# US 6,692,457 B2 · Flow condition sensor assembly for patient infusion device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 6,692,457 B2 - Document ID: US6692457B2 - Status: Granted - Kind: B2 - Application number: 10/087,507 - Filed: 2002-03-01 - Published: 2003-09-04 - Granted: 2004-02-17 - Earliest claimed: 2002-03-01 - Assignees: Insulet Corporation - Inventors: J. Christopher Flaherty - Web page: https://patentgrep.com/patent/US6692457B2 ## CPC - A61M 5/14248: {of the skin patch type} - A61M 5/16809: {by repeated filling and emptying of an intermediate volume} - A61M 5/16831: {Monitoring, detecting, signalling or eliminating infusion flow anomalies (low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066)} - A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body} - A61M 5/16804: {Active flow controllers} - A61M 5/16854: {by monitoring line pressure} - A61M 2205/3327: Measuring - A61M 2205/3355: Controlling downstream pump pressure - A61M 2205/3576: with non implanted data transmission devices, e.g. using external transmitter or receiver - A61M 2205/50: with microprocessors or computers - 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 device for delivering fluid to a patient including an exit port assembly adapted to connect to a transcutaneous patient access tool, a flow path extending from the exit port assembly, and a flow condition sensor assembly including a resilient diaphragm having opposing first and second surfaces. The first surface of the diaphragm is positioned against the flow path, and a chamber wall is positioned adjacent the second surface of the diaphragm and defines a sensor chamber against the second surface of the diaphragm. At least one sensor is arranged to provide a threshold signal when the second surface of the diaphragm expands into the chamber in response to at least one predetermined fluid flow condition occurring in the flow path. ## Claims ### Claim 1 A device for delivering fluid to a patient, comprising: A) an exit port assembly adapted to connect to a transcutaneous patient access tool; B) a flow path extending from the exit port assembly; and C) a flow condition sensor assembly including, a resilient diaphragm having opposing first and second surfaces, with the first surface positioned against the flow path, a chamber wall positioned adjacent the second surface of the diaphragm and defining a sensor chamber adjacent the second surface of the diaphragm, and at least one sensor arranged to provide a threshold signal when the second surface of the diaphragm expands into the chamber in response to at least one predetermined fluid flow condition occurring in the flow path, wherein the sensor comprises a switch positioned within the chamber such that the second surface of the diaphragm closes the switch upon expanding into the chamber in response to the predetermined fluid flow condition within the flow path. ### Claim 2 (depends on 1) A device according to claim 1, wherein the predetermined fluid flow condition comprises one of an occlusion in the flow path, an inadequate flow of fluid in the flow path, and an adequate flow of fluid in the flow path. ### Claim 3 (depends on 1) A device according to claim 1, wherein the flow path includes a reservoir and the flow condition sensor assembly is positioned at an end of the reservoir. ### Claim 4 (depends on 1) A device according to claim 1, wherein the flow path includes a reservoir and a passageway providing fluid communication between the reservoir and the exit port assembly, and the flow condition sensor assembly is positioned against the passageway. ### Claim 5 (depends on 1) A device according to claim 1, wherein the sensor is positioned on a portion of the chamber wall furthest from the flow path and the enclosed chamber has a predetermined volume. ### Claim 6 (depends on 1) A device according to claim 1, wherein the sensor comprises a circuit having a lead positioned on the second surface of the diaphragm and a lead positioned on the chamber wall such that the leads come together and close the circuit when the second surface of the diaphragm expands into the chamber in response to the predetermined fluid flow condition. ### Claim 7 (depends on 1) A device according to claim 1, wherein the sensor comprises a circuit having leads positioned on the chamber wall and a conductive layer positioned on the second surface of the diaphragm such that the conductive layer contacts the leads to close the circuit when the second surface of the diaphragm expands into the chamber in response to the predetermined fluid flow condition. ### Claim 8 (depends on 1) A device according to claim 1, wherein the diaphragm comprises a thin, flat piece of flexible and resilient material. ### Claim 9 (depends on 1) A device according to claim 1, wherein the sensor chamber has a predetermined volume. ### Claim 10 (depends on 1) A device according to claim 1, wherein the flow condition sensor assembly includes an alarm connected to the sensor. ### Claim 11 (depends on 10) A device according to claim 10, wherein the alarm comprises an audible alarm. ### Claim 12 (depends on 10) A device according to claim 10, wherein the alarm comprises a visual alarm. ### Claim 13 (depends on 1) A device according to claim 1, further comprising a processor connected to the sensor of the sensor assembly. ### Claim 14 (depends on 13) A device according to claim 13, further comprising an alarm connected to the processor. ### Claim 15 (depends on 14) A device according to claim 14, wherein the alarm comprises an audible alarm. ### Claim 16 (depends on 14) A device according to claim 14, wherein the alarm comprises a visual alarm. ### Claim 17 (depends on 14) A device according to claim 14, wherein the processor is programmed to activate the alarm upon receiving the threshold signal from the sensor. ### Claim 18 (depends on 14) A device according to claim 14, wherein the processor is programmed to activate the alarm upon receiving the threshold signal from the sensor for more than a predetermined period. ### Claim 19 (depends on 14) A device according to claim 14, wherein the processor is programmed to activate the alarm upon receiving the threshold signal from the sensor for less than a predetermined period. ### Claim 20 (depends on 13) A device according to claim 13, wherein the sensor provides an analog signal and the processor include an analog-to-digital converter for converting the analog single of the sensor into a digital signal. ### Claim 21 (depends on 13) A device according to claim 13, wherein the processor is programmed to provide a signal indicative of an undesired flow condition upon receiving the threshold signal from the sensor. ### Claim 22 (depends on 13) A device according to claim 13, wherein the processor is programmed to provide a signal indicative of an occluded flow condition upon receiving the threshold signal from the sensor for more than a predetermined period. ### Claim 23 (depends on 13) A device according to claim 13, wherein the processor is programmed to provide a signal indicative of a low flow condition upon receiving the threshold signal from the sensor for less than a predetermined period. ### Claim 24 (depends on 1) A device according to claim 1, wherein the flow path includes a reservoir containing a therapeutic fluid. ### Claim 25 (depends on 24) A device according to claim 24, wherein the therapeutic fluid is insulin. ### Claim 26 (depends on 24) A device according to claim 24, further comprising a fill port connected to the reservoir. ### Claim 27 (depends on 24) A device according to claim 24, wherein the reservoir is pressurized. ### Claim 28 (depends on 1) A device according to claim 1, wherein the exit port assembly includes a transcutaneous patient access tool. ### Claim 29 (depends on 28) A device according to claim 28, wherein the transcutaneous patient access tool comprises a needle. ### Claim 30 (depends on 1) A device according to claim 1, wherein a combined volume of the exit port assembly and the flow path is fixed and predetermined. ### Claim 31 (depends on 1) A device according to claim 1, wherein possible expansion of a combined volume of the exit port assembly and the flow path is relatively small compared with the volume of the sensor chamber. ### Claim 32 (depends on 1) A device according to claim 1, further comprising: a dispenser for causing fluid through the flow path to the exit port assembly; a local processor connected to the dispenser and programmed to cause fluid flow to the exit port assembly based upon flow instructions; a wireless receiver connected to the local processor for receiving flow instructions from a separate, remote control device and delivering the flow instructions to the local processor; and a housing containing the flow path, the exit port assembly, the dispenser, the local processor, and the wireless receiver, wherein the housing is free of user input components for providing flow instructions to the local processor. ### Claim 33 (depends on 32) A system including a fluid delivery device according to claim 32, and further comprising a remote control device separate from the fluid delivery device and including: a remote processor; user interface components connected to the remote processor for allowing a user to provide flow instructions to the remote processor; and a transmitter connected to the remote processor for transmitting the flow instructions to the receiver of the fluid delivery device. ### Claim 34 (depends on 1) A device according to claim 1, further comprising: a dispenser for causing fluid through the flow path to the exit port assembly; a local processor connected to the dispenser and programmed to cause fluid flow to the exit port assembly based upon flow instructions, and further programmed to provide flow information; a wireless transmitter connected to the local processor for transmitting the flow information from the local processor to a separate, remote control device; and a housing containing the flow path, the exit port assembly, the dispenser, the local processor, and the wireless transmitter, wherein the housing is free of user output components for providing the flow information from the local processor to a user. ### Claim 35 (depends on 34) A system including a fluid delivery device according to claim 34 and further comprising a remote control device separate from the fluid delivery device and including: a remote processor; user output components connected to the remote processor for allowing a user to receive flow information; and a receiver connected to the remote processor for receiving the flow information from the transmitter of the fluid delivery device. ### Claim 36 (depends on 35) A system according to claim 35, wherein the remote control device includes an alarm connected to the remote processor. ### Claim 37 (depends on 1) A device according to claim 1, wherein the sensor assembly includes multiple sensor chambers positioned against the second surface of the diaphragm. ### Claim 38 (depends on 37) A device according to claim 37, wherein the sensor assembly includes at least one of the sensors in each chamber. ### Claim 39 (depends on 37) A device according to claim 37, wherein each of the sensor chambers of the sensor assembly has a predetermined volume. ### Claim 40 (depends on 1) A device according to claim 1, wherein the sensor assembly includes a second diaphragm positioned against the flow path. ### Claim 41 (depends on 40) A device according to claim 40, wherein the sensor assembly includes a second chamber assembly positioned against the second diaphragm. ### Claim 42 (depends on 41) A device according to claim 41, wherein the sensor assembly includes a second sensor arranged to provide a threshold signal when the second diaphragm expands into the second chamber. ### Claim 43 A device for delivering fluid to a patient, comprising: A) an exit port assembly adapted to connect to a transcutaneous patient access tool; B) a flow path extending from the exit port assembly; and C) a flow condition sensor assembly including, a resilient diaphragm having opposing first and second surfaces, with the first surface positioned against the flow path, a chamber wall positioned adjacent the second surface of the diaphragm and defining a sensor chamber adjacent the second surface of the diaphragm, and at least one sensor arranged to provide a threshold signal when the second surface of the diaphragm expands into the chamber in response to at least one predetermined fluid flow condition occurring in the flow path, wherein the flow condition sensor assembly further comprises at least two laminated layers and the diaphragm is positioned between two of the layers. ### Claim 44 (depends on 43) A device according to claim 43, wherein the at least two laminated layers comprise: a first layer; a second layer received against the first layer, the second and the first layers including at least one groove defining a passageway of the flow path, the second layer including an opening in fluid communication with the passageway, and wherein the resilient diaphragm is received on the second layer covering the opening; and a third layer received over the diaphragm on the second layer, the third layer including the chamber wall defining the chamber over the diaphragm and in alignment with the opening of the second layer. ### Claim 45 (depends on 44) A device according to claim 44, wherein one of the second and the third layers defines a recess receiving the diaphragm, and wherein the recess has a depth about equal to a thickness of the diaphragm such that the diaphragm is secured in a substantially fluid-tight manner between the second and the third layers. ### Claim 46 (depends on 45) A device according to claim 45, wherein a length and a width of the recess are greater than a length and a width of the diaphragm. ### Claim 47 (depends on 43) A device according to claim 43, wherein the sensor is responsive to one of contact, pressure, light, magnetism, strain, and density. ### Claim 48 A device for delivering fluid to a patient, comprising: an exit port assembly adapted to connect to a transcutaneous patient access tool; a flow path extending from the exit port assembly; and a flow condition sensor assembly including, a resilient diaphragm having opposing first and second surfaces, with the first surface positioned against the flow path, a chamber wall positioned adjacent the second surface of the diaphragm and defining a sensor chamber adjacent the second surface of the diaphragm, and at least one sensor arranged to provide a threshold signal when the second surface of the diaphragm expands into the chamber in response to at least one predetermined fluid flow condition occurring in the flow path; and a processor connected to the sensor of the sensor assembly, wherein the processor is programmed to receive the threshold signal from the sensor when the device is primed. ### Claim 49 (depends on 48) A device according to claim 48, wherein the sensor comprises a path way extending through the sensor chamber, and an optical transmitter and an optical receiver positioned at opposite ends of the path way. ### Claim 50 (depends on 48) A device according to claim 48, wherein the processor is programmed to stop operation upon receiving the threshold signal from the sensor. ### Claim 51 (depends on 48) A device according to claim 48, wherein the processor is programmed to stop operation upon receiving the threshold signal from the sensor for more than a predetermined period. ### Claim 52 (depends on 48) A device according to claim 48, wherein the processor is programmed to stop operation upon receiving the threshold signal from the sensor for less than a predetermined period. ### Claim 53 A device for delivering fluid to a patient, comprising: A) a flow path extending from the exit port assembly; B) a flow condition sensor assembly including, a resilient diaphragm having opposing first and second surfaces, with the first surface positioned against the flow path, a chamber wall positioned adjacent the second surface of the diaphragm and defining a sensor chamber adjacent the second surface of the diaphragm, wherein the flow condition sensor assembly further comprises at least two laminated layers and the diaphragm is positioned between two of the layers, and at least one sensor arranged to provide a threshold signal when the second surface of the diaphragm expands into the chamber by a predetermined amount; and C) a processor connected to the sensor and programmed to provide a signal indicative of an undesired flow condition upon receiving the threshold signal from the sensor for more than a predetermined maximum period or for less than a predetermined minimum period. ### Claim 54 (depends on 53) A device according to claim 53, wherein the at least two laminated layers comprise: a first layer; a second layer received against the first layer, the second and the first layers including at least one groove defining a passageway of the flow path, the second layer including an opening in fluid communication with the passageway, and wherein the resilient diaphragm is received on the second layer covering the opening; and a third layer received over the diaphragm on the second layer, the third layer including the chamber wall defining the chamber over the diaphragm and in alignment with the opening of the second layer. ### Claim 55 (depends on 54) A device according to claim 54, wherein one of the second and the third layers defines a recess receiving the diaphragm, and wherein the recess has a depth about equal to a thickness of the diaphragm such that the diaphragm is secured in a substantially fluid-tight manner between the second and the third layers. ### Claim 56 (depends on 55) A device according to claim 55, wherein a length and a width of the recess are greater than a length and a width of the diaphragm. ### Claim 57 (depends on 53) A device according to claim 53, wherein the sensor comprises a path way extending through the sensor chamber, and an optical transmitter and an optical receiver positioned at opposite ends of the path way. ### Claim 58 A device for delivering fluid to a patient, comprising: A) a flow path extending from the exit port assembly; B) a flow condition sensor assembly including, a resilient diaphragm having opposing first and second surfaces, with the first surface positioned against the flow path, a chamber wall positioned adjacent the second surface of the diaphragm and defining a sensor chamber adjacent the second surface of the diaphragm, and at least one sensor arranged to provide a threshold signal when the second surface of the diaphragm expands into the chamber by a predetermined amount, wherein the sensor comprises a switch positioned within the chamber such that the second surface of the diaphragm closes the switch upon expanding into the chamber by the predetermined amount; and C) a processor connected to the sensor and programmed to provide a signal indicative of an undesired flow condition upon receiving the threshold signal from the sensor for more than a predetermined maximum period or for less than a predetermined minimum period. ### Claim 59 (depends on 58) A device according to claim 58, wherein the sensor is responsive to one of contact, pressure, light, magnetic, strain, and density. ### Claim 60 (depends on 58) A device according to claim 58, wherein the sensor is positioned on a portion of the chamber wall furthest from the flow path and the enclosed chamber has a predetermined volume. ### Claim 61 (depends on 58) A device according to claim 58, further comprising an alarm connected to the processor and adapted to be activated upon the processor providing a signal indicative of an undesired flow condition. ### Claim 62 (depends on 61) A device according to claim 61, wherein the alarm comprises an audible alarm. ### Claim 63 (depends on 61) A device according to claim 61, wherein the alarm comprises a visual alarm. ### Claim 64 (depends on 58) A device according to claim 58, wherein the sensor provides an analog signal and the processor include an analog-to-digital converter for converting the analog single of the sensor into a digital signal. ### Claim 65 (depends on 58) A device according to claim 58, wherein the flow path includes a reservoir and the flow condition sensor assembly is positioned at an end of the reservoir. ### Claim 66 (depends on 58) A device according to claim 58, wherein the flow path includes a reservoir and a passageway providing fluid communication between the reservoir and an exit port assembly, and the flow condition sensor assembly is positioned against the passageway. ### Claim 67 (depends on 58) A device according to claim 58, wherein the diaphragm comprises a thin, flat piece of flexible and resilient material. ### Claim 68 (depends on 58) A device according to claim 58, wherein the sensor chamber has a predetermined volume. ### Claim 69 (depends on 58) A device according to claim 58, wherein the flow path includes a reservoir containing a therapeutic fluid. ### Claim 70 (depends on 69) A device according to claim 69, wherein the therapeutic fluid is insulin. ### Claim 71 (depends on 69) A device according to claim 69, wherein the reservoir is pressurized. ### Claim 72 (depends on 58) A device according to claim 58, wherein the flow path includes an exit port assembly includes a transcutaneous patient access tool. ### Claim 73 (depends on 72) A device according to claim 72, wherein the transcutaneous patient access tool comprises a needle. ### Claim 74 (depends on 58) A device according to claim 58, wherein a combined volume of the flow path is substantially fixed and predetermined. ### Claim 75 (depends on 58) A device according to claim 58, further comprising: a dispenser for causing fluid to flow through the flow path; a local processor connected to the dispenser and programmed to cause fluid flow based upon flow instructions; a wireless receiver connected to the local processor for receiving flow instructions from a separate, remote control device and delivering the flow instructions to the local processor; and a housing containing the flow path, the dispenser, the local processor, and the wireless receiver, wherein the housing is free of user input components for providing flow instructions to the local processor. ### Claim 76 (depends on 75) A system including a fluid delivery device according to claim 75, and further comprising a remote control device separate from the fluid delivery device and including: a remote processor; user interface components connected to the remote processor for allowing a user to provide flow instructions to the remote processor; and a transmitter connected to the remote processor for transmitting the flow instructions to the receiver of the fluid delivery device. ### Claim 77 (depends on 58) A device according to claim 58, further comprising: a dispenser for causing fluid to flow through the flow path; a local processor connected to the dispenser and programmed to cause fluid flow through the flow path based upon flow instructions, and further programmed to provide flow information; a wireless transmitter connected to the local processor for transmitting the flow information from the local processor to a separate, remote control device; and a housing containing the flow path, the dispenser, the local processor, and the wireless transmitter, wherein the housing is free of user output components for providing the flow information from the local processor to a user. ### Claim 78 (depends on 77) A system including a fluid delivery device according to claim 77 and further comprising a remote control device separate from the fluid delivery device and including: a remote processor; user output components connected to the remote processor for allowing a user to receive flow information; and a receiver connected to the remote processor for receiving the flow information from the transmitter of the fluid delivery device. ### Claim 79 (depends on 58) A device according to claim 58, wherein the sensor assembly includes multiple sensor chambers positioned against the second surface of the diaphragm. ### Claim 80 (depends on 79) A device according to claim 79, wherein the sensor assembly includes at least one of the sensors in each chamber. ### Claim 81 (depends on 79) A device according to claim 79, wherein each of the sensor chambers of the sensor assembly has a predetermined volume. ### Claim 82 (depends on 58) A device according to claim 58, wherein the sensor assembly includes a second diaphragm positioned against the flow path. ### Claim 83 (depends on 82) A device according to claim 82, wherein the sensor assembly includes a second chamber assembly positioned against the second diaphragm. ### Claim 84 (depends on 83) A device according to claim 83, wherein the sensor assembly includes a second sensor arranged to provide a threshold signal when the second diaphragm expands into the second chamber. ### Claim 85 A device for delivering fluid to a patient, comprising: A) a flow path extending from the exit port assembly; B) a flow condition sensor assembly including, a resilient diaphragm having opposing first and second surfaces, with the first surface positioned against the flow path, a chamber wall positioned adjacent the second surface of the diaphragm and defining a sensor chamber adjacent the second surface of the diaphragm, and at least one sensor arranged to provide a threshold signal when the second surface of the diaphragm expands into the chamber by a predetermined amount, wherein the sensor comprises a circuit having a lead positioned on the second surface of the diaphragm and a lead positioned on the chamber wall such that the leads come together and close the circuit when the second surface of the diaphragm expands into the chamber by the predetermined amount; and C) a processor connected to the sensor and programmed to provide a signal indicative of an undesired flow condition upon receiving the threshold signal from the sensor for more than a predetermined maximum period or for less than a predetermined minimum period. ### Claim 86 A device for delivering fluid to a patient, comprising: A) a flow path extending from the exit port assembly; B) a flow condition sensor assembly including, a resilient diaphragm having opposing first and second surfaces, with the first surface positioned against the flow path, a chamber wall positioned adjacent the second surface of the diaphragm and defining a sensor chamber adjacent the second surface of the diaphragm, and at least one sensor arranged to provide a threshold signal when the second surface of the diaphragm expands into the chamber by a predetermined amount, wherein the sensor comprises a circuit having leads positioned on the chamber wall and a conductive layer positioned on the second surface of the diaphragm such that the conductive layer contacts the leads to close the circuit when the second surface of the diaphragm expands into the chamber in response to the predetermined fluid flow condition; and C) a processor connected to the sensor and programmed to provide a signal indicative of an undesired flow condition upon receiving the threshold signal from the sensor for more than a predetermined maximum period or for less than a predetermined minimum period.