associe WO2001019269A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US09/396,959 1999-09-15
US09/396,959 US6607520B2 (en) 1999-09-15 1999-09-15 Coiled ablation catheter system
US09/539,056 US6632223B1 (en) 2000-03-30 2000-03-30 Pulmonary vein ablation stent and method
US09/539,056 2000-03-30

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Publication Number Publication Date
WO2001019269A1 true WO2001019269A1 (fr) 2001-03-22

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PCT/US2000/024835 WO2001019269A1 (fr) 1999-09-15 2000-09-11 Stent d'ablation de veine pulmonaire et procede de traitement associe
PCT/US2000/024836 WO2001019270A1 (fr) 1999-09-15 2000-09-11 Systeme de catheter d'ablation cardiaque spirale

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WO2003053248A2 (fr) * 2001-12-11 2003-07-03 Medtronic, Inc. Methode et systeme de traitement de tachyarythmies atriales
EP1332724A1 (fr) * 2002-01-31 2003-08-06 Biosense, Inc. Isolation de la veine pulmonaire a l'aide d'une radiofréquence
DE10218426A1 (de) * 2002-04-24 2003-11-06 Biotronik Mess & Therapieg Ablationsvorrichtung für Herzgewebe, insbesondere zur Erzeugung linearer Läsionen zwischen zwei Gefäßmündungen im Herzen
WO2004049976A1 (fr) * 2002-12-03 2004-06-17 Boston Scientific Limited Traitement d'arythmies par modification de proprietes de tissu
WO2004078065A3 (fr) * 2003-03-03 2004-10-21 Sinus Rhythm Technologies Inc Implant de bloc electrique
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US7266414B2 (en) 2003-10-24 2007-09-04 Syntach, Ag Methods and devices for creating electrical block at specific sites in cardiac tissue with targeted tissue ablation
US8257376B2 (en) 2003-11-17 2012-09-04 Syntach Ag Device, a kit and a method for treatment of disorders in the heart rhythm regulation system
US8579955B2 (en) 2001-07-06 2013-11-12 Syntach Ag Anti-arrhythmia devices and methods of use
US9398967B2 (en) 2004-03-02 2016-07-26 Syntach Ag Electrical conduction block implant device

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US8712550B2 (en) * 2008-12-30 2014-04-29 Biosense Webster, Inc. Catheter with multiple electrode assemblies for use at or near tubular regions of the heart
US10166067B2 (en) * 2009-02-12 2019-01-01 St. Jude Medical, Atrial Fibrillation Division, Inc. Ablation catheter and method for electically isolating cardiac tissue
WO2013028993A2 (fr) * 2011-08-24 2013-02-28 Boston Scientific Scimed, Inc. Dispositif et procédés de modulation de nerfs
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Cited By (18)

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US6890329B2 (en) 1999-06-15 2005-05-10 Cryocath Technologies Inc. Defined deflection structure
US8579955B2 (en) 2001-07-06 2013-11-12 Syntach Ag Anti-arrhythmia devices and methods of use
EP1306063A1 (fr) * 2001-10-25 2003-05-02 Curative AG Stent
WO2003053248A3 (fr) * 2001-12-11 2004-02-26 Medtronic Inc Methode et systeme de traitement de tachyarythmies atriales
WO2003053248A2 (fr) * 2001-12-11 2003-07-03 Medtronic, Inc. Methode et systeme de traitement de tachyarythmies atriales
US6814733B2 (en) 2002-01-31 2004-11-09 Biosense, Inc. Radio frequency pulmonary vein isolation
EP1332724A1 (fr) * 2002-01-31 2003-08-06 Biosense, Inc. Isolation de la veine pulmonaire a l'aide d'une radiofréquence
DE10218426A1 (de) * 2002-04-24 2003-11-06 Biotronik Mess & Therapieg Ablationsvorrichtung für Herzgewebe, insbesondere zur Erzeugung linearer Läsionen zwischen zwei Gefäßmündungen im Herzen
WO2004049976A1 (fr) * 2002-12-03 2004-06-17 Boston Scientific Limited Traitement d'arythmies par modification de proprietes de tissu
US7097643B2 (en) 2003-03-03 2006-08-29 Sinus Rhythm Technologies, Inc. Electrical block positioning devices and methods of use therefor
US8409268B2 (en) 2003-03-03 2013-04-02 Syntach Ag Electrical conduction block implant device
WO2004078065A3 (fr) * 2003-03-03 2004-10-21 Sinus Rhythm Technologies Inc Implant de bloc electrique
US8840658B2 (en) 2003-03-03 2014-09-23 Syntach Ag Electrical conduction block implant device
US7266414B2 (en) 2003-10-24 2007-09-04 Syntach, Ag Methods and devices for creating electrical block at specific sites in cardiac tissue with targeted tissue ablation
US8257376B2 (en) 2003-11-17 2012-09-04 Syntach Ag Device, a kit and a method for treatment of disorders in the heart rhythm regulation system
US9295484B2 (en) 2003-11-17 2016-03-29 Syntach Ag Device, a kit and a method for treatment of disorders in the heart rhythm regulation system
US9398967B2 (en) 2004-03-02 2016-07-26 Syntach Ag Electrical conduction block implant device
WO2005096996A1 (fr) * 2004-04-01 2005-10-20 Cappella, Inc. Stent orificiel

Also Published As

Publication number Publication date
CA2388823A1 (fr) 2001-03-22
WO2001019270A1 (fr) 2001-03-22
EP1223876A4 (fr) 2003-05-02
JP2003522561A (ja) 2003-07-29
EP1223876A1 (fr) 2002-07-24
CA2638963A1 (fr) 2001-03-22
CA2638963C (fr) 2012-03-20
CA2388823C (fr) 2008-11-18

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