Catheter trimming and / or securing devices, systems, and methods for intravenous site condition detection and products

Abstract

A method may include using a first temperature sensor to obtain a first temperature measurement at a first location on a patient's body adjacent to the catheter insertion site; using a temperature sensor array to obtain multiple temperature measurements at multiple locations on the patient's body, each of the multiple locations being spaced apart from the first location, and the multiple locations including locations at multiple different distances from the first location; using at least one processor to determine alarm conditions associated with trimming and / or securing devices and / or catheters based on the first temperature measurement and the multiple temperature measurements; and using at least one processor to generate an alarm for a user in response to determining the alarm conditions.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 076,204, filed September 9, 2020, entitled "Catheter Dressing and / or Security Device and System, Method, and Product for Intravenous SiteCondition Detection," the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally relates to dressing and / or securing devices for catheters, and in some non-limiting embodiments or aspects, to systems, devices, products, apparatuses and / or methods for temperature sensing for detecting venous site conditions. Background Technology

[0004] Infected catheters have been shown to have an increased temperature at the catheter insertion site compared to body surface temperature. Clinically, the body has an inflammatory response to the catheter, which can cause an increase in the local temperature around the catheter insertion site where the catheter is inserted into the skin. Catheter-related local temperature differences can have many other sources, such as a response to catheter-introduced medications, extravenous leakage of fluid (e.g., osmosis, extravasation, etc.), a response to piston-like or mechanical catheter movement within the body, an immune response to infectious agents such as bacteria and biofilms formed on the catheter surface or inside the lumen, IV fluid temperature relative to body or ambient temperature, and a foreign body reaction to catheter materials and surfaces, among others.

[0005] Silvah JH, Lima CM, Unamuno Mdo R, Schetino MA, Schetino LP, Fassini PG, CF, Basile-Filho A, Cunha SF, and Marchini JS, in their paper entitled “Body surface infrared thermometry in patients with central venous catheter-related infections,” Einstein, (Sao Paulo), 2015 Jul-Sep, 13(3):364-9, doi:10.1590 / S1679-45082015AO3397, disclose evidence that temperature differences relative to the catheter insertion site indicate infection, the contents of which are incorporated herein by reference in their entirety. Furthermore, elevated temperatures at the catheter insertion site may be due to infection and phlebitis or other irritation of the vein by the catheter or fluid flowing through it. Conversely, decreased temperatures at the catheter insertion site may also indicate a problem, as these decreases may be caused by fluid leakage from the infusion into the tissue. Such leakage can lead to minor consequences such as pain, or in some cases, tissue damage resulting in limb amputation. Furthermore, the catheter tubing and the fluid flowing through it can provide a source of temperature variation, as the fluid being delivered is typically at room temperature or frozen rather than at the patient's body temperature. Therefore, there is a need in the art to improve temperature sensing for detecting conditions at venous sites. Summary of the Invention

[0006] Therefore, improved systems, devices, products, apparatuses and / or methods for temperature sensing for detecting the condition of vein sites are provided.

[0007] According to some non-limiting embodiments or aspects, a method is provided, comprising: obtaining a first temperature measurement at a first location on a patient's body adjacent to the catheter insertion site of the catheter using a first temperature sensor of a catheter trimming and / or fixation device; obtaining a plurality of temperature measurements at a plurality of locations on the patient's body using a temperature sensor array of the trimming and / or fixation device, each of the plurality of locations being spaced apart from the first location, and the plurality of locations including locations at a plurality of different distances from the first location; determining, using at least one processor, an alarm condition associated with the trimming and / or fixation device and / or catheter based on the first temperature measurement and the plurality of temperature measurements; and generating an alarm for a user using at least one processor in response to determining the alarm condition.

[0008] In some non-limiting embodiments or aspects, the method further includes: obtaining a second temperature measurement at the catheter conduit using a second temperature sensor of the trimming and / or fixing device; and determining, using at least one processor, alarm conditions associated with the trimming and / or fixing device and / or catheter based on the first temperature measurement, the second temperature measurement, and multiple temperature measurements.

[0009] According to some non-limiting embodiments or aspects, a system is provided comprising: a catheter trimming and / or fixation device, including: a first temperature sensor configured to obtain a first temperature measurement at a first location on a patient's body adjacent to a catheter insertion site on the patient's body; and a temperature sensor array configured to obtain a plurality of temperature measurements at a plurality of locations on the patient's body, each temperature sensor in the temperature sensor array being spaced apart from the first temperature sensor, and the temperature sensor array including a plurality of temperature sensors at different distances from the first temperature sensor; and one or more processors programmed and / or configured to: determine alarm conditions associated with the trimming and / or fixation device and / or catheter based on the first temperature measurement and the plurality of temperature measurements; and generate an alarm to a user in response to determining the alarm conditions.

[0010] In some non-limiting embodiments or aspects, the trimming and / or fixing device further includes a second temperature sensor configured to obtain a second temperature measurement at the catheter conduit, the second temperature sensor being spaced apart from the first temperature sensor and the temperature sensor array, and one or more processors are further programmed and / or configured to determine alarm conditions associated with the trimming and / or fixing device and / or the catheter based on the first temperature measurement, the second temperature measurement, and multiple temperature measurements.

[0011] According to some non-limiting embodiments or aspects, a device for trimming and / or securing a catheter is provided, comprising: a support member including: a first temperature sensor configured to obtain a first temperature measurement at a first location on a patient's body adjacent to a catheter insertion site; and a temperature sensor array configured to obtain multiple temperature measurements at multiple locations on the patient's body, each temperature sensor in the temperature sensor array being spaced apart from the first temperature sensor on the support member, and the temperature sensor array including multiple temperature sensors at different distances from the first temperature sensor; and a wired or wireless communication device configured to transmit the first temperature measurement and the multiple temperature measurements to one or more processors.

[0012] In some non-limiting embodiments or aspects, the support member further includes a second temperature sensor configured to obtain a second temperature measurement at the conduit passage of the conduit, the second temperature sensor being spaced apart from the first temperature sensor and the temperature sensor array on the support member, and a wired or wireless communication device being configured to transmit the first temperature measurement, the second temperature measurement, and the plurality of temperature measurements to one or more processors.

[0013] According to some non-limiting embodiments or aspects, a computer program product is provided, comprising at least one non-transitory computer-readable medium including program instructions that, when executed by at least one processor, cause the at least one processor to: obtain a first temperature measurement associated with a first location on a patient's body adjacent to a catheter insertion site of a catheter on the patient's body; obtain a plurality of temperature measurements associated with a plurality of locations on the patient's body, each of the plurality of locations being spaced apart from the first location, and the plurality of locations including locations at a plurality of different distances from the first location; determine alarm conditions associated with a catheter and / or a catheter trimming and / or fixation device based on the first temperature measurement and the plurality of temperature measurements; and generate an alarm to a user in response to determining that at least one threshold is met.

[0014] In some non-limiting embodiments or aspects, the instructions further cause at least one processor to obtain a second temperature measurement associated with the catheter conduit of the catheter; and to determine alarm conditions associated with the catheter and / or the dressing and / or securing device for the catheter based on the first temperature measurement, the second temperature measurement, and the plurality of temperature measurements.

[0015] Further embodiments or aspects are set forth in the following numbered clauses:

[0016] Clause 1. A method comprising: obtaining a first temperature measurement at a first location on a patient's body adjacent to a catheter insertion site using a first temperature sensor of a catheter trimming and / or fixation device; obtaining multiple temperature measurements at multiple locations on the patient's body using a temperature sensor array of the trimming and / or fixation device, each of the multiple locations being spaced apart from the first location, and the multiple locations including locations at multiple different distances from the first location; determining, using at least one processor, an alarm condition associated with the trimming and / or fixation device and / or catheter based on the first temperature measurement and the multiple temperature measurements; and generating an alarm for a user using the at least one processor in response to determining the alarm condition.

[0017] Clause 2, the method as described in Clause 1, further comprises: obtaining a first reference measurement at a first location on the patient's body using a first temperature sensor; obtaining multiple reference measurements at the multiple locations on the patient's body using a temperature sensor array; determining multiple first temperature differences between the first reference measurement and each of the multiple reference measurements using at least one processor; determining multiple second temperature differences between a reference measurement at the location furthest from the first location and each of the remaining locations using at least one processor; determining at least one threshold temperature based on the multiple first temperature differences and the multiple second temperature differences using at least one processor; determining that the first temperature measurement, one or more of the multiple temperature measurements, or any combination thereof, satisfies the at least one threshold temperature using at least one processor; and generating an alarm for a user in response to determining that the at least one threshold temperature is satisfied.

[0018] Clause 3, the method of any one of Clauses 1 and 2, further comprises: using at least one processor to determine, at the location furthest from the first location among the plurality of locations, that a temperature measurement value meets a threshold temperature; and in response to determining that the temperature measurement value at the location furthest from the first location among the plurality of locations meets the threshold temperature, using at least one processor to generate an alarm for a user, wherein the alarm includes information associated with potential peeling of the trimming and / or fixing equipment.

[0019] Clause 4. The method of any one of Clauses 1-3 further comprises: using at least one processor to determine that a first temperature measurement and two or more of the plurality of temperature measurements meet a threshold temperature; and in response to determining that the first temperature measurement and the two or more of the plurality of temperature measurements meet the threshold temperature, using at least one processor to generate an alarm for a user, wherein the alarm includes information associated with a potential tunneling of the repair and / or fixing equipment.

[0020] Clause 5, the method of any one of Clauses 1-4, further comprises: using at least one processor to determine that a first temperature measurement and each of the plurality of temperature measurements meet a threshold temperature; and in response to determining that the first temperature measurement and each of the plurality of temperature measurements meet the threshold temperature, using at least one processor to generate an alarm for a user, wherein the alarm includes information associated with potential removal of the tampering and / or fixing equipment.

[0021] Clause 6. The method of any one of Clauses 1-5 further comprises: obtaining a second temperature measurement at the catheter conduit using a second temperature sensor of the trimming and / or fixing device; determining, using at least one processor, that a first change in the second temperature over time satisfies an infusion temperature threshold; storing, using at least one processor, confirmation of an infusion operation associated with a patient record; determining, using at least one processor, that a second change in the second temperature over time after the first change satisfies a flushing temperature threshold; and, in response to determining that the second change in the second temperature over time satisfies the flushing temperature threshold, generating an alarm for a user using at least one processor, wherein the alarm includes a prompt for the user to confirm the flushing fluid delivery.

[0022] Clause 7. The method of any one of Clauses 1-6 further comprises: using at least one processor to determine that at least one variation pattern of at least one of the following satisfies at least one threshold variation pattern: a first temperature measurement, one or more of the plurality of temperature measurements, or any combination thereof; and in response to determining that the at least one variation pattern satisfies the at least one threshold variation pattern, using at least one processor to generate an alarm for a user, wherein the alarm includes information associated with potential problems with trimming and / or fixing equipment and / or conduits.

[0023] Clause 8. The method of any one of Clauses 1-7, wherein the at least one variation mode comprises the variation of a first temperature measurement and one or more individual temperature measurements among the plurality of temperature measurements over time.

[0024] Clause 9. The method of any one of Clauses 1-8, wherein the at least one variation mode comprises the variation of the temperature difference between a first temperature measurement and two or more of the plurality of temperature measurements over time.

[0025] Clause 10, the method of any one of Clauses 1-9, further comprises: using at least one processor to determine the at least one threshold variation pattern based on at least one of the following: patient parameters associated with the patient, drug parameters associated with a drug that has been delivered, is being delivered, or will be delivered to the patient, nursing environment parameters associated with the patient's nursing environment, or any combination thereof.

[0026] Clause 11. The method of any one of Clauses 1-10, wherein the first position and the position closest to the first position among the plurality of positions are located at the same distance from the catheter conduit of the catheter and at the same distance from the catheter insertion site on the patient's body, and wherein the method further comprises: using at least one processor to determine that the change between a first temperature measurement and a temperature measurement at the position closest to the first position among the plurality of temperature measurements satisfies a threshold temperature; and in response to determining that the change between the first temperature measurement and a temperature measurement at the position closest to the first position among the plurality of temperature measurements satisfies a threshold temperature, generating an alarm for a user using at least one processor, wherein the alarm includes information associated with potential problems with the trimming and / or fixation of the device and / or catheter.

[0027] Clause 12. The method of any one of Clauses 1-11 further comprises: using at least one processor to determine that at least one of the following satisfies a threshold temperature increase: (i) an increase in temperature from the furthest of the plurality of locations to a first temperature measurement, and (ii) an increase in the temperature difference between the first temperature measurement and the temperature measurement at the furthest of the plurality of locations to the first temperature measurement; and in response to determining at least one of (i) and (ii), using at least one processor to generate an alarm for a user, wherein the alarm includes information associated with potential problems with trimming and / or fixing equipment and / or conduits.

[0028] Clause 13. The method of any one of Clauses 1-12 further comprises: obtaining a second temperature measurement at the catheter conduit of the catheter using a second temperature sensor of the trimming and / or securing device; determining, using at least one processor, that a temperature reduction between a first location and the location furthest from the first location among the plurality of locations satisfies a threshold temperature; in response to determining that the temperature reduction satisfies the threshold temperature, determining, using at least one processor, that a comparison of the first temperature measurement with at least one of the following satisfies at least one threshold temperature: (i) a second temperature measurement at the current time and at least one time prior to the current time, and (ii) a temperature measurement at a location among the plurality of locations further from the catheter insertion site than the first location; and in response to determining that the at least one threshold temperature is satisfied, generating an alarm for a user using at least one processor, wherein the alarm includes information associated with potential problems with the trimming and / or securing device and / or the catheter.

[0029] Clause 14. The method of any one of Clauses 1-13, wherein the first temperature measurement and the plurality of temperature measurements are obtained at a periodic rate, and wherein the method further comprises: using at least one processor to determine the periodic rate based on at least one of the following: patient parameters associated with the patient, drug parameters associated with a drug that has been delivered, is being delivered or will be delivered to the patient, nursing environment parameters associated with the patient's nursing environment, or any combination thereof.

[0030] Clause 15. The method as described in any one of Clauses 1-14 further includes:

[0031] Multiple temperature sensor arrays are used to obtain multiple temperature measurements at multiple locations on the patient's body using trimming and / or fixation devices, wherein the multiple arrays are spaced apart around the catheter insertion site.

[0032] Clause 16. The method of any one of Clauses 1-15, wherein the plurality of arrays are circumferentially spaced around the catheter insertion site, and wherein the positions associated with each of the plurality of arrays are radially spaced at a plurality of different distances from the catheter insertion site.

[0033] Clause 17. The method of any one of Clauses 1-16, wherein one of the plurality of arrays includes a first temperature sensor.

[0034] Clause 18. The method of any one of Clauses 1-17, wherein the trimming and / or securing device includes a mark or opening indicating the orientation of a support member attached to the catheter insertion site of the catheter on the patient's body, and wherein the mark or opening is aligned with the catheter insertion site of the catheter on the patient's body.

[0035] Clause 19. The method of any one of Clauses 1-18, wherein the trimming and / or fixing device includes a support member, wherein the support member includes a first temperature sensor and the plurality of temperature sensors, and wherein the support member further includes an adhesive layer.

[0036] Clause 20, the method as described in any one of Clauses 1-19, wherein the trimming and / or fixing equipment includes an antimicrobial disc.

[0037] Clause 21. A system comprising: a catheter trimming and / or fixation device, including: a first temperature sensor configured to acquire a first temperature measurement at a first location on a patient's body adjacent to a catheter insertion site on the patient's body; and a temperature sensor array configured to acquire multiple temperature measurements at multiple locations on the patient's body, wherein each temperature sensor in the temperature sensor array is spaced apart from the first temperature sensor, and wherein the temperature sensor array includes multiple temperature sensors at different distances from the first temperature sensor; and one or more processors programmed and / or configured to: determine alarm conditions associated with the trimming and / or fixation device and / or catheter based on the first temperature measurement and the multiple temperature measurements; and generate an alarm for a user in response to determining the alarm conditions.

[0038] Clause 22. A system as described in Clause 21, wherein the first temperature sensor is further configured to obtain a first reference measurement at a first location on the patient's body, wherein the temperature sensor array is further configured to obtain multiple reference measurements at multiple locations on the patient's body, and wherein the one or more processors are further programmed and / or configured to: determine multiple first temperature differences between the first reference measurement and each of the multiple reference measurements; determine multiple second temperature differences between a reference measurement at the temperature sensor furthest from the first temperature sensor in the temperature sensor array and each of the reference measurements at each of the remaining temperature sensors in the temperature sensor array; determine at least one threshold temperature based on the multiple first temperature differences and the multiple second temperature differences; determine that the first temperature measurement, one or more of the multiple temperature measurements, or any combination thereof, satisfies the at least one threshold temperature; and generate an alarm for a user in response to determining that the at least one threshold temperature is satisfied.

[0039] Clause 23. The system as described in any one of Clauses 21 and 22, wherein the one or more processors are further programmed and / or configured to: determine that the temperature measurement at the temperature sensor furthest from the first temperature sensor in the temperature sensor array meets a threshold temperature; and in response to determining that the temperature measurement at the temperature sensor furthest from the first temperature sensor in the temperature sensor array meets the threshold temperature, generate an alarm to a user, wherein the alarm includes information associated with potential peeling of the trimming and / or fixing equipment.

[0040] Clause 24. The system of any one of Clauses 21-23, wherein the one or more processors are further programmed and / or configured to: determine that a first temperature measurement and two or more of the plurality of temperature measurements meet a threshold temperature; and in response to determining that the first temperature measurement and the two or more of the plurality of temperature measurements meet the threshold temperature, generate an alarm to a user, wherein the alarm includes information associated with potential tunneling of the trimming and / or fixing equipment.

[0041] Clause 25. The system of any one of Clauses 21-24, wherein the one or more processors are further programmed and / or configured to: determine that a first temperature measurement and each of the plurality of temperature measurements meet a threshold temperature; and in response to determining that the first temperature measurement and each of the plurality of temperature measurements meet the threshold temperature, generate an alarm to a user, wherein the alarm includes information associated with potential removal of the tampering and / or fixing equipment.

[0042] Clause 26. The system of any one of Clauses 21-25, wherein the trimming and / or fixation device further comprises a second temperature sensor, wherein the second temperature sensor is configured to obtain a second temperature measurement at the catheter conduit of the catheter, wherein the second temperature sensor is spaced apart from the first temperature sensor and the temperature sensor array, and wherein the one or more processors are further programmed and / or configured to: determine that a first change of the second temperature over time satisfies an infusion temperature threshold; store an infusion operation confirmation associated with a patient record; determine that a second change of the second temperature over time after the first change satisfies a flushing temperature threshold; and generate an alarm to a user in response to determining that the second change of the second temperature over time satisfies the flushing temperature threshold, wherein the alarm includes a prompt for the user to confirm the flushing fluid delivery.

[0043] Clause 27. The system of any one of Clauses 21-26, wherein the one or more processors are further programmed and / or configured to: determine that at least one variation pattern of at least one of the following satisfies at least one threshold variation pattern: a first temperature measurement, one or more of the plurality of temperature measurements, or any combination thereof; and in response to determining that the at least one variation pattern satisfies the at least one threshold variation pattern, generate an alarm to a user, wherein the alarm includes information associated with potential problems with trimming and / or fixing equipment and / or conduits.

[0044] Clause 28. The system of any one of Clauses 21-27, wherein the at least one variation mode comprises the variation of a first temperature measurement and one or more individual temperature measurements of the plurality of temperature measurements over time.

[0045] Clause 29. The system of any one of Clauses 21-28, wherein the at least one variation mode comprises the variation of the temperature difference between a first temperature measurement and two or more of the plurality of temperature measurements over time.

[0046] Clause 30, the system of any one of Clauses 21-29, wherein the one or more processors are further programmed and / or configured to determine the at least one threshold variation pattern based on at least one of the following: patient parameters associated with the patient, drug parameters associated with a drug that has been delivered, is being delivered or will be delivered to the patient, care environment parameters associated with the care environment in which the patient is located, or any combination thereof.

[0047] Clause 31. The system of any one of Clauses 21-30, wherein, when the trimming and / or fixation device is attached to the catheter and the patient's body, the first temperature sensor and the temperature sensor closest to the first temperature sensor in the temperature sensor array are located at the same distance from the catheter tubing of the catheter and the same distance from the catheter insertion site of the catheter on the patient's body, and wherein the one or more processors are further programmed and / or configured to: determine that the change between the first temperature measurement and the temperature measurement at the temperature sensor closest to the first temperature sensor in the temperature sensor array among the plurality of temperature measurements satisfies a threshold temperature; and, in response to determining that the change between the first temperature measurement and the temperature measurement at the temperature sensor closest to the first temperature sensor in the temperature sensor array among the plurality of temperature measurements satisfies a threshold temperature, generate an alarm for the user using at least one processor, wherein the alarm includes information associated with potential problems with the trimming and / or fixation device and / or catheter.

[0048] Clause 32. The system of any one of Clauses 21-31, wherein the one or more processors are further programmed and / or configured to: determine at least one of the following: (i) an increase in a temperature measurement value from the temperature measurement value at the temperature sensor furthest away in the temperature sensor array to a first temperature measurement value, and (ii) an increase in a temperature difference between the first temperature measurement value and the temperature measurement value at the temperature sensor furthest away in the temperature sensor array to the first temperature measurement value satisfying a threshold temperature increase; and in response to determining at least one of (i) and (ii), generate an alarm for a user using at least one processor, wherein the alarm includes information associated with potential problems with trimming and / or fixing equipment and / or conduits.

[0049] Clause 33. A system as described in any one of Clauses 21-32, wherein the trimming and / or fixing device further comprises a second temperature sensor, wherein the second temperature sensor is configured to obtain a second temperature measurement at the catheter insertion site, wherein the second temperature sensor is spaced apart from the first temperature sensor and the temperature sensor array, and wherein the one or more processors are further programmed and / or configured to: determine that a temperature decrease between the first temperature sensor and the temperature sensor in the temperature sensor array furthest from the first temperature sensor meets a threshold temperature; in response to determining that the temperature decrease meets the threshold temperature, determine that a comparison of the first temperature measurement with at least one of the following meets at least one threshold temperature: (i) a second temperature measurement at the current time and at least one time prior to the current time, and (ii) a temperature measurement at a temperature sensor in the temperature sensor array further from the catheter insertion site than the first temperature sensor; and in response to determining that the at least one threshold temperature is met, generate an alarm to a user, wherein the alarm includes information associated with potential problems with the trimming and / or fixing device and / or the catheter.

[0050] Clause 34. A system as described in any one of Clauses 21-33, wherein the first temperature measurement and the plurality of temperature measurements are obtained at a periodic rate, and wherein the one or more processors are further programmed and / or configured to determine the periodic rate based on at least one of: patient parameters associated with the patient, drug parameters associated with a drug that has been delivered, is being delivered or will be delivered to the patient, nursing environment parameters associated with the patient's nursing environment, or any combination thereof.

[0051] Clause 35. The system of any one of Clauses 21-34, wherein the trimming and / or fixation device further comprises a plurality of temperature sensor arrays, wherein the plurality of temperature sensor arrays are configured to obtain the plurality of temperature measurements at the plurality of locations on the patient's body, and wherein the plurality of arrays are spaced apart around the trimming and / or fixation device.

[0052] Clause 36. A system as described in any one of Clauses 21-35, wherein the plurality of arrays are spaced apart around the circumference of a circle defined in the plane of the trimming and / or fixing device, and wherein temperature sensors associated with each of the plurality of arrays are radially spaced apart from the center of the circle at a plurality of different distances.

[0053] Clause 37. The system as described in any one of Clauses 21-36, wherein one of the plurality of arrays includes a first temperature sensor.

[0054] Clause 38. The system as described in any one of Clauses 21-37, wherein the trimming and / or securing device includes a mark or opening indicating the orientation of a support member attached to the catheter insertion site on the patient's body.

[0055] Clause 39. The system of any one of Clauses 21-38, wherein the trimming and / or fixing device includes a support member, wherein the support member includes a first temperature sensor and the plurality of temperature sensors, and wherein the support member further includes an adhesive layer.

[0056] Clause 40, the system as described in any one of Clauses 21-39, wherein the trimming and / or fixing equipment includes an antimicrobial disc.

[0057] Clause 41. A device for trimming and / or securing a catheter, comprising: a support member including: a first temperature sensor configured to obtain a first temperature measurement at a first location on a patient's body adjacent to a catheter insertion site; and a temperature sensor array configured to obtain multiple temperature measurements at multiple locations on the patient's body, wherein each temperature sensor in the temperature sensor array is spaced apart from the first temperature sensor on the support member, and wherein the temperature sensor array includes multiple temperature sensors at different distances from the first temperature sensor; and a wired or wireless communication device configured to transmit the first temperature measurement and the multiple temperature measurements to one or more processors.

[0058] Clause 42, the trimming and / or securing device as described in Clause 41, further includes: the one or more processors, wherein the one or more processors are programmed and / or configured to: determine alarm conditions associated with the trimming and / or securing device and / or the catheter based on a first temperature measurement and the plurality of temperature measurements; and generate an alarm to a user in response to determining the alarm conditions.

[0059] Clause 43. A trimming and / or fixation device as described in any one of Clauses 41 and 42, wherein a first temperature sensor is further configured to obtain a first reference measurement at a first location on the patient's body, wherein a temperature sensor array is further configured to obtain multiple reference measurements at multiple locations on the patient's body, and wherein the one or more processors are further programmed and / or configured to: determine multiple first temperature differences between the first reference measurement and each of the multiple reference measurements; determine multiple second temperature differences between a reference measurement at the temperature sensor furthest from the first temperature sensor in the temperature sensor array and each of the reference measurements at each of the remaining temperature sensors in the temperature sensor array; determine at least one threshold temperature based on the multiple first temperature differences and the multiple second temperature differences; determine that the first temperature measurement, one or more of the multiple temperature measurements, or any combination thereof, satisfies the at least one threshold temperature; and generate an alarm for a user in response to determining that the at least one threshold temperature is satisfied.

[0060] Clause 44. The trimming and / or fixing device as described in any one of Clauses 41-43, wherein the one or more processors are further programmed and / or configured to: determine that the temperature measurement at the temperature sensor furthest from the first temperature sensor in the temperature sensor array meets a threshold temperature; and in response to determining that the temperature measurement at the temperature sensor furthest from the first temperature sensor in the temperature sensor array meets the threshold temperature, generate an alarm to a user, wherein the alarm includes information associated with potential peeling of the trimming and / or fixing device.

[0061] Clause 45. The trimming and / or fixing device as described in any one of Clauses 41-44, wherein the one or more processors are further programmed and / or configured to: determine that a first temperature measurement and two or more of the plurality of temperature measurements meet a threshold temperature; and in response to determining that the first temperature measurement and the two or more of the plurality of temperature measurements meet the threshold temperature, generate an alarm to a user, wherein the alarm includes information associated with a potential tunneling of the trimming and / or fixing device.

[0062] Clause 46. The trimming and / or fixing device as described in any one of Clauses 41-45, wherein the one or more processors are further programmed and / or configured to: determine that a first temperature measurement and each of the plurality of temperature measurements meet a threshold temperature; and in response to determining that the first temperature measurement and each of the plurality of temperature measurements meet the threshold temperature, generate an alarm to a user, wherein the alarm includes information associated with the potential removal of the trimming and / or fixing device.

[0063] Clause 47. A trimming and / or fixation device as described in any one of Clauses 41-46, wherein the support member further includes a second temperature sensor, wherein the second temperature sensor is configured to obtain a second temperature measurement at the catheter conduit of the catheter, wherein the second temperature sensor is spaced apart from a first temperature sensor and a temperature sensor array on the support member, and wherein said one or more processors are further programmed and / or configured to: determine that a first change in the second temperature over time satisfies an infusion temperature threshold; store an infusion operation confirmation associated with a patient record; determine that a second change in the second temperature over time after the first change satisfies a flushing temperature threshold; and generate an alarm to a user in response to determining that the second change in the second temperature over time satisfies the flushing temperature threshold, wherein the alarm includes a prompt for the user to confirm the flushing fluid delivery.

[0064] Clause 48. A trimming and / or fixing device as described in any one of Clauses 41-47, wherein the one or more processors are further programmed and / or configured to: determine that at least one variation pattern of at least one of the following satisfies at least one threshold variation pattern: a first temperature measurement, one or more of the plurality of temperature measurements, or any combination thereof; and in response to determining that the at least one variation pattern satisfies the at least one threshold variation pattern, generate an alarm to a user, wherein the alarm includes information associated with potential problems with the trimming and / or fixing device and / or catheter.

[0065] Clause 49. The trimming and / or fixing equipment as described in any one of Clauses 41-48, wherein the at least one variation mode comprises the variation of a first temperature measurement and one or more individual temperature measurements of the plurality of temperature measurements over time.

[0066] Clause 50, the trimming and / or fixing equipment as described in any one of Clauses 41-49, wherein the at least one variation mode comprises the change of temperature difference over time between a first temperature measurement and two or more of the plurality of temperature measurements.

[0067] Clause 51, the trimming and / or fixation device as described in any one of Clauses 41-50, wherein the one or more processors are further programmed and / or configured to: determine the at least one threshold variation pattern based on at least one of: patient parameters associated with the patient, drug parameters associated with a drug that has been delivered, is being delivered or will be delivered to the patient, care environment parameters associated with the care environment in which the patient is located, or any combination thereof.

[0068] Clause 52. A trimming and / or fixation device as described in any one of Clauses 41-51, wherein, when the trimming and / or fixation device is attached to the catheter and the patient's body, the first temperature sensor and the temperature sensor closest to the first temperature sensor in the temperature sensor array are located at the same distance from the catheter tubing of the catheter and the same distance from the catheter insertion site of the catheter on the patient's body, and wherein the one or more processors are further programmed and / or configured to: determine that a change between a first temperature measurement and a temperature measurement at the temperature sensor closest to the first temperature sensor in the temperature sensor array among the plurality of temperature measurements satisfies a threshold temperature; and, in response to determining that a change between a first temperature measurement and a temperature measurement at the temperature sensor closest to the first temperature sensor in the temperature sensor array among the plurality of temperature measurements satisfies a threshold temperature, generate an alarm for a user using at least one processor, wherein the alarm includes information associated with potential problems with the trimming and / or fixation device and / or catheter.

[0069] Clause 53. The trimming and / or fixing device as described in any one of Clauses 41-52, wherein said one or more processors are further programmed and / or configured to: determine at least one of the following: (i) an increase in temperature measurement values ​​from the temperature measurement value at the temperature sensor furthest away in the temperature sensor array to a first temperature measurement value, and (ii) an increase in the first temperature measurement value from the temperature difference between the first temperature measurement value and the temperature measurement value at the temperature sensor furthest away in the temperature sensor array to a threshold temperature increase; and in response to determining at least one of (i) and (ii), generate an alarm for a user using at least one processor, wherein the alarm includes information associated with potential problems with the trimming and / or fixing device and / or conduit.

[0070] Clause 54. A trimming and / or securing device as described in any one of Clauses 41-53, wherein the support member further includes a second temperature sensor, wherein the second temperature sensor is configured to obtain a second temperature measurement at the catheter insertion site, wherein the second temperature sensor is spaced apart from a first temperature sensor and a temperature sensor array on the support member, and wherein said one or more processors are further programmed and / or configured to: determine that a temperature decrease between the first temperature sensor and the temperature sensor in the temperature sensor array furthest from the first temperature sensor meets a threshold temperature; in response to determining that the temperature decrease meets the threshold temperature, determine that a comparison of the first temperature measurement with at least one of the following meets at least one threshold temperature: (i) a second temperature measurement at the current time and at least one time prior to the current time, and (ii) a temperature measurement at a temperature sensor in the temperature sensor array further from the catheter insertion site than the first temperature sensor; and in response to determining that said at least one threshold temperature is met, generate an alarm to a user, wherein the alarm includes information associated with potential problems with the trimming and / or securing device and / or the catheter.

[0071] Clause 55, the trimming and / or fixing device as described in any one of Clauses 41-54, wherein the first temperature measurement and the plurality of temperature measurements are obtained at a periodic rate, and wherein the one or more processors are further programmed and / or configured to determine the periodic rate based on at least one of: patient parameters associated with the patient, drug parameters associated with a drug that has been delivered, is being delivered or will be delivered to the patient, care environment parameters associated with the care environment in which the patient is located, or any combination thereof.

[0072] Clause 56. The trimming and / or fixation device as described in any one of Clauses 41-55, wherein the trimming and / or fixation device further comprises a plurality of temperature sensor arrays, wherein the plurality of temperature sensor arrays are configured to obtain the plurality of temperature measurements at the plurality of locations on the patient's body, and wherein the plurality of arrays are spaced apart around the support member.

[0073] Clause 57. A trimming and / or fixing device as described in any one of Clauses 41-57, wherein the plurality of arrays are spaced apart around the circumference of a circle defined in the plane of a support member, and wherein an array of temperature sensors associated with each of the plurality of arrays is radially spaced apart from the center of the circle at a plurality of different distances.

[0074] Clause 58. A trimming and / or fixing device as described in any one of Clauses 41-57, wherein an array of the plurality of arrays includes a first temperature sensor.

[0075] Clause 59. A trimming and / or fixation device as described in any one of Clauses 41-58, wherein the trimming and / or fixation device includes a mark or opening indicating the orientation of a support member attached to the catheter insertion site on the patient's body.

[0076] Clause 60, the trimming and / or fixing device as described in any one of Clauses 41-59, wherein the support member includes a first temperature sensor and the plurality of temperature sensors, and wherein the support member further includes an adhesive layer.

[0077] Clause 61. The trimming and / or fixing equipment as described in any one of Clauses 41-60, wherein the supporting components include antimicrobial discs.

[0078] Clause 62. A computer program product comprising at least one non-transitory computer-readable medium, the medium including program instructions that, when executed by at least one processor, cause the at least one processor to: obtain a first temperature measurement associated with a first location on a patient's body adjacent to a catheter insertion site of a catheter on the patient's body; obtain a plurality of temperature measurements associated with a plurality of locations on the patient's body, each of the plurality of locations being spaced apart from the first location, and wherein the plurality of locations includes locations at a plurality of different distances from the first location; determine, based on the first temperature measurement and the plurality of temperature measurements, alarm conditions associated with a catheter and / or a catheter trimming and / or fixation device; and generate an alarm to a user in response to determining that the at least one threshold is met.

[0079] Clause 63, a computer program product as described in Clause 62, wherein the instructions further cause the at least one processor to: obtain a first reference measurement associated with a first location on the patient's body; obtain a plurality of reference measurements associated with the plurality of locations on the patient's body; determine a plurality of first temperature differences between the first reference measurement and each of the plurality of reference measurements; determine a plurality of second temperature differences between a reference measurement at the location furthest from the first location and each of the remaining locations; determine at least one threshold temperature based on the plurality of first temperature differences and the plurality of second temperature differences; determine that the first temperature measurement, one or more of the plurality of temperature measurements, or any combination thereof, satisfies the at least one threshold temperature; and generate an alarm for a user in response to determining that the at least one threshold temperature is satisfied.

[0080] Clause 64. A computer program product as described in any one of Clauses 62 and 63, wherein the instructions further cause the at least one processor to: determine that a temperature measurement at the location furthest from the first location among the plurality of temperature measurements meets a threshold temperature; and in response to determining that the temperature measurement at the location furthest from the first location among the plurality of locations meets the threshold temperature, generate an alarm to a user, wherein the alarm includes information associated with potential peeling of the trimming and / or fixing equipment.

[0081] Clause 65. A computer program product as described in any one of Clauses 62-64, wherein the instructions further cause the at least one processor to: determine that a first temperature measurement and two or more of the plurality of temperature measurements meet a threshold temperature; and in response to determining that the first temperature measurement and the two or more of the plurality of temperature measurements meet the threshold temperature, generate an alarm to a user, wherein the alarm includes information associated with a potential tunneling of the repair and / or fixing equipment.

[0082] Clause 66. A computer program product as described in any one of Clauses 62-65, wherein the instructions further cause the at least one processor to: determine that a first temperature measurement and each of the plurality of temperature measurements meet a threshold temperature; and in response to determining that the first temperature measurement and each of the plurality of temperature measurements meet the threshold temperature, generate an alarm to a user, wherein the alarm includes information associated with potential removal of the tampering and / or fixing equipment.

[0083] Clause 67. A computer program product as described in any one of Clauses 62-66, wherein the instructions further cause the at least one processor to: obtain a second temperature measurement associated with the catheter conduit of the catheter; determine that a first change in the second temperature over time satisfies an infusion temperature threshold; store an infusion operation confirmation associated with a patient record; determine that a second change in the second temperature over time after the first change satisfies a flushing temperature threshold; and generate an alarm to a user in response to determining that the second change in the second temperature over time satisfies the flushing temperature threshold, wherein the alarm includes a prompt for the user to confirm the flushing fluid delivery.

[0084] Clause 68. A computer program product as described in any one of Clauses 62-67, wherein the instructions further cause the at least one processor to: determine that at least one variation pattern of at least one of the following satisfies at least one threshold variation pattern: a first temperature measurement, one or more of the plurality of temperature measurements, or any combination thereof; and in response to determining that the at least one variation pattern satisfies the at least one threshold variation pattern, generate an alarm to a user, wherein the alarm includes information associated with potential problems with trimming and / or fixing equipment and / or conduits.

[0085] Clause 69. A computer program product as described in any one of Clauses 62-68, wherein the at least one variation mode comprises the variation of a first temperature measurement and one or more individual temperature measurements of the plurality of temperature measurements over time.

[0086] Clause 70, a computer program product as described in any one of Clauses 62-69, wherein the at least one variation mode comprises the variation of the temperature difference between a first temperature measurement and two or more of the plurality of temperature measurements over time.

[0087] Clause 71, a computer program product as described in any one of Clauses 62-70, wherein the instructions further cause the at least one processor to: determine the at least one threshold variation pattern based on at least one of: patient parameters associated with a patient, drug parameters associated with a drug that has been delivered, is being delivered, or will be delivered to a patient, nursing environment parameters associated with the patient's nursing environment, or any combination thereof.

[0088] Clause 72. A computer program product as described in any one of Clauses 62-71, wherein the first position and the position closest to the first position among the plurality of positions are located at the same distance from the catheter conduit of the catheter and at the same distance from the catheter insertion site on the patient's body, and wherein the instructions further cause the at least one processor to: determine that the change between a first temperature measurement and the temperature measurement at the position closest to the first position among the plurality of temperature measurements satisfies a threshold temperature; and in response to determining that the change between the first temperature measurement and the temperature measurement at the position closest to the first position among the plurality of temperature measurements satisfies the threshold temperature, generate an alarm to a user, wherein the alarm includes information associated with potential problems with the trimming and / or fixation of the device and / or catheter.

[0089] Clause 73. A computer program product as described in any one of Clauses 62-72, wherein said instructions further cause said at least one processor to: determine that at least one of the following satisfies a threshold temperature increase: (i) an increase in temperature measurements from the farthest of the plurality of locations to a first temperature measurement, and (ii) an increase in the temperature difference between the first temperature measurement and the temperature measurement at the farthest of the plurality of locations to the first temperature measurement; and in response to determining at least one of (i) and (ii), generate an alarm to a user, wherein the alarm includes information associated with potential problems with trimming and / or fixing equipment and / or conduits.

[0090] Clause 74. A computer program product as described in any one of Clauses 62-73, wherein the instructions further cause the at least one processor to: obtain a second temperature measurement associated with the catheter conduit of the catheter; determine, using the at least one processor, that a temperature decrease between a first location and the location furthest from the first location among the plurality of locations meets a threshold temperature; in response to determining that the temperature decrease meets the threshold temperature, determine, using the at least one processor, that a comparison of the first temperature measurement with at least one of the following meets at least one threshold temperature: (i) a second temperature measurement at the current time and at least one time prior to the current time, and (ii) a temperature measurement at a location among the plurality of locations further from the catheter insertion site than the first location; and in response to determining that the at least one threshold temperature is met, generate an alarm for a user using the at least one processor, wherein the alarm includes information associated with potential problems with the trimming and / or fixation equipment and / or the catheter.

[0091] Clause 75, a computer program product as described in any one of Clauses 62-74, wherein a first temperature measurement and the plurality of temperature measurements are obtained at a periodic rate, and wherein the instructions further cause the at least one processor to: determine the periodic rate based on at least one of at least one of: patient parameters associated with the patient, drug parameters associated with a drug that has been delivered, is being delivered, or will be delivered to the patient, nursing environment parameters associated with the patient's nursing environment, or any combination thereof.

[0092] Clause 76, a computer program product as described in any one of Clauses 62-75, wherein the plurality of locations comprises a plurality of circumferentially spaced arrays surrounding a circle around a catheter insertion site, and wherein the locations of the plurality of locations associated with each of the plurality of arrays are radially spaced from the catheter insertion site at a plurality of different distances.

[0093] These and other features and characteristics of this disclosure, as well as the operation and function of the related elements of the structure and the economy of assembly and manufacture of the parts, will become more apparent by considering the following description and appended claims with reference to the accompanying drawings, all of which form part of this specification, wherein similar reference numerals denote corresponding parts in the various drawings. However, it should be clearly understood that the drawings are for illustrative and descriptive purposes only and are not intended to be limiting. As used in the specification and claims, the singular forms “a” and “the” include the plural objects unless the context clearly indicates otherwise. Attached Figure Description

[0094] Other advantages and details of embodiments or aspects of this disclosure will be explained in more detail below with reference to exemplary embodiments shown in the accompanying drawings, wherein:

[0095] Figure 1A The figures are non-limiting embodiments or aspects of the environment in which the systems, devices, products, apparatuses and / or methods described herein can be implemented;

[0096] Figure 1B yes Figure 1A A top view of a non-limiting embodiment or aspect of a component of one or more devices and / or one or more systems;

[0097] Figure 1C yes Figure 1A and 1B A schematic diagram of a non-limiting embodiment or aspect of a component of one or more devices and / or one or more systems;

[0098] Figure 1D yes Figure 1A-1C A block diagram of a non-limiting embodiment or aspect of a component of one or more devices and / or one or more systems;

[0099] Figure 1E yes Figure 1A-1D A perspective view of a non-limiting embodiment or aspect of a component of one or more devices and / or one or more systems;

[0100] Figure 2 yes Figure 1A-1E A block diagram of a non-limiting embodiment or aspect of a component of one or more devices and / or one or more systems;

[0101] Figure 3 This is a flowchart of a non-limiting embodiment or aspect of a temperature sensing process for detecting the condition of a vein site;

[0102] Figure 4 This is a flowchart of a non-limiting embodiment or aspect of a temperature sensing process for detecting the condition of a vein site;

[0103] Figure 5 This is a flowchart of a non-limiting embodiment or aspect of a temperature sensing process for detecting the condition of a vein site;

[0104] Figure 6 This is a flowchart of a non-limiting embodiment or aspect of a temperature sensing process for detecting the condition of a vein site;

[0105] Figure 7 A flowchart of a non-limiting embodiment or aspect of a temperature sensing process for detecting the condition of a vein site; and

[0106] Figure 8 This is a flowchart of a non-limiting embodiment or aspect of a temperature sensing process for detecting the condition of a vein site. Detailed Implementation

[0107] It should be understood that this disclosure may take various alternative variations and sequences of steps unless explicitly stated otherwise. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are merely exemplary and non-limiting embodiments or aspects. Therefore, specific dimensions and other physical characteristics relating to the embodiments or aspects disclosed herein should not be considered limiting.

[0108] For the purposes described below, the terms “end,” “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in connection with this disclosure as they are oriented in the accompanying drawings. However, it should be understood that various alternative variations and sequences of steps may be taken in this disclosure unless explicitly stated otherwise. It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary embodiments or aspects of this disclosure. Therefore, unless otherwise indicated, specific dimensions and other physical features relating to the embodiments or aspects of the embodiments disclosed herein should not be considered limiting.

[0109] Unless explicitly stated otherwise, no aspect, component, element, structure, action, step, function, instruction, etc., used herein should be construed as critical or essential. Furthermore, as used herein, "a" is intended to include one or more items and may be used interchangeably with "one or more" and "at least one." Additionally, as used herein, the term "set" is intended to include one or more items (e.g., related items, unrelated items, combinations of related and unrelated items, etc.) and may be used interchangeably with "one or more" or "at least one." Where only one item is intended, the term "one" or similar language is used. Moreover, as used herein, the terms "having" and the like are intended to be open-ended terms. Additionally, the phrase "based on" is intended to mean "at least partially based on," unless otherwise explicitly stated.

[0110] As used herein, the terms "communication" and "transmission" refer to receiving or transmitting one or more signals, messages, commands, or other types of data. For one unit (e.g., any device, system, or component thereof) to communicate with another unit means that the first unit is able to receive data directly or indirectly from and / or transmit data to the second unit. This can refer to a direct or indirect connection that is essentially wired and / or wireless. Furthermore, two units can communicate with each other even if the transmitted data can be modified, processed, relayed, and / or routed between the first and second units. For example, the first unit can communicate with the second unit even if it passively receives data and does not actively transmit data to the second unit. As another example, the first unit can communicate with the second unit if an intermediate unit processes data from one unit and transmits the processed data to the second unit. It should be recognized that many other arrangements are possible.

[0111] Clearly, the systems and / or methods described herein can be implemented in various forms of hardware, software, or combinations of hardware and software. The actual dedicated control hardware or software code used to implement these systems and / or methods does not limit the implementation. Therefore, while this document describes the operation and behavior of the systems and / or methods without reference to specific software code, it should be understood that software and hardware can be designed to implement the systems and / or methods based on the description herein.

[0112] As used herein, the term "computing device" or "computer equipment" can refer to one or more electronic devices configured to communicate directly or indirectly with or through one or more networks. A computing device can be a mobile device, a desktop computer, etc. Furthermore, the term "computer" can refer to any computing device that includes the necessary components for receiving, processing, and outputting data, and typically includes a display, processor, memory, input devices, and network interfaces. "Application" or "Application Programming Interface" (API) refers to computer code or other data stored on a computer-readable medium that can be executed by a processor to facilitate interaction between software components, such as a client-side front-end and / or a server-side back-end for receiving data from a client. "Interface" refers to a generated display, such as one or more graphical user interfaces (GUIs) with which a user can interact directly or indirectly (e.g., via a keyboard, mouse, touchscreen, etc.).

[0113] As used herein, the term "server" can refer to or include one or more processors or computers, storage devices, or similar computer arrangements that are operated by or facilitate communication and processing among multiple parties in a networked environment (such as the Internet). However, it should be recognized that communication can be facilitated through one or more public or private network environments, and various other arrangements are possible. Furthermore, multiple computers communicating directly or indirectly in a networked environment, such as servers or other computerized devices, such as POS devices, can constitute a "system," such as a merchant's POS system. As used herein, the term "data center" can include one or more servers, other computing devices, and / or databases.

[0114] As used herein, the term "mobile device" can refer to one or more portable electronic devices configured to communicate with one or more networks. As examples, mobile devices may include cellular phones (e.g., smartphones or standard cellular phones), portable computers (e.g., tablets, laptops, etc.), wearable devices (e.g., watches, glasses, lenses, clothing, etc.), personal digital assistants (PDAs), and / or other similar devices. As used herein, the terms "client device" and "user device" refer to any electronic device configured to communicate with one or more servers or remote devices and / or systems. Client devices or user devices may include mobile devices, network-enabled appliances (e.g., network-enabled televisions, refrigerators, thermostats, etc.), computers, and / or any other devices or systems capable of communicating with a network.

[0115] As used herein, the term “application” or “application programming interface” (API) refers to computer code, a set of rules, or other data stored on a computer-readable medium that can be executed by a processor to facilitate interaction between software components, such as a client-side frontend and / or a server-side backend for receiving data from a client. “Interface” refers to a generated display, such as one or more graphical user interfaces (GUIs) with which a user can interact directly or indirectly (e.g., via a keyboard, mouse, etc.).

[0116] This document describes several non-limiting embodiments or aspects in conjunction with thresholds. As used herein, satisfying a threshold can refer to a value greater than, more than, higher than, greater than or equal to, less than, less than, lower than, less than or equal to, equal to, etc. In some non-limiting embodiments or aspects, satisfying a threshold can refer to the identification of patterns or trends in signals or measurements as a result of pattern recognition techniques, machine learning techniques, data mining techniques, signal slope analysis, Xbar R-plot analysis, etc., applied to signals or measurements. For example, satisfying a threshold can be based on dynamic time-based analysis of at least one of the following: signals or measurements, multiple signals or measurements, differences between multiple signals or measurements, or any combination thereof. As an example, a threshold can represent a change in quantity and can be represented not by a single number, but by a more complex pattern of change that can be determined based on machine learning and / or pattern recognition.

[0117] Non-limiting embodiments or aspects of this disclosure provide systems, devices, products, apparatuses, and / or methods that use a first temperature sensor for a catheter trimming and / or fixation device to obtain a first temperature measurement at a first location on a patient's body adjacent to the catheter insertion site; use a second temperature sensor for the trimming and / or fixation device to obtain a second temperature measurement at the catheter tubing; and / or use an array of temperature sensors for the trimming and / or fixation device to obtain multiple temperature measurements at multiple locations on the patient's body, each of said multiple locations being spaced apart from the first location, and said multiple locations including locations at multiple different distances from the first location. A processor determines alarm conditions associated with the trimming and / or fixation device and / or catheter based on the first temperature measurement, the second temperature measurement, and / or said multiple temperature measurements, and generates an alarm for a user in response to determining the alarm conditions.

[0118] In this way, more accurate temperature analysis of the intravenous catheter site can be provided, using controlled temperature measurements or readings to interpret fluctuations in the patient's basal body temperature and to interpret temperature effects caused by fluids injected through the catheter. Furthermore, absolute and differential temperature changes over time can be monitored in spatially correlated patterns, where trimming and / or fixation devices are oriented to ensure the catheter tubing is in a known orientation / position, allowing controlled temperature measurements or readings of the patient's skin to be obtained at locations sufficiently far from the catheter entry point, at a defined distance from the patient's infusion tubing, or juxtaposed with the patient's infusion tubing (again sufficiently far from the catheter entry point), and at the catheter entry point, at the same distance from the patient's tubing and the control tubing. For example, alarms can be triggered based on temperature changes over time (e.g., temporal variations) and / or based on temperature changes in a spatial pattern represented by the positioning or location of temperature sensors (e.g., using one or more sensor arrays arranged radially from the catheter insertion site). As an example, if heating (and / or cooling) is performed radially and / or in a widening manner away from the catheter insertion site (e.g., the heated area expands at a given circumference, etc.), then an alarm can be generated at a lower threshold compared to alarms based on a single array or similar non-propagating patterns (e.g., which may be caused by random variations rather than actual temperature changes, etc.). Furthermore, a reference temperature at the outer edge of the trimming and / or securing device (e.g., a temperature obtained at a location not adjacent to the catheter tubing and / or insertion site, etc.) can be used to update the threshold temperature (e.g., the variability of the reference temperature reading due to prolonged catheter placement can be used to ensure that "normal" variability at a given patient site does not trigger an alarm, etc.).

[0119] refer to Figure 1AThis illustrates non-limiting embodiments or aspects of an environment 100 in which the systems, devices, products, apparatuses, and / or methods described herein can be implemented. Figure 1A As shown, environment 100 may include conduit 102, trimming and / or fixing device 104 and / or computing device 106.

[0120] Catheter 102 may include IV catheters, parenteral catheters such as urinary catheters, anesthesia catheters, or any intradermal or subcutaneous object whose surface is sufficient to cause a surface temperature difference. Catheter 102 may be attached to or connected to the patient at a catheter insertion site where it enters the patient's body (e.g., through the skin). In some non-limiting embodiments or aspects, catheter 102 may be connected to an infusion pump, such as... Figure 1A As shown in the image.

[0121] Still referencing Figure 1A And also refer to Figure 1B-1D The adjustment and / or fixing device 104 may include a support member 140 and a first temperature sensor T. l The first temperature sensor T1, the second temperature sensor T2, and the temperature sensor array T3 (e.g., temperature sensors T31 to T3n, etc.) and / or communication device 142. Figure 1B and 1C The catheter 102 is shown as part of the same trimming and / or fixation device 104, but is not a limiting embodiment or aspect. The first temperature sensor T1, the second temperature sensor T2, and the temperature sensor array T3 may be included on multiple different trimming and / or fixation devices and / or multiple different support members. For example, the temperature sensor array T3 may be located anywhere on the patient's body surface and / or inside the patient's body, and / or the second temperature sensor T2 may be located above any portion of the catheter 102. As an example, the first temperature sensor T1 may be located on the needle of the catheter 102 (e.g., at the tip of the needle of the catheter 102 inside the patient's body, etc.). However, it should be noted that including the first temperature sensor T1, the second temperature sensor T2, and the temperature sensor array T3 as part of the same catheter trimming and / or fixation device can make the application of the temperature sensors easier and / or faster. Furthermore, the surface temperature of the entire body varies greatly compared to core body temperature. For example, room temperature, blood circulation, circadian rhythms, systemic infection, clothing / bed movement, etc., can make identifying true temperature differences due to catheter complications more complex. However, measuring and comparing temperatures at or near the catheter insertion site can eliminate most of this variability.

[0122] The support member 140 may include, support, and / or house the first temperature sensor T1, the second temperature sensor T2, the temperature sensor array T3, and / or the communication device 142. In some non-limiting embodiments or aspects, the support member 140 may be transparent. For example, the trimming and / or fixing device 104 may include BD. Devices in a device assembly. In some non-limiting embodiments or aspects, the support member 140 includes markings or openings indicating the orientation of the support member attached to the catheter insertion site of the catheter on the patient's body. For example, the markings or openings may be aligned with the catheter insertion site of the catheter on the patient's body when the trimming and / or securing device 104 is applied to the catheter insertion site in contact with the catheter and / or the patient's body. In some non-limiting embodiments or aspects, the support member 140 includes an adhesive layer. For example, the adhesive layer may be used to attach the trimming and / or securing device 104 to the catheter 102 and / or the patient's body.

[0123] The first temperature sensor T1 can be configured to obtain a first temperature measurement at a first location on the patient's body adjacent to the catheter insertion site of the catheter 102. For example, the first temperature sensor T1 can be located on a portion of the support member 140, which is configured to be placed above and / or adjacent to the catheter insertion site (e.g., adjacent to a mark or opening indicating the orientation of the support member attached at the catheter insertion site).

[0124] The second temperature sensor T2 can be configured to obtain a second temperature measurement at the conduit of the conduit 102. For example, the second temperature sensor T2 can be spaced apart from the first temperature sensor T1 and the temperature sensor array T3 (e.g., spaced apart from the first temperature sensor T1 and the temperature sensor array T3 on the support member 140, etc.).

[0125] The temperature sensor array T3 can be configured to acquire multiple temperature measurements at multiple locations on a patient's body. For example, each of the multiple locations can be spaced apart from a first location, and the multiple locations can include locations at multiple different distances from the first location. As an example, each temperature sensor in the temperature sensor array T3 can be spaced apart from a first temperature sensor T1 and / or a second temperature sensor T2, and the temperature sensor array T3 can include temperature sensors T31 to T3n at multiple different distances from the first temperature sensor T1. In such an example, the temperature sensor array T3 can extend from the interior of the support member 140 toward the edge of the support member 140, wherein the array's temperature sensors T31 are located at the position farthest from the edge (e.g., closest to the catheter insertion site, etc.), and the array's temperature sensors T3n are located at the position closest to the edge (e.g., farthest from the catheter insertion site, etc.).

[0126] In some non-limiting embodiments or aspects, the temperature sensor array T3 may include multiple temperature sensor arrays T3. For example, as Figure 1C As shown, multiple temperature sensor arrays T31-n, T41-n, T51-n, T61-n, ...T n 1-n can be configured to acquire multiple temperature measurements at multiple locations on the patient's body, and multiple temperature sensor arrays T31-n, T41-n, T51-n, T61-n, ...T n The arrays 1-n can be spaced apart around the trimming and / or fixing device 104 (e.g., around the support member 140, etc.). As an example, multiple temperature sensor arrays T31-n, T41-n, T51-n, T61-n, ...T n 1-n can be circumferentially spaced around a circle defined in the plane of the trimming and / or fixing device 104 (e.g., in the plane of the support member 140, etc.), for example, circumferentially spaced around a circle centered on the catheter insertion site, and the temperature sensor T associated with each of the plurality of arrays. n 1-n can be radially spaced from the center of a circle at multiple different distances. For example, a temperature sensor T associated with each array in a plurality of arrays. n 1-n can extend from inside the support member 140 toward the edge of the support member 140, wherein the array of temperature sensors T n 1. The temperature sensor T is located at the position furthest from the edge (e.g., closest to the catheter insertion site, etc.) and is part of the array. n n is located at the position closest to the edge (e.g., furthest from the catheter insertion site). In such an example, the corresponding temperature sensors in different arrays of multiple temperature sensor arrays T31-n, T41-n, T51-n, T61-n, ... Tn1-n (e.g., T32, T42, T52, T62, ... Tn) n (2) These can be located at the same distance (e.g., at the same radius) from the catheter insertion site, the first temperature sensor T1, the second temperature sensor T2, and / or the mark or opening indicating the orientation of the support member attached at the catheter insertion site. In some non-limiting embodiments or aspects, multiple arrays T31-n, T41-n, T51-n, T61-n, ...T n The array in 1-n may include a first temperature sensor T1 (e.g., as shown in the image). Figure 1C (Array T5, etc. shown).

[0127] Temperature sensors can be configured to acquire continuous temperature measurements (e.g., continuous temperature signals over time) or periodic temperature measurements (e.g., instantaneous temperature measurements at intervals over a period of time). For example, periodic temperature measurements can reduce the energy consumption of the temperature sensor. In some non-limiting embodiments or aspects, the periodic rate at which the temperature sensor acquires or measures temperature measurements can be determined based on at least one of the following: patient parameters associated with the patient (e.g., age, height, weight, patient history, such as history of phlebitis, dislocation or other IV complications, risk of complications associated with toddlers, infants, patients with mental illness, etc.), drug parameters associated with drugs that have been delivered, are being delivered, or will be delivered to the patient (e.g., drug type, emulsifier type, dosage, etc.), care environment parameters associated with the patient's care environment (e.g., the area where patient care takes place, such as a ward in a hospital, a hospital system, a hospital, an outpatient center, a geriatric care center, home care, or any other care area or building or space, etc.), or any combination thereof. As an example, temperature sensors can be configured to acquire or measure temperature measurements at a higher rate based on patient parameters associated with a higher risk of complications (e.g., history of phlebitis and / or catheter displacement, infants, etc.), medication parameters associated with a higher risk of complications (e.g., vesicants, etc.), and / or care environments associated with a higher risk of complications (e.g., emergency rooms, etc.).

[0128] In some non-limiting embodiments or aspects, the temperature sensor may include a Texas Instruments LMT70, LMT70A ±0.05°C precision analog temperature sensor and an RTD and a precision NTC thermistor IC. In some non-limiting embodiments or aspects, the temperature sensor may additionally or alternatively measure heat loss as a temperature measurement. For example, a temperature measurement including heat loss measurements may be used to measure temperatures deeper within the patient's lower tissue layers. In some non-limiting embodiments or aspects, the temperature sensor may include an optical sensor and / or an illuminator configured to optically capture the patient's body temperature on a color scale.

[0129] The temperature sensor may be attached to the support member 140 via an adhesive, and / or the temperature sensor may be integrated with and / or directly molded into the support member 140. For example, when the trimming and / or fixation device 104 (e.g., at or near the adhesive layer of the support member 140) is attached to a patient, the temperature sensor may be located on or near the surface of the support member 140 that contacts the patient's skin. In some non-limiting embodiments or aspects, features and / or extensions of the trimming and / or fixation device 104 may accommodate the temperature sensor above and / or near the catheter insertion site on the patient's body.

[0130] Electrical connections to the temperature sensor may be formed or fabricated on or through the support member 140 via wires and / or conductive paths (e.g., formed via metallization (e.g., vapor deposition), conductive ink, polymer, etc.). Electrical connections may connect the temperature sensor to analog and / or digital electronics on the support member 140 and / or elsewhere in the computing device 106, as described in more detail herein. Components and / or electronics of the trimming and / or fixation device 104 may be located on and / or within the support member 140 in a manner that reduces or minimizes visual obstruction through the support member 140 and / or enhances or optimizes the physical geometry of the trimming and / or fixation device 104 for clinical settings.

[0131] In some non-limiting embodiments or aspects, the trimming and / or fixing device 104 may include an antimicrobial disc 160, for example, as Figure 1E As shown in the diagram. For example, the antimicrobial disc 160 may include a first temperature sensor T1, a second temperature sensor T2, a temperature sensor array T3, and / or a communication device 142. As an example, the antimicrobial disc 160 may be placed above the catheter insertion site that comes into contact with the patient's body, and below the support member 140 of the trimming and / or fixation device 104.

[0132] In some non-limiting embodiments or aspects, the antimicrobial disc 160 includes and / or is entirely formed of antimicrobial material (e.g., dried, lyophilized, and / or polymerized antimicrobial material, antimicrobial material embedded in a polymer that is released over time by elution, polymer degradation, and / or by a mechanism of release over time upon triggering, etc.). For example, swelling at the catheter insertion site can cause pressure to be applied to the chamber of the antimicrobial disc 160 that holds the antimicrobial material, thereby causing the release of the antimicrobial material. As an example, fluid released from a wound at the catheter insertion site may cause the polymer of the antimicrobial disc 160 to expand, thereby causing the release of the antimicrobial material (e.g., by increasing the pore size of the polymer, by compressing the chamber in which the antimicrobial material is encapsulated, etc.). For example, localized heat at the catheter insertion site (e.g., due to infection, etc.) may cause increased degradation of the polymer containing the antimicrobial material, thereby stimulating the release of the antimicrobial material from the polymer. In some non-limiting embodiments or aspects, the antimicrobial disc 160 can be used as a visible target directly oriented above the catheter insertion site to further assist in the orientation trimming and / or fixation of the device 104.

[0133] Communication device 142 can be interconnected with computing device 106 via a wired connection, a wireless connection, or a combination of wired and wireless connections (e.g., establishing a connection for communication). For example, communication device 142 can be configured to transmit information and / or data obtained by a first temperature sensor T1, a second temperature sensor T2, and / or a temperature sensor array T3 to computing device 106. In some non-limiting embodiments or aspects, communication device 142 includes wired communication devices, such as one or more cables or wires directly connecting the first temperature sensor T1, the second temperature sensor T2, and / or the temperature sensor array T3 to computing device 106 and / or one or more computing devices or chips connected to the first temperature sensor T1, the second temperature sensor T2, and / or the temperature sensor array T3 directly to computing device 106. In some non-limiting embodiments or aspects, communication device 142 includes wireless communication devices, which include one or more computing devices, chips, contactless transmitters, contactless transceivers, NFC transmitters, RFID transmitters, contact-based transmitters, etc. Such that the communication device 142 can be connected via short (and / or long) range wireless communication connections (e.g., communication connections using the NFC protocol, communication connections using radio frequency identification (RFID), etc.). Communication connections using wireless technology standards, communication connections using Wi-Fi wireless technology standards, and communication connections using Wi-Fi wireless technology standards. The communication connection using wireless technology standards, such as the communication connection using the LoRa wireless technology standard, can directly receive information from the computing device 106 and / or directly transmit information to the computing device 106.

[0134] like Figure 1D As shown, in some non-limiting embodiments or aspects, the trimming and / or fixing device 104 may include a processor 144, a user feedback device 146, a power supply 148, and / or a memory 150. However, the non-limiting embodiments or aspects are not limited thereto, and in some non-limiting embodiments or aspects, the trimming and / or fixing device 104 may include a first temperature sensor T1, a second temperature sensor T2, a temperature sensor array T3, and / or a communication device 142 that are wired and / or wirelessly connected to an external and / or remote processor 144, an external and / or remote user feedback device 146, an external and / or remote power supply 148, and / or an external and / or remote memory 150 (such as a computing device 106, etc.).

[0135] Processor 144 can be programmed and / or configured to be based on the first temperature sensor T lThe processor 144 receives signals or sensor data (e.g., temperature measurements, etc.) from the first temperature sensor T1, the second temperature sensor T2, and / or the temperature sensor array T3 to determine information and / or data associated with conditions (e.g., alarm conditions, etc.) related to the catheter 102 and / or trimming and / or fixation device 104. For example, the processor 144 may be programmed and / or configured to determine alarm conditions associated with the trimming and / or fixation device 104 and / or the catheter 102 based on signals or sensor data (e.g., temperature measurements, etc.) received from the first temperature sensor T1, the second temperature sensor T2, and / or the temperature sensor array T3. In such an example, the processor 144 may determine alarm conditions based on one or more thresholds, as described in more detail herein. For example, the processor 144 may receive signals or sensor data (e.g., temperature measurements, etc.) from the first temperature sensor T1, the second temperature sensor T2, and / or the temperature sensor array T3. l The signals or sensor data (e.g., temperature measurements) received by the second temperature sensor T2 and / or the temperature sensor array T3 are compared with one or more thresholds, and an alarm condition associated with the threshold is generated in response to the threshold being met. In some non-limiting embodiments or aspects, the processor 144 may include a low-power microcontroller unit (MCU).

[0136] User feedback device 146 can be configured to provide feedback to the user from the first temperature sensor T. l Information and / or data associated with signals and / or sensor data (e.g., temperature measurements, etc.) received by the second temperature sensor T2 and / or the temperature sensor array T3 and processed by the processor 144, and / or information and / or data (e.g., information and / or data associated with temperature measurements, differences in temperature measurements, trends or patterns in temperature measurements, etc.), and / or indications and / or alarms associated with the condition of the conduit 102 and / or the trimming and / or fixing device 104. For example, the user feedback device 146 may include at least one of the following: a display, a light-emitting diode (LED), an audio output device (e.g., a buzzer, a speaker, etc.), or any combination thereof.

[0137] Power supply 148 can be configured to power the first temperature sensor T1, the second temperature sensor T2, the temperature sensor array T3, the communication device 142, the processor 144, the user feedback device 146, and / or the memory 150. For example, power supply 148 may include a battery (e.g., a rechargeable battery, a disposable battery, etc.) and / or a connection to an external power source (e.g., a computing device 106, an infusion pump, etc.).

[0138] The memory 150 may be configured to store information associated with signals and / or sensor data (e.g., temperature measurements) received from the first temperature sensor T1, the second temperature sensor T2, and / or the temperature sensor array T3; information and / or data (e.g., alarm conditions) associated with the catheter 102 and / or trimming and / or fixation device 104; patient data / parameters; medication data / parameters; care environment data / parameters; and / or data associated with the location of the catheter and / or catheter insertion site on the patient's body. In some non-limiting embodiments or aspects, the memory 150 may store calibration data associated with one or more calibration settings, one or more reference temperature settings, one or more temperature thresholds, or any combination thereof.

[0139] The computing device 106 may include one or more devices capable of receiving information and / or data from and / or transmitting information and / or data to the trimming and / or fixing device 104. For example, the computing device 106 may include a computing device, a server, a group of servers, a mobile device, a group of mobile devices, etc. In some non-limiting embodiments or aspects, the computing device 106 is connected via a wired connection, such as one or more cables or wires directly connecting the computing device 106 to the first temperature sensor T1, the second temperature sensor T2, and / or the temperature sensor array T3, and / or one or more cables or wires directly connecting the computing device 106 to the trimming and / or fixing device 104 connected to one or more computing devices or chips of the first temperature sensor T1, the second temperature sensor T2, and / or the temperature sensor array T3. In some non-limiting embodiments or aspects, computing device 106 includes one or more computing devices, chips, contactless transmitters, contactless transceivers, NFC transmitters, RFID transmitters, contact-based transmitters, etc., which enable computing device 106 to communicate via short (and / or long) range wireless communication connections (e.g., communication connections using the NFC protocol, communication connections using radio frequency identification (RFID), etc.). Communication connections using wireless technology standards, communication connections using Wi-Fi wireless technology standards, and communication connections using Wi-Fi wireless technology standards. The computing device 106 can receive information directly from and / or transmit information directly to the communication device 142 (such as a communication connection using the LoRa wireless technology standard, etc.). In some non-limiting embodiments or aspects, the computing device 106 may include a reader box for the infusion pump and / or the infusion pump itself. In some non-limiting embodiments or aspects, the computing device 106 may include and / or upload information and / or data to an electronic data management system, such as a hospital record system, a system for collecting trial-related information during clinical trials, etc.

[0140] Figure 1A-1EThe quantity and arrangement of the equipment and systems shown are provided as examples. Figure 1A-1E Compared to the equipment and / or systems shown, there may be additional equipment and / or systems, fewer equipment and / or systems, different equipment and / or systems, or equipment and / or systems with different arrangements. Furthermore, Figure 1A-1E The two or more devices and / or systems shown can be implemented within a single device and / or system, or Figure 1A-1E The single device and / or system shown can be implemented as multiple distributed devices and / or systems. Additionally or alternatively, the collection of devices and / or systems of environment 100 (e.g., one or more devices or systems) can perform one or more functions described as being performed by another collection of devices and / or systems of environment 100.

[0141] Now for reference Figure 2 , Figure 2 This is a diagram of example components of device 200. Device 200 may correspond to one or more devices for trimming and / or fixing device 104 and / or one or more devices for computing device 106. In some non-limiting embodiments or aspects, one or more devices for trimming and / or fixing device 104 and / or one or more devices for computing device 106 may include at least one device 200 and / or at least one component of device 200. Figure 2 As shown, device 200 may include bus 202, processor 204, memory 206, storage unit 208, input unit 210, output unit 212 and communication interface 214.

[0142] Bus 202 may include components that allow communication between parts of device 200. In some non-limiting embodiments or aspects, processor 204 may be implemented in hardware, firmware, or a combination of hardware and software. For example, processor 204 may include a processor (e.g., a central processing unit (CPU), graphics processing unit (GPU), accelerated processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and / or any processing component that can be programmed to perform functions (e.g., a field-programmable gate array (FPGA), application-specific integrated circuit (ASIC), etc.). Memory 206 may include random access memory (RAM), read-only memory (ROM), and / or another type of dynamic or static storage device (e.g., flash memory, magnetic storage, optical storage, etc.) that stores information and / or instructions for use by processor 204.

[0143] Storage component 208 may store information and / or software related to the operation and use of device 200. For example, storage component 208 may include hard disk (e.g., magnetic disk, optical disk, magneto-optical disk, solid-state disk, etc.), optical disk (CD), digital versatile disk (DVD), floppy disk, cassette tape, magnetic tape and / or another type of computer-readable medium, and corresponding drives.

[0144] Input component 210 may include components that allow device 200 to receive information, such as via a user input device (e.g., a touchscreen display, keyboard, keypad, mouse, button, switch, microphone, etc.). Alternatively, input component 210 may include sensors for sensing information (e.g., a Global Positioning System (GPS) component, accelerometer, gyroscope, actuator, etc.). Output component 212 may include components that provide output information from device 200 (e.g., a display, speaker, one or more light-emitting diodes (LEDs), etc.).

[0145] Communication interface 214 may include transceiver-like components (e.g., a transceiver, separate receiver and transmitter, etc.) that enable device 200 to communicate with other devices, such as via a wired connection, a wireless connection, or a combination of wired and wireless connections. Communication interface 214 may allow device 200 to receive information from and / or provide information to another device. For example, communication interface 214 may include an Ethernet interface, an optical interface, a coaxial interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, etc. Interfaces, cellular network interfaces, etc.

[0146] Device 200 can perform one or more processes described herein. Device 200 can perform these processes based on software instructions stored in a computer-readable medium (such as memory 206 and / or storage unit 208) executed by processor 204. Computer-readable media (e.g., non-transitory computer-readable media) are defined herein as non-transitory memory devices. Memory devices include memory space located within a single physical storage device or memory space distributed across multiple physical storage devices.

[0147] Software instructions can be read into memory 206 and / or storage unit 208 via communication interface 214 from another computer-readable medium or from another device. When executed, the software instructions stored in memory 206 and / or storage unit 208 can cause processor 204 to perform one or more processes described herein. Additionally or alternatively, hardwired circuitry may be used in place of or in combination with software instructions to perform one or more processes described herein. Therefore, the embodiments or aspects described herein are not limited to any specific combination of hardware circuitry and software.

[0148] The memory 206 and / or storage component 208 may include data storage or one or more data structures (e.g., a database). The device 200 may be able to receive information from the data storage or one or more data structures in the memory 206 and / or storage component 208, store information in the data storage or one or more data structures, transfer information to the data storage or one or more data structures, or search for information stored in the data storage or one or more data structures.

[0149] Figure 2 The number and arrangement of components shown are provided as examples. In some non-limiting embodiments or aspects, device 200 may include more than Figure 2 The components shown may be more, fewer, different, or arranged differently. Additionally or alternatively, a set of components of device 200 (e.g., one or more components) may perform one or more functions described as being performed by another set of components of device 200.

[0150] Now for reference Figure 3 , Figure 3 This is a flowchart of a non-limiting embodiment or aspect of a process 300 for detecting the condition of a vein site. In some non-limiting embodiments or aspects, one or more steps of process 300 may be performed (e.g., entirely, partially, etc.) by trimming and / or fixing device 104. In some non-limiting embodiments or aspects, one or more steps of process 300 may be performed (e.g., entirely, partially, etc.) by another device or group of devices separate from or including trimming and / or fixing device 104, such as computing device 106 (e.g., one or more devices of computing device 106).

[0151] like Figure 3 As shown, at step 302, process 300 includes associating the trimming and / or fixation device with the patient and / or catheter / catheter insertion site. For example, computing system 106 may receive a unique identifier associated with trimming and / or fixation device 104 and store that unique identifier in a database in association with the patient's unique identifier and / or the unique identifier of catheter 102 and / or the catheter insertion site location of catheter 102 on the patient's body. As an example, a clinician may scan a barcode, RFID tag, etc., on trimming and / or fixation device 104, or trimming and / or fixation device 104 may automatically transmit a signal to the nearest compatible electronic interface (e.g., computing system 106, etc.) to associate itself with the patient when the packaging containing trimming and / or fixation device 104 is opened. The clinician may scan or manually enter the patient's catheter / catheter insertion site to associate it with trimming and / or fixation device 104.

[0152] like Figure 3 As shown, at step 304, process 300 includes placing a trimming and / or securing device at the catheter insertion site of the patient's catheter. For example, a clinician may place the trimming and / or securing device 104 above the catheter insertion site, wherein a mark or opening indicates the orientation of the support member 140 of the trimming and / or securing device 104 for attachment to the catheter insertion site of the catheter 102 on the patient's body, aligned with the catheter insertion site of the catheter 102 on the patient's body. As an example, a clinician may place the trimming and / or securing device 104 above the catheter insertion site such that (i) a first temperature sensor T1 is located on the patient's body at a first position adjacent to and / or above the catheter insertion site of the catheter 102, (ii) a second temperature sensor T2 is located on and / or above the catheter conduit of the catheter 102, and (iii) a temperature sensor array T31-n is located at multiple positions on the patient's body, each of which is spaced apart from the first position, and wherein the multiple positions include positions at multiple different distances from the first position.

[0153] like Figure 3 As shown, at step 306, process 300 includes determining at least one threshold temperature. For example, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may determine at least one threshold temperature. For example, as described in more detail below with respect to step 310, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may compare signals or sensor data (e.g., temperature measurements, etc.) received from the first temperature sensor T1, the second temperature sensor T2, and / or the temperature sensor array T3 with at least one threshold temperature, and in response to the threshold temperature being met, generate an alarm condition associated with that threshold temperature.

[0154] In some non-limiting embodiments or aspects, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may determine at least one threshold temperature based on at least one of the following: patient parameters associated with the patient (e.g., age, height, weight, patient history, such as history of phlebitis, dislocation or other IV complications, risk of complications associated with toddlers, infants, patients with mental illness, etc.), drug parameters associated with drugs that have been delivered, are being delivered or will be delivered to the patient (e.g., drug type, vesicant type, dosage, etc.), care environment parameters associated with the care environment in which the patient is located (e.g., the area where patient care takes place, such as a ward in a hospital, a hospital system, a hospital, an outpatient center, a geriatric care center, home care, or any other care area or building or space, etc.), or any combination thereof. For example, thresholds can be determined or set based on patient parameters associated with a higher risk of complications (e.g., history of phlebitis and / or catheter displacement, infants, etc.), medication parameters associated with a higher risk of complications (e.g., vesicants, etc.), and / or care environments associated with a higher risk of complications (e.g., emergency rooms, etc.), making it easier to meet the threshold (e.g., by lower values ​​and / or amounts of change, etc.). In some non-limiting embodiments or aspects, the threshold for absolute temperature difference may depend on limitations of the temperature sensor used to obtain the temperature measurement value used to determine the absolute temperature difference.

[0155] In some non-limiting embodiments or aspects, the trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may determine at least one threshold temperature based on one or more reference measurements obtained by a first temperature sensor T1, a second temperature sensor T2, and / or a temperature sensor array T3. For example, the first temperature sensor T1 may obtain a first reference measurement at a first location on the patient's body, and the temperature sensor array T3 may obtain multiple reference measurements at multiple locations on the patient's body. As an example, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may determine multiple first temperature differences (e.g., multiple temperature differences between T1 and T31 to T3n, etc.) between a first reference measurement and each of a plurality of reference measurements, determine multiple second temperature differences (e.g., multiple temperature differences between T3n and T31 to T3n-1, etc.) between a reference measurement at a location furthest from the first location and each of the remaining locations, and determine at least one threshold temperature based on the multiple first temperature differences and the multiple second temperature differences. In such an example, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 can determine at least one threshold temperature to provide a baseline for understanding changes in a patient's body temperature to create a threshold for temperature change, such as threshold change = multiplier x average temperature change, where the multiplier can be automatically set and / or predetermined or set by a clinician / hospital, etc. (e.g., the multiplier can be a fraction, such as 0.25, 0.5, etc., or an integer, such as 1, 2, etc.).

[0156] In some non-limiting embodiments or aspects, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may determine at least one threshold temperature as at least one predetermined threshold temperature.

[0157] like Figure 3 As shown, at step 308, process 300 includes obtaining a temperature measurement value. For example, a first temperature sensor T1 may obtain a first temperature measurement value at a first location on the patient's body adjacent to the catheter insertion site of catheter 102, a second temperature sensor T2 may obtain a second temperature measurement value at the catheter tubing of catheter 102, and / or temperature sensor array T3 (and / or T4 to T5) may also be used. n (e.g.,) can obtain multiple temperature measurements at multiple locations on the patient's body. In such an example, each of the multiple locations may be spaced apart from a first location, and the multiple locations may include locations at multiple different distances from the first location.

[0158] like Figure 3As shown, at step 310, process 300 includes determining alarm conditions based on temperature measurements. For example, the trimming and / or fixing equipment 104 (e.g., processor 144, etc.) and / or computing system 106 may determine alarm conditions based on a first temperature measurement (e.g., at T1, etc.), a second temperature measurement (e.g., at T2, etc.), and / or multiple temperature measurements (e.g., at T3, at T...). n (etc.) to determine alarm conditions associated with trimming and / or fixing device 104 and / or conduit 102. As an example, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may determine that a first temperature measurement, a second temperature measurement, one or more of a plurality of temperature measurements, or any combination thereof, satisfy at least one threshold temperature.

[0159] In some non-limiting embodiments or aspects, the trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 can monitor a first temperature measurement (e.g., at T...). l (e.g., at T2, etc.), a second temperature measurement (e.g., at T3, etc.) and / or multiple temperature measurements (e.g., at T3, etc.) n The pattern (e.g., absolute temperature change pattern between different temperature sensors, time-varying temperature change pattern, spatial temperature change pattern, etc.) satisfies at least one threshold change pattern. As an example, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 can determine at least one of the following change patterns: a first temperature measurement, a second temperature measurement, one or more of a plurality of temperature measurements, or any combination thereof, satisfies at least one threshold change pattern. In such an example, at least one change pattern may include the change of one or more individual temperature measurements of the first temperature measurement and the plurality of temperature measurements over time and / or the change of the temperature difference between the first temperature measurement and two or more of the plurality of temperature measurements over time.

[0160] In some non-limiting embodiments or aspects, trimming and / or fixation device 104 (e.g., processor 144, etc.) and / or computing system 106 may use pattern matching techniques and / or machine learning techniques to identify patterns or trends of interest (e.g., to identify threshold patterns or trends, to identify thresholds that satisfy patterns or trends, etc.), such as temperature rise, an increase in temperature over time from the catheter insertion site in one or more temperature sensor arrays, or a migration of temperature over time. In some non-limiting embodiments or aspects, trimming and / or fixation device 104 (e.g., processor 144, etc.) and / or computing system 106 may filter one or more temperature measurements that fail to meet one or more thresholds. For example, short-term temperature changes below a threshold may be filtered to prevent false alarms, as catheter infections typically occur over relatively long periods.

[0161] In some non-limiting embodiments or aspects, the trimming and / or fixation device 104 (e.g., processor 144, etc.) and / or computing system 106 may analyze one or more temperature measurements to increase sensitivity and / or alarm specificity. For example, large temperature changes over shorter time periods may be ignored or filtered (e.g., if the temperature change is due to the patient changing clothes, moving blankets, washing, etc.). As an example, the trimming and / or fixation device 104 may use pattern matching techniques, machine learning techniques, and / or other algorithms to determine whether a daily baseline pattern of the patient's temperature exists to compensate for the daily baseline pattern when determining alarm conditions associated with the trimming and / or fixation device 104 and / or catheter 102.

[0162] Further details regarding non-limiting embodiments or aspects of step 310 are as follows: Figure 4-7 supply.

[0163] like Figure 3 As shown, at step 312, process 300 includes generating an alarm. For example, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may generate an alarm to a user in response to determining alarm conditions. As an example, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may generate an alarm to a user in response to determining that at least one threshold temperature is met. For example, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may generate an alarm to a user in response to determining that at least one change pattern meets at least one threshold change pattern.

[0164] In some non-limiting embodiments or aspects, the alarm includes information and / or data associated with potential problems of trimming and / or securing device 104 and / or catheter 102. For example, the alarm may include information and / or data associated with potential or detected peeling of trimming and / or securing device 104, potential or detected tunneling of trimming and / or securing device 104 (e.g., air path between dressing and skin from the outside to the inside of the dressing), potential or detected removal of trimming and / or securing device, fluid infusion, delivery of flushing fluid, potential or detected catheter migration, potential or detected catheter extravasation, potential or detected catheter infiltration, etc.

[0165] like Figure 3 As shown, at step 314, process 300 includes updating electronic records. For example, trimming and / or fixation device 104 (e.g., processor 144, etc.) and / or computing system 106 may receive user input from a user (e.g., a clinician, etc.) (e.g., instructions to remove trimming and / or fixation device 104, instructions to continue monitoring trimming and / or fixation device 104, etc.) and store the user input in a database in association with a unique identifier associated with trimming and / or fixation device 104, a unique identifier for the patient, a unique identifier for catheter 102 and / or the location of catheter insertion site of catheter 102 on the patient's body and / or other information and / or data associated therewith (e.g., temperature measurements, previous alarms, etc.).

[0166] like Figure 3 As further shown, at step 314, process 300 may also include returning to step 302 (e.g., in response to the clinician removing the trimming and / or fixation device 104, etc.) or returning to and / or continuing to step 308 (e.g., automatically until the indication that the trimming and / or fixation device 104 has been removed, etc., in response to the clinician providing an instruction to continue monitoring the trimming and / or fixation device 104).

[0167] Now for reference Figure 4 , Figure 4 This is a flowchart of a non-limiting embodiment or aspect of a process 400 for detecting the condition of a vein site. In some non-limiting embodiments or aspects, one or more steps of process 400 may be performed (e.g., entirely, partially, etc.) by trimming and / or fixing device 104. In some non-limiting embodiments or aspects, one or more steps of process 400 may be performed (e.g., entirely, partially, etc.) by another device or group of devices that are separate from or include trimming and / or fixing device 104, such as computing system 106 (e.g., one or more devices of computing system 106).

[0168] like Figure 4As shown, at step 402, process 400 includes determining whether a first temperature measurement and each of a plurality of temperature measurements meet a threshold temperature. For example, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may determine whether a first temperature measurement (e.g., at T1, etc.) and each of a plurality of temperature measurements (e.g., at T31 to T3n) meet a threshold temperature (e.g., removing the threshold temperature, etc.).

[0169] like Figure 4 As shown, if at step 402, the trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 determines that each of the first temperature measurement (e.g., at T1, etc.) and multiple temperature measurements (e.g., at T31 to T3n, etc.) meets a threshold temperature (e.g., removal threshold temperature, etc.), then the process can proceed to step 314 of the figure, where the trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 can generate an alarm (e.g., removal alarm, etc.) for the user in response to determining that each of the first temperature measurement and multiple temperature measurements meets the threshold temperature. For example, the alarm may include information associated with a potential or detected removal of the trimming and / or fixing device.

[0170] like Figure 4 As shown, if at step 402, the trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 determines that each of the first temperature measurement (e.g., at T1, etc.) and multiple temperature measurements (e.g., at T31 to T3n, etc.) does not meet a threshold temperature (e.g., removal threshold temperature, etc.), then at step 404, process 400 may include determining whether two or more of the first temperature measurement and multiple temperature measurements meet the threshold temperature. For example, the trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may determine whether two or more of the first temperature measurement (e.g., at T1, etc.) and multiple temperature measurements (e.g., at T31 to T3n-1, etc.) meet a threshold temperature (e.g., tunneling threshold temperature, etc.).

[0171] like Figure 4 As shown, if at step 404, the trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 determine that two or more of the first temperature measurement (e.g., at T1, etc.) and a plurality of temperature measurements (e.g., at T31 to T3n-1, etc.) satisfy a threshold temperature (e.g., tunneling threshold temperature, etc.), then the process can proceed to Figure 3In step 314, the trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may generate an alarm (e.g., a tunneling alarm, etc.) to the user in response to determining that a first temperature measurement and two or more of a plurality of temperature measurements meet a threshold temperature. For example, the alarm may include information associated with a potential or detected tunneling by the trimming and / or fixing device 104.

[0172] like Figure 4 As shown, if at step 404, the trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 determine that two or more of the first temperature measurement (e.g., at T1, etc.) and a plurality of temperature measurements (e.g., at T31 to T3n-1, etc.) do not meet a threshold temperature (e.g., tunneling threshold temperature, etc.), then at step 406, process 400 may include determining whether the temperature measurement at the location furthest from the first location among the plurality of temperature measurements meets the threshold temperature. For example, the trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may determine whether the temperature measurement at the location furthest from the first location among the plurality of temperature measurements (e.g., at T3n, etc.) meets the threshold temperature (e.g., peeling threshold temperature, etc.).

[0173] like Figure 4 As shown, if at step 406, the trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 determine that the temperature measurement at the location furthest from the first location among a plurality of temperature measurements (e.g., at T3n, etc.) meets a threshold temperature (e.g., peeling threshold temperature, etc.), then the process can proceed to... Figure 3 In step 314, at this step, the trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may generate an alarm (e.g., a peeling alarm, etc.) to the user in response to determining that a temperature measurement at the location furthest from the first location among a plurality of locations meets a threshold temperature. For example, the alarm may include information associated with potential or detected peeling of the trimming and / or fixing device 104.

[0174] Therefore, non-limiting embodiments or aspects of this disclosure may provide detection of damaged trimming and / or fixation devices by sensing temperature differences and / or temperatures below a threshold temperature (e.g., below body temperature, etc.) as an indication that the trimming and / or fixation devices are no longer fixed to the patient, tunneled and / or dislodged, and / or provide detection of catheter migration (e.g., partial or complete displacement, etc.) by sensing temperature changes (e.g., temperature changes near or at the catheter insertion site or at the insertion site, etc.).

[0175] Now for reference Figure 5 , Figure 5 This is a flowchart of a non-limiting embodiment or aspect of a process 500 for detecting the condition of a vein site. In some non-limiting embodiments or aspects, one or more steps of process 500 may be performed (e.g., entirely, partially, etc.) by trimming and / or fixing device 104. In some non-limiting embodiments or aspects, one or more steps of process 500 may be performed (e.g., entirely, partially, etc.) by another device or group of devices separate from or including trimming and / or fixing device 104, such as computing system 106 (e.g., one or more devices of computing system 106).

[0176] like Figure 5 As shown, at step 502, process 500 includes determining that a first change in the second temperature over time satisfies an infusion temperature threshold. For example, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may determine that the first change in the second temperature (e.g., at T2, etc.) over time satisfies the infusion temperature threshold.

[0177] like Figure 5 As shown, at step 504, process 500 includes storing confirmation of the infusion operation associated with the patient record in response to determining that a first change in a second temperature (e.g., at T2, etc.) over time satisfies an infusion temperature threshold. For example, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may store confirmation of the infusion operation associated with the patient record in a database.

[0178] like Figure 5 As shown, at step 506, process 500 includes determining that a second change in temperature over time following the first change satisfies a rinsing temperature threshold. For example, trimming and / or fixing equipment 104 (e.g., processor 144, etc.) and / or computing system 106 can determine that a second change in temperature over time (e.g., at T2, etc.) following the first change satisfies a rinsing temperature threshold. Figure 5 As shown, in response to determining that a second change in temperature (e.g., at T2, etc.) over time after a first change satisfies a rinsing temperature threshold, the process can proceed to... Figure 3 In step 314, the trimming and / or fixation device 104 (e.g., processor 144, etc.) and / or computing system 106 may generate an alarm for the user. For example, the alarm may include a prompt for the user to confirm the delivery of the irrigation fluid, and upon receiving confirmation from the user, the trimming and / or fixation device 104 (e.g., processor 144, etc.) and / or computing system 106 may store the confirmation in a database in association with the patient's records.

[0179] Now for reference Figure 6 , Figure 6 This is a flowchart of a non-limiting embodiment or aspect of a process 600 for detecting the condition of a vein site. In some non-limiting embodiments or aspects, one or more steps of process 600 may be performed (e.g., entirely, partially, etc.) by trimming and / or fixing device 104. In some non-limiting embodiments or aspects, one or more steps of process 600 may be performed (e.g., entirely, partially, etc.) by another device or group of devices separate from or including trimming and / or fixing device 104, such as computing system 106 (e.g., one or more devices of computing system 106).

[0180] like Figure 6 As shown, at step 602, process 600 includes determining that the change between a first temperature measurement and the temperature measurement closest to the first location among a plurality of temperature measurements at a plurality of locations satisfies a threshold temperature. For example, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may determine that the change between the first temperature measurement (e.g., at T1, etc.) and the temperature measurement at the nearest location to the first location among a plurality of temperature measurements at a plurality of locations satisfies a threshold temperature. For example, the first location and the location closest to the first location among a plurality of locations may be located at the same distance from the catheter tubing of catheter 102 and the same distance from the catheter insertion site of catheter 102 on the patient's body. As an example, the first temperature sensor T1 and the temperature sensor (e.g., T31, etc.) closest to the first temperature sensor in the temperature sensor array may be located at the same distance from the catheter tubing of catheter 102 and the same distance from the catheter insertion site of catheter 102 on the patient's body.

[0181] like Figure 6 As shown, in response to determining a first temperature measurement value (e.g., at T...), l If the change between the temperature measurement (etc.) and the temperature measurement at the location closest to the first location (e.g., at T31, etc.) among multiple temperature measurements satisfies a threshold temperature, the processing can proceed to... Figure 3 In step 314, the trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may generate an alert for the user. For example, the alert may include information associated with potential problems with the trimming and / or fixing device and / or conduit.

[0182] Now for reference Figure 7 , Figure 7This is a flowchart of a non-limiting embodiment or aspect of a process 700 for detecting the condition of a vein site. In some non-limiting embodiments or aspects, one or more steps of process 700 may be performed (e.g., entirely, partially, etc.) by trimming and / or fixing device 104. In some non-limiting embodiments or aspects, one or more steps of process 700 may be performed (e.g., entirely, partially, etc.) by another device or group of devices separate from or including trimming and / or fixing device 104, such as computing system 106 (e.g., one or more devices of computing system 106).

[0183] like Figure 7 As shown, at step 702, process 700 includes determining at least one of the following: (i) a temperature increase from the temperature measurement at the farthest location among a plurality of locations to a first temperature measurement, and (ii) an increase in the temperature difference between the first temperature measurement and the temperature measurement at the farthest location among the plurality of locations to the first temperature measurement satisfies a threshold temperature increase. For example, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 may determine at least one of the following: (i) a temperature increase from the temperature measurement at the farthest location among the plurality of locations to the first temperature measurement (e.g., T31>T32>T33>T3n-1>T3n, etc.), and (ii) an increase in the temperature difference between the first temperature measurement and the temperature measurement at the farthest location among the plurality of locations to the first temperature measurement (e.g., ΔT1, T3n, etc.) to the first temperature measurement satisfies a threshold temperature increase.

[0184] like Figure 7 As shown, in response to determining at least one of the following: (i) a temperature increase from the temperature measurement at the farthest location among the plurality of locations to a first temperature measurement, and (ii) an increase in the temperature difference between the first temperature measurement and the temperature measurement at the farthest location among the plurality of locations and the first temperature measurement satisfying a threshold temperature increase, then the process can proceed to... Figure 3In step 314, the trimming and / or fixation device 104 (e.g., processor 144, etc.) and / or computing system 106 may generate an alert for the user. For example, the alert may include information associated with potential problems with the trimming and / or fixation device and / or catheter. As an example, if a temperature change indicates that a site is warming beyond predefined criteria, suggesting potential phlebitis and / or infection at that site (e.g., absolute temperature increases from the edge of support member 140 towards the catheter insertion site, T31>T32>T33>T3n-1>T3n, etc., and / or a temporal pattern of increasing temperature difference over time, ΔT1, T3n, etc.), then an alert may be sent to the clinician to check for potential complications at the catheter insertion site. In some non-limiting embodiments or aspects, the trimming and / or fixation device 104 (e.g., processor 144, etc.) and / or computing system 106 may consider (e.g., filter, etc.) the temporal element associated with limited transient warming at initial catheter placement.

[0185] Now for reference Figure 8 , Figure 8 This is a flowchart of a non-limiting embodiment or aspect of a process 800 for detecting the condition of a vein site. In some non-limiting embodiments or aspects, one or more steps of process 800 may be performed (e.g., entirely, partially, etc.) by trimming and / or fixing device 104. In some non-limiting embodiments or aspects, one or more steps of process 800 may be performed (e.g., entirely, partially, etc.) by another device or group of devices separate from or including trimming and / or fixing device 104, such as computing system 106 (e.g., one or more devices of computing system 106).

[0186] like Figure 8 As shown, at step 802, process 800 includes determining that the temperature decrease between a first location and the location furthest from the first location among a plurality of locations meets a threshold temperature. For example, trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 can determine that the temperature decrease between the first location (e.g., at T1, etc.) and the location furthest from the first location among a plurality of locations (e.g., at T3n, etc.) meets a threshold temperature. Figure 8 As shown, in response to determining a first position (e.g., at T) lThe temperature decrease between the first temperature measurement (e.g., at T1, etc.) and the position furthest from the first position (e.g., at T3n, etc.) among multiple positions meets a threshold temperature, and the trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 can determine a comparison between the first temperature measurement (e.g., at T1, etc.) and at least one of the following: (i) a second temperature measurement at the current time and at least one time prior to the current time (e.g., at T2, etc.), and (ii) a temperature measurement at a position among multiple positions that is farther from the catheter insertion site than the first position (e.g., at T32 to T3n, etc.) meets at least one threshold temperature.

[0187] like Figure 8 As shown, in response to determining a first position (e.g., at T) l If the temperature decrease between the first temperature measurement (e.g., at T1, etc.) and the location furthest from the first location (e.g., at T3n, etc.) meets a threshold temperature, the trimming and / or fixing device 104 (e.g., processor 144, etc.) and / or computing system 106 can determine a comparison between the first temperature measurement (e.g., at T1, etc.) and at least one of the following: (i) a second temperature measurement at the current time and at least one time prior to the current time (e.g., at T2, etc.), and (ii) temperature measurements at locations further from the catheter insertion site than the first location (e.g., at T32 to T3n, etc.) among the multiple locations meet at least one threshold temperature, the process can proceed to Figure 3 In step 314, the trimming and / or securing device 104 (e.g., processor 144, etc.) and / or computing system 106 may generate an alarm for the user. For example, the alarm may include information associated with potential problems with the trimming and / or securing device and / or catheter. As an example, if a temperature change indicating infiltration, extravasation, and / or catheter displacement is sensed, T1 (and / or T31) and T... nIf the temperature decreases between two points, then T1 (and / or T31) can be compared with T2 at the current time and at a time prior to the current time (e.g., before the temperature change, etc.) to determine whether the cooling is caused by the temperature change of the infusion fluid (rather than by complications). In such an example, if the cooling does not occur simultaneously (and is not immediately following), such as the cooling of the infusion fluid measured at T2, or if the cooling extends beyond a defined distance such as that defined by temperature sensors T31 to T3n (e.g., if the cooling has reached temperature sensor T33, etc.), then an alert can be sent to the clinician to check for potential complications at the catheter insertion site. In some non-limiting embodiments or aspects, these distances and temperature change thresholds may take into account the time since the infusion fluid temperature change and the expected amount of temperature change based on the thermal diffusivity and cellular thermal output at the catheter insertion site. Therefore, non-limiting embodiments or aspects of this disclosure may provide detection of catheter migration, including partial or complete displacement of the catheter, by sensing temperature changes (e.g., temperature changes around or near the catheter insertion site and / or the portion of the catheter at the catheter insertion site), detecting catheter extravasation, creating data useful for monitoring workflows, automating documentation, and / or detecting patient self-dosing (e.g., in the case of rapid infusion from a flushing syringe or injection of medication from a syringe, the trimming device may sense a decrease in temperature at the start and an increase in temperature at the end of the dose).

[0188] While embodiments or aspects have been described in detail for purposes of illustration and description, it should be understood that such details are for that purpose only, and that embodiments or aspects are not limited to the disclosed embodiments or aspects, but rather, the disclosed embodiments or aspects are intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that this disclosure contemplates that, to the extent possible, one or more features of any embodiment or aspect may be combined with one or more features of any other embodiment or aspect. In fact, any of these features may be combined in a manner not specifically recited in the claims and / or not disclosed in the specification. While each dependent claim listed below may directly depend on one claim, the disclosure of possible implementations includes combinations of each dependent claim with each other claim in the claim set.

Claims

1. A method comprising: A first temperature sensor using a catheter trimming and / or fixation device obtains a first temperature measurement at a first location on the patient's body adjacent to the catheter insertion site. Multiple temperature measurements are obtained at multiple locations on the patient's body using a temperature sensor array of a trimming and / or fixation device, each of the multiple locations being spaced apart from a first location, and the multiple locations including locations at multiple different distances from the first location; At least one processor is used to determine a plurality of first temperature differences between a first temperature measurement and each of the plurality of temperature measurements; Based on the plurality of first temperature differences, at least one processor is used to determine alarm conditions associated with trimming and / or fixing equipment and / or conduits; as well as In response to the determination of alarm conditions, an alarm is generated for the device using at least one processor.

2. The method of claim 1, further comprising: The at least one processor is used to determine (i) a plurality of second temperature differences between (ii) a temperature measurement at the location furthest from the first location among the plurality of temperature measurements and (ii) a plurality of remaining temperature measurements at each of the remaining locations among the plurality of temperature measurements; Using at least one processor, at least one threshold temperature is determined based on the plurality of first temperature differences and the plurality of second temperature differences; At least one processor is used to determine that a first temperature measurement, one or more of the plurality of temperature measurements, or any combination thereof, satisfy the at least one threshold temperature. as well as An alarm is generated for the device in response to the determination that at least one threshold temperature is met.

3. The method of claim 1, further comprising: At least one processor is used to determine that the temperature measurement value among the plurality of temperature measurements at the location farthest from the first location among the plurality of locations satisfies the threshold temperature; as well as In response to the determination that the temperature measurement at the location furthest from the first location among the plurality of locations meets a threshold temperature, an alarm is generated for the device using at least one processor, wherein the alarm includes information associated with potential peeling of the trimming and / or fixing of the device.

4. The method of claim 1, further comprising: At least one processor is used to determine that a first temperature measurement and two or more of the plurality of temperature measurements satisfy a threshold temperature; as well as In response to the determination that two or more of the first temperature measurement and the plurality of temperature measurements meet a threshold temperature, an alarm is generated for the device using at least one processor, wherein the alarm includes information associated with potential tunneling of the device for repair and / or fixation.

5. The method of claim 1, further comprising: At least one processor is used to determine that a first temperature measurement and each of the plurality of temperature measurements satisfy a threshold temperature; as well as In response to the determination that a first temperature measurement and each of the plurality of temperature measurements meet a threshold temperature, an alarm is generated for the device using at least one processor, wherein the alarm includes information associated with the potential removal of the device for repair and / or fixation.

6. The method of claim 1, further comprising: A second temperature measurement value at the conduit tube is obtained using a second temperature sensor of the trimming and / or fixing device; Use at least one processor to determine whether a first change in a second temperature measurement over time satisfies an infusion temperature threshold. Use at least one processor to store confirmations of infusion operations associated with patient records; Use at least one processor to determine whether a second change in a second temperature measurement over time after a first change satisfies a flushing temperature threshold. as well as In response to the determination that a second change in a second temperature measurement over time satisfies a flushing temperature threshold, an alarm is generated for the device using at least one processor, wherein the alarm includes a prompt to the device confirming the delivery of flushing fluid.

7. The method of claim 1, further comprising: Using at least one processor, determine that at least one of the following changes satisfies at least one threshold change pattern: a first temperature measurement, one or more of the plurality of temperature measurements, or any combination thereof; as well as In response to the determination that the at least one change pattern satisfies the at least one threshold change pattern, an alarm is generated for the device using at least one processor, wherein the alarm includes information associated with potential problems related to the trimming and / or fixing of the equipment and / or catheters.

8. The method of claim 7, wherein the at least one variation mode comprises the variation of a first temperature measurement and one or more individual temperature measurements among the plurality of temperature measurements over time.

9. The method of claim 7, wherein the at least one variation mode includes the change of temperature difference over time between a first temperature measurement and two or more of the plurality of temperature measurements.

10. The method of claim 7, further comprising: Using at least one processor, the at least one threshold change pattern is determined based on at least one of the following: patient parameters associated with the patient, drug parameters associated with drugs that have been delivered, are being delivered, or will be delivered to the patient, nursing environment parameters associated with the patient's nursing environment, or any combination thereof.

11. The method of claim 1, wherein the first position and the position closest to the first position among the plurality of positions are located at the same distance from the catheter conduit of the catheter and at the same distance from the catheter insertion site on the patient's body, and wherein the method further comprises: At least one processor is used to determine that the change between a first temperature measurement and the temperature measurement at the location closest to the first location among the plurality of temperature measurements satisfies a threshold temperature. as well as In response to the determination of a threshold temperature, a change between a first temperature measurement and a temperature measurement at the location closest to the first location among the plurality of temperature measurements is satisfied, an alarm is generated for the device using at least one processor, wherein the alarm includes information associated with potential problems related to the trimming and / or fixing of the device and / or conduits.

12. The method of claim 1, further comprising: Use at least one processor to determine that at least one of the following satisfies a threshold temperature increase: (i) an increase in the temperature measurement value at the farthest location among the plurality of temperature measurements to a first temperature measurement value, or (ii) an increase in the temperature difference between the first temperature measurement value and the temperature measurement value at the farthest location among the plurality of locations to the first temperature measurement value; as well as In response to the determination of at least one of (i) or (ii), an alarm is generated for the device using at least one processor, wherein the alarm includes information related to potential problems with the trimming and / or fixing of the device and / or conduit.

13. The method of claim 1, further comprising: A second temperature measurement at the conduit channel is obtained using a second temperature sensor from the trimming and / or fixing device. At least one processor is used to determine that the temperature decrease between a first location and the location furthest from the first location among the plurality of locations meets a threshold temperature. In response to the determination that the temperature decrease meets a threshold temperature, at least one processor is used to determine that a comparison of a first temperature measurement with at least one of the following meets at least one threshold temperature: (i) a second temperature measurement at the current time and at least one time prior to the current time, or (ii) a temperature measurement at a location among the plurality of locations that is further away from the catheter insertion site than the first location; as well as In response to the determination that the at least one threshold temperature is met, an alarm is generated for the device using at least one processor, wherein the alarm includes information associated with potential problems related to the trimming and / or fixing of the device and / or conduits.

14. The method of claim 1, wherein the first temperature measurement and the plurality of temperature measurements are obtained at a periodic rate, and wherein the method further comprises: Using at least one processor, a periodic rate is determined based on at least one of the following: patient parameters related to the patient, drug parameters related to drugs that have been delivered, are being delivered, or will be delivered to the patient, nursing environment parameters related to the patient's nursing environment, or any combination thereof.

15. The method of claim 1, further comprising: Multiple temperature sensor arrays are used to obtain multiple temperature measurements at multiple locations on the patient's body using trimming and / or fixation devices, wherein the multiple temperature sensor arrays are spaced around the catheter insertion site.

16. The method of claim 15, wherein the plurality of temperature sensor arrays are circumferentially spaced around the catheter insertion site, and wherein the locations associated with each array of the plurality of temperature sensor arrays are radially spaced at a plurality of different distances from the catheter insertion site.

17. The method of claim 15, wherein the array of the plurality of temperature sensor arrays includes a first temperature sensor.

18. The method of claim 1, wherein the trimming and / or securing device includes a mark or opening indicating the orientation of a support member attached to the catheter insertion site of the catheter on the patient's body, and wherein the mark or opening is aligned with the catheter insertion site of the catheter on the patient's body.

19. The method of claim 1, wherein the trimming and / or securing device includes a support member, wherein the support member includes a first temperature sensor and a plurality of temperature sensors, and wherein the support member further includes an adhesive layer configured to secure the catheter to the insertion site.

20. The method of claim 1, wherein the trimming and / or fixing device includes an antimicrobial disc having an opening through the antimicrobial disc configured to receive a conduit.

21. A system comprising: A device for trimming and / or securing catheters includes a support member configured to receive a portion of a catheter passing through the support member, the support member comprising: A first temperature sensor is configured to acquire a first temperature measurement at a first location on the patient's body adjacent to the catheter insertion site of a catheter on the patient's body; and A temperature sensor array is configured to acquire multiple temperature measurements at multiple locations on a patient's body, wherein each temperature sensor in the temperature sensor array is spaced apart from a first temperature sensor, and wherein the temperature sensor array includes multiple temperature sensors at different distances from the first temperature sensor; and One or more processors are programmed and / or configured to: Determine a plurality of first temperature differences between the first temperature measurement value and each of the plurality of temperature measurements; Based on the aforementioned multiple first temperature differences, alarm conditions associated with the catheter and / or the catheter trimming and / or fixation devices are determined; and In response to the determination of alarm conditions, an alarm is generated for the device.

22. The system of claim 21, wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: Determine (i) a plurality of second temperature differences between (i) the temperature measurement at the temperature sensor furthest from the first temperature sensor in the temperature sensor array and (ii) a plurality of other temperature measurements at each of the remaining temperature sensors in the temperature sensor array; At least one threshold temperature is determined based on the plurality of first temperature differences and the plurality of second temperature differences; Determine that a first temperature measurement value, one or more of the plurality of temperature measurement values, or any combination thereof, satisfy at least one threshold temperature; as well as An alarm is generated for the device in response to the determination that at least one threshold temperature is met.

23. The system of claim 21, wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: Determine that the temperature measurement value at the temperature sensor furthest from the first temperature sensor in the temperature sensor array among the plurality of temperature measurements satisfies the threshold temperature; and In response to the determination that the temperature measurement value of the temperature sensor farthest from the first temperature sensor in the temperature sensor array meets the threshold temperature, an alarm is generated for the device, wherein the alarm includes information related to potential peeling of the device during tampering and / or fixing.

24. The system of claim 21, wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: Determine that a first temperature measurement value and two or more of the plurality of temperature measurements satisfy a threshold temperature; and In response to the determination that two or more of the first temperature measurement and the plurality of temperature measurements meet a threshold temperature, an alarm is generated for the device, wherein the alarm includes information associated with potential tunneling of the device for repair and / or fixation.

25. The system of claim 21, wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: Determine that the first temperature measurement value and each of the plurality of temperature measurements satisfy a threshold temperature; and In response to the determination that a first temperature measurement and each of the plurality of temperature measurements meet a threshold temperature, an alarm is generated for the device, wherein the alarm includes information associated with the potential removal of the device for repair and / or fixation.

26. The system of claim 21, wherein the trimming and / or fixing device further comprises a second temperature sensor, wherein the second temperature sensor is configured to obtain a second temperature measurement at the conduit passage of the conduit, wherein the second temperature sensor is spaced apart from the first temperature sensor and the temperature sensor array, and wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: The first change of the second temperature measurement value over time is determined to satisfy the infusion temperature threshold. Store infusion operation confirmations associated with patient records; Determine that the second change in the second temperature measurement over time after the first change satisfies the flushing temperature threshold; and In response to the determination that a second change in the second temperature measurement over time satisfies a flushing temperature threshold, an alarm is generated for the equipment, wherein the alarm includes a prompt to the equipment confirming the delivery of flushing fluid.

27. The system of claim 21, wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: At least one of the following changes is determined to satisfy at least one threshold change pattern: a first temperature measurement, one or more of the plurality of temperature measurements, or any combination thereof; and In response to the determination that the at least one change pattern satisfies the at least one threshold change pattern, an alarm is generated for the device, wherein the alarm includes information associated with potential problems related to the trimming and / or fixing of the device and / or catheter.

28. The system of claim 27, wherein the at least one variation mode comprises the variation of a first temperature measurement and one or more individual temperature measurements of the plurality of temperature measurements over time.

29. The system of claim 27, wherein the at least one variation mode includes the change of temperature difference over time between a first temperature measurement and two or more of the plurality of temperature measurements.

30. The system of claim 27, wherein the one or more processors are further programmed and / or configured to: The at least one threshold change pattern is determined based on at least one of the following: patient parameters associated with the patient, drug parameters associated with drugs that have been delivered, are being delivered, or will be delivered to the patient, nursing environment parameters associated with the patient's nursing environment, or any combination thereof.

31. The system of claim 21, wherein the support member includes a mark or opening indicating a catheter insertion site on the patient's body, and wherein the first temperature sensor and the temperature sensor closest to the first temperature sensor in the temperature sensor array are located at the same distance from the mark or the opening, and wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: Determine that the change between the first temperature measurement value and the temperature measurement value at the temperature sensor closest to the first temperature sensor in the temperature sensor array among the plurality of temperature measurements satisfies a threshold temperature; and In response to the determination of a threshold temperature, a change between a first temperature measurement and a temperature measurement at the temperature sensor closest to the first temperature sensor in the temperature sensor array is satisfied, and an alarm is generated for the device using the one or more processors, wherein the alarm includes information associated with potential problems related to trimming and / or fixing the equipment and / or conduits.

32. The system of claim 21, wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: Determine that at least one of the following satisfies the threshold temperature increase: (i) an increase in the temperature measurement value at the temperature sensor furthest away in the temperature sensor array from the first temperature measurement value, or (ii) an increase in the temperature difference between the first temperature measurement value and the temperature measurement value at the temperature sensor furthest away in the temperature sensor array from the first temperature measurement value; and In response to the determination of at least one of (i) or (ii), an alarm is generated for the device using the one or more processors, wherein the alarm includes information associated with potential problems related to the trimming and / or fixing of the device and / or catheter.

33. The system of claim 21, wherein the trimming and / or fixing device further comprises a second temperature sensor, wherein the second temperature sensor is configured to obtain a second temperature measurement at the conduit passage of the conduit, wherein the second temperature sensor is spaced apart from the first temperature sensor and the temperature sensor array, and wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: Determine that the temperature decrease between the first temperature sensor and the temperature sensor farthest from the first temperature sensor in the temperature sensor array meets the threshold temperature. In response to the determination that a temperature decrease satisfies at least one threshold temperature, a comparison of a first temperature measurement with at least one of the following satisfies the at least one threshold temperature: (i) a second temperature measurement at the current time and at least one time prior to the current time, or (ii) a temperature measurement at a temperature sensor in the temperature sensor array that is farther from the catheter insertion site than the first temperature sensor; and In response to the determination that at least one threshold temperature is met, an alarm is generated for the device, wherein the alarm includes information associated with potential problems related to the trimming and / or fixing of the device and / or conduits.

34. The system of claim 21, wherein the first temperature measurement and the plurality of temperature measurements are obtained at a periodic rate, and wherein the one or more processors are further programmed and / or configured to: The periodic rate is determined based on at least one of the following: patient parameters associated with the patient, drug parameters associated with drugs that have been delivered, are being delivered, or will be delivered to the patient, nursing environment parameters associated with the patient's nursing environment, or any combination thereof.

35. The system of claim 21, wherein the trimming and / or fixation device further comprises a plurality of temperature sensor arrays, the plurality of temperature sensor arrays including the temperature sensor array, wherein the plurality of temperature sensor arrays are configured to obtain the plurality of temperature measurements at the plurality of locations on the patient's body, and wherein the plurality of temperature sensor arrays are spaced apart around the trimming and / or fixation device.

36. The system of claim 35, wherein the plurality of arrays are circumferentially spaced around a circle defined in a plane of the trimming and / or fixing device, and wherein the temperature sensors of the plurality of temperature sensor arrays associated with each of the plurality of temperature sensor arrays are radially spaced from the center of the circle at a plurality of different distances.

37. The system of claim 35, wherein the array of the plurality of temperature sensor arrays includes a first temperature sensor.

38. The system of claim 21, wherein the trimming and / or securing device includes a mark or opening indicating the orientation of a support member attached at the catheter insertion site of the catheter on the patient's body.

39. The system of claim 21, wherein the support member includes a first temperature sensor and a plurality of temperature sensors, and wherein the support member further includes an adhesive layer configured to secure the conduit to the insertion site.

40. The system of claim 21, wherein the trimming and / or fixing device includes an antimicrobial disc having an opening through the antimicrobial disc configured to receive a conduit.

41. A device for trimming and / or securing a catheter, comprising: A support member configured to receive a portion of a conduit passing through the support member, the support member comprising: A first temperature sensor is configured to obtain a first temperature measurement at a first location on the patient's body adjacent to the catheter insertion site of the catheter. A temperature sensor array is configured to acquire multiple temperature measurements at multiple locations on a patient's body, wherein each temperature sensor in the temperature sensor array is spaced apart from a first temperature sensor on a support member, and wherein the temperature sensor array includes multiple temperature sensors at different distances from the first temperature sensor; and Wired or wireless communication devices are configured to transmit a first temperature measurement value and the plurality of temperature measurements; and One or more processors, the one or more processors being configured to receive a first temperature measurement value and the plurality of temperature measurements from the wired or wireless communication device, wherein the one or more processors are programmed and / or configured to: Determine multiple first temperature differences between a first temperature measurement value and each of the plurality of temperature measurements; Based on the aforementioned multiple first temperature differences, alarm conditions associated with the catheter and / or the catheter trimming and / or fixation devices are determined; and In response to the determination of alarm conditions, an alarm is generated and sent to the device.

42. The trimming and / or fixing device as claimed in claim 41, wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: Determine (i) a plurality of second temperature differences between (i) the temperature measurement at the temperature sensor furthest from the first temperature sensor in the temperature sensor array and (ii) a plurality of other temperature measurements at each of the remaining temperature sensors in the temperature sensor array; At least one threshold temperature is determined based on the plurality of first temperature differences and the plurality of second temperature differences; Determine that a first temperature measurement value, one or more of the plurality of temperature measurement values, or any combination thereof, satisfy at least one threshold temperature; as well as An alarm is generated for the device in response to the determination that at least one threshold temperature is met.

43. The trimming and / or fixing device as claimed in claim 41, wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: Determine that the temperature measurement value at the temperature sensor furthest from the first temperature sensor in the temperature sensor array among the plurality of temperature measurements satisfies the threshold temperature; and In response to the determination that the temperature measurement value of the temperature sensor farthest from the first temperature sensor in the temperature sensor array meets the threshold temperature, an alarm is generated for the device, wherein the alarm includes information related to potential peeling of the device during tampering and / or fixing.

44. The trimming and / or fixing device as claimed in claim 41, wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: Determine that a first temperature measurement value and two or more of the plurality of temperature measurements satisfy a threshold temperature; and In response to the determination that two or more of the first temperature measurement and the plurality of temperature measurements meet a threshold temperature, an alarm is generated for the device, wherein the alarm includes information associated with potential tunneling of the device for repair and / or fixation.

45. The trimming and / or fixing device as claimed in claim 41, wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: Determine that the first temperature measurement value and each of the plurality of temperature measurements satisfy a threshold temperature; and In response to the determination that a first temperature measurement and each of the plurality of temperature measurements meet a threshold temperature, an alarm is generated for the device, wherein the alarm includes information associated with the potential removal of the device for repair and / or fixation.

46. ​​The trimming and / or fixing device of claim 41, wherein the support member further comprises a second temperature sensor, wherein the second temperature sensor is configured to obtain a second temperature measurement at the conduit passage of the conduit, wherein the second temperature sensor is spaced apart from the first temperature sensor and the temperature sensor array on the support member, and wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: The first change of the second temperature measurement value over time is determined to satisfy the infusion temperature threshold. Store infusion operation confirmations associated with patient records; Determine that the second change in the second temperature measurement over time after the first change satisfies the flushing temperature threshold; and In response to the determination that a second change in the second temperature measurement over time satisfies a flushing temperature threshold, an alarm is generated for the equipment, wherein the alarm includes a prompt to the equipment confirming the delivery of flushing fluid.

47. The trimming and / or fixing device as claimed in claim 41, wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: At least one of the following changes is determined to satisfy at least one threshold change pattern: a first temperature measurement, one or more of the plurality of temperature measurements, or any combination thereof; and In response to the determination that the at least one change pattern satisfies the at least one threshold change pattern, an alarm is generated for the device, wherein the alarm includes information associated with potential problems related to the trimming and / or fixing of the device and / or catheter.

48. The trimming and / or fixing device of claim 47, wherein the at least one variation mode includes the variation of a first temperature measurement and one or more individual temperature measurements of the plurality of temperature measurements over time.

49. The trimming and / or fixing device of claim 47, wherein the at least one variation mode includes the change of temperature difference over time between a first temperature measurement and two or more of the plurality of temperature measurements.

50. The trimming and / or fixing device of claim 47, wherein the one or more processors are further programmed and / or configured to: The at least one threshold change pattern is determined based on at least one of the following: patient parameters associated with the patient, drug parameters associated with drugs that have been delivered, are being delivered, or will be delivered to the patient, nursing environment parameters associated with the patient's nursing environment, or any combination thereof.

51. The trimming and / or fixation device of claim 41, wherein the support member includes a mark or opening indicating a catheter insertion site on the patient's body, and wherein the first temperature sensor and the temperature sensor closest to the first temperature sensor in the temperature sensor array are located at the same distance from the mark or the opening, and wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: Determine that the change between the first temperature measurement value and the temperature measurement value at the temperature sensor closest to the first temperature sensor in the temperature sensor array among the plurality of temperature measurements satisfies a threshold temperature; and In response to the determination of a threshold temperature, a change between a first temperature measurement and a temperature measurement at the temperature sensor closest to the first temperature sensor in the temperature sensor array is satisfied, and an alarm is generated for the device using the one or more processors, wherein the alarm includes information associated with potential problems related to trimming and / or fixing the equipment and / or conduits.

52. The trimming and / or fixing device as claimed in claim 41, wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: Determine that at least one of the following satisfies the threshold temperature increase: (i) an increase in the temperature measurement value at the temperature sensor furthest away in the temperature sensor array from the first temperature measurement value, or (ii) an increase in the temperature difference between the first temperature measurement value and the temperature measurement value at the temperature sensor furthest away in the temperature sensor array from the first temperature measurement value; and In response to the determination of at least one of (i) or (ii), an alarm is generated for the device using the one or more processors, wherein the alarm includes information associated with potential problems related to the trimming and / or fixing of the device and / or catheter.

53. The trimming and / or fixing device of claim 41, wherein the support member further comprises a second temperature sensor, wherein the second temperature sensor is configured to obtain a second temperature measurement at the conduit passage of the conduit, wherein the second temperature sensor is spaced apart from the first temperature sensor and the temperature sensor array on the support member, and wherein, for determining alarm conditions, the one or more processors are further programmed and / or configured to: Determine that the temperature decrease between the first temperature sensor and the temperature sensor in the temperature sensor array that is furthest from the first temperature sensor satisfies at least one threshold temperature. In response to the determination that the temperature decrease satisfies the at least one threshold temperature, a comparison of a first temperature measurement with at least one of the following satisfies the at least one threshold temperature: (i) a second temperature measurement at the current time and at least one time prior to the current time, or (ii) a temperature measurement at a temperature sensor in the temperature sensor array that is further away from the catheter insertion site than the first temperature sensor. as well as In response to the determination that at least one threshold temperature is met, an alarm is generated for the device, wherein the alarm includes information associated with potential problems related to the trimming and / or fixing of the device and / or conduits.

54. The trimming and / or fixing device of claim 41, wherein the first temperature measurement and the plurality of temperature measurements are obtained at a periodic rate, and wherein the one or more processors are further programmed and / or configured to: The periodic rate is determined based on at least one of the following: patient parameters associated with the patient, drug parameters associated with drugs that have been delivered, are being delivered, or will be delivered to the patient, or any combination thereof.

55. The trimming and / or fixation device of claim 41, wherein the trimming and / or fixation device further comprises a plurality of temperature sensor arrays, the plurality of temperature sensor arrays including the temperature sensor array, wherein the plurality of temperature sensor arrays are configured to obtain the plurality of temperature measurements at the plurality of locations on the patient's body, and wherein the plurality of temperature sensor arrays are spaced apart around the support member.

56. The trimming and / or fixing device of claim 55, wherein the plurality of arrays are circumferentially spaced around a circle defined in the plane of the support member, and wherein the temperature sensors in the plurality of temperature sensor arrays associated with each of the plurality of temperature sensor arrays are radially spaced from the center of the circle at a plurality of different distances.

57. The trimming and / or fixing device of claim 55, wherein the array of the plurality of temperature sensor arrays includes a first temperature sensor.

58. The trimming and / or fixation device of claim 41, wherein the trimming and / or fixation device includes a mark or opening indicating the orientation of a support member attached at the catheter insertion site of the catheter on the patient's body.

59. The trimming and / or securing device of claim 41, wherein the support member further comprises an adhesive layer configured to secure the conduit to the insertion site.

60. The trimming and / or fixing device of claim 41, wherein the support member includes an antimicrobial disc having an opening through the antimicrobial disc configured to receive a conduit.

61. A non-transitory computer-readable medium, the medium comprising program instructions that, when executed by at least one processor, cause the at least one processor to: Obtain a first temperature measurement value associated with a first location on the patient's body adjacent to the catheter insertion site of the catheter on the patient's body; Obtain multiple temperature measurements associated with multiple locations on a patient's body, each of the multiple locations being spaced apart from a first location, and the multiple locations including locations at multiple different distances from the first location; Determine multiple first temperature differences between a first temperature measurement value and each of the plurality of temperature measurements; Based on the plurality of first temperature differences, alarm conditions associated with the catheter and / or the device used for catheter trimming and / or fixation are determined; as well as An alarm is generated for the device in response to the determination that at least one threshold is met.

62. The non-transitory computer-readable medium of claim 61, wherein the instructions further cause the at least one processor to: Determine (i) a plurality of second temperature differences between (i) the temperature measurement at the location furthest from the first location among the plurality of temperature measurements and (ii) a plurality of remaining temperature measurements at each of the remaining locations among the plurality of temperature measurements; At least one threshold temperature is determined based on the plurality of first temperature differences and the plurality of second temperature differences; Determine that a first temperature measurement value, one or more of the plurality of temperature measurement values, or any combination thereof, satisfy at least one threshold temperature; as well as An alarm is generated for the device in response to the determination that at least one threshold temperature is met.

63. The non-transitory computer-readable medium of claim 61, wherein the instructions further cause the at least one processor to: Determine that the temperature measurement value at the location furthest from the first location among the plurality of temperature measurements satisfies the threshold temperature; and In response to the determination that the temperature measurement at the location furthest from the first location among the plurality of locations meets a threshold temperature, an alarm is generated for the device, wherein the alarm includes information associated with potential peeling of the device during repair and / or fixing.

64. The non-transitory computer-readable medium of claim 61, wherein the instructions further cause the at least one processor to: Determine that a first temperature measurement value and two or more of the plurality of temperature measurements satisfy a threshold temperature; and In response to the determination that two or more of the first temperature measurement and the plurality of temperature measurements meet a threshold temperature, an alarm is generated for the device, wherein the alarm includes information associated with potential tunneling of the device for repair and / or fixation.

65. The non-transitory computer-readable medium of claim 61, wherein the instructions further cause the at least one processor to: Determine that the first temperature measurement value and each of the plurality of temperature measurements satisfy a threshold temperature; and In response to the determination that a first temperature measurement and each of the plurality of temperature measurements meet a threshold temperature, an alarm is generated for the device, wherein the alarm includes information associated with the potential removal of the device for repair and / or fixation.

66. The non-transitory computer-readable medium of claim 61, wherein the instructions further cause the at least one processor to: Obtain a second temperature measurement associated with the conduit tubing of the catheter; The first change of the second temperature measurement value over time is determined to satisfy the infusion temperature threshold. Store infusion operation confirmations associated with patient records; Determine that the second temperature measurement value, after the first change, changes over time satisfy the flushing temperature threshold. as well as In response to the determination that a second change in the second temperature measurement over time satisfies a flushing temperature threshold, an alarm is generated for the equipment, wherein the alarm includes a prompt to the equipment confirming the delivery of flushing fluid.

67. The non-transitory computer-readable medium of claim 61, wherein the instructions further cause the at least one processor to: At least one of the following changes is determined to satisfy at least one threshold change pattern: a first temperature measurement, one or more of the plurality of temperature measurements, or any combination thereof; and In response to the determination that the at least one change pattern satisfies the at least one threshold change pattern, an alarm is generated for the device, wherein the alarm includes information associated with potential problems related to the trimming and / or fixing of the device and / or catheter.

68. The non-transitory computer-readable medium of claim 67, wherein the at least one variation mode comprises the variation of a first temperature measurement and one or more individual temperature measurements of the plurality of temperature measurements over time.

69. The non-transitory computer-readable medium of claim 67, wherein the at least one variation mode includes the change of temperature difference over time between a first temperature measurement and two or more of the plurality of temperature measurements.

70. The non-transitory computer-readable medium of claim 67, wherein the instructions further cause the at least one processor to: The at least one threshold change pattern is determined based on at least one of the following: patient parameters associated with the patient, drug parameters associated with drugs that have been delivered, are being delivered, or will be delivered to the patient, nursing environment parameters associated with the patient's nursing environment, or any combination thereof.

71. The non-transitory computer-readable medium of claim 61, wherein the first position and the position closest to the first position among the plurality of positions are located at the same distance from the catheter conduit of the catheter and at the same distance from the catheter insertion site on the patient's body, and wherein the instructions further cause the at least one processor to: Determine that the change between the first temperature measurement value and the temperature measurement value at the location closest to the first location among the plurality of temperature measurements satisfies a threshold temperature; and In response to the determination of a threshold temperature that the change between a first temperature measurement and the temperature measurement at the location closest to the first location among the plurality of temperature measurements at the plurality of locations satisfies the threshold temperature, an alarm is generated for the device, wherein the alarm includes information associated with potential problems related to the trimming and / or fixing of the device and / or conduits.

72. The non-transitory computer-readable medium of claim 61, wherein the instructions further cause the at least one processor to: Determine that at least one of the following satisfies the threshold temperature increase: (i) an increase in the temperature measurement value at the farthest location among the plurality of temperature measurements to the first temperature measurement value, or (ii) an increase in the temperature difference between the first temperature measurement value and the temperature measurement value at the farthest location among the plurality of locations to the first temperature measurement value; and In response to the determination of at least one of (i) or (ii), an alarm is generated for the device, wherein the alarm includes information related to potential problems with the trimming and / or fixing of the device and / or conduit.

73. The non-transitory computer-readable medium of claim 61, wherein the instructions further cause the at least one processor to: Obtain a second temperature measurement associated with the conduit tubing of the catheter; At least one processor is used to determine that the temperature decrease between a first location and the location furthest from the first location among the plurality of locations meets a threshold temperature. In response to the determination that the temperature decrease meets a threshold temperature, at least one processor is used to determine that a comparison of a first temperature measurement with at least one of the following meets at least one threshold temperature: (i) a second temperature measurement at the current time and at least one time prior to the current time, or (ii) a temperature measurement at a location among the plurality of locations that is further away from the catheter insertion site than the first location; as well as In response to the determination that the at least one threshold temperature is met, an alarm is generated for the user using at least one processor, wherein the alarm includes information associated with potential problems with trimming and / or fixing equipment and / or catheters.

74. The non-transitory computer-readable medium of claim 61, wherein the first temperature measurement and the plurality of temperature measurements are obtained at a periodic rate, and wherein the instructions further cause the at least one processor to: A periodic rate is determined based on at least one of the following: patient parameters related to the patient, drug parameters related to drugs that have been delivered, are being delivered, or will be delivered to the patient, nursing environment parameters related to the patient's nursing environment, or any combination thereof.

75. The non-transitory computer-readable medium of claim 61, wherein the plurality of locations comprises a plurality of temperature sensor arrays circumferentially spaced around a circle surrounding the catheter injection site, and wherein the locations of the plurality of locations associated with each of the plurality of temperature sensor arrays are radially spaced from the catheter insertion site at a plurality of different distances.

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