Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
  • A61M25/0069—Tip not integral with tube
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/008—Strength or flexibility characteristics of the catheter tip
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
  • A61M2025/0079—Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/008—Strength or flexibility characteristics of the catheter tip
  • A61M2025/0081—Soft tip
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
  • A61M2025/0166—Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M2025/1043—Balloon catheters with special features or adapted for special applications
  • A61M2025/1045—Balloon catheters with special features or adapted for special applications for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M2025/1043—Balloon catheters with special features or adapted for special applications
  • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M2025/1043—Balloon catheters with special features or adapted for special applications
  • A61M2025/1075—Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M25/1011—Multiple balloon catheters

Definitions

• the field of the invention relates to devices for introducing a solution into a channel of the human body, more particularly vessels and in particular the Marshall vein.
• the field of the invention relates to devices for the treatment of certain cardiac pathologies. More particularly, the field of the invention relates to that of catheters comprising means for directing a solution to be injected into a channel, for example of the Marshall vein type.
• Marshall's vein is involved in the causes of cardiac fibrillation-like heart disease such as atrial fibrillation, called FA.
• Marshall's vein is a vein of the heart that is not a priori necessary, but because of its involvement in the occurrence of certain pathologies, it is treated when performing an interventional cardiology act at the level of the heart. heart.
• AF atrial fibrillation is an arrhythmia defined by chaotic activation of the atria. It is triggered by atrial extrasystoles initiating multiple and variable reentries.
• the pulmonary veins, a source of extrasystoles and a substrate for reentry, are recognized as the fundamental structures for the initiation and maintenance of atrial fibrillation. They are therefore the main target of ablation.
• Other structures have similar characteristics: superior vena cava, coronary sinus, Marshall's ligament. If the first two can be treated by ablation, Marshall's ligament is hardly accessible by this type of treatment.
• Marshall's ligament is an embryonic vestige resulting from the involution of the left superior vena cava and its musculature. Incomplete apoptosis of the venous musculature leads to the persistence of several muscle connections between the endocardium and the epicardium. Marshall's ligament is therefore made up of a small venous network, called also "Marshall's vein", closely associated with a muscular arborization. This complex structure is conducive to initiation and maintenance of atrial fibrillation through automaticity and reentry mechanisms. Walking between the left pulmonary veins and the left auricle, Marshall's vein joins the large cardiac vein to collapse into the coronary sinus. Like all veins, it is often subject to anatomical variations of path.
• the invention relates to a medical device comprising:
• a catheter characterized in that it comprises a first injection port of a first volume of a processing solution, the first lumen opening at the distal end of the catheter;
• a connecting element extending the first lumen to the catheter tip having a diameter at its lower distal end to the catheter diameter.
• One advantage is to allow the introduction of a volume of alcohol into a localized region within the Marshall's vein and its site while ensuring a seal of the treated area through a connecting element of the catheter.
• the catheter is deformable and the deformation is controllable.
• said joining element is intended to cooperate with a zone of engagement of a first vessel with a second vessel.
• Cooperation is understood to form in particular a sealed contact between the connecting element and the wall of the landing zone.
• the joining element is intended to form a sealed circumferential contact with a zone of engagement of two vessels.
• the joining element comprises a positioning ring intended to form a bearing surface in contact with the engagement zone, the diameter of the positioning ring being greater than the diameter of the catheter.
• the connecting element comprises two electrodes arranged at its distal end.
• the body of the catheter comprises a plurality of electrodes arranged on at least a portion of its circumference.
• the device comprises a first positioning balloon arranged on the wall of the catheter and intended to create a first sealed boundary with the wall of a first vessel.
• the device comprises a second positioning balloon arranged on the wall of the catheter and intended to create a second sealed boundary with a portion of the wall of the first vessel.
• the connecting element has a length of between 2 mm and 2 cm.
• the joining element comprises a portion having a circumferential edge intended to bear against the walls of a vessel.
• the joining element comprises a profile having a concave or straight portion extending from the distal end of the catheter towards the distal end of the connecting element.
• the joining element comprises a profile having a substantially conical shape.
• the joining element comprises a rounded distal end.
• the joining element is made of deformable material having a ductility greater than a predefined threshold.
• the connecting element is deformable material having an elasticity greater than a predefined threshold.
• the joining element comprises a profile whose diameter varies to form a sealed wall between a first vessel and a second vessel when the distal end of the catheter is positioned in abutment against the wall of the vessel.
• the catheter has at least one electrode disposed at the distal surface of the catheter body for recording electrical activity in the vessel.
• the first light comprises a diameter of between 2F and 5F, preferably 4F.
• the invention relates to a use of a device of the invention for the treatment of the Marshall's vein and its stoma.
• the treatment concerns in particular the alcoholization of this region, in particular with the aim of carrying out a chemical ablation.
• FIG. 1 a sectional view along a longitudinal plane of an embodiment of a device of the invention
• FIG. 2 is a 3D view of an embodiment of a device of the invention.
• FIG. 3A an embodiment of a device of the invention arranged near the anastomosis of vessels 42 and 41;
• Fig 3B an embodiment of a light having an ending forming an appendix
• FIG. 4 a sectional view according to a side plane of an embodiment of a device of the invention.
• FIG. 5 a three-dimensional representation of a heart on the surface of which the Marshall vein is represented;
• FIG. 6A, 6B, 6C different embodiments of the connecting element extending the distal end of the catheter of the invention
• ⁇ 7A, 7B an example of connection between a connecting element and a catheter of the invention
• ⁇ Figure 8 an example of a junction member having distal electrodes for measuring an electric field
• ⁇ Figure 9 An example of a device of the invention comprising a joint member having distal electrodes for measuring a first electric field and electrodes on the surface of the catheter body for measuring a second field electric;
• Figure 10 an example of a device of the invention having a side balloon for sealing a zone vis-à-vis a stoma area of a vessel located downstream of the stoma area,
• Figure 1 1 an example of a device of the invention having side balloons for sealing a stoma area vis-à-vis the zones of a vessel located downstream and upstream of the stoma area.
• Figure 1 shows an embodiment of a device of the invention in a longitudinal section.
• the device 1 comprises a catheter 10 provided with a first light LUi.
• the longitudinal section illustrates an example of a catheter 10 having a coaxial LUi light.
• FIG. 3A schematically illustrates the device of the invention arranged in a first vessel 41.
• the catheter 10 comprises a light LUi making it possible to convey, for example, a volume of a first SOLi solution intended to penetrate into a second vessel 42, such as a vein.
• the invention is particularly advantageous when it is applied to the introduction of a SOLi liquid volume into the Marshall vein 42.
• the device 1 of the invention makes it possible to reach the mouth 43 of the Marshall vein 42 with sufficient accuracy so that SOLi solution can penetrate into said vein.
• Figure 5 shows a three-dimensional view of Marshall's vein 42 on the surface of the myocardium.
• the vessel 41 is the coronary sinus and the vessel 42 is the Marshall vein.
• the injected SOLi solution is an alcohol solution.
• One advantage is to treat the area near the mouth 43 which could not be achieved with the existing solutions addressed to the problem of AF.
• the solution SOLi injected is an iodine solution.
• FIG. 1 represents an injector 31 comprising a solution SOLi intended to be injected into a vessel 42 of the human body.
• a piston 32 is shown to illustrate the function of engaging the SOLi solution in the LUi light.
• a valve 30 allows in this example to open or not the passage to a volume of SOLi solution to be transmitted.
• the valve 30 can make it possible to evacuate a volume of air and / or to control the pressure inside the light LUi.
• Other embodiments are conceivable in order to generate a controlled pressure of the solution SOLi so that it can be ejected towards the zone to be treated 43 via the light LUi and the appendix 20 prolonging the light LUi.
• the first light LUi allows the passage of a guide for directing the catheter 10 until reaching the vessel 42.
• One advantage is to achieve, for example, the interior of the vein Marshall from a guide.
• the catheter 10 of the invention makes it possible to sequence a first treatment at the abutment 43 and a second treatment inside the vessel 42, for example, thanks to a second light LU2, such as that an angioplasty balloon, able to move within the first light LU1 and whose diameter does not exceed that of the appendix 20.
• FIG. 3B represents a case where the second light LU2 comprises a termination forming a Appendix 20, such as a conical shaped termination or having a triangular section.
• the first light LU1 is a light of diameter 4F.
• FIG. 3A represents, in fact, a Marshall vein 42 opening onto a vein 41.
• the catheter 10 is introduced into the vein 41 so as to present the outlet 17 of the distal end of the appendix 20 in the mouth of the Marshall vein 42.
• the catheter 10 has been deflected and present. a deformation that could be controlled by means of a proximal handle 12.
• the undistorted trace of the catheter 10 is retained in Figure 3A.
• An advantage of the invention is that it makes it possible to treat the proximal end of the vessel 42, i.e. the area 43 which would not have been if an arm of a catheter member 10 had entered the vein 42.
• the device 1 comprises a connecting element 20 forming a distal appendix prolonging the light LUi which is integrated in the catheter 10.
• the joining element 20 may be attached to the catheter 10 in different ways. It can be screwed or clipped for example if the distal end 13 of the catheter 10 provides a suitable attachment. According to another embodiment, the appendix is welded or glued to form a single integral part of the catheter 10.
• FIG. 7A represents an exemplary embodiment in which the connecting element 20 comprises a channel 22 extending the light LUi. It further comprises a circumferential groove 21 intended to cooperate with an internal groove 130 of the distal end 13 of the catheter 10 of FIG. 7B.
• the connecting element 20 may be made of slightly deformable material so as to be inserted and ensure occlusion and sealing. According to this embodiment, seals may be added and gluing may be performed to reinforce the integral connection between the joining member 20 and the catheter 10.
• the joining element 20 may comprise different shapes so as to ensure a first sealing function between the vessel 41 and the vessel 42, especially when a treatment solution is injected into the vessel 42. It is advantageous to maintain the distal end 13 of the catheter 10 in contact with the engagement of the vessel 42. The maintenance of the contact ensures that the solution SOLi does not flow back into the vessel 41.
• FIG. 6A shows an exemplary form in which the joining element 20 has an "S" shaped profile. This shape allows a good introduction of the connecting element 20 into the Marshall vein 42 while providing a curved surface to match the shape of the engagement 43.
• FIG. 6B shows another example of the shape of the profile of the joining element 20. In this case, the joining element 20 has a circumference which decreases linearly.
• Appendix 20 has a substantially conical shape. This shape allows a good fit of the junction element 20 in Marshall's vein 42. The diameter and position of the Marshall's vein narrowing is subject to important anatomical variations. This solution therefore makes it possible to obtain an end that is adaptable to different abutment morphologies.
• FIG. 6C represents another variant of profile shape of the appendix 20.
• This "hyperbole" shape makes it possible to ensure the introduction of the distal portion of the catheter 20. It makes it possible to introduce a larger part of the appendix in the vein of Marshall 42 only in the cases of Figures 6A and 6B. This mode is for example suitable if the Marshall's vein 42 has a complex, hypertrophied or abnormal anatomy.
• the joining element 20 comprises a portion 25 intended to penetrate the vessel 42 having a contact surface with the vessel 42 extending over 1 mm to 2 cm, preferably 3 mm to 1 cm.
• the connecting element 20 has an outside diameter smaller than the outside diameter of the catheter 10 over a length of 1 mm to 2 cm, preferably 3 mm to 1 cm.
• the joining element 20 has a rounded end. This embodiment makes it possible not to damage or tear body tissue as it passes through the vessels.
• the joining element 20 is made of a flexible material. It may be, according to one example, deformable so as to adapt to the geometry of the engagement 43 of the Marshall vein 42. It may be made of plastic or elastic material. According to one embodiment, it consists of a polymer material or a silicone.
• the material of the joining element 20 has an elasticity greater than a predefined threshold.
• the threshold is defined for example according to a% of the elasticity of the tissues present on the surface of the vessels in the myocardium, for example that of the coronary sinus.
• the elasticity of the connecting element 20 is substantially close to the average elasticity of the myocardial tissues.
• the material of the joining element 20 has a ductility allowing a slight deformation to ensure a sealed contact cooperating with the geometry of a stuck.
• the joining element 20 is made of hard material to promote its introduction.
• the light LU 1 is coaxial with the catheter 10.
• a guide ensuring the stability of the catheter 10 in a vessel 41, for example a vein-type blood vessel such as the coronary sinus .
• the guide can be removed so as to introduce SOLi solution in a second step.
• the catheter is deflectable.
• the deflection is controlled by a proximal handle.
• the catheter can be, for example, guided from a proximal handle, it is called catheter made deflectable.
• the catheter 10 is compatible with different types of guides that can circulate in a light whose diameter is adapted to its passage.
• a guide can, in fact, be adapted for the purpose of stabilizing the catheter 10.
• the diameter of the distal opening 17 formed by the connecting element 20 can be adapted to the introduction of an alcohol-type treatment solution SOLi, to a developer and / or to the passage of a guide.
• the first light LUi can be used to diffuse a volume of iodine within a vessel 41.
• One advantage is to improve the positioning of the catheter 10 so that the channel 22 of the appendage is precisely opposite the exit opening of the vessel 42 or inside the vessel 42, as illustrated in the zone 43, Figure 3A.
• the injection of iodine by the coaxial light LUi makes it possible to perform a venography of the coronary sinus to locate the Marshall's vein 42.
• This step can be carried out in advance of the positioning of the connecting element 20 with regard to the abutment 43, that is to say to the ostium of the vessel 42 and the vessel 41.
• the injection of alcohol into said vein 42 can be conducted safely by visual assistance from an imaging system.
• the first light LUi is adapted to receive an internal lumen LU2 for the passage of an angioplasty balloon.
• the LU2 lumen can be considered as a small diameter catheter that can be introduced into the LU1 lumen to penetrate more distally into a small caliber vessel.
• the LU1 light is adapted to the passage of an angioplasty balloon.
• the catheter 10 has a diameter between 6 and 9 F allowing it to have at least one central lumen LLI1 but also according to another embodiment of two lights LU1 and LU3.
• Fig. 4 shows an embodiment in which the catheter 10 comprises two lumens LU1 and LU3.
• a guide G1 is introduced into the lumen LU3 so as to guide the catheter 10 and maintain the catheter 10 in a stabilized position during the introduction of SOL1 into the LU1 lumen.
• the device 1 of the invention comprises a sheath of larger diameter than that of the catheter 10.
• the sheath allows the guiding of the catheter 10 to the coronary sinus when it comes to the treatment of Marshall's vein.
• the sheath is an interventional cardiology sheath.
• An advantage of the device 1 of the invention is to allow to perform several functions with a single device.
• the invention relates to a lumen comprising an appendix 20 intended to be secured within the catheter 10 in the coaxial lumen LU1.
• FIG. 3B represents such a light LU2 having an appendix 20.
• the light LU2 can be, for example, positioned within the catheter 10 before it is inserted.
• the catheter 1 comprises one or more collection electrodes arranged in the LU1 light.
• the electrode is arranged to have a conductive portion projecting from the opening 17 of the distal end of the appendix 20.
• the catheter 10 has electrodes on the distal surface of the catheter body for recording electrical activity in the vessel 41.
• the catheter is deflectable.
• the deflection is controlled by a proximal handle.
• the catheter may be, for example, guided from a proximal handle. We speak of catheter made deflectable and thus orientable to facilitate the introduction in the coronary sinus then to the ostium of the vein of Marshall.
• the electrode can be introduced from the proximal opening and be positioned for example by means of a guide at the distal end 17 of the appendix 20.
• the appendix 20 is of deformable material and can be compressed upon its introduction through the proximal end of the catheter 10 to reach the distal end of the catheter 10 where it comes to be hemmed at the distal end of the catheter 10.
• the invention relates to a method of treating the Marshall vein.
• the method comprises:
• a treatment solution SOLi into the first light LUi so that it is conveyed to the landing zone 43 and inside the Marshall vein 42.
• the SOLi treatment solution is an alcohol solution.
• a test liquid such as an iodine solution, is introduced before the treatment solution SOLi in the first light LUi in order to verify the tightness of the contact between the appendix 20 and the wall of the coronary sinus 41, the wall of the vessel 42 or the area forming the entrance of the Marshall vein (vessel 42).
• an introduction of an internal light LU2 in the first light LU1 makes it possible to deliver the developer type solution as an alternative to its routing by the central LU1 light.
• it is removed so as to release the first light LU1 so that the SOLi treatment solution is introduced.
• catheter 10 of the invention is to facilitate the chemical ablation of the area involving the entry of the Marshall vein and the vein itself. Indeed, the catheter 10 provides a destruction of the conduction muscle tissue associated with the Marshall vein. As previously stated, Marshall's vein and its muscular arborization are involved in several ways in the process of atrial fibrillation.
• the invention relates to the use of the catheter for performing an alcoholization of the Marshall vein.
• the catheter 10 is introduced to the mouth 43 of the Marshall's vein 42, the distal appendix 20 is then oriented to cooperate with the wall of the coronary sinus at the area of engagement.
• the outlet of the channel 23 is then oriented opposite the mouth 43 of the Marshall's vein 42.
• the contact between the appendage and the vessel wall at the zone 43 ensures the seal during the introduction of a volume of alcohol in the first LU1 light to be introduced into the Marshall vein 42.
• a volume of alcohol is introduced into the LU1 light.
• An alternative means is to use an angioplasty material with the aforementioned drawbacks in the state of the art.
• a second volume of alcohol may be introduced into the Marshall vein 42 from a device introduced into the first light LU1.
• This embodiment makes it possible to inject a volume of alcohol into the vein 42 and to go beyond the area directly adjacent to the landing zone 43.
• the introduced device may be an angioplasty balloon.
• FIG. 8 represents a connecting element 20 comprising at the distal end 17 of the channel 22 an opening provided on its periphery with at least two electrodes 210 and 21 1.
• the electrodes 210 and 21 are arranged in a connecting element 20 comprising at the distal end 17 of the channel 22 an opening provided on its periphery with at least two electrodes 210 and 21 1.
• the electrodes 210 and 21 are arranged in a connecting element 20 comprising at the distal end 17 of the channel 22 an opening provided on its periphery with at least two electrodes 210 and 21 1.
• the two electrodes 210, 21 1 form a pair of electrodes, including a reference electrode 210 and a working electrode 21 1.
• the two electrodes 210, 21 1 are, for example, separated from one another by an electrical insulator 213 and 212. In the case where the electrodes form an arc at the distal end of the channel 22, the insulating portions 213 and 212 may also form a circular portion.
• the electrodes 210 and 21 1 may be extended inside the catheter 10 by at least one conductive element.
• the conductive elements may be guided, for example, within the catheter 10 by a lumen (not shown). The electric potential can thus be measured from a proximal connector of the catheter 10.
• the proximal material forming the electrodes 210 is a proximal material forming the electrodes 210.
• 212 can be polished metal not to attack the tissues. It may alternatively be of a polymer material to which a conductive powder is injected. Other conductive materials may be used according to other embodiments of the invention.
• An advantage of this configuration is to measure the electrical potential on a wall of a vessel 41, 42 at the staging area 43 or directly on a portion of a wall of a vessel 41 or 42.
• the catheter 10 being deformable from a proximal control, the catheter 10 may be oriented to establish contact between a wall of a vessel and its distal end.
• One advantage is to be able to check the electrical activity in the vessel 41 during a series of heartbeats. This verification makes it possible to validate or not the treatment to be carried out of said vessel 41.
• the joining element 20 comprises a profile 215 adapted to cooperate with the shape of the engagement zone 43 so as to achieve a boundary promoting the sealing of this zone vis-à-vis the upstream and downstream areas of the vessel 41 when the catheter 10 is positioned.
• the joining element 20 comprises a positioning ring 216 having a circumference whose radius may be greater than that of the 10.
• An advantage of a positioning ring 216 is to form a sealed contact at the engaging zone 43.
• the sealing contact forms a ring around the engagement of the vessel 42.
• the positioning ring 21 6 thus makes it possible to secure the tightness of the landing zone 43 to be treated with a SOLi solution.
• the positioning ring 21 6 is a lip forming a rounded edge on the circumference of the distal end of the catheter 10.
• the profile of the lip is convex so as to favor in the first place the contact of this part when the junction element 20 is introduced into the engagement zone 43 towards the vessel 42.
• the positioning ring 21 6 may form a collar, of the collar type.
• the collar 21 6 is removable. In this case, it can be adapted to the geometry of the stitching area 43.
• an image previously made of the area to be treated for example by MRI or by a scanner, makes it possible to choose the joining element 20 when it is removable or allows to choose the ring 216 when it is removable.
• the positioning ring 21 6 is inflatable.
• the inflation is, for example, made from a lumen (not shown) internal to the catheter 10.
• the inflation is preferably carried out remotely.
• a lateral opening on the wall of the catheter 10 can convey a volume of liquid or gas to inflate the positioning ring 21 6.
• the positioning ring 216 is a balloon, the latter can be crimped in a groove of the catheter 10, alternatively the balloon may be glued or heat sealed to the wall of the catheter 10. Bonding may result from a melting of the balloon material into the catheter body.
• the diameter of the joining element 20 decreases beyond the positioning ring 21 6.
• One advantage is to treat the abutment area 43 without the catheter getting too deep into the vessel 42.
• the treatment may be effective in the staging area and not only in the vessel 42.
• the catheter 10 is positioned at the stopping area 43.
• An inflation of the positioning ring 21 6 is performed and a treatment of the area is made from the injection of a volume SOLi solution at this level.
• the positioning ring 216 is deflated and the catheter 10 enters the vessel 42 in order to treat the inside of the vessel 42 with the solution SOLi.
• the catheter 10 is removed.
• Figure 9 shows a catheter 10 provided with a connecting member 20 at its distal end. An operator can then control the orientation of the catheter 10 so as to achieve a curvature sufficient to position the connecting element 20 vis-à-vis the engagement zone 43 to come into contact with the vessel wall 41, 42 at the staging area 43.
• the body of the catheter 10 is provided with electrodes 19 for measuring electrical activity near the staging area 43. It is of interest to verify the electrical conductivity of the vessel 41 downstream or upstream of the landing zone 43, according to how the catheter 10 has entered the vessel 41.
• FIG. 10 shows an example of a catheter 10 having a first lateral balloon 50.
• the lateral balloon 50 is inflated from a first lateral opening of the catheter 10 and a first lumen (not shown) arranged inside. of the catheter 10 and opening on said lateral opening.
• the inflation is made from a first lumen external to the catheter 10.
• the balloon 50 is inflated to form a sealed boundary between the downstream zone at the landing zone 43 and the staging zone 43.
• the balloon 50 can be inflated to block the vessel 41.
• the first balloon 50 makes it possible to improve the tightness of a portion of the vessel 41 vis-à-vis the landing zone 43 to be treated.
• the inflation of the first balloon 50 is carried out until slightly deforming the vessel 41, here visible on the portion 41 1.
• the deformation of the vessel 41 improves the tightness of the boundary formed due to the pressure exerted on the wall of the vessel 41.
• the balloon 50 makes it possible to stabilize the positioning of the catheter 10 when the connecting element 20 bears on the walls of the vessels, especially in the engagement zone 43.
• FIG. 11 shows an example of catheter 10 provided with a first lateral balloon 50 and a second lateral balloon 51.
• the side balloon 51 is inflated from a second lateral opening of the catheter 10 and a second lumen (not shown) arranged inside the catheter 10.
• the inflation can be performed from a second lumen external to the catheter 10.
• the balloon is inflated to form a tight boundary between the zone
• the positioning of the second lateral opening of the catheter for inflating the second balloon 51 is preferably arranged upstream of the first opening in the proximal direction.
• this second opening is arranged substantially 180 ° from the first opening on the wall of the catheter 10.
• the use of two balloons 50, 51 makes it possible to define a sealed zone at the level of the landing zone 43 on the one hand with respect to the downstream zone of the landing zone 43 and on the other hand part opposite an upstream zone of the zone of entry 43.
• the second balloon 51 makes it possible to improve the tightness of a portion of the vessel 41 with respect to the landing zone 43 to be treated.
• the second balloon 51 makes it possible to stabilize the positioning of the catheter 10 when the connecting element 20 bears on the walls of the vessels 41, 42, in particular in the engagement zone 43.
• the balloons 50, 51 may be attached to the catheter surface 10.
• a portion of the outer wall of the catheter 10 forms a wall of the inflated volume.
• the balloons are circumferential and form rings or tori around the catheter 10. This is of particular interest for the balloon 51 to completely occlude the vessel 41 downstream of the staging area 43.
• the balloons extend partially to the circumference of the body of the catheter 10.
• the portion 410 of the vessel 41 located upstream of the landing zone 43 is deformed and the area 41 1 of the vessel 41 located downstream of the landing zone 43 is also deformed.
• This deformation aims to strengthen the tightness of the treated area comprising the stitching area 43.
• the balloon is inflated sufficiently to obtain this result.

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• Heart & Thoracic Surgery (AREA)
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• 2018
  • 2018-05-04 FR FR1800426A patent/FR3080773B1/fr active Active
• 2019
  • 2019-05-02 CN CN201980030345.2A patent/CN112074317B/zh active Active
  • 2019-05-02 US US17/052,436 patent/US11173280B2/en active Active
  • 2019-05-02 WO PCT/EP2019/061212 patent/WO2019211363A1/fr unknown
  • 2019-05-02 EP EP19721607.0A patent/EP3787727A1/de active Pending

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