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JP-7856678-B2 - Simulation device for peripheral blood collection

JP7856678B2JP 7856678 B2JP7856678 B2JP 7856678B2JP-7856678-B2

Inventors

  • アンソニー ブイ．トリス
  • ヴラッド ヤクニッシュ
  • チャールズ ピーター アルトホフ

Assignees

  • ベクトン・ディキンソン・アンド・カンパニー

Dates

Publication Date
20260511
Application Date
20220623
Priority Date
20210629

Claims (20)

  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 relative to the 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 downwards, 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 among the plurality of ports is located on the elongated member representing the middle finger, and the second port among 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 ring finger 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 steps include: operating the pump of the fluid circulation system so that the circulating fluid can be collected in the container of the peripheral blood collection device; A method for providing this.

Description

Field of Invention This disclosure generally relates to devices, training systems, and methods that enable users to practice a variety of tasks related to obtaining peripheral blood samples from patients using peripheral blood collection devices . More specifically, this disclosure relates to simulation devices that enable users to practice sizing and using finger-based peripheral blood collection devices, such as devices configured to incise and compress a finger with a lancet in a controlled manner to collect, stabilize, and dispense a blood sample. Cross-reference of related applications This application claims priority to U.S. Provisional Application No. 63/216,264, filed on 29 June 2021, titled "Simulation device for peripheral blood collection," the entire disclosure of which is incorporated herein by reference in its entirety. Description of Related Technologies Devices for acquiring 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 blood samples for testing purposes. Certain diseases, such as diabetes, require that a patient's blood be tested regularly, for example, to monitor the patient's blood glucose levels. Furthermore, test kits, such as cholesterol test kits, often require blood samples for analysis. Blood collection procedures usually involve pricking a finger or other suitable body site to acquire a blood sample. Typically, the amount of blood required for such tests is relatively small, and a small puncture or incision is usually sufficient to provide enough blood for these tests. Various types of lancet devices have been developed for use in puncturing a patient's skin to acquire peripheral blood samples from the patient. 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. 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 a point-of-care (POC) testing device, or the blood samples can be collected and sent to a testing facility. 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 motionless 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: