Subcutaneous delivery tool

Abstract

Subcutaneous implantation tools and methods of implanting a subcutaneous device using the same. The tool may include a tool body having a longitudinally extending recess having a distal opening and having a tunneler at a distal end of the tool body extending from the distal opening of the recess. The tool may include a plunger slidably fitting within at least a portion of the tool body recess. The recess may be configured to receive an implantable device and the tunneler preferably extends distally from the recess at a position laterally displaced from the device when the device is so located in the recess. Movement of the plunger distally within the recess advances the device distally out of the recess and alongside of and exterior to the tunneler.

What is claimed is: 
     
         1 . A system comprising:
 a first implantation tool portion including a first proximal end and a first distal end, wherein the first implantation tool portion is configured to create a pocket in subcutaneous tissue of a patient;   a second implantation tool portion defining a channel, the second implantation tool portion including a second proximal end and a second distal end, wherein the second implantation tool portion defines a proximal opening of the channel at the second proximal end, wherein the second implantation tool portion defines a distal opening of the channel at the second distal end, wherein the second implantation tool portion defines a lateral opening of the channel on a lateral surface of the second implantation tool portion, wherein the channel is configured to receive an insertable cardiac monitor (ICM) so that the ICM is visible in the channel through the lateral opening, wherein the first proximal end of the first implantation tool portion adjoins the second distal end of the second implantation tool portion; and   a plunger configured to distally advance along the channel through the proximal opening of the channel to push the ICM out of the distal opening of the channel and advance the ICM along an exterior surface of the first implantation tool portion into the pocket in the subcutaneous tissue of the patient.   
     
     
         2 . The system of  claim 1 , wherein the first implantation tool portion is configured to create the pocket in the subcutaneous tissue of the patient via blunt dissection. 
     
     
         3 . The system of  claim 1 ,
 wherein a longest dimension of a cross-section of the first implantation tool portion is shorter than a longest dimension of a cross-section of the second implantation tool portion, and   wherein the cross-section of the first implantation tool portion and the cross-section of the second implantation tool portion correspond to a location at which the first proximal end of the first implantation tool portion adjoins the second distal end of the second implantation tool portion.   
     
     
         4 . The system of  claim 1 , wherein the plunger defines a groove, wherein the second implantation tool portion defines a projection into the channel, and wherein the groove corresponds to and engages with the projection into the channel. 
     
     
         5 . The system of  claim 1 , further comprising an incision tool comprising:
 an incision tool handle;   a blade extending from a distal end of the incision tool handle; and   a pair of incision tool finger grips on the incision tool handle, wherein each incision tool finger grip of the pair of incision tool finger grips is located on an indent in the incision tool handle,   wherein the blade is configured to create an opening in skin of the patient by advancing into the skin of the patient, and wherein the first implantation tool portion is configured to create the pocket in the subcutaneous tissue of the patient via blunt dissection by advancing into the subcutaneous tissue of the patient through the opening in the skin of the patient.   
     
     
         6 . The system of  claim 5 , wherein the incision tool handle comprises a proximal portion, a distal portion, and a center portion, wherein the center portion curves to the proximal portion at a first curve, wherein the center portion curves to the distal portion at a second curve, and wherein the first curve is opposite the second curve relative to a longitudinal axis of the incision tool. 
     
     
         7 . The system of  claim 5 , wherein the pair of incision tool finger grips are located closer to the distal end of the incision tool handle than a proximal end of the incision tool handle so that a user of the incision tool can comfortably hold the incision tool and insert the blade at an angle relative to the skin of the patient. 
     
     
         8 . The system of  claim 1 , wherein the channel is configured to receive an entire length of the ICM from a proximal end of the ICM to a distal end of the ICM. 
     
     
         9 . The system of  claim 1 , wherein the plunger comprises:
 a distal plunger portion configured to move in the channel; and   a proximal plunger portion, wherein a cross-section of the proximal plunger portion at a distal end of the proximal plunger portion is larger than a cross-section of the distal plunger portion at a proximal end of the distal plunger portion.   
     
     
         10 . The system of  claim 9 , wherein a cross-section of the proximal plunger portion at the distal end of the proximal plunger portion is larger than a cross-section of the channel at the proximal opening of the channel. 
     
     
         11 . The system of  claim 9 , wherein the distal end of the proximal plunger portion includes a stop surface which limits distal movement of the plunger by preventing the proximal plunger portion from entering the channel. 
     
     
         12 . The system of  claim 1 , further comprising the ICM, wherein an outer configuration of the ICM comprises an elongated rectangular prism, and wherein the ICM comprises a rounded distal end portion. 
     
     
         13 . The system of  claim 12 , wherein an inner surface of the channel is configured to correspond to the outer configuration of the ICM to prevent rotation of the ICM within the second implantation tool portion. 
     
     
         14 . The system of  claim 13 , wherein the inner surface of the channel includes:
 one or more corner surfaces, wherein each corner surface of the one or more corner surfaces corresponds to a respective corner of the ICM; and   one or more side surfaces, wherein each side surface of the one or more side surfaces corresponds to a respective side of the ICM.   
     
     
         15 . The system of  claim 12 , wherein the outer configuration of the ICM includes rounded corners. 
     
     
         16 . The system of  claim 12 , wherein the rounded distal end portion of the ICM performs blunt dissection as the ICM advances into the subcutaneous tissue. 
     
     
         17 . The system of  claim 12 , wherein the ICM includes a length, a width, and a depth, wherein the width of the ICM is greater than the depth of the ICM such that the ICM has radial asymmetry along a longitudinal axis of the ICM, the radial asymmetry maintaining an orientation of the ICM within the subcutaneous tissue by preventing the ICM from rotating about the longitudinal axis of the ICM. 
     
     
         18 . The system of  claim 1 , wherein the first distal end of the first implantation tool portion is tapered. 
     
     
         19 . The system of  claim 1 , further comprising the ICM, an incision tool, and a sterile package, wherein the ICM within the implantation tool handle, the plunger, and the incision tool are included within the sterile package. 
     
     
         20 . A system comprising:
 an insertable cardiac monitor (ICM);   a first implantation tool portion including a first proximal end and a first distal end, wherein the first implantation tool portion is configured to create a pocket in subcutaneous tissue of a patient;   a second implantation tool portion defining a channel, the second implantation tool portion including a second proximal end and a second distal end, wherein the second implantation tool portion defines a proximal opening of the channel at the second proximal end, wherein the second implantation tool portion defines a distal opening of the channel at the second distal end, wherein the second implantation tool portion defines a lateral opening of the channel on a lateral surface of the second implantation tool portion, wherein the channel is configured to receive the ICM so that the ICM is visible in the channel through the lateral opening, wherein the first proximal end of the first implantation tool portion adjoins the second distal end of the second implantation tool portion; and   a plunger configured to distally advance along the channel through the proximal opening of the channel to push the ICM out of the distal opening of the channel and advance the ICM along an exterior surface of the first implantation tool portion into the pocket in the subcutaneous tissue of the patient.