Fluid sets and related apparatus for pharmaceutical preparation
By combining automated equipment and fluid devices, the problems of human error and operational risks in the preparation of chemotherapy drugs have been solved, enabling precise and safe preparation of chemotherapy drugs and reducing the training needs of operators and the complexity of drug management.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- BIOVALLEY GRP SPA
- Filing Date
- 2021-05-04
- Publication Date
- 2026-06-19
AI Technical Summary
Existing technologies for chemotherapy drug preparation suffer from problems such as poor precision due to human error, high operator training requirements, significant occupational risks, and difficulties in drug management, making it difficult to achieve accurate and safe drug preparation.
A device comprising a base, rotor, and fluid mechanism is used to achieve precise mixing and dispensing of chemotherapy drugs through automated operating tools and control units, reducing human intervention and ensuring the safe and accurate preparation of drugs.
It improves the precision and safety of chemotherapy drug preparation, reduces occupational risks for operators, simplifies drug management processes, and reduces drug waste.
Smart Images
Figure CN115768392B_ABST
Abstract
Description
[0001] Cross-references to related applications
[0002] This patent application claims priority to Italian Patent Application No. 102020000009751, filed on May 4, 2020, the entire disclosure of which is incorporated herein by reference. Technical Field
[0003] This invention relates to fluid groups and related equipment for drug preparation. Background Technology
[0004] As is well known, the ability to administer chemotherapy drugs precisely and individually to each patient is particularly critical in the field of oncology. In fact, because the effective therapeutic concentration (or therapeutic range) window of chemotherapy drugs used in cancer treatment is very narrow, they can produce significant toxic effects.
[0005] From an operational perspective, numerous critical factors exist in the preparation and management of cancer treatment, a process that currently remains largely based on manual intervention by trained operators (e.g., medical staff and / or healthcare professionals). This has negative consequences for both patients and operators, making it difficult to align with advanced and modern healthcare management.
[0006] In particular, the manual preparation of chemotherapy drugs (such as removing components from their respective containers and mixing them together) increases the risk of drug contamination and preparation errors. Furthermore, operators involved in these processes are exposed to these components and drugs, which, due to their toxicity, could potentially have negative impacts on their health.
[0007] The key elements include the following:
[0008] - Poor precision in the preparation of cancer drugs due to human error;
[0009] -In-depth education and specialized training are required for operators responsible for administering chemotherapy drugs;
[0010] - Difficulty in managing large quantities of unused, extremely expensive drugs;
[0011] - Operators involved in the preparation of chemotherapy drugs face high occupational risks.
[0012] Disclosure of the invention
[0013] The purpose of this invention is to provide fluid assembly and related equipment for drug preparation, which overcome the shortcomings of the prior art.
[0014] According to the present invention, a fluid assembly and related apparatus for drug preparation as defined in the appended claims are realized. Brief description of the attached diagram
[0016] To better understand the present invention, preferred non-limiting embodiments thereof will now be described with reference to the accompanying drawings by way of non-limiting examples and in a triaxial Cartesian system XYZ, wherein:
[0017] - Figure 1 This is a schematic perspective view of an apparatus for preparing chemotherapy drugs according to one embodiment;
[0018] - Figure 1A yes Figure 1 A schematic top view of the device in the XY plane;
[0019] - Figure 1B yes Figure 1 A schematic side view of the device in the XZ plane;
[0020] - Figure 2 It is included according to an implementation plan. Figure 1 A schematic perspective view of a fluid device in an apparatus;
[0021] - Figure 3 yes Figure 2 A schematic exploded view of a fluid apparatus;
[0022] - Figure 4 yes Figure 2 A schematic exploded view showing the details of the fluid device;
[0023] - Figures 5A-5D yes Figure 1 A schematic side view of the device in the XZ plane showing details of its operation in the corresponding mode, including... Figure 2 Fluid apparatus;
[0024] - Figure 6 This shows the implementation. Figure 1 A block diagram of the method for using the device.
[0025] Best mode for carrying out the present invention
[0026] In particular, these figures are illustrated with reference to a three-axis Cartesian system XYZ defined by mutually orthogonal X, Y, and Z axes. Gravitational acceleration is then assumed to act along the Z-axis.
[0027] In the following description, elements common to the various embodiments of the invention are indicated by the same reference numerals.
[0028] Figure 1 , Figure 1A and Figure 1B An apparatus for preparing chemotherapeutic drugs is shown (hereinafter referred to as the "apparatus" and indicated by reference number 1).
[0029] The device 1 includes a base 3 configured to rest on a support (not shown, such as a table, a piece of furniture, or a platform), specifically on a surface of the support (not shown) extending in a horizontal XY plane defined by the X and Y axes. The base 3 has an upper surface 3a and a lower surface 3b that are opposite to each other along the Z-axis and extend substantially parallel to each other and parallel to the XY plane.
[0030] The first rotor 9 and the second rotor 11 are supported by the base 3 and have a substantially flat shape. Specifically, the first rotor 9 and the second rotor 11 have main extensions in the XY plane and have a substantially flat circular shape in the XY plane. The rotors 9 and 11 are arranged stacked on top of each other, coaxial with each other, and connected to the base 3 via a central stator 13 fixed to an upper surface 3a, extending perpendicularly to said surface 3a and arranged at the center of the rotors 9 and 11. Specifically, the linear stator 13 has a main extension along a rotation axis 15 parallel to the Z-axis and includes, for example, a rod. The stator 13 has a first lower end (not shown) and a second upper end 13b opposite each other along the Z-axis and is fixed to the base 3 via the first lower end. The rotors 9 and 11 are connected to the stator 13 in a manner known per se (e.g., via corresponding bearings (not shown)) and are configured to rotate relative to the stator 13. Specifically, the stator 13 is centrally positioned relative to the rotors 9 and 11, which rotate relative to the rotation axis 15 (orthogonal to the plane of rotation) in their respective planes of rotation (parallel to the XY plane). Therefore, the rotors 9 and 11 are positioned at different levels along the Z-axis, and in particular, the first (lower) rotor 9 faces the upper surface 3a of the base 3 and is positioned along the Z-axis at a distance from the upper surface 3a that is smaller than the distance shown by the second (upper) rotor 11. In other words, the first lower rotor 9 is positioned along the Z-axis between the base 3 and the second upper rotor 11.
[0031] The first rotor 9 includes a plurality of first seats 17, each first seat 17 being configured to receive a corresponding fluid device 21, as better described below. Each fluid device 21 is connected to a corresponding first fluid container 22 (hereinafter referred to as first container 22). In particular, each first container 22 of a known type includes a first body 22a (e.g., bottle, vial, ampoule) defining a first internal volume and having a through opening closed by a first cap 22b (e.g., made of silicone). Each first container 22 is adapted to contain a corresponding ingredient and is releasably connected at the cap 22b to the corresponding fluid device 21 (e.g., by interlocking), as better described below. Specifically, the first containers 22 and the corresponding fluid devices 21 are arranged at angular intervals at the outer edge of the first rotor 9.
[0032] The second rotor 11 includes a plurality of second seats 19 configured to accommodate corresponding plurality of supports 23. Specifically, each support 23 is releasably connected to a corresponding second seat 19. Each support 23 includes a first surface 23a and a second surface 23b that are opposite to each other along the Z-axis. Figure 5A Each support 23 includes a corresponding second portion (extending at a second surface 23b) shaped to be releasably fitted into a corresponding second seat 19, for example by interlocking to secure the support 23 to the corresponding second seat 19. Thus, the second surface 23b of the support 23 faces the second rotor 11. Each support 23 is releasably connected to a corresponding second fluid container 24 (hereinafter referred to as second container 24), also of a known type. Specifically, each second container 24 includes a second body 24a (e.g., bottle, vial, ampoule) defining a second internal volume and having a through opening closed by a second cap 24b (e.g., made of silicone). Each second container 24 is adapted to contain a corresponding chemotherapy drug to be administered to a corresponding patient. Each second container 24 is releasably connected (e.g., by interlocking) to a corresponding support 23 at a cap 22b. Thus, each cap 22b faces the first surface 23a of the corresponding support 23. Specifically, the second container 24 and the corresponding support 23 are arranged at an angle and at equal intervals at the outer edge of the second rotor 11.
[0033] The diameter of the second rotor 11 is larger than the corresponding diameter of the first rotor 9.
[0034] The operating device 5 is connected (particularly fixed) to the upper surface 3a of the base 3. The operating device 5 has a sidewall 5a facing the rotors 9 and 11.
[0035] The operating device 5 includes a first operating tool (not shown) of a known type, configured to rotate the rotors 9, 11 relative to the stator 13. According to one embodiment, the first operating tool extends from the sidewall 5a. Each of the rotors 9, 11 operates independently, such that the rotors 9, 11 can operate at different speeds and / or at opposite angular directions (e.g., in...). Figure 1B The rotors rotate independently of each other in clockwise and counterclockwise directions (as shown in the top view) and at different angular velocities. For example, the first operating tool 27 includes a first motorized gear mechanism and a second motorized gear mechanism (not shown, e.g., gears). The first motorized gear mechanism is configured to mesh with a first tooth fixed to the first rotor 9 (e.g., fixed to the peripheral surface of the first rotor 9); the second motorized gear mechanism is configured to mesh with a second tooth fixed to the second rotor 11 (e.g., fixed to the peripheral surface of the second rotor 11). Optionally, the first operating tool 27 includes a first belt drive and a second belt drive, which are configured to frictionally engage with the first rotor 9 and the second rotor 11 (e.g., with the side surfaces of rotors 9 and 11), respectively. Optionally, the first operating tool 27 uses an electromagnetic field to move rotors 9 and 11 in a manner known per se. Optionally, the first operating tool 27 is included in the base 3, and the stator 13 includes a corresponding drive tool to actuate rotors 9 and 11. Optionally, the first operating tool 27 is based on direct drive technology.
[0036] Figure 2-4 One of the fluid devices 21 is specifically shown. The fluid device 21 includes a body 59 which is shaped to be releasably connected to (e.g., fitted into) a corresponding first seat 17, for example by interlocking to releasably secure the fluid device 21 to the corresponding first seat 17.
[0037] The fluid device 21 includes a fluid connection tool 25, which is attached to the body 59 and adapted to fluidly connect a first container 22 and a second container 24. The fluid connection tool 25 includes a first hollow needle 60 (hereinafter also referred to as the first needle 60, having a first end 60a and a second end 60b) and a first tubular element 62 (e.g., made of a plastic material and having a first end 62a and a second end 62b). The first needle 60 is configured to connect (e.g., insert) to the second cap 24b via the first end 60a, as better described below. The first tubular element 62 is flexible, connected to the body 59 via the first end 62a, and connected to the second end 60b of the first needle 60 via the second end 62b. The first tubular element 62 and the first needle 60 are connected to each other to allow fluid to flow from the body 59 through the first tubular element 62 and the first needle 60. Specifically, the first tubular element 62 has a first through opening defined between ends 62a and 62b, and the first needle 60 has a second through opening defined between ends 60a and 60b. The first cavity and the second cavity face each other at the second ends 60b and 62b.
[0038] The first needle 60 is releasably supported by a first support portion 152 of the body 59 and is movable relative to the body 59 as shown below. Specifically, the first support portion 152 begins from and extends perpendicularly to surface 59' of the body 59, which faces the containers 22, 24 when they are connected to the body 59. When connected, the first support portion 152 supports the first needle 60 such that the second end 60b of the first needle 60 faces the body 59 (at surface 59') and the first end 60a of the first needle 60 faces the first container 22. Furthermore, in use, the fluid device 21 and the support member 23 are arranged relative to each other such that the first needle 60 faces the second cover 24b along the Z-axis.
[0039] The body 59 has a receiving cavity 59a that accommodates (specifically, includes) a syringe 154 comprising a hollow body 156. The body 156 defines a cavity 158 having a polygonal (e.g., circular) cross-section. The body 156 includes an end 156a having a through opening 160. Inside the cavity 158 is a plunger (or piston) 150 that is movable relative to the body 156 (e.g., by sliding engagement) and operable to generate a pressure gradient (e.g., at the through opening 160). Specifically, the piston 150 is longitudinally movable within the cavity 158 relative to the body 156 and has a first end 150a and a second end 150b opposite each other. The piston 150 includes a sealing element 150' at its first end 150a, which slides in a liquid-sealed manner within the body 156 (specifically, it slides along the inner surface of the body 156 toward the cavity), thereby defining a first chamber 162a and a second chamber 162b with variable volumes within the cavity 158. The chambers 162a and 162b are liquid-sealed apart from each other by the sealing element 150' and have respective volumes that vary as a function of the piston 150's calculated axial position relative to the body 156. Specifically, the first chamber 162a is in fluid communication with the outside of the syringe 154 via a through opening 160 located at the end 156a. For example, piston 150 can move from a first position (compression of first chamber 162a) to a second position (expansion of first chamber 162a): In the first position, sealing element 150' is located at end 156a, and piston 150 is almost completely contained in cavity 158, so the volume of first chamber 162a is smaller than the volume of second chamber 162b (in other words, sealing element 150' has a first distance D1 from end 156a of body 156, and first chamber 162a has a first volume); and in the second position, only sealing element 150' is in cavity 158 and piston 150 is almost completely outside body 156, so the volume of first chamber 162a is larger than the volume of second chamber 162b (in other words, sealing element 150' has a second distance D2 from end 156a of body 156, and first chamber 162a has a second volume, second distance D2 is greater than first distance D1, and second chamber is larger than first chamber 162b).
[0040] The syringe 154 is connected to the first container 22 via a bifurcated element 166, also arranged in the receiving cavity 59a, and a first one-way (check, or non-return) valve 168 (hereinafter referred to as the first valve 168). The first valve 168 has a first end 168a and a second end 168b opposite to each other, and is operable in an open state and optionally in a closed state as a function of a first force caused by a first pressure difference between the ends 168a and 168b. The first pressure difference is a function of a first pressure gradient present at the first valve 168, which in turn is related to the pressure gradient in the through opening 160. In practice, the bifurcated element 166 and the first valve 168 are pneumatically connected to the through opening 160 of the syringe 154. In a static state, the first valve 168 is closed. However, when the pressure gradient in the through-opening 160 points towards the cavity 158 (i.e., towards the interior of the syringe 154) and has an absolute value greater than a first threshold (in other words, when the first force acting on the first valve 168 is greater than the threshold force), the first valve 168 switches from closed to open, allowing fluid to flow only from the first container 22 to the syringe 154 (thus preventing fluid from flowing from the syringe 154 to the first container 22), and then returns to closed when the pressure gradient in the through-opening 160 is exhausted. Conversely, the bifurcation element 166 allows fluid from the syringe 154 to pass along a first fluid path and a second fluid path, as better described below.
[0041] Specifically, the bifurcated element 166 has a first end 166a and a second end 166b opposite to each other. At the second end 166b, the bifurcated element 166 has a first fluid channel 166' and a second fluid channel 166"", and at the first end 166a, the bifurcated element 166 has a third fluid channel 166"'. The fluid channels 166', 166"', and 166"' are arranged in a Y-shape between them (i.e., they are joined and fluidly connected to each other in the connecting portion). The through opening 160 of the syringe 154 is connected to the first end 166a of the bifurcated element 166 (e.g., fixed to and fluidly communicating with the first end 166a of the bifurcated element 166) (specifically, connected to the third fluid channel 166"'). For example, the syringe 154 and the bifurcated element 166 are directly connected to each other or connected via another tubular element (not shown and similar to the first tubular element 62).
[0042] Furthermore, the first fluid passage 166' at the second end 166b is connected to the second end 168b of the first valve 168 via a second tubular element 170 (similar to the first tubular element 62) (e.g., fixed to and in fluid communication with the second end 168b of the first valve 168). The first end 168a of the first valve 168 is connected to the first cap 22b (e.g., fixed to and in fluid communication with the first cap 22b). In particular, the first end 168a is connected to the interface tool 171 (e.g., fixed to and in fluid communication with the interface tool 171; e.g., directly connected or connected via a third tubular element 172 similar to the first tubular element 62), the interface tool 171 being releasably connected to the first container 22.
[0043] The interface tool 171 is at least partially located outside the receiving cavity 59a and includes a second support portion 171b. The second support portion 171b is fixed to the body 59, located outside the receiving cavity 59a, and releasably fixed to the second cap 22b when the first container 22 is connected to the fluid device 21 to physically support and hold the first container 22. The second support portion 171b includes a second hollow needle 171a (hereinafter referred to as the second needle 171, similar to the first needle 60), configured to connect (e.g., insert) into the first cap 22b. Specifically, when the first container 22 is supported by the second support portion 171b, the second needle 171a is inserted into the first cap 22b, thereby allowing fluid communication between the first container 22 and the syringe 154.
[0044] The bifurcation element 166, the second tubular element 170, the first valve 168, the interface tool 171, and the third tubular element 172 (if any) define a first fluid path, which thus intersects with the first fluid channel 166' and the third fluid channel 166"', thereby fluidly connecting the first internal volume and the first chamber 162a to each other.
[0045] A second one-way (check, or non-return) valve 176 (hereinafter referred to as the second valve 176) is located between the fluid connection tool 25 and the bifurcation element 166. The second valve 176 has a first end 176a and a second end 176b opposite to each other, and is operable in an open state and optionally a closed state as a function of a second force caused by a second pressure difference between the ends 176a and 176b. The second pressure difference is a function of a second pressure gradient present at the second valve 176, which in turn is related to the pressure gradient in the through opening 160. In practice, the bifurcation element 166 and the second valve 176 are pneumatically connected to the through opening 160 of the syringe 154. In a static state, the second valve 176 is closed; however, when the pressure gradient in the through opening 160 points toward the bifurcation element 166 (i.e. toward the outside of the syringe 154) and has an absolute value greater than a second threshold (e.g., equal to the first threshold; in other words, when the second force acting on the second valve 176 is greater than another threshold force), the second valve 176 switches from closed to open, allowing fluid to flow only from the syringe 154 to the first needle 60, and thus to the second container 24 (thus preventing fluid from flowing from the second container 24 to the syringe 154), and then returns to closed when the pressure gradient in the through opening 160 is exhausted.
[0046] Specifically, the second fluid passage 166” at the second end 166b is connected to the second end 176b of the second valve 176 via a fourth tubular element 178 (similar to the first tubular element 62) (e.g., fixed to and in fluid communication with the second end 176b of the second valve 176). The first end 176a of the second valve 176 is connected to the first end 62a of the first tubular element 62 (e.g., fixed to and in fluid communication with the first end 62a of the first tubular element 62). The second valve 176 and the fourth tubular element 178 are also included in the receiving cavity 59a.
[0047] The bifurcation element 166, the fourth tubular element 178, the second valve 176, and the fluid connection tool 25 define a second fluid path that intersects with the second fluid channel 166” and the third fluid channel 166””, thereby fluidly connecting the first chamber 162a and the second internal volume to each other.
[0048] More specifically, the fluid device 21 includes the following elements, which are assembled together (e.g., by adhesive bonding) to form a single assembly suitable for leak-free transfer of liquid:
[0049] - Interface tool 171: It is a ventilated spike adapted to pierce the first cap 22b (i.e., the elastomeric cap typically found in medicine bottles) and adapted to extract ingredients from a selected first container 22 while compensating for the internal pressure of the first container 22 (the spike has a dual cavity: one through which ingredients are extracted from the first container 22, and the other allowing an equal volume of air to enter the first container 22 to compensate for the pressure within the first body 22a);
[0050] - First valve 168 and second valve 176: These are one-way valves, each allowing the component to flow only along the [flow direction]. Figure 4 The direction indicated by the corresponding arrow in the image is through;
[0051] Branch element 166: It is a "Y" type accessory with a Luer-lock connector for connecting to syringe 154;
[0052] - Syringe 154: It is a Luer lock syringe;
[0053] - First pin 60: This is a valveless male Luer slide connector, suitable for connection to either a valved or valved female Luer slide connector or a female Luer lock connector; and
[0054] - First tubular element 62, second tubular element 170, third tubular element 172 and fourth tubular element 178: These are the corresponding connecting tubes between the various elements mentioned above, as described in more detail above.
[0055] refer to Figure 1B , Figure 5A The operating device 5 also includes a second operating tool 70, which is configured to move the first needle 60 upward (thus toward the rotor 11 along the Z-axis), thereby connecting the first needle 60 of the fluid device 21 to the second cap 24b of the contemplated second container 24. Specifically, the second operating tool 70 extends from the sidewall 5a and includes a first translation tool 72 and a first clamping tool 74 operably connected to each other.
[0056] A first gripping tool 74 is configured to attach to a first needle 60, thereby allowing the aforementioned movement. Specifically, the first gripping tool 74 includes two arms 74' having respective ends 74"". For example, the arms 74' have a main extension parallel to the X-axis, arranged such that the first needle 60 is positioned parallel to the Y-axis between these ends 74" and the arms 74' are operable to close around the needle 60 and allow it to be gripped. In a first operating state, the ends 74" are separated from each other (they are arranged relative to each other along the Y-axis at a first distance D1); and in a second operating state, the ends 74" are connected to each other (they are arranged relative to each other along the Y-axis at a second distance D2 less than the first distance D1). Specifically, in the second operating state, the ends 74" are abutted against the first needle 60 and thus integral with the ends 74" through friction and / or interlocking with the needle 60. Arm 74' operates in a manner known per se (e.g., by a gear structure, by a motor (e.g., a stepper type), or by at least one translation tool that defines a corresponding path parallel to the Y-axis and is similar to the first translation tool 72 described below).
[0057] The first translation tool 72 is configured to move the first needle 60 relative to the body 59 toward the second rotor 11. The first translation tool 72 includes a first guide element 73 and a first movable element 75, which are movable to each other (e.g., engaging each other by sliding). Specifically, the first guide element 73 is fixed to the sidewall 5a and has a main extension parallel to the Z-axis. In other words, the first guide element 73 defines a first path along which the first movable element 75 is restricted to movement; the first path is linear and parallel to the Z-axis. Specifically, the first guide element 73 extends from the level of the first needle 60 along the Z-axis to the level of the cover 24b.
[0058] The first movable element 75 is moved within the first guide element 73 by a first motor tool (not shown). Specifically, the first motor tool is fixed to the sidewall 5a or to the first guide element 73 and connected to the first movable element 75 to allow it to move from a rest position to an active position within the first guide element 73. For example, the first motor tool includes a stepper motor, or a gear-based linear actuator, or a pneumatic or hydraulic actuator.
[0059] Therefore, the subsequent actions of the first gripping tool 74 and the first translation tool 72 enable the gripping of the first needle 60 arranged in the rest position, and then the first needle 60 is moved parallel to the Z-axis until it is brought into the active position, where the first needle 60 is inserted into the second cover 24b, thereby allowing fluid connection between the first container 22 and the second container 24.
[0060] The operating device 5 also includes a third operating tool 80 (or pumping tool) configured to operate the fluid device 21 to allow fluid to pass between the first container 22 and the first needle 60. Specifically, the third operating tool 80 is controllable to operate a piston 150 to pump fluid from the first container 22 to the second container 24.
[0061] For example, the third operating tool 80 extends from the side wall 5a and includes a second translation tool 272 and a second clamping tool 274 that are operably connected to each other.
[0062] The second gripping tool 274 is configured to connect to the second end 150b of the piston 150. Specifically, the second gripping tool 274 includes two respective arms 274' having corresponding ends 274"". For example, the arms 274' have a main extension parallel to the X-axis, which can be used to position the second end 150b of the piston 150 parallel to the Y-axis between these ends 274" and the arms 274' are operable to close around the piston 150 and allow it to be gripped. In a first operating state, the ends 274" are separated from each other (e.g., they are arranged relative to each other along the Y-axis at a third distance D3); and in a second operating state, the ends 274" are connected to each other (they are arranged relative to each other along the Y-axis at a fourth distance D4 less than the third distance D3). Specifically, in the second operating state, the ends 274" are abutted against the second end 150b of the piston 150 and thus integral with the ends 274" through friction and / or interlocking with the second end 150b. Arm 274' operates in a manner known per se (e.g., by a gear mechanism, by a motor (e.g., a stepper type), or by at least one translation tool that defines a corresponding path parallel to the Y-axis and is similar to the first translation tool 72).
[0063] The second translation tool 272 is configured to move the piston 150 relative to the body 59; optionally, this displacement of the piston 150 occurs toward the sidewall 5a and toward the body 59. The second translation tool 272 includes a second guide element 273 and a second movable element 275, which are movable to each other (e.g., engaging each other by sliding). Specifically, the second guide element 273 is fixed to the sidewall 5a and has a main extension parallel to the X-axis. In other words, the second guide element 273 defines a second path along which the second movable element 275 is restricted to move, the second path being linear and parallel to the X-axis.
[0064] The second movable element 275 is moved within the second guide element 273 via a second motor tool (not shown). Specifically, the second operating tool is fixed to the sidewall 5a or to the second guide element 273 and connected to the second movable element 275 to allow it to move within the second guide element 273 from a first position (e.g., where piston 150 is in a compressed position in the first chamber 162a) to a second position (e.g., where piston 150 is in an expanded position in the first chamber 162a), and vice versa. For example, the third motor tool includes a third stepper motor, or a gear-based linear actuator, or a pneumatic or hydraulic actuator.
[0065] Therefore, the subsequent actions of the second clamping tool 274 and the second translational tool 272 enable the gripping of the piston 150 positioned in the compression position of the first chamber 162a, and subsequently its movement parallel to the X-axis until it is brought into the expansion position of the first chamber 162a, and vice versa. This enables the generation of the pressure gradient to actuate valves 168, 176 and transfer a portion of the components from the first container 22 to the second container 24, as better described below.
[0066] Control unit 83 (e.g., processor, ASIC, PCB, or dedicated controller) is also operatively connected to device 1 and configured to command device 1, and specifically command the first operating tool 27, the second operating tool 70, and the third operating tool 80. In particular, device 1 includes control unit 83 (e.g., control unit 83 is included in base 3 or operating device 5).
[0067] Optionally, device 1 further includes a first interface tool 85', for example, at least one first interface tool 85' is included between a display device (e.g., a screen, also a touchscreen type) and a plurality of buttons. For example, the first interface tool 85' is included in the base 3 or the operating device 5. Furthermore, device 1 can also be operatively connected (e.g., via a wired or electromagnetic connection to the Internet) to a second interface tool 85" (not shown), such as an external electronic device (e.g., a computer, smartphone, keyboard, or mouse). In particular, the second interface tool 85" may include a printing device, such as a label printer. Specifically, the first interface tool 85' and the second interface tool 85" are operatively connected to control unit 83.
[0068] refer to Figures 5A-5D and Figure 6 The method 100 for operating device 1 is described via control unit 83.
[0069] Operating method 100 begins at step 102. Initially, support 23, fluid device 21, and containers 22, 24 are not connected to device 1. In step 102, device 1 is turned on, and prescription data is acquired by an operator or automatically via a first interface tool 85' and / or a second interface tool 85" (e.g., a server in a hospital facility containing patient data archives). The prescription data indicates the prescription to be followed, i.e., the chemotherapy drugs to be prepared for the patient under consideration. Specifically, the prescription data includes:
[0070] • Patient's personal data (first name, last name, date of birth, any additional identifying information);
[0071] • The active substance (or component) of the chemotherapy drug to be prepared;
[0072] • The amount of the specified active substance (or ingredient);
[0073] • Trade name and size (e.g., in mL) of the second container 24 suitable for containing chemotherapy drugs;
[0074] • The type of the second container 24 (e.g., bag, syringe, elastomer);
[0075] • Any substance already present in the second container 24 (e.g., in the case of a bag) and its relative volume; and
[0076] • Delivery time.
[0077] For example, the amount of the active substance in a chemotherapy drug is expressed in weight W. pa (e.g., in mg) delivered and converted to the corresponding weight W of a commercial chemotherapy drug using the following relationship. fc (For example, in mg):
[0078]
[0079] Among them W fc This refers to the weight (in mg) of chemotherapy drug to be administered to the patient under consideration. pa It is the weight (in mg) of the active substance (or component), d fc This refers to the density of the chemotherapy drug (in mg / mL) and c. fc It refers to the concentration of active substances (or components) in chemotherapy drugs.
[0080] In step 102, the setup of device 1 is also performed, for example, in a controlled atmosphere (e.g., under a hood), and includes:
[0081] • Disinfect and clean equipment 1, support 23, fluid device 21, and containers 22 and 24; and
[0082] • Assemble the support 23, fluid device 21, and containers 22 and 24 onto the device 1.
[0083] Specifically, the assembly of the support 23, fluid device 21, and containers 22, 24 into the device 1 is performed by an operator or automatically, and allows loading of all materials and / or objects necessary for the preparation of a specific chemotherapy drug. The support 23, fluid device 21, and containers 22, 24 are identified by reading their associated corresponding identification codes. Specifically, the support 23, fluid device 21, and containers 22, 24 have corresponding labels glued thereto and including corresponding barcodes, or corresponding radio frequency identification (“RFID”) tags suitable for their identification. The fluid device 21 and the first container 22 are releasably secured to each other, and then the fluid device 21 carrying the first container 22 is connected to the first rotor 9, as previously described. Similarly, the support 23 and the second container 24 are releasably secured to each other, and then the support 23 carrying the second container 24 is connected to the second rotor 11, as previously described.
[0084] Then, in step 104, rotors 9 and 11 are positioned, as follows: Figure 5A As shown. Specifically, the second rotor 11 is rotated by the first operating tool 27 to bring the selected second container 24 closer to the operating device 5. The second container 24 is adapted to contain chemotherapy drugs for the patient under consideration. Furthermore, the first rotor 9 is rotated by the first operating tool 27 to bring the selected first container 22 closer to the operating tool 5. The first container 22 contains the components to be inserted into the second container 24 to prepare the chemotherapy drugs for the patient under consideration. Thus, the selected containers 22, 24 overlap each other and are at least partially aligned (parallel to the Z-axis) and face the sidewall 5a of the operating device 5.
[0085] like Figure 5B As shown, in step 106 following step 104, the second operating tool 70 connects the first needle 60 of the selected fluid device 21 to the selected second container 24. The first needle 60 is used to achieve fluid communication between the selected containers 22 and 24.
[0086] like Figure 5C As shown, in step 108 following step 106, the third operating tool 80 is connected to the fluid device 21, as further described below.
[0087] like Figure 5D As shown, in step 110 following step 108, the fluid is transferred from the first container 22 to the second container 24, as better described below.
[0088] In step 112, following step 110, the third operating tool 80 is separated from the fluid device 21, and the procedure is performed as described in step 108 and below. Figure 5C The motion described is the opposite of the motion.
[0089] In step 114, following step 112, the second operating tool 70 moves the first needle 60 downward (i.e., along the Z-axis towards the base 3) and separates the first needle 60 from the second container 24, thereby interrupting the fluid communication between containers 22 and 24. In other words, a movement opposite to the movement described with reference to step 106 is performed.
[0090] In step 116, following step 114, the composition of the chemotherapy drug to be prepared is verified. In particular, it is determined whether other components (located in the corresponding first container 22 other than the previously considered first container 22) need to be added to the second container 24 to obtain the chemotherapy drug.
[0091] If additional components are needed to prepare the chemotherapy drug (output "S" from step 116), the positioning of rotors 9 and 11 is performed again, thus returning to step 104. Specifically, the first rotor 9 is operated to select the first container 22 of interest.
[0092] If no additional components are required to prepare the chemotherapy drug under consideration (output “N” from step 116), operation method 100 ends at step 118, where, for example, device 1 is shut down or device 1 will wait for additional commands for different preparations.
[0093] Furthermore, in step 118, the removal of the support 23, fluid device 21, and containers 22 and 24 from the device 1 can be performed by an operator or automatically in order to prepare the device 1 to perform step 102 again.
[0094] Furthermore, in step 118, an identification tag for the second container 24 can be generated, for example, by the printing device (included in the second interface tool 85" and operatively connected to the control unit 83). Specifically, such a tag may include, for example, a barcode tag or an RFID tag. This tag is adapted to be attached (e.g., glued or fixed) to the second container 24 and indicates data such as the nature of the chemotherapy drug contained in the second container 24 (e.g., the contained chemical composition and / or active substance) and / or the identifier of the patient to whom the chemotherapy drug is to be administered.
[0095] More specifically and refer to Figures 5B-5D The operation of the third operating tool 80 is described (these respective operating modes are shown in this document).
[0096] exist Figure 5B In the middle, the third operating tool 80 is in a position separated from the piston 150, and therefore is in a stationary position.
[0097] exist Figure 5CIn this process, the third operating tool 80 is connected to the piston 150 (step 108). Specifically, the second translation tool 272 translates the second clamping tool 274 along the X-axis, such that the second end 150b of the piston 150 is parallel to the Y-axis between the ends 274". Subsequently, the second clamping tool 274 is connected to the piston 150, placing the ends 274" in a second operating state, such that they are releasably secured to the second end 150b of the piston 150.
[0098] exist Figure 5D In this process, the third operating tool 80 transfers a portion of the component from the first container 22 to the syringe 154. Specifically, the second translation tool 272 translates the second clamping tool 274 and the piston 150 along the X-axis, thereby moving the first end 150a of the piston 150 away from the end 156a of the body 156. In other words, it moves from the compressed position of the first chamber 162a to the expanded position of the first chamber 162a. This creates a first pressure gradient (therefore the pressure at the second ends 168b, 176b is lower than the pressure at the first ends 168a, 176a), which, when the first force is greater than a threshold force, brings the first valve 168 into the open state (while the second valve 176 remains closed). Furthermore, the first pressure gradient, together with gravity, transfers the component from the first container 22 to the first chamber 162a of the syringe 154.
[0099] Similar to the above, the movement of the third operating tool 80 (not shown) is related to... Figure 5D The movement shown is reversed, causing some components to transfer from syringe 154 to the second container 24. Specifically, refer to... Figure 5D As shown in the configuration, the second translation tool 272 again causes the second clamping tool 274 and the piston 150 to move along the X-axis in alignment with the reference. Figure 5D The described movement is a translation in the opposite direction, causing the first end 150a of the piston 150 to move closer to the end 156a of the body 156. In other words, there is a channel from the expanded position of the first chamber 162a to the compressed position of the first chamber 162a. This creates a second pressure gradient (therefore the pressure at the second ends 168b, 176b is greater than the pressure at the first ends 168a, 176a), which, when the second force exceeds another threshold force, brings the second valve 176 into the open state (while the first valve 168 remains closed). Furthermore, the second pressure gradient causes the component to transfer from the first chamber 162a of the syringe 154 to the second container 24.
[0100] The expansion and compression movements of the first chamber 162a, operated by the third operating tool 80, allow the components to be transferred from the first container 22 to the second container 24 (step 110).
[0101] By examining the features of the invention implemented according to the present invention, the advantages that it allows to obtain are obvious.
[0102] Device 1 is an automated system for preparing anticancer drugs, overcoming key factors associated with manual preparation and ensuring a significant improvement in the quality of cancer treatment. In fact, Device 1 allows for significantly improved formulation accuracy, significantly reduced chemical contamination of the environment intended for the preparation of such drugs, and significantly reduced occupational risks for healthcare workers assigned to it.
[0103] Furthermore, device 1 implements a computerized program for managing chemotherapy preparations via control unit 83, for example, for use in a hospital pharmacy. This computerized program can interact with a hospital information system (if any) via standard communication protocols.
[0104] Device 1 is an automated desktop unit that can be easily inserted into a laminar flow hood used for chemotherapy. For example, Device 1 can operate under an ISO 5 vertical laminar flow hood, which is then placed in an ISO 8 air-controlled environment.
[0105] Advantageously, communication between the control unit 83 and the second interface tool 85" is conducted wirelessly to eliminate any wired connection between the sterile interior and exterior environments of the enclosure where the device 1 is located.
[0106] In particular, device 1 allows for the use of a closed-loop fluid system that ensures sterility and protection from environmental contamination during the transfer of chemotherapy drugs from the first container 22 to the second container 24.
[0107] Specifically, the fluid device 21 is made of low-cost medical-grade plastic materials, such as polystyrene, polycarbonate, polyurethane, or PVC, and has an easy-to-manufacture structure. This ensures reduced manufacturing costs and allows for single-use of a disposable type. In other words, the fluid device 21 is connected to the corresponding first container 22 only once and is discarded after the corresponding components are transferred. This significantly reduces the risk of contamination for patients and healthcare workers.
[0108] The fluid device 21 is a standardized interface that allows different types of first containers 22 to be connected to the first rotor 9.
[0109] Furthermore, the chemotherapy drugs are directly metered into a second container 24, which is the final container intended for administration to the patient. This avoids the need for further and subsequent processing, which could be a source of further contamination.
[0110] Each second container 24 is identified by a code (e.g., a QR) containing details of the chemotherapy drug formulation and the patient to whom it is intended. This information is thus verifiable at the time of administration to prevent possible accidental drug exchange.
[0111] The main advantages that can be obtained through device 1 are:
[0112] • Improve the accuracy of chemotherapy drug dosage;
[0113] • Increase the sterility level of injectable formulations;
[0114] • Reduce cell-inhibiting contamination in the surrounding environment (laboratory, pharmacy, hospital);
[0115] • Safer for hospital pharmacy staff (reducing needlestick injuries, reducing hand fatigue symptoms, etc.);
[0116] • It makes patients safer by reducing the risk of accidental medication and / or patient exchanges or incorrect administration;
[0117] • Optimize the use of cell-inhibiting drugs and reduce the significant costs associated with discarding unused cell-inhibiting drugs; and
[0118] • It simplifies the drug preparation process and reduces machine setup time.
[0119] Furthermore, the fluid assembly 21 allows the connection between the first container 22 (i.e., a bottle containing the selected ingredient) and the second container 24 (or the final container of the drug, i.e., a bag, syringe, etc.) to be commanded by the second operating tool 70 of the device 1, with the aim of transferring the ingredient itself in a predetermined amount controlled by the device 1.
[0120] Regarding the first container 22, its connection to the fluid assembly 21 is permanent, thereby causing the first cover 22b to be penetrated by the interface tool 171, and the metal casing of the first cover 22b to engage with the annular nut (e.g., made of plastic) of the interface tool 171.
[0121] Regarding the second container 24, this connection with the fluid unit 21 is achieved by a second operating tool 70, which is used to insert a first pin 60 (i.e., a valveless male Luer sliding connector) into a female Luer lock connector (with a valve) pre-connected to the second container 24 (specifically, the second cap 24b).
[0122] Specifically, the first needle 60 enables the use of the fluid device 21 in the automated equipment 1.
[0123] Obviously, changes and modifications can be made to the invention described and shown herein without departing from the scope of protection of the invention as defined by the appended claims.
[0124] In particular, the first operating tool 27 can also be arranged in the base 3 instead of in the operating tool 5.
[0125] Furthermore, if only the second container 24 can be connected to the device 1, the second rotor 11 can be replaced by a support structure (not shown) fixed to the base 3 (and therefore not rotatable). In this case, after the ingredients have been added to the second container 24 to produce the chemotherapy drug in a manner similar to that described above, the second container 24 is removed and replaced with another second container 24 (automatically or manually) for further preparation of the chemotherapy drug.
[0126] Device 1 can also be used to prepare drugs other than chemotherapy drugs, such as injectable drugs, such as monoclonal antibodies, cytotoxins, hormones and hormone antagonists, antimitotic agents, alkylating agents, and antibiotics.
Claims
1. A fluid assembly (21) connectable to a first container (24) defining a first internal volume suitable for containing a drug, and connected to a second container (22) defining a second internal volume suitable for containing components for preparing the drug, the fluid assembly comprising a first body (59) defining a first cavity (59a), and comprising: - A syringe (154) comprising a second body (156) defining a second cavity (158) for receiving a piston (150), the piston (150) being movable within the second body (156) and together with the second body (156) defining a chamber (162a) having a variable volume as a function of the position of the piston (150) within the second cavity (158); - A first connecting assembly (171, 172) extends partially to the outside of the first cavity (59a) and can be releasably secured to the second container (22) for fluid communication with the second internal volume; - A second connecting assembly (25) extends partially to the outside of the first cavity (59a) and can be releasably secured to the first container (24) for fluid communication with the first internal volume; - A bifurcation element (166) having a first inlet (166') and a second inlet (166'') arranged in fluid communication with the first connecting group (171, 172) and the second connecting group (25) respectively, and further having a third inlet (166''') in fluid communication with the chamber (162a), the third inlet also communicating with the first inlet and the second inlet to create a first fluid path between the second internal volume and the chamber (162a), and a second fluid path between the chamber (162a) and the first internal volume; - A first valve (168) of a one-way type, which is located between the first connecting group (171, 172) and the bifurcation element (166) along the first fluid path, and is controllable according to a first pressure gradient caused by the movement of the piston (150) in the cavity (158) to allow the component to enter from the second container (22) into the chamber (162a) of the syringe (154); and - A second valve (176) of a one-way type, which is located between the second connection group (25) and the bifurcation element (166) along the second fluid path, and can be controlled as a function of a second pressure gradient opposite to the first pressure gradient, to allow the component transferred from the second container (22) to the chamber (162a) of the syringe (154) to enter the first container (24) from the chamber (162a). The second connection group (25) includes a first flexible tubular element (62) and a first hollow needle (60) that is fluidly connected to the second valve (176) through the first flexible tubular element (62). The first hollow needle (60) is movable relative to the first body (59) and can be inserted into the first cap (24b) of the first container (24), thereby allowing fluid communication between the chamber (162a) of the syringe (154) and the first internal volume.
2. The fluid assembly according to claim 1, wherein the second body (156) has a first end (156a) and a second end (156b) opposite to each other, and the chamber (162a) is fluidly connected to the third inlet (166''') at the first end (156a). The piston (150) includes a sealing element (150') that, together with the second body (156), defines the chamber (162a) and slides in a liquid-sealed manner relative to the second body (156) between a first position and a second position. When the sealing element (150') is in the first position, the sealing element (150') has a first distance from the first end (156a) of the second body (156), and the chamber (162a) has a first volume. And when the sealing element (150') is in the second position, the sealing element (150') has a second distance from the first end (156a) of the second body (156), and the chamber (162a) has a second volume, the second distance being greater than the first distance and the second volume being greater than the first volume.
3. The fluid assembly of claim 2, wherein the pumping tool (80) is releasably connected to the piston (150) and is operable to generate the first pressure gradient or the second pressure gradient by moving the piston (150) in the second cavity (158).
4. The fluid assembly according to claim 3, wherein the first valve (168) is operable to switch from a first closed state to a first open state, and the second valve (176) is operable to switch from a second closed state to a second open state. Furthermore, when the sealing element (150') is moved from the first position to the second position by the pumping tool (80), the first pressure gradient applies force such that the first valve (168) is in the first open state and the second valve (176) is in the second closed state. And when the sealing element (150') is moved from the second position to the first position by the pumping tool (80), the second pressure gradient applies an additional force, such that the first valve (168) is in the first closed state and the second valve (176) is in the second open state.
5. The fluid assembly according to claim 1, wherein the first body (59) has a first surface (59') that is oriented toward the second container (22). The first hollow needle (60) is releasably supported by a first support portion (152) of the first body (59), the first support portion (152) extending from the first surface (59') and perpendicular to the first surface (59'). The first hollow needle (60) has a first end (60a) and a second end (60b) opposite to each other, the second end (60b) being fixed to the first flexible tubular element (62). And wherein the first hollow needle (60) is supported by the first support portion (152) such that the second end (60b) can face the first surface (59') and the first end (60a) can face the first cap (24b) of the first container (24).
6. The fluid assembly according to claim 1, wherein the first connection assembly (171, 172) includes a second support portion (171b) fixed to the first body (59), extending to the outside of the first cavity (59a) and configured to support the second container (22). The second support portion (171b) includes a second hollow needle (171a) in fluid communication with the first inlet (166') via the first valve (168), the second hollow needle (171a) being insertable into the second cap (22b) of the second container (22), thereby allowing the fluid communication between the second internal volume and the chamber (162a) of the syringe (154).
7. An apparatus (1) for preparing a drug from at least one component, said apparatus (1) being characterized in that it comprises: - A second rotor (11) is configured to support at least one first container (24), the first container (24) being adapted to contain the drug and disposed on the second rotor (11) in a releasable manner; - At least one fluid assembly (21) as claimed in claim 1; - A first rotor (9) supporting the at least one fluid assembly (21) arranged releasably on the first rotor (9) and releasably connected to a corresponding second container (22) suitable for containing the corresponding components; -Control unit (83); - A connection tool (70) is available to connect to the first container (24) and the second container (22) and is operatively available to the control unit (83). The connection tool (70) is controllable by the control unit (83) to connect the second connection assembly (25) to the first container (24), thereby fluidly connecting the second container (22) to the first container (24). and - A pumping tool (80) connected to the fluid assembly (21) and operably connected to the control unit (83), the pumping tool (80) being controllable by the control unit (83) to transfer the component at least partially from the second container (22) into the first container (24).
8. The device according to claim 7, further comprising a base (3) having a second surface (3a), wherein the second rotor (11) and the first rotor (9) are connected to the second surface (3a). The second rotor (11) and the first rotor (9) extend parallel to the second surface (3a) and are coaxially arranged with respect to a rotation axis (15) perpendicular to the second surface (3a). The first rotor (9) is axially located between the second rotor (11) and the second surface (3a) relative to the rotation axis (15), and is rotatable about the rotation axis (15) relative to the base (3).
9. The device according to claim 8, wherein the first rotor (9) is rotatable relative to the base (3) about the rotation axis (15) and is configured to releasably support the second container (22) by the fluid assembly (21) and support at least another second container (22) by another fluid assembly (21).
10. The device according to claim 8 or claim 9, wherein the second rotor (11) is rotatable relative to the base (3) about the rotation axis (15) and is configured to releasably support the first container (24) and at least another first container (24).
11. The device according to claim 9, further comprising a first operating tool (27) controllable by the control unit (83) and configured to rotate the second rotor (11) and the first rotor (9) independently of each other about the rotation axis (15) relative to the base (3), such that selected first containers (24) and selected second containers (22) can be arranged at corresponding angular positions toward the connecting tool (70) and the pumping tool (80).
12. The device according to claim 8, wherein the connection tool (70) comprises: A first guide element (73) is fixed to the base (3) and defines a first path parallel to the first axis (Z); A first movable element (75) is connected to the first guide element (73) so as to move along the first path; and A first clamping tool (74), which is fixed to the first movable element (75) and can be controlled by the control unit (83) to be releasably connected to the second connecting assembly (25), The connecting tool (70) is controlled by the control unit (83) to connect to the second connecting group (25) via the first clamping tool (74), and then move the second connecting group (25) along the first path to connect the second connecting group (25) to the first container (24), thereby establishing a connection with the fluid channel.
13. The apparatus of claim 12, wherein the pumping tool (80) comprises: - A second guide element (273) is fixed to the base (3) and defines a second path parallel to a second axis (X) orthogonal to the first axis (Z); - A second movable element (275), which is connected to the second guide element (273) for movement along the second path; and - A second clamping tool (274), which is fixed to the second movable element (275) and can be controlled by the control unit (83), is releasably connected to the piston (150). The pumping tool (80) is controlled by the control unit (83) to connect with the piston (150) via the second clamping tool (274), and then the second movable element (275) is moved relative to the second guide element (273) along the second path, thereby moving the piston (150) in the second cavity (158) and generating the first pressure gradient or the second pressure gradient.
14. The device according to claim 13, wherein the second body (156) has a first end (156a) and a second end (156b) opposite to each other, and the chamber (162a) is fluidly connected to the third inlet (166''') at the first end (156a). The piston (150) includes a sealing element (150') that, together with the second body (156), defines the chamber (162a) and slides in a liquid-sealed manner relative to the second body (156) between a first position and a second position. When the sealing element (150') is in the first position, the sealing element (150') has a first distance from the first end (156a) of the second body (156), and the chamber (162a) has a first volume. When the sealing element (150') is in the second position, the sealing element (150') has a second distance from the first end (156a) of the second body (156), and the chamber (162a) has a second volume, wherein the second distance is greater than the first distance and the second volume is greater than the first volume. The first valve (168) is operable to switch from a first closed state to a first open state, and the second valve (176) is operable to switch from a second closed state to a second open state. The pumping tool (80) is controllable by the control unit (83) to move the sealing element (150') from the first position to the second position, with the first pressure gradient applying force such that the first valve (168) is in the first open state and the second valve (176) is in the second closed state, thereby allowing the component to enter from the second container (22) into the chamber (162a) of the syringe (154). And wherein the pumping tool (80) is controlled by the control unit (83) to move the sealing element (150') from the second position to the first position, the second pressure gradient applying an additional force such that the first valve (168) is in the first closed state and the second valve (176) is in the second open state, thereby allowing the component transferred from the second container (22) to the chamber (162a) of the syringe (154) to enter the first container (24) from the chamber (162a).
15. The device of claim 7, wherein the control unit (83) is operatively connected to a printing device (85"), the printing device (85") being controllable by the control unit (83) to produce a label suitable for connection to the first container (24) and for identifying the drug.