US2021393284A1PendingUtilityA1

Medical device for treatment of a sinus and/or an ear and methods of use thereof

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Assignee: SINUSAFE MEDICAL LTDPriority: Jul 3, 2016Filed: Jul 18, 2021Published: Dec 23, 2021
Est. expiryJul 3, 2036(~10 yrs left)· nominal 20-yr term from priority
A61B 2017/320008A61B 2017/00787A61M 25/0113A61B 2017/0046A61B 17/24A61B 2217/005A61B 17/3207A61B 2017/320733A61M 29/00A61M 25/0136A61B 2217/007A61B 2218/007A61B 2218/002
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Claims

Abstract

There is provided herein, a device for treating and/or diagnosing a sinus or an ear condition, the device comprising a housing comprising or functionally connected to: a hollow cannula defining a lumen extending at least partially along the length thereof, the cannula is configured to be at least partially inserted through an ostium into a sinus cavity/ear of a subject; and a flexible grinding wire movable within the cannula's lumen and configured to be inserted into and retrieved out of the sinus cavity through the cannula's lumen, and to rotate along a longitudinal axis thereof and thereby grind, chop and/or stir material present in the sinus cavity and/or inside the hollow cannula, wherein the cannula is in fluid flow communication with an irrigation/aspiration source; and a wire handle functionally connected to the wire, allowing a user to advance and retrieve the wire within the cannula and into and out of the cannula lumen, wherein the device is handheld by a gripping handle.

Claims

exact text as granted — not AI-modified
What we claim is: 
     
         1 . A medical device for treating and/or diagnosing a sinus and/or ear condition, said medical device comprising:
 a housing comprising or functionally connected to:
 a hollow cannula defining a lumen extending at least partially along the length thereof, the cannula is configured to be at least partially inserted through an ostium into a sinus cavity/ear of a subject; 
 a flexible grinding wire, positioned within the cannula's lumen, or alongside it, and configured to be at least partially inserted through an ostium into a sinus cavity/ear of a subject, and to rotate along a longitudinal axis thereof and thereby grind, chop and/or stir material present in said sinus cavity and/or inside said hollow cannula; 
 a liquid tube defining a lumen extending at least partially along the length thereof, wherein the liquid tube connecting the cannula with an irrigation/ aspiration source; and 
 a shaft functionally connecting the grinding wire with a motor, to thereby allow rotating the grinding wire within the cannula lumen and/or the sinus cavity. 
   
     
     
         2 . The device of  claim 1 , further comprising a mechanism for sealing the connection between the shaft and the cannula/liquid tube during rotational and/or forwarded and backward movement of the shaft relative to the cannula/liquid tube, wherein said mechanism is configured to allow irrigation or aspiration via the cannula/liquid tube while the shaft/wire are at least partially positioned within the liquid tube/ cannula's lumen without backflow or spillage of gas or liquids. 
     
     
         3 . The device of  claim 1 , further comprising a wire handle functionally connected to the wire, allowing a user to advance and retrieve the wire within the cannula or alongside the cannula, and into and out of the sinus/ear lumen, wherein the device is handheld by a gripping handle. 
     
     
         4 . The device of  claim 3 , wherein the motor serves as the wire handle. 
     
     
         5 . The device of  claim 2 , wherein the sealing mechanism comprises a cannula/liquid tube seal located within a defined lumen within the housing and surrounding at least portion of the cannula/liquid tube, such that the cannula/liquid tube is distally/proximally movable within the lumen and relative to the handle grip while remaining the cannula/liquid tube cavity sealed from air inlet and liquid outlet during irrigation and aspiration, wherein the cannula/liquid tube seal is further configured to facilitate rotation of the cannula/liquid tube while the cannula/liquid tube remains sealed. 
     
     
         6 . The device of  claim 2 , wherein the sealing mechanism comprises a wire/shaft seal surrounding at least portion of the wire/shaft and facilitating distal/proximal movement of the wire/shaft within and relative to the cannula/liquid tube, while maintaining the cannula/liquid tube sealed from air inlet and liquids outlet during irrigation and aspiration, wherein the wire/shaft seal is further configured to facilitate high RPM rotation of the wire/shaft within and relative to the cannula/liquid tube, while the cannula/liquid tube remains sealed. 
     
     
         7 . The device of  claim 2 , wherein the sealing mechanism comprises an irrigation/ aspiration seal configured for connection and/or detachment of irrigation/ aspiration source to the liquid tube/cannula in a sealed manner. 
     
     
         8 . The device of  claim 1 , further comprising a cannula handle functionally connected to the cannula, allowing a user to advance and retrieve the cannula into a sinus cavity or an ear. 
     
     
         9 . The device of  claim 1 , further comprising straight or banded guiding tube configured to house the cannula therein and bend the cannula as it is being advanced forward, and direct a distal end of the cannula towards a sinus opening. 
     
     
         10 . The device of  claim 1 , further comprising a curve in said cannula distal tip and a cannula rotating mechanism, configured to allow the user to rotate a distal tip of the cannula around a longitudinal axis of the cannula, thus facilitate insertion of the cannula into the sinus cavity. 
     
     
         11 . The device of  claim 9 , further comprising a connector configured for replacing of guiding tubes. 
     
     
         12 . The device of  claim 9 , further comprising a mechanism for changing an angle of a distal section of the guiding tube, to facilitate introduction of the cannula to various sinus regions. 
     
     
         13 . The device of  claim 1 , wherein the irrigation/aspiration source comprises a replaceable syringe, a syphon, and/or a liquid container. 
     
     
         14 . The device of  claim 1 , further comprising a connector connecting between the liquid tube/cannula and the shaft/wire such that when the liquid tube/cannula is moved distally or proximally, the shaft/wire will also be respectively moved distally or proximally, for at least part of the liquid tube/cannula advancement. 
     
     
         15 . The device of  claim 1 , further comprising one or more side ports in the guiding tube or on the housing, wherein the side port are configured for instrumentation insertion through a distal end of the guiding tube. 
     
     
         16 . The device of  claim 15 , wherein the side port is configured to serve as an aspiration port being in fluid flow connection with a distal end of the guiding tube, wherein the aspiration port is configured for suction of aspiration/irrigation fluid from the guiding tube. 
     
     
         17 . The device of  claim 1 , further comprising a hollow trocar configured to house said cannula therein, puncture a sinus wall, sinus floor or ear wall and facilitate insertion of said cannula into the sinus/ear cavity, or wherein the cannula is configured to puncture via an ear or a sinus wall or sinus floor as a trocar. 
     
     
         18 . The device of  claim 9 , further comprising visualization equipment located within or mounted on a distal tip of the guiding tube. 
     
     
         19 . The device according to  claim 1 , further comprising one or more additional diagnostic and/or therapeutic instrument, selected from: guidewire, light-wire for trans-illumination, optic fiber for visualization or recording, optic fiber for pathogen eradication, swab, cutting device, balloon, dilatation device, vibrating piezoelectric crystal, laser or heat source, absorbable material soaked with drug, or any combination thereof. 
     
     
         20 . The device of  claim 1 , further comprising a cannula position marking configured to provide indication regarding the cannula's distal end location and/or orientation in relation to a sinus opening, 
     
     
         21 . The device of  claim 8 , further comprising a locking mechanism for locking the cannula/ liquid tube at a desired position, wherein the locking mechanism is configured to be manually or automatically operable and is located in or connected to the cannula handle/device housing.

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