# US 10,869,963 B2 · Low-cost ambulatory medical pump > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,869,963 B2 - Document ID: US10869963B2 - Status: Granted - Kind: B2 - Application number: 16/207,620 - Filed: 2018-12-03 - Published: 2019-04-04 - Granted: 2020-12-22 - Earliest claimed: 2014-08-28 - Assignees: Zyno Medical, LLC - Applicants: Zyno Medical, LLC - Inventors: Mei Zhang; Chao Young Lee - Web page: https://patentgrep.com/patent/US10869963B2 ## CPC - A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body} - A61M 5/1413: {Modular systems comprising interconnecting elements} - A61M 5/14228: {with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member} - F04B 43/0072: {of tubular flexible members} - F04B 43/082: {the tubular flexible member being pressed against a wall by a number of elements, each having an alternating movement in a direction perpendicular to the axes of the tubular member and each having its own driving mechanism} - F04B 43/12: having peristaltic action - A61M 39/284: {Lever clamps} - A61M 2005/14292: {Computer-based infusion planning or simulation of spatio-temporal infusate distribution} - A61M 2205/502: User interfaces, e.g. screens or keyboards - A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches - A61M 2205/507: Head Mounted Displays [HMD] - A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient - 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)} - F04B: POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS (machines for liquids, or pumps, of rotary-piston or oscillating-piston type F04C; non-positive-displacement pumps F04D; pumping of fluid by direct contact of another fluid or by using inertia of fluid to be pumped F04F) ## Abstract A low-cost medical pump for ambulatory use provides reduced life components combined with a pump lockout enforcing a safe operating limit and preventing reuse after that limit is exceeded. An improved IV line clamp portion minimizes unsupported clamp structure length and provides a dual lock system preventing inadvertent clamp release. ## Claims ### Claim 1 A medical tube assembly detachable from a pump housing holding outwardly extending peristaltic actuator elements, comprising: a flexible medical tube adapted to communicate between an external fluid bag and a patient connection; and a substantially rigid frame having first and second opposed longitudinal walls extending along a longitudinal axis of the frame defined by a longest dimension of the frame and separated by first and second opposed end walls and retaining the medical tube against movement therein wherein the medical tube extends along the longitudinal axis of the frame, the frame including a connector detachably attaching the frame to the pump housing and medical tube guides to align the medical tube along the longitudinal axis of the frame and with the peristaltic actuator elements to permit peristaltic pumping of liquid of the medical tube when the frame is attached to the pump housing; wherein the connector provides a first attachment element including a first hinge portion extending and positioned along one of the first and second opposed longitudinal walls of the frame and to releasably attach to a second hinge portion of the pump housing wherein the first hinge portion is attachable to the second hinge portion to thereby pivot about a hinge axis extended along the longitudinal axis of the frame; wherein the connector provides a second attachment element including receiving tabs extending along the other of the first and second opposed longitudinal walls of the frame and to releasably receive corresponding hooks of the pump housing by movement of the corresponding hooks generally along the pump housing and the other of the first and second longitudinal walls of the frame; wherein the medical tube is comprised of a first material positioned outside of the frame and a second material softer than the first material, the softer material positioned between the opposed first and second ends of the frame. ### Claim 2 (depends on 1) The medical tube assembly of claim 1 wherein one of the first and second hinge portions includes first and second hinges spaced longitudinally along the one of the first and second opposed longitudinal walls of the frame and a longitudinal wall of the pump housing and is receivable by including a pin of the other of the first and second hinge portions extending longitudinally along the other of the frame and the pump housing. ### Claim 3 (depends on 2) The medical tube assembly of claim 2 wherein the first and second hinges are open collars with a first longitudinal edge attached to the one of the first and second opposed longitudinal wall of the frame and a second longitudinal edge extending away from the pump housing. ### Claim 4 (depends on 1) The medical tube assembly of claim 1 wherein the corresponding hooks and the receiving tabs includes three hooks and three receiving tabs. ### Claim 5 (depends on 1) The medical tube assembly of claim 1 wherein the second attachment element further comprises an actuator wherein the corresponding hooks move generally along the pump housing and the other of the first and second longitudinal walls of the frame when the actuator is moved along the longitudinal axis. ### Claim 6 (depends on 5) The medical tube assembly of claim 5 wherein movement of the corresponding hooks along the longitudinal axis is permitted only when activated by a push button pressable in a direction perpendicular to the longitudinal axis. ### Claim 7 (depends on 5) The medical tube assembly of claim 5 wherein the actuator is moved along a sidewall of one of the frame and the pump housing. ### Claim 8 (depends on 1) The medical tube assembly of claim 1 wherein the corresponding hooks and the receiving tabs are spring biased into engagement with the receiving tabs tending to hold the frame against the pump housing. ### Claim 9 (depends on 8) The medical tube assembly of claim 8 wherein the corresponding hooks are beveled to move the corresponding hooks against the spring biasing with attachment but not with detachment. ### Claim 10 (depends on 1) The medical tube assembly of claim 1 wherein the pump housing further holds pressure sensors and the medical tube guides further align the medical tube retained by the frame with the pressure sensors to detect a fluid pressure through the medical tube. ### Claim 11 (depends on 1) The medical tube assembly of claim 1 wherein the second material is silicone. ### Claim 12 (depends on 1) The medical tube assembly of claim 1 wherein the frame further holds a spring biased pinch element configured to compress the medical tube to prevent fluid flow therethrough when the frame and the pump housing are separated. ### Claim 13 (depends on 1) The medical tube assembly of claim 1 wherein the frame is releasably attachable to the pump housing to form a continuous outer surface with an exterior of the pump housing. ### Claim 14 (depends on 1) The medical tube assembly of claim 1 wherein the first and second opposed end walls of the frame provide opposed first and second notches, respectively, the first notch receiving a first fixed bushing of the medical tube and the second notch receiving a second fixed bushing of the medical tube. ### Claim 15 (depends on 1) An ambulatory pump comprising the medical tube assembly of claim 1 and further comprising the pump housing, the pump housing further holding: a pump communicating with the medical tube assembly to pump fluid through the medical tube by peristaltic compression of the medical tube; a user interface for receiving programming commands from a clinician; and an electronic computer communicating with the pump and the user interface and executing a program stored in a non-transitory computer readable storage medium to control operation of the pump. ### Claim 16 (depends on 15) The ambulatory pump of claim 15 wherein the medical tube assembly has a total weight less than one pound and has dimensions of less than 1.5″ by 2″ by 5″. ### Claim 17 (depends on 15) The ambulatory pump of claim 15 wherein the electronic computer communicates with the pump and the user interface to execute the program stored in the non-transitory computer readable storage medium to: (i) monitor operation of the pump to store at least one cumulative pump operation value indicating a cumulative operation of the pump from a time of manufacture of the pump; (ii) receive treatment protocol instructions through the user interface describing an intended future operating limit of the pump to pump fluid through the medical tube in a treatment protocol; (iii) determine whether an amount of operation of the pump necessary to implement received treatment protocol instructions will exceed a predetermined software-enforced service life of the pump reduced by the at least one cumulative pump operation value; and (iv) when the amount of operation of the pump necessary to implement the treatment protocol exceeds the software-enforced service life of the pump reduced by the at least one cumulative pump operation value, prevent operation of the pump. ### Claim 18 A medical tube assembly detachable from a pump housing holding outwardly extending peristaltic actuator elements, comprising: a flexible medical tube adapted to communicate between an external fluid bag and a patient connection; and a substantially rigid frame having first and second opposed longitudinal walls extending along a longitudinal axis of the frame defined by a longest dimension of the frame and separated by first and second opposed end walls and retaining the medical tube against movement therein wherein the medical tube extends along the longitudinal axis of the frame, the frame including a connector detachably attaching the frame to the pump housing and medical tube guides to align the medical tube along the longitudinal axis of the frame and with the peristaltic actuator elements to permit peristaltic pumping of liquid of the medical tube when the frame is attached to the pump housing; wherein the connector provides a first attachment element including a first hinge portion extending and positioned along one of the first and second opposed longitudinal walls of the frame and to releasably attach to a second hinge portion of the pump housing, wherein the first hinge portion is attachable to the second hinge portion to thereby pivot about a hinge axis extended along the longitudinal axis of the frame, and wherein one of the first and second hinge portions includes first and second hinges spaced longitudinally along the one of the first and second opposed longitudinal walls of the frame and a longitudinal wall of the pump housing and is receivable by a pin of the other of the first and second hinge portions extending longitudinally along the other of the frame and the pump housing; wherein the connector provides a second attachment element including receiving tabs extending along the other of the first and second opposed longitudinal walls of the frame and to releasably receive corresponding hooks of the pump housing; wherein the medical tube is comprised of a first material positioned outside of the frame and a second material softer than the first material, the softer material positioned between the opposed first and second ends of the frame.