Delivery Tools for Sleep Disorders Treatment Implant and Methods of Implantation

Abstract

Methods and tools are disclosed for inserting an implant device that treats snoring and apnea of a patient by altering the position of a soft palate. Methods and tools can make an incision in patient's soft and hard palate to create a cavity that can house the implant. The tools can have visually observable markings that can be aligned with the incision, thus controlling the depth of the cavity. A needle having an incision edge can be used to make an incision in patient's soft palate. The needle can be bent into a suitable longitudinal shape to allow easier access and visualization of the process. A blade that makes the cavity in the tissue can be housed inside a channel in the needle. The tools may have stoppers to prevent excessive extension and retraction of the blade thus preventing an excessive cavity depth. Some tools may also house the implant device, which may be implanted after the cavity is formed.

1 - 8 . (canceled) 
     
     
         9 . A cavitation tool for creating a cavity in a palate comprising:
 a posterior end;   an anterior end;   a needle adapted and configured to incise and lift tissue, wherein the needle comprises a posterior end, an anterior end, and a channel extending from the posterior end of the needle to the anterior end of the needle and an incising edge at the posterior end of the needle for incising tissue;   a blade comprising a posterior end, an anterior end, and a cutting element at the posterior end of the blade for creating a tissue cavity in which an implant device may be deployed, wherein the blade slides in the posterior and anterior directions within the channel of the needle and can extend out the posterior end of the needle and anterior end of the needle;   a first handle connected to the needle adapted and configured to control the position of the needle;   and a second handle connected to the blade at the anterior end of the blade, wherein the handle is adapted and configured to slide the blade within the channel of the needle and into the tissue to create the cavity.   
     
     
         10 . The cavitation tool of  claim 9  comprising a stopper connected to the blade at the anterior end of the blade, wherein the stopper is adapted and configured to stop the posterior motion of the blade. 
     
     
         11 . The cavitation tool of  claim 10  comprising a marking on the needle, wherein the marking indicates where to align the tool with the incision to create the cavity appropriately sized for the implant device. 
     
     
         12 . The cavitation tool of  claim 11  wherein the posterior motion of the blade is stopped by the stopper when the cutting element of the blade extends about 2.5 centimeters posterior to the needle marking. 
     
     
         13 . The cavitation tool of  claim 9  wherein the cavitation tool is curved to aid in procedure visualization. 
     
     
         14 . The cavitation tool of  claim 9  wherein the first handle can be injection molded around the needle. 
     
     
         15 . The cavitation tool of  claim 9  wherein the needle comprises at least one of stainless steel, a shape memory metal (e.g. Nitinol), and a plastic. 
     
     
         16 . The cavitation tool of  claim 9  wherein the incising edge is beveled to aid in incising tissue, to aid in moving the needle through the tissue, and to aid in lifting the tissue. 
     
     
         17 . The cavitation tool of  claim 9  wherein the blade comprises at least one of stainless steel, a shape memory metal (e.g. Nitinol), and a plastic. 
     
     
         18 . The cavitation tool of  claim 9  wherein the cutting element of the blade is rounded. 
     
     
         19 . The cavitation tool of  claim 9  wherein the blade is more flexible at the posterior end of the blade than at the anterior end of the blade. 
     
     
         20 . The cavitation tool of  claim 9  wherein the blade comprises a first cutting layer and a second layer, wherein the cutting first layer is adapted and configured to extend posterior to the second layer, and wherein the layers are joined. 
     
     
         21 . The cavitation tool of  claim 9  wherein the blade comprises a single layer and a taper at the posterior end of the blade. 
     
     
         22 . The cavitation tool of  claim 21  wherein the taper of the blade is made by a process chosen from a group consisting of a grinding, chemical etching, or a combination thereof. 
     
     
         23 . The cavitation tool of  claim 9  wherein the blade comprises a heat shrink material and wherein the heat shrink material forms the external surface of the blade and extends up to the cutting element of the blade. 
     
     
         24 . The cavitation tool of  claim 9  wherein the cavitation tool can be sterilized. 
     
     
         25 . An implant delivery tool for deploying an implant device comprising:
 a sheath;   a support tube within a portion of the sheath wherein the support tube and sheath are joined and wherein the support tube comprises a cutout section to limit range of motion for an implant support;   a sheath retractor joined to the support tube;   the implant support within the sheath and within the support tube, wherein the implant support comprises a posterior end, an anterior end, and a third handle fastening element aligning with the cutout section of the support tube, wherein the implant support supports the implant device during deployment into a cavity in the palate; and   a third handle having an implant support fastening element adapted and configured to mate with the third handle fastening element, wherein the third handle has a channel through which the support tube and the sheath slide anteriorly and posteriorly relative to the handle and implant support.   
     
     
         26 . The delivery tool of  claim 25  wherein the sheath is clear or translucent. 
     
     
         27 . The delivery tool of  claim 25  wherein the implant support comprises at least one cutout to increase flexibility. 
     
     
         28 . The delivery tool of  claim 25  wherein the posterior end of the implant support is more flexible than is the anterior end of the implant support. 
     
     
         29 . The delivery tool of  claim 25  wherein the implant support tapers down in thickness from the anterior end of the implant support to the posterior end of the implant support. 
     
     
         30 . The delivery tool of  claim 25  wherein the implant support comprises at least one of stainless steel, a shape memory metal (e.g. Nitinol), and a plastic. 
     
     
         31 . The delivery tool of  claim 25  wherein the implant support comprises an abutting portion against which the implant device abuts during insertion into the cavity for alignment of the implant device during deploymnent. 
     
     
         32 . The delivery tool of  claim 31  wherein the abutting portion is a flap on the implant support. 
     
     
         33 . The delivery tool of  claim 25  wherein the sheath comprises a dimple adapted and configured to align the implant device on the implant support until delivery into the cavity. 
     
     
         34 . The delivery tool of  claim 25  wherein the sheath comprises a sheath flap adapted and configured to laterally support the implant device during insertion into the cavity. 
     
     
         35 . The delivery tool of  claim 25  wherein the delivery tool is adapted and configured to be sterilized. 
     
     
         36 . A delivery and cavitation tool for deploying an implant device comprising:
 a cavitation element for creating a cavity in a palate comprising   a posterior end,   a anterior end,   a needle adapted and configured to incise and lift tissue, wherein the needle comprises a posterior end, an anterior end, and a channel extending from the posterior end of the needle to the anterior end of the needle and an incising edge at the posterior end of the needle for incising tissue,   a blade comprising a posterior end, an anterior end, and a cutting element at the blade posterior end for creating a tissue cavity in which the implant device may be deployed, wherein the blade slides in the posterior and anterior directions within the needle channel and can extend out the posterior end of the needle and anterior end of the needle,   a first handle connected to the needle adapted and configured to control the position of the needle,   and a second handle connected to the blade at the anterior end of the blade, wherein the handle is adapted and configured to slide the blade within the channel of the needle and into the tissue to create the cavity;   and a delivery element for delivering the implant device into the cavity created by the cavitation element comprising   a sheath,   a support tube within a portion of the sheath wherein the support tube and sheath are joined and wherein the support tube comprises a cutout section,   a sheath retractor joined to the support tube,   an implant support within the sheath and within the support tube, wherein the implant support has a third handle fastening element aligning with the cutout section of the support tube, and wherein the implant support supports the implant device during deployment into a cavity in the palate, and   a third handle having an implant support fastening element adapted and configured to mate with the third handle fastening element, wherein the third handle has a channel through which the support tube and the sheath slide anteriorly and posteriorly relative to the handle and implant support.   
     
     
         37 . The tool of  claim 36  wherein the tool can be sterilized.