# US 9,615,851 B2 · Method and apparatus for insertion of a sensor > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,615,851 B2 - Document ID: US9615851B2 - Status: Granted - Kind: B2 - Application number: 13/415,828 - Filed: 2012-03-08 - Published: 2012-10-18 - Granted: 2017-04-11 - Earliest claimed: 2005-11-11 - Assignees: WaveForm Technologies, Inc. - Applicants: Mark Neinast; Robert Bruce; W. Kenneth Ward; Richard G. Sass; Jon Fortuna - Inventors: Mark Neinast; Robert Bruce; W. Kenneth Ward; Richard G. Sass; Jon Fortuna - Web page: https://patentgrep.com/patent/US9615851B2 ## CPC - A61B 5/6849: {in combination with a needle set} - A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement} - A61B 5/1473: invasive, e.g. introduced into the body by a catheter - A61B 17/3403: {Needle locating or guiding means} - A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A device and method for delivering a device such as a sensor or fluid transport structure or a fluid transport structure sensor combination into, for example, mammalian skin. Such a device allows a sensor to penetrate mammalian skin without the use of an introducer device such as a needle. A device in accordance with embodiments of the present disclosure includes a housing for attachment to mammalian skin including an exit port for receiving the distal end of a biosensor and an injection activation device including a mechanism for forcing the sensing device from a first position within the housing, through the exit port to a second position, with sufficiently high velocity to partially penetrate the mammalian skin. ## Claims ### Claim 1 An insertion device comprising: a guidance structure having an exit port and adapted to provide axial support to a flexible analyte sensor wherein the stiffness of the flexible analyte sensor is about 1.4 to about 22.6 grams-force per millimeter of deflection for an unsupported length of 10 millimeters; and an injection activation device associated with the guidance structure, said injection activation device having: a mechanism adapted to apply a high speed motive force to the flexible analyte sensor such that, when the high speed motive force is applied, the flexible analyte sensor moves at least partially through the guidance structure and at least partially passes through the exit port to cause insertion of only the flexible analyte sensor into skin; and wherein the high speed motive force is such that a velocity of the flexible analyte sensor at a time of insertion is approximately 5 meters per second to approximately 15 meters per second, wherein the guidance structure is configured so that an unsupported length of the flexible analyte sensor is less than a buckling length of the flexible analyte sensor above which the flexible analyte sensor will buckle from application of the high speed motive force, and wherein the buckling length of the flexible analyte sensor is determined by a formula Pcr=π2*k/(3*L2), wherein Pcr is a value of the high speed motive force applied to the sensor, k is a stiffness of the flexible analyte sensor, and L is the unsupported length of the flexible analyte sensor. ### Claim 2 (depends on 1) The insertion device of claim 1, wherein the velocity of the flexible analyte sensor at the time of insertion is approximately 6.4 meters per second. ### Claim 3 (depends on 1) The insertion device of claim 1, further comprising a housing having a bottom surface associated with the guidance structure, the guidance structure configured so that the flexible analyte sensor passes through the exit port at an angle from 10 to 40 degrees with respect to the bottom surface of the housing. ### Claim 4 (depends on 3) The insertion device of claim 3, further comprising a nub surrounding the exit port of the guidance structure, the nub configured to indent the skin at an insertion site such that the flexible analyte sensor is inserted into the skin at an angle that is substantially perpendicular to a plane of a local skin surface at the insertion site. ### Claim 5 (depends on 3) The insertion device of claim 3, wherein the flexible analyte sensor is inserted with an inserted length of the sensor of at least 12 millimeters. ### Claim 6 (depends on 1) The insertion device of claim 1, wherein the high speed motive force has a value of about 11 to 53 Newtons. ### Claim 7 (depends on 1) The insertion device of claim 1, wherein the high speed motive force has a value of about 22 Newtons. ### Claim 8 (depends on 1) The insertion device of claim 1, wherein an insertion angle of the sensor with respect to a plane of the skin is from 10 to 40 degrees. ### Claim 9 An insertion device comprising: a guidance structure adapted to provide axial support to a flexible analyte sensor, the guidance structure having an exit port; an injection activation device associated with the guidance structure, said injection activation device having: a mechanism adapted to apply a high speed motive force to the flexible analyte sensor such that, when the high speed motive force is applied, the flexible analyte sensor moves at least partially through the guidance structure and at least partially passes through the exit port to cause insertion of only the flexible analyte sensor into skin; and a tensioning structure configured to tension a surface of the skin so that a distance from the surface of the skin at an insertion site on the surface of the skin to the exit port is less than the buckling length of the sensor, and wherein the high speed motive force is such that a velocity of the flexible analyte sensor at a time of insertion is approximately 5 meters per second to approximately 15 meters per second, and wherein the guidance structure is configured so that an unsupported length of the flexible analyte sensor is less than a buckling length of the flexible analyte sensor above which the flexible analyte sensor will buckle from application of the high speed motive force. ### Claim 10 (depends on 9) The insertion device of claim 9, wherein the tensioning structure includes a nub surrounding the exit port of the guidance structure, the nub configured to indent the skin at an insertion site. ### Claim 11 (depends on 9) The insertion device of claim 9, wherein the tensioning structure includes an adhesive patch disposed on the surface of the skin, the adhesive patch including a hole surrounding an insertion site of the sensor. ### Claim 12 (depends on 9) The insertion device of claim 9, wherein the high speed motive force has a value of about 11 to 53 Newtons. ### Claim 13 (depends on 9) The insertion device of claim 9, wherein the high speed motive force has a value of about 22 Newtons. ### Claim 14 (depends on 9) The insertion device of claim 9, wherein an insertion angle of the sensor with respect to a plane of the skin is from 10 to 40 degrees. ### Claim 15 (depends on 9) The insertion device of claim 9, wherein the velocity of the flexible analyte sensor at the time of insertion is approximately 6.4 meters per second. ### Claim 16 (depends on 9) The insertion device of claim 9, further comprising a housing having a bottom surface associated with the guidance structure, the guidance structure configured so that the flexible analyte sensor passes through the exit port at an angle from 10 to 40 degrees with respect to the bottom surface of the housing. ### Claim 17 (depends on 16) The insertion device of claim 16, further comprising a nub surrounding the exit port of the guidance structure, the nub configured to indent the skin at an insertion site such that the flexible analyte sensor is inserted into the skin at an angle that is substantially perpendicular to a plane of a local skin surface at the insertion site. ### Claim 18 (depends on 16) The insertion device of claim 16, wherein the flexible analyte sensor is inserted with an inserted length of the sensor of at least 12 millimeters.