WO2018065047A1 - Method for protecting a patient's esophagus while ablating tissue of the patient's heart and intra-esophageal system therefor - Google Patents

Method for protecting a patient's esophagus while ablating tissue of the patient's heart and intra-esophageal system therefor Download PDF

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Publication number
WO2018065047A1
WO2018065047A1 PCT/EP2016/073772 EP2016073772W WO2018065047A1 WO 2018065047 A1 WO2018065047 A1 WO 2018065047A1 EP 2016073772 W EP2016073772 W EP 2016073772W WO 2018065047 A1 WO2018065047 A1 WO 2018065047A1
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Prior art keywords
esophagus
intra
patient
heart
esophageal
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PCT/EP2016/073772
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French (fr)
Inventor
Philippe DEBRUYNE
Original Assignee
Dr. Philippe Debruyne Bvba
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Priority to PCT/EP2016/073772 priority Critical patent/WO2018065047A1/en
Publication of WO2018065047A1 publication Critical patent/WO2018065047A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/04—Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • 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
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00084—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00818—Treatment of the gastro-intestinal system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/30—Surgical pincettes without pivotal connections
    • A61B2017/306—Surgical pincettes without pivotal connections holding by means of suction
    • 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
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/04—Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery
    • A61B2090/0409—Specification of type of protection measures
    • A61B2090/0427—Prevention of contact
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/42—Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
    • A61B5/4222—Evaluating particular parts, e.g. particular organs
    • A61B5/4233—Evaluating particular parts, e.g. particular organs oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device

Definitions

  • the invention pertains to the technical field of esophagus displacement in function of minimally invasive treatments of organs inside the body of a living subject. More specifically, this invention pertains to a method for protecting a patient's esophagus while ablating tissue of the patient's heart and an intra-esophageal system therefor.
  • Esophagus lesions are quite common after pulmonary vein isolation and resulting vagal nerve damage is not uncommon. Such nerve damage frequently gives rise to problems with gastric emptying. Esophagus lesions are frequently asymptomatic but can also lead to a fistula between the left atrium and the esophagus, a medical condition with nearly 100% mortality.
  • the present invention aims to resolve at least some of the problems mentioned above.
  • a first aspect of the present invention provides a method for protecting a patient's esophagus 2 while ablating tissue of the patient's heart, comprising the steps of: - inserting an intra-esophageal system into the esophagus 2 of a body;
  • the intra-esophageal system applies a negative pressure along an area of the esophagus 2.
  • the application of a negative pressure creates a suction force which moves the esophagus 2 from an initial position close to the patient's heart to a second position further away from the patient's heart.
  • the application of a suction force is an intuitive and well-controllable means to move the esophagus 2 without damaging the esophagus 2.
  • a second aspect of the present invention provides an intra-esophageal system for protecting a patient's esophagus 2 while ablating tissue of the patient's heart, wherein the system comprises a cranial part 34, a caudal part 36, and a mid-part 35 in between said cranial 34 and caudal parts 36, wherein at least an area of said mid-part 35 is provided with perforations 20, wherein at least one of said parts 34, 35, 36 comprises at least one balloon 8, 9, 11, 21, and wherein at least one of said parts is operably connectable to pneumatic lines 15, 16, 17, 18, 22.
  • the perforations 20 in the mid-part 35 are optimally suitable to transfer a negative pressure which is applied in said mid-part 35 to the esophagus 2.
  • the esophagus 2 will be moved from an initial position close to the patient's heart to a second position further away from the patient's heart.
  • the cranial 34 and caudal parts 36 allow occluding the esophagus 2 around said mid-part 35, which enables the application of a negative pressure which is confined to said mid-part 35 and which can be directed to the esophagus 2 by said perforations 20.
  • the intra-esophageal system is easy to construct and may be constructed from affordable materials. DESCRI PTI ON OF Fl GURES
  • FIG. 1 is a left lateral view of a human's heart left atrium 1 and esophagus 2, showing the esophagus 2 prior to widening (A), when widened (B) and with an area of the esophagus 2 which is displaced from the left atrium 1 (C), according to an embodiment of the present invention.
  • FIG. 2 shows an embodiment of an intra-esophageal system according to the present invention without (A) and with (B) a vacuum between two balloons 11, 21.
  • FIG.3 shows another embodiment of an intra-esophageal system according to the present invention without A and with B a vacuum between two balloons 9, 11.
  • FIG. 4 is a left lateral view of a human left atrium 1 and esophagus 2, showing the different steps (A-H) of a displacement method of the esophagus 2 away from the left atrial posterior wall, according to an embodiment of the present invention.
  • Atrial fibrillation is the most common human arrhythmia.
  • the incidence of atrial fibrillation increases with, and thus, the incidence of atrial fibrillation is becoming more prevalent as the average lifespan continues to increase.
  • Atrial fibrillation is associated with increased morbidity and mortality and, in particular, a general decrease in quality of life for those afflicted with atrial fibrillation.
  • Patients are at an increased risk of stroke unless they are treated adequately with anticoagulants.
  • Anticoagulant treatment however, increases a patient's risk of bleeding, which carries with it its own set of dangers.
  • Medications currently available for treating atrial fibrillation have proven to be only moderately effective in decreasing the incidence of recurrent atrial fibrillation, and these mediations do not decrease the patient's risk of having a stroke.
  • Atrial fibrillation has been to perform ablation of selected areas of the left atrium. There is evidence to suggest that ablating these areas of the left atrium serves to cure or prevent recurrence of atrial fibrillation. Typically, ablations of this type are carried out via an intravascular catheter using radiofrequency or microwave energy to cause thermal damage to the selected parts of the left atrial tissue.
  • the posterior wall of the left atrium is particularly targeted for ablation because the pulmonary veins enter the atrium at this area of the left atrium.
  • the esophagus may, however, be positioned so as to overlie one or more of these veins, thereby making the desired encirclement risky.
  • a significant and lethal complication of atrial fibrillation ablation is the accidental occurrence of an atrio-esophageal fistula following the development of lesions on the posterior wall of the left atrium. Because the esophagus is generally closely positioned to the posterior wall of the left atrium, thermal injury may result in the occurrence of the atrio-esophageal fistula.
  • fractionated electrograms and vagal plexi are also in close vicinity of the esophagus. These are also common targets of atrial fibrillation ablation. Again, the location of the esophagus may hinder application of a sufficient energy to successfully ablate enough tissue of the left atrium to prevent recurrence of atrial fibrillation. Further, the esophagus is a mobile structure. Thus, one cannot rely on a medical image, such as a CT scan, made before procedure for determining the actual position of the esophagus relative to the left atrium at the time of ablation.
  • the present invention aims to effectively reduce the risk of damage to the esophagus 2 during cardiac ablation by moving the esophagus 2 away from the heart during treatment.
  • a first aspect of the present invention provides a method for protecting a patient's esophagus 2 while ablating tissue of the patient's heart, comprising the steps of:
  • the intra-esophageal system applies a negative pressure along an area of the esophagus 2.
  • the application of a negative pressure creates a suction force which moves the esophagus 2 from an initial position close to the patient's heart to a second position further away from the patient's heart.
  • the application of a suction force is an intuitive and well-controllable means to move the esophagus 2 without damaging the esophagus 2.
  • the method according to the first aspect of the present invention applying a negative pressure to move the esophagus 2 from a patient's heart is not to be regarded as obvious to a person skilled in the art, since such person would rather use or optimize the commonly applied procedures for reducing damage to the esophagus.
  • the present invention provides a method according to the first aspect of the invention, wherein the intra-esophageal system is operated by i) expanding the diameter of the esophagus 2 along a portion that exceeds the area where the negative pressure will be applied to afterwards, followed by ii) moving the esophagus 2 from said initial position to said second position by applying a negative pressure along said area. Accordingly, by first expanding the diameter of the esophagus 2, the area of the esophagus 2 wall which receives the negative pressure may be moved further from the heart then when the esophagus 2 would not be expanded. This is an efficient and easy manner to allow a sufficient displacement of the esophagus 2 by applying a negative pressure.
  • FIG. 1 depicts a left lateral view of a human's heart left atrium 1 and esophagus 2, showing the esophagus 2 prior to widening (A), when widened (B) and with an area of the esophagus which is displaced from the left atrium 1 (C).
  • the diameter of the esophagus matches X1 , as indicated on FIG. 1.
  • the combination of widening (B) the esophagus 2 to a diameter X2 followed by displacement of said area of the esophagus 2 further away from the heart allows for a sufficient distance between the esophagus 2 and heart, as indicated by X4.
  • the diameter of the esophagus 2 is locally decreased to diameter X3.
  • the widening or expansion of the esophagus is performed with a flexible and expandable means. Yet any means to widen or expand the esophagus which does not damage the esophagus substantially, as known in the prior art, may be used.
  • the present invention provides a method according to the first aspect of the invention, wherein said negative pressure is applied along an area of the esophagus 2 which faces the patient's left atrium 1.
  • said negative pressure is applied along an area of the esophagus 2 which faces the patient's left atrium 1.
  • the esophagus 2 is displaced or moved further away from the left atrial posterior wall.
  • FIG. 1 where the distance X4 depicts the thus created distance between the left atrial posterior wall and the esophageal anterior side.
  • anterior 5, posterior 6 and cranial 7 orientations are shown on Fl G. 1.
  • the posterior wall of the left atrium 1 is particularly targeted for ablation in the context of treatment of atrial fibrillation because the pulmonary veins enter the atrium at this area of the left atrium 1.
  • Displacement of the esophagus 2 further away from the left atrial posterior wall by applying a negative pressure according to the first aspect of the present invention is thus a safe and convenient method to enable the performance of left atrium 1 posterior wall ablation while reducing the risk of damaging the esophagus during ablation.
  • the present invention provides a method according to the first aspect of the invention, wherein said negative pressure is applied along at least 1%, more preferably at least 5%, even more preferably at least 10%, even more preferably at least 15%, even more preferably at least 20%, even more preferably at least 25%, even more preferably at least 30%, even more preferably at least 40% and even more preferably at least 50% of said area of the esophagus 2.
  • Applying said negative pressure over a substantial part of said area of the esophagus 2 allows for a gentle and spread application of negative pressure and thus a well-guided displacement of the esophagus 2 from an initial position close to the patient's heart to a second position further away from the patient's heart.
  • Such well-guided and gentle displacement is beneficial to reduce the risk of damage to the esophagus 2 while ablating the heart in the proximity of the esophagus 2.
  • the present invention provides a method according to the first aspect of the invention, wherein the intra-esophageal system comprises a cranial part 34 which is suited to be placed into the esophagus 2 at a position which is located more cranially than said area of the esophagus 2 along which a negative pressure is applied, a caudal part 36 which is suited to be placed into the esophagus 2 at a position which is located closer to the stomach 5 than said area of the esophagus 2, and a mid-part 35 between said cranial 34 and caudal parts 36, which mid-part 35 is suited to be placed into the esophagus 2 along said area of the esophagus 2, wherein at least one of said parts 34, 35, 36 comprises at least one balloon 8, 9, 11, 21 , and wherein moving the esophagus 2 from an initial position close to the patient's heart to a second position further away from the patient's heart by operating the intra
  • the present invention provides a method according to the first aspect of the invention, wherein the intra-esophageal system is inserted into and removed from the esophagus 2 by means of a stylet that is attachable to the intra-esophageal system.
  • a stylet is a convenient means for insertion or removal of the intra-esophageal system as a stylet is relatively stiff and can thus be used to transport the intra-esophageal system in a targeted manner to the desired placement into a patient's esophagus 2.
  • the present invention provides a method according to the first aspect of the invention, wherein the intra-esophageal system is inserted into and removed from the esophagus 2 by means of a lumen.
  • Positive attributes of a lumen are its flexibility and softness.
  • the lumen is included within the intra-esophageal system and does not communicate with said cranial 34, mid- 35 and caudal parts 36.
  • the lumen is selected as a casing 19 enveloping said cranial part 34, mid-part 35 and caudal part 36, wherein said casing 19 may further be used to allow the creation of a negative pressure at level of said mid-part 35 when an occlusion of the esophagus 2 is created at said mid-part 35 by means of said cranial 34 and caudal parts 36.
  • the intra-esophageal system is inserted into the esophagus 2 by means of a probe enclosing said system, which probe is preferably retracted from the body once the system is inserted. Subsequently, the system may be removed from the esophagus 2 by any suitable means.
  • the present invention provides a method according to the first aspect of the invention, further comprising the step of measuring the temperature at level of the patient's heart while ablating said heart. Measuring the temperature at level of the patient's heart while ablating said heart delivers information to estimate if the applied ablation energy and resulting temperature could result in damage of the esophagus 2. Measuring the temperature thus delivers information one may use to take action to prevent esophageal damage during ablation of the heart.
  • the present invention provides a method according to the first aspect of the invention, further comprising the step of increasing the applied negative pressure along said area of the esophagus 2 when the measured temperature increases when ablating tissue of the patient's heart. Accordingly, the displacement of the esophagus 2 from the patient's heart is increased when the temperature as generated by ablating the heart increases. In such way, the esophagus 2 can be effectively protected from damage for a wide range of ablation energies and created temperatures. Besides, the amount of the applied negative pressure is determined with respect of the applied ablation energy, and excessive application of negative pressure is thus prevented.
  • the present invention provides a method according to the first aspect of the invention, further comprising the step of imaging the patient's heart and esophagus 2 while ablating tissue of the patient's heart. Imaging of the patient's heart and esophagus 2 is an additional means to reduce the risk of esophageal damage during ablation of a patient's heart, since the risk of accidental damage of the esophagus 2 by a wrong placement of an ablation catheter is reduced when images of the patient's heart 2 and esophagus are available.
  • the size and structures of the esophagus 2 vary among the population. An image of a patient's heart and esophagus 2 thus delivers valuable information to determine in which extent the esophagus 2 is best displaced with respect to the heart while ablating said heart.
  • a second aspect of the present invention provides an intra-esophageal system for protecting a patient's esophagus 2 while ablating tissue of the patient's heart, wherein the system comprises a cranial part 34, a caudal part 36, and a mid-part 35 in between said cranial 34 and caudal parts 36, wherein at least an area of said mid-part 35 is provided with perforations 20, wherein at least one of said parts 34, 35, 36 comprises at least one balloon 8, 9, 11, 21, and wherein at least one of said parts 34, 35, 36 is operably connectable to pneumatic lines 15, 16, 17, 18, 22.
  • Said intra-esophageal system according to the second aspect of the present invention is suited and configured to be placed in the esophagus 2 of a patient.
  • cranial and caudal are terms for the orientation of the individual parts of the intra-esophageal system which are based on the manner wherein the intra- esophageal system is desirably placed in the esophagus 2 for protection of the esophagus 2 while ablating tissue of the patient's heart, with the cranial part 34 desirably placed more cranially than the caudal part 36, which on its turn is desirably placed more caudally than the cranial part 34.
  • At least one of said parts 34, 35, 36 is operably connected to pneumatic lines 15, 16, 17, 18, 22.
  • the cranial part 34 is connected to a guiding means.
  • the cranial part 34 may be connectable and preferably connected to a wire for guiding the intra-esophageal system.
  • said perforations 20 are positioned at a limited region with respect of the circumference of said mid-part 35.
  • said perforations 20 are placed in a manner that when the intra-esophageal system is placed in the esophagus 2 of a patient, a negative pressure can specifically be applied through the perforations 20 towards the area of the esophagus 2 which faces the left atrium 1.
  • the intra-esophageal system is a single- use system, for the sake of hygienic considerations.
  • FIG. 2 shows a preferred embodiment of such system according to the second aspect of the present invention without (A) and with (B) a vacuum applied between two balloons 11, 21.
  • the perforations 20 in the mid-part 35 are optimally suitable to transfer a negative pressure which is applied in said mid-part 35 to the esophagus 2.
  • the esophagus 2 will be moved from an initial position close to the patient's heart to a second position further away from the patient's heart.
  • the cranial 34 and caudal parts 36 allow occluding the esophagus 2 around said mid-part 35, which enables the application of a negative pressure which is confined to said mid-part 35 and which can be directed to the esophagus 2 by said perforations 20.
  • the intra-esophageal system is easy to construct and may be constructed from affordable materials.
  • the intra-esophageal system according to the second aspect of the present invention applying a negative pressure to move the esophagus 2 from a patient's heart is not to be regarded as obvious to a person skilled in the art, since such person would rather use or optimize traditional intra-esophageal systems comprising only one-balloon or alternative arrangements than devise an intra- esophageal system with more than one balloon.
  • said cranial 34, mid- 35 and caudal parts 36 are suited to be enveloped by a casing 19 comprising perforations 20 at level of said mid-part 35.
  • said cranial 34, mid- 35 and caudal parts 36 are enveloped by a casing 19 comprising perforations 20 at level of said mid-part 35.
  • Such casing 19 has the advantage that it functions as a perforated body as well as a means to hold the cranial 34, mid- 35 and caudal parts 36 together.
  • such casing 19 is anchored to the side of any present balloons 8, 9, 11, 21 which faces away from the heart when the intra-esophageal system is placed into the esophagus 2.
  • the intra-esophageal system comprises a tube comprising perforations 20 as an embodiment of said mid-part 35.
  • Such perforated tube has the advantage that it is a very simple structure and thus contributes to a simple and cost-effective construction of the intra- esophageal system.
  • the present invention provides an intra-esophageal system according to the second aspect of the invention, wherein said perforations 20 are distributed over at least 15%, more preferably over at least 20%, even more preferably over at least 25%, even more preferably over at least 30%, even more preferably at least 40% and even more preferably at least 50% of the area of said mid-part 35.
  • Applying said negative pressure over a substantial part of said area of the mid-part 35 and subsequently over a substantial part of the esophagus 2 allows for a gentle and spread application of negative pressure and thus a well- guided displacement of the esophagus 2 from an initial position close to the patient's heart to a second position further away from the patient's heart.
  • the displacement of the esophagus 2 is caused by suction of the esophagus 2 wall which is effected by the applied negative pressure.
  • Such gentle and well-guided displacement is beneficial to reduce the risk of damage to the esophagus 2 while ablating the heart in the proximity of the esophagus 2.
  • the present invention provides an intra-esophageal system according to the second aspect of the invention, wherein the at least one balloon 8, 9, 11, 21 is shaped as an asymmetric dumbbell which comprises two linked elliptical portions of which the transition between them is placed outwardly with regard to a central longitudinal axis through the balloon.
  • asymmetric dumbbell which comprises two linked elliptical portions of which the transition between them is placed outwardly with regard to a central longitudinal axis through the balloon.
  • Such shaped balloon enables an effective occlusion of the esophagus 2 at level of said mid-part 35.
  • the asymmetric placement of said transition which transition is preferably elongated and is to be interpreted as an embodiment of the mid-part 35 of the intra-esophageal system, allows for the mid-part 35 to shrink asymmetrically when a negative pressure is applied to the mid-part 35, which is optimally suited to move a patient's esophagus 2 away from the patient's heart.
  • asymmetric dumbbell-shaped balloon has the advantage that it can both be used to provide the necessary occlusion and to move the esophagus 2 away from the heart in a well-directed manner.
  • the present invention provides an intra-esophageal system according to the second aspect of the invention, wherein said cranial 34 and caudal parts 36 both comprise at least one balloon 8, 9, 11, 21, and wherein said balloons 8, 9, 11, 21 of said parts 34, 36 are spaced apart from each other and thus establishing an intermediate space between them at level of said mid- part 35, and wherein said balloons 11 of said cranial part 34 and said balloons 8, 9, 21 of said caudal part 36 are connectable through a connection which is placed outwardly with regard to a central longitudinal axis through said balloons 8, 9, 11, 21.
  • said balloons 11 of said cranial part 34 and said balloons 8, 9, 21 of said caudal part 36 are connected through such connection.
  • the balloons 8, 9, 11, 21 of the cranial 34 and caudal parts 36 allow for an effective occlusion of the esophagus 2 at level of said mid-part 35. Furthermore, the outward placement of said connection, which connection is preferably elongated and is to be interpreted as an embodiment of the mid-part 35 of the intra-esophageal system, allows for the mid-part 35 to shrink asymmetrically when a negative pressure is applied to the mid-part 35, which is optimally suited to move a patient's esophagus 2 away from the patient's heart.
  • Using balloons 8, 9, 11, 21 for both cranial 34 and caudal parts 36 is a most easy way for creating an occlusion of the esophagus 2 at level of said mid-part.
  • the cranial part 34 comprises a balloon 11 in close contact with a lumen, which lumen enables the insertion of existing probes such as temperature probes for measuring the temperature of the esophagus 2.
  • the cranial part 34 comprises a balloon 11 in close contact with an open lumen associated with an air closing system, such as a system functioning by elastic recoil or striction, for aiding in an efficient occlusion of the esophagus 2 at level of said mid-part 35.
  • the present invention provides an intra-esophageal system according to the second aspect of the invention, wherein said cranial part 34 comprises at least one balloon 11 and said caudal part comprises two spatially separated balloons 8, 9 , the latter two being a first balloon 8 that is configured to be positioned in the patient's stomach 3 in the proximity of the patient's diaphragm 4, and a second balloon 9 that is configured to be positioned in the patient's esophagus 2 in the proximity of the patient's diaphragm 4.
  • FIG. 3 shows a preferred embodiment of an intra-esophageal system according to the present invention without A and with B a vacuum between two balloons 9, 11.
  • the present invention provides an intra-esophageal system according to the second aspect of the invention, of which at least one balloon 8, 9, 11, 21 is ovoid-shaped.
  • Ovoid-shaped balloons are preferable since they show, when placed in the esophagus 2, a larger contact area with the epithelium of the esophagus 2 when compared with spherical balloons.
  • spherical, conical or any other suitable shapes or combination of shapes can be used for the at least one balloon 8, 9, 11, 21 of the intra-esophageal system.
  • the balloons may be compliant, non-compliant, semi-compliant and could have a different shape in function of the pressure used for inflating the balloons.
  • the present invention provides an intra-esophageal system according to the second aspect of the invention, wherein at least one of said cranial 34, mid- 35 and caudal parts 36 comprises temperature sensors with localization means and/or radio-opaque markers.
  • the mid-part 35 comprises temperature sensors with localization means and/or radio-opaque markers.
  • the temperature sensors may only be placed at the side of the intra- esophageal system which is closest to the heart, when placed into an esophagus 2 of a patient, or the temperature sensors may be placed circularly along the intra- esophageal system.
  • such temperature sensors allow to localize the position of at least a part of such intra-esophageal system, which can be used to determine and follow-up its position inside a patient's esophagus.
  • Such radio-opaque markers can be visualized by radioscopy and can hence be used to visualize the esophagus 2 and the heart of a patient while ablating the heart of said patient. Additionally, such radio-opaque markers and the visualization achieved by radioscopy can easily be integrated in an imaging system.
  • the use of temperature sensors with localization means and/or radio-opaque markers for imaging are additional safety measures to decrease the risk of esophageal damage during ablation of the heart.
  • a third aspect of the present invention provides a use of an intra-esophageal system according to the second aspect of the present invention as an intra- esophageal system in the method according to the first aspect of the present invention. Accordingly, all technical accomplishments and positive characteristics of the intra-esophageal system according to the second aspect of the present invention are combined with those of the method according to the first aspect of the present invention. Examples
  • FIG. 4 is a left lateral view of a human left atrium 1 and esophagus 2, showing the different steps (A-H) of a displacement method of the esophagus 2 away from the left atrial posterior wall, according to a preferred embodiment of the present invention.
  • anterior 5, posterior 6 and cranial 7 orientations are shown on FIG. 4.
  • the pneumatical lines 15, 16, 17, 18 for inflation of balloons or for the application of a negative pressure at level of an area of the esophagus 2 are not shown.
  • the cranial 34, mid- 35 and caudal parts 36 of the intra-esophageal system are not provided with reference numerals in Fl G.4.
  • Step A in FIG.4 depicts an undisturbed esophagus 2 with a diameter X1.
  • an intra-esophageal system is inserted into the esophagus 2.
  • a physiological gel may be applied to the system in order to facilitate a good contact of the system with the esophagus 2.
  • the system comprises a balloon 11 at level of the cranial part 34 and first 8 and second balloons 9 at level of the caudal part 36 which are all enveloped by a casing 19 which comprises perforations 20 along a selected area between said balloon 11 at level of the cranial part 34 and second balloon 9 at level of the caudal part 36, which selected area is located at level of the mid-part 35 of the system.
  • the intra-esophageal system is inserted with the help of a stylet which is also enveloped by said casing 19.
  • Said stylet comprises a wire 25, stylet casing 26 and inside region 27.
  • the stylet also gives a certain rigidity to the posterior side or the side of the intra-esophageal system facing away from the heart, which limits the excursion of the esophageal posterior wall when applying a negative pressure in a next step and thus favoring the displacement of the esophageal anterior wall away from the heart.
  • the intra-esophageal system may also be formed in a floppy manner on its side facing away from the heart when placed inside the esophagus 2.
  • step C said first balloon 8 of the caudal part 36, which is placed in the stomach 3 in the proximity of the diaphragm 4, is expanded.
  • the expanded first balloon 8 serves as an anchor for the intra-esophageal system and thus fixates the intra-esophageal system which is helpful for correct positioning of it.
  • step D said second balloon 8 at level of the caudal part 36 is expanded, while said balloon 11 at level of the cranial part 34 is expanded in step E. Accordingly, the diameter of the esophagus 2 is enlarged. As a result, the distance along which the esophagus 2 can be displaced is enlarged.
  • step F a vacuum is applied in the mid-part 35 of the casing 19 which is occluded by the second balloon 9 at level of the caudal part 36 and the balloon 11 at level of the cranial part 34.
  • the perforations 20 are located at level of an area of the esophagus 2 which faces the left atrium 1, resulting in a suction performed on said area which results in the displacement over a distance X4 of the anterior side of the esophagus 2 from the posterior wall of the left atrium 1.
  • FIG.4 shown distribution of perforations 20 along a substantial part of the area of the casing 19 at level of the mid-part 35 enables a gentle and spread application of negative pressure and thus a gentle and well-guided displacement of the esophagus 2 along the esophageal region of interest. This is a safe, easy and convenient manner for esophagus displacement.
  • the area 23 created between the posterior wall of the left atrium 1 and the esophagus 2 allows for an effective ablation of the left atrial posterior wall without damaging the esophagus 2.
  • the casing 19 may be provided with integrated temperature sensors for measuring the temperature at level of the esophagus 2 and heart while ablating the heart.
  • Measuring the temperature at the position of the temperature sensors while ablating the patient's heart delivers information to estimate if the applied ablation energy and resulting temperature could result in damage of the esophagus 2. Measuring the temperature thus delivers information one may use to take action to prevent esophageal damage during ablation of the heart.
  • step G the balloons 8, 9, 11 are deflated and the applied negative pressure is relieved from the intra-esophageal system and in step H, the system is retracted from the esophagus 2 and thus of the body of the patient, leaving the esophagus 2 in its original state.

Abstract

The present invention concerns a method for protecting a patient's esophagus (2) while ablating tissue of the patient's heart, comprising the steps of: - inserting an intra-esophageal system into the esophagus (2) of a body; - moving the esophagus (2) from an initial position close to the patient's heart to a second position further away from the patient's heart by operating the intra-esophageal system; - ablating tissue of the patient's heart; - returning the esophagus (2) into said initial position by relaxing the intra- esophageal system; and - removing the intra-esophageal system from the esophagus (2), wherein during the step of moving the esophagus (2) from an initial position to a second position, the intra-esophageal system applies a negative pressure along an area of the esophagus (2). The present invention further concerns an intra- esophageal system and a use of the intra-esophageal system as an intra- esophageal system in the method of the present invention.

Description

METHOD FOR PROTECTING A PATIENT'S ESOPHAGUS WHILE ABLATING TISSUE OF THE PATIENT'S HEART AND I NTRA- ESOPHAGEAL SYSTEM THEREFOR TECH N I CAL Fl ELD
The invention pertains to the technical field of esophagus displacement in function of minimally invasive treatments of organs inside the body of a living subject. More specifically, this invention pertains to a method for protecting a patient's esophagus while ablating tissue of the patient's heart and an intra-esophageal system therefor.
BACKGROUND Esophagus lesions are quite common after pulmonary vein isolation and resulting vagal nerve damage is not uncommon. Such nerve damage frequently gives rise to problems with gastric emptying. Esophagus lesions are frequently asymptomatic but can also lead to a fistula between the left atrium and the esophagus, a medical condition with nearly 100% mortality.
There is no optimal strategy or device to protect the esophagus during left atrial posterior wall ablation. Mechanical displacement of the esophagus has been proposed to increase the distance between a radio-frequency ablation source and the esophagus. This methodology seems to be agressive and is not able to provide an esophagus protection in all the patients.
There remains a need in the art for a convenient method and means to properly displace and thus protect the esophagus during cardiac procedures such as left atrial posterior wall ablation, effectively leading to a reduced risk of esophagus lesions in those patients.
The present invention aims to resolve at least some of the problems mentioned above. SUMMARY OF THE I NVENTI ON
A first aspect of the present invention provides a method for protecting a patient's esophagus 2 while ablating tissue of the patient's heart, comprising the steps of: - inserting an intra-esophageal system into the esophagus 2 of a body;
- moving the esophagus 2 from an initial position close to the patient's heart to a second position further away from the patient's heart by operating the intra-esophageal system;
- ablating tissue of the patient's heart;
- returning the esophagus 2 into said initial position by relaxing the intra- esophageal system; and
- removing the intra-esophageal system from the esophagus 2,
wherein during the step of moving the esophagus (2) from an initial position to a second position, the intra-esophageal system applies a negative pressure along an area of the esophagus 2.
The application of a negative pressure creates a suction force which moves the esophagus 2 from an initial position close to the patient's heart to a second position further away from the patient's heart. The application of a suction force is an intuitive and well-controllable means to move the esophagus 2 without damaging the esophagus 2.
A second aspect of the present invention provides an intra-esophageal system for protecting a patient's esophagus 2 while ablating tissue of the patient's heart, wherein the system comprises a cranial part 34, a caudal part 36, and a mid-part 35 in between said cranial 34 and caudal parts 36, wherein at least an area of said mid-part 35 is provided with perforations 20, wherein at least one of said parts 34, 35, 36 comprises at least one balloon 8, 9, 11, 21, and wherein at least one of said parts is operably connectable to pneumatic lines 15, 16, 17, 18, 22.
The perforations 20 in the mid-part 35 are optimally suitable to transfer a negative pressure which is applied in said mid-part 35 to the esophagus 2. As a result, when using the intra-esophageal system, the esophagus 2 will be moved from an initial position close to the patient's heart to a second position further away from the patient's heart. The cranial 34 and caudal parts 36 allow occluding the esophagus 2 around said mid-part 35, which enables the application of a negative pressure which is confined to said mid-part 35 and which can be directed to the esophagus 2 by said perforations 20. As an additional asset, the intra-esophageal system is easy to construct and may be constructed from affordable materials. DESCRI PTI ON OF Fl GURES
For a better understanding of the present invention, reference is made to the detailed description of the invention, by way of example, which is to be read in conjunction with the following drawings, wherein:
FIG. 1 is a left lateral view of a human's heart left atrium 1 and esophagus 2, showing the esophagus 2 prior to widening (A), when widened (B) and with an area of the esophagus 2 which is displaced from the left atrium 1 (C), according to an embodiment of the present invention.
FIG. 2 shows an embodiment of an intra-esophageal system according to the present invention without (A) and with (B) a vacuum between two balloons 11, 21.
FIG.3 shows another embodiment of an intra-esophageal system according to the present invention without A and with B a vacuum between two balloons 9, 11.
FIG. 4 is a left lateral view of a human left atrium 1 and esophagus 2, showing the different steps (A-H) of a displacement method of the esophagus 2 away from the left atrial posterior wall, according to an embodiment of the present invention.
DETAI LED DESCRI PTI ON OF THE I NVENTI ON Unless otherwise defined, all terms used in disclosing the invention, including technical and scientific terms, have the meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
Atrial fibrillation is the most common human arrhythmia. The incidence of atrial fibrillation increases with, and thus, the incidence of atrial fibrillation is becoming more prevalent as the average lifespan continues to increase. Atrial fibrillation is associated with increased morbidity and mortality and, in particular, a general decrease in quality of life for those afflicted with atrial fibrillation. Patients are at an increased risk of stroke unless they are treated adequately with anticoagulants. Anticoagulant treatment however, increases a patient's risk of bleeding, which carries with it its own set of dangers. Medications currently available for treating atrial fibrillation have proven to be only moderately effective in decreasing the incidence of recurrent atrial fibrillation, and these mediations do not decrease the patient's risk of having a stroke.
One method of treating atrial fibrillation has been to perform ablation of selected areas of the left atrium. There is evidence to suggest that ablating these areas of the left atrium serves to cure or prevent recurrence of atrial fibrillation. Typically, ablations of this type are carried out via an intravascular catheter using radiofrequency or microwave energy to cause thermal damage to the selected parts of the left atrial tissue.
The posterior wall of the left atrium is particularly targeted for ablation because the pulmonary veins enter the atrium at this area of the left atrium. Thus, encircling the pulmonary veins with continuous rings of lesions is common in this procedure. The esophagus may, however, be positioned so as to overlie one or more of these veins, thereby making the desired encirclement risky. A significant and lethal complication of atrial fibrillation ablation is the accidental occurrence of an atrio-esophageal fistula following the development of lesions on the posterior wall of the left atrium. Because the esophagus is generally closely positioned to the posterior wall of the left atrium, thermal injury may result in the occurrence of the atrio-esophageal fistula.
In addition to the foregoing, fractionated electrograms and vagal plexi are also in close vicinity of the esophagus. These are also common targets of atrial fibrillation ablation. Again, the location of the esophagus may hinder application of a sufficient energy to successfully ablate enough tissue of the left atrium to prevent recurrence of atrial fibrillation. Further, the esophagus is a mobile structure. Thus, one cannot rely on a medical image, such as a CT scan, made before procedure for determining the actual position of the esophagus relative to the left atrium at the time of ablation.
The present invention aims to effectively reduce the risk of damage to the esophagus 2 during cardiac ablation by moving the esophagus 2 away from the heart during treatment.
A first aspect of the present invention provides a method for protecting a patient's esophagus 2 while ablating tissue of the patient's heart, comprising the steps of:
- inserting an intra-esophageal system into the esophagus 2 of a body; - moving the esophagus 2 from an initial position close to the patient's heart to a second position further away from the patient's heart by operating the intra-esophageal system;
- ablating tissue of the patient's heart;
- returning the esophagus 2 into said initial position by relaxing the intra- esophageal system; and
- removing the intra-esophageal system from the esophagus 2,
wherein during the step of moving the esophagus (2) from an initial position to a second position, the intra-esophageal system applies a negative pressure along an area of the esophagus 2.
The application of a negative pressure creates a suction force which moves the esophagus 2 from an initial position close to the patient's heart to a second position further away from the patient's heart. The application of a suction force is an intuitive and well-controllable means to move the esophagus 2 without damaging the esophagus 2. The method according to the first aspect of the present invention applying a negative pressure to move the esophagus 2 from a patient's heart is not to be regarded as obvious to a person skilled in the art, since such person would rather use or optimize the commonly applied procedures for reducing damage to the esophagus.
In a preferred embodiment, the present invention provides a method according to the first aspect of the invention, wherein the intra-esophageal system is operated by i) expanding the diameter of the esophagus 2 along a portion that exceeds the area where the negative pressure will be applied to afterwards, followed by ii) moving the esophagus 2 from said initial position to said second position by applying a negative pressure along said area. Accordingly, by first expanding the diameter of the esophagus 2, the area of the esophagus 2 wall which receives the negative pressure may be moved further from the heart then when the esophagus 2 would not be expanded. This is an efficient and easy manner to allow a sufficient displacement of the esophagus 2 by applying a negative pressure. The principle of this preferred embodiment is shown in FIG. 1 that depicts a left lateral view of a human's heart left atrium 1 and esophagus 2, showing the esophagus 2 prior to widening (A), when widened (B) and with an area of the esophagus which is displaced from the left atrium 1 (C). At stage A, the diameter of the esophagus matches X1 , as indicated on FIG. 1. The combination of widening (B) the esophagus 2 to a diameter X2 followed by displacement of said area of the esophagus 2 further away from the heart allows for a sufficient distance between the esophagus 2 and heart, as indicated by X4. Together with the displacement of the esophagus 2 with respect of the heart, the diameter of the esophagus 2 is locally decreased to diameter X3. In preferred embodiments, the widening or expansion of the esophagus is performed with a flexible and expandable means. Yet any means to widen or expand the esophagus which does not damage the esophagus substantially, as known in the prior art, may be used.
In a preferred embodiment, the present invention provides a method according to the first aspect of the invention, wherein said negative pressure is applied along an area of the esophagus 2 which faces the patient's left atrium 1. As a result, the esophagus 2 is displaced or moved further away from the left atrial posterior wall. This is clearly shown in FIG. 1, where the distance X4 depicts the thus created distance between the left atrial posterior wall and the esophageal anterior side. For the sake of clarity, anterior 5, posterior 6 and cranial 7 orientations are shown on Fl G. 1. The posterior wall of the left atrium 1 is particularly targeted for ablation in the context of treatment of atrial fibrillation because the pulmonary veins enter the atrium at this area of the left atrium 1. Displacement of the esophagus 2 further away from the left atrial posterior wall by applying a negative pressure according to the first aspect of the present invention is thus a safe and convenient method to enable the performance of left atrium 1 posterior wall ablation while reducing the risk of damaging the esophagus during ablation.
In a preferred embodiment, the present invention provides a method according to the first aspect of the invention, wherein said negative pressure is applied along at least 1%, more preferably at least 5%, even more preferably at least 10%, even more preferably at least 15%, even more preferably at least 20%, even more preferably at least 25%, even more preferably at least 30%, even more preferably at least 40% and even more preferably at least 50% of said area of the esophagus 2. Applying said negative pressure over a substantial part of said area of the esophagus 2 allows for a gentle and spread application of negative pressure and thus a well-guided displacement of the esophagus 2 from an initial position close to the patient's heart to a second position further away from the patient's heart. Such well-guided and gentle displacement is beneficial to reduce the risk of damage to the esophagus 2 while ablating the heart in the proximity of the esophagus 2.
In a preferred embodiment, the present invention provides a method according to the first aspect of the invention, wherein the intra-esophageal system comprises a cranial part 34 which is suited to be placed into the esophagus 2 at a position which is located more cranially than said area of the esophagus 2 along which a negative pressure is applied, a caudal part 36 which is suited to be placed into the esophagus 2 at a position which is located closer to the stomach 5 than said area of the esophagus 2, and a mid-part 35 between said cranial 34 and caudal parts 36, which mid-part 35 is suited to be placed into the esophagus 2 along said area of the esophagus 2, wherein at least one of said parts 34, 35, 36 comprises at least one balloon 8, 9, 11, 21 , and wherein moving the esophagus 2 from an initial position close to the patient's heart to a second position further away from the patient's heart by operating the intra-esophageal system comprises the steps of:
inflating the at least one balloon 8, 9, 11, 21 of the intra-esophageal system, thereby generating an occlusion of the esophagus 2 at level of said mid-part 35; and
applying a negative pressure at level of said mid-part 35, which pressure is directed to and applied along said area of the esophagus 2, and wherein returning the esophagus 2 into said initial position by relaxing the intra-esophageal system is performed by deflating the at least one balloon 8, 9, 11, 21. The use of a system comprising said parts 34, 35, 36 which comprise at least one balloon 8, 9, 11, 21 is a cheap, intuitive and easy way to delineate a region of the intra-esophageal system where a negative pressure can be applied. For the protection of the esophagus 2 during ablation of the heart in proximity of the esophagus 2, such multi-component and balloon comprising system is, to our knowledge, not described in the prior art. Such system can furthermore be regarded as inventive, since a person skilled in the art would rather optimize one- balloon systems or alternative arrangements than devise a multi-component balloon comprising system. In a preferred embodiment, the present invention provides a method according to the first aspect of the invention, wherein the intra-esophageal system is inserted into and removed from the esophagus 2 by means of a stylet that is attachable to the intra-esophageal system. A stylet is a convenient means for insertion or removal of the intra-esophageal system as a stylet is relatively stiff and can thus be used to transport the intra-esophageal system in a targeted manner to the desired placement into a patient's esophagus 2. In a preferred embodiment, the present invention provides a method according to the first aspect of the invention, wherein the intra-esophageal system is inserted into and removed from the esophagus 2 by means of a lumen. Positive attributes of a lumen are its flexibility and softness. In one embodiment, the lumen is included within the intra-esophageal system and does not communicate with said cranial 34, mid- 35 and caudal parts 36. In another embodiment, the lumen is selected as a casing 19 enveloping said cranial part 34, mid-part 35 and caudal part 36, wherein said casing 19 may further be used to allow the creation of a negative pressure at level of said mid-part 35 when an occlusion of the esophagus 2 is created at said mid-part 35 by means of said cranial 34 and caudal parts 36. In another preferred embodiment, the intra-esophageal system is inserted into the esophagus 2 by means of a probe enclosing said system, which probe is preferably retracted from the body once the system is inserted. Subsequently, the system may be removed from the esophagus 2 by any suitable means.
In a preferred embodiment, the present invention provides a method according to the first aspect of the invention, further comprising the step of measuring the temperature at level of the patient's heart while ablating said heart. Measuring the temperature at level of the patient's heart while ablating said heart delivers information to estimate if the applied ablation energy and resulting temperature could result in damage of the esophagus 2. Measuring the temperature thus delivers information one may use to take action to prevent esophageal damage during ablation of the heart.
In a preferred embodiment, the present invention provides a method according to the first aspect of the invention, further comprising the step of increasing the applied negative pressure along said area of the esophagus 2 when the measured temperature increases when ablating tissue of the patient's heart. Accordingly, the displacement of the esophagus 2 from the patient's heart is increased when the temperature as generated by ablating the heart increases. In such way, the esophagus 2 can be effectively protected from damage for a wide range of ablation energies and created temperatures. Besides, the amount of the applied negative pressure is determined with respect of the applied ablation energy, and excessive application of negative pressure is thus prevented. This is cost-effective and furthermore safe for the esophagus 2, since excessive displacement of the esophagus 2 on its own may result in damage to the esophagus 2. In a preferred embodiment, the present invention provides a method according to the first aspect of the invention, further comprising the step of imaging the patient's heart and esophagus 2 while ablating tissue of the patient's heart. Imaging of the patient's heart and esophagus 2 is an additional means to reduce the risk of esophageal damage during ablation of a patient's heart, since the risk of accidental damage of the esophagus 2 by a wrong placement of an ablation catheter is reduced when images of the patient's heart 2 and esophagus are available. Furthermore, the size and structures of the esophagus 2 vary among the population. An image of a patient's heart and esophagus 2 thus delivers valuable information to determine in which extent the esophagus 2 is best displaced with respect to the heart while ablating said heart.
A second aspect of the present invention provides an intra-esophageal system for protecting a patient's esophagus 2 while ablating tissue of the patient's heart, wherein the system comprises a cranial part 34, a caudal part 36, and a mid-part 35 in between said cranial 34 and caudal parts 36, wherein at least an area of said mid-part 35 is provided with perforations 20, wherein at least one of said parts 34, 35, 36 comprises at least one balloon 8, 9, 11, 21, and wherein at least one of said parts 34, 35, 36 is operably connectable to pneumatic lines 15, 16, 17, 18, 22.
Said intra-esophageal system according to the second aspect of the present invention is suited and configured to be placed in the esophagus 2 of a patient. The terms cranial and caudal are terms for the orientation of the individual parts of the intra-esophageal system which are based on the manner wherein the intra- esophageal system is desirably placed in the esophagus 2 for protection of the esophagus 2 while ablating tissue of the patient's heart, with the cranial part 34 desirably placed more cranially than the caudal part 36, which on its turn is desirably placed more caudally than the cranial part 34. In a preferred embodiment, at least one of said parts 34, 35, 36 is operably connected to pneumatic lines 15, 16, 17, 18, 22. In embodiments, the cranial part 34 is connected to a guiding means. For example, the cranial part 34 may be connectable and preferably connected to a wire for guiding the intra-esophageal system. In a preferred embodiment, said perforations 20 are positioned at a limited region with respect of the circumference of said mid-part 35. Preferably, said perforations 20 are placed in a manner that when the intra-esophageal system is placed in the esophagus 2 of a patient, a negative pressure can specifically be applied through the perforations 20 towards the area of the esophagus 2 which faces the left atrium 1. This is especially desired since the posterior wall of the left atrium 1 is particularly targeted for ablation in the context of treatment of atrial fibrillation because the pulmonary veins enter the atrium at this area of the left atrium 1. The perforations 20 may be placed evenly, asymmetrically or circularly, depending on the placement of the perforations 20 which is the most optimal to achieve a desired displacement of an esophagus 2 away from a patient's heart. Preferably, the intra-esophageal system is a single- use system, for the sake of hygienic considerations. As an example of an intra- esophageal system, FIG. 2 shows a preferred embodiment of such system according to the second aspect of the present invention without (A) and with (B) a vacuum applied between two balloons 11, 21.
The perforations 20 in the mid-part 35 are optimally suitable to transfer a negative pressure which is applied in said mid-part 35 to the esophagus 2. As a result, when using the intra-esophageal system, the esophagus 2 will be moved from an initial position close to the patient's heart to a second position further away from the patient's heart. The cranial 34 and caudal parts 36 allow occluding the esophagus 2 around said mid-part 35, which enables the application of a negative pressure which is confined to said mid-part 35 and which can be directed to the esophagus 2 by said perforations 20. As an additional asset, the intra-esophageal system is easy to construct and may be constructed from affordable materials. The intra-esophageal system according to the second aspect of the present invention applying a negative pressure to move the esophagus 2 from a patient's heart is not to be regarded as obvious to a person skilled in the art, since such person would rather use or optimize traditional intra-esophageal systems comprising only one-balloon or alternative arrangements than devise an intra- esophageal system with more than one balloon.
In a preferred embodiment, said cranial 34, mid- 35 and caudal parts 36 are suited to be enveloped by a casing 19 comprising perforations 20 at level of said mid-part 35. Preferably, said cranial 34, mid- 35 and caudal parts 36 are enveloped by a casing 19 comprising perforations 20 at level of said mid-part 35. Such casing 19 has the advantage that it functions as a perforated body as well as a means to hold the cranial 34, mid- 35 and caudal parts 36 together. Preferably, such casing 19 is anchored to the side of any present balloons 8, 9, 11, 21 which faces away from the heart when the intra-esophageal system is placed into the esophagus 2. In another preferred embodiment, the intra-esophageal system comprises a tube comprising perforations 20 as an embodiment of said mid-part 35. Such perforated tube has the advantage that it is a very simple structure and thus contributes to a simple and cost-effective construction of the intra- esophageal system. In a preferred embodiment, the present invention provides an intra-esophageal system according to the second aspect of the invention, wherein said perforations 20 are distributed over at least 15%, more preferably over at least 20%, even more preferably over at least 25%, even more preferably over at least 30%, even more preferably at least 40% and even more preferably at least 50% of the area of said mid-part 35. Applying said negative pressure over a substantial part of said area of the mid-part 35 and subsequently over a substantial part of the esophagus 2 allows for a gentle and spread application of negative pressure and thus a well- guided displacement of the esophagus 2 from an initial position close to the patient's heart to a second position further away from the patient's heart. The displacement of the esophagus 2 is caused by suction of the esophagus 2 wall which is effected by the applied negative pressure. Such gentle and well-guided displacement is beneficial to reduce the risk of damage to the esophagus 2 while ablating the heart in the proximity of the esophagus 2. In a preferred embodiment, the present invention provides an intra-esophageal system according to the second aspect of the invention, wherein the at least one balloon 8, 9, 11, 21 is shaped as an asymmetric dumbbell which comprises two linked elliptical portions of which the transition between them is placed outwardly with regard to a central longitudinal axis through the balloon. Such shaped balloon enables an effective occlusion of the esophagus 2 at level of said mid-part 35. Furthermore, the asymmetric placement of said transition, which transition is preferably elongated and is to be interpreted as an embodiment of the mid-part 35 of the intra-esophageal system, allows for the mid-part 35 to shrink asymmetrically when a negative pressure is applied to the mid-part 35, which is optimally suited to move a patient's esophagus 2 away from the patient's heart. Such asymmetric dumbbell-shaped balloon has the advantage that it can both be used to provide the necessary occlusion and to move the esophagus 2 away from the heart in a well-directed manner. In a preferred embodiment, the present invention provides an intra-esophageal system according to the second aspect of the invention, wherein said cranial 34 and caudal parts 36 both comprise at least one balloon 8, 9, 11, 21, and wherein said balloons 8, 9, 11, 21 of said parts 34, 36 are spaced apart from each other and thus establishing an intermediate space between them at level of said mid- part 35, and wherein said balloons 11 of said cranial part 34 and said balloons 8, 9, 21 of said caudal part 36 are connectable through a connection which is placed outwardly with regard to a central longitudinal axis through said balloons 8, 9, 11, 21. Preferably, said balloons 11 of said cranial part 34 and said balloons 8, 9, 21 of said caudal part 36 are connected through such connection. The balloons 8, 9, 11, 21 of the cranial 34 and caudal parts 36 allow for an effective occlusion of the esophagus 2 at level of said mid-part 35. Furthermore, the outward placement of said connection, which connection is preferably elongated and is to be interpreted as an embodiment of the mid-part 35 of the intra-esophageal system, allows for the mid-part 35 to shrink asymmetrically when a negative pressure is applied to the mid-part 35, which is optimally suited to move a patient's esophagus 2 away from the patient's heart. Using balloons 8, 9, 11, 21 for both cranial 34 and caudal parts 36 is a most easy way for creating an occlusion of the esophagus 2 at level of said mid-part.
In a preferred embodiment, the cranial part 34 comprises a balloon 11 in close contact with a lumen, which lumen enables the insertion of existing probes such as temperature probes for measuring the temperature of the esophagus 2. In another preferred embodiment, the cranial part 34 comprises a balloon 11 in close contact with an open lumen associated with an air closing system, such as a system functioning by elastic recoil or striction, for aiding in an efficient occlusion of the esophagus 2 at level of said mid-part 35. In a preferred embodiment, the present invention provides an intra-esophageal system according to the second aspect of the invention, wherein said cranial part 34 comprises at least one balloon 11 and said caudal part comprises two spatially separated balloons 8, 9 , the latter two being a first balloon 8 that is configured to be positioned in the patient's stomach 3 in the proximity of the patient's diaphragm 4, and a second balloon 9 that is configured to be positioned in the patient's esophagus 2 in the proximity of the patient's diaphragm 4. The positioning of the balloons 8, 9 towards each other allows the combination of the at least one balloon 11 of the cranial part 34 and the first balloon 8 to occlude the esophagus 2 around said mid-part 35 to allow the application of a negative pressure for the displacement of the esophagus 2, while the second balloon 9 is suited to be expanded in a patient's stomach 3 at the level of the diaphragm 7. An expanded second balloon 9 at that location serves as an anchor for the intra- esophageal system and thus fixates the system which is helpful for correct positioning of it. As an example, FIG. 3 shows a preferred embodiment of an intra-esophageal system according to the present invention without A and with B a vacuum between two balloons 9, 11. In a preferred embodiment, the present invention provides an intra-esophageal system according to the second aspect of the invention, of which at least one balloon 8, 9, 11, 21 is ovoid-shaped. Ovoid-shaped balloons are preferable since they show, when placed in the esophagus 2, a larger contact area with the epithelium of the esophagus 2 when compared with spherical balloons. It should however be understood that spherical, conical or any other suitable shapes or combination of shapes can be used for the at least one balloon 8, 9, 11, 21 of the intra-esophageal system. Another aspect to be mentioned is that the balloons may be compliant, non-compliant, semi-compliant and could have a different shape in function of the pressure used for inflating the balloons.
In a preferred embodiment, the present invention provides an intra-esophageal system according to the second aspect of the invention, wherein at least one of said cranial 34, mid- 35 and caudal parts 36 comprises temperature sensors with localization means and/or radio-opaque markers. Preferably, the mid-part 35 comprises temperature sensors with localization means and/or radio-opaque markers. The temperature sensors may only be placed at the side of the intra- esophageal system which is closest to the heart, when placed into an esophagus 2 of a patient, or the temperature sensors may be placed circularly along the intra- esophageal system. Besides measuring the temperature, such temperature sensors allow to localize the position of at least a part of such intra-esophageal system, which can be used to determine and follow-up its position inside a patient's esophagus. Such radio-opaque markers can be visualized by radioscopy and can hence be used to visualize the esophagus 2 and the heart of a patient while ablating the heart of said patient. Additionally, such radio-opaque markers and the visualization achieved by radioscopy can easily be integrated in an imaging system. The use of temperature sensors with localization means and/or radio-opaque markers for imaging are additional safety measures to decrease the risk of esophageal damage during ablation of the heart. A third aspect of the present invention provides a use of an intra-esophageal system according to the second aspect of the present invention as an intra- esophageal system in the method according to the first aspect of the present invention. Accordingly, all technical accomplishments and positive characteristics of the intra-esophageal system according to the second aspect of the present invention are combined with those of the method according to the first aspect of the present invention. Examples
The following example is intended to further clarify the present invention, and is nowhere intended to limit the scope of the present invention. EXAMPLE 1
FIG. 4 is a left lateral view of a human left atrium 1 and esophagus 2, showing the different steps (A-H) of a displacement method of the esophagus 2 away from the left atrial posterior wall, according to a preferred embodiment of the present invention. For the sake of clarity, anterior 5, posterior 6 and cranial 7 orientations are shown on FIG. 4. Besides, for the sake of clarity, the pneumatical lines 15, 16, 17, 18 for inflation of balloons or for the application of a negative pressure at level of an area of the esophagus 2 are not shown. For those pneumatical lines, reference is made to FIG. 3. Also, for the sake of clarity, the cranial 34, mid- 35 and caudal parts 36 of the intra-esophageal system are not provided with reference numerals in Fl G.4. For those parts, reference is made to Fl G.3.
Step A in FIG.4 depicts an undisturbed esophagus 2 with a diameter X1. In step B, an intra-esophageal system is inserted into the esophagus 2. For insertion, a physiological gel may be applied to the system in order to facilitate a good contact of the system with the esophagus 2. The system comprises a balloon 11 at level of the cranial part 34 and first 8 and second balloons 9 at level of the caudal part 36 which are all enveloped by a casing 19 which comprises perforations 20 along a selected area between said balloon 11 at level of the cranial part 34 and second balloon 9 at level of the caudal part 36, which selected area is located at level of the mid-part 35 of the system. The intra-esophageal system is inserted with the help of a stylet which is also enveloped by said casing 19. Said stylet comprises a wire 25, stylet casing 26 and inside region 27. The stylet also gives a certain rigidity to the posterior side or the side of the intra-esophageal system facing away from the heart, which limits the excursion of the esophageal posterior wall when applying a negative pressure in a next step and thus favoring the displacement of the esophageal anterior wall away from the heart. To achieve such selective displacement, the intra-esophageal system may also be formed in a floppy manner on its side facing away from the heart when placed inside the esophagus 2. In step C, said first balloon 8 of the caudal part 36, which is placed in the stomach 3 in the proximity of the diaphragm 4, is expanded. The expanded first balloon 8 serves as an anchor for the intra-esophageal system and thus fixates the intra-esophageal system which is helpful for correct positioning of it. In step D, said second balloon 8 at level of the caudal part 36 is expanded, while said balloon 11 at level of the cranial part 34 is expanded in step E. Accordingly, the diameter of the esophagus 2 is enlarged. As a result, the distance along which the esophagus 2 can be displaced is enlarged. In step F, a vacuum is applied in the mid-part 35 of the casing 19 which is occluded by the second balloon 9 at level of the caudal part 36 and the balloon 11 at level of the cranial part 34. As shown, the perforations 20 are located at level of an area of the esophagus 2 which faces the left atrium 1, resulting in a suction performed on said area which results in the displacement over a distance X4 of the anterior side of the esophagus 2 from the posterior wall of the left atrium 1. The in FIG.4 shown distribution of perforations 20 along a substantial part of the area of the casing 19 at level of the mid-part 35 enables a gentle and spread application of negative pressure and thus a gentle and well-guided displacement of the esophagus 2 along the esophageal region of interest. This is a safe, easy and convenient manner for esophagus displacement. The area 23 created between the posterior wall of the left atrium 1 and the esophagus 2 allows for an effective ablation of the left atrial posterior wall without damaging the esophagus 2. The casing 19 may be provided with integrated temperature sensors for measuring the temperature at level of the esophagus 2 and heart while ablating the heart. Measuring the temperature at the position of the temperature sensors while ablating the patient's heart delivers information to estimate if the applied ablation energy and resulting temperature could result in damage of the esophagus 2. Measuring the temperature thus delivers information one may use to take action to prevent esophageal damage during ablation of the heart. In step G, the balloons 8, 9, 11 are deflated and the applied negative pressure is relieved from the intra-esophageal system and in step H, the system is retracted from the esophagus 2 and thus of the body of the patient, leaving the esophagus 2 in its original state.

Claims

CLAI MS
1. Method for protecting a patient's esophagus (2) while ablating tissue of the patient's heart, comprising the steps of:
- inserting an intra-esophageal system into the esophagus (2) of a body; moving the esophagus (2) from an initial position close to the patient's heart to a second position further away from the patient's heart by operating the intra-esophageal system;
ablating tissue of the patient's heart;
- returning the esophagus (2) into said initial position by relaxing the intra-esophageal system; and
removing the intra-esophageal system from the esophagus (2), characterized in that during the step of moving the esophagus (2) from an initial position to a second position, the intra-esophageal system applies a negative pressure along an area of the esophagus (2).
2. Method according to claim 1, wherein the intra-esophageal system is operated by i) expanding the diameter of the esophagus (2) along a portion that exceeds the area where the negative pressure will be applied to afterwards, followed by ii) moving the esophagus (2) from said initial position to said second position by applying a negative pressure along said area.
3. Method according to claim 1 or 2, wherein said negative pressure is applied along an area of the esophagus (2) which faces the patient's left atrium
(1) -
4. Method according to any of claims 1 to 3, wherein said negative pressure is applied along at least 1% of said area of the esophagus (2).
5. Method according to any of claims 1 to 4, wherein the intra-esophageal system comprises a cranial part (34) which is suited to be placed into the esophagus (2) at a position which is located more cranially than said area of the esophagus (2) along which a negative pressure is applied, a caudal part (36) which is suited to be placed into the esophagus (2) at a position which is located closer to the stomach (5) than said area of the esophagus
(2) , and a mid-part (35) between said cranial (34) and caudal parts (36), which mid-part (35) is suited to be placed into the esophagus (2) along said area of the esophagus (2), wherein at least one of said parts (34, 35, 36) comprises at least one balloon (8, 9, 11, 21), and wherein moving the esophagus (2) from an initial position close to the patient's heart to a second position further away from the patient's heart by operating the intra-esophageal system comprises the steps of:
inflating the at least one balloon (8, 9, 11, 21) of the intra-esophageal system, thereby generating an occlusion of the esophagus 2 at level of said mid-part (35); and
applying a negative pressure at level of said mid-part (35), which pressure is directed to and applied along said area of the esophagus 2, and wherein returning the esophagus (2) into said initial position by relaxing the intra-esophageal system is performed by deflating the at least one balloon (8,
9, 11, 21).
Method according to any of claims 1 to 5, wherein the intra-esophageal system is inserted into and removed from the esophagus 2 by means of a stylet that is attachable to the intra-esophageal system.
Method according to any of claims 1 to 6, wherein the intra-esophageal system is inserted into and removed from the esophagus 2 by means of a lumen which is able to envelop the intra-esophageal system.
Method according to any of claims 1 to 7, further comprising the step of measuring the temperature at level of the patient's heart while ablating said heart.
Method according to claim 8, further comprising the step of increasing the applied negative pressure along said area of the esophagus (2) when the measured temperature increases when ablating tissue of the patient's heart.
10. Intra-esophageal system for protecting a patient's esophagus (2) while ablating tissue of the patient's heart, characterized in that the system comprises a cranial part (34), a caudal part (36), and a mid-part (35) in between said cranial (34) and caudal parts (36), wherein at least an area of said mid-part (35) is provided with perforations (20), wherein at least one of said parts (34, 35, 36) comprises at least one balloon (8, 9, 11, 21), and wherein at least one of said parts (34, 35, 36) is operably connectable to pneumatic lines (15, 16, 17, 18, 22).
11. Intra-esophageal system according to claim 10, wherein said perforations (20) are distributed over at least 15% of the area of said mid-part (35).
12. Intra-esophageal system according to claim 10 or 11, wherein the at least one balloon (8, 9, 11, 21) is shaped as an asymmetric dumbbell which comprises two linked elliptical portions of which the transition between them is placed outwardly with regard to a central longitudinal axis through the balloon.
13. Intra-esophageal system according to claim 10 or 11, wherein said cranial (34) and caudal parts (36) both comprise at least one balloon (8, 9, 11, 21), and wherein said balloons (8, 9, 11, 21) of said parts (34, 36) are spaced apart from each other and thus establishing an intermediate space between them at level of said mid-part (35), and wherein said balloons (11) of said cranial part (34) and said balloons (8, 9, 21)of said caudal part (36) are connectable through a connection which is placed outwardly with regard to a central longitudinal axis through said balloons (8, 9, 11, 21 ).
14. Intra-esophageal system according to any of claims 10 to 13, wherein the at least one balloon (8, 9, 11 , 21 ) is ovoid-shaped.
15. Intra-esophageal system according to any of claims 10 to 14, wherein at least one of said cranial (34), mid- (35) and caudal parts (36) comprises temperature sensors with localization means and/or radio-opaque markers.
PCT/EP2016/073772 2016-10-05 2016-10-05 Method for protecting a patient's esophagus while ablating tissue of the patient's heart and intra-esophageal system therefor WO2018065047A1 (en)

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