DUAL INFUSION SYSTEM FOR TEMPERATURE ADJUSTMENT AND METHOD
20180271698 ยท 2018-09-27
Assignee
Inventors
Cpc classification
A61M2205/3626
HUMAN NECESSITIES
A61M5/1413
HUMAN NECESSITIES
A61F2007/126
HUMAN NECESSITIES
A61F7/12
HUMAN NECESSITIES
A61M5/44
HUMAN NECESSITIES
International classification
Abstract
The present invention is directed to a device and a method, particularly suitable for temperature adjustment of a patient and/or suitable for fever treatment and/or normothermia and/or hypothermia. The device comprises at least one connection to at least one reservoir suitable to provide infusion fluid; at least one assembly controller for controlling the temperature and/or flow rate of the infusion fluid; at least one temperature controller adapted for cooling and/or heating the temperature of the infusion fluid so that the infusion fluid is delivered with a pre-set temperature; and/or at least one flow controller for controlling the flow of the infusion fluid; and at least two outgoing ducts; wherein the flow controller is adapted to feed the outgoing ducts with different flow rates.
Claims
1. A device, for temperature adjustment of a patient and/or suitable for fever treatment and/or normothermia and/or hypothermia, comprising: a. at least one connection to at least one reservoir suitable to provide infusion fluid; b. at least one assembly controller for controlling the temperature and/or flow rate of the infusion fluid; c. at least one temperature controller adapted for cooling and/or heating the temperature of the infusion fluid so that the infusion fluid is delivered with a pre-set temperature; and/or d. at least one flow controller for controlling the flow of the infusion fluid; and e. at least a first outgoing duct and a second outgoing duct; f. wherein the flow controller is adapted to feed the outgoing ducts with different flow rates.
2. The device according to claim 1 wherein the flow controller is adapted to feed a first outgoing duct with a first base flow rate and a second outgoing duct with a bolus flow rate being higher than the first base flow rate.
3. The device according to claim 1, wherein the device is adapted to deliver infusion fluid with a continuous, intermittent and/or sequential base flow rate of 40 to 125 ml/h and/or a volume of 960 ml to 3000 ml per day and/or a continuous, intermittent and/or sequential bolus flow rate of more than 125 ml/h.
4. The device according to claim 1, wherein the device is adapted to deliver infusion fluid with a continuous, intermittent and/or sequential base flow rate of 40 to 125 ml/h and/or a volume of 960 ml to 3000 ml per day to the first outgoing duct and a continuous, intermittent and/or sequential bolus flow rate of more than 125 ml/h to the second outgoing duct.
5. The device according to claim 1, wherein the device is adapted to deliver infusion fluid with a continuous, intermittent and/or sequential base flow rate of 40 to 125 ml/h and/or a volume of 960 ml to 3000 ml per day to the first outgoing duct and a continuous, intermittent and/or sequential bolus flow rate of more than 2000 ml/h to the second outgoing duct.
6. The device according to claim 5, wherein the device is adapted to deliver the bolus flow rate amounts of at least 2000 ml/h to 4000 ml/h.
7. The device according to claim 1, wherein at least a first branch or first reservoir duct of the connection to the reservoir is adapted to feed infusion fluid through a neutral section in the temperature controller and/or directly into the flow controller so that the infusion fluid can be fed into the first outgoing duct and/or wherein at least a second branch of the connection to the reservoir or second reservoir duct is adapted to feed infusion fluid through the temperature controller which is adapted to deliver downstream temperature controlled infusion fluid.
8. The device according to claim 7, wherein the device is adapted so that at least the first of the outgoing ducts is fed with infusion fluid with the base flow rate and the second outgoing duct is fed with infusion fluid with the bolus flow rate.
9. The device according to claim 1, wherein a first outgoing duct and/or a second outgoing duct is/are adapted to deliver infusion fluid to a central venous catheter (CVC) and/or to a peripheral venous catheter (PVC), respectively.
10. The device according to claim 1, wherein at least a first outgoing duct is adapted to deliver infusion fluid to a central venous catheter (CVC) and/or at least a second outgoing duct is adapted to deliver infusion fluid to a peripheral venous catheter (PVC).
11. The device according to claim 1, further comprising at least one temperature sensor being adapted to deliver at least one temperature signal and wherein the assembly controller is adapted to receive and compute the temperature signal from the temperature sensor and/or to activate the flow controller, particularly when a pre-set and/or given threshold temperature has been sensed by the temperature sensor.
12. The device according to claim 1, wherein the temperature controller and/or the flow controller and/or the controller or any two of these elements are modular components that are adapted to be electrically and/or electronically and/or fluidly connected to each other with respective connectors.
13. The device according to claim 1, wherein the temperature controller is adapted to provide infusion fluid at a temperature of between 1 C. and 46 C., preferably from 4 C. to 42 C.
14. The device according to claim 1, wherein the temperature controller is adapted to provide infusion fluid at a temperature of at least 1 C. and of at most 14 C.
15. The device according to claim 1, wherein the flow controller comprises at least one pump and wherein the assembly controller is adapted to stop the pump for a preset or given time and preferably to restart the pump after having received and computed the temperature signal from the temperature sensor after the preset or given time and a preset or given threshold temperature is reached or exceeded.
16. The device according to claim 1, wherein the temperature controller comprises at least one cooling section adapted to cool infusion fluid and at least one heating section adapted to heat infusion fluid, the cooling section and the heating section being arranged in parallel and/or in series.
17. The device according to claim 1, wherein the temperature controller further comprises a neutral section for not influencing the temperature of the infusion fluid.
18. The device according to claim 1, wherein the assembly controller is configured to receive input signals from at least one external computer system and/or to communicate with such system, such as an electronic patient file system.
19. The device according to claim 1, wherein the temperature sensor is suitable for measuring the temperature of blood, brain and/or esophagus of a patient and to deliver the temperature signal.
20. The device according to claim 11, wherein the preset threshold temperature is at least 36 C. and at most 38 C.
21. The device according to claim 11, wherein the preset threshold temperature is at least 36.9 C. and more preferably 37.5 C.
22. The device according to claim 1, wherein the preset threshold temperature is at least around 32 C. to stop delivery of infusion fluid and at most around 34 C. to (re-)start delivery of infusion fluid at least for given or pre-set time, and the device being preferably adapted to keep this temperature for around 12 to 24 hours and to further preferably then increase the temperature by around 0.25 C./h to 0.5 C./h until a preset temperature, such as normal physiological body temperature, is reached.
23. The device according to claim 1, wherein the preset amount of cold infusion fluid is at least 0.1 l and at most 4.0 l, preferably at most 2.0 l.
24. The device according to claim 1, wherein the flow controller is adapted to deliver the infusion fluid in a minimum time period of 1 min and/or a maximum amount of 90 min.
25. The device according to claim 1, wherein the preset time period is at least 1 min and at most 6 h.
26. The device according to claim 1, further comprising a display for the information of a user and/or manipulation of the assembly controller by a user.
27. The device according to claim 1, wherein the controller comprises a storage for storing the temperatures detected and/or the pump activities and/or infusion amounts delivered and a display for displaying this information.
28. The device according to claim 1, further comprising a rack and at least one of the assembly controller, the temperature controller and/or the flow controller is/are adapted for an arrangement in the rack.
29. The method, for temperature adjustment of a patient and/or suitable for fever treatment and/or normothermia and/or hypothermia, preferably with a device according to claim 1, comprising the following steps in any order: a. connecting at least one reservoir suitable to provide infusion fluid to at least one connection; b. controlling the temperature and/or flow rate of the infusion fluid by at least one assembly controller; c. cooling and/or heating the temperature of the infusion fluid so that the infusion fluid is delivered with a pre-set temperature by at least one temperature controller; and/or d. controlling the flow of the infusion fluid by at least one flow controller; e. delivering infusion fluid by at least two outgoing ducts; and f. feeding the outgoing ducts (14, 15) with different flow rates by the flow controller.
30. The method according to claim 1, wherein the infusion fluid delivered by a base rate of 40 ml/h to 125 ml/h is warmed up to around 37.2 C. until the threshold is detected, and then is cooled down when the threshold has been detected and optionally another infusion fluid and/or the same infusion fluid is additionally cooled and delivered with the bolus rate of more than 125 ml/h.
31. The method according to claim 1, wherein the infusion fluid is initially delivered in a minimum amount of 0.8 l and/or subsequently between 100 ml and 1.0 l with flow rates of between 40 ml/h and 8000 ml/h.
32. The method according to claim 1, wherein the preset threshold temperature is at least around 32 C. to stop delivery of infusion fluid and at most around 34 C. to (re-)start delivery of infusion fluid at least for given or pre-set time, and the method adapted to keep this temperature for around 12 to 24 hours and to further preferably then increase the temperature by around 0.25 C./h to 0.5 C./h until a preset temperature, such as normal physiological body temperature, is reached.
33. The method according to claim 1, wherein the infusion fluid is delivered for a minimum time period of 1 min and/or a maximum amount of 90 min.
34. The method of treating a mammal the method according to claim 1.
Description
PREFERRED EMBODIMENTS
[0075] The present invention will become more fully understood from the description before and particularly below and the accompanying drawings that are given by way of illustration only and show and/or exemplify preferred aspects thereof, and wherein
[0076]
[0077]
[0078]
[0079]
[0080]
[0081]
[0082]
[0083]
[0084] The reservoir 10 can be covered with or function as a thermal insulation or thermal treatment device in case the infusion fluid contained is preferred to be kept at temperatures different from room temperature.
[0085] Another or a plurality of reservoir(s) 10 can also be provided to provide either different infusion fluids and/or the same infusion fluids for different purposes and/or with different temperatures. One particular and non-exhaustive example is the provision of infusion fluids to different parts of a patient. This is explained in more detail above and/or below.
[0086] The infusion fluid is delivered by a reservoir duct 11 or pipe 11. In case of more than one reservoir, a respective or, in case of a combined delivery of fluids, a smaller number of ducts (not shown) may also be provided. For reasons of simplicity, just one reservoir duct 11 is shown in
[0087] Downstream and/or below the reservoir 10 one or more device(s) 20 to 40 can be arranged for the further control of the infusion(s) and/or temperature(s) and/or flow rate(s) of the infusion fluid(s). The separation or modularity of components 20 to 40 shown in
[0088] In the embodiment shown, an assembly controller 20 is shown which can (but must not) control one or all the further components 30, 40 described. The assembly controller 20 can be supported and held in place with an assembly controller holder 5, in the embodiment shown at the infusion holder 1. However, it can also be arranged in a different manner, such as in a rack (not shown). Moreover, it can comprise one or more displays 21 for the information of and/or manipulation by a user.
[0089] A first sensor S1 or a plurality of first sensors S1 can be arranged in, at and/or adjacent the reservoir 10 in order to sense, determine and/or measure the parameters of the infusion fluid contained in the reservoir 10, such as its temperature, composition, volume, level etc. The sensor S1 can be connected to the assembly controller 20 by a wire 13 and/or wirelessly.
[0090] Connected or even attached to the assembly controller 20 is a temperature controller 30, preferably downstream of the assembly controller 20. Alternatively, the assembly controller 20 can be arranged in parallel with the temperature controller 30 and/or any further controller. The temperature controller 30 is essentially, but not necessarily used to control and/or influence the temperature of the infusion fluid approaching from the reservoir(s) 10 through the duct(s) 11. The temperature controller 30 can be supported and held in place with a temperature controller holder 6, in the embodiment shown at the infusion holder 1. However, it can also be arranged in a different manner, such as in a rack (not shown).
[0091] Downstream of the temperature controller 30, a flow controller 40 can be arranged. Alternatively or additionally, the flow controller 40 or any further flow controller 40 can be arranged upstream of the temperature controller 30. The flow controller is primarily, but not necessarily used to control the flow rate and/or flow pressure to a container or a patient (both not shown). The flow controller 40 can be supported and held in place with a flow controller holder 7, in the embodiment shown at the infusion holder 1. However, it can also be arranged in a different manner, such as in a rack (not shown).
[0092] In the embodiment shown, a first outgoing duct 14 is shown leading to a container or patient delivering infusion fluid with the temperature and/or flow rate being controlled. Additionally, a second and optionally further outgoing duct(s) 15 can deliver infusion fluid with a different temperature and/or a different flow rate.
[0093] Optionally, a second sensor S2 or a set of second sensors S2 are provided to sense, determine and/or measure any parameters of interest for the control of the infusion fluid, its temperature and/or flow rate. It can measure the temperature of a container or patient and/or further conditions, such as other parameters. The second sensor(s) S2 can be connected to the assembly controller 20 by a wire 17 and/or wirelessly.
[0094] For a better illustration, a bed 50 for a patient (not shown) is also depicted in
[0095]
[0096] A third sensor S3 can sense, determine and/or measure conditions, such as presence of the duct 11a and/or temperature, flow rate and/or pressure etc. in the duct 11 or one of the ducts 11a. The third sensor S3 can be connected to the electronic controller 23 by a wire 26 and/or wirelessly. A fourth sensor S4 can sense, determine and/or measure conditions, such as presence of the duct 11 and/or temperature, flow rate and/or pressure etc. in one of the ducts 11b. Further sensors can be present but are not shown. The fourth sensor S4 can be connected to the electronic controller 23 by a hard wire 27 and/or wirelessly.
[0097]
[0098] An incoming duct control section 32 can be arranged which can be controlled preferably by the assembly controller 20 in order to control the distribution of the infusion fluid(s) downstream in the temperature controller 30. For this reason, one or more or a plurality of valves V1 to V4 are shown. In one preferred embodiment, a first duct 11a delivers a first or a part of an infusion fluid, and a second duct 11b delivers a second or a part of the first infusion fluid. With optional control valve V1 they can be merged, or kept separated, or mixing amounts can be controlled. E.g., the separation of the two incoming first and second ducts 11a, 11b can be realized in case a second reservoir (not shown) is positioned or hung up with an infusion fluid which is supposed to be delivered at room temperature, either because the infusion fluid should not have room temperature and/or because the way of delivery to a patient requires room temperature. In case of one reservoir of infusion fluid not being heated and/or cooled, the present device or assembly is able to also control the delivery of further infusion fluids in a centralized manner. Further optional valves V2, V3 and/or V4 can (but must not) control the delivery of the infusion fluids to the further sections.
[0099] A tempering section (heating and/or cooling section) can comprise a neutral section 33a, a heating section 33b and/or a cooling section 33c. Instead or additionally, two or more cooling and/or heating stages with different cooling or heating capabilities can be arranged. The user and/or the assembly controller (not shown in
[0100] In an optional outgoing duct control section 34, the further delivery of the infusion fluids can (but must not) be controlled. The fluids leaving the neutral section 33a, the heating section 33b and/or the cooling section 33c can be further mixed, merged or left unmixed by valves V5 to V7 in order to allow a further delivery and/or amounts according to the needs. In the embodiment shown, a first outgoing duct 14 can be provided and an optional second outgoing duct 15 and/or any further outgoing ducts (not shown) can be provided. Just one of them or more outgoing ducts can also be arranged. With optional control valve V5, they can be merged or kept separated or amounts can be mixed. The same or similar applies for the further valves V6 and/or V7 which can directly allow, permit or control amounts to go to the first outgoing duct 14 and/or second outgoing duct 15 or any further ducts (not shown).
[0101] In the temperature controller 30, common or separate pumps can be provided (not shown in the present embodiment). This holds particularly true in case there is a severe pressure drop either before, in or immediately after the temperature controller 30. Such pump can be provided at either duct or line in front of, through and/or behind one or more of the sections 32, 33a, 33b, 33c, 34 described.
[0102] The temperature controller 30 can also provide feedback or closed loop controls or controlling sections which can particularly cooperate with the assembly controller 20 and/or sensors which are shown or not shown.
[0103] The embodiment shown in
[0104] Sensor S5 and/or sensor S6 and/or further sensors can be arranged and adapted to sense, determine and/or measure any parameters of interest of the infusion fluid(s) and/or the first outgoing duct 14 and/or second outgoing duct 15 and/or further ducts. Such parameters can be the temperature(s), flow rate(s), pressure(s) etc. of the infusion fluid(s) contained in the ducts 14, 15. The same applies to sensor(s) S8 and/or sensor(s) S7 and/or further sensors (not shown). However, these may sense, determine and/or measure the parameter before the fluids and/or ducts 14, 15 are leaving the flow controller and/or whole assembly of devices according to the present invention.
[0105] In the embodiment shown, a first pump 43 and/or a second pump 44 can be arranged for each outgoing duct 14, 15. Just one pump for each or just for one duct can also be provided. In case of a peristaltic pump one actor can also activate the flow in each duct 14, 15 on two sides of the turning actuator. A valve V8 can allow to separate and/or merge and/or defining amounts to be mixed between the two ducts 14, 15. A valve V9 and/or a valve V10 can further control the flow or amounts of flow either upstream and/or downstream of the pumps 43, 44.
[0106]
[0107] The assembly controller 20 can be inserted into the rack 60 in the top-most position of all components 20, 30, 40 but can also be arranged in the middle or below the other components 30, 40.
[0108] A first reservoir duct 11a and a second reservoir duct 11b can be guided into the assembly controller 20, e.g., in a plug-in configuration from any side. As an example the plug-in configuration is shown from the front so that a user can take these ducts coming from any reservoir (not shown in
[0109] Any of the controllers 20, 30, 40 can also be connected with connectors being arranged in their neighboring surfaces. In the configuration shown, they would be arranged in the bottom surface of assembly controller 20 and in the top surface of the element below, in the example shown, the top surface of temperature controller 30.
[0110] The ducts 11a, 11b and/or the ducts 14, 15 can be of any type. E.g., they can be flexible and/or rigid and/or can be provided in the form of fixed connectors, particularly for the connection between the different components 20, 30, 40. Also, as indicated in the temperature controller 30, ports 14 and 15 can be provided for connecting any such ducts and/or rigid connectors in any of the components for any of the ducts 11a, 11b, 14, 15.
[0111] The assembly controller 20 can comprise a monitor 21. In case it cannot be used as a user input device, or, additionally, a keyboard 25 can be also provided as a user interface. Moreover, other components can be provided, such as turning knobs 26, 27 for changing parameters used often etc. An emergency knob 27 can also be provided, like the ones 36, 46 in any other of the components 30, 40.
[0112] The temperature controller 30 and/or the flow controller 40 can also comprise monitors 35 and 45 respectively, for monitoring and/or for user interface purposes.
[0113]
[0114] The reservoir duct 11 can split up to the first reservoir duct 11a and the second reservoir duct 11b. As mentioned before, further branches can be realized. In the embodiments shown, the first and second reservoir ducts are fed by the same reservoir 10. Optionally or additionally, one or more reservoirs can be provided feeding either one of the first or second reservoir ducts or any other duct either with any one of the components 20 to 40, or can circumvent the components 20 to 40. In the embodiment shown, the first reservoir duct 11a enters the temperature controller 30 in order to allow its temperature to be controlled and/or modified. The respective infusion fluid can then be fed into the flow controller 40 and can leave this in a first outgoing duct 14.
[0115] The second reservoir duct 11b can circumvent the temperature controller 30 and can directly go into the flow controller as it may not be necessary or even detrimental to modify its temperature. The respective infusion fluid may then leave via a second outgoing duct 15.
[0116] The afore-described embodiment may be adapted to an infusion by means of a central venous catheter (CVC) and a separated infusion by a peripheral venous catheter (PVC). Either one may be fed by infusion fluid being temperature controlled or not temperature controlled. This can be particularly useful when delivering a bolus dosage with a rather high flow rate in temperature controlled form and a base rate with a lower flow rate in non-temperature controlled form. The bolus dosage can then go to either catheter, such as the central venous catheter, in case a quickly effective cooling is desired. Examples of such dosages according to the present invention are mentioned before and below.
[0117]
[0118] Thus, it has been found that the present invention and aspects thereof enable a faster and further preferably more precisely adjusted or positively controlled temperatures of the infusion fluid. Thus, more individualized and a better adjusted flow of infusion fluids can be realized or a patient can be treated more according to the needs detected in real time or close to real time.
[0119] As used herein, including in the claims, singular forms of terms are to be construed as also including the plural form and vice versa, unless the context indicates otherwise. Thus, it should be noted that as used herein, the singular forms a, an, and the include plural references unless the context clearly dictates otherwise.
[0120] Throughout the description and claims, the terms comprise, including, having, and contain and their variations should be understood as meaning including but not limited to, and are not intended to exclude other components.
[0121] The present invention also covers the exact terms, features, values and ranges etc. in case these terms, features, values and ranges etc. are used in conjunction with terms such as about, around, generally, substantially, essentially, at least etc. (i.e., about 3 shall also cover exactly 3 or substantially constant shall also cover exactly constant).
[0122] The term at least one should be understood as meaning one or more, and therefore includes both embodiments that include one or multiple components. Furthermore, dependent claims that refer to independent claims that describe features with at least one have the same meaning, both when the feature is referred to as the and the at least one.
[0123] It will be appreciated that variations to the foregoing embodiments of the invention can be made while still falling within the scope of the invention. Alternative features serving the same, equivalent or similar purpose can replace features disclosed in the specification, unless stated otherwise. Thus, unless stated otherwise, each feature disclosed represents one example of a generic series of equivalent or similar features.
[0124] Use of exemplary language, such as for instance, such as, for example and the like, is merely intended to better illustrate the invention and does not indicate a limitation on the scope of the invention unless so claimed. Any steps described in the specification may be performed in any order or simultaneously, unless the context clearly indicates otherwise.
[0125] All of the features and/or steps disclosed in the specification can be combined in any combination, except for combinations where at least some of the features and/or steps are mutually exclusive. In particular, preferred features of the invention are applicable to all aspects of the invention and may be used in any combination.