Systems and methods for implanting an implantable cardiac monitor

Abstract

Systems and methods are provided for implanting an implantable cardiac monitor. An insertion system includes an implantable cardiac monitor (ICM). An insertion housing comprises a passage extending from a first end of the insertion housing to a second end of the insertion housing. The passage configured to receive the obturator and a receptacle in communication with the passage and an external environment. The receptacle configured to receive the ICM. An obturator is configured to move within the passage when the obturator is moved relative to the insertion housing. The obturator has a channel forming section at a distal end thereof and a motion limiter is provided on at least one of the shaft and the insertion housing.

What is clamied is: 
     
         1 . An insertion system comprising:
 an implantable cardiac monitor (ICM);   an insertion housing comprising:
 a passage extending from a first end of the insertion housing to a second end of the insertion housing, the passage configured to receive the obturator; and 
 a receptacle in communication with the passage and an external environment, the receptacle configured to receive the ICM; 
   an obturator configured to move within the passage when the obturator is moved relative to the insertion housing, the obturator having a channel forming section at a distal end thereof; and   a motion limiter provided on at least one of the shaft and the insertion housing.   
     
     
         2 . The system of  claim 1 , wherein the second range represents an ICM final implant path and the motion limiter defines an end of the ICM final implant path, a distal end of the obturator being positioned substantially flush with the second end of the insertion housing when reaching the end of the ICM final implant path. 
     
     
         3 . The system of  claim 1 , wherein the first range represents a pocket formation path, the motion limiter includes a latch arm located along a side of a shaft of the obturator and at least one recessed region in the passage, the latch an extending laterally outward from the side into the at least one recessed region when the obturator moves to an end of the pocket fonnation path and when the obturator moves to an end of the ICM final implant path. 
     
     
         4 . The system of  claim 1 , wherein the motion limiter includes at least one latch and at least one recessed region provided on the obturator and insertion housing. 
     
     
         5 . The system of  claim 1 , wherein the obturator includes a channel forming section provided at a distal end of the obturator, the channel forming section having a cross-seetion and being sized and dimensioned similar to a cross-section, size and dimension of the ICM. 
     
     
         6 . The system of  claim 5 , wherein the channel forming section of the obturator is configured to be utilized during a blunt dissection stabbing action to form an initial channel under patient tissue. 
     
     
         7 . The system of  claim 1 , wherein the injector housing includes a blunt dissection barrel provided at the second end, the blunt dissection barrel is configured to be utilized during a blunt dissection stabbing action to form an initial channel under patient tissue, the blunt dissection barrel having a length that is shorter than a length of the ICM. 
     
     
         8 . The system of  claim 7 , wherein the length of the blunt dissection barrel is no more than one third of a length of the ICM. 
     
     
         9 . A method for operating an insertion system, the method comprising:
 inserting an obturator into a passage in an insertion housing such that the obturator extends from a first end of the insertion housing through a second end of the insertion housing;   inserting an implantable cardiac monitor (ICM) into a receptacle of the insertion housing, wherein the receptacle is in communication with the tube of the insertion housing,   the obturator configured to move along a first range until the channel forming section extends a predetermined distance from the second end of the insertion housing, the predetermined distance being defined by the motion limiter;   the obturator configured to move along a second range in which the channel forming section forces the ICM from the second end of the insertion housing.   
     
     
         10 . The method of  claim 9 , further comprising initially positioning the obturator and insertion housing in a blunt dissection state, when a obturator and a blunt dissection barrel at the second end of the insertion housing is inserted through an incision to a desired depth, moving along a range of motion corresponding to an ICM pocket formation path until reaching a fully inserted position corresponding to an ICM pocket formation state. 
     
     
         11 . The method of  claim 9 , further comprising applying force to a handle of the obturator to maintain a channel forming section at the distal end of the obturator extended from the second end of the insertion housing to form an ICM pocket. 
     
     
         12 . The method of  claim 11 , further comprising, once the ICM pocket is formed, pulling back on the obturator until the channel forming section of the obturator is positioned behind the receptacle of the insertion housing in order to permit the ICM to move into the passage. 
     
     
         13 . The method of  claim 12 , further comprising applying force to the handle of the obturator to direct the distal end of the obturator to discharge the ICM from the second end of the insertion housing into the ICM pocket. 
     
     
         14 . The method of  claim 9 , further comprising moving the obturator relative to the insertion housing until reaching a motion limiter, the motion limiter definingat least one of an end for a pocket forming state or an ICM final implant state for the obturator and insertion housing. 
     
     
         15 . An insertion system comprising:
 an implantable cardiac monitor (ICM) including first and second ICM electrodes configured to be utilized in connection with sensing physiologic signals, the first and second ICM electrodes separated by an electrode spacing; and   a medical instrument, comprising:
 a shaft with an channel preparation element configured to be inserted subcutaneously into an ICM channel region; and 
 first and second instrument electrodes provided on the channel preparation element and configured to sense physiologic signals during an ICM implant process, 
 the first and second instrument electrodes separated by the electrode spacing. 
   
     
     
         16 . The system of  claim 15 , wherein the channel preparation element represents a needle having a distal end and a proximal end, the first and second instrument electrodes provided on the needle at the distal and proximal ends, respectively, conductors coupled to the first and second instrument electrodes and extending along the needle, the conductors having proximal ends with contacts configured to be electrically coupled to at least one of the ICM or an external device. 
     
     
         17 . The system of  claim 16 , wherein the medical instrument further comprises a syringe coupled to the proximal end of the needle. 
     
     
         18 . The system of  claim 15 , wherein the medical instrument further comprises a probe body that includes a receptacle configured to receive the ICM, the receptacle including first and second contacts spaced apart from one another and positioned to align with the first and second ICM electrodes, the first and second contacts electrically coupled to the first and second instrument electrodes and configured to convey physiologic signals sensed by the first and second instrument electrodes to the ICM. 
     
     
         19 . The system of  claim 18 , wherein the channel preparation element represents a needle with a distal end and a proximal end, the proximal end coupled to the probe body, the first and second instrument electrodes provided on the distal and proximal ends, respectively, of the needle. 
     
     
         20 . The system of  claim 15 , wherein the medical instrument comprises:
 an insertion housing comprising:
 a passage extending from a first end of the insertion housing to a second end of the insertion housing, the passage configured to receive the obturator; and 
 a receptacle in communication with the passage and an external environment, the receptacle configured to receive the ICM; 
   the shaft representing an obturator configured to move within the passage when the obturator is moved relative to the insertion housing,   the channel preparation element representing a channel forming section at a distal end of the obturator,   the first and second instrument electrodes provided on the channel forming section and configured to collect the physiologic signals when the channel forming section is extended to a pocket formation state subcutaneously in the ICM channel region.   
     
     
         21 . A method for mapping an implant location and orientation for an implantable cardiac monitoring (ICM) device, the method comprising:
 inserting an channel preparation element of a medical instrument subcutaneously into a ICM candidate location at a particular orientation;   sensing physiologic signals at instrument electrodes located along the channel preparation element;   utilizing one or more processors to analyze a characteristic of interest from the physiologic signals relative to a signal criterion; and   designating the ICM candidate location and orientation as a final ICM implant location based on the analysis of the characteristic of interest.   
     
     
         22 . The method of  claim 21 , further comprising maintaining the channel preparation element at an ICM candidate position and orientation while sensing the physiologic signals. 
     
     
         23 . The method of  claim 21 , further comprising recording the physiologic signals at the ICM, wherein the ICM analyzes the characteristic of interest from the physiologic signals. 
     
     
         24 . The method of  claim 21 , further comprising recording the physiologic signals to the ICM, wherein the ICM designates whether the ICM candidate location and orientation qualifies as a final ICM implant location. 
     
     
         25 . The method of  claim 21 , further comprising conveying the physiologic signals to the ICM, the ICM conveying the physiologic signals to an external device, the external monitoring device performing the analyzing operation. 
     
     
         26 . The method of  claim 21 , wherein the channel preparation element represents a needle having a distal end and a proximal end, the instrument electrodes provided on the needle at the distal and proximal ends, the method comprising conveying the physiologic signals from the instrument electrodes to at least one of the ICM or an external device. 
     
     
         27 . The method of  claim 21 , wherein the medical instrument comprises a probe body, the method further comprising inserting the ICM into a receptacle provided in the probe body where ICM electrodes on the ICM engage contacts within the receptacle, the ICM recording the physiologic signals sensed by the instrument electrodes.