Systems and methods for mechanical displacement of the esophagus - Patents.com

Abstract

An exemplary assembly for use with a vacuum system and an esophageal positioning device includes an introducer, the esophageal positioning device including a first segment and a second segment. The second segment is pivotally connected to the first segment. A gap portion of the introducer outer tube is defined along a longitudinal axis between the introducer tube tip 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 radial vacuum holes.

Description

[Technical field]

[0001] The present disclosure relates to medical devices and methods for esophageal vacuum suction sealing coupled with mechanical displacement of a patient's esophagus. [Background technology]

[0002] The number of patients experiencing atrial fibrillation ("AF") is projected to increase to 10 million in 20 years. The cost of treating a patient with AF ranges from US$2,000 to US$10,000 annually. The most effective and scalable 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 in the left atrium of the heart. Ablation results in the destruction of cardiac cells. The areas of the heart targeted for ablation are those areas that cause AF. These areas in the left atrium are within 2-4 millimeters of the esophagus, therefore, a major concern is that the release of energy from the ablation catheter may travel forward and damage the esophagus. Approximately 103,000 AF ablation procedures are performed annually in the United States, with an additional 57,000 procedures performed outside the United States. A significant complication of AF ablation procedures is damage to the esophagus resulting in an atrioesophageal fistula. This communication occurs between the esophagus and the heart because the ablation energy irritates 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 cardiac infection and stroke. Atrioesophageal fistulas occur in approximately 0.6% of patients, and the outcome is usually fatal or associated with significant morbidity. Furthermore, the precursor lesion to atrioesophageal fistulas is an ulcer in the esophagus, which also results from injury to the esophagus and occurs in approximately 30% of patients. Therefore, electrophysiologists, physicians performing ablation procedures, are very concerned about preventing injury to the esophagus and avoiding atrioesophageal fistulas.

[0003] Conventional treatments include inserting devices into the esophagus to monitor temperature and to discontinue delivery of ablation energy if there is a change in luminal esophageal temperature, however, these devices are unable to displace the esophagus away from the source of ablation energy and therefore do not provide an active protection mechanism to protect against damage to the esophagus.

[0004] Therefore, there is a need for an improved system for displacing the esophagus to reduce the risk of damage to the esophagus. Summary of the Invention

[0005] Devices, systems, and methods are provided for vacuum suction contact and mechanical displacement of the esophagus. In particular, assemblies for use with vacuum systems and esophageal positioning devices are disclosed. Similarly, mechanical esophageal displacement systems and methods of use are also disclosed.

[0006] The esophagus is a flexible muscular organ that is often displaced during medical procedures. When mechanical forces are simply applied to displace the esophagus, tenting of the esophagus may result, rather than actual movement and displacement of the organ region. More specifically, the mechanical forces displace the leading edge of the esophageal wall, but the trailing edge of the esophageal wall moves only a small distance, if at all. Due to the resulting tenting of the esophagus, the mechanical displacement cannot provide a protective effect. The system disclosed herein utilizes an aspiration vacuum to apply a uniform force to the esophagus to attract and seal the esophageal wall 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. In general, the esophagus follows the directional change of the esophageal positioning device through the assembly. This directional change can be easily visualized by the physician on the x-ray machine 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 risk of damage to the esophagus, and the operator can confidently ablate the target area 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 upon articulation. In some embodiments, the second segment is sized to displace the esophageal wall approximately four centimeters upon articulation.

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

[0010] An exemplary esophageal positioner of a mechanical esophageal displacement system 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 upon articulation.

[0011] An exemplary method of using the mechanical esophageal displacement system includes inserting an assembly into a patient's esophagus through the mouth or nasal cavity. The assembly includes an introducer having a soft outer tube, a vacuum port, and a tube tip. The soft outer tube is sized to enter the esophagus through the mouth or nasal cavity, and the soft outer tube 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 within the body of the outer tube from the proximal end toward the distal end. In some embodiments, the perforated outer surface includes a plurality of vacuum holes that are circumferentially disposed around the soft outer tube and extend radially therefrom. Because the plurality of vacuum holes are circumferentially disposed around the soft outer tube, the plurality of vacuum holes are located on multiple sides of the tube and can suction the esophagus from multiple directions. The one or more internal vacuum passages are in fluid communication with the plurality of vacuum holes for applying a vacuum to the esophageal wall via a vacuum system. The tube tip is located at a distal end of the outer tube. The vacuum port includes a vacuum port body, a vacuum line hook-up, and a vacuum port cap.

[0012] Various implementations include an assembly including an introducer. The 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 pivotally connected to the first segment and a distal end opposite and spaced apart from the proximal end. The second segment is pivotable about the first segment between a first position and a second position upon articulation. The distal end of the second segment is disposed along the central axis at the first position, and the distal end of the second segment is displaced from the central axis at the second position.

[0013] The introducer is sized to receive the esophageal positioning device. The introducer includes a soft outer tube and a tube tip. The soft outer tube is sized to pass through the mouth or nasal cavity and into the esophagus. The soft 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 about 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 is located at a distal end of the outer tube.

[0014] A gap portion of the outer tube is defined along a longitudinal axis between the tube tip 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 distal end of the second segment remains the same distance from the proximal end of the second segment in 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 implementations, the density of radial vacuum holes is highest adjacent the distal end of the outer tube, and the density of radial vacuum holes gradually decreases in a direction along the longitudinal axis from the distal end of the outer tube toward the proximal end of the outer tube.

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

[0018] In some implementations, the length of the gap portion of the outer tube measured along the longitudinal axis is between 10 mm and 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.

[0019] In certain implementations, the introducer further includes one or more eyelets extending radially outward from the outer tube, each of the one or more eyelets defining an eyelet opening, the eyelet openings of each of the one or more eyelets being axially aligned with one another along the outer tube.

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

[0021] Various other implementations include a mechanical esophageal displacement system including an assembly including an introducer and an esophageal positioning device, the assembly being operably coupled to a vacuum system.

[0022] The introducer is sized to receive the esophageal positioning device. The introducer includes a soft outer tube and a tube tip. The soft outer tube is sized to enter the esophagus through the mouth or nasal cavity. The soft 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 about the longitudinal axis. The plurality of radial vacuum holes are in fluid communication with a dual vacuum system to apply a vacuum to the esophageal wall, and the tube tip 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 having a central axis, a proximal end pivotally connected to the first segment, and a distal end spaced opposite the proximal end, the second segment being pivotable between a first position and a second position upon articulation about the first segment.

[0024] A gap portion of the outer tube is defined along the longitudinal axis between the tube tip 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 housing a plurality of distal bands, the distal ends of the bands being slidable relative to one another 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 radial vacuum holes is highest adjacent the distal end of the outer tube, and the density of radial vacuum holes gradually decreases in a direction along the longitudinal axis from the distal end of the outer tube toward the proximal end of the outer tube.

[0027] In some implementations, the body of the outer tube has an end measured along the longitudinal axis from the tube tip to a pivot connection between the first and second segments of the esophageal positioning device when the esophageal positioning device is disposed within the introducer, and only the end of the body of the outer tube defines a plurality of radial vacuum holes.

[0028] In some implementations, the length of the gap portion of the outer tube measured along the longitudinal axis is between 10 mm and 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.

[0029] In some implementations, the introducer further includes one or more eyelets extending radially outward from the outer tube, each of the one or more eyelets defining an eyelet opening, the eyelet openings of each of the one or more eyelets being axially aligned with one another along the outer tube.

[0030] In some implementations, 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 implementations, the one or more occlusion balloons include a first occlusion balloon and a second occlusion balloon. The first occlusion balloon is disposed at a distal end of the outer tube and the second occlusion balloon is disposed in a portion of the outer tube adjacent a pivot connection between the first and second segments of the esophageal positioning device when the esophageal positioning device is disposed within the introducer.

[0031] Various other implementations include a method of using a mechanical esophageal displacement system, the method including inserting the above-described assembly into a patient's esophagus via the mouth or nasal cavity, coupling a vacuum system to a vacuum line hook-up of an introducer, advancing the above-described esophageal positioning device through an 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 about 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 body of the introducer.

[0033] In some implementations, the density of radial vacuum holes is highest adjacent the distal end of the outer tube, and the density of radial vacuum holes gradually decreases in a direction along the longitudinal axis from the distal end of the outer tube toward 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 a pivot connection between the first and second segments of the esophageal positioning device when the esophageal positioning device is disposed within the introducer, and 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 between 10 mm and 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 eyelets extending radially outward from the outer tube, each of the one or more eyelets defining an eyelet opening, the eyelet openings of each of the one or more eyelets being axially aligned with one another along the outer tube.

[0037] In some implementations, 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 implementations, the one or more occlusion balloons include a first occlusion balloon and a second occlusion balloon. The first occlusion balloon is disposed at a distal end of the outer tube and the second occlusion balloon is disposed in a portion of the outer tube adjacent a pivot connection between the first and second segments of the esophageal positioning device when the esophageal positioning device is disposed within the introducer.

[0038] An exemplary method further includes advancing an 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 about the first segment upon articulation.

[0039] An exemplary method further includes snapping a handle of the esophageal positioning device into 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 to a selected angle about the first segment.

[0040] 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 become apparent from the description and drawings, and from the claims.

[0041] For purposes of facilitating an understanding of and illustrating the present disclosure, exemplary features and implementations are disclosed in the accompanying drawings, it being understood, however, that the disclosure is not limited to the precise arrangements and instrumentalities shown, and like reference characters denote similar elements throughout the several views. [Brief description of the drawings]

[0042] [Figure 1] FIG. 1 is a perspective view of an exemplary mechanical esophageal displacement system in accordance with the present disclosure; [Diagram 2] 2 is a perspective view of an exemplary assembly of the mechanical esophageal displacement system of FIG. 1 in accordance with the present disclosure. [Diagram 3] FIG. 3 is an enlarged perspective view of a portion of the assembly of FIG. 2. [Figure 4] FIG. 2 is a cross-sectional view of the assembly of FIG. 1. [Diagram 5] FIG. 2 is a cross-sectional view of the mechanical esophageal displacement system of FIG. 1. [Figure 6] FIG. 2 is an enlarged view of a portion of the mechanical esophageal displacement system of FIG. 1. [Figure 7] FIG. 2 is a perspective view of a portion of the mechanical esophageal displacement system of FIG. [Figure 8] FIG. 2 is a perspective view of a portion of the mechanical esophageal displacement system of FIG. [Figure 9] 2 is a perspective view of an exemplary esophageal positioning device of the mechanical esophageal displacement system of FIG. 1. [Figure 10] 10 is a perspective close-up view of a portion of the esophageal positioning device of FIG. [Figure 11] FIG. 11 is a side view of a portion of the esophageal positioning device of FIG. [Figure 12] FIG. 11 is a top view of a portion of the esophageal positioning device of FIG. [Figure 13] FIG. 2 is an exemplary diagram of the mechanical esophageal displacement system of FIG. 1, showing the mechanical esophageal displacement system being advanced down the patient's esophagus. [Figure 14] 2 is an exemplary diagram of the proximal band stack assembly of the mechanical esophageal displacement system of FIG. 1 showing a force being applied to the proximal band stack assembly in the direction of the esophageal passage, in accordance with the present disclosure. [Figure 15] 2 is another exemplary view of the proximal band stack assembly of the mechanical esophageal displacement system of FIG. 1, illustrating a force being applied in a direction perpendicular to the direction of the esophageal passage, in accordance with the present disclosure. [Figure 16]2 illustrates a top view of a portion of the mechanical esophageal displacement system of FIG. 1 showing the esophageal positioning device positioned in a first angular orientation. [Figure 17] FIG. 17 is a top close-up view of a portion of the esophageal positioning device of FIG. [Figure 18] 2 illustrates a top view of a portion of the mechanical esophageal displacement system of FIG. 1, showing the esophageal positioning device positioned in a linear orientation. [Figure 19] 2 illustrates a top view of a portion of the mechanical esophageal displacement system of FIG. 1 showing the esophageal positioning device positioned in a second angular orientation. [Figure 20] FIG. 20 is a top close-up view of a portion of the esophageal positioning device of FIG. [Figure 21] 2 is a top view of a portion of the esophageal positioning device of the mechanical esophageal displacement system of FIG. 1 in accordance with the present disclosure. [Figure 22] FIG. 2 is a perspective view of a handle of the mechanical esophageal displacement system of FIG. 1. [Diagram 23] FIG. 2 is a perspective view of the internal components of the handle of the mechanical esophageal displacement system of FIG. [Figure 24] FIG. 24 is a side cross-sectional view of the internal components of the handle of FIG. 23. [Diagram 25] 2 is a cross-sectional view of another exemplary assembly of the mechanical esophageal displacement system of FIG. 1. [Figure 26] FIG. 13 is a top view of another exemplary mechanical esophageal displacement system in accordance with the present disclosure. [Figure 27] FIG. 27 is a perspective close-up view of the exemplary mechanical esophageal displacement system of FIG. 26. [Figure 28] FIG. 27 is a top close-up view of the exemplary mechanical esophageal displacement system of FIG. 26. [Figure 29] FIG. 1 is a perspective view of another exemplary mechanical esophageal displacement system in accordance with the present disclosure; [Diagram 30] FIG. 30 is a perspective view of an exemplary assembly of the mechanical esophageal displacement system of FIG. 29. [Diagram 31] FIG. 30 is a perceptive, cross sectional view of a portion of the mechanical esophageal displacement system of FIG. 29. [Diagram 32] FIG. 30 is a front view of a portion of the mechanical esophageal displacement system of FIG. [Diagram 33] FIG. 1 is a perceptive view of another exemplary mechanical esophageal displacement system in accordance with the present disclosure. [Diagram 34] FIG. 13 is a perspective cross-sectional view of another exemplary mechanical esophageal displacement system in accordance with the present disclosure. [Diagram 35] FIG. 2 is a perspective view of another exemplary assembly according to the present disclosure. [Diagram 36] FIG. 1 is a perspective view of another exemplary mechanical esophageal displacement system in accordance with the present disclosure; [Figure 37] FIG. 1 is a perspective view of another exemplary mechanical esophageal displacement system in accordance with the present disclosure; [Figure 38] FIG. 1 is a perspective view of another exemplary mechanical esophageal displacement system in accordance with the present disclosure; [Figure 39] FIG. 2 is a perspective view of another exemplary assembly according to the present disclosure. [Diagram 40] FIG. 1 is a perspective view of another exemplary mechanical esophageal displacement system in accordance with the present disclosure; [Diagram 41] FIG. 1 is a perspective view of another exemplary mechanical esophageal displacement system in accordance with the present disclosure; [Diagram 42] FIG. 2 is a perspective view of another exemplary assembly according to the present disclosure. [Diagram 43] FIG. 2 is a perspective view of another exemplary assembly according to the present disclosure. [Diagram 44] FIG. 13 is a side view of a mechanical esophageal displacement system according to another implementation. [Diagram 45] FIG. 13 is a side view of a mechanical esophageal displacement system according to another implementation. [Figure 46] FIG. 13 is a side view of a mechanical esophageal displacement system according to another implementation. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0043] The following are some exemplary descriptions of the subject matter of Applicant's invention. Certain terminology is used herein for convenience only and should not be construed as limiting the invention. In the drawings, the same reference numbers are used to designate the same elements throughout the several views. Although several examples are provided, it is understood that various modifications may nevertheless 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 content clearly dictates otherwise. As used herein, the term "comprising" and variations thereof are used synonymously with the term "including" and variations thereof and are open-ended, non-limiting terms. Although the terms "comprising" and "including" are used herein to describe various embodiments, to present more specific embodiments of the present invention, the terms "consisting essentially of" and "consisting of" can be used in place of "comprising" and "including" and are also disclosed.

[0044] 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, but rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements.

[0045] 1-25 show an example of a mechanical esophageal displacement system 1 according to the present disclosure for mechanically displacing the esophagus during a medical procedure via vacuum suction fitting of a segment of the esophagus. As shown in FIGS. 1 and 5, the exemplary mechanical esophageal displacement system 1 includes an assembly 5 and an esophageal positioning device 13, where 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, where the assembly 5 includes one or more disposable pieces that can be removed and / or replaced after the 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] 2-5, 13, and 25 show an example of an assembly 5 that is disposable in accordance with the present disclosure. The exemplary assembly 5 includes an introducer 2 that is sized to receive an esophageal positioning device 13. The esophageal positioning device 13 may be a reusable component of the system 1, with the esophageal positioning device being inserted into the lumen of the introducer 2 after it has been 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 single piece assembly 5 may be designed to be disposable or sterilized for repeated use. The patient 37 may be a human or other animal.

[0047] 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 to pass through the mouth or nasal cavity into the esophagus. 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 outer tube body 140 includes a perforated outer surface 150 that spans the entire length of the outer tube and one or more internal vacuum passages 21 (see FIGS. 4 and 25) that extend a distance within the body 140 of the outer tube 125 from the proximal end 135 toward the distal end 130. In some embodiments, the perforated outer surface 150 includes a plurality of vacuum holes 3 that are circumferentially spaced around the soft outer tube 125 and extend radially therefrom, as seen in FIGS. 1-3. The multiple vacuum holes 3 are circumferentially spaced around the flexible outer tube 125 so that the multiple vacuum holes 3 are located on multiple sides of the tube 125 and can suction the esophagus from multiple directions. One or more internal vacuum passages 21 are in fluid communication with the multiple vacuum holes 3 for applying vacuum to the esophageal wall via a vacuum system. The outer tube 125, or portions thereof, can be made from a soft polymer such as, for example, polyvinyl chloride (PVC) or silicone. The outer tube 125 is flexible enough not to add unnecessary stiffness to the system 1 that the esophageal positioning device 13 may need to overcome, but not too flexible that the outer tube 125 creases during insertion of the introducer 2 into the esophagus. In some embodiments, the outer tube 125 includes a lubricious material coating (e.g., hydroglide) to facilitate introduction into the esophagus and minimize trauma to the esophagus.

[0048] While the outer tube 125 can be made from a single material, in some embodiments, the multi-durometer outer tube 125 is made from two or more materials to achieve the desired stiffness 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 material, while the portion between the distal end 130 and the proximal end 135, which includes the multiple radial vacuum holes 3, is made from a softer material. The harder distal end 130 makes it easier to introduce the soft outer tube 125 into the esophagus. The softer material of the portion including the multiple radial vacuum holes 3 allows this portion of the soft outer tube 125 to collapse, and the diameter of the soft outer tube 125 becomes smaller, enhancing the collapse of the esophagus. This consequently moves the esophagus further away from the heart, providing a better circumferential fit of the esophagus to the soft outer tube 125.

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

[0050] As discussed above, the esophageal segment may be fitted to the introducer 2 via vacuum suction. To that end, the perforated outer surface 150 of the introducer 2 may include multiple radial vacuum holes 3 that may be positioned at various locations around the outer surface 150. In some embodiments, the multiple or radial vacuum holes 3 are positioned along the outer surface 150 starting approximately 3-5 inches from the tube tip 4 and extend a length of approximately 2 inches from the starting location. The multiple holes 3 are designed to be in fluid communication with one or more internal vacuum passages 21 such that when a vacuum is coupled to the assembly 5 and activated, the vacuum system can generate a vacuum between the esophageal wall and the outer tube 125. The fluid communication may be direct or indirect. In some embodiments, the one or more internal vacuum passages 21 extend toward, but do not extend to, the distal end 130. For example, in some embodiments, the one or more internal vacuum passages 21 extend to, but do not extend beyond, the location of the most distal radial vacuum hole 3. In some embodiments, the one or more internal vacuum passages 21 extend the entire length of the body 140. In some embodiments, the one or more internal vacuum passages 21 include one or more cylindrical rings that each or together define a cavity axially aligned with the lumen 137 (not shown). In some embodiments, the body 140 does not include one or more internal vacuum passages 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 capable of providing sufficient suction to seal a portion of the outer tube 125 to a portion of the esophageal wall may 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 Figures 1-3, 5, and 13, the introducer 2 can include a tube tip 4 located at the distal end 130 of the outer tube 125. In some embodiments, the tube tip 4 includes a hard polymer tip having a soft circular profile, the tip is bonded to the distal end 130 of the outer tube 125, and the tube tip 4 is a closed structure. Because the tube tip 4 is designed to be in direct contact with the esophageal passageway, the tube tip 4 is shaped so as not to harm the esophagus. The tube tip 4 can include, for example, a half-dome shape. In some embodiments, the tube tip 4 is a closed structure and is not a lumen.

[0052] As shown in Figures 1, 2, 5, 13, the assembly 5 can further include a vacuum port 155 including a vacuum port body 6 and a vacuum port cap 7. In some embodiments, the vacuum port cap 7 is a hard polymer cap coupled to the vacuum port body 6. The vacuum port cap 7 can further include a snap mechanism feature and a quick release hinge mechanism (not shown) for connecting and disconnecting 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-up 170 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 can further include a vacuum port valve and a lever (not shown), which can control the vacuum system.

[0053] In some embodiments, the introducer 2 further includes a plurality of radiopaque markers (not shown) located proximal to a location 180 where the pivot pin 16 would be within the introducer 2. In some embodiments, the plurality of radiopaque markers extend distally along or within the outer tube 125 of the introducer 2 from the location 180 approximately where the pivot pin 16 would be to the location of the tube tip 4. In some embodiments, the plurality of radiopaque markers extend a distance of about 4-6 centimeters from the tube tip 4. In some embodiments, the radiopaque markers are present throughout the entire 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 approximately 4 centimeters upon articulation. In some embodiments, the second segment 115 is 4-6 centimeters long. As shown in Figures 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, with the distal band assembly 12 housing a plurality of distal bands 185. As shown in Figures 7-8, the distal band guard 8 holds the distal band assembly 12 at its distal end 190 by a pin 9 that passes 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 hard polymer. The distal bands 185 may be made of, for example, spring steel. The distal pivot retainer 14 may be made of, for example, 300 or 400 series stainless steel or 17-4 stainless steel. The distal bands 185 may be assembled to the distal pivot retainer 14 by welding, using pins, or gluing. Because the bands 185 are free to flex at the distal end 190, the distal bands 185 may be rigidly attached to the distal pivot retainer 14.

[0055] As shown in Figures 7-8, in some embodiments, all but one of the distal bands 185 have a slot 195 at the distal end to prevent interference with the pin when the band is flexing. One distal band 10, either the top or outer band, includes a hole 200 rather than a slot 195, which limits the band 10 from sliding when the distal bands 185 are flexing. The hole 200 further assists in locating the 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 soft tube 125 during insertion.

[0056] As shown in FIGS. 10-24 , in some embodiments, the first segment 110 includes a proximal pivot retainer 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 retainer 15 houses the proximal stack band assembly 19. The proximal bands 210 may be rigidly attached to the proximal pivot retainer 15, as the proximal bands 210 are free to flex at their proximal ends 215 within the handle 105. In some embodiments, the proximal pivot retainer 15 limits the distal pivot retainer 14 from articulating beyond a selected angle on either side, for example 45 degrees, to prevent risk of damage to the esophagus from excessive translation.

[0057] 14-15, the proximal band stack assembly 19 can provide stiffness in a direction perpendicular to the direction of the esophageal passage 220 (FIG. 15) while maintaining flexibility in the direction of the esophageal passage 225. Flexibility can be maintained through the use of thin bands (FIG. 14) that are stacked one and the other to form a thick think body (FIG. 15) in the direction of the normal force provided by the esophagus.

[0058] Like the distal band assembly 12, the proximal band stack assembly 19 may be made from a variety of suitable materials including, for example, 300 or 400 series stainless steel or a hard polymer. The plurality of proximal bands 210 may be made from, for example, spring steel. The articulation pivot pin 16 may 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 allows them to pivot. 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.

[0059] As shown in Figures 10-12 and 17-20, in some embodiments, the mechanical esophageal displacement system 1 further includes an articulation drive cable 18. This cable 18 can transmit user 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 in which the distal band assembly 12 and the proximal band assembly 19 are parallel to one another. In some embodiments, the mechanical esophageal displacement system 1 includes a feedback mechanism that measures and displays the distance the device has been articulated from its neutral position. In some embodiments, the cable 18 is approximately 0.024 inches in diameter and is made from braided stainless steel or polymers such as UHMWPE, liquid crystal polymer, or other high strength braided or monofilament polymers. In some embodiments, the mechanical esophageal displacement system 1 further includes an articulation cable crimp 17. As shown in Figures 16-20, the cable crimp 17 can be a small ball that is crimped and friction fitted onto the stainless steel braided cable 18. This crimp 17 provides a mechanism on the cable 18 that can interlock with the distal pivot retainer 14 when pulled left or right to articulate the system 1. A ball may be crimped and friction fitted onto the articulation cable 18 to provide an interlocking surface. In some embodiments, the articulation drive cable 18 is coupled to the distal pivot retainer 14 by welding in addition to or as an alternative to 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 14, such as 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 cables 18 from the handle 105 to the articulation pivot pin 16, the plurality of proximal band cable guides 20 being evenly spaced along the plurality of proximal bands 210. The proximal band cable guides 20 may be welded or bonded to one or more of the proximal bands 210 to keep the proximal bands 210 aligned while still allowing the bands 210 to slide and translate independently when flexed. The proximal band cable guides 20 help guide the articulation drive cables 18 down the length of the esophageal positioning device 13. The proximal band cable guides 20 provide additional stiffness and structure to the proximal band stack assembly 19 while still allowing the stack band assembly 19 to flex.

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

[0062] 22, the handle 105 of the esophageal positioning device 13 may include one or more snap hooks 26 located on the articulating handle case half 22 and / or on the locking handle case half 23. The snap hooks 26 may 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 can include, for example, upper handle band retainer 27, lower handle band retainer 28, pulley gear 29, cable pulley 30, input gear 31, proximal band handle retainer pin 32, locking cone clutch 33, articulation input shaft 34, articulation input shaft bushing 35, and articulation pulley shaft bushing 36.

[0064] In some embodiments, the upper and lower handle band retainers 27, 28 receive the proximal ends 215 of the multiple proximal bands 185 via a pin, hole, and slot feature in the proximal band 185, allowing the bands 185 to translate while flexing. The upper and lower retainers 27, 28 may be made from a polymer or aluminum, for example. The upper and lower retainers 27, 28 may be held in place by ribs 230 found on the articulating handle case half 22 and the locking handle case half 23.

[0065] In some embodiments, pulley gear 29 comprises a large gear that is attached to cable pulley 30 via two pins. In some embodiments, pulley gear 29 is concentric with lock control knob 24 and pulley shaft 235. In some embodiments, pulley gear 29 is approximately 2-3 times larger in diameter than the diameter of input gear 31.

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

[0067] In some embodiments, the input gear 31 is a small gear that is 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 a user of the system 1 when articulating the esophageal positioning device 13. The input torque may be reduced, for example, by a factor of 2-3, based on a given ratio of the input gear 31 to the pulley gear 29. Thus, in some embodiments, the operator need not apply or is limited to applying more than 80 ounces per inch of torque to control the knobs 24, 25. For example, in some embodiments, a fail-safe mechanism may be used such that the articulation control knob 25 will lock out if the operator applies a preset torque (e.g., more than 80 ounces per inch) to the articulation control knob 25. Thus, locking out the knob 25 may help avoid injury to the operator.

[0068] In some embodiments, the proximal band handle retainer pins 32 interface with the proximal band stack assembly 19 and the upper and lower handle band retainers 27, 28 to hold the proximal band 185 in place. The proximal band handle retainer pins 32 align the portions of the upper and lower handle band retainers 27, 28 when they are assembled together. The retaining pins 32 align with slots in the proximal bands 185 except for one, which allows the bands 185 to slide relative to each other during flexion.

[0069] In some embodiments, the lock cone clutch 33 may be attached to the lock control knob 24 via threads 260 and interference ribs 265. The lock cone clutch 33 may include threads on its outer diameter that interlock with threads on the lock handle case halves 23. When the lock knob 24 is twisted, such as clockwise, the lock cone clutch 33 moves inward and interferes with the cone shaft on the cable pulley 30, which effectively slows or locks the cable pulley 30 in its current position.

[0070] In some embodiments, the articulation input shaft 34 has a flat surface, e.g., D-shaped. The flat surface allows for engagement with the input gear 31 via a set screw. The input shaft 34 may be, for example, approximately 0.25 inches in diameter. In some embodiments, the articulation input shaft bushing 35 allows the articulation input shaft 34 to rotate freely. Similarly, in some embodiments, the articulation pulley shaft bushing 36 allows the articulation pulley shaft 34 to rotate freely. The articulation input shaft bushing 35 and the articulation pulley shaft bushing 36 further help maintain proper alignment of the handle 105 components.

[0071] In some embodiments, the esophageal positioning device 13 includes a clutch and / or force gauge system to limit 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 multiple sensors (e.g., thermistors and / or temperature sensors) along the device to allow for 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, which 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 on a real-time imaging display (e.g., MRI, ultrasound (intracardiac, transesophageal, or transthoracic) imaging, or CT imaging), thus achieving three-dimensional imaging of the anatomy and the device. In some embodiments, the introducer 2 or esophageal positioning device 13 includes a port for receiving a gastrografine injection or other substance used to contour and visualize the esophagus with x-ray. In some embodiments, a ratchet articulation control is provided such that one click of the ratchet articulation control knob in a counterclockwise direction can cause 15 degrees of articulation to the left or 1.5 cm of translation to the left, depending on which is preferred 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, ultrasound imaging (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 can be used, for example, to visualize and measure through the esophagus to view intracardiac objects such as catheters, transseptal techniques / devices, evaluation of intracardiac thrombi, evaluation of intracardiac defects such as atrial septal defects, visualize / measure pulmonary vein devices, visualize / measure mapping devices (e.g., multi-electrode baskets), visualize / measure left atrial appendages and left atrial appendage closure devices, visualize / measure devices placed within the pericardium, and other cardiac related products.

[0073] In some embodiments, the band stacks 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 width of the distal or proximal bands 185, 210 can be shaped to maximize stiffness depending on 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 such that the profile of the bands 185, 210 assumes 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 or cable band guide 20 of the introducer 2. Additionally, cutting the bands of the proximal assembly 19 (or distal assembly 12) at different widths can increase the stiffness of the system 1 because the amount of material in contact with the inner surface of the outer tube or cable band guide 20 is increased.

[0074] While many materials are disclosed for the various components of assembly 5, in some embodiments, all components of assembly 5 are made from non-ferrous materials to enable use with advanced mapping systems or in MRI procedure rooms.

[0075] Also provided is a method of using the mechanical esophageal displacement system 1. An exemplary method includes inserting an assembly 5 into the esophagus of a patient 37 through the mouth or nasal cavity (FIG. 13). The assembly 5 includes an introducer 2 having a soft outer tube 125, a vacuum port 155, and a tube tip 4. The soft outer tube 125 is sized to enter the esophagus through the patient's mouth or nasal cavity, and 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 within the body 140 of the outer tube 125 from the proximal end 135 toward the distal end 130. In some embodiments, the perforated outer surface 150 includes a plurality of vacuum holes 3 spaced circumferentially around the flexible outer tube 125 and extending radially therefrom, as seen in FIGS. 1-3. The plurality of vacuum holes 3 are spaced circumferentially around the flexible outer tube 125 such that the plurality of vacuum holes 3 are located on multiple sides of the tube 125 and can suction the esophagus from multiple directions. One or more internal vacuum passages 21 are in fluid communication with the plurality of vacuum holes 3 for applying 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 hook-up 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 an esophageal positioning device 13 through the outer tube of the introducer 2, the esophageal positioning device 13 including 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 120 is coupled to the handle 105. The second segment 115 is pivotally connected to the first segment 110 via the articulation pivot pin 16. The articulation drive mechanism 120 is configured to pivot the second segment 115 about the first segment 110 upon articulation.

[0077] The exemplary method further includes snapping the handle 105 of the esophageal positioning device 13 into the vacuum port cap 7 of the introducer 2, engaging the vacuum system to seal a portion of the outer tube 125 against the esophageal wall, and articulating the articulation drive mechanism 120 to pivot the second segment 115 to a selected angle about the first segment 110, for example, about a 45 degree angle.

[0078] FIG 26 illustrates 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 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 approximately 4 centimeters, e.g., 3.992 centimeters.

[0079] Figure 27 is a perspective close-up view of the exemplary mechanical esophageal displacement system of Figure 26, highlighting an articulation pin operatively coupled to the coil to articulate the segments of the esophageal positioner about the pin. Figure 28 is a top close-up view of the exemplary mechanical esophageal displacement system of Figure 26, highlighting exemplary dimensions.

[0080]

[0023] Figure 29 is a perspective view of another exemplary mechanical esophageal displacement system according to the present disclosure. Similar to the embodiment shown in Figure 1 above, the exemplary mechanical esophageal displacement system of Figure 29 includes pulleys and cables for articulating corresponding segments of an esophageal positioning device.

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

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

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

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

[0085] 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 an assembly.

[0086] Fig. 35 is a perspective view of another exemplary assembly according to the present disclosure, which includes a tube 825 having a collapsible portion 810 that can be actuated by a guidewire and / or 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 FIGURE 36 includes an esophageal displacement device that provides articulation via shafts 910, 912, right-hand threaded rod 914, and left-hand threaded rod 916, which are axially coupled together. When a cable 920 connected to the left-hand threaded rod is rotated, threaded openings 922, 924 in the shafts 910, 912 move the threaded rods 914, 916 up and down, respectively, tilting an articulation plate 918 hinged to the opposite ends of the shafts 910, 912.

[0088] 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 drive 1010 that provides articulation via a worm gear 1012.

[0089] 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 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 which the assembly includes an outer tube 1210, similar to outer tube 125, made from a material that deforms into a particular 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 meet via a pair of axial ridges 1314, 1316, respectively, which 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 with angled surfaces 1414, 1416, respectively, such that the angle between the two pieces 1410, 1412 changes from aligned to a right angle upon 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-like tube 1510 having a flexible portion 1512 on only one side 1514, so that when a vacuum is applied, it deflects one side 1514 of the assembly.

[0094] 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 biases the assembly in a given direction.

[0095] 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 FIG. 44 is similar to the assembly of the embodiment shown in FIGS. 1-43. As such, similar reference numbers used in the assemblies shown in FIGS. 1-43 are used to indicate similar features included in the assembly 1705 shown in FIG. 44. The esophageal positioning device 13 of the assembly 1705 is the same as the esophageal positioning device 13 shown in FIGS. 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 shaft 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 the 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 greater.

[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 a 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 Figures 1-43, the first segment 110 of the esophageal positioning device 13 shown in Figure 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, in which distal ends 190 of the bands 185 are slidable relative to one another along a central axis 121.

[0099] The introducer 1702 includes a soft outer tube 125 sized to pass through the mouth or nasal passageway and into the esophagus. 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 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 one another along the outer tube 125 such that a wire, cable, or tube may be disposed within each of the eyelet openings 147. The eyelets 143 couple the wire, cable, or tube to the outer tube 125 to provide communication with devices disposed in the assembly.

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

[0101] 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 between 25 mm and 30 mm. In some implementations, the length of the gap portion of the outer tube measured along the longitudinal axis is between 10 mm and 30 mm.

[0102] The body 140 defines a plurality of radial vacuum holes 3 circumferentially spaced about the longitudinal axis 141. The plurality of radial vacuum 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 a plurality of radial vacuum holes 3. The radial vacuum holes 3 of the body 140 of the outer tube 125 shown in FIG. 44 are arranged in eight rings of eight circumferentially spaced vacuum holes 3. However, in other implementations, the rings of circumferentially spaced vacuum holes include any number of circumferentially spaced vacuum holes. In some implementations, the rings of circumferentially spaced vacuum holes include any number of circumferentially spaced vacuum holes. In some implementations, different rings of circumferentially spaced vacuum holes include different numbers of circumferentially spaced vacuum holes. In some implementations, the plurality of vacuum holes are not arranged in a ring, but are arranged in any pattern.

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

[0104] In 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 esophageal positioning device 13 are advanced to a desired location in the esophagus, contrast fluid is introduced through the introducer 1702 such that the contrast fluid flows through the vacuum port 3. The contrast fluid can be detected by x-ray or fluoroscopy to determine the location of the esophageal assembly 1705. Once the introducer 1702 and esophageal positioning device 13 are in the desired location in the patient's esophagus, the vacuum system is engaged. The vacuum system creates a suction at the vacuum port 3 of the introducer 1702, sealing a portion of the outer tube 125 against the esophageal wall. The second segment 115 of the esophageal positioning device 13 is then articulated about the first segment 110 from the initial position to the second position such that a portion of the esophagus is displaced a desired distance. Because the esophageal wall is in apposition to the introducer 1702, the entire esophagus can be moved.

[0105] The spacing and location of the vacuum holes 3 defined by the introducer 1702 increases the ability of the vacuum holes 3 to adhere to and suck in the esophageal wall. Because the suction holes 3 are spaced circumferentially around the introducer 1702, the vacuum holes 3 can adhere to the entire circumferential area of ​​a portion of the esophageal wall. This draws the esophageal wall in and sucks it in against the introducer 1702, ensuring that all of the esophagus is displaced upon articulation of the second segment 115 without dragging the loose tail end of the esophagus behind it.

[0106] During articulation of the second segment 115, the distal end 119 of the second segment 115 is the portion of the esophageal positioning device 13 that displaces the furthest and receives the greatest amount of torque. Therefore, it is important that the esophagus is tightly fitted to the introducer 1702 adjacent the distal end 119 of the second segment 115 to provide an optimal grip. The gap portion 131 of the introducer 1702 shown in FIG. 44 is configured 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 suction causes the introducer 1702 to collapse. The portions of the introducer 1702 that include the esophageal positioning device 13 are limited in how much they can collapse by the size of the bands of the esophageal positioning device 13. However, the gap portion 131 can collapse radially further than the portions of the introducer 1702 that include the esophageal positioning device 13. Because the gap portion 131 defines the highest density of vacuum holes 3, the esophageal wall can be drawn more tightly into a smaller area by the vacuum holes 3 defined by the gap portion 131 of the introducer 1702. The collapse of the gap portion 131 of the introducer 1702, and the high density of vacuum holes 3 defined by the gap portion 131 of the introducer 1702, ensures that the esophagus is tightly sealed against the end of the introducer 1702.

[0107] The higher density of vacuum holes 3 defined by the gap portion 131 also allows 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 portion of the esophagus proximate the gap portion 131 allows the end of the introducer 1702 where the gap portion 131 is located to be more easily detected.

[0108] FIG. 45 illustrates another implementation of an assembly 1805 including an introducer 1802. The assembly illustrated in FIG. 45 is similar to the assembly 1705 of the embodiment illustrated in FIG. 44. Accordingly, reference numbers similar to those used for the assembly 1705 illustrated in FIG. 44 are used to indicate similar features included in the assembly 1805 illustrated in FIG. 45. The gap portion 131 of the introducer 1802 illustrated in FIG. 45 defines the highest density of radial vacuum holes 3 adjacent 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 a direction from the distal end 130 of the outer tube 125 toward the proximal end 135 of the outer tube 125.

[0109] FIG. 46 illustrates another implementation of an assembly 1905 that includes an introducer 1902. The assembly 1905 illustrated in FIG. 46 is similar to the assemblies 1705, 1805 of the embodiment illustrated in FIGS. 44-45. Accordingly, similar reference numbers to those used for the assemblies 1705, 1805 illustrated in FIGS. 44-45 are used to indicate similar features included in the assembly 1905 illustrated in FIG. 46. However, the introducer 1902 illustrated in FIG. 46 includes two occlusion balloons 149, 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 positioned adjacent a 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 within the introducer 1902. The distal balloon 149 is positioned adjacent a distal end of the end portion 133 of the outer tube 125. Thus, all of 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 spaced from the first end 153 of the inflation tube 151 on an opposite side 157, 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 coupled to the second end 157 of one of the inflation tubes 151. The body 159 of each of the inflation tubes 151 extends through an eyelet opening 147 in an eyelet 143 of the outer tube 125 such that the body 159 of the inflation tube 151 is coupled to the body 140 of the outer tube 125. The inflation tubes 151 extend along the outer tube 125 such that the first end 153 of the inflation tube 151 is adjacent the proximal end 135 of the outer tube 125. First ends 153 of inflation tubes 151 are each connected to a pump (not shown) for inflating occlusion balloons 149. The pump may be a manual pump or an automatic pump.

[0111] Once the introducer 1702 and esophageal positioning device 13 are positioned in the patient's esophagus, the pump is activated causing air to flow from the pump through the inflation tube 151 and into the occlusion balloon 149. The occlusion balloon 149 is inflated so that the outer surface of the occlusion balloon 149 abuts the inner wall of the esophagus forming a seal. Because all of the vacuum holes 3 are defined by the end portions 133 of the outer tube 125 between the proximal and distal balloons 149, the only portion of the esophagus that is introduced to be suctioned by the vacuum holes 3 is the portion occluded by the occlusion balloon 149.

[0112] It should be noted that while some of the means for biasing the assembly have been described above, the assembly may also be articulated using any other means known in the art including, for example, springs, fluid / air filled containers, magnets, etc.

[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 in the following claims and all equivalents thereof. Furthermore, it is recognized that many embodiments may be conceived that do not achieve all of the advantages of some embodiments, but the absence of a particular advantage should not necessarily be interpreted as meaning that such an embodiment is outside the scope of the present invention.

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

Claims

1. 1. An assembly for use with a vacuum system and an esophageal positioning device, the esophageal positioning device including a first segment and a second segment, the first segment having a central axis, the second segment having a proximal end pivotally connected to the first segment and a distal end opposite and spaced apart from the proximal end, the second segment pivotable about the first segment between a first position and a second position upon articulation, the distal end of the second segment disposed along the central axis at the first position and the distal end of the second segment displaced from the central axis at the second position, the assembly comprising: an introducer sized to receive the esophageal positioning device, a soft outer tube sized to pass through the mouth or nasal cavity and into the esophagus, the soft outer tube including a longitudinal axis, a distal end, a proximal end, and a body, the body defining a plurality of radial vacuum holes spaced circumferentially about the longitudinal axis, the plurality of radial vacuum holes in fluid communication with the vacuum system to apply a vacuum to an esophageal wall; a tube tip located at the distal end of the outer tube; The introducer comprises an outer tube gap portion is defined along the longitudinal axis between the tube tip 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; an assembly wherein the distal end of the second segment remains the same distance from the proximal end of the second segment in the first position and in the second position.

2. The assembly of claim 1 , wherein the gap portion defines a higher density of radial vacuum holes than any other portion of the body of the introducer.

3. 2. The assembly of claim 1, wherein a density of radial vacuum holes is highest adjacent the distal end of the outer tube and wherein a density of radial vacuum holes gradually decreases in a direction along the longitudinal axis from the distal end of the outer tube toward the proximal end of the outer tube.

4. the body of the outer tube has an end portion measured along the longitudinal axis from the tube tip to a 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; The assembly of claim 1 , wherein only the end portion of the body of the outer tube defines the plurality of radial vacuum holes.

5. The assembly of claim 1, wherein the length of the gap portion of the outer tube measured along the longitudinal axis is between 10 mm and 30 mm.

6. 6. The assembly of claim 5, wherein the length of the gap portion of the outer tube measured along the longitudinal axis is 28 mm.

7. The assembly of claim 5 , wherein the second segment has a length of 40 mm or more.

8. the introducer further comprises one or more eyelets extending radially outward from the outer tube; The assembly of claim 1 , wherein each of the one or more eyelets defines an eyelet opening, the eyelet openings of each of the one or more eyelets being axially aligned with one another along the outer tube.

9. The assembly of claim 1 , wherein the introducer further comprises one or more occlusion balloons extending radially outward from the outer tube, the one or more occlusion balloons being inflatable.

10. 10. The assembly of claim 9, wherein the one or more occlusion balloons include a first occlusion balloon and a second occlusion balloon, the first occlusion balloon disposed at the distal end of the outer tube and the second occlusion balloon disposed in a portion of the outer tube adjacent a pivot connection between the first and second segments of the esophageal positioning device when the esophageal positioning device is disposed within the introducer.

11. 1. A mechanical esophageal displacement system, comprising: an assembly operably connected to a vacuum system; The assembly comprises: an introducer sized to receive an esophageal positioning device, a soft outer tube sized to pass through the mouth or nasal cavity and into the esophagus, the soft outer tube including a longitudinal axis, a distal end, a proximal end, and a body, the body defining a plurality of radial vacuum holes spaced circumferentially about the longitudinal axis, the plurality of radial vacuum holes in fluid communication with the vacuum system to apply a vacuum to an esophageal wall; a tube tip located at the distal end of the outer tube; The introducer comprising: the esophageal positioning device; Including, The esophageal positioning device comprises: A first segment; a second segment having a central axis, a proximal end pivotally connected to the first segment, and a distal end opposite and spaced apart from the proximal end, the second segment pivotable about the first segment between a first position and a second position upon articulation; Including, an outer tube gap portion is defined along the longitudinal axis between the tube tip 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 housing a plurality of distal bands, the distal end of each distal band being slidable relative to one another along the central axis.

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

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

14. the body of the outer tube has an end measured along the longitudinal axis from the tube tip to a pivot connection between the first and second segments of the esophageal positioning device when the esophageal positioning device is disposed within the introducer; The mechanical esophageal displacement system of claim 11 , wherein only the end of the body of the outer tube defines the plurality of radial vacuum holes.

15. 12. The mechanical esophageal displacement system of claim 11, wherein a length of the gap portion of the outer tube measured along the longitudinal axis is between 10 mm and 30 mm.

16. 16. The mechanical esophageal displacement system of claim 15, wherein the length of the gap portion of the outer tube measured along the longitudinal axis is 28 mm.

17. 16. The mechanical esophageal displacement system of claim 15, wherein the second segment has a length of 40 mm or more.

18. the introducer further comprises one or more eyelets extending radially outward from the outer tube; 12. The mechanical esophageal displacement system of claim 11, wherein each of the one or more eyelets defines an eyelet opening, the eyelet openings of each of the one or more eyelets being axially aligned with one another along the outer tube.

19. 12. The mechanical esophageal displacement system of claim 11, wherein the introducer further comprises one or more occlusion balloons extending radially outward from the outer tube, the one or more occlusion balloons being inflatable.

20. 20. The mechanical esophageal displacement system of claim 19, wherein the one or more occlusion balloons include a first occlusion balloon and a second occlusion balloon, the first occlusion balloon disposed at the distal end of the outer tube and the second occlusion balloon disposed in a portion of the outer tube adjacent a pivot connection between the first and second segments of the esophageal positioning device when the esophageal positioning device is disposed within the introducer.

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