CN114947981B

CN114947981B - Biopsy brush

Info

Publication number: CN114947981B
Application number: CN202110199643.3A
Authority: CN
Inventors: 黄景川; 杨帆
Original assignee: Changzhou Lunghealth Medtech Co ltd
Current assignee: Changzhou Lunghealth Medtech Co ltd
Priority date: 2021-02-22
Filing date: 2021-02-22
Publication date: 2024-05-24
Anticipated expiration: 2041-02-22
Also published as: CN114947981A

Abstract

The embodiment of the invention discloses a biopsy brush, which comprises an insertion component, a bristle component and a positioning component, wherein the insertion component is tubular and is used for being inserted into a body of a living body; the bristle component is connected with the insertion component and driven by the insertion component to reach the focus position of the organism; the positioning component is arranged at the end part, close to the bristle component, in the insertion component and is used for positioning the bristle component in the muscle body. According to the biopsy brush provided by the embodiment of the invention, the position of the bristle assembly in the muscle body of the organism is positioned through the positioning assembly, so that the position of a biopsy tool is accurately determined, the sampling of a lesion is more accurate, and the accuracy of biopsy is further improved.

Description

Biopsy brush

Technical Field

The invention relates to the technical field of medical appliances, in particular to a biopsy brush.

Background

In modern medicine, endoscopy has become increasingly important for the early detection and treatment of tumors. The conventional endoscope can enter a natural cavity of a human body to acquire images at the front end of the endoscope for observation, and a biopsy tool is used for forceps inspection, brushing inspection and needle suction inspection of living tissues, so that diseases are correctly diagnosed. Typically these biopsy modes are performed under direct view under an endoscopic imaging system. However, for the lesions which can not be reached and visualized by the endoscope at the deep or back of the natural cavity wall of the human body, a doctor can not visually identify the lesions through an imaging system, so that a biopsy tool can not be accurately positioned, and therefore, the tissues of the target lesions or the tissues which are not the target lesions can not be obtained, and misdiagnosis is caused. Although the position of the focus can be calibrated by utilizing the magnetic navigation positioning system, the position of the biopsy tool in the human body can not be accurately determined when the focus is subjected to clamp examination, brush examination and needle suction examination, so that the focus is easily sampled inaccurately, and the accuracy of biopsy is further affected.

Disclosure of Invention

The embodiment of the invention provides a biopsy brush which can accurately determine the position of a biopsy tool in a human body, accurately sample a focus and improve the accuracy of biopsy.

The embodiment of the invention provides a biopsy brush, which comprises:

An insertion member having a tubular shape for insertion into a body of a living body;

The bristle component is connected with the insertion component and driven by the insertion component to reach the focus position of the body;

And the positioning assembly is arranged at the end part, close to the bristle assembly, in the insertion assembly and is used for positioning the bristle assembly at the position in the muscle body.

Further, the bristle sub-assembly includes:

Brushing;

the periphery of the bristle fixing piece is connected with the bristles, and one end of the bristle fixing piece is connected with the insertion assembly;

The guide head includes opposed closed and open ends, the open ends connecting the bristle holder to an end remote from the insert assembly.

Further, the closed end is a round head with a closed head end.

Further, the closed end is provided with a spike facing away from the open end.

Further, the bristle fixing piece is a winding metal wire formed by spirally winding at least two steel wires, and the bristle is fixedly wound on the surface of the winding metal wire.

Further, the bristles have a cylindrical shape or an inverted tapered shape in a space formed at the outer circumference of the bristle holder.

Further, the insertion assembly comprises an inner tube and an outer tube, the positioning assembly is arranged in the inner tube and is connected with the winding metal wire, and the inner tube is positioned in the outer tube and moves back and forth in the outer tube to drive the winding metal wire to extend out of or retract into the outer tube.

Further, the positioning assembly comprises a magnetic navigation positioning sensor and a sensor protection cap;

the magnetic navigation positioning sensor is arranged in the sensor protection cap, and the sensor protection cap is fixed at the end part in the inner tube.

Further, the positioning assembly comprises a magnetic navigation positioning sensor, a sensor protection cap and a sensor protection sheath;

The sensor protection sheath is arranged in the inner tube in a penetrating mode, the sensor protection sheath is close to the end portion of the winding metal wire and connected with the sensor protection cap, and the magnetic navigation positioning sensor is arranged in the sensor protection cap.

Further, the positioning assembly comprises a magnetic navigation positioning sensor, the magnetic navigation positioning sensor is fixed at the end part in the inner tube, at least two steel wires are spirally wound on the outer wall of the end part of the inner tube, where the magnetic navigation positioning sensor is arranged, to form the winding metal wire.

Further, the outer tube is a single-cavity plastic tube or a multi-layer structure woven tube consisting of a plastic layer, a metal woven wire layer and a plastic layer from inside to outside.

Further, the inner tube is any one of a single-cavity metal flat wire/round wire tightly wound spring tube, a flexible metal thin-wall tube, a metal flexible snake bone tube cut by laser, a single-cavity multi-layer structure braided tube, a single-cavity/multi-cavity plastic tube and a single-cavity multi-strand stainless steel wire wound hollow steel wire rope, or is formed by splicing a plurality of structural forms in a multi-section manner;

The single-cavity multi-layer structure braided tube comprises a plastic layer, a stainless steel braided wire layer and a plastic layer from inside to outside.

Further, the insertion assembly further comprises a limiting block, and the limiting block penetrates through the outer tube and can reciprocate along the surface of the outer tube.

Further, a handle assembly is included, the handle assembly including a hand-held portion, a distal portion, and a proximal portion;

The hand-held part comprises a movable hand-held part and a fixed hand-held part;

the movable hand-held part is connected with the end part of the inner tube far away from the bristle assembly, and the distal end part is connected with the end part of the outer tube far away from the bristle assembly;

The handle assembly is provided with a compression spring which enables the distal end part and the hand-held part to move relatively, and the compression spring is respectively connected with the distal end part and the hand-held part.

Further, a channel part communicated with the inner tube is arranged in the handle assembly, and an interface part communicated with the channel part is arranged at the end part of the proximal end part.

The biopsy brush comprises the insertion component and the bristle component which are connected with each other, the positioning component is arranged in the end part, close to the bristle component, of the insertion component, and the position of the bristle component in the muscle of the organism is positioned through the positioning component, so that the position of a biopsy tool is accurately determined, the sampling of a lesion is more accurate, and the accuracy of biopsy is further improved.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention and do not constitute a limitation on the invention. In the drawings:

FIG. 1 is a schematic view showing a partial cross-sectional structure of a biopsy brush according to an embodiment of the present invention;

FIG. 2 is a schematic perspective view of a bristle sub-assembly of a biopsy brush according to an embodiment of the present invention;

FIG. 3 is a schematic cross-sectional view of a guide head of a biopsy brush according to an embodiment of the present invention;

FIG. 4 is a schematic cross-sectional view of another guide head of a biopsy brush according to an embodiment of the present invention;

FIG. 5 is a schematic side view of a bristle sub-assembly of a biopsy brush according to an embodiment of the present invention;

FIG. 6 is a schematic side view of another bristle sub-assembly of a biopsy brush according to an embodiment of the present invention;

FIG. 7 is a schematic cross-sectional view of an inner tube of a biopsy brush according to an embodiment of the present invention;

FIG. 8 is a schematic cross-sectional view of another inner tube of a biopsy brush according to an embodiment of the present invention;

FIG. 9 is a schematic side view of a biopsy brush according to an embodiment of the present invention;

FIG. 10 is a schematic cross-sectional view of a positioning assembly of a biopsy brush according to an embodiment of the present invention;

FIG. 11 is a schematic view showing a partial cross-sectional structure of a biopsy brush according to an embodiment of the present invention;

Fig. 12-21 are flowcharts illustrating an operation method of a biopsy brush according to an embodiment of the present invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to specific embodiments of the present invention and corresponding drawings. It will be apparent that the described embodiments are only some, but not all, embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

Referring to fig. 1, a schematic cross-sectional view of a biopsy brush according to an embodiment of the present invention is shown, wherein the biopsy brush comprises an insertion assembly 10, a bristle assembly 20 and a positioning assembly 30.

Wherein the insertion assembly 10 is tubular for insertion into a body of a living being; the bristle assembly 20 is connected to the end of the insertion assembly 10, and is driven by the insertion assembly 10 to reach the focus position of the body; the positioning assembly 30 is disposed within the insert assembly 10 near the end of the bristle assembly 20 for positioning the bristle assembly 20 within the muscle.

Specifically, the tubular insertion assembly 10 is used for being inserted into a body of a living body, wherein the living body comprises an animal body, a human body and the like, and the human body is taken as an example for illustration, the insertion assembly 10 enters the human body under the action of machinery or manpower, the front end of the insertion assembly 10 is connected with the bristle assembly 20, along with the movement of the insertion assembly 10 in the human body, the bristle assembly 20 can be conveyed to a focus position in the human body, and the bristle assembly 20 can sample a focus of the human body; the end of the insertion assembly 10, which is close to the bristle assembly 20, i.e. the front end of the insertion assembly 10 is provided with the positioning assembly 30, the positioning assembly 30 is arranged in the tube body of the insertion assembly 10 and moves in the human body along with the insertion assembly 10, and the positioning assembly 30 has a positioning function and can position the bristle assembly 20 in the human body, so that the position of the bristle assembly 20 is accurately determined, the sampling of a disease is more accurate, and the accuracy of biopsy is further improved.

The insert assembly 10, the bristle assembly 20, and the positioning assembly 30 are described in detail below with reference to fig. 2-11.

Wherein the bristle sub-assembly 20 comprises:

Bristles 210;

A bristle holder 220, wherein the bristles 210 are connected to the outer circumference of the bristle holder 220, and one end of the bristle holder 220 is connected to the insert 10;

a guide head 230, the guide head 230 including opposed closed ends 2301 and open ends 2302, the open ends 2302 connecting the end of the bristle holder 220 remote from the insert assembly 10.

Specifically, opposite ends of the bristle holder 220 are respectively connected to the guide head 230 and the insert assembly 10, the bristles 210 are connected to the outer circumference of the bristle holder 220, the closed end 2301 of the guide head 230 functions to guide the movement of the bristle holder 20 in the body tissue, and the end of the bristle holder 220 is inserted into the open end 2302 of the guide head 230 and connected to the inner wall thereof; or at a port of the open end 2302.

Further, referring to fig. 3, in a preferred embodiment of the present invention, the closed end 2301 is a rounded end with a closed head end, and the guide head 230 is a rounded end, which is far away from the open end 2302, and is designed to guide the biopsy brush to pass through the cavity of the human body tissue, thereby increasing the smoothness of the operation of the device and improving the comfort of the patient.

In addition, referring to fig. 4, the closed end 2301 is provided with a spike 2303 facing away from the open end 2302. Here, the guide head 230 is spike-shaped, the side of the closed end 2301 facing away from the open end 2302 is provided with the spike 2303, the spike 2303 has a sharper tip for puncturing a harder lesion, facilitating sampling of the bristles 210.

In other preferred embodiments of the present invention, the guide head 230 is made of a material including, but not limited to, stainless steel, and may be manufactured by powder metallurgy/machining/stamping.

Further, referring to fig. 5 and 6, in other preferred embodiments of the present invention, the bristles 210 are formed in a cylindrical shape or in an inverted cone shape at the outer circumference of the bristle holder 220.

Specifically, one end of the plurality of bristles 210 is connected to the outer circumference of the bristle holder 220, and the other end is a free end, and the bristles 210 have better flexibility and form a specific space shape on the outer circumference of the bristle holder 220 without being subjected to external pressure, such as a cylindrical shape as shown in fig. 5 and an inverted cone shape as shown in fig. 6.

The specific material of the bristles 210 includes, but is not limited to, one of PA6, PA46, and PA 66.

Further, in other preferred embodiments of the present invention, the bristle holder 220 is a winding wire 221 formed by spirally winding at least two steel wires, and the bristles 210 are wound and fixed on the surface of the winding wire 221.

Specifically, at least two of the wires are spirally wound with each other, and a plurality of the bristles 210 are wound and fixed therein during the winding process, and the guide head 230 is connected at an end thereof, thereby forming the bristle sub-assembly 20. Wherein at least two of the wires are spirally wound with each other to form the wound wire 221, wherein the wound wire 221 is only one form of the bristle holder 220, which may also be a brush handle like a toothbrush, to which the bristles 210 are implanted.

Accordingly, the length of the wire length around which the bristles 210 are wound is 5-20mm, and is at the front end of the wound wire 221.

The number of wires helically wound around each other in the preferred embodiment is 3-6. The section of the steel wire is round wire or flat wire.

The wound wire 221 is a stainless steel material or a nitinol wire.

Fig. 5 and 6 illustrate one type of the winding wire 221 formed by spirally winding 2 round stainless steel wires, respectively.

Still further, in other preferred embodiments of the present invention, the insertion assembly 10 includes an inner tube 110 and an outer tube 120, the positioning assembly 30 is disposed in the inner tube 110 and is connected to the winding wire 221, and the inner tube 110 is disposed in the outer tube 120 and reciprocates in the outer tube 120 to drive the winding wire to extend out of or retract into the outer tube 120.

Here, the inner tube 110 is connected to the bristle sub-assembly 20 without a connection relationship between the outer tube 120 and the bristle sub-assembly 20, specifically, one end of the inner tube 110 is connected to the wound wire 221, and the positioning member 30 is disposed in the end of the inner tube 110 such that the positioning member 30 is adjacent to the wound wire 221, i.e., adjacent to the bristle sub-assembly 20, thereby facilitating positioning of the bristle sub-assembly 20; the outer tube 120 is sleeved on the outer periphery of the inner tube 110, and the inner tube 110 and the outer tube 120 can move relatively, so that the bristle assembly 20 can retract into the end of the outer tube 120 or extend out of the end of the outer tube 120. Wherein retraction into the end of the outer tube 120 is when the biopsy brush is traversing within the body tissue lumen; and the condition of extending out of the end of the outer tube 120 is when the biopsy brush samples a lesion sample in human body tissue.

In addition, the outer tube 120 is a single-cavity plastic tube or a multi-layer woven tube consisting of plastic layers, metal woven wire layers and plastic layers from inside to outside.

Specifically, one end of the outer tube 120 is open for the bristle sub-assembly 20 to extend out of, or retract into, the open mouth during operation; the other end is connected with a structure for placing the insertion assembly 10 into human body tissue. Here, the outer tube 120 may be a multi-layer woven tube, which is formed by a plastic layer, a metal woven wire layer, a plastic layer, etc. from inside to outside; the outer tube 120 may also be a single-lumen plastic tube, wherein the plastic material includes, but is not limited to, one of PE/PP/POM/PTFE/PI/PA/PEEK.

In addition, in other preferred embodiments, PET, PE, PTFEP, PP layers can be added to the outer surface of the plastic tube and the woven tube with the multi-layer structure, and these layers have better lubrication, so that the surface movement resistance of the outer tube 120 can be reduced, and the comfort of the patient when the outer tube 120 moves between human body tissues can be improved.

Further, the inner tube 110 is any one of a single-cavity flat metal wire/round wire tightly wound spring tube, a flexible metal thin-wall tube, a laser cut metal flexible snake bone tube, a single-cavity multi-layer structure braided tube, a single-cavity/multi-cavity plastic tube, a single-cavity multi-strand stainless steel wire wound hollow steel wire rope, or is formed by splicing multiple structural forms;

Here, one end of the inner tube 110 is connected with the winding wire 221 of the bristle sub-assembly 20 by insertion, the insertion-fit distance is 1-10mm, and the other end is connected with a structure for inserting the insert sub-assembly 10 into human body tissue;

In another possible embodiment, the inner tube 110 and the bristle sub-assembly 20 are not connected, but are spaced apart from each other by a distance and are disposed in parallel with the inner cavity of the outer tube 120;

In yet another possible embodiment, the winding wire 221 of the bristle sub-assembly 20 is formed by winding a plurality of wires around the end of the inner tube 110 in a spiral manner, the inner tube 110 is used as an inner channel of the bristle sub-assembly 20, and the inner cavity of the outer tube 120 is also used for the reciprocal movement of the bristle sub-assembly 20 and the inner tube 110.

Optionally, PET, PE, PTFEP, PP layers can be added on the surface of the single-cavity metal round wire/round wire tightly wound spring tube, and the layers have better lubrication, so that the surface movement resistance of the inner tube 110 can be reduced, the smoothness of the outer tube 120 and the inner tube 110 during relative movement is improved, and the operation sensitivity of the bristle assembly 20 is improved.

The single-cavity/multi-cavity plastic pipe can be made of PE/PP/POM/PTFE/PI/PA/PEEK materials.

The single lumen/multi-lumen plastic tube contains at least 1 lumen. The number of chambers 1101+N is 1-4 for 1 main chamber 1101+N sub-chambers 1102. The subchamber 1102 may be entirely within the tube wall thickness as shown in fig. 7; the subchambers 1102 may also be partially exposed to the outer surface of the tubing, as shown in FIG. 8, which illustrates 1 main chamber 1101+4 subchambers 1102, respectively.

Further, reinforcing wires 1103 may be provided in the main lumen 1101 and/or the subchambers 1102 for reinforcing the tensile strength of the tubular body and for receiving tension in connection with the pull rod 240 of the bristle sub-assembly 20. The reinforcing wire 1103 is a single metal round wire or flat wire or a steel wire rope wound by a plurality of metal round wires/flat wires.

The hollow steel wire rope wound by the multi-strand metal wires in the single cavity is spirally wound by the multi-strand metal round wires/flat wires and comprises multiple layers.

The number of the stranded metal round wires/flat wires is N, and the number of N is 4-12.

The number of the layers is N, and the number of N is 1-3.

In addition, referring to fig. 9, the insertion assembly 10 further includes a stopper 130, and the stopper 130 is disposed outside the outer tube 120 and can reciprocate along the surface of the outer tube 120.

Specifically, the limiting block 130 is disposed outside the outer tube 120 in a penetrating manner, and is used as a depth limiting mark for controlling the insertion assembly 10 to enter the human body tissue cavity, and can reciprocate along the surface of the outer tube 120.

In a preferred embodiment, the material of the limiting block 130 includes, but is not limited to, silica gel.

Further, the biopsy brush further comprises a handle assembly 40, the handle assembly 40 comprising a handpiece 410, a distal end 420, and a proximal end 430;

The hand-held portion 410 includes a movable hand-held portion 411 and a fixed hand-held portion 412. The movable grip 411 is connected to the end of the inner tube 110 remote from the bristle sub-assembly 20, and the distal end 420 is connected to the end of the outer tube 120 remote from the bristle sub-assembly 20;

the handle assembly 40 is provided with a compression spring 440 for relatively moving the distal end portion 420 and the hand-held portion 410, and the compression spring 440 is connected to the distal end portion 420 and the hand-held portion 410, respectively.

Specifically, the hand holding portion 410 is designed by using ergonomics, in order to adapt to the hand control structure of an operator, the distal end portion 420 and the proximal end portion 430 are located on two sides of the hand holding portion 410, the hand holding portion 410 is provided with a movable hand holding portion 411 and a fixed hand holding portion 412, the distal end portion 420 is fixedly connected with the outer tube 120, the movable hand holding portion 411 is fixedly connected with the inner tube 110, the compression spring 440 provided on the handle assembly 40 is respectively connected with the distal end portion 420 and the hand holding portion 410, the compression spring 440 can enable the distal end portion 420 and the hand holding portion 410 to have a relative separation trend, the bristle assembly 20 is guaranteed to retract into the open opening of the outer tube 120 in a static state so as to conveniently enter a body or a channel, the movable hand holding portion 411 is fixedly connected with the inner tube 110, the operator moves close to or separate from the distal end portion 420 by moving the movable hand holding portion 411, and then the inner tube 110 moves relatively, so that the bristle assembly 20 can retract into the open state of the outer tube 120 or the open state of the outer tube 120.

Still further, a channel portion (not shown) communicating with the inner tube 110 is provided in the handle assembly 40, and an interface portion 450 communicating with the channel portion is provided at an end of the proximal portion 430.

Specifically, the channel portion is disposed inside the handle assembly 40 and is used for connecting with the inner tube 110 or disposing the inner tube 110, the interface portion 450 is communicated with the channel portion and is disposed at the end of the proximal portion 430 and is used for inserting the inner tube 110 and inserting the positioning assembly 30.

Optionally, a connection may be provided on the handle assembly 40 for connecting to a dedicated auxiliary consumable/endoscopic gateway interface.

Optionally, an interface portion may be provided on the handle assembly 40 for cable plug connection of the positioning assembly 30.

Further, in a preferred embodiment of the present invention, the positioning assembly 30 includes a magnetic navigation positioning sensor 310 and a sensor protective cap 320;

the magnetic navigation positioning sensor 310 is disposed in the sensor protection cap 320, and the sensor protection cap 320 is fixed to the end portion in the inner tube 110.

Specifically, as shown in fig. 1, the sensor protection cap 320 has a tubular structure with an opening at one end and a closed end, the magnetic navigation positioning sensor 310 is disposed at the closed end of the sensor protection cap 320, and the closed end is close to the wound wire 221 and is connected with the wound wire 221, and the whole positioning assembly 30 is fixedly connected to the end of the inner tube 110 close to the bristle assembly 20, and is not detachable therebetween. Here, the bristle sub-assembly 20 may be relatively moved with respect to the outer tube 120 by the inner tube 110, so that the bristle sub-assembly 20 protrudes out of the end of the outer tube 120 or is contracted into the end of the outer tube 120. The sensor protection cap 320 protects the magnetic navigation positioning sensor 310, and the end of the magnetic navigation positioning sensor 310 far from the bristle assembly 20 is connected to an external device, including but not limited to a magnetic navigation device or other display device, through a sensor cable that is inserted into the inner tube 110 and out of the interface 450 to connect with the external device.

Further, referring to fig. 10, in another preferred embodiment of the present invention, in order to facilitate the placement and removal of the magnetic navigation positioning sensor 310, the positioning assembly 30 further includes a sensor protecting sheath 330, the winding wire 221 is connected to the end of the inner tube 110, the sensor protecting sheath 330 is inserted into the inner tube 110, the end of the sensor protecting sheath 330 close to the winding wire 221 is connected to the sensor protecting cap 320, and the magnetic navigation positioning sensor 310 is disposed in the sensor protecting cap 320.

Specifically, the sensor protection sheath 330 is used as a catheter sheath for placing and taking out the magnetic navigation positioning sensor 310, the magnetic navigation positioning sensor 310 is placed in the sensor protection cap 320, the open end of the sensor protection cap 320 is connected with the end of the sensor protection sheath 330, and the connector of the sensor protection cap 320 and the sensor protection sheath 330 enters the inner tube 110 from the interface 450 to reach a position close to the bristle assembly 20 for positioning. Reference may be made to the description of the above embodiments for the connection of the magnetic navigation positioning sensor 310 to an external device, which is not described herein.

Further, referring to fig. 11, in other preferred embodiments of the present invention, the positioning assembly 30 includes a magnetic navigation positioning sensor 310, the magnetic navigation positioning sensor 310 is fixed at the end portion inside the inner tube 110, and at least two steel wires are spirally wound around the outer wall of the end portion of the inner tube 110 where the magnetic navigation positioning sensor 310 is disposed to form the winding wire 221.

Specifically, the magnetic navigation positioning sensor 310 is fixedly connected to the end portion inside the inner tube 110, and is not detachable therebetween, while at least two steel wires are spirally wound around the outer circumference of the portion of the inner tube 110 where the magnetic navigation positioning sensor 310 is disposed so as to form a winding wire 221, and the bristles are wound therein so as to form the bristle assembly 20, and the bristle assembly 20, the positioning assembly 30, and the inner tube 110 keep moving together and move relative to the outer tube 120, so that the bristle assembly 20 extends out of the end portion of the outer tube 120 or contracts into the end portion of the outer tube 120. Also, reference is made to the description of the above embodiments for the connection of the magnetic navigation positioning sensor 310 to an external device, and the description is omitted here.

The method for using the biopsy brush is described in detail below, and the process and method for performing lung positioning biopsy under magnetic navigation condition by using the biopsy brush are specifically described. Fig. 12-15 are flowcharts of a biopsy performed by the biopsy brush under magnetic navigation through an index catheter for lung positioning.

S100: CT images are imported, and a three-dimensional model of a pulmonary bronchial tree structure and a three-dimensional model of pulmonary vessels (arteries and veins) are reconstructed.

In step 100, the pulmonary bronchi and pulmonary vessels need to use different thresholds, respectively, in order to separate from other tissues. The reconstructed bronchus and vessel model needs to be superimposed in the same three-dimensional model for observation (different colors can be used to distinguish between the bronchus and vessel model).

S200, sketching a focus point A to be sampled, as shown in FIG. 12.

S300, using the focus point A as the navigation path end point, and planning a navigation path from the main carina to the focus point A according to the magnetic navigation path planning step in the prior art, as shown in FIG. 13.

S400, penetrating the magnetic navigation positioning biopsy brush into the guiding catheter and connecting the magnetic navigation positioning biopsy brush with the magnetic navigation positioning system.

S500, the operation guide catheter reaches the focus point A along the navigation path, as shown in fig. 14.

S600, operating the magnetic navigation positioning biopsy brush handle to sample the living body, as shown in fig. 15.

Specifically, the coordinates of the path actually passed through in the magnetic navigation positioning system are recorded in the process. And comparing the coordinates with navigation path coordinates in the three-dimensional model of the bronchial tree structure, so that the coordinates of the focus point A needing to be reached in the magnetic navigation positioning system are corrected to be matched with the coordinates in the three-dimensional model of the bronchial tree structure, positioning errors and then in-vivo sampling errors are reduced, and accuracy is improved.

Alternatively, in steps S200-S600, if the target lesion is behind the tracheal wall or there is no obvious tracheal access location, as shown at B in fig. 16, a puncture wall breaking tool is used to manually create access to the target lesion. The method comprises the following steps:

As shown in fig. 16, a focal point B to be sampled is sketched in S200. And simultaneously drawing a puncture broken wall point B', wherein the point is selected to be as close to the point B as possible or a position convenient for puncture.

Referring to fig. 16, in S300, a main navigation path from the main carina to the puncture point B 'is planned according to the magnetic navigation path planning step in the prior art with the puncture point B' as the navigation path end point. Meanwhile, a puncture path from the puncture point B 'to the focus point B is planned by taking the puncture point B' as a starting point and the focus point B as an end point, and is used as a secondary navigation path.

Referring to fig. 17, in S400, a puncture wall breaking tool is inserted into a guide catheter, and a puncture is performed with a puncture point B' as a starting point, so as to manufacture a channel reaching a focus point B.

Referring to fig. 18, in S500, the guiding catheter and the wall breaking puncture tool are operated to puncture along the secondary navigation path to reach the focal point B, and then the wall breaking tool is withdrawn to insert the magnetic navigation positioning biopsy brush.

As shown in FIG. 20, a magnetic navigation positioning biopsy brush handle is manipulated in S600 to perform biopsy.

Alternatively, in steps S400-S500, the magnetic navigation positioning biopsy brush may be integrated in the biopsy brush using the positioning assembly 30, or the magnetic navigation positioning biopsy brush may be used as a separate assembly/product using the positioning assembly 30.

Alternatively, in steps S400-S500, when the positioning assembly 30 is used as a magnetic navigation positioning biopsy brush of a separate assembly/product, the positioning assembly 30 may be inserted directly into the guiding catheter, and the guiding catheter is operated to reach the focal point a. The positioning assembly 30 is then withdrawn and assembled into a magnetic navigation positioning biopsy brush, which is then threaded into the guide catheter and extended from its distal end for sampling. The reason for this is that the distal end of the biopsy brush is a longer metal entity, which affects the curve shape of the distal end of the guiding catheter, and makes it difficult for the guiding catheter to select the corresponding tracheal bifurcation at the tracheal bifurcation by using a specific curve shape, so that it is difficult to smoothly reach the focus point of the track along the navigation path, and the operation time is prolonged.

Optionally, when the positioning component is used as a magnetic navigation positioning biopsy brush of an independent component/product, after biopsy brush forceps are used for detection, the positioning component can be pulled out on the spot, sterilized and wiped and then inserted into other forceps, brushes, needles and other tools capable of realizing guidance of a magnetic navigation system for multiple times of composite biopsy, so that the positive detection rate is improved.

Alternatively, in steps S400-500, if the target focal point is located at a shallower lung, it can be reached with a bronchoscope and directly visualized with its imaging system, as at focal point C in FIG. 20. Or after the bronchoscope arrives, although the bronchoscope cannot be directly observed by using an imaging system of the bronchoscope, the focus point is clung to the tracheal wall, such as focus point D in fig. 21 (corresponding tools and methods should be used for puncturing the tracheal wall in advance, such as a special puncture wall breaking tool, or a biopsy forceps, a biopsy brush and a biopsy needle with a puncture head). The guiding catheter is not needed to be used, and the magnetic navigation positioning biopsy brush is directly penetrated into the bronchoscope forceps channel and extends out of the front end of the forceps channel, and then enters the focal point position for sampling.

It should also be noted that the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one … …" does not exclude the presence of other like elements in a process, method, article or apparatus that comprises the element.

It will be appreciated by those skilled in the art that embodiments of the present invention may be provided as a method, system, or computer program product. Accordingly, the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects. Furthermore, the present invention may take the form of a computer program product embodied on one or more computer-usable storage media (including, but not limited to, disk storage, CD-ROM, optical storage, and the like) having computer-usable program code embodied therein.

The foregoing is merely exemplary of the present invention and is not intended to limit the present invention. Various modifications and variations of the present invention will be apparent to those skilled in the art. Any modification, equivalent replacement, improvement, etc. which come within the spirit and principles of the invention are to be included in the scope of the claims of the present invention.

Claims

1. A biopsy brush, comprising:

The positioning assembly is arranged at the end part, close to the bristle assembly, in the insertion assembly and is used for positioning the bristle assembly in the muscle body;

wherein the bristle sub-assembly comprises:

Brushing;

The bristle fixing piece is a winding metal wire formed by spirally winding at least two steel wires, the bristle is fixedly wound on the surface of the winding metal wire, the space formed by the bristle at the periphery of the bristle fixing piece is cylindrical or reverse conical, and one end of the bristle fixing piece is connected with the insertion component;

the guide head comprises a closed end and an open end which are opposite to each other, the open end is connected with one end of the bristle fixing piece, which is far away from the insertion assembly, and the closed end is provided with a spike which is far away from the open end;

the insertion assembly comprises an inner tube, a limiting block and an outer tube, the positioning assembly is arranged in the inner tube and is connected with the winding metal wire, and the inner tube is positioned in the outer tube and moves back and forth in the outer tube to drive the winding metal wire to extend out of or retract into the outer tube; the limiting block is arranged outside the outer tube in a penetrating way and can reciprocate along the surface of the outer tube;

the device further comprises a handle assembly, wherein the handle assembly comprises a hand-held part, a distal end part and a proximal end part;

the hand-held part is provided with a compression spring which enables the distal end part and the hand-held part to move relatively, and the compression spring is respectively connected with the distal end part and the hand-held part.

2. The biopsy brush of claim 1, wherein the closed end is a rounded head with a closed head end.

3. The biopsy brush of claim 1, wherein the positioning assembly comprises a magnetically permeable positioning sensor and a sensor protective cap;

4. The biopsy brush of claim 1, wherein the positioning assembly comprises a magnetically permeable positioning sensor, a sensor protective cap, and a sensor protective sheath;

5. The biopsy brush of claim 1, wherein the positioning assembly comprises a magnetic navigation positioning sensor secured to an end within the inner tube, at least two steel wires helically wound around an outer wall of the inner tube at the end of the inner tube where the magnetic navigation positioning sensor is disposed forming the wound wire.

6. The biopsy brush of claim 1, wherein the outer tube is a single lumen plastic tube or a braided tube of a multi-layer construction comprising a plastic layer, a metal braided wire layer, a plastic layer from inside to outside.

7. The biopsy brush of claim 1, wherein the inner tube is any one of a single-lumen metal flat wire/round wire tightly wound spring tube, a flexible metal thin-wall tube, a laser cut metal flexible snake bone tube, a single-lumen multi-layer structure braided tube, a single-lumen/multi-lumen plastic tube, a single-lumen multi-strand stainless steel wire wound hollow steel wire rope, or a multi-section splice of the above;

8. The biopsy brush of claim 1, wherein a channel portion is provided in the handle assembly in communication with the inner tube, and wherein an end of the proximal portion is provided with an interface portion in communication with the channel portion.