Tympanic membrane therapeutic device
A therapeutic device ( 1 ) has a stem ( 3 ) having a distal end ( 60 ) configured for insertion in a patient's ear canal with latching by suction to the tympanic membrane so that there is no relative movement despite patient head movement. A needle ( 63 ) punctures the membrane after suction is applied by negative pressure via a lumen ( 66 ). The needle tip is located within a suction cup which grips the membrane. A hand-held control device ( 2 ) is coupled to the stem and has a user-actuated controller ( 8 ) for controlling application of negative pressure ( 7 ) to the suction lumen.
1 . A therapeutic device comprising:
an ear canal stem having a distal end for insertion in a patient's ear canal, the stem comprising:
a lumen for application of suction, the lumen having at its proximal end a suction source or a coupler for connection to a suction source,
a needle having a tip for piercing a tympanic membrane, and
a suction cup, positioned at the distal end of the stem, within which the tip of the needle is located, the suction cup being linked with the lumen that is for application of suction and being configured for engaging the tympanic membrane and gripping the membrane by suction,
wherein the stem further comprises a lumen linked with the needle for delivery of a therapeutic fluid, the lumen that is linked with the needle for delivery of the therapeutic fluid having a proximal end with a coupler for connection to a fluid source, the needle being configured for piercing the tympanic membrane and for delivering the therapeutic fluid.
2 . The therapeutic device of claim 1 , further comprising a hand-held control device for coupling to the stem, said control device having a user-actuated controller for regulating application of negative pressure to the lumen that is for application of suction.
3 . The therapeutic device of claim 2 , wherein the hand-held control device comprises a housing for coupling to the stem, and a handle, and wherein the user-actuated controller comprises trigger buttons for user actuation positioned on the handle.
4 . The therapeutic device of claim 2 , wherein the hand-held control device comprises a coupler for connection to a suction source.
5 . The therapeutic device of claim 1 , wherein the needle is mounted at an acute angle to a longitudinal axis of the stem.
6 . The therapeutic device of claim 1 , wherein the distal end of the stem further comprises a hub supporting the suction cup and the needle.
7 . The therapeutic device of claim 6 , wherein the hub includes a conduit to receive a liner defining the lumen that is for application of suction and is surrounded by a flexible sleeve which retains the hub in place.
8 . The therapeutic device of claim 7 , wherein the suction cup is formed from the flexible sleeve.
9 . The therapeutic device of claim 7 , wherein the flexible sleeve comprises a silicone over-molded construction.
10 . The therapeutic device of claim 1 , further comprising a housing having a syringe pusher for mounting a syringe with the therapeutic fluid in fluid communication with the lumen linked with the needle for delivery of the therapeutic fluid.
11 . The therapeutic device of claim 1 , wherein the stem further comprises a plurality of sensor electrodes at the distal end, and the therapeutic device further comprises a circuit for applying drive signals to the plurality of sensor electrodes and a sensor circuit for monitoring at least one electrical parameter to determine if the plurality of sensor electrodes are in contact with the tympanic membrane or in contact with the ear canal, and to generate an output to indicate at an output device whether the plurality of sensor electrodes are in contact with the tympanic membrane.
12 . The therapeutic device of claim 11 , wherein at least one sensor electrode in the plurality of sensor electrodes comprises the needle.
13 . The therapeutic device of claim 12 , wherein at least one sensor electrode in the plurality of sensor electrodes comprises a non-lumen needle spaced apart from the needle.
14 . The therapeutic device of claim 11 , further comprising a hand-held control device for coupling to the stem and having a user-actuated controller for controlling application of negative pressure to the suction lumen that is for application of suction, and wherein the output device is mounted to the hand-held control device.
15 . The therapeutic device of claim 1 , wherein there is a gap in a longitudinal direction of the stem between a distal end of the needle and a plane formed by a distal edge of the suction cup before application of the suction.
16 . The therapeutic device of claim 15 , wherein the plane formed by the distal edge of the suction cup before application of the suction is at an acute angle relative to a longitudinal axis of the stem.