# US 10,945,649 B2 · Medical device inserters and processes of inserting and using medical devices > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,945,649 B2 - Document ID: US10945649B2 - Status: Granted - Kind: B2 - Application number: 17/008,630 - Filed: 2020-08-31 - Published: 2020-12-24 - Granted: 2021-03-16 - Earliest claimed: 2010-03-24 - Assignees: Abbott Diabetes Care Inc. - Applicants: Abbott Diabetes Care Inc. - Inventors: Daniel H. Lee; Michael R. Love; Louis G. Pace; Phillip Yee - Web page: https://patentgrep.com/patent/US10945649B2 ## CPC - A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)} - A61B 5/1411: {by percutaneous method, e.g. by lancet} - A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)} - A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement} - A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)} - A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes} - A61B 5/150022: {for capillary blood or interstitial fluid} - A61B 5/150259: {Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape} - A61B 5/150282: {for piercing elements, e.g. blade, lancet, canula, needle} - A61B 5/150396: {Specific tip design, e.g. for improved penetration characteristics} - A61B 5/150419: {comprising means for capillary action} - A61B 5/150427: {Specific tip design, e.g. for improved penetration characteristics} - A61B 5/150511: {Details of construction of shaft} - A61B 5/15087: {short range, e.g. between console and disposable (using implanted devices A61B5/150877)} - A61B 5/15107: {Piercing being assisted by a triggering mechanism} - A61B 5/15113: {Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button} - A61B 5/15117: {comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap} - A61B 5/1513: {comprising linear sliding guides (comprising tooth-shaped elements A61B5/15132)} - A61B 5/15186: {Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use} - A61B 5/1519: {comprising driving means, e.g. a spring, for propelling the piercing unit} - A61B 5/15194: {fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin} - A61B 5/157: {Devices} characterised by integrated means for measuring characteristics of blood - A61B 5/6848: {Needles} - A61B 5/6865: {Access ports} - A61B 17/34: Trocars; Puncturing needles - A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body} - A61B 5/0002: {Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07)} - A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20) - A61B 5/15016: {by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element} - A61B 5/150732: {Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube} - A61B 2017/00384: {Actuation of one tool by pushing two buttons simultaneously} - A61B 2560/063: Devices specially adapted for delivering implantable medical measuring apparatus - A61M 2005/1585: {Needle inserters} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. ## Claims ### Claim 1 An inserter assembly for inserting a glucose sensor into a subject, the inserter assembly comprising: an inserter housing; the glucose sensor disposed within the inserter housing, wherein a part of the glucose sensor is configured to be inserted under a skin surface of the subject; a rotor disposed within the inserter housing, the rotor comprising a rotor follower projection; a torsion spring received within the rotor, wherein the torsion spring is configured to cause rotation of the rotor and the rotor follower projection; a first slidable body disposed within the inserter housing, the first slidable body comprising a slot, wherein the rotor follower projection is received within the slot, and wherein the rotation of the rotor and the rotor follower projection causes the first slidable body, a second slidable body, and the glucose sensor to advance within the inserter housing in a linear direction towards an insertion site on the skin surface of the subject; the second slidable body disposed within the inserter housing, wherein the second slidable body is coupled with a needle; and a compression spring configured to expand and to retract the second slidable body and the needle in a linear direction away from the insertion site while the glucose sensor remains at the insertion site. ### Claim 2 (depends on 1) The inserter assembly of claim 1, wherein the rotation of the rotor and the rotor follower projection causes the first slidable body and the second slidable body to advance simultaneously. ### Claim 3 (depends on 1) The inserter assembly of claim 1, wherein at least a portion of the glucose sensor is disposed within the needle during advancement of the first slidable body in the linear direction towards the insertion site. ### Claim 4 (depends on 1) The inserter assembly of claim 1, wherein the torsion spring comprises a winding, a first end extending from the winding, and a second end extending from the winding. ### Claim 5 (depends on 4) The inserter assembly of claim 4, wherein the first end of the torsion spring engages with the inserter housing and the second end of the torsion spring engages with the rotor. ### Claim 6 (depends on 1) The inserter assembly of claim 1, wherein the slot comprises a straight portion. ### Claim 7 (depends on 1) The inserter assembly of claim 1, wherein the housing comprises a recess in which the rotor is received. ### Claim 8 (depends on 1) The inserter assembly of claim 1, wherein a force applied by the rotor follower projection against a wall of the slot advances the first slidable body. ### Claim 9 (depends on 1) The inserter assembly of claim 1, wherein the slot in the first slidable body with the rotor follower projection received within the slot allows the first slidable body to advance towards the skin surface of the subject. ### Claim 10 (depends on 1) The inserter assembly of claim 1, wherein the rotor follower projection is configured to rotate in a circular path. ### Claim 11 (depends on 1) The inserter assembly of claim 1, wherein the rotor comprises a cylindrical shape. ### Claim 12 (depends on 1) The inserter assembly of claim 1, wherein the torsion spring comprises a center aperture that receives a second projection of the inserter assembly, wherein the torsion spring is configured to rotate around the second projection. ### Claim 13 (depends on 1) The inserter assembly of claim 1, further comprising a button configured to release the torsion spring when the button is depressed. ### Claim 14 (depends on 1) The inserter assembly of claim 1, wherein the glucose sensor comprises a proximal retention portion, a distal insertion portion, and a bendable portion located therebetween. ### Claim 15 (depends on 14) The inserter assembly of claim 14, wherein the bendable portion of the glucose sensor is configured to bend prior to coupling of on body electronics to the glucose sensor. ### Claim 16 (depends on 14) The inserter assembly of claim 14, wherein the bendable portion of the glucose sensor is configured to bend during coupling of on body electronics to the glucose sensor. ### Claim 17 (depends on 1) The inserter assembly of claim 1, wherein the torsion spring is provided in a pre-loaded state. ### Claim 18 An inserter assembly for inserting a glucose sensor into a subject, the inserter assembly comprising: an inserter housing comprising a recess; the glucose sensor disposed within the inserter housing, wherein a part of the glucose sensor is configured to be inserted under a skin surface of the subject; a rotor comprising a cylindrical shape, wherein the rotor is disposed within the recess of the inserter housing, and wherein the rotor comprises a rotor follower projection; a torsion spring received within the rotor, wherein the torsion spring is configured to cause rotation of the rotor and the rotor follower projection, wherein the torsion spring comprises a center aperture configured to receive a second projection of the inserter assembly, and wherein the torsion spring is configured to rotate around the second projection; a first slidable body disposed within the inserter housing, the first slidable body comprising a slot, wherein the rotor follower projection is received within the slot, and wherein the rotation of the rotor and the rotor follower projection causes the first slidable body, a second slidable body, and the glucose sensor to advance within the inserter housing in a linear direction towards an insertion site on the skin surface of the subject; a button configured to release the torsion spring when the button is depressed; the second slidable body disposed within the inserter housing, wherein the second slidable body is coupled with a needle; and a compression spring configured to expand and to retract the second slidable body and the needle in a linear direction away from the insertion site while the glucose sensor remains at the insertion site, wherein a first end of the compression spring is in contact with the first slidable body and a second end of the compression spring is in contact with the second slidable body, and wherein the rotation of the rotor and the rotor follower projection causes the first slidable body and the second slidable body to advance simultaneously towards the insertion site. ### Claim 19 (depends on 18) The inserter assembly of claim 18, wherein the torsion spring comprises a winding, a first end extending from the winding, and a second end extending from the winding, and wherein the first end of the torsion spring engages with the inserter housing and the second end of the torsion spring engages with the rotor. ### Claim 20 (depends on 18) The inserter assembly of claim 18, wherein the slot comprises a straight portion. ### Claim 21 (depends on 18) The inserter assembly of claim 18, wherein a force applied by the rotor follower projection against a wall of the slot advances the first slidable body. ### Claim 22 (depends on 18) The inserter assembly of claim 18, wherein the slot in the first slidable body with the rotor follower projection received within the slot allows the first slidable body to advance towards the skin surface of the subject. ### Claim 23 (depends on 18) The inserter assembly of claim 18, wherein the rotor follower projection is configured to rotate in a circular path. ### Claim 24 (depends on 18) The inserter assembly of claim 18, wherein the glucose sensor comprises a proximal retention portion, a distal insertion portion, and a bendable portion located therebetween. ### Claim 25 (depends on 24) The inserter assembly of claim 24, wherein the bendable portion of the glucose sensor is configured to bend prior to coupling of on body electronics to the glucose sensor. ### Claim 26 (depends on 24) The inserter assembly of claim 24, wherein the bendable portion of the glucose sensor is configured to bend during coupling of on body electronics to the glucose sensor. ### Claim 27 (depends on 18) The inserter assembly of claim 18, wherein at least a portion of the glucose sensor is disposed within the needle during advancement of the first slidable body in the linear direction towards the insertion site. ### Claim 28 (depends on 18) The inserter assembly of claim 18, wherein the torsion spring is provided in a pre-loaded state.