WO2019174708A1

WO2019174708A1 - Device for deflecting an esophagus of a patient away from a treatment area outside of the esophagus

Info

Publication number: WO2019174708A1
Application number: PCT/EP2018/056063
Authority: WO
Inventors: Philippe DEBRUYNE
Original assignee: Dr Philippe Debruyne bvba
Current assignee: Dr Philippe Debruyne bvba
Priority date: 2018-03-12
Filing date: 2018-03-12
Publication date: 2019-09-19
Anticipated expiration: 2020-09-12

Abstract

The invention concerns a method for deflecting an esophagus (1) of a patient away from a treatment area outside of the esophagus (1), comprising the steps of: ‒ positioning within the patient's esophageal lumen (2) an elongate body (3) comprising a distal end (4), a proximal end (9), and a movable section (5) in between; and ‒ moving the movable section (5) to deflect the esophagus (1) and thereby increasing the distance (D1, D2) between the esophagus (1) and the treatment area, wherein said movable section (5) is expandable and is moved by expanding the section. The invention further concerns a device for deflecting an esophagus (1) of a patient away from a treatment area outside of the esophagus (1), and a use of a device according to the invention in a method according to the invention.

Description

DEVICE FOR DEFLECTING AN ESOPHAGUS OF A PATIENT AWAY FROM A

TREATMENT AREA OUTSIDE OF THE ESOPHAGUS

TECH N I CAL FI ELD

The invention relates to a method for deflecting an esophagus of a patient away from a treatm ent area outside of the esophagus according to the preamble of claim 1 and to a device for deflecting an esophagus of a patient away from a treatm ent area outside of the esophagus according to the pream ble of claim 9.

BACKGROU N D

Esophagus lesions are quite com mon after pulmonary vein isolation and resulting vagal nerve damage is not uncom mon . Such nerve damage frequently gives rise to problems with gastric em ptying. Esophagus lesions are frequently asymptom atic but can also lead to a fistula between the left atrium and the esophagus, a m edical condition with nearly 1 00% mortality. There is no optimal strategy or device to protect the esophagus during left atrial posterior wall ablation. Mechanical displacem ent of the esophagus has been proposed to increase the distance between a radio-frequency ablation source and the esophagus. This m ethodology seems to be agressive and is not able to provide an esophagus protection in all the patients.

There rem ains 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.

US 2008003341 5 A1 describes a m ethod of adjusting the curvature of the esophagus during a therapeutic procedure in a treatment area outside of the esophagus. The m ethod includes positioning within the esophagus an elongate body having a distal tip, a controlled curvature section , and a flexible section wherein the length of the controlled curvature section is less than the length of the thoracic portion of the esophagus. According to US 200800341 5 A1 , the curvature of the controlled curvature section is adjusted to increase the distance between the esophagus and a treatment area outside of the esophagus.

US 20080033415 A1 shows the problem that the elongate body has a complicated construction comprising many parts, and that the elongate body is not easy to use. Besides, the distal tip according to US 20080033415 A1 , having a relatively small surface area, can exercise a high pressure on the wall of the esophageal lumen when the controlled curvature section is adjusted to increase the distance between the esophagus and a treatment area outside of the esophagus. Such high pressure may be stressful to the esophagus.

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 deflecting an esophagus of a patient away from a treatment area outside of the esophagus, according to claim 1.

The expansion of the movable section positioned with the patient’s esophageal lumen is an intuitive means to move the esophagus without damaging the esophagus. Through the expansion movement of the movable section, the wall of the esophageal lumen is stressed evenly such that excessive pressurizing of individual locations of the esophagus is avoided, which avoids damaging the esophagus. Furthermore, the method according to the first aspect of the present invention is suitable for a diversity of esophagus morphologies within the population, since by its expansion movement, the movable section’s shape can assume any morphological shape of esophageal lumens.

Preferred embodiments of the method are provided in claims 2 to 8.

A second aspect of the present invention provides a device for deflecting an esophagus of a patient away from a treatment area outside of the esophagus, according to claim 9. Since the movable section of the elongate body of the device according to the second aspect of the present invention is made of an expandable material, it can be and is adapted to be expanded into a longitudinally bent cylindrical shape. This is not possible with conventional stents which are norm ally used in the prior art , which stents only are able to expand in a circumferential manner. Expansion of the device into a longitudinally bent cylindrical shape is very suitable to deflect an esophagus of a patient away from a treatm ent area outside of the esophagus, when the device is positioned in the esophagus. As an additional asset, the device according to the second aspect of the present invention com prises a m inimum of components, is easy to construct and m ay be constructed from affordable m aterials.

Preferred em bodim ents of the device are provided in claims 9 to 14.

A third aspect of the present invention provides a use of a device according to the second aspect of the present invention in a method according to the first aspect of the present invention, according to claim 15.

D ESCRI PTI ON OF FI GU RES

Fig. 1 A-C shows schem atic representations of anteroposterior views of a patient’s esophagus before (A) and after (B) positioning an elongate body com prising a movable section within the esophageal lumen , and of the esophagus after expanding the section (C) , according to em bodiments of the present invention.

Fig. 2A-B shows schematic representations of left anterior oblique views of a patient’s esophagus and left atrium before positioning an elongate body com prising a movable section within the esophageal lum en (A) and after positioning of the body within the lum en and following expansion of the section (B) , according to embodiments of the present invention .

Fig. 3A-B shows schematic representations of left anterior oblique views of a patient’s esophagus and left atrium before positioning an elongate body com prising a movable section within the esophageal lumen (A) and after positioning of the body within the lum en and following expansion of the section (B) , according to embodiments of the present invention. DETAI LED DESCRI PTI ON OF THE I NVENTI ON

The recitation of numerical ranges by endpoints includes all numbers and fractions subsumed within that range, as well as the recited endpoints.

The term “treatment area”, as used herein, can be understood as an area where surgical, therapeutic and/or cosmetic treatments are to be applied, and which area is outside of the esophagus yet in the same patient’s body. In a preferred embodiment said treatment area is an ablation site. In a preferred embodiment, said area is located on the left atrium of a patient’s heart, and preferably on the left atrial wall.

A first aspect of the present invention provides a method for deflecting an esophagus of a patient away from a treatment area outside of the esophagus, comprising the steps of:

- positioning within the patient’s esophageal lumen an elongate body comprising a distal end, a proximal end, and a movable section in between; and

- moving the movable section to deflect the esophagus and thereby increasing the distance between the esophagus and the treatment area, wherein said movable section is expandable and is moved by expanding the section.

The elongate body, and also the movable section of the elongate body, has an elongate form, which form is optimally suited to be positioned inside the esophageal lumen of a patient. At the start of positioning the elongate body, the elongate body can be inserted through any suited external body opening of a patient as known from the prior art, such as, but not limited to nostril or mouth openings. Preferably, the elongate body is positioned manually. To enable the positioning inside the esophageal lumen, positioning means attachable to, and preferably reversibly attachable to, the elongate body may be used, such as, for example, by means of a stylet that is attachable, and preferably reversibly attachable, to the elongate body. After increasing the distance between the esophagus and the treatment area by expanding the movable section, the esophagus is protected from surgical, therapeutic and/or cosmetic treatments which are applied to a treatment are outside of the esophagus. After one or more of such treatments, the elongate body can be retracted from the esophageal lumen. Preferably, the movable section is reduced to its original reduced state before retraction of the elongate body from the esophageal lumen.

The expansion of the movable section positioned with the patient’s esophageal lumen is an intuitive means to move the esophagus without damaging the esophagus. Through the expansion movement of the movable section, the wall of the esophageal lumen is stressed evenly such that excessive pressurizing of individual locations of the esophagus is avoided, which avoids damaging the esophagus. Furthermore, the method according to the first aspect of the present invention is suitable for a diversity of esophagus morphologies within the population, since by its expansion movement, the movable section’s shape can assume any morphological shape of esophageal lumens. The method according to the first aspect of the present invention expanding the movable section positioned with the patient’s esophageal lumen to increase the distance between the esophagus and a treatment area outside of the esophagus, 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 increasing the distance between the esophagus and a treatment area outside of the esophagus.

In a preferred embodiment, the present invention provides a method according to the first aspect of the invention, wherein at the end of the positioning step, the elongate body is disposed entirely within the esophageal lumen. When disposed entirely within the esophageal lumen, the elongate body is optimally positioned for deflecting the esophagus away from a treatment area by expansion of the movable section of the elongate body.

In a preferred embodiment, the present invention provides a method according to the first aspect of the invention, wherein said movable section is expanded along the patient’s frontal plane while simultaneously performing one or more spontaneous curvatures along the patient’s sagittal plane, through which expansion and simultaneous one or more curvatures the esophagus is deflected from the treatment area outside of the esophagus. Preferably, the esophagus is deflected in the anteroposterior direction. Through such specific expansion along the frontal plane and one or more curvatures along the sagittal plane of the movable section of the elongate body, the esophagus is most suitably deflected by assuming a considerable curvature, which curvature can be preserved optimally by the well-distributed tension effected by the movable section on the walls of the esophageal lumen by the expansion along the patient’s frontal plane.

According to a preferred embodiment, the present invention provides a method according to the first aspect of the invention, wherein said movable section is expanded along the patient’s frontal plane while simultaneously performing one spontaneous curvature, which can also be called a “main curvature”, along the patient’s sagittal plane, through which expansion and simultaneous one curvature the esophagus is deflected from the treatment area outside of the esophagus. Preferably, the esophagus is deflected in the anteroposterior direction. According to another preferred embodiment, the present invention provides a method according to the first aspect of the invention, wherein said movable section is expanded along the patient’s frontal plane while simultaneously performing three curvatures along the patient’s sagittal plane, being i) a main curvature which is at least located along the part of the esophagus which is deflected from the treatment area, next to ii) a first additional curvature located distally with respect to said main curvature and iii) next to a second additional curvature located proximally with respect to said main curvature, through which expansion and simultaneous three curvatures the esophagus is deflected from the treatment area outside of the esophagus. In this context, “located distally” can be interpreted as being more closely located with regard to a patient’s mouth while “located proximally” can be interpreted as being more closely located to a patient’s stomach. The embodiment of the method providing exactly one curvature provides the advantage of simplicity while the method providing said three curvatures provides an advantageous additional support of the main curvature by said first and second additional curvatures. In other words, said first and second additional curvatures help to keep the main curvature in place.

In a preferred embodiment, the present invention provides a method according to the first aspect of the invention, wherein said movable section is inflatable and is expanded by inflating the section. Any suitable inflatable material as known in the prior art may be used. An example of a suitable inflatable material is a balloon. The balloon may be inflated by entering an air supply tube into the movable section and by providing air or another suitable gas, or alternatively a liquid, inside the inflatable material of said movable section. An inflatable movable section is an especially easy construction of the movable section, and allows well- controlled expansion and good contact with the wall of the esophageal lumen when expanding the section. Additionally, such inflatable movable section may easily be deflated after a surgical, therapeutic and/or cosmetic treatment performed on the treatment area outside of the esophagus, and, in its deflated state, may easily be retracted from the esophageal lumen.

In a preferred embodiment, the present invention provides a method according to the first aspect of the invention, wherein said movable section is self-expandable and wherein said movable section is initially at least partly enveloped by and guided by a delivering tube while positioning said elongate body, and wherein said movable section of the elongate body is subsequently expanded by self-expansion of the section after retracting said tube at least partly from the esophageal lumen.

The part of the movable section that is enveloped by the delivering tube is restrained from expanding by self-expansion to its expanded state. Preferably, said delivering tube is dimensioned in such a way that it can be easily initially inserted into the esophageal lumen without or with minimal straining of the esophagus. By at least partly retracting said delivering tube, the parts of the movable section that self-expand may be selected in a most easy and efficient manner. Self-expansion of the movable section does only necessitate that the delivering tube is at least partly removed, and does not require external powered means, such as an air pump, or any connecting parts, such as air tubes, for expansion. Therefore, self-expansion of the self-expandable movable section of the elongate body by retracting the delivering tube at least partly can be performed with a minimum of parts, which is advantageous for procedural efficiency, i.e., by the absence of additional parts, such as air tubes, which may prove obstruent, and which is also advantageous from an economical and environmental point of view. The method according to the first aspect of the present invention involving self-expanding of the movable section positioned with the patient’s esophageal lumen, by at least partly retracting the delivering tube, to increase the distance between the esophagus and a treatment area outside of the esophagus, 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 increasing the distance between the esophagus and a treatment area outside of the esophagus.

According to preferred embodiments, said self-expandable movable section of the elongate body is made of a braided mesh, which is braided such that its preferred stable state is fully expanded. The wires of the mesh can be made of a spring m aterial such as stainless steel, cobalt-chrom e-nickel ( Elgiloy wire) , nitinol or the like. Alternatively, the self-expanding balloon wires may be made of a plastic such as PET, PMMA, polyurethane, nylon or the like. The wires m ay or m ay not be heat hardened to im part greater spring-like properties and m emory to the m esh. Spaces present between the braid wires are preferably filled with a thin m em brane m ade from an elastomeric m aterial such as polyurethane, silicone rubber, polyolefin , polyam ide copolym ers and the like. The m em brane can be form ed by dip molding, insert molding or it can be form ed separately and glued in place. Those skilled in the art will appreciate that the self-expandable movable section both shortens in length and widens in diameter as it achieves its expanded state.

I n a preferred embodim ent, the present invention provides a m ethod according to the first aspect of the invention, wherein during the step of retracting said delivering tube, the tube is retracted until the level of the cervical portion of the esophagus while still enveloping part of the movable section . This allows sufficient deflection of the esophagus away from a treatment area outside of the esophagus while still enveloping part of the movable section , such that the elongate body can easily be retracted from the esophageal lum en after a surgical, therapeutic and/or cosm etic treatm ent perform ed on the treatm ent area. Preferably, prior to retracting the elongate body from the esophageal lum en , the self-expandable movable section is reduced to its original state. This reduction to its original state m ay be perform ed by replacing the delivering tube around the movable section , such that the self-expansion of the movable section is again restricted at least partly by the enveloping delivering tube.

I n a preferred em bodim ent, the present invention provides a m ethod according to the first aspect of the invention, wherein a stylet is attached to said elongate body, which stylet is used to guide the elongate body during the step of positioning the elongate body within the esophageal lum en, which stylet therefore provides an efficient and easy m eans for guiding the positioning of the elongate body. Likewise, the stylet m ay be conveniently used to retract the elongate body afterwards from the esophageal lum en .

I n a preferred embodim ent, the present invention provides a m ethod according to the first aspect of the invention , wherein said treatm ent area is located on the patient’s left atrium , and is preferably located on the patient’s left atrial wall. Due to the proximity of the left atrium and the esophagus in a patient, protection of the esophagus, performed by deflecting the esophagus according to the method according to the first aspect of the present invention, against damage while performing surgical, therapeutic and/or cosmetic treatments on the treatment area is of particular importance. The present method is especially suited to deflect the esophagus away from the left atrium in order to protect the esophagus from damage during treatment of a treatment area on the left atrium, and preferably on the left atrial wall.

A second aspect of the present invention provides a device for deflecting an esophagus of a patient away from a treatment area outside of the esophagus, comprising an elongate body comprising a distal end, a proximal end, and a movable section in between, wherein said movable section is made of an expandable material and is adapted to be expanded into a longitudinally bent cylindrical shape.

Since the movable section of the elongate body of the device according to the second aspect of the present invention is made of an expandable material, it can be and is adapted to be expanded into a longitudinally bent cylindrical shape. This is not possible with conventional stents which are normally used in the prior art, which stents only are able to expand in a circumferential manner. Expansion of the device into a longitudinally bent cylindrical shape is very suitable to deflect an esophagus of a patient away from a treatment area outside of the esophagus, when the device is positioned in the esophagus. As an additional asset, the device according to the second aspect of the present invention comprises a minimum of components, is easy to construct and may be constructed from affordable materials. The device according to the second aspect of the present invention for deflecting the esophagus away from a treatment area outside of the esophagus, is not to be regarded as obvious to a person skilled in the art, since such person would rather optimize the commonly applied devices for such purpose comprising many different parts which are difficult to manufacture, instead of simplifying the construction of such devices.

In a preferred embodiment, said longitudinally bent cylindrical shape shows exactly one main curvature. When being placed into an esophagus of a patient, such main curvature is ideally suited for deflecting the esophagus and thereby increasing the distance between the esophagus and the treatment area. In another preferred embodiment, said longitudinally bent cylindrical shape shows three curvatures, being i) a main curvature which when placed into a patient’s esophagus is at least located along the part of the esophagus which is deflected from the treatment area, ii) a first additional curvature located distally with respect to said main curvature and iii) a second additional curvature located proximally with respect to said main curvature. In this context, “located distally” can be interpreted as being more closely located with regard to a patient’s mouth while “located proximally” can be interpreted as being more closely located to a patient’s stomach, when the device is placed inside a patient’s esophagus. The embodiment of the longitudinally bent cylindrical shape showing exactly one main curvature provides the advantage of simplicity while the longitudinally bent cylindrical shape showing said three curvatures provides an advantageous additional support of the main curvature by said first and second additional curvatures. In other words, said first and second additional curvatures help to keep the main curvature in place.

Said movable section of the elongate body can be made of any suited expandable material as known from the prior art. In a preferred embodiment, the expandable material is an inflatable material. Each suitable inflatable material known from the prior art may be used. An example of a suitable inflatable material is a conventional balloon. The balloon may be inflated by entering an air supply tube into the movable section and by providing air or another suitable gas, or alternatively a liquid, inside the inflatable material. A movable section made of an inflatable material is an especially easy construction of the movable section, and allows well-controlled expansion and good contact with the wall of the esophageal lumen when expanding the section. Additionally, such movable section made of an inflatable material may easily be deflated after a surgical, therapeutic and/or cosmetic treatment performed on the treatment area outside of the esophagus, and, in its deflated state, may easily be retracted from the esophageal lumen.

In a preferred embodiment, the present invention provides a device according to the second aspect of the invention, wherein said movable section is made of a self-expanding material. Said movable section of the elongate body can be made of any suited self-expanding material as known from the prior art. According to preferred embodiments, said self-expanding material is a braided mesh, which is braided such that its preferred stable state is fully expanded. The wires of the mesh can be made of a spring material such as stainless steel, cobalt-chrome- nickel (Elgiloy wire), nitinol or the like. Alternatively, the wires may be made of a plastic such as PET, PMMA, polyurethane, nylon or the like. The wires may or may not be heat hardened to impart greater spring-like properties and memory to the mesh. Spaces present between the braid wires are preferably filled with a thin membrane made from an elastomeric material such as polyurethane, silicone rubber, polyolefin, polyamide copolymers and the like. The membrane can be formed by dip molding, insert molding or it can be formed separately and glued in place. Those skilled in the art will appreciate that the movable section made of a self-expanding material both shortens in length and widens in diameter as it achieves its expanded state. Preferably, the preferred stable state of such movable section made of a self-expanding material is a longitudinally bent cylindrical shape.

Self-expansion of the movable section does not need any external action or external energy supply, and does not require external powered means, such as an air pump, or any connecting parts, such as air tubes, for expansion. Therefore, self-expansion of the movable section of the elongate body made of a self expanding material can be performed with a minimum of parts, which is advantageous for procedural efficiency, i.e. , by the absence of additional parts, such as air tubes, which may prove obstruent, and which is also advantageous from an economical and environmental point of view.

In a preferred embodiment, the present invention provides a device according to the second aspect of the invention, wherein the length of the movable section is less than the length of the esophagus. Preferably, the length of the movable section is 50% to 95%, more preferably 60% to 90% and even more preferably 70% to 85% of the length of the esophagus. A length of the movable section that is less than the length of the esophagus, and especially a length according to said preferred length ratios, is especially suited to enable the movable section to be disposed entirely within the esophageal lumen while the movable section is also long enough to efficiently deflect the esophagus from a treatment area outside of the esophagus by expansion of the movable section.

In a preferred embodiment, the present invention provides a device according to the second aspect of the invention, wherein said device comprises a retractable delivering tube which is arranged to envelop, preferably in close contact, said movable section at least partly. Preferably, the delivering tube thereby at least partly envelops said movable section that is made of a self-expanding material while said movable section is in an original non-expanded state. Preferably, said delivering tube is dimensioned in such a way that it can be easily initially inserted into the esophageal lumen without or with minimal straining of the esophagus. Preferably, the length of said delivering tube is at least 70%, more preferably at least 80%, even more preferably at least 85%, yet even more preferably at least 90% and most preferably at least 95% of the length of said movable section. Such length of the retractable delivering tube is especially suitable for partly enveloping the movable section. When the device comprises said delivering tube, self expansion only necessitates that the restraining means is at least partly removed, and does not require external powered means, such as an air pump, or any connecting parts, such as air tubes, for expansion. Therefore, self-expansion of the movable section of the elongate body made of a self-expanding material by retracting the delivering tube at least partly can be performed with a minimum of parts, which is advantageous for procedural efficiency, i.e. , by the absence of additional parts, such as air tubes, which may prove obstruent, and which is also advantageous from an economical and environmental point of view. The retractable nature of the delivering tube also allows the tube to still envelop a part of the movable section after the delivering tube is partly retracted in order to enable self-expansion of the movable section made of a self-expanding material. This allows sufficient deflection of the esophagus away from a treatment area outside of the esophagus while still enveloping part of the movable section, such that the elongate body can easily be retracted from the esophageal lumen after a surgical, therapeutic and/or cosmetic treatment performed on the treatment area.

A third aspect of the present invention provides a use of a device according to the second aspect of the present invention in a method according to the first aspect of the present invention. Accordingly, all technical accomplishments and positive characteristics of the device 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.

In what follows, the invention is described with reference to non-limiting examples or figures illustrating the invention, which are not intended to or may be interpreted to limit the scope of the invention. EXAM PLES

EXAM PLE 1

Exam ple 1 relates to a m ethod and a device for deflecting an esophagus of a patient away from a treatm ent area, preferably an ablation site, outside of the esophagus. I n this Example 1 , the treatm ent area is located on the patient’s left atrium . To better illustrate Example 1 , reference is made to Fig. 1 A-C and Fig. 2A- B. Fig. 1 A-C shows schematic representations of anteroposterior views of a patient’s esophagus before (A) and after (B) positioning an elongate body com prising a movable section within the esophageal lumen, and of the esophagus after expanding the section (C) , according to embodim ents of the present invention. Fig. 2A-B shows schem atic representations of left anterior oblique views of a patient’s esophagus and left atrium before positioning an elongate body comprising a movable section within the esophageal lumen (A) and after positioning of the body within the lumen and following expansion of the section (B) , according to embodiments of the present invention .

I n a first step, a device com prising an elongate body 3 which com prises a distal end 4, a proximal end 9 and a movable section 5 in between , is positioned within the patient’s esophageal lum en 2. The movable section 5 is less long than the length of the patient’s esophagus 1 , and, in particular, has a length which is 70% to 85% of the length of the esophagus 1 . At the end of the positioning step, the movable section 5 is disposed entirely within the esophageal lumen 2. The patient’s esophagus 1 prior to and after positioning of the elongate body 3 is shown in Fig. 1 A and Fig. 1 B, respectively. The movable section 5 is partly enveloped by a delivering tube 6. The delivering tube 6 has a length that is at least 95% of the length of the movable section 5. I n this Exam ple 1 , the movable section 5 is made of a self-expanding material, which m aterial com prises a braided m esh of wires, which is braided such that its preferred stable state is fully expanded. The wires of the m esh are made of polyurethane and spaces between the braid wires are filled with a thin m em brane of polyurethane. I n particular, the preferred stable state of said self-expandable movable section 5 is a longitudinally bent cylindrical shape. After retracting said tube 6 partly from the esophageal lumen 2, the movable section 5 self-expands into a longitudinally bent cylindrical shape, thereby following a direction 7 along the patient’s frontal plane ( Fig. 1 C) while sim ultaneously perform ing one spontaneous curvature C1 along the patient’s sagittal plane ( Fig. 2B) , and thereby deflecting the esophagus 1 away from the patient’s left atrium 8. I n particular, the delivering tube 6 is retracted until the level of the cervical portion of the esophagus 1 while still enveloping part of the movable section 5. Partly retraction of the delivering tube 6, when com pared to full retraction of the tube 6, shows the advantage that afterwards the elongate body 3 can be sim ply retracted from the esophageal lum en 2 by means of the delivering tube 6 still partly enveloping the movable section 5. Said spontaneous curvature C1 , also called a “m ain” curvature, can be seen in the left anterior oblique views of Fig. 2, showing the patient’s esophagus 1 and left atrium 8 before positioning the elongate body 3 within the esophageal lum en 2 ( Fig. 2A) and after positioning of the body 3 within the lumen and following expansion of the movable section 5 of the elongate body 3 ( Fig. 2B) . Due to said self-expansion, the distance D1 , D2 between the patient’s esophagus 1 and left atrium 8 is considerably increased. This increase in distance protects the esophagus 1 from treatm ents, such as ablation treatm ents, applied on a treatment area, such as one or more specific locations of the patient’s left atrial wall, located on the patient’s left atrium 8.

Said expansion and simultaneous curvature C1 as achieved by self-expansion of the self-expandable movable section 5 according to this Example 1 is not possible when using stents which are often used in the prior art, since stents only expand in a circumferential manner. Besides, the use of a self-expandable movable section 5 as described here is a very simple and straightforward m anner for deflecting an esophagus 1 away from a treatment area and thereby efficiently protecting the esophagus 1 . Moreover, the construction of the device is very simple and uses a m inim um of materials, which materials are affordable.

EXAM PLE 2

Exam ple 2 relates to a m ethod and a device for deflecting an esophagus of a patient away from a treatm ent area, preferably an ablation site, outside of the esophagus. I n this Example 2, the treatm ent area is located on the patient’s left atrium . To better illustrate Exam ple 2, reference is m ade to Fig. 3A-B. Fig. 3A-B shows schematic representations of left anterior oblique views of a patient’s esophagus and left atrium before positioning an elongate body com prising a movable section within the esophageal lumen (A) and after positioning of the body within the lum en and following expansion of the section (B) , according to em bodiments of the present invention.

Exam ple 2 is the sam e as Exam ple 1 , except for the spontaneous curvature which is obtained along the patient’s sagittal plane ( Fig. 3B) . According to Exam ple 2, the movable section 5 self-expands into a particular longitudinally bent cylindrical shape, thereby following a direction 7 along the patient’s frontal plane while sim ultaneously perform ing three spontaneous curvatures along the patient’s sagittal plane ( Fig. 3B) , being i) a main curvature C1 which is at least located along the part of the esophagus 1 which is deflected from the left atrium 8, next to ii) a first additional curvature C2 located distally with respect to said main curvature and iii) next to a second additional curvature C3 located proxim ally with respect to said main curvature, through which expansion and simultaneous three curvatures C1 -C3 the esophagus 1 is deflected from the left atrium 8. I n this context, “located distally” can be interpreted as being more closely located with regard to a patient’s mouth while“located proxim ally” can be interpreted as being more closely located to a patient’s stomach. The addition of said first C2 and second additional curvatures C3 provides an advantageous support of the m ain curvature C1 by said additional curvatures C2, C3. I n other words, said first C2 and second additional curvatures C3 help to keep the m ain curvature C1 in place.

Claims

CLAI MS

1 . A m ethod for deflecting an esophagus ( 1 ) of a patient away from a treatm ent area outside of the esophagus ( 1 ) , comprising the steps of :

- positioning within the patient’s esophageal lumen (2) an elongate body (3) com prising a distal end (4) , a proximal end (9) , and a movable section (5) in between ; and

- moving the movable section (5) to deflect the esophagus ( 1 ) and thereby increasing the distance ( D1 , D2) between the esophagus ( 1 ) and the treatment area,

characterized in t hat , said movable section (5) is expandable and is moved by expanding the section .

2. Method according to claim 1 , wherein at the end of the positioning step, the elongate body (3) is disposed entirely within the esophageal lumen (2) .

3. Method according to claim 1 or 2, wherein said movable section (5) is expanded along the patient’s frontal plane while simultaneously perform ing one or more spontaneous curvatures (C1 -C3) along the patient’s sagittal plane, through which expansion and sim ultaneous one or more curvatures the esophagus ( 1 ) is deflected from the treatment area outside of the esophagus ( 1 ) .

4. Method according to any of claims 1 to 3, wherein said movable section (5) is inflatable and is expanded by inflating the section.

5. Method according to any of claims 1 to 4, wherein said movable section (5) is self-expandable and wherein said movable section (5) is initially at least partly enveloped by and guided by a delivering tube (6) while positioning said elongate body (3) , and wherein said movable section (5) of the elongate body (3) is subsequently expanded by self-expansion of the section after retracting said tube at least partly from the esophageal lum en (2) .

6. Method according to claim 5, wherein during the step of retracting said delivering tube (6) , the tube is retracted until the level of the cervical portion of the esophagus ( 1 ) while still enveloping part of the movable section (5) .

7. Method according to any of claims 1 to 6, wherein a stylet is attached to said elongate body (3) , which stylet is used to guide the elongate body (3) during the step of positioning the elongate body (3) within the esophageal lum en (2) .

8. Method according to any of claims 1 to 7, wherein said treatment area is located on the patient’s left atrium (8).

9. A device for deflecting an esophagus (1) of a patient away from a treatment area outside of the esophagus (1), comprising an elongate body (3) comprising a distal end (4), a proximal end (9), and a movable section

(5) in between, characterized in that said movable section (5) is made of an expandable material and is adapted to be expanded into a longitudinally bent cylindrical shape.

10. Device according to claim 9, wherein said movable section (5) is made of a self-expanding material.

11. Device according to claim 9 or 10, wherein the length of the movable section (5) is less than the length of the esophagus (1).

12. Device according to claim 11 , wherein the length of the movable section (5) is 50% to 95% of the length of the esophagus (1).

13. Device according to any of claims 9 to 12, wherein said device comprises a retractable delivering tube (6) which is arranged to envelop said movable section (5) at least partly.

14. Device according to claim 13, wherein the length of said delivering tube (6) is at least 70% of the length of said movable section (5).

15. Use of a device according to any of claims 9 to 14 in a method according to any of claims 1 to 8.