Clamp for a chemical solution container assembly, chemical solution injection device having the clamp, and chemical solution injection system
Patent Information
- Application Number
- JP2024063193
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-10-30
- Filing Date
- 2024-04-10
- Publication Date
- 2025-06-02
- Estimated Expiration
- 2039-10-30
AI Technical Summary
Existing drug solution injection devices risk syringe assembly detachment during operation if the clamper is not properly closed, and electrical sensors for detection can fail, leading to unreliable operation.
A clamper with a first and second holding structure that securely attaches and locks the syringe assembly by moving between open and closed positions, incorporating magnetic attraction and a spring plunger mechanism to ensure secure attachment, and uses sensors to confirm closure.
The clamper effectively prevents syringe detachment by ensuring secure attachment and provides reliable closure detection, enhancing the safety and reliability of drug solution injection operations.
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Abstract
Description
[Technical field]
[0001] The present invention relates to a clamper for holding a liquid medicine container assembly when a liquid medicine is injected using a liquid medicine injection device, and to various devices having the clamper. [Background technology]
[0002] Medical imaging diagnostic devices include CT (Computed Tomography) scanners, MRI (Magnetic Resonance Imaging) devices, PET (Positron Emission Tomography) devices, angiography devices, and MRA (MR Angio) devices. When taking fluoroscopic images of a subject using these devices, a contrast agent, saline solution, or other medicinal liquid is often injected into the subject.
[0003] Injection of a liquid medicine into a subject is generally performed automatically using a liquid medicine injector. The liquid medicine injector has an injection head to which a liquid medicine container such as a syringe filled with a liquid medicine or a liquid medicine bag is detachably attached, and an injection control unit that controls the operation of the injection head. The injection head has a clamper for fixing the liquid medicine container to the injection head, and a drive mechanism for discharging the liquid medicine from the liquid medicine container to the outside while the liquid medicine container is fixed to the injection head.
[0004] In a liquid injection device that injects a liquid medicine filled in a liquid medicine container, in order to inject an accurate amount of liquid medicine safely, it is important that the liquid medicine container is held in the liquid injection device so that the liquid medicine container does not shift position or become detached from the liquid injection device during injection.
[0005] Patent Document 1 (WO 2011 / 099551) discloses a liquid injection device having a syringe mounting part on which a syringe assembly is attached, and a clamper that holds the syringe assembly mounted on the syringe mounting part. The clamper has a base member on which a flange of the syringe assembly is placed, a flange pressing member, and an engagement structure. The flange pressing member is supported by the base member so as to be rotatable between an open position and a closed position. The engagement structure locks the flange pressing member to the base member in the closed position.
[0006] In the liquid injector described in Patent Document 1, the flange of the syringe assembly is placed on the base member with the flange presser member in the open position. The flange presser member is then rotated to the closed position, and the flange presser member is locked to the base member by the engagement structure. This holds the syringe assembly in place. [Prior art documents] [Patent documents]
[0007] Patent Document 1: International Publication No. 2011 / 099551 Summary of the Invention [Problem to be solved by the invention]
[0008] However, in the liquid injector described in Patent Document 1, the syringe assembly is held by closing the clamper after the syringe assembly is mounted on the syringe mounting part. Therefore, as long as the syringe assembly is mounted on the syringe mounting part, the liquid injector may be able to operate even if the user forgets to close the clamper. If a liquid injection operation, which is one of the operations of the liquid injector, is performed with the clamper not closed, there is a possibility that the syringe assembly may fall off during the liquid injection operation.
[0009] This problem can be solved by using a sensor that detects whether the clamper is closed or not, but this type of sensor is usually a sensor that detects changes in an electrical output value, and if the sensor itself breaks down or has some other problem, it will not be able to detect that the clamper is closed.
[0010] An object of the present invention is to provide a clamper etc. that can effectively mount a drug solution container assembly in a predetermined position and can effectively perform the closing operation of the clamper. [Means for solving the problem]
[0011] According to one aspect of the present invention, there is provided a clamper for removably holding a drug solution container assembly, comprising: a first holding structure having a first receiving portion that receives a part of the drug solution container assembly in a circumferential direction; a second holding structure having a second receiving portion that receives a portion of the circumferential direction of the drug solution container assembly and that cooperates with the first holding structure to hold the drug solution container assembly; having A clamper is provided in which the second holding structure is supported so that it can move between an open position and a closed position relative to the first holding structure and so that in the open position the second receiving portion can receive a portion of the drug solution container assembly.
[0012] According to another aspect of the present invention, A clamper according to the present invention; a drive mechanism for discharging the liquid contained in the liquid container assembly held by the clamper from the liquid container assembly; A medical fluid injection device having the following features is provided.
[0013] According to yet another aspect of the present invention, The drug solution injection device of the present invention, a drug solution container assembly for containing a drug solution; A system is provided having:
[0014] (Definitions of terms used in this specification) The "axial direction" of a drug container assembly or a syringe assembly refers to the longitudinal direction of the drug container assembly or the syringe assembly. A typical drug container assembly or a syringe assembly has an opening for discharging drug at one end in the axial direction. The "radial direction" of a drug container assembly or a syringe assembly refers to a direction perpendicular to the "axial direction". Effect of the Invention
[0015] According to the present invention, the liquid chemical container assembly can be attached to a predetermined position by utilizing the movement of the liquid chemical container assembly that accompanies the closing operation of the clamper. [Brief description of the drawings]
[0016] [Figure 1] 1 is a schematic block diagram of a medical imaging system in accordance with an embodiment of the present invention; [Diagram 2] 2 is a perspective view showing an example of the appearance of an injection head that can be provided in the liquid injector shown in FIG. 1. FIG. [Diagram 3] 3 is a perspective view of a syringe mounting portion of the injection head shown in FIG. 2. [Figure 4A] 1A and 1B are diagrams illustrating an embodiment of an arrangement of a first holding structure and a second holding structure. [Figure 4B] 13A to 13C are diagrams illustrating another embodiment of the arrangement of the first holding structure and the second holding structure. [Figure 5A] 4 is a perspective view of the syringe mounting portion shown in FIG. 3, showing a state in which the second retaining structure is in an open position and receives a syringe assembly. FIG. [Figure 5B] 5B is a perspective view of the syringe mounting portion as viewed from the front side in the state shown in FIG. 5A. FIG. [Figure 6A] 4 is a perspective view of the syringe mounting portion shown in FIG. 3, showing a state in which a clamper holds a syringe assembly. [Figure 6B] 6B is a perspective view of the syringe mounting portion as viewed from the front side in the state shown in FIG. 6A. FIG. [Figure 7A]13A and 13B are diagrams showing an example of an arrangement of magnetically attractive members that the clamper and syringe assembly may have. [Figure 7B] FIG. 7A shows the syringe assembly received in the second holding structure. [Figure 7C] 13 is a perspective view of another embodiment of a syringe assembly having a magnetically attractive member. FIG. [Figure 8A] FIG. 13 is a perspective view of an injection head having a clamper according to another embodiment. [Figure 8B] 7B shows the injection head shown in FIG. 7A with the syringe assembly received in the second holding structure in the open position. [Figure 9] 1 is a perspective view showing one embodiment of a syringe release mechanism that can be applied to the clamper of the present invention; FIG. [Figure 10] 13 is a perspective view of a main portion of a clamper, showing an example of the arrangement of a closure detection sensor and a drug solution container detection sensor. FIG. [Figure 11] FIG. 11 is a schematic block diagram of another embodiment of a system having a liquid drug injection device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0017] 1, there is shown a block diagram of a medical imaging system according to an embodiment of the present invention, which includes a liquid injector 100 and a medical imaging device 500. The liquid injector 100 and the medical imaging device 500 can be connected to each other so that data can be transmitted and received between them. The connection between the two can be wired or wireless.
[0018] The medical image pickup apparatus 500 has an imaging operation unit 520 that performs imaging operations and an imaging control unit 510 that controls the operation of the imaging operation unit 520, and can acquire medical images including tomographic images and / or three-dimensional images of a subject into which a liquid has been injected by the liquid injector 100. The imaging operation unit 520 usually has a bed for the subject, an electromagnetic wave irradiation unit that irradiates electromagnetic waves into a predetermined space on the bed, and the like. The imaging control unit 510 controls the operation of the entire medical image pickup apparatus, such as determining imaging conditions and controlling the operation of the imaging operation unit 520 according to the determined imaging conditions. The imaging control unit 510 can be configured to include a so-called microcomputer, and can have a CPU, a ROM, a RAM, and an interface with other devices. A computer program for controlling the medical image pickup apparatus 500 is implemented in the ROM. The CPU controls the operation of each part of the medical image pickup apparatus 500 by executing various functions corresponding to the computer program.
[0019] The medical imaging apparatus 500 may further include a display unit 504 such as a liquid crystal display capable of displaying imaging conditions and acquired medical images, and an input unit 503 such as a keyboard and / or a mouse for receiving input of imaging conditions and the like. At least a part of the data used to determine the imaging conditions is input from the input unit 503 and transmitted to the imaging control unit 510. Data displayed on the display unit 504 is transmitted from the imaging control unit 510. A touch panel having a touch screen arranged as an input unit on the display of the display unit may also be used as the input unit 503 and the display unit 504. A part of the input unit 503, the display unit 504, and the imaging control unit 510 may be incorporated into one housing as a console for the medical imaging apparatus.
[0020] The liquid injector 100 is a device used to inject a liquid medicine filled in a syringe assembly 200, which is a liquid medicine container assembly, into a blood vessel of a subject via an injection circuit 300, and includes at least one piston driving mechanism 130, at least one input unit 103, at least one display unit 104, and an injection control unit 101. The piston driving mechanism 130 is a mechanism for operating a piston of a syringe, and in this embodiment, the liquid injector 100 is configured to be able to mount two syringe assemblies 200 so that two types of liquid medicine (e.g., contrast medium and saline) can be injected separately or simultaneously, and includes two piston driving mechanisms 130 for independently operating the pistons of the two syringe assemblies 200. However, the number of piston driving mechanisms 130 may be one or three or more depending on the number of syringe assemblies 200 mounted on the liquid injector 100.
[0021] Injection control unit 101 determines injection conditions such as the injection amount and injection speed of the liquid using at least a part of the data input from input unit 103, controls the operation of piston drive mechanism 130 so that the liquid is injected from the syringe according to the determined injection conditions, controls the display of display unit 104, and controls the operation of the entire liquid injector. Injection control unit 101 can be configured to include a so-called microcomputer, and can have a CPU, ROM, RAM, and interfaces with other devices. A computer program for controlling liquid injector 100 is implemented in the ROM. The CPU can control the operation of each part of liquid injector 100 by executing various functions corresponding to the computer program.
[0022] Input unit 103 is a unit that accepts input of data and the like used by injection control unit 101 to determine injection conditions of the medicinal liquid. Input unit 103 may be, for example, a known input device such as a keyboard and / or a mouse. Data input from input unit 103 is transmitted to injection control unit 101, and data displayed on display unit 104 is transmitted from injection control unit 101. Display unit 104 is controlled by injection control unit 101 to display data and the like required to determine injection conditions of the medicinal liquid, to display the injection protocol, to display the injection operation, to display various warnings, and the like.
[0023] An injection protocol indicates what kind of medicinal liquid is to be injected, in what amount, and at what speed. The injection speed may be constant or may change over time. When multiple types of medicinal liquid, for example, a contrast medium and a physiological saline solution, are injected, the injection protocol also includes information on the order in which the medicinal liquids are to be injected. Any known injection protocol can be used as the injection protocol. Also, a known procedure can be used for creating the injection protocol. Also, the injection protocol may include a maximum allowable value (pressure limit) for the injection pressure. When a pressure limit is set, the injection pressure is monitored during the injection operation, and the operation of the piston drive mechanism 130 is controlled so that the injection pressure does not exceed the set pressure limit.
[0024] The display unit 104 may be a known display device such as a liquid crystal display device. A touch panel having a touch screen disposed as an input unit on the display of the display unit may also be used as the input unit 103 and the display unit 104.
[0025] The components of liquid injector 100 described above can be arranged together in one housing or separately in multiple housings. For example, liquid injector 100 can have injection head 100a and console 100b as housings. Injection head 100a can have piston drive mechanism 130, and syringe assembly 200 can be removably attached thereto. Console 100b can have injection control unit 101, input unit 103, and display unit 104. Input unit 103 and / or display unit 104 separate from input unit 103 and display unit 104 of injection control unit 101 may be provided in injection head 100a, or may be provided separately from injection head 100a and console 100b.
[0026] As shown in FIG. 2, the injection head 100a is configured so that two syringe assemblies 200 can be removably mounted in parallel to each other as drug solution container assemblies (for simplicity, only one syringe assembly 200 is shown in FIG. 2).
[0027] In the illustrated embodiment, the syringe assembly 200 has a syringe 220 and a protective cover 270 into which the syringe 220 is inserted. The syringe 220 is generally called a rodless syringe, and has a cylinder 221 and a piston 222 inserted in the cylinder 221 so as to be movable forward and backward. A cylinder flange 221a and a nozzle portion 221b are formed at the end and the front end of the cylinder 221, respectively. A convex portion (not shown) held by the piston drive mechanism 130 is integrally formed at the end of the piston 222. The syringe 220 may be a prefilled type syringe provided by a pharmaceutical manufacturer in a state filled with a medicinal liquid, or may be a field-filled type syringe filled with a medicinal liquid at a medical site.
[0028] As the piston 222 moves toward the tip of the cylinder 221, the medicinal liquid filled in the syringe 220 is pushed out of the syringe 220 via the nozzle portion 221b. An extension tube (not shown) with an injection needle or catheter connected to its tip is connected to the nozzle portion 221b, and the injection needle or catheter is punctured or inserted into the blood vessel of the subject, so that the medicinal liquid in the syringe 220 can be injected into the subject. Examples of the medicinal liquid filled in the syringe 220 include a contrast agent and physiological saline. For example, one of the syringes 220 may be filled with a contrast agent, and the other may be filled with physiological saline. In the injection of a medicinal liquid that is not intended for capturing a medical image, a medicinal liquid for treatment, such as an anticancer drug, instead of a contrast agent, may be filled in the syringe 220 and administered to the subject.
[0029] The liquid medicine injected using liquid medicine injector 100 often has a high viscosity, such as a contrast agent. In particular, when an angiography apparatus is used to capture an image of the blood vessels of a subject, the contrast agent is injected through a thin catheter. As a result, the internal pressure of cylinder 221 tends to become very high during the injection of the contrast agent. This high internal pressure causes cylinder 221 to expand, which can cause various problems in the injection of the liquid medicine.
[0030] Protective cover 270 is a cylindrically configured part in which cylinder 221 is inserted without any gap between the outer peripheral surface of cylinder 221 and the inner peripheral surface of protective cover 270 in order to suppress expansion due to an increase in the internal pressure of cylinder 221 during injection of the chemical solution. In order for protective cover 270 to fulfill this role, protective cover 270 is formed with a thickness that has sufficient mechanical strength to withstand the internal pressure acting on cylinder 221 during injection of the chemical solution.
[0031] An opening is formed at the tip of protective cover 270, and cylinder 221 is inserted into protective cover 270 with nozzle portion 221b protruding from this opening. At the end of protective cover 270, cover flange 271 is formed with a ring-shaped recess that receives cylinder flange 221a of cylinder 221.
[0032] Injection head 100a has two piston drive mechanisms 130 (see FIG. 1) that are driven independently of each other to advance and retract pistons 222 of two attached syringe assemblies 200, and are disposed in correspondence with the positions at which each syringe assembly 200 is attached. Each piston drive mechanism 130 has a presser 131 that holds the aforementioned convex portion at the end of piston 222, a drive source (not shown) such as a motor that advances and retracts presser 131, and a power transmission mechanism (not shown) that connects them.
[0033] Syringe assembly 200 attached to injection head 100a can inject the medicinal liquid filled in syringe 220 into a subject by advancing piston 222 by piston drive mechanism 130. If two syringe assemblies 200 are attached to injection head 100a, the medicinal liquids filled in the two syringes 200 can be injected into a subject separately, sequentially, or simultaneously by appropriately controlling the operation of each piston drive mechanism 130. For piston drive mechanism 130, a known mechanism that is generally used in this type of injection device can be adopted.
[0034] As described above, the operation of each piston drive mechanism 130 is controlled by injection control unit 101 according to the injection protocol when injecting a liquid drug, but it is preferable to allow each piston drive mechanism 130 to be operated arbitrarily in other ways as well. For this reason, input unit 103 may further include button group 103a and / or manual knob 103b, including a button for arbitrarily advancing presser 131 and a button for arbitrarily retracting presser 131, on injection head 100a. Injection control unit 101 controls the operation of each piston drive mechanism in response to the operator's pressing of each button of button group 103a and rotation of manual knob 103b.
[0035] The tip of injection head 100a is provided with syringe assembly receiver 120 and clamper 140 which constitute a syringe mounting portion on which syringe assembly 200 is placed. Syringe assembly receiver 120 is located closer to the tip than clamper 140 and has two recesses 121 which can individually receive the outer circumferential surface of protective cover 270. Syringe assembly 200 is received by syringe assembly receiver 120 with nozzle portion 221b facing the tip and placed on the syringe mounting portion, and cover flange 271 is held by clamper 140, thereby fixing it to injection head 100a.
[0036] Next, the clamper 140 will be described in more detail with reference to FIG.
[0037] [Basic structure of the clamper] The clamper 140 has a first holding structure 141 and at least one second holding structure 142 that cooperate to hold the syringe assembly 200. The first holding structure 141 and the second holding structure are configured to hold the syringe assembly 200 in a state in which the syringe assembly 200 is placed on the syringe placement portion. In this embodiment, the clamper 140 has two second holding structures 142 so that the injection head 100a (see FIG. 2) can mount two syringe assemblies 200. However, the number of second holding structures 142 may be one or three or more, depending on the number of syringe assemblies 200 mounted on the injection head 100a. The configuration of the first holding structure 142 and the configuration of the syringe assembly receiver 120 are changed depending on the number of syringe assemblies 200 that can be mounted. For example, if the number of syringe assemblies 200 that can be attached is one, the first holding structure 141 has one flange receiving portion 141a (described below), and the syringe assembly receiver 120 has one recess 121.
[0038] The clamper 140 may further include at least one support member that supports the first holding structure 141 and the second holding structure 142 relative to the injection head 100a. In this embodiment, the clamper 140 includes, as support members, a center shaft 150a and two clamper shafts 150b arranged on both sides of the center shaft 150a in parallel with the center shaft 150a. The first holding structure 141 is fixedly supported relative to the injection head 100a by the center shaft 150a and the two clamper shafts 150b. Meanwhile, the two second holding structures 142 are supported by the left and right clamper shafts 150b, respectively, to be rotatable about the clamper shafts 150b.
[0039] The distance between the center shaft 150a and the clamper shaft 150b is larger than the diameter of the cover flange 271 (see FIG. 1) of the syringe assembly 200 held by the clamper 140. The first holding structure 141 has two flange receiving portions 141a (first receiving portions) located between the center shaft 150a and the clamper shaft 150b as a structure for receiving a part of the syringe assembly 200 in the outer circumferential direction. In this embodiment, each flange receiving portion 141a is configured as a recess that can receive a part of the cover flange 271 along the outer circumferential direction of the syringe assembly 200, while being substantially immovable in the axial direction of the syringe assembly 200 and movable in the radial direction. The first holding structure 141 can be configured by one member or by combining a plurality of members.
[0040] The second holding structure 142 is supported movably between an open position and a closed position relative to the first holding structure 141, and is configured to receive a part of the circumferential direction of the flange assembly 200 in the open position, and to cooperate with the first holding structure 141 to hold the syringe assembly 200 in the closed position. In order to receive and hold the syringe assembly 200, the second holding structure 142 also has a flange receiving portion 142a (second receiving portion) as a structure for receiving a part of the circumferential direction of the syringe assembly 200, similar to the first holding structure 141. In this embodiment, the flange receiving portion 142a is configured as a recess that can receive a part of the cover flange 271 along the circumferential direction, while being substantially immovable in the axial direction of the syringe assembly 200, and movable in the radial direction. The flange receiving portion 142a is preferably provided with an anti-slip member 142b for making it difficult for the syringe assembly 200 to rotate. The material constituting the non-slip member 142b may be any material, and for example, the non-slip member 142b may be made of a rubber material such as silicone rubber. By making the non-slip member 142b of a rubber material, the non-slip member 142b may also function as a cushion. The second holding structure 142 may be made of one member, or may be made of a combination of multiple members.
[0041] The flange receiving portion 141a of the first holding structure 141 and the flange receiving portion 142a of the second flange holding structure 142 are configured such that, when the second holding structure 142 is in the closed position, both flange receiving portions 141a, 142a cooperate to receive the cover flange 271 immovably in both the axial and radial directions of the syringe assembly 200. This allows the syringe assembly 200 to be held.
[0042] In this specification, "immovable" does not only mean that the target structure does not move at all, but also means that it can move within a clearance range caused by design dimensional tolerances, etc.
[0043] In order for the flange receiving portions 141a and 142a to cooperate to receive the syringe assembly 200 so as to be immovable in the radial direction, when the second holding structure 142 is in the closed position, for example, as shown in FIG. 4A, the total length of the length L1 and the length L2 may be more than half the total circumference of the syringe assembly 200 in the circumferential direction. The length L1 is the circumferential length of the portion of the syringe assembly 200 received by the flange receiving portion of the first holding structure 141. The length L2 is the circumferential length of the portion of the syringe assembly 200 received by the flange receiving portion of the second holding structure 142. Alternatively, as shown in FIG. 4B, each of the lengths L3 and L4 may be less than half the total circumference of the syringe assembly 200 in the circumferential direction. Lengths L3 and L4 are circumferential lengths of a portion of syringe assembly 200 that is not received by either the flange receiving portion of first holding structure 141 or the flange receiving portion of second holding structure 142. In this embodiment, the former configuration is adopted. Note that first holding structure 141 and second holding structure 142 may be disposed consecutively in the circumferential direction of syringe assembly 200, or may be disposed separately.
[0044] The shapes of first holding structure 141 and second holding structure 142 are not particularly limited and may be any shape. However, it is preferable that at least the inner surface of each (the surface facing the syringe assembly when the syringe assembly is held) has a shape having a length along the outer circumferential direction of syringe assembly 200 so as to be able to receive a part of the outer circumferential direction of syringe assembly 200. In this embodiment, since syringe assembly 200 has a cylindrical outer shape as a whole, flange receiving portion 141a of first holding structure 141 and flange receiving portion 142a of second holding structure 142 are formed in a substantially semicircular arc shape.
[0045] The second holding structure 142 may move along any path as long as it can move between the open position and the closed position. For example, the movement of the second holding structure 142 between the open position and the closed position may be a rotation as in this embodiment, a linear movement, or a combination of these.
[0046] Also, as long as the second holding structure 142 is supported so as to be movable between the open position and the closed position, any portion of the second holding structure 142 may be supported, and one end portion or other portion may be supported. In this embodiment, the second holding structure 142 is configured to have a semicircular arc shape as a whole corresponding to the outer shape of the syringe assembly 200, and is supported by the clamper shaft 150b at a longitudinal intermediate portion of the semicircular arc shape so as to be rotatable around the clamper shaft 150b. As a result, the second holding structure 142 is configured such that a part of the flange receiving portion 141a is located in the flange receiving portion 141a of the first holding structure 141 when in the closed position, and a part of the flange receiving portion 142a located in the flange receiving portion 141a is released from the flange receiving portion 141a as the second holding structure 142 moves toward the open position.
[0047] An example of a procedure for mounting and removing syringe assembly 200 to injection head 100a having a clamper of this embodiment will be described below.
[0048] When mounting syringe assembly 200 on injection head 100a, the user first moves second holding structure 142 to the open position. In this state, the user places syringe assembly 200 on second holding structure 142 so that cover flange 271 of syringe assembly 200 is received in flange receiving portion 142a of second holding structure 142 (see FIGS. 5A and 5B).
[0049] As described above, in this embodiment, the flange receiving portions 141a, 142a of the first holding structure 141 and the second holding structure 142 are both formed in a semicircular arc shape, and the second holding structure 142 is supported at its intermediate portion in the longitudinal direction (direction along the arc). In this case, as shown in FIG. 3, the open position can be a position where the orientation of the open end of the flange receiving portion 142a of the second holding structure 142 is the same as the orientation of the open end of the flange receiving portion 141a of the first holding structure 141. As a result, in the open position, the second holding structure 142 is in a position that makes it easy to receive the syringe assembly 200. In addition, the syringe assembly 200 can be received at any position between the open position and the closed position that generates a space between the first holding structure 141 and the second holding structure 142 into which the syringe assembly 200 can be inserted from the radial direction. In other words, the open position can be any position that creates a space between the first retaining structure 141 and the second retaining structure 142 through which the syringe assembly 200 can be inserted radially.
[0050] Furthermore, with this configuration, when second holding structure 142 is in the open position, a part of second holding structure 142 is in a position that blocks the reception of syringe assembly 200 into flange receiving portion 141a of first holding structure 141. Therefore, when attaching syringe assembly 200 in the open position, syringe assembly 200 cannot be received by first holding structure 141, and the user will inevitably place syringe assembly 200 on second holding structure 142 instead of first holding structure 141.
[0051] Next, the user moves the second holding structure 142 in which the syringe assembly 200 is received to the closed position (FIGS. 6A and 6B). By moving the second holding structure 142 to the closed position, the syringe assembly 200 moves (rotates) together with the second holding structure 142 and is received by the syringe assembly receiver 120, whereby the syringe assembly 200 is mounted at a fixed position placed on the syringe mounting portion. At the same time, the cover flange 271 of the syringe assembly 200 is held by the first holding structure 141 and the second holding structure 142.
[0052] Once syringe assembly 200 has been attached to injection head 100a in this manner, the medicinal liquid can be injected into the subject by following the same conventional procedures as above, such as connecting an injection needle or catheter to syringe assembly 200 via an extension tube, setting the injection conditions for the medicinal liquid, and operating medicinal liquid injector 100.
[0053] Syringe assembly 200 attached to injection head 100a can be removed from injection head 100a by reversing the above-described attachment procedure.
[0054] As described above, in this embodiment, syringe assembly 200 is mounted in a fixed position by placing syringe assembly 200 on second holding structure 142 when second holding structure 142 is in the open position, and then moving second holding structure 142 to the closed position in this state. This allows syringe assembly 200 to be mounted in a fixed position and held by clamper 140 at the same time by an extremely intuitive action of moving second holding structure 142 on which syringe assembly 200 is placed from the open position to the closed position. Moreover, since placement of syringe assembly 200 on the syringe placement portion and closing of clamper 140 are performed at the same time, it is possible to prevent the syringe assembly 200 placed on the syringe placement portion from being forgotten to be held by clamper 140.
[0055] [Other favorable factors] (Stopper of the second holding structure) The clamper 140 may have a stopper for the open position and / or the closed position of the second holding structure 142. By having the stopper for the open position, the position of the second holding structure 142 can be stabilized in the open position, and the syringe assembly 200 can be easily received by the second holding structure 142. By having the stopper mechanism for the closed position, the clamper 140 can be kept in a closed state when the second holding structure 142 is in the closed position. As these stopper mechanisms, any mechanism that can detachably hold the second holding structure 142 in the open position and / or the closed position can be used.
[0056] An example of the stopper is a combination of a spring plunger attached to the second holding structure 142 and an engagement recess formed in a member that contacts the second holding structure 142 in the open position and / or the closed position. The relationship between the spring plunger and the engagement recess may be reversed. The spring plunger has a main body, a movable body such as a ball or a pin held in the main body so as to be movable forward and backward relative to the main body, and a spring that biases the movable body from inside the main body. The spring plunger is configured such that a part of the movable body protrudes from the main body due to the biasing force of the spring in an unloaded state, but the movable body sinks into the main body when a load is applied. The engagement recess is formed at a position facing the spring plunger when the second holding structure 142 is in the open position and / or the closed position. As a result, in the open position and / or the closed position, the movable body of the spring plunger protrudes due to the biasing force of the spring and engages with the engagement recess, functioning as a stopper.
[0057] (Medicine container locking mechanism) The clamper 140 may have a syringe lock structure that detachably locks the syringe assembly 200 received in the first holding structure 141. An example of the syringe lock mechanism is a holding hook 143 (see FIG. 3, etc.) provided in the first holding structure 141. The holding hook 143 is provided in the flange receiving portion 141a of the first holding structure 141 at a position where it engages with the outer circumferential surface of the cover flange 271 of the syringe assembly 200 received in the flange receiving portion 141a. By having the syringe lock mechanism, the syringe assembly 200 can be fixed in a fixed position well even if the holding by the clamper 140 is insufficient. The clamper 140 may also have both the syringe lock mechanism and a lock mechanism for the second holding structure 142 in the closed position, thereby enabling the syringe assembly 200 to be held more firmly.
[0058] (Operation lever) The second holding structure 142 may have an operating lever 144 for a user to move the second holding structure 142 between the open position and the closed position. The position of the operating lever 144 on the second holding structure 142 may be arbitrary, but by providing the operating lever 144 at an end part away from the rotation center of the second holding structure 142, the second holding structure 142 can be moved (rotated) with a smaller force. In addition, when the second holding structure 142 is in the closed position, the operating lever 144 is preferably disposed at a part of the second holding structure 142 farthest from the syringe mounting part (syringe assembly receiver 120) when the syringe assembly 200 is viewed from the axial direction (see, for example, FIG. 6B). By disposing the operating lever 144 at such a position, it becomes easier for the user to operate the second holding structure 142 when moving it from the closed position to the open position.
[0059] (Adsorption of drug solution containers) The clamper 140 can be configured so that the syringe assembly 200 received in the second holding structure 142 is attracted to the second holding structure 142. Magnetism can be used to attract the syringe assembly 200. An example of an attraction structure using magnetism is shown in FIG. 7A. As shown in FIG. 7A, the second holding structure 142 and the syringe assembly 200 each have magnetic attraction members 145a and 145b. As shown in FIG. 6B, these magnetic attraction members 145a and 145b face each other when the syringe assembly 200 is received in the second holding structure 142, and are arranged at positions where one magnetic attraction member 145a and the other magnetic attraction member 145b are paired. In the illustrated embodiment, the magnetic attraction member 145b on the syringe assembly 200 side is arranged near or inside the outer circumferential surface of the cover flange 271, and the magnetic attraction member 145a on the second holding structure 142 side is arranged on the flange receiving portion 142a.
[0060] By magnetically attracting syringe assembly 200 received in second holding structure 142 by magnetic attraction members 145a, 145b, syringe assembly 200 can be reliably received in second holding structure 142 without falling from second holding structure 142, regardless of the position of injection head 100a, for example, when the tip side (syringe assembly receiver 120 side) of injection head 100a is facing upward. In addition, when second holding structure 142 receiving syringe assembly 200 is rotated from the open position to the closed position, syringe assembly 200 can be prevented from falling off second holding structure 142. Furthermore, when second holding structure 142 is rotated from the closed position to the open position, syringe assembly 200 is also rotated to the open position, so that syringe assembly 200 can be easily removed.
[0061] Combinations of the pair of magnetic attraction members 145a, 145b include a combination of magnets and a combination of a ferromagnetic material such as iron and a magnet. By using magnets for both of the pair of magnetic attraction members 145a, 145b, a stronger attraction force can be obtained. The number of pairs of magnetic attraction members 145a, 145b may be one pair or multiple pairs. By having multiple pairs of magnetic attraction members 145a, 145b, not only can the syringe assembly 200 be more strongly attracted, but also the syringe assembly 200 can be attracted to the second holding structure 142 in a specific direction in the circumferential direction. This is effective when the circumferential direction of the syringe assembly 200 to be held by the clamper 140 is fixed.
[0062] When magnetic attraction member 145a provided in second holding structure 142 is a magnet, as shown in Fig. 7C, a magnetic attraction band 145c extending in the circumferential direction of syringe assembly 200 can be used as the magnetic attraction member provided in syringe assembly 200. In the example shown in Fig. 7C, magnetic attraction band 145c is fixed to the outer peripheral surface of cover flange 271 of protective cover 270. This makes it possible to alleviate restrictions on the circumferential orientation of syringe assembly 200 when syringe assembly 200 is held by second holding structure 142.
[0063] The magnetic attraction band 145c can be a ferromagnetic material formed into a flexible sheet shape, or a ferromagnetic material processed into a curved shape along the outer circumferential surface of the cover flange 271. Furthermore, the magnetic attraction band 145c can be a rubber magnet that can be curved along the outer circumferential surface of the cover flange 271, or a magnet formed into a curved shape along the outer circumferential surface of the cover flange 271.
[0064] The length of the magnetic attraction band 145c in the circumferential direction of the syringe assembly 200 may be arbitrary, but it is preferable that the magnetic attraction band 145c is as long as possible in order to more effectively exert the above-mentioned effect. In the example shown in Fig. 7, the magnetic attraction band 145c has a length that covers almost the entire circumference of the outer circumferential surface of the cover flange 271, excluding the portion where the release button 280 provided on the cover flange 271 of the protective cover 270 is present. When such a syringe assembly 200 is held by the second holding structure 142 having a plurality of magnets that are the plurality of magnetic attraction members 145a as shown in Fig. 6A, at least one of the magnetic attraction members 145a can attract the syringe assembly 200 regardless of the orientation of the syringe assembly 200 in the circumferential direction.
[0065] 7C has release button 280, but release button 280 is not an essential component. Therefore, if syringe assembly 200 does not have release button 280, magnetic attraction band 145c having a length that covers the entire circumference of the outer circumferential surface of cover flange 271 can be used.
[0066] Here, the release button 280 will be briefly described. The release button 280 is a mechanism for holding the syringe 220 in the protective cover 270 and releasing the same. The release button 280 is rotatably supported by the cover flange 271 by a shaft parallel to the diameter direction of the cover flange 271. The release button 280 is rotatable between a first position where the release button 280 engages with the rear end surface of the cylinder of the syringe 220 and a second position where the engagement is released. The release button 280 is elastically supported so as to rotate from the first position to the second position when operated. Since the syringe assembly 200 has the release button 280, the release button 280 must be operated in order to remove the syringe 220 from the protective cover 270, and therefore the syringe 220 can be prevented from accidentally falling off the protective cover 270.
[0067] (Holds the entire circumference of the liquid medicine container) In the embodiment described above, second holding structure 142 is supported at a longitudinal intermediate portion along the outer circumferential direction of syringe assembly 200, and when second holding structure 142 is in the closed position, clamper 140 is configured to hold syringe assembly 200 with a portion of syringe assembly 200 in the circumferential direction being open. However, clamper 140 may be configured to hold syringe assembly 200 over the entire circumference.
[0068] An example of such a clamper 140 is shown in FIG. 8A. The clamper 140 shown in FIG. 8A can be configured similarly to the clamper 140 shown in FIG. 3 and the like, except that one end of the second holding structure 142 is supported by a clamper shaft (not shown). With one end of the second holding structure 142 supported, the second holding structure 142 opens widely relative to the first holding structure 141 when the second holding structure 142 is in the open position. This allows the second holding structure 142 to receive the syringe assembly 200 at a position relatively distant from various structures such as the presser 131 of the injection head 100a, as shown in FIG. 8B. This reduces the possibility of damage to the injection head 100a and / or the syringe assembly 200 caused by accidentally hitting the syringe assembly 200 against a main structure of the injection head 100a when the syringe assembly 200 is attached to the injection head 100a.
[0069] 8A and 8B, in a configuration in which second holding structure 142 is supported rotatably at its end, even if second holding structure 142 is moved from the closed position to the open position, syringe assembly 200 may remain received in syringe assembly receiver 120 and first holding structure 141. In this state, presser 131 may be engaged with piston 222, making it difficult to remove syringe assembly 200.
[0070] Therefore, it is preferable that the clamper 140 has a syringe release mechanism that releases the syringe assembly 200 from the flange receiver 141a of the first holding structure 141 as the second holding structure 142 moves from the closed position to the open position. An example of the syringe release mechanism will be described with reference to Fig. 9. Fig. 8 shows the clamper 140 having the syringe release mechanism together with the syringe assembly receiver 120, but the second holding structure of the clamper 140 is omitted.
[0071] As shown in Fig. 9, the first holding structure 141 is provided with a spring plunger 145 as a syringe release mechanism. The spring plunger 145 has a main body, a movable body such as a ball or pin held in the main body so as to be movable forward and backward relative to the main body, and a spring that biases the movable body from inside the main body. In the embodiment shown in Fig. 8, two spring plungers 145 are arranged for each of the two flange receivers 141a of the first holding structure 141, with the movable body protruding from the flange receiver 141a.
[0072] According to this configuration, when second holding structure 142 is moved from the open position to the closed position while receiving syringe assembly 200, cover flange 271 of syringe assembly 200 is received by flange receiving portion 141a of first holding structure 141 while pushing the movable body of spring plunger 145 into the main body, whereby syringe assembly 200 is held by clamper 140. On the other hand, when second holding structure 142 is moved from the closed position toward the open position and the holding of syringe assembly 200 by first holding structure 141 and second holding structure 142 is released, spring plunger 145 is released from the load of syringe assembly 200. As a result, the movable body of spring plunger 145 protrudes due to the biasing force of the spring. This causes the cover flange 271 of the syringe assembly 200 to be lifted from the flange receiving portion 141 a by the spring plunger 145 , and as a result, the syringe assembly 200 is released from the first retaining structure 141 .
[0073] When the spring plunger 145 is used as the syringe release mechanism, the movable body of the spring plunger 145 is preferably a pin. This allows the stroke of the movable body to be increased. The number of spring plungers 145 per flange receiving portion 141a may be one, or may be three or more. The position of the spring plunger 145 may also be arbitrary.
[0074] The movable body of spring plunger 145 may include a magnet by incorporating a magnet or by configuring the movable body itself as a magnet. In this case, syringe assembly 200 is configured such that a ferromagnetic material such as iron or a magnet is disposed at a position facing spring plunger 145 when syringe assembly 200 is held by clamper 140, and syringe assembly 200 is magnetically attracted to spring plunger 145. This prevents syringe assembly 200 from jumping up due to the force of the spring of spring plunger 145 when syringe assembly 200 is released from first holding structure 141 by spring plunger 145.
[0075] The magnet may be disposed separately from the spring plunger 145. For example, a magnet may be disposed at the position where the spring plunger 145 is disposed in Fig. 9, and the spring plunger may be disposed at an intermediate position between the two magnets. With such a configuration, the syringe assembly 200 can be easily removed.
[0076] (Closing detection sensor) Injection head 100a preferably has a closure detection sensor 111 (see FIG. 1) that detects that second holding structure 142 is in the closed position and switches its output between ON and OFF depending on whether the second holding structure 142 is in the closed position. Any sensor can be used as closure detection sensor 111, which can detect an object to be detected when second holding structure 142 moves to the closed position and the distance between the object to be detected is equal to or less than a predetermined distance (including contact). Examples of closure detection sensor 111 include an optical sensor that optically detects the presence or absence of an object to be detected within a detection area, a proximity sensor such as a Hall sensor that uses magnetism as a detection medium to detect the presence or absence and position of an object to be detected, and a mechanical switch that switches between ON and OFF depending on whether the object to be detected is in contact or not.
[0077] Either the closure detection sensor 111 or the object to be detected can be disposed in the second holding structure 142, and the other of the closure detection sensor 105 or the object to be detected can be disposed in a member that moves relative to the second holding structure 142 as the second holding structure 142 moves between the open position and the closed position. For example, the closure detection sensor 105 can be disposed in the first holding structure 141, and the object to be detected can be disposed in the second holding structure 142. Note that when the closure detection sensor 111 is an optical sensor, the second holding structure 142 itself can also be the object to be detected.
[0078] (Medicine container detection sensor) The injection head 100a may have a syringe detection sensor 112 (see FIG. 1) which is a liquid container detection sensor that detects that the syringe assembly 200 is placed on the syringe placement section and switches its output between ON and OFF depending on the state change between detection and non-detection. The syringe detection sensor 112 may be the same as the closure detection sensor. The syringe detection sensor may be disposed at a portion where the distance from the syringe assembly 200 is equal to or less than a predetermined distance (including contact) when the syringe assembly 200 is placed on the syringe placement section, for example, the syringe assembly receiver 120 and the first holding structure 141 of the clamper 140. On the other hand, the detection object detected by the syringe detection sensor 106 may be disposed at a portion of the syringe assembly 200 which may be detected by the syringe detection sensor when the syringe assembly 200 is placed on the syringe placement section, for example, the protective cover 270. When the syringe detection sensor 112 is an optical sensor, the protective cover 270 itself can be the detection target.
[0079] (Example of placement of closure detection sensor and chemical container detection sensor) Fig. 10 shows an example of the arrangement of the above-mentioned closure detection sensor 111 and syringe detection sensor 112. Note that the syringe assembly receiver is omitted in Fig. 10.
[0080] In the example shown in FIG. 10, a Hall sensor is disposed as the closure detection sensor 111 at a position of the first holding structure 141 facing an end portion of the second holding structure 142 that is far from the rotation center of the second holding structure 142 when the second holding structure 142 is in the closed position. A magnet 111a, which is a detection object detected by the closure detection sensor 111, is disposed at a position of the second holding structure 142 facing the closure detection sensor 111 when the second holding structure 142 is in the closed position. By disposing the Hall sensor and the magnet 111a as the closure detection sensor 111 in this manner, the moving distance of the magnet 111a, which is a detection object, can be increased while the second holding structure 142 moves from the open position to the closed position. As a result, it is possible to detect with higher accuracy that the second holding structure 142 is in the closed position.
[0081] As shown in FIG. 10, the syringe detection sensor 112 can be disposed on the flange receiving portion 141a of the first holding structure 141. In particular, in the example shown in FIG. 10, the syringe detection sensor 112 is disposed at a position of the flange receiving portion 141a adjacent to the other flange receiving portion 141a and facing the second holding structure 142. An optical sensor is used as the syringe detection sensor 112. By disposing the syringe detection sensor 112 at a position adjacent to the other flange receiving portion 141a, the wiring of the two syringe detection sensors 112 can be routed together. By disposing the syringe detection sensor 112 at a position facing the second holding structure 142, the detection of the syringe assembly 200 can be made less susceptible to the influence of external light.
[0082] (Operation of the drug injection device using the sensor detection results) Injection control unit 101 can control the operation of liquid injector 100 by utilizing the detection results of the above-mentioned closure detection sensor 111 and liquid container detection sensor 112. The operation of liquid injector 100 by utilizing the detection results of these sensors will be described below.
[0083] (1) Self-check operation at startup When liquid injector 100 is started (powered ON), injection control unit 101 performs a self-check such as moving presser 131 back and forth to check the operation of piston drive mechanism 130. At this time, in various operations of liquid injector 100, it is important that second holding structure 142 of clamper 140 is in the closed position, and it is preferable to check with priority whether it can be reliably detected that second holding structure 142 is in the closed position, in other words, whether closure detection sensor 111 is operating normally.
[0084] Therefore, when liquid injector 100 is started, injection control unit 101 checks whether second holding structure 142 is in the closed position, i.e., whether closure detection sensor 111 is ON, and if closure detection sensor 111 is OFF and / or if closure detection sensor 111 changes from ON to OFF during the self-check operation, it is preferable to notify the operator that second holding structure 142 is not in the closed position. The notification can be made by displaying on display unit 104. In response to the notification that second holding structure 142 is not in the closed position, the operator can set second holding structure 142 to the closed position. When injection control unit 101 confirms that closure detection sensor 111 is ON, it performs the self-check operation. Alternatively, injection control unit 101 may notify the operator that second holding structure 142 is not in the closed position and prompt the operator to restart liquid injector 100.
[0085] In addition, for example, in the case of the clamper 140 shown in FIG. 8A, in the case where the presser 131 and the second holding structure 142 are not buffered together regardless of the position of the second holding structure 142 when the presser 131 moves forward, it is not necessary to check the above-mentioned closure detection sensor 111 after the chemical liquid injector 100 is started.
[0086] (2) Operation in cleaning mode Liquid injector 100 often has a cleaning mode for cleaning the shaft supporting presser 131. To clean the shaft, presser 131 needs to be advanced with syringe assembly 200 not attached to injection head 100a. When cleaning the shaft, it is easier to clean it when second holding structure 142 is fixed in a fixed position rather than being in a state where it can move freely.
[0087] Therefore, it is preferable that injection control unit 101 checks closure detection sensor 111 when the cleaning mode is started, and if closure detection sensor 111 is OFF, i.e., if second holding structure 142 is not in the closed position, causes display unit 104 to display a message urging the user to close the clamper. Injection control unit 101 may further cause display unit 104 to display a message urging the user to restart liquid injector 100. Furthermore, during the cleaning mode, if closure detection sensor 111 is OFF, operation of piston drive mechanism 130 is prohibited.
[0088] In addition, even during operation in the cleaning mode, if the clamper 140 shown in FIG. 8A is configured such that when the presser 131 moves forward, the presser 131 and the second holding structure 142 do not interfere with each other regardless of the position of the second holding structure 142, then it is not necessary to check the closure detection sensor 111 described above after the chemical liquid injector 100 is started.
[0089] (3) Forward movement of the presser The operation of the piston drive mechanism 130 for advancing the presser 131 under the control of the injection control unit 101 is performed under the condition that the closure detection sensor 111 detects that the second holding structure 142 is in the closed position and that the syringe detection sensor 112 detects that the syringe assembly 200 is attached, i.e., both the closure detection sensor 111 and the syringe detection sensor 112 are ON. In other words, when at least one of the closure detection sensor 111 and the piston detection sensor 112 is OFF during and during the operation of the piston drive mechanism 130 for advancing the presser 131, the injection control unit 101 prohibits the operation of the piston drive mechanism 130 for advancing the presser 131 (when the piston drive mechanism 130 is in operation, the operation of the piston drive mechanism 130 is stopped). This applies not only to the advancing operation of the presser 131 according to the injection protocol, but also to the advancing operation by operating the button of the operation button group 103a and the advancing operation by operating the manual knob 103b. In addition, along with prohibiting or stopping the operation of the piston drive mechanism 130, the injection control unit 101 may notify the operator that the operation has been prohibited or stopped, for example, by displaying a message and / or a pictogram on the display unit 104.
[0090] However, when an optical sensor arranged in the first holding structure 141 is used as the syringe detection sensor 112, if a medicinal liquid (e.g., contrast medium) adheres to the periphery of an area detectable by the syringe detection sensor 112, the syringe detection sensor 112 may change from ON to OFF even if the second holding structure 142 remains in the closed position (the closure detection sensor remains ON). However, in reality, it is unlikely that the syringe assembly 200 will be removed from the clamper 140 with the second holding structure 142 in the closed position, that is, the syringe detection sensor 112 will change from ON to OFF. Therefore, during the forward movement of the presser 131, when the closure detection sensor 111 is ON, it is preferable that the injection control unit 101 permits the operation of the piston drive mechanism 130 for the forward movement of the presser 131 even if the syringe detection sensor 112 changes from ON to OFF. This is also true during the injection operation of the medicinal liquid, and in that case, it is preferable to continue the operation of the piston drive mechanism 130. In addition, along with permitting or continuing the operation of the piston drive mechanism 130, the injection control unit 101 may notify the operator that the operation has been permitted or continued, for example, by displaying a message and / or a pictogram on the display unit 104.
[0091] (4) Retraction of the presser In response to the operation of buttons 103a and manual knob 103b of injection head 100a, injection control unit 101 can control piston drive mechanism 130 to retract presser 131. The retraction operation of presser 131 is unrelated to the injection operation of the medicinal liquid and is often performed with syringe assembly 200 attached to injection head 100a. Therefore, injection control unit 101 can permit the operation of piston drive mechanism 130 to retract presser 131 regardless of the detection results of closure detection sensor 111 and syringe detection sensor 112.
[0092] 3, for example, it is possible that presser 131 may collide with second holding structure 142 when it retracts, depending on the position of second holding structure 142. When clamper 140 has such a configuration, it is preferable that injection control unit 101 does not permit operation of piston drive mechanism 130 that retracts presser 131 when closure detection sensor 111 is OFF, and notifies the operator that second holding structure 142 is not in the closed position. The notification to the operator that second holding structure 142 is not in the closed position may be, for example, by displaying a message and / or a pictogram on display unit 104.
[0093] Furthermore, when an optical sensor arranged in the first holding structure 141 is used as the syringe detection sensor 112, as with the forward movement of the presser 131, even if the syringe detection sensor 112 changes from ON to OFF during the backward movement of the presser 131, it is preferable to allow the operation of the piston driving mechanism 130 for the forward movement of the presser 131 as long as the closure detection sensor 111 is ON.
[0094] (5) Automatic forward movement of the presser The liquid injector 100 can have a function of filling an empty syringe assembly 200 that is not filled with a liquid with a liquid. The liquid can be filled into the syringe assembly 200 from a large-capacity container, such as a liquid bag or a liquid bottle, that has a larger capacity than the syringe assembly 200. In this case, after the empty syringe assembly 200 is attached to the injection head 101a, the syringe assembly 200 and the large-capacity container are connected by a tube, and in this state, the syringe assembly 200 can be filled with the liquid by retracting the presser 131. However, if the syringe assembly 200 has a rodless type syringe 220, the presser 131 cannot be engaged with the piston 222 when the syringe assembly 200 is attached to the injection head 100a unless the piston 222 is at the rearmost end position.
[0095] Therefore, when filling syringe assembly 200 with a liquid medicine, first, syringe assembly 200 is attached to injection head 100a with piston 222 positioned at the rearmost end. Next, piston 222 is pushed toward the tip of syringe assembly 200 by presser 131, moving it to the frontmost end inside cylinder 221 and pushing out the air inside syringe 220. At this stage, the path to the injection needle or catheter is blocked, and syringe 220 is not fluidly connected to the blood vessel of the subject. Then, syringe assembly 200 is connected to a large-capacity container, and piston 222 is moved backward by presser 131.
[0096] Among the above series of operations, the forward movement of presser 131 for moving piston 222 from the rear end to the front end can be performed automatically. In this case, it is necessary that syringe assembly 200 is correctly attached to injection head 100a. Therefore, it is preferable to automatically move presser 131 forward when it is determined that syringe assembly 200 is correctly attached based on the detection results of closure detection sensor 11 and syringe detection sensor 112. The determination of whether syringe assembly 200 is correctly attached and the control of the forward movement of presser 131 can be performed by injection control unit 101. When closure detection sensor 111 and syringe detection sensor 112 are turned ON, injection control unit 101 determines that syringe assembly 200 is correctly attached, and controls the operation of piston drive mechanism 130 so that presser 131 moves piston 222 to the front end.
[0097] When determining whether the syringe assembly 200 is correctly attached to the injection head 100a based on the detection results of the closure detection sensor 111 and the syringe detection sensor 112, the order in which the closure detection sensor 111 and the syringe detection sensor 112 change from OFF to ON when the syringe assembly 200 is attached to the injection head 100a can be taken into consideration.
[0098] Depending on the arrangement of the closure detection sensor 111 and the syringe detection sensor 112, the detection accuracy of these sensors, and the like, the following patterns are possible for the order in which the sensors change from OFF to ON.
[0099] (i) Syringe detection sensor ON → Closure detection sensor ON For example, in a structure in which closure detection sensor 111 and syringe detection sensor 112 change from OFF to ON by moving second holding structure 142 on which syringe assembly 200 is placed to the closed position, if the detectable range of syringe detection sensor 112 is larger than the detectable range of closure detection sensor 111, when syringe assembly 200 is attached, syringe detection sensor 112 changes from OFF to ON, and then closure detection sensor 111 changes from OFF to ON. The same is true when syringe detection sensor 112 is arranged so that syringe assembly 200 is detected by placing syringe assembly 200 on second holding structure 142 in the open position.
[0100] (ii) Closure detection sensor ON → Syringe detection sensor ON If the detectable range of closure detection sensor 111 and the detectable range of syringe detection sensor 112 are reversed to pattern (i), when syringe assembly 200 is attached, closure detection sensor 111 changes from OFF to ON, and then syringe detection sensor 112 changes from OFF to ON.
[0101] (iii) The order in which the sensors turn ON does not matter. In cases other than pattern (i) and pattern (ii), the syringe detection sensor 112 may change from OFF to ON after the closure detection sensor 111 changes from OFF to ON, or the closure detection sensor 111 may change from OFF to ON after the syringe detection sensor 112 changes from OFF to ON. In such cases, regardless of the order in which the closure detection sensor 111 and the syringe detection sensor 112 change from OFF to ON, the condition for automatic forward movement of the presser 131 is that the closure detection sensor 111 and the syringe detection sensor 112 change from OFF to ON.
[0102] Injection head 100a may further include a limit sensor 113 (see FIG. 1) that detects when presser 131 is located at the rear end. If injection head 100a includes rear end limit sensor 113, injection control unit 101 preferably checks whether syringe assembly 200 is correctly attached to injection head 100a, as described above, after confirming that limit sensor 113 is ON.
[0103] After the syringe assembly 200 is attached, it may become necessary to remove the syringe assembly 200 for some reason. For such a case, it is preferable that the automatic forward movement is not started immediately when the attachment of the syringe assembly 200 is detected (both the closure detection sensor 111 and the syringe detection sensor 112 are turned ON), but is started after a predetermined time (e.g., 2 seconds) has elapsed since the attachment of the syringe assembly 200 is detected. In this case, if the second holding mechanism 142 is opened (at least one of the closure detection sensor 111 and the syringe detection sensor 112 is turned OFF) before the predetermined time has elapsed after the attachment of the syringe assembly 200 is detected, the automatic forward movement is canceled. During the above-mentioned predetermined time, the injection control unit 101 may notify the operator that the automatic forward movement can be canceled, for example, by displaying a message and / or a pictogram on the display unit 104, by generating a sound by a sound device, or by a combination of these. In this case, when the above-mentioned cancel operation is accepted, the display on display unit 104 and / or the sound from the sound generator are stopped. The start of automatic forward movement may further include a condition that no input operation is being performed on input unit 103 including operation button group 103a of injection head 101a.
[0104] The drug solution is filled into syringe assembly 200 with the tip side of injection head 100a facing upward. After filling syringe assembly 200 with the drug solution, the operator often lightly taps the rear end of syringe assembly 200 to remove air bubbles that have been introduced into syringe assembly 200 due to the filling of the drug solution. At this time, closure detection sensor 111 and syringe detection sensor 112 may malfunction, causing injection control unit 101 to determine that syringe assembly 200 has been attached to injection head 100a. This determination causes presser 131 to automatically move forward even though syringe assembly 200 is filled with the drug solution.
[0105] To prevent this, it is preferable that injection control unit 101, after presser 131 has automatically advanced, does not automatically advance again until injection of the liquid medicine is performed. It can be determined that the liquid medicine has been injected by the fact that presser 131 has advanced (through a retreating movement) after automatically advancing presser 131. However, since the above-mentioned air bleeding accompanies the advancement of presser 131, it is necessary to distinguish between air bleeding and injection of the liquid medicine. Therefore, when the advancement movement time of presser 131 exceeds the operation time of presser 131 for air bleeding, injection control unit 101 determines that the operation of presser 131 is an operation for injecting the liquid medicine. Usually, the operation time of presser 131 for air bleeding is less than 0.5 seconds, so that, for example, when presser 131 has advanced for 0.5 seconds or more, it can be determined that the operation of injecting the liquid medicine has been performed. Thereafter, when the closure detection sensor 111 and the syringe detection sensor 112 change from OFF to ON in the predetermined order described above, the injection control unit 101 can start the automatic advancement of the presser 131.
[0106] Also, during the automatic forward movement of the presser 131, the syringe detection sensor 112 may change from ON to OFF. In this case, it is considered that the syringe detection sensor 112 cannot detect the syringe assembly 200 due to a malfunction such as the liquid being applied to the syringe assembly 200. Therefore, when the syringe detection sensor 112 changes from ON to OFF during the automatic forward movement of the presser 131, it is preferable that the injection control unit 101 controls the operation of the piston drive mechanism 130 to stop the automatic forward movement of the presser 131. Also, when there is an ON / OFF change of the closure detection sensor 111 and the closure detection sensor 112 other than the above during the automatic forward movement, and when an operation other than an operation for "accelerating" or "decelerating" the forward movement of the presser 131 is performed on the input unit 103 including the operation button group 103a of the injection head 100a, the injection control unit 101 may control the operation of the piston drive mechanism 130 to stop the automatic forward movement. Furthermore, when the operation of piston drive mechanism 130 is stopped, injection control unit 101 may notify the operator that the operation has been stopped, for example, by displaying a message and / or a pictogram on display unit 104.
[0107] (6) Resetting the accumulated amount Injection control unit 101 can count the cumulative amount of injected medicinal liquid for each syringe assembly 200 based on the forward distance of presser 131, and store the counted cumulative amount in a memory within injection control unit 101. It is preferable that the cumulative amount is automatically reset when syringe assembly 200 is replaced. Thus, injection control unit 101 can be configured to reset the cumulative amount in the memory when syringe detection sensor 112 changes from OFF to ON (i.e., syringe assembly 200 is attached). Alternatively, in the case where injection head 100a has rear end limit sensor 113, injection control unit 101 can also be configured to reset the cumulative amount in the memory when limit sensor 113 is ON (i.e., presser 131 is located at the rear end) and closure detection sensor 11 changes from OFF to ON.
[0108] (7) Consideration of the order of detection by each sensor In a series of operations for mounting syringe assembly 100 on injection head 100a, which involves placing syringe assembly 200 on second holding structure 142 and then moving second holding structure 142, when syringe assembly 200 is mounted in a predetermined procedure, the order of detection by closure detection sensor 111 and syringe detection sensor 112 is often determined depending on the arrangement and type of closure detection sensor 111 and syringe detection sensor 112. When the order of detection by the sensors is determined in this manner, as long as syringe assembly 200 is mounted in the predetermined procedure, it is impossible for a sensor that should detect later to turn ON before a sensor that should detect first turns ON.
[0109] Therefore, it is preferable that the injection control unit 101 ignores the detection result of the sensor that is to be detected later unless the sensor that is to be detected first out of the closure detection sensor 111 and the syringe detection sensor 112 turns ON, or uses the change of the sensor that is to be detected first as a trigger to check the detection result of the sensor that is to be detected later. For example, when the syringe assembly 200 is attached, if the closure detection sensor turns ON first and then the syringe detection sensor 112 turns ON, the injection control unit 101 can ignore the detection result of the syringe detection sensor 112 unless the closure detection sensor 111 turns ON (the second holding structure 142 does not move to the closed position). Alternatively, the injection control unit 101 can use the change of the closure detection sensor 111 turning ON as a trigger to check the detection result of the syringe detection sensor 112.
[0110] (RFID system) Fig. 11 shows a block diagram of another embodiment of a system including a liquid injector. The system shown in Fig. 11 differs from the system shown in Fig. 1 in that it includes an RFID system, and can be used in place of liquid injector 100 and syringe assembly 200 shown in Fig. 1. The mechanical configuration of liquid injector 100, such as the clamper of injection head 100a, may be the same as those described above. Therefore, the following description will be mainly focused on the RFID system, and a detailed description of the mechanical configuration will be omitted.
[0111] As shown in FIG. 11, the RFID system includes a syringe assembly 200 having an RFID tag 223 and an RFID module 166 that reads data recorded on the RFID tag 223 .
[0112] RFID tag 223 is a type of data carrier that can be composed of a microchip. Therefore, RFID tag 223 can be attached to any position of syringe assembly 200. RFID tag 223 can be attached to syringe assembly 200 by any means, such as attaching RFID tag 223 to the surface of a member constituting syringe assembly 200 with an adhesive sheet or embedding RFID tag 223 in a member constituting syringe assembly 200.
[0113] 2, when the syringe assembly 200 has the syringe 220 and the protective cover 270, the RFID tag 223 may be attached to either the syringe 220 or the protective cover 270. However, when the RFID tag 223 is attached to the protective cover 270, the protective cover 270 and the syringe 220 need to be managed together, so from the viewpoint of ease of management, it is preferable that the RFID tag 223 is attached to the syringe 220. On the other hand, from the viewpoint of ease of securing a good communication distance for reading data, it is preferable that the RFID tag 223 is attached to the protective cover 270. The syringe 220 may be a prefilled type syringe provided by a pharmaceutical manufacturer in a state filled with a medicinal liquid, or may be a field-filled type syringe filled with a medicinal liquid at a medical site.
[0114] RFID module 166 has an RFID control circuit 164 and an antenna 165, and is configured to have a function (reader function) of reading data recorded in RFID tag 223 via antenna 165 and transmitting the read data to injection control unit 101. RFID module 166 can also have a function (writer function) of recording data transmitted from injection control unit 101 in RFID tag 223 via antenna 165. RFID control circuit 164 controls the data transmission and reception operations in RFID module 166.
[0115] The data recorded in the RFID tag 223 includes various data on the liquid medicine filled in the syringe 220, such as the manufacturer, type of liquid medicine, product number, contained ingredients (especially, iodine content concentration when the liquid medicine is a contrast medium), filled amount, lot number, expiration date, etc., as well as various data on the syringe 220, such as the manufacturer, product number, unique identification number, allowable pressure value, capacity, piston stroke, necessary dimensions of each part, lot number, etc. At least a part of this data can be transmitted to the medical imaging device 500 (see FIG. 1).
[0116] RFID module 166 may be incorporated in liquid injector 100, or may be a handheld module configured separately from liquid injector 100 and connected to liquid injector 100 so as to be able to send and receive data.
[0117] When RFID module 166 is incorporated in liquid injector 100, RFID control circuit 164 can be installed at any position on liquid injector 100. In FIG. 10, RFID control circuit 164 is shown installed on injection head 100a, but RFID control circuit 164 may be installed on console 100b. Antenna 165 can also be installed at any position on liquid injector 100, but antenna 165 is preferably installed at a position on injection head 100a that faces RFID tag 223 when syringe assembly 200 is attached to injection head 100a. This makes it possible to read out the data recorded on RFID tag 223 when attachment of syringe assembly 200 to injection head 100a is complete.
[0118] 11, only one of the two syringe assemblies 200 has an RFID tag 223, but all of the syringe assemblies 200 attached to injection head 100a may have RFID tags 223. In this case, RFID module 166 can have antennas 165 in the same number as the number of syringe assemblies 200 attached to injection head 100a, as necessary.
[0119] Further, although the above description has been given of the case where the data carrier is an RFID tag 223, the above description is not limited to a data reading system using RFID technology, and it is also possible to apply other data reading systems that can read various data about syringe assembly 200 from syringe assembly 200.
[0120] (Another form of drug container assembly) In the above-described embodiment, the syringe assembly 200 having the syringe 220 and the protective cover 270 has been exemplified as the liquid medicine container assembly. However, if the protective cover 270 is not necessary, the syringe assembly 200 may be composed of only the syringe 220. The liquid medicine container assembly may also be in a form other than a syringe, for example, in the form of a liquid medicine bag. The liquid medicine bag may have a flexible bag and a discharge tool attached to the bag for discharging the liquid medicine filled in the bag to the outside of the bag.
[0121] As a drive mechanism for discharging the liquid from the liquid container assembly of the liquid injector, a drive mechanism appropriate for the form of the liquid container assembly can be used. For example, when the liquid container assembly is a liquid bag, a tube-type pump or the like can be used as a drive mechanism for discharging the liquid from the liquid bag.
[0122] [Note] The present invention has been described in detail above, and the present specification discloses the invention described in the following appendices. However, the disclosure of the present specification is not limited to the following appendices.
[0123] (Appendix 1) A clamper for removably holding a drug solution container assembly, a first holding structure having a first receiving portion that receives a part of the drug solution container assembly in a circumferential direction; a second holding structure having a second receiving portion that receives a portion of the circumferential direction of the drug solution container assembly and that cooperates with the first holding structure to hold the drug solution container assembly; having A clamper in which the second holding structure is supported so as to be movable between an open position and a closed position relative to the first holding structure and so that in the open position the second receiving portion can receive a portion of the drug solution container assembly.
[0124] (Appendix 2) The clamper described in Appendix 1, wherein the first receiving portion and the second receiving portion are configured such that, in the open position, the first receiving portion and the second receiving portion each receive the drug solution container assembly so that they cannot move in the axial direction but can move in the radial direction, and in the closed position, the first receiving portion and the second receiving portion cooperate to hold the drug solution container assembly so that it cannot move in either the axial direction or the radial direction.
[0125] (Appendix 3) The clamper according to claim 2, wherein the first receiving portion and the second receiving portion are formed as recesses that receive a flange formed on an outer peripheral surface of the drug solution container assembly.
[0126] (Appendix 4) A clamper as described in any one of appendix 1 to 3, wherein the second retaining structure is configured to move from the closed position toward the open position to release the drug solution container assembly from the first receiving portion.
[0127] (Appendix 5) A clamper as described in Appendix 4, wherein the second retaining structure has a length along the outer periphery of the drug solution container assembly and is rotatably supported at an intermediate portion of the length so that a portion of the second receiving portion is positioned within the first receiving portion in the closed position.
[0128] (Appendix 6) A clamper as described in any one of appendix 1 to 5, wherein the second retaining structure, when in the open position, is in a position that blocks reception of the drug solution container assembly into the first receiving portion.
[0129] (Appendix 7) A clamper as described in Appendix 4, having an opening mechanism that releases the drug solution container assembly from the first receiving portion by moving the second holding structure from the closed position toward the open position.
[0130] (Appendix 8) 8. The clamper of claim 7, wherein the release mechanism is at least one spring plunger disposed in the first receiving portion.
[0131] (Appendix 9) 9. A clamper as described in any one of appendix 1 to 8, wherein the second holding structure has an adsorption structure that magnetically adsorbs the drug solution container assembly.
[0132] (Appendix 10) A clamper according to any one of appendixes 1 to 9; a drive mechanism for discharging the liquid contained in the liquid container assembly held by the clamper from the liquid container assembly; A drug solution injection device having the same.
[0133] (Appendix 11) 11. The liquid medicine injection device of claim 10, further comprising a read system for reading the data from the liquid medicine container assembly having a data carrier on which the data is recorded.
[0134] (Appendix 12) A liquid injector according to claim 10 or 11; a drug solution container assembly for containing a drug solution; A system having
[0135] (Appendix 13) 13. The system of claim 12, wherein the drug container assembly includes a drug syringe.
[0136] (Appendix 14) 14. The system of claim 13, wherein the liquid syringe is a prefilled liquid syringe. [Explanation of symbols]
[0137] 100 Chemical injection device 100a injection head 101 Injection control unit 111 Closure detection sensor 112 Syringe detection sensor 113 Rear limit sensor 120 Syringe assembly receiver 130 Piston drive mechanism 131 Pressa 140 Clamper 141 First retention structure 141a Flange receiving part 142 Second retention structure 142a Flange receiving part 143 Retaining Hook 144 Operating lever 145 Spring Plunger 150a center shaft 150b Clamper shaft 164 RFID control circuit 165 Antenna 166 RFID Module 200 Syringe Assembly 220 Syringe 223 RFID Tags 270 Protective Cover 271 Cover flange 500 Medical imaging device
Claims
1. A clamper for removably holding a drug solution container assembly, a first holding structure having a first receiving portion that receives a part of the drug solution container assembly in a circumferential direction; a second holding structure having a second receiving portion that receives a part of the circumferential direction of the drug solution container assembly and that cooperates with the first holding structure to hold the drug solution container assembly; having A clamper in which the second holding structure is supported so as to be movable between an open position and a closed position relative to the first holding structure and so that in the open position the second receiving portion can receive a portion of the drug solution container assembly.
2. The clamper described in claim 1, wherein the first receiving portion and the second receiving portion are configured so that in the open position, the first receiving portion and the second receiving portion each receive the drug solution container assembly so that they cannot move in the axial direction but can move in the radial direction, and in the closed position, the first receiving portion and the second receiving portion cooperate to hold the drug solution container assembly so that it cannot move in either the axial direction or the radial direction.
3. 3. The clamper according to claim 2, wherein the first receiving portion and the second receiving portion are formed as recesses that receive flanges formed on an outer peripheral surface of the drug solution container assembly.
4. 4. A clamper as described in claim 1, wherein the second retaining structure is configured to move from the closed position toward the open position to release the drug solution container assembly from the first receiving portion.
5. The clamper described in claim 4, wherein the second retaining structure has a length along the outer periphery of the drug solution container assembly and is rotatably supported at an intermediate portion of said length so that a portion of the second receiving portion is positioned within the first receiving portion in the closed position.
6. 6. The clamper according to claim 1, wherein the second holding structure is in a position that blocks the first receiving portion from receiving the drug solution container assembly when the second holding structure is in the open position.
7. The clamper according to claim 4 , further comprising an opening mechanism for releasing the drug solution container assembly from the first receiving portion by moving the second holding structure from the closed position toward the open position.
8. 8. The clamper of claim 7, wherein the release mechanism is at least one spring plunger disposed in the first receiving portion.
9. 9. The clamper according to claim 1, wherein the second holding structure has an attraction structure that magnetically attracts the drug solution container assembly.
10. A clamper according to any one of claims 1 to 9, a drive mechanism for discharging the liquid contained in the liquid container assembly held by the clamper from the liquid container assembly; A drug solution injection device having the same.
11. 11. The liquid medicine injector according to claim 10, further comprising a read system for reading out the data from the liquid medicine container assembly having a data carrier on which the data is recorded.
12. The drug solution injector according to claim 10 or 11, a drug solution container assembly for containing a drug solution; A system having
13. The system of claim 12 , wherein the medical fluid container assembly includes a medical fluid syringe.
14. The system according to claim 13 , wherein the liquid syringe is a pre-filled type liquid syringe.