Thermal mixer and device having fluids to be mixed used in thermal mixer

Abstract

A temperature-controlled mixing device is used to stir a fluid to be mixed in a mixing device at a predetermined temperature. The mixing device includes a magnetic stir bar housed therein. The temperature-controlled mixing device includes a heat exchange module, a magnetic stirring module, and a control module. The heat exchange module includes a heat exchange unit and a cooling and / or heating element. The magnetic stirring module includes a magnetic component and a drive component. The drive component is drively connected to the magnetic component. The control module is used to control the cooling and / or heating element to correspondingly regulate the fluid to be mixed in the mixing device to a predetermined temperature, and to drive the drive component to rotate the magnetic component so that the magnetic component drives the magnetic stir bar to rotate by magnetic attraction to mix the fluid to be mixed.

Description

Technical Field

[0001] This invention relates to a temperature-controlled mixing device and a mixing device for use in the temperature-controlled mixing device. Prior Technology

[0002] With the booming development of the biomedical industry, a large number of temperature-sensitive biomedical materials and / or biological cells are being used in biological agents (such as regenerative medicine (stem cell) preparations). The administration process of biological agents may require the homogenization of at least two materials to form a sterile biological agent, which is then directly injected for use.

[0003] However, when biological agents are mixed, the probability of contamination is relatively high, and the biological cells in the agents are prone to rupture due to excessive internal pressure, making it difficult to maintain cell viability. In addition, it is difficult to maintain a constant temperature during the mixing process, and the mixed biological agents are prone to denaturation due to excessively high temperatures.

[0004] Therefore, there is a need to provide an advanced temperature-controlled mixing device and a mixing device that uses the temperature-controlled mixing device. Summary of the Invention

[0005] An embodiment of the present invention discloses a temperature-controlled mixing device for stirring a fluid to be mixed in a mixing device at a predetermined temperature. The mixing device includes a magnetic stir bar housed therein. The fluid to be mixed includes a temperature-sensitive first material and a second material. The temperature-controlled mixing device includes a heat exchange module, a magnetic stirring module, and a control module. The heat exchange module includes a heat exchange unit and a cooling and / or heating element. The heat exchange unit includes a heat conduction element thermally coupled to the mixing device. The cooling and / or heating element is thermally coupled to the heat conduction element. The magnetic stirring module includes a magnetic component and a drive component. The magnetic component is spaced in a ring in the mixing device for magnetic coupling to the magnetic stir bar. The drive component is drively connected to the magnetic component for driving the magnetic component to rotate relative to the mixing device. The control module is communicatively connected to the cooling and / or heating elements and the drive assembly, and is used to control the cooling and / or heating elements to adjust the fluid to be mixed in the mixing device to a predetermined temperature, and to drive the drive assembly to rotate the magnetic assembly so that the magnetic assembly drives the magnetic stir bar to rotate by magnetic attraction to mix the fluid to be mixed.

[0006] Another embodiment of the present invention discloses a mixing device applicable to the temperature-controlled mixing device described above, wherein the mixing device includes: a magnetic stir bar for the fluid to be mixed and a device body. The fluid to be mixed includes a temperature-sensitive first material and a second material. The device body contains the fluid to be mixed and the magnetic stir bar, which are thermally coupled to the heat conduction element of the temperature-controlled mixing device and spaced apart from the magnetic component.

[0007] According to the temperature-controlled mixing device and mixing device disclosed in the above embodiments, a magnetic stir bar is placed in the mixing device containing a temperature-sensitive first material (e.g., biological cells or other temperature-sensitive biomedical materials), and the mixing device is placed in a heat exchange module. A heat exchange unit and cooling and / or heating elements are used to exchange heat with the mixing device to correspondingly regulate the temperature of the temperature-sensitive first material filled in the mixing device, thereby achieving constant temperature control of the mixing environment. Simultaneously, the magnetic component of the magnetic stirring module drives the magnetic stir bar located in the mixing device to rotate by magnetic attraction, and the rotation speed of the magnetic component is regulated by the control module. This allows for thorough mixing of the temperature-sensitive biomedical material and / or biological cells in a closed, sterile environment without excessively applying mechanical stress or pressure to the temperature-sensitive material. Simple Explanation of the Diagram

[0008] To provide a better understanding of the above and other aspects of this specification, specific embodiments are described below in conjunction with the accompanying drawings: Figure 1A is a perspective view of a temperature-controlled mixing device and a mixing device according to an embodiment of this specification; Figure 1B is a perspective view of some components of the temperature-controlled mixing device and the mixing device 140, based on Figure 1A; Figure 1C is a cross-sectional schematic diagram of some components of the temperature-controlled mixing device and the mixing device, based on Figure 1A; Figure 1D is a three-dimensional schematic diagram of the mixing device shown in Figure 1A; Figure 1E illustrates a structural schematic of the heat exchange unit and its auxiliary thermal insulation unit; Figure 2A is a perspective view of some components of a temperature-controlled mixing device, including a magnetic stirring module and with some structures omitted, based on Figure 1A; Figures 2B and 2C are partial side views of the temperature-controlled mixing device when the magnetic stirring module is operating at different heights, based on Figure 2A. Figure 2D is a three-dimensional schematic diagram of some components of the magnetic stirring module, based on Figure 2A; Figure 3A is a perspective view of a portion of the internal structure of a temperature-controlled mixing device, with some parts omitted, according to another embodiment of this specification. Figure 3B is a partial side view of the temperature-controlled mixing device, based on Figure 3A; and Figure 3C is a three-dimensional schematic diagram of some components including a magnetic stirring module, with some structures omitted, based on Figure 3A. Implementation

[0009] This invention provides a temperature-controlled mixing device and a mixing apparatus using this device. The device can regulate the temperature of temperature-sensitive materials contained within the mixing apparatus, achieving constant temperature control of the mixing environment. Simultaneously, it allows for thorough mixing of temperature-sensitive biomedical materials and / or biological cells in a closed, sterile environment without excessive mechanical stress or pressure on the temperature-sensitive materials. To make the embodiments and other objects, features, and advantages of this invention more apparent, several embodiments are described below in detail with reference to the accompanying drawings.

[0010] However, it must be noted that these specific embodiments and methods are not intended to limit the present invention. The present invention can still be implemented using other features, elements, methods, and parameters. The proposed preferred embodiments are merely illustrative of the technical features of the present invention and are not intended to limit the scope of the patent application. Those skilled in the art will be able to make equivalent modifications and variations based on the description in the following specification without departing from the spirit and scope of the present invention. In different embodiments and drawings, the same elements will be represented by the same element symbols.

[0011] Please refer to Figures 1A to 1D. Figure 1A is a perspective view of the temperature-controlled mixing device 100 and the mixing device 140 according to an embodiment of this specification. Figure 1B is a perspective view of some components of the temperature-controlled mixing device 100 and the mixing device 140 according to Figure 1A. Figure 1C is a cross-sectional view of some components of the temperature-controlled mixing device 100 and the mixing device 140 according to Figure 1A. Figure 1D is a perspective view of the mixing device 140 according to Figure 1A.

[0012] The temperature-controlled mixing device 100 includes a housing unit 150, a heat exchange module 110, a magnetic stirring module 120, and a control module 130, which are used to stir the fluid 140B to be mixed in the mixing device 140 at a predetermined temperature.

[0013] The mixing device 140 includes: a device body 140A, a fluid to be mixed 140B, and a magnetic stirrer 140C. The device body 140A is used to fill the fluid to be mixed 140B and to house the magnetic stirrer 140C. In one embodiment, the device body 140A can be a drug delivery device for temperature-sensitive materials, such as an injection syringe, which generally includes a hollow cylindrical body (not otherwise labeled), a flange 140A1 formed at the rear end of the body, and a push rod 140A2 that can be slidably fitted into the body along the axial direction of the body; the fluid to be mixed 140B and the magnetic stirrer 140C are housed within the body of the device body 140A.

[0014] The fluid to be mixed 140B can be a liquid fluid, solid fluid, liquid-solid fluid, or liquid-gas fluid that requires mixing or stirring, and includes a temperature-sensitive first material (not shown) and a second material (not shown). In one embodiment, the device body 140A of the mixing device 140 can be pre-filled with one of the temperature-sensitive first material and the second material, and the other of the temperature-sensitive first material and the second material can be injected / filled into the device body 140A as needed (e.g., for intraoperative use in one embodiment), thereby allowing the device body 140A of the mixing device 140 to contain the fluid to be mixed 140B, including the temperature-sensitive first material and the second material.

[0015] The temperature-sensitive first material is, for example, a temperature-sensitive biomedical material; specifically, the temperature-sensitive first material includes an injectable gel (in one embodiment, for example, highly biocompatible collagen) that can form a flowable state below a threshold temperature (e.g., human body temperature in one embodiment) and a non-flowable state above the threshold temperature. It is worth mentioning that, in one embodiment, the predetermined temperature is below the threshold temperature. The second material is, for example, a biological cell; specifically, the second material may include stem cells for regenerative medicine or living cells, intercellular matrix, culture medium, or other working solutions for other biomedical fields, but the invention is not limited thereto.

[0016] In one embodiment, the magnetic stir bar 160 is, for example, a permanent magnet magnetized along its axial direction with N-type and S-type magnetic poles at its opposite ends, used to stir various liquid fluids, solid fluids, liquid-solid fluids, or liquid-gas fluids. The magnetic stir bar 140C can be shaped as a rod, column, capsule, star, or any shaped disc, and is not limited thereto. In some embodiments, the outer surface of the magnetic stir bar 140C may also be covered with a protective coating (for example, a Teflon coating in one embodiment) to increase the water resistance and durability of the magnetic stir bar 140C.

[0017] The housing unit 150 houses the heat exchange module 110, the magnetic stirring module 120, and the control module 130, and includes an upper frame assembly 151 and a lower frame assembly 152. The upper frame assembly 151 includes a shelf 151A, a bracket 151B spaced apart from the shelf 151A, and a plurality of spacers disposed between the shelf 151A and the bracket 151B to support the shelf 151A and the bracket 151B relative to each other. The shelf 151A has an axially penetrating mounting hole 151O. The bracket 151B includes a bracket body 151B1 and a limiting groove 151B2 extending axially through the bracket body 151B1. The limiting groove 151B2 has a first groove portion 151B3 arranged axially on opposite top sides for the flange 140A1 of the mixing device 140's body 140A to abut against, and a second groove portion 151B4 located on opposite bottom sides for the cylinder of the mixing device 140's body 140A to be inserted into. The shelf 151A, bracket 151B, and support member 151C assembled together by the upper frame assembly 151 can jointly define the first working space 151S. In this embodiment, the support member 151C is fixedly positioned to the shelf 151A and bracket 151B respectively by a plurality of screw fasteners 153; however, the present invention is not limited thereto. In some embodiments, the support member 151C can also be connected and fixed to the shelf 151A and the bracket 151B by means such as welding or adhesive.

[0018] The lower frame assembly 152 is disposed on the bottom side of the upper frame assembly 151, which can define the second working space 152S and includes at least one through hole 152O communicating with the second working space 152S.

[0019] In some embodiments of this specification, the housing unit 150 may optionally include a cover plate 154 with an axially extending opening 154O. The cover plate 154 is detachably disposed in the limiting groove 151B2, and its opening 154O allows the push rod 140A2 of the mixing device 140 to pass through, thereby assisting in confining the flange 140A1 of the mixing device 140 within the first groove portion 151B3 of the limiting groove 151B2, and preventing the mixing device 140 from shifting or detaching during the mixing process.

[0020] The heat exchange module 110 includes a heat exchange unit 111, a cooling and / or heating element 112, and a heat dissipation unit 113, for thermally coupling the mixing device 140 to exchange heat with it. In some embodiments of this specification, the heat exchange unit 111 may include a heat conduction element 111A and a heat insulation element 111B.

[0021] The heat-conducting element 111A is generally cylindrical and made of a thermally conductive material (e.g., metal in one embodiment). It includes a first conductive portion 111A1 disposed in a first working space 151S of the upper frame assembly and passing through a mounting hole 151O in the shelf 151A, and a second conductive portion 111A2 integrally formed on the bottom side of the first conductive portion 111A1 and located in the second working space. The top opening of the first conductive portion 111A1 corresponds to the limiting groove 151B2 of the bracket 151B, for at least a portion of the mixing device 140 to be inserted for thermal coupling. In some embodiments of this specification, the radial cross-sectional area of ​​the second conductive portion 111A2 is larger than the radial cross-sectional area of ​​the first conductive portion 111A1, thereby increasing the thermal coupling area and improving the heat exchange efficiency. The heat insulation element 111B is made of at least one heat insulation material (in one embodiment, for example, polystyrene and / or thermal insulation cotton), and its shape corresponds to the heat conduction element 111A. It includes a first insulation part 111B1 that is disposed on the outside of the first conduction part 111A1 and similar in arrangement to the first conduction part 111A1, assembled in the first working space and passing through the mounting hole 151O of the shelf 151A, and a second insulation part 111B2 that is integrally formed on the bottom side of the first insulation part 111B1 and sandwiched between the shelf 151A and the second conduction part 111A2, for isolating the outside from the heat conduction element 111A.

[0022] In other embodiments of this specification, the heat exchange unit 111 may further include at least one auxiliary heat insulation unit 160. Please refer to Figure 1E, which is a schematic diagram illustrating the structure of the heat exchange unit 111 and its auxiliary heat insulation unit 160. The auxiliary heat insulation unit 160 includes: a first auxiliary heat insulation element 162, a second auxiliary heat insulation element 163, a first fixing member 161, and a second fixing member 164. The first auxiliary heat insulation element 162 (in one embodiment, for example, a heat-insulating collar with an attached edge) is made of heat-insulating material, is assembled on the second insulation portion 111B2, and partially protrudes from the layer plate 151A. The second auxiliary heat insulation element 163 (in one embodiment, for example, a washer-shaped heat-insulating collar) is also made of heat-insulating material, is sleeved on the first auxiliary heat insulation element 162, and sandwiches the layer plate 151A between the first auxiliary heat insulation element 162 and the first auxiliary heat insulation element 162. The first fixing member 161 and the second fixing member 164 are correspondingly assembled together to fix the first auxiliary heat insulation element 162 and the second auxiliary heat insulation element 163 to the second conductive part 111A2, the second insulating part 111B2, and the shelf 151A. In one embodiment, the first fixing member 161 is, for example, a screw, and the second fixing member 164 is, for example, a locking plate, but not limited thereto. In addition, in this embodiment, the number of auxiliary heat insulation units 160 is two, and they are arranged in a ring shape relative to the axis of the heat conduction element 111A and the heat insulation element 111B. In some embodiments, the number and arrangement of the auxiliary heat insulation units 160 can be adjusted according to design requirements, which will not be described in detail here. Through the mechanism design of the auxiliary heat insulation unit 160, the heat conduction element 111A and the heat insulation element 111B can be stably installed on the shelf 151A, and the heat conduction element 111A is isolated from the outside world together with the heat insulation element 111B.

[0023] A cooling and / or heating element 112 is disposed in the second working space 152S of the lower frame assembly. It is thermally coupled to the bottom side of the second conductive portion 111A2 of the heat conduction element 111A and is communicatively connected to the control module 130. The control module 130 can send signals to regulate the operating temperature of the cooling and / or heating element 112, thereby enabling the heat conduction element 111A, together with the mixing device 140 inserted therein, to be cooled and / or heated to a predetermined temperature. In some embodiments of this specification, the cooling and / or heating element 112 may include a thermoelectric cooling chip. Utilizing the Peltier effect of the semiconductor material of the thermoelectric cooling chip, when direct current passes through multiple electrical couplers (not shown) composed of two semiconductor materials with different electrical properties (P-type semiconductor bumps and N-type semiconductor bumps) connected in series, heat can be absorbed and released at the two ends of the electrical coupler respectively, for the purpose of cooling and / or heating.

[0024] The heat dissipation unit 113 is also housed in the second working space 152S, and includes: a heat spreader 113A, a fan assembly 113B, a heat pipe assembly 113C, and a fin assembly 113D, for dissipating heat from the cooling and / or heating element 112 together with the heat conduction element 111A and the mixing device 140. The heat spreader 113A is thermally coupled to the cooling and / or heating element 112 and the heat pipe assembly 113C at opposite ends, respectively; the heat pipe assembly 113C is thermally coupled to the fin assembly 113D on the side away from the heat spreader 113A; the fan assembly 113B is spaced apart on the opposite outer side of the heat pipe assembly 113C and the fin assembly 113D, and its assembly position corresponds to the through hole (not otherwise labeled) of the lower frame assembly 152, for promoting heat conduction and heat convection in the second working space 152S and exhausting air to the through hole. The fan assembly 113B is communicatively connected to the control module 130, and the control module 130 can send signals to control the rotation of the fan assembly 113B. In this embodiment, the heat dissipation unit consists of a heat spreader, a fan assembly with multiple fans, a heat pipe assembly with multiple heat pipes, and a fin assembly with multiple fins, but the present invention is not limited thereto. In some embodiments, the heat dissipation unit can adjust its structural composition and the number of each component according to design requirements (e.g., heat dissipation efficiency in one embodiment), which will not be elaborated here.

[0025] Please refer to Figures 2A to 2D. Figure 2A is a perspective view of some components of the temperature-controlled mixing device 100, including the magnetic stirring module 120 and with some structures omitted, based on Figure 1A. Figures 2B and 2C are partial side views of the temperature-controlled mixing device 100 when the magnetic stirring module 120 is operating at different heights, based on Figure 2A. Figure 2D is a perspective view of some components of the magnetic stirring module 120 shown in Figure 2A. As shown, the magnetic stirring module 120 includes a magnetic component 121, a drive component 122, and a support component 123, used to drive the magnetic stir bar 140C in the mixing device 140 to rotate at least one predetermined speed by magnetic attraction.

[0026] A magnetic component 121 is spaced in a ring around a heat exchange unit 111, together with a mixing device 140 inserted into the heat exchange unit 111, and includes an annular rotor 121A and a magnet unit 121B. The annular rotor 121A has an axially penetrating opening 121O that allows the heat exchange unit 111 and the mixing device 140 to pass through it. The magnet unit 121B may include at least one N-type magnetic element 121B1 and at least one S-type magnetic element 121B2 embedded in the annular rotor 121A and arranged opposite to each other, for magnetic coupling to a magnetic stir bar 140C in the mixing device 140. The N-type magnetic element 121B1 and the S-type magnetic element 121B2 have the same number, shape, size, and magnetic attraction field. In this embodiment, the N-type magnetic element 121B1 and the S-type magnetic element 121B2 are, for example, one magnetically coupled to the magnetic stirrer 140C; however, the present invention is not limited to the number of N-type magnetic elements 121B1 and S-type magnetic elements 121B2. In other embodiments, the number of N-type magnetic elements 121B1 and S-type magnetic elements 121B2 may be two or more. Furthermore, in one embodiment, the N-type magnetic element 121B1 and the S-type magnetic element 121B2 may each be a permanent magnet, for example, a magnet made of a rare earth metal or a neodymium iron boron magnet, and the magnetic attraction force of the N-type magnetic element and the S-type magnetic element is greater than the magnetic attraction force of the N-type magnetic pole and the S-type magnetic pole of the magnetic stirrer 140C.

[0027] The drive assembly 122 includes: a belt 122B, a belt drive pulley 122C connected to the annular rotor 121A via the belt 122B, and a drive motor 122D pivotally mounted on its shaft 122A and the belt drive pulley 122C, for driving the annular rotor 121A of the magnetic assembly 121 to rotate relative to the heat exchange unit 111 and the mixing device 140. The drive motor is communicatively connected to the control module 130, and the control module 130 can send signals to control the rotation of the drive motor. In this embodiment, the drive assembly drives the magnetic assembly to rotate via the belt, belt drive pulley, and drive motor, but the present invention is not limited to the form of the drive assembly. In other embodiments, the drive assembly may also be any form that enables the magnetic assembly to rotate relative to the heat exchange unit and the mixing device. When the control module 130 controls the drive motor 122D to rotate, the rotating shaft 122A pivotally connected to the drive motor 122D will drive the belt drive pulley 122C to rotate. The belt 122B will drive the annular rotor 121A of the magnetic component 121, together with the magnet unit 121B, to rotate relative to the heat exchange unit 111 and the mixing device 140. Simultaneously, the N-type magnetic component and the S-type magnetic component of the magnet unit 121B will drive the magnetic stir bar 140C of the mixing device 140 to rotate by magnetic attraction to stir the fluid 140B to be mixed.

[0028] Please refer to Figure 1A. The support assembly 123 is mounted on the housing unit and includes: a support base 123A for mounting the magnetic assembly 121 and the drive assembly 122, and a vertical bracket 123B. One end of the vertical bracket 123B is mounted on the lower frame assembly 152, and the other end is mounted together with the support base 123A. The support base 123A includes: a platform 123A1, generally inverted L-shaped, mounted with the vertical bracket 123B; a mounting plate 123T, generally annular; and a plurality of retaining members 123C, spaced apart from each other, located between the platform 123A1 and the mounting plate 123T. The platform 123A1 partially protrudes from the first working space and has a through hole 123O corresponding to the limiting groove 151B2 of the bracket 151B, for passing through the heat exchange unit 111 of the magnetic assembly 121 and the mixing device 140. Each retaining member 123C has a body portion 123CB that passes through the platform 123A1 and the mounting plate 123T at its opposite ends, and two retaining portions 123CH (e.g., support wheels) spaced apart in the body portion 123CB for the outer edges of the top and bottom sides of the annular rotor 121A of the magnetic component 121 to abut against each other. This allows the annular rotor 121A of the magnetic component 121 to be rotatably retained between the retaining portions 123CH of the retaining members 123C. The belt 122B and belt drive wheel 122C of the drive assembly 122 are located on the top side of the platform 123A1 in cooperation with the annular rotor 121A of the magnetic component 121. The drive motor 122D is assembled on the bottom side of the platform 123A1 and its shaft 122A passes through the platform 123A1 to be pivotally connected to the belt drive wheel 122C. At this time, the outer edges of the top and bottom sides of the annular rotor 121A are only in movable contact with the holding portion 123CH of the holding member 123C, and are spaced apart from the stage 123A1 and the mounting plate 123T (i.e., not in contact). In this embodiment, for example, there are six holding members to securely hold the annular rotor; however, the present invention is not limited to the number of holding members. In other embodiments, there may be two to five, or more than six, holding members, as long as the annular rotor is rotatably held relative to the holding members.

[0029] In some embodiments of this specification, the support assembly 123 may also include a lifting assembly 124 disposed between the support base 123A and the vertical support 123B, for example, to move the support base 123A relative to the vertical support 123B in the vertical direction, thereby causing the support base 123A together with the magnetic assembly 121 to be displaced relative to the heat exchange unit 111 and the mixing device 140 in the vertical direction (i.e., the axial direction of the magnetic assembly 121 together with the heat exchange unit 111), and simultaneously causing the magnet unit 121B of the magnetic assembly 121 to drive the magnetic stir bar 140C of the mixing device 140 to be displaced in the vertical direction by magnetic attraction.

[0030] The lifting assembly 124 includes: a first sliding member 124A (in one embodiment, for example, a slider) coupled to the side of the support 123A relative to the vertical bracket 123B; a second sliding member 124B (in one embodiment, for example, a guide groove 124D) assembled to the vertical bracket 123B and correspondingly slidable on the first sliding member 124A; and a lifting drive mechanism 124C (in one embodiment, for example, a linear slide including a ball screw, a ball nut, a belt, and a lifting motor) driven by the first sliding member 124A for driving the first sliding member 124A to slide vertically relative to the second sliding member 124B. The lifting drive mechanism 124C is communicatively connected to the control module 130, and the control module 130 can send signals to control the movement of the lifting drive mechanism 124C. By controlling the lifting drive mechanism 124 through the control module 130, the support seat 123A together with the first sliding member 124A can slide vertically relative to the second sliding member 124B, thereby adjusting the vertical height of the magnetic component 121 relative to the magnetic stir bar 140C of the mixing device 140, and then changing the height position of the magnetic stir bar 140C in the mixing device 140 by magnetic attraction.

[0031] Please refer to Figures 1A, 2B, and 2C. The control module 130 is located in the housing unit and is communicatively connected to the cooling and / or heating element 112 and fan assembly 113B of the heat exchange unit 110. It is used to regulate the operating temperature of the cooling and / or heating element 112 so that the fluid 150 to be mixed in the mixing device 140 can be stirred at a predetermined temperature. The control module 130 is also communicatively connected to the drive motor 122D of the drive assembly 122 of the magnetic stirring module 120. It is used to correspondingly regulate the mixing speed and mixing time of the magnetic assembly 121 and its magnet unit 121B relative to the magnetic stir bar 140C of the mixing device 140. The control module 130 is also communicatively connected to the lifting drive mechanism of the lifting assembly 124 of the magnetic stirring module 120. It is used to correspondingly regulate the mixing position of the magnetic assembly 121 and its magnet unit 121B relative to the magnetic stir bar 140C of the mixing device 140.

[0032] When the lifting drive mechanism of the lifting assembly 124, together with the first sliding member 124A, the support seat 123A, and the magnetic assembly 121, slides down or up in the vertical direction under the control module 130, and when the drive motor 122D of the drive assembly 122 rotates in conjunction with the magnetic assembly 121 and its magnet unit 121B under the control module 130, the magnetic stirrer 140C of the mixing device 140, which is affected by the magnetic attraction of the magnet unit 121B of the magnetic assembly 121, also moves down or up and / or rotates synchronously, and stirs the fluid 140B to be mixed up and down, thereby promoting uniform mixing and improving mixing efficiency. During the mixing process, the cooling and / or heating elements 112 and / or fan assembly 113B can also be controlled by the control module 130 to stir at a predetermined temperature, so as to avoid the material properties of the liquid to be mixed being affected by temperature changes during the mixing process (for example, material denaturation or damage to the second material in one embodiment).

[0033] Please refer to Figures 3A to 3C. Figure 3A is a perspective view of the temperature-controlled mixing device 300 and some components of the mixing device 140, with some structures omitted, according to another embodiment of this specification. Figure 3B is a partial side view of the temperature-controlled mixing device 300, based on Figure 3A. Figure 3C is a perspective view of some components including the magnetic stirring module 120, with some structures omitted, based on Figure 3A. The structure of the temperature-controlled mixing device 300 is generally similar to that of the temperature-controlled mixing device 100, except that the housing unit 350 omits the upper frame assembly 151, and the structure of the bracket 311C is different.

[0034] In this embodiment, the magnetic component 121 and drive component 122 of the magnetic stirring module 120 are fixed in the second working space 352S of the lower frame assembly 352 of the housing unit 350 by the support component 323 (including the bearing seat 323A). The bracket 311C for supporting and positioning the flange 140A1 of the mixing device 140 is an integrally formed and continuously bent plate structure, and has a bracket body 311C1 in a general Z-shape, and a limiting part 311C3 formed on the free end of the top side of the bracket body 311C1; the bottom side of the bracket body 311C1 is fixed to the shelf 352A of the lower frame assembly 352 of the housing unit 350. By means of the mechanism design of the bracket 311C, the flange 140A1 of the mixing device 140 can be limited to the bracket body 311C1 and the limiting part 311C3, so as to prevent the mixing device 140 from shifting or falling off during the mixing process.

[0035] The following describes the mixing test of the temperature-controlled mixing device 100 using a mixing device 140 containing biological cells and biomedical material colloids, and compares it with the conventional manual mixing method using syringes under the same conditions to verify the mixing effect of the temperature-controlled mixing device 100.

[0036] In one embodiment of this specification, the fluid to be mixed (e.g., containing 1.8 ml of biomedical material colloid (e.g., BIO-INK) and 0.2 ml of mesenchymal stem cells (MSCs)) is added to the mixing device, which is then placed in a temperature-controlled mixing device 100 for mixing. The magnetic stir bar 140C is set to rotate at 30 times per minute (rpm) for 12 minutes. In a control group, a syringe containing the biomedical material colloid is connected to another syringe containing mesenchymal stem cells, and the mixture is manually pushed back and forth several times (e.g., 40 times). Afterward, the syringes in both the mixing device and the control group are divided into upper, middle, and lower sections. 0.6 ml of the contents from each section is taken out, and the number of cells and the viability of cells in each section are calculated using a cell counter (Adam). The coefficient of variation (CV = deviation / mean) of the cell count and viability is calculated to assess the mixing uniformity.

[0037] The test results are shown in Table 1 (Examples in this specification) and Table 2 (Control Group): Table 1 Example Total number of cells Survival rate V% average Mean standard deviation (std) coefficient of variation CV superior 1.72E +05 93% 1.80E +05 6018.5 3.34% middle 1.83E +05 89% Down 1.86E +05 85% Table 2 control group Total number of cells Survival rate V% Mean standard deviation (std) coefficient of variation CV superior 2.20E +05 78% 2.31E +05 24916 10.38% 2.32E +05 79% middle 2.04E +05 90% 2.74E +05 89% Down 2.51E +05 88% 2.06E +05 80%

[0038] The test results show that the coefficient of variation of the three parts of the mixing device after mixing with the temperature-controlled mixing device 100 is 3.34%, which is much smaller than the coefficient of variation of the same three parts after manual mixing with a syringe (10.78%) in the control group. Therefore, the cell uniformity is better when mixed with the temperature-controlled mixing device 100.

[0039] In another embodiment of this specification, another mixing test was conducted. 1.8 ml of biomedical material colloid and 0.2 ml of mesenchymal stem cells were respectively filled into two mixing devices, and then placed into two temperature-controlled mixing devices 100 for mixing. Next, the control module 130 was used to turn off the heat exchange module 110 of one temperature-controlled mixing device 100 and turn on the heat exchange module 110 of the other temperature-controlled mixing device 100, thereby comparing the mixing effect with and without temperature control under the same conditions (the magnetic stir bar 140C was rotated at 30 times per minute for 12 minutes).

[0040] The test results are shown in Table 3: Table 3 Average number of cells Mean standard deviation (std) coefficient of variation CV Low temperature control 5.41E+05 1.81E +04 3.34% No temperature control 5.53E+05 1.89E +05 34.11%

[0041] The test results showed that after mixing under low temperature control, the coefficient of variation of the three parts was 3.34%, which was much smaller than the coefficient of variation of the three parts (34.11%) after mixing without temperature control.

[0042] In another embodiment of this specification, another mixing test was conducted. 1.8 ml of biomedical material colloid and 0.2 ml of mesenchymal stem cells were respectively filled into two mixing devices 140, and then placed into two temperature-controlled mixing devices 100 for mixing. During the mixing process, the control module 130 controlled the magnetic stirring module 120 of one of the temperature-controlled mixing devices 100 to reciprocate downward and upward movements relative to its mixing device 140 (as shown in Figures 2B and 2C). Simultaneously, the magnetic stirring module 120 of the other temperature-controlled mixing device 100 was controlled to be in a lower operating position relative to its mixing device (as shown in Figure 2B). Then, staining agent was added, and the mixing effect was visually compared. The test results showed that the mixing effect of the temperature-controlled mixing device, which could be slidably moved to different heights (as shown in Figures 2B and 2C), was significantly better.

[0043] According to the above embodiments, this specification provides a temperature-controlled mixing device and a mixing device, wherein the mixing device containing a temperature-sensitive first material houses a magnetic stir bar, and the temperature-controlled mixing device provides a heat exchange unit and its cooling and / or heating elements to adjust the mixing temperature of the mixing device during the mixing process, thereby achieving constant temperature control of the mixing environment; and the temperature-controlled mixing device provides a magnetic stirring module with a magnetic component and a lifting component to adjust the mixing position and mixing speed of the magnetic stir bar of the mixing device during the mixing process, so as to achieve the purpose of fully mixing temperature-sensitive biomedical materials and / or biological cells in a closed sterile environment without excessively applying mechanical stress and pressure to the fluid to be mixed.

[0044] Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Anyone skilled in the art can make some modifications and refinements without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention shall be determined by the appended claims.

[0045] 100: Temperature-controlled mixing device 110: Heat exchange module 111: Heat exchange unit 111A: Heat transfer element 111A1: First Conducting Section 111A2: Second Conducting Section 111B: Thermal insulation element 111B1: First Isolation Section 111B2: Second Isolation Section 112: Cooling and / or heating elements 113: Heat dissipation unit 113A: Heat Spreader Plate 113B: Fan Assembly 113C: Heat pipe assembly 113D: Fin assembly 120: Magnetic stirring module 121: Magnetic Components 121A: Annular rotor 121B: Magnet Unit 121O: Opening 121X: Central axis 122: Driver Components 122A: Shaft 122B: Belt 122C: Belt drive pulley 122D: Drive motor 123: Support components 123A: Support base 123A1: Platform 123B: Vertical support 123C: Holding component 123CB: Body part 123CH: Fixed Section 123O: Through hole 123T: Mounting plate 124: Lifting Component 124A: First sliding member 124B: Second slider 124C: Lifting drive mechanism 124D: Guide groove 130: Control Module 131: Circuit Components 140: Mixing device 140A:Device body 140A1: Flange 140A2: Pulley 140B: Fluid to be mixed 140C: Magnetic stir bar 150: Housing Unit 151: Upper Frame Group 151A: Sheet 151B: Bracket 151B1: Bracket Body 151C: Support component 151B2: Limiting groove 151B3: First slot 151B4: Second groove section 151C: Support component 151S: First Workspace 151O: Mounting Hole 152: Lower Frame Group 152S Second Workspace 152O through hole 153: Screw Locking Parts 154: Cover plate 154O: Opening 160: Auxiliary thermal insulation element 161: First fastener 162: First auxiliary thermal insulation element 163: Second auxiliary thermal insulation element 164: Second fastener 300: Temperature-controlled mixing device 311C: Bracket 311C1: Bracket Body 311C3: Limiting part 323: Support Components 323A: Bearing base 350: Housing Unit 352A: Sheet 352: Lower Frame Group 352S: Second Workspace

[0046] none

Claims

1. A temperature-controlled mixing device for stirring a fluid to be mixed in a mixing device at a predetermined temperature, the mixing device including a magnetic stir bar housed therein, the fluid to be mixed including a temperature-sensitive first material and a second material, the temperature-controlled mixing device comprising: a heat exchange module including: A heat exchange unit includes a heat conduction element thermally coupled to the mixing device; And a consistent cooling and / or heating element, thermally coupled to the heat conduction element; A magnetic stirring module includes: a magnetic component, spaced in a ring around the mixing device for magnetic coupling to the magnetic stir bar; and a drive component, connected to the magnetic component for driving the magnetic component to rotate relative to the mixing device; and a support component, including: a support base for assembling the magnetic component and the drive component. A vertical support, with the support base assembled together; and a lifting assembly, disposed between the support base and the vertical support, for driving the support base to move relative to the vertical support in a vertical direction, thereby causing the support base, together with the magnetic assembly, to move relative to the heat exchange unit and the mixing device in the vertical direction, and simultaneously driving the magnetic stir bar in the mixing device to move in the vertical direction by magnetic attraction; and a control module, communicatively connected to the cooling and / or heating element and the drive assembly, for controlling the cooling and / or heating element to correspondingly adjust the mixing fluid in the mixing device to be at the predetermined temperature, and driving the drive assembly to drive the magnetic assembly to rotate so that the magnetic assembly drives the magnetic stir bar to rotate by magnetic attraction to mix the mixing fluid.

2. The temperature-controlled mixing device as described in claim 1, wherein the magnetic component comprises: An annular rotor is provided for the heat exchange unit and the mixing device to pass through, and is connected to the drive assembly for transmission. And a magnet unit, including at least one N-type magnetic element and at least one S-type magnetic element embedded in the annular rotor and arranged opposite to each other, for magnetically coupling to the magnetic stir bar of the mixing device.

3. The temperature-controlled mixing device as described in claim 2, wherein the drive assembly includes a belt, a belt drive pulley that is driven by the belt to the annular rotor, and a drive motor pivotally connected to the belt drive pulley and communicatively connected to the control module; when the control module drives the drive motor to rotate the belt drive pulley, the belt will drive the annular rotor and the magnet unit to rotate relative to the heat exchange unit and the mixing device.

4. The temperature-controlled mixing device as described in claim 1, wherein the support base comprises: A platform, assembled with the vertical support; a mounting plate, spaced apart from the platform; And a number of retaining members, fixed between the platform and the mounting plate and spaced apart from each other, the retaining members being in movable contact with the annular rotor, so that the annular rotor is rotatably held between the retaining members.

5. The temperature-controlled mixing device as described in claim 1, wherein the lifting assembly comprises: A first sliding member is attached to one side of the bearing seat relative to the vertical support; A second sliding member is assembled on the vertical support and can be correspondingly slidably disposed on the first sliding member; and a lifting drive mechanism is drivenly connected to the first sliding member to drive the first sliding member to slide relative to the second sliding member in the vertical direction.

6. The temperature-controlled mixing device as claimed in claim 1, wherein the heat exchange unit further includes a heat insulation element disposed on the outside of the heat conduction element to isolate the outside from the heat conduction element.

7. The temperature-controlled mixing device as claimed in claim 6, wherein the heat exchange unit further includes an auxiliary heat insulation unit installed on the heat conduction element and the heat insulation element, for isolating the outside world from the heat conduction element together with the heat insulation element.

8. A mixing apparatus suitable for a temperature-controlled mixing apparatus as described in any one of claims 1 to 7, the mixing apparatus comprising: a mixing fluid including a temperature-sensitive first material and a second material; a magnetic stir bar; and an apparatus body for receiving the mixing fluid and the magnetic stir bar for thermal coupling with the heat-conducting element of the temperature-controlled mixing apparatus and spaced apart from the magnetic component.

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