A device for in situ inflatable vacuum-assisted fistula-therapy

The device of any of the preceding claims, wherein said at least one expandable unit is configured to be inserted into the fistula while the inflatable balloon is in a deflated state, such that no shear force is applied on an endoluminal surface of the fistula.

The device of any of the preceding claims, wherein the inflatable balloon is configured to expand the outer expandable envelope when at least partially inflated.

The device of claim any of the preceding claims, wherein the inflatable balloon when at least partially inflated is configured to press an outer surface of the outer expendable envelope to contact an endoluminal surface of the fistula.

The device of any of the preceding claims, wherein said at least one vacuum tube is disposed on an outer surface of the inflatable balloon.

The device of any of the preceding claims, wherein said at least one vacuum tube has flexible properties, such that the outer shape of the at least one vacuum tube corresponds to the shape of the outer surface of said inflatable balloon.

The device of any of the preceding claims, further comprising at least one vacuum suction port being configured for connecting between a plurality of vacuum tubes of the same expandable unit.

The device of any of the preceding claims, further comprising at least one connection port being configured for connecting at least one expandable unit to another expandable unit provided in series;

• wherein, when connected, permits fluid communication between consecutive expandable units.

The device of any of the preceding claims, wherein each expandable unit is configured to be in situ at least partially selectively inflated or at least partially selectively deflated independently one to the other.

The device of any of the preceding claims, wherein each expandable unit is configured to be in situ selectively at least partially inflated or deflated to different discrete dimensions to provide an external shape of the device corresponding to internal dimensions of a fistula.

The device of any of the preceding claims, wherein each expandable unit is configured to be sequentially at least partially inflated with respect to another expandable unit being placed proximally to form a distal portion having an adjustable length being configured to be deployed in fistulas of different dimensions.

The device of any of the preceding claims, wherein each expandable unit is configured to be selectively at least partially deflated to provide an external shape of the device corresponding to the internal dimensions of the fistula.

The device of any of the preceding claims, wherein each expandable unit is configured to be sequentially at least partially deflated with respect to the expandable unit being placed distally to allow gradual removal of the device as the fistula heals and shrinks.

The device of any one of the preceding claims, further comprising a control unit being connectable to a pressure source, said control unit being configured and operable to apply vacuum in a constant or variable manner via said at least one vacuum tube to each at least one expandable unit separately.

The device of any of the preceding claims, wherein said inner core further comprises at least one insertion channel being configured and operable for at least one of temporary insertion manipulation or activation of at least one of (i) at least one surgical tool or (ii) an immobilizer being configured and operable to be attached to the fistula.

The device of any one of the preceding claims, wherein said at least one expandable unit has a length in the range of about 10 mm to 100 mm.

The device of any one of the preceding claims, wherein said outer expandable envelope is at least partially coated with at least one material being capable of at least one of accelerating healing or treating an infection.