HK40016525A - Systems and methods for mechanical displacement of an esophagus - Google Patents

Description

System and method for mechanical displacement of esophagus

Cross Reference to Related Applications

Priority of U.S. provisional patent application No.62/448,139 entitled "Systems and Methods for Mechanical Displacement of an Esophagus" filed 2017, 1, 19, the entire contents of which are incorporated herein by reference.

Technical Field

The present disclosure relates to medical devices and methods for vacuum suction adhesion of the esophagus in combination with mechanical displacement of the patient's esophagus.

Background

It is predicted that the number of patients experiencing atrial fibrillation ("AF") will increase to 1000 ten thousand in 20 years. The cost of treatment for patients with AF ranges from $ 2,000 to $ 10,000 per year. The most effective and common method of treating AF is using a procedure known as 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 results in destruction of cardiac cells. The cardiac region targeted for ablation is the region that causes AF. These areas in the left atrium are located within 2-4 mm of the esophagus, so the main problem is that energy from the ablation catheter can radiate forward and damage the esophagus. Approximately 103,000 AF ablation procedures are performed annually in the united states, and 57,000 additional procedures are performed outside the united states. A serious complication of AF ablation procedures is that esophageal injury results in an atrioesophageal fistula. This communication occurs between the esophagus and the heart as ablation energy inflames the heart and esophagus. Subsequent healing results in the formation of a hole/communication between the heart (sterile organ) and the esophagus (non-sterile organ). This communication may lead to infection of the heart and cause a stroke. About 0.6% of patients develop atrioesophageal fistulas, with almost always fatal or concomitant significant morbidity. In addition, the precursor to an atrioesophageal fistula is an oesophageal ulcer, which is also the cause of oesophageal damage, which is present in about 30% of patients. Therefore, it is of great interest for electrophysiologists, i.e., physicians performing ablation procedures, to prevent esophageal damage and avoid atrioesophageal fistulas.

Conventional therapies include inserting a device into the esophagus to monitor temperature and discontinue delivery of ablation energy once the esophageal temperature changes within the cavity. However, these devices do not displace the esophagus away from the ablation energy source and therefore do not provide an active protection mechanism to prevent damage to the esophagus.

Accordingly, there is a need for an improved system for displacing the esophagus to reduce the risk of esophageal damage.

Disclosure of Invention

Devices, systems, and methods for vacuum suction adhesion and mechanical displacement of the esophagus are provided. In particular, an assembly for use with a vacuum system and an esophageal positioning device is disclosed. Mechanical esophageal displacement systems and methods of use are also disclosed.

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 result in bulging of the esophagus rather than actual movement and displacement of the organ region. More specifically, the mechanical force will displace the leading edge of the esophageal wall, while the trailing edge of the esophageal wall will only move a small distance, if at all. The resulting esophageal bulge does not provide the protective benefits of mechanical displacement. The system disclosed herein utilizes a suction vacuum to apply a uniform force to the esophagus to draw in and adhere the esophageal wall in a circumferential manner. Under such physiological conditions, with the application of mechanical force, the entire circumferential segment of the esophagus is displaced and the trailing edge of the esophagus is lag-free. Generally, the esophagus follows the change in direction of the esophageal positioning device via the assembly. By using radiopaque markers, such a change of direction may be easily visualized to the physician on the X-ray device. Visualization provides immediate feedback to the physician. By moving the esophagus out of the ablation field, the AF procedure can be performed relatively safely without risk of damage to the esophagus, and the operator can safely ablate the target area without worrying about damage to the esophagus.

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 segment, a second segment, 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 segment about the first segment upon articulation. In some embodiments, the second segment is sized to displace about 4 centimeters of esophageal wall upon articulation.

The introducer of this exemplary assembly includes a soft recirculating outer tube and a tube tip. The soft outer tube is sized to enter the esophagus through an oral or nasal passage, wherein the soft outer tube comprises a distal end, a proximal end, a lumen, and a body. The body of the outer tube includes a perforated outer surface and one or more internal vacuum channels extending a distance within the body of the outer tube from the proximal end to the distal end. In some embodiments, the perforated outer surface includes a plurality of vacuum holes spaced circumferentially around the soft outer tube and extending radially therefrom. Since the plurality of vacuum holes are spaced circumferentially around the soft outer tube, the plurality of vacuum holes are positioned on multiple sides of the tube and can suction the esophagus from multiple directions. The one or more internal vacuum channels are in fluid communication with the plurality of vacuum holes to apply vacuum to the esophageal wall via the vacuum system. The tube tip is positioned at the distal end of the outer tube.

An exemplary mechanical esophageal displacement system includes an assembly and an esophageal positioning device, wherein the assembly is operably coupled to a vacuum system. The assembly includes an introducer comprising a soft recirculating outer tube and a tube tip. The soft outer tube is sized to enter the esophagus through an oral or nasal passage, wherein the soft outer tube comprises a distal end, a proximal end, a lumen, and a body. The body of the outer tube includes a perforated outer surface and one or more internal vacuum channels extending a distance within the body of the outer tube from the proximal end to the distal end. In some embodiments, the perforated outer surface includes a plurality of vacuum holes spaced circumferentially around the soft outer tube and extending radially therefrom. Since the plurality of vacuum holes are spaced circumferentially around the soft outer tube, the plurality of vacuum holes are positioned on multiple sides of the tube and can suction the esophagus from multiple directions. The one or more internal vacuum channels are in fluid communication with the plurality of vacuum holes to apply vacuum to the esophageal wall via the vacuum system. The tube tip is positioned at the distal end of the outer tube.

The esophageal positioning device of the exemplary mechanical esophageal displacement system comprises a handle, a first segment, a second segment, 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 segment about the first segment upon articulation.

An exemplary method of using a mechanical esophageal displacement system includes inserting the assembly into the patient's esophagus via an oral or nasal passage. The assembly includes an introducer having a soft recirculating outer tube, a vacuum port, and a tube tip. The soft outer tube is sized to enter the esophagus through an oral or nasal passage, wherein the soft outer tube comprises a distal end, a proximal end, a lumen, and a body. The body of the outer tube includes a perforated outer surface and one or more internal vacuum channels extending a distance within the body of the outer tube from the proximal end to the distal end. In some embodiments, the perforated outer surface includes a plurality of vacuum holes spaced circumferentially around the soft outer tube and extending radially therefrom. Since the plurality of vacuum holes are spaced circumferentially around the soft outer tube, the plurality of vacuum holes are positioned on multiple sides of the tube and can suction the esophagus from multiple directions. The one or more internal vacuum channels are in fluid communication with the plurality of vacuum holes to apply vacuum to the esophageal wall via the vacuum system. The tube tip is positioned at the distal end of the outer tube. The vacuum port includes a vacuum port body, a vacuum line hook, and a vacuum port cover.

The exemplary method further comprises advancing an esophageal positioning device through the outer tube of the introducer, wherein the esophageal positioning device comprises a handle, a first segment, a second segment, 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 segment about the first segment upon articulation.

The exemplary method further comprises: snapping a handle of the esophageal positioning device to a vacuum port cap of the introducer; engaging a 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.

The details of one or more embodiments of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the disclosure will be apparent from the description and drawings, and from the claims.

Drawings

For the purpose of facilitating an understanding of, and for the purpose of illustrating, the present disclosure, there is disclosed in the accompanying drawings exemplary features and embodiments, however, it is to be understood that the disclosure is not limited to the precise arrangements and instrumentalities shown, and wherein like reference numerals represent like elements throughout the several views, and wherein:

FIG. 1 is a perspective view of an exemplary mechanical esophageal displacement system according to the present disclosure;

FIG. 2 is a perspective view of exemplary components of the mechanical esophageal displacement system of FIG. 1 according to the present disclosure;

FIG. 3 is an enlarged perspective view of a portion of the assembly of FIG. 2;

FIG. 4 is a cross-sectional view of the assembly of FIG. 1;

FIG. 5 is a cross-sectional view of the mechanical esophageal displacement system of FIG. 1;

FIG. 6 is an enlarged view of a portion of the mechanical esophageal displacement system of FIG. 1;

FIG. 7 is a perspective view of a portion of the mechanical esophageal displacement system of FIG. 1;

FIG. 8 is a perspective view of a portion of the mechanical esophageal displacement system of FIG. 1;

FIG. 9 is a perspective view of an exemplary esophageal positioning device of the mechanical esophageal displacement system of FIG. 1;

FIG. 10 is an enlarged perspective view of a portion of the esophageal positioning device of FIG. 9;

FIG. 11 is a side view of a portion of the esophageal positioning device of FIG. 10;

FIG. 12 is a top view of a portion of the esophageal positioning device of FIG. 10;

FIG. 13 is a schematic view of the mechanical esophageal displacement system of FIG. 1, wherein the view shows the mechanical esophageal displacement system being advanced down the esophagus of a patient;

FIG. 14 is a schematic view of the proximal band laminate assembly of the mechanical esophageal displacement system of FIG. 1, wherein the view shows a force being applied to the proximal band laminate assembly in a direction along the esophageal passageway, in accordance with the present disclosure;

FIG. 15 is another schematic diagram of the proximal band laminate assembly of the mechanical esophageal displacement system of FIG. 1, showing a force being applied in a direction perpendicular to the esophageal passage, according to the present disclosure;

FIG. 16 shows a top view of a portion of the mechanical esophageal displacement system of FIG. 1, wherein the view shows the esophageal positioning device being positioned in a first angular orientation;

FIG. 17 is an enlarged top view of a portion of the esophageal positioning device of FIG. 16;

FIG. 18 shows a top view of a portion of the mechanical esophageal displacement system of FIG. 1, wherein the view shows the esophageal positioning device being positioned in a straight orientation;

FIG. 19 shows a top view of a portion of the mechanical esophageal displacement system of FIG. 1, wherein the view shows the esophageal positioning device being positioned at a second angular orientation;

FIG. 20 is an enlarged top view of a portion of the esophageal positioning device of FIG. 19;

FIG. 21 is a top view of a portion of the esophageal positioning device of the mechanical esophageal displacement system of FIG. 1 according to the present disclosure;

FIG. 22 is a perspective view of a handle of the mechanical esophageal displacement system of FIG. 1;

FIG. 23 is a perspective view of the internal components of the handle of the mechanical esophageal displacement system of FIG. 1;

FIG. 24 is a side cross-sectional view of the internal components of the handle of FIG. 23;

FIG. 25 is a cross-sectional view of another exemplary assembly of the mechanical esophageal displacement system of FIG. 1;

FIG. 26 is a top view of another exemplary mechanical esophageal displacement system according to the present disclosure;

FIG. 27 is an enlarged perspective view of the exemplary mechanical esophageal displacement system of FIG. 26;

FIG. 28 is an enlarged top view of the exemplary mechanical esophageal displacement system of FIG. 26;

FIG. 29 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure;

FIG. 30 is a perspective view of exemplary components of the mechanical esophageal displacement system of FIG. 29;

FIG. 31 is a perspective cutaway view of a portion of the mechanical esophageal displacement system of FIG. 29;

FIG. 32 is a front view of a portion of the mechanical esophageal displacement system of FIG. 29;

FIG. 33 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure;

FIG. 34 is a perspective cutaway view of another exemplary mechanical esophageal displacement system according to the present disclosure;

FIG. 35 is a perspective view of another exemplary assembly according to the present disclosure;

FIG. 36 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure;

FIG. 37 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure;

FIG. 38 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure;

FIG. 39 is a perspective view of another exemplary assembly according to the present disclosure;

FIG. 40 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure;

FIG. 41 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure;

FIG. 42 is a perspective view of another exemplary assembly according to the present disclosure; and is

Fig. 43 is a perspective view of another exemplary assembly according to the present disclosure.

Detailed Description

The following are descriptions of several illustrations of applicants' inventive subject matter. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. In the drawings, like elements are designated with like reference numerals throughout the several views. Numerous examples are provided, however, it will be appreciated that various modifications may be made without departing from the spirit and scope of the disclosure herein. As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used herein, the term "comprise" and variations thereof are used synonymously with the term "comprise" and variations thereof, and are open, non-limiting terms. Although the terms "comprising" and "including" have been used herein to describe various embodiments, the terms "consisting essentially of …" and "consisting of …" may be used in place of "comprising" and "including" to provide more specific embodiments of the invention and are also disclosed.

The present invention will now be described more fully hereinafter with reference to specific embodiments thereof. Indeed, the 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.

Fig. 1-25 show an example of a mechanical esophageal displacement system 1 for mechanically displacing an esophagus during a medical procedure via vacuum suction adhesion of a section of the esophagus according to the present disclosure. As shown in fig. 1 and 5, an exemplary mechanical esophageal displacement system 1 comprises 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 comprises 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, esophageal positioning device 13 comprises 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 section 110 and the second section 115 may be linear structures.

Fig. 2-5, 13, 25 show examples of disposable assemblies 5 according to the present disclosure. The exemplary assembly 5 includes an introducer 2 sized to receive an esophageal positioning device 13. The esophageal positioning device 13 can be a reusable component of the system 1 that will be inserted into the lumen of the introducer 2 after it is advanced down the esophagus of the patient 37. However, in some embodiments, the introducer 2 and esophageal positioning device 13 are manufactured as a single device, and the one-piece assembly 5 can be disposable or can be designed to be sterilized for reuse. The patient 37 may be a human or other animal.

As shown in fig. 5, the introducer 2 includes a soft outer tube 125. In some embodiments, the soft outer tube 125 is cylindrical. The soft outer tube 125 is sized so that it can enter the esophagus through the mouth or nasal passage. 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 fig. 4 and 25) that extend a 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 spaced circumferentially around the soft outer tube 125 and extending radially therefrom, as can be seen in fig. 1-3. Since the plurality of vacuum holes 3 are circumferentially spaced around the soft outer tube 125, the plurality of vacuum holes 3 are positioned on multiple sides of the tube 125 and can suck the esophagus 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 outer tube 125, or portions thereof, may be made of a soft polymer such as polyvinyl chloride (PVC) or silicone. The outer tube 125 is flexible enough that it does not add unnecessary stiffness to the system 1 that the esophageal positioning device 13 needs to overcome, but is not so flexible 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 lubricious material (e.g., a hydro glide pad) to facilitate introduction into the esophagus and minimize esophageal trauma.

While the outer tube 125 may be made of a single material, in some embodiments, the multi-durometer outer tube 125 is made of more than one material to achieve a 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 material), while the portion between the distal end 130 and the proximal end 135 that includes the plurality of radial vacuum holes 3 is made of a more flexible material. The harder distal end 130 facilitates the introduction of 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. This therefore moves the esophagus further away from the heart and makes the esophagus adhere better circumferentially to the soft outer tube 125.

In some embodiments, the assembly 5 may include a telescoping mechanism on at least a portion of the device to facilitate passage of the device into the esophagus. Once in the desired position within the esophagus, the telescoping section can be extended to deploy the entire device.

As described above, a section of the esophagus may 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 that 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 of between about three and five inches from the tube tip 4, and spanning a length of about two inches from the starting position. The 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 create 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, but not to, distal end 130. For example, in some embodiments, one or more internal vacuum channels 21 extend up to, but not through, the most distal location of the radial vacuum holes 3. 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 comprise 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 may 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 mm Hg. 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.

As shown in fig. 1-3, 5, and 13, 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 comprises a hard polymer tip having a soft rounded profile, wherein the tip is bonded 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 comprise a half-dome shape. In some embodiments, the tube tip 4 is a closed structure rather than a lumen.

As shown in fig. 1, 2, 5, 13, the assembly 5 may further include a vacuum port 155 including a vacuum port body 6 and a vacuum port cover 7. In some embodiments, the vacuum port cover 7 is a hard polymeric cover that is bonded to the vacuum port body 6. The vacuum port cap 7 may also include a snap feature geometry and a quick release hinge mechanism (not shown) to couple and decouple 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 in fluid communication with one or more internal vacuum channels 21. The vacuum port body 6 may be bonded to both the introducer 2 and the vacuum port cover 7 to form an airtight seal. In some embodiments, the body 6 further comprises a vacuum port valve and a lever (not shown), wherein the lever can control the vacuum system.

In some embodiments, the introducer 2 further includes a plurality of radiopaque markers (not shown) positioned proximate to locations 180 where the pivot pin 16 will reside within the introducer 2. In some embodiments, the plurality of radiopaque markers generally span the dwell location 180 distally from the pivot pin 16 to the location of the tube tip 4 along or within the outer tube 125 of the introducer 2. In some embodiments, the plurality of radiopaque markers span a distance of about four to six centimeters from the tube tip 4. In some embodiments, the radiopaque markers are located throughout the outer tube 125.

As described above, in some embodiments, esophageal positioning device 13 comprises handle 105, first segment 110, second segment 115, articulation pivot pin 16, and articulation drive mechanism 120. In some embodiments, second segment 115 is sized to displace about 4 centimeters of esophageal wall upon articulation. In some embodiments, the length of the second section 115 is between four and six centimeters. As shown in fig. 4-21, the second section 115 may include a distal band lamination assembly 12, a distal band guard 8, and a distal pivot holder 14, wherein the distal band assembly 12 houses a plurality of distal bands 185. As shown in fig. 7-8, the distal band guard 8 retains the distal band assembly 12 at the distal end 190 by pins 9 passing through the plurality of distal bands 185. The distal band assembly 12 may be made of a variety of suitable materials including, for example, 420 stainless steel or a hard polymer. The plurality of distal bands 185 may be made of, for example, spring steel. The distal pivot holder 14 may be made of, for example, 420 stainless steel or 17-4 stainless steel. The plurality of distal straps 185 may be assembled to the distal pivot retainer 14 by welding, using pins, or by bonding. As distal band 185 is free to flex at distal end 190, band 185 may be rigidly attached to distal pivot holder 14.

As shown in fig. 7-8, 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 bands flex. One distal band 10 (apical or outer band) includes an aperture 200 instead of a slot 195, wherein the aperture 200 restricts the band 10 from sliding as the plurality of distal bands 185 flex. The holes 200 also help position the plurality of distal straps 185 of the distal strap assembly 12. In some embodiments, the distal guard 8 has a rounded tip 205 that is free of sharp edges to prevent damage to the outer hose 125 during insertion.

As shown in fig. 10-24, in some embodiments, the first segment 110 includes a proximal pivot holder 15, an articulation drive cable 18, and a proximal band lamination assembly 19. The proximal belt assembly 19 includes a plurality of proximal belts 210. The proximal pivot holder 15 houses a proximal belt lamination assembly 19. As proximal band 210 is free to flex at proximal end 215 in handle 105, proximal band 210 may be rigidly attached to proximal pivot holder 105. In some embodiments, proximal pivot retainer 15 limits distal pivot retainer 14 from articulating more than a selected angle (e.g., 45 degrees) to each side to prevent the risk of esophageal damage due to excessive translation.

As shown in fig. 14-15, the proximal band laminate assembly 19 may provide stiffness in a direction 220 perpendicular to the esophageal passage direction (fig. 15) while maintaining flexibility in a direction 225 along the esophageal passage. Flexibility can be maintained by using thin strips stacked on top of each other (fig. 14) to form a body that is believed to be in the direction of the normal force provided by the esophagus (fig. 15).

Similar to the distal band assembly 12, the proximal band laminate assembly 19 may be made of a variety of suitable materials including, for example, 420 stainless steel or a hard polymer. The plurality of proximal bands 210 may be made of, for example, spring steel. The articulation pivot pin 16 may be made of, for example, 420 stainless steel or 17-4 stainless steel. An articulation pivot pin 16 connects and allows pivoting of both the distal pivot retainer 14 and the proximal pivot retainer 15. The articulation pivot pin 16 may be press fit into the proximal pivot retainer 15 and held in a loose fit by the distal pivot retainer 14.

As shown in fig. 10-12 and 17-20, in some embodiments, the mechanical esophageal displacement system 1 further comprises 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 articulate the second segment 110 45 degrees left or right from a neutral position, wherein the distal strap assembly 12 and the proximal strap 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, cable 18 has a diameter of about 0.024 inches and is made from braided stainless steel or a polymer such as UHMWPE, Vectran, or Orion. In some embodiments, the mechanical esophageal displacement system 1 further comprises an articulation cable crimp 17. As shown in fig. 16-20, the cable crimp 17 may be a ball that is compressed and friction fit onto the stainless steel braided cable 18. The crimp 17 provides a feature on the cable 18 that can interface with the distal pivot holder 14 when pulled left or right to articulate the system 1. The ball may be compressed and friction fit onto the articulation cable 18 to provide an interfacing surface. In some embodiments, the articulation drive cable 18 may also be coupled to the distal pivot holder 14 by welding in addition to or instead of the cable crimp 17. Other types of mechanical or chemical fasteners may be used to operably couple the articulation drive cable 18 to the distal pivot retainer 18, such as integrally formed, chemically bonded, or mechanically or magnetically engaged.

In some embodiments, mechanical esophageal displacement system 1 further comprises a plurality of proximal strap cable guides 20 that guide articulation cables 18 from handle 105 to articulation pivot pins 16, wherein the plurality of proximal strap cable guides 20 are evenly spaced along the plurality of proximal straps 210. The proximal ribbon cable guide 20 can be welded or bonded to one or more of the proximal ribbons 210 in order to maintain the alignment of the proximal ribbons 210 while still allowing the ribbons 210 to slide and translate independently when bent. The proximal strap cable guide 20 helps guide the articulation drive cable 18 down the length of the esophageal positioning device 13. The proximal ribbon cable guide 20 provides additional rigidity and structure to the proximal ribbon laminate assembly 19 while still allowing the laminate ribbon assembly 19 to flex.

As shown in fig. 1, 9, 13, 22-24, the handle 105 of the esophageal positioning device 13 can include a variety of components. As shown in fig. 22, in some embodiments, the handle 105 comprises a two-piece outer housing comprising an articulating handle shell half 22 and a locking handle shell half 23. In some embodiments, the articulating handle shell half 22 may be made of a polymer or metal and may be, for example, about 1.9 inches in diameter and about 5 inches in length. The articulation handle housing half 22 may house a plurality of proximal bands 185, an articulation drive mechanism 120, and an articulation control knob 25. In some embodiments, the locking handle shell halves 23 may be made of a polymer or metal, and may be about 1.9 inches in diameter and about 5 inches in length, for example. The locking handle shell half 23 may house the proximal band 185, the articulation drive mechanism 120, and the locking control knob 24. The locking control knob 24 may be twisted to increase the friction of the system 1 and fully lock the system 1 at the selected articulation angle. Twisting the lock 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 either 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 in a counterclockwise direction may articulate the tube tip 4 of the assembly 5. The articulation control knob 25 may be, for example, about two inches in diameter. In this way, the articulation control knob 25 may articulate the second segment 115 to the right when rotated in a first direction, and the articulation control knob 25 may articulate the second segment 115 to the left when rotated in a second direction.

As shown in fig. 22, the handle 105 of the esophageal positioning device 13 can include one or more snap hooks 26 positioned on the articulating handle shell half 22 and/or on the locking handle shell half 23. Snap hooks 26 may be used to interface and couple the handle 105 to the vacuum port cover 7 of the assembly 5.

As shown in fig. 23-24, the handle 105 of the esophageal positioning device 13 can include, for example, a top handle strap holder 27, a bottom handle strap holder 28, a pulley transmission 29, a cable pulley 30, an input gear 31, a proximal strap handle holder 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.

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

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

In some embodiments, the articulation cable 18 is attached to the cable pulley 30 with the right side cable 18 attached to the top pulley aperture 250. The articulation cable 18 may be routed around the pin of the cable pulley 30.

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 may be reduced by a factor of two to three, for example, based on a given ratio of input gear 31 to pulley transmission 29. As such, in some embodiments, the operator does not need to or is limited to applying a torque in excess of 80 ounces/inch to control the knobs 24, 25. For example, in some embodiments, a failsafe mechanism may be employed such 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 may help avoid injury to the operator.

In some embodiments, the proximal band handle holder pin 32 interfaces with the proximal band lamination assembly 19 and the top and bottom handle band holders 27, 28 to hold the proximal band 185 in place. When assembled together, the proximal strap handle holder pins 32 align with portions of the top handle strap holder 27 and the bottom handle strap holder 28. The retaining pins 32 are aligned with slots in the proximal bands 185 other than one, which allows the bands 185 to slide past each other when bent.

In some embodiments, the locking cone clutch 33 may be attached to the locking control knob 24 via a screw 260 and interference rib 265. The locking cone clutch 33 may include threads on the outer diameter that interface with the threads of the locking handle shell half 23. When the locking knob 24 is twisted, for example, when twisted clockwise, the locking cone clutch 33 moves inward and interferes with the cone shaft on the cable pulley 30, which effectively slows and/or locks the cable pulley 30 in the current position.

In some embodiments, articulation input shaft 34 has a flat face that is, for example, D-shaped. The flat surface allows interfacing 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 articulation pulley shaft bushing 36 further help maintain proper alignment of the handle 105 components.

In some embodiments, the esophageal positioning device 13 includes a clutch and/or a load cell system for limiting the torque that can be applied by the user. In some embodiments, a sensor (e.g., a thermistor or 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 for simultaneous measurement of temperature at different anatomical locations of the esophagus. In some embodiments, a 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 esophageal positioning device 13 via a mapping screen. In some embodiments, a 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) to enable three-dimensional imaging of the anatomy and the device. In some embodiments, the introducer 2 or esophageal positioning device 13 includes a port to receive diatrizoate injection or other material for delineating and visualizing the esophagus on X-rays. In some embodiments, a ratchet articulation control is provided such that one click of the ratchet articulation control knob in a counterclockwise direction may cause a 15 degree leftward articulation or a 1.5 centimeter leftward translation, depending on the operator's desire. 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 from being developed against the esophagus.

In some embodiments, the esophageal positioning device 13 comprises other imaging devices used with visualization techniques. Such imaging devices may include, for example, fiber optic light sources with cameras, ultrasound imaging devices (e.g., doppler), and the like. These imaging devices can be used to visualize the esophagus before, during, and after application of ablation energy, as well as at other times during the procedure. Ultrasound imaging devices may be used, for example: visualization and measurement through the esophagus to view intracardiac objects such as catheters, transseptal techniques/devices, assessment of intracardiac thrombi, assessment of intracardiac defects such as atrial septal defects; a visualization/measurement pulmonary vein device; visualization/measurement mapping devices (e.g., multi-electrode baskets); visualizing/measuring the left atrial appendage and the left atrial appendage closure device; visualization/measurement of devices placed inside the pericardial sac; and other heart related products.

In some embodiments, the belt laminates of the distal belt assembly 12 or the proximal belt assembly 19 have different widths. Figure 25 shows an example of a proximal band assembly 19 having proximal bands 210 of different widths. The width of the distal band 185 or the proximal band 210 can be shaped to maximize stiffness according to the contour of the outer tube 125 of the introducer 2. For example, if the outer tube 125 of the introducer 2 is circular in profile shape, the distal band 185 or the proximal band 210 may be cut such that the profile 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 of the introducer 2 or cable band guide 20. Further, cutting the tape of the proximal assembly 19 (or distal assembly 12) at different widths may increase the stiffness of the system 1 as the amount of material in contact with the inner surface of the outer tube or cable tape guide 20 increases.

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

A method of using the mechanical esophageal displacement system 1 is also provided. An exemplary method includes inserting the assembly 5 into the esophagus of a patient 37 via an oral or nasal passage (fig. 13). The assembly 5 includes an introducer 2 having a soft recirculating 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 mouth or nasal passage of a patient, wherein the soft outer tube 125 includes a distal end 130, a proximal end 135, a lumen 137 (see fig. 4 and 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 that extend a 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 spaced circumferentially around the soft outer tube 125 and extending radially therefrom, as can be seen in fig. 1-3. Since the plurality of vacuum holes 3 are circumferentially spaced around the soft outer tube 125, the plurality of vacuum holes 3 are positioned on multiple sides of the tube 125 and can suction the esophagus 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.

The exemplary method further comprises advancing an esophageal positioning device 13 through the outer tube of the introducer 2, wherein the esophageal positioning device 13 comprises a handle 105, a first segment 110, a second segment 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 an articulation pivot pin 16. The articulation drive mechanism 120 is configured to pivot the second segment 115 about the first segment 110 upon articulation.

The exemplary method further comprises: snapping the handle 105 of the esophageal positioning device 13 to the vacuum port cap 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 about 45 degrees.

Fig. 26 illustrates another exemplary mechanical esophageal displacement system according to the present disclosure. The mechanical esophageal displacement system includes a flexible coil 410 wrapped around a portion of an esophageal displacement device. Similar to the embodiment seen in fig. 1 above, the exemplary mechanical esophageal displacement system of fig. 26 can displace the esophagus by about 4 centimeters, e.g., 3.992 centimeters.

FIG. 27 is an enlarged perspective view of the exemplary mechanical esophageal displacement system of FIG. 26. This view highlights the articulation pin operably coupled to the coil to articulate the segment of the esophageal positioning device around the pin. FIG. 28 is an enlarged top view of the exemplary mechanical esophageal displacement system of FIG. 26, wherein the view highlights exemplary dimensions.

FIG. 29 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. Similar to the embodiment seen in fig. 1 above, the exemplary mechanical esophageal displacement system of fig. 29 includes pulleys and cables to articulate respective segments of the esophageal positioning device.

FIG. 30 is a perspective view of exemplary components of the mechanical esophageal displacement system of FIG. 29. This view shows an outer tube 125 having a long tail 412 with a radiopaque marker 414.

Fig. 31 is a perspective cut-away view of a portion of the mechanical esophageal displacement system of fig. 29. This view highlights the vacuum channels 21 and holes of the assembly.

Fig. 32 is a front view of a portion of the mechanical esophageal displacement system of fig. 29. This view highlights the connections between the segments of the esophageal positioning device. This view includes clevis 515, pin 516, cable 518, crimp 517, weld 518, and top and bottom pulley halves 514, 516.

Fig. 33 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. This view shows the esophageal positioning device with fishing rod 610, eyelet 612, tether line 614, and cable 618, where the cable receives anchor 616.

Fig. 34 is a perspective cutaway view of another exemplary mechanical esophageal displacement system according to the present disclosure. The mechanical esophageal displacement system of fig. 34 includes an esophageal displacement device that rotates to compress a spring 710 operably coupled to the assembly.

Fig. 35 is a perspective view of another exemplary assembly according to the present disclosure. In fig. 35, the assembly includes a tube 825 with a foldable portion 810, wherein the foldable portion 810 can be actuated by a guidewire and/or vacuum pressure.

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

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

Fig. 38 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. The mechanical esophageal displacement system of fig. 38 includes a gear assembly 1110 that provides articulation via leaf springs 1112.

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

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

FIG. 41 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. The mechanical esophageal displacement system of fig. 40 comprises an esophageal displacement device having two pieces 1410, 1412 with angled faces 1414, 1416, respectively, wherein the angle between the two pieces 1410, 1412 changes from aligned to perpendicular upon rotation.

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

Fig. 43 is a perspective view of another exemplary assembly according to the present disclosure. The assembly of fig. 43 includes a gel liquid portion 1610 that deflects the assembly in a given direction.

Although some 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, liquid/air reservoirs, magnets, etc.

Although only a few exemplary embodiments of this invention have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention, which is defined in the following claims and all equivalents thereto. Moreover, it is to be appreciated that many embodiments may be conceived that do not achieve all of the advantages of some embodiments, yet the absence of a particular advantage shall not be construed to necessarily mean that such an embodiment is outside the scope of the present invention.

Materials, systems, devices, compositions, and components are disclosed that can be used, can be used with, can be used to prepare, or be a product of the disclosed methods, systems, and devices. These and other components are disclosed herein, and it is understood that when combinations, sub-groups, interactions, groups, etc. of these components are disclosed that while specific reference of each various individual and collective combinations and permutations of these components may not be explicitly disclosed, each is specifically contemplated and described herein.

Claims (29)

1. An assembly for use with a vacuum system and an esophageal positioning device, the esophageal positioning device comprising a handle, a first segment coupled to the handle, a second segment pivotally connected to the first segment, and an articulation drive mechanism that pivots the second segment about the first segment when articulated, the assembly comprising:

an introducer, the introducer comprising:

a soft outer tube sized to enter an esophagus through an oral or nasal passage, the soft outer tube comprising a distal end, a proximal end, a lumen, and a body, wherein the body defines a plurality of radial vacuum holes spaced circumferentially around the soft outer tube and 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 an esophageal wall via the vacuum system; and

a tube tip positioned at the distal end of the outer tube.

2. The assembly of 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.

3. The assembly of claim 1, wherein the introducer further comprises a vacuum port comprising a vacuum port body and a vacuum port cover, wherein the vacuum port body comprises a vacuum line hook in fluid communication with the one or more internal vacuum passages, wherein the vacuum port body is bonded to both the introducer and the vacuum port cover to form an airtight seal.

4. The assembly of claim 3, wherein the vacuum port body further comprises a vacuum port valve and a lever, wherein the lever controls the vacuum system.

5. The assembly of claim 3, wherein the vacuum port cap comprises a hard polymer cap bonded to the vacuum port body and includes a snap feature and a quick release hinge mechanism to selectively couple a handle of the esophageal positioning device to the proximal end of the outer tube.

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

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

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

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

10. 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 an esophagus through an oral or nasal passage, the soft outer tube comprising a distal end, a proximal end, a lumen, and a body, wherein the body defines a plurality of vacuum holes spaced circumferentially around the outer tube and 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 an esophageal wall via the vacuum system; and

a tube tip positioned at the distal end of the outer tube; and

the esophageal positioning device, wherein the esophageal positioning device comprises:

a handle selectively coupleable to the assembly;

a first section coupled to the handle;

a second section pivotally connected to the first section; and

an articulation drive mechanism that pivots the second segment about the first segment upon articulation.

11. The mechanical esophageal displacement system of claim 10, wherein the second segment is sized to displace about 4 centimeters of the esophageal wall upon articulation.

12. The mechanical esophageal displacement system of claim 10, 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.

13. The mechanical esophageal displacement system of claim 10, wherein the introducer further comprises a vacuum port comprising a vacuum port body and a vacuum port cover, wherein vacuum port body comprises a vacuum line hook in fluid communication with the one or more internal vacuum channels, wherein the vacuum port body is bonded to both the introducer and the vacuum port cover to form an airtight seal.

14. The mechanical esophageal displacement system of claim 13, wherein the vacuum port body further comprises a vacuum port valve and a lever, wherein the lever controls the vacuum system.

15. The mechanical esophageal displacement system of claim 13, wherein the vacuum port cap comprises a hard polymer cap bonded to the vacuum port body and comprises a snap feature and a quick-release hinge mechanism to selectively couple a handle of the esophageal positioning device to the proximal end of the outer tube.

16. The mechanical esophageal displacement system of claim 10, wherein the second segment is pivotally connected to the first segment via an articulation pivot pin, wherein the introducer further comprises a plurality of radiopaque markers positioned proximate to where the pivot pin will reside within the introducer, wherein the plurality of radiopaque markers span distally from the location to the tube tip.

17. The mechanical esophageal displacement system of claim 10, wherein the plurality of vacuum holes are positioned along an outer surface of the outer tube such that at least a portion of the plurality of vacuum holes span at least a portion of the outer tube designed to cover the second section of the esophageal positioning device when the esophageal positioning device is fully received within the introducer.

18. The mechanical esophageal displacement system of claim 10, wherein the second segment comprises a distal band lamination assembly, a distal band guard, and a distal pivot retainer, wherein the distal band assembly houses a plurality of distal bands, wherein all but one of the bands has a slot at a distal end of the plurality of distal bands, wherein the one band has a hole at the distal end instead of a slot, wherein the distal band guard retains the distal band assembly by a pin through the plurality of distal bands, and wherein the distal guard has a rounded tip.

19. The mechanical esophageal displacement system of claim 18, wherein the first segment comprises a proximal pivot holder, an articulation drive cable, a proximal band lamination assembly comprising a plurality of proximal bands, wherein the proximal pivot holder houses the proximal band lamination assembly, wherein the proximal pivot holder limits the distal pivot holder to articulation more than 45 degrees to each side to prevent risk of damage to the esophagus due to excessive translation.

20. The mechanical esophageal displacement system of claim 19, wherein the second segment is pivotally connected to the first segment via an articulation pivot pin, and wherein the articulation pivot pin connects and allows pivoting of both the distal pivot retainer and the proximal pivot retainer.

21. The mechanical esophageal displacement system of claim 20, wherein the second segment is pivotally connected to the first segment via an articulation pivot pin, and wherein the articulation drive cable transmits input from a user through the handle to the articulation pivot pin to articulate the device about 45 degrees left or backwards.

22. The mechanical esophageal displacement system of claim 21, wherein the second segment is pivotally connected to the first segment via an articulation pivot pin, and further comprising a plurality of proximal strap cable guides that guide the articulation cable from the handle to the articulation pivot pin, wherein the plurality of proximal strap cable guides are evenly spaced along the plurality of proximal straps.

23. The mechanical esophageal displacement system of claim 22, wherein the handle comprises:

a two-piece shell structure comprising an articulation handle shell half and a locking handle shell half; and

a plurality of snap hooks interfacing and coupling with the vacuum port cap;

wherein the articulation handle shell half houses the plurality of proximal bands, the articulation drive mechanism, and an articulation control knob that articulates the second segment to the right when rotated in a first direction and articulates the second segment to the left when rotated in a second direction; and is

Wherein the locking handle shell half houses the plurality of proximal bands, the articulation drive mechanism, and a locking control knob.

24. The mechanical esophageal displacement system of claim 23, wherein the handle further comprises a top handle strap holder and a bottom handle strap holder, wherein the top holder and the bottom holder accommodate proximal ends of the plurality of proximal straps using pin and hole and slot features of the proximal straps to allow the plurality of proximal straps to translate when bent.

25. The mechanical esophageal displacement system of claim 24, further comprising one or more sensors at the tube tip.

26. The mechanical esophageal displacement system of claim 10, wherein the outer tube comprises a multi-durometer material such that a stiffness of the outer tube varies along the body of the outer tube.

27. The mechanical esophageal displacement system of claim 10, further comprising a feedback mechanism for indicating the degree to which a vacuum seal has been formed between the assembly and the esophagus.

28. A method of using a mechanical esophageal displacement system, the method of using a mechanical esophageal displacement system comprising:

inserting an assembly into the esophagus of a patient via an oral or nasal passage, wherein the assembly comprises:

an introducer, the introducer comprising:

a soft outer tube sized to enter an esophagus through an oral or nasal passage, the soft outer tube comprising a distal end, a proximal end, a lumen, and a body, wherein the body defines a plurality of vacuum holes spaced circumferentially around the outer tube and 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 an esophageal wall via the vacuum system; 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;

a vacuum line hook coupling a vacuum system to the introducer;

advancing an esophageal positioning device through the outer tube of the introducer, wherein the esophageal positioning device comprises a handle, a first segment coupled to the handle, a second segment pivotally connected to the first segment via an articulation pivot pin, and an articulation drive mechanism that pivots the second segment about the first segment when articulated;

snapping the handle of the esophageal positioning device to the vacuum port cap of the introducer;

engaging the vacuum system to adhere a portion of the outer tube to an esophageal wall; and

articulating the articulation drive mechanism to pivot the second section about the first section to a selected angle.

29. The method of claim 28, wherein the selected angle is 45 degrees.