Systems and methods for mechanical displacement of an esophagus
An example assembly for use with a vacuum system and an esophageal positioning device esophageal positioning device includes an introducer, in which the esophageal positioning device includes a handle, a first segment, a second segment and an articulation driving mechanism. The first segment being coupled to the handle. The second segment being pivotally connected to the first segment. The articulation driving mechanism being configured to pivot the second segment about the first segment upon articulation.
1. An assembly for use with a vacuum system comprising:
a handle;
a first segment coupled to the handle;
a second segment connected to the first segment via an articulation pivot pin, the second segment defining a second segment proximal end coupled to the articulation pivot pin and a second segment distal end, the second segment defining a constant length and shape between the second segment distal end and the second segment proximal end;
an articulation drive cable that pivots the second segment about the first segment; and
an introducer including a soft outer tube sized to pass through a mouth or nasal passage into an esophagus, the soft outer tube defining a plurality of radial vacuum holes configured to apply a vacuum to an esophageal wall via the vacuum system.
2. The assembly of claim 1 , further comprising a tube tip positioned on a distal end of the soft outer tube, the tube tip comprises a hard polymer tip having a soft, circular contour, wherein the tube tip is bonded to the distal end of the soft outer tube.
3. The assembly of claim 1 , wherein the introducer further includes a vacuum port comprising a vacuum port body and a vacuum port cap,
wherein the vacuum port body comprises a vacuum line hook up that is in fluid communication with one or more internal vacuum passages,
wherein the vacuum port body is bonded to both the introducer and the vacuum port cap to create an air tight seal.
4. The assembly of claim 3 , wherein the vacuum port body further includes a vacuum port valve and a lever, wherein the lever controls the vacuum system.
5. The assembly of claim 3 , wherein the vacuum port cap includes a hard polymer cap that is bonded to the vacuum port body to selectively couple the handle to the soft outer tube.
6. The assembly of claim 1 ,
wherein the introducer further comprises a plurality of radiopaque markers positioned adjacent to the articulation pivot pin,
wherein the plurality of radiopaque markers span distally to a tube tip.
7. The assembly of claim 1 , wherein the plurality of radial vacuum holes are positioned adjacent to the second segment.
8. The assembly of claim 1 , wherein the soft outer tube comprises a multi-durometer material such that a stiffness of the soft outer tube varies along a length of the soft outer tube.
9. The assembly of claim 1 , further comprising a feedback mechanism to indicate a degree to which a vacuum seal has been formed between the assembly and the esophageal wall.
10. A mechanical esophageal displacement system comprising:
a outer tube defining a plurality of vacuum holes spaced circumferentially around the outer tube and an internal vacuum passage in fluid communication with the plurality of vacuum holes to apply a vacuum to an esophageal wall;
a tube tip located at a distal end of the outer tube; and
an esophageal positioning device sized to be received within the outer tube, the esophageal positioning device including:
a handle;
a first segment coupled to the handle;
a second segment pivotally connected to the first segment via an articulation pivot pin; and
an articulation drive cable that pivots the second segment about the first segment upon actuation between a first position and a second position,
wherein the first segment has a central axis and the second segment has a distal end,
wherein 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, and
wherein the distal end of the second segment remains a same distance from the articulation pivot pin in the first position and the second position.
11. The mechanical esophageal displacement system of claim 10 , wherein the second segment is sized to displace the esophageal wall by about 4 centimeters upon articulation.
12. The mechanical esophageal displacement system of claim 10 , wherein the tube tip comprises a hard polymer tip having a soft, circular contour, and
wherein the tube tip is bonded to the distal end of the outer tube.
13. The mechanical esophageal displacement system of claim 10 , wherein the outer tube further includes a vacuum port comprising a vacuum port body and a vacuum port cap,
wherein the vacuum port body comprises a vacuum line hook up that is in fluid communication with an internal vacuum passage,
wherein the vacuum port body is bonded to both the outer tube and the vacuum port cap to create an air tight seal.
14. The mechanical esophageal displacement system of claim 13 , wherein the vacuum port body further includes a vacuum port valve and a lever,
wherein the lever is configured to control a vacuum system.
15. The mechanical esophageal displacement system of claim 13 , wherein the vacuum port cap includes a hard polymer cap that is bonded to the vacuum port body to selectively couple a handle of the esophageal positioning device to a proximal end of the outer tube.
16. The mechanical esophageal displacement system of claim 10 ,
wherein the outer tube further includes a plurality of radiopaque markers positioned adjacent the articulation pivot pin, and
wherein the plurality of radiopaque markers span distally to the tube tip.
17. The mechanical esophageal displacement system of claim 10 , wherein at least one of the plurality of vacuum holes is positioned adjacent the second segment.
18. The mechanical esophageal displacement system of claim 10 , wherein the second segment comprises
a distal band laminate assembly,
a distal band guard, and
a distal pivot retainer,
wherein the distal band laminate assembly houses a plurality of distal bands in which all but one of the bands has a slot at a distal end of the plurality of distal bands,
wherein the one band has a hole rather than a slot at the distal end,
wherein the distal band guard retains the distal band laminate assembly by a pin that passes through the plurality of distal bands, and wherein the distal band guard has a rounded tip.
19. The mechanical esophageal displacement system of claim 18 , wherein the first segment comprises
a proximal pivot retainer an articulation drive cable, an
a proximal band laminate assembly comprising a plurality of proximal bands,
wherein the proximal pivot retainer houses the proximal band laminate assembly,
wherein the proximal pivot retainer limits the distal pivot retainer from articulating more than 45 degrees to each side to prevent risk of damage to the esophageal wall due to excessive translation.
20. The mechanical esophageal displacement system of claim 19 ,
wherein the articulation pivot pin connects both the distal pivot retainer and the proximal pivot retainer and allows them to pivot.