Mammary gland biopsy auxiliary device under ultrasonic guidance

Abstract

The invention discloses an auxiliary device for breast biopsy under ultrasonic guidance, and belongs to the field of medical instruments. The device comprises an ultrasonic probe clamping module and a needle guiding module. The ultrasonic probe clamping module is adaptive to ultrasonic probes of different models through a flexible fixing belt (3), so that firm fixation is ensured; the needle guide module adopts a dual-drive sliding table and a telecentric mechanism, so that horizontal adjustment, vertical movement and needle insertion angle adjustment of a needle insertion point are realized, and a biopsy needle is prevented from puncturing important tissues such as nerves and blood vessels. The device ensures the motion precision through closed-loop or open-loop control of a motor, and adopts manual operation in the puncture process to ensure the safety. The breast biopsy device solves the problems of high operation threshold, insufficient precision and poor adaptability in the prior art, has the advantages of compact structure, high flexibility, wide application range and the like, and remarkably improves the accuracy and safety of breast biopsy.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and in particular relates to an automated auxiliary device used in breast biopsy surgery under ultrasound guidance. Background Art

[0002] Breast cancer is a highly prevalent malignant tumor in women, and its early diagnosis is crucial for effective treatment. Breast biopsy is a key method for obtaining pathological tissue, and ultrasound-guided biopsy has become the preferred method in clinical practice due to its advantages such as real-time imaging and lack of radiation hazards.

[0003] In current clinical practice, ultrasound-guided biopsy mainly relies on manual operation by doctors, which has the following technical bottlenecks:

[0004] (1) High operating threshold: The doctor needs to operate the ultrasound probe and biopsy needle at the same time, which requires strict spatial positioning ability and a long learning curve for novices.

[0005] (2) Accuracy is easily affected: Long-term surgery causes fatigue in doctors, which may cause the needle insertion angle to deviate and increase the risk of repeated punctures.

[0006] Although patent CN111671474 proposes an automated solution, it has the following defects:

[0007] (1) The ultrasonic probe clamp adopts a rigid structure with poor adaptability;

[0008] (2) Insufficient freedom of adjustment of the needle insertion point, making it impossible to avoid blood vessels;

[0009] (3) The automatic needle insertion design lacks an emergency needle withdrawal mechanism and has low safety. Summary of the Invention

[0010] To address the above issues, the present invention provides a modular ultrasound-guided breast biopsy auxiliary device, the core structure and connection relationship of which are as follows:

[0011] Ultrasonic probe clamping module, including:

[0012] Base 1: It adopts flange structure and is rigidly connected to the end of the robot arm through M6 bolts to support the entire device;

[0013] Ultrasound probe holder 2: It adopts a hollow structure, one end is connected to the base 1, and the other end is covered with a silicone anti-slip layer on the inside, which improves the probe's fit and anti-displacement ability;

[0014] Flexible fixing belt 3: It is fastened to the threaded hole of the probe holder 2 by bolts, provides adjustable tension, and is available in multiple lengths to accommodate different probe models;

[0015] The needle guidance module includes a dual-drive slide and a telecentric mechanism;

[0016] Among them, the dual-drive slide includes:

[0017] Slide base 4: installed on the ultrasound probe holder 2, used to install the optical rod 5, lead screw and motor;

[0018] Optical bar 5: installed on the slide base 4, used to guide the movement of the slider;

[0019] Upper slider lead screw 6: mounted on the slide base 4 through a bearing and connected to the upper slider 11 drive motor 9 through a coupling 8;

[0020] Lower slider lead screw 7: mounted on the slide base 4 through a bearing and connected to the lower slider 12 drive motor 10 through a coupling 8;

[0021] Upper slider drive motor 9: installed on the slide base 4, its single rotation can drive the needle entry point to rotate around the hinge axis between the lower slider 12 and the telecentric mechanism base 14 to achieve horizontal adjustment;

[0022] Lower slider drive motor 10: installed on the slide base 4, and rotates synchronously with the upper slider drive motor 9 in the same direction to drive the needle insertion point to move in the vertical direction;

[0023] Upper slider 11: engages with the upper slider screw 6, slides on the light bar 5, forms a spiral transmission pair, and does not contact the lower slider screw 7;

[0024] Lower slider 12: engages with the lower slider screw 7, slides on the light bar 5, forms a spiral transmission pair, and does not contact the upper slider screw 6;

[0025] The telecentric mechanism includes:

[0026] Small rod 13: hinged to the upper slider 11 and the telecentric mechanism base 14, used to support the telecentric mechanism base 14 and adjust its angle;

[0027] Telecentric mechanism base 14: hinged to the small rod 13, the lower slider 12, the first crossbar 16, and the second crossbar 17, used to support the telecentric mechanism;

[0028] Telecentric mechanism motor 15: mounted on the telecentric mechanism base 14, with its output shaft connected to the second crossbar 17;

[0029] The first crossbar 16 and the second crossbar 17 are hinged to the telecentric mechanism base 14, the first longitudinal bar 18, and the second longitudinal bar 19 to form a parallelogram mechanism to guide the movement of the needle guide 20;

[0030] Needle guide 20: hinged to the first longitudinal rod 18 and the second longitudinal rod 19. A guide hole is provided on the needle guide 20 for guiding the biopsy needle to puncture.

[0031] The motion control logic of the present invention is as follows:

[0032] Horizontal adjustment of the needle entry point: the upper slider drive motor 9 rotates alone, and drives the upper slider screw 6 to rotate through the coupling 8, so that the upper slider 11 moves along the optical bar 5; the upper slider 11 pushes the telecentric mechanism base 14 to rotate around the hinge axis of the lower slider 12 through the small rod 13, thereby realizing the horizontal offset of the needle entry point.

[0033] Vertical movement of the needle entry point: the upper slider drive motor 9 and the lower slider drive motor 10 rotate synchronously in the same direction, and drive the upper slider screw 6 and the lower slider screw 7 to rotate through the coupling 8, so that the upper slider 11 and the lower slider 12 move horizontally at the same speed along the optical bar 5, driving the telecentric mechanism to rise and fall vertically as a whole, thereby adjusting the height of the needle entry point.

[0034] Needle insertion angle adjustment: the telecentric mechanism motor 15 drives the second crossbar 17 to rotate; the second crossbar 17 drives the parallelogram mechanism 16 / 17 / 18 / 19 to move, so that the needle guide 20 rotates around the telecentric point, so that the axis of the guide hole is aligned with the lesion target.

[0035] The beneficial effects of the present invention are:

[0036] 1. This device integrates the ultrasound probe and the puncture guide mechanism to ensure that the puncture needle is always within the ultrasound imaging range.

[0037] 2. The device has three degrees of freedom, which allows flexible adjustment of the needle insertion point and angle to avoid important areas such as blood vessels;

[0038] 3. The dual-drive slide structure of this device has the advantages of compact structure and high strength compared with the traditional series structure;

[0039] 4. This device uses flexible fixing belts 3 with various specifications and is locked with bolts. Compared with rigid ultrasonic probe fixing plates, it has a wider range of applications and a more secure fixation.

[0040] 5. This device uses a needle guide 20 to guide the doctor during puncture. The puncture process relies on pure manual needle insertion without an active propulsion mechanism. In an emergency, the biopsy needle can be directly withdrawn, which improves puncture accuracy, reduces the doctor's labor intensity, and ensures safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] For ease of explanation, the present invention is described in detail with reference to the following specific embodiments and accompanying drawings:

[0042] Figure 1 It is a schematic diagram of the overall structure of the present invention;

[0043] Figure 2 This is a schematic diagram of the ultrasonic probe clamping module of the present invention;

[0044] Figure 3This is a schematic diagram of the dual-drive slide structure of the present invention;

[0045] Figure 4 Schematic diagram of the telecentric mechanism of the present invention;

[0046] Figure 5 This is a schematic diagram of the flexible fixing belt of the present invention in a flattened state;

[0047] In the figure: 1 base, 2 ultrasound probe holder, 3 flexible fixing belt, 4 slide base, 5 optical bar, 6 upper slider screw, 7 lower slider screw, 8 coupling, 9 upper slider drive motor, 10 lower slider drive motor, 11 upper slider, 12 lower slider, 13 small rod, 14 telecentric mechanism base, 15 telecentric mechanism motor, 16 first cross bar, 17 second cross bar, 18 first longitudinal bar, 19 second longitudinal bar, 20 needle guide. DETAILED DESCRIPTION

[0048] In order to make the purpose, technical solutions and advantages of the present invention clearer, the following Figure 1-5 The present invention is described in detail with specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the scope of protection of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without making any creative efforts shall fall within the scope of protection of the present invention.

[0049] The specific implementation of the present invention adopts the following technical solutions:

[0050] Step 1: Preoperative Assembly. Place the ultrasound probe in the groove of the ultrasound probe holder 2. Select a fixing strap 3 of the appropriate size based on the size of the ultrasound probe and secure it. Bolt both ends of the strap 3 into the threaded holes of the ultrasound probe holder 2. Adjust the bolts to ensure the tension of the flexible fixing strap 3 is moderate. Bolt the entire device to the flange at the end of the robotic arm.

[0051] Step 2: System initialization. Start the motor controllers of the dual-drive slide and the telecentric mechanism, perform zero calibration, and reset the upper slide 11 and the lower slide 12 to their initial positions.

[0052] Step 3: Intraoperative positioning.

[0053] Coarse positioning: The robotic arm moves the device to the target breast area so that the ultrasound probe scanning plane covers the lesion.

[0054] Horizontal adjustment of the needle entry point: control the upper slider drive motor 9 to rotate alone, drive the upper slider 11 to move along the optical bar 5 through the coupling 8 and the upper slider screw 6, and the upper slider 11 pushes the telecentric mechanism base 14 to rotate around the hinge axis of the lower slider 12 through the small rod 13 to achieve horizontal offset of the needle entry point.

[0055] The needle entry point moves vertically: The controller controls the upper slider drive motor 9 and the lower slider drive motor 10 to rotate synchronously in the same direction, and drives the upper slider 11 and the lower slider 12 to move horizontally at the same speed along the optical bar 5 through the coupling 8, the upper slider screw 6, and the lower slider screw 7, driving the telecentric mechanism to move vertically as a whole to adjust the height of the needle entry point;

[0056] Needle insertion angle adjustment: control the rotation of the telecentric mechanism motor 15, drive the second crossbar 17 to drive the parallelogram mechanism 16 / 17 / 18 / 19 to move, and make the needle guide 20 rotate around the distal point until the axis of the guide hole is aligned with the lesion target.

[0057] Step 4: Puncture biopsy. The doctor inserts the biopsy needle into the guide hole of the needle guide 20 and advances the needle at the set angle to the target point. The biopsy gun is fired to take a sample. After the sample is taken, the biopsy needle is withdrawn from the needle guide 20.

[0058] Emergency treatment: If there is an abnormality in the equipment or the patient moves, the doctor can directly withdraw the biopsy needle. The device has no active propulsion mechanism and relies on manual puncture to ensure timely needle removal.

[0059] Step 5: Postoperative treatment: Loosen the bolts of the fixing belt 3, remove the ultrasound probe and disinfect it; disassemble the needle guide 20 and sterilize it at high temperature, and wipe and disinfect the remaining parts.

[0060] In one embodiment of the present invention, a closed-loop control scheme using DC reduction motors is employed: the upper and lower slider drive motors 9 and 10 are DC reduction motors, with quadrature encoders mounted on their output shafts. A controller outputs PWM signals to drive the motors, and the quadrature encoder signals are fed back to the controller.

[0061] In this embodiment, the needle entry point is adjusted horizontally as follows: the controller controls the upper slider drive motor 9 to rotate independently, while the lower slider 12 is held stationary by the mechanical self-locking mechanism of the lead screw 7. The controller continuously monitors the encoder signal from the lower slider motor 10. If unexpected rotation of the lower slider motor 10 is detected, a reverse PWM pulse is immediately triggered to reset the position of the lower slider 12, ensuring stable self-locking of the lower slider 12.

[0062] In this embodiment, the vertical movement of the needle insertion point adopts a constant angle difference PID control: First, the initial value of the encoder angle (θ 10 ,θ 20 ), calculate the initial angle difference Δθ0 = θ 10 -θ 20 (corresponding to the mechanical spacing of the slider); during the movement, the angle values ​​(θ1, θ2) are monitored in real time and the current angle deviation is calculated: Δθ e =(θ1-θ2)-Δθ0; Dynamically adjust the PWM duty ratio of the two motors through the PID controller to make Δθ eIt approaches zero, thus ensuring that: (θ1-θ2)≡Δθ0, that is, the two sliders strictly maintain the initial spacing and move synchronously.

[0063] In another embodiment of the present invention, an open-loop control scheme of a stepper motor is adopted: the motor 9 / 10 is replaced by a two-phase stepper motor, and the controller outputs a pulse signal to control the stepper motor.

[0064] In this embodiment, the needle entry point is adjusted horizontally as follows: the controller controls the upper slider drive motor 9 to rotate alone, and the lower slider 12 remains stationary by relying on the mechanical self-locking of the screw 7. At the same time, the controller controls the lower slider motor 10 to enter the holding state, and uses the holding torque of the stepper motor to resist external force disturbances.

[0065] In this embodiment, the vertical movement of the needle insertion point is achieved by generating a synchronous pulse sequence from the controller to ensure synchronous rotation of the two motors. The stepper motor controller uses microstepping technology to smooth the motion and avoid slider desynchronization caused by stepper vibration.

[0066] The above embodiments are merely preferred embodiments of the present invention and are not intended to limit the scope of protection of the present invention. Any equivalent replacement or improvement of the structure or material, such as deformation or change, without departing from the spirit of the technical solution of the present invention, by any person skilled in the art shall be included within the scope of protection of the claims of the present invention.

Claims

1. An ultrasound-guided breast biopsy auxiliary device, characterized in that: include: An ultrasonic probe clamping module comprises a base (1), an ultrasonic probe frame (2) fixed to the base (1), and a flexible fixing belt (3) for restraining the ultrasonic probe; The needle guidance module includes a dual-drive slide and a telecentric mechanism; The double-drive slide comprises a slide base (4) mounted on an ultrasonic probe frame (2), an upper slider drive motor (9) and a lower slider drive motor (10) mounted on the slide base (4), and a parallel optical bar (5), an upper slider lead screw (6), and a lower slider lead screw (7); the upper slider lead screw (6) is mounted on the slide base (4) through a bearing and is connected to the upper slider drive motor (9) through a coupling (8); the lower slider lead screw (7) is mounted on the slide base (4) through a bearing and is connected to the lower slider drive motor (10) through a coupling (8); the upper slider (11) engaged with the upper slider lead screw (6) and the lower slider (12) engaged with the lower slider lead screw (7) are both slidably sleeved on the optical bar (5); The telecentric mechanism comprises a small rod (13) hinged to the upper slider (11), a telecentric mechanism base (14) hinged to the lower slider (12) and the small rod (13), and a telecentric mechanism motor (15) fixed to the telecentric mechanism base (14); the output shaft of the telecentric mechanism motor (15) is fixed to the second crossbar (17); the first crossbar (16) and the second crossbar (17) are hinged to the telecentric mechanism base (14), the first longitudinal rod (18) and the second crossbar (17) are hinged to the second crossbar (17), and the second longitudinal rod (19) are hinged to the first crossbar (16) and the second crossbar (17) to form a parallelogram mechanism; the needle guide (20) is hinged to the first longitudinal rod (18) and the second longitudinal rod (19).

2. The device according to claim 1, characterized in that The needle guide (20) is provided with a small hole for guiding the insertion of the biopsy needle.

3. The device according to claim 2, characterized in that The axis of the guide hole of the needle guide (20) always passes through the distal point and is always within the ultrasonic imaging plane.

4. The device according to claim 2, characterized in that: The biopsy needle guide hole of the needle guide (20) has no active propulsion mechanism, and the puncture process relies on manual operation.

5. The device according to claim 1, characterized in that The telecentric mechanism motor (15) drives the second crossbar (17) to rotate, and changes the angle of the needle guide (20) through the parallelogram mechanism (first crossbar 16, second crossbar 17, first longitudinal bar 18, second longitudinal bar 19), so that the biopsy needle always enters the needle around the telecentric point.

6. The device according to claim 1, characterized in that When the upper slider driving motor (9) rotates alone, the telecentric mechanism base (14) is driven to rotate around the hinge axis of the lower slider (12) through the small rod (13), thereby achieving horizontal adjustment of the needle insertion point; When the upper slider driving motor (9) and the lower slider driving motor (10) rotate synchronously in the same direction, the upper slider (11) and the lower slider (12) are driven to move in the same direction along the optical bar (5), thereby realizing vertical movement of the needle insertion point.

7. The device according to claim 6, characterized in that: The synchronous control of the dual-drive slide adopts any of the following schemes: DC motor closed-loop control: The two motors (9, 10) are equipped with quadrature encoders, and the controller dynamically adjusts the PWM signal through the PID algorithm to maintain the initial angle difference; Open-loop control of stepper motors: The controller outputs a synchronous pulse sequence, combined with micro-stepping technology to ensure synchronous movement of the slider.

8. The device according to claim 6, characterized in that: When the needle entry point is adjusted horizontally, the lower slider (12) is mechanically self-locked by the lower slider lead screw (7), and the lower slider drive motor (10) monitors the encoder signal in real time or enters a holding torque state to prevent accidental displacement.

9. The device according to claim 1, characterized in that The flexible fixing belt (3) is a flexible plastic or metal belt, which is locked and fixed to the ultrasonic probe frame (2) by bolts.

10. The device according to claim 1, characterized in that The flexible probe fixing belt (3) is provided with a variety of length specifications, and can be adapted to different types of ultrasonic probes by replacing belt bodies of different sizes.

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