Simulation device for peripheral blood collection

Abstract

A simulation device that allows a user to practice using a blood sampling device includes a base support, a puncture target connected to the base support configured to be repeatedly punctured by a lancet of the blood sampling device to practice using the peripheral blood sampling device, and a fluid circulation system. The fluid circulation system includes a fluid reservoir, at least one port disposed within the puncture target, a tube extending at least partially through the puncture target between the reservoir and the at least one puncture port, and a pump for circulating fluid from the reservoir to the at least one puncture port. The puncture target is sized to be connected to the blood sampling device such that the peripheral blood sampling device punctures the target and the at least one puncture port to establish fluid communication with the tube and the reservoir.

Description

Technical Field

[0001] Field of the Invention The present disclosure generally relates to devices, training systems, and methods that enable a user to practice various tasks related to obtaining a peripheral blood sample from a patient using a Peripheral blood collection device . More specifically, the present disclosure relates to a simulation device that enables a user to practice sizing and using finger-based peripheral blood collection devices, such as devices configured to lance, squeeze, collect, stabilize, and dispense a blood sample by incising a finger in a controlled manner.

Background Art

[0002] Cross-Reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / 216,264, filed June 29, 2021, entitled "Simulation Device for Peripheral Blood Collection", the entire disclosure of which is hereby incorporated by reference in its entirety.

[0003] Description of Related Art Devices for obtaining and collecting biological samples, such as blood samples, are commonly used in the medical industry. One type of blood collection commonly performed in the medical field is peripheral blood collection, which is often done to collect a blood sample for testing purposes. In certain diseases, such as diabetes, for example, it is necessary to regularly test a patient's blood to monitor the patient's blood sugar level. Additionally, test kits, such as cholesterol test kits, often require a blood sample for analysis. Blood collection procedures typically involve piercing a finger or other suitable body location to obtain a blood sample. Typically, the amount of blood required for such tests is relatively small, and a small puncture or incision usually provides a sufficient amount of blood for these tests. Various types of lancet devices have been developed for piercing a patient's skin to obtain a peripheral blood sample from the patient.

[0004] Many different types of lancet devices are commercially available to individual consumers, as well as to hospitals, clinics, and medical offices. Such devices typically include a pointed component, such as a needle, or a sharp component, such as a blade, used to quickly create a puncture wound or a rapid incision in the patient's skin to allow a small amount of blood to flow out. To simplify peripheral blood collection, lancet devices have evolved into automated devices that puncture or incise the patient's skin when a trigger mechanism is activated. In some devices, the needle or blade is held in a waiting position until it is triggered by the user. When triggered, the needle or blade punctures or incises the patient's skin, for example, the skin of a finger. Often, a spring is incorporated into the device to provide the "automatic" force needed to puncture or incise the patient's skin.

[0005] One type of contact-actuated lancet device having the feature of automatic protrusion and retraction of a puncture or cutting element from the device is described in Patent Document 1, which is owned by Becton Dickinson & Company, the assignee of this application. This lancet device includes a housing and a lancet structure having a puncture element. The lancet structure is positioned within the housing and is adapted to movement between a pre-retaining or pre-actuated position in which the puncture element is held inside the housing and a puncture position in which the puncture element extends through the front end of the housing. The lancet device includes a drive spring positioned inside the housing to bias the lancet structure toward the puncture position and a retaining hub that holds the lancet structure in the retracted position against the bias of the drive spring. The retaining hub includes a pivot lever that interferingly engages with the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure toward the rear end of the housing, at least partially compressing the drive spring and releasing the lever from interfering engagement with the lancet structure. The received blood samples are then collected and / or tested. This testing can be performed using point-of-care (POC) testing devices, or the blood samples can be collected and sent to a testing facility.

[0006] The use of lancet devices for peripheral blood collection can be complex and require a high level of skill from the healthcare professional performing the blood collection procedure. The multi-step nature of the peripheral blood collection process can introduce several uncertainties that can lead to sample quality issues, such as hemolysis, insufficient sample stabilization, and microthrombi. The use of lancet devices for obtaining blood samples results in several variable factors that contribute to achieving peripheral blood sample collection, including, but are not limited to, keeping the lancet stationary during the procedure, obtaining sufficient blood flow from the puncture site, collecting sufficient blood, and preventing coagulation. Some of the most common causes of process variability include: (1) improper washing of the lancet incision site and improper removal of the initial drop, which may result in contaminated samples; (2) inconsistent lancet incision site and depth, which may result in insufficient sample volume and a large proportion of interstitial fluid; (3) inconsistent compression techniques and excessive pressure near the lancet incision site to facilitate blood collection (e.g., milking of blood), which may result in hemolyzed samples; (4) variable transfer interfaces and collection techniques, which may result in hemolyzed or contaminated samples; and (5) insufficient mixing of samples with anticoagulants, which may result in microthrombi.

[0007] While peripheral blood collection devices and assemblies have been developed to simplify the peripheral blood collection process, such as finger-based peripheral blood collection devices configured to incise and compress a finger with a lancet in a controlled manner, collect a blood sample, stabilize it, and dispense it, it is still necessary for healthcare professionals to practice and gain experience in the peripheral blood collection process to reduce errors. The simulation devices, training systems, and methods disclosed herein are intended to provide healthcare professionals with the opportunity to gain such experience before interacting with patients. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] U.S. Patent No. 9,380,975 [Patent Document 2] U.S. Patent Application Publication No. 2019 / 0216380 [Patent Document 3] U.S. Patent Application Publication No. 2019 / 0223772 Specification [Patent Document 4] International Publication No. 2020 / 167746 brochure [Overview of the project]

[0009] According to aspects of the present disclosure, a simulation device that enables a user to practice using a peripheral blood collection device includes a base support, a puncture target connected to the base support and configured to be repeatedly punctured by the lancet of the peripheral blood collection device in order to practice using the peripheral blood collection device, and a fluid circulation system. The fluid circulation system includes a fluid reservoir, at least one port located within the puncture target, and at least one of the reservoir and no po A tube extending at least partially through the puncture target between the tube and the reservoir, and at least one no po Includes a pump for circulating fluid to the puncture site. The puncture target is sized to connect to the peripheral blood collection device, and as a result the peripheral blood collection device connects to the target and at least one no po The port is punctured to establish fluid communication with the tube and reservoir. Once fluid communication is established and the pump circulates fluid from the reservoir, the fluid is discharged from at least one port. Peripheral blood collection device It is collected in the container.

[0010] According to another aspect of the present disclosure, a method for practicing the sizing and use of a peripheral blood collection device includes the step of inserting a puncture target elongated member of the aforementioned simulation device through one or more openings of a sizing card for identifying an opening that best fits the puncture target elongated member. Peripheral blood collection deviceInsert the holder, Peripheral blood collection device The method further includes the step of activating the device to puncture the elongated member and at least one puncture portion of the peripheral blood device. Finally, the method activates the pump of the fluid circulation system so that the circulating fluid Peripheral blood collection device The process includes the step of enabling collection into a container.

[0011] Non-limiting examples relating to embodiments of the present disclosure are described herein in the following numbered sections.

[0012] Section 1. A simulation device that enables a user to practice using a peripheral blood collection device, the simulation device comprising: a base support; a puncture target connected to the base support, configured to be repeatedly punctured by the lancet of the peripheral blood collection device for practicing the use of the peripheral blood collection device; a fluid reservoir; at least one port located within the puncture target; a tube extending at least partially through the puncture target between the reservoir and the at least one puncture port; and a pump for circulating fluid from the reservoir to the at least one puncture port, wherein the puncture target is sized to connect to the peripheral blood collection device, and as a result the peripheral blood collection device punctures the target and at least one puncture port to establish fluid communication with the tube and reservoir, and when fluid communication is established and the pump circulates fluid from the reservoir, the fluid is discharged from at least one port. Peripheral blood collection device A simulation device collected inside a container.

[0013] Section 2. The simulation device described in Section 1, wherein the base support is configured to support the puncture target with a vertical clearance of at least 6 inches between the puncture target and the bottom of the base support.

[0014] Section 3. The base support includes a first member configured to rest on a surface and a second member extending from the first member, and the puncture target is the simulation device described in Section 1 or Section 2 that extends from the second member of the base support.

[0015] Section 4. The base support is the simulation device described in any one of Sections 1 to 3, and includes a flexible arm attached to be rotatable and / or pivotable with respect to the support member.

[0016] Section 5. The flexible arm is the simulation device described in Section 4, and includes at least one hinge configured to bend in one or more directions to adjust the position of the puncture target with respect to the support member.

[0017] Section 6. The flexible arm is the simulation device described in Section 4 or Section 5, and pivots and / or rotates to raise or lower the height of the puncture target with respect to the bottom of the base support.

[0018] Section 7. The pump is the simulation device described in any one of Sections 1 to 6, and includes an electric pump.

[0019] Section 8. The pump is the simulation device described in any one of Sections 1 to 6, and includes a manually operated mechanical pump.

[0020] Section 9. The fluid circulation system is the simulation device described in any one of Sections 1 to 7, and further includes a remote control device operably connected to the pump and configured to operate and / or control the flow rate of the pump.

[0021] Section 10. The pump is the simulation device described in any one of Sections 1 to 7, and draws fluid from the reservoir at a flow rate of about 5 μL / s.

[0022] Section 11. The fluid in the reservoir is a simulation device as described in any of Sections 1 to 10, including the liquid of the simulated blood.

[0023] Section 12. The puncture target comprises a proximal end connected to the base support and a distal end comprising a plurality of elongated members representing fingers, and is a simulation device as described in any of Sections 1 to 11, and the fluid circulation system includes a plurality of ports located in the elongated members representing fingers.

[0024] Section 13. The dimensions of the hand model are selected based on the 50th percentile anatomical measurements of the size of an adult hand, and it is a simulation device as described in Section 12.

[0025] Section 第14節。手のモデルの複数の長形部材は、 Peripheral blood collection device a ring finger member sized to receive a first size and Peripheral blood collection device at least include a middle finger member sized to receive a second size larger than the first size, and it is a simulation device as described in Section 12 or 13.

[0026] Section 15. The hand model is oriented in the direction of the left hand, and the hand model is arranged in a state where the flat palm faces downward and the plurality of elongated members represent fingers spaced apart, and it is a simulation device as described in any of Sections 12 to 14.

[0027] Section 16. The hand model comprises an internal frame reproducing the bones of a human hand and an elastomeric cover covering the internal frame configured to reproduce the appearance and feel of human skin, and it is a simulation device as described in any of Sections 12 to 15.

[0028] Section 17. The cover includes an elastomeric sheet, and it is a simulation device as described in Section 16.

[0029] Section 18. The first of several ports port It is positioned on the elongated member representing the middle finger among the multiple elongated members, and the second of the multiple ports port This is a simulation device described in any of Sections 12 to 17, which is positioned on a long, rectangular member representing the ring finger.

[0030] Section 19. The simulation device described in Section 18, in which the elongated member representing a finger other than the middle or ring finger is flexible and can be bent away from the middle and / or ring finger, thereby allowing the user to access and manipulate the middle and / or ring finger to practice the procedure.

[0031] Section 20. A method for practicing the size classification and use of a peripheral blood collection device, the method comprising the steps of inserting the elongated member to be punctured of a simulation device described in any of Sections 1 to 19 through one or more openings of a sizing card in order to identify an opening that best fits the elongated member to be punctured, and inserting the elongated member to be punctured into the size corresponding to the identified opening. Peripheral blood collection device The step of inserting the holder, Peripheral blood collection device Activate the elongated member and peripheral blood collection The steps include puncturing at least one puncture site of the device and activating the pump of the fluid circulation system so that the fluid circulates Peripheral blood collection device It includes a step that allows the contents to be collected in a container. [Brief explanation of the drawing]

[0032] [Figure 1A] This is a perspective view of a peripheral blood collection device and collection container for obtaining a blood sample from a patient's finger, according to an aspect of the present disclosure. [Figure 1B] Figure 1A is a cross-sectional view of the peripheral blood collection device and lancet according to an aspect of this disclosure. [Figure 1C] This is a perspective view of a holder for a peripheral blood collection device according to an aspect of the present disclosure. [Figure 1D]This is a schematic diagram showing a top view of the holder shown in Figure 1C, which is connected to the patient's finger for performing a blood collection procedure. [Figure 1E] This is another schematic diagram showing a front view of the holder in Figure 1C that is connected to the patient's finger. [Figure 2A] This is a perspective view showing a set of peripheral blood collection devices of different sizes that can be used for collecting peripheral blood from a patient according to aspects of this disclosure. [Figure 2B] Figure 2A shows a diagram of a sizing card for determining the size classification of a finger to be punctured, using one of the peripheral blood collection devices shown in Figure 2A, according to an aspect of the present disclosure. [Figure 3] This is a perspective view of a simulation device for practicing the procedure of collecting peripheral blood, according to an aspect of the present disclosure. [Figure 4] This is a perspective view of another embodiment of a simulation device for practicing the performance of peripheral blood collection procedures according to an aspect of the present disclosure. [Figure 5] This is a schematic diagram of a simulation device for practicing the procedure of collecting peripheral blood, according to an aspect of the present disclosure. [Figure 6] This flowchart shows a method for using a simulation device to practice performing a peripheral blood collection procedure according to an aspect of the present disclosure. [Figure 7A] This figure shows the use of a simulation device for collecting peripheral blood samples using a peripheral blood collection device, according to an aspect of this disclosure. [Figure 7B] This figure shows the use of a simulation device for collecting peripheral blood samples using a peripheral blood collection device, according to an aspect of this disclosure. [Figure 7C] This figure shows the use of a simulation device for collecting peripheral blood samples using a peripheral blood collection device, according to an aspect of the present disclosure. [Figure 7D] This figure shows the use of a simulation device for collecting peripheral blood samples using a peripheral blood collection device, according to an aspect of the present disclosure. [Figure 7E]This figure shows the use of a simulation device for collecting peripheral blood samples using a peripheral blood collection device, according to an aspect of the present disclosure. [Figure 7F] This figure shows the use of a simulation device for collecting peripheral blood samples using a peripheral blood collection device, according to an aspect of the present disclosure. [Figure 7G] This figure shows the use of a simulation device for collecting peripheral blood samples using a peripheral blood collection device, according to an aspect of the present disclosure. [Figure 7H] This figure shows the use of a simulation device for collecting peripheral blood samples using a peripheral blood collection device, according to an aspect of the present disclosure. [Figure 7I] This figure shows the use of a simulation device for collecting peripheral blood samples using a peripheral blood collection device, according to an aspect of the present disclosure. [Modes for carrying out the invention]

[0033] The following description is provided to enable those skilled in the art to manufacture and use the embodiments described, which have been conceived for carrying out the present invention. However, various modifications, equivalents, variations, and substitutions will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the present invention.

[0034] For the purposes of the following description, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives should be understood as relating to the present invention as oriented in the drawings. However, it should be understood that the present invention may envision alternative variations and step sequences unless explicitly specified otherwise. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are merely illustrative embodiments of the present invention. Therefore, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0035] This disclosure relates to a simulation device 110 (shown in Figures 3-5 and 7A-7I) that enables a user to simulate a capillary puncture procedure, thereby allowing the user to become familiar with how such a procedure is performed. The user may be a trained healthcare professional, such as a nurse, a phrebotomist, or another trained healthcare provider, who needs to become familiar with the use of a particular peripheral blood collection device 10. The user may also be a healthcare professional who has no experience in blood collection but can perform minor blood collection procedures, such as a pharmacist or pharmacy technician. In some cases, the user may also want to practice before performing a puncture procedure on his or her own finger using the device 10. Peripheral blood collection device There may also be patients who need to gain experience using 10. The simulation device 110 of this disclosure allows the user to classify fingers by size and determine the correct size Peripheral blood collection device Identify 10, Peripheral blood collection device This allows you to practice the steps for positioning the cuff or holder 12 in the correct position on the patient's finger. Peripheral blood collection deviceOnce the device is attached to the finger, the user can practice puncturing their finger. Peripheral blood collection device While the fluid (i.e., the liquid of fake blood) is collected in the 10 containers 16, it can be observed. In some examples, the simulation device 110 allows the user / healthcare worker to observe certain types Peripheral blood collection device It can be used to test healthcare professionals to ensure they are confident in using the device. The test can be conducted by an examiner, instructor, or trainer. For example, a trainer can set up and operate the simulation device 110 and observe when a user performs a simulated blood collection procedure using the simulation device 110.

[0036] In some examples, the simulation device 110 may include an anatomically accurate model of a human hand that can have the appearance and feel of a real hand, thereby providing the user with the most realistic simulation experience possible. For example, the hand model of the simulation device 110 may include a basic structure formed from plastic and metal parts (i.e., 3D printed parts) connected to each other to replicate the structure of the bones of a human hand. The hand model may also include a cover formed from a rubber-like or leather-like material to approximate the appearance and feel of human skin. The fingers of the model hand may be bent so that fingers not being used for a simulated blood collection procedure can be articulated, or the user can position them appropriately on the hand model. Peripheral blood collection device It can be moved aside so that 10 can be positioned. In some examples, the hand model can be mounted on a support structure such as a plate, which can move up and down and rotate around an axis to replicate the pronation and supination of a human wrist. The hand model can also be mounted on a flexible arm or hinged arm, such as an arm used to support a computer display, to enhance its adjustability.

[0037] The simulation device 110 of this disclosure may also include a fluid circulation system, which includes, for example, a flexible or rigid tube configured to transport a fluid (i.e., a liquid of simulated blood) from a reservoir through a model of a hand, and a pump for controlling the flow of the fluid through the fluid circulation system. The user (or trainer or test supervisor) can operate the pump, for example, by starting or stopping the pump at appropriate times and / or controlling the flow rate of the pump. The circulating fluid is transported from the tube or other parts of the fluid circulation system 110 to simulate the blood collection procedure. Peripheral blood collection device It is discharged into 10 collection containers.

[0038] Peripheral blood collection device As described above, the simulation device 110 of this disclosure allows the user Peripheral blood collection device It allows practice of performing puncture procedures using device 10. It can be used in conjunction with the simulation device 110 of this disclosure. Peripheral blood collection device Ten examples are shown in Figures 1A-1E. Peripheral blood collection device 10 can be, for example, a complete, fully integrated, finger-based peripheral blood collection device capable of dissecting, collecting, and stabilizing high-volume peripheral blood samples of up to or exceeding 500 microliters with a lancet. The simulation device 110 can also be of other types, such as a device formed from separable components (i.e., a finger cuff, lancet, and reservoir) that can be connected to and / or used to acquire blood samples. Peripheral blood collection device It can also be used in conjunction with 10. The simulation device 110 can also simulate other venous access devices, such as syringes, needle cannulas, and other injection devices, as well as other types of punctures, lancets and other injection devices, as are well known in the field of medical device technology. Peripheral blood collection deviceIt can also be used to train in its use. Other exemplary peripheral blood collection devices and assemblies that can be used with the simulation device 110 of this disclosure are described, for example, in Patent Document 2, titled “Device for acquiring blood samples,” Patent Document 3, titled “Device for blood adhesion flow,” and Patent Document 4, titled “Rotating and connecting capillary collector,” each of which is incorporated herein by reference in whole.

[0039] See Figures 1A and 1B for an example. Peripheral blood collection device 10 includes an integrated holder 12, a lancet housing or lancet 14 (shown in Figure 1B) for puncturing the patient's finger 19 (shown in Figures 1D and 1E), and a collection container 16 (shown in Figure 1A). In other examples, Peripheral blood collection device 10 may be provided as a semi-integrated device 10, for example, including an integrated lancet housing and collection container that can be connected to a separate holder. In other examples, the semi-integrated device may have an inline flow and an integrated lancet housing and collection container that can be connected to a separate holder.

[0040] The holder 12 is configured to receive a sample source for supplying a biological sample, such as a blood sample, for example, a patient's finger 19. As shown in Figures 1C-1E, the holder 12 generally includes a finger receiving portion 20 having a first opening 22, an operating portion 24, a port 26 having a second opening 28, and a fingertip guard 30. In some examples, the fingertip guard 30 provides a stopping portion for properly adjusting and securing the finger 19 within the holder 12. The fingertip guard 30 further helps to ensure that the patient's finger 19 is positioned correctly within the finger receiving portion 20, and as a result, that the pressure applied to the patient's finger 19 results in adequate blood flow. The fingertip guard 30 may have a curved fingertip rest that ensures the patient's finger 19 stops at the end of the finger receiving portion 20, while allowing the patient's fingernail to move away from the end of the finger receiving portion 20. The finger receiving portion 20 allows the use of the holder 12 for artificial and natural fingernail styles present in the patient population.

[0041] The first opening 22 of the finger receiving portion 20 is configured to receive a sample source, for example, a finger 19. The sample source may also include other parts of the body that can be fitted into the first opening 22, such as toes or other limbs. The port 26 communicates with the finger receiving portion 20. For example, when the finger 19 is received in the holder 12, the port 26 communicates with a portion of the finger 19. As will be described in more detail herein, the holder 12 can be sized for use in specific subsets of patients. For example, a small holder may be appropriately sized for the lower quartile (25%–50%) of patients. Medium and large holders 12 can be sized for use in the lower middle quartile (25%–50%) and upper middle quartile (50%–75%) of patients, respectively.

[0042] The second opening 28 of port 26 is configured to receive a lancet housing or lancet 14 (shown in Figure 1B) and a collection container 16 (shown in Figure 1A). In some examples, port 26 further includes a locking portion 32 to securely receive the lancet housing or lancet 14 and the collection container 16 into port 26.

[0043] The working part 24 of the device 10 is transitionable between a first position in which the holder 12 defines a first diameter and a second position in which the holder 12 defines a second diameter, the second diameter being less than the first diameter. Furthermore, in the first position, the holder 12 defines a first ellipse shape. In the second position, the holder 12 defines a second ellipse shape, the first ellipse shape being different from the second ellipse shape. In this way, with the holder 12 in the second position having a reduced diameter, a portion of the holder 12 contacts the sample source (i.e., finger 19), and the working part 24 of the holder 12 can pump and / or extract blood, as will be described in more detail below.

[0044] In some examples, the actuation part 24 includes a contact member 34. When the actuation part 24 is in a first position, the contact member 34 is in a disengaged position, i.e., brought to a first position relative to the sample source so that the contact member 34 can make slight contact with the sample source. When the actuation part 24 is in a second position, the contact member 34 is in an engaged position, i.e., brought to a second position relative to the finger 19 so that the contact member 34 is in applied pressure contact with the finger 19, and the actuation part 24 of the holder 12 can pump and / or extract blood. For example, when the contact member 34 is in the engaged position, the contact member 34 applies pressure to the sample source.

[0045] In some examples, the working part 24 includes a pump member 36 for applying pressure to the finger 19, such as a pair of opposing tabs or wings 38. Each of the wings 38 may include a contact member 34. The holder 12 may also include a living hinge portion 42. The living hinge portion 42 allows the user to compress the wings 38 between a first position (passive) and a second position (active). Blood is drawn from the patient's finger 19. liquid Using a tab or wing 38 for removal is thought to minimize hemolysis while maintaining adequate blood flow from the patient's finger 19. The resting position and hinge of the wing 38 are designed to flex to accommodate the patient's largest finger within the holder 12 without blood obstruction, while maintaining contact and retention of the patient's smallest finger that can fit within the holder 12. In some examples, the wing 38 may be positioned in the finger receiving portion 20 at a location proximal to the patient's fingernail and distal to the first joint of the patient's finger to avoid hard tissue of the patient's finger 19.

[0046] The holder 12 may be configured to allow the user to repeatedly squeeze and release the wings 38 to pump and / or extract blood from the finger 19 until a desired amount of blood fills the collection container 16. The wings 38 are configured to be flexible to hold the holder 12 on the patient's finger 19, maintaining light contact with a range of patient finger sizes that can be used with the holder 12. The wings 38 may also provide active pressure characteristics to the holder 12.

[0047] In some examples, the holder 12 may include a stabilization extension 40, which provides additional support to ensure the holder 12 is securely fitted to the finger 19. In one example, the finger receiving portion 20 generally forms a C-shaped member and includes multiple internal gripping members intended to provide additional grip and support to ensure the holder 12 is securely fitted to the finger 19. The stabilization extension 40 helps maintain contact with the patient's finger 19 during use of the holder 12 while avoiding blood supply to the patient's finger 19 and the knuckles.

[0048] To obtain a blood sample Peripheral blood collection device 10 also includes a lancet housing or lancet 14 (shown in Figure 1B) that is detachably connected to a port 26 of the holder 12. Referring to Figure 1B, the lancet housing or lancet 14 may include an entry or opening 50, an interior 52, a puncture element 54, an engagement portion 56, a retractable mechanism 58, and a drive spring 60. The puncture element 54 may be movable between a pre-actuated position in which the puncture element 54 is held within the interior 52 of the lancet housing 14 and a puncture position in which at least a portion of the puncture element 54 extends through the entry 50 of the lancet housing or lancet 14 to incise a portion of the finger 19 with the lancet. In one example, the lancet 14 of this disclosure is a contact-actuated lancet and may be constructed in accordance with the features disclosed in Patent Document 1, titled “Contact-Actuated Lancet Device,” which is incorporated herein by reference.

[0049] In some embodiments, the holder 12 and the lancet housing or lancet 14 are separate components that can be detachably connected to the port 26 of the holder 12. In such embodiments, the lancet housing or lancet 14 includes an engaging portion 56. The lancet housing or lancet 14 can be pushed into the port 26 of the holder 12 so that the engaging portion 56 of the lancet housing or lancet 14 locks into the locking portion 32 of the holder 12. In this way, the lancet housing 14 is securely connected and locked to the holder 12 so that the puncture element 54 of the lancet housing 14 can be actuated to cut or puncture a sample source, such as a finger 19, with the lancet. In some embodiments, the port 26 of the holder 12 includes a number of ribs within the port 26 for securing and locking the lancet 14 or collection container 16.

[0050] To activate the lancet 14, the lancet 14 is pressed against the finger 19, activating the retractable mechanism 58 and drive spring 60 of the lancet 14, which incises the finger 19 with the lancet. After puncture, the puncture element 54 is immediately retracted and securely fixed inside the lancet housing 14 52. Once the finger 19 is punctured, the blood sample is squeezed from the finger 19 into the collection container 16. The collection container 16 may also contain a sample stabilizer, such as an anticoagulant, to stabilize the blood sample and / or the components of the blood sample placed inside the collection container 16. The collection container 16 may also contain at least one filling line corresponding to a predetermined amount of sample. The collection container 16 may also display / measure the amount of blood collected.

[0051] To use the peripheral blood collection device 10 shown in Figure 1A-1E, the desired finger 19 is first washed, a holder 12 of the appropriate size for the desired finger 19 is selected and securely fitted onto the finger 19. Next, the lancet housing or lancet 14 is connected to the port 26 of the holder 12. As described above, the lancet housing or lancet 14 is pushed into the port 26 of the holder 12, and the engaging portion 56 of the lancet housing or lancet 14 is locked into the locking portion 32 of the holder 12. In this way, the lancet housing or lancet 14 is securely connected and locked to the holder 12, and the puncture element 54 of the lancet housing 14 is activated to cut or puncture the finger 19 with the lancet. With the lancet 14 connected to the port 26 of the holder 12, the lancet 14 communicates with the finger 19.

[0052] If it is desirable to activate the lancet 14 to make an incision in the skin of the finger 19 with the lancet, the lancet 14 is pressed against the finger 19 to activate the retractable mechanism 58 of the lancet 14, making an incision in the finger 19 with the lancet. After the finger 19 has been incised with the lancet and blood flow has been brought out of the finger 19, the lancet 14 is removed from the holder 12 and the collection container 16 is pushed into the port 26 of the holder 12. With the container 16 properly secured in the holder 12 for blood sample collection, the user repeatedly compresses and releases the wings 38 of the holder 12 until the desired amount of blood has been collected in the collection container 16, thereby collecting blood from the finger 19. liquid It delivers and / or extracts blood. Advantageously, when the holder 12 is attached to the finger 19, it does not restrict blood flow and defines the incision site and the compression site of the finger with the lancet. The compression tab or wing 38 provides a predefined range of compression pressure that is applied consistently across the entire finger 19. In doing so, the holder 12 provides a mild, controlled massage of the finger 19 that facilitates blood extraction and minimizes any potential hemolysis.

[0053] Once the desired amount of blood liquid Once collected in container 16, the blood collector portion, including the collection container 16, can be detached from the collection device 10 to send the collected sample to a diagnostic instrument and / or testing device. Once detached from the collection device 10, the blood collector portion can be sealed via a cap or partition to protect the blood sample in the collection container 16.

[0054] Multi-size peripheral blood collection kit The aforementioned holder 12 and Peripheral blood collection deviceDevice 10 offers advantages over conventional peripheral blood collection devices. In particular, the holder 12 is configured to conform to the characteristics of the patient's finger, ensuring that the holder 12 remains consistently and securely in place and applies pressure to the correct location. This feature was achieved by analyzing several anatomical sources (finger width and length, finger joint and artery locations) to limit compression to soft tissue near the collection site while avoiding pressure on hard tissue or blood vessels. Furthermore, Peripheral blood collection device The wing portion 38 of the 10 is configured to apply pressure in two stages. The first stage has pressure on the finger 19 that increases in proportion to the applied pressure. However, as the intensity increases, the wing portion 38 begins to flex and bend until the wing portion 38 makes contact and can no longer be moved. This two-stage pressure application allows for sufficient pressure to obtain adequate blood flow, but limits the maximum pressure to avoid hemolysis.

[0055] In order to achieve such advantages in how pressure is applied to the finger 19 during a blood collection procedure, it is important that the holder 12 is precisely sized for the patient's finger, meaning that the holder 12 is neither too loose nor too tight to function properly. For example, if the holder 12 is too loose, it may move around on the finger 19 or fall off the finger 19 during the blood collection procedure. If the holder 12 is too tight, it may restrict blood flow or cause pain to the patient.

[0056] Since it is impractical to manufacture holders 12 of infinite sizes, a set or kit 62 containing a random number of holders 12 of different sizes can be provided to the user. For example, as shown in Figure 2A, Peripheral blood collection deviceThe set of 10a, 10b, 10c, and 10d may include device 10a with a small holder 12a, device 10b with a medium holder 12b, device 10c with a large holder 12c, and device 10d with an extra-large holder 12d. Devices 10a, 10b, 10c, and 10d of different sizes are designed to fit patients with different hand and finger sizes. For example, devices 10a, 10b, 10c, and 10d of different sizes can be manufactured to accommodate individuals with different finger widths, finger heights, and / or finger lengths (i.e., the distance between the fingertip and the second joint of the finger used for the puncture procedure). In particular, the sizes of various components of devices 10a, 10b, 10c, and 10d, such as the diameter of the first opening 22 and / or the length of the finger receiving portion 20 of the holder 12, can vary for each size of device 10a, 10b, 10c, and 10d to accommodate patients with different finger diameters.

[0057] The dimensions for the different sizes of devices 10a, 10b, 10c, and 10d can be determined, for example, from size charts of average-sized adult and / or pediatric patients and other anatomical data. For example, the smallest device 10a can be sized to accommodate finger width and length corresponding to the 25th percentile of an average adult. Similarly, the medium device 10b can be sized for people whose hand and / or finger size falls between the 25th and 50th percentiles, the large device 10c can be sized for people whose hand and / or finger size falls between the 50th and 75th percentiles, and the extra-large device 10d can be sized for people whose finger size falls between the 75th and 100th percentiles. In some examples, the size range of devices 10a, 10b, 10c, and 10d can be further optimized, for example, to minimize the mismatch between holder size and person's finger size for the largest possible population. In other examples, the size range may be optimized so that substantially equal numbers of people in the population use each of the device sizes 10a, 10b, 10c, and 10d. In that case, the size range for small and very large devices (i.e., size The difference between the maximum value of the range and the minimum value of the size range will be greater than the size range of the medium device 10b and the large device 10c, due to the substantial normal distribution of the patient's finger size. To determine the appropriate size of the sampling devices 10a, 10b, 10c, and 10d, the user may measure the patient's finger and / or perform some other sizing activity to determine the correct holder 12 for the particular patient's finger being punctured.

[0058] The simulation device 110 of this disclosure is of any size Peripheral blood collection device This allows users to practice determining which sizes 10a, 10b, 10c, and 10d should be used for which finger, and once the correct size classification is determined, the user can practice determining which size is correct. Peripheral blood collection deviceThis allows you to practice collecting peripheral blood samples using this method. See Figure 2B. Peripheral blood collection device A sizing tool, or card 70, is described, which can be used to verify the size classifications 10a, 10b, 10c, and 10d. The sizing tool 70 can, for example, verify different sizes Peripheral blood collection device It can be a flat card including an oval opening 72 sized to correspond to 10a, 10b, 10c, and 10d. The card 70 can be formed from laminated cardboard or any other affordable material that is sturdy enough to maintain the shape of the card 70, so that the card 70 can be disinfected between uses and reused many times. Alternatively, the sizing card 70 can be disposable and intended to be used once for a particular patient before performing a blood sampling procedure on the patient. In that case, the sizing card 70 can be formed from a less sturdy material such as thin cardboard or paper. In some examples, the opening 72 is Peripheral blood collection device The major diameter D1 corresponding to the maximum width of the fingers for 10a, 10b, 10c, and 10d, Peripheral blood collection device An elliptical opening 72 having a minor diameter D2 corresponding to the maximum height of the fingers 10a, 10b, 10c, and 10d. The opening 72 may further include a notch 74 at the top of each opening 72. The purpose of the notch 74 is to make it easier for the user to insert the card 70 into the patient's finger and / or remove the card 70 from the patient's finger during size classification.

[0059] In some cases, the top opening 72 of the card 70 may have a major axis D1 and a minor axis D2 corresponding to the dimensions of a small device 10a. The bottom opening 72 may have a major axis D1 and a minor axis D2 corresponding to an extra-large device 10d. To use the sizing card 70, the user inserts the patient's finger to be used in the puncture procedure through the top opening 72 to determine whether a small device 10a should be used. For accurate size classification, the finger should pass through the opening 72 up to the first joint of the finger, or slightly past the first joint of the finger. If the top opening 72 is too tight, the opening 72 will not pass through the patient's finger up to the first joint, which means that the small device 10a is too small for the finger. In that case, the user should examine the finger using the other openings 72 on the card 70 (i.e., the openings 72 sized for the medium device 10b, the large device 10c, and, if necessary, the extra-large device 10d) to determine which opening 72 is sized to pass through the patient's finger up to the first joint of the finger, or slightly beyond the first joint. The user should then select the opening 72 that best fits the finger to be used for the puncture procedure. Peripheral blood collection device Sizes 10a, 10b, 10c, and 10d should be used.

[0060] Puncture and blood sampling simulation device Examples of a simulation device 110 that allows a user to practice using a peripheral blood collection device, such as any peripheral blood collection device 10 shown in Figures 1A-1E, and to collect a peripheral blood sample are shown in Figures 3-5 and 7A-7I. As previously mentioned, the simulation device 110 allows a user, such as a phrebotomist, medical technician, nurse, physician, or other medical technician, to practice, for example, sizing the collection device 10 (i.e., selecting a collection device 10 of the appropriate size for the patient's finger), inserting the collection device 10 onto the patient's finger, Peripheral blood collection deviceThe simulation device 110 of this disclosure allows practice of steps for using the peripheral blood collection device 10, including activating the lancet 14 to make an incision in the finger with the lancet and collecting a peripheral blood sample in the collection device 10 and associated container 16. Peripheral blood collection device It can be used with 10 or any other sampling device or sampling assembly. The simulation device 110 can also be used with a wide variety of other medical devices configured to cut, puncture, injure, or otherwise manipulate areas of a patient's fingers, hands, wrists, forearms, or other appendages or limbs. For example, the simulation device 110 may be used to practice performing injection or blood sampling procedures using a syringe. In other examples, the simulation device 110 may be used to practice other procedures using a surgical scalpel and other surgical instruments.

[0061] Referring to Figure 3-5, the simulation device 110 includes a base support 112, a puncture target 114 connected to the base support 112 and configured to be repeatedly punctured by the lancet of the peripheral blood collection device 10 so that the device 110 can be used multiple times, and a fluid circulation system 116 for circulating fluid (i.e., simulated liquid blood) through the puncture target 114. As will be described in more detail with reference to Figure 5, the fluid circulation system 116 includes a fluid reservoir 118 and a fluid reservoir 118 so that the fluid flows out of the puncture site during the simulated blood collection procedure. Peripheral blood collection device The system may include a puncture port 120 located on a puncture target 114 that can be punctured by 10 lancets, a tube 122 extending at least partially through the target 114 between a reservoir 118 and the port 120, and a pump 124 for circulating fluid from the reservoir 118 to the port 120.

[0062] As will be described in more detail herein, the puncture target 114 is Peripheral blood collection deviceIt is the appropriate size to be inserted into holder 12 of 10. When inserted into holder 12, Peripheral blood collection device To establish fluid communication between the container 16 and the tube 122 and reservoir 118 of the fluid circulation system 116, the puncture target 114 can be punctured with the lancet of the peripheral blood collection device 10 along with the port 120. When fluid communication with the tube 122 / reservoir 118 is established, fluid can be discharged from the reservoir 118 to the port 120 The pump 124 can be operated to circulate the fluid through the tube 122. The circulating fluid can be discharged from the punctured port 120 and collected in the container 16 of the peripheral blood collection device 10, simulating the peripheral blood collection procedure.

[0063] The base support 112 of the simulation device 110 can be any suitable support structure for maintaining the object 114 at the appropriate height and orientation to allow the user to practice performing blood sampling procedures. For example, the base support 112 can be configured to support the puncture object 114 with an appropriate vertical clearance distance (i.e., 10 inches, 8 inches, 6 inches, or 4 inches) between the lowest or bottom of the object 114 and the surface on which the base support 112 rests (i.e., the surface of a table or counter). In some examples, the base support 112 is a cabinet or housing that includes an internal space or compartment for housing components of the fluid circulation system 116, such as a pump 124, tubing 122, and / or a reservoir 118.

[0064] For example, as shown in Figure 3, the base support 112 is configured to rest on a surface (i.e., a table or counter) and is substantially horizontal. The section Material 126 may be included. First Component 126 is reservoir 118, pump Pu1The base support 112 may be a box or housing containing components of the simulation device 110, such as member 24 and / or tube 122. The base support 112 may also include a substantially vertical plate or second member 128 extending from the first member 126. The puncture target 114 may be connected to and extend from the vertical plate or second member 128 with sufficient clearance (i.e., about 6 inches or more) between the target 114 and the surface on which the first member 126 and / or simulation device 110 rest.

[0065] In some examples, as shown in Figure 4, the base support 112 may include a flexible and / or supple arm 130. To allow the user to adjust the position of the object 114, the supple arm 130 may be mounted between a first member 126 and a vertical plate or a second member 128. The supple arm 130 may be similar to the supple support arms used in electronic displays, computer monitors, televisions, and similar devices. In some examples, the supple arm 130 may be rotatably mounted to the first member 126, allowing the user to rotate the arm 130 and the object 114. The supple arm 130 may include, for example, a first elongated member 132 and a second elongated member 134 connected by a hinge 136. By opening and closing the hinge 136, the user can adjust the height of the object 114, for example, to simulate the pronation and supination of a patient's wrist, and the hinge 136 allows the user to practice moving their hand to the appropriate height before performing a blood sampling procedure.

[0066] In some examples, the base support 112 may include a heating device for warming the puncture target 114, so that the target 114 feels as lifelike and realistic as possible. Various types of electronic heating devices, such as a heatable surface, coating, or coil, may be embedded in or connected to the base support 112. In other examples, the base support 112 may be heated by an electronic device located within the base support 112, such as a pump 124. Before using the simulation device 110, the puncture target 114 may be moved downwards toward the base support 112. The heating device is turned on, allowing it to warm the puncture target 114. Once the puncture target 114 has warmed to a sufficient temperature, the user can turn off the heating device and raise the puncture target 114 to an appropriate (i.e., easily accessible) height, and begin the blood collection procedure.

[0067] Refer to Figures 3 and 5 in detail. The puncture target 114 is usually, Peripheral blood collection device These are elongated members of appropriate dimensions (i.e., appropriate length and thickness) that are inserted into the holder 12 of the 10. Peripheral blood collection device The puncture target 114 can be formed from any material that can be repeatedly punctured by 10 lancets 14 or by other cutting tools that do not make cuts or otherwise deform. For example, the puncture target 114 can be formed from a support structure 140 covered with a sheet or cover 142 of synthetic or natural elastomer material. In some examples, the sheet or cover 142 can be self-sealing, meaning that the lancets 14 do not leave noticeable holes, tears, or marks in the sheet or cover 142. In other examples, for example, a port 120 of a fluid circulation system 116, Peripheral blood collection device If the material can be sealed immediately after being punctured with a lancet 14, it may not be self-sealing.

[0068] In some examples, the puncture target 114 is an anatomically accurate model 144 of a human hand, including, for example, the forearm, wrist 146, palm 148, four fingers (i.e., ring finger 150, middle finger 152, index finger 154, little finger 156), and thumb. In other examples, the puncture target 114 can be a more abstract model, including, for example, a cylindrical member sized to approximate the width, height, and length of human fingers. Since most right-handed patients prefer to have the puncture performed on their non-dominant hand, the hand model 144 can have a left-handed orientation. The wrist portion 146 or the proximal portion of the hand model engages with a base support 112, from which the palm 148 and fingers 150, 152, 154, 156 of the model 144 extend. The palm 148 of the hand model 144 is generally flat and downward-facing, facilitating proper positioning of the patient's hand during the puncture procedure. Furthermore, fingers 150, 152, 154, and 156 can be spaced apart or separated, allowing the user to touch and manipulate each individual finger. In some examples, fingers 150, 152, 154, and 156 can be flexible, allowing the user to move the unpunctured fingers 150, 152, 154, and 156 out of the way.

[0069] Peripheral blood collection device Since 10 is generally used with either the middle finger 152 or the ring finger 150, the puncturable port 120 of the fluid circulation system 116 can be located within the distal portion of the ring finger 150 and / or middle finger 152 of an anatomically accurate hand model 144. The other fingers 154, 156 of the hand model 144 (the other fingers 154, 156 do not include the puncture port 120) can be flexible, and / or the middle finger 152 and / or ring finger 150 It can be bent away from the center, thereby allowing the user to easily access and manipulate the middle and / or ring fingers 150, 152 to practice blood collection procedures.

[0070] The hand model 144 can be any size determined, for example, based on what types of blood sampling procedures the user typically performs and / or what types of blood sampling procedures the user wants to practice. In some examples, the hand model 144 can be sized according to the average hand size of an average adult. For example, the hand dimensions, such as finger length, finger circumference, palm circumference, and overall hand length, can be the 50th percentile dimensions for an adult, or average dimensions. In other examples, such as for a user whose work typically involves handling pediatric patients, the hand model dimensions can be for an average pediatric patient (i.e., the 50th percentile dimensions for a 12-year-old patient).

[0071] In some examples, the support structure 140 of the hand model 144 is an internal frame structure having a structure and appearance that represents the bones of a human hand. For example, the support structure 140 may include multiple elongated members that are fixedly connected to each other or hinged to each other in order to replicate the connections between the finger bones and the bones of the hand. The support structure 140 can be formed by any manufacturing technique suitable for forming multiple connecting members of a relatively small size. For example, the elongated members of the internal frame or support structure 140 can be made by 3D printing using manufacturing procedures, as is well known in 3D printing techniques. The various elongated members of the frame or support structure 140 can be connected to each other by adhesive and / or mechanical fasteners, or by any other convenient method. A cover 142 is placed over the internal frame or support structure 140. The cover 142 can be made from an elastomer material such as natural or synthetic rubber that has the appearance and feel of human skin. In other examples, the cover 142 may include leather or a similar material that has a similar appearance and feel to skin. Furthermore, the cover 142 may be, Peripheral blood collection deviceIt should be thin enough to be punctured by 10 lancets 14. The cover 142 may also have a color and / or texture that replicates the appearance of skin in order to provide the user with a more realistic simulation experience. The cover 142 can be attached to the internal frame or support structure 140 by any suitable connectors, including mechanical fasteners or connectors (i.e., staples, pins, threads, nails, or similar connectors), as is known in the art, or by using adhesive.

[0072] As mentioned above, in some examples, the puncturable ports 120 of the fluid circulation system 116 are located on both the middle finger 152 and the ring finger 150 of the hand model 144. In that case, the ring finger 150 is connected to one size peripheral blood collection device 10 (i.e., the medium-sized one shown in Figure 2A). Peripheral blood collection device The middle finger 152 can be sized to accept a larger peripheral blood collection device 10 (i.e., the large capillary collection device 10c shown in Figure 2A or an extra-large one). Peripheral blood collection device It can be sized to accept 10d). This structure allows users to choose different sizes. Peripheral blood collection device This allows users to practice performing blood collection procedures using device 10, as well as to practice classifying the sizes of peripheral blood collection devices 10.

[0073] Referring in detail to Figure 5, the fluid circulation system 116 of the simulation device 110 includes a fluid reservoir 118, a tube 122 extending from the reservoir 118 through the puncture target 114, and a puncture port 120 which can be located, for example, on the fingers 150, 152 of the target 114. The tube 122 of the fluid circulation system 116 can be any flexible or rigid plastic tube known in the art, such as tubes used in medical procedures (i.e., surgical procedures including intravenous injection procedures, dialysis procedures, and / or extracorporeal blood flow). The tube 122 can also be a flexible tube commonly used as a building material, such as a flexible tube commonly used in HVAC systems. As mentioned above, the tube 122 extends from the reservoir 118 to the puncture port 120. In some examples, the tube 122 is completely housed within the base support 112 and / or the target 114. In other examples, some portions of the tube 122 may be outside the base support 112 and / or object 114 and may be held in place relative to the base support 112 and / or object 114 by clips, fasteners, staples, or other connectors, for example, as is known in the art.

[0074] The puncture port 120 of the fluid circulation system 116 is Peripheral blood collection device The diagram shows a portion of the fluid circulation system 116, positioned to be punctured by 10 lancets 14. For example, as previously mentioned, the puncture port 120 can be located near the distal ends of the ring finger 150 and middle finger 152 of the hand model 144. Preferably, the puncture port 120 is self-sealing, meaning that the port seals once the fluid flow through the fluid circulation system 116 stops, so that the simulation device 110 can be used for multiple simulated blood collection procedures. In some examples, the puncture port 120 is simply a fluid circulation The length of the tube connected to the other part of tube 122 of system 116, and / or the fluid circulationIt is simply the length of the tube 122 of system 116, integrated with the rest of the tube. In other examples, the puncture port 120 is Peripheral blood Sampling device 10 The reinforced portion of the tube, or the more rigid portion of the tube, can be shown, configured to be repeatedly punctured by the lancet 14. Alternatively, the puncture port 120 These can be enlarged, sealed cavities or recesses within fingers 150, 152 that are fluidically connected to tube 122 for supplying fluid to and from port 120.

[0075] The pump 124 of the fluid circulation system 116 can be any variety of automatic or manually operated pumps that can generate a fluid flow through the fluid circulation system 116 at an appropriate flow rate, as is known in the art. For example, an appropriate flow rate can be about 2 μL / s to about 10 μL / s, or preferably about 5 μL / s. In some examples, the pump 124 is an electric pump, such as a rotary pump, peristaltic pump, air pump, or other pump structures known in the art. The pump 124 can be powered by a battery or by alternating current supplied, for example, from a wall outlet. In other examples, the pump 124 can be a manually operated pump, such as a manual piston pump, hand bulb pump, or similar device, as is known in the art, for propelling the fluid through the tube.

[0076] In some examples, the pump 124 can be connected to the remote control device 138 by a wired connection or by a wireless connection, such as by a short-range wireless data transmitter (i.e., a Bluetooth® transmitter). Peripheral blood collection deviceIndividuals practicing the use of the 10, and / or users such as trainers or examination supervisors, can operate the pump 124 by controlling the flow of fluid through the fluid circulation system 116, for example, by using the remote control device 138 to turn the pump 124 on or off. In some examples, users may also be able to control pump operating parameters such as flow rate using the remote control device 138. In other examples, pump operating parameters may be adjusted by buttons, knobs, and other selectors on the housing of the pump 124. Beneficially, the remote control device 138 allows other individuals, such as trainers, examination supervisors, instructors, or another person managing the examination, to operate the pump 124 while remaining away from the simulation device 110. This allows the trainer to observe the blood collection activity performed by the user and activate the pump 124 at the appropriate time without distracting the user or otherwise interfering with the user while he or she performs tasks associated with the simulated blood collection procedure.

[0077] The reservoir 118 of the fluid circulation system 116 can be any suitable container sized to hold a sufficient amount of fluid (i.e., the fluid of simulated blood) to substantially fill the tube 122 of the circulation system 116. In some examples, the reservoir 118 includes a separate and / or removable cup 158 (i.e., removable from the base support 112 and / or other components of the fluid circulation system 116) having a lid 160 with an opening for receiving the end of the tube 122 extending from the base support 112 or the puncture target 114. In such examples, the user can set up the simulation device 110 by placing the end of the tube 122 into the cup 158. When ready for use, the cup 158 can be placed in a selected location inside the base support 112 or remain outside the base support 112. After a period of training practice or examination using the simulation device 110 is completed, the user can remove the lid 160 from the cup 158 and discard any remaining fluid. After use, the user can fill the cup 158 with water or cleaning fluid to circulate the water or cleaning fluid through the tube 122 and pump 124 of the fluid circulation system 116. In other examples, the reservoir 118 may be integrated with the base support 112 and / or the puncture target 114. In such cases, the user can fill the reservoir 118 with fluid, for example, by flowing fluid into the built-in reservoir 118 through a fluid filling port.

[0078] How to use a simulation device to practice performing peripheral blood sampling. Figure 6 is a flowchart illustrating a training method that can be performed by a user of the simulation device 110 to practice size classification and use of the peripheral blood collection device 10. As shown in step 210, the user first practices, for example, using a vertical plate or SecondThe user adjusts the position of the puncture target 114 or the hand model 144 by grasping part of component 128 and / or object 114 and moving it up and down to a comfortable position for the user. Figure 7B shows a diagram illustrating a user grasping the simulation device 110 and adjusting the position of the puncture target 114. In step 212, the user then places the distal end of tube 122 of the fluid circulation system 116 into the reservoir 118, as shown in Figure 7C, to establish fluid communication between the reservoir 118 of the fluid circulation system 116, the pump 124, and the puncture port 120. Once tube 122 is in the reservoir 118, the reservoir 118 can be placed in a suitable location within the housing of the base support 112, such as next to the pump 124, as shown in Figure 7D. In step 214, once the fluid circulation system 116 is ready for use, the user then adjusts the position of fingers 152, 154, and 156 of the hand model 144 so that the finger to be used for the puncture procedure (i.e., the ring finger 150) is easily accessible and manipulated, as shown in Figure 7E.

[0079] In step 216, the user then inserts their fingers 150 into the different openings 72 of the sizing card 70 to determine which size Peripheral blood collection device Determine whether 10 should be used for puncture and blood collection. As previously mentioned, the opening of the sizing card 70 should be large enough to move smoothly over the finger 150 beyond the first joint of the finger. As shown in Figure 7F, the top opening 72 of the sizing card 70 (small Peripheral blood collection The device (corresponding to device 10a) is too tight, preventing smooth movement of the finger 150 up to the first joint. As shown in Figure 7G, the second opening 72 (medium Peripheral blood collection device (Corresponding to 10b) is the correct size for a ring finger of 150.

[0080] In step 218, as shown in Figure 7H, the user then selects the correct size Peripheral blood collection device Insert holder 12 into the ring finger 150 of hand model 144. Semi-integrated. Peripheral blood collection device(That is, the lancet 14 and / or container 16 are not integrally formed with the holder 12) Peripheral blood collection device Regarding 10), after the holder 12 is attached to the fingers 152 of the hand model 144, the user may also attach the lancet 14 and container 16 to the holder 12. Once the holder 12 and / or Peripheral blood collection device When the 10 other components are connected to the ring finger 150 of the hand model 144, as previously described in relation to Figures 1A-1E, the user Peripheral blood collection device Activate 10 and puncture finger 150. Specifically, once activated, Peripheral blood collection device Ten lancets 14 puncture the cover 142 of the hand model 144 and the port 120 of the fluid circulation system 116. Peripheral blood collection device Fluid communication is established between the 10 containers 16 and the components of the fluid circulation system 116.

[0081] In step 220, immediately before or after the puncture is performed, the user (or trainer or test supervisor) can activate the pump 124 to circulate the fluid (i.e., the fluid of the simulated blood) through the fluid circulation system 116 of the simulation device 110. The circulating fluid is then discharged through the punctured port 120. Peripheral blood collection device The fluid is discharged into containers 16, thereby simulating peripheral blood collection as shown in Figure 7I. As previously mentioned, when the fluid is being collected, the user Peripheral blood collection device The 10 blade sections 38 can be manipulated to enhance the fluid flow and circulate the liquid through the tube. 122 and / or from puncture port 120 Peripheral blood collection device It effectively distributes the contents into 10 collection containers 16.

[0082] In step 222, once the appropriate amount of fluid has been collected in container 16, the user turns off pump 124 to stop the fluid from circulating through fluid circulation system 116. Peripheral blood collection deviceThe 10 containers 16 can be removed from the holder 12, thereby completing the blood collection procedure. The user may also remove the holder 12 from the ring finger 150 of the hand model 144. As previously mentioned, the puncture port 120 of the fluid circulation system 116 is intended to self-seal, and once the holder 12 and lancet 14 are removed, the port 120 seals, allowing the simulation device 110 to be used for further simulated blood collection procedures.

[0083] In step 224, if no other simulated actions are performed using the simulation device 110 for a period of time, the user can clean the fluid circulation system 116 of the simulation device 110 by discarding any remaining liquid from the reservoir 118. Once the liquid has been discarded, the user can fill the reservoir 118 with water or cleaning fluid and operate the pump 124 to clean the tubes of the fluid circulation system 116. 122 Water or cleaning solution can be circulated through it.

[0084] Different examples of simulation devices and methods are shown in the accompanying drawings and described in detail above, but other examples will be apparent to those skilled in the art without departing from the scope and spirit of the invention and will be readily fabricated by those skilled in the art. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The invention as described above is defined by the appended claims, and all modifications to the invention that fall within the meaning and equivalence of the claims are encompassed within those scopes.

Claims

1. A simulation device that enables a user to practice using a peripheral blood collection device, wherein the simulation device is Base support and, A puncture target connected to the base support, configured to be repeatedly punctured by the lancet of the peripheral blood collection device in order to practice the use of the peripheral blood collection device, wherein the puncture target is formed from an internal frame structure and a cover that covers the internal frame structure, and comprises a plurality of elongated members representing fingers, A fluid circulation system comprising: a fluid reservoir; at least one port disposed within the plurality of elongated members such that the cover covers at least one port; a tube extending at least partially through the puncture target between the reservoir and the at least one port; and a pump for circulating fluid from the reservoir to the at least one port; Equipped with, The puncture targets are classified by size so as to be connected to the peripheral blood collection device, and as a result the peripheral blood collection device punctures the puncture targets and the at least one port to establish fluid communication with the tube and reservoir. When the fluid communication is established and the pump circulates the fluid from the reservoir, the fluid is discharged from at least one port and collected in the container of the peripheral blood collection device. A simulation device in which at least one of the ports, or the cover, is self-sealing.

2. The simulation device according to claim 1, wherein the base support is configured to support the puncture target with a vertical clearance of at least 6.0 inches between the puncture target and the bottom of the base support.

3. The simulation device according to claim 1, wherein the base support comprises a first member configured to rest on a surface and a second member extending from the first member, and the puncture target extends from the second member of the base support.

4. The simulation device according to claim 1, wherein the base support comprises a flexible arm mounted to be rotatable and / or pivotable with respect to a support member.

5. The simulation device according to claim 4, wherein the flexible arm comprises at least one hinge configured to bend in one or more directions to adjust the position of the puncture target relative to the support member.

6. The simulation device according to claim 4, wherein the flexible arm pivots and / or rotates to raise or lower the height of the puncture target relative to the bottom of the base support.

7. The simulation device according to claim 1, wherein the pump includes an electric pump.

8. The simulation device according to claim 1, wherein the pump includes a manually operated mechanical pump.

9. The simulation device according to claim 1, further comprising a remote control device operably connected to the pump, configured to operate and / or control the flow rate of the pump.

10. The simulation device according to claim 1, wherein the pump draws fluid from the reservoir at a flow rate of approximately 5 μL / s.

11. The simulation device according to claim 1, wherein the fluid in the reservoir contains a liquid of simulated blood.

12. The simulation device according to claim 1, wherein the puncture target comprises a substantially anatomically accurate model of a hand, including a proximal end connected to the base support and a distal end comprising the plurality of elongated members representing fingers, and the fluid circulation system comprises a plurality of ports disposed in the elongated members representing the fingers.

13. The simulation device according to claim 12, wherein the dimensions of the hand model are selected based on anatomical measurements at the 50th percentile relative to the size of an adult hand.

14. The simulation device according to claim 12, wherein the plurality of elongated members of the hand model comprises at least a ring finger member sized to receive the peripheral blood collection device of a first size, and a middle finger member sized to receive the peripheral blood collection device of a second size larger than the first size.

15. The simulation device according to claim 12, wherein the hand model is oriented to face left, the hand model is positioned with a flat palm facing downward, and the plurality of elongated members represent fingers that are spaced apart.

16. The simulation device according to claim 12, wherein the internal frame replicates the bones of a human hand, and the cover includes an elastomer cover configured to replicate the appearance and feel of human skin.

17. The simulation device according to claim 16, wherein the cover includes an elastomer sheet.

18. The simulation device according to claim 12, wherein the first port of the plurality of ports is located on the elongated member representing the middle finger, and the second port of the plurality of ports is located on the elongated member representing the ring finger.

19. The simulation device according to claim 18, wherein the elongated member representing a finger other than the middle finger or the ring finger is flexible and can be bent away from the middle finger and / or the ring finger, thereby allowing the user to access and manipulate the middle finger and / or the ring finger in order to practice the procedure.

20. A method for practicing the size classification and use of peripheral blood collection devices, wherein the method is: To identify the opening that best fits the elongated member to be punctured, the simulation device according to claim 1 is inserted through one or more openings of the sizing card. The steps include inserting the holder of the peripheral blood collection device, which is sized to correspond to the identified opening, into the elongated member to be punctured, The steps include: activating the peripheral blood collection device to puncture the elongated member and at least one puncture portion of the peripheral blood collection device; The pump of the fluid circulation system is activated, thereby circulating the fluid The steps include: allowing the blood to be collected in the container of the peripheral blood collection device; A method for providing this.

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