Flexible biopsy forceps with hollow channels for real-time biopsy of lung lesions

Abstract

The present invention provides a flexible biopsy forceps with a hollow channel for real-time biopsy of lung lesions, comprising an insertion portion having a hollow channel capable of accommodating a medical device for image-guided imaging; a gripping portion disposed at the distal end of the insertion portion, comprising a first metal groove and a second metal groove capable of interlocking to form a space for accommodating a biopsy specimen, while forming an opening at the distal end to allow the medical device to pass through; an operating portion disposed at the proximal end of the insertion portion and connected to the gripping portion via a connecting device; the operating portion capable of driving the first and second metal grooves to pivot. The present invention can meet the needs of real-time lung biopsy under the guidance of radial bronchial ultrasound or confocal laser endoscopic probes, improve the diagnosis rate of peripheral lung lesions, avoid radiation exposure of medical workers and patients, and provide high-quality pathology / microbiology test samples for later treatment.

Description

Technical Field

[0001] The invention relates to a real-time biopsy forceps guided by a radial bronchial ultrasound or confocal laser endoscopic probe that can be used for lung lesions, and belongs to the technical field of endoscopic medical systems. Background Art

[0002] Lung cancer ranks first among all major cancers in my country and is the leading cause of death among men. Accurate diagnosis of early-stage lung cancer expands treatment options and improves the patient's five-year survival rate. Post-biopsy histopathology / cytopathology is the gold standard for early-stage lung cancer diagnosis, while high-quality biopsy tissue is the preferred specimen for molecular diagnosis. Biopsies of peripheral lung lesions are typically performed through percutaneous needle biopsy, image-guided biopsy, and electromagnetic navigation biopsy. Percutaneous needle lung biopsy for diagnosing peripheral lung lesions requires radiation exposure, posing a risk to patients and staff and potentially leading to complications such as pneumothorax and bleeding. Existing navigation technologies fundamentally reconstruct a spatial coordinate system for lung nodules based on chest CT images, planning a suitable path to the lesion site for biopsy. However, CT data only represents the instantaneous spatial position at the time of the scan. Due to respiratory motion during biopsy, it is difficult to ensure that the position of the lung nodule remains consistent with the scan. Studies have shown that the average displacement of a nodule between inspiration and expiration can reach as much as 2 cm. Therefore, instantaneous X-ray positioning confirmation of biopsy is an independent factor in improving the diagnostic rate of navigation-guided pulmonary nodule biopsy.

[0003] The diagnostic yield of peripheral pulmonary nodules using navigational techniques alone is approximately 75%. Without X-ray localization, diagnostic performance remains unsatisfactory. Furthermore, the image processing hardware required for navigational techniques is expensive. Radial endobronchial ultrasound probes can pinpoint lesion location, facilitating biopsy of peripheral pulmonary lesions. However, they often require the assistance of a guide sheath. While the addition of a guide sheath has improved diagnostic yield, the sheath is expensive and requires the radial endobronchial ultrasound probe to be withdrawn and then the biopsy forceps inserted, which also carries the risk of displacement and prevents real-time visual biopsy, thus reducing accuracy. Confocal laser endomicroscopy (CLEM) can access the peripheral lungs through a sheath to determine benign or malignant nodules. However, given the current need for molecular diagnosis of lung cancer, it cannot replace pathological biopsy. Similar to radial endobronchial ultrasound, CLEM-guided biopsy requires the confocal laser endomicroscopy probe to be withdrawn and then the biopsy forceps inserted, preventing real-time visual biopsy. Summary of the Invention

[0004] In order to address the above-mentioned deficiencies such as radiation exposure, positioning accuracy of the navigation system, and displacement errors during the retraction of the radial endobronchial ultrasound probe or confocal laser endomicroscopy probe, the present invention aims to provide a flexible biopsy forceps with a hollow channel for real-time biopsy of lung lesions guided by radial endobronchial ultrasound or confocal laser endomicroscopy probe.

[0005] The technical solutions of the present invention are as follows.

[0006] A flexible biopsy forceps with a hollow channel for real-time biopsy of lung lesions, comprising

[0007] an insertion portion having a hollow channel and extending from a proximal end to a distal end along an axis, wherein the hollow channel is capable of accommodating a medical instrument for image-guided imaging;

[0008] a gripper portion disposed at the distal end of the insertion portion, comprising a first metal slot located at the upper portion and a second metal slot located at the lower portion; the first metal slot and the second metal slot are capable of pivoting about a common pivot axis and interlocking to form a space for accommodating a biopsy specimen, while also forming an opening at the distal end; the size of the opening is substantially equal to the cross-section of the hollow cavity and is located on the axis to allow passage of the medical instrument;

[0009] The operating portion is arranged at the proximal end of the insertion portion and is connected to the clamping portion through a connecting device; the operating portion can drive the first metal slot and the second metal slot to pivot through the connecting device.

[0010] Preferably, the medical device is a radial bronchial ultrasound probe or a confocal laser microendoscopic probe.

[0011] Preferably, the proximal opening of the hollow clamp channel is located at the side of the operating portion, and the distal opening is located at the root of the clamping portion.

[0012] Preferably, the engaging edges of the first metal groove and the second metal groove on both sides of the opening have cutting structures for clamping living tissue.

[0013] Preferably, the cutting structure comprises a cutting edge provided along the biting edge.

[0014] Preferably, the cutting structure comprises an alligator tooth structure provided along the biting edge.

[0015] Preferably, the connecting device is a push-link structure, which is connected to the tail ends of the first jaw and the second jaw at the distal end, and is connected to the pull ring of the operating part at the proximal end.

[0016] Preferably, the inserting portion comprises a substantially cylindrical flexible clamp body with an outer diameter of 1.8 mm to 2.4 mm.

[0017] Preferably, the hollow clamp channel is located at the center of the flexible clamp body, and its inner diameter is 1.2mm-2.0mm.

[0018] Preferably, the proximal end of the hollow forceps channel is provided with a Luer connector, which enables tools such as a small endobronchial ultrasound probe, a confocal laser microendoscopic probe, and an electromagnetic navigation positioning guide wire to enter the tip of the biopsy forceps.

[0019] Through the above technical solutions, the present invention can achieve the following technical effects.

[0020] 1. The biopsy forceps described in the present invention enable real-time lung biopsy under the guidance of radial bronchial ultrasound or confocal laser endoscopic probes, reducing the error caused by re-entering the biopsy forceps after withdrawing the radial bronchial ultrasound or confocal laser endoscopic probe. The present invention achieves real-time visual biopsy, which will improve the accuracy of peripheral lung nodule biopsy compared to existing navigation technologies. Because the lung nodule coordinate system generated by chest CT reconstruction based on existing navigation technologies is not real-time and synchronized with the biopsy phase, and the displacement of lesions is affected by respiratory motion. At the same time, biopsy through the natural cavity may reduce the risk of pneumothorax and bleeding compared to percutaneous puncture biopsy, providing high-quality tissue samples and bronchoalveolar lavage fluid / washing fluid for subsequent pathological / molecular biological diagnosis.

[0021] 2. The biopsy forceps of the present invention can be used for real-time biopsy under the guidance of radial bronchial ultrasound or confocal laser endoscopic probes, without the need for external X-rays to assist in positioning. This eliminates the risk of radiation exposure for medical workers and patients, and the need to wear bulky forceps clothing improves the surgical experience and reduces fatigue for the operator, thereby further enhancing the accuracy of the biopsy procedure.

[0022] 3. The biopsy forceps of the present invention have a simple structure and feasible processing technology. Compared with the biopsy tools used with bronchial navigation technology, which cost nearly 10,000 yuan, they have a significant price advantage, reducing the financial burden on patients and the social burden of diagnosing peripheral lung lesions such as lung cancer. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a schematic diagram of the overall structure of the biopsy forceps of the present invention;

[0024] Figure 2 yes Figure 1 A cross-sectional view of the overall structure of the middle biopsy forceps;

[0025] Figure 3 yes Figure 1 Enlarged cross-sectional view of the jaw structure of the medium biopsy forceps

[0026] Figure 4 yes Figure 1 Overall schematic diagram of the jaws of the middle biopsy forceps in the open state;

[0027] Figure 5 yes Figure 1 A partially enlarged schematic diagram of the jaws of the middle biopsy forceps in the open state;

[0028] Figure 6 yes Figure 1 Overall schematic diagram of the jaws of the middle biopsy forceps in the closed state;

[0029] Figure 7 yes Figure 1 A partially enlarged schematic diagram of the closed jaws of the biopsy forceps.

[0030] The meanings of the reference numerals in the accompanying drawings are as follows:

[0031] 1. Operating part; 2. Operating part pull ring; 3. Flexible clamp body; 4. Clamping part; 5. Luer connector at the entrance of the clamp channel; 6. Push-pull rod; 7. Connecting rod rivet; 8. Jaw rivet; 9. Push-pull connecting rod; 10. Push-pull rod hollow structure; 11. Push-pull connecting rod hollow structure; 12. Connecting rod rivet hollow structure; 13. Jaw rivet hollow structure; 14. Jaw hollow structure. DETAILED DESCRIPTION

[0032] The present invention is further described below with reference to the accompanying drawings. A biopsy forceps for real-time lung biopsy using a radial ultrasound probe minimizes the error associated with withdrawing the probe and then reinserting the biopsy forceps, as well as the non-real-time nature of image-guided biopsy techniques. It also avoids radiation exposure to medical personnel and patients during further positioning.

[0033] As attached Figure 1 As shown, a flexible biopsy forceps with a hollow channel for real-time biopsy of lung lesions includes an inserting portion, a clamping portion 4, and an operating portion 1.

[0034] The insertion portion has a hollow clamp channel and extends from the proximal end to the distal end along an axis. The hollow clamp channel can accommodate a medical instrument used for image navigation imaging to pass through.

[0035] The gripper portion 4 is located at the distal end of the insertion portion 1 and comprises a first metal slot at the top and a second metal slot at the bottom. The first and second metal slots are connected by a jaw rivet 8, which has a hollow jaw rivet structure 13. These rivets 8 are capable of pivoting about a common pivot axis and interlocking to form a space for accommodating a biopsy specimen, while also forming an opening at the distal end. The opening is substantially the same size as the cross-section of the hollow cavity and is located on the axis to allow passage of the medical instrument.

[0036] The operating portion 1 is disposed at the proximal end of the insertion portion and is connected to the clamping portion 4 via a connecting device; the operating portion 1 can drive the first metal slot and the second metal slot to pivot via the connecting device.

[0037] In a preferred embodiment, the medical device is a radial bronchial ultrasound probe or a confocal laser microendoscopic probe for image navigation, such as a small endobronchial ultrasound probe, a confocal laser microendoscopic probe, or an electromagnetic navigation positioning guide wire.

[0038] In a preferred embodiment, the proximal opening of the hollow clamp channel is located at the side of the operating portion, and the distal opening is located at the root of the clamping portion 4.

[0039] In a preferred embodiment, the engaging edges of the first metal groove and the second metal groove on both sides of the opening have cutting structures for clamping living tissue.

[0040] In a preferred embodiment, the cutting structure comprises a cutting edge disposed along the biting edge.

[0041] In a preferred embodiment, the cutting structure includes crocodile teeth arranged along the occlusal edge. In this embodiment, the clamping portion is a "snake mouth clamp," i.e., the front end of the jaws is formed by a hollow jaw structure 14 with a circular opening to allow passage of medical instruments such as radial ultrasound probes, and the jaws are provided with teeth on both sides for occlusal engagement, facilitating tissue biopsy.

[0042] In a preferred embodiment, the connecting device is a push-and-link structure. The push-and-link structure includes a push-and-pull connecting rod 9, and the push-and-pull connecting rod 9 has a push-and-pull connecting rod hollow structure 11. The push-and-pull connecting rod 9 is connected to the tail ends of the first jaw and the second jaw at the distal end through a connecting rod rivet 7, and is connected to the operating part pull ring 2 at the proximal end through a push-and-pull rod 6, and the push-and-pull rod 6 has a push-and-pull rod hollow structure 10. Thus, the operating part 1 is connected to the clamping part through the push-and-link system, and the opening and closing of the metal jaws can be controlled by the push-and-pull action of the operating part pull ring 2. The push-and-pull rod hollow structure 10 and the push-and-pull connecting rod hollow structure 11 are interconnected to allow the medical device to pass through.

[0043] In a preferred embodiment, the inserting portion comprises a substantially cylindrical flexible clamp body 3 with an outer diameter of 1.8 mm to 2.4 mm.

[0044] In a preferred embodiment, the hollow clamp channel is located at the center of the flexible clamp body 3 and has an inner diameter of 1.2 mm to 2.0 mm.

[0045] In a preferred embodiment, the proximal end of the hollow channel is provided with a channel entrance Luer connector 5, allowing tools such as a small endobronchial ultrasound probe, a confocal laser microendoscopic probe, and an electromagnetic navigation guide to enter the front end of the biopsy forceps. The hollow channel is located below and to the side of the operating portion, with its distal end at the base of the clamping portion 4. The hollow channel allows for passage of the small ultrasound probe and can also be connected to a syringe for bronchoalveolar lavage / washing, recovering the bronchoalveolar lavage / washing fluid for tumor cell / pathogen testing.

[0046] The present invention uses the following process.

[0047] When a chest CT scan reveals peripheral lung lesions, a biopsy is often required to further confirm the condition of the lesion. The device of the present invention, combined with an endobronchial ultrasound probe or a confocal laser endomicroscopy probe, can quickly and accurately perform a biopsy of peripheral lung lesions.

[0048] After the patient is under local or general anesthesia, the bronchoscope is passed through the glottis into the main bronchial cavity. Based on the previous CT imaging data, the bronchoscope is advanced into the lung lobe or segment. An endobronchial ultrasound probe is placed into the hollow channel of the present invention beforehand, and the front end of the ultrasound probe is inserted into the clamping portion of the present invention, while the jaws remain closed. The present invention and the ultrasound probe are then inserted into the biopsy channel of the bronchoscope through the biopsy channel, and then exit the biopsy channel to within the visual range of the bronchoscope.

[0049] According to the CT image positioning, the endobronchial ultrasound probe is extended from the jaws of the present invention to the vicinity of the lesion. The endobronchial ultrasound probe is pushed to reach the lesion. After the lesion is found and accurately located, the operating part is slowly pushed to open the biopsy forceps, and the biopsy forceps is pushed forward. When the ultrasound image of the lesion disappears, it means that the opened jaws just cover the ultrasound probe and have reached the lesion site. The ultrasound probe is withdrawn 5mm-10mm, and the operating part is controlled to open the jaws and then bite them again. Part of the lesion tissue is bitten off by rotating the present invention. The present invention and the ultrasound probe are then taken out from the biopsy forceps channel of the bronchoscope, and the specimen is removed. Repeat this several times, and the biopsy operation can be stopped when the amount of tissue sample removed meets the pathological requirements.

[0050] When a confocal laser microendoscopic probe is used to guide a biopsy, the operation process is similar to that of an endobronchial ultrasound probe. The confocal laser microendoscopic probe is extended from the jaws of the present invention to the vicinity of the lesion according to CT image positioning. The confocal laser microendoscopic probe is pushed to reach the lesion. After the lesion is found and accurately located, the operating unit is slowly pushed to open the biopsy forceps. The biopsy forceps is pushed forward. When the confocal laser endoscopic image of the lesion disappears, it indicates that the opened jaws just cover the confocal laser endoscopic probe and have reached the lesion site. The probe is withdrawn 5mm-10mm, and the operating unit is controlled to open the jaws and then bite them again. Part of the lesion tissue is bitten off by rotating the present invention. Subsequently, the present invention and the ultrasound probe are removed from the biopsy forceps channel of the bronchoscope and the specimen is removed. This is repeated several times. The biopsy operation can be stopped when the amount of tissue sample removed meets the pathological requirements.

[0051] The foregoing description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention are intended to be within the scope of protection of the present invention.

Claims

1. A flexible biopsy forceps with a hollow channel for real-time biopsy of lung lesions, characterized in that: include: An insertion portion having a hollow channel extending from a proximal end to a distal end along an axis, the hollow channel being capable of accommodating a medical device for image-guided imaging; the insertion portion comprising a substantially cylindrical flexible jaw body having an outer diameter of 1.8 mm to 2.4 mm; the hollow channel being located at the center of the flexible jaw body and having an inner diameter of 1.2 mm to 2.0 mm; A gripper portion, disposed at the distal end of the insertion portion, comprising a first metal slot at the upper portion and a second metal slot at the lower portion; the first and second metal slots are capable of pivoting about a common pivot axis and engaging with each other to form a space for accommodating a biopsy specimen, while also forming an opening at the distal end; the size of the opening is substantially equal to the cross-section of the hollow jaw channel and is located on the axis to allow passage of the medical instrument; the pivot axis has a hollow structure for passage of the medical instrument; the first and second metal slots are connected by a jaw rivet having a hollow jaw rivet structure; an operating portion, which is disposed at the proximal end of the insertion portion and is connected to the clamping portion via a connecting device; the operating portion is capable of driving the first metal slot and the second metal slot to pivot through the connecting device; The connecting device is a push-link structure, which includes a push-pull connecting rod, wherein the push-pull connecting rod is connected to the tail ends of the first metal groove and the second metal groove at the distal end, and is connected to the operating part pull ring through the push-pull rod at the proximal end, and the engagement and opening of the first metal groove and the second metal groove are controlled by the push-pull action of the operating part pull ring; The opening of the clamping portion, the push-pull rod hollow structure of the push-pull rod, the push-pull connecting rod hollow structure of the push-pull connecting rod, and the hollow structure of the pivot shaft are interconnected to allow the medical device to pass through; The proximal opening of the hollow clamp channel is located at the side of the operating part, and the distal opening is located at the root of the clamping part.

2. A flexible biopsy forceps with a hollow channel for real-time biopsy of lung lesions according to claim 1, characterized in that: The medical device is a radial bronchial ultrasound probe or a confocal laser microendoscopic probe.

3. The flexible biopsy forceps with a hollow channel for real-time biopsy of lung lesions according to claim 1, characterized in that: The engaging edges of the first metal groove and the second metal groove on both sides of the opening have cutting structures for clamping living tissue.

4. The flexible biopsy forceps with a hollow channel for real-time biopsy of lung lesions according to claim 3, characterized in that: The cutting structure includes a cutting edge disposed along the biting edge.

5. The flexible biopsy forceps with a hollow channel for real-time biopsy of lung lesions according to claim 3, characterized in that: The cutting structure includes an alligator tooth structure disposed along the biting edge.

6. The flexible biopsy forceps with a hollow channel for real-time biopsy of lung lesions according to claim 1, characterized in that: The proximal end of the hollow clamp channel is provided with a Luer connector.

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