System for accessing a cochlear implant lead insertion site
Systems and methods can be employed for access to a middle ear for delivery of a formulation to a targeted site under direct visualization. The formulation, in some cases, can be delivered to a cochlear implant lead insertion site where a lead of a cochlear implant device enters a patient's cochlea.
1 . A method of delivering a self-gelling therapeutic composition at a cochlear implant lead insertion site of a cochlea, the method comprising:
inserting a therapeutic gel delivery shaft through a transmastoid pathway toward a cochlear implant lead;
while the therapeutic gel delivery shaft is positioned through the transmastoid pathway such that a distal port of the therapeutic gel delivery shaft is proximate to the cochlear implant lead, depositing a liquid dosage of the self-gelling therapeutic composition out of the distal port of the therapeutic gel delivery shaft onto an exterior of the cochlear implant lead at the cochlear implant lead insertion site of a round window niche of the cochlea, said self-gelling therapeutic composition comprising: an anti-inflammatory therapeutic agent and a polymer gel composition including water, a functional polymer of about 5% to about 15% by weight of the polymer gel composition, and a crosslinker of about 0.2% to about 0.6% by weight of the polymer gel composition, wherein the distal port of the therapeutic gel delivery shaft is sized to deposit the liquid dosage of the self-gelling therapeutic composition to output a sustained release of the anti-inflammatory therapeutic agent into the cochlea; and
after said depositing the liquid dosage of the self-gelling therapeutic composition out of the distal port of the therapeutic gel delivery shaft, using direct visualization of the cochlear implant lead insertion site to verify that the self-gelling therapeutic composition is retained as a gel substance along the exterior of the cochlear implant lead at the round window niche of the cochlea.
2 . The method of claim 1 , wherein the self-gelling therapeutic composition is retained as the gel substance to seal the cochlear implant lead insertion site at the round window niche of the cochlea.
3 . The method of claim 1 , further comprising withdrawing the therapeutic gel delivery shaft from the transmastoid pathway while the self-gelling therapeutic composition is retained as the gel substance along the cochlear implant lead at the round window niche of the cochlea such that the gel substance both outputs the sustained release of the anti-inflammatory therapeutic agent into the cochlea and seals the cochlear implant lead insertion site.
4 . The method of claim 3 , wherein the sustained release of the anti-inflammatory therapeutic agent occurs over a period of weeks after said depositing the liquid dosage of the self-gelling therapeutic composition.
5 . The method of claim 4 , wherein the sustained release of the anti-inflammatory therapeutic agent encompasses any one or a combination of a first order release, a zero order release, and an intermediate release to the zero order release and the first order release.
6 . The method of claim 4 , wherein the sustained release of the anti-inflammatory therapeutic agent comprises a controlled release of the anti-inflammatory therapeutic agent via passive molecular diffusion driven by a concentration gradient across a membrane.
7 . The method of claim 1 , further comprising urging the self-gelling therapeutic composition to flow from a reservoir containing the self-gelling therapeutic composition toward the distal port of the therapeutic gel delivery shaft in response to movement of an actuator of the reservoir.
8 . The method of claim 7 , wherein the actuator of the reservoir is a syringe plunger of a treatment actuator device.
9 . The method of claim 8 , wherein the treatment actuator device comprises the reservoir, the syringe plunger, and a flexible tube extending distally from the reservoir and in fluid communication with the therapeutic gel delivery shaft.
10 . The method of claim 9 , wherein the flexible tube of the treatment actuator device is releasably mated to a Luer lock connector coupled to the therapeutic gel delivery shaft.
11 . The method of claim 1 , wherein said using direct visualization of the cochlear implant lead insertion site comprises capturing image data of the distal port of the therapeutic gel delivery shaft using a camera device.
12 . The method of claim 11 , wherein said using direct visualization of the cochlear implant lead insertion site comprises simultaneously capturing image data of both the distal port of the therapeutic gel delivery shaft and the self-gelling therapeutic composition deposited at the cochlear implant lead insertion site of the cochlea.
13 . The method of claim 11 , wherein said using direct visualization of the cochlear implant lead insertion site comprises the capturing image data of the distal port of the therapeutic gel delivery shaft using the camera device including a tip-mounted camera fixedly mounted at a distal end of a visualization shaft and oriented toward the distal port of the therapeutic gel delivery shaft.
14 . The method of claim 13 , wherein the image data captured by the tip-mounted camera is communicated via an image data cable to a user interface display to present a real-time location of the deposited self-gelling therapeutic composition relative to the cochlear implant lead insertion site and relative to the distal port.
15 . The method of claim 13 , wherein the therapeutic gel delivery shaft and the visualization shaft are side-by-side shafts being fixedly mounted to a handle in a stationary position relative to one another and extending distally from the handle such that the distal port of the therapeutic gel delivery shaft is positioned distally of the visualization shaft, the tip-mounted camera capturing the distal port of the therapeutic gel delivery shaft from a position that is fixed relative to the therapeutic gel delivery shaft.
16 . The method of claim 15 , wherein the visualization shaft and the therapeutic gel delivery shaft are sized so that the distal port of the therapeutic gel delivery shaft and the tip-mounted camera both fit within a middle ear while the tip-mounted camera provides the direct visualization of the therapeutic gel delivery shaft during said depositing the liquid dosage of the self-gelling therapeutic composition from the distal port of the therapeutic gel delivery shaft at the cochlear implant lead insertion site.
17 . The method of claim 15 , wherein the distal port of the therapeutic gel delivery shaft extends distally beyond the tip-mounted camera by a distal extension distance within a range from 1 mm to 5 mm.
18 . The method of claim 15 , wherein the visualization shaft has an exterior diameter that is larger than an outer diameter of the therapeutic gel delivery shaft, and a combined maximum width of the visualization shaft and the therapeutic gel delivery shaft is less than 2 mm so that the side-by-side shafts are sized to fit within the transmastoid pathway during said depositing the liquid dosage of the self-gelling therapeutic composition.
19 . The method of claim 18 , wherein at least a portion of the side-by-side shafts are located within the transmastoid pathway and the handle is located fully outside of the transmastoid pathway during said depositing the liquid dosage of the self-gelling therapeutic composition from the distal port of the therapeutic gel delivery shaft at the cochlear implant lead insertion site.
20 . The method of claim 18 , wherein a maximum width of the handle is greater than the combined maximum width of the visualization shaft and the therapeutic gel delivery shaft.
21 . The method of claim 13 , wherein the visualization shaft includes both the tip-mounted camera mounted at a first location on the distal end of the visualization shaft and an illumination source mounted at a second location on the distal end of the visualization shaft so as to emit light distally toward the distal port of the therapeutic gel delivery shaft.
22 . A method of delivering a self-gelling therapeutic formulation at a cochlear implant lead insertion site of a cochlea, the method comprising:
inserting a therapeutic gel delivery shaft through a transmastoid pathway toward a cochlear implant lead;
while the therapeutic gel delivery shaft is positioned through the transmastoid pathway such that a distal port of the therapeutic gel delivery shaft is proximate to the cochlear implant lead, depositing the self-gelling therapeutic formulation out of the distal port of the therapeutic gel delivery shaft onto the cochlear implant lead insertion site at a round window niche of the cochlea, said self-gelling therapeutic formulation comprising: an anti-inflammatory therapeutic agent and a polymer gel composition including water, a functional polymer of about 5% to about 15% by weight of the polymer gel composition, and a crosslinker of about 0.2% to about 0.6% by weight of the polymer gel composition, wherein the distal port of the therapeutic gel delivery shaft is sized to deposit a dosage of the self-gelling therapeutic formulation to output a sustained release of the anti-inflammatory therapeutic agent into the cochlea;
after said depositing the self-gelling therapeutic formulation out of the distal port of the therapeutic gel delivery shaft, using direct visualization of the cochlear implant lead insertion site to verify that the self-gelling therapeutic formulation is retained as a gel substance along the cochlear implant lead at the round window niche of the cochlea, wherein said depositing the self-gelling therapeutic formulation causes the self-gelling therapeutic formulation to seal the cochlear implant lead insertion site at the round window niche of the cochlea; and
inserting the cochlear implant lead into the cochlea prior to said depositing the self-gelling therapeutic formulation out of the distal port of the therapeutic gel delivery shaft onto the cochlear implant lead insertion site at the round window niche of the cochlea.
23 . The method of claim 22 , further comprising, prior to said inserting the cochlear implant lead into the cochlea, depositing an initial dose of the self-gelling therapeutic formulation at the round window niche of the cochlea.