Radial artery puncture device supporting rotation transformation of an ultrasound probe

Abstract

This invention belongs to the field of medical devices and relates to a radial artery puncture device supporting the rotation and adjustment of an ultrasound probe. It includes: a frame assembly comprising a vertical support arm and a horizontal mounting base, providing overall support for the device and connecting to an external positioning device; a probe rotation adjustment module, mounted on the horizontal mounting base, including a first drive motor, a coupling, and a probe holder, the first drive motor being vertically mounted and its output shaft coaxially connected to the probe holder via the coupling; a puncture needle insertion module, located to the side of the probe holder, including a second drive motor, a linear guide rail, a lead screw transmission mechanism, and a puncture needle clamp; and an angle adjustment connection assembly including an angle adjustment plate, a hinge shaft, and an angle locking mechanism. The device offers continuous and stable imaging; high-precision automated needle insertion, eliminating the influence of hand tremors; independently adjustable puncture angle to adapt to different anatomical conditions; compact structure and high integration; and a reduced learning curve, facilitating standardization and promotion.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a radial artery puncture device that supports the rotation and transformation of an ultrasound probe. Background Technology

[0002] Radial artery puncture is one of the most common vascular puncture procedures in clinical anesthesia, intensive care, emergency resuscitation, and interventional diagnosis and treatment. Due to its superficial anatomical location, relatively fixed course, and ease of hemostasis, the radial artery is widely used in arterial catheterization, blood gas analysis, and percutaneous coronary intervention. However, the radial artery has a small diameter (typically 2–3 mm in adults), significant locational variation, and is easily difficult to locate palpably due to patient position, subcutaneous tissue thickness, and arteriosclerosis. Therefore, ultrasound-guided radial artery puncture has gradually become the standard procedure.

[0003] In traditional ultrasound-guided puncture procedures, the operator holds the ultrasound probe in one hand, adjusting its position and angle to acquire images of the target blood vessel in either the transverse (short axis) or longitudinal (long axis) section, while holding the puncture needle in the other hand, completing the puncture under the guidance of real-time ultrasound images. This operational mode has the following inherent defects and shortcomings:

[0004] The procedure requires extremely high hand-eye coordination: the operator must simultaneously maintain the stability of the ultrasound probe, keep the target blood vessel within the imaging plane, and control the puncture needle to precisely enter the blood vessel along a preset path. During the procedure, any slight hand tremor can cause the probe to deviate from the target, the imaging plane to be lost, or the puncture needle to deviate from the center of the blood vessel, resulting in a "missing target" phenomenon, increasing the puncture failure rate and the risk of blood vessel damage.

[0005] Switching between imaging planes is cumbersome and prone to losing the target: During puncture, the operator typically needs to observe the vessel diameter and surrounding tissue relationships in the transverse (short axis) section of the vessel, and dynamically observe the needle tip's path within the vessel in the longitudinal (long axis) section. In traditional procedures, manually rotating the probe to switch planes not only requires the operator to have a high level of spatial imagination, but also easily causes imaging plane shifts and vessel loss during rotation, requiring repeated repositioning and significantly extending the operation time.

[0006] Precise control and maintenance of the needle insertion angle are challenging: the depth of the radial artery varies among patients, and even within the same patient, the vascular depth at different puncture segments may differ due to varying degrees of subcutaneous tissue compression. The ideal puncture angle should match the vascular depth and needle insertion path to ensure the needle tip enters the center of the vessel with minimal trauma. However, it is difficult to precisely set and maintain a constant puncture angle manually, especially during the puncture process, as changes in the operator's hand posture can easily cause deviations in the needle insertion angle, increasing the risk of posterior wall penetration and hematoma formation.

[0007] Operational dependence on experience: Existing technology is highly dependent on the operator's personal experience and feel, with a steep learning curve, low success rate for beginners, and insufficient standardization of operation, which is not conducive to technology promotion and standardized training.

[0008] Therefore, there is an urgent need to provide an automated auxiliary device that can achieve precise rotation switching of the ultrasound probe, adjustable puncture angle, and highly controllable needle insertion process. Summary of the Invention

[0009] To address the aforementioned deficiencies in the prior art, the present invention provides a radial artery puncture device that supports the rotational transformation of an ultrasound probe, comprising:

[0010] A rack assembly, comprising a vertical support arm and a horizontal mounting base, for providing overall support for the device and connecting to an external positioning device;

[0011] A probe rotation adjustment module is set on the horizontal mounting base and includes a first drive motor, a coupling and a probe holder. The first drive motor is vertically mounted and its output shaft is coaxially connected to the probe holder through the coupling. It is used to drive the ultrasound probe to rotate around its imaging center axis to realize the switching between the horizontal axis section and the vertical axis section.

[0012] The puncture needle insertion module is located on the side of the probe holder and includes a second drive motor, a linear guide rail, a screw transmission mechanism and a puncture needle clamp. The second drive motor drives the puncture needle clamp to make linear feed motion along the linear guide rail through the screw transmission mechanism.

[0013] An angle adjustment connection assembly, connected between the probe holder and the puncture needle module, includes an angle adjustment plate, a hinge shaft, and an angle locking mechanism, used to adjust the pitch angle of the puncture needle module relative to the central axis of the ultrasound probe.

[0014] Preferably, the probe holder has a cylindrical or frame-shaped structure, with an internal cavity that matches the shape of the ultrasound probe. The inner wall of the cavity is provided with an elastic buffer layer. The side or bottom of the probe holder is provided with a locking mechanism for locking and fixing the ultrasound probe. The rotation axis of the first drive motor, the central axis of the coupling, the central axis of the probe holder, and the imaging central axis of the ultrasound probe are collinear.

[0015] Preferably, the first drive motor is a stepper motor or a servo motor. When a section switching command is received, the probe holder is driven to rotate the ultrasonic probe 90° around the Z-axis. During the rotation, the spatial position of the imaging center of the ultrasonic probe remains unchanged.

[0016] Preferably, the extension direction of the linear guide is parallel to the clamping axis of the puncture needle holder, and the straightness accuracy of the linear guide is not less than 0.01 mm / 100 mm; the screw drive mechanism is a ball screw pair, and its screw lead is... The lead screw nut is fixedly connected to the slider of the linear guide, and the slider's movement displacement Angle relative to the second drive motor satisfy: ,in, The unit is mm. The unit is rad. The unit is mm.

[0017] Preferably, the second drive motor is a DC servo motor or a stepper motor, and its output shaft is connected to the lead screw of the lead screw transmission mechanism via a coupling. The second drive motor drives the needle insertion speed of the puncture needle holder. With motor speed satisfy: ,in, The unit is mm / s. The unit is r / min. This refers to the lead of the leadscrew, in mm.

[0018] Preferably, the angle adjustment plate is provided with an arc-shaped slide groove or a multi-hole position adjustment disc, and the angle locking mechanism includes a locking handle and a locking screw. The locking screw passes through the arc-shaped slide groove or the multi-hole position adjustment disc and is connected to the probe holder or frame assembly. When the locking handle is released, the angle adjustment plate rotates around the hinge axis to change the puncture angle of the puncture needle module relative to the ultrasound probe. The adjustment range of the puncture angle is 10° to 60°.

[0019] Preferably, the puncture angle is based on the blood vessel depth measured by ultrasound. and the horizontal offset distance of the puncture needle tip It is determined that the following geometric relationship is satisfied: ,in, The puncture angle is expressed in degrees (°). The vertical depth of the blood vessel center from the skin surface, in mm. The distance in the horizontal direction between the puncture point of the needle tip on the skin surface and the center of the ultrasound probe is measured in mm.

[0020] Preferably, the puncture needle clamp includes a clamp base and a movable pressure cap. The clamp base is fixed on the slider of the linear guide rail. A V-groove is provided at the front end of the clamp base. The movable pressure cap is connected to the clamp base by a hinge and locked by an eccentric wheel handle. The center line of the V-groove is parallel to the movement direction of the linear guide rail, and the parallelism error is not greater than 0.02 mm / 100 mm.

[0021] Preferably, the system further includes a motion controller electrically connected to the first and second drive motors. The motion controller has a built-in position closed-loop control algorithm for controlling the probe rotation angle and needle insertion displacement. For probe rotation control, the control law is as follows:

[0022] ,in, This refers to the motor's output torque, expressed in N·m. This refers to angular deviation, in degrees. This is a proportionality constant, with units of N·m / °.

[0023] The integral coefficient is expressed in N·m / (°·s). is the differential coefficient, with units of N·m·s / °.

[0024] Preferably, the vertical support arm of the frame assembly is provided with a standard interface for connecting with an external robotic arm or lifting platform, and the lower surface of the horizontal mounting base is precision machined to form an installation reference surface. The probe rotation adjustment module, the puncture needle insertion module, and the angle adjustment connection assembly are all assembled with the installation reference surface as the positioning reference.

[0025] The radial artery puncture device supporting ultrasound probe rotation according to the present invention has the following beneficial effects:

[0026] (1) One-click switching between horizontal and vertical axes, continuous and stable imaging: The first drive motor directly drives the ultrasound probe to rotate around its imaging center axis, realizing the rapid switching between the horizontal axis and the vertical axis. During the rotation, the blood vessel target is always located in the imaging center, avoiding the loss of the imaging plane caused by manual rotation and significantly reducing the difficulty of operation.

[0027] (2) The high-precision automated needle insertion can eliminate the influence of hand tremors: The puncture needle is driven by a linear guide rail and a screw transmission mechanism. The needle insertion path has high straightness accuracy, adjustable speed and good repeatability, which completely eliminates the interference of human hand physiological tremor on puncture accuracy and effectively reduces the risk of posterior wall penetration of blood vessels.

[0028] (3) The puncture angle can be independently adjusted to adapt to different anatomical conditions: The angle adjustment connection component allows the puncture needle module to be steplessly adjusted within the range of 10° to 60° relative to the ultrasound probe. The operator can select the best puncture angle according to the vascular depth measured by ultrasound before the operation and the patient's body shape to achieve personalized and precise puncture.

[0029] (4) Compact structure and high integration: Each functional module adopts a modular and integrated design, realizing the three core functions of probe rotation, puncture needle insertion and angle adjustment in a limited space. The overall structure is compact and easy to use in space-constrained environments such as operating rooms and interventional rooms.

[0030] (5) Lowering the learning curve and facilitating standardization: Transforming complex hand-eye coordination operations into mechanical motion control reduces reliance on the operator's personal experience, helps shorten the training cycle, and promotes the standardization and normalization of radial artery puncture operations. Attached Figure Description

[0031] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort. The present invention will be further described below in conjunction with the drawings and embodiments. In the drawings:

[0032] Figure 1 This is a three-dimensional structural schematic diagram of the radial artery puncture device that supports the rotation and transformation of the ultrasound probe according to the present invention;

[0033] Figure 2 This is a left view of the radial artery puncture device of the present invention that supports the rotation and transformation of the ultrasound probe;

[0034] Figure 3 This is a side view of the radial artery puncture device of the present invention that supports the rotation and transformation of the ultrasound probe;

[0035] Figure 4 This is a right view of the radial artery puncture device of the present invention that supports the rotation and transformation of the ultrasound probe;

[0036] Figure 5 This is a top view of the radial artery puncture device of the present invention that supports the rotation and transformation of the ultrasound probe.

[0037] In the diagram, 1- 1-Type support frame, 2-Probe rotation drive motor (first drive motor), 3-Coupling, 4-Ultrasonic probe holder, 5-Ultrasonic probe, 6-Puncture angle adjustment plate, 7-Puncture needle drive motor (second drive motor), 8-Needle insertion linear guide rail, 9-Puncture needle clamp. Detailed Implementation

[0038] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0039] It should be noted that if the embodiments of the present invention involve directional indicators (such as up, down, left, right, front, back, etc.), the directional indicators are only used to explain the relative positional relationship and movement of the components in a certain specific posture (as shown in the figure). If the specific posture changes, the directional indicators will also change accordingly.

[0040] Furthermore, if the embodiments of this invention involve descriptions such as "first" or "second," these descriptions are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of those features. Additionally, the technical solutions of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. If the combination of technical solutions is contradictory or impossible to implement, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection claimed by this invention.

[0041] Figure 1 This is a three-dimensional structural schematic diagram of the radial artery puncture device that supports the rotation and transformation of the ultrasound probe according to the present invention; Figure 2 This is a left view of the radial artery puncture device of the present invention that supports the rotation and transformation of the ultrasound probe; Figure 3 This is a side view of the radial artery puncture device of the present invention that supports the rotation and transformation of the ultrasound probe; Figure 4 This is a right view of the radial artery puncture device of the present invention that supports the rotation and transformation of the ultrasound probe; Figure 5 This is a top view of the radial artery puncture device of the present invention, which supports the rotation and transformation of the ultrasound probe. (See also...) Figures 1-5 In the radial artery puncture device supporting the rotation and transformation of the ultrasound probe provided in the first embodiment of the present invention, at least a frame assembly is included. The frame assembly includes a vertical support arm and a horizontal mounting base, which are used to provide overall support for the device and connect to an external positioning device.

[0042] The probe rotation adjustment module is set on a horizontal mounting base and includes a first drive motor, a coupling and a probe holder. The first drive motor is vertically mounted and its output shaft is coaxially connected to the probe holder through the coupling. It is used to drive the ultrasound probe to rotate around its imaging center axis to realize the switching between the horizontal axis section and the vertical axis section.

[0043] The puncture needle insertion module is located on the side of the probe holder and includes a second drive motor, a linear guide rail, a screw transmission mechanism and a puncture needle clamp. The second drive motor drives the puncture needle clamp to make linear feed motion along the linear guide rail through the screw transmission mechanism.

[0044] An angle adjustment connection assembly, connected between the probe holder and the puncture needle module, includes an angle adjustment plate, a hinge shaft, and an angle locking mechanism, used to adjust the pitch angle of the puncture needle module relative to the central axis of the ultrasound probe.

[0045] The gantry assembly serves as the overall supporting foundation for the device, bearing all functional modules and connecting with external robotic arms, lifting platforms, or operating table fixation devices to achieve overall spatial posture adjustment and locking of the device. The gantry assembly adopts... The structure comprises mutually perpendicular vertical support arms and a horizontal mounting base. The upper end or side of the vertical support arms has a standard interface for rigid connection to external positioning devices (such as multi-degree-of-freedom robotic arms, manually adjustable columns, or operating table guide rails). The horizontal mounting base serves as the mounting platform for the core functional modules; its lower surface or side has precision-machined planes and positioning pin holes to ensure the relative positional accuracy between the probe rotation adjustment module, the puncture needle insertion module, and the angle adjustment connecting assembly.

[0046] The probe rotation adjustment module is used to carry the ultrasound probe and drive it to make precise rotational movements around the vertical axis (Z-axis) to achieve rapid switching of the ultrasound imaging plane between the transverse and longitudinal sections of the blood vessel.

[0047] The probe holder has a cylindrical or frame-shaped structure with an internal cavity that matches the shape of the ultrasound probe. The inner wall of the cavity is provided with an elastic buffer layer. The side or bottom of the probe holder is provided with a locking mechanism for locking and fixing the ultrasound probe. The rotation axis of the first drive motor, the central axis of the coupling, the central axis of the probe holder, and the imaging central axis of the ultrasound probe are collinear.

[0048] The first drive motor is a stepper motor or servo motor, vertically mounted with its output shaft pointing vertically downwards, fixed to the upper surface of a horizontal mounting base via a motor mount. The output shaft of the first drive motor is fixedly connected to one end of a coupling. The coupling is either a rigid coupling or a flexible diaphragm coupling, with its other end coaxially fixed to the upper connecting shaft of the probe holder. The coupling transmits the rotational torque output by the motor and compensates for any minor coaxiality deviations that may occur during assembly, preventing additional bending moments on the motor shaft or the probe holder.

[0049] The probe holder has a cylindrical or frame-shaped structure with an internal cavity that matches the shape of the ultrasound probe. The inner wall of the cavity is lined with an elastic buffer layer (such as a silicone or polyurethane pad) to provide uniform contact pressure when holding the probe, while absorbing high-frequency vibrations to prevent interference with ultrasound imaging. The probe holder has a locking mechanism on its side or bottom, such as an eccentric cam lock or a knob-type clamping structure, to securely fix the ultrasound probe within the holder and prevent loosening or displacement during rotation.

[0050] The rotation axis of the first drive motor is aligned with the central axis of the probe holder and the central axis of the ultrasound probe imaging. When the first drive motor receives a control command, it drives the probe holder to rotate the ultrasound probe around the Z-axis by a preset angle (typically 0° corresponds to the transverse axis section, and 90° corresponds to the longitudinal axis section). Since the rotation axis coincides with the imaging center of the ultrasound probe, the target point of the blood vessel remains near the center of the imaging plane during rotation, eliminating the need for manual target repositioning and thus achieving non-destructive switching of the imaging plane.

[0051] The puncture needle insertion module is located on the side of the probe holder and is used to automate the feeding and retraction of the puncture needle.

[0052] The linear guide rail includes a guide rail body and a slidingly fitted slider. The guide rail body is fixedly mounted on a guide rail base along the needle insertion direction, and the guide rail base is fixedly connected to the angle adjustment connecting assembly. The extension direction of the guide rail body is the feed direction of the puncture needle. The extension direction of the linear guide rail is parallel to the clamping axis of the puncture needle holder. The straightness accuracy of the linear guide rail is not less than 0.01 mm / 100 mm to ensure the straightness of the needle insertion path. The screw drive mechanism is a ball screw pair with a lead of [missing information]. The lead screw nut is fixedly connected to the slider of the linear guide, and the slider's movement displacement Angle with the second drive motor satisfy: ,in, The unit is mm. The unit is rad. The unit is mm.

[0053] In practical implementation, the lead screw transmission mechanism includes a lead screw and a matching lead screw nut. Both ends of the lead screw are supported in bearing housings by rolling bearings, and the bearing housings are fixed to both ends of the guide rail base. The lead screw is coaxially connected to the output shaft of the second drive motor via a coupling. The lead screw nut is fixedly connected to the slider on the linear guide rail, forming an integrated moving platform.

[0054] The second drive motor is a DC servo motor or a stepper motor. Its output shaft is connected to the lead screw of the lead screw transmission mechanism via a coupling. The second drive motor is fixed to a motor mounting plate, which is rigidly connected to the angle adjustment connection assembly. The second drive motor drives the needle insertion speed of the puncture needle holder. With motor speed satisfy: ,in, The unit is mm / s. The unit is r / min. This refers to the lead of the leadscrew, in mm.

[0055] An angle adjustment connection assembly connects the probe holder and the puncture needle module, used to adjust the pitch angle of the puncture needle module relative to the central axis of the ultrasound probe, thereby adapting to the puncture requirements of blood vessels at different depths. This assembly includes: an angle adjustment plate, a hinge shaft, and an angle locking mechanism.

[0056] The angle adjustment plate is a rigid plate component, with one end of it rotatably connected to the side wall of the probe holder or the horizontal mounting base of the frame assembly via a hinge shaft. The other end of the angle adjustment plate is fixedly connected to the guide rail base of the puncture needle insertion module.

[0057] The angle adjustment plate is equipped with an arc-shaped slide groove or a multi-hole position adjustment plate. The angle locking mechanism includes a locking handle and a locking screw. The locking screw passes through the arc-shaped slide groove or the multi-hole position adjustment plate and is connected to the probe holder or frame assembly. When the locking handle is released, the angle adjustment plate rotates around the hinge axis, changing the puncture angle of the puncture needle module relative to the ultrasound probe. The adjustment range of the puncture angle is 10° to 60°.

[0058] The puncture angle is based on the depth of the blood vessel measured by ultrasound. and the horizontal offset distance of the puncture needle tip It is determined that the following geometric relationship is satisfied: ,in, The puncture angle is expressed in degrees (°). The vertical depth of the blood vessel center from the skin surface, in mm. The distance in the horizontal direction between the puncture point of the needle tip on the skin surface and the center of the ultrasound probe is measured in mm.

[0059] The puncture needle clamp includes a clamp base and a movable pressure cap. The clamp base is fixed on a slider of a linear guide rail, and the puncture needle clamp moves linearly along the guide rail with the slider. A V-groove is provided at the front end of the clamp base. The movable pressure cap is connected to the clamp base by a hinge and locked by an eccentric wheel handle. The center line of the V-groove is parallel to the direction of movement of the linear guide rail, and the parallelism error is no greater than 0.02 mm / 100 mm.

[0060] The puncture needle clamp includes a clamp body and a quick-locking structure. The front end of the clamp body is provided with a slot or gripper that matches the puncture needle barrel or needle seat. The quick-locking structure adopts a spring-return clamping or knob-type pressing method to realize the quick installation and removal of the puncture needle and ensure that the axis of the puncture needle is strictly parallel to the direction of movement of the linear guide rail.

[0061] In practical implementation, this device also includes a motion controller, which is electrically connected to the first drive motor and the second drive motor. The motion controller has a built-in position closed-loop control algorithm for controlling the probe rotation angle and needle insertion displacement. For probe rotation control, the control law is as follows:

[0062] ,in, This refers to the motor's output torque, expressed in N·m. This refers to angular deviation, in degrees. This is a proportionality constant, with units of N·m / °. The integral coefficient is expressed in N·m / (°·s). is the differential coefficient, with units of N·m·s / °.

[0063] When the second drive motor is working, its output torque is converted into linear motion of the screw nut through the screw drive, which drives the slider and puncture needle holder to make high-precision feeding motion along the linear guide rail, thereby realizing the automatic insertion and retraction of the puncture needle.

[0064] The vertical support arm of the frame assembly is equipped with a standard interface for connecting with an external robotic arm or lifting platform. The lower surface of the horizontal mounting base is precision machined to form an installation reference surface. The probe rotation adjustment module, the puncture needle insertion module, and the angle adjustment connection assembly are all assembled with the installation reference surface as the positioning reference.

[0065] The working process of the device of the present invention is as follows:

[0066] (1) The device is connected to the external positioning device through the frame assembly, and the whole device is moved above the patient's puncture site so that the ultrasound probe contacts the patient's skin with appropriate pressure. The transverse section image of the radial artery is obtained through the ultrasound host to confirm the location and depth of the blood vessel.

[0067] (2) Based on the blood vessel depth measured by ultrasound image, loosen the locking mechanism of the angle adjustment connection component, adjust the angle of the puncture needle module so that the puncture needle can accurately point to the blood vessel target point on the predetermined needle insertion path, and lock the angle after adjustment.

[0068] (3) When it is necessary to switch from the transverse axis section to the longitudinal axis section to observe the puncture needle travel path, the control system sends a rotation command to the first drive motor. The motor drives the probe holder and the ultrasound probe to rotate precisely 90°. Since the rotation center coincides with the imaging center, the vascular target remains in the center of the imaging field of view and does not need to be repositioned.

[0069] (4) The control system sends a needle insertion command to the second drive motor. The motor drives the puncture needle holder to feed linearly along the linear guide at a set speed (e.g., 5-20 mm / s) via a lead screw drive. The puncture needle pierces the skin and subcutaneous tissue and enters the radial artery lumen. During the puncture, the needle tip position can be monitored in real time by ultrasound. After confirming successful puncture, the motor can be controlled to rotate in the opposite direction to complete the needle withdrawal or catheter placement operation.

[0070] The beneficial effects of the present invention, through the design of the above embodiments, are as follows:

[0071] (1) One-click switching between horizontal and vertical axes, continuous and stable imaging: The first drive motor directly drives the ultrasound probe to rotate around its imaging center axis, realizing the rapid switching between the horizontal axis and the vertical axis. During the rotation, the blood vessel target is always located in the imaging center, avoiding the loss of the imaging plane caused by manual rotation and significantly reducing the difficulty of operation.

[0072] (2) The high-precision automated needle insertion can eliminate the influence of hand tremors: The puncture needle is driven by a linear guide rail and a screw transmission mechanism. The needle insertion path has high straightness accuracy, adjustable speed and good repeatability, which completely eliminates the interference of human hand physiological tremor on puncture accuracy and effectively reduces the risk of posterior wall penetration of blood vessels.

[0073] (3) The puncture angle can be independently adjusted to adapt to different anatomical conditions: The angle adjustment connection component allows the puncture needle module to be steplessly adjusted within the range of 10° to 60° relative to the ultrasound probe. The operator can select the best puncture angle according to the vascular depth measured by ultrasound before the operation and the patient's body shape to achieve personalized and precise puncture.

[0074] (4) Compact structure and high integration: Each functional module adopts a modular and integrated design, realizing the three core functions of probe rotation, puncture needle insertion and angle adjustment in a limited space. The overall structure is compact and easy to use in space-constrained environments such as operating rooms and interventional rooms.

[0075] (5) Lowering the learning curve and facilitating standardization: Transforming complex hand-eye coordination operations into mechanical motion control reduces reliance on the operator's personal experience, helps shorten the training cycle, and promotes the standardization and normalization of radial artery puncture operations.

[0076] Example 2

[0077] This embodiment provides a radial artery puncture device that supports the rotation and transformation of an ultrasound probe. For example... Figure 1 As shown, the main body of the device is made of aluminum profiles or stainless steel. Type support frame 1. The support frame 1 consists of two parts: a vertical support arm and a horizontal mounting base. The vertical support arm has a rectangular cross-section and can be fitted with weight-reducing holes to lower the overall weight. The back or side of the vertical support arm has a standard dovetail groove or interface plate for connecting to an external multi-degree-of-freedom robotic arm or manual lifting platform. The horizontal mounting base is integrally formed with the vertical support arm or fixedly connected by high-strength bolts. Its lower surface is precision milled to a flatness of no more than 0.02 mm, serving as the installation reference for the core functional modules.

[0078] The upper surface of the horizontal mounting base is provided with motor mounting holes, locating pin holes, and threaded connection holes for mounting the first drive motor 2 of the probe rotation adjustment module. The lower part of the horizontal mounting base provides rotation space for the probe holder 4 and an interface for mounting the angle adjustment plate 6.

[0079] Example 3

[0080] The probe rotation adjustment module includes a probe rotation drive motor 2, a coupling 3, and an ultrasonic probe holder 4.

[0081] The probe rotation drive motor 2 is a two-phase hybrid stepper motor with a step angle of 1.8° and a torque of not less than 0.5 N·m, which is sufficient to drive the ultrasonic probe 5 and its clamping mechanism to rotate smoothly. The motor is mounted on a horizontal mounting base via a flange, and its output shaft extends vertically downward. The end of the output shaft is provided with a flat key or a D-shaped cut surface for circumferential positioning with the coupling 3.

[0082] Coupling 3 is a rigid coupling made of aluminum alloy. Its two ends are fixed to the motor output shaft and the connecting shaft of the probe holder 4 respectively by set screws or clamping. To ensure coaxiality, a laser alignment instrument is used for adjustment during assembly to ensure that the coaxiality error of the motor shaft, coupling and probe holder connecting shaft does not exceed 0.05 mm.

[0083] The ultrasound probe holder 4 is a cylindrical structure, integrally machined from aluminum alloy, with its internal cavity dimensions matching the shape of the ultrasound probe 5. A 2 mm thick medical-grade silicone buffer layer is adhered to the inner wall of the holder to prevent scratches on the probe surface and to absorb high-frequency micro-vibrations during motor rotation. An operating window is provided on one side of the holder for easy manual fine-tuning of the probe position or connection of the ultrasound cable. A quick-locking knob is located at the lower end of the holder; the knob, via a screw, drives a pressure plate to firmly press the bottom of the probe, ensuring that the probe does not shift at any rotation angle.

[0084] In terms of control strategy, the first drive motor 2 is driven by an external motion controller, which has a preset position closed-loop control algorithm. When a tangent switching command is received, the controller drives the motor to rotate 90° using a trapezoidal velocity curve. The acceleration in the acceleration phase is set to 500° / s², the speed in the constant speed phase is set to 30° / s, and the deceleration in the deceleration phase is set to 500° / s², with a total switching time of less than 0.5 s. After rotating to the correct position, the controller enables the motor to maintain torque to prevent the probe from unexpectedly deflecting due to external forces.

[0085] Example 4

[0086] The puncture needle insertion module includes a puncture needle insertion drive motor 7, a needle insertion linear guide rail 8, a lead screw transmission mechanism, and a puncture needle clamp 9. This module is connected to the side of the probe holder 4 via an angle adjustment plate 6.

[0087] The puncture needle drive motor 7 is a miniature DC servo motor with a rated power of 10 W and a rated speed of 3000 rpm. It is equipped with an incremental encoder with a resolution of no less than 1000 lines / revolution to achieve closed-loop position control. The motor output shaft is connected to the lead screw via a miniature elastic diaphragm coupling to compensate for axial and radial misalignments.

[0088] The needle insertion linear guide 8 is a miniature rolling linear guide with a width of 12 mm. The slider is equipped with four rows of balls, and the rated dynamic load is not less than 2 kN. The guide length is 120 mm, and the effective stroke is 80 mm. The guide body is fixed to the guide base by locating pins and screws. The guide base is made of 6061 aluminum alloy, and the flatness of the mounting surface connecting it to the angle adjustment plate 6 is no greater than 0.01 mm.

[0089] The lead screw drive mechanism adopts a miniature ball screw pair with a nominal diameter of 6 mm, a lead of 2 mm, an accuracy grade of C5, and an axial clearance of no more than 0.01 mm. Both ends of the lead screw are supported by miniature angular contact ball bearings, which are preloaded to eliminate axial movement. The lead screw nut and the slider are rigidly connected via an adapter plate to form a moving platform. The moving platform is equipped with an mounting interface for the puncture needle clamp 9.

[0090] The puncture needle clamp 9 adopts a split structure, including a clamp base and a movable cap. The clamp base is fixed to the moving platform, and its front end is machined with a V-groove for holding the puncture needle barrel. The movable cap is connected to the base via a hinge and locked by an eccentric wheel handle. The parallelism error between the center line of the V-groove and the direction of movement of the linear guide rail is controlled within 0.02 mm / 100 mm, ensuring that the puncture needle feed direction is strictly consistent with the guide rail direction.

[0091] In terms of motion control, let the feed displacement of the puncture needle be... (Unit: mm), the rotation angle of the second drive motor is... (Unit: rad), lead screw is (Unit: mm), then the relationship between displacement and rotation angle is: ,in, The lead of the leadscrew represents the linear displacement of the nut produced by one revolution of the leadscrew. In this embodiment, Therefore, the motor rotates every time The puncture needle advances 2 mm along the arc.

[0092] Let the motor speed be (Unit: r / min) then needle insertion speed (Unit: mm / s) is: By adjusting the motor speed, the needle insertion speed can be continuously adjusted within the range of 0 to 30 mm / s to adapt to the requirements of different puncture tissue characteristics (such as the density of subcutaneous tissue, the elasticity of blood vessel walls, etc.) on the needle insertion speed.

[0093] To ensure puncture safety, a position limit protection logic is set in the controller. When the puncture needle advances to the preset maximum stroke (e.g., 50 mm) or encounters abnormally increased resistance (monitored by motor current feedback), the control system immediately stops feeding and automatically retracts 2 mm to avoid over-puncture.

[0094] Example 5

[0095] The angle adjustment connection assembly includes a puncture angle adjustment plate 6, a hinge shaft, and an angle locking mechanism.

[0096] The puncture angle adjustment plate 6 is made of 304 stainless steel plate with a thickness of 8 mm. One end of it is provided with a hinge hole, which forms a rotating pair with the lug on the side wall of the probe holder 4 through the hinge shaft. The hinge shaft is a precision stepped shaft with a fit clearance of no more than 0.01 mm to ensure stability during the angle adjustment process.

[0097] An arc-shaped groove is provided on the angle adjustment plate 6. The radius of the groove is centered on the hinge shaft, and the central angle covers 70°. The width of the arc-shaped groove is 10 mm, which is used to pass through the locking screw. The locking screw has a diameter of 8 mm, one end of which is fixed in the threaded hole on the side wall of the probe holder 4, and the other end passes through the arc-shaped groove and connects to the locking handle. The locking handle is a knurled handwheel with an internal cam-type force-increasing structure, which can provide a locking force of not less than 500 N. A copper friction plate is provided between the locking handle and the angle adjustment plate to increase the coefficient of friction and prevent direct wear between the metal surfaces.

[0098] During angle adjustment, the operator first loosens the locking handle, allowing the angle adjustment plate 6 to rotate freely. Then, based on the vascular depth measured preoperatively by ultrasound... (Unit: mm) and the horizontal distance from the needle tip to the skin puncture point. (Unit: mm), calculate the required puncture angle (Unit: °), its geometric relationship satisfies: .in, The vertical depth from the center of the blood vessel to the skin surface. This refers to the horizontal offset distance between the puncture point of the needle tip on the skin surface and the center of the ultrasound probe. The theoretical puncture angle can be calculated using the above formula. After rotating the angle adjustment plate 6 to the corresponding angle, the operator tightens the locking handle to complete the locking.

[0099] The end of the angle adjustment plate 6 is fixedly connected to the guide rail base of the puncture needle module by bolts. The connection surface is provided with positioning pin holes to ensure that the angle relationship remains unchanged after each disassembly and assembly.

[0100] Example 6

[0101] This embodiment details the collaborative relationships between the modules and the standardized operating procedures.

[0102] Step 1: Fixing and initial positioning of the device. The support frame 1 connects to the end effector of a multi-degree-of-freedom robotic arm next to the operating table via a standard interface. The robotic arm is manually or semi-automatically controlled by the operator, allowing the ultrasound probe 5 to lightly touch the skin in the radial artery region of the patient's forearm. A transverse section image is acquired through the ultrasound host, confirming that the radial artery is located in the center of the image, and its depth, diameter, and surrounding tissue relationship are clearly visible.

[0103] Step 2: Pre-adjustment of the puncture angle. Measure the vertical distance from the center of the radial artery to the skin surface on the transverse section of the ultrasound. And based on the horizontal offset of the puncture needle clamp 9 relative to the center line of the ultrasound probe. Using the formula Calculate the required puncture angle. Loosen the locking handle of the puncture angle adjustment plate 6, adjust the puncture needle module to the corresponding angle, and then lock it.

[0104] Step 3: Probe View Switching. The operator sends a "vertical axis switch" command to the control system via a foot switch or touchscreen. The control system drives the probe rotation motor 2 to rotate 90° according to a preset trapezoidal speed curve, switching the ultrasound probe 5 from the transverse axis view to the vertical axis view. Since the rotation axis coincides with the imaging center, the vertical axis image of the radial artery is immediately displayed without the need for repositioning.

[0105] Step 4: Automated Puncture. Under real-time monitoring in the longitudinal section, after the operator confirms the target position of the needle tip, the control system sets the needle insertion speed (e.g., 10 mm / s) and target stroke (e.g., 30 mm), triggering the "needle insertion" command. The puncture needle insertion drive motor 7 drives the lead screw to rotate according to the set parameters. The slider drives the puncture needle holder 9 to make precise linear movements along the needle insertion linear guide rail 8, allowing the puncture needle to pierce the skin, subcutaneous tissue, and enter the radial artery lumen. During the needle insertion process, the control system collects real-time feedback from the motor encoder and current. When a sudden change in resistance (current drops and then stabilizes) is detected when the needle tip enters the blood vessel lumen, or when the stroke reaches the preset value, the feeding automatically stops.

[0106] Step 5: Needle retraction or catheter placement. After successful puncture, the operator can manually or via control system commands reverse the motor to retract the puncture needle, completing the arterial catheterization or blood collection procedure.

[0107] Example 7

[0108] To achieve the above-mentioned automated operation, this device is equipped with a dedicated control system, including a motion controller, a motor driver, a human-machine interface, and sensor modules.

[0109] The motion controller uses a 32-bit microcontroller based on the ARM Cortex-M4 core, with a main frequency of 168 MHz. It integrates 6 pulse outputs and an encoder feedback interface, supporting trapezoidal acceleration / deceleration, S-curve acceleration / deceleration, and position comparison output functions. The controller internally integrates angle conversion algorithms, needle feed speed planning algorithms, and safety protection logic.

[0110] The motor driver uses a microstepping stepper motor driver and a DC servo driver, with a microstepping ratio of up to 256 microsteps, ensuring the smooth operation of the motor at low speeds.

[0111] The human-machine interface uses a 7-inch color touchscreen, displaying information including: current probe rotation angle, puncture angle setting, needle insertion speed, needle insertion displacement, and needle insertion status (in progress / completed / alarm). Operators can set various parameters via the touchscreen and switch probe sections using the "one-click horizontal axis" and "one-click vertical axis" buttons.

[0112] The sensor module includes: a zero-point position sensor installed in the probe holder 4 (for resetting the motor rotation origin), limit sensors installed at both ends of the puncture needle insertion module (for preventing overtravel), and a pressure sensor installed near the puncture needle holder 9 (for real-time monitoring of puncture resistance). The signals from each sensor are input to the motion controller in real time for closed-loop control and safety protection.

[0113] In the control algorithm, for probe rotation control, position closed-loop control is adopted, and its control law is:

[0114] ,in, This refers to the motor's output torque (unit: N·m). Angular deviation (unit: °) This is the proportionality coefficient (with a value of 0.5 N·m / °). The integral coefficient (with a value of 0.05 N·m / (°·s)). The differential coefficient is 0.01 N·m·s / °. This control law enables rapid response, no overshoot, and positioning accuracy better than 0.1° during probe rotation.

[0115] For needle insertion control, a combination of speed feedforward and position feedback control is adopted to ensure the smoothness of needle insertion speed and the accuracy of endpoint positioning.

[0116] Example 8

[0117] To ensure the biocompatibility, corrosion resistance and long-term stability of the device, key components are made of specific materials and manufactured using appropriate processes.

[0118] The L-shaped support frame 1 and probe holder 4 are made of 6061-T6 aluminum alloy and are machined in one setup using a CNC machining center to ensure geometric accuracy between the mounting surfaces. The surfaces are hard anodized with an oxide film thickness of not less than 20μm and a surface hardness of not less than HV 400 to enhance wear resistance and corrosion resistance.

[0119] The angle adjustment plate 6, locking handle and other load-bearing components are made of 304 stainless steel and are processed after heat treatment (solution treatment) to ensure sufficient strength and toughness.

[0120] Components that come into direct contact with the patient's skin and the puncture needle, such as the clamping surface of the puncture needle clamp 9, are made of medical-grade polyetheretherketone material, which can withstand high-temperature and high-pressure sterilization to ensure the safety of clinical use.

[0121] All fasteners (bolts, screws) are made of stainless steel and are coated with medical-grade anti-loosening adhesive during assembly to prevent loosening under vibration.

[0122] Example 9

[0123] In a clinical simulation application, a case with a radial artery depth of 3.5 mm was selected. The operator first positioned the device using a robotic arm to obtain a clear transverse section of the radial artery. Based on... The calculated puncture angle is approximately 13.1°. After adjusting the angle adjustment plate from 6° to 13°, lock it in place. Switch to the longitudinal section with one key, set the needle insertion speed to 10 mm / s and the needle travel to 20 mm, then initiate automatic needle insertion. The puncture needle advances linearly along the preset path. Real-time ultrasound imaging shows the needle tip accurately entering the blood vessel lumen, with no posterior wall penetration or deviation observed. The entire operation takes approximately 40 seconds, significantly shorter than the average time for traditional manual procedures (approximately 2-3 minutes). Simulation results demonstrate that the device of this invention significantly improves puncture efficiency and accuracy.

[0124] This invention has been described with reference to specific embodiments, but those skilled in the art will understand that various changes and equivalent substitutions can be made without departing from the scope of the invention. Furthermore, numerous modifications can be made to this invention to suit specific applications without departing from its protection scope. Therefore, this invention is not limited to the specific embodiments disclosed herein, but includes all embodiments falling within the scope of the claims.

Claims

1. A radial artery puncture device supporting the rotation and transformation of an ultrasound probe, characterized in that, include: A rack assembly, comprising a vertical support arm and a horizontal mounting base, for providing overall support for the device and connecting to an external positioning device; A probe rotation adjustment module is set on the horizontal mounting base and includes a first drive motor, a coupling and a probe holder. The first drive motor is vertically mounted and its output shaft is coaxially connected to the probe holder through the coupling. It is used to drive the ultrasound probe to rotate around its imaging center axis to realize the switching between the horizontal axis section and the vertical axis section. The puncture needle insertion module is located on the side of the probe holder and includes a second drive motor, a linear guide rail, a screw transmission mechanism and a puncture needle clamp. The second drive motor drives the puncture needle clamp to make linear feed motion along the linear guide rail through the screw transmission mechanism. An angle adjustment connection assembly, connected between the probe holder and the puncture needle module, includes an angle adjustment plate, a hinge shaft, and an angle locking mechanism, used to adjust the pitch angle of the puncture needle module relative to the central axis of the ultrasound probe.

2. The radial artery puncture device supporting ultrasound probe rotation according to claim 1, characterized in that, The probe holder has a cylindrical or frame-shaped structure, and its interior is provided with a receiving cavity that matches the shape of the ultrasound probe. The inner wall of the receiving cavity is provided with an elastic buffer layer. The side or bottom of the probe holder is provided with a locking mechanism for locking and fixing the ultrasound probe. The rotation axis of the first drive motor, the central axis of the coupling, the central axis of the probe holder, and the imaging central axis of the ultrasound probe are collinear.

3. The radial artery puncture device supporting ultrasound probe rotation according to claim 1, characterized in that, The first drive motor is a stepper motor or a servo motor. When a section switching command is received, the probe holder is driven to rotate the ultrasonic probe 90° around the Z-axis. During the rotation, the spatial position of the imaging center of the ultrasonic probe remains unchanged.

4. The radial artery puncture device supporting ultrasound probe rotation according to claim 1, characterized in that, The linear guide rail extends parallel to the clamping axis of the puncture needle holder, and the straightness accuracy of the linear guide rail is not less than 0.01 mm / 100 mm; the screw drive mechanism is a ball screw pair, and its lead is... The lead screw nut is fixedly connected to the slider of the linear guide, and the slider's movement displacement Angle relative to the second drive motor satisfy: ,in, The unit is mm. The unit is rad. The unit is mm.

5. The radial artery puncture device supporting ultrasound probe rotation according to claim 1, characterized in that, The second drive motor is a DC servo motor or a stepper motor, and its output shaft is connected to the lead screw of the lead screw transmission mechanism via a coupling. The second drive motor drives the needle insertion speed of the puncture needle holder. With motor speed satisfy: ,in, The unit is mm / s. The unit is r / min. This refers to the lead of the leadscrew, in mm.

6. The radial artery puncture device supporting ultrasound probe rotation according to claim 1, characterized in that, The angle adjustment plate is provided with an arc-shaped slide groove or a multi-hole position adjustment plate. The angle locking mechanism includes a locking handle and a locking screw. The locking screw passes through the arc-shaped slide groove or the multi-hole position adjustment plate and is connected to the probe holder or frame assembly. When the locking handle is released, the angle adjustment plate rotates around the hinge axis, changing the puncture angle of the puncture needle module relative to the ultrasound probe. The adjustment range of the puncture angle is 10° to 60°.

7. The radial artery puncture device supporting ultrasound probe rotation according to claim 6, characterized in that, The puncture angle is based on the blood vessel depth measured by ultrasound. and the horizontal offset distance of the puncture needle tip It is determined that the following geometric relationship is satisfied: ,in, The puncture angle is expressed in degrees (°). The vertical depth of the blood vessel center from the skin surface, in mm. The distance in the horizontal direction between the puncture point of the needle tip on the skin surface and the center of the ultrasound probe is measured in mm.

8. The radial artery puncture device supporting ultrasound probe rotation according to claim 1, characterized in that, The puncture needle clamp includes a clamp base and a movable pressure cap. The clamp base is fixed on the slider of the linear guide rail. A V-groove is provided at the front end of the clamp base. The movable pressure cap is connected to the clamp base by a hinge and locked by an eccentric wheel handle. The center line of the V-groove is parallel to the movement direction of the linear guide rail, and the parallelism error is no greater than 0.02 mm / 100 mm.

9. The radial artery puncture device supporting ultrasound probe rotation according to claim 1, characterized in that, It also includes a motion controller, which is electrically connected to the first and second drive motors. The motion controller has a built-in position closed-loop control algorithm for controlling the probe rotation angle and needle insertion displacement. For probe rotation control, the control law is: ,in, This refers to the motor's output torque, expressed in N·m. This refers to angular deviation, in degrees. This is a proportionality constant, with units of N·m / °. The integral coefficient is expressed in N·m / (°·s). is the differential coefficient, with units of N·m·s / °.

10. The radial artery puncture device supporting ultrasound probe rotation according to claim 1, characterized in that, The vertical support arm of the frame assembly is provided with a standard interface for connecting with an external robotic arm or lifting platform. The lower surface of the horizontal mounting base is precision machined to form an installation reference surface. The probe rotation adjustment module, the puncture needle insertion module, and the angle adjustment connection assembly are all assembled with the installation reference surface as the positioning reference.

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