Injection device

Abstract

1. An apparatus for preparing an infusion fluid comprising: a first portion including a fluid conduit comprising an electrically conductive material; and a second portion selectively connectable to the first portion and including at least one sensor for detecting fluid in the fluid conduit and a power source and / or a connection function to the power source, wherein mechanical connection between the first portion and the second portion electrically connects the fluid conduit to the power source and / or the connection function to the power source.

Description

[Technical field]

[0001] Related Applications This application claims priority under 35 U.S.C. § 120 to U.S. Provisional Patent Application No. 17 / 694,881, filed March 15, 2022, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] Some embodiments of the present invention relate to injection systems, and more particularly and non-exclusively to injection devices for injecting a warmed fluid into a subject.

[0003] Background art includes U.S. Patent No. 9,533,109, U.S. Patent No. 10,485,921, U.S. Patent No. 10,747,241, and U.S. Patent No. 4,657,160. Summary of the Invention

[0004] Below is a non-exhaustive list including some example embodiments of the present invention, including embodiments having fewer than all of the features in the examples and embodiments that use features from more than one example, even if not explicitly listed below.

[0005] Example 1 a first portion comprising a fluid conduit including a conductive material having a non-zero resistance; a second portion selectively connectable and disconnectable in situ to the first portion, at least one sensor for sensing a property of the fluid in the fluid conduit and / or a property of the fluid conduit; and A power source having a power supply and / or a connection to an external power source; a second portion, a mechanical coupling between the first portion and the second portion electrically connecting the fluid conduit to the power source; Equipment for preparation of infusion solutions.

[0006] Example 2 The fluid conduit is elongated, has a shape that includes one or more changes in direction, and follows a path around the interior volume; The apparatus described in Example 1.

[0007] Example 3 The fluid conduit is a coil of tubing, the fluid conduit being wound around the interior volume. The apparatus described in Example 2.

[0008] Example 4 the second portion has a body sized and shaped to fit within the interior volume, and the mechanical coupling includes inserting the body into the interior volume; 10. The device according to example 2 or 3.

[0009] Example 5 The body fits into the interior volume through an opening to the interior volume, and the second portion has a base that is larger than the opening. The apparatus described in Example 4.

[0010] Example 6 the first portion is sized and shaped to fit within the lumen of the second portion; The apparatus described in Example 3.

[0011] Example 7 the lumen of the second portion includes a cover that is closed to hold the first portion in place within the lumen of the second portion; The apparatus described in Example 6.

[0012] Example 8 the second portion includes at least one second portion electrical contact; the first portion includes an electrical circuit having at least one first portion electrical contact portion, and during the mechanical coupling, the at least one second portion electrical contact portion contacts the second portion electrical contact portion; An apparatus according to any one of Examples 1 to 7.

[0013] Example 9 the first portion includes at least one electrical connector electrically connecting the fluid conduit to the first portion electrical contacts; The apparatus described in Example 8.

[0014] Example 10 the electrical connector comprises a portion configured to be slidably mounted onto the fluid conduit; The apparatus described in Example 9.

[0015] Example 11 The portion is an electrical contact between the electrical connector and the fluid conduit. The apparatus described in Example 10.

[0016] Example 12 the portion includes a lumen sized and shaped to receive the fluid conduit and to be in electrical contact with the fluid conduit; The device described in Example 11.

[0017] Example 13 The portion is a loop that extends around at least 50% of the circumference of the fluid conduit. The device described in Example 12.

[0018] Example 14 the at least one sensor includes a non-contact sensor, a non-contact infrared (IR) temperature sensor, or a contact temperature sensor; An apparatus according to any one of Examples 1 to 13.

[0019] Example 15 The sensor is configured to remain outside of the first portion when the second portion is mechanically coupled to the first portion. An apparatus according to any one of Examples 1 to 14.

[0020] Example 16 the second portion comprises a housing, and the at least one sensor is disposed within the housing of the second portion, and upon connection of the first portion to the second portion, the at least one sensor is positioned adjacent to a portion of the fluid conduit; An apparatus according to any one of Examples 1 to 15.

[0021] Example 17 a housing enclosing the second portion of the circuitry; The device described in Example 16.

[0022] Example 18 The at least one sensor senses the fluid conduit through a window in the housing of the second portion. 18. The device according to example 16 or 17.

[0023] Example 19 the window comprises a material that is transparent to IR radiation; The device described in Example 18.

[0024] Example 20 the window comprises germanium; The apparatus described in Example 19.

[0025] Example 21 the first portion comprises a housing extending around the fluid conduit while having one or more openings to the fluid conduit, and when the first and second portions are coupled, the one or more sensors are adjacent the one or more openings; An apparatus according to any one of Examples 1 to 20.

[0026] Example 22 the at least one sensor includes a contact sensor, the contact sensor contacting and sensing the fluid conduit through coupling between the first portion and the second portion; An apparatus according to any one of Examples 1 to 21.

[0027] Example 23 The power supplied by the power source to the fluid conduit acts to heat the fluid conduit. An apparatus according to any one of Examples 1 to 22.

[0028] Example 24 a processor configured to receive measurement signals from the at least one sensor and generate, based on the measurement signals, a control signal for controlling the power source; An apparatus according to any one of Examples 1 to 23.

[0029] Example 25 the second portion includes at least one electrical contact portion housed in a removable portion of the second portion; An apparatus according to any one of Examples 1 to 24.

[0030] Example 26 A microswitch is provided which is actuated by coupling of the first portion and the second portion. An apparatus according to any one of Examples 1 to 25.

[0031] Example 27 Actuation of the microswitch allows for the transfer of power from the power source to the fluid conduit; The device described in Example 26.

[0032] Example 28 The microswitch is housed within the removable portion of the second part along with the electrical contacts of the second part. The device described in Example 27.

[0033] Example 29 One or more portions of the fluid conduit are covered with an infrared absorbing material; The device according to any one of Examples 1 to 28.

[0034] Example 30 a power source is external to the device and connected to the second part; An apparatus according to any one of Examples 1 to 29.

[0035] Example 31 The first and second portions are configured for quick press connection to provide a mechanical interlock and an electrical connection. An apparatus according to any one of Examples 1 to 30.

[0036] Example 32 the second portion comprises at least one connector configured to electrically and mechanically engage the fluid conduit; An apparatus according to any one of Examples 1 to 31.

[0037] Example 33 At least one connector includes a resilient clip sized and configured to directly and securely fasten to the fluid conduit; The device described in Example 32.

[0038] Example 34 attaching the fluid conduit, the fluid conduit comprising an electrically conductive material, to a power source such that the fluid conduit is mechanically and electrically connected to the power source such that an electrical current provided by the power source heats the fluid conduit; providing an infusion fluid to an inlet of a fluid conduit; sensing the fluid conduit with one or more non-contact sensors spaced from the fluid conduit to provide a measurement signal; controlling a power supply based on the measurement signal; 16. A method for infusion solution preparation comprising:

[0039] Example 35 The detection includes infrared detection. The method of Example 34.

[0040] Example 36 the one or more non-contact sensors are located within the housing and the fluid conduit is located outside the housing; The method according to example 34 or 35.

[0041] Example 37 The power source or the connection to the power source is located within the housing. The method of Example 36.

[0042] Example 38 A housing having a window; a sensor configured to sense a fluid conduit outside the housing through the window; Power source or connection to power source; A base for an injection device comprising:

[0043] Example 39 a processor or a connection to a processor configured to receive measurements from the sensor and control a power source based on the measurements; The base described in Example 38.

[0044] Example 40 at least one connector attached to the hollow metal conduit; The base of Example 38 or 39.

[0045] Example 41 a fluid conduit comprising an electrically conductive material; a first electrical connector attached to a first portion of the fluid conduit; a second electrical connector attached to a second portion of the fluid conduit, the second electrical connector forming an electrically conductive path between the first portion and the second portion of the fluid conduit; One or both of the first and second connectors may include a loop sized and shaped to extend around and contact a portion of the fluid conduit; a first contact portion extending from the first surface of the loop; a second contact portion extending from the second surface of the loop; Equipment for preparation of infusion solutions.

[0046] Example 42 One or both of the first contact portion and the second contact portion have a size and / or shape that allows the contact portion to be deflected by being electrically connected to a power source; The device described in Example 41.

[0047] Example 43 a housing that covers an outer surface of the fluid conduit with an inner surface open to an interior volume; 43. The device according to example 41 or 42.

[0048] Example 44 The conduit has a shape of a coil including at least two turns and is wound around the interior volume; The device described in Example 43.

[0049] Example 45 a second portion selectively connectable to the first portion; The second part is A power source and / or a connection to a power source; a contact portion electrically connected to a power source; at least one sensor for detecting fluid in the fluid conduit; The device described in Example 44.

[0050] Example 46 an electrical connector for connecting the injection conduit to a power source, a loop sized and shaped to extend around and contact a portion of the tubular infusion conduit; a first contact portion extending from the first surface of the loop; a second contact portion extending from the second surface of the loop; An electrical connector comprising:

[0051] Example 47 1. An apparatus for the preparation of an infusion solution, comprising: a first portion including a fluid conduit through which a fluid to be injected passes; a second portion selectively connectable to the first portion, the second portion comprising at least one sensor for sensing a property of the fluid conduit and / or a fluid within the fluid conduit; a mechanical coupling between the first and second portions such that the at least one sensor is positioned proximate to the fluid conduit for measuring the fluid conduit; Device.

[0052] Example 48 A disposable part of an injection heater, comprising: a folded sterile fluid conduit comprising an electrically conductive material; a first connector for medical tubing attached to a first end of the fluid conduit; a second connector for medical tubing attached to the first end of the fluid conduit; the fluid conduit defines at least two designated locations for mechanical and electrical engagement, each of the designated locations having an axial length greater than 0.5 cm; Disposable parts for injection heaters.

[0053] Example 49 A temperature control circuit; Power source or connection to power source; at least one connector configured to stably, directly and reversibly engage the heating conduit and provide both a mechanical engagement and a supply of electrical power from a power source to the heating conduit for heating; A base for an injection device comprising:

[0054] Example 50 the at least one connector includes at least two connectors each having a resilient clip portion for clamping directly around the body of the heating conduit; The base described in Example 49.

[0055] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this invention belongs.Although methods and materials similar or equivalent to those described herein can be used to practice or test embodiments of this invention, exemplary methods and / or materials are described below.In case of conflict, the patent specification, including definitions, shall prevail.In addition, the materials, methods, and examples are merely illustrative and are not necessarily intended to be limiting.

[0056] Implementation of methods and / or systems according to embodiments of the present invention may include performing or completing selected tasks manually, automatically, or a combination thereof. Further, depending on the actual instrumentation and equipment of embodiments of the methods and / or systems of the present invention, some selected tasks may be performed using an operating system, by hardware, software, or firmware, or a combination thereof.

[0057] For example, hardware for performing selected tasks according to embodiments of the present invention may be implemented as a chip or circuit. As software, selected tasks according to embodiments of the present invention may be implemented as a number of software instructions executed by a computer using any suitable operating system. In an exemplary embodiment of the present invention, one or more tasks according to exemplary embodiments of the methods and / or systems described herein are performed by a data processor, such as a computing platform for executing a number of instructions. The data processor optionally includes volatile memory for storing instructions and / or data, and / or non-volatile storage (e.g., magnetic hard disk, removable media) for storing instructions and / or data. Optionally, a network connection is also provided. A display and / or a user input device, such as a keyboard or mouse, are also optionally provided.

[0058] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this invention belongs.Although methods and materials similar or equivalent to those described herein can be used to practice or test embodiments of this invention, exemplary methods and / or materials are described below.In case of conflict, the patent specification, including definitions, shall prevail.In addition, the materials, methods, and examples are merely illustrative and are not necessarily intended to be limiting.

[0059] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this invention belongs.Although methods and materials similar or equivalent to those described herein can be used to practice or test embodiments of this invention, exemplary methods and / or materials are described below.In case of conflict, the patent specification, including definitions, shall prevail.In addition, the materials, methods, and examples are merely illustrative and are not necessarily intended to be limiting.

[0060] As will be appreciated by those skilled in the art, some embodiments of the present invention may be embodied as a system, a method, or a computer program product. Thus, some embodiments of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, microcode, etc.), or an embodiment combining software and hardware aspects, generally referred to herein as a "circuit," "module," or "system." Furthermore, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer readable mediums having computer readable program code embodied on the medium. Implementation of the method and / or system of some embodiments of the present invention may involve performing and / or completing selected tasks manually, automatically, or a combination thereof. Furthermore, some selected tasks may be performed by hardware, by software, or by firmware, and / or by a combination thereof (e.g., using an operating system), depending on the actual facility and equipment of some embodiments of the method and / or system of the present invention.

[0061] For example, hardware for performing selected tasks according to some embodiments of the present invention may be implemented as a chip or circuit. As software, selected tasks according to some embodiments of the present invention may be implemented as a number of software instructions executed by a computer using any suitable operating system. In an exemplary embodiment of the present invention, one or more tasks according to some exemplary embodiments of the methods and / or systems described herein are performed by a data processor, such as a computing platform for executing a number of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage, e.g., a magnetic hard disk and / or removable media, for storing instructions and / or data. Optionally, a network connection is also provided. Optionally, a display device and / or a user input device (e.g., a keyboard or mouse) are further provided.

[0062] In some embodiments of the present invention, any combination of one or more computer readable media may be utilized. The computer readable medium may be a computer readable signal medium or a computer readable storage medium. The computer readable storage medium may be, for example, but not limited to, any electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, or a device, or a suitable combination thereof. More specific examples (non-exclusive list) of computer readable storage media include an electrical connection having one or more wires, a portable computer disk, a hard disk, a random access memory (RAM), a read only memory (ROM), an erasable programmable read only memory (EPROM or flash memory), an optical fiber, a portable compact disk read only memory (CD-ROM), an optical storage device, a magnetic storage device, or a suitable combination thereof. As used herein, a computer readable storage medium refers to any tangible medium that can contain or store a program for use by or in connection with an instruction execution system, device, or device.

[0063] A computer-readable signal medium may include a propagated data signal having computer-readable program code embodied therein, for example, in base band or as part of a carrier wave. Such propagated signals may take any of a variety of forms, including electromagnetic, optical, or any suitable combination thereof. A computer-readable signal medium is not a computer-readable storage medium, and may be any computer-readable medium capable of communicating, propagating, or transporting an instruction execution system, device, or program used in connection with a device.

[0064] Data stored on or using a computer readable medium may be transmitted using any suitable medium, or a combination of any suitable medium, including but not limited to wireless, wireline, fiber optic cable, RF, etc.

[0065] Computer program code for carrying out operations of some embodiments of the present invention may be written in any combination of one or more programming languages, including object-oriented programming languages ​​such as Java, Smalltalk, C++, and conventional procedural programming languages ​​such as the "C" programming language. The program code may be executed entirely on the user's computer, partially on the user's computer, as a stand-alone software package, partially on the user's computer and partially on a remote computer, entirely on the user's computer, or entirely on a remote computer or server, where the remote computer may be connected to the user's computer via any type of network, such as a local area network (LAN) or wide area network (WAN), or may be connected to an external computer (e.g., via the Internet using an Internet Service Provider).

[0066] Some embodiments of the present invention may be described below with reference to flowcharts and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the present invention. It will be understood that each block of the flowcharts and / or block diagrams, and combinations of each block of the flowcharts and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general purpose computer, a special purpose computer, or other programmable data processing apparatus, and executed as instructions executed via the processor of the computer or other programmable data processing apparatus to form means for implementing these functions / operations.

[0067] These computer program instructions may be stored on a computer-readable medium that can direct a computer, other programmable data processing apparatus, or other device to perform certain operations, such that the instructions stored on the computer-readable medium can result in an article of manufacture that includes instructions that perform certain functions / operations of the flowcharts and / or block diagrams.

[0068] The computer program instructions may be loaded into a computer, other programmable data processing apparatus, or other device and cause the computer, other programmable apparatus, or other device to execute a series of operational steps to generate a computer-implemented process, such that the instructions executing on the computer or other programmable apparatus provide processing for implementing a particular function / operation of the flowcharts and / or block diagrams.

[0069] Some of the methods described herein are generally designed to be used only by a computer and may not be feasible or practical to perform purely manually by a human expert. A human expert wishing to manually perform a similar task, such as inspecting an object, would be expected to use an entirely different method, e.g., utilizing specialized knowledge and / or the pattern recognition capabilities of the human brain, which may be much more efficient than manually performing the steps of the methods described herein.

[0070] Certain embodiments of the present invention are described herein, by way of example only, with reference to the accompanying drawings, in which it is emphasized that the details shown hereinafter, with particular reference to the drawings, are for the purposes of illustration and for the purpose of detailed description of embodiments of the present invention. Similarly, from viewing the description together with the drawings, it will become apparent to those skilled in the art how embodiments of the present invention may be practiced. [Brief description of the drawings]

[0071] [Figure 1] 1 is a simplified schematic diagram of a system according to some embodiments of the present invention. [Diagram 2] 1 illustrates a method of preparing an infusion solution, according to some embodiments of the present invention. [Figure 3A] 1 is a simplified schematic diagram of a first portion of an injection device, according to some embodiments of the present invention. [Figure 3B] 1 is a simplified schematic diagram of a portion of a first portion of an injection device, according to some embodiments of the present invention. [Figure 4A] 2 is a simplified schematic diagram of a second portion of an injection device, according to some embodiments of the present invention. [Figure 4B] 1 is a simplified schematic diagram of a portion of a second portion of an injection device, according to some embodiments of the present invention. [Diagram 5] 1 is a schematic diagram of a simplified injection device, according to some embodiments of the present invention. [Figure 6]1A-1D illustrate methods of assembling portions of an injection device, according to some embodiments of the present invention. [Figure 7] 1A-1D illustrate methods of assembling portions of an injection device, according to some embodiments of the present invention. [Figure 8] 1 illustrates a method of treatment using an injection device, according to some embodiments of the present invention. [Figure 9A] 1A-1D are simplified schematic diagrams of connectors according to some embodiments of the present invention. [Figure 9B] 4A-4D are simplified schematic diagrams of contact portions according to some embodiments of the present invention. [Figure 9C] 1 is a simplified schematic diagram of a connector and contact portion according to some embodiments of the present invention. [Figure 9D] 1A-1D are simplified schematic diagrams of connectors according to some embodiments of the present invention. [Figure 10] 1 is a cross-sectional view of a simplified injection device according to some embodiments of the present invention. [Figure 11A] 1 is a simplified schematic diagram of a portion of a second portion of an injection device, according to some embodiments of the present invention. [Figure 11B] 1 is a simplified schematic diagram of a portion of a second portion of an injection device, according to some embodiments of the present invention. [Figure 11C] 1 is a simplified schematic diagram of a portion of a second portion of an injection device, according to some embodiments of the present invention. [Figure 11D] 1A-1D are simplified schematic diagrams of connectors according to some embodiments of the present invention. [Figure 12A] 1 is a schematic diagram of a simplified injection device, according to some embodiments of the present invention. [Figure 12B] 1 is a schematic diagram of a simplified injection device, according to some embodiments of the present invention. [Figure 12C] 2 is a simplified schematic diagram of a second portion of an injection device, according to some embodiments of the present invention. [Figure 13]13A-13C show coil heaters that attach directly to the connector of the second portion of the injection heating apparatus, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0072] Some embodiments of the present invention relate to injection systems, and more particularly and non-exclusively to injection devices for injecting a warmed fluid into a subject.

[0073] overview A broad aspect of some embodiments of the present invention relates to the preparation of an infusate, where a conduit through which the infusate flows for the preparation of the infusate is disposable, and where a circuit for the preparation (e.g., heating) of the infusate, including, for example, a sensor and / or sensor circuit, is included by a separate reusable portion selectively attachable to the conduit.

[0074] One aspect of some embodiments of the invention relates to an infusion device that includes a first portion (e.g., lacking a sensor) housing a conduit for an infusate and a second portion housing one or more sensors for measuring a parameter of the infusate. Optionally, in some embodiments, the second portion includes a power source for the supply of power and / or connectivity to the power source, and in some embodiments, a mechanical interlocking of the portions electrically connects the power source to the first portion to process the infusate.

[0075] In some embodiments, fluid processing and / or preparation includes temperature control (e.g., heating and / or cooling and / or maintaining at a desired temperature and / or temperature range) of the fluid and / or the conduit through which the fluid flows. Note that in some embodiments, the fluid is heated, for example, by heating one or more portions of the conduit. In some embodiments, the conduit comprises an electrically conductive material, and current passing through the conduit (and current provided by the power source) heats the conduit and / or the infusate.

[0076] By way of example, the fluid temperature may be controlled to within the range of about normal body temperature (37° C.), e.g., 36-39° C., or within intermediate ranges, such as 30%, 20%, 10%, 5% below body temperature, above body temperature, etc. In some embodiments, the control may allow the temperature to drop below body temperature by a large percentage, e.g., to be maintained at 35-37° C.

[0077] In some embodiments, the fluid temperature is controlled as part of the treatment of a health condition. For example, in some embodiments, the fluid temperature is controlled to be higher than normal human body temperature to treat hypothermia. For example, the fluid temperature is controlled to be 37-42°C, 38-42°C, 40-42°C, about 42°C, or lower, higher, or intermediate temperatures or ranges. For example, in some embodiments, the fluid temperature is controlled to be lower than normal human body temperature as part of the treatment of one or more of, for example, head trauma, oxygen deprivation, fever. For example, the fluid temperature is controlled to be 30-36°C, 32-34°C, about 33°C, or lower, higher, or intermediate temperatures or ranges.

[0078] In some embodiments, the measured body temperature of the subject is used as feedback for controlling the temperature of the fluid. For example, a processor that generates the control signal receives measurements from one or more sensors that collect body temperature measurements of the patient.

[0079] Alternatively, in some embodiments, measuring the patient's ambient air temperature (e.g., as provided to a processor that generates a control signal generated by one or more sensors located external to one or more of the device portions (e.g., external sensors that provide data to the processor)) is used as feedback for controlling the temperature of the fluid.

[0080] In some embodiments, the fluid is treated and / or prepared instead of or in addition to temperature control, for example by one or more of filtering, charging, agitating, and flow control.

[0081] In some embodiments, the infusion fluid comprises one or more of blood, a blood product, a medication, or a hydration fluid.

[0082] Although the delivery of infusate is generally described herein, delivery of other fluids to a patient is also envisioned and / or encompassed. For example, in some embodiments, the delivery and / or preparation (e.g., heating) of fluid is for perfusion fluid during a medical procedure, e.g., during surgery. In some embodiments, the delivery and / or preparation is for tube feeding and / or hydration, e.g., via one or more of a nasogastric tube, a nasojejunal tube, a percutaneous endoscopic gastrostomy, and a jejunostomy tube.

[0083] In certain embodiments of the invention, the infusate comprises a contrast agent, for example for x-ray, nuclear medicine, ultrasound and / or MRI imaging. In some embodiments of the invention, the device is made as part of an imaging system or a fluid pumping system (e.g., syringe pump, food pump). For example, in a two-part device, the disposable heated tube may be selectively attached directly to a control that is part of the imaging device or syringe pump.

[0084] In some embodiments of the invention, the device includes an input to indicate the fluid to be heated. This may be used to better control heating (e.g., by a heater control circuit) by using the fluid identity as an indication of its specific heat capacity constant. Fluids with lower heat capacity constants may benefit from gentler heating. Other optional inputs include desired temperature, desired effect (e.g., body temperature, cooling, heating), and desired flow rate (e.g., best temperature control, fastest flow).

[0085] In some embodiments of the invention, such contrast agent is injected as a bolus of, for example, 50-100 mL at 4 mL / sec. Smaller or slower boluses can be provided and the volumes can be larger or smaller. In one embodiment, the bolus material is heated as a whole (within a heating coil conduit) and injected as soon as it is sufficiently hot. In other embodiments, the contrast agent may be delivered more continuously, for example over a period of 1-20 minutes, such as over a period of 3-9 minutes.

[0086] One aspect of some embodiments of the present invention relates to attaching a first portion to a second portion to precisely achieve and / or maintain alignment between a conduit in the first portion and a sensor in the second portion.

[0087] In some embodiments, attachment includes locking the parts together once connected.

[0088] In some embodiments, the mechanical connection of the two portions closes a switch, and in some embodiments, power is provided to the circuitry of the portions only when the switch is closed.

[0089] In some embodiments, the housing of the first and / or second portion maintains the conduit and / or sensor in a fixed spatial relationship to one another.

[0090] A broad aspect of some embodiments of the present invention relates to a first part that is easily buildable and / or inexpensive. In some embodiments, the first part includes a conduit and includes a housing for the conduit, the housing holding the conduit in place. In some embodiments, the first part includes a connector for connecting the conduit to a power source. In some embodiments, a first part with a low number of parts (e.g., housing, conduit, and optionally connectors) is easier to build and / or easier to clean and / or easier to test. A potential advantage of reduced circuitry, e.g., elimination of sensors, is that in some embodiments, there is no requirement for electrical testing, e.g., safety testing.

[0091] In some embodiments, the first portion includes a housing having up to two portions, or up to one to four portions, or a fewer, greater, or intermediate number of portions. In some embodiments, the housing does not enclose the conduit, and a portion of the conduit (e.g., an interior portion of the conduit adjacent an interior space defined by the shape of the conduit) can be in intimate contact with another portion of the device, such as a sensor in the second portion.

[0092] In one form of the invention, the first part does not include a specific connector, and optionally does not include a housing. Rather, one or more connectors of the second part are mechanically and electrically attached directly to the conduit. It should be noted that the connectors may be snap connectors, such as a resilient normally closed clip that includes two or more expanding lips. When the conduit is pressed against the lips, the clip is forced open and the conduit is forced into the clip and may optionally be secured to the expanding portion of the clip. Such clips provide mechanical interlocking and / or alignment in addition to electrical coupling.

[0093] In some embodiments of the invention, the first portion includes a housing formed of a polymeric material, such as, for example, nylon. The coil may define a lumen into which the second portion is inserted. Alternatively, the second portion may include a hollow portion into which at least a portion, or all, of the first portion is inserted. Alternatively, the two portions interlock, but optionally, a portion of one portion remains outside the other portion, or vice versa.

[0094] In use, for example, the following procedure can be used in the field or clinic: The first part is attached to the infusion system, for example via an infusion tube. It is then attached to a second part provided in a separate package and / or not associated with the first part, for example using a snap connection or other type of connection based on geometric interference or press fit, elastic or plastic deformation, or other connection. For example, a connection that takes up to 30 seconds to make manually, preferably 10 seconds or less. Optionally, the connection aligns a sensor, for example an IR sensor, of the second part to a specific part of the conduit. The connection also provides both a mechanical connection and an electrical connection of power from the second part to the first part. Optionally, the user indicates one or more parameters, such as a desired temperature, to the second part. If necessary, the device (second part) may be attached to a power source, such as a mains power source or a portable power source. After infusion, the first part may be detached from the second part and discarded or sterilized. The first part can be easily releasably connected in the field without the use of permanent connectors, such as glue, screws, bolts, etc. In some embodiments of the invention, the first part is repeatedly detachable. Alternatively, the first part (e.g., the housing) may include one or more tabs that break when removed from the second part.

[0095] In some embodiments of the invention, the second portion containing the sensor undergoes a calibration process, for example, by heating a known amount and measuring the change in signal from the sensor. Such measurements can be used, for example, to determine baseline and slope corrections for the sensor.

[0096] One aspect of some embodiments of the invention relates to a disposable fluid heating component comprising an elongated folded conduit with an internal diameter of less than 1 cm, e.g., 4-6 mm, a length of 30-300 cm, e.g., 150-250 cm or less than 1 m, and a connection to medical tubing (e.g., an IV line) at either end. In some embodiments of the invention, the component comprises a metal or other material having a resistivity to form an electrically conductive tube, e.g., stainless steel. Optionally, the tube is coated with a biocompatible layer on the inside. Alternatively, the tube is coated with an electrical insulator on the outside. Optionally, insulation is avoided at the points of mechanical grip. Also, the tube does not have a sensor attached to it, but a sensor may contact or be directed at it in use. Optionally, one or more portions of the conduit are treated to better interface with an external (e.g., part of the second portion), contact or non-contact sensor.

[0097] In some embodiments of the invention, an electrical circuit (e.g., wires) connects the tube to a connector that provides an electrical connection. In some embodiments, no connector is used. Instead, one or more designated portions of the tube are predefined to act as both an electrical and mechanical connection.

[0098] An enclosure is optionally provided to protect the conduit from the outside (and vice versa).

[0099] One aspect of some embodiments of the invention relates to a mechanical and electrical connector for a heating conduit, formed from a folded sheet of material, e.g., a conductive and / or resilient material, e.g., steel or copper, with the folds defining a lumen surrounding at least 70% of the circumference of the subject conduit. The conduit can be, for example, stainless steel tubing having a diameter of 3 mm to 8 mm. In some embodiments of the invention, a connector extends away from the defined lumen and terminates in an electrical connector, e.g., in the form of a flat flange. In some embodiments of the invention, the electrical connector also functions as a mechanical connector and includes a width and, optionally, a shape to aid in locking into a corresponding connector.

[0100] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of elements and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments and of being practiced or carried out in various ways.

[0101] Exemplary System FIG. 1 is a simplified schematic diagram of a system 100 according to some embodiments of the present invention.

[0102] In some embodiments, the system 100 includes an injection device 102 that prepares a fluid for injection into a subject 104. In some embodiments, the fluid is received from a fluid reservoir 106, passes through the injection device 102, and is treated and / or prepared for injection before the fluid is delivered to the subject 104.

[0103] In some embodiments, the injection device 102 includes a fluid conduit 108 through which the fluid prepared for injection flows.

[0104] In some embodiments, the fluid passing through the fluid conduit 108 is heated by heating the fluid conduit 108 itself. In some embodiments, the fluid conduit 108 comprises an electrically conductive material, and heating of the conduit 108 is performed by passing an electric current through the material of the conduit 108.

[0105] In some embodiments, the system 100 includes one or more power sources 110, 110a that provide electrical current to the conduit 108 for heating thereof.

[0106] In some embodiments, the infusion device 102 itself includes the power source 110. For example, in some embodiments, the second portion 114 includes the power source. Alternatively, or alternatively, in addition to including the power source 110, in some embodiments the infusion device 102 includes the ability to connect to an external power source 110a.

[0107] As an example, the infusion device 102 does not itself include a power source, but does include the ability to connect to an external power source 110a.

[0108] In some embodiments, the infusion device 102 has at least two connectable portions 112, 114. The first portion 112 contains the conduit 108 and the second portion 114 contains the power source 110 (e.g., a rechargeable and / or non-rechargeable battery). In some embodiments, the connection of the two portions 112, 114 connects the power source 110 (and / or the ability to connect to a power source) to the conduit 108 to heat the conduit 108.

[0109] In some embodiments, the first portion 112 includes a housing 120. In some embodiments, the second portion 114 includes a housing 122. In some embodiments, the portions 112, 114 are connected, for example, by connecting the housings 120, 122 with one or more housing connectors (e.g., housing connector 466 in FIGS. 4A, 5). In some embodiments, the housing connectors prevent relative movement between the sensor and the conduit 108, which may increase the accuracy of the sensor's measurement of the conduit 108.

[0110] In some embodiments, first portion 112 is disposable (and / or configured to be sterilized), and in some embodiments, second portion 114 is, for example, multi-use and, for example, does not come into contact with infusion fluid.

[0111] In some embodiments, the first portion 112 includes electrical circuits 124 , 126 , 128 , 130 , 132 , 134 that electrically connect the conduit 108 to the power source 110 via, for example, electrical circuits 136 , 138 , 140 of the second portion 114 .

[0112] In some embodiments, first portion conduit contact portions 126, 128 connect the conduit 108 to first portion connector contact portions 132, 134, for example, by first portion connectors 128, 130.

[0113] In some embodiments, the contact portions 132, 134 of the first portion are connected to the contact portions 136, 138 of the second portion. In some embodiments, the contact portions 132, 134 of the first portion are electrically (and optionally mechanically) connected to the contact portions 136, 138 of the second portion.

[0114] In some embodiments, the second portion 114 optionally includes one or more sensors 116, 118. In some embodiments, the sensors 116, 118 measure one or more characteristics of the conduit 108, such as, for example, the conduit temperature, for one or more portions of the conduit 108.

[0115] In some embodiments, the sensors 116, 118 include one or more contact and / or non-contact sensors. A contact sensor contacts a portion of the device to be measured, such as the conduit 108. In some embodiments, the sensors 116, 118 include one or more temperature sensors (e.g., IR sensors, thermistors).

[0116] Connection of the first portion 112 and the second portion 114 causes a contact sensor to contact the portion to be measured. For example, in some embodiments, the contact sensor of the second portion 114 is caused to sufficiently contact the conduit 108 (e.g., by sizing and / or shaping and / or elastic and / or plastic deformation of one or more portions) to measure the conduit 108. For example, in some embodiments, the contact sensor is spring-loaded to the contact portion to be measured. For example, in some embodiments, the contact sensor is moved to contact the portion to be measured after and / or as part of connection of the portions 112, 114.

[0117] As an example, the sensors 116, 118 include non-contact sensors, such as infrared (IR) sensors (and / or sensors that detect the temperature of the conduit 108 through the housing 112 (e.g., sensors that detect the temperature of the conduit 108 through a through hole and / or a transparent window (e.g., windows 482, 484, 486, 488, 490 in FIG. 4A ) in the housing 112).

[0118] In some embodiments, the conduit 108 includes a non-IR reflective material, with the potential advantage of improving the accuracy of the temperature measurement of the conduit by the IR sensor. As an example, at least a portion of the conduit adjacent to the IR sensor is painted and / or covered with an IR absorbing material, for example, with a non-glossy (e.g., matte) material and / or a black material. In some embodiments, the coating is thin (e.g., less than 0.5 mm thick, or less than 0.1 mm thick, or less, or more, or of intermediate thickness, with the potential advantage of reducing insulation of the conduit by the coating and / or potentially improving the accuracy of the temperature measurement).

[0119] In some embodiments, the non-reflective material is located only in the area of ​​the conduit that is to be sensed, for example, if a patch of the conduit includes the material, for example, in some embodiments, a portion of the conduit may have non-reflective material attached thereto, for example, a sticker attached thereto.

[0120] In some embodiments, the device 102 includes additional sensors in addition to or instead of the temperature sensor. For example, a flow sensor detects flow in the conduit 108. For example, an ultrasonic sensor detects flow in the conduit through one or more ultrasonically transparent portions (e.g., portions having sufficiently low attenuation) of the conduit 108. In some embodiments, the ultrasonic sensor is hosted by the second portion, e.g., the measurement conduit 108, through one or more windows or holes provided in the housing of the second portion.

[0121] In some embodiments, the flow rate of fluid over time and / or the volume of fluid delivered (e.g., within a given time period) is determined using the power delivered to the conduit. In some embodiments, the processor 150, 152 records the power delivered by the power source 110, 110a, for example, over time. In some embodiments, the measured temperature of one or more portions of the conduit (e.g., temperature measured by one or more of the sensors 116, 118).

[0122] In some embodiments, the flow rate is determined using Equation 1 below. Q=mCΔT (Equation 1)

[0123] where Q is the heat energy supplied, m is the mass of the fluid, C is the specific heat capacity of the material being heated, and ΔT is the temperature change of the material being heated.

[0124] In some embodiments, ΔT is determined using measurements (eg, sensor measurements 116, 118 in one or more portions of the conduit) and / or assumptions (eg, assumptions regarding input fluid temperature and / or output fluid temperature).

[0125] In some embodiments, if Q (e.g., delivered power), C (e.g., for blood, approximately 4, if the specific heat of the conduit material and / or the responsiveness of the conduit material to power changes is taken into account), and ΔT (e.g., measured by a sensor in the device) are known, in some embodiments mass per time (e.g., determined using the density of the fluid) is used to determine the flow rate of the fluid and / or the volume delivered in a given time.

[0126] A potential benefit of being able to determine the volume delivered is increased information to the caregiver regarding the amount of fluid delivered. In some embodiments, the user interfaces 154, 156 are used to display the fluid flow rate and / or total volume injected over a time period. In some embodiments, the user specifies (e.g., selects in the user interface) which portion of the displayed data to display, e.g., the flow rate and / or volume for a specified (e.g., selected in the user interface) time period. Extraction of such flow rates may be useful for manual fluid delivery systems, automated systems, and / or gravity-based systems. For example, the injection rate of a contrast bolus may be extracted. The device also optionally includes human perceptible indications, such as audio or visual indications to indicate operation within and / or outside of desired parameters. Optionally or additionally, a data feed to an external device may be provided to transmit the above information and / or conformance with desired parameters.

[0127] In some embodiments, the fluid reservoir 106 is connected to the conduit 108 via an input fluid connector 144, which in some embodiments is an airtight connection. In some embodiments, the fluid reservoir 106 is connected to the connector 144 via tubing 142.

[0128] In some embodiments, an infusion device 146 (eg, for delivering fluid to the subject 104) is connected to the conduit via an output fluid connector 148, which in some embodiments is an airtight connection.

[0129] In some embodiments, the system 100 includes one or more processors 150, 152. In some embodiments, the processor 150 receives sensor measurement signals from the sensors 116, 118.

[0130] In some embodiments, the processor 150, 152 sends a control signal to the power source 110 to control the flow of current from the power source 110 to the conduit 108, for example based on sensor measurements. In some embodiments, the system 100 includes a device processor 150 hosted by the second portion 114.

[0131] In some embodiments, the sensors 116, 118 are digital sensors that provide a digital output, hi some embodiments, this digital measurement signal is converted to an analog signal, for example by the processors 150, 152.

[0132] Alternatively or additionally, in addition to having a device processor 150, in some embodiments the system includes an external processor 152, for example hosted by an external electrical device. For example, in some embodiments the device 102 itself does not include a processor, and processing is provided by the external processor 152.

[0133] 1 shows the processor 152 connected (wired and / or wirelessly) to the device processor 150. However, in some embodiments, the processor 152 interfaces directly with other parts of the infusion device 102, such as, for example, the power supply 110.

[0134] In some embodiments, the system 100 includes one or more user interfaces 154, 156. For example, there are one or more device user interfaces 154 hosted by the second portion 114. For example, one or more external user interfaces 156 are hosted by an external electronic device. In some embodiments, a user inputs control commands, etc. and / or receives communications (e.g., measurement data and / or alerts, etc.) via the user interfaces 156, 154.

[0135] In some embodiments, the system 100 includes one or more memories 158, 160. For example, there is a device memory 158 hosted in the second portion 114. For example, one or more external memories 160 can be hosted by an external electronic device.

[0136] In one embodiment, the second portion 114 hosts the sensors 116, 118 but lacks a processor and / or power source, and hosts the power source 110a and / or connectivity to the processor 152. In some embodiments, an additional portion, the third portion, houses the power source 110a and the processor 152.

[0137] Exemplary Methods FIG. 2 is a diagram illustrating a method of preparing an infusion solution, according to some embodiments of the present invention.

[0138] In some embodiments, the fluid conduit is connected to a heating circuit at 200. For example, with reference to FIG.

[0139] In some embodiments, at 202, the temperature of the fluid flowing through the fluid conduit and / or the temperature of the fluid conduit is controlled while the fluid flows through the fluid conduit.

[0140] In some embodiments, the temperature of the fluid conduit and / or infusate is controlled using feedback measurements of sensors sensing the conduit and / or fluid (eg, sensors 116, 118; FIG. 1).

[0141] In some embodiments, the power supplied to the conduit is controlled based on the sensed temperature.

[0142] In some embodiments, the amount of current delivered to the conduit is controlled based on the sensed temperature, for example if the conduit is supplied with pulsed current the delivered current is adjusted (e.g. the pulse duty cycle remains the same but the magnitude of the current is adjusted) based on the sensed measurement.

[0143] In some embodiments, the temperature regulation control employs pulse width modulation (PWM), e.g., adjusting the duty cycle (e.g., the pulse magnitude remains the same but the duty cycle is adjusted) based on the sensed measurements.

[0144] In some embodiments, both the pulse width and magnitude are adjusted.

[0145] In some embodiments, for example, one or more other methods in the field of temperature control are employed based on the sensed temperature of the conduit (and / or the fluid within the conduit), for example, to control the power supplied to heating the conduit.

[0146] Exemplary Multi-Part Infusion Device FIG. 3A is a simplified schematic diagram of a first portion 312 of an injection device, according to some embodiments of the present invention.

[0147] FIG. 3B is a simplified schematic diagram of a portion of the first portion 312 of the injection device, according to some embodiments of the present invention.

[0148] In some embodiments, Figures 3A and 3B show the same first portion 312, with Figure 3B showing the first portion 312 with the housing portion 378 removed.

[0149] In some embodiments, first portion 312 (eg, FIGS. 3A and / or 3B) includes one or more features shown and / or described with respect to first portion 112 of FIG.

[0150] In some embodiments, the first portion 312 includes a conduit 308 that, in some embodiments, includes one or more features of the conduit 108 of FIG.

[0151] In some embodiments, the conduit 308 includes an electrically conductive and / or thermally conductive material. For example, it is made of an electrically conductive and / or thermally conductive material (e.g., a metal, such as stainless steel, aluminum, and / or a combination thereof). As an example, the conduit 308 includes (e.g., is formed of) stainless steel. In some embodiments, the conduit 308 includes an electrically conductive material (e.g., a conductive coating, e.g., a conductive wire) attached to a tubular structure.

[0152] In some embodiments, the conduit 308 is an elongated structure having a lumen (e.g., tubing) with a shape that changes direction one or more times. In some embodiments, the shape of the conduit 308 defines an interior space 331, also referred to herein as first portion lumen 331.

[0153] In some embodiments, the conduit 308 is a coil of tubing. In some embodiments, the coil has at least 1 turn, e.g., 1-20 turns, or 5-15 turns, or 8-12 turns, or about 9 turns, or fewer turns, or more turns, or an intermediate number of turns.

[0154] In some embodiments, the total length of the conduit 308 is selected based on the desired impedance of the conduit 308. In some embodiments, the conduit 308 does not have a coil. As an example, the coiling of the conduit is defined by the minimum coil size permitted by the material of the conduit 308, e.g., the minimum coil size permitted in the manufacturing coiling process without risk of cracking and / or other mechanical failure of the tube. A potential advantage of increasing the number of coils (e.g., for a given conduit length) is a smaller size of the device. As an example, the conduit 308 is a stainless steel tubing coil, the cross section of the tubing (inner and / or outer cross-sectional dimensions) being 0.5-10 mm, or 1-5 mm, or 2-4 mm, or about 3 mm, or smaller than these ranges, or larger than these ranges, or intermediate ranges between these ranges, or between these ranges. In some embodiments, the walls of the conduit are sufficiently thin and / or the conduit material is sufficiently thermally conductive such that measurements of the temperature of the conduit accurately portray the temperature of the fluid within the conduit. In some embodiments, the wall thickness of the conduit is 0.01-1 mm, or 0.05-1 mm, or 0.1-0.7 mm, or 0.2-0.5 mm, or the lower or upper limits or thicknesses of these ranges. In some embodiments (e.g., for tube cross sections of 0.5-10 mm, or 1-5 mm, or 2-4 mm, or about 3 mm, or smaller, larger, or intermediate ranges or diameters), the total length of the conduit measured along the central longitudinal axis of the coil is 1000-5000 mm, or 1000-3000 mm, or 2000-3000 mm, or 2100-2300 mm, or about 2200 mm, or shorter, longer, or intermediate lengths or ranges.

[0155] In some embodiments, wider cross sections are employed for the conduit, for example in cases where high fluid delivery rates are desired (e.g., blood delivery during bleeding, e.g., irrigation). In some embodiments, the cross section of the tube is 2-15 mm, or 3-6 mm, or 4-5 mm, or smaller, or larger, or intermediate cross sections, or intermediate ranges. For example, for this cross section, in some embodiments, the total length of the conduit is 2000-4000 mm, or 2500-3500 mm, or about 3000 mm, or shorter, longer, or intermediate lengths or ranges.

[0156] In some embodiments, the first portion 312 includes housings 376, 378 (which include one or more features of the housing 120 of FIG. 1).

[0157] In some embodiments, the housings 376, 378 cover an exterior portion of the conduit 308 while leaving an interior portion of the conduit 308 uncovered. A potential advantage is that the second portion of the sensor can be positioned closer to the conduit, potentially improving the accuracy of sensing the conduit (e.g., the temperature of the conduit).

[0158] In some embodiments, the housing 376, 378 mechanically supports, for example, the coil structure of the conduit 308. For example, in addition to or instead of covering the coil, the housing 376, 378 mechanically supports the conduit 308. For example, in some embodiments, the housing 376, 378 includes a protrusion 392 that in some embodiments protrudes inwardly from the housing body 376, 378, beyond the coil, toward a central region of the space defined by the coil structure, and optionally beyond the coil. In some embodiments, the protrusion 392 aligns with and / or at least partially penetrates the space 317 between the turns of the coil of the conduit 308. In some embodiments, the housing 376, 378 has a protrusion 392 for each space 317 of the conduit 308. A potential benefit of the protrusion 392 is mechanical strengthening of the conduit 308, which may, for example, reduce the risk of deformation and / or breakage and / or electrical shorting of the conduit 308. In some embodiments, the protrusions 392 are electrically and / or thermally insulating, for example made of an insulating plastic. Electrical insulation may prevent short circuits between the turns of the conduit 308.

[0159] In some embodiments, the housing 378 includes one or more supports for connection to a fluid reservoir and / or connection to an infusion device. For example, in some embodiments, the housing 378 includes a guide portion 370 sized and / or shaped to receive tubing and / or other connection elements for connection to a fluid reservoir (e.g., a fluid reservoir and / or tubing including one or more features of the fluid reservoir 106 and / or connection elements 142, 144 of FIG. 1). In some embodiments, the housing 378 includes a guide portion 372 sized and / or shaped to guide a connection element for connection to an infusion device (e.g., a connection element including one or more features of the elements 146, 148 of FIG. 1). In some embodiments, one or both of the guide portions 370, 372 include recesses and / or protrusions.

[0160] In some embodiments, when the housing 378 is in position over the conduit 308, the guide portions 370, 372 are aligned with the conduit openings 321, 323 (e.g., the conduit inlet 321 and the conduit outlet 323). In Figure 3B, the conduit outlet 323 is located behind the connector 333 and is not directly visible in the figure. For example, the guide portions 370, 372 allow a connecting tubing to be connected with a corresponding opening in the conduit 308 when guided into the housing.

[0161] In some embodiments, the first portion housing includes multiple housing portions 376, 378 (e.g., two housing portions 376, 378). In some embodiments, the housing portions are connected around the conduit 308. The connection between the housing portions 376, 378 is by interlocking connections, for example, at one or more connection regions 380. In some embodiments, each housing portion 376, 378 includes at least one connector portion (which in some embodiments includes a protrusion and a recess) on each side of the housing.

[0162] For example, with respect to connection region 380, front housing portion 378 has at least one notch that fits over protrusion 319 of rear housing portion 376, connecting portions 376, 378. As an example, each housing connection region 380, 381 includes two such connections, as shown, for example, in Figures 3A-3B.

[0163] In some embodiments, the housings 376, 378 include an insulating material, e.g., an electrically insulating material, e.g., a thermally insulating material. In some embodiments, the housings (optionally including the protrusions 392) are insulating (e.g., electrically and / or thermally insulating), e.g., include and / or are formed of an insulating material, e.g., a polymer.

[0164] In some embodiments, the first portion 312 includes one or more electrical connectors 333, 329. For example, in some embodiments, there is a first electrical connector 333 connected to a beginning region of the coil of the conduit 308 and a second electrical connector 329 connected to a final region of the coil. In some embodiments, when a voltage is applied (e.g., by connecting the connectors 333, 329 to the second portion 414), a current flows through the conduit 308 and the conduit 308 heats up.

[0165] Additional exemplary details regarding connectors 333, 329 are described with respect to Figures 9A-9C.

[0166] FIG. 4A is a simplified schematic diagram of a second portion 414 of an injection device, according to some embodiments of the present invention.

[0167] FIG. 4B is a simplified schematic diagram of a portion of the second portion 414 of the injection device, according to some embodiments of the present invention.

[0168] In some embodiments, second portion 414 includes one or more of the features described and / or illustrated with respect to second portion 114 .

[0169] In some embodiments, the second portion 414 includes a housing 422 (eg, including one or more features of the housing 122 of FIG. 1).

[0170] In some embodiments, the second portion 414 hosts one or more sensors. In some embodiments, one or more sensors sense the conduit (e.g., conduit 308; FIGS. 3A-3B) through windows 482, 484, 486, 490 in the housing 422. In some embodiments, multiple sensors sense the conduit through a single window. In some embodiments, the sensors sense the conduit through multiple windows. In one embodiment, each sensor senses the conduit through a dedicated window. In some embodiments, the window is adjacent to the conduit, e.g., in close and / or direct contact with the window, e.g., with a separation between the window and the conduit (and / or between the conduit and the sensor) of up to 0.1-2 mm, 0.1-1 mm, or 0.1-0.5 mm, or smaller, larger, or intermediate ranges or distances.

[0171] Potential advantages of the window are, for example, sealing the second part against the hole from ingress of dirt and / or dust and / or fluids, and / or facilitating cleaning of the second part (e.g., for reuse).

[0172] In some embodiments, the window is transparent to radiation detected by the sensor. For example, in the case of detection of IR (infrared) radiation by an IR sensor, in some embodiments, the window covering is transparent to IR (e.g., minimally attenuates (e.g., less than 20%)). For example, materials include one or more of silicon, as well as germanium, poly(methyl methacrylate), polycarbonate, zinc selenide (ZnSe), zinc sulfide (ZnS), calcium fluoride (CaF2), and magnesium fluoride (MgF2). In one example embodiment, the window includes and / or is formed from germanium.

[0173] In some embodiments, housing 422 includes a base 423 and a body 425. In some embodiments, body 425 is sized and / or shaped to fit into the space defined by conduit 308 (FIGS. 3A-3B). In some embodiments, base 423 forms a stepped portion 427 that extends away from body 425. In some embodiments, body 425 and stepped portion 427 are sized and / or shaped to hold a first portion (e.g., first portion 312; FIGS. 3A-3B) in place of second portion 414.

[0174] In some embodiments, the stepped portion 427 hosts an electrical connection between the first and second portions 414, 312. For example, in some embodiments, the stepped portion hosts an electrical connection housing 401 that is part of the base 423, which extends from the stepped portion towards the body 425.

[0175] In some embodiments, Figure 4B shows the electrical connection housing 401 and its contents. In Figure 4B, the housing 401 is shown as transparent. In some embodiments, the electrical contacts of the second portion 414 are contained by the electrical connection housing 401 and the contact openings 403, 405 that provide access to the contacts.

[0176] In some embodiments, the electrical connection housing 401 is a separate unit that is removable and / or replaceable. A potential benefit is that the life of the second portion 414 may be extended if other portions of the second portion 414 remain functional even if the connection is worn (e.g., the connection is open and potentially exposed to dirt and / or fluids).

[0177] In some embodiments, optionally, the second portion 414 includes a switch 491 (e.g., a microswitch) that is engaged when the first portion 312 (FIGS. 3A and / or 4B and / or 5) is attached to the second portion 414. As an example, when the switch 491 is engaged, the power supply to the first portion 312 is connected. A potential advantage is that the device operates only when the switch 491 verifies that the portions 414, 312 are correctly aligned, for example, for accurate sensing by a sensor in the second portion 414. In some embodiments, the switch 491 is hosted by the electrical connection housing 401.

[0178] In some embodiments, the housing 401 houses the sensor 490 and / or a window 491 to the sensor 490. In some embodiments, the sensor 490 is an IR sensor, for example, an analog IR sensor.

[0179] 4A , in some embodiments, the second portion 414 includes a connector 466 for connection of the first portion 312 and the second portion 414. In some embodiments, the connector 466 is a latch 466 connector. When the latch 466 connects the first and second portions 312, 414, the latch 466 extends from the connecting portion 468 into the second portion 414 and overlaps the housing 376 of the first portion 312.

[0180] Optionally, in some embodiments, the end of the latch 466 opposite the end that overlaps the housing of the first portion fits into a notch 480 in the housing 425 of the second portion 414. In some embodiments, a double-sided latch connection between the portions may improve attachment strength and / or reduce movement between the portions. Reducing movement between the portions has the potential advantage of improving the measurement accuracy of measurements taken by the sensor if movement between the sensor and the conduit is reduced.

[0181] In some embodiments, the latch 466 is a pivot latch that rotates about a connector 469 that allows rotation of the latch to connect and disconnect the first and second portions. In some embodiments, the notch 480 is located under a protrusion 483 in the housing of the second portion 414.

[0182] In some embodiments, the latch 466 can be disengaged from the notch 480 and / or pivoted out of overlap with the first portion 312 to allow the portions 312, 414 to be connected and / or disconnected.

[0183] In some embodiments, second portion 414 includes a handle 462. In some embodiments, handle 462 has a size and / or shape (e.g., the lumen of handle 463) to connect the device to a pole, e.g., an IV pole. In some embodiments, handle 462 includes a flexible and / or resilient material, and in some embodiments, the handle is opened by deforming the handle to increase the size of an opening 467 for insertion of a pole, and then returning the handle to its previous position to close opening 467.

[0184] A potential advantage of being able to connect the second portion to, for example, a pole is that the injection device can be positioned relative to the fluid reservoir and / or subject, for example to control the pressure on the fluid within the device.

[0185] In some embodiments, the inside 465 of the handle is textured, the texture reducing the likelihood of the device slipping on the pole to which it is attached. The texture may, for example, increase friction between the pole and the handle. In some embodiments, the texture includes projections, e.g., ridges, where the texture projections are 0.1-3 mm high from the surface of the body of the handle 462.

[0186] In some embodiments, second portion 412 includes a cabled electrical connection and / or data connection to one or more external devices. In some embodiments, the connection (not shown) exits second portion housing 423 through strain relief 474. In some embodiments, strain relief 474 reduces strain on a flexible attachment to housing 423, which in some embodiments is rigid.

[0187] In some embodiments, housing 422 (e.g., including body 425 and base 423) includes and / or is formed from plastic (e.g., molded plastic). In some embodiments, connections of the portions of the housing are by metal fittings, e.g., screws and / or nuts. In one embodiment, housing 422 includes and / or is formed from reinforced nylon, e.g., fiberglass reinforced nylon.

[0188] FIG. 5 is a schematic diagram of a simplified injection device 502, according to some embodiments of the present invention.

[0189] FIG. 5 shows, in some embodiments, a device 502 that includes a first portion 312 and a second portion 414 that are coupled together.

[0190] In some embodiments, first portion 312 includes one or more features described and / or shown in association with first portion 312 of Figures 3A-3B and / or first portion 112 of Figure 1. In some embodiments, second portion 414 includes one or more features as described and / or shown in Figure 4A and / or as described and / or shown in association with first portion 114 and / or shown in Figure 1.

[0191] In some embodiments, first portion 312 fits into second portion 414. In some embodiments, first portion 312 includes a lumen sized and / or shaped to receive body 425 of the housing of second portion 414.

[0192] For example, as described with respect to FIG. 4A, in some embodiments, the base 423 of the housing of the second portion prevents movement of the first portion 312 in a direction from the body 425 to the base 423.

[0193] In some embodiments, the connector 466 spans the opening of the first portion to the lumen 331 and prevents the first portion 312 from separating from the second portion 414 .

[0194] In some embodiments, when the first portion 312 is positioned relative to the second portion 414 (e.g., as shown in FIG. 5 ), the sensor of the second portion 414 and / or a window (a window to the sensor) of the second portion are aligned with the conduit 308 of the first portion 312. For example, including one or more features shown and / or described with respect to FIG.

[0195] Returning to FIG. 3A , in some embodiments, first portion 312 and / or second portion 414 have one or more of length 396, depth 387, and height 398 that are between 3 and 20 cm, or between 3 and 15 cm, or between 3 and 10 cm, or smaller or larger, or intermediate values ​​or ranges.

[0196] Exemplary Methods of Assembly FIG. 6 illustrates a method of assembling a portion of an injection device, according to some embodiments of the present invention.

[0197] In some embodiments, at 600, a conduit is provided.

[0198] In some embodiments, at 601, at least a portion of the conduit is optionally coated, for example, with an IR absorbing material (eg, an IR absorbing material as described elsewhere herein).

[0199] In some embodiments, at 602, power connectors are slid onto both ends of the conduit.

[0200] In some embodiments, at 603, connecting tubing is attached to the conduit, e.g., tubing for connecting a fluid reservoir to a conduit inlet. For example, tubing for connecting to an infusion device is connected to the conduit outlet. In some embodiments, the connected tubing is PVC tubing, and in some embodiments, elastic deformation of the tubing seals the connection between the tubing and the conduit.

[0201] In some embodiments, at 604, a portion of the conduit housing is connected onto the housing.

[0202] In some embodiments, at 606, a safety check is performed, including, for example, a visual inspection, including, for example, a fluid conduit check, where fluid is passed through the conduit to ensure proper fluid flow, e.g., no blockages and / or no leaks.

[0203] In some embodiments, one or more parts are sterilized at 608. Alternatively, in some embodiments, at least the conduit is provided in a sterile condition and the sterility is maintained during assembly.

[0204] FIG. 7 illustrates a method of assembling a portion of an injection device, according to some embodiments of the present invention.

[0205] In some embodiments, a housing top is provided at 700. Referring again to FIG. 4A, in some embodiments, the top has a housing body and a base. In some embodiments, the top includes one or more supports within the top.

[0206] In some embodiments, at 702, a handle is optionally attached to the top of the housing, for example, by a connector extending from within the housing to a handle located outside the housing, where example connectors include, for example, screws, screws and bolts, snap fits connecting from either side of the housing, etc.

[0207] In some embodiments, the electrical circuitry is attached at 704. For example, the electrical circuitry is attached by being placed within the housing. In some embodiments, one or more circuit boards are positioned within and / or attached to the housing. In some embodiments, a support helps position and / or prevent movement of the circuitry and / or circuit boards. In some embodiments, elements are attached to the support, for example, by adhesive and / or connecting elements. In some embodiments, instead of or in addition to attaching the circuitry and / or circuit boards to the top of the housing, the circuitry and / or circuit boards are attached to the base of the second part housing (base 431; see FIG. 4A).

[0208] In some embodiments, at 706, a base is attached to the housing containing the second portion, e.g., on top of the housing, to close the housing. In some embodiments, a power source is optionally inserted into the space defined within the housing prior to closing the housing (e.g., by the base). The power source is electrically connected to the circuitry within the housing before and / or after insertion into the housing.

[0209] Exemplary Methods of Treatment FIG. 8 illustrates a method of treatment using an injection device, according to some embodiments of the present invention.

[0210] In some embodiments, the subject is evaluated, for example by a medical professional, at 800. The evaluation, in some embodiments, is to determine whether the subject requires a fluid infusion and / or what conditions are required for the subject to be infused with a fluid.

[0211] The conditions include one or more of the following: type of fluid, fluid flow rate, fluid temperature, location of injection on the patient, injection equipment (eg, size of injection tubing).

[0212] In some embodiments, at 802, for example, where the fluid conduit is provided by a "first portion," the fluid conduit is coupled to the base unit, for example, as described elsewhere herein (e.g., first portion 112 of FIG. 1, e.g., first portion 312 of FIGS. 3A-3B and / or FIG. 5). In some embodiments, the base unit has one or more features of a "second portion" described elsewhere herein (e.g., second portion 114 of FIG. 1, e.g., second portion 414 of FIG. 4A and / or FIG. 5).

[0213] In some embodiments, the fluid conduit is coupled to the base unit, for example, by being mounted on and / or around and / or on a portion of the base unit, hi some embodiments, the fluid conduit is connected to the base unit, for example, by one or more connectors.

[0214] In some embodiments, the fluid reservoir is fluidly connected to a fluid conduit at 804, for example by attaching tubing from an IV bag to an inlet of the fluid conduit, and in some embodiments, the tubing is flexible and / or resilient such that proper sizing of the conduit inlet and / or tubing allows for a sealed fluid connection.

[0215] In some embodiments, the fluid conduit and the subject are fluidly connected at 806, for example, by attaching an inlet of the infusion device to the conduit and an outlet of the infusion device to the subject. Note that in some embodiments, the infusion device is flexible and / or resilient, and proper sizing of the conduit outlet and / or tubing of the infusion device allows for a sealed fluid connection.

[0216] In some embodiments, one or more of steps 804, 806, 808 are performed in a different order.

[0217] Optionally, in some embodiments, at 808, one or more parameters of the fluid conditions are received, for example, by the base unit, according to the evaluation made in step 800. The parameters are entered into the base unit, for example, by a user via a user interface (e.g., 154 in FIG. 1), or are received, for example, from a remote processor 152 to the unit processor 150. Alternatively, in some embodiments, the fluid conditions are automatic and / or set.

[0218] In some embodiments, a controller (e.g., hosted in the base unit) controls the fluid flowing through the conduit according to fluid conditions / fluid condition parameters at 810. For example, the fluid conduit is heated while the fluid flows through the conduit according to a required temperature of the injected fluid.

[0219] In some embodiments, measurements are collected at 812 during control of the fluid by the base unit, and in some embodiments the measurements are used to verify that fluid conditions are being met.

[0220] In some embodiments, at 814, the subject receives infusion fluid, if necessary, after measuring / verifying that required fluid parameters are met.

[0221] In some embodiments, at 816, the fluid is monitored and measurements (e.g., collected by the base unit) are used, for example, as feedback to the base unit and / or a user interface. For example, in some embodiments, temperature measurement feedback is used as an input to a heating circuit in the base unit. For example, the measurements are used as feedback to a user interface to indicate that a user needs to take action, for example, to supply another fluid reservoir.

[0222] In some embodiments, at 818, the subject is optionally re-evaluated (eg, periodically).

[0223] At 820, in some embodiments, re-evaluation is used in one or more of steps 808-814. For example, in some embodiments, re-evaluation is used to update (e.g., change) fluid condition parameters in the reference units, for example, as described with respect to step 808.

[0224] Exemplary Electrical Connections FIG. 9A is a simplified schematic diagram of a connector 333, according to some embodiments of the present invention.

[0225] FIG. 9B is a simplified schematic diagram of contact portion 436 according to some embodiments of the present invention.

[0226] FIG. 9C is a simplified schematic diagram of connector 333 and contact portion 436 according to some embodiments of the present invention.

[0227] FIG. 9D is a simplified schematic diagram of a connector 329 according to some embodiments of the present invention.

[0228] In some embodiments, Figures 9A and 9C show connector 333 of Figure 3B, a portion of first portion 312 that electrically connects conduit 308 to second portion 414 (Figure 4A), e.g., a portion of first portion 312 that electrically connects to contact portion 436 of the second portion (in some embodiments, contact portion 436 is contained by electrical connection housing 401 of Figure 4A). In some embodiments, Figure 9D shows connector 329 of Figure 3B, a portion of first portion 312 that electrically connects conduit 308 to second portion 414 (Figure 4A), e.g., connects to contact portion of second portion 414. In some embodiments, contact portion includes components as shown in Figure 9B, e.g., mounted to a circuit board.

[0229] In some embodiments, the connector 333 includes a first contact portion 924 and a second contact portion 932 connected by a body 928, 935. In some embodiments, the first contact portion 924 makes electrical contact with the conduit (e.g., a conduit) by extending to surround a portion of the conduit.

[0230] In some embodiments, one or both of the contact portions 924, 926 are configured to be slideably fitted into a conduit (e.g., the conduit 308, FIG. 3B and / or FIG. 10), e.g., having a lumen sized and / or shaped to receive the conduit 308.

[0231] In some embodiments, the first contact portion 932 and / or the second contact portion 937 of the connector 333 (and / or the contact portion 934 of the connector 329) are standard high power contact portions, which in some embodiments are capable of connecting and disconnecting a large number of times, e.g., at least 5-1000 times, or at least 20-100 times, or fewer times, or more times, or an intermediate number of times, or a range therebetween. The contact portions 924, 926, 436 are defined as high power capable of passing at least 100W-2kW, or 100W-1kW, 600W-800W, or less or more power.

[0232] In some embodiments, the connector body includes at least one surface portion extending from the first contact portion 924 to the second contact portion 932. In some embodiments, the connector body includes two surfaces 928, 935, with each surface 928, 935 extending from a different side of the first contact portion 924. Optionally, in some embodiments, the second contact portion 932 includes two contact surfaces 932, 937. In some embodiments, each surface 932, 937 extends from a respective side of the connector body 928, 935.

[0233] 9C, the contact surface portions 932, 937 include one or more portions that deflect (e.g., resiliently) when positioned over the second portion contact portions 436. In some embodiments, the reaction force of the contact surface portions 932, 937 against the contact portions 436 may improve the quality of the electrical connection between the contact portions and may reduce the likelihood of dislodgment and / or disconnection between the first portion contact portions 932, 937 and the second portion contact portions 436.

[0234] In some embodiments, the shape of the contact portions (e.g., both contact portions 932, 937) includes one or more narrowing portions 939, 939a that include portions of the contact portions that approach (e.g., turn toward) the center of the space defined by the connector body portions 928, 935 and / or the contact surface portions 932, 932.

[0235] In some embodiments, the constriction 939, 939a is smaller in one or more dimensions than the second portion contact portions 436. In some embodiments, connecting the connectors 333, 436 may cause at least a portion of the contact portions 932, 937 to flex (e.g., resiliently) at the constriction 939.

[0236] In some embodiments, the conduit contact portion 924, 926 itself provides both an electrical connection and a mechanical connection to the conduit. In some embodiments, the contact portion 924 surrounds the conduit by at least 10-95%, or 30-70%, or 40-60%, or a lower, higher, or intermediate range or percentage of the circumference of the cross section of the conduit. In some embodiments, the contact portion 924 extends along a portion of the cross section of the conduit, for example, as shown in Figures 3B, 9A, 9C. In some embodiments, the contact portion encircles the conduit at least once. In some embodiments, the contact portion encircles the conduit multiple times, for example, by wrapping the conduit multiple times. In some embodiments, the conduit contact portion 924, 926 has a width 941 of 1-20 mm, or 5-15 mm, or 7-15 mm, or about 8 mm, or about 9 mm, or at least 5 mm, or a narrower, wider, or intermediate width or length. In some embodiments, the conduit contact portions 924, 926 have a large surface area in contact with the conduit when coupled to the conduit, for example, the surface area in contact is the percentage of the conduit circumference in contact as described above times the exemplary width as described above times 2PiR, where R is the radius of the conduit, which is half the exemplary diameter shown in the legends of Figures 3A and / or 3B herein.

[0237] Potential advantages of a contact portion that surrounds and / or encircles the conduit and / or is wider are the mechanical strength and / or quality of the electrical connection between the contact portion 924 and the conduit 308 (e.g., the quality of the electrical connection related to the contact area between the contact portion and the conduit).

[0238] In some embodiments, the conductive material of the body 935 is insulated from the unattached portion of the conduit, for example, by an insulating separator 994 disposed between the body 935 and the conduit. As an example, the separator 994 is attached to the connector 333 by fitting to at least a portion of the body 928, 935.

[0239] 9D and 3B, referring to the conduit connector 329, in some embodiments, the connector 329 includes a first contact portion 926 and a second contact portion 934. In some embodiments, the first contact portion 926 includes one or more features described and / or illustrated with respect to the first contact portion 924 of the connector 333. In some embodiments, the second contact portion 934 includes one or more features described and / or illustrated with respect to the second contact portions 932, 937. In some embodiments, the connector 329 does not have a body and / or a separator.

[0240] A second portion contact portion 436 is then described which in some embodiments also represents a contact portion for connection with connector 329. In some embodiments, contact portion 436 includes a body 943 to which the first portion connector connects. In one example embodiment, contact portion 436 is attached to a circuit board via, for example, pins 945 for connection to a power source via the circuit board.

[0241] Example Detection FIG. 10 is a cross-sectional view of a simplified injection device 502, according to some embodiments of the present invention.

[0242] In some embodiments, Figure 10 shows a cross-sectional view of the first portion 312 connected to the second portion 414 of the device shown in Figure 5. The side 378 (Figures 3A, 5) of the housing of the first portion is not shown (and / or is not present).

[0243] In FIG. 10, the windows 482, 484, 486 in the second portion housing 425 are visible. In some embodiments, the windows 482, 484, 486 comprise a material that is more transparent to signals measured by the sensors 1016, 1017, 1018 than other materials of the housing 425. For example, in some embodiments, the sensors include infrared (IR) sensors 1016, 1017, 1018 for measuring the temperature of the conduit 308 (e.g., in some embodiments, the fluid within the conduit). In some embodiments, the sensors 1016, 1017, 1018 are aligned with their respective windows. In some embodiments (e.g., as described with respect to FIG. 3A), the first portion housing holds the conduit 308 with the coil aligned with the windows 482, 484, 486 and / or the sensors 1016, 1017, 1018. In some embodiments, the device 502 includes additional sensors, for example, for measuring other areas of the coil. In some embodiments, sensors 1016, 1017, 1018 sense various turns but regions of the coil in the conduit 308. In some embodiments, one or more additional sensors are used to measure other regions of the coil (e.g., a sensor aligned with window 488 in FIG. 4A).

[0244] In some embodiments, the sensors 1016, 1017, 1018 are positioned at a maximum distance of 0.5-5 mm from the windows 482, 484, 486, respectively. In some embodiments, one or more sensors are in direct contact (e.g., glued) with each window. In some embodiments, the sensors 1016, 1017, 1018 are positioned by being attached to an element 1047, which in some embodiments is positioned by the housing 422 of the second part. In some embodiments, the element 1047 is a circuit board that provides connections to other electrical circuitry of the sensors 1016, 1017, 1018, such as a processor and / or a power source. In some embodiments, the additional electrical circuitry of the second part is implemented on one or more additional circuit boards 1049 housed by the housing 422 of the second part.

[0245] Exemplary Safety Features In some embodiments, the infusion system (eg, system 100) includes one or more safety features.

[0246] 1, in some embodiments, the processor identifies one or more safety risks (e.g., a temperature outside a safe range) based on measurements received from the sensors 116, 118. In some embodiments, identifying one or more safety risks generates an alert in a user interface and / or disconnects power to the conduit.

[0247] In some embodiments, the system 100 comprises one or more safety features independent of the processor 110. Control of the circuitry in the event of a failure and / or malfunction of the processor 110 is envisioned.

[0248] In one embodiment, the infusion device 102 includes a disconnect circuit that, in some embodiments, disconnects the power source 110 from the conduit. In some embodiments, the disconnect circuit is hosted by the second portion 414. In one embodiment, the disconnect circuit is independent of a processor (e.g., processors 150, 152). For example, in some embodiments, the disconnect circuit is configured to operate independently of the control circuitry and / or electrical circuitry of other portions of the second portion.

[0249] Referring again to FIG. 4A, in some embodiments, the second portion 414 includes a disconnect circuit including an analog IR sensor 490. Here, if the sensor 490 detects heat (e.g., heat in the conduit and / or other circuitry) above a threshold, the sensor 490 cuts off power to the second portion 414 and / or power from the second portion 414 to the first portion 312. In some embodiments, the sensor 490 and the sensor 1018 sense the conduit 308 (optionally the same portion of the conduit 308), for example, via respective corresponding windows 491 in the housing 422 of the second portion 414. In some embodiments, the windows 422, 491 are adjacent to and / or allow sensing of the conduit from various directions (e.g., around the conduit). A potential advantage is that measurements from one sensor 490, 1018 can be calibrated and / or verified using measurements from the other sensor 490, 1018. In some embodiments, sensor measurements taken from different regions of the conduit are used to self-calibrate the sensor, for example, where assumptions are made regarding the temperature at different points in the conduit (e.g., that the temperature is constant).

[0250] In some embodiments, calibration of sensor measurements and / or verification that the sensors are operational is performed (e.g., by a processor (e.g., processors 150 and / or 152 of FIG. 1 )) by comparing measurements provided by different sensors.

[0251] Exemplary Connectors FIG. 11A is a simplified schematic diagram of a portion of the second portion 414 of the injection device, according to some embodiments of the present invention.

[0252] FIG. 11B is a simplified schematic diagram of a portion of the second portion 414 of the injection device, according to some embodiments of the present invention.

[0253] FIG. 11C is a simplified schematic diagram of a portion of the second portion 414 of the injection device, according to some embodiments of the present invention.

[0254] FIG. 11D is a simplified schematic diagram of a cover element 1109, according to some embodiments of the present invention.

[0255] In some embodiments, the infusion device system includes a cover 1111 for one or more parts of the device. In some embodiments, it covers the contact openings of the second part 414 (e.g., contact openings 403, 405 in FIG. 4A). A potential advantage is, for example, that the contacts are protected from ingress of dirt and / or moisture. In some embodiments, the cover 1111 surrounds the contact opening housing 401 (FIG. 4A) on one or more sides, which in some embodiments extends toward the housing step 427 (FIG. 4A).

[0256] In some embodiments, the cover 1109 is part of the base connector 1109, with the cover 1111 disposed on a first side of the base connector 1109. In some embodiments, the cover element 1109 includes a base 1115 that connects the cover 1111 to the housing connector 1113. In some embodiments, the base connector 1115 is used as a handle to connect the second portion 414, for example, to a pole or hook.

[0257] In some embodiments, the base connector 1109 comprises a flexible and / or elastic material. In one example embodiment, the cover element 1109 comprises silicone rubber. For example, in some embodiments, the cover 1111 is attached to the contact housing by elastic deformation of the cover material. In some embodiments, the elasticity and / or flexibility of the base 1115 allows the base to deform around other elements (e.g., a pole between the base and the housing underside 431) to hold, for example, an infusion device to the element.

[0258] In some embodiments, the housing connector 1113 extends upward from the underside 431, and in some embodiments, into a recess 1151 of the housing 422 of the second portion 414. In some embodiments, the connector 1113 is attached to the housing 422 by inserting one or more connectors (e.g., screws) into a channel 1153 of the housing 422, e.g., passing through the channel 1153 and extending into an aligned channel 1155 of the housing 422, e.g., the channel 1155 of the recess 1151.

[0259] In some embodiments, the housing connector 1113 is attached to the housing to reduce the likelihood of the cover 1111 falling off and / or the cover element 1109 becoming lost.

[0260] Additional Exemplary Embodiments FIG. 12A is a schematic diagram of a simplified injection device 1202, according to some embodiments of the present invention.

[0261] FIG. 12B is a schematic diagram of a simplified injection device 1202, according to some embodiments of the present invention.

[0262] FIG. 12C is a simplified schematic diagram of a second portion 1214 of the injection device, according to some embodiments of the present invention.

[0263] In some embodiments, FIGS. 12A-12C show the same injection device 1202.

[0264] In some embodiments, first portion 1212 and / or second portion 1214 include one or more features described and / or illustrated with respect to first portion 112 and / or second portion 114 of FIG. 1, respectively.

[0265] In some embodiments, the first portion 1212 and the second portion 1214 are coupled by inserting the first portion 1212 into the lumen 1251 of the housing 1222 of the second portion.

[0266] In some embodiments, e.g., in contrast to the examples shown in Figures 3A-3B, 4A-4B, and / or 5, sensors are located outside the conduit coil, e.g., on one side of the conduit coil, in addition to sensing hosted by the portion located within the lumen defined by the conduit coil. For example, Figure 12C shows windows 1282, 1284 for sensors housed within the housing 1222 of the second portion. In some embodiments, the windows 1282, 1284 include one or more features of the windows 482, 484, 486, 491 of Figures 4A-4B and / or 10.

[0267] In some embodiments, the housing 1222 houses a switch (e.g., a switch having the features of switch 491 of FIGS. 4A-4B) and / or a contact portion (e.g., a contact portion having the features of contact portions 436, 436a of FIGS. 4A-4B and / or FIGS. 9B-9C) and / or a sensor (e.g., a sensor having the features of sensor 490 of FIG. 4B). Note that configurations in which the "smart portion" (base) or at least the sensor of the "smart portion" is outside the "conduit portion" can also be provided in other designs. In some embodiments, the sensor is provided in a portion of the base that remains outside the coil portion (e.g., wider) even though other portions of the base (e.g., the battery) are located within the volume defined by the conduit.

[0268] In some embodiments, the lumen 1251 is closed by a cover portion 1253 of the housing 1222. In one example, the cover portion 1253 is attached to the housing 1222 by a hinge 1255.

[0269] 12B-12C show device 1202 without cover portion 1253. In some embodiments, however, the cover portion is opened, for example, for insertion of first portion 1212, for example, by rotating about hinge 1255.

[0270] In some embodiments, the second portion 1214 includes a connector 1266 that, for example, holds the cover portion 1253 in place, thereby holding the first portion 1212 in place within the lumen. A potential advantage is to align the conduit in the first portion 1212 with the sensor in the second portion.

[0271] In some embodiments, the device 1202 includes a clip 1263, for example, for attaching the device 1202 to a pole, for example, an IV pole. In some embodiments, the clip 1263 is attached to the housing 1222 of the second portion 1214.

[0272] In some embodiments, device 1202 includes a connection to external power and / or data, for example, via cable 1275. In some embodiments, cable 1275 extends through strain relief 1274 (which in some embodiments includes one or more features of strain relief 474 of FIG. 4A).

[0273] In some embodiments, the first portion 1212 includes a handle 1271 within a housing 1276 of the first portion 1212. In some embodiments, a user grasps the handle 1271 and inserts the first portion into the lumen 1251, e.g., to engage the first portion 1212 with the second portion 1214, e.g., with a contact and / or a microswitch.

[0274] As mentioned above, the connection circuitry of the first part is optional. Figure 13 shows a coil heater 1302 that is attached directly to a connector or two connectors (1312, 1314) of the second part of the infusion heating apparatus according to some embodiments of the present invention. In one example, the coil heater 1302 comprises a stainless steel tube / conduit that provides resistive heating. Power is optionally provided by attachment to one or more connectors 1312, 1314 having the shape of a clip, as shown.

[0275] In some embodiments of the invention, the ends 1306, 1304 of the coil heater 1302 include connectors for attaching infusion tubing. Optionally, the coil heater 1302 is provided with a short section of infusion tubing already attached (e.g., using adhesive or a press fit), which itself terminates in a standard infusion tubing connector (not shown, optionally a plastic polymer connector). Such connectors may also be used in other embodiments described herein.

[0276] The hollow portion 1308 is optionally sized and shaped to fit and / or be inserted into a smart second section, for example, as described above.

[0277] A potential advantage of using such a connector is that the coil heater 1302 is enclosed in a housing, preventing / reducing electrical and / or thermal contact, and only a short infusion tubing section can exit the housing. However, the housing is optional in some embodiments. Electrical and / or thermal insulation may be provided directly on the coil heater 1302, for example, by spray application. Such insulation may be useful to prevent short circuits between different coils of the heater. Also, an external electrically insulating housing (e.g., made of plastic) is used if desired.

[0278] In some embodiments of the invention, the coil heater 1302 is attached to a second portion (e.g., including power, control, and / or sensors) using a single connector or a pair of connectors. Figure 13 shows an example using a pair of connectors 1312, 1314. The coil heater 1302 optionally includes designated electrical connection points where there is no electrical insulation on the coil heater 1302. The connectors 1312, 1314 are any connectors that mechanically stabilize the coil heater 1302 while resiliently gripping with sufficient force to ensure a good electrical connection via contact.

[0279] In some embodiments of the invention, the connectors 1312, 1314 are snap clip connectors. Detailing the connector 1312 (connector 1314 can be the same), the base 1320 is optionally attached to the second part and may include one or more threaded holes for connecting to electrical wires. Reference numeral 1310 denotes side walls, two of which are optionally provided and resiliently pre-positioned to bend toward each other. In other embodiments, the two walls intersect and then pass each other, so that what was the outer wall becomes the inner wall that engages the conduit. The wall 1310 optionally includes three sections. A wide section 1318 near the base 1320 is included, where the width refers to the distance from the opposing wall. The width may provide stability when attached to the second part. It includes a narrow section 1322 and a wide section 1316 above it, so that a tube inserted from above will push the two walls apart to enter the wide section 1316 and stop at the narrow section 1322. Optionally, the top flared portion 1328 is wide enough at rest to allow the coil heater 1302, and particularly section 1324 of the coil heater 1302, to be positioned laterally and then pushed down (towards the base 1320). This allows section 1324 of the coil heater 1302 to reach (and then be elastically gripped by) the wider section 1316 of the connector 1312, forcing the sidewall 1310 aside. The length of section 1316 (along the tube axis) can be, for example, 0.5-3 cm, e.g., 8-15 mm. Section 1316 is optionally rounded with a radius of curvature similar to that of the coil heater 1302, such that it contacts the coil heater 1302 over at least 30%, 40%, 50%, 60% or more of its circumference.

[0280] Connector 1312 is preferably made of a resilient metal, such as steel, and is smooth, or may include one or more protrusions or scratches to improve grip of section 1324. Additionally, connector 1312 has an outer surface coated with an electrically insulating layer.

[0281] In some embodiments of the invention, alignment between the coil heater 1302 and the second section is provided through the hollow portion 1308. Also, optionally or additionally, alignment is provided by the (axial) length of the connectors 1312, 1314. Note that a single connector may be used if it includes separate electrical paths for each end of the coil. Such a connector may be formed from two separate connections attached with a non-conductive layer such as adhesive, or may be non-conductive with the conductive paths provided as a layer, with each end of the conduit contacting a different electrical polarity.

[0282] In some embodiments of the invention, sections 1324, 1326 are provided with one or more bumps to align them with connectors 1312, 1314. For example, a plastic protrusion may be molded into either end of section 1324 to guide and / or better mate connector 1312 with a non-protruding portion of section 1324.

[0283] A potential advantage of the design of Figure 13 is that the coil heater 1302 is easy to manufacture and / or sterilize. The coil heater 1302 can also be inexpensively manufactured to be disposable. In use, the coil heater 1302 can be "dropped in" directly into the connectors 1312, 1314 in the disposable part without the need for additional mechanical parts to stabilize the connector part, providing a robust mechanical connection.

[0284] In some embodiments of the invention, a contact temperature sensor is integrated into the clip, for example, in a layer between the wall 1310 and the conduit. The elasticity of the clip can be used to ensure consistent and repeatable thermal contact so that measurements are accurate after removal and insertion of the tube.

[0285] Contrast media examples As mentioned above, the devices described herein can be used to heat various types of fluids delivered to the body, a particular example being contrast media.

[0286] In some embodiments of the invention, the second part is provided as part of an imaging system (e.g., CT machine, X-ray machine) or as part of a contrast pump system (e.g., syringe pump). For each patient, the pump is filled with contrast and the disposable first part is optionally attached to the integrated second part. Alternatively, a separate heater may be provided.

[0287] It should be noted that flow in contrast injection systems is often not continuous. Optionally, the heater controller is notified when flow has stopped and / or is expected to start, so that the energy provided for heating can be modified and / or the timing adjusted. Because flow rates are typically low and / or the volume of contrast may be relatively small, the entire amount of contrast may be contained within the coil heater, and thus filling includes attaching a source of saline to advance the contrast into the heater and flush the contrast out of the heater. In some embodiments of the invention, the flow rate is dependent on the heating rate. Optionally, the system is configured to allow heating at a desired delivery rate, for example, 4-8 mL / sec. In other examples, the contrast is heated and the pump is activated to deliver into the body once a set temperature is reached. This may be useful for delivery of a bolus that fits within the volume of the coil lumen.

[0288] In some embodiments of the invention, the heater is attached to one fluid source for the contrast agent and one fluid source for the purging material (e.g., saline), optionally with this connection upstream in the system.

[0289] Note that the contrast agent may have a lower specific heat than water, allowing lower energies and / or heating rates to be used. Optionally, the second portion includes inputs to indicate the heated material, maximum flow rate and / or other heating parameters.

[0290] In one example, the contrast agent is Iomeron (Iomeprol solution), available in iodine concentrations of 150, 250, 300, 350, and 400 mg / ml.

[0291] The specific heat capacity of iomeprol at 37°C (c p ) value is 1.15 J / g°K. p The variation of with temperature and concentration is minimal. On the other hand, the specific heat of water at 37°C, c p The value is 4.178 J / g°K. If 1 g of Iomeron 400 solution contains 0.565 g of iomeprol and 0.435 g of water, the specific heat (c p ) = 2.47 J / g°K (e.g., about 75% of water).

[0292] In some embodiments of the invention, specific heat is ignored in the specification (although it may be used in designing for power and heating capacity) and instead temperature sensing and responsive power control is used over a wide range of heat capacities. Actual heating behavior can be extrapolated based on measurements and future temperatures can be predicted (e.g. heat capacity can be extracted from the behavior).

[0293] Specific properties of the heating contrast agent that can be provided by the systems described herein include the following: Rapid warming: For example, a patient receives 80 mL of contrast medium (maximum 140 mL). Typical filling rates are 2-4 mL / s, so filling is usually completed within 1 minute. Upper limit of temperature that would cause discomfort or damage: For example, the sensor system described herein can be used to ensure that heating is below 41°C. · No dead space: Optionally, the system has no dead space other than the length of tubing that can be flushed as needed. Working at high pressures (e.g. 400mmHg but could be 1000mmHg) provided by metal tubing.

[0294] general It is expected that many related injection technologies will be developed during the life of the patent which will be produced from this application, and the scope of the terms "injection" and "injection device" is intended to include, a priori, all such new technologies.

[0295] As used herein, "about" refers to ±20%.

[0296] The terms "comprises," "comprising," "includes," "including," "having" and conjugations thereof mean "including but not limited to."

[0297] The term "consisting of" means "including and limited to."

[0298] The term "consisting essentially of" means that a composition, method, or structure may include additional ingredients, steps, and / or moieties, provided that the additional ingredients, steps, and / or moieties do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0299] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, "a compound" or "at least one compound" includes a plurality of compounds, and may also include mixtures thereof.

[0300] Throughout this application, various embodiments of the invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity, and is not an inflexible limitation of the scope of the invention. Thus, the description of a range should be considered to specifically disclose all of the possible subranges, as well as each individual numerical value within that range. For example, the description of a range such as 1 to 6 is intended to specifically disclose not only the subranges 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., but also each individual numerical value within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the magnitude of the range.

[0301] Whenever a numerical range is given herein, it is intended to include any recited number (fractional or integer) within the range given. The phrases "range between" a first designated number and a second designated number and "range from" a first designated number to a second designated number are used interchangeably herein and are intended to include the first designated number and the second designated number, and all fractional and integer numbers therebetween.

[0302] As used herein, the term "method" means manner, means, techniques, and procedures for accomplishing a given task, including, but not limited to, those known to practitioners in the chemical, pharmacological, biological, biochemical, and medical fields or that can be readily developed by practitioners from known manners, means, techniques, and procedures.

[0303] The term "treating" as used herein includes arresting, substantially inhibiting, slowing, or reversing the progression of a condition, substantially ameliorating the clinical or cosmetic symptoms of a condition, or substantially preventing the worsening of the clinical or cosmetic symptoms of a condition.

[0304] It will be understood that certain features of the invention that are, for clarity, described in the context of separate embodiments, may also be provided in a single embodiment in any combination of those features. Conversely, several features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or with respect to other described embodiments as appropriate. Certain features described in the context of various embodiments should not be construed as essential to that embodiment, unless the particular embodiment is inoperable without that element.

[0305] While the present invention has been described in conjunction with specific embodiments thereof, many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0306] It is the intention of the applicant that all publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication, patent, and patent application was specifically and individually incorporated herein by reference.In addition, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention.Also, to the extent that section headings are used, they should not necessarily be construed as limiting.In addition, the priority documents of this application, if any, are incorporated herein by reference in their entirety.

Claims

1. a first portion comprising a fluid conduit including a conductive material having a non-zero resistance; a second portion selectively connectable and disconnectable in situ to the first portion, at least one sensor for sensing a property of a fluid in the fluid conduit and / or a property of the fluid conduit; and A power source having a power supply and / or a connection to an external power source; a second portion, a mechanical coupling between the first portion and the second portion electrically connecting the fluid conduit to the power source; Equipment for preparation of infusion solutions.

2. the fluid conduit is elongated, has a shape that includes one or more changes in direction, and follows a path around the interior volume; 2. The apparatus of claim 1.

3. the fluid conduit is a coil of tubing, the fluid conduit being wound around the interior volume; 3. The apparatus of claim 2.

4. the second portion has a body sized and shaped to fit into the interior volume, and the mechanical connection includes inserting the body into the interior volume.

4. Apparatus according to claim 2 or 3.

5. the body fits into the interior volume through an opening to the interior volume, the second portion having a base larger than the opening.

5. The apparatus of claim 4.

6. the first portion is sized and shaped to fit within the lumen of the second portion; 4. The apparatus of claim 3.

7. the lumen of the second portion includes a cover that is closed to hold the first portion in place within the lumen of the second portion; 7. The apparatus of claim 6.

8. the second portion includes at least one second portion side electrical contact portion; the first portion includes an electrical circuit having at least one first portion electrical contact portion, and during mechanical coupling, the at least one second portion electrical contact portion contacts the second portion electrical contact portion; An apparatus according to any one of claims 1 to 7.

9. the first portion includes at least one electrical connector electrically connecting the fluid conduit to the first portion electrical contacts.

9. The apparatus of claim 8.

10. the electrical connector includes a portion configured to be slidably mounted onto the fluid conduit; 10. The apparatus of claim 9.

11. the portion being an electrical contact between the electrical connector and the fluid conduit; 11. The apparatus of claim 10.

12. the portion includes a lumen sized and shaped to receive the fluid conduit and to be in electrical contact with the fluid conduit; 12. The apparatus of claim 11.

13. the portion is a loop extending around at least 50% of the circumference of the fluid conduit; 13. The apparatus of claim 12.

14. the at least one sensor comprises a non-contact sensor, a non-contact infrared (IR) temperature sensor, or a contact temperature sensor; An apparatus according to any one of claims 1 to 13.

15. the sensor is configured to remain outside of the first portion when the second portion is mechanically coupled to the first portion. An apparatus according to any one of claims 1 to 14.

16. the second portion comprises a housing, the at least one sensor is disposed within the housing of the second portion, and upon connection of the first portion to the second portion, the at least one sensor is positioned adjacent to a portion of the fluid conduit. An apparatus according to any one of claims 1 to 15.

17. the housing encloses the second portion of circuitry; 17. The apparatus of claim 16.

18. the at least one sensor senses the fluid conduit through a window in the housing of the second portion.

18. Apparatus according to claim 16 or 17.

19. the window comprises a material that is transparent to IR radiation; 20. The apparatus of claim 18.

20. the window comprises germanium; 20. The apparatus of claim 19.

21. the first portion comprises a housing extending around the fluid conduit while having one or more openings to the fluid conduit, and when the first portion and the second portion are coupled, the one or more sensors are adjacent the one or more openings. Apparatus according to any one of claims 1 to 20.

22. the at least one sensor includes a contact sensor, the contact sensor contacting and sensing the fluid conduit through a connection between the first portion and the second portion; Apparatus according to any one of claims 1 to 21.

23. the power supplied by the power source to the fluid conduit acts to heat the fluid conduit; Apparatus according to any one of claims 1 to 22.

24. a processor configured to receive a measurement signal from the at least one sensor and generate a control signal for controlling the power source based on the measurement signal. Apparatus according to any one of claims 1 to 23.

25. the second portion includes at least one electrical contact housed in a removable portion of the second portion; Apparatus according to any one of claims 1 to 24.

26. a microswitch actuated by coupling of the first portion and the second portion; Apparatus according to any one of claims 1 to 25.

27. Actuation of the microswitch enables power transfer from the power source to the fluid conduit.

27. The apparatus of claim 26.

28. The microswitch is housed within a removable portion of the second section along with electrical contacts of the second section.

28. The apparatus of claim 27.

29. one or more portions of the fluid conduit are covered with an infrared absorbing material; Apparatus according to any one of claims 1 to 28.

30. the power source is external to the device and connected to the second portion; 30. Apparatus according to any one of claims 1 to 29.

31. the first and second portions are configured for a quick press connection to provide the mechanical interlock and the electrical connection. Apparatus according to any one of claims 1 to 30.

32. the second portion comprises at least one connector configured to electrically and mechanically engage the fluid conduit; Apparatus according to any one of claims 1 to 31.

33. the at least one connector comprises a resilient clip sized and configured to directly and securely fasten to the fluid conduit; 33. The apparatus of claim 32.

34. attaching a fluid conduit comprising an electrically conductive material to a power source such that the fluid conduit is mechanically and electrically connected to the power source such that an electrical current provided by the power source heats the fluid conduit; providing an infusion fluid to an inlet of the fluid conduit; sensing the fluid conduit with one or more non-contact sensors spaced from the fluid conduit to provide a measurement signal; controlling the power supply based on the measurement signal; 16. A method for infusion solution preparation comprising:

35. The sensing includes sensing infrared light.

35. The method of claim 34.

36. the one or more non-contact sensors are located within a housing and the fluid conduit is located outside the housing.

36. The method of claim 34 or 35.

37. The power source or a function for connecting to the power source is located within the housing.

37. The method of claim 36.

38. A housing having a window; a sensor configured to sense a fluid conduit outside the housing through the window; and Power source or connection to power source; A base for an injection device comprising:

39. a processor or a connection to a processor configured to receive measurements from the sensor and control the power source based on the measurements; 39. The base of claim 38.

40. at least one connector attached to the hollow metal conduit; 40. A base according to claim 38 or 39.

41. a fluid conduit comprising an electrically conductive material; a first electrical connector attached to a first portion of the fluid conduit; a second electrical connector attached to a second portion of the fluid conduit, the second electrical connector forming an electrically conductive path between the first portion and the second portion of the fluid conduit; One or both of the first and second connectors may include: a loop sized and shaped to extend around and contact a portion of the fluid conduit; a first contact portion extending from a first surface portion of the loop; a second contact portion extending from the second surface portion of the loop. Equipment for preparation of infusion solutions.

42. one or both of the first contact portion and the second contact portion have a size and / or shape that allows the contact portion to bend when electrically connected to a power source; 42. The apparatus of claim 41.

43. a housing covering an outer surface of the conduit with an inner surface open to an interior volume; 43. Apparatus according to claim 41 or 42.

44. the conduit has a coil shape including at least two turns and is wound around the interior volume; 44. The apparatus of claim 43.

45. a second portion selectively connectable to the first portion; The second portion is said power source and / or a connection to said power source; the contact portion electrically connected to the power source; at least one sensor for detecting fluid in the fluid conduit; 45. The apparatus of claim 44.

46. an electrical connector for connecting the injection conduit to a power source, a loop sized and shaped to extend around and contact a portion of the tubular infusion conduit; a first contact portion extending from a first surface portion of the loop; a second contact portion extending from a second surface of the loop; An electrical connector comprising:

47. 1. An apparatus for the preparation of an infusion solution, comprising: a first portion including a fluid conduit through which a fluid to be injected passes; a second portion selectively connectable to the first portion, the second portion comprising at least one sensor for sensing a property of the fluid conduit and / or a fluid within the fluid conduit; a mechanical coupling between the first portion and the second portion such that the at least one sensor is positioned proximate to the fluid conduit for measuring the fluid conduit; Device.

48. A disposable part of an injection heater, comprising: a folded sterile fluid conduit comprising an electrically conductive material; a first connector for medical tubing attached to a first end of the fluid conduit; a second connector for medical tubing attached to the first end of the fluid conduit; the fluid conduit defines at least two designated locations for mechanical and electrical engagement, each of the designated locations having an axial length greater than 0.5 cm; Disposable parts for injection heaters.

49. A temperature control circuit; Power source or connection to power source; at least one connector configured to stably, directly and reversibly engage a heating conduit and provide both a mechanical engagement and a supply of electrical power from the power source to the heating conduit for heating; A base for an injection device comprising:

50. the at least one connector includes at least two connectors each having a resilient clip portion for clamping directly around a body of the heating conduit; 50. The base of claim 49.

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