CN113243946A

CN113243946A - Needle assembly and sampling needle

Info

Publication number: CN113243946A
Application number: CN202010086823.6A
Authority: CN
Inventors: 王涛; 唐志; 刘伟; 李常青
Original assignee: Micro Tech Nanjing Co Ltd
Current assignee: Micro Tech Nanjing Co Ltd
Priority date: 2020-02-11
Filing date: 2020-02-11
Publication date: 2021-08-13
Also published as: WO2021159552A1

Abstract

The embodiment of the invention provides a needle assembly and a sampling needle, relating to the field of medical equipment, wherein the needle assembly comprises a memory needle head with a first channel and a needle tube with a second channel, the memory needle head is connected with the needle tube, and the first channel is communicated with the second channel; the bending rigidity of the memory needle is larger than that of the needle tube. The sampling needle includes a needle assembly. The needle assembly is convenient to process and manufacture, and the cost is reduced; meanwhile, the needle assembly is flexible to operate when in use, the memory needle head can accurately reach the position to be punctured in the repeated puncturing operation process, and the success rate of the operation is improved.

Description

Needle assembly and sampling needle

Technical Field

The invention relates to the field of medical equipment, in particular to a needle assembly and a sampling needle.

Background

Under the guidance of an ultrasonic bronchoscope/ultrasonic endoscope, a tissue or cytology sample is obtained after puncture and suction by using a sampling needle, which is clinically commonly called EBUS/EUS examination. The EBUS can locate the specific position of the lesion outside the bronchus by ultrasound, avoid blood vessels under the guidance of color Doppler, and obtain cells and tissues of the corresponding part by needle aspiration and biopsy, thereby achieving the purpose of diagnosing diseases. The EUS examination has higher accuracy on the primary tumor and local nodule stage of pancreatic cancer.

The inventor finds in research that the existing sampling needle has at least the following defects:

firstly, in EBUS/EUS examination, a doctor can adjust a forceps lifting device according to a required puncture focus when operating and using an instrument, when the needle tube is at an extreme position, the needle tube and an endoscope channel and the forceps lifting device generate rigid confrontation, so that the needle output resistance is large, the distal end of the needle is easy to deform after the needle is forcibly output, and the subsequent continuous use cannot be realized;

secondly, at present, sampling needles with small needle discharging resistance are designed on the market, but when the sampling needles are discharged, the far ends of the sampling needles have no or low-rigidity support, the puncture is easy to deviate, and the needle tube is permanently deformed after puncture at the limit position and cannot be recovered;

thirdly, the existing sampling needle has high processing and manufacturing cost.

Disclosure of Invention

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

Embodiments of the invention may be implemented as follows:

in a first aspect, embodiments provide a needle assembly comprising:

the memory needle is connected with the needle tube, and the first channel is communicated with the second channel; the bending rigidity of the memory needle is larger than that of the needle tube.

In an alternative embodiment, the needle assembly further comprises a connector, and the memory needle is connected with the needle tube through the connector.

In an alternative embodiment, the connecting piece is provided with a third channel, both ends of the third channel along the extending direction of the third channel are open, the memory needle is communicated with one end of the third channel in the extending direction of the memory needle, and the needle tube is communicated with the other end of the third channel in the extending direction of the memory needle.

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

In an alternative embodiment, the memory needle is provided with a first convex part, the connecting piece is provided with a second convex part, and the first convex part is abutted against the second convex part to prevent the memory needle from being separated from the third channel in the extending direction of the third channel towards the direction far away from the needle tube.

In an alternative embodiment, the first protrusion protrudes from the outer circumferential surface of the memory needle in a direction having an angle with the extending direction of the first channel; the second convex part protrudes out of the inner wall of the third channel along the direction which forms an included angle with the extending direction of the third channel; the memory needle is inserted into the third channel to make the first convex part and the second convex part abut against each other.

In an alternative embodiment, at least one of the first and second projections is an annular structure.

In an alternative embodiment, the needle tube and the connecting piece are fixed relative to each other in the extending direction of the third channel, and one end of the needle near the needle tube abuts against the needle tube to prevent the memory needle from being separated from the third channel in the extending direction of the third channel towards the direction near the needle tube.

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

In an alternative embodiment, the needle assembly further comprises a guide provided with a fourth channel, the guide being located in the third channel; the fourth channel is provided with a reducing section, the first end of the reducing section is close to the needle tube, the second end of the reducing section is close to the memory needle head, and the inner diameter of the reducing section is gradually reduced from the first end to the second end; the two ends of the guide piece along the extending direction are respectively propped against the memory needle head and the needle tube.

In an alternative embodiment, the fourth channel further comprises a first radiused section and a second radiused section, the first radiused section communicating with the first end, the first radiused section having an inner diameter equal to the inner diameter of the first end; the second end is communicated with the second end, and the second equal-diameter section is equal to the inner diameter of the second end.

In an alternative embodiment, the needle assembly further comprises an annular distal seal disposed between the outer circumferential surface of the memory needle and the inner circumferential surface of the connector.

In an optional embodiment, a through hole is formed in the wall of the needle tube; the needle assembly further includes a proximal seal configured to couple with the needle cannula to block the through-hole.

In an alternative embodiment, the needle assembly further comprises a fastener, the proximal seal has a fastening portion adjacent to the memory needle, the fastener is sleeved outside the fastening portion, and the fastening portion is in interference fit with the fastener.

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

In a second aspect, embodiments provide a sampling needle, comprising:

a handle and a needle assembly according to any of the preceding embodiments, the handle being connected to the needle cannula of the needle assembly.

The beneficial effects of the embodiment of the invention include, for example:

to sum up, the embodiment provides a needle subassembly, including memory syringe needle and needle tubing that link to each other, the bending rigidity of memory syringe needle is greater than the bending rigidity of needle tubing, and the memory syringe needle is difficult for producing crooked elastic deformation in the extending direction more than the needle tubing, and in the process of going out the needle, the needle tubing is easy deformation more to can reduce the resistance of endoscope pincers way to the needle subassembly, guarantee simultaneously that the memory syringe needle is difficult for the deformation after carrying out a lot of puncture in extreme position. The bending rigidity of the memory needle head and the bending rigidity of the needle tube are different, the memory needle head and the needle tube are assembled into a whole after being separately processed, and the processing difficulty is low; meanwhile, in the processing process of the memory needle head and the needle tube, when the product is unqualified due to errors, the unqualified memory needle head or needle tube can be replaced before the memory needle head and the needle tube are assembled, compared with the situation that the needle head or the needle tube cannot be replaced independently when the product is unqualified in the traditional needle head and needle tube with an integrated structure, the resources are saved, and the processing and manufacturing cost of the needle assembly is reduced; and the memory needle head and the needle tube are processed separately, so that the processing difficulty is reduced, and the processing quality is improved.

The embodiment also provides a sampling needle, which comprises the needle assembly, and the sampling needle is low in processing and manufacturing cost and convenient and reliable to use.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained according to the drawings without inventive efforts.

FIG. 1 is a schematic structural view of a needle assembly provided in this embodiment;

FIG. 2 is a schematic structural view of a deformed structure of the needle assembly provided in this embodiment;

FIG. 3 is a schematic structural diagram of a memory needle according to the present embodiment;

FIG. 4 is a schematic structural view of the needle cannula provided in this embodiment;

FIG. 5 is a schematic view of a portion of the enlarged structure at V in FIG. 2;

FIG. 6 is a schematic view of a portion of the enlarged structure at VI in FIG. 2;

fig. 7 is a schematic structural diagram of the connecting member provided in this embodiment;

FIG. 8 is a schematic view of a portion of the enlarged structure shown at VIII in FIG. 2;

fig. 9 is a schematic structural view of a guide member provided in the present embodiment;

FIG. 10 is a schematic structural diagram of the sampling needle according to the present embodiment (the distal end of the memory needle is in a force-bending state);

FIG. 11 is a schematic diagram of a portion of the enlarged structure at XI in FIG. 10;

fig. 12 is a schematic view of a deformed structure of the memory needle according to the present embodiment.

Icon:

010-a sampling needle; 001-a needle assembly; 100-memory needles; 110 — a first channel; 200-needle tube; 210-a second channel; 220-a deletion; 230-installing the pipe section; 300-a first projection; 310-an outer circumferential surface; 320-distal torus; 400-a proximal seal; 410-a fastening portion; 500-a fastener; 600-a connector; 610-a third channel; 620-circular weld; 700-a second projection; 800-a distal seal; 900-a guide; 910-a fourth channel; 911-first diameter section; 912-a variable diameter section; 9121-a first end; 9122-a second end; 913-a second equal radius segment; 002-outer sleeve; 003-handle.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments 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.

It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.

In the description of the present invention, it should be noted that if the terms "upper", "lower", "inside", "outside", etc. indicate an orientation or a positional relationship based on that shown in the drawings or that the product of the present invention is used as it is, this is only for convenience of description and simplification of the description, and it does not indicate or imply that the device or the element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus should not be construed as limiting the present invention.

Furthermore, the appearances of the terms "first," "second," and the like, if any, are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.

It should be noted that the features of the embodiments of the present invention may be combined with each other without conflict.

In this embodiment, it should be noted that, as will be understood by those skilled in the art, when the sampling needle 010 is used, the front end of the sampling needle 010 contacts with a human body, and the rear end of the sampling needle 010 is operated by an operator, and for convenience of description, an end of each component of the sampling needle 010 near the front end of the sampling needle 010 is referred to as a distal end, and an end of each component near the rear end of the sampling needle 010 is referred to as a proximal end.

Referring to fig. 1, the present embodiment provides a needle assembly 001 for puncturing tissue of a sample to be sampled for sampling, which can be used alone or in combination with an endoscope (not shown), and the needle assembly 001 has low difficulty in manufacturing, low manufacturing cost, and high processing quality; when the needle assembly 001 is matched with an endoscope for use, the needle tube 200 can generate corresponding elastic deformation along with the bending shape of a forceps channel of the endoscope, the resistance is small, the needle tube can easily slide in the forceps channel, and the operation is more flexible; moreover, the memory needle 100 is not easy to generate elastic deformation, and the puncture position is accurate and reliable.

Referring to fig. 1, a needle assembly 001 of the present embodiment includes a memory needle 100 having a first channel 110 and a needle tube 200 having a second channel 210, the memory needle 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 100 is greater than that of the needle tube 200, and the memory needle 100 is less likely to elastically deform relative to the needle tube 200.

In the needle assembly 001 of the present embodiment, the bending stiffness of the memory needle 100 and the bending stiffness of the needle tube 200 are different, and the bending stiffness of the memory needle 100 and the bending stiffness of the needle tube 200 may be different. When the memory needle 100 and the needle tube 200 are processed separately and then assembled into a whole, the processing difficulty is low, and particularly, when the memory needle 100 and the needle tube 200 are respectively processed by adopting materials with different elastic moduli, the processing difficulty can be reduced to a greater extent; meanwhile, in the processing process of the memory needle 100 and the needle tube 200, when the product is unqualified due to errors, the unqualified memory needle 100 or the needle tube 200 can be replaced before the memory needle 100 and the needle tube 200 are assembled, compared with the situation that the needle or the needle tube 200 cannot be replaced independently when the product is unqualified in the traditional needle and the needle tube 200 which are of an integrated structure, the resources are saved, and the processing and manufacturing cost of the needle assembly 001 is reduced; and the memory needle 100 and the needle tube 200 are processed separately, so that the processing difficulty is reduced, and the processing quality is improved. Meanwhile, as the bending rigidity of the memory needle 100 is greater than that of the needle tube 200, the memory needle 100 is less prone to deformation than the needle tube 200, when the needle assembly 001 is matched with an endoscope and a forceps channel of the endoscope has a bending section, the needle tube 200 is more prone to generating elastic deformation along with the deformation of the forceps channel, the sliding resistance of the needle assembly 001 in the forceps channel is small, the required external force in the puncture process is small, the operation is more flexible, and the hand feeling experience of an operator during use is improved. In addition, in the process of puncturing, according to the operation requirement, the forceps lifting device needs to be lifted to a larger angle (for example, 20-25 degrees), at the moment, the memory needle 100 is driven by the forceps lifting device to generate elastic deformation, and as the bending rigidity of the memory needle 100 is greater than that of the needle tube 200, the force for recovering the elastic deformation is larger, so that the memory needle 100 can be recovered to the original state after generating the elastic deformation, thereby ensuring that the accuracy of the puncturing position can be ensured in the process of puncturing for many times, and improving the success rate of the operation.

Referring to fig. 3, in the present embodiment, optionally, the distal end of the memory needle 100 is configured to penetrate human tissue, and the distal end of the memory needle 100 is beveled such that the distal end of the memory needle 100 is pointed to facilitate piercing of the tissue for sampling.

Referring to fig. 12, in an alternative embodiment, the distal end of memory needle 100 has a plurality of bevels arranged around the circumference of memory needle 100.

Further, the memory needle 100 is a tubular structure, alternatively, 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 extending direction of the memory needle 100. It should be noted that, since the memory needle 100 can be elastically deformed by an external force, the following description about the structure of the memory needle 100 is only the original state of the memory needle 100, that is, the state of the memory needle 100 that is not elastically deformed by the external force. Optionally, the memory needle 100 extends along a straight line, that is, the memory needle 100 is in a straight tube shape, the end surface of the proximal end of the memory needle 100 is a circular ring, and the center of the circular ring is located on the axis of the memory needle 100.

In this embodiment, the memory needle 100 may be made of a super-elastic alloy, which may be, but is not limited to, cobalt-chromium alloy, copper-zinc-aluminum 36 alloy, iron-manganese-silicon alloy, gold-cadmium alloy, copper-aluminum-nickel alloy, and nickel-titanium alloy. In this embodiment, the memory needle 100 is made of nitinol.

In this embodiment, optionally, the memory needle 100 is provided with a first protrusion 300, the first protrusion 300 is an annular structure, the first protrusion 300 is located on the outer circumferential surface of the memory needle 100, and the first protrusion 300 extends around the axis of the memory needle 100. Optionally, the first protrusion 300 protrudes from the outer circumferential surface of the memory needle 100 along 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 protrusion 300 may not be provided as an annular protrusion structure, and when the first protrusion 300 is not provided as an annular protrusion structure, the number of the first protrusions 300 may be plural, and the plural first protrusions 300 are uniformly spaced along the circumferential direction of the memory needle 100.

Optionally, the first protrusion 300 and the memory needle 100 are two separate parts, and the first protrusion 300 and the memory needle 100 are processed separately and then assembled into a whole. Optionally, the first protrusion 300 is disposed on the outer circumferential surface of the memory needle 100, and an end surface of the proximal end of the first protrusion 300 and an 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 can be fixedly connected in other manners.

It should be noted that in other embodiments, the first protrusion 300 may be disposed to 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.

Alternatively, the first protrusion 300 may be made of the same material as the memory needle 100.

Referring to fig. 2 and 4, in the present embodiment, the needle tube 200 may be a cylindrical tube, the lumen of the needle tube 200 is a second channel 210, and both ends of the second channel 210 along the extending direction thereof are open. The distal end and the proximal end of the needle tube 200 in the extending direction are circular ring surfaces, and the inner diameter of the needle tube 200 is larger than the inner diameter of the memory needle 100 so as to facilitate the operation instrument to enter the memory needle 100 through the needle tube 200. Alternatively, needle cannula 200 may be formed from a stainless steel material.

In this embodiment, optionally, a missing portion 220 is disposed on a tube wall of the needle tube 200, the missing portion 220 may be a recess or a through hole, and a thickness of the needle tube 200 at a position of the missing portion 220 is smaller than a thickness of other positions, it should be noted that, when the missing portion 220 is a through hole, it may be understood that a wall thickness of the missing portion 220 at the through hole is zero. Through setting up deletion portion 220, needle tubing 200 is more easily produced elastic deformation, reduces the rigidity antagonism of needle tubing 200 and endoscope pincers way, and needle tubing 200 yields in the endoscope bending more easily, goes out the needle more easily, improves and goes out the problem that the memory syringe needle easily takes place unrecoverable deformation after the needle by force.

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 extends in a spiral line around the axis of the needle tube 200 along the extending direction of the needle tube 200, the missing part 220 is convenient to process, and the structure of the needle tube 200 is more regular and the deformation is more uniform. When the number of the missing portions 220 is plural, the plurality of the missing portions 220 are arranged on the needle tube 200 at intervals.

Referring to fig. 2 and 5, it should be noted that the end of the missing part 220 close to the distal end of the needle cannula 200 is spaced from the distal end of the needle cannula 200, and the section between the distal end of the needle cannula 200 and the missing part 220 is a mounting section 230 of the needle cannula 200, in other words, the missing part 220 is not disposed on the mounting section 230.

Referring to fig. 2 and 6, optionally, when the missing portion 220 is configured as a through hole, a proximal seal 400 is disposed on the needle tube 200, and the proximal seal 400 is configured to block the through hole.

Optionally, the proximal seal 400 is disposed around the outer circumference of the needle cannula 200, and the proximal seal 400 is not disposed outside the mounting tube section 230 of the needle cannula 200.

Further, the portion of the proximal seal 400 near the mounting tube segment 230 is provided as a fastening portion 410, and the fastening portion 410 is externally sleeved with a fastening member 500, and the fastening member 500 is in interference fit with the fastening portion 410. That is, the fastening member 500 provides the fastening portion 410 with a locking force inward along the radial direction of the needle tube 200, so that the fastening portion 410 is pressed between the needle tube 200 and the fastening member 500, thereby improving the binding force between the fastening portion 410 and the needle tube 200, and in the process of the elastic deformation of the needle tube 200, the fastening portion 410 is not easily separated from the needle tube 200 due to the deviation or the turning-up, and the effect of the proximal end sealing member 400 in sealing the through hole is good.

Referring to fig. 2 and 7, in the present embodiment, optionally, the needle assembly 001 further includes a connecting member 600, and the memory needle 100 and the needle cannula 200 are connected by the connecting member 600.

Optionally, the connecting member 600 has a third channel 610, and both ends of the connecting member 600 along the extending direction of the third channel 610 are open, that is, both ends of the third channel 610 along the extending direction thereof are open. Further, the cross section of the connecting piece 600 is circular, 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, so that the connecting piece is convenient to process and manufacture, and is also convenient to connect with the memory needle 100 and the needle tube 200.

Further, a second protrusion 700 is disposed on the connector 600, the second protrusion 700 is a ring-shaped structure, the second protrusion 700 is located on the inner wall of the third channel 610, and the second protrusion 700 extends around the axis of the connector 600. Optionally, the second protrusion 700 is circular, the second protrusion 700 protrudes from the inner wall of the third channel 610 along a direction perpendicular to the extending direction of the connecting member 600, and the second protrusion 700 and the connecting member 600 are coaxially disposed. One end surface of the second protrusion 700 in the extending direction thereof and the end surface of the distal end of the connection member 600 are located in the same plane, and the other end surface of the second protrusion 700 in the extending direction thereof and the proximal end of the connection member 600 have a distance therebetween, so that the connection member 600 and the second protrusion 700 form a stepped structure.

In other embodiments, the second protrusions 700 may not be arranged in an annular structure, and when the second protrusions 700 are not arranged in an annular convex structure, the number of the second protrusions 700 may be multiple, and the multiple second protrusions 700 are uniformly spaced along the circumference of the third channel 610.

In other embodiments, the second protrusion 700 may protrude from the outer circumferential surface of the connector 600 in a direction having an angle with the extending direction of the third channel 610, so as to be in abutting engagement with the first protrusion 300 disposed on the inner wall of the first channel 110 of the memory needle 100.

It should be noted that the second protrusion 700 and the connecting member 600 may be integrally formed, so that the structure is more stable.

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

Optionally, a distal seal 800 is disposed between the first projection 300 and the connector 600. Further, the first protrusion 300 has an outer circumferential surface 310 and a distal annular surface 320 near the distal end of the memory needle 100, the outer circumferential surface 310 is connected to the distal annular surface 320, and the distal sealing member 800 wraps the outer circumferential surface 310 and the distal annular surface 320 at the same time, i.e., a sealing portion with an included angle is formed between the memory needle 100 and the connecting member 600, thereby improving the sealing effect.

In this embodiment, optionally, the distal seal 800 is fixed to the first protrusion 300 on the outer periphery of the memory needle 100, and forms an integral structure with the first protrusion 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 connecting member 600, so as to facilitate assembling.

In this embodiment, the distal sealing element 800 is made of a polymer elastic material. The polymeric elastic material may be, but is not limited to, latex, PTFE (Poly tetra fluoroethylene polytetrafluoroethylene) or Pebax (polyether block polyamide).

Referring to fig. 2 and fig. 9, in this embodiment, optionally, the needle assembly 001 further includes a guiding element 900, the guiding element 900 is a tubular structure with a circular cross section, a lumen of the guiding element 900 is a fourth channel 910, the fourth channel 910 includes a first diameter section 911, a variable diameter section 912 and a second diameter section 913 connected in sequence from the proximal end to the distal end, and the first diameter section 911, the variable diameter section 912 and the second diameter section 913 are coaxial. The reducing section 912 has a first end 9121 and a second end 9122 in the extending direction thereof, and the inner diameter of the reducing section 912 gradually decreases from the first end 9121 to the second end 9122, i.e., the first end 9121 is the larger end of the reducing section 912 and the second end 9122 is the smaller end of the reducing section 912. The first radiused section 911 is connected to the first end 9121 and the second radiused section 913 is connected to the second end 9122. In use, an instrument enters from the first diameter section 911 and passes through the diameter-changing section 912 to reach the second diameter section 913, the inner diameter of the first diameter section 911 is large, the instrument can conveniently enter the first diameter section 911, and the diameter-changing section 912 has a guiding function, and the instrument can be conveniently guided to enter the second diameter section 913.

The needle assembly 001 assembly process provided by this embodiment includes, for example:

referring to fig. 2, a memory needle 100, a needle tube 200, a connecting member 600 and a guiding member 900 are selected to be matched, a distal end sealing member 800 is fixed outside a first convex portion 300 of the memory needle 100, a proximal end sealing member 400 is fixed outside the needle tube 200, and a fastening member 500 is sleeved on the proximal end sealing member 400 and is close to the distal end of the needle tube 200. The distal end of the memory needle 100 is inserted into the third channel 610 from the proximal end of the connector 600, the first projection 300 on the memory needle 100 abuts against the second projection 700 in the third channel 610, and the movement of the memory needle 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 being separated from the third channel 610 from the distal end of the third channel 610. Since the first protrusion 300 and the second protrusion 700 are both configured as a ring structure, the memory needle 100 can be directly inserted into the third channel 610 without rotating the memory needle 100 or the connector 600 to adjust the positions of the first protrusion 300 and the second protrusion 700, which is more convenient to assemble. And the first convex part 300 and the second convex part 700 are both in annular structures, and the contact area of the first convex part and the second convex part is large, so that the abutting effect is good, the slippage is not easy, and the limit is reliable. When the first protrusion 300 and the second protrusion 700 abut against each other, the position of the memory needle 100 is the final mounting position, and at this time, the distal end of the memory needle 100 extends out of the distal end of the third channel 610, so that the distal end of the memory needle 100 can pierce through the tissue, and the portion of the memory needle 100 located outside the third channel 610 can be elastically deformed under the action of the forceps lifter to accurately pierce through the tissue. After the memory needle 100 is inserted into the third channel 610, the guide 900 is inserted into the third channel 610 from the proximal end of the connecting member 600, the second equal-diameter section 913 of the guide 900 abuts against the proximal end of the memory needle 100, and the inner diameter of the second equal-diameter section 913 is equal to the inner diameter of the memory needle 100. The distal end of the needle cannula 200 is inserted into the third channel 610 from the proximal end of the connector 600, the mounting tube 230 of the needle cannula 200 is inserted into the connector 600, and the missing portion 220 of the needle cannula 200 is not inserted into the connector 600. After needle cannula 200 is inserted into third channel 610, the distal end of needle cannula 200 abuts the proximal end of guide 900 and the inside diameter of needle cannula 200 is equal to the inside diameter of first constant diameter segment 911 of guide 900. After the needle tube 200 abuts against the guide section, the needle tube 200 is fixedly connected with the connecting piece 600, so that the first convex part 300 and the guide piece 900 are clamped between the second convex part 700 and the needle tube 200, and the movement of the memory needle 100 and the guide piece 900 in the extending direction of the third channel 610 is limited by the second convex part 700 and the needle tube 200, so that an operator can drive the memory needle 100, the guide piece 900 and the connecting piece 600 to move together when operating the needle tube 200.

Alternatively, the needle cannula 200 and the coupling 600 may be secured by welding, with an annular weld 620 formed between the needle cannula 200 and the coupling 600 and around the coupling 600. When the needle assembly 001 is assembled, a portion of the distal seal 800 is compressed between the first protrusion 300 and the second protrusion 700, and the remaining portion is compressed between the first protrusion 300 and the inner wall of the third channel 610, the fluid entering from the distal end of the memory needle 100 will not leak from the distal end of the connector 600; meanwhile, an annular weld 620 is formed between the mounting tube segment 230 of the needle tube 200 and the connector 600, and the mounting tube segment 230 is not provided with the missing part 220 in the form of a through hole, so that the fluid entering the first passage 110 from the distal end of the memory needle 100 cannot leak from the proximal end of the connector 600 while flowing through the fourth passage 910 and the second passage 210. In addition, the portion of the needle tube 200 having the through hole is provided with the proximal end sealing member 400, the proximal end sealing member 400 is sleeved outside the needle tube 200, when the fluid flows in the needle tube 200, the fluid does not leak out of the needle tube 200 from the through hole, and the fluid sample collected by the memory needle 100 can be smoothly transported to a 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 connecting member 600. Similarly, the needle tube 200 can be sleeved outside the connecting piece 600. In this embodiment, the memory needle 100 is inserted into the connector 600, the needle tube 200 is inserted into the connector 600, and the inner diameters of the first passage 110 of the memory needle 100 and the second passage 210 of the needle tube 200 can be designed to be larger, so as to facilitate the operation of the instrument.

The needle assembly 001 provided by the embodiment is used with an endoscope, the memory needle 100 of the needle assembly 001 is inserted into a forceps channel of the endoscope, and the needle tube 200 is operated to enable the memory needle 100 and the needle tube 200 to slide in the forceps channel to reach a position to be punctured, so that the bending rigidity of the needle tube 200 is small, the needle tube 200 is easy to deform, the friction force between the needle tube 200 and the forceps channel of the endoscope is reduced, namely, the resistance force applied when the needle tube 200 slides relative to the forceps channel is small, and the operation is flexible and convenient. The bending rigidity of the memory needle head 100 is high, the memory needle head 100 is not easy to deform in the puncturing process, the memory needle head 100 can be restored to the original state even if the memory needle head 100 is elastically deformed under the action of external force, the puncturing is accurate and reliable, and the success rate of the operation is improved.

The needle assembly 001 provided by the embodiment comprises the memory needle 100 and the needle tube 200 which are made of two different materials, the memory needle 100 and the needle tube 200 are respectively and independently processed, the processing difficulty is reduced, one of the memory needle 100 and the needle tube 200 can be replaced as required in the assembling process, and the cost is reduced.

Referring to fig. 10 and 11, fig. 11 is a partial structural view of the sampling needle 010 with the memory needle 100 bent under force. This embodiment still provides a sample needle 010, including handle 003, outer tube 002 and foretell needle subassembly 001, the outer tube 002 cover is established outside needle subassembly 001, and outer tube 002 all is connected with handle 003 with needle tubing 200, can make needle tubing 200 and memory syringe needle 100 along the reciprocating sliding of the extending direction of outer tube 002 in outer tube 002 through operating handle 003.

The sampling needle 010 provided by the embodiment is convenient to process and manufacture and operate, and the memory needle head 100 can accurately reach the position to be punctured, so that the success rate of the operation is improved.

The above description is only for the specific embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the appended claims.

Claims

1. A needle assembly, wherein the needle assembly comprises:

the memory needle comprises a memory needle head with a first channel and a needle tube with a second channel, wherein the memory needle head is connected with the needle tube, and the first channel is communicated with the second channel; the bending rigidity of the memory needle is larger than that of the needle tube.

2. The needle assembly of claim 1, wherein:

the needle assembly further comprises a connecting piece, and the memory needle head is connected with the needle tube through the connecting piece.

3. The needle assembly of claim 2, wherein:

the connecting piece is provided with a third channel, two ends of the third channel in the extension direction of the third channel are both open, the memory needle head is communicated with one end of the third channel in the extension direction of the third channel, and the needle tube is communicated with the other end of the third channel in the extension direction of the third channel.

4. A needle assembly as defined in claim 3, wherein:

the memory needle head and the needle tube are inserted into the third channel, the distal end of the memory needle head is exposed out of the third channel, and the proximal end of the needle tube is exposed out of the third channel.

5. A needle assembly as defined in claim 3, wherein:

the memory needle head is provided with a first convex part, the connecting piece is provided with a second convex part, and the first convex part is abutted against the second convex part so as to prevent the memory needle head from being separated from the third channel in the extending direction of the third channel towards the direction far away from the needle tube.

6. The needle assembly of claim 5, wherein:

the first convex part protrudes out of the peripheral surface of the memory needle head along the direction which forms an included angle with the extending direction of the first channel; the second convex part protrudes out of the inner wall of the third channel along the direction which forms an included angle with the extending direction of the third channel; the memory needle head is inserted into the third channel so that the first convex part is abutted against the second convex part.

7. A needle assembly according to claim 5 or 6, wherein:

at least one of the first and second projections is an annular structure.

8. The needle assembly of claim 5, wherein:

the needle tube and the connecting piece are relatively fixed in the extending direction of the third channel, and one end of the needle head, which is close to the needle tube, is abutted against the needle tube so as to prevent the memory needle head from being separated from the third channel in the direction of approaching the needle tube in the extending direction of the third channel.

9. The needle assembly of claim 8, wherein:

the needle tube with the connecting piece welding, and form annular welding seam between the needle tube with the connecting piece.

10. A needle assembly as defined in claim 3, wherein:

the needle assembly further comprises a guide having a fourth channel, the guide being located in the third channel; the fourth channel is provided with a reducing section, the first end of the reducing section is close to the needle tube, the second end of the reducing section is close to the memory needle head, and the inner diameter of the reducing section is gradually reduced from the first end to the second end; two ends of the guide piece along the extension direction of the guide piece are respectively abutted against the memory needle head and the needle tube.

11. The needle assembly of claim 10, wherein:

the fourth channel further comprises a first constant diameter section and a second constant diameter section, the first constant diameter section is communicated with the first end, and the inner diameter of the first constant diameter section is equal to that of the first end; the second end is in communication with the second end, and the second radiused section is equal to the inner diameter of the second end.

12. A needle assembly as defined in claim 3, wherein:

the needle assembly further includes an annular distal seal disposed between an outer peripheral surface of the memory needle and an inner peripheral surface of the connector.

13. 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 seal configured to couple with the needle cannula to block the through-hole.

14. The needle assembly of claim 13, wherein:

the needle assembly further comprises a fastener, the proximal end sealing element is provided with a fastening part close to the memory needle head, the fastener is sleeved outside the fastening part, and the fastening part is in interference fit with the fastener.

15. The needle assembly of claim 1, wherein:

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

16. A sampling needle, comprising:

a handle and a needle assembly as claimed in any one of claims 1 to 15, the handle being connected to a needle cannula of the needle assembly.