JP-2022530554-A5 -

Dates

Publication Date

20230512

Application Date

20200430

Description

Balloon dilation devices can be used to dilate the Eustachian tube. The present invention provides, for example, the following: (Item 1) A balloon expansion device having a distal end and a proximal end, wherein the balloon expansion device is - A handle extending from the proximal end to the distal end of the balloon expansion device, - A shaft extending from the distal end of the balloon expansion device toward the proximal end of the balloon expansion device, wherein the shaft has an expansion lumen, - An inflatable balloon fixedly positioned on the shaft, wherein the balloon is fluidly connected to the expansion lumen, and as a result can be inflated and deflated by supplying fluid into or out of the balloon through the expansion lumen. A balloon expansion device comprising: at least one sensor coil disposed on the shaft, wherein the at least one sensor coil is configured to capture an electromagnetic field and to provide a sensor coil signal representing the position and orientation of the sensor coil. (Item 2) The balloon expansion device according to item 1, wherein the shaft has a malleable tip region extending from the distal end of the balloon expansion device toward the proximal end of the balloon expansion device, and the inflatable balloon is fixedly disposed on the shaft in the malleable tip region. (Item 3) The balloon inflatable device according to item 1 or 2, wherein the at least one sensor is located on the shaft at the distal end of the balloon inflatable device. (Item 4) A balloon expansion device according to at least one of items 1 to 3, comprising a second sensor coil disposed on the shaft, wherein the second sensor coil is displaced a certain distance longitudinally from the at least one sensor coil. (Item 5) The balloon expansion device according to item 4, wherein the shaft has a malleable tip region extending from the distal end of the balloon expansion device toward the proximal end of the balloon expansion device, and the second sensor coil is disposed on the shaft adjacent to the malleable tip region. (Item 6) A balloon inflatable device according to at least one of items 1 to 5, having a central lumen extending from the distal end of the balloon inflatable device toward the proximal end of the balloon inflatable device, wherein the central lumen has a distal opening at the distal end of the balloon inflatable device and a proximal opening at the proximal end of the balloon inflatable device. (Item 7) The balloon expansion device according to item 6, wherein the central lumen has a diameter of 0.5 mm to 1.0 mm, preferably 0.6 mm to 1.0 mm, and more preferably 0.7 mm to 1.0 mm. (Item 8) The balloon expansion device according to item 6 or 7, comprising a marker carrier detachably disposed inside the central lumen and extending along the length of the central lumen, wherein the marker carrier comprises the at least one sensor coil. (Item 9) The balloon expansion device according to at least one of items 1 to 8, wherein the shaft has a length of 80 mm to 220 mm, preferably 90 mm to 180 mm, more preferably 110 mm to 140 mm, for example 130 mm. (Item 10) The balloon expansion device according to at least one of items 2 to 9, wherein the malleable tip region has a length of 10 mm to 60 mm, preferably 20 mm to 50 mm, more preferably 25 mm to 35 mm, for example 30 mm. (Item 11) The balloon expansion device according to at least one of items 2 to 10, wherein in the malleable tip region, the shaft is made of a material having an ultimate tensile strength of up to 720 Nmm² . (Item 12) The balloon expansion device according to at least one of items 1 to 11, wherein the shaft has an outer diameter of 1.2 mm to 1.8 mm, preferably 1.2 mm to 1.6 mm, and more preferably 1.2 mm to 1.4 mm. (Item 13) The balloon inflatable device according to at least one of items 1 to 12, wherein at the distal end of the balloon inflatable device, the shaft has a rounded and smoothed tip. (Item 14) The balloon expansion device according to at least one of items 1 to 13, wherein the balloon has a length of 10 mm to 25 mm, preferably 15 mm to 20 mm, and more preferably 18 mm. (Item 15) A balloon inflation device according to at least one of items 1 to 14, wherein when inflated, the balloon has a maximum diameter of 3 mm to 10 mm, preferably 5 to 8 mm, and more preferably 6 mm. (Item 16) A balloon inflation device according to at least one of items 1 to 15, wherein the balloon is configured to maintain an inflation pressure of up to 12 atmospheres. (Item 17) The balloon expansion device according to at least one of items 1 to 16, wherein the handle comprises a mounting portion for attaching a fluid source to the expansion lumen, and the expansion lumen extends from the mounting portion to a connection point where the balloon is fluidly connected to the expansion lumen. (Item 18) It is a medical system, - A balloon expansion device having an inflatable balloon and at least one sensor coil, - A position detection syst