US2019217095A1PendingUtilityA1

Implantable nasal stimulator systems and methods

54
Assignee: OCULEVE INCPriority: Oct 22, 2014Filed: Jan 15, 2019Published: Jul 18, 2019
Est. expiryOct 22, 2034(~8.3 yrs left)· nominal 20-yr term from priority
A61N 1/36046A61N 1/3606A61N 1/37205A61N 2001/37294A61N 1/3756
54
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Claims

Abstract

Described here are systems, devices, and methods for implanting a nasal stimulator into nasal tissue and electrically stimulating nasal tissue. In some variations, a nasal microstimulator implantation system may comprise an implantation tool and an implantable microstimulator. An implantation tool may comprise a shaft and features to releasably attach a microstimulator. A microstimulator may comprise a passive stimulation circuit and one or more electrodes. In other variations, a nasal implantation system may additionally comprise one or more additional devices, such as a controller, an electrical probe, and/or a dissection tool.

Claims

exact text as granted — not AI-modified
1 .- 20 . (canceled) 
     
     
         21 . A system, comprising:
 a microstimulator configured to be implanted into nasal tissue of a nasal cavity of a patient, the microstimulator including at least one electrode for delivering an electrical stimulus to nasal tissue to thereby increase tear production in the patient; and   an implantation device comprising an elongate shaft having a distal end configured to releasably couple to the microstimulator.   
     
     
         22 . The system of  claim 21 , wherein the electrical stimulus is pulsed. 
     
     
         23 . The system of  claim 21 , wherein the electrical stimulus comprises a biphasic symmetric pulse waveform. 
     
     
         24 . The system of  claim 23 , wherein the frequency of the biphasic pulse waveform is between 20 Hz and 80 Hz. 
     
     
         25 . The system of  claim 21 , wherein the electrical stimulus has a waveform with a varying pulse width. 
     
     
         26 . The system of  claim 21 , wherein the electrical stimulus has a waveform with a varying frequency. 
     
     
         27 . The system of claim  221 , wherein the electrical stimulus has a waveform with a varying amplitude. 
     
     
         28 . The system of  claim 21 , wherein the microstimulator includes a dissipation circuit configured to receive an output signal from a controller and, based on the received output signal, deliver an electrical current to nasal tissue. 
     
     
         29 . The system of  claim 21 , wherein the microstimulator includes one or more fixation elements that promote tissue ingrowth. 
     
     
         30 . The system of  claim 21 , wherein the distal end of the implantation device includes a friction holder including one or more friction elements configured to contact at least a portion of the microstimulator and frictionally resist movement of the microstimulator relative to the implantation device. 
     
     
         31 . The system of  claim 30 , wherein the implantation device includes a pusher slidably disposed within a lumen of the elongate shaft and movable between a proximal position and a distal position, the pusher configured to release the microstimulator from the friction holder when in the distal position. 
     
     
         32 . The system of  claim 21 , wherein the implantation device includes a retractable cover that extends over the microstimulator in an extended position and exposes at least a part of the microstimulator in a retracted position. 
     
     
         33 . The system of  claim 32 , wherein the retractable cover includes a distal end having a sharp edge for making an incision in nasal tissue. 
     
     
         34 . The system of  claim 33 , wherein the distal end of the retractable cover is curved and wraps at least partially around the distal end of the microstimulator when the retractable cover is in the extended position. 
     
     
         35 . The system of  claim 34 , wherein the retractable cover is flexible thereby allowing the curved distal end of the retractable cover to straighten when the retractable cover is retracted to expose at least a part of the microstimulator. 
     
     
         36 . The system of  claim 21 , wherein the implantation device includes a tension system for releasably coupling the microstimulator to a distal end of the implantation tool, the tension system comprising a tensioning element that, when under tension, secures the microstimulator against the distal end of the implantation device. 
     
     
         37 . The system of  claim 21 , further comprising an electrical probe comprising an electrode coupled to an endoscope, the electrode configured to electrically stimulate nasal tissue for determining an implantation site along the nasal cavity. 
     
     
         38 . The system of  claim 21 , further comprising a dissection tool configured to form an implantation site in the nasal cavity for implanting the microstimulator, the dissection tool comprising a blade positioned at a distal end of a dissection shaft and a suction opening extending through a portion of the blade. 
     
     
         39 . A system, comprising:
 a microstimulator configured to be implanted into nasal tissue of a nasal cavity of a patient, the microstimulator including at least one electrode for delivering an electrical stimulus to nasal tissue to thereby increase tear production in the patient;   an implantation device comprising an elongate shaft having a distal end configured to releasably couple to the microstimulator;   an electrical probe comprising an electrode coupled to an endoscope, the electrode configured to electrically stimulate nasal tissue for determining an implantation site along the nasal cavity; and   a dissection tool configured to form the implantation site in the nasal cavity for implanting the microstimulator, the dissection tool comprising a blade positioned at a distal end of a dissection shaft and a suction opening extending through a portion of the blade.   
     
     
         40 . The system of  claim 39 , wherein the microstimulator includes a dissipation circuit configured to receive an output signal from a controller and, based on the received output signal, deliver an electrical current to nasal tissue.

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