CN117357169A - Endoscope apparatus, biopsy sampling device, and method of using biopsy sampling device - Google Patents

Abstract

The patent relates to the technical field of medical equipment and provides an endoscope, a biopsy sampling device thereof and a using method of the biopsy sampling device. Wherein the biopsy sampling device is applied to an endoscope, comprising: the device comprises a sheath, a puncture widening mechanism capable of penetrating into the sheath, and a sampling mechanism capable of penetrating into the sheath; the head end of the sheath tube can be bent so as to adjust the direction in which the puncture widening mechanism and the sampling mechanism extend out of the sheath tube; the puncture widening mechanism is used for penetrating through the inner wall of the cavity and forming widening holes on the inner wall; the sampling mechanism is used for passing through the widening hole and entering the target tissue for sampling. The biopsy sampling device provided by the patent enables the puncture widening mechanism and the sampling mechanism to still accurately face the target tissue in the finer lower-level cavity through the bent sheath tube, and the success rate of sampling operation is improved. The technical scheme of the patent is particularly suitable for sampling lung tissues.

Description

Endoscope apparatus, biopsy sampling device, and method of using biopsy sampling device

Technical Field

The patent relates to the technical field of medical instruments, in particular to an endoscope device, a biopsy sampling device thereof and a use method of the biopsy sampling device.

Background

An endoscope is a device integrated with an image sensor, an optical lens, an illumination light source, and a precision mechanical structure. The endoscope can enter the human body cavity through the oral cavity, the trachea or other natural pore canals and can observe tissues in the human body, carry out biopsy, minimally invasive surgery and the like. The endoscope in the prior art enables doctors to intuitively see real-time pictures in human bodies, and improves diagnosis and treatment convenience.

The conventional endoscope can enter a natural cavity of a human body, acquire images at the front end of the endoscope for observation, and use a biopsy tool for sampling operations such as forceps, brushing, needle suction and the like of living tissues, so that diseases can be accurately diagnosed. Typically these biopsy modes are performed under direct view under an endoscopic imaging system.

In the prior art, a biopsy sampling device is positioned within an endoscope, with the orientation of the biopsy sampling device being controlled by bending the endoscope head. This works well in most of the channels. However, in some relatively thin lumens, such as the distal branches of the trachea, it is difficult to align the endoscope with the target tissue at a relatively close distance because the diameter of the lumen is very small.

Disclosure of Invention

To solve or at least partially solve the above technical problems, the present patent provides an endoscopic apparatus and a biopsy sampling device thereof, and a method of using a biopsy sampling device. Wherein the biopsy sampling device is applied to the endoscope, includes:

the device comprises a sheath, a puncture widening mechanism capable of penetrating into the sheath, and a sampling mechanism capable of penetrating into the sheath;

the head end of the sheath tube can be bent so as to adjust the direction in which the puncture widening mechanism and the sampling mechanism extend out of the sheath tube;

the puncture widening mechanism is used for penetrating through the inner wall of the cavity and forming widening holes on the inner wall;

the sampling mechanism is used for passing through the widening hole and entering the target tissue for sampling.

Optionally, the puncture widening mechanism comprises a puncture needle and a widening component sleeved on the puncture needle, wherein the radial width of the widening component gradually decreases from one side close to the extended sheath to one side far away from the extended sheath, so as to widen the wall of the cavity penetrated by the puncture needle and form a widening hole;

the puncture needle head can independently move in a telescopic manner relative to the widening component along the length direction of the puncture needle head.

Optionally, the sampling mechanism comprises:

a housing enclosing an accommodation space for accommodating the sampled tissue, the housing being provided with an opening communicating with the accommodation space;

the shell can rotate by taking the axis of the shell as a rotating shaft;

the first blade is arranged on one side of the opening, one side of the first blade is provided with a cutting edge, the cutting edge surface of the first blade faces the accommodating space, and the cutting edge direction of the first blade faces the rotating direction.

Optionally, the sampling mechanism further comprises a second blade, the second blade is arranged on the other side of the opening, one side of the second blade is edged, the edge-opened surface of the second blade faces away from the accommodating space, and the edge direction of the second blade faces away from the rotating direction.

Alternatively, the distance between the first blade and the second blade gradually decreases from the head end of the housing toward the tail end of the housing until the first blade and the second blade cross over each other, and the first blade is closer to the accommodating space than the second blade.

Optionally, the second blade is removably attached to the opening.

Optionally, the puncture widening mechanism is arranged on the sampling mechanism,

the puncture widening mechanism comprises:

the puncture needle extends out from the top end of the shell, and can move along the length direction of the puncture needle and retract into the accommodating space;

the widening component is arranged at the top end of the shell, and the radial width of the widening component gradually decreases from one side close to the shell to one side far away from the shell, so that the widening component is used for widening the wall of the cavity penetrated by the puncture needle and forming a widening hole.

Optionally, the opening extends to a side wall of the widening part.

The patent also provides an endoscopic apparatus comprising the biopsy sampling device described above.

The patent also provides a using method of the biopsy sampling device, which comprises the following steps:

moving the endoscope along the lumen to a target position;

extending the sheath from the head end of the endoscope, bending the sheath under the view of the camera of the endoscope, and orienting the sheath to the target tissue;

extending out of the head end of the sheath tube to puncture and widen the wall of the cavity to form a widened hole;

continuing to push the sheath tube to enable the sheath tube to pass through the widening hole along a passage constructed by the puncturing widening mechanism;

retracting the puncture widening mechanism;

a sampling mechanism is extended from the head end of the sheath to reach/approximate the target tissue for subsequent manipulation.

The application method of the biopsy sampling device of the patent enables the puncture widening mechanism and the sampling mechanism to still accurately face the target tissue in the finer lower-level cavity through bending the sheath tube, and improves the success rate of sampling operation. The technical scheme of the patent is particularly suitable for sampling lung tissues.

Drawings

In order to more clearly illustrate the embodiments of the present patent, a brief description of the related drawings will be provided below. It is understood that the drawings in the following description are only for illustrating some embodiments of the present patent, and that one of ordinary skill in the art can obtain many other technical features and connection relationships not mentioned herein from the drawings.

FIG. 1 is a schematic view of an endoscopic device according to an embodiment of the present disclosure, with an airway removed for illustration, in a three-dimensional combination prior to lancing and sampling;

FIG. 2 is an enlarged schematic view of a portion of FIG. 1 at area A;

FIG. 3 is a schematic perspective view of an endoscopic apparatus provided in accordance with an embodiment of the present invention, with a sheath and sampling mechanism of a biopsy sampling device extending from a working channel of the endoscope;

FIG. 4 is an enlarged partial schematic view of the head end of a sampling mechanism of a biopsy sampling device with dual blades according to an embodiment of the present disclosure;

FIG. 5 is an enlarged partial schematic view of the head end of a sampling mechanism of a biopsy sampling device with a single blade according to an embodiment of the present disclosure;

FIG. 6 is a schematic illustration of a biopsy sampling device according to an embodiment of the present disclosure entering an airway of a patient under a planned path and puncturing the airway wall with a puncturing widening mechanism;

FIG. 7 is a schematic illustration of a piercing widening mechanism of a biopsy sampling device piercing a target tissue according to an embodiment of the present disclosure;

FIG. 8 is a schematic view of a biopsy sampling device according to an embodiment of the present disclosure after withdrawal of the lancing widening mechanism and penetration of the sampling mechanism;

FIG. 9 is a partial schematic view of another biopsy sampling device at the tip of the present patent embodiment wherein the lancing widening mechanism and sampling mechanism are combined;

FIG. 10 is a partial schematic view of another biopsy sampling device at the tip of the present patent embodiment in which the lancing widening mechanism and sampling mechanism are combined and the opening of the receiving space extends to the side wall of the widening section.

Reference numerals and names in the drawings are as follows:

1. a biopsy sampling device; 11. a sheath; 12. a puncture widening mechanism; 121. a puncture needle; 122. a widening part; 13. a sampling mechanism; 131. a housing; 132. an accommodation space; 133. a first blade; 134. a second blade; 2. an endoscope; 21. a camera; 22. a lighting lamp; 3. a target tissue; 4. and an airway.

Detailed Description

The technical solutions in the embodiments of the present patent will be described in detail below with reference to the accompanying drawings in the embodiments of the present patent.

In the prior art, a biopsy sampling device is positioned within an endoscope, with the orientation of the biopsy sampling device being controlled by bending the endoscope head. This works well in most of the channels.

However, in some relatively thin lumens, such as the distal branches of the trachea, the endoscope is difficult to bend due to the very small diameter of the lumen. If the target tissue is to be aligned by bending of the endoscope, the endoscope is required to bend in the relatively thicker tracheal branch that is farther from the target tissue, which undoubtedly increases the chances of penetration, sampling, etc. of normal tissue during biopsy sampling, and increases the risk of inaccurate sampling locations.

In view of the above, the patent provides an endoscope device, a biopsy sampling device thereof and a use method of the biopsy sampling device, so as to reduce the biopsy operation difficulty of the endoscope and improve the biopsy success rate.

Embodiment one

Referring to fig. 1, a first embodiment of the present patent proposes an endoscopic apparatus and a biopsy sampling device 1 applied to the endoscopic apparatus for performing a biopsy sampling operation on a target tissue 3. The endoscopic apparatus comprises an endoscope 2 and a biopsy sampling device 1. Referring to fig. 2 and 3, the biopsy sampling apparatus 1 includes:

a sheath tube 11, a puncture widening mechanism 12 capable of penetrating into the sheath tube 11, and a sampling mechanism 13 capable of penetrating into the sheath tube 11;

the head end of the sheath 11 can be bent to adjust the direction in which the puncture widening mechanism 12 and the sampling mechanism 13 extend from the sheath 11;

the puncture widening mechanism 12 is used for puncturing through the inner wall of the cavity and forming widening holes on the inner wall;

the sampling mechanism 13 is used to sample through the widened hole and into the target tissue.

In this patent, a camera 21 and an illumination lamp 22 may be provided on the head end of the endoscope 2. By illumination of the illumination lamp 22, it is ensured that the camera 21 obtains a field of view in the cavity. And the sheath 11 does not need to be provided with the devices, so that the diameter of the sheath can be set to be relatively smaller and more flexible. In this way, even in the narrower lower lumen, the sheath 11 can still be controlled to bend, and in addition, a positioning sensor can be further disposed on the sheath 11 to position.

The sheath 11 of the present patent, in combination with the real-time image information acquired by the camera 21 and the positioning sensor information integrated with itself, can move along a pre-operative planned path within the lumen and be in close proximity to the target tissue 3, known as the lesion.

The head end of the sheath tube 11 provided by the patent is provided with a pre-bending or bending control structure, so that the bending function can be realized. The pre-bending means that the sheath tube 11 itself has a certain bending curvature. When the sheath 11 is extended from the head end of the endoscope 2, bending is naturally formed under the action of self stress. While the specific implementation of the bending control structure of the sheath 11 may be consistent with the endoscope 2, it will not be explained in this patent. The bending of the sheath 11 not only can provide channel support for the operation of the puncture widening mechanism 12 and the sampling mechanism 13, but also can further adjust the pointing angle of the sheath 11 by controlling the bending of the sheath 11 or rotating the sheath 11 after the puncture widening mechanism 12 pierces the cavity wall and the sheath 11 passes through the cavity wall along the puncture widening mechanism 12 and enters the external space of the cavity, so that the sampling mechanism 13 detected in the sheath 11 can be conveniently and correctly oriented to the target focus point, and the sampling operation is convenient.

The puncture widening mechanism 12 and the sampling mechanism 13 provided by the present patent can adopt various mechanisms in the prior art, and can basically meet the realization of the technical purpose of the present patent. In order to further increase the puncturing, wall breaking, widening and sampling efficiency and sampling success rate, the present patent discloses an improved puncturing and widening mechanism 12 and sampling mechanism 13, and details as follows:

referring to fig. 2, the puncture widening mechanism 12 includes a puncture needle 121 and a widening part 122 sleeved on the puncture needle 121, the radial width of the widening part 122 gradually decreases from a side near the extended sheath 11 to a side far from the extended sheath 11 for widening the wall of the lumen penetrated by the puncture needle 121 and forming a widening hole;

the puncture needle 121 can be independently moved in a telescopic manner along its length with respect to the widening 122. The specific structure for realizing the telescopic movement can be consistent with that of the telescopic movement of a single sheath tube or consumable in the prior art, so that the detailed description is not needed.

The piercing needle 121 has a sharp head end that facilitates piercing the wall of the lumen. As an aid to the piercing needle 121, the widening member 122 tapers in size in the manner described above and thus has an approximately conical shape. The piercing needle 121 may protrude from the top of the widening member 122 and may pierce the length of the protruding needle 121. Therefore, when the puncture needle 121 punctures the wall of the cavity, the pushing of the widening part 122 can smoothly enlarge the hole punctured by the puncture needle 121, thereby opening the wall-broken opening and forming the widening hole.

Referring to fig. 3 and 4, the sampling mechanism 13 includes a housing 131, the housing 131 enclosing an accommodating space 132 for accommodating the tissue to be sampled, and the housing 131 is provided with an opening communicating with the accommodating space 132; the housing 131 is rotatable about its own axis as a rotation axis;

the first blade 133 is disposed on one side of the opening, the first blade 133 is single-sided, the opening surface of the first blade 133 faces the accommodating space 132, and the cutting edge direction of the first blade 133 faces the rotation direction.

As an alternative, the sampling mechanism 13 may further include a second blade 134 disposed on the other side of the opening, the second blade 134 may also be single-sided with the sharpened face of the second blade 134 facing away from the receiving space 132, and the blade direction of the second blade 134 facing away from the direction of rotation.

In use, the sampling mechanism 13 may access the extra-luminal space through the path provided by the sheath 11 to/near the target tissue 3. When the sampling mechanism 13 is advanced into and out of the target tissue 3, a cell sample of the target tissue 3 can be scraped directly with the first blade 133 and the second blade 134. In addition, when the sampling mechanism 13 is positioned in the target tissue 3, the first blade 133 can scrape a larger amount of tissue cell sample even further in the target tissue 3 by rotating the driving housing 131 in the arrow direction of fig. 4 or 5. The scraped tissue is embedded in the receiving space 132, enabling biopsy sampling. It should be noted that a positioning sensor may also be provided at the head end of the sampling mechanism 13 to position the sampling position.

Because pathological diagnosis has requirements on focal tissue structure and tissue quantity for diagnosis, the tissue obtained by a sampling tool with smaller outer diameter and finer outer diameter is usually used, and the diagnostic value is low and repeated sampling is needed. That is, some sampling tools of the prior art fail to obtain tissue samples that meet the requirements of pathological diagnosis. For example, the fragmented tissue obtained by the cytobrush can only be used for cell culture, and cannot be subjected to pathological analysis; the amount of tissue obtained by the biopsy needle or the biopsy forceps with smaller outer diameter is too small, and the biopsy needle or the biopsy forceps need to repeatedly enter the sheath 11 for sampling a plurality of times, and the risk of misalignment and inaccurate sampling position of the sheath 11 is increased when the biopsy needle or the biopsy forceps repeatedly enter the sheath 11.

In contrast, the sampling mechanism 13 provided in the present application can obtain a sufficient amount of sheet-like tissue structure by wrapping the first blade 133 and the second blade 134 by using the accommodating space 132 formed by enclosing the housing 131, or the hollow space inside the head end housing of the sampling mechanism 13. And once can carry out the sample of multichip, can also prevent that tissue structure from falling out accommodation space 132, can satisfy pathological diagnosis's demand better, avoided the risk that the repeated entering sheath 11 of sampling brought.

In fig. 3 and 4, a structure in which the first blade 133 and the second blade 134 are provided at the same time is illustrated. However, in practice, as shown in fig. 5, when only the first blade 133 is provided, a desired tissue can be scraped, and the biopsy operation is completed.

However, when the first blade 133 and the second blade 134 are provided at the same time, the presence of the second blade 134 can guide the tissue to cut into the blade edge portion of the first blade 133, and the removed tissue can be better retained. Moreover, the second blade 134 can also prevent the diseased tissue from falling out of the opening into the patient to contaminate normal cells, which is of positive significance.

It should be noted that, the first blade 133 provided in the embodiment of the present disclosure is a single-sided blade, and the blade surface faces the accommodating space 132, and the blade direction of the first blade 133 faces the rotation direction. This arrangement ensures that the excised tissue can smoothly slide into the accommodation space 132 along the blade portion during excision sampling of the diseased tissue.

In contrast, the open face of the second blade 134 faces away from the receiving space 132, and the direction of the edge of the second blade 134 faces away from the direction of rotation. In this way, the relatively rough unsprung face of the second blade 134 may prevent tissue that has entered the receiving space 132 from falling out of the opening. The second blade 134 has a more versatile cutting edge because the first blade 133 is replaced by the reverse rotation to sample when the first blade 133 is not successfully sampled.

Further alternatively, as shown in fig. 4, the distance between the first blade 133 and the second blade 134 gradually decreases from the head end of the housing 131 toward the tail end of the housing 131 until the first blade 133 and the second blade 134 cross over each other, and the first blade 133 is closer to the accommodation space 132 than the second blade 134.

By disposing the first blade 133 closer to the accommodation space 132 and forming the first blade 133 and the second blade 134 into a cross-overlapping structure that approximates a "V" shape with each other, it is possible to facilitate the second blade 134 to cut the tissue cut by the first blade 133 and to increase the amount of cells scraped by the sampling mechanism 13 when the housing is moved into and out of the target tissue 4. This can prevent the first blade 133 from cutting an excessively large wound or cutting irregular tissue fragments, prevent the spread and contamination of lesion tissue, and thus improve safety.

Additionally, alternatively, the second blade 134 may be removably attached to the opening. This mounting can be achieved by screws, snaps. The second blade 134 is configured to be detachable, so that the sampled biological tissue can be removed from the receiving space 132 more conveniently. Of course, the first blade 133 may also be provided to be detachable. However, both blades are detachable, which increases the cost and complicates the structure of the sampling mechanism 13 as a single use. Thus, only the second blade 134 is provided to be detachable, which can be made to be compatible with cost and functionality.

Based on the above-mentioned endoscope apparatus and biopsy sampling device 1, the present patent also provides a method for using the biopsy sampling device 1, which comprises the following steps:

moving the endoscope 2 along the lumen to a target position;

extending the sheath 11 from the head end of the endoscope 2, and bending the sheath 11 under the field of view of the camera 21 of the endoscope 2 so that the sheath is directed 11 toward the target tissue 3;

a puncture widening mechanism 12 extends from the head end of the sheath 11 to puncture and widen the wall of the cavity to form a widening hole;

continuing to push the sheath 11 to enable the sheath 11 to pass through the widening hole along a passage constructed by the puncture widening mechanism 12;

retracting the puncture widening mechanism 12;

a sampling mechanism 13 is extended from the head end of the sheath 11 to reach/approximate the target tissue 3 for subsequent manipulation.

The application method of the biopsy sampling device 1 of the patent enables the puncture widening mechanism 12 and the sampling mechanism 13 to still accurately face the target tissue 3 in a finer lower-level cavity through bending the sheath tube 11, and improves the success rate of sampling operation. The technical scheme of the patent is particularly suitable for sampling lung tissues.

Clinical data from the Huaxi hospital showed that the ratio of no airway direct access was greater than 40% in all lung nodules. For such lung nodules, percutaneous puncture or airway puncture wall breaking sampling is often used if sampling biopsy is to be performed. Percutaneous puncture is a serious risk of pneumothorax, infection, etc., so from the safety point of view, it is more recommended to intervene through the airway clinically. Clinically, the wall breaking operation can be carried out after the optimal wall breaking puncture point in the airway is reached through preoperative path planning, and then the sample is taken after the wall breaking puncture point reaches the target nodule through a section of lung parenchyma region.

However, in the field of pulmonary tissue sampling, the following problems still need to be solved in the prior art sampling method:

firstly, the puncture wall breaking operation is carried out on the air passage, so that the difficulty is high. The airway has a multi-stage structure, and when a lung nodule is adjacent to an upper airway, the difficulty of wall breaking operation is still high. Referring to fig. 6, the position and shape of the airway 4 is illustrated in fig. 6 by dashed lines. Obviously, when a lung nodule is adjacent to the distal lower airway, the inner diameter of the lower airway is very narrow and conventional bronchoscopes cannot form a sufficiently large bend angle, thus making it difficult to achieve the desired puncture angle.

Second, in the case of the wall breaking operation of the airway 4, since the endoscope 2 cannot pass through the airway 4, the direct view of the target tissue 3, for example, the lung parenchyma, is obtained. Therefore, in the prior art, it is generally necessary to repeatedly confirm the relative position of the sampling mechanism 13 and the target tissue 3 by means of an imaging device on the premise of a long distance. Repeated confirmation of the adjustment sampling by the imaging device increases the risk of excessive radiation exposure for the patient and doctor.

Furthermore, the directional controllability of the puncture widening mechanism 12 after wall breaking is completely determined by the direction of the head end of the endoscope 2, so that it is difficult to adjust the angle of the puncture widening mechanism extending out of the airway 4 after the puncture is completed.

The technical problems can be solved under the technical scheme of the patent. For clarity of illustration, the sampling process of the biopsy sampling device 1 of the present patent will be explained in detail below taking the sampling of the airway 4 as an example.

1. Referring to fig. 6, an endoscope 2, i.e., a bronchoscope, is used to access the patient's airway 4 under a planned path by means of electromagnetic navigation or other navigation device, and deep into the lower airway 4 closest to the target tissue 3.

2. The pre-bending/bending control sheath tube 11 is extended and adjusted to form an ideal puncture wall breaking angle. The puncture widening mechanism 12 is operated to protrude from the inside of the working channel of the sheath 11. The piercing needle 121 of the piercing widening mechanism 12 will pierce the airway wall and protrude from the airway 4.

3. The widening element 122 is pushed forward until the widening element 122 passes beyond the wall of the gas channel along the guide of the piercing needle 121, at which point the piercing opening in the wall of the gas channel is widened by the widening element 122, forming a widening opening. The advancement of the pre-curved/bend-controlling sheath 11 is then continued until the pre-curved/bend-controlling sheath 11 also passes out of the airway wall. At this time, if the orientation of the puncture needle 121 is correct, the puncture needle 121 can be continuously advanced. If the orientation of the puncture needle 121 is incorrect, the electromagnetic navigation signal or the CT image can be combined to assist in rotating the pre-bent sheath 11, or the orientation of the puncture needle 121 can be finely adjusted by using the bent sheath 11. In this way, a desired working channel can be established for the sampling mechanism 13.

4. Referring to fig. 7, the puncture needle 121 of the puncture widening mechanism 12 is further advanced to puncture the correct target tissue 3. By retracting the puncture needle 121 and pushing the widening 122, a sampling hole of sufficient size can be formed in the target tissue 3, facilitating penetration of the sampling mechanism 13. Of course, since the target tissue 3 is relatively soft with respect to the lumen wall, it is also possible to directly penetrate into the sampling mechanism 13 without widening the target tissue 3.

5. Referring to fig. 8, the puncture widening mechanism 12 is withdrawn, and the sampling mechanism 13 is inserted into the sheath 11 and protrudes from the head end of the sheath 11. The sampling mechanism 13 is advanced further to enter the already formed sampling hole in the target tissue 3. The target tissue 3 can be scraped by rotating the sampling mechanism 13 to sample.

According to the above steps, it can be seen that compared with the prior art, the present patent has the following beneficial effects:

firstly, in the technical scheme of the patent, the sheath 11 has a pre-bending or bending control structure, so that the angle of broken wall can be adjusted in the extremely narrow lower airway 4, and an ideal puncture effect can be obtained at an ideal puncture position.

Secondly, the head ends of the sheath tube 11 and the sampling mechanism 13 are internally provided with positioning sensors, and the real-time positions and the directions of the head ends of the sheath tube 11 and the sampling mechanism 13 can be obtained in an electromagnetic induction mode, so that the process of repeatedly confirming by using image equipment is omitted, and the safety in the whole operation process and the reliability of sampling are improved.

Furthermore, the direction of the sheath 11 can be further adjusted after wall breaking by controlling the pre-bending or bending control structure of the sheath, and the sampling accuracy can be better improved on the premise of combining with a positioning sensor.

Second embodiment

The second embodiment of the present patent provides a biopsy sampling device 1 and associated method of use and endoscope 2. The second embodiment is a further improvement of the first embodiment, the main improvement being that in the second embodiment of the present patent, see fig. 9, optionally, a puncture widening mechanism 12 is mounted on the sampling mechanism 13.

Specifically, the puncture widening mechanism 12 may include:

the puncture needle 121, the puncture needle 121 extends from the top end of the housing 131, and the puncture needle 121 can move along the length direction and retract into the accommodating space 132;

and a widening part 122 provided at the top end of the housing 131, the radial width of the widening part 122 gradually decreasing from a side close to the housing 131 to a side far from the housing 131, for widening the wall of the cavity penetrated by the penetration needle 121 and forming a widening hole.

That is, in the present embodiment, the puncture widening mechanism 12 and the sampling mechanism 13 are integrally connected. By integrating both the puncture widening mechanism 12 and the sampling mechanism 13, the overall structure of the biopsy sampling device 1 of the present application can be greatly simplified. The operation flow is simpler and the cost is lower. For clarity, this embodiment is also exemplified by airway 4 sampling, and a sampling procedure is given as follows.

1. Using an endoscope 2, i.e. a bronchoscope, an electromagnetic navigation or other navigation device is used to access the patient's airway 4 under a planned path and deep into the lower airway 4 closest to the target tissue 3.

2. The pre-bending/bending control sheath tube 11 is extended and adjusted to form an ideal puncture wall breaking angle. The puncture widening mechanism 12 is operated to protrude from the inside of the working channel of the sheath 11. The piercing needle 121 of the piercing widening mechanism 12 will pierce the airway wall and protrude from the airway 4.

3. The widening element 122 is pushed forward until the widening element 122 passes beyond the wall of the gas channel along the guide of the piercing needle 121, at which point the piercing opening in the wall of the gas channel is widened by the widening element 122, forming a widening opening. The advancement of the pre-curved/bend-controlling sheath 11 is then continued until the pre-curved/bend-controlling sheath 11 also passes out of the airway wall. At this time, if the orientation of the puncture needle 121 is correct, the puncture needle 121 can be continuously advanced. If the orientation of the puncture needle 121 is incorrect, the electromagnetic navigation signal or the CT image can be combined to assist in rotating the pre-bent sheath 11, or the orientation of the puncture needle 121 can be finely adjusted by using the bent sheath 11. In this way, a desired working channel can be established for the sampling mechanism 13.

4. The puncture needle 121 of the puncture widening mechanism 12 is further advanced to puncture the correct target tissue 3. Retracting the needle 121 into the accommodation space 132, even below the accommodation space 132, closer to the trailing end of the sheath 11, may leave the accommodation space 132. It will be appreciated that if the piercing needle 121 is merely retracted into the receiving space 132, the tissue cut by the sampling mechanism 13 will tend to take a curled shape around the piercing needle 121. When biopsy tissue is extracted, the tissue is spread into a sheet shape, and the subsequent treatment is easy. However, this has the disadvantage that the piercing needle 121 occupies a part of the receiving space 132 and the amount of biopsy tissue available is relatively small. On the other hand, if the puncture needle 121 is retracted to a position below the accommodating space 132, the tissue extracted by the sampling mechanism 13 is not different from that of the first embodiment, and therefore, the discussion will not be repeated.

5. By continuing to advance the widening section 122, a sampling hole of a sufficient size can be formed in the target tissue 3, the sampling mechanism 13 is directly drilled into the sampling hole, and the operation of scraping the target tissue 3 can be completed once by rotating the sampling mechanism 13 to sample. Of course, since the target tissue 3 is relatively soft with respect to the lumen wall, it is also possible to directly penetrate into the sampling mechanism 13 without widening the target tissue 3.

According to the above steps, compared with the first embodiment, the second embodiment of the present patent omits the step of withdrawing the puncture widening mechanism 12 by combining the puncture widening mechanism 12 and the sampling mechanism 13, avoids the position variation of the target tissue 3 possibly caused by the change of the environment in the living body when withdrawing the puncture widening mechanism 12, and further improves the success rate of sampling.

Furthermore, it will be appreciated that the consumable components of the biopsy sampling device 1 are typically disposable in order to prevent cross-contamination. By combining the puncture widening mechanism 12 and the sampling mechanism 13, the components in the sheath tube 11 can be shared, so that the cost can be greatly saved, and the pollution of consumables to the environment can be reduced.

Embodiment III

The third embodiment of the present patent provides a biopsy sampling device 1 and associated methods of use and endoscope 2. The third embodiment is a further improvement of the second embodiment, the main improvement being that in the third embodiment of the present patent, see fig. 10, its opening extends to the side wall of the widening section 122. Since the first blade 133 is arranged at one side of the opening, the first blade 133 will also extend to the location of the widening section 122.

When the opening is extended to the side wall of the widening part 122, the inner space of the hollow widening part 122 is fully utilized, which not only saves materials but also increases the volume of the receiving space 132.

Since the widening part 122 is conical as a whole, the target tissue 3 will more easily invade the opening in the widening part 122 into the receiving space 132 during the widening than the cylindrical housing 131 side wall. Thus, the amount of invasion of the target tissue 3 is significantly increased when the opening is extended to the side wall of the widening section 122, compared to the second embodiment. When the sampling mechanism 13 rotates, the widening section 122 rotates synchronously, which makes it possible for the first blade 133 to cut and sample a large amount of the target tissue 3 more smoothly.

That is, extending the opening to the side wall of the widening section 122 not only serves to increase the accommodating space 132, increase the volume of tissue that can be sampled, but also can reduce the difficulty of cutting the target tissue 3 by the first blade 133, significantly improving the sampling efficiency.

It will be evident to those skilled in the art that the present patent is not limited to the details of the foregoing illustrative embodiments, and that the present patent may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive, the scope of the patent being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.

Claims (10)

1. A biopsy sampling device for use with an endoscope, comprising:

the device comprises a sheath, a puncture widening mechanism capable of penetrating into the sheath and a sampling mechanism capable of penetrating into the sheath;

the head end of the sheath tube can be bent so as to adjust the direction in which the puncture widening mechanism and the sampling mechanism extend out of the sheath tube;

the puncture widening mechanism is used for penetrating through the inner wall of the cavity and forming widening holes on the inner wall;

the sampling mechanism is used for passing through the widening hole and entering a target tissue for sampling.

2. The biopsy sampling device of claim 1, wherein the puncture widening mechanism comprises a puncture needle and a widening member sleeved on the puncture needle, the widening member having a radial width gradually decreasing from a side near the extended sheath to a side away from the extended sheath for widening a wall of a lumen penetrated by the puncture needle and forming the widening aperture;

the puncture needle head can independently move in a telescopic manner along the length direction of the puncture needle head and relative to the widening component.

3. The biopsy sampling device of claim 1, wherein the sampling mechanism comprises:

a housing enclosing an accommodation space for accommodating the sampled tissue, the housing being provided with an opening communicating with the accommodation space;

the shell can rotate by taking the axis of the shell as a rotating shaft;

the first blade is arranged on one side of the opening, one side of the first blade is provided with a cutting edge, the cutting edge of the first blade faces the accommodating space, and the cutting edge direction of the first blade faces the rotating direction.

4. The biopsy sampling device of claim 3, wherein the sampling mechanism further comprises a second blade disposed on the other side of the opening, the second blade having a single sided sharpened face, the sharpened face of the second blade facing away from the receiving space, and the direction of the blade edge of the second blade facing away from the direction of rotation.

5. The biopsy sampling device of claim 4, wherein the spacing of the first blade and the second blade decreases from the leading end of the housing toward the trailing end of the housing until the first blade and the second blade cross over each other, the first blade being closer to the receiving space than the second blade.

6. The biopsy sampling device of claim 4, wherein the second blade is removably coupled to the opening.

7. A biopsy sampling device according to any one of claims 3 to 6, wherein the puncture widening means is mounted on the sampling means,

the puncture widening mechanism comprises:

the puncture needle head extends out of the top end of the shell, and can move along the length direction of the puncture needle head and retract into the accommodating space;

the widening component is arranged at the top end of the shell, and the radial width of the widening component gradually decreases from one side close to the shell to one side far away from the shell, so that the widening component is used for widening the wall of the cavity penetrated by the puncture needle and forming the widening hole.

8. The biopsy sampling device of claim 7, wherein the opening extends to a sidewall of the widening section.

9. An endoscopic apparatus comprising a biopsy sampling device according to any one of claims 1 to 8.

10. A method of using a biopsy sampling device, comprising the steps of:

moving the endoscope along the lumen to a target position;

extending a sheath from a head end of an endoscope, bending the sheath under a camera view of the endoscope, and orienting the sheath toward a target tissue;

extending out of the head end of the sheath tube to puncture and widen the cavity wall to form a widened hole;

continuing to push the sheath tube to enable the sheath tube to pass through the widening hole along a passage built by the puncture widening mechanism;

retracting the puncture widening mechanism;

a sampling mechanism is extended from the head end of the sheath to reach/approximate the target tissue for subsequent manipulation.