# US 10,946,139 B2 · Disposable assembly for drug infusion with pressure sensing for identification of and injection into fluid-filled anatomic spaces > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,946,139 B2 - Document ID: US10946139B2 - Status: Granted - Kind: B2 - Application number: 15/796,439 - Filed: 2017-10-27 - Published: 2018-03-08 - Granted: 2021-03-16 - Earliest claimed: 2012-07-03 - Assignees: Milestone Scientific, Inc. - Applicants: Milestone Scientific, Inc. - Inventors: Mark N. Hochman - Web page: https://patentgrep.com/patent/US10946139B2 ## CPC - A61M 5/168: Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters - G16H 20/17: delivered via infusion or injection - A61B 5/032: {Spinal fluid pressure} - A61F 9/0008: {Introducing ophthalmic products into the ocular cavity or retaining products therein (putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00)} - A61M 5/178: Syringes - A61M 19/00: Local anaesthesia (syringes therefor A61M5/00); Hypothermia (A61M5/42 takes precedence; cooling blood in a bypass of the arterial system A61M1/36) - A61M 2005/1588: {having means for monitoring, controlling or visual inspection, e.g. for patency check or for avoiding extravasation} - A61M 2205/581: by audible feedback - A61M 2205/583: by visual feedback - A61M 2205/6018: providing set-up signals for the apparatus configuration - A61M 2205/6045: having complementary physical shapes for indexing or registration purposes - 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)} - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## Abstract A disposable fluid flow assembly for operation in connection with a fluid pump configured to provide a flow of fluid to the disposable fluid flow assembly is provided. The disposable fluid flow assembly includes an elongated flexible tube, a needle hub connected with the flexible tube, a pressure sensor for sensing fluid pressure, and an identification circuit embedded connected with the pressure sensor. The identification is configured to provide a plurality of signals to the central controller of the fluid pump when the disposable needle assembly is connected with the fluid pump. The plurality of signals may include various signals, such as a signal to identify physical characteristics of the assembly, a signal to ensure that the assembly is authentic, a signal to ensure that the disposable assembly is not re-used, and/or a signal to ensure that the pressure signal is connected and operating properly. ## Claims ### Claim 1 A disposable fluid flow assembly for operation in connection with a fluid pump configured to provide a flow of fluid to the disposable fluid flow assembly, wherein the fluid pump comprises a central controller having a memory and the central controller is configured to control the flow of fluid in response to manual commands input via an input element, wherein the disposable fluid flow assembly comprises: an elongated flexible tube; a needle hub connected with the flexible tube, wherein the hub is configured for connecting a needle with the hub; a pressure sensor for sensing fluid pressure, wherein the pressure sensor is connected with the tube or the hub; a data line having a first end electrically connected with the pressure sensor and a second end having an electrical connector for connecting the data line with the fluid pump; an identification circuit embedded within or connected to the first electrical connector, wherein the identification circuit is configured to provide a plurality of signals to the central controller of the fluid pump when the disposable needle assembly is connected with the fluid pump, wherein the plurality of signals, including: a configuration signal indicative of the physical characteristics of the disposable needle assembly; a verification signal indicative of the disposable needle assembly being cooperable with the fluid pump; a first use signal identifying the particular disposable needle assembly so that the central controller can detect whether the specific disposable needle assembly was previously used. ### Claim 2 (depends on 1) The disposable assembly of claim 1 comprising an elongated handle, wherein the hub forms a portion of the elongated handle. ### Claim 3 (depends on 2) The disposable assembly of claim 2 wherein the handle is substantially rigid. ### Claim 4 (depends on 2) The disposable assembly of claim 2 wherein the handle has a length and a width and the length is substantially longer than the width. ### Claim 5 (depends on 2) The disposable assembly of claim 2 wherein the flexible tube is substantially longer than the elongated handle. ### Claim 6 (depends on 1) The disposable assembly of claim 1 wherein the identification circuit comprises memory for storing data that uniquely identifies the disposable assembly. ### Claim 7 (depends on 6) The disposable assembly of claim 6 wherein the first use signal comprises the data that uniquely identifies the disposable assembly. ### Claim 8 (depends on 1) The disposable assembly of claim 1 wherein the identification circuit is configured such that the first use signal provides an indication of previous use such that when the first use signal is communicated with the central controller the central controller will prevent operation of the pump if the disposable assembly was previously used. ### Claim 9 (depends on 1) The disposable assembly of claim 1 wherein the fluid flow assembly comprises a pre-filled syringe comprising fluid and the configuration signal comprises data regarding the fluid in the syringe. ### Claim 10 (depends on 1) The disposable assembly of claim 1 wherein the identification circuit provides a control element between the pressure sensor and the central controller when the disposable assembly is connected to the fluid pump. ### Claim 11 (depends on 1) The disposable assembly of claim 1 wherein the identification circuit is configured to ensure that only correctly sized and sterilized disposable assemblies are connected with the fluid pump. ### Claim 12 (depends on 1) The disposable assembly of claim 1 wherein the configuration signal comprises data regarding the length and diameter of the elongated tube. ### Claim 13 (depends on 1) The disposable assembly of claim 1 wherein the identification circuit is configured so that the signals provided by the identification signal override settings stored in the central controller regarding the physical characteristics of the disposable assembly when the disposable assembly is connected with the fluid pump. ### Claim 14 (depends on 1) The disposable assembly of claim 1 comprising a syringe substantially permanently attached to the needle hub, the pressure sensor and the identification circuit. ### Claim 15 (depends on 1) The disposable assembly of claim 1 comprising a needle permanently affixed to the needle hub, wherein the needle hub is substantially permanently connected with the tubing and the pressure sensor. ### Claim 16 (depends on 1) The disposable assembly of claim 1 wherein the needle hub comprises a connector for connecting a needle assembly to the needle hub. ### Claim 17 (depends on 1) The disposable assembly of claim 1 wherein the pressure sensor is an electronic pressure sensor configured to provide signals indicative of the fluid pressure in the fluid line. ### Claim 18 (depends on 1) The disposable assembly of claim 1 wherein the configuration signal comprises a signal operable by the central controller to control the fluid flow parameters of flow rate and pressure used with the disposable assembly when the disposable assembly is connected with the fluid pump. ### Claim 19 The disposable assembly of 18 wherein the identification circuit is substantially permanently connected with the pressure sensor. ### Claim 20 (depends on 1) The disposable fluid flow assembly of claim 1, wherein the first use signal includes data identifying the number of cycles or length of time that the disposable needle assembly has been used. ### Claim 21 (depends on 20) The disposable assembly of claim 20 wherein the data line is configured so that the identification circuit receives signals from the central controller when the disposable assembly is connected with the fluid pump and wherein the identification circuit is configured to receive signal from the central controller regarding the number of cycles or the amount of time that the disposable assembly is used with the fluid pump and wherein the identification circuit is configured to store data regarding the number of cycles or the amount of time. ### Claim 22 (depends on 21) The disposable assembly of claim 21 wherein the identification circuit is configured to provide the use signal to the central controller when the disposable assembly is connected with the fluid pump and the use signal is configured so that the central controller limits operation of the fluid pump in response to the use signal. ### Claim 23 (depends on 20) The disposable assembly of claim 20 wherein the identification circuit is configured so that the content or information of the identification circuit can be altered by the central controller when the disposable connector is connected with the fluid pump. ### Claim 24 (depends on 20) The disposable assembly of claim 20 comprising a syringe fixedly connected with the pressure sensor and the identification circuit, wherein the configuration signal provides data to the central controller when the disposable assembly is connected with the fluid pump such that the fluid pump purges a pre-set quantity of fluid from the syringe. ### Claim 25 (depends on 20) The disposable assembly of claim 20 comprising an elongated handle, wherein the hub forms a portion of the elongated handle. ### Claim 26 (depends on 25) The disposable assembly of claim 25 wherein the handle is substantially rigid. ### Claim 27 (depends on 20) The disposable assembly of claim 20 comprising a syringe substantially permanently attached to the needle hub, the pressure sensor and the identification circuit. ### Claim 28 (depends on 20) The disposable assembly of claim 20 comprising a needle permanently affixed to the needle hub, wherein the needle hub is substantially permanently connected with the tubing and the pressure sensor. ### Claim 29 (depends on 20) The disposable assembly of claim 20 wherein the configuration signal comprises a signal operable by the central controller to control the fluid flow parameters of flow rate and pressure used with the disposable assembly when the disposable assembly is connected with the fluid pump. ### Claim 30 (depends on 20) The disposable assembly of claim 20 wherein the identification circuit is configured to provide a connection verification circuit verifying that the pressure sensor is electrically connected with the fluid pump when the disposable assembly is connected with the fluid pump. ### Claim 31 A disposable fluid flow assembly for operation in connection with a fluid pump configured to provide a flow of fluid to the disposable fluid flow assembly, wherein the fluid pump comprises a central controller having a memory and the central controller is configured to control the flow of fluid in response to manual commands input via an input element, wherein the disposable fluid flow assembly comprises: an elongated flexible tube; a needle hub connected with the flexible tube, wherein the hub is configured for connecting a needle with the hub a pressure sensor for sensing fluid pressure, wherein the pressure sensor is connected with the tube or the hub; and an identification circuit connected with the pressure sensor wherein the identification is configured to provide a plurality of signals to the central controller of the fluid pump when the disposable needle assembly is connected with the fluid pump, wherein the plurality of signals, including: a configuration signal indicative of the physical characteristics of the disposable needle assembly; a verification signal indicative of the disposable needle assembly being cooperable with the fluid pump; a first use signal identifying the particular disposable needle assembly so that the central controller can detect whether the specific disposable needle assembly was previously used. ### Claim 32 (depends on 31) The disposable assembly of claim 31 comprising a data connector configured to provide a data connection between the identification circuit and the fluid pump.