Devices and methods for insertion and/or pressurization of a balloon catheter for balloon dilation of the eustachian tube and other anatomical passageways accessible through the nostril of a human
Methods and apparatuses for insertion and/or pressurization of a balloon catheter for balloon dilation of anatomical passageways in the head of a person such as the Eustachian tube and Sinus passageways. The insertion devices comprise a balloon catheter guiding tube for receiving and guiding the balloon catheter, and a device body rigidly attached to a proximal end of the balloon catheter guiding tube. The pressurization devices comprise a syringe body with a syringe barrel, a proximal thruster guide section, external hand or finger engagement geometries, a plunger with a distal plunger head and a plunger rod, and a thruster having a proximal end with a finger or hand engagement portion.
1 . A handheld insertion device for balloon dilation of the Eustachian tube or any other anatomic passageway in the head of a person, the device comprising:
a balloon catheter,
a syringe assembly comprising several parts, the several parts comprising a syringe barrel, a sealing element and a plunger rod,
a balloon catheter guiding tube for receiving and guiding the balloon catheter,
a device body rigidly attached to a proximal end of the balloon catheter guiding tube,
the balloon catheter having a distal inflatable part to be advanced out from a distal end of the balloon catheter guiding tube and a proximal part being fluidically connectable to the syringe assembly for inflation and pressurization of the balloon catheter,
wherein the device body comprises guiding means for movement of one or more parts of the syringe assembly towards the balloon catheter guiding tube, and wherein,
the balloon catheter is operably coupled to one or more parts of the syringe assembly for advancing the balloon catheter out from the distal end of the balloon catheter guiding tube by linear motion of the one or more parts of the syringe assembly,
wherein:
the guiding means for movement of one or more parts of the syringe assembly towards the balloon catheter guiding tube comprises guiding means for movement of the syringe barrel towards the balloon catheter guiding tube;
the syringe barrel is fluidically connectable to the proximal part of the balloon catheter to cause inflation and pressurization of the distal inflatable part of the balloon catheter; and
the syringe barrel is the part of the syringe assembly which is operably coupled to the balloon catheter for advancing the balloon catheter out from the distal end of the balloon catheter guiding tube by linear motion of the syringe barrel.
2 . The handheld insertion device according to claim 1 , wherein:
the guiding means for movement of one or more parts of the syringe assembly towards the balloon catheter guiding tube comprises guiding means for movement of the entire syringe assembly towards the balloon catheter guiding tube.
3 . The handheld insertion device according to claim 1 , wherein:
the one or more parts of the syringe assembly coupled to the balloon catheter includes the plunger rod, coupled to the balloon catheter such that the plunger rod and balloon catheter move in unison.
4 . The handheld insertion device according to claim 1 , wherein:
the one or more parts of the syringe assembly coupled to the balloon catheter includes the syringe barrel, coupled to the balloon catheter such that the syringe barrel and balloon catheter move in unison.
5 . The handheld insertion device according to claim 1 , wherein:
the plunger rod is configured for linear motion within the syringe barrel to cause inflation and pressurization of the distal inflatable part;
and the plunger rod is the part of the syringe assembly which is operably coupled to the balloon catheter for advancing the balloon catheter out from the distal end of the balloon catheter guiding tube.
6 . The handheld insertion device according to claim 1 , wherein:
the handheld insertion device has a primary configuration, in which the syringe assembly and the balloon catheter are in a first position where the distal inflatable part of the balloon catheter is uninflated and fully retracted inside the balloon catheter guiding tube with the plunger rod retracted relative to the syringe barrel, the syringe barrel being filled with water, a secondary configuration in which the syringe assembly and balloon catheter are in a second position where the distal inflatable part of the balloon catheter is advanced out from the distal end of the balloon catheter guiding tube and wherein the plunger rod is retracted relative to the syringe barrel, and a tertiary configuration in which the syringe assembly and balloon catheter are in the second position with the plunger rod inserted into the syringe barrel and the balloon catheter in an inflated configuration.
7 . The handheld insertion device according to claim 6 , wherein:
the guiding means comprises a first thruster operably coupled to a distal part of the syringe assembly configured to move the syringe assembly and the balloon catheter from the first position to the second position and comprises a second thruster operably coupled to a proximal part of the syringe assembly configured to move the plunger rod relative to the syringe barrel for inflation and pressurization of the balloon catheter.
8 . The device according to claim 6 , comprising only one single thruster operably coupled to a proximal end of the syringe assembly, the single thruster being configured to first move the syringe assembly and the balloon catheter from the first position to the second position and subsequently to move the plunger rod relative to the syringe barrel for inflation and pressurization of the balloon catheter.
9 . A handheld insertion device for balloon dilation of the Eustachian tube or any other anatomic passageway in the head of a person, the device comprising:
a balloon catheter,
a syringe assembly comprising several parts, the several parts comprising a syringe barrel, a sealing element and a plunger rod,
a balloon catheter guiding tube for receiving and guiding the balloon catheter,
a device body rigidly attached to a proximal end of the balloon catheter guiding tube,
the balloon catheter having a distal inflatable part to be advanced out from the distal end of the balloon catheter guiding tube and a proximal part being fluidically connectable to the syringe assembly for inflation and pressurization of the balloon catheter,
wherein the device body comprises guiding means for movement of one or more parts of the syringe assembly towards the balloon catheter guiding tube, and wherein
the balloon catheter is operably coupled to one or more parts of the syringe assembly for advancing the balloon catheter out from the distal end of the balloon catheter guiding tube by linear motion of the one or more parts of the syringe assembly,
wherein:
the guiding means for movement of one or more parts of the syringe assembly towards the balloon catheter guiding tube comprises guiding means for movement of the entire syringe assembly towards the balloon catheter guiding tube.
10 . The handheld insertion device according to claim 9 , wherein:
the handheld insertion device has a primary configuration, in which the syringe assembly and the balloon catheter are in a first position where the distal inflatable part of the balloon catheter is uninflated and fully retracted inside the balloon catheter guiding tube with the plunger rod retracted relative to the syringe barrel, the syringe barrel being filled with water, a secondary configuration in which the syringe assembly and balloon catheter are in a second position where the distal inflatable part of the balloon catheter is advanced out from the distal end of the balloon catheter guiding tube and wherein the plunger rod is retracted relative to the syringe barrel, and a tertiary configuration in which the syringe assembly and balloon catheter are in the second position with the plunger rod inserted into the syringe barrel and the balloon catheter in an inflated configuration.
11 . The handheld insertion device according to claim 10 , wherein:
the guiding means comprises a first thruster operably coupled to a distal part of the syringe assembly configured to move the syringe assembly and the balloon catheter from the first position to the second position and comprises a second thruster operably coupled to a proximal part of the syringe assembly configured to move the plunger rod relative to the syringe barrel for inflation and pressurization of the balloon catheter.
12 . The device according to claim 11 , comprising a locking arrangement for preventing movement of the plunger rod relative to the syringe barrel when the syringe assembly and the balloon catheter are in the first position or between the first position and the second position.
13 . The handheld insertion device according to claim 9 , wherein:
the one or more parts of the syringe assembly coupled to the balloon catheter includes the plunger rod, coupled to the balloon catheter such that the plunger rod and balloon catheter move in unison.
14 . The device according to claim 10 , comprising only one single thruster operably coupled to a proximal end of the syringe assembly, the single thruster being configured to first move the syringe assembly and the balloon catheter from the first position to the second position and subsequently to move the plunger rod relative to the syringe barrel for inflation and pressurization of the balloon catheter.
15 . The device according to claim 10 , comprising a locking arrangement for preventing movement of the plunger rod relative to the syringe barrel when the syringe assembly and the balloon catheter are in the first position or between the first position and the second position.
16 . The device according to claim 15 , wherein the locking arrangement comprises one or more resistance elements creating a resistance between the plunger rod and syringe barrel such that a second force F 2 required to move the plunger rod relative to the syringe barrel is substantially higher than a first force F 1 required to move the syringe assembly and the balloon catheter from the first position to the second position.
17 . A handheld insertion device for balloon dilation of the Eustachian tube or any other anatomic passage way in the head of a person, the device comprising:
a balloon catheter,
a syringe assembly comprising several parts, the several parts comprising a syringe barrel, a sealing element and a plunger rod,
a balloon catheter guiding tube for receiving and guiding the balloon catheter,
a device body rigidly attached to a proximal end of the balloon catheter guiding tube,
the balloon catheter having a distal inflatable part to be advanced out from the distal end of the balloon catheter guiding tube and a proximal part being fluidically connectable to the syringe assembly for inflation and pressurization of the balloon catheter,
wherein the device body comprises guiding means for movement of one or more parts of the syringe assembly towards the balloon catheter guiding tube, and wherein
the balloon catheter is operably coupled to one or more parts of the syringe assembly for advancing the balloon catheter out from the distal end of the balloon catheter guiding tube by linear motion of the one or more parts of the syringe assembly,
wherein:
the one or more parts of the syringe assembly coupled to the balloon catheter includes the syringe barrel, coupled to the balloon catheter such that the syringe barrel and balloon catheter move in unison.
18 . The handheld insertion device according to claim 17 , wherein:
the one or more parts of the syringe assembly coupled to the balloon catheter includes the plunger rod, coupled to the balloon catheter such that the plunger rod and balloon catheter move in unison.
19 . The handheld insertion device according to claim 17 , wherein:
the handheld insertion device has a primary configuration, in which the syringe assembly and the balloon catheter are in a first position where the distal inflatable part of the balloon catheter is uninflated and fully retracted inside the balloon catheter guiding tube with the plunger rod retracted relative to the syringe barrel, the syringe barrel being filled with water, a secondary configuration in which the syringe assembly and balloon catheter are in a second position where the distal inflatable part of the balloon catheter is advanced out from the distal end of the balloon catheter guiding tube and wherein the plunger rod is retracted relative to the syringe barrel, and a tertiary configuration in which the syringe assembly and balloon catheter are in the second position with the plunger rod inserted into the syringe barrel and the balloon catheter in an inflated configuration.
20 . The handheld insertion device according to claim 19 , wherein:
the guiding means comprises a first thruster operably coupled to a distal part of the syringe assembly configured to move the syringe assembly and the balloon catheter from the first position to the second position and comprises a second thruster operably coupled to a proximal part of the syringe assembly configured to move the plunger rod relative to the syringe barrel for inflation and pressurization of the balloon catheter.
21 . The device according to claim 19 , comprising only one single thruster operably coupled to a proximal end of the syringe assembly, the single thruster being configured to first move the syringe assembly and the balloon catheter from the first position to the second position and subsequently to move the plunger rod relative to the syringe barrel for inflation and pressurization of the balloon catheter.
22 . The device according to claim 19 , comprising a locking arrangement for preventing movement of the plunger rod relative to the syringe barrel when the syringe assembly and the balloon catheter are in the first position or between the first position and the second position.
23 . The device according to claim 22 , wherein the locking arrangement comprises a first locking mechanism, where in the first locking mechanism comprises a movable locking member, in the form of a spherical locking member, the movable locking member having a locked position in which relative movement between the syringe barrel and the plunger rod is prevented and an unlocked position in which relative movement between the syringe barrel and the plunger rod is enabled.