System and introducer for mechanical displacement of esophagus

Abstract

To provide a medical device and an introducer for vacuum suction adhesion of the esophagus of a patient combined with mechanical displacement of the esophagus.SOLUTION: An introducer 1702 includes a soft outer tube 125 sized to pass through a mouth or nasal cavity and into an esophagus. The soft outer tube includes a longitudinal axis 141, a distal end 130, a proximal end 135, and a body 140 configured to receive an articulable esophageal positioning device 13 having a pivot connection and a distal end of the device. The body includes an end portion 133 between the pivot connection and the distal end of the soft outer tube, a gap portion 131 between the distal end of the device and the distal end of the soft outer tube, at least one radial vacuum hole 3 disposed in the gap portion and spaced circumferentially about the longitudinal axis, and a tube tip 4 located at the distal end of the soft outer tube.SELECTED DRAWING: Figure 44

Description

Technical Field

[0001] The present disclosure relates to a medical device and an introducer for esophageal vacuum suction adhesion associated with mechanical displacement of a patient's esophagus.

Background Art

[0002] The number of patients experiencing atrial fibrillation ("AF") is predicted to increase to 10 million in 20 years. The cost of treating patients with AF ranges from $2,000 to $10,000 per year. The most effective and widespread method of treating AF is a procedure called catheter ablation. Catheter ablation is designed to deliver energy (e.g., radiofrequency and cryoenergy) through a catheter placed within the left atrium of the heart. Ablation results in the destruction of heart cells. The areas of the heart targeted for ablation are the areas that cause AF. These areas within the left atrium are within 2 - 4 millimeters of the esophagus, and thus, a major concern is that the release of energy from the ablation catheter may progress forward and damage the esophagus. In the United States, approximately 103,000 AF ablation procedures are performed each year, and an additional 57,000 procedures are performed outside the United States. A serious complication of AF ablation procedures is damage to the esophagus resulting in an atrial - esophageal fistula. This communication occurs because ablation energy causes inflammation in the heart and esophagus. 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 heart infection and stroke. Atrial - esophageal fistulas occur in approximately 0.6% of patients and the outcome is usually fatal or associated with significant morbidity. Furthermore, a precursor lesion to atrial - esophageal fistulas is an ulcer within the esophagus, which also results from esophageal damage and occurs in approximately 30% of patients. Thus, electrophysiologists, physicians performing ablation procedures, are very concerned about preventing damage to the esophagus and avoiding atrial - esophageal fistulas.

[0003] Conventional treatment methods involve inserting a device into the esophagus to monitor temperature and to stop the delivery of ablation energy if there is a change in the luminal esophageal temperature. However, these devices cannot displace the esophagus in a direction away from the energy source of the ablation, and thus do not provide an active protection mechanism for protecting against damage to the esophagus.

[0004] Accordingly, there is a need for an improved system for displacing the esophagus in order to reduce the risk of damage to the esophagus. SUMMARY OF THE INVENTION

[0005] 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. Similarly, a mechanical esophageal displacement system, and method of use are also disclosed.

[0006] The esophagus is a flexible muscular organ that is often moved during medical procedures. If a mechanical force is simply applied to move the esophagus, rather than the actual movement and displacement of the regions of the organ, esophageal tenting can result. More specifically, the mechanical force displaces the leading edge of the esophageal wall, while the trailing edge of the esophageal wall moves only a small distance, if at all. As a result of the resulting esophageal tenting, mechanical displacement cannot provide a protective effect. The system disclosed herein utilizes a suction vacuum to apply a uniform force to the esophagus in order to draw the esophageal wall and bring the esophageal wall into intimate contact in a circumferential manner. Under this physiological condition, with the application of the mechanical force, the entire circumferential segment of the esophagus is displaced and there is no lagging or trailing edge of the esophagus. Generally, the esophagus follows the orientation changes of the esophageal positioning device via the assembly. This orientation change can be easily visualized by the physician on the X-ray device through the use of radiopaque markers. The visualization provides the physician with immediate feedback. By moving the esophagus outside the ablation field, the AF procedure can proceed relatively safely without the risk of damage to the esophagus, and the operator can ablate the target area with confidence without concern for esophageal injury.

[0007] 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 segment is coupled to the handle. The second segment is pivotally connected to the first segment. The articulation drive mechanism is configured to pivot the second segment about the first segment during articulation. In some embodiments, the second segment is sized to displace the esophageal wall by about 4 centimeters during articulation.

[0008] An exemplary assembly introducer includes a flexible outer circumferential tube and a tube tip. The flexible outer tube is sized to enter the esophagus through the mouth or nasal cavity and includes 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 passages that extend a distance from the proximal end to the distal end within the body of the outer tube. In some embodiments, the perforated outer surface includes a plurality of vacuum holes that are circumferentially disposed around and radially extend from the flexible outer tube. Because the plurality of vacuum holes are circumferentially disposed around the flexible outer tube, the plurality of vacuum holes are located on multiple sides of the tube and can aspirate the esophagus from multiple directions. The one or more internal vacuum passages are in fluid communication with the plurality of vacuum holes to apply a vacuum to the esophageal wall via a vacuum system. The tube tip is located at the distal end of the outer tube.

[0009] An exemplary mechanical esophageal displacement system includes an assembly and an esophageal positioning device, the assembly being operably connectable to a vacuum system. The assembly includes an introducer that includes a flexible outer circumferential tube and a tube tip. The flexible outer tube is sized to enter the esophagus through the mouth or nasal cavity and includes 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 passages that extend a distance from the proximal end to the distal end within the body of the outer tube. In some embodiments, the perforated outer surface includes a plurality of vacuum holes that are circumferentially disposed around and radially extend from the flexible outer tube. Because the plurality of vacuum holes are circumferentially disposed around the flexible outer tube, the plurality of vacuum holes are located on multiple sides of the tube and can aspirate the esophagus from multiple directions. The one or more internal vacuum passages are in fluid communication with the plurality of vacuum holes to apply a vacuum to the esophageal wall via a vacuum system. The tube tip is located at the distal end of the outer tube.

[0010] The esophageal positioning device of an exemplary mechanical esophageal displacement system includes a handle, a first segment, a second segment, and an articulation drive mechanism. The first segment is connected to the handle. The second segment is pivotally connected to the first segment. The articulation drive mechanism is configured to pivot the second segment around the first segment during articulation.

[0011] An exemplary method of using a mechanical esophageal displacement system includes inserting an assembly into a patient's esophagus via the mouth or nasal cavity. The assembly includes an introducer having a flexible outer cannula, a vacuum port, and a tube tip. The flexible outer cannula is sized to enter the esophagus through the mouth or nasal cavity and includes a distal end, a proximal end, a lumen, and a body. The body of the outer cannula includes a perforated outer surface and one or more internal vacuum passages extending distally from the proximal end within the body of the outer cannula. In some embodiments, the perforated outer surface includes a plurality of vacuum holes circumferentially disposed around and radially extending from the flexible outer cannula. Since the plurality of vacuum holes are circumferentially disposed around the flexible outer cannula, the plurality of vacuum holes are located on multiple sides of the tube and can aspirate the esophagus from multiple directions. The one or more internal vacuum passages are in fluid communication with the plurality of vacuum holes to apply a vacuum to the esophageal wall via a vacuum system. The tube tip is located at the distal end of the outer cannula. The vacuum port includes a vacuum port body, a vacuum line hookup, and a vacuum port cap.

[0012] Various implementations include an assembly that includes an introducer. This assembly is for use with a vacuum system and an esophageal positioning device. The esophageal positioning device includes a first segment and a second segment. The first segment has a central axis, and the second segment has a proximal end connected to pivot about the first segment and a distal end opposite and spaced from the proximal end. The second segment is pivotable about the first segment between a first position and a second position during articulation. The distal end of the second segment is disposed along the central axis in the first position, and the distal end of the second segment is displaced from the central axis in the second position.

[0013] The introducer is sized to receive the esophageal positioning device. The introducer includes a flexible outer tube and a tube tip portion. The flexible outer tube is sized to enter the esophagus through the mouth or nasal cavity. The flexible outer tube includes a longitudinal axis, a distal end, a proximal end, and a body. The body defines a plurality of radial vacuum holes circumferentially disposed around the longitudinal axis. The plurality of radial vacuum holes are in fluid communication with a vacuum system to apply a vacuum to the esophageal wall. The tube tip portion is located at the distal end of the outer tube.

[0014] A gap portion of the outer tube is defined along the longitudinal axis between the tube tip portion of the introducer and the distal end of the second segment of the esophageal positioning device when the esophageal positioning device is disposed inside the introducer. The gap portion defines one or more of the radial vacuum holes. The distal end of the second segment remains at the same distance from the proximal end of the second segment at the first position and the second position.

[0015] In some implementations, the gap portion defines a higher density of radial vacuum holes than any other portion of the body of the introducer.

[0016] In some embodiments, the density of the radial vacuum holes is highest adjacent to the distal end of the outer tube, and the density of the radial vacuum holes gradually decreases in a direction from the distal end of the outer tube towards the proximal end of the outer tube along the longitudinal axis.

[0017] In some embodiments, the body of the outer tube has an end measured along the longitudinal axis from the tip of the tube to the pivot connection between the first segment and the second segment of the esophageal positioning device when the esophageal positioning device is disposed within the introducer. Only the end of the body of the outer tube defines a plurality of radial vacuum holes.

[0018] In some embodiments, the length of the gap portion of the outer tube measured along the longitudinal axis is between 10 mm and 30 mm. In some embodiments, the length of the gap portion of the outer tube measured along the longitudinal axis is 28 mm. In some embodiments, the length of the second segment is 40 mm or more.

[0019] In some embodiments, the introducer further includes one or more airlets extending radially outward from the outer tube. Each of the one or more airlets defines an airlet opening, and the airlet openings of each of the one or more airlets are axially aligned with each other along the outer tube.

[0020] In some embodiments, the introducer further includes one or more occlusion balloons extending radially outward from the outer tube. In some embodiments, the one or more occlusion balloons include a first occlusion balloon and a second occlusion balloon. The first occlusion balloon is disposed at the distal end of the outer tube, and the second occlusion balloon is disposed at a portion of the outer tube adjacent to the pivot connection between the first segment and the second segment of the esophageal positioning device when the esophageal positioning device is disposed within the introducer.

[0021] Various other embodiments include a mechanical esophageal displacement system including an assembly. The assembly includes an introducer and an esophageal positioning device. The assembly is operably coupled to a vacuum system.

[0022] The introducer is sized to receive an esophageal positioning device. The introducer includes a flexible outer tube and a tube tip portion. The flexible outer tube is sized to enter the esophagus through the mouth or nasal cavity. The flexible outer tube includes a longitudinal axis, a distal end, a proximal end, and a body. The body defines a plurality of radial vacuum holes circumferentially disposed around the longitudinal axis. The plurality of radial vacuum holes are in fluid communication with a multi-vacuum system to apply a vacuum to the esophageal wall. The tube tip portion is located at the distal end of the outer tube.

[0023] The esophageal positioning device includes a first segment and a second segment. The second segment has a central axis, a proximal end connected to pivot about the first segment, and a distal end spaced opposite the proximal end. The second segment is pivotable between a first position and a second position during articulation about the first segment.

[0024] A gap portion of the outer tube is defined along the longitudinal axis between the tube tip portion of the introducer and the distal end of the second segment of the esophageal positioning device when the esophageal positioning device is disposed within the introducer. The gap portion defines one or more of the radial vacuum holes. The second segment includes a distal band stack assembly that houses a plurality of distal bands whose distal ends are slidable relative to each other along the central axis.

[0025] In some implementations, the gap portion defines a higher density of radial vacuum holes than any other portion of the body of the introducer.

[0026] In some implementations, the density of the radial vacuum holes is highest adjacent to the distal end of the outer tube and decreases gradually in a direction along the longitudinal axis from the distal end to the proximal end of the outer tube.

[0027] In some embodiments, the body of the outer tube has an end measured along the longitudinal axis from the distal end of the tube to the pivot connection between the first segment and the second segment of the esophageal positioning device when the esophageal positioning device is disposed inside the introducer. Only the end of the body of the outer tube defines a plurality of radially extending vacuum holes.

[0028] In some embodiments, the length of the gap portion of the outer tube measured along the longitudinal axis is 10 mm to 30 mm. In some embodiments, the length of the gap portion of the outer tube measured along the longitudinal axis is 28 mm. In some embodiments, the length of the second segment is 40 mm or more.

[0029] In some embodiments, the introducer further includes one or more outlets extending radially outward from the outer tube. Each of the one or more outlets defines an outlet opening, and the outlet openings of each of the one or more outlets are axially aligned with each other along the outer tube.

[0030] In some embodiments, the introducer further includes one or more occlusion balloons extending radially outward from the outer tube. The one or more occlusion balloons are inflatable. In some embodiments, the one or more occlusion balloons include a first occlusion balloon and a second occlusion balloon. The first occlusion balloon is disposed at the distal end of the outer tube, and the second occlusion balloon is disposed on a portion of the outer tube adjacent to the pivot connection between the first segment and the second segment of the esophageal positioning device when the esophageal positioning device is disposed inside the introducer.

[0031] Various other implementations include methods of using a mechanical esophageal displacement system. The method includes inserting the above-described assembly into a patient's esophagus via the mouth or nasal cavity, connecting a vacuum system to the vacuum line hookup of the introducer, advancing the above-described esophageal positioning device through the outer tube of the introducer, engaging the vacuum system to adhere a portion of the outer tube to the esophageal wall, and articulating the second segment around the first segment at a selected angle from a first position to a second position.

[0032] In some implementations, the gap portion defines a higher density of radial vacuum holes than any other portion of the introducer body.

[0033] In some implementations, the density of the radial vacuum holes is highest adjacent to the distal end of the outer tube, and the density of the radial vacuum holes gradually decreases in a direction along the longitudinal axis from the distal end of the outer tube towards the proximal end of the outer tube.

[0034] In some implementations, the body of the outer tube has an end measured along the longitudinal axis from the tube tip to the pivot connection between the first and second segments of the esophageal positioning device when the esophageal positioning device is disposed inside the introducer. Only the end of the body of the outer tube defines a plurality of radial vacuum holes.

[0035] In some implementations, the length of the gap portion of the outer tube measured along the longitudinal axis is 10 mm to 30 mm. In some implementations, the length of the gap portion of the outer tube measured along the longitudinal axis is 28 mm. In some implementations, the length of the second segment is 40 mm or more.

[0036] In some implementations, the introducer further includes one or more airlets extending radially outward from the outer tube. Each of the one or more airlets defines an airlet opening, and the airlet openings of each of the one or more airlets are axially aligned with each other along the outer tube.

[0037] In some embodiments, the introducer further includes one or more occlusion balloons that extend radially outward from the outer tube. The one or more occlusion balloons are inflatable. In some embodiments, the one or more occlusion balloons include a first occlusion balloon and a second occlusion balloon. The first occlusion balloon is disposed at the distal end of the outer tube, and the second occlusion balloon is disposed on a portion of the outer tube adjacent to the pivot connection between the first segment and the second segment of the esophageal positioning device when the esophageal positioning device is disposed inside the introducer.

[0038] The exemplary method further includes advancing the esophageal positioning device through the outer tube of the introducer, the esophageal positioning device including 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 connected to the first segment. The articulation drive mechanism is configured to pivot the second segment around the first segment during articulation.

[0039] The exemplary method further includes snap-fitting the handle of the esophageal positioning device to the 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 at a selected angle around the first segment.

[0040] Details of one or more embodiments of the present disclosure are set forth in the accompanying drawings and the following description. Other features, objects, and advantages of the present disclosure will be apparent from the description and drawings, as well as from the claims.

[0041] To facilitate understanding of the present disclosure and for purposes of illustration, exemplary features and implementations are disclosed in the accompanying drawings, however, it is understood that the present disclosure is not limited to the exact arrangements and means shown, and that like reference characters indicate like elements throughout the several views.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0043] The following is an illustration of some examples of the subject matter of the applicant's invention. Certain terms are used herein for convenience only and should not be construed as limiting the present invention. In the drawings, the same reference numerals are used throughout several figures to designate the same elements. Although multiple embodiments are provided, it is understood that various modifications may be made without departing from the spirit and scope of the present disclosure. 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 "comprising" and variations thereof are used synonymously with the term "including" and variations thereof and are non-limiting terms. The terms "comprising" and "including" are used herein to describe various embodiments, but the terms "consisting essentially of" and "consisting of" may be used in place of "comprising" and "including" to present more specific embodiments of the present invention, which are also disclosed.

[0044] The present invention will now be described more fully hereinafter with reference to specific embodiments of the invention. In fact, the invention can 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.

[0045] Figures 1-25 illustrate embodiments of a mechanical esophageal displacement system 1 according to the present disclosure for mechanically displacing the esophagus during a medical procedure via vacuum suction adhesion of segments of the esophagus. As shown in FIGS. 1 and 5, an exemplary mechanical esophageal displacement system 1 includes an assembly 5 and an esophageal positioning device 13, and the assembly 5 is operably connectable to a vacuum system (not shown). In some embodiments, the assembly 5 is a disposable component of the mechanical esophageal displacement system 1, and the assembly 5 includes one or more disposable pieces that can be removed and / or replaced after a medical procedure. As discussed in more 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. The first segment 110 and the second segment 115 can be, for example, linear structures.

[0046] FIGS. 2-5, 13, 25 illustrate embodiments of the disposable assembly 5 according to the present disclosure. An exemplary assembly 5 includes an introducer 2 sized to receive the esophageal positioning device 13. The esophageal positioning device 13 may be a reusable component of the system 1, and this esophageal positioning device is inserted into the lumen of the introducer after the introducer 2 has been 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 this single-piece assembly 5 may be disposable or designed to be sterilized for repeated use. The patient 37 can be a human or other animal.

[0047] As shown in FIG. 5, the introducer 2 includes a flexible outer tube 125. In some embodiments, the flexible outer tube 125 is cylindrical. The flexible outer tube 125 is sized to be able to enter the esophagus through the mouth or nasal cavity. The flexible 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 extending over the entire length of the outer tube and one or more internal vacuum passages 21 (see FIGS. 4 and 25) extending a distance from the proximal end 135 towards 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 flexible outer tube 125 and radially extend therefrom, as seen in FIGS. 1-3. Since the plurality of vacuum holes 3 are circumferentially spaced around the flexible outer tube 125, the plurality of vacuum holes 3 are located on multiple sides of the tube 125 and can suction the esophagus from multiple directions. The one or more internal vacuum passages 21 are in fluid communication with the plurality of vacuum holes 3 to apply a vacuum to the esophageal wall via a vacuum system. The outer tube 125, or a portion thereof, can be made from a flexible polymer such as, for example, polyvinyl chloride (PVC) or silicone. The outer tube 125 has sufficient flexibility so as not to add unnecessary rigidity to the system 1 that the esophageal positioning device 13 may need to overcome, but is not so flexible that the outer tube 125 folds up while the introducer 2 is being inserted into the esophagus. In some embodiments, the outer tube 125 includes a lubricious material coating (e.g., Hydrolide) to facilitate introduction into the esophagus and minimize trauma to the esophagus.

[0048] The outer tube 125 can be made from a single material, but in some embodiments, a multi-durometer outer tube 125 is made from two or more materials to achieve the desired rigidity at various portions along the outer tube 125. In some embodiments, the distal end 130 is made from a harder material, such as a combination of silicone and polyurethane or other materials, while the portion between the distal end 130 and the proximal end 135, which includes a plurality of radial vacuum holes 3, is made from a more flexible material. The harder distal end 130 makes it easier to introduce the soft outer tube 125 into the esophagus. The more flexible material of the portion including the plurality of radial vacuum holes 3 allows this portion of the soft outer tube 125 to collapse, reducing the diameter of the soft outer tube 125 and enhancing the collapse of the esophagus. As a result, this moves the esophagus further away from the heart and provides better circumferential adhesion of the esophagus to the soft outer tube 125.

[0049] In some embodiments, the assembly 5 can include a telescoping mechanism on at least a portion of the device to facilitate entry of the device into the esophagus. When in the desired position within the esophagus, the telescoping portion can expand to deploy the entire device.

[0050] As described above, the esophageal segment can be adhered to the introducer 2 via vacuum suction. For that purpose, the perforated outer surface 150 of the introducer 2 can include a plurality of radial vacuum holes 3 that can be positioned at various locations around the outer surface 150. In some embodiments, the plurality of or radial vacuum holes 3 are positioned along the outer surface 150 starting at a location about 3 to 5 inches from the distal tip 4 of the tube and extending for a length of about 2 inches from the starting position. When the vacuum is connected to and activated in the assembly 5, the plurality of holes 3 are designed to be in fluid communication with one or more internal vacuum passages 21 such that the vacuum system can create a vacuum between the esophageal wall and the outer tube 125. The fluid communication can be direct or indirect. In some embodiments, one or more internal vacuum passages 21 extend toward the distal end 130 but do not extend to the distal end 130. For example, in some embodiments, one or more internal vacuum passages 21 extend to the location of the most distal radial vacuum hole 3 but do not extend beyond it. In some embodiments, one or more internal vacuum passages 21 extend over the entire length of the body 140. In some embodiments, one or more internal vacuum passages 21 include one or more cylindrical rings (not shown) that respectively or together define cavities axially aligned with the lumen 137. In some embodiments, the body 140 does not include one or more internal vacuum passages 21, rather, the plurality of radial vacuum holes 3 are in fluid communication with the lumen 137 and the vacuum is applied to the lumen 137 to create a vacuum between the esophageal wall and the outer tube 125. Any suitable vacuum system that can provide sufficient suction to adhere a portion of the outer tube 125 to a portion of the esophageal wall can be used. One suitable exemplary vacuum system is a vacuum pump that provides a suction force of 300 millimeters of mercury. In some embodiments, the mechanical esophageal displacement system 1 includes a feedback mechanism such as a manometer to confirm that a vacuum seal has been formed along the esophagus by measuring a change in pressure within the system.

[0051] As shown in FIGS. 1-3, 5, and 13, the introducer 2 can include a tube tip portion 4 that is located at the distal end 130 of the outer tube 125. In some embodiments, the tube tip portion 4 includes a rigid polymer tip having a soft, circular profile, the tip is coupled to the distal end 130 of the outer tube 125, and the tube tip portion 4 is a closed structure. Since the tube tip portion 4 is designed to contact the esophageal passage directly, the tube tip portion 4 is shaped so as not to harm the esophagus. The tube tip portion 4 can include, for example, a semi-dome shape. In some embodiments, the tube tip portion 4 is a closed structure and not a lumen.

[0052] As shown in FIGS. 1, 2, 5, and 13, the assembly 5 can further include a vacuum port 155 that includes a vacuum port body 6 and a vacuum port cap 7. In some embodiments, the vacuum port cap 7 is a rigid polymer cap coupled to the vacuum port body 6. The vacuum port cap 7 can further include a snap mechanism shape and a quick release hinge mechanism (not shown) for connecting and separating 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 hookup 170 that is in fluid communication with one or more internal vacuum passages 21. The vacuum port body 6 can be coupled to both the introducer 2 and the vacuum port cap 7 to form an airtight seal. In some embodiments, the body 6 further includes a vacuum port valve and a lever (not shown), and the lever can control the vacuum system.

[0053] In some embodiments, the introducer 2 further includes a plurality of radiopaque markers (not shown) located proximal to the position 180 where the pivot pin 16 would be present within the introducer 2. In some embodiments, the plurality of radiopaque markers extends distally along or within the outer tube 125 of the introducer 2 from the position 180 of the approximate location where the pivot pin 16 would be present to the position of the tube tip 4. In some embodiments, the plurality of radiopaque markers extends a distance of about 4 to 6 centimeters from the tube tip 4. In some embodiments, the radiopaque markers are present throughout the outer tube 125.

[0054] As described above, 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. In some embodiments, the second segment 115 is sized to displace the esophageal wall about 4 centimeters during articulation. In some embodiments, the second segment 115 has a length of 4 to 6 centimeters. As shown in FIGS. 4-21, the second segment 115 can include a distal band stack assembly 12, a distal band guard 8, and a distal pivot retainer 14, and the distal band assembly 12 houses a plurality of distal bands 185. As shown in FIGS. 7-8, the distal band guard 8 holds the distal band assembly 12 at the distal end 190 by pins 9 that pass through the plurality of distal bands 185. The distal band assembly 12 can be made from a variety of suitable materials, including, for example, 300 or 400 series stainless steel or a rigid polymer. The plurality of distal bands 185 can be made from, for example, spring steel. The distal pivot retainer 14 can be made from, for example, 300 or 400 series 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 adhesion. Since the bands 185 are free to bend at the distal end 190, the distal bands 185 can be firmly attached to the distal pivot retainer 14.

[0055] As shown in FIGS. 7-8, in some embodiments, all but one of the distal bands 185 have a slot 195 at the distal end so that they do not interfere with the pins when the band is bent. One distal band 10, which is either the upper or outer band, includes a hole 200 instead of a slot 195, and the hole 200 restricts the sliding of the band 10 when the plurality of distal bands 185 are bent. The hole 200 further aids in identifying the positions of the plurality of distal bands 185 of the distal band assembly 12. In some embodiments, the distal guard 8 has a rounded tip 205 without sharp edges to prevent damage to the outer flexible tube 125 during insertion.

[0056] As shown in FIGS. 10-24, in some embodiments, the first segment 110 includes a proximal pivot holder 15, an articulation drive cable 18, and a proximal band stack assembly 19. The proximal band assembly 19 includes a plurality of proximal bands 210. The proximal pivot holder 15 houses the proximal stacked band assembly 19. Since the proximal bands 210 are free to bend at the proximal end 215 within the handle 105, the proximal bands 210 can be rigidly attached to the proximal pivot holder 15. In some embodiments, the proximal pivot holder 15 limits the articulation of the distal pivot holder 14 beyond a selected angle, such as 45 degrees, on each side to prevent the risk of damage to the esophagus due to excessive translational movement.

[0057] As shown in FIGS. 14-15, the proximal band stack assembly 19 can provide rigidity in a direction 220 (FIG. 15) perpendicular to the direction of the esophageal path while maintaining flexibility in the direction 225 of the esophageal path. The flexibility can be maintained by the use of thin bands (FIG. 14) laminated together (one and other) to form a thick (think) body in the direction of the vertical force provided by the esophagus (FIG. 15).

[0058] Similar to the distal band assembly 12, the proximal band stack assembly 19 can be made from a variety of suitable materials, including, for example, 300 or 400 series stainless steel or rigid polymers. The plurality of proximal bands 210 can be made from, for example, spring steel. The articulation pivot pin 16 can be made from, for example, 300 or 400 series stainless steel or 17-4 stainless steel. The articulation pivot pin 16 connects both the distal pivot retainer 14 and the proximal pivot retainer 15 and enables them to pivot. The articulation pivot pin 16 can be press fit into the proximal pivot retainer 15 and held in a loose fit by the distal pivot retainer 14.

[0059] As shown in FIGS. 10-12 and FIGS. 17-20, in some embodiments, the mechanical esophageal displacement system 1 further includes an articulation drive cable 18. This cable 18 transmits the force input by the user from the handle 105 to the articulation pivot pin 16 to articulate the second segment 110 45 degrees to the left or right from the neutral position where the distal band assembly 12 and the proximal band 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 by which the device is articulated from its neutral position. In some embodiments, the cable 18 is approximately 0.024 inches in diameter and is made of braided stainless steel or a polymer such as UHMWPE, liquid crystal polymer, or other high-strength braided or monofilament polymer. In some embodiments, the mechanical esophageal displacement system 1 further includes an articulation cable crimp 17. As shown in FIGS. 16-20, the cable crimp 17 can be a small ball that is crimped and friction fit onto the stainless steel braided cable 18. This crimp 17 provides on the cable 18 a mechanism that can interact with the distal pivot holder 14 when pulled to the left or right to articulate the system 1. The ball can be crimped and friction fit onto the articulation cable 18 to provide an interaction surface. In some embodiments, the articulation drive cable 18 is connected to the distal pivot holder 14 by welding in addition to or as an alternative to the cable crimp 17. Other types of mechanical or chemical fasteners can be used to operably connect the articulation drive cable 18 to the distal pivot holder 18, such as being integrally formed, chemically bonded, or mechanically or magnetically joined.

[0060] In some embodiments, the mechanical esophageal displacement system 1 further includes a plurality of proximal band cable guides 20 that guide the articulation cable 18 from the handle 105 to the articulation pivot pin 16, and the plurality of proximal band cable guides 20 are evenly spaced along the plurality of proximal bands 210. The proximal band cable guides 20 can be welded or coupled to one or more of the proximal bands 210 to allow them to slide and translate independently while still maintaining the proximal bands 210 in an aligned state and when the bands 210 are bent. The proximal band cable guides 20 assist in guiding the articulation drive cable 18 downwardly over the entire 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.

[0061] As shown in FIGS. 1, 9, 13, 22-24, the handle 105 of the esophageal positioning device 13 can include various components. As shown in FIG. 22, in some embodiments, the handle 105 includes a two-piece outer housing including a gimbal handle case half 22 and a lock handle case half 23. In some embodiments, the gimbal handle case half 22 can be made of a polymer or metal and can be, for example, approximately 1.9 inches in diameter and approximately 5 inches in length. The gimbal handle case half 22 can house a plurality of proximal bands 185, a gimbal drive mechanism 120, and a gimbal control knob 25. In some embodiments, the lock handle case half 23 can be made of a polymer or metal and can be, for example, approximately 1.9 inches in diameter and approximately 5 inches in length. The lock handle case half 23 can house the proximal band 185, the gimbal drive mechanism 120, and a lock control knob 24. The lock control knob 24 can be twisted to apply friction to the system 1 and to fully lock the system 1 at a selected gimbal angle. Twisting the lock control knob 25 in the opposite direction releases the gimbal drive mechanism 120, allowing the gimbal drive mechanism 120 to move freely. The knob 24 can be, for example, approximately 1 inch in overall diameter. The gimbal control knob 25 can be rotated in a first or second direction. In some embodiments, rotating the control knob clockwise can cause the tube tip 4 of the assembly 5 to gimbal to the right, while rotating the control knob 25 counterclockwise can cause the tube tip 4 of the assembly 5 to gimbal. The diameter of the gimbal control knob 25 can be, for example, approximately 2 inches. Thus, the gimbal control knob 25 can cause the second segment 115 to gimbal to the right when rotated in a first direction and to gimbal to the left when rotated in a second direction.

[0062] As shown in FIG. 22, the handle 105 of the esophageal positioning device 13 can include one or more snap hooks 26 located on the gimbal handle case half 22 and / or on the lock handle case half 23. The snap hooks 26 can be used to interlock and connect the handle 105 to the vacuum port cap 7 of the assembly 5.

[0063] As shown in FIGS. 23-24, the handle 105 of the esophageal positioning device 13 may include, for example, an upper handle band holder 27, a lower handle band holder 28, a pulley gear 29, a cable pulley 30, an input gear 31, a proximal band handle holder pin 32, a lock cone clutch 33, a articulation input shaft 34, an articulation input shaft bushing 35, and an articulation pulley shaft bushing 36.

[0064] In some embodiments, the upper and lower handle band holders 27, 28 accommodate the proximal ends 215 of the plurality of proximal bands 185 via the pin, hole, and slot mechanism of the proximal band 185, allowing the band 185 to translate while bending. The upper and lower holders 27, 28 may be made of, for example, a polymer or aluminum. The upper and lower holders 27, 28 may be held in place by ribs 230 found on the articulation handle case half 22 and on the lock handle case half 23.

[0065] In some embodiments, the pulley gear 29 includes a large gear attached to the cable pulley 30 via two pins. In some embodiments, the pulley gear 29 is concentric with the lock control knob 24 and the pulley shaft 235. In some embodiments, the pulley gear 29 has a diameter that is approximately two to three times larger than the diameter of the input gear 31.

[0066] In some embodiments, the articulation cable 18 is attached to the cable pulley 30 with the right cable 18 attached to the upper pulley hole 250. The articulation cable 18 may be routed around the pins of the cable pulley 30.

[0067] In some embodiments, the input gear 31 is a small gear attached to the articulation control knob shaft 255 and to the pulley gear 29. The input gear 31 is used to reduce the amount of input torque required by the user of the system 1 when articulating the esophageal positioning device 13. The input torque can be reduced, for example, 2 to 3 times based on a given ratio of the input gear 31 to the pulley gear 29. Thus, in some embodiments, the operator is not required to apply, or is restricted from applying, more than 80 ounces per inch of torque to control the knobs 24, 25. For example, in some embodiments, a failsafe mechanism can be used such that when the operator applies a preset torque (e.g., greater than 80 ounces per inch) to the articulation control knob 25, the articulation control knob 25 locks. Thus, the lockout of the knob 25 can help prevent injury to the operator.

[0068] In some embodiments, the proximal band handle holder pin 32 holds the proximal band 185 in place in conjunction with the proximal band stack assembly 19 and the upper and lower handle band holders 27, 28. The proximal band handle holder pin 32 aligns portions of the upper and lower handle band holders 27, 28 when they are assembled together. The retaining pin 32 aligns with all but one of the slots in the proximal band 185, whereby the bands 185 are able to slide relative to each other when flexed.

[0069] In some embodiments, the lock cone clutch 33 can be attached to the lock control knob 24 via a screw 260 and an interference rib 265. The lock cone clutch 33 can include threads on its outer diameter that engage threads on the lock handle case half 23. When the lock knob 24 is turned, e.g., clockwise, the lock cone clutch 33 moves inward and interferes with the cone shaft on the cable pulley 30, whereby the cable pulley 30 is effectively slowed or locked in its current position.

[0070] In some embodiments, the articulation input shaft 34 has a flat surface that is, for example, D-shaped. The flat surface enables interlocking with the input gear 31 via a set screw. The input shaft 34 can be, for example, approximately 0.25 inches in diameter. In some embodiments, the articulation input shaft bushing 35 enables the articulation input shaft 34 to rotate freely. Similarly, in some embodiments, the articulation pulley shaft bushing 36 enables the articulation pulley shaft 34 to rotate freely. The articulation input shaft bushing 35 and the articulation pulley shaft bushing 36 further assist in maintaining proper alignment of the handle 105 components.

[0071] In some embodiments, the esophageal positioning device 13 includes a clutch and / or a force gauge 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 located at the distal end 190 of the esophageal positioning device 13. In some embodiments, the esophageal positioning device 13 includes a plurality of sensors (e.g., thermistors and / or temperature sensors) along the device to enable simultaneous temperature measurements at various anatomical locations of the esophagus. In some embodiments, the thermistor, temperature sensor, or other sensor is operably connected to a computer, and 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) imaging or CT imaging), and thus to achieve 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 gastrografin injection or other substance used to outline and visualize the esophagus with X-rays. In some embodiments, ratchet joint movement control is provided such that one counterclockwise click of the ratchet joint movement control knob can cause a 15-degree joint movement to the left or a 1.5-cm translational movement to the left, depending on which is desired by the operator. In some embodiments, an audible click is provided as feedback to the operator regarding the amount of tension being 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.

[0072] In some embodiments, the esophageal positioning device 13 includes other imaging devices for use with visualization techniques. Such imaging devices can include, for example, a fiber optic light source with a camera, ultrasonic imaging (e.g., Doppler), and the like. 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. Ultrasonic imaging can be used, for example, to visualize and measure through the esophagus to view intracardiac objects such as catheters, transseptal techniques / devices, evaluate intracardiac thrombi, evaluate intracardiac defects such as atrial septal defects, visualize / measure pulmonary vein devices, visualize / measure mapping devices (e.g., multi-electrode baskets), visualize / measure the left atrial appendage and left atrial appendage closure devices, visualize / measure devices placed within the pericardium, and other heart-related products.

[0073] In some embodiments, the band laminates of the distal or proximal band assemblies 12, 19 have different widths. FIG. 25 shows an example of a proximal band assembly 19 having a proximal band 210 with different widths. The widths of the distal or proximal bands 185, 210 can be shaped to maximize rigidity according to the profile shape of the outer tube 125 of the introducer 2. For example, if the profile shape of the outer tube 125 of the introducer 2 is circular, the distal or proximal bands 185, 210 can be cut so that the profiles of the bands 185, 210 take the shape of a circle. The use of different widths can provide a more space-efficient interaction between the bands 185, 210 and the outer tube of the introducer 2 or the cable band guide 20. Further, cutting the bands of the proximal assembly 19 (or distal assembly 12) to different widths can increase the amount of material in contact with the inner surface of the outer tube or cable band guide 20, thereby increasing the rigidity of the system 1.

[0074] Although many materials are disclosed for the various components of the assembly 5, in some embodiments, all components of the assembly 5 are made from non-ferrous materials to enable use in combination with advanced mapping systems or for use within an MRI treatment room.

[0075] Also provided is a method of using the mechanical esophageal displacement system 1. An exemplary method includes inserting the assembly 5 into the esophagus of the patient 37 via the mouth or nasal cavity (FIG. 13). The assembly 5 includes an introducer 2 having a flexible outer extracorporeal tube 125, a vacuum port 155, and a tube tip 4. The flexible outer tube 125 is sized to enter the esophagus through the patient's mouth or nasal cavity, and the flexible outer tube 125 includes a distal end 130, a proximal end 135, a lumen 137 (see FIGS. 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 passages 21 that extend a 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 and radially extending from the flexible outer tube 125 as seen in FIGS. 1-3. Since the plurality of vacuum holes 3 are circumferentially spaced around the flexible outer tube 125, the plurality of vacuum holes 3 are located on multiple sides of the tube 125 and can aspirate the esophagus from multiple directions. The one or more internal vacuum passages 21 are in fluid communication with the plurality of vacuum holes 3 to apply a vacuum to the esophageal wall via a vacuum system. The tube tip 4 is located at the distal end 130 of the outer tube 125. The vacuum port 155 includes a vacuum port body 6, a vacuum line hookup 170, and a vacuum port cap 7. In some embodiments, the body includes a continuous inner surface 145.

[0076] The exemplary method further includes advancing the esophageal positioning device 13 through the outer tube of the introducer 2, and the esophageal positioning device 13 includes a handle 105, a first segment 110, a second segment 115, a gimbal pivot pin 16, and a gimbal drive mechanism 120. The first segment 120 is coupled to the handle 105. The second segment 115 is pivotally connected to the first segment 110 via the gimbal pivot pin 16. The gimbal drive mechanism 120 is configured to pivot the second segment 115 around the first segment 110 during gimbal movement.

[0077] The exemplary method further includes snapping the handle 105 of the esophageal positioning device 13 onto 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 at a selected angle, such as about 45 degrees, around the first segment 110.

[0078] FIG. 26 shows another exemplary mechanical esophageal displacement system according to the present disclosure. The mechanical esophageal displacement system includes a flexible coil 410 wound around a portion of the 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, for example, 3.992 centimeters.

[0079] FIG. 27 is a perspective enlarged view of the exemplary mechanical esophageal displacement system of FIG. 26. This figure emphasizes an articulation pin operably connected to the coil to articulate a segment of the esophageal positioning device around the pin. FIG. 28 is a top enlarged view of the exemplary mechanical esophageal displacement system of FIG. 26, which emphasizes exemplary dimensions.

[0080] 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 for articulating corresponding segments of the esophageal positioning device.

[0081] FIG. 30 is a perspective view of an exemplary assembly of the mechanical esophageal displacement system of FIG. 29. This figure shows an outer tube 125 having a long tail 412 with a radiopaque marker 414.

[0082] FIG. 31 is a perspective cross-sectional view of a portion of the mechanical esophageal displacement system of FIG. 29. This figure emphasizes the vacuum passage 21 and the holes of the assembly.

[0083] Figure 32 is a front view of a portion of the mechanical esophageal displacement system of FIG. 29. This figure emphasizes the connection between segments of the esophageal positioning device. This figure includes clevis 515, pin 516, cable 518, crimp 517, weld 518, upper pulley half 514, and lower pulley half 516.

[0084] Figure 33 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. This figure shows an esophageal positioning device having a fishing rod 610, an eyelet 612, a cinch wire 614, and a cable 618, and the cable 618 houses an anchor 616.

[0085] Figure 34 is a perspective cross-sectional 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.

[0086] Figure 35 is a perspective view of another exemplary assembly according to the present disclosure. In FIG. 35, the assembly includes a tube 825 having a crushable portion 810, and the crushable portion 810 can be actuated by a guide wire and / or a vacuum pressure.

[0087] Figure 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 includes an esophageal displacement device that provides articulation via shafts 910, 912, a right-handed threaded rod 914, and a left-handed threaded rod 916, and the right-handed threaded rod 914 and the left-handed threaded rod 916 are axially connected together. When a cable 920 connected to the left-handed threaded rod is rotated, the threaded openings 922, 924 in the shafts 910, 912 move the threaded rods 914, 916 up and down, respectively, and tilt an articulation plate 918 hingedly connected to opposite ends of the shafts 910, 912.

[0088] Figure 37 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. The mechanical esophageal displacement system of Figure 37 includes a gear drive 1010 that provides articulation via a worm gear 1012.

[0089] Figure 38 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. The mechanical esophageal displacement system of Figure 38 includes a gear drive 1110 that provides articulation via a leaf spring 1112.

[0090] Figure 39 is a perspective view of another exemplary assembly according to the present disclosure. In Figure 39, the assembly includes an outer tube 1210 similar to the outer tube 125 made of a material that deforms into a specific shape when wet.

[0091] Figure 40 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. The mechanical esophageal displacement system of Figure 40 includes an upper section 1310 and a lower section 1312 that mate via a set of axial ridges 1314, 1316 respectively, and the axial ridges 1314, 1316 prevent rotation. The upper section 1310 and the lower section 1312 are loosely connected via a wire 1318. When the wire 1318 is pulled up, the lower section 1312 is locked in place.

[0092] Figure 41 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. The mechanical esophageal displacement system of Figure 40 includes an esophageal displacement device having two pieces 1410, 1412 each having angled surfaces 1414, 1416 respectively, and the angle between the two pieces 1410, 1412 changes from an aligned state to a right angle state during rotation.

[0093] Figure 42 is a perspective view of another exemplary assembly according to the present disclosure. The assembly of Figure 42 includes a straw-shaped tube 1510 having a flexible portion 1512 only on one side 1514, and thus, when a vacuum is applied, it deflects one side 1514 of the assembly.

[0094] Figure 43 is a perspective view of another exemplary assembly according to the present disclosure. The assembly of Figure 43 includes a gel liquid portion 1610 that deflects the assembly in a given direction.

[0095] Figure 44 shows an assembly 1705 for use with a vacuum system (not shown) and an esophageal positioning device 1713 according to another implementation. The assembly 1705 includes an introducer 1702 and a handle 105.

[0096] The assembly 1705 shown in Figure 44 is similar to the assemblies of the embodiments shown in Figures 1 - 43. For this reason, like reference numerals used for the assemblies shown in Figures 1 - 43 are used to denote like features included in the assembly 1705 shown in Figure 44. The esophageal positioning device 13 of the assembly 1705 is the same as the esophageal positioning device 13 shown in Figures 1 - 43. The esophageal positioning device 13 of the assembly 1705 includes a first segment 110 and a second segment 115. The first segment 110 has a proximal end 111 coupled to the handle, a distal end 113 spaced distally from the proximal end 111, and a central axis 121 extending from the proximal end 111 to the distal end 113. The second segment 115 has a proximal end 117 pivotally connected to the distal end 113 of the first segment 110 by a pivot pin 16, and a distal end 119 spaced distally from the proximal end 117 of the second segment 115. In some implementations, the length of the second segment 115 measured from the proximal end 117 to the distal end 119 is 40 mm or more.

[0097] The second segment 115 is pivotable about the pivot pin 16 between a first position and a second position. In the first position, the distal end 119 of the second segment 115 is disposed along the central axis 121 of the first segment 110, and in the second position, the distal end 119 of the second segment 115 is displaced from the central axis 121.

[0098] Similar to the esophageal positioning device 13 shown in FIGS. 1-43, the first segment 110 of the esophageal positioning device 13 shown in FIG. 44 includes a proximal band assembly 19, and the second segment 115 includes a distal band assembly 12. The distal band assembly 12 includes a plurality of distal bands 185 that are slidable relative to each other along a central axis 121 at the distal ends 190 of the bands 185.

[0099] The introducer 1702 includes a flexible outer tube 125 sized to enter the esophagus through the oral or nasal passageway. The outer tube 125 includes a proximal end 135, a distal end 130 spaced distally from the proximal end 135, a body 140 extending between the proximal end 135 and the distal end 130, and a longitudinal axis 141 extending along the body 140 from the proximal end 135 to the distal end 130. The introducer 1702 also includes a tube tip portion 4 located at the distal end 130 of the outer tube 125. The introducer 1702 further includes a plurality of eyelets 143 extending radially outward from the outer tube 125. Each of the eyelets 143 shown in FIG. 44 defines an eyelet opening 147. The eyelet openings 147 of each of the one or more eyelets 143 are axially aligned with each other along the outer tube 125, and a wire, cable, or tube can be disposed inside each of the eyelet openings 147. The eyelets 143 connect a wire, cable, or tube to the outer tube 125 to provide communication with a device disposed in the assembly.

[0100] The outer tube 125 is sized such that the esophageal positioning device 13 can be inserted into the introducer 1702. As shown in FIG. 44, when the esophageal positioning device 13 is disposed inside the introducer 1702, a gap portion 131 of the body 140 of the outer tube 125 is defined between the distal end 4 of the introducer 1702 and the distal end 119 of the second segment 115 of the esophageal positioning device 13 along the longitudinal axis 141. The body 140 of the outer tube 125 has an end portion 133 measured along the longitudinal axis 141 from the distal end 4 to the pivot connection between the first segment 110 and the second segment 115 of the esophageal positioning device 13 when the esophageal positioning 13 device is disposed inside the introducer 1702.

[0101] In the implementation shown in FIG. 44, the length of the gap portion 131 of the outer tube 125 measured along the longitudinal axis 141 is 28 mm. However, in other implementations, the length of the gap portion of the outer tube measured along the longitudinal axis is 25 mm to 30 mm. In some implementations, the length of the gap portion of the outer tube measured along the longitudinal axis is 10 mm to 30 mm.

[0102] The body 140 defines a plurality of radially spaced-apart circumferentially around the longitudinal axis 141. The plurality of radially spaced-apart holes 3 are in fluid communication with a vacuum system to apply a vacuum to the esophageal wall. Only the end portion 133 of the body 140 of the outer tube 125 defines the plurality of radially spaced-apart holes 3. The radially spaced-apart holes 3 of the body 140 of the outer tube 125 shown in FIG. 44 are arranged in eight rings of eight radially spaced-apart holes 3. However, in other implementations, the ring of radially spaced-apart holes includes any number of radially spaced-apart holes circumferentially. In some implementations, the ring of radially spaced-apart holes includes any number of radially spaced-apart holes circumferentially. In some implementations, different rings of radially spaced-apart holes include different numbers of radially spaced-apart holes circumferentially. In some implementations, the plurality of holes are not arranged in a ring shape but in an arbitrary pattern.

[0103] The gap portion 131 of the outer tube 125 shown in FIG. 44 defines three of the eight rings of the circumferentially spaced vacuum holes 3. As shown in FIG. 44, the distance between adjacent rings of the circumferentially spaced vacuum holes 3, measured along the longitudinal axis 141, varies along the outer tube 125. The distance between adjacent rings of the circumferentially spaced vacuum holes 3 defined by the gap portion 131 is the shortest distance between adjacent rings of the vacuum holes 3 defined by the body 140 of the outer tube 125. Thus, the gap portion 131 defines the highest density of radially extending vacuum holes 3 in any portion of the body 140 of the outer tube 125 of the introducer 1702.

[0104] During use, the introducer 1702 of the assembly 1705 is inserted into the patient's nose or mouth and advanced into the esophagus, and the esophageal positioning device 13 is advanced through the outer tube 125 of the introducer 1702. In some implementations, after the introducer 1702 and the esophageal positioning device 13 have been advanced to the desired position in the esophagus, contrast fluid is introduced through the introducer 1702 such that the contrast fluid flows through the vacuum holes 3. The contrast fluid can be detected by X-ray or fluoroscopy to determine the position of the assembly 1705 in the esophagus. When the introducer 1702 and the esophageal positioning device 13 are in the desired position in the patient's esophagus, the vacuum system is engaged. The vacuum system creates a suction force in the vacuum holes 3 of the introducer 1702, causing a portion of the outer tube 125 to adhere to the esophageal wall. The second segment 115 of the esophageal positioning device 13 then articulates around the first segment 110 from an initial position to a second position such that a portion of the esophagus is displaced by a desired distance. Since the esophageal wall is adhered to the introducer 1702, the entire esophagus can be moved.

[0105] The spacing and position of the vacuum holes 3 defined by the introducer 1702 increase the ability of the vacuum holes 3 to adhere closely to the esophageal wall and draw it in. Since the suction holes 3 are circumferentially spaced around the introducer 1702, the vacuum holes 3 can adhere to the entire circumferential region of a part of the esophageal wall. As a result, the esophageal wall is drawn in, pressed against and drawn in by the introducer 1702, and all parts of the esophagus are reliably displaced during the articulation of the second segment 115 without dragging the non-adhering distal end of the esophagus behind it.

[0106] During the articulation of the second segment 115, the distal end 119 of the second segment 115 is displaced farthest and is the part that receives the maximum amount of torque. Therefore, in order to provide an optimal grip, it is important that the esophagus adheres firmly to the introducer 1702 adjacent to the distal end 119 of the second segment 115. The gap portion 131 of the introducer 1702 shown in FIG. 44 is set to include the highest density of vacuum holes 3 along the introducer 1702. When the esophageal positioning device 13 is inserted into the introducer 1702, the second segment 115 of the esophageal positioning device 13 does not extend into the gap portion 131 of the introducer 1702. When suction is applied to the introducer 1702, the introducer 1702 is crushed by the suction. The portions of the introducer 1702 including the esophageal positioning device 13 are limited in how much they can be crushed by the size of the band of the esophageal positioning device 13. However, the gap portion 131 can be crushed more radially than the portions of the introducer 1702 including the esophageal positioning device 13. Since the gap portion 131 defines the highest density of vacuum holes 3, the esophageal wall can be drawn in more tightly and in a smaller area by the vacuum holes 3 defined by the gap portion 131 of the introducer 1702. The crushing of the gap portion 131 of the introducer 1702 and the high-density vacuum holes 3 defined by the gap portion 131 of the introducer 1702 ensure that the esophagus adheres firmly to the end of the introducer 1702.

[0107] The higher density vacuum holes 3 defined by the gap portion 131 also enable a greater amount of contrast fluid to flow through the gap portion 131 of the introducer 1702. When viewed by X-ray or fluoroscopy, the greater amount of contrast fluid entering the esophageal portion near the gap portion 131 enables the end of the introducer 1702 where the gap portion 131 is located to be more easily detected.

[0108] FIG. 45 shows another implementation of the assembly 1805 including the introducer 1802. The assembly shown in FIG. 45 is similar to the assembly 1705 of the embodiment shown in FIG. 44. Accordingly, reference numerals similar to those used for the assembly 1705 shown in FIG. 44 are used to denote similar features included in the assembly 1805 shown in FIG. 45. The gap portion 131 of the introducer 1802 shown in FIG. 45 defines the highest density of radial vacuum holes 3 adjacent to the distal end 130 of the outer tube 125. The density of the radial vacuum holes 3 gradually decreases along the longitudinal axis 141 in the direction from the distal end 130 of the outer tube 125 toward the proximal end 135 of the outer tube 125.

[0109] Figure 46 shows another implementation of the assembly 1905 that includes the introducer 1902. The assembly 1905 shown in Figure 46 is similar to the assemblies 1705, 1805 of the embodiments shown in Figures 44 - 45. Therefore, reference numbers similar to those used for the assemblies 1705, 1805 shown in Figures 44 - 45 are used to indicate similar features included in the assembly 1905 shown in Figure 46. However, the introducer 1902 shown in Figure 46 includes two occlusion balloons 149, namely a proximal balloon and a distal balloon. The occlusion balloons 149 are disposed on the outer surface of the body 140 of the outer tube 125 and are expandable radially outward from the outer tube 125. The proximal balloon 149 is disposed adjacent to the proximal end of the end portion 133 of the outer tube 125 that is located at the pivot connection between the first segment 110 and the second segment 115 of the esophageal positioning device 13 when the esophageal positioning device 13 is disposed inside the introducer 1902. The distal balloon 149 is disposed adjacent to the distal end of the end portion 133 of the outer tube 125. Therefore, all the vacuum holes 3 are defined between the proximal balloon 149 and the distal balloon 149.

[0110] The assembly also includes two inflation tubes 151. Each inflation tube 151 has a first end 153, a second end opposite the first end 153 and spaced from the first end 153 of the inflation tube 151, and a body 159 extending from the first end 153 of the inflation tube 151 to the second end 157 of the inflation tube 151. Each of the occlusion balloons 149 is connected to one of the second ends 157 of the inflation tubes 151. The body 159 of each inflation tube 151 extends through the inlet opening 147 of the inlet 143 of the outer tube 125 such that the body 159 of the inflation tube 151 is connected to the body 140 of the outer tube 125. The inflation tubes 151 extend along the outer tube 125 such that the first ends 153 of the inflation tubes 151 are adjacent to the proximal end 135 of the outer tube 125. The first ends 153 of the inflation tubes 151 are each connected to a pump (not shown) for inflating the occlusion balloons 149. The pump can be a manual pump or an automatic pump.

[0111] When the introducer 1702 and the esophageal positioning device 13 are disposed in the patient's esophagus, the pump is activated and air flows from the pump through the inflation tube 151 into the occlusion balloon 149. The occlusion balloon 149 is inflated such that the outer surface of the occlusion balloon 149 abuts against the inner wall of the esophagus to form a seal. Since all of the vacuum holes 3 are defined by the end portion 133 of the outer tube 125 between the proximal balloon 149 and the distal balloon 149, the only portion of the esophagus that is introduced to be aspirated by the vacuum holes 3 is the portion occluded by the occlusion balloon 149.

[0112] Although some of the means for deflecting the assembly have been described above, it should be noted that the assembly can also be articulated using any other means known in the art, including, for example, springs, fluid / air filled containers, magnets, and the like.

[0113] Although a few exemplary embodiments of the present 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 substantially departing from the novel teachings and advantages of the present invention. Accordingly, all such modifications are intended to be included within the scope of the present invention, which is defined by the following claims and all their equivalents. Further, although many embodiments can be envisioned that do not achieve all of the advantages of some embodiments, it is recognized that the absence of a particular advantage should not necessarily be construed as meaning that such an embodiment is outside the scope of the present invention.

[0114] Substances, systems, and devices are disclosed that can be used for, used with, used to prepare, or are products of the disclosed methods, systems, and devices. These and other components are disclosed herein, and where combinations, subsets, interactions, groups, etc. of these components are disclosed, specific references to each of the various individual and collective combinations and permutations of these components may not be explicitly disclosed, but each is specifically contemplated and understood to be described herein.

Claims

1. Comprising a flexible outer tube sized to enter into the esophagus through the mouth or nasal cavity, The flexible outer tube includes a longitudinal axis, a distal end, a proximal end, a pivotal connection portion, and a body configured to receive a joint-movable esophageal positioning device having a distal end of the device, The body is, An end portion between the pivotal connection portion and the distal end of the flexible outer tube, A gap portion between the distal end of the device and the distal end of the flexible outer tube, A plurality of radial vacuum holes disposed in the gap portion and circumferentially spaced around the longitudinal axis, A tube tip portion located at the distal end of the flexible outer tube, An introducer comprising.

2. The radial vacuum holes are also disposed in the end portion outside the gap portion, The gap portion defines a higher density of radial vacuum holes than the end portion, The introducer according to claim 1.

3. The density of the radial vacuum holes is highest adjacent to the distal end of the flexible outer tube, The density of the radial vacuum holes gradually decreases in a direction from the distal end of the flexible outer tube toward the proximal end of the flexible outer tube along the longitudinal axis, The introducer according to claim 1.

4. Only the end portion of the body of the flexible outer tube defines the plurality of radial vacuum holes, The introducer according to claim 1.

5. The length of the gap portion measured along the longitudinal axis is 10 mm to 30 mm, The introducer according to claim 1.

6. The length of the gap portion measured along the longitudinal axis is 28 mm, The introducer according to claim 1.

7. The length of the end portion is 40 mm or more, The introducer according to claim 1.

8. Further comprising one or more eyelets extending radially outward from the flexible outer tube, Each of the one or more eyelets defines an eyelet opening, and the eyelet openings of each of the one or more eyelets are axially aligned with each other along the flexible outer tube, The introducer according to claim 1.

9. Further comprising one or more occluding balloons extending radially outward from the flexible outer tube, The one or more occluding balloons are inflatable, The introducer according to claim 1.

10. The plurality of occluding balloons includes a first occluding balloon and a second occluding balloon, the first occluding balloon is disposed at the distal end of the flexible outer tube, the second occluding balloon is disposed at a portion of the flexible outer tube adjacent to the pivotal connection portion of the articulatable esophageal positioning device, The introducer according to claim 9.

11. A mechanical esophageal displacement system including an esophageal positioning device and an introducer, the esophageal positioning device includes a first segment, a second segment that defines the distal end of the esophageal positioning device, the second segment including a plurality of distal bands that are slidable relative to each other, a pivotal connection portion between the first segment and the second segment, and includes the introducer includes a flexible outer tube sized to enter the esophagus through the mouth or nasal cavity the flexible outer tube includes a longitudinal axis, a distal end, a proximal end, and a body sized to receive the esophageal positioning device, the body includes an end portion between the pivotal connection portion and the distal end of the flexible outer tube, a gap portion between the distal end of the esophageal positioning device and the distal end of the flexible outer tube, a plurality of radial vacuum holes disposed in the gap portion and circumferentially spaced around the longitudinal axis, a tube tip portion located at the distal end of the flexible outer tube, and includes the radial vacuum holes are in fluid communication with a vacuum system to apply a vacuum to the esophageal wall, A mechanical esophageal displacement system.

12. The gap portion defines a higher density of radial vacuum holes than any other portion of the body of the introducer, The mechanical esophageal displacement system according to claim 11.

13. The density of the radial vacuum holes is highest adjacent to the distal end of the flexible outer tube, the density of the radial vacuum holes gradually decreases along the longitudinal axis in a direction from the distal end of the flexible outer tube toward the proximal end of the flexible outer tube, The mechanical esophageal displacement system according to claim 11.

14. Only the end portion defines the radial vacuum holes, The mechanical esophageal displacement system according to claim 11.

15. The length of the gap portion of the flexible outer tube measured along the longitudinal axis is 10 mm to 30 mm, The mechanical esophageal displacement system according to claim 11.

16. The length of the gap portion of the soft outer tube measured along the longitudinal axis is 28 mm. The mechanical esophageal displacement system according to claim 11.

17. The length of the second segment is 40 mm or more. The mechanical esophageal displacement system according to claim 11.

18. The introducer further includes one or more airlets extending radially outward from the soft outer tube. Each of the one or more airlets defines an airlet opening. The airlet openings of each of the one or more airlets are axially aligned with each other along the soft outer tube. The mechanical esophageal displacement system according to claim 11.

19. The introducer further includes one or more occlusion balloons extending radially outward from the soft outer tube. The one or more occlusion balloons are inflatable. The mechanical esophageal displacement system according to claim 11.

20. A plurality of the occlusion balloons include a first occlusion balloon and a second occlusion balloon. The first occlusion balloon is disposed at the distal end of the soft outer tube. The second occlusion balloon is disposed at a part of the soft outer tube adjacent to the pivot connection between the first segment and the second segment of the esophageal positioning device when the esophageal positioning device is disposed inside the introducer. The mechanical esophageal displacement system according to claim 19.

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