CN115120314A - Puncture system - Google Patents

Abstract

The present invention relates to a puncture system. The puncture system comprises a handle assembly and a puncture assembly connected with the handle assembly, the puncture assembly comprises an outer pipe and a puncture piece, the outer pipe is in a hollow tubular shape, at least part of the puncture piece is contained in the outer pipe, and the far end of the puncture piece can be exposed out of or contained in the far end of the outer pipe. The puncture element in the puncture system moves to the inside of the human body along with the outer tube element. The puncture piece does not need to be inserted from the near end of the outer pipe and then slides to the far end of the outer pipe, so that the inner wall of the outer pipe is prevented from being damaged in the sliding process of the puncture piece to generate debris, and the risk of forming thrombus to harm a patient is reduced.

Description

Puncture system

Technical Field

The invention relates to the field of medical instruments, in particular to a puncture system.

Background

Conventional puncture needles are made of a stainless steel tube. When the puncture needle is conveyed in the conveying sheath, the conveying sheath is easy to deform when encountering a bent blood vessel, so that the inner surface of the conveying sheath is easy to contact with the puncture needle, the inner surface of the conveying sheath is damaged by the puncture needle to generate fragments, and once the fragments enter the blood vessel, thrombus is easy to generate to bring harm to a patient.

Disclosure of Invention

In view of the above, there is a need for a lancing system in which a lance is less likely to puncture the inner wall of an outer tube to generate debris.

The puncture system comprises a handle assembly and a puncture assembly which is contained in the handle assembly and fixedly connected with the handle assembly, the puncture assembly comprises an outer pipe and a puncture element, the outer pipe is in a hollow tubular shape, at least part of the puncture element is contained in the outer pipe, the far end of the puncture element can be exposed out of or contained in the far end of the outer pipe, and the near end of the puncture element penetrates out of the near end of the outer pipe.

The puncture element in the puncture system moves to the inside of the human body along with the outer tube. The puncture piece does not need to be inserted from the near end of the outer pipe piece and then slides to the far end of the outer pipe piece, so that the inner wall of the outer pipe piece is prevented from being damaged in the sliding process of the puncture piece to generate fragments, and the risk that thrombus is formed by the fragments to harm a patient is reduced.

Drawings

Fig. 1 is a schematic structural view of a puncture system according to a first embodiment of the present application.

Fig. 2 is an exploded view of a puncture system according to a first embodiment of the present application.

Fig. 3 is a schematic view of the spike assembly of the first embodiment of the present application in a stowed condition.

Fig. 4a is a schematic top view of the handle body according to the first embodiment of the present application.

Fig. 4b is a schematic view of the first handle member, the first control member and the second control member.

Fig. 4c is a schematic view of the second handle member, the first control member, and the second control member.

Fig. 5 is a schematic view of the spike assembly of the first embodiment of the present application in an extended condition.

FIG. 6a is a schematic view showing the connection of the first fixing member, the second fixing member, the outer tubular member and the puncturing member.

Fig. 6b is a schematic structural diagram of the first fixing member.

Fig. 7 is a schematic structural view of a part of the second control member.

Fig. 8a is a schematic structural diagram of a second fixing member.

Fig. 8b is a top view of the second fixing member.

Fig. 8c is a schematic view of the seal structure.

Fig. 9 is a schematic view of a puncture assembly according to a first embodiment of the present application, which is bent and deformed.

Fig. 10 is a schematic view of the structure of a piercing member according to the first embodiment of the present application.

Fig. 11a is a schematic view of a supporting portion and a main body portion in a second embodiment of the present application.

FIG. 11b is a schematic view of the distal end of a spike assembly of a second embodiment of the present application.

Fig. 11c is an enlarged schematic view of the structure at X in fig. 11 b.

Fig. 12 is a schematic view of a bending element according to a second embodiment of the present application.

Fig. 13 is a schematic view of a bending member according to a third embodiment of the present application.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

In the field of interventional medical devices, the "distal end" is defined as the end that is distal from the operator during the procedure, and the "proximal end" is defined as the end that is proximal to the operator during the procedure. "axial" refers to a direction parallel to the line joining the centers of the distal and proximal ends of the medical device, and "radial" refers to a direction perpendicular to the axial direction.

Referring to fig. 1 to 5, a puncture system 1 according to a first embodiment of the present application, the puncture system 1 is used for puncturing in a human body. Particularly, the puncture is not limited to fossa ovalis puncture, interatrial puncture or puncture in transjugular intrahepatic portosystemic shunt. In the present embodiment, the puncture system 1 is used to puncture the fossa ovalis for example.

Referring to fig. 1-3, the lancing system 1 includes a handle assembly 10 and a lancing assembly 20 housed within the handle assembly 10 and fixedly connected to the handle assembly 10. Spike assembly 20 includes an external tube 21 and a spike 22. The outer tube 21 is connected to the handle assembly 10. The outer pipe member 21 has a hollow tubular shape. In the present exemplary embodiment, the piercing element 22 is plugged into the outer tube 21. At least part of the piercing member 22 is housed inside the outer tube member 21. In the present embodiment, the extending direction of the puncture element 22 in the outer tube 21 is the same as the extending direction of the outer tube 21. Distal end 22a of piercing element 22 is proximal to distal end 21a of outer tube 21. Proximal end 22b of piercing element 22 extends through proximal end 21b of outer member 21.

In this embodiment, at least part of the piercing member 22 is housed within the outer tube 21, with the distal end 22a of the piercing member 22 being proximal to the distal end 21a of the outer tube. The puncture member 22 is moved into the human body together with the external tube 21. During the puncture operation, the puncture element 22 does not need to be inserted from the proximal end 21b of the outer tube 21 and then slide to the distal end 21a of the outer tube 21, so that the inner wall of the outer tube 21 is prevented from being damaged and chippings are prevented from being generated during the process that the puncture element 22 slides in the outer tube 21, and the risk of the patient being harmed by the chippings formed into thrombus is reduced.

In this embodiment, the fact that the distal end 22a of piercing element 22 is close to the distal end 21a of outer tube 21 means that the distal end 22a of piercing element 22 is close to the end surface of the distal end 21a of outer tube 21, and the end surface of the distal end 22a of piercing element 22 is not flush with the end surface of the distal end 21a of outer tube 21, i.e. piercing element 22 is received in outer tube 21 or part of piercing element 22 is exposed outside outer tube 21.

In this embodiment, the distal end 22a of the puncturing member 22 is always accommodated in the outer tube member 21 without exposing the outer tube member 21 during the sliding of the outer tube member 21 to a designated area of the human body. For example, during the process of sliding the outer tube 21 to the vicinity of the fossa ovalis of the heart, the outer tube 21 will bend and deform when encountering the curved blood vessel channel of the human body, and the puncture element 22 does not expose the outer tube 21, so as to prevent the puncture element 22 from stabbing the human body.

In this embodiment, piercing member 22 extends through outer member 21 and proximal end 22b of piercing member 22 is also adjacent proximal end 21b of outer member 21. Specifically, proximal end 22b of piercing element 22 extends beyond proximal end 21b of outer element 21.

Referring to fig. 1 and 2, in the present embodiment, the handle assembly 10 has a receptacle 113. The receptacle 113 receives a portion of the spike assembly 20. The receiving member 113 receives the proximal end of the puncture member 22 and the proximal end of the outer tube 21. Specifically, the handle assembly 10 includes a handle body 11. The handle body 11 includes a first handle member 111 and a second handle member 112 connected to the first handle member 111. In the present embodiment, the accommodating space surrounded by the first handle member 111 and the second handle member 112 is an accommodating member 113.

Referring to fig. 4a, 4b and 4c, the first handle member 111 is provided with a fastener 1112. The second handle member 112 is provided with a retainer 1122. In the embodiment, the fastening member 1112 protrudes from the first handle member 111 in the axial direction close to the handle assembly 10, and the fastening member 1112 is hook-shaped as a whole. Snap 1112 protrudes in a negative Y-axis direction. The retainer 1122 is recessed from the second handle member 112 in an axial direction away from the handle assembly 10, and the retainer 1122 is generally in the form of a groove. In FIG. 4c, the retainer 1122 is concave toward the negative Y-axis. The retainer 1122 and the fastener 1112 cooperate to close and fix the first handle 111 and the second handle 112 together. It is understood that, in other embodiments, the fastening element 1112 can be a groove, and the holding element 1122 can be a boss.

In this embodiment, the first handle member 111 is fixedly connected to the second handle member 112. Specifically, glue (not shown) is further disposed between the first handle member 111 and the second handle member 112, and the glue fixedly connects the first handle member 111 and the second handle member 112. In other embodiments, the first handle member 111 and the second handle member 112 may be engaged with the locking member having an internal thread by other means, such as melting at high temperature, etc., or by providing a thread on the outer wall of the first handle member 111 and a thread on the outer wall of the second handle member 112. The specific manner is not limited, and the first handle member 111 and the second handle member 112 can be fixed.

It will be appreciated that in other embodiments, the handle assembly 10 may be integrally formed. That is, the first and second handle members 111 and 112 are integrally formed.

Referring to fig. 1, 3 and 5, in the present embodiment, the puncturing assembly 20 can slide relative to the handle assembly 10 in the axial direction. Specifically, the lancet 22 of the lancet assembly 20 is slidable relative to the handle body 11 of the handle assembly 10 in the axial direction. The spike assembly 20 has a stowed condition and an extended condition. Wherein, the accommodating state and the extending state can be mutually converted. The extended state means that a part of the distal end 22a of the puncturing member 22 is exposed outside the distal end 21a of the outer tube member 21. The accommodated state means that the distal end 22a of the puncturing member 22 is accommodated in the distal end 21a of the outer tube member 21.

The handle assembly 10 also includes a first control member 12. The first control member 12 is provided at least one of the first and second handle members 111 and 112. Referring to fig. 1 and 2, in the present embodiment, the number of the first control members 12 is two, and the two first control members are respectively disposed on the first handle member 111 and the second handle member 112. The first control member 12 is connected to the proximal end of the penetrating member 22. The first control member 12 is used for controlling the axial sliding of the piercing member 22 with respect to the handle body 11. That is, referring to fig. 5, the first control member (not shown) can control the puncturing element 22 to slide axially, so that the distal end 22a of the puncturing element 22 extends out of the outer tube 21. Referring to FIG. 3, alternatively, the distal end 22a of piercing element 22 is controlled to extend into outer tube 21.

It will be appreciated that the first control member 12, upon receiving an external force, transmits the force to the puncturing element 22, causing the puncturing element 22 to slide in the axial direction. In the present embodiment, the first control member 12 receives external action to slide axially relative to the handle body 11. The first control member 12 is connected with the puncturing member 22, and the first control member 12 carries the puncturing member 22 to slide, so that the puncturing member 22 passes through the outer member 21 to perform puncturing operation. It will be appreciated that in this embodiment, the first control member 12 is indirectly connected to the proximal end of the penetrating member 22. In other embodiments, the first control member 12 may be directly connected to the penetrating member 22.

At least one of the first and second handle members 111 and 112 is provided with a first limit hole 1111. The first limit hole 1111 limits a stroke of the first control member 12. The first limiting hole 1111 is connected to the accommodating member 113. Referring to fig. 2, fig. 4a, fig. 4b and fig. 4c, in the present embodiment, the first handle part 111 and the second handle part 112 are both provided with a first limiting hole 1111. The first limit hole 1111 in the first handle member 111 and the first limit hole 1111 in the second handle member 112 have the same shape, and the first limit hole 1111 in the first handle member 111 and the first limit hole 1111 in the second handle member 112 are opposite to each other. In this embodiment, the first position-limiting hole 1111 is a through hole. It is understood that in other embodiments, there may be only one first control member 12 and the first limiting hole 1111 used in cooperation with the first control member 12.

Referring to fig. 2, in the present embodiment, the handle assembly 10 further includes a first fixing member 13. The first fixing member 13 is accommodated in the accommodating member 113. The first attachment member 13 is attached to the proximal end (not shown) of the piercing member 22. Specifically, the first fixing piece 13 includes a first fixing piece body 131. The proximal end of the piercing member 22 extends into the first fastener body 131 and is fixedly attached to the first fastener body 131. It can be understood that at least a portion of the first fixing member body 141 is opposite to the first position-limiting hole 1111. That is, the projection of the first limiting hole 1111 inward in the radial direction at least partially falls on the first fixing member body 131. In this embodiment, the first control member 12 receives external action and slides relative to the handle body 11 in the axial direction, and the first control member 12 drives the first fixing member 13 and the puncturing member 22 to slide relative to the handle body 11 in the axial direction. In other embodiments, the external force directly acts on the first fixing member 13, so that the first fixing member 13 slides in the axial direction relative to the handle body 11, and the first fixing member 13 drives the puncturing element 22 to slide in the axial direction relative to the handle body 11.

Referring to fig. 2, in the present embodiment, the first fixing element 13 further includes a first fixing portion 132 connected to the first fixing element body 131. The first fixing portion 132 is connected to an outer wall of the first fixing body 131. In the embodiment, the first fixing portion 132 is integrally formed with the first fixing body 131. The first fixing portion 132 passes through the first limiting hole 1111 and is connected to the first control member 12. Specifically, the first fixing portion 132 is disposed at an outer wall of the first fixing member 13 and protrudes radially outward at the outer wall of the first fixing member 13. After passing through the first limiting hole 1111, a part of the first fixing portion 132 is connected to the first control member 12. It can be understood that a portion of the first fixing portion 132 is opposite to the first limiting hole 1111. That is, a part of the first fixing portion 132 is opposite to the hole wall of the first limiting hole 1111.

In this embodiment, the first fixing portion 132 passes through a portion of the first limiting hole 1111 and is fixedly connected to the first control member 12. Specifically, the first control member 12 is provided with a first catch 121. The first fixing portion 132 extends into the first retaining portion 121 and is fixedly connected to the first retaining portion 121. The first catching portion 121 is a groove. The first fixing portion 132 is in interference fit with the first retaining portion 121. In other embodiments, the first clamping portion 121 and the first fixing portion 132 are further adhered by glue, so that the first clamping portion 121 and the first fixing portion 132 are stably connected.

In the embodiment, the number of the first fixing portions 132, the number of the first limiting holes 1111, and the number of the first control members 12 are the same. That is, the number of the first fixing portions 132 is two, and the first fixing portions pass through the first limit hole 1111 of the first handle 111 and the first limit hole 1111 of the second handle 112, respectively. The two first fixing portions 132 are symmetrically distributed about the axial direction of the handle assembly 10, so that the whole first fixing member 13 is uniformly stressed, and the first fixing member 13 can smoothly slide in the axial direction relative to the handle body 11. In other embodiments, the number of the first fixing portions 132 is not limited, so that the first control member 12 can control the sliding of the puncturing member 22 through the first fixing portions 132. In other embodiments, the first fixing portion 132 is a groove, and is inserted into the first holding portion 121 and fixed in the first fixing portion 132.

Referring to fig. 4a, 4b and 4c, in the present embodiment, the first position-limiting hole 1111 includes a first position-limiting portion 1111a and a second position-limiting portion 1111b opposite to the first position-limiting portion 1111 a. The first limit portion 1111a and the second limit portion 1111b are arranged at intervals in the axial direction. The first limiting portion 1111a and the second limiting portion 1111b are two opposite hole walls of the first limiting hole 1111. The other hole walls of the first limiting hole 1111, the first limiting portion 1111a and the second limiting portion 1111b define a first limiting hole 1111. The first position-limiting portion 1111a is a distal end of the first position-limiting hole 1111, and the second position-limiting portion 1111b is a proximal end of the first position-limiting hole 1111.

The first limit hole 1111 limits an axial stroke of the first control member 12. That is, the first limit portion 1111a and the second limit portion 1111b limit the axial stroke of the first control member 12, thereby limiting the axial stroke of the first fixing member 13 and the puncturing member 22. The sliding of the lancet 22 in the axial direction is specifically performed as follows.

Referring to fig. 2, fig. 4b, fig. 4c and fig. 5, on one hand, the first control member 12 slides from the proximal end of the first position-limiting hole 1111 to the distal end of the first position-limiting hole 1111, the first control member 12 drives the first fixing portion 132 and the puncturing member 22 to slide in a direction away from the proximal end 11b of the handle body 11, and the puncturing member 22 gradually extends out of the outer tube 21. The first fixing portion 132, a portion of which is opposite to the first limiting hole 1111, is limited by the distal end of the first limiting hole 1111 after abutting against the distal end of the first limiting hole 1111. The first fixing portion 132 cannot be slid further in a direction away from the proximal end 11b of the handle body 11. The piercing member 22 and the first control member 12 cannot slide further in a direction away from the proximal end 11b of the handle body 11.

On the other hand, the first control member 12 slides from the distal end of the first stopper hole 1111 toward the proximal end of the first stopper hole 1111. The first control member 12 drives the first fixing portion 132 and the puncturing member 22 to slide toward the proximal end 11b of the handle body 11. The first fixing portion 132, which is partially opposite to the first limiting hole 1111, is abutted against the proximal end of the first limiting hole 1111 and then limited by the second limiting portion 1111 b. The first fixing portion 132 cannot slide in a direction close to the proximal end 11b of the handle body 11. The puncturing member 22 and the first control member 12 cannot be slid further in the proximal direction of the handle body 11.

In this embodiment, the cross-sectional area of the first fixing element body 131 is larger than the first limiting hole 1111, so that the first fixing element body 131 cannot pass through the first limiting hole 1111, and the first fixing element 13 is not easily separated from the handle body 11.

The distance D1 between the first limit portion 1111a and the second limit portion 1111b in the axial direction corresponds to the stroke of the entire puncturing element 22 in one puncturing operation. The stroke of the first control member 12 sliding in the first limit hole 1111 in the direction away from the proximal end of the handle body 11 is the same as the stroke of the integral puncturing member 22 sliding. Because the puncturing element 22 bends in the human body, the stroke of the distal end of the puncturing element 22 is smaller than or equal to the stroke of the whole puncturing element 22, and is smaller than or equal to the axial distance between the first limiting part 1111a and the second limiting part 1111 b.

In a conventional puncturing operation, a doctor generally holds a joint of a puncturing member with a hand and applies a pushing force to the joint of the puncturing member to cause a needle tip of the puncturing member to puncture an atrial septum. Due to the inertia effect, after the doctor punctures the interatrial septum by the puncture piece, the hand of the doctor continues to push the joint of the puncture piece, so that the needle point of the puncture piece continues to move, and the stroke is overlarge. This easily punctures the left atrial wall, resulting in pericardial tamponade. Alternatively, the aorta is easily punctured causing serious complications. And the pushing force exerted by the doctor on the joint of the puncture piece is uneven, so that the puncture piece slides in the sheath. Puncture piece 22 in this application receives the restriction of first spacing hole 1111 and can not continue to advance after puncturing the interatrial septum, avoids puncture piece 22 to continue to stab the left atrium wall, has improved the degree of safety that utilizes puncture piece 22 to carry out the puncture operation. Moreover, the two first control members 12 are respectively arranged on the first handle member 111 and the second handle member 112, and the acting force applied by the doctor is transmitted to the puncturing member 22 by pushing the two first control members 12, so that the acting force applied to the puncturing member 22 is more uniform, the puncturing member 22 can smoothly slide in the axial direction, and the puncturing stability of the puncturing member 22 is improved.

Referring to fig. 1, 4b and 4c, in the present embodiment, a plurality of protrusions are disposed on an outer wall of the first control member 12 at intervals, and a protruding direction of the protrusions is opposite to an opening direction of the first holding portion 121. The bulges can increase the friction force between the hand of the doctor and the first control element 12, and the doctor can push the first control element 12 to slide conveniently.

Referring again to fig. 2, 6a and 6b, the first fixing member body 131 is provided with a first connector passage 1311, the proximal end (not shown) of the puncturing element 22 is fixed in the first connector passage 1311, and the inner cavity of the puncturing element 22 is communicated with the first connector passage 1311.

The puncture system 1 further comprises a first connecting member 16. The first connector channel 1311 communicates with the interior of both the first connector 16 and the piercing member 22, so that the first liquid medium can be transported into the body via the first connector 16, the first connector channel 1311 and the piercing member 22 in sequence. In this embodiment, the puncture element 22 communicates with the first connector 16 through the first connector passage 1311 in the first holder body 131.

In other embodiments, a portion of the puncturing element 22 is received and fixed in the first fixing element 131, and a portion of the puncturing element 22 extending out of the first fixing element body 131 is communicated with the first connecting element 16. I.e. the proximal end of the piercing member 22 is in direct communication with the first coupling member 16. The first liquid medium can be fed directly into the piercing member 22 via the first connecting element 16, which improves the efficiency of feeding the first liquid medium into the piercing member 22.

The first connecting member 16 includes a first connecting portion 162 and a first switching portion 161 connected to the first connecting portion 162. The first switching portion 161 is disposed outside the handle assembly 10. A proximal end of the first connection portion 162 is connected to the first switch portion 161. The distal end of the first connection portion 162 is connected to the first connector passage 1311, and the first connection portion 162 communicates with the first connector passage 1311.

Specifically, when the first switch portion 161 is in the normally open state, the first liquid medium or the guide wire can be introduced through the first switch portion 161. A first liquid medium or guide wire is moved through the first connector portion 162 into the first connector channel 1311. And then through the lumen of the piercing member 22 into the body. It is to be understood that the first liquid medium is not limited to being a contrast agent or being saline or the like. The first switch 161 functions to prevent blood from passing therethrough when it is normally closed. In this embodiment, the first switch portion 161 is a three-way valve, and the first connection portion 162 is a hollow tubular structure.

The first fixing body 131 is further provided with a second passage 1312 spaced apart from the first connector passage 1311. That is, there is no communication between the first connector channel 1311 and the second channel 1312. The second passage 1312 has an inner diameter larger than that of the first connector passage 1311. The puncture assembly 20 further comprises a second connector 17. A second connector 17 is also provided on the outside of the handle assembly 10. Part of the second connecting member 17 is connected to the outer pipe member 21 by means of a second channel 1312 provided therein.

Referring again to fig. 1, 3 and 5, in the present embodiment, the outer tube 21 can slide relative to the handle assembly 10 in the axial direction. That is, the distal end 21a of the outer tube 21 is slidable in the axial direction away from the handle assembly 10 to convert the puncture assembly 20 from the extended state to the stored state. The distal end 21a of the outer tube 21 is also slidable in a direction approaching the handle body 11 to switch the puncture element 22 from the accommodated state to the extended state.

Specifically, referring to FIG. 2, the handle assembly 10 further includes a second fastener 15 located distally of the first fastener 13. The second fixing member 15 is used to fix the outer pipe member 21. The second fixing member 15 is accommodated in the accommodating member 113. The second fixing member 15 is spaced apart from the first fixing member 13. The second fixture 15 is located distally of the first fixture 13, i.e. in the axial direction, the proximal end of the first fixture 13 is closer to the proximal end of the puncture system 1 than the second fixture 15. First fastener 13 is fixedly attached to proximal end 22b of piercing member 22 to facilitate manipulation of distal end 22a of piercing member 22 by first fastener 13 to extend beyond distal end 21a of outer member 21 or into distal end 21a of outer member 21.

Referring to fig. 1, 2 and 7, the handle assembly 10 further includes a second control member 14. The second control member 14 is spaced from the first control member 12. The second control element 14 is connected to the outer element 21. The second control member 14 is used to control the sliding of the outer tubular member 21 in the axial direction with respect to the piercing member 22.

In this embodiment, the outer tube 21 can slide relative to the handle body 11, so as to precisely adjust the position of the outer tube 21 in the human body. The second control part 14 controls the outer pipe part 21 to slide relative to the handle body 11 in the axial direction, so that the outer pipe part slides towards the direction far away from the near end of the handle body 11 and covers the puncture part 22 again, and the puncture part 22 is accommodated in the hollow pipe body of the outer pipe part 21, thereby reducing the risk that the puncture part 22 punctures the inner wall of the human body and improving the safety degree of the operation.

In the present embodiment, the first control member 12 is closer to the proximal end of the puncture system 1 than the second control member 14. After the first control member 12 controls the puncturing member 22 to be converted from the accommodated state to the extended state and to puncture the atrial septum, the second control member 14 needs to be controlled to slide in a direction away from the proximal end of the puncturing system 1 to control the outer member 21 to re-cover the puncturing member 22. Since the first control member 12 is closer to the proximal end of the puncture system 1 than the second control member 14, that is, the second control member 14 is farther from the proximal end of the puncture system 1 than the first control member 12, the second control member 14 is controlled to slide in a direction away from the proximal end of the puncture system 1, the second control member 14 does not gradually approach the first control member 12, but gradually moves away from the first control member 12, the first control member 12 is not easily touched by mistake in the process of controlling the second control member 14, the puncture member 22 is prevented from being changed in position of the human body by touching the first control member 12, and the puncture needle 22 is prevented from changing in position by touching the first control member 12, if the first control member 12 is retracted after being touched passively, the puncture needle 22 will retract into the outer tube 21, so that the distal end of the puncture assembly 20 rebounds to the right atrium and cannot enter the left atrium.

With reference to fig. 4a, 4b and 4c, the second control member 14 covers part of the first handle member 111 and part of the second handle member 112. The first handle member 111 and the second handle member 112 are both provided with notches 200. The indentation 200 is formed by a portion of the outer surface of the first handle member 111 or a portion of the outer surface of the second handle member 112 being radially inwardly concave. The second control member 14 is seated on the notch 200. The two opposite side walls of the notch 200 serve to limit the axial travel of the second control member 14.

Referring to fig. 2 and 7, the second control member 14 includes a second retaining portion 141 and a connecting thread 142 spaced apart from the second retaining portion 141. The second catch 141 is a groove provided on the inner surface of the second control member 14 and recessed toward the outer surface of the second control member 14. The second catch 141 of the second control member 14 is used for cooperating with the second fixing member 15 to control the axial movement of the second fixing member 15. The second control member 14 is connected to the screw thread 142 for adjusting the deformation and bending of the outer pipe member 21. In the embodiment, the second retaining portion 141 and the connecting thread 142 are both disposed on the inner surface of the second control member 14, and the connecting thread 142 and the second retaining portion 141 can simultaneously move axially along with the second control member 14. In other embodiments, the connecting threads 142 and the second catch 141 may be provided in different sub-components of the second control member 14, respectively. As long as the connecting screw 142 and the second catch 141 can move in the axial direction in synchronization.

In the present embodiment, the second control member 14 is connected to the proximal end of the outer tube 21, and the second control member 14 is indirectly connected to the proximal end of the outer tube 21. In other embodiments, the second control member 14 may also be directly connected to the proximal end of the outer tubular member 21.

Referring to fig. 4a, 4b and 4c, in the present embodiment, the handle assembly 10 is provided with a second limiting hole 1113. The second stopper hole 1113 serves to limit the axial stroke of the second control member 14. Specifically, the first handle member 111 of the handle assembly 10 is provided with a second limiting hole 1113. The second hole 1113 and the first hole 1111 are spaced apart. The second stopper hole 1113 extends from the outer wall of the handle body 11 to the receptacle 113 in the handle body 11. Part of the second control member 14 is connected to the proximal end of the outer tubular member 21 through the first stopper hole 1111. The proximal end of at least part of the outer tubular member 21 is aligned with the second limiting hole 1113. The second handle member 112 is also provided with a second stopper hole 1113. The second limiting hole 1113 of the second handle member 112 is opposite to the second limiting hole 1113 of the first handle member 111.

Referring to fig. 2, the second fixing member 15 includes a second fixing member body 151. The proximal end of the outer tube 21 extends into the second fixing member body 151 and is fixedly connected to the second fixing member body 151.

In this embodiment, the second fixing member 15 further includes a second fixing portion 152 connected to the second fixing member body 151. The second fixing portion 152 is connected to an outer wall of the second fixing body 151. The second fixing portion 152 passes through the second limiting hole 1113 and is connected to the second control member 14. Specifically, with reference to fig. 4b, 4c and 7, the second fixing portion 152 protrudes radially from the outer wall of the second fixing body. The second fixing portion 152 passes through the second limiting hole 1113 and is fastened to the second retaining portion 141 of the second control element 14. In the axial movement process of the second control member 14, the distal end side wall and the proximal end side wall of the second holding portion 141 hold the distal end outer wall and the proximal end outer wall of the second fixing portion 152, and drive the second fixing portion 152 and the second fixing member body 151 to move in the axial direction. In this embodiment, a portion of the second fixing portion 152 is opposite to the second limiting hole 1113.

Referring to fig. 4a, 4b and 4c, in the present embodiment, the second hole 1113 includes a third limiting portion 1113a and a fourth limiting portion 1113b opposite to the third limiting portion 1113 a. The third stopper portion 1113a and the fourth stopper portion 1113b are arranged at intervals in the axial direction. The third stopper portion 1113a and the fourth stopper portion 1113b limit the stroke of the second control member 14 in the axial direction. The third limiting portion 1113a is a distal end of the second limiting hole 1114, and the fourth limiting portion 1113b is a proximal end of the second limiting hole 1113.

On the one hand, referring to fig. 3 and fig. 4b, when the second control member 14 slides from the proximal end of the second position-limiting hole 1113 to the distal end of the second position-limiting hole 1113, the second control member 14 drives the second fixing portion 152 and the outer tube 21 to slide toward the proximal end 11b away from the handle body 11. External tube 21 gradually covers distal end 22a of piercing member 22. When the second fixing portion 152 abuts against the distal end of the second limiting hole 1114, the second fixing portion 152 is limited by the distal end of the second limiting hole 1114, and the second fixing portion 152 and the puncturing element 22 cannot slide in a direction away from the proximal end 11b of the handle body 11. The second fixing portion 152 and the outer tube 21 cannot slide further in a direction away from the proximal end 11b of the handle body 11. This process converts the puncturing element 22 from the extended state to the accommodated state.

On the other hand, referring to fig. 4b and fig. 5, when the second control member 14 slides from the distal end of the second limiting hole 1113 to the proximal end of the second limiting hole 1113, the second control member 14 drives the second fixing portion 152 and the outer tube 21 to slide toward the proximal end 11b of the handle body 11, so that the distal end 22a of the puncturing element 22 is gradually exposed out of the outer tube 21. When the second fixing portion 152 abuts against the proximal end of the second limiting hole 1113, the second fixing portion 152 is limited by the proximal end of the second limiting hole 1113, and the second fixing portion 152 and the puncturing element 22 cannot slide in the direction close to the proximal end of the handle assembly 10. This process converts the puncturing element 22 from the accommodated state to the extended state.

The third limiting portion 1113a and the fourth limiting portion 1113b are two opposite hole walls of the second limiting hole 1113, respectively. The other hole walls of the second limiting hole 1113, the third limiting portion 1113a and the fourth limiting portion 1113b enclose a second limiting hole 1113. The cross-sectional area of the second fixing member 151 is larger than the second limiting hole 1113, so that the second fixing member 151 cannot pass through the second limiting hole 1113, and the second fixing member 151 is not easy to separate from the handle body 11.

In this embodiment, the axial travel of outer member 21 is greater than or equal to the axial travel of piercing member 22. Therefore, after the puncturing piece 22 punctures the atrial septum, the outer tube 21 slides towards the direction far away from the near end of the handle assembly 10, and can completely cover the puncturing piece 22 again, so that the risk that the puncturing piece 22 punctures the inner wall of the human body is reduced, and the safety degree of the operation is improved.

The outer pipe member 21 is movable by an axial stroke of a distance D2 in the axial direction between the third stopper portion 1113a and the fourth stopper portion 1113 b. The piercing member 22 can move by an axial stroke of a distance D1 in the axial direction between the first limit portion 1111a and the second limit portion 1111 b. Wherein D2 is greater than or equal to D1, such that the axial travel of outer tube 21 is greater than the axial travel of piercing element 22, such that outer tube 21 can re-cover piercing element 22 after piercing element 22 has extended out of outer tube 21. The outer tubular element 21 is movable through the same axial stroke as the second control element 14. The axial travel of the piercing element 22 is the same as the axial travel of the first control element 12.

In this embodiment, during the sliding of the outer tube 21 away from the proximal end 11b of the handle body 11, the puncturing element 22 is kept stationary relative to the proximal end 11b of the handle body 11, so as to ensure that the position of the puncturing element 22 in the human body is kept unchanged, and prevent the puncturing element 22 from moving and easily puncturing the left atrial wall.

Referring to fig. 2, fig. 6a, fig. 8a and fig. 8b, the second fixing member 15 has a communicating cavity 1512 communicated with the inner cavity of the outer tube 21, and a puncturing member passage 1511 communicated with the communicating cavity 1512. The piercing member 22 is inserted through the outer tube 21 via the piercing member passage 1511 and the communication cavity 1512. Specifically, the second fastener body 151 includes a spike channel 1511. The proximal end of the outer tube 21 is inserted into the second fixing member body 151. The spike channel 1511 is opposite the first connector channel 1311. The spike 22 passes through the spike channel 1511 and is inserted into the outer tube 21.

In this embodiment, the second fixture body 151 further includes a communication cavity 1512 and a second connector channel 1513. Second connector channel 1513 is spaced from piercing member channel 1511 and second connector channel 1513 communicates with communicating chamber 1512. The communication chamber 1512 is in communication with the spike channel 1511. Second connector channel 1513 communicates with piercing member channel 1511 through communication lumen 1512.

Referring to fig. 1, 2 and 6a, the second connecting member 17 can be used for introducing a second liquid medium. The second liquid medium can be delivered into the body through the second connecting member 17, the second connecting member passage 1513, the communicating chamber 1512 and the outer tube 21 in sequence. Specifically, the second connector 17 includes a second switch portion 171 and a second connecting portion 172 connected to the second switch portion 171. The second switch 171 is disposed outside the handle body 11. The proximal end of the second connecting member 17 is connected to the second switch portion 171. Part of the second connection portion 172 passes through the second passage 1312. The distal end of the second connecting portion 172 is connected to the second connector passage 1513 and the communicating chamber 1512. When the second switch 171 is in the normally open state, the second liquid medium can be introduced through the second switch 171. The second liquid medium moves to the second connecting member channel 1513, the communicating cavity 1512 and the inner cavity of the outer tube 21 via the second connecting portion 172 and enters the human body. It is to be understood that the second liquid medium is not limited to physiological saline or the like, and is determined according to actual needs.

In one aspect, during venting of piercing system 1, the first liquid medium flows through first connector 16, first connector passageway 1311 and piercing member 22, and the gas in first connector 16, first connector passageway 1311 and piercing member 22 is vented out of piercing system 1. The second liquid medium flows through the second connector 17, the second connector passage 1513, the communicating chamber 1512 and the outer tube 21, and the gas in the second connector 17, the second connector passage 1513, the communicating chamber 1512 and the outer tube 21 is discharged out of the puncture system 1. The embodiment can effectively exhaust the gas in the puncture system 1 out of the puncture system 1, and avoid air embolism in the operation process. It will be appreciated that during venting, gas in the piercing system 1 cannot be completely vented by the first liquid medium alone flowing through the first connector 16, the first connector passageway 1311 and the piercing element 22, or by the second liquid medium alone flowing through the second connector 17, the communicating chamber 1512 and the outer tube 21. This is because the evacuation of the first connector 16, the first connector passage 1311, and the puncture element 22 is independent of the evacuation of the second connector 17, the second connector passage 1513, the communication chamber 1512, and the outer tube 21.

On the other hand, when the first liquid medium is a contrast medium, the first liquid medium flows out from the distal end 22a of the puncture element 22, so that the position of the distal end 22a of the puncture element 22 can be accurately determined, a doctor can conveniently control the puncture interatrial space of the puncture element 22, and the accuracy of the puncture operation is improved.

Referring to fig. 6a, 8b and 8c, the proximal end of the second fixing element body 151 is provided with a communication groove 19. The communication groove 19 communicates with the lancet channel 1511. The proximal end of the second fixing member body 151 is also provided with a joint 151 c. The junction 151c is spaced from the spike channel 1511. The joint 151c is used to connect with the second connection portion 172. The second connecting portion 172 is inserted into the joint 151c and communicates with the second connecting member passage 1513.

Referring to fig. 6a, 8a and 8c, the handle assembly 10 further includes a sealing member 18. The sealing member 18 is attached and fixed to the proximal end surface of the second fixing member body 151, and seals the opening of the communication groove 19 in the second fixing member body 151, preventing the liquid from flowing through the gap between the communication groove 19 and the sealing member 18. The manner of attaching and fixing the sealing member 18 to the proximal end surface of the second fixing member body 151 is not limited to one or a combination of a plurality of bonding, insertion, and the like.

In the present embodiment, the entire seal 18 has a cubic shape, the seal 18 is provided with an opening 181, the opening 181 penetrates the proximal end surface and the distal end surface of the seal 18, and the opening 181 communicates with the communication groove 19. The spike 22 is connected to the spike channel 1511 through the opening 181. The inner wall of the opening 181 has an interference fit with the piercing member 22 to prevent fluid from flowing through the space between the piercing member 22 and the opening 181.

The side wall of the partial seal 18 is concave towards the axial direction in which the opening 181 is located. This portion abuts against the side wall of the joint 151c in the second mount body 151, so that the seal member 18 and the second mount body 151 are more compact.

Referring to fig. 9, the spike assembly 20 is bendable. Specifically, the outer tube 21 in the puncture assembly 20 can be bent and deformed. Referring to fig. 2 and 3, the lancing system 1 further includes a bend adjustment assembly 30. The bend adjustment assembly 30 is connected to the spike assembly 20 and the bend adjustment assembly 30 is also connected to the handle assembly 10. The bend adjustment assembly 30 controls the bending deformation of the spike assembly 20. In the present embodiment, the outer tube 21 is adjusted in shape by the bending unit 30. In other embodiments, the outer tubular member 21 may be pre-formed, i.e. already in a bent state, before being introduced into the interior of the human body.

Specifically, the bending adjustment assembly 30 includes an adjusting member 31, a bending adjustment member 33, and a pulling member 32 connected between the adjusting member 31 and the bending adjustment member 33. The adjuster 31 is accommodated in the accommodating member 113. The adjusting member 31 is spaced apart from the second fixing member 15 and is disposed on a side of the second fixing member 15 away from the first fixing member 13. The adjusting member 31 is sleeved on the outer wall of the outer pipe member 21, and the adjusting member 31 can slide on the outer wall of the outer pipe member 21. The bend adjuster 33 is disposed within the distal end of the outer tubular member 21 and is secured within the distal end of the outer tubular member 21. The bend-adjusting member 33 drops in a radially inward projection onto the distal end of the piercing member 22. The proximal end of the pulling member 32 is connected to the adjusting member 31. The distal end of the pulling member 32 is connected to the bend adjuster 33.

The adjusting member 31 is connected to the second control member 14. Referring to fig. 2, 4a, 4b and 4c, at least one of the first handle member 111 and the second handle member 112 is provided with a third limiting hole 300. The third hole 300 and the second hole 1113 are spaced apart. The third stopper hole 300 penetrates from the outer wall of the handle body 11 to the receptacle 113 in the handle body 11. Part of the adjusting member 31 protrudes from the third limiting hole 300 and is screwed with the connecting screw 142 in the second control member 14.

The specific process of the second control member 14 adjusting the position of the adjusting member 31 to bend the outer pipe member 21 is explained as follows. For example, the second control member 14 abuts against the side wall of the notch 200 at the proximal end, the side wall of the notch 200 at the proximal end is used as a support, the side wall rotates relative to the axis of the handle body 11, and the adjusting member 31 slides on the outer wall of the outer tube 21 relative to the handle body 11 along with the rotation of the second control member 14. When the second control member 14 slides the adjusting member 31 toward the proximal end of the outer tube 21, the adjusting member 31 pulls the pulling member 32 and the bending member 33 toward the proximal end of the outer tube 21, so that the distal end of the outer tube 21 is bent toward the proximal end of the outer tube 21. Bending outer tube 21 in a direction proximal to the proximal end of outer tube 21 also causes piercing member 22 to bend in the same direction. In the present embodiment, the bending adjusting member 33 is a hollow ring structure, and the bending adjusting member 33 can be used as a developing point.

In this embodiment, the outer tube 21 can be bent to deform, so that the shape of the outer tube 21 in the human body can be adjusted, the distal end of the outer tube 21 can be directed to a predetermined position, the puncturing element 22 can puncture the predetermined position accurately, and the accuracy of puncturing by the puncturing element 22 can be improved.

In this embodiment, the puncture element 22 is bendable. Specifically, the distal end 22a of the penetrating member 22 is provided with a bendable structure 211. Referring to fig. 10, the flexible structure 211 allows the distal end 22a of the puncturing member 22 to be flexibly deformed, thereby facilitating adjustment of the orientation of the distal end surface of the puncturing member 22. The bendable structure 211 is directly opposite the distal end of the outer tube 21. When the puncture assembly 20 is in the accommodated state, the bendable structure 211 is accommodated within the distal end of the outer tube 21. It is understood that the bendable structure 211 may be spiral, dovetail, etc. in shape. It is to be understood that in other embodiments, the shape of the flexible construct 211 is not limited, subject to the distal end of the puncturing element 22 being flexible. In this embodiment, the lancet 22 is configured by the bend-adjusting assembly 30. In other embodiments, the piercing member 22 may be pre-formed, i.e., already in a bent state, prior to insertion into the body.

In this embodiment, the piercing member 22 is hollow and tubular. The end face of the distal end 22a of the puncturing member 22 is recessed toward the proximal end of the puncturing member 22 to form an inclined puncturing surface having a sharp tip angle for facilitating stress concentration and improving puncturing efficiency.

Second embodiment

Referring to fig. 11a, 11b, 11c and 12, the puncture system 1a of the present embodiment is substantially the same as the first embodiment, except that in the present embodiment, the bending-adjusting member 33a has elasticity. The bending piece 33a is a hollow tubular knot. The bend-adjusting member 33a is disposed within the distal end 210a of the outer tubular member 210. The pulling member 31a is connected between an adjusting member (not shown) and the bending member 33 a.

The handle assembly includes a bend adjustment control (not shown) for controlling adjustment of the distal bend of the outer tubular member 21. The specific structure of the bend-adjusting control part can refer to the second control part in the first embodiment. The bending control member is screwed with the adjusting member, and the bending control member rotates relative to the handle assembly (not shown) to drive the adjusting member and the traction member 31a to slide relative to the handle assembly. When the bending control member drives the adjusting member and the pulling member 31a to slide toward the proximal end of the handle assembly, the bending member 33a bends toward the proximal end of the handle assembly, so that the distal end of the external tube 210 and the distal end of the puncturing member 220 bend toward the proximal end of the handle assembly. It will be appreciated that the pulling member 31a is formed of a resilient metallic or non-metallic material such as a nickel titanium wire.

In this embodiment, the distal end 210a of the external tube 210 includes a body portion 2101 and a support portion 2102 connected to the body portion 2101. The support 2102 protrudes along a proximal end facing away from the outer tube 210. The bending piece 33a is fitted over the outer surface of the supporting portion 2102. The radially inward projection of the bending piece 33a falls on the radially inward projection of the supporting portion 2102.

The outer tube 210 is provided with a first through hole 211. The first through hole 211 penetrates the proximal end of the outer tube 210 and the distal end 210a of the outer tube 210. That is, the first through hole 211 penetrates the main body 2101 and the support 2102. The first through hole 211 is for receiving the piercing member 220.

The outer tube 210 is further provided with an outer tube passage 212, and the outer tube passage 212 is spaced apart from the first through hole 211. External tube channel 212 extends through body portion 2101. The outer pipe passage 212 is disposed inside the outer pipe 210, and the outer pipe passage 212 extends in the same direction as the first through hole 211. The distal end of the pulling member 31a extends through the sidewall of the outer tube 210 along the outer tube passage 212 to the bending member 33a and is fixedly connected to the bending member 33 a. In other embodiments, the bending member 33a can be omitted, and in this case, the pulling member 31a is directly fixed to the distal end 210a of the outer tube 210, and the pulling member 31a pulls the distal end 210a of the outer tube 210 to bend. In other embodiments, pulling element 31a is directly fixed to distal end 210a of outer tube 210 and is not connected to crimping element 33 a. The pulling member 31a pulls the distal end 210a of the outer tube 210 to bend under the external force, and the bending member 33a bends along with the outer tube 210. After the external force is removed, the bending member 33a returns to its original shape, and the elastic force of the bending member 33a returning to its original shape also causes the outer tube 210 to have its original shape.

In this embodiment, the handle assembly further includes a spacer 19a, the spacer 19a having a hollow tubular structure. The spacer 19a is provided on the outer wall of the bend adjusting piece 33 a. The spacer 19a is formed of a polymer material. The partition 19a accommodates a part of the pulling member 31a therein. The distal end of the pulling element 31a passes through the lumen of the spacer 19a and is fixedly attached to the support 2102.

In this embodiment, distal end 210a of outer tube 210 further includes a cover 2103. The covering portion 2103 covers the spacer 19a, and the covering portion 2103 covers a portion of the supporting portion 2102 which is exposed from the main body portion 2101. The proximal end of the covering portion 2103 is flush with the distal end of the main body portion 2101, thereby avoiding the formation of a height difference between the covering portion 2103 and the main body portion 2101 to affect the withdrawal of the external tube 210 from the human body.

The covering portion 2103 also covers the outer wall of the bending adjusting piece 33a, so that the bending adjusting piece 33a is stably accommodated in the outer tube 210, and the bending adjusting piece 33a is prevented from falling off from the outer tube 210.

In this embodiment, the spacer 19a separates the pulling element 31a from the covering portion 2103, and the portion of the pulling element 31a in the inner cavity of the spacer 19a can move relative to the spacer 19a, so that the portion of the pulling element 31a covered by the covering portion 2103 can be prevented from being held and limited by the covering portion 2103 and being unable to slide relative to the spacer 19a, and the supporting portion 2102 can not be bent.

In this embodiment, the material of the covering portion 2103 is a polymer material, as in the case of the main body portion 2101. The cover portion 2103 is fusible with the main body portion 2101 in a molten state. In other embodiments, the material from which the cover portion 2103 is made may be different from the material from which the body portion 2101 is made.

In this embodiment, the covering portion 2103 has a melting point lower than that of the spacer 19 a. In the process of fusing the covering portion 2103 with the main body portion 2102 in the molten state, the spacer 19a is not melted, so that the molten covering portion 2103 is prevented from completely fixing the pull wire 31a in the spacer 19a and the spacer 19a into a whole. Preferably, in this embodiment, the proximal end of the spacer 19a is farther from the distal end of the outer tube 210 than the proximal end of the bending member 33a, so as to prevent the covering portion 2103 from covering the proximal end surface of the spacer 19a, and more effectively prevent the melted covering portion 2103 from completely fixing the pull wire 31a in the spacer 19a and the spacer 19a into a whole.

In this embodiment, the distal end of the retractor 31a passes through the distal end of the spacer 19a and is covered and secured by the cover 2013. When the pulling member 31a is pulled, the pulling member 31a can slide in the partition 19a toward the proximal end of the handle assembly, and the distal end of the pulling member 31a pulls the covering portion 2103, so that the bending member 33a and the supporting portion 2102 are bent toward the proximal end of the handle assembly. In other embodiments, the distal end of the pulling member 31a is fixedly connected to the bending member 33a after passing through the spacer 19 a. When the pulling member 31a is pulled, the distal end of the pulling member 31a pulls the bending member 33a, so that the bending member 33a and the supporting portion 2102 are bent toward the proximal end of the handle assembly.

Referring to fig. 12, the outer wall of the bending member 33a has a plurality of elastic portions 330a and a plurality of openings 330 b. Each opening portion 330b is connected between two adjacent elastic portions 330 a. The opening 330b is a groove structure formed on the bending adjusting member 33 a. The opening 330b reduces the rigidity of the bending adjuster 33a, and makes the bending adjuster 33a more easily bent.

Further, when the second control member drives the adjusting member 31a to slide toward the proximal end of the outer tube 210, the adjacent elastic portions 330a approach each other, and the opening 330b between the adjacent two elastic portions 330a gradually shrinks, so that the bending member 33a is deformed and bent as a whole.

In this embodiment, the number of the openings 330b per unit length is gradually increased from the proximal end 331 of the bending member to the distal end 332 of the bending member. The stiffness of the bend-adjusting member 33a decreases from the bend-adjusting member proximal end 331 to the bend-adjusting member distal end 332. The bend adjuster 33a is more easily bent in a direction from the bend adjuster proximal end 331 to the bend adjuster distal end 332. In other embodiments, the number of openings 330b per unit length is constant from the proximal end 331 of the bending member to the distal end 332 of the bending member.

Third embodiment

Referring to fig. 13, the puncture system 1b of the present embodiment is substantially the same as the second embodiment except that a plurality of openings 340b are connected and spirally extend along the outer wall of the bending member 330 to form a whole.

The pitch of the adjacent two openings 340b decreases from the proximal end 3301 of the bending member to the distal end 3302 of the bending member. The bending-adjusting member 330 has a stiffness that gradually decreases from the proximal end 3301 to the distal end 3302 of the bending-adjusting member, and the bending-adjusting member 330 is more easily bent from the proximal end 3301 to the distal end 3302 thereof. In other embodiments, the pitch of the opening 340b remains constant from the proximal end 3301 to the distal end 3302 of the bending member 330.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is specific and detailed, but not to be understood as limiting the scope of the invention. It should be noted that various changes and modifications can be made by those skilled in the art without departing from the spirit of the invention, and these changes and modifications are all within the scope of the invention. Therefore, the protection scope of the present patent should be subject to the appended claims.

Claims (12)

1. The puncture system is characterized by comprising a handle assembly and a puncture assembly which is contained in the handle assembly and fixedly connected with the handle assembly, wherein the puncture assembly comprises an outer pipe and a puncture piece, the outer pipe is in a hollow tubular shape, at least part of the puncture piece is contained in the outer pipe, the far end of the puncture piece can be exposed out of or contained in the far end of the outer pipe, and the near end of the puncture piece penetrates out of the near end of the outer pipe.

2. The lancing system of claim 1, wherein the handle assembly further comprises a first control member coupled to the lancet for controlling the sliding of the lancet.

3. The lancing system of claim 2, wherein the handle assembly is provided with a first stop hole that limits axial travel of the first control member.

4. A puncture system according to claim 2 or 3, wherein the external tube is slidable relative to the handle assembly.

5. The lancing system of claim 4, wherein the handle assembly further comprises a second control member spaced from the first control member, the second control member coupled to the outer tube, the second control member controlling sliding movement of the outer tube relative to the lance.

6. The lancing system of claim 5, wherein the handle assembly is provided with a second stop hole that limits axial travel of the second control member.

7. A lancing system according to claim 5, wherein the axial travel of movement of said outer tube is greater than or equal to the axial travel of movement of said lance.

8. The lancing system of claim 1, wherein the handle assembly includes a first securing member for securing the lancing element and a second securing member distal to the first securing member for securing the external tube.

9. The lancing system of claim 8, further comprising a first connector, the first connector having a first connector channel, the first connector channel communicating with both the interior of the lancing member and the interior of the first connector such that a first liquid medium can be delivered into the body sequentially through the first connector, the first connector channel, and the lancing member.

10. The puncture system according to claim 9, wherein the second fixing member has a communicating chamber communicating with the inner chamber of the outer member, and a puncture member passage communicating with the communicating chamber, and the puncture member is inserted through the outer member via the puncture member passage and the communicating chamber.

11. A puncture system according to claim 10, further comprising a second connecting member in communication with the communicating chamber, such that a second liquid medium can be delivered into the body sequentially through the second connecting member, the communicating chamber, and the outer member.

12. The lancing system of claim 1, wherein the lancing assembly is flexibly deformable.

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