Punch biopsy device and punch biopsy system

Abstract

The embodiment of the specification relates to the technical field of medical instruments, in particular to a puncture biopsy device and a puncture biopsy system. The puncture biopsy device comprises an optical probe and a trocar needle; the optical probe comprises an optical observation core and a liquid injection pipeline; the distal end of the optical observation core is provided with an observation end face, the proximal end of the liquid injection pipeline is provided with a liquid injection port, and the distal end of the liquid injection pipeline is provided with a liquid outlet port; the liquid injection port is used for injecting transparent fluid into the liquid injection pipeline; the transparent fluid flowing out of the liquid outlet port forms a liquid optical coupling area used for coupling the observation end face and target tissue; the outer diameter of the optical probe is smaller than the inner diameter of the trocar needle; when the optical probe is inserted into the trocar needle, a backflow gap is formed between the outer wall of the optical probe and the inner wall of the trocar needle, and the backflow gap is used for backflow of the transparent fluid in the liquid optical coupling area. The embodiment of the specification can construct the liquid optical coupling area and reduce the pollution of blood and tissue debris to the observation area.

Description

Technical Field

[0001] The embodiments in this specification relate to the field of medical device technology, and in particular to a puncture biopsy device and a puncture biopsy system. Background Technology

[0002] A biopsy is a medical procedure that involves inserting a needle into a living organism to obtain a tissue sample. When using traditional biopsy needles for deep tissue sampling, doctors cannot directly observe the area near the sampling window for blood vessels, necrotic tissue, cavities, or non-target tissue, leading to risks of sampling failure or bleeding. To address this, optical probes or miniature cameras can be introduced into the biopsy needle to provide visualization. However, in practice, the lenses of optical probes or miniature cameras are easily contaminated by blood, tissue fluid, or tissue debris, resulting in blurred images or even complete loss of vision, making it impossible for doctors to effectively observe the area near the sampling window. Summary of the Invention

[0003] The purpose of the embodiments in this specification is to provide a puncture biopsy device and a puncture biopsy system to create a liquid optical coupling zone between the observation end face and the target tissue, thereby reducing the contamination of the observation area by blood and tissue debris.

[0004] This specification provides an embodiment of a puncture biopsy device; The biopsy device includes an optical probe and a trocar needle. The optical probe includes an optical observation core and a liquid injection channel running along the axial direction of the optical observation core; The optical observation core has an observation end face at its distal end, the liquid injection pipe has an injection port at its proximal end, and an outlet port at its distal end. The injection port is used to inject transparent fluid into the liquid injection pipe, and the transparent fluid flowing out of the outlet port forms a liquid optical coupling zone for coupling the observation end face with the target tissue. The outer diameter of the optical probe is smaller than the inner diameter of the cannula puncture needle; When the optical probe is inserted into the cannula puncture needle, a reflux gap is formed between the outer wall of the optical probe and the inner wall of the cannula puncture needle. The reflux gap is used for the return of transparent fluid in the liquid optical coupling zone.

[0005] In some embodiments, the cannula puncture needle has a sampling window for the target tissue to enter, and the observation end face and the fluid outlet port are axially located within the sampling window.

[0006] In some embodiments, the cannula puncture needle is provided with a cutting component that can move relative to the sampling window, the cutting component being used to cut the target tissue entering the sampling window; There is a gap between the cutting component and the optical probe for the flow of transparent fluid.

[0007] In some embodiments, the liquid outlet port is tilted toward the observation end face.

[0008] In some embodiments, the liquid outlet port is located behind the end face of the observation end; Alternatively, the liquid outlet port is located in front of the observation end face; Alternatively, the liquid outlet port is flush with the end face of the observation end.

[0009] In some embodiments, the optical probe includes a multi-cavity composite tube; The optical observation core and the liquid injection pipe are located inside the multi-cavity composite tube.

[0010] In some embodiments, the liquid injection conduit is coaxially sleeved on the outside of the optical observation core.

[0011] In some embodiments, the liquid outlet is an annular liquid outlet located on the outer periphery of the observation end; Alternatively, the liquid outlet port may include a plurality of liquid outlet holes circumferentially distributed around the outer periphery of the observation end.

[0012] In some embodiments, at least one guide groove is provided on the outer wall of the optical probe along the axial direction, and the guide groove and the inner wall of the cannula puncture needle form at least a portion of the reflux gap.

[0013] In some embodiments, the optical observation core includes at least one of the following: Imaging components, illumination components, and lens components.

[0014] In some embodiments, the imaging component is communicatively connected to an image display device via a cable disposed within the optical observation core or the optical probe.

[0015] In some embodiments, the device further includes a multi-port connector, the multi-port connector having a converging cavity inside, and the multi-port connector having a docking port and a probe inlet port communicating with the converging cavity; the docking port is used to communicate with the needle tail end of the cannula puncture needle, and the optical probe is movably inserted into the probe inlet port and extends outward through the converging cavity and the docking port in sequence.

[0016] In some embodiments, the multi-port connector is further provided with a return port; The return port is connected to the converging cavity, and the converging cavity is connected to the return gap.

[0017] This specification also provides an embodiment of a puncture biopsy system, comprising: A biopsy device includes an optical probe, a cannula puncture needle, and a multi-port connector. The optical probe includes an optical observation core and a fluid injection channel running axially along the optical observation core. The distal end of the optical observation core has an observation end face, the proximal end of the fluid injection channel has an injection port, and the distal end of the fluid injection channel has an outlet port. The injection port is used to inject a transparent fluid into the fluid injection channel, and the transparent fluid flowing out of the outlet port forms a liquid optical coupling zone for coupling the observation end face with the target tissue. The outer diameter of the optical probe is smaller than the inner diameter of the cannula puncture needle. When the optical probe is inserted into the cannula puncture needle, a reflux gap is formed between the outer wall of the optical probe and the inner wall of the cannula puncture needle. The reflux gap is used for the return of the transparent fluid in the liquid optical coupling zone. The multi-port connector has a converging cavity communicating with the reflux gap and a reflux port communicating with the converging cavity. Fluid supply device; the fluid supply device is connected to the injection port; Negative pressure suction device; the negative pressure suction device is connected to the return port.

[0018] In some embodiments, the system further includes a controller; the controller is configured to control the injection parameters of the fluid supply device and / or the return parameters of the negative pressure suction device according to the state information of the liquid optical coupling zone, the fluid supply device is configured to inject transparent fluid into the injection pipeline according to the injection parameters, and the negative pressure suction device is configured to suction transparent fluid from the return port according to the return parameters.

[0019] In some embodiments, the puncture biopsy device further includes a state sensing unit; The state sensing unit is used to acquire the state information of the liquid optical coupling region.

[0020] In some embodiments, the state sensing unit includes a first pressure sensor; The first pressure sensor is used to detect the first pressure within the liquid optical coupling region; The status information includes the first pressure.

[0021] In some embodiments, the state sensing unit includes a second pressure sensor; The second pressure sensor is used to detect the second pressure of the transparent fluid in the injection pipeline and / or the third pressure of the transparent fluid in the reflux gap; the status information includes the second pressure and / or the third pressure.

[0022] In some embodiments, the optical observation core includes an imaging component; The imaging component is used to acquire image information of the target tissue; The status information includes the image information.

[0023] In some embodiments, the system further includes an image display device; The image display device is communicatively connected to the imaging component of the optical observation core.

[0024] As can be seen from the technical solutions provided in the embodiments of this specification above, the puncture biopsy device includes an optical probe and a cannula puncture needle. The optical probe includes an optical observation core and a fluid injection channel running along the axial direction of the optical observation core. A reflux gap can be formed between the outer wall of the optical probe and the inner wall of the cannula puncture needle, allowing the transparent fluid flowing out from the outlet port of the fluid injection channel to form a dynamic liquid optical coupling zone between the end face of the observation end and the target tissue. Simultaneously, the reflux gap enables the return of the transparent fluid. This reflux helps to remove blood, debris, and excess fluid, reducing the diffusion of the transparent fluid in deep tissues and minimizing local tissue disturbance. Furthermore, the dynamic liquid optical coupling zone allows the transparent fluid to continuously flush away blood, tissue fluid, and debris from the end face of the observation end, thus preventing image blurring or even complete loss of vision. Additionally, the liquid optical coupling zone fills the space between the end face of the observation end and the irregular tissue surface, reducing reflection, scattering, and obstruction caused by air, blood, and tissue fluid, thereby improving observation clarity. Furthermore, the transparent fluid in the liquid optical coupling zone can naturally conform to irregular soft tissue surfaces, achieving effective adhesion without rigid contact with the tissue surface and reducing pressure on the tissue. Additionally, the liquid optical coupling zone is a liquid-permeable space, not affecting the entry of target tissue into the sampling window or the sampling operation itself. Attached Figure Description

[0025] To more clearly illustrate the technical solutions in the embodiments or prior art of this specification, the drawings used in the description of the embodiments or prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this specification. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0026] Figure 1 This is a functional structure diagram of the multi-port connector in the embodiments of this specification; Figure 2 This is a cross-sectional view of the multi-port connector in the embodiments of this specification; Figure 3 This is a schematic diagram of the functional structure of the optical probe in the embodiments of this specification. Figure 1 ; Figure 4 This is a schematic diagram of the functional structure of the optical probe in the embodiments of this specification. Figure 2 ; Figure 5This is a schematic diagram of the functional structure of the cannula puncture needle in the embodiments of this specification; Figure 6 This is a schematic diagram showing the connection relationship between the optical probe and the multi-channel connector in the embodiments of this specification; Figure 7 This is a schematic diagram showing the connection relationship between the cannula puncture needle and the multi-port connector in the embodiments of this specification; Figure 8 This is a schematic diagram showing the positional relationship between the optical probe and the cannula puncture needle in the embodiments of this specification; Figure 9 This is a schematic diagram of the reflux gap in the embodiments of this specification; Figure 10 This is a schematic diagram of the flow path of the transparent fluid in the embodiments of this specification.

[0027] Explanation of reference numerals in the attached figures: 1. Optical probe; 11. Injection channel; 111. Injection port; 112. Outlet port; 12. Optical observation core; 2. Cannula puncture needle; 3. Multi-port connector; 31. Probe inlet port; 32. Return port; 33. Docking port; 34. Converging cavity; 35. Dynamic sealing assembly; 4. Return gap. Detailed Implementation

[0028] The technical solutions in the embodiments of this specification will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this specification, and not all embodiments. Based on the embodiments in this specification, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of this specification.

[0029] In related technologies, a solid transparent optical coupling pad or transparent end cap can be placed in front of the lens of an optical probe or miniature camera to adhere to the target tissue and drain some blood. However, the adhesion stability of a solid transparent optical coupling pad or transparent end cap is poor for soft tissue, tumor tissue, or irregular surfaces. For example, if it adheres tightly to drain blood, the solid transparent optical coupling pad or transparent end cap can easily compress the tissue, causing tissue deformation or damage; if the adhesion is not tight enough, the solid transparent optical coupling pad or transparent end cap may not be able to effectively drain blood, making the field of view easily obstructed. In addition, the solid structure occupies physical space, which may affect the entry of the target tissue into the sampling window and the sampling operation of the target tissue.

[0030] This specification provides an embodiment of a puncture biopsy device. Please refer to [link to documentation]. Figure 7The biopsy device includes an optical probe 1 and a cannula puncture needle 2. The optical probe 1 is used to acquire image information of the observation area, allowing the physician to directly observe whether there are blood vessels, necrotic tissue, cavities, or non-target tissue near the sampling window of the cannula puncture needle 2, reducing the risk of sampling failure or bleeding. The observation area can be the area near the sampling window. For example, the observation area can include the area visible through the sampling window located outside the cannula puncture needle, or it can include the area adjacent to the sampling window located inside the cannula puncture needle. The cannula puncture needle 2 is used to puncture into the body to sample the target tissue and also provides an insertion channel for the optical probe 1.

[0031] The target tissue can be soft tissue. Soft tissue can include brain tissue, breast tissue, thyroid gland, liver, or other target tissues.

[0032] In some embodiments, please refer to Figure 3 , Figure 4 , Figure 5 , Figure 8 , Figure 9 and Figure 10 The optical probe 1 includes an optical observation core 12 and a fluid injection channel 11. The fluid injection channel 11 is arranged axially alongside the optical observation core 12, and the extension path of the fluid injection channel 11 and the optical observation core 12 is approximately parallel. The optical observation core 12 is used to acquire image information of the observation area, so that the doctor can directly observe whether there are blood vessels, necrotic tissue, cavities or non-target tissues near the sampling window of the cannula puncture needle 2, reducing the risk of sampling failure or bleeding. The fluid injection channel 11 serves as a transmission channel for transparent fluid to form a liquid optical coupling zone.

[0033] The optical observation core 12 can be a miniature camera assembly, a fiber optic imaging assembly, a fiber optic bundle, a CMOS (Complementary Metal Oxide Semiconductor) imaging assembly, a miniature endoscopic probe with an illumination source, or other optical components that can be used to observe tissue surfaces. The optical observation core 12 includes at least one of the following: an imaging assembly, an illumination assembly, and a lens assembly. The imaging assembly can include a camera, a CMOS imaging chip, a CCD (Charge Coupled Device) imaging element, etc. The imaging assembly is used to image the observation area. The illumination assembly can include an LED (Light Emitting Diode), a miniature bulb, an optical fiber, etc. The illumination assembly is used to provide illumination for the imaging.

[0034] The optical observation core 12 extends axially, thus having an elongated shape. The distal end of the optical observation core 12 can serve as the observation end. One or more of an imaging component, an illumination component, and a lens component are integrated at the observation end, enabling the acquisition of image information near the sampling window. The imaging component and the illumination component can be connected to external devices via cables. For example, the imaging component can be connected to an image display device via a cable, and the illumination component can be connected to a power source via a cable. The cables can be located inside the optical observation core 12, or they can be located inside the optical probe 1 and outside the optical observation core 12.

[0035] The injection conduit 11 extends axially, thus having an elongated shape. The injection conduit 11 can be, for example, an injection microtube. An injection port 111 is located at the proximal end of the injection conduit 11. The injection port 111 communicates with a fluid supply device. The injection port 111 can communicate with the fluid supply device via a standard connector. The standard connector can include a medical Luer connector. The fluid supply device can include an infusion pump, etc. The fluid supply device can inject a transparent fluid into the injection conduit 11 through the injection port 111. The transparent fluid can be physiological saline, artificial cerebrospinal fluid, medical transparent irrigation solution, or other transparent liquids suitable for medical use. An outlet port 112 is located at the distal end of the injection conduit 11. The transparent fluid flows within the injection conduit 11 and exits through the outlet port 112. The transparent fluid exiting from the outlet port 112 fills the area between the observation end face and the target tissue, thereby forming a liquid optical coupling zone for coupling the observation end face and the target tissue. The observation end face can be the end face of the observation end of the optical observation core 12. This end face can be a transparent surface, such as a glass surface or a polished end face. During a biopsy, the target tissue, the biological tissue to be sampled, is located in front of the observation end face. After the target tissue enters the cannula puncture needle 2 through the sampling window, the fluid supply device injects transparent fluid into the injection channel 11 through the injection port 111. The transparent fluid flowing out of the outlet port 112 fills the area between the observation end face and the surface of the target tissue that has entered the sampling window, forming a liquid optical coupling zone. The liquid optical coupling zone is located inside the cannula puncture needle 2. Optionally, before the target tissue enters the cannula puncture needle 2 through the sampling window, the fluid supply device can also inject transparent fluid into the injection channel 11 through the injection port 111. The transparent fluid flowing out of the outlet port 112 fills the area between the observation end face and the surface of the target tissue located outside the cannula puncture needle 2, forming a liquid optical coupling zone. The transparent fluid extends outward through the sampling window to drain blood and tissue fluid, etc.

[0036] The cannula puncture needle 2 has a needle tip. The needle tip can be a puncture tip. The puncture tip is used to puncture and enter the body to reach the target area for sampling the target tissue. The other end of the cannula puncture needle 2 opposite to the needle tip is a needle tail end. The cannula puncture needle 2 has an axially extending cavity. At least a portion of the optical probe 1 can be placed within the cavity of the cannula puncture needle 2. The outer diameter of the optical probe 1 is smaller than the inner diameter of the cannula puncture needle 2. The outer diameter of the optical probe 1 is its external diameter. For example, the outer diameter of the optical probe 1 is 0.7 mm to 1.2 mm. The inner diameter of the cannula puncture needle 2 is the diameter of the internal cavity of the cannula puncture needle 2. For example, the inner diameter of the cannula puncture needle 2 is 1.5 mm to 2.5 mm. Thus, when the optical probe 1 is inserted into the cannula puncture needle 2, a reflux gap 4 can be formed between the outer wall of the optical probe 1 and the inner wall of the cannula puncture needle 2. The reflux gap 4 can serve as a reflux channel for transparent fluid reflux, allowing transparent fluid from the liquid optical coupling zone to reflux. In this way, the injection port 111, injection pipe 11, outlet port 112, liquid optical coupling zone, and reflux gap 4 together form the fluid path.

[0037] The reflux process allows excess transparent fluid to be drawn out, reducing its diffusion in deep tissues and minimizing local tissue disturbance. Additionally, during biopsy procedures using a puncture biopsy device, blood and debris are generated; reflux also helps remove these contaminants. The liquid optical coupling zone, formed by the transparent fluid, is continuously updated. The transparent fluid in the liquid optical coupling zone continuously flushes away blood, tissue fluid, and debris from the observation end face, preventing image blurring or complete loss of field of view. Furthermore, the liquid optical coupling zone fills the space between the observation end face and irregular tissue surfaces, reducing reflection, scattering, and obstruction caused by air, blood, and tissue fluid, thereby improving observation clarity. Moreover, as a transparent fluid area, the transparent fluid in the liquid optical coupling zone naturally conforms to irregular soft tissue surfaces, achieving effective adhesion without rigid contact and reducing tissue pressure. Finally, the liquid optical coupling zone is a liquid-permeable space, not affecting the entry of target tissue into the sampling window or the sampling operation itself.

[0038] In the above embodiments, the distal end is the end facing the needle tip. The proximal end is the end facing the needle tail. The anterior direction is the direction towards the distal end (away from the operator). The posterior direction is the direction towards the proximal end (closer to the operator).

[0039] In some embodiments, the cannula puncture needle 2 has a sampling window. The sampling window is an opening provided on the cannula puncture needle 2. The sampling window may be located at the tip of the cannula puncture needle 2, or it may be located on the side wall near the tip. The shape of the sampling window may be, for example, rectangular, elliptical, or circular. The sampling window is used to allow target tissue from the target area to enter the interior of the cannula puncture needle 2 for sampling. The observation end face and the liquid outlet port 112 are axially located within the sampling window to image the area near the sampling window and to form a liquid optical coupling zone in the area near the sampling window. The axial direction is the direction extending along the central axis of the cannula puncture needle 2 or the optical probe 1.

[0040] Therefore, the liquid optical coupling zone can cover the area where the sampling window is located, so that the observation end can clearly observe the target tissue entering the sampling window through the liquid optical coupling medium. At the same time, the transparent fluid flowing out of the liquid outlet 112 can wash the tissue surface near the sampling window and the sampling window, and promptly remove blood, tissue fluid and debris, maintaining a clear field of view during the sampling process.

[0041] In some embodiments, when the tip of the cannula puncture needle 2 reaches the target area, the target tissue can naturally penetrate into the sampling window under the pressure within the organism. Alternatively, a local negative pressure can be created inside the cannula puncture needle 2 to draw the target tissue into the sampling window. The cannula puncture needle 2 is equipped with a cutting component that can move relative to the sampling window. After the target tissue enters the cannula puncture needle 2 through the sampling window, the cutting component can cut the target tissue that has entered the sampling window, thereby achieving puncture sampling of the target tissue. The cutting component is a cutting tube or cutting blade that can move axially. The operator can control the cutting component to move axially via a handle or push-pull rod to cut the target tissue that has entered the sampling window, thereby achieving puncture sampling of the target tissue. Of course, the operator can also control the cutting component in other ways. This specification does not specifically limit the control method of the cutting component in the embodiments.

[0042] In some embodiments, the cutting component and optical probe 1 may be located inside the cannula puncture needle 2. A gap for the flow of transparent fluid exists between the cutting component and the optical probe 1. This gap communicates with a liquid optical coupling region. The transparent fluid within this gap may originate from the liquid optical coupling region. The transparent fluid in the liquid optical coupling region can pass through this gap into the reflux gap 4. Thus, the transparent fluid flowing through this gap can carry away tissue debris or blood generated when the cutting component cuts the target tissue.

[0043] In some embodiments, the outer wall of the optical probe 1 may be provided with at least one axially spaced guide groove. The guide groove and the inner wall of the cannula puncture needle 2 form at least a portion of the reflux gap 4. The guide groove can enhance the reflux of transparent fluid, thereby reducing the risk of the reflux gap 4 being blocked by soft tissue, blood clots, or debris.

[0044] In some embodiments, the fluid outlet 112 is adjacent to the observation end face. The axial distance between the fluid outlet 112 and the observation end face is less than a preset value. For example, the axial distance between the fluid outlet 112 and the observation end face is 0 mm to 5 mm. The fluid outlet 112 may be located behind or in front of the observation end face; or, the fluid outlet 112 may be flush with the observation end face. The fluid outlet 112 may be inclined toward the observation end face. For example, the fluid outlet 112 may be inclined toward the front or the side-front of the observation end face. This enhances the flushing effect of the transparent fluid flowing from the fluid outlet 112 on the blood, tissue fluid, and debris adhering to the observation end face, more effectively keeping the observation end face clean and thus preventing loss of field of view.

[0045] In some embodiments, the liquid outlet port 112 can be an annular liquid outlet located on the outer periphery of the observation end.

[0046] Alternatively, the liquid outlet port 112 may include multiple liquid outlet holes circumferentially distributed around the outer periphery of the observation end. In this way, the transparent fluid flowing out of the liquid outlet port 112 can uniformly surround the observation end, thereby forming a more stable liquid optical coupling zone.

[0047] In some embodiments, the optical probe 1 may include a multi-cavity composite tube. The optical observation core 12 and the liquid injection channel 11 can be disposed within the multi-cavity composite tube. Thus, the optical observation core 12 and the liquid injection channel 11 can be arranged side-by-side within the same flexible outer sheath, forming a side-by-side composite optical probe structure. This simple and convenient method of forming a composite optical probe structure by adding the liquid injection channel 11 next to the optical observation core 12 is quite effective.

[0048] The injection conduit 11 can also be coaxially sleeved on the outside of the optical observation core 12. Thus, the optical observation core 12 and the injection conduit 11 can together form a coaxial annular probe structure. This allows an annular injection conduit to be formed around the outer periphery of the optical observation core 12.

[0049] In some embodiments, please refer to Figure 1 , Figure 2 , Figure 6 and Figure 7The biopsy device may also include a multi-port connector 3. The multi-port connector 3 may be, for example, a Y-type valve or a T-type valve injection molded from medical-grade polycarbonate. The multi-port connector 3 can connect to the optical probe 1 and the cannula puncture needle 2. The multi-port connector 3 has a converging cavity 34 inside. The converging cavity 34 can communicate with the reflux gap 4. The multi-port connector 3 has a reflux port 32 communicating with the converging cavity 34. Thus, the reflux gap 4 can communicate with the reflux port 32 through the converging cavity 34. The reflux port 32 can be connected to a negative pressure aspiration device. The negative pressure aspiration device is used to aspirate transparent fluid, causing the transparent fluid in the liquid optical coupling zone to reflux through the reflux gap 4. It is also used to provide negative pressure so that target tissue outside the cannula puncture needle 2 enters the cannula puncture needle 2 through the sampling window for cutting and sampling. The negative pressure aspiration device may include a negative pressure suction pump, a vacuum pump, etc. The reflux port 32 can be connected to the negative pressure aspiration device through a standard connector. Standard connectors may include medical Luer connectors.

[0050] The multi-port connector 3 may also be provided with a docking port 33 communicating with the converging cavity 34 and a probe introduction port 31. The docking port 33 is used to communicate with the needle tail end of the cannula puncture needle 2. In addition, the optical probe 1 can extend into the cannula puncture needle 2. Furthermore, the optical probe 1 can also be movably inserted into the probe introduction port 31 and extend outward by passing through the converging cavity 34 and the docking port 33 in sequence. Thus, the optical probe 1 can be conveniently inserted into the cannula puncture needle 2 through the multi-port connector 3, and the converging cavity 34 is connected to the reflux gap 4, thereby forming a channel for the return of transparent fluid.

[0051] Optionally, one or more of a filter, a one-way valve, and a collection chamber may be provided between the return port 32 and the collection chamber 34. The filter is used to intercept tissue debris, preventing it from entering the negative pressure suction device and causing blockage or contamination. The one-way valve is used to prevent backflow of the transparent fluid, avoiding contamination of the return gap 4 or affecting the stability of the liquid optical coupling zone. The collection chamber is used to collect the returned transparent fluid, as well as blood, tissue debris, etc.

[0052] Optionally, a dynamic sealing component 35 may be provided on the inner wall of the probe inlet port 31. The optical probe 1 can be inserted into the probe inlet port 31 through the dynamic sealing component 35. The dynamic sealing component 35 may be, for example, a medical-grade self-lubricating silicone O-ring. Thus, the optical probe 1 can slide and seal with the dynamic sealing component 35. The optical probe 1 can slide axially relative to the cannula puncture needle 2 while maintaining a seal, thereby achieving a dynamic sliding seal.

[0053] Optionally, a limiting ring is provided on the outer wall of the optical probe 1. The limiting ring abuts against the outer end face of the probe inlet port 31. The limiting ring can be sleeved on the outer wall of the optical probe 1 and engage with the damping mechanism of the outer wall of the optical probe 1 to limit the maximum length of the optical probe 1 extending into the cannula puncture needle 2, preventing the observation end from extending excessively and interfering with the cutting assembly. The outer wall of the optical probe 1 may also be provided with a scale, which is used to indicate the length of the optical probe 1 extending into the cannula puncture needle 2.

[0054] The following describes a scenario example of an embodiment of this specification.

[0055] The operator (e.g., a physician) determines the length of the cannula 2 used for this biopsy. The optical probe 1 is inserted through the probe inlet port 31 and slid to the specified length. After reaching the specified length, it is locked using a retaining ring. The docking port 33 is then connected to the needle tail end of the cannula 2. At this point, the observation end is located at the rear edge of the sampling window of the cannula 2. The operator can then insert the needle tip of the cannula 2 into the biological body to reach the target area. The imaging component of the optical observation core 12 can image the observation area. The image display device can display the corresponding image information. The operator can observe whether there are blood vessels, necrotic tissue, cavities, or non-target tissue near the sampling window using the image information.

[0056] When the tip of the cannula puncture needle 2 reaches the target area, the target tissue can naturally penetrate into the sampling window under the pressure within the body. Alternatively, if it is determined that there is no risk of sampling failure or bleeding, a negative pressure aspiration device can be controlled. This allows the negative pressure aspiration device to create a local negative pressure inside the cannula puncture needle 2 through negative pressure aspiration, thereby drawing the target tissue into the sampling window. A fluid supply device is controlled so that a transparent fluid can be injected into the injection channel 11 through the injection port 111. The transparent fluid flows within the injection channel 11 and exits through the outlet port 112. The transparent fluid exiting the outlet port 112 flows through the area near the observation end, forming a liquid optical coupling zone between the end face of the observation end and the target tissue in front. The negative pressure aspiration device creates a local negative pressure inside the cannula puncture needle 2 through negative pressure aspiration, allowing the transparent fluid in the liquid optical coupling zone to enter the reflux gap 4. The reflux gap 4 serves as a reflux channel for the transparent fluid to return, allowing the transparent fluid in the liquid optical coupling zone to return. The returned transparent fluid can enter the negative pressure suction device through the converging chamber 34 and the return port 32.

[0057] The operator controls the cutting component to move axially via a handle or push-pull lever, cutting the target tissue into the sampling window to achieve puncture and sampling of the target tissue. During puncture biopsy procedures using this device, blood and debris are generated. The transparent fluid in the liquid optical coupling zone continuously flushes away blood, tissue fluid, and debris from the observation end face, thus preventing image blurring or even complete loss of vision. Additionally, the transparent fluid in the liquid optical coupling zone also draws out blood and debris.

[0058] This specification also provides a puncture biopsy system. The puncture biopsy system may include the above-described puncture biopsy device.

[0059] In some embodiments, the biopsy system may further include a fluid supply device. The fluid supply device may be connected to the injection port 111. The fluid supply device can inject a clear fluid into the injection conduit 11 through the injection port 111. The return port 32 allows the clear fluid to flow back naturally. Alternatively, the biopsy system may further include a negative pressure aspiration device. The negative pressure aspiration device is connected to the return port 32. This allows the clear fluid to flow back from the return port 32 via negative pressure aspiration.

[0060] In some embodiments, the biopsy system may further include an image display device. The image display device may be communicatively connected to the imaging component of the optical observation core 12, thereby displaying image information near the sampling window.

[0061] In some embodiments, during deep tissue visualization and biopsy procedures, a liquid optical coupling zone needs to be constructed near the regional window to obtain a stable and clear field of view, thereby reducing contamination of the observation area by blood and tissue debris. However, if the pressure of the liquid optical coupling zone is too low, external blood and tissue fluid can easily infiltrate the observation area, leading to contamination of the field of view. If the pressure of the liquid optical coupling zone is too high, transparent fluid may seep into the interstitial spaces, causing mechanical disturbance or fluid infiltration damage to the tissue. Therefore, the pressure of the liquid optical coupling zone needs to be within a preset range to maintain a slightly positive pressure state.

[0062] The biopsy system may include a controller. The controller may be a computer device, a control chip, etc. The controller can control the injection parameters of the fluid supply device and / or the return parameters of the negative pressure aspiration device based on the status information of the liquid optical coupling zone. The status information reflects the pressure state of the liquid optical coupling zone. The fluid supply device can inject transparent fluid into the injection channel 11 according to the injection parameters. The negative pressure aspiration device can aspirate transparent fluid from the return port 32 according to the return parameters. This controls the input and / or return states of the transparent fluid, keeping the pressure of the liquid optical coupling zone within a preset range, thereby maintaining a slightly positive pressure state in the liquid optical coupling zone during dynamic circulation, avoiding tissue damage while maintaining a clear field of vision.

[0063] The pressure in the liquid optical coupling zone can be the pressure of the transparent fluid within the zone. The preset interval is used to inhibit the intrusion of external contaminating liquids into the observation area. The preset interval can be a pressure range formed by an upper pressure boundary and a lower pressure boundary. The preset interval can be below a tissue damage threshold. For example, the upper pressure boundary may be less than the tissue damage threshold. In practical applications, the preset interval can be determined based on the target tissue, needle diameter, animal experiments, and clinical validation results.

[0064] In some embodiments, the biopsy device may further include a state sensing unit. The state sensing unit can acquire state information of the liquid optical coupling zone. Optionally, the state sensing unit may include a first pressure sensor. The first pressure sensor is disposed inside the cannula puncture needle 2, near the liquid optical coupling zone or near the sampling window. The first pressure sensor can be a miniature pressure sensor that can directly detect the first pressure within the liquid optical coupling zone. The controller can control the injection parameters of the fluid supply device and / or the reflux parameters of the negative pressure aspiration device according to the first pressure. This maintains a slightly positive pressure state in the liquid optical coupling zone. Optionally, the state sensing unit may further include a second pressure sensor. The second pressure sensor is used to detect the second pressure of the transparent fluid in the injection channel 11 and the third pressure of the transparent fluid in the reflux gap 4. The controller can control the injection parameters of the fluid supply device according to the second and third pressures. The controller can also control the reflux parameters of the negative pressure aspiration device according to the second and third pressures. This maintains a slightly positive pressure state in the liquid optical coupling zone.

[0065] Injection parameters may include one or more of injection flow rate, injection pressure, and injection rate. The magnitude of the injection parameters is positively correlated with the pressure of the transparent fluid within the liquid optical coupling zone. Return parameters may include one or more of return flow rate, return pressure, and return rate. The magnitude of the return parameters is inversely correlated with the pressure of the transparent fluid within the liquid optical coupling zone.

[0066] After detecting a first pressure within the liquid optical coupling zone, the first pressure sensor can send the first pressure to the controller. The controller can determine whether the first pressure is within a preset range. If the first pressure is within the preset range, the controller can keep the injection and reflux parameters unchanged. If the first pressure is below the preset range, the controller can increase the injection parameters and / or decrease the reflux parameters to increase the pressure in the liquid optical coupling zone. If the first pressure is above the preset range, the controller can decrease the injection parameters and / or increase the reflux parameters to decrease the pressure in the liquid optical coupling zone. A first pressure below the preset range can mean the first pressure is less than the lower pressure limit. A first pressure above the preset range can mean the first pressure is greater than the upper pressure limit.

[0067] Optionally, if the first pressure is lower than a preset range, the controller can further calculate a first difference between the first pressure and the lower pressure limit. If the first difference exceeds a preset threshold, a first warning message can be issued. This first warning message indicates that the pressure in the liquid optical coupling zone is too low. Optionally, if the first pressure is higher than a preset range, the controller can further calculate a second difference between the first pressure and the upper pressure limit. If the second difference exceeds a preset threshold, a second warning message can be issued. This second warning message indicates that the pressure in the liquid optical coupling zone is too high.

[0068] The second pressure sensor may include a pressure sensor disposed within the injection pipe 11 and a pressure sensor disposed within the reflux gap 4. The pressure sensor disposed within the injection pipe 11 can detect the second pressure of the transparent fluid within the injection pipe 11. The pressure sensor disposed within the reflux gap 4 can detect the third pressure of the transparent fluid within the reflux gap 4.

[0069] The controller can calculate the fluid passage characteristics based on the second and third pressures; and can control the injection parameters and / or reflux parameters based on the fluid passage characteristics. The fluid passage characteristics include at least one of the following: fluid passage resistance, fluid passage pressure difference, and height of the connected liquid column. The controller can calculate the difference between the second and third pressures. This difference represents the real-time pressure drop of the transparent fluid between the injection pipe 11 and the reflux gap 4. The controller can calculate the real-time resistance of the fluid passage based on the real-time pressure drop and the injection parameters; and can control the injection parameters and / or reflux parameters based on the real-time resistance. For example, the injection parameters may include the injection flow rate. The controller can calculate the ratio of the real-time pressure drop to the injection flow rate as the real-time resistance. When the real-time resistance increases, it indicates that there are bends, partial blockages, or changes in the flow channel cross-section caused by the action of cutting components in the fluid passage. The controller can increase the injection parameters and / or decrease the reflux parameters to compensate for the pressure loss caused by the increased real-time resistance. When the real-time resistance decreases, the controller can decrease the injection parameters and / or increase the reflux parameters to avoid excessive pressure in the liquid optical coupling zone. In practical applications, a resistance range can also be preset. The controller can determine whether the real-time resistance is within the resistance range. If the real-time resistance is within the resistance range, the controller can keep the injection and return parameters unchanged. If the real-time resistance is below the resistance range, the controller can decrease the injection parameters and / or increase the return parameters. If the real-time resistance is above the resistance range, the controller can increase the injection parameters and / or decrease the return parameters. This maintains a slightly positive pressure state in the liquid optical coupling zone.

[0070] The controller can also calculate the height of the connecting liquid column in the fluid passage based on the second and third pressures. For example, the controller can calculate the height of the connecting liquid column using the formula Δh=(P2-P3-ΔP) / (ρ×g). P2 represents the second pressure, P3 represents the third pressure, ΔP represents the dynamic pressure loss, and ΔP is related to the injection flow rate. ΔP can be obtained by looking up a table based on the injection flow rate. ρ represents the density of the transparent fluid, and g represents the acceleration due to gravity. Δh represents the height of the connecting liquid column. Δh can be understood as the vertical height difference between the pressure sensor in the injection pipe 11 and the pressure sensor in the return gap 4. When the height of the connecting liquid column increases, it means that the pressure sensor in the injection pipe 11 is higher than the pressure sensor in the return gap 4, and the controller can decrease the injection parameters and / or increase the return parameters. When the height of the connecting liquid column decreases, it means that the pressure sensor in the injection pipe 11 is lower than the pressure sensor in the return gap 4, and the controller can increase the injection parameters and / or decrease the return parameters. This counteracts pressure fluctuations caused by changes in the orientation of the biopsy device, maintaining a slightly positive pressure in the liquid optical coupling zone.

[0071] In some embodiments, the imaging component of the optical observation core 12 can acquire image information of the target tissue. The controller can control the injection parameters and / or reflux parameters based on the image information. Specifically, the controller can extract feature information of the target tissue based on the image information; determine the pressure change trend of the liquid optical coupling zone based on the feature information of the target tissue; and control the injection parameters and / or reflux parameters based on the pressure change trend of the liquid optical coupling zone.

[0072] The feature information may include at least one of the following: boundary displacement of the target tissue, boundary deformation rate, and regional area change rate. The feature information represents the boundary deformation state of the target tissue under pressure in the liquid optical coupling zone. The feature information can be extracted from the image information using a machine learning model. When the feature information indicates that the boundary of the target tissue is continuously moving outward from the sampling window, the controller determines that the pressure in the liquid optical coupling zone is increasing, and therefore can decrease the injection parameters and / or increase the reflux parameters. When the feature information indicates that the boundary of the target tissue is retracting and collapsing inward from the sampling window, the controller determines that the pressure in the liquid optical coupling zone is decreasing, and therefore can increase the injection parameters and / or decrease the reflux parameters.

[0073] This specification also provides a control method that can be applied to a controller.

[0074] The control method may include the following steps.

[0075] Step 101: Based on the state information of the liquid optical coupling zone, control the injection parameters of the fluid supply device and / or the return parameters of the negative pressure suction device. The fluid supply device is used to inject transparent fluid according to the injection parameters, and the negative pressure suction device is used to suction transparent fluid according to the return parameters.

[0076] The control method described in this specification can control the injection parameters of the fluid supply device and / or the return parameters of the negative pressure suction device based on the state information of the liquid optical coupling zone. This allows control over the input and / or return states of the transparent fluid, thereby keeping the pressure in the liquid optical coupling zone within a preset range and maintaining a slightly positive pressure state.

[0077] In some embodiments, the biopsy device may include a state sensing unit. The state sensing unit is used to acquire state information of the liquid optical coupling region. The state information reflects the pressure state of the liquid optical coupling region.

[0078] In some embodiments, the state sensing unit may include a first pressure sensor. The first pressure sensor is used to detect a first pressure within the liquid optical coupling zone. The state information includes the first pressure. The controller can control the injection parameters of the fluid supply device and / or the return parameters of the negative pressure suction device according to the first pressure to maintain a slightly positive pressure state in the liquid optical coupling zone.

[0079] In some embodiments, the state sensing unit may include a second pressure sensor. The second pressure sensor is used to detect a second pressure of the transparent fluid in the injection pipe 11 and a third pressure of the transparent fluid in the return gap 4. The state information includes the second pressure and the third pressure. The controller can control the injection parameters of the fluid supply device based on the second pressure and the third pressure. The controller can also control the return parameters of the negative pressure suction device based on the second pressure and / or the third pressure.

[0080] In some embodiments, the optical observation core 12 includes an imaging component. The imaging component is used to acquire image information of the target tissue. The state information may include the image information. The controller can control the injection parameters of the fluid supply device and / or the return parameters of the negative pressure suction device based on the image information. Specifically, the controller can extract feature information of the target tissue based on the image information; and can control the injection parameters of the fluid supply device and / or the return parameters of the negative pressure suction device based on the feature information of the target tissue. The feature information is used to represent the boundary deformation state of the target tissue under the pressure of the liquid optical coupling zone.

[0081] This specification also provides a control device, which can be applied to a controller and includes the following units.

[0082] The control unit is used to control the injection parameters of the fluid supply device and / or the return parameters of the negative pressure suction device according to the state information of the liquid optical coupling zone. The fluid supply device is used to inject transparent fluid according to the injection parameters, and the negative pressure suction device is used to suction transparent fluid according to the return parameters.

[0083] This specification also provides a computer-readable storage medium storing a computer program that, when executed by a processor, implements the above-described control method.

[0084] This specification also provides a computer program product, which includes a computer program that, when executed by a processor, implements the above-described control method.

[0085] The various embodiments in this specification are described in a progressive manner. Similar or identical parts between embodiments can be referred to mutually. Each embodiment focuses on describing the differences from other embodiments. In particular, system embodiments are basically similar to method embodiments, so the description is relatively simple; relevant parts can be referred to the descriptions in the method embodiments. In the description of this specification, the terms "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the embodiments in this specification. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described can be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification and the features of different embodiments or examples.

[0086] Although the process described above includes multiple operations that occur in a specific order, it should be clearly understood that these processes may include more or fewer operations that can be executed sequentially or in parallel (e.g., using parallel processors or a multithreaded environment).

[0087] The above description is merely an embodiment of this application and is not intended to limit the scope of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of the claims of this application.

[0088] All articles and references disclosed herein, including patent applications and publications, are incorporated herein by reference for various purposes. The term “consistent essentially of” used to describe a combination should include the identified elements, components, parts, or steps, as well as other elements, components, parts, or steps that do not substantially affect the essential novelty of the combination. The use of the terms “comprising” or “including” to describe combinations of elements, components, parts, or steps herein also contemplates embodiments that are substantially composed of such elements, components, parts, or steps. The use of the term “may” herein is intended to indicate that any described attribute included by “may” is optional.

[0089] Multiple elements, components, parts, or steps can be provided by a single integrated element, component, part, or step. Alternatively, a single integrated element, component, part, or step can be divided into multiple separate elements, components, parts, or steps. The use of "a" or "an" to describe an element, component, part, or step does not imply the exclusion of other elements, components, parts, or steps.

[0090] It should be understood that the above description is for illustrative purposes and not for limitation. Many embodiments and applications beyond the provided examples will be apparent to those skilled in the art upon reading the above description. For purposes of completeness, all articles and references, including patent applications and publications, are incorporated herein by reference.

Claims

1. A puncture biopsy device, characterized in that, The biopsy device includes an optical probe and a trocar needle. The optical probe includes an optical observation core and a liquid injection channel running along the axial direction of the optical observation core; The cannula puncture needle has a sampling window, the distal end of the optical observation core has an observation end face, the proximal end of the injection tube has an injection port, and the distal end of the injection tube has an outlet port. The injection port is used to inject transparent fluid into the injection tube, and the transparent fluid flowing out of the outlet port fills the area between the observation end face and the surface of the target tissue that has entered the sampling window, so as to form a liquid optical coupling zone inside the cannula puncture needle. The liquid optical coupling zone is used to couple the observation end face with the target tissue. The outer diameter of the optical probe is smaller than the inner diameter of the cannula puncture needle; When the optical probe is inserted into the cannula puncture needle, a reflux gap is formed between the outer wall of the optical probe and the inner wall of the cannula puncture needle. The reflux gap is used for the return of transparent fluid in the liquid optical coupling zone.

2. The apparatus according to claim 1, characterized in that, The cannula puncture needle is provided with a cutting component that can move relative to the sampling window. The cutting component is used to cut the target tissue that enters the sampling window. There is a gap between the cutting component and the optical probe for the flow of transparent fluid.

3. The apparatus according to claim 1, characterized in that, The liquid outlet port is tilted toward the end face of the observation end.

4. The apparatus according to claim 1, characterized in that, The liquid outlet port is located behind the end face of the observation end; Alternatively, the liquid outlet port is located in front of the observation end face; Alternatively, the liquid outlet port is flush with the end face of the observation end.

5. The apparatus according to claim 1, characterized in that, The optical probe includes a multi-cavity composite tube; The optical observation core and the liquid injection pipe are located inside the multi-cavity composite tube.

6. The apparatus according to claim 1, characterized in that, The liquid injection pipe is coaxially sleeved on the outside of the optical observation core.

7. The apparatus according to claim 1, characterized in that, The liquid outlet is an annular liquid outlet located on the outer periphery of the observation end; Alternatively, the liquid outlet port may include a plurality of liquid outlet holes circumferentially distributed around the outer periphery of the observation end.

8. The apparatus according to claim 1, characterized in that, At least one flow guide groove is provided on the outer wall of the optical probe along the axial direction, and the flow guide groove and the inner wall of the cannula puncture needle form at least a part of the reflux gap.

9. The apparatus according to claim 1, characterized in that, The optical observation core includes at least one of the following: Imaging components, illumination components, and lens components.

10. The apparatus according to claim 9, characterized in that, The imaging component is communicatively connected to the image display device via a cable disposed within the optical observation core or the optical probe.

11. The apparatus according to claim 1, characterized in that, The device also includes a multi-port connector, which has a converging cavity inside. The multi-port connector has a docking port and a probe inlet port that communicate with the converging cavity. The docking port is used to communicate with the needle tail end of the cannula puncture needle. The optical probe is movably inserted into the probe inlet port and extends outward through the converging cavity and the docking port in sequence.

12. The apparatus according to claim 11, characterized in that, The multi-port connector also has a return port; The return port is connected to the converging cavity, and the converging cavity is connected to the return gap.

13. A puncture biopsy system, characterized in that, include: Puncture biopsy device; The biopsy device includes an optical probe, a trocar needle, and a multi-port connector. The optical probe includes an optical observation core and a fluid injection channel running axially along the optical observation core; the cannula puncture needle has a sampling window, the distal end of the optical observation core has an observation end face, the proximal end of the fluid injection channel has an injection port, and the distal end of the fluid injection channel has an outlet port. The injection port is used to inject a transparent fluid into the fluid injection channel, and the transparent fluid flowing out of the outlet port fills the area between the observation end face and the surface of the target tissue that has entered the sampling window, so as to form a liquid optical coupling zone inside the cannula puncture needle. The liquid optical coupling zone is used to couple the observation end face to the target tissue; the outer diameter of the optical probe is smaller than the inner diameter of the cannula puncture needle; when the optical probe is inserted into the cannula puncture needle, a reflux gap is formed between the outer wall of the optical probe and the inner wall of the cannula puncture needle, and the reflux gap is used for the transparent fluid of the liquid optical coupling zone to reflux; the multi-port connector has a converging cavity communicating with the reflux gap and a reflux port communicating with the converging cavity; Fluid supply device; the fluid supply device is connected to the injection port; Negative pressure suction device; the negative pressure suction device is connected to the return port.

14. The system according to claim 13, characterized in that, The system further includes a controller; the controller is used to control the injection parameters of the fluid supply device and / or the return parameters of the negative pressure suction device according to the state information of the liquid optical coupling zone, the fluid supply device is used to inject transparent fluid into the injection pipeline according to the injection parameters, and the negative pressure suction device is used to suction transparent fluid from the return port according to the return parameters.

15. The system according to claim 13, characterized in that, The puncture biopsy device also includes a status sensing unit; The state sensing unit is used to acquire the state information of the liquid optical coupling region.

16. The system according to claim 15, characterized in that, The state sensing unit includes a first pressure sensor; The first pressure sensor is used to detect the first pressure within the liquid optical coupling region; The status information includes the first pressure.

17. The system according to claim 15, characterized in that, The state sensing unit includes a second pressure sensor; The second pressure sensor is used to detect the second pressure of the transparent fluid in the injection pipeline and / or the third pressure of the transparent fluid in the reflux gap; the status information includes the second pressure and / or the third pressure.

18. The system according to claim 15, characterized in that, The optical observation core includes an imaging component; The imaging component is used to acquire image information of the target tissue; The status information includes the image information.

19. The system according to claim 13, characterized in that, The system also includes an image display device; The image display device is communicatively connected to the imaging component of the optical observation core.

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