CN115633993A - Biopsy needle - Google Patents

Abstract

The embodiment of the invention discloses a biopsy needle, which comprises an insertion component, a needle head and a positioning component, wherein the insertion component is tubular and is used for inserting a living body; the needle head is connected to the end part of the insertion assembly and driven by the insertion assembly to reach the focus position of the body, the needle head is of a hollow structure, and a puncture angle is arranged at the end part, far away from the insertion assembly, of the needle head; the positioning assembly is arranged at the end part, close to the needle, in the insertion assembly and used for positioning the position of the needle in the muscle body. According to the biopsy needle provided by the embodiment of the invention, the position of the needle head in the organism is positioned through the positioning assembly, and the position of a biopsy tool is accurately determined, so that the focus sampling is more accurate, and the biopsy accuracy is further improved.

Description

Biopsy needle

Technical Field

The invention relates to the technical field of medical instruments, in particular to a biopsy needle.

Background

In modern medicine, endoscopy has become increasingly important for the early detection and treatment of tumors. The conventional endoscopy can enter a natural cavity of a human body to acquire an image at the front end of the endoscope for observation, and biopsy tools are used for clamp examination, brush examination and needle suction examination of living tissues, so that the diseases are correctly diagnosed. Usually these biopsy procedures are performed under direct vision under an endoscopic imaging system. However, for the focus which can not be reached and seen by the endoscope in the natural cavity deep or behind the cavity wall, the doctor can not visually identify through the imaging system, so that the biopsy tool can not be accurately positioned, and therefore the tissue of the target focus can not be obtained or the tissue which is not the target focus can not be obtained, and misdiagnosis can be caused. Although the position of the focus can be calibrated by using the magnetic navigation positioning system, the position of a biopsy tool in a human body can not be accurately determined when the focus is subjected to clamp detection, brushing detection and needle suction detection, so that the focus sampling is easy to be inaccurate, and the accuracy of biopsy is further influenced.

Disclosure of Invention

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

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

an insertion assembly having a tubular shape for insertion into a body of a living being;

the needle head is connected to the end part of the insertion assembly and driven by the insertion assembly to reach the focus position of the body, the needle head is of a hollow structure, and a puncture angle is formed in the end part, far away from the insertion assembly, of the needle head;

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

Further, the needle head is cylindrical or regular prism-shaped.

Further, the insertion assembly includes an inner tube and an outer tube, the inner tube being located within the outer tube and reciprocating within the outer tube;

one end of the inner tube is connected with the needle head, and the positioning assembly is arranged in the inner tube and close to the position of the needle head.

Further, the outer pipe is a braided pipe with a multilayer structure, and comprises a PTFE/PEBAX/PA/PE/PI layer, a metal braided wire layer and a PEBAX/PTFE/PA/PE/PI layer from outside to inside respectively.

Furthermore, the outer tube is a single-cavity plastic tube, and the plastic material is PE/PP/POM/PTFE/PI/PA/PEEK.

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

the braided tube of the single-cavity multilayer structure comprises a PTFE layer, a stainless steel braided wire layer and a PEBAX layer from inside to outside.

Further, the surface of the tightly wound spring tube of the single-cavity flat metal wire/round metal wire is provided with a PET (polyethylene terephthalate), PE (polyethylene terephthalate), PTFEP (polyethylene terephthalate) and PP (polypropylene) layer.

Furthermore, the insertion assembly further comprises a limiting block, wherein the limiting block is arranged outside the outer pipe in a penetrating mode and can move along the surface of the outer pipe in a reciprocating mode.

Further, the locating component comprises a magnetic navigation locating sensor and a sensor protective cap, the sensor protective cap is integrated on the inner tube and close to the position of the needle head, and the magnetic navigation locating sensor is arranged in the sensor protective cap.

Further, locating component includes magnetic navigation positioning sensor, sensor protective cap and sensor protection sheath pipe, the sensor protective cap and the sensor protection sheath pipe is established intraductally, the open end of sensor protective cap with a tip connection of sensor protection sheath pipe, magnetic navigation positioning sensor establishes be close to in the sensor protection sheath pipe the tip of sensor protective cap.

Further, the biopsy needle further comprises a handle assembly comprising a handle 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 handheld part is connected with the end of the inner tube far away from the needle head, and the distal end part is connected with the end of the outer tube far away from the needle head;

and the handle assembly is provided with a compression spring which enables the distal end part and the handheld part to move relatively, and the compression spring is respectively connected with the distal end part and the handheld 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 needle comprises an insertion assembly and a needle head which are connected with each other, the positioning assembly is arranged in the end part, close to the needle head, of the insertion assembly, the position of the needle head in a muscle of a living body is positioned through the positioning assembly, the position of a biopsy tool is accurately determined, lesion sampling is more accurate, and biopsy accuracy is 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 not to limit the invention. In the drawings:

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

FIG. 2 is a perspective view of a needle head of a biopsy needle according to an embodiment of the present invention;

FIG. 3 is a perspective view of a needle head and insertion assembly of a biopsy needle according to an embodiment of the present invention;

FIG. 4 is a cross-sectional view of an outer tube of a biopsy needle according to an embodiment of the present invention;

FIG. 5 is a cross-sectional view of an inner tube of a biopsy needle according to an embodiment of the present invention;

FIG. 6 is a cross-sectional view of an alternative inner tube of a biopsy needle in accordance with embodiments of the present invention;

FIG. 7 is a side view of a biopsy needle according to an embodiment of the present invention;

FIG. 8 is a schematic view of a partial cross-sectional structure of a biopsy needle provided in accordance with an embodiment of the present invention;

fig. 9-18 are flow charts illustrating a method of operating a biopsy needle according to embodiments 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 the specific embodiments of the present invention and the accompanying drawings. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

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

Wherein the insertion assembly 10 is tubular for insertion into a body of a living being; the needle 20 is connected to the end of the insertion component 10 and driven by the insertion component 10 to reach the focal position of the body, the needle 20 is of a hollow structure, and the end far away from the insertion component 10 is provided with a puncture angle 210; the positioning assembly 30 is disposed at an end of the insertion assembly 10 adjacent to the needle 20 for positioning the needle 20 within the body.

Specifically, the tubular insertion assembly 10 is used for being inserted into a body of a living organism, where the living organism includes an animal body, a human body, etc., and the human body is taken as an example, the insertion assembly 10 enters the human body under the action of a machine or a human, the front end of the insertion assembly 10 is connected with the needle 20, the needle 20 can be conveyed to a lesion position in the human body along with the movement of the insertion assembly 10 in the human body, the needle 20 is a hollow tubular structure, and one end away from the insertion assembly 10 is provided with the puncture angle 210, the puncture angle 210 is used for puncturing the lesion, and the lesion of the human body is sampled through the hollow tubular structure of the needle 20; the end part of the insertion assembly 10 close to the needle 20, that is, 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 position of the needle 20 in the human body, so that the position of the needle 20 is accurately determined, the lesion sampling is more accurate, and the biopsy accuracy is further improved.

Further, in other preferred embodiments of the present invention, the needle 20 is cylindrical or regular prism.

Specifically, referring to fig. 2 and 3, the needle 20 is shown as being cylindrical, but in other embodiments, the needle 20 may be shaped as a regular prism, where it is only necessary to ensure that the needle 20 is hollow and the end thereof away from the insertion assembly 10 is provided with the piercing angle 210. Here, the needle 20 is set to be cylindrical or regular prism, so that the needle 20 can enter human tissues more smoothly, and the comfort of a patient during a biopsy operation is improved.

In addition, in other preferred embodiments of the present invention, the insertion assembly 10 includes an inner tube 110 and an outer tube 120, the inner tube 110 being located inside the outer tube 120 and reciprocating inside the outer tube 120;

one end of the inner tube 110 is connected to the needle 20, and the positioning assembly 30 is disposed in the inner tube 110 and near the needle 20.

Specifically, the positioning assembly 30 is disposed inside the inner tube 110 and adjacent to the needle 20 to better position the needle 20, and one end of the inner tube 110 is connected to the needle 20 so as to be reciprocally moved inside the outer tube 120 through the inner tube 110, so that the needle 20 can be extended out of the end of the outer tube 120 or retracted into the outer tube 120. If the biopsy needle enters or exits the lesion of the human body, the needle 20 may be optionally retracted into the outer tube 120 to avoid unnecessary damage to the body tissue caused by the needle 20; when the focus position of the human body is reached and the puncture sampling is carried out on the focus position, the needle 20 can be selected to extend out of the outer tube 120 to carry out corresponding operation.

In one preferred embodiment of the present invention, the outer tube 120 is a multi-layer braided tube, which comprises a PTFE/PEBAX/PA/PE/PI layer, a metal braided wire layer, and a PEBAX/PTFE/PA/PE/PI layer from the outside to the inside.

Specifically, as shown in fig. 4, the outermost layer 1201 and the innermost layer 1202 are made of any one of PTFE, PEBAX, PA, PE, and PI, which have a good lubricating effect, reduce the exercise resistance of the surface and inner wall of the outer tube 120, improve the comfort of the patient when the outer tube 120 is moved between human body tissues, and improve the smoothness of the inner tube 110 when the inner tube 110 is moved back and forth in the outer tube 120.

In addition, in other preferred embodiments of the present invention, the outer tube 120 is a single-lumen plastic tube made of PE/PP/POM/PTFE/PI/PA/PEEK.

Specifically, the single-lumen plastic tube has a certain elasticity that varies with the shape of the body tissue tract, so that the insertion assembly 10 can enter the body tissue and reach the target lesion site under manual or mechanical action, and has a high strength in the radial direction, so as to provide a reciprocating path for the inner tube 110, so that the relative movement between the two is facilitated, and the needle 20 can be extended or retracted into the outer tube 120. The single-cavity plastic tube is made of at least one material selected from the group consisting of PE, PP, POM, PTFE, PI, PA and PEEK, and these materials have a good lubricating effect, so that the surface movement resistance of the outer tube 120 can be reduced, the comfort of the patient during the movement of the outer tube 120 between the tissues of the human body can be improved, and the smoothness of the inner tube 110 during the reciprocating movement in the outer tube 120 can be improved.

Furthermore, in another preferred embodiment of the present invention, the inner tube 110 is any one of a single-lumen stainless steel flat/round tightly-wound spring tube, a flexible metal thin-wall tube, a laser-cut stainless steel flexible snake bone tube, a single-lumen multi-layer braided tube, a single-lumen/multi-lumen plastic tube, a single-lumen multi-strand stainless steel wire-wound hollow steel wire rope, and a flexible thin-wall metal tube, or may be formed by multi-segment splicing of the above structural forms;

the braided tube of the single-cavity multilayer structure comprises a PTFE layer, a stainless steel braided wire layer and a PEBAX layer from inside to outside.

Optionally, the surface of the tightly wound spring tube of the stainless steel round wire/round wire with a single lumen may be added with PET, PE, PTFEP, PP layers, and these coatings have better lubrication effect, which may reduce the surface motion resistance of the inner tube 110, improve the smoothness when the outer tube 120 and the inner tube 110 move relatively, and improve the operation sensitivity of the needle 20.

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

The single/multi-lumen plastic tube contains at least 1 lumen. The number of 1 main cavity 1101+ N sub-cavities 1102, N is 1-4 in the multi-cavity case. The subcavities 1102 may be completely within the tubing wall thickness, as shown in fig. 5; sub-cavity 1102 may also be partially exposed on the outer surface of the tube, as shown in fig. 6, where 1 main cavity 1101+4 sub-cavities 1102 are respectively shown above.

Further, a reinforcing wire 1103 can be penetrated in the main lumen 1101 and/or the sub-lumen 1102 for reinforcing the tensile strength of the tube body and connecting with the pull rod 240 of the needle 20 to bear the tensile force. The reinforcing wire 1103 is a single stainless steel round wire or flat wire, or a steel wire rope wound by multiple stainless steel round wires.

The hollow steel wire rope wound by the multi-strand stainless steel wire with the single cavity is spirally wound by the multi-strand stainless steel round wire/flat wire and comprises a plurality of layers.

The number of the multi-strand stainless steel round wires/flat wires is N, and the number of N is 4-12.

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

In addition, referring to fig. 7, 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 serves as a depth limiting mark for controlling the insertion assembly 10 to enter the 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, silicone.

Further, in another preferred embodiment of the present invention, please refer to fig. 7, the biopsy needle further comprises a handle assembly 40, wherein the handle assembly 40 comprises a handheld portion 410, a distal portion 420 and a proximal portion 430;

the hand-held portion 410 includes a movable hand-held portion 411 and a fixed hand-held portion 412;

the movable handle 411 is connected to the end of the inner tube 110 away from the needle 20, and the distal end 420 is connected to the end of the outer tube 120 away from the needle 20;

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

Further, a compression spring 440 is disposed on the handle assembly 40 for moving the distal portion 420 and the hand-held portion 410 relatively, and the compression spring 440 is connected to the distal portion 420 and the hand-held portion 410 respectively. Specifically, the hand-held portion 410 is designed ergonomically, and is adapted to the hand control structure of the operator, the distal portion 420 and the proximal portion 430 are respectively disposed at two sides of the hand-held portion 410, the hand-held portion 410 is provided with a movable hand-held portion 411 and a fixed hand-held portion 412, the distal portion 420 is fixedly connected with the outer tube 120, the movable hand-held 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 portion 420 and the hand-held portion 410, the compression spring 440 can ensure that the relative separation tendency of the distal portion 420 and the hand-held portion 410 ensures that the needle 20 is retracted into the outer tube 120 for entering the body or the channel in the static state, the movable hand-held portion 411 is fixedly connected with the inner tube 110, and the operator can make the needle 20 protrude out of the outer tube 120 by moving the movable hand-held portion 411 and the distal portion 420 to approach or separate from each other, so as to complete the biopsy and the puncture and sampling of the lesion sample of the body tissue.

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

Specifically, the channel portion is disposed inside the handle assembly 40 for connecting with the inner tube 110 or disposing the inner tube 110, and the connecting portion 450 is communicated with the channel portion and opened at the end of the proximal portion 430 for a penetration inlet of the inner tube 110, an insertion inlet of the positioning assembly 30, and the like.

Optionally, a connection portion may be disposed on the handle assembly 40 for connecting a dedicated auxiliary consumable/endoscopic forceps channel interface.

The positioning assembly 30 will be described in detail below.

Referring to fig. 8, in a preferred embodiment of the present invention, the positioning assembly 30 comprises a magnetic navigation positioning sensor 310 and a sensor protection cap 320, the sensor protection cap 320 is integrated on the inner tube 110 near the needle 20, and the magnetic navigation positioning sensor 310 is disposed in the sensor protection cap 320.

In the present embodiment, the positioning component 30 and the insertion component 10 are integrally non-detachable, specifically, the sensor protection cap 320 is a tubular structure with one end open and the other end closed, wherein the closed section faces the needle 20, the open end is connected with the end of the inner tube 110 or inserted into the inner tube 110, so that the sensor protection cap 320 and the inner tube 110 are integrated, and the magnetic navigation positioning sensor 310 is disposed in the sensor protection cap 320, wherein the sensor protection cap 320 protects the magnetic navigation positioning sensor 310, and the end of the magnetic navigation positioning sensor 310 away from the needle 20 is connected with an external device through a sensor cable, wherein the sensor cable is inserted into the inner tube 110 and passes through the interface portion 450 to be connected with the external device, which includes but is not limited to a magnetic navigation device or other display device.

Referring to fig. 1, in another preferred embodiment of the present invention, the positioning component includes a magnetic navigation positioning sensor 310, a sensor protection cap 320 and a sensor protection sheath 330, the sensor protection cap 320 and the sensor protection sheath 330 are disposed in the inner tube 110, the open end of the sensor protection cap 320 is connected to one end of the sensor protection sheath 330, and the magnetic navigation positioning sensor 310 is disposed in the sensor protection sheath 330 near the end of the sensor protection cap 320.

In particular, the sensor protection sheath 330 herein serves as an introducer sheath for placement and removal of the magnetic navigation positioning sensor 310 to promote ease of installation and operation of the biopsy needle. 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 between the sensor protection cap 320 and the sensor protection sheath 330 enters the inner tube 110 from the interface part 450, and then reaches the position close to the needle 20 to position the needle. For the connection between the magnetic navigation positioning sensor 310 and the external device, reference may be made to the description of the above embodiments, which are not repeated herein.

The method for using the biopsy needle is described in detail below, and particularly relates to a process and a method for performing lung location biopsy by using the biopsy needle under a magnetic navigation condition. Fig. 9-18 are flow charts of lung localization biopsies taken with the biopsy needle under magnetic navigation conditions through a guiding catheter.

S100: CT images are imported and three-dimensional models of the pulmonary bronchial tree structure and of the 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 be separated from other tissues. The reconstructed bronchus and blood vessel models need to be superposed in the same three-dimensional model for observation (different color regions can be adopted for the bronchus and blood vessel models).

S200, a focus point A needing sampling is outlined, and the focus point A is shown in figure 9.

S300, using the focus point a as the navigation path end point, according to the magnetic navigation path planning procedure in the prior art, a navigation path from the main carina to the focus point a is planned, as shown in fig. 10.

And S400, inserting the magnetic navigation positioning biopsy needle into the guide catheter and connecting the magnetic navigation positioning biopsy needle with a magnetic navigation positioning system.

S500, operating the finger guide tube to reach the focus point A along the navigation path, as shown in figure 11.

S600, operating the handle of the magnetic navigation positioning biopsy needle to perform biopsy sampling, as shown in figure 12.

Specifically, the coordinates of the path actually traversed 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 as to correct the coordinates of the focus point A to be reached in the magnetic navigation positioning system to be matched with the coordinates in the three-dimensional model of the bronchial tree structure, thereby reducing positioning errors and errors of later in vivo sampling and improving the accuracy.

Alternatively, in steps S200-S600, if the target lesion is behind the tracheal wall or there is no significant tracheal access, as at point B in fig. 13, a puncture wall breaking tool is used to manually create a pathway to the target lesion. The method comprises the following steps:

referring to fig. 13, a lesion point B to be sampled is outlined in S200. Meanwhile, a puncture wall breaking point B' is drawn, and the position which is as close as possible to the point B or the position which is convenient for puncture is selected.

Referring to fig. 13, in S300, a main navigation path from the main carina to the puncture point B 'is planned according to the magnetic navigation path planning procedure 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 as a secondary navigation path by taking the puncture point B' as a starting point and the focus point B as an end point.

Referring to fig. 14, in S400, a puncture wall breaking tool is inserted into the guide catheter to make a puncture starting from the puncture point B' to create a passage leading to the focal point B.

As shown in fig. 15, in S500, the guide catheter and the wall-breaking puncture tool are punctured along the secondary navigation path to reach the lesion point B, and then the wall-breaking puncture tool is withdrawn to insert the magnetic navigation positioning biopsy needle.

As shown in fig. 16, the magnetic navigation positioning biopsy needle handle is operated in S600 to perform biopsy.

Optionally, in steps S400-S500, a magnetic navigation positioning biopsy needle with the positioning assembly 30 integrated into the biopsy needle may be used, or the positioning assembly 30 may be used as a separate assembly/product magnetic navigation positioning biopsy needle.

Optionally, in steps S400-S500, when the positioning assembly 30 is used as a magnetic navigation positioning biopsy needle of a separate assembly/product, the positioning assembly 30 may be inserted directly into the guiding catheter first, and the guiding catheter may be operated to reach the focal point a. The positioning assembly 30 is then withdrawn and assembled into a biopsy needle to form a magnetic navigation positioning biopsy needle, which is then inserted into the guide catheter and extended out of its distal end for sampling. The reason for this is that the distal end portion of the biopsy needle is a long metal entity, which affects the curved shape of the distal end of the guide catheter, and the guide catheter is difficult to enter at the corresponding tracheal bifurcation selected by the specific curved shape, so that the guide catheter is difficult to smoothly reach the target lesion site along the navigation path, and the operation time is prolonged.

Optionally, when the positioning assembly is used as a magnetic navigation positioning biopsy needle of an independent assembly/product, after biopsy needle forceps detection, the positioning assembly can be drawn out on site, sterilized, wiped and inserted into other tools capable of guiding a magnetic navigation system, such as forceps, brushes, needles and the like, to perform multiple compound biopsies, so as to improve the positive detection rate.

Alternatively, in step S400-500, if the target focal point is located in a shallow lung, it can be reached by using a bronchoscope and directly observed visually by using its imaging system, such as the focal point C in fig. 17. Or the bronchoscope can not be observed by the image system directly after arriving, but the focus point clings to the trachea wall, such as focus point D in fig. 18 (correspondingly, a tool or a method should be used to puncture the trachea wall in advance, such as a special puncture wall breaking tool, or a biopsy needle with a puncture head, a biopsy brush, or a biopsy needle). The magnetic navigation positioning biopsy needle is directly inserted into the bronchoscope forceps channel and extends out of the front end of the forceps channel without using a guide catheter, and then enters the focus 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 a … …" does not exclude the presence of another identical element in a process, method, article, or apparatus that comprises the element.

As will be appreciated by one skilled in the art, 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 above description is only an example of the present invention, and is not intended to limit the present invention. Various modifications and alterations to this invention will become apparent to those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the scope of the claims of the present invention.

Claims (12)

1. A biopsy needle, comprising:

an insertion assembly having a tubular shape for insertion into a body of a living being;

the needle head is connected to the end part of the insertion assembly and driven by the insertion assembly to reach the focus position of the body, the needle head is of a hollow structure, and a puncture angle is formed in the end part, far away from the insertion assembly, of the needle head;

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

2. The biopsy needle of claim 1, wherein the needle head is cylindrical or regular prism shaped.

3. The biopsy needle of claim 1, wherein the insertion assembly comprises an inner tube and an outer tube, the inner tube being located within the outer tube and reciprocating within the outer tube;

one end of the inner tube is connected with the needle head, and the positioning assembly is arranged in the inner tube and close to the position of the needle head.

4. The biopsy needle of claim 3, wherein the outer tube is a braided tube of a multilayer structure, comprising a PTFE/PEBAX/PA/PE/PI layer, a metal braided wire layer, and a PEBAX/PTFE/PA/PE/PI layer, respectively, from the outside to the inside.

5. The biopsy needle of claim 3, wherein the outer tube is a single lumen plastic tube made of PE/PP/POM/PTFE/PI/PA/PEEK.

6. The biopsy needle according to claim 3, wherein the inner tube is any one of a single-cavity stainless steel flat/round wire tightly-wound spring tube, a flexible metal thin-wall tube, a laser-cut metal flexible snake bone tube, a single-cavity multilayer structure braided tube, a single-cavity/multi-cavity plastic tube, a single-cavity multi-strand stainless steel wire wound hollow steel wire rope and a flexible thin-wall stainless steel tube, or is formed by multi-segment splicing of the above multiple structural forms;

the braided tube of the single-cavity multilayer structure comprises a PTFE layer, a stainless steel braided wire layer and a PEBAX layer from inside to outside.

7. The biopsy needle of claim 6, wherein the surface of the single lumen metal flat/round wire close-wound spring tube is provided with a layer of PET, PE, PTFEP, PP.

8. The biopsy needle of claim 3, wherein the insertion assembly further comprises a stopper disposed through the outer tube and reciprocally movable along a surface of the outer tube.

9. The biopsy needle of claim 3, wherein the positioning assembly comprises a magnetic navigation positioning sensor integrated into the inner tube proximate the needle location and a sensor protective cap disposed within the sensor protective cap.

10. The biopsy needle of claim 3, wherein the positioning assembly comprises a magnetic navigation positioning sensor, a sensor protective cap, and a sensor protective sheath, the sensor protective cap and the sensor protective sheath being disposed within the inner tube, the open end of the sensor protective cap being coupled to an end of the sensor protective sheath, the magnetic navigation positioning sensor being disposed within the sensor protective sheath proximate the end of the sensor protective cap.

11. The biopsy needle of claim 3, further comprising a handle assembly comprising 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 handheld part is connected with the end of the inner tube far away from the needle head, and the distal end part is connected with the end of the outer tube far away from the needle head;

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

12. The biopsy needle of claim 11, wherein a channel portion is provided in the handle assembly in communication with the inner tube, and an end of the proximal end portion is provided with an interface portion in communication with the channel portion.

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