WO2021159552A1

WO2021159552A1 - Needle assembly and sampling needle

Info

Publication number: WO2021159552A1
Application number: PCT/CN2020/076150
Authority: WO
Inventors: 王涛; 唐志; 刘伟; 李常青
Original assignee: 南微医学科技股份有限公司
Priority date: 2020-02-11
Filing date: 2020-02-21
Publication date: 2021-08-19
Also published as: CN113243946A

Abstract

Provided are a needle assembly (001) and a sampling needle (010). The needle assembly (001) comprises a memory needle tip (100) having a first channel (110) and a needle tube (200) having a second channel (210). The memory needle tip (100) is connected to the needle tube (200), and the first channel (110) is communicated with the second channel (210); the bending rigidity of the memory needle tip (100) is greater than that of the needle tube (200). The sampling needle comprises the needle assembly (001). The needle assembly (001) is convenient to process and manufacture, and the costs are reduced. The needle assembly (001) is flexible to operate, and the memory needle tip (100) can accurately reach a position to be punctured during repeated puncturing, thereby improving the success rate of an operation.

Description

Needle assembly and sampling needle

Cross-references to related applications

This application claims the priority of the Chinese patent application with the application number CN202010086823.6 and the name "Needle Assembly and Sampling Needle" submitted to the Chinese Patent Office on February 11, 2020, the entire content of which is incorporated into this application by reference.

Technical field

This application relates to the field of medical equipment, and specifically to a needle assembly and a sampling needle.

Background technique

Under the guidance of an ultrasound bronchoscope/endoscopic ultrasound, a tissue or cytology sample is obtained after aspiration with a sampling needle, which is often referred to as EBUS/EUS examination in clinical practice. EBUS can locate the specific location of extrabronchial lesions through ultrasound, avoid blood vessels under the guidance of color Doppler, and obtain the cells and tissues of the corresponding parts through needle aspiration and biopsy, so as to achieve the purpose of confirming the disease. The EUS examination has high accuracy in staging the primary tumor and local nodules of pancreatic cancer.

The inventor found in the research that the existing sampling needles have at least the following defects:

First, in the EBUS/EUS examination, the doctor will adjust the forceps lifter according to the required puncture lesions when operating and using the instrument. At the extreme position, the needle tube will be rigidly opposed to the endoscope forceps and the forceps lifter, resulting in needle ejection. The resistance is large, and the distal end of the needle is easily deformed after the needle is forced out, resulting in the inability to continue to use it in the future;

Second, at present, there are sampling needles with low needle resistance on the market, but the distal end of this type of sampling needle has no or low rigid support when the needle is discharged, the puncture is easy to deviate, and the needle tube is permanently deformed after puncture at the limit position and cannot be recovered. ；

Third, the existing sampling needle has high processing and manufacturing costs.

Summary of the invention

The purpose of the present application includes, for example, providing a needle assembly and a sampling needle, which can not only reduce the needle resistance, but also can restore the deformation of the needle after deformation, and can be reused; and can reduce the processing and manufacturing cost of the sampling needle.

The embodiments of this application can be implemented as follows:

In a first aspect, an embodiment provides a needle assembly, and the needle assembly includes:

A memory needle with a first channel and a needle tube with a second channel, the memory needle is connected with the needle tube and the first channel is connected with the second channel; the bending stiffness of the memory needle is greater than the bending stiffness of the needle tube.

In an alternative embodiment, the needle assembly further includes a connector, and the memory needle and the needle tube are connected by the connector.

In an alternative embodiment, the connector is provided with a third channel, and both ends of the third channel are open along the extension direction of the third channel, the memory needle communicates with one end of the third channel in the extension direction, and the needle tube is connected to the third channel. The three channels are connected at the other end in the extending direction.

In an alternative embodiment, both the memory needle and the needle tube are inserted into the third channel, and the distal end of the memory needle exposes the third channel, and the proximal end of the needle tube exposes the third channel.

In an alternative embodiment, the memory needle is provided with a first protrusion, and the connecting member is provided with a second protrusion. The first protrusion and the second protrusion are resisted to prevent the memory needle from being in the third channel The extension direction of the detachment from the third channel is toward the direction away from the needle tube.

In an alternative embodiment, the first convex portion protrudes from the outer peripheral surface of the memory needle along a direction that has an angle with the extending direction of the first channel; the second convex portion has an angle with the extending direction of the third channel. The direction protrudes from the inner wall of the third channel; the memory needle is inserted into the third channel so that the first convex part and the second convex part resist.

In an alternative embodiment, at least one of the first convex portion and the second convex portion has an annular structure.

In an alternative embodiment, the needle tube and the connector are relatively fixed in the extension direction of the third channel, and the needle is held against the needle tube at the end close to the needle tube to prevent the memory needle from approaching the needle tube in the extension direction of the third channel The direction leaves the third channel.

In an alternative embodiment, the needle tube is welded to the connector, and an annular weld is formed between the needle tube and the connector.

In an alternative embodiment, the needle assembly further includes a guide member provided with a fourth channel, the guide member is located in the third channel; the fourth channel has a variable diameter section, the first end of the variable diameter section is close to the needle tube, The second end of the guide member is close to the memory needle, and the inner diameter of the diameter-reducing section gradually decreases from the first end to the second end; the two ends of the guide member along the extension direction of the guide member respectively resist the memory needle and the needle tube.

In an optional embodiment, the fourth channel further includes a first equal diameter section and a second equal diameter section. The first equal diameter section is connected to the first end, and the inner diameter of the first equal diameter section is equal to the inner diameter of the first end. ; The second equal diameter section is connected to the second end, and the inner diameter of the second equal diameter section and the second end are equal.

In an alternative embodiment, the needle assembly further includes a ring-shaped distal seal, and the distal seal is provided between the outer circumferential surface of the memory needle and the inner circumferential surface of the connector.

In an optional embodiment, the tube wall of the needle tube is provided with a through hole; the needle assembly further includes a proximal end seal, and the proximal end seal is configured to be connected with the needle tube to block the through hole.

In an alternative embodiment, the needle assembly further includes a fastener, the proximal seal has a fastening part close to the memory needle, the fastener is sleeved outside the fastening part, and the fastening part and the fastener pass Surplus fit.

In an alternative embodiment, the memory needle is made of cobalt-chromium alloy, copper-zinc-aluminum 36 alloy, iron-manganese-silicon alloy, gold-cadmium alloy, copper-aluminum alloy, copper-aluminum-nickel alloy or nickel-titanium alloy.

In a second aspect, an embodiment provides a sampling needle, and the sampling needle includes:

For the handle and the needle assembly of any one of the foregoing embodiments, the handle is connected to the needle tube of the needle assembly.

The beneficial effects of the embodiments of the present application include, for example:

In summary, this embodiment provides a needle assembly including a memory needle and a needle tube connected. The bending stiffness of the memory needle is greater than that of the needle tube, and the memory needle is less prone to bend in the extension direction than the needle tube. Due to the elastic deformation, the needle tube is more easily deformed during the needle ejection process, thereby reducing the resistance of the endoscope forceps to the needle assembly, and at the same time ensuring that the memory needle is not easily deformed after multiple punctures at the limit position. The bending rigidity of the memory needle and the needle tube is different. If the memory needle and the needle tube are separated for processing and then assembled into one body, the processing difficulty is low; at the same time, when the memory needle and the needle tube are processed, there is an error that causes the product to be unqualified. Before assembling the memory needle and needle tube, the unqualified memory needle or needle tube can be replaced. Compared with the traditional one-piece needle and needle tube, the needle or needle tube cannot be replaced separately when the product is unqualified, which saves resources. , The cost of processing and manufacturing the needle assembly is reduced; and the memory needle and the needle tube are processed separately, which reduces the processing difficulty and improves the processing quality.

This embodiment also provides a sampling needle, including the above-mentioned needle assembly, the sampling needle has low processing and manufacturing costs, and is convenient and reliable to use.

Description of the drawings

In order to more clearly describe the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings that need to be used in the embodiments. It should be understood that the following drawings only show certain embodiments of the present application, and therefore do not It should be regarded as a limitation of the scope. For those of ordinary skill in the art, other related drawings can be obtained based on these drawings without creative work.

Figure 1 is a schematic diagram of the structure of the needle assembly provided by this embodiment;

2 is a schematic structural diagram of the deformed structure of the needle assembly provided by this embodiment;

3 is a schematic diagram of the structure of the memory needle provided by this embodiment;

4 is a schematic diagram of the structure of the needle tube provided by this embodiment;

Fig. 5 is a schematic structural diagram of a partially enlarged structure at V in Fig. 2;

Fig. 6 is a schematic structural diagram of a partial enlarged structure at VI in Fig. 2;

FIG. 7 is a schematic diagram of the structure of the connector provided by this embodiment;

Fig. 8 is a schematic structural diagram of a partially enlarged structure at VIII in Fig. 2;

Figure 9 is a schematic structural diagram of the guide provided by this embodiment;

Figure 10 is a schematic diagram of the structure of the sampling needle provided by this embodiment (the distal end of the memory needle is in a state of being bent under force);

FIG. 11 is a schematic structural diagram of a partially enlarged structure at XI in FIG. 10;

FIG. 12 is a schematic diagram of the deformed structure of the memory needle provided by this embodiment.

icon:

010-sampling needle; 001-needle assembly; 100-memory needle; 110-first channel; 200-needle tube; 210-second channel; 220-missing part; 230-installation pipe section; 300-first convex part; 310 -Outer circumferential surface; 320-distal torus; 400-proximal seal; 410-fastening part; 500-fastener; 600-connecting piece; 610-third channel; 620-circular weld; 700 -Second protrusion; 800-distal seal; 900-guide member; 910-fourth channel; 911-first equal diameter section; 912-reducing section; 9121-first end; 9122-second end; 913-Second equal diameter section; 002-Outer tube; 003-Handle.

Detailed ways

In order to make the purpose, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments It is a part of the embodiments of the present application, but not all of the embodiments. The components of the embodiments of the present application generally described and shown in the drawings herein may be arranged and designed in various different configurations.

Therefore, the following detailed description of the embodiments of the application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely represents selected embodiments of the application. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of this application.

It should be noted that similar reference numerals and letters indicate similar items in the following figures. Therefore, once a certain item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

In the description of this application, it should be noted that if the terms "upper", "lower", "inner" and "outer" indicate the orientation or positional relationship, it is based on the orientation or positional relationship shown in the drawings, or It is the orientation or positional relationship that the product of the invention is usually placed in use, only for the convenience of describing the application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation , Therefore cannot be understood as a restriction on this application.

In addition, if the terms "first" and "second" appear, they are only used for distinguishing description, and cannot be understood as indicating or implying relative importance.

It should be noted that, in the case of no conflict, the features in the embodiments of the present application can be combined with each other.

In this embodiment, it should be noted that those skilled in the art can understand that when the sampling needle 010 is used, the front end of the sampling needle 010 is in contact with the human body, and the rear end of the sampling needle 010 is for the operator to operate. For ease of description, the following content In each of the parts of the sampling needle 010, the end close to the front end of the sampling needle 010 is called the distal end, and the end of each part close to the rear end of the sampling needle 010 is called the proximal end.

Please refer to Figure 1. This embodiment provides a needle assembly 001, which is configured to puncture the tissue of the body to be sampled for sampling. It can be used alone or in conjunction with an endoscope (not shown). The needle assembly 001 is difficult to manufacture Low, low processing cost, and high processing quality; when the needle assembly 001 is used in conjunction with an endoscope, the needle tube 200 can produce corresponding elastic deformation with the curved shape of the clamp channel of the endoscope, and the resistance received is small, and it is easy to be in the clamp channel Sliding, the operation is more flexible; and the memory needle 100 is not easy to produce elastic deformation, and the puncture position is accurate and reliable.

Please refer to FIG. 1, the needle assembly 001 provided in this embodiment includes a memory needle 100 with a first channel 110 and a needle tube 200 with a second channel 210. The memory needle 100 is connected to the needle tube 200 and the first channel 110 is connected to the second channel. The channel 210 is connected; the bending stiffness of the memory needle 100 is greater than the bending stiffness of the needle tube 200, and the memory needle 100 is less prone to elastic deformation than the needle tube 200.

In the needle assembly 001 provided in this embodiment, the bending stiffness of the memory needle 100 and the needle tube 200 are different, and the processing and manufacturing materials of the two may be different, or the two may be processed with the same material and different processes are used to form different bending stiffness. structure. During processing, the memory needle 100 and the needle tube 200 are separated for processing and then assembled into one body. The processing difficulty is low, especially when the memory needle 100 and the needle tube 200 are processed separately with materials with different elastic modulus, it can be reduced to a greater extent Difficulty in processing; At the same time, during the processing of the memory needle 100 and the needle tube 200, if an error occurs and the product is unqualified, the unqualified memory needle 100 or needle tube 200 can be replaced before the memory needle 100 and the needle tube 200 are assembled Compared with the traditional integrated needle and needle tube 200, the needle or needle tube 200 cannot be replaced separately when the product is unqualified. This saves resources and reduces the cost of processing and manufacturing the needle assembly 001; and the memory needle 100 and needle tube 200 is processed separately, which reduces the processing difficulty and improves the processing quality. At the same time, since the bending rigidity of the memory needle 100 is greater than that of the needle tube 200, the memory needle 100 is more difficult to deform than the needle tube 200. When the needle assembly 001 is matched with the endoscope and the clamp channel of the endoscope has a curved section, the needle tube The 200 is easier to deform elastically with the deformation of the forceps. The sliding resistance of the needle assembly 001 in the forceps is small, the external force required during the puncture process is small, the operation is more flexible, and the hand experience of the operator is improved. In addition, during the puncture process, the forceps lifter needs to be raised to a larger angle (for example, 20°-25°) according to the surgical requirements. At this time, the memory needle 100 undergoes elastic deformation under the drive of the forceps lifter. The bending rigidity of the needle 100 is greater than that of the needle tube 200, and its force to restore elastic deformation is greater, so that the memory needle 100 can be restored to the original state after elastic deformation, thereby ensuring the accuracy of the puncture position during multiple punctures , Improve the success rate of surgery.

Referring to FIG. 3, in this embodiment, optionally, the distal end of the memory needle 100 is configured to puncture human tissue, and the distal end of the memory needle 100 has a bevel, so that the distal end of the memory needle 100 is a pointed end. Sampling is performed in the penetration tissue.

Please refer to FIG. 12. Optionally, in other embodiments, the distal end of the memory needle 100 has a plurality of inclined surfaces, and the plurality of inclined surfaces are arranged around the circumference of the memory needle 100.

Further, the memory needle 100 has a tubular structure. Optionally, the memory needle 100 may be a cylindrical tube, the lumen of the memory needle 100 is the first channel 110, and the end surface of the proximal end of the memory needle 100 is perpendicular to The extension direction of the memory needle 100. It should be noted that since the memory needle 100 can produce elastic deformation under the action of external force, the following description of the structure of the memory needle 100 is only the original state of the memory needle 100, that is, the memory needle 100 is not subjected to external force. A state of elastic deformation. Optionally, the memory needle 100 extends along a straight line, that is, the memory needle 100 is a straight tube, the proximal end of the memory needle 100 is a torus, and the center of the torus is on the axis of the memory needle 100 .

In this embodiment, optionally, the memory needle 100 can be made of a superelastic alloy, which can be, but is not limited to, cobalt-chromium alloy, copper-zinc-aluminum 36 alloy, iron-manganese-silicon alloy, gold-cadmium alloy , Copper-aluminum alloy, copper-aluminum-nickel alloy and nickel-titanium alloy. It should be noted that, in this embodiment, the memory needle 100 is made of Nitinol.

In this embodiment, optionally, the memory needle 100 is provided with a first convex portion 300, the first convex portion 300 has a ring structure, the first convex portion 300 is located on the outer peripheral surface of the memory needle 100, and the first convex portion 300 extends around the axis of the memory needle 100. Optionally, the first protrusion 300 protrudes from the outer peripheral surface of the memory needle 100 in a direction perpendicular to the axis of the memory needle 100, and the axis of the first protrusion 300 coincides with the axis of the memory needle 100.

It should be understood that in other embodiments, the first convex portion 300 may not be provided in the annular convex structure, and when the first convex portion 300 is not provided in the annular convex structure, the number of the first convex portions 300 may be more than one. , The plurality of first protrusions 300 are arranged at even intervals along the circumferential direction of the memory needle 100.

Optionally, the first protrusion 300 and the memory needle 100 are two independent components, and the first protrusion 300 and the memory needle 100 are separately processed and then assembled into one body. Optionally, the first convex portion 300 is sleeved on the outer peripheral surface of the memory needle 100, and the end surface of the proximal end of the first convex portion 300 and the end surface of the proximal end of the memory needle 100 are located in the same plane.

Optionally, the first protrusion 300 is welded to the memory needle 100. Obviously, in other embodiments, the memory needle 100 and the first protrusion 300 may be fixedly connected in other ways.

It should be noted that in other embodiments, the first protrusion 300 may protrude from the inner wall of the first channel 110 in a direction having an angle with the extending direction of the memory needle 100.

Optionally, the first protrusion 300 can be made of the same material as the memory needle 100.

2 and 4, in this embodiment, optionally, the needle tube 200 may be a cylindrical tube, the lumen of the needle tube 200 is the second channel 210, and both ends of the second channel 210 along the extending direction are open. mouth. The distal and proximal ends of the needle tube 200 along its extending direction are both toroids. The inner diameter of the needle tube 200 is larger than the inner diameter of the memory needle 100 so that the operating instrument can enter the memory needle 100 through the needle tube 200. Optionally, the needle tube 200 may be made of stainless steel.

In this embodiment, optionally, a missing part 220 is provided on the tube wall of the needle tube 200. The missing part 220 may be a recessed part or a through hole. The thickness of the needle tube 200 at the position of the missing part 220 is smaller than the thickness of other positions. However, when the missing portion 220 is a through hole, it can be understood that the wall thickness of the missing portion 220 at the through hole is zero. By providing the missing part 220, the needle tube 200 is more prone to elastic deformation, reducing the rigidity of the needle tube 200 and the endoscope clamp channel, the needle tube 200 is easier to succumb to the bending of the endoscope, the needle is easier to exit, and the memory after the needle is forced out is improved. The needle is prone to irreversible deformation.

Optionally, the number of the missing part 220 may be one or more. When the number of the missing part 220 is one, the missing part 220 may be a spiral structure, that is, the missing part 220 surrounds the axis of the needle tube 200 along the extension direction of the needle tube 200 Extending in a spiral line, the missing portion 220 is convenient for processing, and the structure of the needle tube 200 is more regular and the deformation is more uniform. When the number of the missing parts 220 is multiple, the multiple missing parts 220 are arranged on the needle tube 200 at intervals.

2 and 5, it should be noted that the end of the missing part 220 close to the distal end of the needle tube 200 is spaced from the distal end of the needle tube 200, and the tube section between the distal end of the needle tube 200 and the missing part 220 is the length of the needle tube 200. The installation pipe section 230, in other words, the installation pipe section 230 is not provided with the missing portion 220.

2 and 6, optionally, when the missing portion 220 is configured as a through hole, the needle tube 200 is provided with a proximal end seal 400, and the proximal end seal 400 is configured to block the through hole.

Optionally, the proximal end seal 400 is sleeved on the outer peripheral surface of the needle tube 200, and the proximal end seal 400 is not provided outside the installation tube section 230 of the needle tube 200.

Further, the portion of the proximal seal 400 close to the installation pipe section 230 is provided as a fastening portion 410, the fastening portion 410 is sheathed with a fastener 500, and the fastener 500 is in interference fit with the fastening portion 410. That is, the fastener 500 provides the fastening part 410 with a locking force inward in the radial direction of the needle tube 200, so that the fastening part 410 is squeezed between the needle tube 200 and the fastener 500, thereby improving the fastening. The binding force of the part 410 and the needle tube 200 makes it difficult for the fastening part 410 to be separated from the needle tube 200 due to deviation or turning up during the elastic deformation of the needle tube 200, and the proximal sealing member 400 has a good effect of sealing the through hole.

Referring to FIGS. 2 and 7, in this embodiment, optionally, the needle assembly 001 further includes a connecting piece 600, and the memory needle 100 and the needle tube 200 are connected by the connecting piece 600.

Optionally, the connecting member 600 has a third channel 610, and both ends of the connecting member 600 in the extending direction of the third channel 610 are open, that is, both ends of the third channel 610 in the extending direction are open. . Further, the cross-sectional shape of the connecting piece 600 is a circular ring, the cross-section of the connecting piece 600 is a plane perpendicular to the extending direction of the connecting piece 600, and the shape of the connecting piece 600 is regular, which is convenient for processing and manufacturing, and also convenient for memory The needle 100 and the needle tube 200 are connected.

Further, the connecting member 600 is provided with a second convex portion 700, the second convex portion 700 has an annular structure, the second convex portion 700 is located on the inner wall of the third channel 610, and the second convex portion 700 extends around the axis of the connecting member 600 . Optionally, the second convex portion 700 has a circular ring shape, the second convex portion 700 protrudes from the inner wall of the third channel 610 along the extending direction perpendicular to the connecting member 600, and the second convex portion 700 is arranged coaxially with the connecting member 600 . One end surface of the second protrusion 700 in the extending direction is in the same plane as the end surface of the connecting member 600, and the other end surface of the second protrusion 700 in the extending direction is spaced from the proximal end of the connecting member 600. , So that the connecting member 600 and the second protrusion 700 form a stepped structure.

In other embodiments, the second convex portion 700 may not be provided in an annular structure, and when the second convex portion 700 is not provided in an annular convex structure, the number of the second convex portions 700 may be multiple, and multiple second The protrusions 700 are arranged at even intervals along the circumferential direction of the third channel 610.

In other embodiments, the second protrusion 700 may protrude from the outer peripheral surface of the connecting member 600 in a direction having an angle with the extending direction of the third channel 610, so as to be connected to the first channel 110 of the memory needle 100. The first protrusion 300 on the inner wall resists and fits.

It should be noted that the second protrusion 700 and the connecting member 600 can be integrally formed, and the structure is stronger.

2 and 8, in this embodiment, optionally, the needle assembly 001 further includes a distal seal 800, the distal seal 800 is provided between the memory needle 100 and the connector 600 to prevent the first The channel 110 communicates with the gap between the outer circumferential surface of the memory needle 100 and the inner wall of the connecting member 600, that is, to prevent the fluid in the first channel 110 from leaking.

Optionally, the distal end sealing member 800 is disposed between the first protrusion 300 and the connecting member 600. Further, the first convex portion 300 has an outer circumferential surface 310 and a distal toroidal surface 320 close to the distal end of the memory needle 100. The outer circumferential surface 310 and the distal toroidal surface 320 are connected, and the distal seal 800 simultaneously wraps the outer circumferential surface. The circumferential surface 310 and the distal annular surface 320, that is, the memory needle 100 and the connector 600 form a sealing portion with an included angle, thereby improving the sealing effect.

In this embodiment, optionally, the distal seal 800 is fixed on the first convex portion 300 on the outer peripheral surface of the memory needle 100, and forms an integral structure with the first convex portion 300. When assembling, the memory needle 100 is inserted into the third channel 610, and the distal seal 800 is squeezed between the memory needle 100 and the connector 600 for easy assembly.

In this embodiment, optionally, the distal end seal 800 is made of a polymer elastic material. The polymer elastic material can be, but is not limited to, latex, PTFE (Polytetrafluoroethylene) or Pebax (Polyether block polyamide).

2 and 9, in this embodiment, optionally, the needle assembly 001 further includes a guide member 900, the guide member 900 is a tubular structure with a circular cross section, and the lumen of the guide member 900 is the fourth channel 910. The fourth channel 910 includes a first equal diameter section 911, a variable diameter section 912, and a second equal diameter section 913 that are sequentially connected from the proximal end to the distal end, the first equal diameter section 911, the variable diameter section 912, and the second equal diameter section 913 The diameter section 913 is coaxial. The diameter reducing section 912 has a first end 9121 and a second end 9122 in the extending direction. The inner diameter of the diameter reducing section 912 gradually decreases from the first end 9121 to the second end 9122, that is, the first end 9121 is a diameter reducing section. The larger end of the section 912 and the second end 9122 are the smaller end of the variable diameter section 912. The first equal diameter section 911 is connected to the first end 9121, and the second equal diameter section 913 is connected to the second end 9122. When in use, the instrument enters from the first equal diameter section 911 and passes through the variable diameter section 912 to reach the second equal diameter section 913. The inner diameter of the first equal diameter section 911 is large, so the instrument can easily enter the first equal diameter section 911 and change The diameter section 912 has a guiding function, which is convenient for guiding the instrument into the second equal diameter section 913.

The assembly process of the needle assembly 001 provided in this embodiment includes, for example:

Please refer to Fig. 2, the matching memory needle 100, needle tube 200, connector 600 and guide 900 are selected. The first protrusion 300 of the memory needle 100 is externally fixed with a distal seal 800, and the needle tube 200 is externally fixed with a proximal end The seal 400 and a fastener 500 sleeved on the proximal seal 400 close to the distal end of the needle tube 200. Insert the distal end of the memory needle 100 into the third channel 610 from the proximal end of the connector 600, and the first protrusion 300 on the memory needle 100 and the second protrusion 700 in the third channel 610 resist, and the memory needle The movement of 100 toward the distal end of the connector 600 in the extending direction of the third channel 610 is restricted, thereby preventing the memory needle 100 from detaching from the distal end of the third channel 610 from the third channel 610. Since the first convex part 300 and the second convex part 700 are both arranged in a ring structure, it is sufficient to directly insert the memory needle 100 into the third channel 610, and there is no need to rotate the memory needle 100 or the connector 600 to adjust the first convex part The positions of 300 and the second convex part 700 are more convenient for assembly. In addition, the first convex portion 300 and the second convex portion 700 are both annular structures, and the contact area between the two is large, the resisting effect is good, it is not easy to slip off, and the limit is reliable. When the first protrusion 300 and the second protrusion 700 resist, the position of the memory needle 100 is the final installation position. At this time, the distal end of the memory needle 100 extends out of the distal end of the third channel 610, which is convenient for The distal end of the memory needle 100 pierces the tissue, and the part of the memory needle 100 located outside the third channel 610 can be elastically deformed under the action of the forceps lifter to accurately puncture the tissue. After the memory needle 100 is inserted into the third channel 610, the guide member 900 is inserted into the third channel 610 from the proximal end of the connecting member 600, and the second equal-diameter section 913 of the guide member 900 abuts against the proximal end of the memory needle 100 , The inner diameter of the second equal-diameter section 913 is equal to the inner diameter of the memory needle 100. Then, the distal end of the needle tube 200 is inserted into the third channel 610 from the proximal end of the connector 600, the installation tube section 230 of the needle tube 200 is mated with the connector 600, and the missing part 220 on the needle tube 200 is not inserted into the connector 600. After the needle tube 200 is inserted into the third channel 610, the distal end of the needle tube 200 abuts against the proximal end of the guide member 900, and the inner diameter of the needle tube 200 is equal to the inner diameter of the first equal-diameter section 911 of the guide member 900. After the needle tube 200 is against the guide section, the needle tube 200 is fixedly connected to the connecting member 600, so that the first protrusion 300 and the guide member 900 are clamped between the second protrusion 700 and the needle tube 200, and the memory needle 100 and The movement of the guide member 900 in the extending direction of the third channel 610 is restricted by the second protrusion 700 and the needle tube 200, so that the operator can drive the memory needle 100, the guide member 900 and the connecting member 600 to move together when the needle tube 200 is operated.

Optionally, the needle tube 200 and the connecting piece 600 may be fixed by welding, and an annular weld 620 surrounding the connecting piece 600 is formed between the needle tube 200 and the connecting piece 600. When the needle assembly 001 is assembled, part of the distal seal 800 is squeezed between the first protrusion 300 and the second protrusion 700, and the remaining part is squeezed between the first protrusion 300 and the third channel 610 Between the inner walls, the fluid entering from the distal end of the memory needle 100 will not leak from the distal end of the connector 600; at the same time, an annular weld 620 is formed between the installation tube section 230 of the needle tube 200 and the connector 600, and the installation tube section 230 Without the missing portion 220 that is a through hole, the fluid entering the first channel 110 from the distal end of the memory needle 100 will not leak from the proximal end of the connector 600 when flowing through the fourth channel 910 and the second channel 210. In addition, the part of the needle tube 200 with a through hole is provided with a proximal end seal 400, and the proximal end seal 400 is sleeved outside the needle tube 200. When fluid flows in the needle tube 200, it will not leak from the through hole to the outside of the needle tube 200. The fluid sample collected by the needle 100 can be smoothly transported to the sample collection device (not shown) through the first channel 110, the fourth channel 910, and the second channel 210.

It should be noted that the memory needle 100 can also be sleeved outside the connector 600. In the same way, the needle tube 200 can be sleeved outside the connector 600. In this embodiment, the memory needle 100 is inserted into the connector 600, and the needle tube 200 is inserted into the connector 600. The inner diameters of the first channel 110 of the memory needle 100 and the second channel 210 of the needle tube 200 can be designed to be larger, which is convenient for the equipment. operate.

The needle assembly 001 provided in this embodiment is used in conjunction with an endoscope. The memory needle 100 of the needle assembly 001 is inserted into the clamp channel of the endoscope, and the needle tube 200 is operated so that the memory needle 100 and the needle tube 200 slide in the clamp channel to reach the puncture In the process of positioning, the bending rigidity of the needle tube 200 is small, and it is easy to deform, reducing the friction between the needle tube 200 and the clamp channel of the endoscope, that is, the resistance of the needle tube 200 when sliding relative to the clamp channel is small, and the operation is flexible and convenient. The memory needle 100 has a large bending rigidity, the memory needle 100 is not easily deformed during the puncture process, and even if the memory needle 100 is elastically deformed under the action of external force, it can be restored to the original state, the puncture is accurate and reliable, and the success rate of the operation is improved. .

The needle assembly 001 provided in this embodiment includes a memory needle 100 and a needle tube 200 made of two different materials. The memory needle 100 and the needle tube 200 are processed separately, which reduces the difficulty of processing, and can be replaced as needed during the assembly process. One of them, reducing costs.

Please refer to FIG. 10 and FIG. 11. FIG. 11 shows a schematic diagram of a partial structure of the sampling needle 010 that the memory needle 100 is bent under a force. This embodiment also provides a sampling needle 010, including a handle 003, an outer tube 002, and the above-mentioned needle assembly 001. The outer tube 002 is sleeved outside the needle assembly 001, and the outer tube 002 and the needle tube 200 are both connected to the handle 003. The operating handle 003 can make the needle tube 200 and the memory needle 100 slide back and forth in the outer tube 002 along the extension direction of the outer tube 002.

The sampling needle 010 provided in this embodiment is easy to manufacture and operate, and the memory needle 100 can accurately reach the position to be punctured, thereby increasing the success rate of the operation.

The above are only specific implementations of this application, but the protection scope of this application is not limited to this. Any person skilled in the art can easily think of changes or substitutions within the technical scope disclosed in this application, All should be covered within the scope of protection of this application. Therefore, the protection scope of this application should be subject to the protection scope of the claims.

Claims

A needle assembly, characterized in that the needle assembly includes:

A memory needle with a first channel and a needle tube with a second channel. The memory needle is connected to the needle tube and the first channel is in communication with the second channel; the bending stiffness of the memory needle is greater than that of the second channel. State the bending stiffness of the needle tube.
The needle assembly of claim 1, wherein:

The needle assembly further includes a connecting piece, and the memory needle and the needle tube are connected through the connecting piece.
The needle assembly of claim 2, wherein:

The connector is provided with a third channel, both ends of the third channel are open along the extension direction, the memory needle communicates with one end of the third channel in the extension direction, and the needle tube It communicates with the other end of the third passage in its extending direction.
The needle assembly of claim 3, wherein:

Both the memory needle and the needle tube are inserted into the third channel, and the distal end of the memory needle exposes the third channel, and the proximal end of the needle tube exposes the third channel.
The needle assembly of claim 3, wherein:

The memory needle is provided with a first protrusion, the connecting member is provided with a second protrusion, and the first protrusion is against the second protrusion to prevent the memory needle from being in place. The extension direction of the third channel departs from the third channel in a direction away from the needle tube.
The needle assembly of claim 5, wherein:

The first convex portion protrudes from the outer peripheral surface of the memory needle along a direction having an angle with the extending direction of the first channel; the second convex portion has a clip along the extending direction of the third channel The direction of the angle protrudes from the inner wall of the third channel; the memory needle is inserted into the third channel so that the first convex portion and the second convex portion resist.
The needle assembly according to claim 5 or 6, characterized in that:

At least one of the first convex portion and the second convex portion has an annular structure.
The needle assembly of claim 5, wherein:

The needle tube and the connecting member are relatively fixed in the extension direction of the third channel, and the needle is held against the needle tube at the end close to the needle tube to prevent the memory needle from being in the third channel. The extending direction of the channel departs from the third channel toward the direction close to the needle tube.
The needle assembly of claim 8, wherein:

The needle tube is welded to the connecting piece, and an annular weld is formed between the needle tube and the connecting piece.
The needle assembly of claim 3, wherein:

The needle assembly further includes a guide member having a fourth channel, the guide member is located in the third channel; the fourth channel has a diameter-reducing section, and the first end of the diameter-reducing section is close to the needle tube, The second end of the variable diameter section is close to the memory needle, and the inner diameter of the variable diameter section gradually decreases from the first end to the second end; The ends are respectively held against the memory needle and the needle tube.
The needle assembly of claim 10, wherein:

The fourth channel further includes a first equal diameter section and a second equal diameter section. The first equal diameter section is in communication with the first end. The inner diameters are equal; the second equal diameter section communicates with the second end, and the inner diameters of the second equal diameter section and the second end are equal.
The needle assembly of claim 3, wherein:

The needle assembly further includes a ring-shaped distal end seal, and the distal end seal is disposed between the outer circumferential surface of the memory needle and the inner circumferential surface of the connecting member.
The needle assembly of claim 1, wherein:

The tube wall of the needle tube is provided with a through hole; the needle assembly further includes a proximal end sealing member configured to be connected with the needle tube to block the through hole.
The needle assembly of claim 13, wherein:

The needle assembly further includes a fastener, the proximal seal has a fastening part close to the memory needle, the fastener is sleeved outside the fastening part, and the fastening part is connected to the The fastener has an interference fit.
The needle assembly of claim 1, wherein:

The memory needle is made of cobalt-chromium alloy, copper-zinc-aluminum 36 alloy, iron-manganese-silicon alloy, gold-cadmium alloy, copper-aluminum alloy, copper-aluminum-nickel alloy or nickel-titanium alloy.
A sampling needle, characterized in that the sampling needle comprises:

A handle and the needle assembly according to any one of claims 1-15, wherein the handle is connected to the needle tube of the needle assembly.