A rotary cutting needle

Abstract

The application provides a rotary cutting needle, comprising an outer needle tube, an inner needle tube and a fluid interface. A tissue window is arranged on the sidewall of the distal end of the outer needle tube; the inner needle tube is eccentrically arranged in the outer needle tube to form a fluid subchannel. The periphery of the tissue window is further provided with a lesion density recognition and nerve detection sensor. The application integrates an independent fluid transmission channel, and can realize in-situ flushing and precise drug delivery of a lesion wound without withdrawing the needle, thereby greatly improving the operation efficiency and safety. The application integrates a lesion detection function, can focus on excision and reduce normal tissue damage; through early nerve detection and early drug delivery, pain can be effectively reduced and the medical experience can be improved; the application can also automatically identify the amount of bleeding and automatically adjust the flushing and suction frequency or the flushing and suction amount, thereby realizing timely and effective hemostasis, avoiding needle channel blockage and improving the efficiency.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a rotary cutting needle for tissue biopsy or excision. Background Technology

[0002] Minimally invasive excision procedures (such as minimally invasive excision of breast lesions, liver or kidney biopsy and resection) are widely used in clinical tumor resection and pathological biopsy due to their advantages of minimal trauma, rapid recovery, and precise positioning. The excision needle, as the core instrument in this type of surgery, typically consists of an outer needle tube and an inner needle tube that moves within it. The lesion tissue is captured through tissue fenestrations on the sidewall of the outer needle tube, and the rotation or axial movement of the inner needle tube, combined with negative pressure suction, is used to cut and collect the lesion tissue.

[0003] However, existing rotary cutting needles still have the following drawbacks in actual clinical applications: First, existing rotary cutting needles lack fluid transport pathways that are independent of the cutting channel, making it difficult to perform in-situ flushing and drug delivery without affecting the cutting operation.

[0004] Conventional rotary cutting needles typically employ a concentric, tightly fitted structure between the outer and inner cannulas, with the internal space largely occupied by the inner cannulas and the main channel for tissue cutting / aspiration. When removing calcifications or highly vascularized lesions, bleeding or hematoma is highly likely to occur in the surgical area. Although some products now have irrigation functions, the lack of an independent fluid delivery pathway often necessitates pausing the cutting procedure, withdrawing the inner cannulas, or even completely retracting the needle before irrigation or local drug administration can be performed. This significantly increases the complexity of the surgical procedure, prolongs the operation time, and frequent pauses or needle withdrawals can lead to secondary trauma and lesion localization errors.

[0005] Second, existing technologies lack real-time monitoring of intraoperative bleeding and an intelligent closed-loop response mechanism.

[0006] During the excision process, because it is impossible to visually observe the wound surface of deep tissues, doctors mainly rely on experience to judge the degree of bleeding and manually adjust the irrigation or hemostatic dosage. The waste fluid aspirated under negative pressure usually contains blood, saline, and tissue debris. Existing equipment cannot quantitatively detect the bleeding concentration in the aspiration tubing in real time, making it difficult to accurately control the timing and dosage of irrigation and medication. This can easily lead to over-irrigation or untimely hemostasis, posing a risk to surgical safety. Summary of the Invention

[0007] The following provides a brief overview of one or more aspects to offer a basic understanding of them. This overview is not an exhaustive summary of all conceived aspects, nor is it intended to identify key or decisive elements of all aspects, nor to define the scope of any or all aspects. Its sole purpose is to present some concepts of one or more aspects in a simplified form to prepare for the more detailed descriptions that follow.

[0008] The purpose of this invention is to solve the above-mentioned problems and provide a rotary cutting needle that integrates an independent fluid transmission channel without increasing the overall outer diameter of the rotary cutting needle. It can achieve in-situ irrigation and precise drug delivery of the wound without the need for needle withdrawal, and can perform real-time detection and adaptive closed-loop control of intraoperative bleeding. It can also automatically identify and accurately locate lesions (such as calcifications) to reduce the cutting of normal tissues.

[0009] The technical solution of this invention is as follows: This invention discloses a rotary cutting needle, comprising: The external needle tube has a tissue window on its distal sidewall; An inner needle tube is disposed inside the outer needle tube. The axis of the inner needle tube is offset relative to the axis of the outer needle tube, so that a secondary fluid channel extending along the axial direction of the outer needle tube is formed between the outer wall of the inner needle tube and the inner wall of the outer needle tube. The secondary fluid channel avoids the area where the tissue window is located in the circumferential direction. A fluid interface is disposed near the proximal end of the outer needle tube and communicates with the secondary fluid channel. The fluid interface is used to connect to a fluid source.

[0010] According to one embodiment of the rotary cutting needle of the present invention, at least one spray hole is provided on the side of the inner needle tube opposite to the tissue window, and the spray hole is in communication with the fluid secondary channel.

[0011] According to one embodiment of the rotary cutting needle of the present invention, the secondary fluid channel includes at least a flushing channel and an infusion channel; the fluid interface includes at least a flushing interface and an infusion interface respectively communicating with the flushing channel and the infusion channel; the flushing interface is used to connect to a flushing source, and the infusion interface is used to connect to an infusion source.

[0012] According to one embodiment of the rotary cutting needle of the present invention, at least one isolation strip extending axially along the outer needle tube is provided between the outer wall of the inner needle tube and the inner wall of the outer needle tube, the isolation strip dividing the fluid secondary channel into at least the flushing channel and the infusion channel.

[0013] According to one embodiment of the rotary cutting needle of the present invention, the spray hole includes at least: The liquid spray nozzle is connected to the infusion channel; The flushing nozzle is connected to the flushing channel.

[0014] According to one embodiment of the rotary cutting needle of the present invention, the drug spray orifice and the tissue window are located on opposite sides of the inner needle tube; The number of drug spray holes is multiple, distributed along the axial and / or circumferential direction of the inner needle tube to form a micropore array; The axis of the micropores in the micropore array forms an acute angle with the radial direction of the inner needle tube, so that the sprayed liquid forms a fan-shaped atomization surface.

[0015] According to one embodiment of the rotary cutting needle of the present invention, the rotary cutting needle further includes: A fluid switching valve is connected to the fluid interface and is connected to both a flushing source and an infusion source. The fluid switching valve is used to selectively connect the fluid secondary channel to either the flushing source or the infusion source.

[0016] According to one embodiment of the rotary cutting needle of the present invention, the rotary cutting needle further includes: A negative pressure return line is connected to the inner needle tube, and the negative pressure return line is used to connect to a negative pressure source; A bleeding detection module is installed on the negative pressure return pipeline to detect the amount of liquid bleeding flowing through the negative pressure return pipeline in real time and generate a bleeding signal. An adaptive control module, coupled to the bleeding detection module, is configured to: receive the bleeding signal, determine a flushing strategy based on the bleeding signal, and control the flushing source connected to the fluid sub-channel to output flushing fluid according to the flushing strategy.

[0017] According to one embodiment of the rotary cutting needle of the present invention, the bleeding detection module includes: A transparent conduit is connected in series to the negative pressure return conduit; A photoelectric sensor is used to emit light signals through the transparent tube and receive transmitted or reflected light signals to detect the blood concentration in the flowing liquid and generate the bleeding amount signal. A snap-fit ​​clamp is fixed to the outside of the transparent pipe and used to clamp the photoelectric sensor; A light-shielding component is wrapped around the outside of the photoelectric sensor and the transparent conduit to shield ambient light.

[0018] According to one embodiment of the rotary cutting needle of the present invention, the bleeding detection module further includes at least one of the following: The calibration unit is configured to control the photoelectric sensor to detect the clear flushing fluid flowing through the negative pressure return pipeline when the system is started, and to generate calibration parameters based on the detection results to calibrate the photoelectric sensor. The bubble detection unit is configured to determine whether there are bubbles in the negative pressure return pipeline based on the sudden change in the electrical signal output by the photoelectric sensor, and to ignore the bleeding measurement data in the current time period or issue an alarm signal when bubbles are detected. A temperature sensor is disposed at the photoelectric sensor and used to detect its operating temperature. The bleeding detection module is configured to perform temperature compensation on the bleeding signal based on the operating temperature.

[0019] According to one embodiment of the rotary cutting needle of the present invention, the rinsing strategy includes adjusting at least one of the flow rate, pressure, and pulse frequency of the rinsing fluid output from the rinsing source.

[0020] According to an embodiment of the rotary cutting needle of the present invention, the rinsing strategy includes at least one of a basic rinsing mode, a pulse rinsing mode, a powerful rinsing mode, and an adaptive adjustment mode; The adaptive control module is configured as follows: Based on the relationship between the bleeding volume signal and the preset threshold, select to switch to the basic irrigation mode, the pulse irrigation mode, or the powerful irrigation mode; or The bleeding volume signal is used as a control input to dynamically adjust the flushing flow rate, thereby forming a closed-loop control.

[0021] According to one embodiment of the rotary cutting needle of the present invention, the rinsing strategy further includes temperature regulation of the rinsing fluid; in the powerful rinsing mode, the adaptive control module controls the heating unit to preheat the rinsing fluid to near body temperature.

[0022] According to one embodiment of the rotary cutting needle of the present invention, the rotary cutting needle further includes a phase synchronization controller, the phase synchronization controller being used to acquire real-time angular position signals of the inner needle tube and / or its distal cutting blade, and to control the synchronization of fluid action and cutting phase based on the angular position signals: During the tissue aspiration phase when the tissue opening is open, the fluid valve communicating with the fluid secondary channel is closed; In the phase after the tissue opening is closed and the cutting is completed, the flushing valve connected to the flushing channel is opened to perform pulse flushing.

[0023] According to one embodiment of the rotary cutting needle of the present invention, the phase synchronization controller is further configured to: control the cutting to pause when a preset cutting interval is reached, and open the drug valve connected to the infusion channel to perform in-situ drug delivery.

[0024] According to one embodiment of the rotary cutting needle of the present invention, a micro accumulator is connected in series at the outlet of the fluid valve and / or the drug valve. The micro accumulator is a medical silicone airbag structure used to absorb pressure pulsations generated by valve switching.

[0025] According to one embodiment of the rotary cutting needle of the present invention, the rotary cutting needle further includes a self-cleaning process, which is configured to: when a preset cleaning trigger condition is met, control the fluid source to output a high-pressure pulse flushing fluid higher than a preset normal flushing pressure, which flows through the fluid secondary channel and flushes outward from the nozzle in the opposite direction to remove the blockage at the nozzle.

[0026] According to an embodiment of the rotary cutting needle of the present invention, the preset cleaning trigger condition includes at least one of the following: To achieve the preset operation time or cutting / drug administration interval; The fluid flow rate at the nozzle was detected to be lower than a preset flow rate threshold. A manually triggered cleaning command has been received; Before administering the dosing order.

[0027] According to one embodiment of the rotary cutting needle of the present invention, the rotary cutting needle further includes a pressure sensor disposed between the fluid switching valve and the flushing source for detecting flushing pressure; The adaptive control module is coupled to the pressure sensor and is configured to: During self-cleaning, the output pressure of the rinsing source is adjusted to a preset cleaning pressure value based on feedback from the pressure sensor. After cleaning is completed, the output pressure of the rinsing source is restored to the preset normal rinsing pressure.

[0028] According to one embodiment of the rotary cutting needle of the present invention, the fluid switching valve is configured to: temporarily switch the flushing source to communicate with the infusion channel during self-cleaning, so that the high-pressure pulse flushing fluid flows through the infusion channel and backwashes outward from the drug spray hole; and during the cleaning process, the flushing channel remains in communication with the flushing source to continuously perform flushing.

[0029] According to one embodiment of the rotary cutting needle of the present invention, the rotary cutting needle further includes: A flushing fluid preheating module is disposed between the flushing source and the fluid interface, and is used to heat the flushing fluid entering the fluid sub-channel; The constant temperature control module, coupled to the flushing fluid preheating module, is configured to detect the real-time temperature of the flushing fluid and adjust the heating power of the flushing fluid preheating module based on the deviation between the real-time temperature and the preset target temperature, so as to stabilize the temperature of the flushing fluid within the preset target temperature range.

[0030] According to one embodiment of the rotary cutting needle of the present invention, the rinsing fluid preheating module includes a tubular heater, wherein the tubular heater is provided with a spiral flow channel or a serpentine flow channel inside, for increasing the heat exchange area and residence time of the rinsing fluid in the tubular heater.

[0031] According to one embodiment of the rotary cutting needle of the present invention, the temperature control module includes: A temperature sensor is installed at the outlet of the flushing fluid preheating module or at the fluid interface to detect the real-time temperature of the flushing fluid after heating. The controller, connected to the temperature sensor and the flushing fluid preheating module, is configured to dynamically adjust the heating power based on the deviation between the real-time temperature and the preset target temperature.

[0032] According to one embodiment of the rotary cutting needle of the present invention, the rinsing fluid preheating module adopts a two-stage series temperature control structure, including: The preheating section is used to rapidly heat the rinsing fluid to a first temperature close to the preset target temperature. A fine heating section, connected in series downstream of the preheating section, is used to finely adjust and stabilize the rinsing fluid to the preset target temperature; The preheating section and the fine heating section are each controlled by an independent temperature sensor and controller.

[0033] According to one embodiment of the rotary cutting needle of the present invention, the constant temperature control module further includes an overheat protection unit, which includes a hardware comparator circuit and an overheat temperature sensor independent of the controller, and is configured to: immediately cut off the power supply of the rinsing fluid preheating module and issue an alarm when the rinsing fluid temperature is detected to exceed a preset safety threshold.

[0034] According to one embodiment of the rotary cutting needle of the present invention, a lesion density identification sensor is provided around the tissue window of the outer needle tube. The lesion density identification sensor is electrically connected to the adaptive control module and is used to detect the density distribution signal of the tissue around the tissue window in real time. The adaptive control module is configured to guide the outer needle tube to adjust the rotation angle or axial position according to the density distribution signal fed back by the lesion density identification sensor so that the tissue window is aligned with the target lesion.

[0035] According to one embodiment of the rotary cutting needle of the present invention, a nerve detection sensor is provided around the tissue window of the outer needle tube. The nerve detection sensor is located at a 90-degree angle to the tissue window in the circumferential direction. The nerve detection sensor is electrically connected to the adaptive control module for real-time monitoring of nerve distribution signals around the tissue window. The adaptive control module is configured to automatically control the fluid switching valve to open the infusion channel and the infusion source when the nerve distribution signal detected by the nerve detection sensor reaches a preset threshold, so as to pre-add local anesthetic drug to the sensitive area where the nerve detection sensor is located through the drug spray hole to reduce the patient's pain.

[0036] Compared with the prior art, the present invention has the following advantages: First, it enables in-situ irrigation and drug administration without the need for needle withdrawal, effectively improving surgical efficiency and reducing the risk of secondary lesion localization.

[0037] This invention employs an outer needle tube with a tissue window on its distal sidewall; an inner needle tube, positioned inside the outer needle tube, with its axis offset relative to the outer needle tube's axis. This creates a secondary fluid channel extending axially along the outer needle tube between the outer and inner walls of the inner and outer needle tubes, circumferentially avoiding the area containing the tissue window; and a fluid interface, located proximal to the outer needle tube and communicating with the secondary fluid channel, for connecting to a fluid source. Utilizing this eccentrically arranged secondary fluid channel, irrigation fluid or medication can be directly delivered to the wound area. During the excision procedure, the surgeon can perform in-situ irrigation, local medication administration, and hemostasis without withdrawing the inner needle tube or the entire needle, simplifying the surgical procedure, shortening the operation time, and avoiding lesion localization errors and secondary tissue damage caused by needle withdrawal and re-puncture.

[0038] Secondly, it integrates lesion and nerve intelligent detection functions, achieving precise resection and early pain relief without increasing the overall outer diameter of the external needle tube, greatly reducing tissue damage and postoperative pain for patients.

[0039] This invention offsets the axis of the inner needle tube relative to the axis of the outer needle tube, creating a secondary fluid channel extending axially along the outer needle tube between the outer wall of the inner needle tube and the inner wall of the outer needle tube. This structure cleverly utilizes the eccentric gap as a fluid transport path, eliminating the need for additional cannulas or external tubing. It integrates an independent fluid channel without increasing the overall outer diameter of the rotary cutting needle, maintaining the advantages of minimally invasive puncture. Furthermore, a lesion density sensor closely detects the lesion, guiding the rotary cutting needle precisely to the target area for focused resection, significantly reducing damage to normal tissue. Simultaneously, a pre-positioned circumferential nerve detection sensor (e.g., at a 90-degree angle to the tissue window) monitors nerve distribution in real time, automatically administering local anesthetic when a preset threshold is reached, achieving analgesia before the patient experiences pain, minimizing intraoperative and postoperative pain and improving the patient's overall experience.

[0040] Third, it enables real-time quantitative detection and adaptive closed-loop control of intraoperative blood loss, significantly enhancing operational accuracy and surgical safety.

[0041] This invention employs a negative pressure reflux pipeline connected to an inner needle tube, which is used to connect to a negative pressure source. A bleeding detection module, located on the negative pressure reflux pipeline, is used to detect the amount of fluid bleeding flowing through it in real time and generate a bleeding signal. An adaptive control module, coupled to the bleeding detection module, is configured to: receive the bleeding signal, determine an irrigation strategy based on the signal, and control the output of irrigation fluid from the irrigation source connected to the secondary fluid channel according to the irrigation strategy. By monitoring the bleeding concentration of the waste fluid in real time along the negative pressure reflux path, this invention overcomes the uncertainty of relying on the doctor's subjective experience, achieving an in-situ closed-loop hemostasis response of "detection-feedback-control." This ensures precise adaptive adjustment of irrigation flow rate, pressure, or frequency, significantly improving the intelligence and safety of the surgical procedure. Attached Figure Description

[0042] The above-described features and advantages of the present invention will be better understood after reading the following detailed description of embodiments of the present disclosure in conjunction with the accompanying drawings. In the drawings, components are not necessarily drawn to scale, and components having similar related characteristics or features may have the same or similar reference numerals.

[0043] Figure 1 This is a schematic diagram of the structure of the first embodiment of the rotary cutting needle of the present invention; Figure 2 for Figure 1 A partial structural schematic diagram of the rotary cutting needle embodiment shown; Figure 3 for Figure 1 A schematic diagram of another state of the rotary cutting needle embodiment shown; Figure 4 for Figure 1 A schematic cross-sectional view of the rotary cutting needle embodiment shown; Figure 5 This is a schematic diagram of the structure of a second embodiment of the rotary cutting needle of the present invention; Figure 6 for Figure 5 A partial structural schematic diagram of the rotary cutting needle embodiment shown; Figure 7 This is a schematic diagram of the bleeding detection module in the third embodiment of the rotary cutting needle of the present invention; Figure 8 This is a schematic cross-sectional view of the bleeding detection module in an embodiment of the rotary cutting needle of the present invention.

[0044] Figure labels and names: 1. External needle tube; 11. Tissue fenestration; 2. Inner needle tube; 3. Secondary channel; 31. Flushing channel; 32. Infusion channel; 4. Fluid interface; 5. Isolation strip; 6. Spray nozzle; 61. Liquid spray nozzle; 62. Rinse nozzle; 7. Negative pressure return pipeline; 8. Bleeding detection module; 81. Transparent tubing; 82. Photoelectric sensor; 821. Light source; 822. Photodetector; 83. Clip-on fixture; 9. Cutting knife. Detailed Implementation

[0045] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments. It should be noted that the aspects described below with reference to the accompanying drawings and specific embodiments are merely exemplary and should not be construed as limiting the scope of protection of the present invention in any way.

[0046] Example 1

[0047] Figure 1 The structure of a first embodiment of the rotary cutting needle of the present invention is shown. See also Figures 1 to 4 The rotary cutting needle in this embodiment includes an outer needle tube 1, an inner needle tube 2, and a fluid interface 3.

[0048] The external needle tube 1 serves as a puncture and guide, and its distal sidewall is provided with a tissue window 11. The tissue window 11 is used to capture and aspirate the lesion tissue to be removed under negative pressure. A fluid interface 3 is provided at the proximal end of the external needle tube 1. The external needle tube 1 can be a hollow tube made of medical-grade stainless steel or nickel-titanium alloy.

[0049] The inner needle tube 2 is located inside the outer needle tube 1 and can slide or rotate axially relative to the outer needle tube 1. The inner needle tube 2 has a channel inside to accommodate the cutting blade 9, so as to complete the cutting and collection of lesion tissue by rotating and moving axially in conjunction with the tissue window 11.

[0050] The core of this embodiment lies in the construction of the fluid secondary channel 4. For example... Figure 2 and Figure 4 As shown, in order to integrate a secondary fluid channel 4 into the rotary cutting needle without increasing the outer diameter of the needle tube, the axis of the inner needle tube 2 is offset downwards (or to one side) relative to the axis of the outer needle tube 1, creating a gap between the outer wall of the inner needle tube 2 and the inner wall of the outer needle tube 1. With the inner needle tube 2 eccentrically positioned, the gap between the outer wall of the inner needle tube 2 and the inner wall of the outer needle tube 1 naturally forms a secondary fluid channel 4 extending axially along the outer needle tube 1. This secondary fluid channel 4 avoids the area where the tissue opening 11 is located in the circumferential direction, thereby preventing fluid transport from interfering with the tissue cutting process.

[0051] The fluid interface 4 is fixedly disposed at the proximal end of the outer needle tube 1, and its internal passage is connected to the secondary fluid channel 3. The fluid interface 4 is used to connect to an external fluid source (such as an irrigation source or an infusion source) to introduce external fluid into the secondary fluid channel 3. It is worth mentioning that, in some embodiments, the irrigation source may use physiological saline containing adrenaline to irrigate the surgical area and achieve rapid hemostasis. The infusion source may use physiological saline containing local anesthetic to administer additional anesthetic during the operation to reduce patient pain. The fluid interface 4 can be formed by opening a window at the proximal end of the outer needle tube 1 corresponding to the secondary channel 3; in some preferred embodiments, a connecting connector can also be fixed to the outer needle tube 1 by laser welding to connect to the fluid interface 4, thereby achieving connection to the irrigation source or infusion source.

[0052] like Figure 3 As shown, the nozzle 6 is located on the inner needle tube 2 on the side opposite to the tissue opening 11 (i.e., the side facing away from the tissue opening 11). The nozzle 6 is connected to the secondary fluid channel 3. The irrigation fluid or drug solution input from the fluid source enters the secondary fluid channel 3 through the fluid interface 4, and is finally sprayed from the nozzle 6 onto the lesion area where the tissue opening 11 is located, achieving in-situ irrigation or in-situ drug administration. The nozzle 6 is used to effectively guide the fluid in the secondary fluid channel 3 to the surgical area. The nozzle 6 can be located on the inner needle tube 2 at a position 180° opposite to the tissue opening 11. There can be one or more nozzles 6. When multiple nozzles 6 are used, they can be arranged in a row along the axial direction of the inner needle tube 2 to form an array of nozzles 6 to expand the fluid coverage area. For example, 3-5 nozzles 6 can be set, each nozzle 6 with a diameter of 0.2-0.4 mm and a spacing of 2-3 mm between adjacent nozzles 6. The nozzles 6 can be processed by laser drilling or electrical discharge machining, and the diameter tolerance can be controlled within ±0.02 mm. The inner wall of the nozzle 6 can be polished to reduce fluid resistance and prevent the drug solution from crystallizing and adhering. The axis of the nozzle 6 can be aligned with the radial direction of the inner needle tube 2, or it can be at a certain angle (such as 15°-30°) to achieve directional spraying.

[0053] Through the above-mentioned structural and positional connections, the components cleverly utilize the eccentric gap to integrate the fluid secondary channel 3 without increasing the overall outer diameter of the outer needle tube 1, thus achieving the function of in-situ flushing and precise drug delivery without needle withdrawal.

[0054] In this embodiment, the natural gap generated by the eccentric structure serves as a fluid channel. Without increasing the needle's outer diameter or installing a separate cannula, an independent fluid pathway can be formed inside the rotary cutting needle, enabling flushing and / or drug delivery without needle withdrawal. In some embodiments, one side of the inner needle tube 2 can be tightly attached to the side where the tissue opening 11 of the outer needle tube 1 is located, thereby obtaining the maximum gap to ensure that the fluid flow rate in the secondary channel 3 meets the requirements. It is worth mentioning that in some embodiments, a crescent-shaped gap can be formed between the outer needle tube 1 and the inner needle tube 2; or, the gap between the outer needle tube 1 and the inner needle tube 2 can be designed as a smoothly rounded irregular hole to facilitate flushing and cleaning. In actual production, this eccentric structure can be directly integrally formed using laser sintering of metal powder, or the outer needle tube 1 and inner needle tube 2 can be processed separately using a precision drawing process and then fixed together by laser welding or medical bonding.

[0055] In this embodiment, the rotary cutting needle is eccentrically positioned, redistributing the geometric space between the inner and outer needle tubes to form a continuous channel, namely the fluid secondary channel 3. The fluid secondary channel 3 is completely isolated from the negative pressure main channel at the center of the inner needle tube 2, and they do not interfere with each other. After the fluid enters the fluid secondary channel 3 from the proximal fluid interface 4, it flows distally along the gap. Since the gap avoids the tissue opening area 11, the fluid will not leak directly to the outside, but will be confined within the fluid secondary channel until it reaches the distal nozzle.

[0056] This innovative design utilizes the gap created by the eccentric structure as a secondary fluid channel, integrating an independent fluid pathway for the rotary cutting needle without increasing the needle's outer diameter. Doctors can directly irrigate and / or administer medication to the surgical area through the secondary fluid channel 3 without withdrawing the needle, completely avoiding target loss, secondary trauma, and infection risks caused by needle withdrawal, significantly improving surgical efficiency and safety.

[0057] In this embodiment, as Figure 2 The secondary fluid channel 3 is a single, undivided channel. To switch between irrigation and drug delivery functions, the cutting needle also includes a fluid switching valve. This valve connects to the fluid interface 4 at the proximal end of the cutting needle and is also connected to both an irrigation source and an infusion source. The fluid switching valve selectively connects the secondary fluid channel 3 to either the irrigation source or the infusion source. Notably, when negative pressure needs to be generated within the inner needle cannula to draw in the tissue to be cut, the connection between the secondary fluid channel 3 and the irrigation or infusion source can be severed using the fluid switching valve or other valves, ensuring the secondary fluid channel remains sealed and thus guaranteeing the negative pressure effect within the inner needle cannula.

[0058] Fluid switching valves can be implemented in several ways. One method is a manually operated rotary valve, consisting of a valve body and a rotatable valve core. The valve body has three ports: a common port (connecting to the fluid interface 4 of the rotary cutting needle), a flushing source port, and an infusion source port. The valve core has an arc-shaped flow channel. By rotating the valve core, the arc-shaped flow channel can selectively connect the common port to the flushing source port or the infusion source port. The rotation angle of the valve core can be controlled by a knob or dial on the handle, and a positioning mechanism (such as spring ball positioning) is provided to allow the doctor to clearly perceive the switching position. Another method is a solenoid valve assembly, using two independent two-position two-way solenoid valves. One is connected in series in the flushing source line, and the other is connected in series in the infusion source line. The common end of the two solenoid valves is connected to the fluid interface 4 of the rotary cutting needle through a tee connector. When flushing is needed, the flushing valve opens and the infusion valve closes; when medication is needed, the infusion valve opens and the flushing valve closes. The solenoid valves can be controlled by a foot switch or a button on the control panel to achieve rapid switching. Another approach is an electric rotary valve, which uses a miniature motor to drive the rotary valve core. The motor can be a stepper motor or a DC geared motor, and it is connected to the valve core through a transmission mechanism (such as gears or worm gears). The control system controls the motor to rotate to a specified angle according to user instructions or preset programs to achieve automatic switching. This solution is suitable for scenarios that require integration with an intelligent control system.

[0059] Example 2

[0060] Figure 5 The structure of a second embodiment of the rotary cutting needle of the present invention is shown. See also Figure 5 This embodiment is the same as the first embodiment in terms of basic structure, namely, it includes an outer needle tube 1, an inner needle tube 2, and a fluid secondary channel 3 formed by eccentric arrangement.

[0061] The core of this embodiment lies in the optimization of the internal structure of the fluid sub-channel 3. For example... Figure 6 As shown, in order to simultaneously perform flushing and infusion functions within a single fluid sub-channel 3 and avoid mixing of the two fluids, the fluid sub-channel 3 includes at least a flushing channel 31 and an infusion channel 32. The flushing channel 31 is used to connect to a flushing source, and the infusion channel 32 is used to connect to an infusion source. To achieve this functional division, at least one axially extending isolation strip 5 is provided between the outer wall of the inner needle tube 2 and the inner wall of the outer needle tube 1. This isolation strip 5 divides the fluid sub-channel 3 into at least the flushing channel 31 and the infusion channel 32.

[0062] Specifically, the isolation strip 5 can be integrally formed with the outer needle tube 1 or the inner needle tube 2, or it can be installed as a separate sealing strip. The isolation strip 5 extends axially, and its length is consistent with the effective length of the fluid sub-channel 3. The number of isolation strips 5 can be one, dividing the gap into two independent fan-shaped sub-channels; or multiple, dividing the fluid sub-channel 3 into more sub-channels to meet more complex fluid requirements. The cross-sectional shape of the isolation strip 5 can be rectangular, trapezoidal, or arc-shaped, and its height matches the maximum thickness of the gap to ensure complete separation. The material of the isolation strip 5 can be the same medical-grade stainless steel or nickel-titanium alloy as the needle tube, or it can be a flexible polymer material (such as polyetheretherketone, PEEK) to provide better sealing and fit. In this way, by setting the axially extending isolation strip 5 in the gap, the originally continuous space is physically divided into multiple independent sub-channels. Each sub-channel is connected to the corresponding fluid source at its proximal end and communicates with the corresponding nozzle 6 at its distal end. Specifically, in this embodiment, two isolation strips 5 are provided to divide the secondary channel 3 into three sub-channels, wherein the sub-channel located in the center is the infusion channel 32, and the sub-channels located on both sides are the flushing channels 31.

[0063] In this embodiment, the isolation strip 5 ensures that the fluids in the flushing channel 31 and the infusion channel 32 do not interfere with each other, achieving true isolation and preventing the medication from being diluted by the flushing fluid or the flushing fluid from being contaminated by the medication. This ensures the independence and reliability of the two fluid channels. Furthermore, since the two channels are physically independent, they can operate simultaneously or at different times, providing a superior performance foundation for the multifunctional integrated rotary cutting needle.

[0064] It is worth mentioning that, in this embodiment, as Figure 6 As shown, the number of fluid interfaces 4 located near the proximal end of the outer needle tube 1 is the same as the number of sub-channels, corresponding to the flushing channel 31 and the infusion channel 32. Moreover, in order to avoid spatial interference when the flushing channel 31 and the infusion channel 32 are connected to the flushing source and the infusion source respectively, the multiple fluid interfaces 4 are staggered.

[0065] To further optimize the function of nozzle 6 and ensure that each nozzle performs its specific function, such as... Figure 5 As shown, the nozzle 6 includes at least a drug spray nozzle 61 and a flushing nozzle 62. The drug spray nozzle 61 is connected to the infusion channel 32 and is specifically used for spraying drug solution; the flushing nozzle 62 is connected to the flushing channel 31 and is specifically used for spraying flushing solution. For example, the flushing nozzle 62 can be designed with a larger aperture (e.g., 0.3mm-0.5mm) to achieve high-flow-rate flushing; while the drug spray nozzle 61 can be designed with a smaller aperture (e.g., 20μm-50μm) to achieve atomized drug spraying. The flushing nozzle 62 and the drug spray nozzle 61 can be arranged alternately along the axial direction of the inner needle tube 2, or they can be respectively set in different axial regions.

[0066] In a particularly preferred embodiment, to achieve precise in-situ drug delivery, the drug spray orifices 61 are located on either side of the inner needle tube 2, opposite to the tissue window 11. Multiple drug spray orifices 61 are distributed along the axial and / or circumferential direction of the inner needle tube 2, forming a micropore array. The axis of the micropores forms an acute angle with the radial direction of the inner needle tube 2, so that the sprayed drug solution forms a fan-shaped atomized surface. For example, 3-5 sets of micropore arrays can be arranged axially on the inner needle tube 2, each set containing 5-10 micropores, with the axis of the micropores forming an angle of 30°-60° with the radial direction. When the drug solution is sprayed from these micropores, it forms a fan-shaped atomized surface covering the lesion area, significantly improving the drug penetration efficiency and uniformity.

[0067] In this way, through the comprehensive design of position, quantity and angle, precise control of drug spraying is achieved, which can form a fan-shaped atomization surface covering the lesion area, significantly improving the drug infiltration efficiency and uniformity, and realizing efficient in-situ precise drug delivery.

[0068] Example 3

[0069] This embodiment is a further improvement based on the first or second embodiment. The improvement is that the rotary cutting needle and intelligent control function are integrated into a complete closed-loop system to achieve in-situ adaptive irrigation based on real-time bleeding feedback.

[0070] like Figure 7 As shown, the rotary cutting needle also includes a negative pressure return line 7, a bleeding detection module 8, and an adaptive control module. The negative pressure return line 7 is connected to the inner needle tube 2 and is used to connect to a negative pressure source to generate negative pressure, enabling tissue aspiration, cutting, and fluid aspiration. The bleeding detection module 8 is located on the negative pressure return line 7 and is used to detect the amount of bleeding in the surgical area in real time and generate a bleeding signal. The adaptive control module is coupled to the bleeding detection module 8 and is configured to receive the bleeding signal, determine an irrigation strategy based on the bleeding signal, and control the irrigation source to output irrigation fluid according to the irrigation strategy.

[0071] like Figure 7 and Figure 8 As shown, the bleeding detection module 8 may include a transparent tubing 81, a photoelectric sensor 82, a clamping fixture 83, and a light-shielding element. The transparent tubing 81 is used to connect to the negative pressure return tubing 7, allowing the flowing liquid to be optically detected. The photoelectric sensor 82 is used to emit and receive light signals to detect blood concentration. The clamping fixture 83 is used to fix the photoelectric sensor 82 to the transparent tubing 81, enabling detachable installation. In some embodiments, the clamping fixture can enclose the transparent tubing 81 and the photoelectric sensor 82 to shield ambient light and ensure detection accuracy. The light-shielding element, wrapped around the outside of the photoelectric sensor 82 and the transparent tubing 81, is used to shield ambient light.

[0072] like Figure 8 As shown, the photoelectric sensor 82 may include a light source 821 and a photodetector 822. The light source 821 emits light of a specific wavelength, and the photodetector 822 receives the light after it passes through the transparent tube 81 and generates a corresponding electrical signal. Preferably, the light source 821 can emit light of at least two different wavelengths to achieve dual-wavelength measurement and eliminate interference factors such as tube material and liquid turbidity. For example, the first wavelength can be selected near the absorption peak of hemoglobin, such as 660nm red light; the second wavelength can be selected near the isoabsorption point of hemoglobin, such as 940nm near-infrared light. By analyzing the absorption difference between the two wavelengths, the concentration of blood in the return tube can be accurately calculated, thereby estimating the amount of bleeding in the surgical area.

[0073] The bleeding detection module 8 may also include a calibration unit configured to control the photoelectric sensor 82 to detect the clear flushing fluid flowing through the return pipeline during system startup, and generate calibration parameters based on the detection results to calibrate the photoelectric sensor 82. Automatic calibration effectively compensates for measurement deviations caused by factors such as device aging, temperature drift, or pipeline differences. The bleeding detection module 8 may also include a bubble detection unit configured to determine the presence of air bubbles in the return pipeline based on abrupt changes in the electrical signal output by the photoelectric sensor 82. When air bubbles are detected, the system may temporarily ignore the bleeding measurement data for that time period or issue an alarm to alert the operator. The bleeding detection module 8 may also include a temperature sensor to detect the operating temperature of the photoelectric sensor 82 and compensate for the bleeding signal based on the operating temperature to eliminate the influence of temperature drift on the measurement results.

[0074] The adaptive control module can be a microcontroller or a digital signal processor. This module internally stores multiple preset flushing strategies. Each flushing strategy includes adjusting at least one parameter among the flushing fluid flow rate, pressure, and pulse frequency. Specifically, the irrigation strategy can include the following modes: Basic irrigation mode, which continuously irrigates at a low constant flow rate (e.g., 5-10 ml / min), suitable for scenarios with small bleeding volumes, to maintain a basically clear surgical field; Pulsed irrigation mode, which irrigates with intermittent high-flow-rate pulses, suitable for scenarios with moderate bleeding volumes. Pulse parameters can include pulse flow rate, pulse width, and pulse interval. For example, the pulse flow rate is set to 20-30 ml / min, the pulse width to 0.5-1 second, and the pulse interval to 2-5 seconds, effectively removing blood clots with instantaneous high-pressure impact while avoiding tissue damage that may be caused by continuous high-flow-rate irrigation; Powerful irrigation mode, which continuously irrigates at the maximum flow rate (e.g., 30-50 ml / min), suitable for scenarios with large bleeding volumes, to quickly control bleeding and restore the surgical field; Adaptive adjustment mode, which dynamically adjusts the irrigation flow rate according to the real-time bleeding volume signal using a PID control algorithm. The bleeding volume signal is used as the control input, and the irrigation flow rate is used as the control output. After proportional, integral, and derivative calculations, a PWM is output in real time. The signal adjusts the speed / flow rate of the flushing pump, forming a closed-loop control system. When the bleeding signal increases, the flushing flow rate is increased proportionally, and when the bleeding signal decreases, the flushing flow rate is gradually reduced until it returns to the basic flushing mode.

[0075] The adaptive control module selects a suitable strategy from the preset strategies based on the magnitude and trend of the bleeding signal, or dynamically adjusts the irrigation parameters. For example, multiple bleeding thresholds can be set. When the bleeding signal is below the first threshold, a basic irrigation mode is used; when the bleeding signal is above the first threshold but below the second threshold, a pulse irrigation mode is switched; and when the bleeding signal is above the second threshold, a powerful irrigation mode is switched. The thresholds can be set based on clinical experience or adjusted by the physician according to the patient's specific condition. Furthermore, the irrigation strategy can also include adjusting the irrigation fluid temperature, for example, preheating the irrigation fluid to near body temperature in powerful irrigation mode to reduce the impact of cold stimulation on the patient.

[0076] Furthermore, the adaptive control module is configured to execute a phase-locked time-multiplexed fluid control strategy. Specifically, the phase synchronization controller reads the encoder signal from the inner needle motor to obtain the real-time angular position of the cutting blade and strictly limits the fluid control actions to a specific time window: 1. Phase A (Open window, tissue aspiration): Close all fluid valves, maintain maximum negative pressure, and prevent fluid from interfering with tissue aspiration; 2. Phase B (window closed, cutting complete): Open the flushing valve for 30~60ms, and the high-pressure pulse removes residual tissue from the cutting edge; 3. Phase C (specific interval, such as after every 10 cuts): Pause cutting, open the drug valve for 200ms, and administer the drug in situ.

[0077] Through this "cutting-fluid phase-locking mechanism," the system executes high-pressure pulse flushing only at the instant the cutting blade closes the tissue window, avoiding damage to fragile tissue samples that have been aspirated by the high-pressure fluid. This achieves the flushing function while protecting the integrity of the sample, improving the accuracy of pathological diagnosis. Furthermore, a miniature accumulator with a medical-grade silicone airbag structure is connected in series at the valve outlet to absorb pressure pulsations generated by high-speed switching, ensuring smooth jetting.

[0078] In this embodiment, the rotary cutting needle uses a photoelectric sensor 82 to detect the blood concentration in the negative pressure return line 7 in real time, thereby indirectly reflecting the amount of bleeding in the surgical area. The adaptive control module dynamically adjusts the irrigation parameters based on the bleeding signal using a preset strategy or PID algorithm, forming a closed-loop control system based on real-time feedback. When bleeding increases, the system automatically increases the irrigation intensity to quickly remove blood and restore the field of vision; when bleeding decreases, the system automatically reduces the irrigation intensity to avoid over-irrigation. This adaptive adjustment mechanism ensures that the irrigation operation matches the bleeding state in real time.

[0079] In this embodiment, the rotary cutting needle is upgraded from a purely mechanical tool to an intelligent closed-loop system. This system can automatically determine and execute corresponding irrigation strategies based on real-time detected bleeding signals without withdrawing the needle, achieving "intelligent in-situ hemostasis." This frees up the surgeon's hands, optimizes the surgical procedure, and significantly improves surgical safety. Simultaneously, through multi-mode irrigation strategies and adaptive adjustment, it can provide optimal irrigation results in different bleeding scenarios, avoiding tissue damage caused by blind irrigation or unclear vision due to insufficient irrigation.

[0080] Example 4

[0081] This embodiment is a further improvement based on the first, second or third embodiment. The improvement is that it provides a self-cleaning scheme for the nozzle 6 based on channel switching and reverse perfusion to solve the problem that the nozzle 6 may be blocked by tissue debris or blood clots.

[0082] Specifically, depending on the architecture of the secondary channel 3, this solution has two implementation methods.

[0083] For the single-channel structure in the first embodiment, a fluid switching valve can be used to temporarily switch the flushing source to connect with the secondary fluid channel 3, allowing high-pressure flushing fluid to backwash the nozzle 6. When the system determines that nozzle 6 needs cleaning, the fluid switching valve connects the secondary fluid channel 3 to the flushing source. The flushing source outputs a high-pressure, short-duration pulse of flushing fluid (e.g., 2-3 times the pressure of normal flushing, lasting 0.5-1 seconds), which is sprayed outward from the secondary fluid channel 3 through nozzle 6, dislodging the blockage. The flushed blockage and flushing fluid are then sucked away by the negative pressure of the main channel at the center of the inner needle tube 2. After cleaning is completed, the switching valve returns to normal operating mode.

[0084] To precisely control the cleaning process, a pressure sensor can be installed on the pipeline between the fluid switching valve and the flushing source to monitor the flushing pressure in real time. When the system determines that cleaning is required, the adaptive control module (such as the control module described in the third embodiment) adjusts the output pressure of the flushing source according to the feedback from the pressure sensor to reach a preset cleaning pressure value (e.g., 0.3-0.5 MPa) and maintains it for a preset cleaning duration. After cleaning is completed, the control module restores the output pressure of the flushing source to the normal flushing pressure (e.g., 0.1-0.2 MPa).

[0085] The cleaning judgment logic can be based on a variety of triggering conditions: it can be based on a preset time interval (such as automatically performing cleaning after every 10 drug administration operations); it can be based on the flow detection of nozzle 6, and cleaning can be triggered when the flow of nozzle 6 is detected to be lower than a preset threshold; it can also be manually triggered by the doctor through the control panel; and it can also be performed before drug administration operations.

[0086] For the dual-channel architecture in the second embodiment, an additional fluid switching valve can be set to temporarily switch the flushing source to connect with the infusion channel 32, realizing reverse flushing from the inside of the drug spray nozzle 61 to the outside. After the system determines that the nozzle 6 needs cleaning, the fluid switching valve temporarily connects the flushing source with the infusion channel 32. The flushing source outputs high-pressure pulse flushing fluid, which enters the infusion channel 32 from the proximal end and flows in reverse to the drug spray nozzle 61 at the distal end, flushing away the blockage. After cleaning is completed, the switching valve is restored, the flushing source is reconnected to the flushing channel 31, and the infusion source is reconnected to the infusion channel 32.

[0087] In this implementation, since the flushing channel 31 and the infusion channel 32 are physically completely isolated, the backflushing only acts on the infusion channel 32 and its corresponding drug spray nozzle 61, without affecting the normal operation of the flushing channel 31. Therefore, during the cleaning process, the flushing channel 31 can continue to maintain its flushing function, realizing parallel operation of cleaning and flushing, and further improving the continuous working capability of the system.

[0088] To ensure that backflushing does not impact the infusion source, a one-way valve can be installed between the infusion channel 32 and the infusion source. This one-way valve only allows the medication to flow from the infusion source to the infusion channel 32, preventing backflushing fluid from entering the infusion source. Simultaneously, a solenoid valve is installed between the flushing source and the infusion channel 32 to control the on / off state of backflushing.

[0089] The cleaning effect can be verified by performing the normal drug administration procedure again after backflushing and checking whether the flow rate or spray pressure of the drug spray nozzle 61 has returned to normal levels. If the test results do not meet the preset standards, the system can automatically repeat the cleaning operation or issue an alarm to prompt the doctor to intervene manually.

[0090] Both of the above implementation methods utilize the reverse flow of high-pressure flushing fluid to apply impact force from inside the nozzle 6 outwards, flushing away blockages. Simultaneously, the negative pressure in the main channel promptly removes the flushed blockages and flushing fluid. No additional cleaning tubing or physical scrubbing mechanism is required; automatic cleaning of the nozzle 6 can be achieved solely through optimized design of the control logic and switching valves. This effectively prevents nozzle 6 from clogging, ensures the long-term reliability of the in-situ drug delivery function, reduces intraoperative interruptions and instrument changes, and improves the continuity and efficiency of the surgery. The parallel cleaning scheme under the dual-channel architecture further ensures that the cleaning operation does not affect the continuous flushing function.

[0091] Example 5

[0092] This embodiment can be implemented based on the rotary cutting needle structure of the first or second embodiment. The core improvement of this embodiment lies in providing a solution for preheating and maintaining a constant temperature of the irrigation fluid, so as to solve the problems of tissue cold stimulation, vasoconstriction, and patient discomfort that may be caused by the entry of low-temperature irrigation fluid into the surgical area.

[0093] In this embodiment, the rotary cutting needle also includes a rinsing fluid preheating module and a constant temperature control module. The rinsing fluid preheating module is disposed between the rinsing source and the fluid interface 4 of the rotary cutting needle, and is used to heat the rinsing fluid. The constant temperature control module is coupled to the rinsing fluid preheating module and is configured to detect the real-time temperature of the rinsing fluid, and adjust the heating power of the preheating module based on the deviation between the real-time temperature and the preset target temperature, so that the rinsing fluid temperature is stabilized within the preset target temperature range.

[0094] The flushing fluid preheating module may include a tubular heater with a heating chamber through which the flushing fluid is heated as it flows. The heating chamber may have a spiral or serpentine flow path to increase the residence time and heat exchange area of ​​the flushing fluid, thereby improving heating efficiency. The heating element may be a ceramic heating plate or a metal heating wire, with its outer wall covered by an insulating and heat-insulating layer to reduce heat loss and ensure electrical safety. The volume of the heating chamber can be designed according to the required flow rate and temperature rise; for example, for a flushing flow rate of 10-30 ml / min and a temperature rise requirement from room temperature (approximately 25°C) to body temperature (approximately 37°C), the volume of the heating chamber may be designed to be 2-5 ml.

[0095] The constant temperature control module includes a temperature sensor and a controller. The temperature sensor is located at the outlet of the heating chamber or at the fluid interface 4 of the rotary cutting needle, and is used to detect the real-time temperature of the rinsing fluid after heating. The temperature sensor can be a thermocouple or a thermistor, with a measurement accuracy of ±0.1℃. The controller is connected to the temperature sensor and the heating element, and uses a PID control algorithm to dynamically adjust the power output of the heating element based on the deviation between the real-time temperature and the preset target temperature (e.g., 37℃). When the real-time temperature is lower than the target temperature, the controller increases the heating power; when the real-time temperature is higher than the target temperature, the controller decreases the heating power or temporarily shuts off the heating element. Through closed-loop control, the rinsing fluid temperature can be stabilized within the preset target temperature range of ±0.5℃.

[0096] To further improve the response speed and stability of temperature control, the preheating module can employ a multi-stage heating structure. For example, it can consist of a preheating stage and a fine heating stage. The preheating stage uses a high-power heating element to rapidly heat the rinsing fluid to near the target temperature (e.g., 35°C); the fine heating stage uses a lower-power heating element to finely regulate the rinsing fluid, ensuring it remains precisely stable at the target temperature. The preheating stage and the fine heating stage are controlled by independent temperature sensors and controllers, forming a two-stage series temperature control system.

[0097] The temperature control module may also include an overheat protection unit, configured to immediately cut off the power to the heating element and issue an alarm when the temperature of the irrigation fluid exceeds a safe threshold (e.g., 39°C), preventing thermal damage to the tissue caused by overheating of the irrigation fluid. The overheat protection unit can be implemented using an independent temperature sensor and hardware comparator circuit, independent of the controller's software logic, to ensure protection is still provided in the event of controller failure.

[0098] The irrigation fluid is heated online using a tubular heater, and the heating power is precisely adjusted using a PID closed-loop control algorithm, ensuring that the irrigation fluid is heated and stabilized at the preset target temperature before entering the rotary cutting needle. The multi-stage heating structure further optimizes the response speed and stability of temperature control, while the overheat protection unit provides hardware-level safety assurance independent of the control logic. Therefore, this implementation achieves online preheating and constant temperature control of the irrigation fluid, ensuring that the temperature of the irrigation fluid entering the surgical area is close to body temperature. This effectively avoids tissue cold stimulation, vasoconstriction, and patient discomfort caused by low-temperature irrigation fluid, improving surgical comfort and safety, while ensuring the stability and consistency of the irrigation fluid temperature.

[0099] Example 6

[0100] This embodiment can be implemented based on the rotary cutting needle structure of the first to fifth embodiments. The improvement of this embodiment is the addition of a lesion density recognition sensor.

[0101] The lesion density identification sensor is deployed at the edge of the incision groove or base of the external needle tube. For breast microcalcifications (such as hydroxyapatite crystals) and high-hardness dense masses, the sensor can be a miniature high-frequency ultrasound transducer array (miniature A / B ultrasound probe), a miniature electro-impedance spectroscopy sensor (EIS), or an optical coherence tomography (OCT) probe.

[0102] When the rotary cutting needle punctures the lesion area, the sensor uses high-frequency acoustic reflection / impedance difference to obtain the density distribution and dielectric constant distribution of the tissue directly above and to the side of the incision groove in real time, accurately identifying the boundary and central density distribution of the microcalcification clusters.

[0103] The adaptive control module, in conjunction with the lesion density recognition sensor, performs the following functions: The adaptive control module receives density recognition signals. When it detects that the tissue density / calcification signal on one side of the incision groove is significantly higher than that in other directions, it prompts the doctor to rotate the needle axially or move it forward and backward through the orientation indicator light at the end of the handle or the software interface, so that the incision groove is precisely aligned with the core area of ​​the highest density of the calcification lesion.

[0104] The adaptive control module dynamically adjusts the rotational and forward propulsion speed of the inner needle cutting blade based on the identified tissue hardness / density. When a high-density calcified area / fibroadenoma is identified, the cutting blade speed is automatically increased and the feed speed is reduced to prevent jamming or incomplete cutting. When identified as normal fat / glandular tissue, standard cutting parameters are restored to achieve precise, on-demand cutting.

[0105] Example 7

[0106] This embodiment can be implemented based on the rotary cutting needle structure of the first to sixth embodiments. The improvement of this embodiment is the addition of a nerve detection sensor (pain and nerve perception component).

[0107] A nerve detection sensor is installed around the tissue window of the external needle tube. The nerve detection sensor is located at a 90-degree angle to the tissue window in the circumferential direction. The nerve detection sensor is electrically connected to the adaptive control module to monitor the nerve distribution signal around the tissue window in real time.

[0108] The adaptive control module, in conjunction with the neural detection sensor, achieves the following functions.

[0109] When the neural distribution signal detected by the neural detection sensor reaches a preset threshold, the adaptive control module immediately triggers the intelligent early analgesia mechanism: The adaptive control module automatically controls the fluid switching valve to open the infusion channel and infusion source, and pre-sprays local anesthetic (such as lidocaine) into the sensitive area where the nerve detection sensor is located through the drug spray nozzle. Because the nerve detection sensor is positioned at a 90-degree angle to the tissue window in the circumferential direction, it can detect peripheral nerves and pre-add anesthetic before the tissue window turns to this area during the rotation of the rotary cutting needle (such as rotary cutting in the 0–12 o'clock direction).

[0110] By performing local anesthesia before the patient experiences pain, even if the subsequent cutting action severs the tiny nerve endings in the area, the patient will not experience severe pain. This achieves a painless rotary cutting experience of "early detection, early analgesia, and smooth cutting," greatly improving the comfort of the surgery and the patient's medical experience.

[0111] The prior description of this disclosure is provided to enable any person skilled in the art to make or use this disclosure. Various modifications to this disclosure will be apparent to those skilled in the art, and the general principles defined herein may be applied to other variations without departing from the spirit or scope of this disclosure. Therefore, this disclosure is not intended to be limited to the examples and designs described herein, but should be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A rotary cutting needle, characterized in that, include: The external needle tube has a tissue window on its distal sidewall; An inner needle tube is disposed inside the outer needle tube. The axis of the inner needle tube is offset relative to the axis of the outer needle tube, so that a secondary fluid channel extending along the axial direction of the outer needle tube is formed between the outer wall of the inner needle tube and the inner wall of the outer needle tube. The secondary fluid channel avoids the area where the tissue window is located in the circumferential direction. A fluid interface is disposed near the proximal end of the outer needle tube and communicates with the secondary fluid channel. The fluid interface is used to connect to a fluid source.

2. The rotary cutting needle according to claim 1, characterized in that, The inner needle tube has at least one spray hole on the side opposite to the tissue window, and the spray hole is connected to the fluid secondary channel.

3. The rotary cutting needle according to claim 2, characterized in that, The fluid secondary channel includes at least a flushing channel and an infusion channel; the fluid interface includes at least a flushing interface and an infusion interface that are respectively connected to the flushing channel and the infusion channel; the flushing interface is used to connect to a flushing source, and the infusion interface is used to connect to an infusion source.

4. The rotary cutting needle according to claim 3, characterized in that, At least one isolation strip extending axially along the outer needle tube is provided between the outer wall of the inner needle tube and the inner wall of the outer needle tube, and the isolation strip divides the fluid secondary channel into at least the flushing channel and the infusion channel.

5. The rotary cutting needle according to claim 3, characterized in that, The nozzle includes at least: The liquid spray nozzle is connected to the infusion channel; The flushing nozzle is connected to the flushing channel.

6. The rotary cutting needle according to claim 5, characterized in that, The drug spray nozzle and the tissue window are located on opposite sides of the inner needle tube; The number of drug spray holes is multiple, distributed along the axial and / or circumferential direction of the inner needle tube to form a micropore array; The axis of the micropores in the micropore array forms an acute angle with the radial direction of the inner needle tube, so that the sprayed liquid forms a fan-shaped atomization surface.

7. The rotary cutting needle according to claim 1, characterized in that, The rotary cutting needle also includes: A fluid switching valve is connected to the fluid interface and is connected to both a flushing source and an infusion source. The fluid switching valve is used to selectively connect the fluid secondary channel to either the flushing source or the infusion source.

8. The rotary cutting needle according to any one of claims 1-7, characterized in that, The rotary cutting needle also includes: A negative pressure return line is connected to the inner needle tube, and the negative pressure return line is used to connect to a negative pressure source; A bleeding detection module is installed on the negative pressure return pipeline to detect the amount of liquid bleeding flowing through the negative pressure return pipeline in real time and generate a bleeding signal. An adaptive control module, coupled to the bleeding detection module, is configured to: receive the bleeding signal, determine a flushing strategy based on the bleeding signal, and control the flushing source connected to the fluid sub-channel to output flushing fluid according to the flushing strategy.

9. The rotary cutting needle according to claim 8, characterized in that, The bleeding detection module includes: A transparent conduit is connected in series to the negative pressure return conduit; A photoelectric sensor is used to emit light signals through the transparent tube and receive transmitted or reflected light signals to detect the blood concentration in the flowing liquid and generate the bleeding amount signal. A snap-fit ​​clamp is fixed to the outside of the transparent pipe and used to clamp the photoelectric sensor; A light-shielding component is wrapped around the outside of the photoelectric sensor and the transparent conduit to shield ambient light.

10. The rotary cutting needle according to claim 9, characterized in that, The bleeding detection module also includes at least one of the following: The calibration unit is configured to control the photoelectric sensor to detect the clear flushing fluid flowing through the negative pressure return pipeline when the system is started, and to generate calibration parameters based on the detection results to calibrate the photoelectric sensor. The bubble detection unit is configured to determine whether there are bubbles in the negative pressure return pipeline based on the sudden change in the electrical signal output by the photoelectric sensor, and to ignore the bleeding measurement data in the current time period or issue an alarm signal when bubbles are detected. A temperature sensor is disposed at the photoelectric sensor and used to detect its operating temperature. The bleeding detection module is configured to perform temperature compensation on the bleeding signal based on the operating temperature.

11. The rotary cutting needle according to claim 8, characterized in that, The flushing strategy includes adjusting at least one of the following parameters: the flow rate, pressure, and pulse frequency of the flushing fluid output from the flushing source.

12. The rotary cutting needle according to claim 11, characterized in that, The flushing strategy includes at least one of the following: basic flushing mode, pulse flushing mode, powerful flushing mode, and adaptive adjustment mode; The adaptive control module is configured as follows: Based on the relationship between the bleeding volume signal and the preset threshold, select to switch to the basic irrigation mode, the pulse irrigation mode, or the powerful irrigation mode; or The bleeding volume signal is used as a control input to dynamically adjust the flushing flow rate, thereby forming a closed-loop control.

13. The rotary cutting needle according to claim 12, characterized in that, The flushing strategy also includes temperature regulation of the flushing fluid; in the powerful flushing mode, the adaptive control module controls the heating unit to preheat the flushing fluid to near body temperature.

14. The rotary cutting needle according to claim 8, characterized in that, The rotary cutting needle also includes a phase synchronization controller, which is used to acquire the real-time angular position signal of the inner needle tube and / or its distal cutting blade, and control the synchronization of fluid movement and cutting phase based on the angular position signal: During the tissue aspiration phase when the tissue opening is open, the fluid valve communicating with the fluid secondary channel is closed; In the phase after the tissue opening is closed and the cutting is completed, the flushing valve connected to the flushing channel is opened to perform pulse flushing.

15. The rotary cutting needle according to claim 14, characterized in that, The phase synchronization controller is also configured to: when a preset number of cutting intervals is reached, control the cutting to pause and open the drug valve connected to the infusion channel to perform in-situ drug delivery.

16. The rotary cutting needle according to claim 15, characterized in that, A micro accumulator is connected in series at the outlet of the fluid valve and / or the drug solution valve. The micro accumulator is a medical silicone airbag structure used to absorb pressure pulsations generated during valve switching.

17. The rotary cutting needle according to claim 2, characterized in that, The rotary cutting needle also includes a self-cleaning process, which is configured to: when a preset cleaning trigger condition is met, control the fluid source to output a high-pressure pulse flushing fluid that is higher than the preset normal flushing pressure, which flows through the fluid secondary channel and flushes outward from the nozzle in the opposite direction to remove the blockage at the nozzle.

18. The rotary cutting needle according to claim 17, characterized in that, The preset cleaning trigger condition includes at least one of the following: To achieve the preset operation time or cutting / drug administration interval; The fluid flow rate at the nozzle was detected to be lower than a preset flow rate threshold. A manually triggered cleaning command has been received; Before administering the dosing order.

19. The rotary cutting needle according to claim 17, characterized in that, The rotary cutting needle also includes a pressure sensor disposed between the fluid switching valve and the flushing source for detecting flushing pressure; The adaptive control module is coupled to the pressure sensor and is configured to: During self-cleaning, the output pressure of the rinsing source is adjusted to a preset cleaning pressure value based on feedback from the pressure sensor. After cleaning is completed, the output pressure of the rinsing source is restored to the preset normal rinsing pressure.

20. The rotary cutting needle according to claim 17, characterized in that, The fluid switching valve is configured to: temporarily switch the flushing source to be connected to the infusion channel during self-cleaning, so that the high-pressure pulse flushing fluid flows through the infusion channel and backwashes outward from the drug spray hole; and during the cleaning process, the flushing channel remains connected to the flushing source to continuously perform flushing.

21. The rotary cutting needle according to claim 1, characterized in that, The rotary cutting needle also includes: A flushing fluid preheating module is disposed between the flushing source and the fluid interface, and is used to heat the flushing fluid entering the fluid sub-channel; The constant temperature control module, coupled to the flushing fluid preheating module, is configured to detect the real-time temperature of the flushing fluid and adjust the heating power of the flushing fluid preheating module based on the deviation between the real-time temperature and the preset target temperature, so as to stabilize the temperature of the flushing fluid within the preset target temperature range.

22. The rotary cutting needle according to claim 21, characterized in that, The flushing fluid preheating module includes a tubular heater, which has a spiral or serpentine flow channel inside to increase the heat exchange area and residence time of the flushing fluid within the tubular heater.

23. The rotary cutting needle according to claim 22, characterized in that, The constant temperature control module includes: A temperature sensor is installed at the outlet of the flushing fluid preheating module or at the fluid interface to detect the real-time temperature of the flushing fluid after heating. The controller, connected to the temperature sensor and the flushing fluid preheating module, is configured to dynamically adjust the heating power based on the deviation between the real-time temperature and the preset target temperature.

24. The rotary cutting needle according to claim 23, characterized in that, The rinsing fluid preheating module adopts a two-stage series temperature control structure, including: The preheating section is used to rapidly heat the rinsing fluid to a first temperature close to the preset target temperature. A fine heating section, connected in series downstream of the preheating section, is used to finely adjust and stabilize the rinsing fluid to the preset target temperature; The preheating section and the fine heating section are each controlled by an independent temperature sensor and controller.

25. The rotary cutting needle according to claim 24, characterized in that, The constant temperature control module also includes an overheat protection unit, which includes a hardware comparator circuit and an overheat temperature sensor independent of the controller. It is configured to immediately cut off the power supply to the flushing fluid preheating module and issue an alarm when the flushing fluid temperature is detected to exceed a preset safety threshold.

26. The rotary cutting needle according to claim 8, characterized in that, A lesion density identification sensor is provided around the tissue window of the external needle tube. The lesion density identification sensor is electrically connected to the adaptive control module and is used to detect the density distribution signal of the tissue around the tissue window in real time. The adaptive control module is configured to guide the external needle tube to adjust the rotation angle or axial position according to the density distribution signal fed back by the lesion density identification sensor so that the tissue window is aligned with the target lesion.

27. The rotary cutting needle according to claim 8, characterized in that, A nerve detection sensor is provided around the tissue window of the external needle tube. The nerve detection sensor is located at a 90-degree angle to the tissue window in the circumferential direction. The nerve detection sensor is electrically connected to the adaptive control module and is used to monitor the nerve distribution signal around the tissue window in real time. The adaptive control module is configured to automatically control the fluid switching valve to open the infusion channel and the infusion source when the nerve distribution signal detected by the nerve detection sensor reaches a preset threshold, so as to pre-add local anesthetic drug to the sensitive area where the nerve detection sensor is located through the drug spray hole to reduce the patient's pain.

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