# US 12,178,994 B2 · Flexible cannula insertion device, system and process > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,178,994 B2 - Document ID: US12178994B2 - Status: Granted - Kind: B2 - Application number: 18/134,512 - Filed: 2023-04-13 - Published: 2023-08-10 - Granted: 2024-12-31 - Earliest claimed: 2017-05-08 - Assignees: Medtronic MiniMed, Inc. - Applicants: Medtronic MiniMed, Inc. - Inventors: Chia-Hung Chiu; Hsifu Wang; Rebecca K. Gottlieb - Web page: https://patentgrep.com/patent/US12178994B2 ## CPC - A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body} - A61L 29/041: {obtained by reactions only involving carbon-to-carbon unsaturated bonds} - A61L 29/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds - A61M 5/142: Pressure infusion, e.g. using pumps - A61M 5/14248: {of the skin patch type} - A61M 25/0009: {Making of catheters or other medical or surgical tubes} - A61M 25/0043: {characterised by structural features} - A61M 39/02: Access sites - A61M 39/08: Tubes; Storage means specially adapted therefor - 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 2017/3454: {Details of tips} - A61M 25/065: {Guide needles} - A61M 2005/1585: {Needle inserters} - A61M 2005/1586: {Holding accessories for holding infusion needles on the body} - A61M 2005/1587: {suitable for being connected to an infusion line after insertion into a patient} - A61M 2025/0059: {having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking} - 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)} - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract An insertion set system includes a base configured to be secured to a patient, and a flexible tubing on the base. The flexible tubing has a distal end portion forming a cannula to be inserted into the patient. An inserter having a needle is received by the base. The needle has a channel in which the distal end portion of the flexible tubing is received. The needle is able to slide relative to the flexible tubing, to selectively withdraw the needle off of the distal end portion of the flexible tubing. The base may include a passage for fluid flow arranged transverse to the axial dimension of the distal end portion of the flexible tubing. ## Claims ### Claim 1 An insertion set system comprising: a base configured to be secured to a patient; a flexible tubing supported by the base, the tubing having a flexible distal end portion located external to the base, the distal end portion forming a flexible cannula that is configured to be inserted into the patient when or while the base is secured to the patient, the tubing has a length portion extending into the base; an inserter having a needle arranged coaxial with the tubing and configured to slide relative to the tubing, to selectively withdraw the needle from at least the distal end portion of the tubing; and a rigid holding pin or hollow tube fixed to the base and arranged to inhibit movement of the tubing with the needle while the needle is being withdrawn from the distal end portion of the tubing. ### Claim 2 (depends on 1) The insertion set system of claim 1, wherein the base has a passage through which the needle of the inserter extends, and wherein the rigid holding pin or hollow tube has a length section that extends into the passage. ### Claim 3 (depends on 2) The insertion set system of claim 2, wherein the rigid holding pin or hollow tube is arranged to abut an end of the length portion of the tubing within the passage to inhibit movement of the tubing with the needle while the needle is being withdrawn from the distal end portion of the tubing. ### Claim 4 (depends on 2) The insertion set system of claim 2, wherein the rigid holding pin or hollow tube has a further length section that extends into the base transverse to an axial length dimension of the length portion of the tubing. ### Claim 5 (depends on 1) The insertion set system of claim 1, wherein the needle of the inserter has a needle passage in which at least the distal end portion and the length portion of the tubing are received, the needle being able to slide relative to the tubing, to selectively withdraw the needle off of at least the distal end portion of the tubing. ### Claim 6 (depends on 5) The insertion set system of claim 5, wherein the needle and the tubing are in a first state in which at least the distal end portion and the length portion of the tubing are received in the needle passage, and wherein the needle is moveable along a length dimension of the distal end portion of the tubing to a second state in which the needle is separated from at least the distal end portion of the tubing. ### Claim 7 (depends on 1) The insertion set system of claim 1, wherein the rigid holding pin or hollow tube is arranged to abut or is partially received in an end of the length portion of the tubing to inhibit movement of the tubing with the needle while the needle is being withdrawn from the distal end portion of the tubing. ### Claim 8 (depends on 1) The insertion set system of claim 1, wherein: the needle of the inserter has a length dimension, a needle passage along the length dimension, and a slot-shaped opening extending along at least a portion of the length dimension, the slot-shaped opening being open to the needle passage; and the rigid holding pin or hollow tubing extends into the needle passage, through the slot-shaped opening of the needle. ### Claim 9 (depends on 1) The insertion set system of claim 1, wherein the inserter has an inserter body to which the inserter needle is attached, the inserter body being selective received by the base and selectively removable from the base, wherein the inserter needle receives the length portion and distal end portion of the tubing when the inserter body is received by the base, and wherein the inserter needle is withdrawn from at least the distal end portion of the tubing when the inserter needle is removed from the base. ### Claim 10 (depends on 1) The insertion set system of claim 1, wherein the hollow tube has a first end connected in fluid flow communication with the length portion of the tubing, for conveying fluid to or from the tubing. ### Claim 11 (depends on 10) The insertion set system of claim 10, wherein the hollow tube has a second end configured for connecting in fluid communication with an external tubing that extends at least partially outside of the base. ### Claim 12 (depends on 11) The insertion set system of claim 11, wherein the hollow tube has a length section that extends in the base transverse to an axial length dimension of the length portion of the tubing. ### Claim 13 (depends on 1) The insertion set system of claim 1, wherein the rigid holding pin comprises an elongated rigid wire or shaft. ### Claim 14 (depends on 13) The insertion set system of claim 13, wherein the elongated rigid wire or shaft has a first length section extending in the base transverse to an axial length dimension of the length portion of the tubing. ### Claim 15 (depends on 14) The insertion set system of claim 14, the base has a passage through which the needle of the inserter extends and wherein the rigid wire or shaft has a second length section extending into the passage and in contact with the length portion of the tubing. ### Claim 16 (depends on 15) The insertion set system of claim 15, wherein the elongated rigid wire or shaft has a bent section between the first and second length sections. ### Claim 17 A method of making an insertion set system, the method comprising: providing a base configured to be secured to a patient; supporting a flexible tubing by the base, the tubing having a flexible distal end portion located external to the base, the distal end portion forming a flexible cannula that is configured to be inserted into the patient when or while the base is secured to the patient, the tubing has a length portion extending into the base; arranging an inserter needle coaxial with the tubing and slideable relative to the tubing, to selectively withdraw the needle from at least the distal end portion of the tubing; fixing a rigid holding pin or hollow tube to the base; and arranging the rigid holding pin or hollow tube to inhibit movement of the tubing with the needle while the needle is being withdrawn from the distal end portion of the tubing. ### Claim 18 (depends on 17) The method of claim 17, further comprising providing the base with a passage, extending the needle of the inserter into the passage, and extending a length section of the rigid holding pin or hollow tube into the passage. ### Claim 19 (depends on 18) The method of claim 18, further comprising arranging the tubing to contact an end of the length portion of the tubing within the passage to inhibit movement of the tubing with the needle while the needle is being withdrawn from the distal end portion of the tubing. ### Claim 20 (depends on 18) The method of claim 18, wherein the needle and the tubing are in a first state in which at least the distal end portion and the length portion of the tubing are received in the passage, and wherein the needle is moveable along a length dimension of the distal end portion of the tubing to a second state in which the needle is separated from at least the distal end portion of the tubing.