Systems and methods for mechanical displacement of esophagus

Abstract

The present disclosure provides an exemplary assembly for use with a vacuum system and an esophageal positioning device that includes an introducer, where the esophageal positioning device includes a handle, a first section, a second section, and an articulation drive mechanism. The first section is coupled to the handle. The second section is pivotally connected to the first section. The articulation drive mechanism is configured to pivot the second section about the first section upon articulation.

Description

[0001] This application is a divisional application based on the Chinese patent application with application number 201880015298.X (international application number PCT / US2018 / 014467), application date January 19, 2018, and invention name “System and method for mechanical displacement of esophagus”. Technical Field

[0003] The present disclosure relates to medical devices and methods for vacuum aspiration adhesion of the esophagus combined with mechanical displacement of a patient's esophagus. Background Art

[0004] It is predicted that the number of patients experiencing atrial fibrillation ("AF") will increase to 10 million within 20 years. The cost of treating AF patients ranges from $2,000 to over $10,000 per year. The most effective and common method of treating AF is to use a procedure called catheter ablation. Catheter ablation is designed to deliver energy (e.g., radiofrequency and cryogenic energy) through a catheter placed in the left atrium of the heart. Ablation causes damage to heart cells. The target ablation area of ​​the heart is the area that causes AF. These areas in the left atrium are within 2-4 mm of the esophagus, so the main problem is that the energy from the ablation catheter can radiate forward and damage the esophagus. In the United States, approximately 103,000 AF ablation procedures are performed each year, and another 57,000 procedures are performed outside the United States. A serious complication of AF ablation procedures is damage to the esophagus leading to atrioesophageal fistula. This connection occurs between the esophagus and the heart because the ablation energy inflames the heart and esophagus. The subsequent healing results in a hole / communication between the heart (a sterile organ) and the esophagus (a non-sterile organ). This communication can lead to infection of the heart and cause a stroke. An atrioesophageal fistula occurs in approximately 0.6% of patients, and the outcome is almost always fatal or accompanied by significant morbidity. In addition, a precursor to an atrioesophageal fistula is an esophageal ulcer, which is also the cause of esophageal damage, which occurs in approximately 30% of patients. Therefore, electrophysiologists, the physicians performing ablation procedures, are very concerned about preventing damage to the esophagus and avoiding atrioesophageal fistulas.

[0005] Conventional therapy involves inserting a device into the esophagus to monitor temperature and suspending the delivery of ablative energy once the intraluminal esophageal temperature changes. However, these devices are unable to displace the esophagus away from the ablative energy source and therefore do not provide an active protection mechanism to prevent esophageal damage.

[0006] Therefore, there is a need for improved systems for displacing the esophagus to reduce the risk of esophageal damage. Summary of the invention

[0007] Devices, systems and methods for vacuum suction adhesion and mechanical displacement of the esophagus are provided. Specifically, components for use with a vacuum system and an esophageal positioning device are disclosed. A mechanical esophageal displacement system and method of use are also disclosed.

[0008] The esophagus is a flexible muscular organ and often moves during medical procedures. If only mechanical force is applied to move the esophagus, it may cause esophageal bulge rather than actual movement and displacement of the organ area. More specifically, the mechanical force will displace the leading edge of the esophageal wall, and the trailing edge of the esophageal wall will only move a short distance, if at all. The resulting esophageal bulge cannot provide the protective benefits of mechanical displacement. The system disclosed herein utilizes a suction vacuum to apply a uniform force to the esophagus to suck in the esophageal wall and adhere to the esophageal wall in a circumferential manner. Under such physiological conditions, as the mechanical force is applied, the entire circumferential segment of the esophagus is displaced and the trailing edge of the esophagus is free of hysteresis. Generally speaking, the esophagus follows the directional changes of the esophageal positioning device via this component. By using radiopaque markers, this directional change may be easily visualized to the doctor on an X-ray device. Visualization provides instant feedback to the doctor. By moving the esophagus outside the ablation field, the AF procedure can be performed relatively safely without the risk of damage to the esophagus, and the operator can safely ablate the target area without worrying about damage to the esophagus.

[0009] An exemplary assembly includes an introducer for use with a vacuum system and an esophageal positioning device. The esophageal positioning device includes a handle, a first section, a second section, and an articulation drive mechanism. The first section is coupled to the handle. The second section is pivotally connected to the first section. The articulation drive mechanism is configured to pivot the second section around the first section upon articulation. In some embodiments, the second section is sized to displace the esophageal wall by approximately 4 centimeters upon articulation.

[0010] The introducer of this exemplary assembly includes a soft circulation outer tube and a tube tip. The size of the soft outer tube is set to enter the esophagus through the mouth or nasal passage, wherein the soft outer tube includes a distal end, a proximal end, a lumen and a main body. The main body of the outer tube includes a perforated outer surface and one or more internal vacuum channels, and the one or more internal vacuum channels extend a certain distance from the proximal end to the distal end in the main body of the outer tube. In some embodiments, the perforated outer surface includes a plurality of vacuum holes, which are circumferentially spaced around the soft outer tube and extend radially therefrom. Because a plurality of vacuum holes are circumferentially spaced around the soft outer tube, a plurality of vacuum holes are positioned on a plurality of sides of the tube and can aspirate the esophagus from a plurality of directions. One or more internal vacuum channels are in fluid communication with a plurality of vacuum holes to apply vacuum to the esophageal wall via a vacuum system. The tube tip is positioned at the distal end of the outer tube.

[0011] An exemplary mechanical esophageal displacement system includes an assembly and an esophageal positioning device, wherein the assembly is operably connected to a vacuum system. The assembly includes an introducer, which includes a soft circulation outer tube and a tube tip. The size of the soft outer tube is set to enter the esophagus through the mouth or nasal passage, wherein the soft outer tube includes a distal end, a proximal end, a lumen and a main body. The main body of the outer tube includes a perforated outer surface and one or more internal vacuum channels, and the one or more internal vacuum channels extend a certain distance from the proximal end to the distal end in the main body of the outer tube. In some embodiments, the perforated outer surface includes a plurality of vacuum holes, which are circumferentially spaced around the soft outer tube and extend radially therefrom. Since a plurality of vacuum holes are circumferentially spaced around the soft outer tube, a plurality of vacuum holes are positioned on a plurality of sides of the tube and can be sucked from multiple directions. One or more internal vacuum channels are in fluid communication with a plurality of vacuum holes to apply vacuum to the esophageal wall via a vacuum system. The tube tip is positioned at the distal end of the outer tube.

[0012] The esophageal positioning device of the exemplary mechanical esophageal displacement system includes a handle, a first section, a second section and an articulation drive mechanism. The first section is coupled to the handle. The second section is pivotally connected to the first section. The articulation drive mechanism is configured to pivot the second section around the first section when the articulation is performed.

[0013] An exemplary method using a mechanical esophageal displacement system includes inserting an assembly into the patient's esophagus via an oral or nasal passage. The assembly includes an introducer having a soft circulation outer tube, a vacuum port, and a tube tip. The size of the soft outer tube is set to enter the esophagus through an oral or nasal passage, wherein the soft outer tube includes a distal end, a proximal end, a lumen, and a main body. The main body of the outer tube includes a perforated outer surface and one or more internal vacuum channels, and the one or more internal vacuum channels extend a certain distance from the proximal end to the distal end in the main body of the outer tube. In some embodiments, the perforated outer surface includes a plurality of vacuum holes, which are circumferentially spaced around the soft outer tube and extend radially therefrom. Since a plurality of vacuum holes are circumferentially spaced around the soft outer tube, a plurality of vacuum holes are positioned on a plurality of sides of the tube and can be used to aspirate the esophagus from a plurality of directions. One or more internal vacuum channels are in fluid communication with a plurality of vacuum holes to apply vacuum to the esophageal wall via a vacuum system. The tube tip is positioned at the distal end of the outer tube. The vacuum port includes a vacuum port main body, a vacuum line hook, and a vacuum port cover.

[0014] The exemplary method also includes advancing an esophageal positioning device through an outer tube of the introducer, wherein the esophageal positioning device includes a handle, a first segment, a second segment, and an articulation drive mechanism. The first segment is coupled to the handle. The second segment is pivotally coupled to the first segment. The articulation drive mechanism is configured to pivot the second segment around the first segment upon articulation.

[0015] The exemplary method also includes snapping a handle of the esophageal positioning device to a vacuum port cap of the introducer; engaging the vacuum system to adhere a portion of the outer tube to the esophageal wall; and articulating the articulation drive mechanism to pivot the second segment about the first segment to a selected angle.

[0016] The details of one or more embodiments of the present disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the present disclosure will be apparent from the description, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] To facilitate understanding of the present disclosure and for the purpose of illustrating the present disclosure, exemplary features and embodiments are disclosed in the accompanying drawings, it being understood, however, that the present disclosure is not limited to the precise arrangements and instrumentality shown, and wherein like reference characters denote like elements throughout the several views, and in the drawings:

[0018] Figure 1 is a perspective view of an exemplary mechanical esophageal displacement system according to the present disclosure;

[0019] Figure 2 According to the present disclosure Figure 1 A perspective view of exemplary components of a mechanical esophageal displacement system;

[0020] Figure 3 for Figure 2 an enlarged perspective view of a portion of an assembly of;

[0021] Figure 4 for Figure 1 a cross-sectional view of a component;

[0022] Figure 5 for Figure 1 Cross-sectional view of the mechanical esophageal displacement system;

[0023] Figure 6 for Figure 1 An enlarged view of a portion of the mechanical esophageal displacement system;

[0024] Figure 7 for Figure 1 A perspective view of a portion of a mechanical esophageal displacement system;

[0025] Figure 8 for Figure 1 A perspective view of a portion of a mechanical esophageal displacement system;

[0026] Fig. 9 for Figure 1 A perspective view of an exemplary esophageal positioning device of a mechanical esophageal displacement system;

[0027] Fig.10 for Fig. 9An enlarged perspective view of a portion of an esophageal positioning device;

[0028] Fig.11 for Fig.10 A side view of a portion of an esophageal positioning device;

[0029] Fig.12 for Fig.10 A top view of a portion of an esophageal positioning device;

[0030] Fig.13 for Figure 1 A schematic diagram of a mechanical esophageal displacement system of FIG. 1 , wherein the view shows the mechanical esophageal displacement system being advanced down the esophagus of a patient;

[0031] Fig.14 According to the present disclosure Figure 1 A schematic diagram of a proximal belt laminate assembly of a mechanical esophageal displacement system, wherein the view shows that a force is being applied to the proximal belt laminate assembly in the direction of the esophageal passage;

[0032] Fig.15 According to the present disclosure Figure 1 Another schematic diagram of a proximal belt laminate assembly of a mechanical esophageal displacement system, wherein the view shows that a force is being applied in a direction perpendicular to the direction of the esophageal passage;

[0033] Fig.16 Show Figure 1 A top view of a portion of a mechanical esophageal displacement system of claim 1, wherein the view shows the esophageal positioning device being positioned in a first angle orientation;

[0034] Fig.17 for Fig.16 An enlarged top view of a portion of an esophageal positioning device;

[0035] Fig.18 Show Figure 1 A top view of a portion of a mechanical esophageal displacement system of FIG. 1 , wherein the view shows the esophageal positioning device being positioned in a straight orientation;

[0036] Fig.19 Show Figure 1 a top view of a portion of a mechanical esophageal displacement system of claim 1, wherein the view shows the esophageal positioning device being positioned in a second angle orientation;

[0037] Fig. 20 for Fig.19 An enlarged top view of a portion of an esophageal positioning device;

[0038] Fig.21 According to the present disclosure Figure 1 A top view of a portion of an esophageal positioning device of a mechanical esophageal displacement system;

[0039] Fig. 22 for Figure 1 A perspective view of a handle of a mechanical esophageal displacement system;

[0040] Fig.23 for Figure 1 A perspective view of the internal components of a handle of a mechanical esophageal displacement system;

[0041] Fig.24 for Fig.23 A side cross-sectional view of the internal components of the handle;

[0042] Fig.25 for Figure 1 A cross-sectional view of another exemplary component of a mechanical esophageal displacement system;

[0043] Fig.26 is a top view of another exemplary mechanical esophageal displacement system according to the present disclosure;

[0044] Fig. 27 for Fig.26 An enlarged perspective view of an exemplary mechanical esophageal displacement system;

[0045] Fig.28 for Fig.26 An enlarged top view of an exemplary mechanical esophageal displacement system;

[0046] Fig.29 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure;

[0047] Fig.30 for Fig.29 A perspective view of exemplary components of a mechanical esophageal displacement system;

[0048] Fig.31 for Fig.29 a perspective cutaway view of a portion of a mechanical esophageal displacement system;

[0049] Fig.32 for Fig.29 Anterior view of a portion of a mechanical esophageal displacement system;

[0050] Fig.33 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure;

[0051] Fig.34 is a perspective cross-sectional view of another exemplary mechanical esophageal displacement system according to the present disclosure;

[0052] Fig.35 is a perspective view of another exemplary assembly according to the present disclosure;

[0053] Fig.36is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure;

[0054] Fig.37 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure;

[0055] Fig.38 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure;

[0056] Fig.39 is a perspective view of another exemplary assembly according to the present disclosure;

[0057] Fig.40 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure;

[0058] Fig.41 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure;

[0059] Fig.42 is a perspective view of another exemplary assembly according to the present disclosure; and

[0060] Fig.43 is a perspective view of another exemplary assembly according to the present disclosure. DETAILED DESCRIPTION

[0061] The following is a description of several illustrations of the applicant's inventive subject matter. Certain terms used herein are for convenience only and should not be considered as limitations on the present invention. In the accompanying drawings, the same reference numerals are used to designate the same elements throughout several drawings. Many examples are provided, but it should be understood that various modifications can be made without departing from the spirit and scope disclosed herein. As used in this specification and the appended claims, the singular forms "one", "a", "said" include plural references unless the context clearly indicates otherwise. The term "comprising" and its variant forms used herein are used synonymously with the term "including" and its variant forms, and are open, non-restrictive terms. Although the terms "comprising" and "including" have been used herein to describe various embodiments, the terms "consisting essentially of" and "consisting of" can be used to replace "comprising" and "including" to provide more specific embodiments of the present invention and are also disclosed.

[0062] The present invention will now be described more fully hereinafter with reference to specific embodiments of the present invention. Indeed, the present invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements.

[0063] Figures 1 to 25An example of a mechanical esophageal displacement system 1 for mechanically displacing the esophagus during a medical procedure via vacuum suction adhesion of a section of the esophagus is shown in accordance with the present disclosure. Figure 1 and Figure 5 As shown, an exemplary mechanical esophageal displacement system 1 includes an assembly 5 and an esophageal positioning device 13, wherein the assembly 5 is operably coupled to a vacuum system (not shown). In some embodiments, the assembly 5 is a disposable component of the mechanical esophageal displacement system 1, wherein the assembly 5 includes one or more disposable parts that can be removed and / or replaced after a medical procedure. As will be discussed in further detail below, in some embodiments, the esophageal positioning device 13 includes a handle 105, a first segment 110, a second segment 115, an articulation pivot pin 16, and an articulation drive mechanism 120. For example, the first segment 110 and the second segment 115 can be linear structures.

[0064] Figures 2 to 5 , Fig.13 , Fig.25 An example of a disposable assembly 5 according to the present disclosure is shown. The exemplary assembly 5 includes an introducer 2 that is sized to receive an esophageal positioning device 13. The esophageal positioning device 13 can be a reusable component of the system 1 that is inserted into the lumen of the introducer after the introducer 2 is advanced down the esophagus of the patient 37. However, in some embodiments, the introducer 2 and the esophageal positioning device 13 are manufactured as a single device, and the single-piece assembly 5 can be disposable or can be designed to be sterilized for repeated use. The patient 37 can be a human or other animal.

[0065] like Figure 5 As shown, the introducer 2 includes a soft outer tube 125. In some embodiments, the soft outer tube 125 is cylindrical. The size of the soft outer tube 125 is set so that it can enter the esophagus through the oral or nasal passages. The soft outer tube 125 includes a distal end 130, a proximal end 135, a lumen 137, and a body 140. In some embodiments, the body 140 includes a continuous inner surface 145. The body 140 of the outer tube includes a perforated outer surface 150 along the length of the outer tube, and one or more internal vacuum channels 21 (see Figure 4 and Fig.25 ), the one or more internal vacuum channels extend a certain distance within the body 140 of the outer tube 125 from the proximal end 135 to the distal end 130. In some embodiments, the perforated outer surface 150 includes a plurality of vacuum holes 3 that are circumferentially spaced around the soft outer tube 125 and extend radially therefrom, such as Figures 1 to 3. As the plurality of vacuum holes 3 are spaced circumferentially around the soft outer tube 125, the plurality of vacuum holes 3 are positioned on the plurality of sides of the tube 125 and the esophagus can be sucked from a plurality of directions. One or more internal vacuum channels 21 are in fluid communication with the plurality of vacuum holes 3 to apply a vacuum to the esophageal wall via the vacuum system. The outer tube 125 or its parts can be made of soft polymers such as polyvinyl chloride (PVC) or silicone. The outer tube 125 is flexible enough so that the system 1 does not add unnecessary rigidity that the esophageal positioning device 13 needs to overcome, but it is not too flexible so that the outer tube 125 does not bunch up when the introducer 2 is inserted into the esophagus. In some embodiments, the outer tube 125 includes a coating of lubricating material (e.g., a hydro-slip pad) to facilitate introduction into the esophagus and minimize esophageal trauma.

[0066] Although the outer tube 125 can be made of a single material, in some embodiments, the multi-durometer outer tube 125 is made of more than one material to achieve the desired stiffness at different portions along the outer tube 125. In some embodiments, the distal end 130 is made of a harder material (e.g., a combination of silicone and polyurethane or other materials), while the portion between the distal end 130 and the proximal end 135 including the plurality of radial vacuum holes 3 is made of a more flexible material. The harder distal end 130 is more conducive to introducing the soft outer tube 125 into the esophagus. The more flexible material of the portion containing the plurality of radial vacuum holes 3 allows the portion of the soft outer tube 125 to fold, thereby creating a smaller diameter soft outer tube 125 and enhancing the folding of the esophagus. Therefore, this moves the esophagus further away from the heart and allows the esophagus to better adhere circumferentially to the soft outer tube 125.

[0067] In some embodiments, assembly 5 may include a telescoping mechanism on at least a portion of the device to facilitate entry of the device into the esophagus. Once located at a desired location within the esophagus, the telescoping portion may be extended to deploy the entire device.

[0068] As described above, a certain section of the esophagus can be adhered to the introducer 2 via vacuum suction. To this end, the perforated outer surface 150 of the introducer 2 may include a plurality of radial vacuum holes 3, which may be positioned at various locations around the outer surface 150. In some embodiments, a plurality of radial vacuum holes 3 are positioned along the outer surface 150, starting at a distance between about three and five inches from the tube tip 4, and spanning a length of about two inches from the starting position. A plurality of holes 3 are designed to be in fluid communication with one or more internal vacuum channels 21, so that when the vacuum system is coupled to the assembly 5 and turned on, the vacuum system can generate a vacuum between the esophageal wall and the outer tube 125. The fluid communication may be direct or indirect. In some embodiments, one or more internal vacuum channels 21 extend toward the distal end 130 but do not extend to the distal end. For example, in some embodiments, one or more internal vacuum channels 21 extend until the most distal position of the radial vacuum hole 3 but do not pass through the position. In some embodiments, one or more internal vacuum channels 21 extend through the entire length of the body 140. In some embodiments, the one or more internal vacuum channels 21 include one or more cylindrical rings that each or collectively define a chamber (not shown) that is axially aligned with the lumen 137. In some embodiments, the body 140 does not include one or more internal vacuum channels 21, but rather a plurality of radial vacuum holes 3 are in fluid communication with the lumen 137, and a vacuum is applied to the lumen 137 to create a vacuum between the esophageal wall and the outer tube 125. Any suitable vacuum system can be used that is capable of providing sufficient suction to adhere a portion of the outer tube 125 to a portion of the esophageal wall. One suitable exemplary vacuum system is a vacuum pump that provides a suction of 300 mmHg. In some embodiments, the mechanical esophageal displacement system 1 includes a feedback mechanism such as a pressure gauge to confirm that a vacuum seal has been formed along the esophagus by measuring pressure changes in the system.

[0069] like Figures 1 to 3 , Figure 5 and Fig.13 As shown, the introducer 2 may include a tube tip 4 positioned at the distal end 130 of the outer tube 125. In some embodiments, the tube tip 4 includes a hard polymer tip with a soft rounded profile, wherein the tip is coupled to the distal end 130 of the outer tube 125, wherein the tube tip 4 is a closed structure. The shape of the tube tip 4 does not damage the esophagus because the tube tip 4 is designed to be in direct contact with the esophageal passage. For example, the tube tip 4 may include a semi-dome shape. In some embodiments, the tube tip 4 is a closed structure rather than a lumen.

[0070] like Figure 1 , Figure 2 , Figure 5 , Fig.13As shown, the assembly 5 can also include a vacuum port 155, which includes a vacuum port body 6 and a vacuum port cover 7. In some embodiments, the vacuum port cover 7 is a hard polymer cover that is bonded to the vacuum port body 6. The vacuum port cover 7 can also include a snap feature geometry and a quick release hinge mechanism (not shown) to connect and separate the handle of the esophageal positioning device 13 to the proximal end 135 of the outer tube 125. In some embodiments, the vacuum port body 6 includes a vacuum line hook 170 that is in fluid communication with one or more internal vacuum channels 21. The vacuum port body 6 can be coupled to both the introducer 2 and the vacuum port cover 7 to form an airtight seal. In some embodiments, the body 6 also includes a vacuum port valve and a lever (not shown), wherein the lever can control the vacuum system.

[0071] In some embodiments, the introducer 2 further includes a plurality of radiopaque markers (not shown) positioned proximate to the location 180 where the articulation pivot pin 16 will reside within the introducer 2. In some embodiments, the plurality of radiopaque markers span distally along or within the outer tube 125 of the introducer 2 from the location 180 where the articulation pivot pin 16 will approximately reside to the location of the tube tip 4. In some embodiments, the plurality of radiopaque markers span a distance of approximately four to six centimeters from the tube tip 4. In some embodiments, the radiopaque markers are located on the entire outer tube 125.

[0072] As described above, in some embodiments, the esophageal positioning device 13 includes a handle 105, a first section 110, a second section 115, an articulation pivot pin 16, and an articulation drive mechanism 120. In some embodiments, the second section 115 is sized to displace the esophageal wall by approximately 4 centimeters upon articulation. In some embodiments, the length of the second section 115 is between four and six centimeters. Figures 4 to 21 As shown, the second section 115 may include a distal tape lamination assembly 12, a distal tape guard 8, and a distal pivot holder 14, wherein the distal tape lamination assembly 12 accommodates a plurality of distal tapes 185. Figures 7 and 8 As shown, the distal band guard 8 holds the distal band laminate assembly 12 at the distal end 190 by a pin 9 passing through a plurality of distal bands 185. The distal band laminate assembly 12 can be made of various suitable materials (including, for example, 420 stainless steel or a hard polymer). The plurality of distal bands 185 can be made of, for example, spring steel. The distal pivot retainer 14 can be made of, for example, 420 stainless steel or 17-4 stainless steel. The plurality of distal bands 185 can be assembled to the distal pivot retainer 14 by welding, using pins, or by bonding. With the distal band 185 free to flex at the distal end 190, the band 185 can be rigidly attached to the distal pivot retainer 14.

[0073] like Figures 7 and 8 As shown, in some embodiments, all but one of the distal bands 185 have a slot 195 at the distal end to avoid interference with the pin when the band is flexed. One distal band 10 (top band or outer band) includes a hole 200 instead of a slot 195, wherein the hole 200 limits the band 10 from sliding when the plurality of distal bands 185 are flexed. The hole 200 also helps position the plurality of distal bands 185 of the distal band laminate assembly 12. In some embodiments, the distal guard 8 has a rounded tip 205 that has no sharp edges to prevent damage to the outer hose 125 during insertion.

[0074] like Figures 10 to 24 As shown, in some embodiments, the first section 110 includes a proximal pivot holder 15, an articulation drive cable 18, and a proximal band laminate assembly 19. The proximal band laminate assembly 19 includes a plurality of proximal bands 210. The proximal pivot holder 15 houses the proximal band laminate assembly 19. The proximal bands 210 can be rigidly attached to the proximal pivot holder 105 as the proximal bands 210 are free to flex at the proximal ends 215 in the handle 105. In some embodiments, the proximal pivot holder 15 limits the distal pivot holder 14 from articulating beyond a selected angle (e.g., 45 degrees) to each side to prevent the risk of damage to the esophagus due to excessive translation.

[0075] like Figure 14 to Figure 15 As shown, the proximal belt laminate assembly 19 can provide stiffness in a direction 220 perpendicular to the esophageal passage direction ( Fig.15 ) while maintaining flexibility along the esophageal passage direction 225. By using thin strips stacked on top of each other ( Fig.14 ) can remain flexible to form a body that is considered to be in the direction of the normal force provided by the esophagus ( Fig.15 ).

[0076] Similar to the distal band laminate assembly 12, the proximal band laminate assembly 19 can be made of various suitable materials (including, for example, 420 stainless steel or hard polymers). A plurality of proximal bands 210 can be made of, for example, spring steel. The articulation pivot pin 16 can be made of, for example, 420 stainless steel or 17-4 stainless steel. The articulation pivot pin 16 connects the distal pivot retainer 14 and the proximal pivot retainer 15 and allows them to pivot. The articulation pivot pin 16 can be press-fitted into the proximal pivot retainer 15 and maintain a loose fit through the distal pivot retainer 14.

[0077] like Figures 10 to 12 and Figures 17 to 20As shown, in some embodiments, the mechanical esophageal displacement system 1 also includes an articulation drive cable 18. The cable 18 can transmit the user's input force from the handle 105 to the articulation pivot pin 16 to cause the second section 110 to articulate 45 degrees to the left or right from a neutral position, wherein the distal belt laminate assembly 12 and the proximal belt laminate assembly 19 are parallel to each other. In some embodiments, the mechanical esophageal displacement system 1 includes a feedback mechanism that measures and displays the distance the device articulates from its neutral position. In some embodiments, the cable 18 has a diameter of approximately 0.024 inches and is made of braided stainless steel or a polymer such as UHMWPE, Vectran, or Orion. In some embodiments, the mechanical esophageal displacement system 1 also includes an articulation cable crimping portion 17. As shown Figures 16 to 20 As shown, the cable crimp 17 can be a small ball that compresses and friction fits onto the stainless steel braided cable 18. The crimp 17 provides a feature on the cable 18 that can interface with the distal pivot retainer 14 when pulled left or right to allow the system 1 to articulate. The ball can be compressed and friction fit onto the articulation cable 18 to provide an interface surface. In some embodiments, in addition to or as an alternative to the cable crimp 17, the articulation drive cable 18 can also be connected to the distal pivot retainer 14 by welding. Other types of mechanical fasteners or chemical fasteners can be used to operably connect the articulation drive cable 18 to the distal pivot retainer 18, such as integrally formed, chemically bonded, or mechanically or magnetically engaged.

[0078] In some embodiments, the mechanical esophageal displacement system 1 further includes a plurality of proximal band cable guides 20 that guide the articulation cables 18 from the handle 105 to the articulation pivot pin 16, wherein the plurality of proximal band cable guides 20 are evenly spaced along the plurality of proximal bands 210. The proximal band cable guides 20 may be welded or bonded to one or more of the proximal bands 210 so as to maintain the proximal bands 210 aligned while still allowing the bands 210 to slide and translate independently when bent. The proximal band cable guides 20 help guide the articulation drive cables 18 downward along the length of the esophageal positioning device 13. The proximal band cable guides 20 provide additional rigidity and structure to the proximal band laminate assembly 19 while still allowing the laminate band assembly 19 to bend.

[0079] like Figure 1 , Fig. 9 , Fig.13 , Figure 22 to Figure 24 As shown, the handle 105 of the esophagus positioning device 13 may include a variety of components. Fig. 22As shown, in some embodiments, the handle 105 includes a two-piece outer shell, which includes an articulation handle shell half 22 and a locking handle shell half 23. In some embodiments, the articulation handle shell half 22 can be made of a polymer or metal, and, for example, its diameter can be about 1.9 inches and its length can be about 5 inches. The articulation handle shell half 22 can accommodate a plurality of proximal bands 185, an articulation drive mechanism 120, and an articulation control knob 25. In some embodiments, the locking handle shell half 23 can be made of a polymer or metal, and, for example, its diameter can be about 1.9 inches and its length can be about 5 inches. The locking handle shell half 23 can accommodate the proximal band 185, the articulation drive mechanism 120, and the locking control knob 24. The locking control knob 24 can be twisted to increase the friction of the system 1 and completely lock the system 1 at a selected articulation angle. Twisting the locking control knob 25 in the opposite direction releases the articulation drive mechanism 120 to allow the articulation drive mechanism 120 to move freely. The overall diameter of the knob 24 may be, for example, about one inch. The articulation control knob 25 may be rotated in a first direction or a second direction. In some embodiments, rotating the control knob in a clockwise direction may articulate the tube tip 4 of the assembly 5 to the right, while rotating the control knob 25 counterclockwise may articulate the tube tip 4 of the assembly 5. The diameter of the articulation control knob 25 may be, for example, about two inches. Thus, when rotated in the first direction, the articulation control knob 25 may articulate the second section 115 to the right, and when rotated in the second direction, the articulation control knob 25 may articulate the second section 115 to the left.

[0080] like Fig. 22 As shown, the handle 105 of the esophageal positioning device 13 can include one or more snap hooks 26 positioned on the articulation handle shell half 22 and / or on the locking handle shell half 23. The snap hooks 26 can be used to interface and couple the handle 105 to the vacuum port cover 7 of the assembly 5.

[0081] like Figure 23 to Figure 24 As shown, the handle 105 of the esophageal positioning device 13 may include, for example, a top handle belt retainer 27, a bottom handle belt retainer 28, a pulley transmission 29, a cable pulley 30, an input gear 31, a proximal handle belt retainer pin 32, a locking cone clutch 33, an articulation input shaft 34, an articulation input shaft bushing 35 and an articulation pulley shaft bushing 36.

[0082] In some embodiments, the top handle strap retainer 27 and the bottom handle strap retainer 28 accommodate the proximal ends 215 of the plurality of proximal straps 185 via the pin, hole and slot features of the proximal strap 185 to allow the strap 185 to translate when bent. The top handle strap retainer 27 and the bottom handle strap retainer 28 can be made of, for example, a polymer or aluminum. The top handle strap retainer 27 and the bottom handle strap retainer 28 can be held in place together by ribs 230 found on the articulation handle shell half 22 and on the locking handle shell half 23.

[0083] In some embodiments, the pulley transmission 29 includes a large gear attached to the cable pulley 30 via two pins. In some embodiments, the pulley transmission 29 is concentric with the locking control knob 24 and the pulley shaft 235. In some embodiments, the diameter of the pulley transmission 29 is about two to three times the diameter of the input gear 31.

[0084] In some embodiments, the articulation cables 18 are attached to the cable pulleys 30, with the right cable 18 attached to the top pulley hole 250. The articulation cables 18 can be routed around the pins of the cable pulleys 30.

[0085] In some embodiments, the input gear 31 is a pinion gear attached to the articulation control knob shaft 255 and to the pulley drive 29. The input gear 31 is used to reduce the amount of input torque required by the user of the system 1 when the esophageal positioning device 13 is articulated. The input torque can be reduced by two to three times, for example, based on a given ratio of the input gear 31 to the pulley drive 29. Thus, in some embodiments, the operator is not required or restricted from applying more than 80 ounces / inch of torque to control the knobs 24, 25. For example, in some embodiments, a fail-safe mechanism can be employed so that the articulation control knob 25 is locked when the operator applies a preset torque (e.g., greater than 80 ounces / inch) to the articulation control knob 25. Thus, the locking of the knob 25 can help avoid injury to the operator.

[0086] In some embodiments, the proximal strap handle retainer pin 32 interfaces with the proximal strap laminate assembly 19 and the top handle strap retainer 27 and the bottom handle strap retainer 28 to hold the proximal strap 185 in place. When assembled together, the proximal strap handle retainer pin 32 aligns with portions of the top handle strap retainer 27 and the bottom handle strap retainer 28. The retaining pin 32 aligns with the slots in all but one of the proximal straps 185, which allows the straps 185 to slide past each other when bent.

[0087] In some embodiments, the locking cone clutch 33 can be attached to the locking control knob 24 via screws 260 and interference ribs 265. The locking cone clutch 33 can include threads on an outer diameter that interface with threads of the locking handle housing half 23. When the locking knob 24 is twisted, such as when twisted clockwise, the locking cone clutch 33 moves inward and interferes with the tapered shaft on the cable pulley 30, which effectively slows the cable pulley 30 and / or locks it in its current position.

[0088] In some embodiments, the articulation input shaft 34 has a flat face, which is, for example, D-shaped. The flat face allows for interface with the input gear 31 via a set screw. The diameter of the input shaft 34 may be, for example, about 0.25 inches. In some embodiments, the articulation input shaft bushing 35 allows the articulation input shaft 34 to rotate freely. Similarly, in some embodiments, the articulation pulley shaft bushing 36 allows the articulation pulley shaft 34 to rotate freely. The articulation input shaft bushing 35 and the articulation pulley shaft bushing 36 further help maintain proper alignment of the handle 105 components.

[0089] In some embodiments, the esophageal positioning device 13 includes a clutch and / or a dynamometer system for limiting the torque that the user can apply. In some embodiments, a sensor (e.g., a thermistor or a temperature sensor) is positioned at the distal end 190 of the esophageal positioning device 13. In some embodiments, the esophageal positioning device 13 includes multiple sensors (e.g., thermistors and / or temperature sensors) along the device to allow simultaneous measurement of temperature at different anatomical locations of the esophagus. In some embodiments, the thermistor, temperature sensor, or other sensor is operably connected to a computer, wherein the computer displays a virtual image of the introducer 2 and / or the esophageal positioning device 13 via a mapping screen. In some embodiments, the thermistor, temperature sensor, or other sensor is used to display the device in a real-time imaging display (e.g., MRI, ultrasound (intracardiac, transesophageal, or transthoracic) or CT imaging), thereby achieving three-dimensional imaging of the anatomical structure and the device. In some embodiments, the introducer 2 or the esophageal positioning device 13 includes a port for receiving a diatrizoate injection or other materials for outlining and visualizing the esophagus on an X-ray. In some embodiments, a ratchet articulation control is provided so that one click of the ratchet articulation control knob in a counterclockwise direction can cause 15 degrees of articulation to the left or 1.5 centimeters of translation to the left, depending on what the operator desires. In some embodiments, an audible click is provided to the operator as feedback regarding the amount of tension delivered to the knob. In some embodiments, a safety release mechanism is incorporated into the esophageal positioning device 13 to prevent excessive force on the esophagus.

[0090] In some embodiments, the esophageal positioning device 13 includes other imaging devices used with visualization techniques. Such imaging devices may include, for example, a fiber optic light source with a camera, an ultrasound imaging device (e.g., Doppler), etc. These imaging devices can be used to visualize the esophagus before, during, and after the application of ablation energy, as well as at other times during the procedure. The ultrasound imaging device can be used, for example: to visualize and measure through the esophagus to observe intracardiac objects such as catheters, transseptal techniques / devices, assessment of intracardiac thrombi, assessment of intracardiac defects such as atrial septal defects; visualization / measurement of pulmonary vein devices; visualization / measurement of mapping devices (e.g., multi-electrode baskets); visualization / measurement of the left atrial appendage and left atrial appendage closure devices; visualization / measurement of devices placed inside the pericardium; and other heart-related products.

[0091] In some embodiments, the tape laminates of the distal tape laminate assembly 12 or the proximal tape laminate assembly 19 have different widths. Fig.25 An example of a proximal band laminate assembly 19 having proximal bands 210 of varying widths is shown. The width of the distal band 185 or the proximal band 210 can be shaped to maximize stiffness according to the contour shape of the outer tube 125 of the introducer 2. For example, if the contour shape of the outer tube 125 of the introducer 2 is circular, the distal band 185 or the proximal band 210 can be cut so that the contour of the bands 185, 210 is circular. The use of different widths can provide a more space-saving interaction between the bands 185, 210 and the outer tube or cable band guide 20 of the introducer 2. In addition, cutting the bands of the proximal assembly 19 (or distal assembly 12) with different widths can increase the stiffness of the system 1 because the amount of material in contact with the inner surface of the outer tube or cable band guide 20 is increased.

[0092] While a variety of materials are disclosed for various portions of assembly 5, in some embodiments, all components of assembly 5 are made of non-ferrous materials to allow for use with advanced mapping systems or in MRI procedure rooms.

[0093] Methods of using the mechanical esophageal displacement system 1 are also provided. An exemplary method includes inserting the assembly 5 through the oral or nasal passage ( Fig.13 ) is inserted into the esophagus of the patient 37. The assembly 5 includes an introducer 2 having a soft circulation outer tube 125, a vacuum port 155, and a tube tip 4. The soft outer tube 125 is sized to enter the esophagus through the patient's oral or nasal passage, wherein the soft outer tube 125 includes a distal end 130, a proximal end 135, a lumen 137 (see Figure 4 and Fig.25) and a body 140. The body 140 of the outer tube 125 includes a perforated outer surface 150 and one or more internal vacuum channels 21 extending a certain distance from the proximal end 135 to the distal end 130 within the body 140 of the outer tube 125. In some embodiments, the perforated outer surface 150 includes a plurality of vacuum holes 3 that are circumferentially spaced around the soft outer tube 125 and extend radially therefrom, such as Figures 1 to 3 14. As the plurality of vacuum holes 3 are spaced circumferentially around the soft outer tube 125, the plurality of vacuum holes 3 are positioned on multiple sides of the tube 125 and the esophagus can be suctioned from multiple directions. One or more internal vacuum channels 21 are in fluid communication with the plurality of vacuum holes 3 to apply vacuum to the esophageal wall via the vacuum system. The tube tip 4 is positioned at the distal end 130 of the outer tube 125. The vacuum port 155 includes a vacuum port body 6, a vacuum line hook 170, and a vacuum port cover 7. In some embodiments, the body includes a continuous inner surface 145.

[0094] The exemplary method also includes advancing the esophageal positioning device 13 through the outer tube of the introducer 2, wherein the esophageal positioning device 13 includes a handle 105, a first section 110, a second section 115, an articulation pivot pin 16, and an articulation drive mechanism 120. The first section 120 is coupled to the handle 105. The second section 115 is pivotably connected to the first section 110 via the articulation pivot pin 16. The articulation drive mechanism 120 is configured to pivot the second section 115 about the first section 110 upon articulation.

[0095] The exemplary method also includes snapping the handle 105 of the esophageal positioning device 13 to the vacuum port cover 7 of the introducer 2; engaging the vacuum system to adhere a portion of the outer tube 125 to the esophageal wall; and articulating the articulation drive mechanism 120 to pivot the second segment 115 about the first segment 110 to a selected angle, such as an angle of approximately 45 degrees.

[0096] Fig.26 Another exemplary mechanical esophageal displacement system according to the present disclosure is shown. The mechanical esophageal displacement system includes a flexible coil 410 wrapped around a portion of the esophageal displacement device. Figure 1 Similar to the implementation scheme seen in, Fig.26 An exemplary mechanical esophageal displacement system can displace the esophagus by approximately 4 centimeters, for example, 3.992 centimeters.

[0097] Fig. 27 for Fig.26 An enlarged perspective view of an exemplary mechanical esophageal displacement system of FIG. The view highlights an articulation pin that is operably coupled to the coil to allow a segment of the esophageal positioning device to articulate about the pin. Fig.28 for Fig.26 An enlarged top view of an exemplary mechanical esophageal displacement system of FIG. 1 , wherein the view highlights exemplary dimensions.

[0098] Fig.29 FIG. 1 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. Figure 1 Similar to the implementation scheme seen in, Fig.29 An exemplary mechanical esophageal displacement system of includes pulleys and cables to articulate respective segments of the esophageal positioning device.

[0099] Fig.30 for Fig.29 1. A perspective view of exemplary components of a mechanical esophageal displacement system of FIG. 1. The view shows an outer tube 125 having a long tail 412 with a radiopaque marker 414.

[0100] Fig.31 for Fig.29 A perspective cutaway view of a portion of a mechanical esophageal displacement system of FIG. The view highlights the vacuum channel 21 and the aperture of the assembly.

[0101] Fig.32 for Fig.29 1. A front view of a portion of a mechanical esophageal displacement system of FIG. 1. This view highlights the connections between the segments of the esophageal positioning device. This view includes U-clip 515, pin 516, cable 518, crimp 517, weld 518, and top pulley half 514 and bottom pulley half 516.

[0102] Fig.33 6 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. This view shows an esophageal positioning device having a fishing rod 610, a metal ring 612, a tie line 614, and a cable 618, wherein the cable houses an anchor 616.

[0103] Fig.34 is a perspective cross-sectional view of another exemplary mechanical esophageal displacement system according to the present disclosure. Fig.34 The mechanical esophageal displacement system includes an esophageal displacement device that rotates to compress a spring 710 that is operably coupled to the assembly.

[0104] Fig.35 is a perspective view of another exemplary assembly according to the present disclosure. Fig.35 In the embodiment, the assembly includes a tube 825 having a foldable portion 810, wherein the foldable portion 810 can be actuated by a guide wire and / or vacuum pressure.

[0105] Fig.36 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. Fig.36The mechanical esophageal displacement system of the present invention includes an esophageal displacement device that provides articulation via shafts 910, 912, a right-hand screw 914, and a left-hand screw 916, wherein the right-hand screw 914 and the left-hand screw 916 are axially coupled together. When a cable 920 connected to the left-hand screw is rotated, threaded openings 922, 924 in the shafts 910, 912 move up and down along the screws 914, 916, respectively, thereby tilting an articulation plate 918 hingedly connected to the opposite ends of the shafts 910, 912.

[0106] Fig.37 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. Fig.37 The mechanical esophageal displacement system includes a gear transmission 1010 that provides articulation via a worm gear 1012 .

[0107] Fig.38 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. Fig.38 The mechanical esophageal displacement system includes a gear transmission 1110 that provides articulation via a leaf spring 1112.

[0108] Fig.39 is a perspective view of another exemplary assembly according to the present disclosure. Fig.39 , the assembly includes an outer tube 1210 similar to outer tube 125 that is made of a material that deforms into a particular shape when wet.

[0109] Fig.40 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. Fig.40 The mechanical esophageal displacement system of the invention comprises a top section 1310 and a bottom section 1312 which are matched together via a set of axial ridges 1314, 1316, respectively, which prevent rotation. The top section 1310 and the bottom section 1312 are loosely connected together via a wire 1318. When the wire 1318 is pulled up, the bottom section 1312 is locked into place.

[0110] Fig.41 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. Fig.40 The mechanical esophageal displacement system includes an esophageal displacement device having two parts 1410, 1412, the two parts having angled faces 1414, 1416, respectively, wherein the angle between the two parts 1410, 1412 changes from alignment to perpendicular when rotated.

[0111] Fig.42 is a perspective view of another exemplary assembly according to the present disclosure. Fig.42The assembly includes a straw-like tube 1510 having a flexible portion 1512 on only one side 1514 so that a vacuum when applied causes one side 1514 of the assembly to deflect.

[0112] Fig.43 is a perspective view of another exemplary assembly according to the present disclosure. Fig.43 The component includes a gel liquid portion 1610 that causes the component to deflect in a given direction.

[0113] While certain means for deflecting the assembly have been described above, it should be noted that the assembly may also be articulated using any other means known in the art including, for example, springs, fluid / air reservoirs, magnets, and the like.

[0114] Although only a few exemplary embodiments of the present invention are described in detail above, it will be readily appreciated by those skilled in the art that many modifications may be made in the exemplary embodiments without substantially departing from the novel teachings and advantages of the present invention. Therefore, all such modifications are intended to be included within the scope of the present invention, which is defined by the appended claims and all equivalents thereof. In addition, it should be appreciated that it is conceivable that many embodiments may not achieve all the advantages of some embodiments, but the absence of a particular advantage should not be interpreted as necessarily meaning that such embodiments are outside the scope of the present invention.

[0115] Disclosed are materials, systems, devices, compositions, and components that can be used in, with, in making, or as products of the disclosed methods, systems, and apparatus. These and other components are disclosed herein, and it should be understood that when combinations, subgroups, interactions, groups, etc. of these components are disclosed, even though specific reference to each of the various individual and collective combinations and arrangements of these components may not be explicitly disclosed, each is specifically contemplated and described herein.

Claims

1. An assembly for use with a vacuum system and an esophageal positioning device, the esophageal positioning device comprising a first section and a second section, wherein: The first segment has a central axis and the second segment has a proximal end pivotally connected to the first segment and a distal end spaced apart from the proximal end, the second segment being pivotable about the first segment between a first position and a second position when articulated, wherein in the first position the distal end of the second segment is disposed along the central axis and in the second position the distal end of the second segment is displaced from the central axis, the assembly comprising: An introducer sized to receive an esophageal positioning device, the introducer comprising: a soft outer tube sized to enter the esophagus through the oral or nasal passages, the soft outer tube comprising a distal end, a proximal end, and a body, wherein the body defines a plurality of radial vacuum holes spaced circumferentially about the soft outer tube, wherein the plurality of radial vacuum holes are in fluid communication with the vacuum system to apply a vacuum to the esophageal wall; and a tube tip positioned at a distal end of the outer tube; The distal end of the second section maintains the same distance from the proximal end of the second section at both the first position and the second position.

2. The assembly according to claim 1, wherein When the esophageal positioning device is disposed in the introducer, a distal end of the second section of the esophageal positioning device is spaced apart from a tube tip of the introducer.

3. The assembly according to claim 1, wherein: The tube tip comprises a hard polymer tip having a soft rounded profile, wherein the tip is bonded to the distal end of the outer tube.

4. The assembly according to claim 1, wherein: The introducer also includes one or more internal vacuum channels extending a distance within the body of the outer tube from the proximal end to the distal end, wherein the one or more internal vacuum channels are in fluid communication with the plurality of vacuum holes to apply a vacuum to the esophageal wall via the vacuum system.

5. The assembly according to claim 4, wherein: The introducer also includes a vacuum port, which includes a vacuum port body and a vacuum port cover, wherein the vacuum port body includes a vacuum line hook connected to the one or more internal vacuum channel fluids, and wherein the vacuum port body is coupled to the introducer and the vacuum port cover to form an airtight seal.

6. The assembly of claim 1 further comprising an articulation pivot pin pivotally connecting the second section to the first section, wherein The introducer also includes a plurality of radiopaque markers positioned proximate a location where the articulation pivot pin will reside within the introducer, and wherein the plurality of radiopaque markers span distally from the location to the tube tip.

7. The assembly according to claim 1, wherein: The introducer further includes a plurality of radiopaque markers for indicating movement of the second section in multiple directions.

8. The assembly of claim 1, wherein: The plurality of vacuum holes are positioned along the outer surface of the outer tube such that at least a portion of the plurality of vacuum holes spans at least a portion of the outer tube, and at least a portion of the outer tube is designed to cover the second section of the esophageal positioning device when the esophageal positioning device is fully received within the introducer.

9. The assembly of claim 1, wherein: The outer tube comprises a multi-durometer material such that the stiffness of the outer tube varies along a body of the outer tube.

10. The assembly of claim 1 further comprising a feedback mechanism for indicating the extent to which a vacuum seal has been formed between the assembly and the esophagus.

11. The assembly according to claim 1, wherein: The outer tube also includes an ultrasound imaging device.

12. The assembly of claim 1, wherein: The outer tube also includes a fiber optic light source and a camera.

13. The assembly of claim 1, wherein: The second section is sized to displace the esophageal wall by 1.5 centimeters or more upon articulation.

14. A mechanical esophageal displacement system comprising the assembly according to claim 30.

15. A mechanical esophageal displacement system comprising: An assembly operably coupled to a vacuum system, the assembly comprising: An introducer sized to receive an esophageal positioning device, the introducer comprising: a soft outer tube sized to enter the esophagus through the oral or nasal passages, the soft outer tube comprising a distal end, a proximal end, and a body, wherein the body defines a plurality of radial vacuum holes spaced circumferentially about the soft outer tube, wherein the plurality of vacuum holes are in fluid communication with the vacuum system to apply a vacuum to the esophageal wall; and a tube tip positioned at a distal end of the outer tube; The esophagus positioning device, wherein the esophagus positioning device comprises: The first segment; and a second segment having a central axis, a proximal end pivotally connected to the first segment, and a distal end spaced opposite and apart from the proximal end, the second segment being pivotable about the first segment between a first position and a second position when articulated, Wherein the second section comprises a distal tape laminate assembly housing a plurality of distal tapes, wherein distal ends of the tapes are slidable relative to each other along a central axis.

16. The mechanical esophageal displacement system of claim 15, wherein: The esophageal positioning device also includes a handle selectively coupleable to the assembly and the first section, and at least one articulation drive cable, wherein the at least one articulation drive cable pivots the second section about the first section.

17. The mechanical esophageal displacement system of claim 16, wherein: The second section includes a distal band guard and a distal pivot retainer, wherein all but one of the bands have slots at distal ends of the plurality of distal bands, wherein the one band has holes at the distal end instead of slots, wherein the distal band guard retains the distal band assembly via pins passing through the plurality of distal bands, and wherein the distal guard has a rounded tip.

18. The mechanical esophageal displacement system of claim 15, wherein: The introducer also includes one or more internal vacuum channels extending a distance within the body of the outer tube from the proximal end to the distal end, wherein the one or more internal vacuum channels are in fluid communication with the plurality of vacuum holes to apply a vacuum to the esophageal wall via the vacuum system.

19. The mechanical esophageal displacement system of claim 15, wherein: When the esophageal positioning device is disposed within the introducer, a distal end of the second section of the esophageal positioning device is spaced apart from a tube tip of the introducer.

20. The mechanical esophageal displacement system of claim 15, wherein: The introducer further includes a plurality of radiopaque markers for indicating movement of the second section in multiple directions.

21. The mechanical esophageal displacement system of claim 20, wherein: The plurality of distal bands and the plurality of proximal bands include a polymer.

22. The mechanical esophageal displacement system of claim 20, wherein: The plurality of distal bands and the plurality of proximal bands comprise stainless steel.

23. The mechanical esophageal displacement system of claim 15, further comprising one or more sensors at the tube tip.

24. The mechanical esophageal displacement system of claim 15, wherein: The outer tube comprises a multi-durometer material such that the stiffness of the outer tube varies along a body of the outer tube.

25. The mechanical esophageal displacement system of claim 15, further comprising a feedback mechanism for indicating the extent to which a vacuum seal has been formed between the assembly and the esophagus.

26. The mechanical esophageal displacement system of claim 15, wherein: The outer tube also includes an ultrasound imaging device.

27. The mechanical esophageal displacement system of claim 15, wherein: The outer tube also includes a fiber optic light source and a camera.

28. A method of using a mechanical esophageal displacement system, the method comprising: Inserting an assembly into the esophagus of a patient via the oral or nasal passage, wherein the assembly comprises: An importer, the importer comprising: a soft outer tube sized to enter the esophagus through the oral or nasal passages, the soft outer tube comprising a distal end, a proximal end, and a body, wherein the body defines a plurality of vacuum holes spaced circumferentially about the soft outer tube, wherein the plurality of vacuum holes are in fluid communication with the vacuum system for applying a vacuum to the esophageal wall; a vacuum port comprising a vacuum port body, a vacuum line hook, and a vacuum port cover; and a tube tip positioned at the distal end of the outer tube; coupling a vacuum system to the vacuum line hook of the introducer; advancing an esophageal positioning device through the outer tube of the introducer, wherein the esophageal positioning device comprises a first segment and a second segment, wherein the first segment has a central axis and the second segment has a proximal end pivotally connected to the first segment and a distal end spaced opposite the proximal end, the second segment being pivotable about the first segment between a first position and a second position when articulated, wherein in the first position the distal end of the second segment is disposed along the central axis and in the second position the distal end of the second segment is displaced from the central axis; wherein the distal end of the second section maintains the same distance from the proximal end of the second section at both the first position and the second position; engaging the vacuum system to adhere a portion of the outer tube to the esophageal wall; and The second section is articulated about the first section at a selected angle from a first position to a second position.

29. The method according to claim 28, wherein: The introducer also includes one or more internal vacuum channels extending a distance within the body of the outer tube from the proximal end to the distal end, wherein the one or more internal vacuum channels are in fluid communication with the plurality of vacuum holes to apply a vacuum to the esophageal wall via the vacuum system.

30. The method of claim 28, wherein: When the esophageal positioning device is disposed within the introducer, a distal end of the second section of the esophageal positioning device is spaced apart from a tube tip of the introducer.

31. The method of claim 28, wherein: The introducer further includes a plurality of radiopaque markers for indicating movement of the second section in multiple directions.

32. The method of claim 28, wherein: The selected angle is 45 degrees.

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