Resorbable, drug-eluting submucosal turbinate implant device and method

Abstract

Implants are placed in turbinate mucosal tissue using a surgical device having a proximal grip portion and a distal hollow sharp needle portion that is manipulated using the grip portion and inserted submucosally into mucosal turbinate tissue. One or more biodegradable, drug-eluting solid implants are disposed within the needle. The implants have one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features along their length. An actuator disposed within the device is used to deliver one or more of the implants from the needle into the mucosal turbinate tissue and submucosally bury at least one such tissue-engaging feature therein.

1 . (canceled) 
     
     
         2 . A surgical device, comprising:
 a barrel including an elongated bore defined therein, the barrel operably connected to a needle alignment portion having a distal end;   a hollow needle configured to project from the distal end of the needle alignment portion and configured for submucosal insertion into mucosal turbinate tissue;   one or more biodegradable, drug-eluting solid implants disposed within the hollow needle, each of the one or more implants having a length and one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features along the length; and   a selectively removable actuator disposed within the elongated bore and configured to incrementally deliver each of the one or more of the implants from the hollow needle into the mucosal turbinate tissue and submucosally bury at least one of the implant withdrawal-discouraging, mucosal tissue-engaging surface features in the mucosal turbinate tissue.   
     
     
         3 . The device according to  claim 2 , wherein the selectively removable actuator includes a slider mechanism configured to regulate the delivery of the one or more implants into the mucosal turbinate tissue. 
     
     
         4 . The device according to  claim 3 , wherein the elongated bore includes one or more openings axially defined along a side thereof, the openings configured to mechanically interface with the slider mechanism to regulate delivery of the one or more implants in increments. 
     
     
         5 . The device according to  claim 4 , wherein the slider mechanism includes:
 a body configured to be slidably received within the elongated bore;   a flexible pin extending distally from the body and configured to extend through the needle alignment portion and into the hollow needle; and   one or more flexible arms disposed proximate the flexible pin and configured to project laterally and proximally therefrom, the one or more flexible arms including corresponding one or more latches at a distal end of the one or more flexible arms configured to axially register with corresponding one or more openings in the elongated bore to regulate delivery of the one or more implants dependent upon distal advancement of the slider mechanism within the elongated bore.   
     
     
         6 . The device according to  claim 5 , wherein the device contains two or more implants. 
     
     
         7 . The device according to  claim 5 , wherein the one or more openings in the elongated bore provide visible, audible or tactile feedback of the progress of each of the one or more implants through the hollow needle. 
     
     
         8 . The device according to  claim 2 , wherein the device has one or more latches that prevent unintended removal of the selectively removable actuator from the device. 
     
     
         9 . The device according to  claim 5 , wherein the one or more latches prevent unintended removal of the selectively removable actuator from the device. 
     
     
         10 . The device according to  claim 2 , wherein at least one of the needle alignment portion or the hollow needle is bent. 
     
     
         11 . The device according to  claim 2 , wherein the device is sealed in sterile packaging. 
     
     
         12 . The device according to  claim 2 , wherein the implant includes a polymeric matrix with a drug impregnated therein, a drug dispersed therein, or a drug coated thereon. 
     
     
         13 . The device according to  claim 2 , wherein the implant is configured to degrade in less than one month in mucosal turbinate tissue. 
     
     
         14 . The device according to  claim 12 , wherein the implant is configured such that the drug elutes from the implant for at least three days and for less than one month. 
     
     
         15 . The device according to  claim 12 , wherein the drug includes an angiotensin convertin enzyme (ACE) inhibitor; angiotensin receptor blocker (ARBS); antihistamine; steroidal or non-steroidal anti-inflammatory agent; chymase inhibitor; cyclooxygenase-2 (COX-2) inhibitor; decongestant; matrix metalloproteinase (MMP) inhibitor; mucolytic; therapeutic polymer or combinations thereof. 
     
     
         16 . The device according to  claim 12 , wherein the drug includes doxycycline, TIMP metallopeptidase inhibitor  1 , or dexamethasone. 
     
     
         17 . The device according to  claim 2 , wherein the one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features include projections. 
     
     
         18 . The device according to  claim 17 , wherein the projections comprise bumps, ribs, hooks or a ratchet rack. 
     
     
         19 . The device according to  claim 2 , wherein the one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features include recesses. 
     
     
         20 . The device according to  claim 19 , wherein the recesses comprise dimples, grooves or porosity. 
     
     
         21 . The device according to  claim 2 , wherein the one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features include a braided structure.