Surgical tools and methods for delivering a neurostimulator into the pterygopalatine fossa

Abstract

One aspect of the present disclosure includes a delivery tool configured to deliver a neurostimulator into a pterygopalatine fossa of a subject. The neurostimulator can include a body connected to an integral stimulation lead having one or more stimulating electrodes. The delivery tool can comprise a handle, an elongated shaft extending from the handle, a hub portion, and a double barrel sheath. The hub portion can be located between the shaft and a spine member that extends axially away from the hub portion. The hub portion can be sized and dimensioned to releasably mate with the neurostimulator. The double barrel sheath can be connected to the spine member. A central lumen can extend through at least a portion of the shaft and the hub portion. The central lumen can be adapted to receive a lead ejector for selective deployment of the stimulation lead from the double barrel sheath.

The following is claimed: 
     
         1 . A delivery tool configured to deliver a neurostimulator into a pterygopalatine fossa (PPF) of a subject, the neurostimulator including a body connected to an integral stimulation lead having one or more stimulating electrodes, the delivery tool comprising:
 a handle;   an elongated shaft extending from the handle;   a hub portion located between the shaft and a spine member that extends axially away from the hub portion, the hub portion being sized and dimensioned to releasably mate with the neurostimulator; and   a double barrel sheath connected to the spine member;   wherein a central lumen extends through at least a portion of the shaft and the hub portion, the central lumen being adapted to receive a lead ejector for selective deployment of the stimulation lead from the double barrel sheath.   
     
     
         2 . The delivery tool of  claim 1 , wherein the central lumen is in fluid communication with a first lumen of the double barrel sheath. 
     
     
         3 . The delivery tool of  claim 1 , wherein the spine member is disposed within a second lumen of the double barrel sheath. 
     
     
         4 . The delivery tool of  claim 1 , wherein a partial section of a first barrel comprising the double barrel sheath includes a lateral seam adapted to permit egress of the stimulation lead from the first lumen during deployment of the neurostimulator. 
     
     
         5 . The delivery tool of  claim 4 , wherein a proximal end of the seam terminates at an aperture adapted to receive the stimulation lead of the neurostimulator therethrough. 
     
     
         6 . A method for deploying a neurostimulator in close proximity to a sphenopalatine ganglion (SPG) of a subject, the neurostimulator including a body connected to an integral stimulation lead having one or more stimulating electrodes, the method comprising the steps of:
 (a) loading the neurostimulator onto a delivery tool, the delivery tool comprising a handle, an elongated shaft extending from the handle, a hub portion located between the shaft and a spine member that extends axially away from the hub portion, and a double barrel sheath connected to the spine member, at least a portion of the shaft and the hub portion including a central lumen extending therethrough;   (b) advancing the delivery tool so that the stimulation lead of the neurostimulator is adjacent a pterygopalatine fossa (PPF) of the subject;   (c) deploying an ejector lead through the central lumen of the delivery tool to cause the stimulation lead to emerge from the double barrel sheath so that the stimulation lead is in close proximity to the SPG; and   (d) withdrawing the delivery tool so that the neurostimulator remains implanted in the subject.   
     
     
         7 . The method of  claim 6 , wherein steps (c) and (d) are performed simultaneously. 
     
     
         8 . The method of  claim 6 , wherein a partial section of a first barrel comprising the double barrel sheath includes a lateral seam adapted to permit egress of the stimulation lead from the first lumen during deployment of the neurostimulator. 
     
     
         9 . A navigation-compatible delivery tool configured to deliver a neurostimulator into a pterygopalatine fossa (PPF) of a subject, the neurostimulator including a body connected to an integral stimulation lead having one or more stimulating electrodes, the delivery tool comprising:
 a handle;   an elongated shaft extending from the handle;   a hub portion located between the shaft and a trunk member that extends axially away from the hub portion;   a spine member connected to and extending from the trunk member; and   a double barrel sheath connected to the spine member.   
     
     
         10 . The delivery tool of  claim 9 , further including a lead ejector for selective deployment of the stimulation lead from the double barrel sheath. 
     
     
         11 . The delivery tool of  claim 10 , wherein a central lumen extends through at least a portion of the shaft and the hub portion, the central lumen being adapted to receive the lead ejector. 
     
     
         12 . The delivery tool of  claim 11 , wherein the central lumen is in fluid communication with a first lumen of the double barrel sheath. 
     
     
         13 . The delivery tool of  claim 9 , wherein the spine member is disposed within a second lumen of the double barrel sheath. 
     
     
         14 . The delivery tool of  claim 9 , wherein a partial section of a first barrel comprising the double barrel sheath includes a lateral seam adapted to permit egress of the stimulation lead from the first lumen during deployment of the neurostimulator. 
     
     
         15 . The tool of  claim 14 , wherein a proximal end of the seam terminates at an aperture adapted to receive the stimulation lead of the neurostimulator therethrough. 
     
     
         16 . The tool of  claim 9 , wherein a first barrel comprising the double barrel sheath has a circular cross-section and a second barrel comprising the double barrel sheath has a rectangular cross-section. 
     
     
         17 . A navigation-assisted method for deploying a neurostimulator in close proximity to a sphenopalatine ganglion (SPG) of a subject, the neurostimulator including a body connected to an integral stimulation lead having one or more stimulating electrodes, the method comprising the steps of:
 (a) loading the neurostimulator onto a delivery tool, the delivery tool comprising a handle, an elongated shaft extending from the handle, a hub portion located between the shaft and a trunk member that extends axially away from the hub portion, a spine member connected to and extending from the trunk member, and a double barrel sheath connected to the spine member;   (b) advancing the delivery tool so that the stimulation lead of the neurostimulator is adjacent a pterygopalatine fossa (PPF) of the subject;   (c) manipulating the handle to cause a lead ejector of the delivery tool to displace the stimulation lead from the double barrel sheath so that the stimulation lead is in close proximity to the SPG; and   (d) withdrawing the delivery tool so that the neurostimulator remains implanted in the subject;   wherein steps (b)-(d) are performed using a navigation system.   
     
     
         18 . The method of  claim 17 , wherein steps (c) and (d) are performed simultaneously. 
     
     
         19 . The method of  claim 17 , wherein a partial section of a first barrel comprising the double barrel sheath includes a lateral seam adapted to permit egress of the stimulation lead from the first lumen during deployment of the neurostimulator.