Insertion device for an insertion set and method of using the same

Abstract

An insertion device and insertion set. The insertion device for inserting at least a portion of at least one piercing member of an insertion set through the skin of a patient includes a device housing, a carrier body and a driver. The carrier body is slidably received within the device housing for movement between an advanced position and a retracted position. The carrier body also includes a receiving structure to support the insertion set in a position with the at least one piercing member oriented for insertion through the skin of the patient at a predetermined angle relative to the skin of the patient upon movement of the carrier body from the retracted position to the advanced position. The driver is operatively coupled between the device housing and the carrier body to urge the carrier body with a controlled force and speed from the retracted position toward the advanced position to place at least a portion of the at least one piercing member of the insertion set thorough the skin of the patient to install the insertion set to the patient. The receiving structure of the carrier body is removable from the insertion set while maintaining the installation of the insertion set to the patient.

1 .- 37 . (canceled) 
     
     
         38 . A system comprising an insertion set and an insertion device adapted to insert at least a portion of at least one piercing member of the insertion set through the skin of a patient, the insertion device comprising:
 a device housing;   a carrier body slidably received within the device housing adapted to move between an advanced position and a retracted position, the carrier body including a receiving structure to support the insertion set in a position with the at least one piercing member oriented for insertion through the skin of the patient at a predetermined angle relative to the skin of the patient upon movement of the carrier body from the retracted position to the advanced position, the carrier body is disposed after each insertion and when shipped contains the insertion set pre-installed; and   a driver operatively coupled between the device housing and the carrier body to urge the carrier body with a controlled force and speed from the retraced position toward the advanced position to place at least a portion of the at least one piercing member of the insertion set thought the skin of the patient to install the insertion set to the patient;   wherein the receiving structure of the carrier body is adapted to be removed from the insertion set while maintaining installation of the insertion set to the patient, and the insertion set is adapted to be left on the skin of the patient without the piercing member and the piercing member hub by removing the insertion device from the skin of the patient, the insertion device being engaged to the at least one piercing member and piercing member hub to withdraw the at least one piercing member and piercing member hub from the insertion set.   
     
     
         39 . A system according to  claim 38 , wherein the at least one piercing member is separable from the carrier body. 
     
     
         40 . A system according to  claim 38 , wherein the at least one piercing member extends through a cannula of the insertion set. 
     
     
         41 . A system according to  claim 38 , wherein the predetermined angle relative to the skin is about 90 degrees, or is between 90 degrees and 10 degrees. 
     
     
         42 . A system according to  claim 38 , wherein the predetermined angle relative to the skin is between 0 degrees and 10 degrees after insertion. 
     
     
         43 . A system according to  claim 38 , wherein the insertion set is one of a transcutaneous insertion set, and a subcutaneous insertion set. 
     
     
         44 . A system according to  claim 38 , wherein the insertion set either rests mainly on the surface of the skin after insertion, or is implanted in the skin of the patient after insertion. 
     
     
         45 . A system according to  claim 38 , wherein the at least one piercing member is one of a needle, and a plurality of needles, or the at least one piercing member are micro-needles. 
     
     
         46 . A system according to  claim 38 , wherein the insertion set is an infusion set, or a sensor set, or both an infusion set and sensor set combined into a integral unit. 
     
     
         47 . A system according to  claim 38 , wherein the device housing has a forward end defining a generally planar angled insertion contact surface for placement against the patient's skin with the device housing in a predetermined orientation relative to the patient's skin that mirrors the predetermined angle relative to the patient's skin. 
     
     
         48 . A system according to  claim 38 , further including a trigger mechanism that actuates the driver. 
     
     
         49 . A system according to  claim 38 , wherein the driver includes at least one spring for spring-loaded movement of the carrier body from the retracted position to the advanced position. 
     
     
         50 . A system according to  claim 38 , wherein the driver includes a force changing mechanism that permits alteration of the controlled force and speed of the carrier body moving from the retracted position to the advanced position from one insertion cycle to another insertion cycle. 
     
     
         51 . A system according to  claim 38 , wherein the device housing and the carrier body include a cooperatively engageable track mechanism for guiding movement of the carrier body between the advanced and retracted positions while retaining the carrier body against rotation relative to the device housing. 
     
     
         52 . A system according to  claim 38 , wherein the insertion device engages a hub of the at least one piercing member to withdraw the at least one piercing member from the insertion set.