# US 11,027,061 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 11,027,061 B2 - Document ID: US11027061B2 - Status: Granted - Kind: B2 - Application number: 15/973,471 - Filed: 2018-05-07 - Published: 2018-11-08 - Granted: 2021-06-08 - 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/US11027061B2 ## 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 externally to a patient; a flexible tubing supported by the base and having a distal end portion located external to the base, the distal end portion forming a cannula that is configured to be inserted into the patient, when or while the base is secured externally to the patient; and an inserter having a needle, the needle having a needle channel within the needle in which at least the distal end portion of the flexible tubing is received such that the distal end portion of the flexible tubing is located within the needle, the needle being able to slide relative to the flexible tubing, to selectively withdraw the needle off of at least the distal end portion of the flexible tubing. ### Claim 2 (depends on 1) The insertion set system of claim 1, wherein the needle and the flexible tubing are in a first state in which at least the distal end portion of the flexible tubing is received in the needle channel, and wherein the needle is moveable along a length dimension of the distal end portion of the flexible tubing to a second state in which the needle is separated from the distal end portion of the flexible tubing. ### Claim 3 (depends on 1) The insertion set system of claim 1, further comprising a fluid coupling, wherein the flexible tubing has a second end opposite the distal end portion, and wherein the second end of the flexible tubing is connected in fluid flow communication with the fluid coupling. ### Claim 4 (depends on 3) The insertion set system of claim 3, wherein: the needle of the inserter having a 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 channel; the flexible tubing includes a length portion extending from the distal end portion to the second end of the flexible tubing, the length portion extending out of the needle channel, through the slot-shaped opening of the needle. ### Claim 5 (depends on 4) The insertion set system of claim 4, wherein the length portion of the flexible tubing that extends out of the needle channel has a bend of between 90° and 160°. ### Claim 6 (depends on 4) The insertion set system of claim 4, wherein the slot shaped opening in the needle has a first width extending from a distal end of the needle, along a first portion of the length dimension of the needle, and a second width extending along a second portion of the length dimension of the needle, the second width being larger than the first width. ### Claim 7 (depends on 1) The insertion set system of claim 1, wherein: the distal end portion of the flexible tubing has a length extending along an axial dimension of the flexible tubing; the base has a chamber in fluid flow communication with the flexible tubing; and the base has a fluid flow channel extending transverse to the axial dimension. ### Claim 8 (depends on 7) The insertion set system of claim 7, wherein the channel in the base extends from the chamber at an angle of between 90° and 160° relative to an axial dimension of the distal end portion of the flexible tubing. ### Claim 9 (depends on 7) The insertion set system of claim 7, further comprising a first septum on the base, at a location in alignment with the axial dimension of the flexible tubing and the chamber, wherein the needle extends through the first septum and the chamber, when the distal end portion of the flexible tubing is received in the needle channel. ### Claim 10 (depends on 9) The insertion set system of claim 9, further comprising a second septum located in the channel of the base or between the channel of the base and the chamber, the second septum configured to be pierced by a further needle for connection of a further tubing to the channel of the base. ### Claim 11 (depends on 7) The insertion set system of claim 7, wherein: the flexible tubing has a further length portion extending from the distal end portion into the base; the base includes a tubing channel through which the further length portion of the flexible tubing extends, and a collar fixing the further length portion of the flexible tubing to the base within the needle channel of the base, wherein the needle is pierced through the collar when the distal end portion of the flexible tubing is received in the needle channel. ### Claim 12 (depends on 7) The insertion set system of claim 7, wherein: the flexible tubing has a further length portion extending from the distal end portion into the base; the insertion set system further comprising a holding pin arranged and configured to abut an end portion of the further length portion of the flexible tubing and inhibit movement of the flexible tubing with the needle while the needle is being withdrawn off of the distal end portion of the flexible tubing, the holding pin being moveable away from the end portion of the further length of the flexible tubing, after the needle has been withdrawn off of the distal end portion of the flexible tubing. ### Claim 13 (depends on 1) The insertion set system of claim 1, wherein: the distal end portion of the flexible tubing has a length extending along an axial dimension of the flexible tubing; the flexible tubing has a further length portion extending from the distal end portion into the base; and the insertion set system further comprising a holding pin arranged and configured to abut an end portion of the further length portion of the flexible tubing and inhibit movement of the flexible tubing with the needle while the needle is being withdrawn off of the distal end portion of the flexible tubing. ### Claim 14 (depends on 13) The insertion set system of claim 13, wherein the holding pin comprises a rigid wire or stop structure that is fixed to the base. ### Claim 15 (depends on 13) The insertion set system of claim 13, wherein: the needle of the inserter has a 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 channel; and the holding pin extends out of the needle channel, through the slot-shaped opening of the needle. ### Claim 16 (depends on 1) The insertion set system of claim 1, wherein: the flexible tubing has a further length portion extending from the distal end portion into the base; the insertion set system further comprising a rigid hollow tube connected in fluid flow communication with an end portion of the further length portion of the flexible tubing and abutting the end portion of the further length portion of the flexible tubing to inhibit movement of the flexible tubing with the needle while the needle is being withdrawn off of the distal end portion of the flexible tubing. ### Claim 17 (depends on 16) The insertion set system of claim 16, wherein: the needle of the inserter has a 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 channel; and the rigid hollow tube has a length portion that extends out of the needle channel, through the slot-shaped opening of the needle. ### Claim 18 (depends on 16) The insertion set system of claim 16, wherein the rigid hollow tube is fixed to the base and is configured to be connected in fluid flow communication with a further tubing located at least partially external to the base. ### Claim 19 (depends on 1) The insertion set of claim 1, wherein the needle comprises a structure made of a material having sufficient rigidity to pierce skin of the patient, the needle structure having a hollow interior that defines the channel within the needle and in which the distal end portion of the flexible tubing is located. ### Claim 20 (depends on 1) The insertion set of claim 1, wherein the base has a surface that is configured to be secured to the patient, external to the patient's skin. ### Claim 21 (depends on 1) The insertion set of claim 1, wherein the base has a surface on which an adhesive is provided, for securing the base to a patient's skin. ### Claim 22 (depends on 1) The insertion set of claim 1, wherein the needle extends through the base when the distal end portion of the flexible tubing is located within the needle. ### Claim 23 An insertion set system, comprising: a base configured to be secured to a patient; a flexible tubing supported by the base and having a distal end portion located external to the base, the distal end portion forming a cannula that is configured to be inserted into the patient, when or while the base is secured to the patient; and an inserter having a needle, the needle having a needle channel in which at least the distal end portion of the flexible tubing is received, the needle being able to slide relative to the flexible tubing, to selectively withdraw the needle off of at least the distal end portion of the flexible tubing; wherein: the flexible tubing has a further length portion extending from the distal end portion into the base; and the base includes a tubing channel through which the further length portion of the flexible tubing extends, and a collar fixing the further length portion of the flexible tubing to the base within the needle channel of the base, wherein the needle is pierced through the collar when the distal end portion of the flexible tubing is received in the needle channel. ### Claim 24 A method of making an insertion set system comprising: providing a base configured to be secured externally to a patient; supporting a flexible tubing supported by the base, with a distal end portion of the flexible tubing located external to the base, the distal end portion forming a cannula that is configured to be inserted into the patient, when or while the base is secured to the patient; receiving by the base, an inserter having a needle, the needle having a needle channel within the needle; receiving at least the distal end portion of the flexible tubing in the needle channel within the needle for sliding movement, wherein the needle is able to slide relative to the flexible tubing, to selectively withdraw the needle off of at least the distal end portion of the flexible tubing.