# US 11,998,328 B2 · Medical device for transcutaneously inserting an insertable element into a body tissue > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,328 B2 - Document ID: US11998328B2 - Status: Granted - Kind: B2 - Application number: 16/226,960 - Filed: 2018-12-20 - Published: 2019-04-25 - Granted: 2024-06-04 - Earliest claimed: 2016-06-22 - Assignees: Roche Diabetes Care, Inc. - Applicants: Roche Diabetes Care, Inc. - Inventors: Joachim Jäger - Web page: https://patentgrep.com/patent/US11998328B2 ## CPC - A61B 5/14865: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors} - A61B 5/145: Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value {; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue} (non-radiation detecting or locating of foreign bodies in blood A61B5/06) - 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 5/6833: {Adhesive patches} - A61B 17/3415: {for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters (A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06)} - A61B 17/3423: {Access ports, e.g. toroid shape introducers for instruments or hands (access sites for liquids A61M39/0247)} - A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)} - A61M 5/14248: {of the skin patch type} - A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body} - A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure} - A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes} - A61B 5/6843: {Monitoring or controlling sensor contact pressure} - A61B 5/6848: {Needles} - A61B 2017/00867: {shape memory effect} - A61M 5/1407: {Infusion of two or more substances} - A61M 5/145: using pressurised reservoirs, e.g. by means of pistons - A61M 5/162: Needle sets, i.e. connections by puncture between reservoir and tube - A61M 2005/14252: {with needle insertion means} - A61M 2005/1585: {Needle inserters} - A61M 2005/1586: {Holding accessories for holding infusion needles on the body} - 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 A medical device for transcutaneously inserting an insertable element into a body tissue. The medical device includes an insertable element and an insertion cannula for subcutaneously inserting the insertable element. The insertable element includes an in vivo distal end for subcutaneous insertion and an ex vivo proximal end. The insertion cannula has a lumen configured to receive the insertable element that is fully or partially enclosed by a wall of the insertion cannula. The wall comprises at least one shape memory alloy wherein the insertion cannula is stored in a first shape configuration and is configured to be transformable into a second shape configuration for insertion. ## Claims ### Claim 1 A medical device for performing a transcutaneous insertion into a body tissue, wherein the medical device comprises: an insertable element, wherein the insertable element is flexible and includes an in vivo distal end for subcutaneous insertion and an ex vivo proximal end; an insertion cannula for subcutaneously inserting the insertable element, the insertion cannula having a lumen which fully or partially is enclosed by a wall of the insertion cannula, wherein the insertable element is received in the lumen, wherein the wall comprises at least one shape memory alloy, wherein the insertion cannula is stored in a first shape configuration, and wherein the insertion cannula is configured to be transformable into a second shape configuration for insertion, wherein the in vivo distal end of the insertable element adopts a first shape corresponding to the first shape configuration when the insertion cannula is in the first shape configuration and the in vivo distal end of the insertable element adopts a second shape corresponding to the second shape configuration when the insertion cannula is transformed into the second shape configuration for insertion; and a patch configured to be mounted onto the skin of a user wherein the insertion cannula is configured such that the insertion cannula is withdrawn into the patch after insertion of the insertable element and the insertable element is configured to stay at least partially within the body tissue after the insertion cannula is withdrawn into the patch. ### Claim 2 (depends on 1) The medical device according to claim 1, wherein the insertion cannula is one of: a closed cannula with the wall circumferentially enclosing the lumen; a slotted cannula, with the insertion cannula having a slot extending in an axial direction. ### Claim 3 (depends on 1) The medical device according to claim 1, wherein at least a portion of the insertion cannula has an essentially rectangular shape. ### Claim 4 (depends on 1) The medical device according to claim 1, wherein the shape memory alloy includes a superelastic or a pseudoelastic shape memory alloy, which is configured to change a shape of the insertion cannula depending on mechanical stress. ### Claim 5 (depends on 1) The medical device according to claim 1, wherein the insertion cannula forms at least one arch when in the second shape configuration. ### Claim 6 (depends on 1) The medical device according to claim 1, wherein the medical device includes an integrated insertion mechanism which comprises at least one drive unit, wherein the drive unit is configured to urge the insertion cannula in a direction of insertion. ### Claim 7 (depends on 1) The medical device according to claim 1, wherein the patch includes a patch base and an integrated insertion mechanism configured for driving the insertion cannula from the first shape configuration into the second shape configuration. ### Claim 8 (depends on 7) The medical device according to claim 7, wherein the medical device further comprises at least one element connectable to the patch base, wherein the integrated insertion mechanism is configured to be driven by a connecting force exerted when connecting the element to the patch base. ### Claim 9 (depends on 7) The medical device according to claim 7, wherein the medical device further comprises at least one electronics unit configured for interacting with the insertable element. ### Claim 10 (depends on 9) The medical device according to claim 9, wherein the integrated insertion mechanism is a linear sliding mechanism, wherein the electronics unit comprises at least one linear sliding receptacle and the patch comprises at least one linear sliding guide rail or vice versa, wherein the linear sliding receptacle and the linear sliding guide rail in conjunction form a linear sliding connector configured for establishing a releasable mechanical connection between the electronics unit and the patch. ### Claim 11 (depends on 9) The medical device according to claim 9, wherein the electronics unit comprises at least one electronics unit bayonet contour, wherein the patch comprises at least one patch bayonet contour, wherein the patch bayonet contour and the electronics unit bayonet contour in conjunction form a bayonet connector configured for establishing a releasable mechanical connection between the electronics unit and the patch. ### Claim 12 (depends on 1) An analyte measurement device for detecting an analyte in a body fluid, the analyte measurement device comprising a medical device according to claim 1, wherein the insertable element comprises an analyte sensor for detecting the analyte in the body fluid, the analyte measurement device further having an evaluation device interacting with the analyte sensor. ### Claim 13 (depends on 1) A medication delivery device for delivering at least one medication to a user, the medication delivery device comprising a medical device according claim 1, wherein the insertable element comprises at least one of an infusion cannula or a dosing tube, and wherein the medication device further comprises at least one medication pump fluidly coupled to the insertable element. ### Claim 14 (depends on 1) A method for performing a transcutaneous insertion, wherein the method comprises: a) providing the medical device according to claim 1, the medical device having an electronics unit and the patch includes a patch base; b) placing the patch base onto the skin; and c) inserting the insertable element into the body tissue. ### Claim 15 (depends on 1) The medical device according to claim 1, wherein the insertable element is configured to stay at least partially within the body tissue after the insertion cannula is withdrawn into the patch.