WO2022206491A1 - Puncture system - Google Patents

Puncture system Download PDF

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Publication number
WO2022206491A1
WO2022206491A1 PCT/CN2022/082278 CN2022082278W WO2022206491A1 WO 2022206491 A1 WO2022206491 A1 WO 2022206491A1 CN 2022082278 W CN2022082278 W CN 2022082278W WO 2022206491 A1 WO2022206491 A1 WO 2022206491A1
Authority
WO
WIPO (PCT)
Prior art keywords
puncture
assembly
bending
handle assembly
handle
Prior art date
Application number
PCT/CN2022/082278
Other languages
French (fr)
Chinese (zh)
Inventor
李安宁
邱礼彪
刘鹏
Original Assignee
深圳市先健呼吸科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 深圳市先健呼吸科技有限公司 filed Critical 深圳市先健呼吸科技有限公司
Publication of WO2022206491A1 publication Critical patent/WO2022206491A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
    • A61B17/3496—Protecting sleeves or inner probes; Retractable tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3454—Details of tips

Definitions

  • the invention relates to the field of medical instruments, in particular to a puncture system.
  • Traditional puncture needles are made of a stainless steel tube.
  • the puncture needle is delivered into the human body through a delivery sheath.
  • the puncture system includes a handle assembly and a puncture assembly, the puncture assembly is accommodated in the handle assembly and is fixedly connected with the handle assembly, and the puncture assembly can be bent and deformed relative to the handle assembly.
  • the puncture assembly can be bent and deformed, which is convenient to adjust the shape of the puncture assembly in the human body, so as to make the distal end of the puncture assembly face a predetermined position, so that the puncture assembly can accurately puncture the predetermined position and improve the puncturing accuracy of the puncture assembly.
  • FIG. 1 is a schematic structural diagram of a puncture system provided by a first embodiment of the present application.
  • FIG. 2 is an exploded view of the puncturing system provided by the first embodiment of the present application.
  • FIG. 3 is a schematic diagram of the puncture assembly in the accommodated state according to the first embodiment of the present application.
  • Fig. 4a is a schematic top view of the structure of the handle body in the first embodiment of the present application.
  • Fig. 4b is a schematic diagram of the first handle member, the first control member and the second control member.
  • Fig. 4c is a schematic diagram of the second handle member, the first control member, and the second control member.
  • FIG. 5 is a schematic diagram of the puncture assembly in the extended state according to the first embodiment of the present application.
  • Fig. 6a is a schematic diagram of the connection of the first fixing piece, the second fixing piece, the outer pipe piece and the puncturing piece.
  • FIG. 6b is a schematic structural diagram of the first fixing member.
  • FIG. 7 is a schematic structural diagram of a part of the second control member.
  • Fig. 8a is a schematic structural diagram of the second fixing member.
  • FIG. 8b is a schematic top view of the structure of the second fixing member.
  • Figure 8c is a schematic diagram of the structure of the seal.
  • FIG. 9 is a schematic diagram of the bending deformation of the puncture assembly in the first embodiment of the present application.
  • FIG. 10 is a schematic structural diagram of the piercing member in the first embodiment of the present application.
  • FIG. 11a is a schematic diagram of the support part and the main body part in the second embodiment of the application.
  • Fig. 11b is a schematic diagram of the distal end of the puncture assembly in the second embodiment of the present application.
  • FIG. 11c is an enlarged schematic view of the structure at X in FIG. 11b.
  • FIG. 12 is a schematic diagram of the bending member in the second embodiment of the application.
  • FIG. 13 is a schematic diagram of the bending member in the third embodiment of the application.
  • distal end is defined as the end away from the operator during the operation
  • proximal end is defined as the end close to the operator during the operation.
  • Axial refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device
  • radial refers to the direction perpendicular to the above-mentioned axial direction.
  • a puncture system 1 is provided by the first implementation of the present application, and the puncture system 1 is used to perform puncture in a human body. Specifically, it is not limited to fossa ovalis puncture, atrial septal puncture, or intrahepatic portocaval shunting via the jugular vein. In this embodiment, the puncture system 1 is used for puncturing the fossa ovalis as an example for description.
  • the puncture system 1 includes a handle assembly 10 and a puncture assembly 20 accommodated in the handle assembly 10 and fixedly connected to the handle assembly 10 .
  • the piercing assembly 20 includes an outer tubular member 21 and a piercing member 22 .
  • the outer tube 21 is connected to the handle assembly 10 .
  • the outer pipe member 21 has a hollow tubular shape.
  • the piercing member 22 is inserted into the outer pipe member 21 . At least part of the piercing member 22 is accommodated in the outer tubular member 21 .
  • the extending direction of the puncturing member 22 in the outer tubular member 21 is the same as the extending direction of the outer tubular member 21 .
  • the distal end 22a of the piercing member 22 is close to the distal end 21a of the outer tubular member 21 .
  • the proximal end 22b of the piercing member 22 passes through the proximal end 21b of the outer tubular member 21 .
  • the piercing member 22 is accommodated in the outer tube member 21, and the distal end 22a of the piercing member 22 is close to the distal end 21a of the outer tube member.
  • the piercing member 22 is moved into the inside of the human body together with the outer tube member 21 .
  • the puncture member 22 does not need to be inserted from the proximal end 21b of the outer tube member 21, and then slide to the distal end 21a of the outer tube member 21, so as to avoid damage to the outer tube member 21 during the sliding process of the puncture member 22 in the outer tube member 21. Debris can be generated from the inner wall, reducing the risk of these debris forming a blood clot and harming the patient.
  • the distal end 22a of the piercing member 22 is close to the distal end 21a of the outer tubular member 21 means that the distal end 22a of the piercing member 22 is close to the end surface of the distal end 21a of the outer tubular member 21, and the distal end 22a of the piercing member 22
  • the end face of the piercing member 21 is not flush with the end face of the distal end 21a of the outer tubular member 21 , that is, the piercing member 22 is accommodated in the outer tubular member 21 or part of the piercing member 22 is exposed outside the outer tubular member 21 .
  • the distal end 22 a of the puncturing member 22 is always accommodated in the outer tube 21 without exposing the outer tube 21 .
  • the outer tube 21 will bend and deform when it encounters a curved blood vessel channel of the human body, while the puncture member 22 does not reveal the outer tube 21, so as to avoid the puncture member 22 from stabbing the human body .
  • the piercing member 22 penetrates through the outer tube member 21 , and the proximal end 22 b of the piercing member 22 is also close to the proximal end 21 b of the outer tube member 21 . Specifically, the proximal end 22b of the piercing member 22 protrudes from the proximal end 21b of the outer tubular member 21 .
  • the handle assembly 10 has a receiving member 113 .
  • the accommodating member 113 accommodates part of the puncturing assembly 20 .
  • the accommodating member 113 accommodates the proximal end of the puncturing member 22 and the proximal end of the outer tubular member 21 .
  • 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 with the first handle member 111 .
  • the accommodating space formed by the first handle member 111 and the second handle member 112 is the accommodating member 113 .
  • the first handle member 111 is provided with a fastening member 1112 .
  • the second handle member 112 is provided with a resisting member 1122.
  • the clasping member 1112 protrudes from the first handle member 111 toward the axial direction of the handle assembly 10 , and the clasping member 1112 is in the shape of a hook as a whole.
  • the fastener 1112 protrudes toward the negative direction of the Y-axis.
  • the resisting member 1122 is concave inward from the second handle member 112 in an axial direction away from the handle assembly 10 , and the resisting member 1122 is in the shape of a groove as a whole. In Fig.
  • the abutting member 1122 is concave in the negative direction of the Y-axis.
  • the resisting member 1122 and the buckling member 1112 cooperate with each other, so that the first handle member 111 and the second handle member 112 are closed and fixed together.
  • the fastening member 1112 may be a groove, and the resisting member 1122 may be in the shape of a boss.
  • the first handle member 111 and the second handle member 112 are fixedly connected.
  • glue (not shown) is further provided between the first handle member 111 and the second handle member 112 , and the glue makes the first handle member 111 and the second handle member 112 fixedly connected.
  • other methods such as high temperature melting, etc., or by providing threads on the outer wall of the first handle member 111 and threads on the outer wall of the second handle member 112, the first handle member 111 and the The second handle member 112 cooperates with each other, and is threadedly connected with a locking member having an internal thread.
  • the specific manner is not limited, as long as the first handle member 111 and the second handle member 112 can be fixed.
  • the handle assembly 10 may be integrally formed. That is, the first handle member 111 and the second handle member 112 are integrally formed.
  • the piercing assembly 20 in the axial direction, can slide relative to the handle assembly 10 .
  • the piercing member 22 in the piercing assembly 20 can slide relative to the handle body 11 in the handle assembly 10 .
  • the piercing assembly 20 has a accommodated state and an extended state. Among them, the contained state and the extended state can be converted into each other.
  • the extended state means that the distal end 22a of the partial piercing member 22 is exposed outside the distal end 21a of the outer tubular member 21 .
  • the accommodated state refers to that the distal end 22 a of the puncturing member 22 is accommodated in the distal end 21 a of the outer tubular member 21 .
  • the handle assembly 10 also includes a first control 12 .
  • the first control part 12 is disposed on at least one of the first handle part 111 and the second handle part 112 .
  • the number of the first control members 12 is two, which 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 piercing member 22 .
  • the first control member 12 is used to control the piercing member 22 to slide relative to the handle body 11 in the axial direction. That is, referring to FIG.
  • the first control member (not shown) can control the puncturing member 22 to slide in the axial direction, so that the distal end 22a of the puncturing member 22 extends out of the outer tubular member 21 .
  • the distal end 22a of the piercing member 22 can protrude into the outer tubular member 21.
  • the first control member 12 transmits the force to the puncturing member 22, so that the puncturing member 22 slides in the axial direction.
  • the first control member 12 slides relative to the handle body 11 in the axial direction under the action of the outside world.
  • the first control member 12 is connected with the puncture member 22, and the first control member 12 slides with the puncture member 22, so that the puncture member 22 passes through the outer tube member 21 to perform a puncture operation.
  • the first control member 12 is indirectly connected to the proximal end of the puncturing member 22 .
  • the first control member 12 may be directly connected to the piercing member 22 .
  • At least one of the first handle member 111 and the second handle member 112 is provided with a first limiting hole 1111 .
  • the first limiting hole 1111 limits the stroke of the first control member 12 .
  • the first limiting hole 1111 communicates with the receiving member 113 .
  • both the first handle member 111 and the second handle member 112 are provided with first limiting holes 1111 .
  • the shape of the first limiting hole 1111 in the first handle member 111 and the first limiting hole 1111 in the second handle member 112 are the same, and the first limiting hole 1111 in the first handle member 111 and the second handle member 1111 have the same shape.
  • the first limiting hole 1111 in 112 is directly opposite.
  • the first limiting hole 1111 is a through hole. It can be understood that, in other embodiments, there may be only one first control member 12 and a first limiting hole 1111 used in cooperation with the first control member 12 .
  • 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 fixing member 13 is connected to the proximal end of the piercing member 22 (not shown).
  • the first fixing member 13 includes a first fixing member body 131 .
  • the proximal end of the piercing member 22 extends into the first fixing member body 131 and is fixedly connected with the first fixing member body 131 .
  • at least part of the first fixing member body 141 is directly opposite to the first limiting hole 1111 . That is, the radially inward projection of the first limiting hole 1111 at least partially falls on the first fixing member body 131 .
  • the first control member 12 receives external action to slide relative to the handle body 11 in the axial direction, and the first control member 12 drives the first fixing member 13 and the piercing member 22 to slide relative to the handle body 11 in the axial direction.
  • the external force directly acts on the first fixing member 13 to make the first fixing member 13 slide relative to the handle body 11 in the axial direction, and the first fixing member 13 drives the puncturing member 22 to slide relative to the handle body 11 in the axial direction.
  • the first fixing member 13 further includes a first fixing portion 132 connected with the first fixing member body 131 .
  • the first fixing portion 132 is connected to the outer wall of the first fixing member body 131 .
  • the first fixing portion 132 is integrally formed with the first fixing member body 131 .
  • the first fixing portion 132 is connected to the first control member 12 through the first limiting hole 1111 .
  • the first fixing portion 132 is disposed on the outer wall of the first fixing member 13 and protrudes radially outward from the outer wall of the first fixing member 13 .
  • Part of the first fixing portion 132 is connected to the first control member 12 after passing through the first limiting hole 1111 . Understandably, part of the first fixing portion 132 is directly opposite to the first limiting hole 1111 . That is, a part of the first fixing portion 132 is directly opposite to the hole wall of the first limiting hole 1111 .
  • 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 .
  • the first control member 12 is provided with a first clamping portion 121 .
  • the first fixing portion 132 extends into the first holding portion 121 and is fixedly connected with the first holding portion 121 .
  • the first holding portion 121 is a groove.
  • the first fixing portion 132 is in an interference fit with the first clamping portion 121 .
  • the first clamping portion 121 and the first fixing portion 132 are also bonded with glue, so that the first clamping portion 121 and the first fixing portion 132 are stably connected.
  • the number of the first fixing parts 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, which respectively pass through the first limiting hole 1111 of the first handle member 111 and the first limiting hole 1111 of the second handle member 112 .
  • the two first fixing portions 132 are symmetrically distributed with respect to the axial direction of the handle assembly 10 , so that the entire first fixing member 13 is uniformly stressed, and the first fixing portion 13 can smoothly slide relative to the handle body 11 in the axial direction.
  • the number of the first fixing parts 132 is not limited, as long as the first control member 12 can control the sliding of the puncturing member 22 through the first fixing part 132 .
  • the first fixing portion 132 is a groove, which is inserted into the first clamping portion 121 and fixed in the first fixing portion 132 .
  • the first limiting hole 1111 includes a first limiting portion 1111a and a second limiting portion 1111b opposite to the first limiting portion 1111a.
  • the first limiting portion 1111a and the second limiting portion 1111b are arranged at intervals in the axial direction.
  • the first limiting portion 1111 a and the second limiting portion 1111 b are two opposite hole walls of the first limiting hole 1111 , respectively.
  • the other hole walls of the first limiting hole 1111 and the first limiting portion 1111 a and the second limiting portion 1111 b enclose the first limiting hole 1111 .
  • the first limiting portion 1111 a is the distal end of the first limiting hole 1111
  • the second limiting portion 1111 b is the proximal end of the first limiting hole 1111 .
  • the first limiting hole 1111 limits the axial stroke of the first control member 12 . That is, the first limiting portion 1111a and the second limiting portion 1111b limit the axial stroke of the first control member 12 to limit the axial stroke of the first fixing member 13 and the puncturing member 22 .
  • the sliding process of the piercing member 22 in the axial direction is as follows.
  • the first control member 12 slides from the proximal end of the first limiting hole 1111 to the distal end of the first limiting hole 1111, and the first control member 12 drives the
  • the first fixing portion 132 and the puncturing member 22 slide in a direction away from the proximal end 11 b of the handle body 11 , and the puncturing member 22 gradually extends out of the outer tube member 21 .
  • Part of the first fixing portion 132 facing the first limiting hole 1111 is restrained by the distal end of the first limiting hole 1111 after pressing against the distal end of the first limiting hole 1111 .
  • the first fixing portion 132 cannot continue to slide 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 continue to slide away from the proximal end 11 b of the handle body 11 .
  • the first control member 12 slides toward the proximal end of the first limiting hole 1111 at the distal end of the first limiting hole 1111 .
  • the first control member 12 drives the first fixing portion 132 and the piercing member 22 to slide toward the proximal end 11 b of the handle body 11 .
  • Part of the first fixing portion 132 facing the first limiting hole 1111 is restrained by the second limiting portion 1111b after pressing against the proximal end of the first limiting hole 1111 .
  • the first fixing portion 132 cannot slide in a direction close to the proximal end 11 b of the handle body 11 .
  • the piercing member 22 and the first control member 12 cannot continue to slide toward the proximal end of the handle body 11 .
  • the cross-sectional area of the first fixing member body 131 is larger than that of the first limiting hole 1111 , so that the first fixing member body 131 cannot pass through the first limiting hole 1111 , so that the first fixing member 13 cannot be easily disengaged Handle body 11 .
  • the axial distance D1 between the first limiting portion 1111a and the second limiting portion 1111b corresponds to the stroke of the entire puncturing member 22 in one puncturing process.
  • the sliding stroke of the first control member 12 in the direction away from the proximal end of the handle body 11 in the first limiting hole 1111 is the same as the sliding stroke of the integral puncturing member 22 . Since the piercing member 22 is bent in the human body, the stroke of the distal end of the piercing member 22 is less than or equal to the stroke of the entire piercing member 22, and less than or equal to the axial distance between the first limiting portion 1111a and the second limiting portion 1111b .
  • a doctor uses a traditional puncture piece to perform a puncture procedure.
  • the doctor holds the joint of the puncture piece by hand and applies a pushing force to the joint of the puncture piece, so that the needle tip of the puncture piece pierces the interatrial septum.
  • the doctor's hand continues to push the joint of the puncture piece, so that the needle tip of the puncture piece continues to travel, resulting in an excessive stroke.
  • This can easily puncture the wall of the left atrium, resulting in cardiac tamponade.
  • the thrust force exerted by the doctor on the joint of the puncture piece is uneven, which affects the sliding of the puncture piece in the sheath.
  • the puncture member 22 in the present application penetrates the interatrial septum, it is restricted by the first limiting hole 1111 and will not continue to travel, which prevents the puncture member 22 from continuing to puncture the left atrium wall, and improves the use of the puncture member 22 for puncture surgery. level of security.
  • the two first control members 12 are respectively disposed on the first handle member 111 and the second handle member 112, and the force exerted by the doctor is transmitted to the puncture member 22 by pushing the two first control members 12, so that the puncture member 22
  • the acting force received is more uniform, the puncturing member 22 can slide smoothly in the axial direction, and the puncturing stability of the puncturing member 22 is improved.
  • the outer wall of the first control member 12 is provided with a plurality of protrusions arranged at intervals, and the protruding direction of the protrusions is opposite to the opening direction of the first clamping portion 121 .
  • These protrusions can increase the friction between the doctor's hand and the first control member 12 , so that the doctor can push the first control member 12 to slide.
  • the first fixing member body 131 is provided with a first connecting member channel 1311, the proximal end (not shown) of the piercing member 22 is fixed in the first connecting member channel 1311, and the piercing member 22 is punctured in the first connecting member channel 1311.
  • the inner cavity of the member 22 communicates with the first connecting member channel 1311 .
  • the piercing system 1 also includes a first connector 16 .
  • the first connector channel 1311 communicates with the inside of the first connector 16 and the piercing component 22 , so that the first liquid medium can be delivered to the body through the first connector 16 , the first connector channel 1311 and the piercing component 22 in sequence.
  • the piercing member 22 communicates with the first connecting member 16 through the first connecting member channel 1311 in the first fixing member body 131 .
  • a part of the piercing member 22 is accommodated and fixed in the first fixing member 131 , and a part of the piercing member 22 extending out of the first fixing member body 131 communicates with the first connecting member 16 . That is, the proximal end of the piercing member 22 is in direct communication with the first connecting member 16 .
  • the first liquid medium can be directly input into the puncturing member 22 through the first connecting member 16 , so as to improve the efficiency of inputting the first liquid medium to the puncturing 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 switch portion 161 is provided outside the handle assembly 10 .
  • the proximal end of the first connection part 162 is connected to the first switch part 161 .
  • the distal end of the first connecting portion 162 is connected to the first connecting member channel 1311 , and the first connecting portion 162 is communicated with the first connecting member channel 1311 .
  • the first liquid medium or the guide wire can be introduced through the first switch portion 161 .
  • the first liquid medium or the guide wire is moved into the first connecting member channel 1311 through the first connecting portion 162 .
  • the first liquid medium is not limited to a contrast agent or a physiological saline.
  • the first switch portion 161 is in a normally closed state, it can prevent the passage of blood.
  • the first switch portion 161 is a three-way valve, and the first connection portion 162 is a hollow tubular structure.
  • the first fixing member body 131 is further provided with a second channel 1312 spaced from the first connecting member channel 1311 . That is, there is no communication between the first connector channel 1311 and the second channel 1312 .
  • the inner diameter of the second channel 1312 is larger than the inner diameter of the first connector channel 1311 .
  • the piercing assembly 20 also includes a second connector 17 .
  • the second connector 17 is also provided outside the handle assembly 10 . Part of the second connecting member 17 is connected to the outer pipe member 21 through the second channel 1312 .
  • the outer pipe member 21 can slide relative to the handle assembly 10 in the axial direction. That is, the distal end 21a of the outer tube 21 can slide in the axial direction in a direction away from the handle assembly 10, so that the puncture assembly 20 is converted from the extended state to the accommodated state.
  • the distal end 21a of the outer tubular member 21 can also slide toward the direction close to the handle body 11, so that the puncturing member 22 is converted from the accommodating state to the extending state.
  • the handle assembly 10 further includes a second fixing member 15 located at the distal side of the first fixing member 13 .
  • the second fixing member 15 is used for fixing 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 fixing member 15 is located at the distal side of the first fixing member 13 , that is, in the axial direction, the proximal end of the first fixing member 13 is closer to the proximal end of the puncture system 1 than the second fixing member 15 .
  • the first fixing member 13 is fixedly connected with the proximal end 22b of the puncturing member 22, so that the distal end 22a of the puncturing member 22 can be controlled to extend out of the distal end 21a of the outer tubular member 21 or into the distal end of the outer tubular member 21 through the first fixing member 13 21a.
  • the handle assembly 10 further includes a second control member 14 .
  • the second control member 14 is spaced apart from the first control member 12 .
  • the second control member 14 is connected to the outer pipe member 21 .
  • the second control member 14 is used to control the sliding of the outer tube member 21 relative to the puncturing member 22 in the axial direction.
  • 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 member 14 controls the outer tube member 21 to slide relative to the handle body 11 in the axial direction, so that it slides away from the proximal end of the handle body 11 and covers the puncture member 22 again, and accommodates the puncture member 22 in the hollow tube body of the outer tube member 21.
  • 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 puncture member 22 to change from the contained state to the extended state and penetrates the interatrial septum, the second control member 14 needs to be controlled to slide away from the proximal end of the puncture system 1 to control the outer tube 21 to cover the puncture again. Piece 22.
  • the second control member 12 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 away from the proximal end of the puncture system 1 than the first control member 12, the second control member 12 is controlled 14 is slid away from the proximal end of the puncture system 1 , the second control part 14 will not gradually approach the first control part 12 , but will gradually move away from the first control part 12 , and the second control part 14 is not easily touched by mistake in the process of controlling the second control part 14 To the first control member 12, avoid touching the first control member 12 by mistake and change the position of the puncture member 22 in the human body, and avoid touching the first control member 12 to change the position of the puncture needle 22, such as the first control member 12 is retracted after passive contact, and the puncture needle 22 will be retracted into the outer tube 21, so that the distal end of the puncture assembly 20 will bounce back to the right atrium and cannot enter the left atrium.
  • 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 a notch 200 .
  • the notch 200 is formed by a part of the outer surface of the first handle member 111 or a part of the outer surface of the second handle member 112 which is radially inwardly concave.
  • the second control member 14 is seated on the notch 200 .
  • the two opposite side walls of the notch 200 are used to limit the axial travel of the second control member 14 .
  • the second control member 14 includes a second holding portion 141 and a connecting thread 142 spaced from the second holding portion 141 .
  • the second holding portion 141 is a groove formed on the inner surface of the second control member 14 and recessed toward the outer surface of the second control member 14 .
  • the second holding portion 141 in the second control member 14 is used to cooperate with the second fixing member 15 to control the axial movement of the second fixing member 15 .
  • the connecting thread 142 of the second control member 14 is used to adjust the deformation and bending of the outer pipe member 21 .
  • the second holding 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 holding portion 141 can move axially with the second control member 14 at the same time.
  • the connecting thread 142 and the second clamping portion 141 may be respectively provided in different sub-components of the second control member 14 . As long as the connecting thread 142 and the second clamping portion 141 can move in the axial direction synchronously.
  • the second control member 14 is connected to the proximal end of the outer tube member 21 , and the second control member 14 is indirectly connected to the proximal end of the outer tube member 21 . In other embodiments, the second control member 14 can also be directly connected with the proximal end of the outer tube member 21 .
  • the handle assembly 10 is provided with a second limiting hole 1113.
  • the second limiting hole 1113 is used to limit the axial stroke of the second control member 14 .
  • the first handle member 111 in the handle assembly 10 is provided with a second limiting hole 1113 .
  • the second limiting hole 1113 is spaced apart from the first limiting hole 1111 .
  • the second limiting hole 1113 penetrates from the outer wall of the handle body 11 to the receiving member 113 in the handle body 11 .
  • Part of the second control member 14 is connected to the proximal end of the outer tube member 21 through the first limiting hole 1111 .
  • the second handle member 112 is also provided with a second limiting hole 1113 .
  • the second limiting hole 1113 of the second handle member 112 is directly opposite to the second limiting hole 1113 of the first handle member 111 .
  • the second fixing member 15 includes a second fixing member body 151 .
  • the proximal end of the outer tubular member 21 extends into the second fixing member body 151 and is fixedly connected with the second fixing member body 151 .
  • the second fixing member 15 further includes a second fixing portion 152 connected with the second fixing member body 151 .
  • the second fixing portion 152 is connected to the outer wall of the second fixing member body 151 .
  • the second fixing portion 152 is connected to the second control member 14 through the second limiting hole 1113 .
  • 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 with the second clamping portion 141 in the second control member 14 .
  • the distal side wall and the proximal side wall of the second holding portion 141 clamp the distal outer wall and the proximal outer wall of the second fixing portion 152 and drive the second fixing portion 152 and the second fixing member body 151 moves in the axial direction.
  • part of the second fixing portion 152 is directly opposite to the second limiting hole 1113 .
  • the second limiting hole 1113 includes a third limiting portion 1113a and a fourth limiting portion 1113b opposite to the third limiting portion 1113a.
  • the third limiting portion 1113a and the fourth limiting portion 1113b are arranged at intervals in the axial direction.
  • the third limiting portion 1113a and the fourth limiting portion 1113b limit the stroke of the second control member 14 in the axial direction.
  • the third limiting portion 1113 a is the distal end of the second limiting hole 1114
  • the fourth limiting portion 1113 b is the proximal end of the second limiting hole 1113 .
  • the second control member 14 drives the second control member 14
  • the fixing portion 152 and the outer tubular member 21 slide away from the proximal end 11 b of the handle body 11 .
  • the outer tubular member 21 gradually covers the distal end 22a of the piercing member 22 .
  • the second fixing portion 152 After the second fixing portion 152 is pressed against the distal end of the second limiting hole 1114 , the second fixing portion 152 is restrained by the distal end of the second limiting hole 1114 , and the second fixing portion 152 and the piercing member 22 cannot continue to move away from The handle body 11 slides in the direction of the proximal end 11b. The second fixing portion 152 and the outer tube 21 cannot continue to slide in the direction away from the proximal end 11b of the handle body 11. In this process, the piercing member 22 is converted from the extended state to the accommodated state.
  • the second fixing portion 152 After the second fixing portion 152 is pressed against the proximal end of the second limiting hole 1113, the second fixing portion 152 is restrained by the proximal end of the second limiting hole 1113, and the second fixing portion 152 and the piercing member 22 cannot approach the handle along the Assembly 10 slides in the direction of the proximal end. In this process, the piercing member 22 is converted from the accommodated state to the extended state.
  • the third limiting portion 1113 a and the fourth limiting portion 1113 b are two opposite hole walls of the second limiting hole 1113 , respectively.
  • the other hole walls of the second limiting hole 1113 and the third limiting portion 1113a and the fourth limiting portion 1113b enclose the second limiting hole 1113 .
  • the cross-sectional area of the second fixing member body 151 is larger than that of the second limiting hole 1113 , so that the second fixing member 151 cannot pass through the second limiting hole 1113 , so that the second fixing member 151 cannot easily be separated from the handle body 11 .
  • the movable axial stroke of the outer tubular member 21 is greater than or equal to the movable axial stroke of the piercing member 22 . In this way, after the puncturing member 22 punctures the interatrial septum, the outer tube 21 slides away from the proximal end of the handle assembly 10 to completely cover the puncturing member 22 again, thereby reducing the risk of puncturing the inner wall of the human body by the puncturing member 22 and improving the safety of the operation.
  • the movable axial stroke of the outer pipe member 21 is the distance D2 in the axial direction between the third limiting portion 1113a and the fourth limiting portion 1113b.
  • the movable axial stroke of the piercing member 22 is the distance D1 in the axial direction between the first limiting portion 1111a and the second limiting portion 1111b.
  • D2 is greater than or equal to D1
  • the movable axial stroke of the outer tubular member 21 is greater than the movable axial stroke of the puncturing member 22, so that the outer tubular member 21 can cover the puncturing member 22 again after the puncturing member 22 extends out of the outer tubular member 21.
  • the movable axial stroke of the outer pipe member 21 is the same as the movable axial stroke of the second control member 14 .
  • the movable axial stroke of the piercing member 22 is the same as the movable axial stroke of the first control member 12 .
  • the puncturing member 22 remains stationary relative to the proximal end 11b of the handle body 11 to ensure that the position of the puncturing member 22 in the human body remains unchanged , to prevent the puncturing member 22 from moving and puncturing the wall of the left atrium easily.
  • the second fixing member 15 is provided with a communication cavity 1512 communicating with the inner cavity of the outer pipe member 21 , and a puncturing member channel 1511 communicating with the communication cavity 1512 .
  • the piercing member 22 is inserted through the outer tubular member 21 through the piercing member channel 1511 and the communication cavity 1512 .
  • the second fixing member body 151 includes a piercing member channel 1511 .
  • the proximal end of the outer pipe member 21 is inserted into the second fixing member body 151 .
  • the piercing member channel 1511 is opposite to the first connecting member channel 1311 .
  • the piercing member 22 passes through the piercing member channel 1511 and is inserted into the outer tubular member 21 .
  • the second fixing member body 151 further includes a communication cavity 1512 and a second connecting member channel 1513 .
  • the second connecting member channel 1513 is spaced apart from the piercing member channel 1511 , and the second connecting member channel 1513 communicates with the communication cavity 1512 .
  • the communication cavity 1512 communicates with the piercing member channel 1511 .
  • the second connecting member channel 1513 communicates with the piercing member channel 1511 through the communication cavity 1512 .
  • the second connecting member 17 can be used to introduce the second liquid medium.
  • the second liquid medium can be delivered to the body through the second connector 17 , the second connector channel 1513 , the communication cavity 1512 and the outer tube 21 in sequence.
  • the second connector 17 includes a second switch part 171 and a second connection part 172 connected to the second switch part 171 .
  • the second switch portion 171 is provided outside the handle body 11 .
  • the proximal end of the second connecting member 17 is connected to the second switch portion 171 .
  • a portion of the second connection portion 172 passes through the second channel 1312 .
  • the distal end of the second connecting portion 172 is connected with the second connecting member channel 1513 and the communication cavity 1512 .
  • the second liquid medium can be introduced through the second switch portion 171 .
  • the second liquid medium moves through the second connecting portion 172 to the second connecting member channel 1513 , the communication cavity 1512 , and the inner cavity of the outer pipe member 21 to enter the human body.
  • the second liquid medium is not limited to physiological saline, etc., and is determined according to actual needs.
  • the first liquid medium flows through the first connector 16, the first connector channel 1311 and the puncture component 22, and the first connector 16, the first connector channel 1311 and the The gas in the puncturing member 22 is discharged out of the puncturing system 1 .
  • the second liquid medium flows through the second connector 17 , the second connector channel 1513 , the communication cavity 1512 , and the outer tube 21 , connecting the second connector 17 , the second connector channel 1513 , the communication cavity 1512 and the outer tube 21 .
  • the gas is expelled out of the puncture system 1 .
  • This embodiment can effectively discharge the gas in the puncture system 1 out of the puncture system 1 to avoid air embolism during the operation.
  • the first liquid medium when the first liquid medium is contrast fluid, the first liquid medium flows out from the distal end 22a of the puncturing member 22, and the position of the distal end 22a of the puncturing member 22 can be accurately determined, which is convenient for the doctor to control the puncturing member 22 to puncture the interatrial septum , to improve the accuracy of puncture surgery.
  • the proximal end of the second fixing member body 151 is provided with a communication groove 19 .
  • the communication groove 19 communicates with the piercing member channel 1511 .
  • the proximal end of the second fixing member body 151 is also provided with a joint 151c.
  • the joint 151c is spaced apart from the piercing member channel 1511 .
  • the joint 151c is used to connect with the second connection portion 172 .
  • the second connecting portion 172 is penetrated inside the joint 151c and communicated with the second connecting member channel 1513 .
  • the handle assembly 10 further includes a sealing member 18 .
  • the sealing member 18 is attached to and fixed on the proximal end face of the second fixing member body 151 , and seals the opening of the communication groove 19 in the second fixing member body 151 to prevent liquid from flowing through the gap between the communication groove 19 and the sealing member 18 .
  • the manner in which the sealing member 18 is attached to and fixed to the proximal end face of the second fixing member body 151 is not limited to one or more combinations such as bonding and plugging.
  • the sealing member 18 is in the shape of a cube as a whole, and the sealing member 18 is provided with an opening 181 .
  • the piercing member 22 is connected to the piercing member channel 1511 through the opening 181 .
  • the inner wall of the opening 181 is in an interference fit with the piercing member 22 to prevent liquid from flowing through the gap between the piercing member 22 and the opening 181 .
  • the side wall of the partial seal 18 is concave in the axial direction in which the opening 181 is located. This part fits the side wall of the joint 151c in the second fixing member body 151 , so that the space between the sealing member 18 and the second fixing member body 151 is more compact.
  • the piercing assembly 20 can be bent and deformed. Specifically, the outer tubular member 21 in the puncturing assembly 20 can be bent and deformed.
  • the puncturing system 1 further includes a bending assembly 30 .
  • the bending assembly 30 is connected with the piercing assembly 20 , and the bending assembly 30 is also connected with the handle assembly 10 .
  • the bending assembly 30 controls the bending deformation of the puncturing assembly 20 .
  • the shape of the outer tube 21 is adjusted by the bending assembly 30 .
  • the outer tubular member 21 may be prefabricated and deformed, that is, it is already in a bent state before being inserted into the human body.
  • the bending assembly 30 includes an adjusting member 31 , a bending member 33 , and a pulling member 32 connected between the adjusting member 31 and the bending member 33 .
  • the adjusting member 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 tube member 21 , and the regulating member 31 can slide on the outer wall of the outer tube member 21 .
  • the bending member 33 is disposed in the distal end of the outer tubular member 21 and fixed in the distal end of the outer tubular member 21 .
  • the radially inward projection of the bending element 33 falls onto the distal end of the piercing element 22 .
  • the proximal end of the pulling member 32 is connected with the adjusting member 31 .
  • the distal end of the pulling member 32 is connected with the bending member 33 .
  • the regulating element 31 is connected to the second control element 14 .
  • 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 limiting hole 300 is spaced apart from the second limiting hole 1113 .
  • the third limiting hole 300 penetrates from the outer wall of the handle body 11 to the receiving member 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 thread 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 described as follows.
  • the second control member 14 abuts the side wall at the proximal end of the notch 200 , is supported by the side wall at the proximal end of the notch 200 , rotates relative to the axis of the handle body 11 , and the adjusting member 31 rotates with the rotation of the second control member 14 . It slides on the outer wall of the outer tube 21 relative to the handle body 11 .
  • the adjustment member 31 pulls the traction member 32 and the bending member 33 toward the proximal end of the outer tubular member 21, so that the distal end of the outer tubular member 21 approaches the proximal end of the outer tubular member 21.
  • the direction of the proximal end of the outer tube 21 is bent.
  • the bending of the outer tubular member 21 toward the proximal end of the outer tubular member 21 also causes the piercing member 22 to bend in the same direction.
  • the bending member 33 has a hollow annular structure, and the bending member 33 can be used as a developing point.
  • the outer tube member 21 can be bent and deformed, which is convenient to adjust the shape of the outer tube member 21 in the human body, so that the distal end of the outer tube member 21 faces a predetermined position, so that the puncture member 22 can accurately puncture the predetermined position, and improve the 22 Accuracy of puncture.
  • the piercing member 22 can be bent and deformed.
  • the distal end 22a of the piercing member 22 is provided with a bendable structure 211 .
  • the bendable structure 211 can bend and deform the distal end 22 a of the piercing member 22 , so as to adjust the orientation of the distal end surface of the piercing member 22 .
  • the bendable structure 211 is directly opposite the distal end of the outer tube 21 .
  • the bendable structure 211 is accommodated in the distal end of the outer tubular member 21 .
  • the shape of the bendable structure 211 can be a spiral or a dovetail.
  • the shape of the bendable structure 211 is not limited, as long as the distal end of the piercing member 22 is bendable.
  • the shape of the piercing member 22 is adjusted by the bending assembly 30 .
  • the piercing member 22 may be prefabricated, that is, it is in a bent state before being inserted into the human body.
  • the piercing member 22 is in the shape of a hollow tube.
  • the end surface of the distal end 22a of the puncturing element 22 is concave toward the proximal end of the puncturing element 22 to form an inclined puncturing surface.
  • the puncture system 1a provided in this embodiment is basically the same as the first embodiment, the difference is that in this embodiment, the bending member 33a has elasticity.
  • the bending member 33a is in the form of a hollow tubular knot.
  • the bending member 33a is disposed within the distal end 210a of the outer tubular member 210 .
  • the pulling member 31a is connected between the adjusting member (not shown) and the bending member 33a.
  • the handle assembly includes a bending control member (not shown), and the bending control member is used to control and adjust the bending of the distal end of the outer tubular member 21 .
  • 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.
  • 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 is bent toward the proximal end of the handle assembly, so that the distal end of the outer tubular member 210 and the distal end of the puncturing member 220 move closer to the proximal end of the handle assembly.
  • the direction of the proximal end of the handle assembly is bent.
  • the pulling member 31a is formed of an elastic metal or non-metal material such as nickel-titanium wire.
  • the distal end 210a of the outer tube 210 includes a main body portion 2101 and a support portion 2102 connected to the main body portion 2101 .
  • the support portion 2102 protrudes along the proximal end facing away from the outer tube 210 .
  • the bending part 33a is sleeved on the outer surface of the support part 2102 .
  • the radially inward projection of the bending member 33 a falls on the radially inward projection of the support portion 2102 .
  • the outer tube 210 is provided with a first through hole 211 .
  • the first through hole 211 penetrates through the proximal end of the outer tubular member 210 and the distal end 210a of the outer tubular member 210 . That is, the first through hole 211 penetrates through the main body portion 2101 and the support portion 2102 .
  • the first through hole 211 is used to accommodate the piercing member 220 .
  • the outer tube 210 is further provided with an outer tube channel 212, and the outer tube channel 212 is spaced from the first through hole 211.
  • the outer tube passage 212 penetrates the main body portion 2101 .
  • the outer tube channel 212 is disposed in the outer tube 210 , and the extension direction of the outer tube channel 212 is the same as the extension direction of the first through hole 211 .
  • the distal end of the pulling member 31a extends to the bending member 33a through the side wall of the outer tube member 210 along the outer tube member channel 212, and is fixedly connected with the bending member 33a. In other embodiments, the bending member 33a may be omitted.
  • the pulling member 31a is directly fixed on the distal end 210a of the outer tubular member 210, and the pulling member 31a pulls the distal end 210a of the outer tubular member 210 to bend.
  • the pulling member 31a is directly fixed on the distal end 210a of the outer tubular member 210, and is not connected with the bending member 33a.
  • the pulling member 31a pulls the distal end 210a of the outer tubular member 210 to bend under the action of an external force, and the bending member 33a bends together with the outer tubular member 210 .
  • the bending member 33a After the external force is removed, the bending member 33a returns to its original shape, and at the same time, the elastic force of the bending member 33a to restore the original shape also makes the outer pipe member 210 the original shape.
  • the handle assembly further includes a spacer 19a, and the spacer 19a is a hollow tubular structure.
  • the spacer 19a is provided on the outer wall of the bending member 33a.
  • the spacer 19a is formed of a polymer material.
  • Part of the pulling member 31a is accommodated in the spacer 19a. The distal end of the pulling member 31a passes through the inner cavity of the spacer 19a and is fixedly connected with the supporting portion 2102 .
  • the distal end 210a of the outer tubular member 210 further includes a covering portion 2103 .
  • the cover part 2103 covers the spacer 19a, and the cover part 2103 covers the part of the support part 2102 exposed from the main body part 2101 .
  • the proximal end of the covering part 2103 is flush with the distal end of the main body part 2101 , so as to avoid a height difference between the covering part 2103 and the main body part 2101 which would affect the withdrawal of the outer tube 210 from the human body.
  • the covering portion 2103 also covers the outer wall of the bending member 33a, so that the bending member 33a is stably accommodated in the outer pipe member 210 and prevents the bending member 33a from falling off from the outer pipe member 210.
  • the spacer 19a separates the pulling member 31a and the covering portion 2103, and the portion of the pulling member 31a in the inner cavity of the spacer 19a can move relative to the spacer 19a, thereby preventing the pulling member 31a from being covered by the covering portion 2103. Part of it is resisted and limited by the covering part 2103 and cannot slide relative to the spacer 19a, so that the supporting part 2102 cannot be bent.
  • the material for forming the cover portion 2103 is the same as the material for forming the main body portion 2101 , which is a polymer material.
  • the cover portion 2103 may be fused with the main body portion 2101 in a molten state.
  • the material of the covering portion 2103 may be different from the material of the main portion 2101 .
  • the melting point of the covering portion 2103 is lower than the melting point of the spacer 19a.
  • the spacer 19a will not be melted, thereby preventing the melted cover part 2103 from completely fixing the pulling wire 31a in the spacer 19a and the spacer 19a into one.
  • the proximal end of the spacer 19a is farther away from the distal end of the outer tube 210 than the proximal end of the bending element 33a, so as to prevent the covering portion 2103 from covering the proximal end face of the spacer 19a, and more effectively prevent molten
  • the covering portion 2103 completely secures the pulling wire 31a in the spacer 19a and the spacer 19a into one body.
  • the distal end of the pulling member 31a passes through the distal end of the spacer 19a, and is covered and fixed by the covering portion 2013 .
  • the pulling member 31a can slide toward the proximal end of the handle assembly within the spacer 19a, 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 face the proximal end of the handle assembly bending.
  • the distal end of the pulling member 31a is fixedly connected to the bending member 33a after passing through the spacer 19a. 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 support portion 2102 are bent toward the proximal end of the handle assembly.
  • the outer wall of the bending member 33a has a plurality of elastic portions 330a and a plurality of opening portions 330b.
  • Each opening portion 330b is connected between two adjacent elastic portions 330a.
  • the opening 330b is a groove structure formed on the bending member 33a. The opening portion 330b can reduce the rigidity of the bending part 33a, so that the bending part 33a is easier to bend.
  • the second control member drives the adjustment member 31a to slide toward the proximal end of the outer pipe member 210, the adjacent elastic portions 330a approach each other, and the opening portion 330b between the two adjacent elastic portions 330a gradually shrinks, so that the bending member 33a is deformed and bent as a whole.
  • the distribution number of the openings 330b per unit length increases gradually in the direction from the proximal end 331 of the bending member to the distal end 332 of the bending member.
  • the stiffness of the bending member 33a gradually decreases in the direction from the proximal end 331 of the bending member to the distal end 332 of the bending member. In the direction from the proximal end 331 of the bending member to the distal end 332 of the bending member, the bending member 33a is easier to bend.
  • the distribution number of the openings 330b per unit length remains unchanged in the direction from the proximal end 331 of the bending member to the distal end 332 of the bending member.
  • the puncture system 1b provided in this embodiment is basically the same as that of the second embodiment, the difference is 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 pitches of the two adjacent openings 340b gradually decrease in the direction from the proximal end 3301 of the bending member to the distal end 3302 of the bending member.
  • the stiffness of the bending member 330 gradually decreases from the proximal end 3301 of the bending member to the distal end 3302 of the bending member, and the bending member 330 is easier to bend in the direction from the proximal end 3301 to the distal end 3302 of the bending member.
  • the pitch of the opening portion 340b remains unchanged in the direction from the proximal end 3301 to the distal end 3302 of the bending member 330 .

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Abstract

A puncture system (1), comprising a handle assembly (10) and a puncture assembly (20). The puncture assembly (20) is accommodated in the handle assembly (10) and is fixedly connected to the handle assembly (10). The puncture assembly (20) is bendable and deformable relative to the handle assembly (10). The puncture assembly (20) is bendable and deformable so as to adjust the shape of the puncture assembly (20) in the human body, so that a distal end of the puncture assembly (20) faces a predetermined position, and the puncture assembly (20) accurately punctures the predetermined position, thereby improving the accuracy of puncturing of the puncture assembly (20).

Description

穿刺***puncture system 技术领域technical field
本发明涉及医疗器械领域，特别是涉及一种穿刺***。The invention relates to the field of medical instruments, in particular to a puncture system.
背景技术Background technique
传统的穿刺针由一根不锈钢管制成。穿刺针在通过输送鞘内输送至人体内。然而传统的穿刺针，在进行穿刺的过程中，往往不易于控制穿刺针的形态，容易降低穿刺针穿刺的准确性。Traditional puncture needles are made of a stainless steel tube. The puncture needle is delivered into the human body through a delivery sheath. However, in the traditional puncture needle, it is often difficult to control the shape of the puncture needle during the puncture process, which easily reduces the puncture accuracy of the puncture needle.
发明内容SUMMARY OF THE INVENTION
基于此，有必要提供穿刺***，可调整穿刺***中穿刺组件的形态，提高穿刺***穿刺的精确程度。Based on this, it is necessary to provide a puncture system, which can adjust the shape of the puncture component in the puncture system and improve the accuracy of the puncture of the puncture system.
所述穿刺***包括手柄组件和穿刺组件，所述穿刺组件收容于所述手柄组件内，且与所述手柄组件固定相连，所述穿刺组件可相对手柄组件弯曲变形。The puncture system includes a handle assembly and a puncture assembly, the puncture assembly is accommodated in the handle assembly and is fixedly connected with the handle assembly, and the puncture assembly can be bent and deformed relative to the handle assembly.
所述穿刺组件可弯曲变形，便于调整穿刺组件在人体的形态，以便使穿刺组件的远端朝向预定的位置，使穿刺组件准确地穿刺预定的位置，提高穿刺组件穿刺的精确程度。The puncture assembly can be bent and deformed, which is convenient to adjust the shape of the puncture assembly in the human body, so as to make the distal end of the puncture assembly face a predetermined position, so that the puncture assembly can accurately puncture the predetermined position and improve the puncturing accuracy of the puncture assembly.
附图说明Description of drawings
图1为本申请第一实施例提供的穿刺***的结构示意图。FIG. 1 is a schematic structural diagram of a puncture system provided by a first embodiment of the present application.
图2为本申请第一实施例提供的穿刺***的***图。FIG. 2 is an exploded view of the puncturing system provided by the first embodiment of the present application.
图3为本申请第一实施例中穿刺组件处于收容状态下的示意图。FIG. 3 is a schematic diagram of the puncture assembly in the accommodated state according to the first embodiment of the present application.
图4a为本申请第一实施例中手柄本体的俯视结构示意图。Fig. 4a is a schematic top view of the structure of the handle body in the first embodiment of the present application.
图4b为第一手柄件、第一控制件、第二控制件的示意图。Fig. 4b is a schematic diagram of the first handle member, the first control member and the second control member.
图4c为第二手柄件、第一控制件、第二控制件的示意图。Fig. 4c is a schematic diagram of the second handle member, the first control member, and the second control member.
图5为本申请第一实施例中穿刺组件处于伸出状态下的示意图。FIG. 5 is a schematic diagram of the puncture assembly in the extended state according to the first embodiment of the present application.
图6a为第一固定件、第二固定件、外管件、穿刺件的连接示意图。Fig. 6a is a schematic diagram of the connection of the first fixing piece, the second fixing piece, the outer pipe piece and the puncturing piece.
图6b为第一固定件的结构示意图。FIG. 6b is a schematic structural diagram of the first fixing member.
图7为部分第二控制件的结构示意图。FIG. 7 is a schematic structural diagram of a part of the second control member.
图8a为第二固定件的结构示意图。Fig. 8a is a schematic structural diagram of the second fixing member.
图8b为第二固定件的俯视结构示意图。FIG. 8b is a schematic top view of the structure of the second fixing member.
图8c为密封件的结构示意图。Figure 8c is a schematic diagram of the structure of the seal.
图9为本申请第一实施例中穿刺组件弯曲变形的示意图。FIG. 9 is a schematic diagram of the bending deformation of the puncture assembly in the first embodiment of the present application.
图10为本申请第一实施例中穿刺件的结构示意图。FIG. 10 is a schematic structural diagram of the piercing member in the first embodiment of the present application.
图11a为本申请第二实施例中支撑部及主体部的示意图。FIG. 11a is a schematic diagram of the support part and the main body part in the second embodiment of the application.
图11b为本申请第二实施例中穿刺组件远端的示意图。Fig. 11b is a schematic diagram of the distal end of the puncture assembly in the second embodiment of the present application.
图11c为图11b中X处的放大结构示意图。FIG. 11c is an enlarged schematic view of the structure at X in FIG. 11b.
图12为本申请第二实施例中调弯件的示意图。FIG. 12 is a schematic diagram of the bending member in the second embodiment of the application.
图13为本申请第三实施例中调弯件的示意图。FIG. 13 is a schematic diagram of the bending member in the third embodiment of the application.
具体实施方式Detailed ways
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施的限制。In order to make the above objects, features and advantages of the present invention more clearly understood, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present invention. Therefore, the present invention is not limited by the specific implementation disclosed below.
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。Unless otherwise defined, 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 terms used herein in the description of the present invention are for the purpose of describing specific embodiments only, and are not intended to limit the present invention.
在介入医疗器械领域，定义“远端”为手术过程中远离操作者的一端，定义“近端”为手术过程中靠近操作者的一端。“轴向”指平行于医疗器械远端中心和近端中心连线的方向，“径向”指垂直于上述轴向的方向。In the field of interventional medical devices, the "distal end" is defined as the end away from the operator during the operation, and the "proximal end" is defined as the end close to the operator during the operation. "Axial" refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device, and "radial" refers to the direction perpendicular to the above-mentioned axial direction.
请参阅图1至图5，本申请第一实施提供的穿刺***1，穿刺***1用于在人体内进行穿刺。具体不限于为卵圆窝穿刺、房间隔穿刺、或者经颈静脉肝内门腔静脉分流术中穿刺。在本实施例，以穿刺***1穿刺卵圆窝为例进行说明。Referring to FIGS. 1 to 5 , a puncture system 1 is provided by the first implementation of the present application, and the puncture system 1 is used to perform puncture in a human body. Specifically, it is not limited to fossa ovalis puncture, atrial septal puncture, or intrahepatic portocaval shunting via the jugular vein. In this embodiment, the puncture system 1 is used for puncturing the fossa ovalis as an example for description.
请参阅图1至图3，穿刺***1包括手柄组件10和收容于手柄组件10内且与手柄组件10固定相连的穿刺组件20。穿刺组件20包括外管件21和穿刺件22。外管件21与手柄组件10连接。外管件21呈中空管状。在本实施例中，穿刺件22与外管件21插接。至少部分穿刺件22收容在外管件21内。在本实施例中，穿刺件22在外管件21内的延伸方向，与外管件21的延伸方向相同。穿刺件22的远端22a靠近外管件21的远端21a。穿刺件22的近端22b穿出外管件21的近端21b。Referring to FIGS. 1 to 3 , the puncture system 1 includes a handle assembly 10 and a puncture assembly 20 accommodated in the handle assembly 10 and fixedly connected to the handle assembly 10 . The piercing assembly 20 includes an outer tubular member 21 and a piercing member 22 . The outer tube 21 is connected to the handle assembly 10 . The outer pipe member 21 has a hollow tubular shape. In this embodiment, the piercing member 22 is inserted into the outer pipe member 21 . At least part of the piercing member 22 is accommodated in the outer tubular member 21 . In this embodiment, the extending direction of the puncturing member 22 in the outer tubular member 21 is the same as the extending direction of the outer tubular member 21 . The distal end 22a of the piercing member 22 is close to the distal end 21a of the outer tubular member 21 . The proximal end 22b of the piercing member 22 passes through the proximal end 21b of the outer tubular member 21 .
在本实施例中，至少部分穿刺件22收容在外管件21内，且穿刺件22的远端22a靠近外管件的远端21a。穿刺件22随着外管件21一同移至人体内部。在穿刺手术过程中，穿刺件22无需先从外管件21的近端21b插接，再滑至外管件21的远端21a，避免在穿刺件22在外管件21内滑动过程中损伤外管件21的内壁而产生碎屑，降低这些碎屑形成血栓危害病人的风险。In this embodiment, at least part of the piercing member 22 is accommodated in the outer tube member 21, and the distal end 22a of the piercing member 22 is close to the distal end 21a of the outer tube member. The piercing member 22 is moved into the inside of the human body together with the outer tube member 21 . During the puncture operation, the puncture member 22 does not need to be inserted from the proximal end 21b of the outer tube member 21, and then slide to the distal end 21a of the outer tube member 21, so as to avoid damage to the outer tube member 21 during the sliding process of the puncture member 22 in the outer tube member 21. Debris can be generated from the inner wall, reducing the risk of these debris forming a blood clot and harming the patient.
在本实施例中，穿刺件22的远端22a靠近外管件21的远端21a指的是，穿刺件22的远端22a靠近外管件21远端21a的端面，且穿刺件22的远端22a的端面与外管件21远端21a的端面并未平齐，即穿刺件22收容在外管件21内或者部分穿刺件22裸露在外管件21外。In this embodiment, the distal end 22a of the piercing member 22 is close to the distal end 21a of the outer tubular member 21 means that the distal end 22a of the piercing member 22 is close to the end surface of the distal end 21a of the outer tubular member 21, and the distal end 22a of the piercing member 22 The end face of the piercing member 21 is not flush with the end face of the distal end 21a of the outer tubular member 21 , that is, the piercing member 22 is accommodated in the outer tubular member 21 or part of the piercing member 22 is exposed outside the outer tubular member 21 .
在本实施例中，在外管件21滑至人体指定区域的过程中，穿刺件22的远端22a一直收容在外管件21内，而不会显露出外管件21。例如，外管件21在滑至心脏卵圆窝附近的过程中，外管件21遇到人体弯曲的血管通道会发生弯曲变形，而穿刺件22并没有显露出外管件21，避免穿刺件22刺伤人体。In this embodiment, when the outer tube 21 slides to the designated area of the human body, the distal end 22 a of the puncturing member 22 is always accommodated in the outer tube 21 without exposing the outer tube 21 . For example, in the process of sliding the outer tube 21 to the vicinity of the fossa ovale of the heart, the outer tube 21 will bend and deform when it encounters a curved blood vessel channel of the human body, while the puncture member 22 does not reveal the outer tube 21, so as to avoid the puncture member 22 from stabbing the human body .
在本实施例中，穿刺件22贯穿外管件21内，穿刺件22的近端22b也靠近外管件21的近端21b。具体地，穿刺件22的近端22b伸出外管件21的近端21b。In this embodiment, the piercing member 22 penetrates through the outer tube member 21 , and the proximal end 22 b of the piercing member 22 is also close to the proximal end 21 b of the outer tube member 21 . Specifically, the proximal end 22b of the piercing member 22 protrudes from the proximal end 21b of the outer tubular member 21 .
请参阅图1和图2，在本实施例中，手柄组件10具有收容件113。收容件113收容部分穿刺组件20。收容件113收容穿刺件22的近端、及外管件21的近端。具体地，手柄组件10包括手柄本体11。手柄本体11包括第一手柄件111和与第一手柄件111连接的第二手柄件112。在本实施例中，第一手柄件111和第二手柄件112共同围成的收容空间为收容件113。Referring to FIGS. 1 and 2 , in this embodiment, the handle assembly 10 has a receiving member 113 . The accommodating member 113 accommodates part of the puncturing assembly 20 . The accommodating member 113 accommodates the proximal end of the puncturing member 22 and the proximal end of the outer tubular member 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 with the first handle member 111 . In this embodiment, the accommodating space formed by the first handle member 111 and the second handle member 112 is the accommodating member 113 .
请参阅图4a、图4b和图4c，第一手柄件111设有扣合件1112。第二手柄 件112设有抵持件1122。在本实施例中，扣合件1112自第一手柄件111朝靠近手柄组件10的轴向凸起，扣合件1112整体呈钩状。扣合件1112朝Y轴的负方向凸起。抵持件1122自第二手柄件112朝远离手柄组件10的轴向内凹，抵持件1122整体呈凹槽状。在图4c中，抵持件1122朝Y轴负方向内凹。抵持件1122与扣合件1112相互配合，使第一手柄件111和第二手柄件112合拢固定在一起。可以理解地，在其他实施例中，扣合件1112可以为凹槽，抵持件1122可以呈凸台状。Please refer to FIG. 4a , FIG. 4b and FIG. 4c , the first handle member 111 is provided with a fastening member 1112 . The second handle member 112 is provided with a resisting member 1122. In this embodiment, the clasping member 1112 protrudes from the first handle member 111 toward the axial direction of the handle assembly 10 , and the clasping member 1112 is in the shape of a hook as a whole. The fastener 1112 protrudes toward the negative direction of the Y-axis. The resisting member 1122 is concave inward from the second handle member 112 in an axial direction away from the handle assembly 10 , and the resisting member 1122 is in the shape of a groove as a whole. In Fig. 4c, the abutting member 1122 is concave in the negative direction of the Y-axis. The resisting member 1122 and the buckling member 1112 cooperate with each other, so that the first handle member 111 and the second handle member 112 are closed and fixed together. It can be understood that, in other embodiments, the fastening member 1112 may be a groove, and the resisting member 1122 may be in the shape of a boss.
在本实施例中，第一手柄件111与第二手柄件112固定连接。具体地，第一手柄件111和第二手柄件112之间还设有胶水(图未示)，胶水使第一手柄件111和第二手柄件112固定连接。在其他实施例中，可通过其他方式，例如高温熔融等，或者通过在第一手柄件111的外壁上设有螺纹，第二手柄件112的外壁上也设有螺纹，第一手柄件111及第二手柄件112相互配合，与具有内螺纹的锁紧件螺纹连接。具体的方式不作限定，以能将第一手柄件111和第二手柄件112固定为准。In this embodiment, the first handle member 111 and the second handle member 112 are fixedly connected. Specifically, glue (not shown) is further provided between the first handle member 111 and the second handle member 112 , and the glue makes the first handle member 111 and the second handle member 112 fixedly connected. In other embodiments, other methods, such as high temperature melting, etc., or by providing threads on the outer wall of the first handle member 111 and threads on the outer wall of the second handle member 112, the first handle member 111 and the The second handle member 112 cooperates with each other, and is threadedly connected with a locking member having an internal thread. The specific manner is not limited, as long as the first handle member 111 and the second handle member 112 can be fixed.
可以理解地，在其他实施例中，手柄组件10可以为一体成型。即，第一手柄件111和第二手柄件112一体成型。It will be understood that in other embodiments, the handle assembly 10 may be integrally formed. That is, the first handle member 111 and the second handle member 112 are integrally formed.
请参阅图1、图3及图5，在本实施例中，在轴向方向上，穿刺组件20可相对手柄组件10滑动。具体地，在轴向方向上，穿刺组件20中的穿刺件22，可相对手柄组件10中的手柄本体11滑动。穿刺组件20具有收容状态和伸出状态。其中，收容状态和伸出状态可相互转换。伸出状态指的是，部分穿刺件22的远端22a显露在外管件21的远端21a外。收容状态指的是，穿刺件22的远端22a收容在外管件21的远端21a内。Referring to FIG. 1 , FIG. 3 and FIG. 5 , in this embodiment, in the axial direction, the piercing assembly 20 can slide relative to the handle assembly 10 . Specifically, in the axial direction, the piercing member 22 in the piercing assembly 20 can slide relative to the handle body 11 in the handle assembly 10 . The piercing assembly 20 has a accommodated state and an extended state. Among them, the contained state and the extended state can be converted into each other. The extended state means that the distal end 22a of the partial piercing member 22 is exposed outside the distal end 21a of the outer tubular member 21 . The accommodated state refers to that the distal end 22 a of the puncturing member 22 is accommodated in the distal end 21 a of the outer tubular member 21 .
手柄组件10还包括第一控制件12。第一控制件12设置在第一手柄件111和第二手柄件112中的至少一个。请参阅图1和图2，在本实施例中，第一控制件12的数量为两个，分别设置在第一手柄件111和第二手柄件112上。第一控制件12与穿刺件22的近端连接。第一控制件12用于控制穿刺件22相对手柄本体11在轴向滑动。即，请参阅图5，第一控制件(图未示)可控制穿刺件22在轴向滑动，使穿刺件22的远端22a伸出外管件21外。请参阅图3，或者控制 穿刺件22的远端22a伸入外管件21内。The handle assembly 10 also includes a first control 12 . The first control part 12 is disposed on at least one of the first handle part 111 and the second handle part 112 . Referring to FIGS. 1 and 2 , in this embodiment, the number of the first control members 12 is two, which 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 piercing member 22 . The first control member 12 is used to control the piercing member 22 to slide relative to the handle body 11 in the axial direction. That is, referring to FIG. 5 , the first control member (not shown) can control the puncturing member 22 to slide in the axial direction, so that the distal end 22a of the puncturing member 22 extends out of the outer tubular member 21 . Please refer to FIG. 3 , or control the distal end 22a of the piercing member 22 to protrude into the outer tubular member 21.
可以理解地，第一控制件12在接收外界的作用力后，将作用力传至穿刺件22，使穿刺件22在轴向滑动。在本实施例中，第一控制件12接收外界的作用在轴向相对手柄本体11滑动。第一控制件12与穿刺件22相连，第一控制件12带着穿刺件22滑动，使穿刺件22穿出外管件21进行穿刺手术。可以理解地，本实施例中，第一控制件12与穿刺件22的近端间接连接。在其他实施例中，第一控制件12可与穿刺件22直接连接。Understandably, after receiving the external force, the first control member 12 transmits the force to the puncturing member 22, so that the puncturing member 22 slides in the axial direction. In this embodiment, the first control member 12 slides relative to the handle body 11 in the axial direction under the action of the outside world. The first control member 12 is connected with the puncture member 22, and the first control member 12 slides with the puncture member 22, so that the puncture member 22 passes through the outer tube member 21 to perform a puncture operation. Understandably, in this embodiment, the first control member 12 is indirectly connected to the proximal end of the puncturing member 22 . In other embodiments, the first control member 12 may be directly connected to the piercing member 22 .
第一手柄件111和第二手柄件112中至少一个设置有第一限位孔1111。第一限位孔1111限制第一控制件12的行程。第一限位孔1111与收容件113相连通。请参阅图2、图4a、图4b和图4c，在本实施例中，第一手柄件111和第二手柄件112均设置有第一限位孔1111。第一手柄件111中的第一限位孔1111和第二手柄件112中的第一限位孔1111的形状相同，且第一手柄件111中的第一限位孔1111和第二手柄件112中的第一限位孔1111正对。在本实施例中，第一限位孔1111为通孔。可以理解的是，其他实施例中，也可以仅有一个第一控制件12及与第一控制件12相配合使用的第一限位孔1111。At least one of the first handle member 111 and the second handle member 112 is provided with a first limiting hole 1111 . The first limiting hole 1111 limits the stroke of the first control member 12 . The first limiting hole 1111 communicates with the receiving member 113 . Referring to FIGS. 2 , 4 a , 4 b and 4 c , in this embodiment, both the first handle member 111 and the second handle member 112 are provided with first limiting holes 1111 . The shape of the first limiting hole 1111 in the first handle member 111 and the first limiting hole 1111 in the second handle member 112 are the same, and the first limiting hole 1111 in the first handle member 111 and the second handle member 1111 have the same shape. The first limiting hole 1111 in 112 is directly opposite. In this embodiment, the first limiting hole 1111 is a through hole. It can be understood that, in other embodiments, there may be only one first control member 12 and a first limiting hole 1111 used in cooperation with the first control member 12 .
请参阅图2，在本实施例中，手柄组件10还包括第一固定件13。第一固定件13收容在收容件113内。第一固定件13连接穿刺件22的近端(图未示)。具体地，第一固定件13包括第一固定件本体131。穿刺件22的近端伸入第一固定件本体131，并与第一固定件本体131固定连接。可以理解地，至少部分第一固定件本体141与第一限位孔1111正对。即，第一限位孔1111沿径向向内的投影，至少部分落在第一固定件本体131上。在本实施例中，第一控制件12接收外界的作用在轴向相对手柄本体11滑动，第一控制件12带动第一固定件13及穿刺件22在轴向相对手柄本体11滑动。在其他实施例中，外力直接作用于第一固定件13，使第一固定件13在轴向相对手柄本体11滑动，第一固定件13带动穿刺件22在轴向相对手柄本体11滑动。Referring to FIG. 2 , in this 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 fixing member 13 is connected to the proximal end of the piercing member 22 (not shown). Specifically, the first fixing member 13 includes a first fixing member body 131 . The proximal end of the piercing member 22 extends into the first fixing member body 131 and is fixedly connected with the first fixing member body 131 . Understandably, at least part of the first fixing member body 141 is directly opposite to the first limiting hole 1111 . That is, the radially inward projection of the first limiting hole 1111 at least partially falls on the first fixing member body 131 . In this embodiment, the first control member 12 receives external action to slide relative to the handle body 11 in the axial direction, and the first control member 12 drives the first fixing member 13 and the piercing 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 to make the first fixing member 13 slide relative to the handle body 11 in the axial direction, and the first fixing member 13 drives the puncturing member 22 to slide relative to the handle body 11 in the axial direction.
请参阅图2，在本实施例中，第一固定件13还包括与第一固定件本体131连接的第一固定部132。第一固定部132与第一固定件本体131的外壁连接。在本实施例中，第一固定部132与第一固定件本体131一体成型。第一固定部132 穿过第一限位孔1111与第一控制件12连接。具体地，第一固定部132设置在第一固定件13的外壁，并在第一固定件13的外壁径向向外突出。部分第一固定部132穿过第一限位孔1111后，与第一控制件12连接。可以理解地，部分第一固定部132与第一限位孔1111正对。即，部分第一固定部132与第一限位孔1111的孔壁正对。Referring to FIG. 2 , in this embodiment, the first fixing member 13 further includes a first fixing portion 132 connected with the first fixing member body 131 . The first fixing portion 132 is connected to the outer wall of the first fixing member body 131 . In this embodiment, the first fixing portion 132 is integrally formed with the first fixing member body 131 . The first fixing portion 132 is connected to the first control member 12 through the first limiting hole 1111 . Specifically, the first fixing portion 132 is disposed on the outer wall of the first fixing member 13 and protrudes radially outward from the outer wall of the first fixing member 13 . Part of the first fixing portion 132 is connected to the first control member 12 after passing through the first limiting hole 1111 . Understandably, part of the first fixing portion 132 is directly opposite to the first limiting hole 1111 . That is, a part of the first fixing portion 132 is directly opposite to the hole wall of the first limiting hole 1111 .
在本实施例中，第一固定部132穿过第一限位孔1111的部分，与第一控制件12固定连接。具体地，第一控制件12设有第一卡持部121。第一固定部132伸入第一卡持部121，并与第一卡持部121固定连接。第一卡持部121为凹槽。第一固定部132与第一卡持部121过盈配合。在其他实施例中，还用胶水粘接第一卡持部121和第一固定部132，使第一卡持部121和第一固定部132稳定连接。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 clamping portion 121 . The first fixing portion 132 extends into the first holding portion 121 and is fixedly connected with the first holding portion 121 . The first holding portion 121 is a groove. The first fixing portion 132 is in an interference fit with the first clamping portion 121 . In other embodiments, the first clamping portion 121 and the first fixing portion 132 are also bonded with glue, so that the first clamping portion 121 and the first fixing portion 132 are stably connected.
在本实施例中，第一固定部132的数量、第一限位孔1111的数量、第一控制件12的数量相同。即，第一固定部132的数量为两个，分别穿过第一手柄件111的第一限位孔1111和第二手柄件112的第一限位孔1111。两个第一固定部132关于手柄组件10的轴向对称分布，使第一固定件13整体受力均匀，第一固定13能够平稳地相对手柄本体11在轴向滑动。在其他实施例中，第一固定部132的数量不作限定，以第一控制件12可通过第一固定部132控制穿刺件22滑动为准。其他实施例中，第一固定部132为凹槽，与第一卡持部121插接并固定在第一固定部132内。In this embodiment, the number of the first fixing parts 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, which respectively pass through the first limiting hole 1111 of the first handle member 111 and the first limiting hole 1111 of the second handle member 112 . The two first fixing portions 132 are symmetrically distributed with respect to the axial direction of the handle assembly 10 , so that the entire first fixing member 13 is uniformly stressed, and the first fixing portion 13 can smoothly slide relative to the handle body 11 in the axial direction. In other embodiments, the number of the first fixing parts 132 is not limited, as long as the first control member 12 can control the sliding of the puncturing member 22 through the first fixing part 132 . In other embodiments, the first fixing portion 132 is a groove, which is inserted into the first clamping portion 121 and fixed in the first fixing portion 132 .
请参阅图4a、图4b和图4c，在本实施例中，第一限位孔1111包括第一限位部1111a和与第一限位部1111a相对的第二限位部1111b。第一限位部1111a和第二限位部1111b在轴向间隔排布。第一限位部1111a和第二限位部1111b分别为第一限位孔1111相对的两个孔壁。第一限位孔1111的其他孔壁，与第一限位部1111a和第二限位部1111b围成第一限位孔1111。第一限位部1111a为第一限位孔1111的远端，第二限位部1111b为第一限位孔1111的近端。4a, 4b and 4c, in this embodiment, the first limiting hole 1111 includes a first limiting portion 1111a and a second limiting portion 1111b opposite to the first limiting portion 1111a. The first limiting portion 1111a and the second limiting portion 1111b are arranged at intervals in the axial direction. The first limiting portion 1111 a and the second limiting portion 1111 b are two opposite hole walls of the first limiting hole 1111 , respectively. The other hole walls of the first limiting hole 1111 and the first limiting portion 1111 a and the second limiting portion 1111 b enclose the first limiting hole 1111 . The first limiting portion 1111 a is the distal end of the first limiting hole 1111 , and the second limiting portion 1111 b is the proximal end of the first limiting hole 1111 .
第一限位孔1111限制第一控制件12的轴向行程。即，第一限位部1111a和第二限位部1111b限制第一控制件12在轴向的行程，来限制第一固定件13及穿刺件22在轴向的行程。穿刺件22在轴向的滑动过程具体如下。The first limiting hole 1111 limits the axial stroke of the first control member 12 . That is, the first limiting portion 1111a and the second limiting portion 1111b limit the axial stroke of the first control member 12 to limit the axial stroke of the first fixing member 13 and the puncturing member 22 . The sliding process of the piercing member 22 in the axial direction is as follows.
请参阅图2、图4b、图4c和图5，一方面，第一控制件12在第一限位孔1111的近端滑向第一限位孔1111的远端，第一控制件12带动第一固定部132、穿刺件22朝远离手柄本体11近端11b的方向滑动，穿刺件22逐渐伸出外管件21。部分与第一限位孔1111正对的第一固定部132，抵持到第一限位孔1111的远端后，被第一限位孔1111的远端限制。第一固定部132无法继续朝远离手柄本体11近端11b的方向滑动。穿刺件22、及第一控制件12也无法继续向远离手柄本体11近端11b方向滑动。2, 4b, 4c and 5, on the one hand, the first control member 12 slides from the proximal end of the first limiting hole 1111 to the distal end of the first limiting hole 1111, and the first control member 12 drives the The first fixing portion 132 and the puncturing member 22 slide in a direction away from the proximal end 11 b of the handle body 11 , and the puncturing member 22 gradually extends out of the outer tube member 21 . Part of the first fixing portion 132 facing the first limiting hole 1111 is restrained by the distal end of the first limiting hole 1111 after pressing against the distal end of the first limiting hole 1111 . The first fixing portion 132 cannot continue to slide 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 continue to slide away from the proximal end 11 b of the handle body 11 .
另一方面，第一控制件12在第一限位孔1111的远端滑向第一限位孔1111的近端。第一控制件12带动第一固定部132、穿刺件22朝靠近手柄本体11的近端11b的方向滑动。部分与第一限位孔1111正对的第一固定部132，抵持到第一限位孔1111的近端后，被第二限位部1111b限制。第一固定部132无法沿靠近手柄本体11近端11b的方向滑动。穿刺件22、及第一控制件12也无法继续向靠近手柄本体11近端方向滑动。On the other hand, the first control member 12 slides toward the proximal end of the first limiting hole 1111 at the distal end of the first limiting hole 1111 . The first control member 12 drives the first fixing portion 132 and the piercing member 22 to slide toward the proximal end 11 b of the handle body 11 . Part of the first fixing portion 132 facing the first limiting hole 1111 is restrained by the second limiting portion 1111b after pressing against the proximal end of the first limiting hole 1111 . The first fixing portion 132 cannot slide in a direction close to the proximal end 11 b of the handle body 11 . The piercing member 22 and the first control member 12 cannot continue to slide toward the proximal end of the handle body 11 .
在本实施例中，第一固定件本体131的横截面积大于第一限位孔1111，而使得第一固定件本体131无法通过第一限位孔1111，使得第一固定件13不易于脱离手柄本体11。In this embodiment, the cross-sectional area of the first fixing member body 131 is larger than that of the first limiting hole 1111 , so that the first fixing member body 131 cannot pass through the first limiting hole 1111 , so that the first fixing member 13 cannot be easily disengaged Handle body 11 .
第一限位部1111a和第二限位部1111b之间在轴向的距离D1，对应穿刺件22整体在一次穿刺过程的行程。第一控制件12在第一限位孔1111朝远离手柄本体11近端的方向滑动的行程，与整体穿刺件22也在滑动的行程相同。由于穿刺件22在人体内发生弯曲，穿刺件22远端的行程小于或者等于整体穿刺件22的行程，小于或者等于第一限位部1111a和第二限位部1111b之间在轴向的距离。The axial distance D1 between the first limiting portion 1111a and the second limiting portion 1111b corresponds to the stroke of the entire puncturing member 22 in one puncturing process. The sliding stroke of the first control member 12 in the direction away from the proximal end of the handle body 11 in the first limiting hole 1111 is the same as the sliding stroke of the integral puncturing member 22 . Since the piercing member 22 is bent in the human body, the stroke of the distal end of the piercing member 22 is less than or equal to the stroke of the entire piercing member 22, and less than or equal to the axial distance between the first limiting portion 1111a and the second limiting portion 1111b .
医生用传统的穿刺件进行穿刺的手术过程，一般用手握住穿刺件的接头，向穿刺件的接头施加推力，使穿刺件的针尖穿破房间隔。由于惯性作用，医生用穿刺件刺穿房间隔之后，医生的手继续推穿刺件的接头，使穿刺件的针尖继续行进而导致行程过大。这样容易刺伤左心房壁，导致心包填塞。或者，容易刺入主动脉造成严重的并发症。且医生对穿刺件的接头施加的推力不均匀，影响穿刺件在鞘管中滑动。本申请中的穿刺件22在穿破房间隔之后，受到第一限 位孔1111的限制而不会在继续行进，避免穿刺件22继续刺伤左心房壁，提高了利用穿刺件22进行穿刺手术的安全程度。再者，两个第一控制件12分别设置在第一手柄件111和第二手柄件112上，医生施加的作用力经推动两个第一控制件12传递至穿刺件22，使得穿刺件22的受到的作用力更加均匀，穿刺件22可平稳地在轴向滑动，提高穿刺件22穿刺的稳定程度。A doctor uses a traditional puncture piece to perform a puncture procedure. Generally, the doctor holds the joint of the puncture piece by hand and applies a pushing force to the joint of the puncture piece, so that the needle tip of the puncture piece pierces the interatrial septum. Due to inertia, after the doctor pierces the atrial septum with the puncture piece, the doctor's hand continues to push the joint of the puncture piece, so that the needle tip of the puncture piece continues to travel, resulting in an excessive stroke. This can easily puncture the wall of the left atrium, resulting in cardiac tamponade. Alternatively, it is easy to pierce the aorta causing serious complications. In addition, the thrust force exerted by the doctor on the joint of the puncture piece is uneven, which affects the sliding of the puncture piece in the sheath. After the puncture member 22 in the present application penetrates the interatrial septum, it is restricted by the first limiting hole 1111 and will not continue to travel, which prevents the puncture member 22 from continuing to puncture the left atrium wall, and improves the use of the puncture member 22 for puncture surgery. level of security. Furthermore, the two first control members 12 are respectively disposed on the first handle member 111 and the second handle member 112, and the force exerted by the doctor is transmitted to the puncture member 22 by pushing the two first control members 12, so that the puncture member 22 The acting force received is more uniform, the puncturing member 22 can slide smoothly in the axial direction, and the puncturing stability of the puncturing member 22 is improved.
请参阅图1、图4b和图4c，在本实施例中，第一控制件12的外壁设有多个间隔设置的凸起，凸起突出的方向与第一卡持部121的开口方向相反。这些凸起，可增大医生的手部与第一控制件12的摩擦力，便于医生推动第一控制件12滑动。Please refer to FIG. 1 , FIG. 4 b and FIG. 4 c , in this embodiment, the outer wall of the first control member 12 is provided with a plurality of protrusions arranged at intervals, and the protruding direction of the protrusions is opposite to the opening direction of the first clamping portion 121 . These protrusions can increase the friction between the doctor's hand and the first control member 12 , so that the doctor can push the first control member 12 to slide.
请再次参阅图2、图6a及图6b，第一固定件本体131设有第一连接件通道1311，穿刺件22的近端(图未示)固定在第一连接件通道1311内，且穿刺件22的内腔与第一连接件通道1311相连通。2, 6a and 6b again, the first fixing member body 131 is provided with a first connecting member channel 1311, the proximal end (not shown) of the piercing member 22 is fixed in the first connecting member channel 1311, and the piercing member 22 is punctured in the first connecting member channel 1311. The inner cavity of the member 22 communicates with the first connecting member channel 1311 .
穿刺***1还包括第一连接件16。第一连接件通道1311与第一连接件16及穿刺件22内部均连通，使得第一液体介质可依次经第一连接件16、第一连接件通道1311及穿刺件22输送至体内。在本实施例中，穿刺件22通过第一固定件本体131中的第一连接件通道1311，与第一连接件16连通。The piercing system 1 also includes a first connector 16 . The first connector channel 1311 communicates with the inside of the first connector 16 and the piercing component 22 , so that the first liquid medium can be delivered to the body through the first connector 16 , the first connector channel 1311 and the piercing component 22 in sequence. In this embodiment, the piercing member 22 communicates with the first connecting member 16 through the first connecting member channel 1311 in the first fixing member body 131 .
在其他实施例中，部分穿刺件22收容并固定在第一固定件131内，穿出第一固定件本体131的部分穿刺件22与第一连接件16连通。即穿刺件22的近端与第一连接件16直接连通。第一液体介质经第一连接件16可直接输入穿刺件22内，提高第一液体介质输入到穿刺件22的效率。In other embodiments, a part of the piercing member 22 is accommodated and fixed in the first fixing member 131 , and a part of the piercing member 22 extending out of the first fixing member body 131 communicates with the first connecting member 16 . That is, the proximal end of the piercing member 22 is in direct communication with the first connecting member 16 . The first liquid medium can be directly input into the puncturing member 22 through the first connecting member 16 , so as to improve the efficiency of inputting the first liquid medium to the puncturing member 22 .
第一连接件16包括第一连接部162和与第一连接部162相连的第一开关部161。第一开关部161设置在手柄组件10外。第一连接部162的近端与第一开关部161连接。第一连接部162的远端与第一连接件通道1311连接，且第一连接部162与第一连接件通道1311相连通。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 switch portion 161 is provided outside the handle assembly 10 . The proximal end of the first connection part 162 is connected to the first switch part 161 . The distal end of the first connecting portion 162 is connected to the first connecting member channel 1311 , and the first connecting portion 162 is communicated with the first connecting member channel 1311 .
具体地，第一开关部161为常开状态时，可通过第一开关部161导入第一液体介质或者导丝。第一液体介质或者导丝经第一连接部162移至第一连接件通道1311内。再经穿刺件22的内腔进入人体。可以理解地，第一液体介质不限于为造影剂或者是生理盐水等。第一开关部161为常闭状态时，可起到阻止 血液通过的作用。在本实施例中，第一开关部161为三通阀，第一连接部162为中空的管状结构。Specifically, when the first switch portion 161 is in a normally open state, the first liquid medium or the guide wire can be introduced through the first switch portion 161 . The first liquid medium or the guide wire is moved into the first connecting member channel 1311 through the first connecting portion 162 . Then enter the human body through the inner cavity of the puncturing member 22 . It can be understood that the first liquid medium is not limited to a contrast agent or a physiological saline. When the first switch portion 161 is in a normally closed state, it can prevent the passage of blood. In this embodiment, the first switch portion 161 is a three-way valve, and the first connection portion 162 is a hollow tubular structure.
第一固定件本体131还设有与第一连接件通道1311间隔设置的第二通道1312。即，第一连接件通道1311与第二通道1312之间不连通。第二通道1312的内径大于第一连接件通道1311的内径。穿刺组件20还包括第二连接件17。第二连接件17也设置在手柄组件10外。部分第二连接件17通过设于第二通道1312与外管件21连接。The first fixing member body 131 is further provided with a second channel 1312 spaced from the first connecting member channel 1311 . That is, there is no communication between the first connector channel 1311 and the second channel 1312 . The inner diameter of the second channel 1312 is larger than the inner diameter of the first connector channel 1311 . The piercing assembly 20 also includes a second connector 17 . The second connector 17 is also provided outside the handle assembly 10 . Part of the second connecting member 17 is connected to the outer pipe member 21 through the second channel 1312 .
请再次参阅图1、图3和图5，在本实施例中，在轴向方向上，外管件21可相对手柄组件10滑动。即，外管件21的远端21a在轴向方向上，可朝着远离手柄组件10的方向滑动，使穿刺组件20从伸出状态转换为收容状态。外管件21的远端21a也可朝着靠近手柄本体11的方向滑动，使穿刺件22从收容状态转换为伸出状态。Referring again to FIGS. 1 , 3 and 5 , in this embodiment, the outer pipe member 21 can slide relative to the handle assembly 10 in the axial direction. That is, the distal end 21a of the outer tube 21 can slide in the axial direction in a direction away from the handle assembly 10, so that the puncture assembly 20 is converted from the extended state to the accommodated state. The distal end 21a of the outer tubular member 21 can also slide toward the direction close to the handle body 11, so that the puncturing member 22 is converted from the accommodating state to the extending state.
具体地，请参阅图2，手柄组件10还包括位于第一固定件13远侧的第二固定件15。第二固定件15用于固定外管件21。第二固定件15收容于收容件113内。第二固定件15与第一固定件13间隔设置。第二固定件15位于第一固定件13远侧，即在轴向方向上，第一固定件13的近端相较第二固定件15更靠近穿刺***1的近端。第一固定件13与穿刺件22的近端22b固定连接，便于通过第一固定件13来控制穿刺件22的远端22a伸出外管件21的远端21a，或者伸入外管件21的远端21a内。Specifically, referring to FIG. 2 , the handle assembly 10 further includes a second fixing member 15 located at the distal side of the first fixing member 13 . The second fixing member 15 is used for fixing 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 fixing member 15 is located at the distal side of the first fixing member 13 , that is, in the axial direction, the proximal end of the first fixing member 13 is closer to the proximal end of the puncture system 1 than the second fixing member 15 . The first fixing member 13 is fixedly connected with the proximal end 22b of the puncturing member 22, so that the distal end 22a of the puncturing member 22 can be controlled to extend out of the distal end 21a of the outer tubular member 21 or into the distal end of the outer tubular member 21 through the first fixing member 13 21a.
请参阅图1、图2及图7，手柄组件10还包括第二控制件14。第二控制件14与第一控制件12间隔设置。第二控制件14与外管件21连接。第二控制件14用于控制外管件21在轴向上相对穿刺件22滑动。Please refer to FIG. 1 , FIG. 2 and FIG. 7 , the handle assembly 10 further includes a second control member 14 . The second control member 14 is spaced apart from the first control member 12 . The second control member 14 is connected to the outer pipe member 21 . The second control member 14 is used to control the sliding of the outer tube member 21 relative to the puncturing member 22 in the axial direction.
在本实施例中，外管件21可相对手柄本体11滑动，便于精准地调整外管件21在人体内的位置。第二控制件14控制外管件21在轴向相对手柄本体11滑动，使其朝远离手柄本体11近端的方向滑动并重新覆盖穿刺件22，将穿刺件22收容在外管件21中空的管体内，从而降低穿刺件22刺伤人体内壁的风险，提高手术的安全程度。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 member 14 controls the outer tube member 21 to slide relative to the handle body 11 in the axial direction, so that it slides away from the proximal end of the handle body 11 and covers the puncture member 22 again, and accommodates the puncture member 22 in the hollow tube body of the outer tube member 21. Thereby, the risk of puncturing the inner wall of the human body by the puncturing member 22 is reduced, and the safety degree of the operation is improved.
在本实施例中，第一控制件12相较第二控制件14更靠近穿刺***1的近 端。第一控制件12控制穿刺件22从收容状态转化为伸出状态并穿破房间隔后，需要控制第二控制件14朝远离穿刺***1近端的方向滑动，来控制外管件21重新覆盖穿刺件22。由于第一控制件12相较第二控制件14更靠近穿刺***1的近端，即，第二控制件14相较第一控制件12更加远离穿刺***1的近端，控制第二控制件14朝远离穿刺***1近端的方向滑动，第二控制件14不会逐渐靠近第一控制件12，而是会逐渐远离第一控制件12，在控制第二控制件14的过程不易误触到第一控制件12，避免误触到第一控制件12而改变穿刺件22在人体的位置，避免碰触到第一控制件12而使穿刺针22的位置发生改变，如第一控制件12被动碰触后回撤，穿刺针22将回缩至外管21内，使得穿刺组件20的远端回弹到右心房而不能进入左心房。In this 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 puncture member 22 to change from the contained state to the extended state and penetrates the interatrial septum, the second control member 14 needs to be controlled to slide away from the proximal end of the puncture system 1 to control the outer tube 21 to cover the puncture again. Piece 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 away from the proximal end of the puncture system 1 than the first control member 12, the second control member 12 is controlled 14 is slid away from the proximal end of the puncture system 1 , the second control part 14 will not gradually approach the first control part 12 , but will gradually move away from the first control part 12 , and the second control part 14 is not easily touched by mistake in the process of controlling the second control part 14 To the first control member 12, avoid touching the first control member 12 by mistake and change the position of the puncture member 22 in the human body, and avoid touching the first control member 12 to change the position of the puncture needle 22, such as the first control member 12 is retracted after passive contact, and the puncture needle 22 will be retracted into the outer tube 21, so that the distal end of the puncture assembly 20 will bounce back to the right atrium and cannot enter the left atrium.
结合图4a、图4b及图4c，第二控制件14覆盖部分第一手柄件111和部分第二手柄件112。第一手柄件111与第二手柄件112均设有缺口200。缺口200由第一手柄件111的部分外表面或第二手柄件112的部分外表面径向向内凹形成。第二控制件14安放在缺口200上。缺口200相对的两个侧壁用于限制第二控制件14的轴向行程。Referring to FIGS. 4 a , 4 b and 4 c , 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 a notch 200 . The notch 200 is formed by a part of the outer surface of the first handle member 111 or a part of the outer surface of the second handle member 112 which is radially inwardly concave. The second control member 14 is seated on the notch 200 . The two opposite side walls of the notch 200 are used to limit the axial travel of the second control member 14 .
请参阅图2和图7，第二控制件14包括第二卡持部141和与第二卡持部141间隔设置的连接螺纹142。第二卡持部141为设于第二控制件14内表面上的向第二控制件14外表面凹陷的凹槽。第二控制件14中第二卡持部141用于与第二固定件15配合，控制第二固定件15轴向移动。第二控制件14连接螺纹142用于调整外管件21变形弯曲。在本实施例中，第二卡持部141与连接螺纹142均设于第二控制件14的内表面，连接螺纹142和第二卡持部141可同时随第二控制件14轴向移动。在其他实施例中，连接螺纹142和第二卡持部141可分别设置在第二控制件14中不同的子部件中。只要连接螺纹142和第二卡持部141能够同步在轴向移动即可。Referring to FIG. 2 and FIG. 7 , the second control member 14 includes a second holding portion 141 and a connecting thread 142 spaced from the second holding portion 141 . The second holding portion 141 is a groove formed on the inner surface of the second control member 14 and recessed toward the outer surface of the second control member 14 . The second holding portion 141 in the second control member 14 is used to cooperate with the second fixing member 15 to control the axial movement of the second fixing member 15 . The connecting thread 142 of the second control member 14 is used to adjust the deformation and bending of the outer pipe member 21 . In this embodiment, the second holding 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 holding portion 141 can move axially with the second control member 14 at the same time. In other embodiments, the connecting thread 142 and the second clamping portion 141 may be respectively provided in different sub-components of the second control member 14 . As long as the connecting thread 142 and the second clamping portion 141 can move in the axial direction synchronously.
在本实施例中，第二控制件14与外管件21的近端连接，且第二控制件14与外管件21的近端间接连接。在其他实施例中，第二控制件14也可以与外管件21的近端直接连接。In this embodiment, the second control member 14 is connected to the proximal end of the outer tube member 21 , and the second control member 14 is indirectly connected to the proximal end of the outer tube member 21 . In other embodiments, the second control member 14 can also be directly connected with the proximal end of the outer tube member 21 .
请参阅图4a、4b和图4c，在本实施例中，手柄组件10设置有第二限位孔 1113。第二限位孔1113用于限制第二控制件14的轴向行程。具体地，手柄组件10中第一手柄件111设有第二限位孔1113。第二限位孔1113与第一限位孔1111间隔设置。第二限位孔1113从手柄本体11的外壁贯穿至手柄本体11内的收容件113。部分第二控制件14通过第一限位孔1111，与外管件21的近端连接。至少部分外管件21的近端与第二限位孔1113正对。第二手柄件112也设有第二限位孔1113。第二手柄件112的第二限位孔1113与第一手柄件111的第二限位孔1113正对。4a, 4b and 4c, in this embodiment, the handle assembly 10 is provided with a second limiting hole 1113. The second limiting hole 1113 is used to limit the axial stroke of the second control member 14 . Specifically, the first handle member 111 in the handle assembly 10 is provided with a second limiting hole 1113 . The second limiting hole 1113 is spaced apart from the first limiting hole 1111 . The second limiting hole 1113 penetrates from the outer wall of the handle body 11 to the receiving member 113 in the handle body 11 . Part of the second control member 14 is connected to the proximal end of the outer tube member 21 through the first limiting hole 1111 . At least a portion of the proximal end of the outer tubular member 21 is directly opposite to the second limiting hole 1113 . The second handle member 112 is also provided with a second limiting hole 1113 . The second limiting hole 1113 of the second handle member 112 is directly opposite to the second limiting hole 1113 of the first handle member 111 .
请参阅图2，第二固定件15包括第二固定件本体151。外管件21的近端伸入第二固定件本体151，并与第二固定件本体151固定连接。Referring to FIG. 2 , the second fixing member 15 includes a second fixing member body 151 . The proximal end of the outer tubular member 21 extends into the second fixing member body 151 and is fixedly connected with the second fixing member body 151 .
在本实施例中，第二固定件15还包括与第二固定件本体151连接的第二固定部152。第二固定部152与第二固定件本体151的外壁连接。第二固定部152穿过第二限位孔1113与第二控制件14连接。具体地，结合图4b、图4c及图7，第二固定部152在第二固定本体的外壁向径向突出。第二固定部152穿过第二限位孔1113，并与第二控制件14中的第二卡持部141扣合。第二控制件14在轴向移动过程中，第二卡持部141的远端侧壁及近侧壁夹持第二固定部152的远端外壁及近端外壁，并带动第二固定部152及第二固定件本体151在轴向移动。在本实施例中，部分第二固定部152与第二限位孔1113正对。In this embodiment, the second fixing member 15 further includes a second fixing portion 152 connected with the second fixing member body 151 . The second fixing portion 152 is connected to the outer wall of the second fixing member body 151 . The second fixing portion 152 is connected to the second control member 14 through the second limiting hole 1113 . Specifically, referring to FIGS. 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 with the second clamping portion 141 in the second control member 14 . During the axial movement of the second control member 14 , the distal side wall and the proximal side wall of the second holding portion 141 clamp the distal outer wall and the proximal outer wall of the second fixing portion 152 and drive the second fixing portion 152 and the second fixing member body 151 moves in the axial direction. In this embodiment, part of the second fixing portion 152 is directly opposite to the second limiting hole 1113 .
请参阅图4a、图4b和图4c，在本实施例中，第二限位孔1113包括第三限位部1113a和与第三限位部1113a相对的第四限位部1113b。第三限位部1113a和第四限位部1113b在轴向间隔排布。第三限位部1113a和第四限位部1113b限制第二控制件14在轴向的行程。第三限位部1113a为第二限位孔1114的远端，第四限位部1113b为第二限位孔1113的近端。4a, 4b and 4c, in this embodiment, the second limiting hole 1113 includes a third limiting portion 1113a and a fourth limiting portion 1113b opposite to the third limiting portion 1113a. The third limiting portion 1113a and the fourth limiting portion 1113b are arranged at intervals in the axial direction. The third limiting portion 1113a and the fourth limiting portion 1113b limit the stroke of the second control member 14 in the axial direction. The third limiting portion 1113 a is the distal end of the second limiting hole 1114 , and the fourth limiting portion 1113 b is the proximal end of the second limiting hole 1113 .
一方面，请参阅图3和图4b，当第二控制件14从第二限位孔1113的近端滑向第二限位孔1113的远端的过程中，第二控制件14带动第二固定部152、外管件21朝远离手柄本体11近端11b滑动。外管件21逐渐覆盖穿刺件22的远端22a。当第二固定部152抵持到第二限位孔1114的远端后，第二固定部152被第二限位孔1114的远端限制，第二固定部152及穿刺件22无法继续朝远离手柄本体11近端11b的方向滑动。第二固定部152及外管件21也无法继续朝 远离手柄本体11近端11b的方向滑动。这个过程，穿刺件22从伸出状态转换为收容状态。3 and 4b, when the second control member 14 slides from the proximal end of the second limiting hole 1113 to the distal end of the second limiting hole 1113, the second control member 14 drives the second control member 14 The fixing portion 152 and the outer tubular member 21 slide away from the proximal end 11 b of the handle body 11 . The outer tubular member 21 gradually covers the distal end 22a of the piercing member 22 . After the second fixing portion 152 is pressed against the distal end of the second limiting hole 1114 , the second fixing portion 152 is restrained by the distal end of the second limiting hole 1114 , and the second fixing portion 152 and the piercing member 22 cannot continue to move away from The handle body 11 slides in the direction of the proximal end 11b. The second fixing portion 152 and the outer tube 21 cannot continue to slide in the direction away from the proximal end 11b of the handle body 11. In this process, the piercing member 22 is converted from the extended state to the accommodated state.
另一方面，请参阅图4b和图5，当第二控制件14从第二限位孔1113的远端滑向第二限位孔1113的近端的过程中，第二控制件14带动第二固定部152、外管件21朝靠近手柄本体11近端11b滑动，从而使得穿刺件22的远端22a逐渐显露在外管件21外。当第二固定部152抵持到第二限位孔1113的近端后，第二固定部152被第二限位孔1113的近端限制，第二固定部152及穿刺件22无法沿靠近手柄组件10近端的方向滑动。这个过程，穿刺件22从收容状态转换为伸出状态。On the other hand, referring to FIGS. 4b and 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 first The two fixing parts 152 and the outer tube 21 slide toward the proximal end 11 b of the handle body 11 , so that the distal end 22 a of the puncturing member 22 is gradually exposed outside the outer tube 21 . After the second fixing portion 152 is pressed against the proximal end of the second limiting hole 1113, the second fixing portion 152 is restrained by the proximal end of the second limiting hole 1113, and the second fixing portion 152 and the piercing member 22 cannot approach the handle along the Assembly 10 slides in the direction of the proximal end. In this process, the piercing member 22 is converted from the accommodated state to the extended state.
第三限位部1113a、第四限位部1113b分别为第二限位孔1113的两个相对的孔壁。第二限位孔1113的其他孔壁，与第三限位部1113a和第四限位部1113b围成第二限位孔1113。第二固定件本体151的横截面积大于第二限位孔1113，使得第二固定件151无法通过第二限位孔1113，使得第二固定件151不易于脱离手柄本体11。The third limiting portion 1113 a and the fourth limiting portion 1113 b are two opposite hole walls of the second limiting hole 1113 , respectively. The other hole walls of the second limiting hole 1113 and the third limiting portion 1113a and the fourth limiting portion 1113b enclose the second limiting hole 1113 . The cross-sectional area of the second fixing member body 151 is larger than that of the second limiting hole 1113 , so that the second fixing member 151 cannot pass through the second limiting hole 1113 , so that the second fixing member 151 cannot easily be separated from the handle body 11 .
在本实施例中，外管件21可移动的轴向行程大于或者等于穿刺件22可移动的轴向行程。如此，待穿刺件22穿刺房间隔后，外管件21朝远离手柄组件10近端方向滑动，能够重新完全覆盖穿刺件22，从而降低穿刺件22刺伤人体内壁的风险，提高手术的安全程度。In this embodiment, the movable axial stroke of the outer tubular member 21 is greater than or equal to the movable axial stroke of the piercing member 22 . In this way, after the puncturing member 22 punctures the interatrial septum, the outer tube 21 slides away from the proximal end of the handle assembly 10 to completely cover the puncturing member 22 again, thereby reducing the risk of puncturing the inner wall of the human body by the puncturing member 22 and improving the safety of the operation.
外管件21可移动的轴向行程为，第三限位部1113a和第四限位部1113b之间在轴向上的距离D2。穿刺件22可移动的轴向行程为，第一限位部1111a和第二限位部1111b之间在轴向上的距离D1。其中，D2大于或等于D1，使外管件21可移动的轴向行程大于穿刺件22可移动的轴向行程，使得外管件21在穿刺件22伸出外管件21后，可重新覆盖穿刺件22。外管件21可移动的轴向行程，与第二控制件14可移动的轴向行程相同。穿刺件22可移动的轴向行程，与第一控制件12可移动的轴向行程相同。The movable axial stroke of the outer pipe member 21 is the distance D2 in the axial direction between the third limiting portion 1113a and the fourth limiting portion 1113b. The movable axial stroke of the piercing member 22 is the distance D1 in the axial direction between the first limiting portion 1111a and the second limiting portion 1111b. Where D2 is greater than or equal to D1, the movable axial stroke of the outer tubular member 21 is greater than the movable axial stroke of the puncturing member 22, so that the outer tubular member 21 can cover the puncturing member 22 again after the puncturing member 22 extends out of the outer tubular member 21. The movable axial stroke of the outer pipe member 21 is the same as the movable axial stroke of the second control member 14 . The movable axial stroke of the piercing member 22 is the same as the movable axial stroke of the first control member 12 .
在本实施例中，外管件21朝远离手柄本体11近端11b的方向滑动的过程中，穿刺件22相对手柄本体11近端11b保持静止，以保证穿刺件22在人体内的位置保持不变，避免穿刺件22移动而容易刺伤左心房壁。In this embodiment, during the process of sliding the outer tube 21 away from the proximal end 11b of the handle body 11, the puncturing member 22 remains stationary relative to the proximal end 11b of the handle body 11 to ensure that the position of the puncturing member 22 in the human body remains unchanged , to prevent the puncturing member 22 from moving and puncturing the wall of the left atrium easily.
请参阅图2、图6a、图8a及图8b，第二固定件15设有与外管件21内腔相连通的连通腔1512、与连通腔1512相连通的穿刺件通道1511。穿刺件22经穿刺件通道1511及连通腔1512穿设于外管件21。具体地，第二固定件本体151包括穿刺件通道1511。外管件21的近端插接于第二固定件本体151内。穿刺件通道1511与第一连接件通道1311相对。穿刺件22穿过穿刺件通道1511，并插接在外管件21内。Referring to FIGS. 2 , 6 a , 8 a and 8 b , the second fixing member 15 is provided with a communication cavity 1512 communicating with the inner cavity of the outer pipe member 21 , and a puncturing member channel 1511 communicating with the communication cavity 1512 . The piercing member 22 is inserted through the outer tubular member 21 through the piercing member channel 1511 and the communication cavity 1512 . Specifically, the second fixing member body 151 includes a piercing member channel 1511 . The proximal end of the outer pipe member 21 is inserted into the second fixing member body 151 . The piercing member channel 1511 is opposite to the first connecting member channel 1311 . The piercing member 22 passes through the piercing member channel 1511 and is inserted into the outer tubular member 21 .
在本实施例中，第二固定件本体151还包括连通腔1512和第二连接件通道1513。第二连接件通道1513与穿刺件通道1511间隔设置，第二连接通道1513与连通腔1512连通。连通腔1512与穿刺件通道1511连通。第二连接件通道1513通过连通腔1512与穿刺件通道1511连通。In this embodiment, the second fixing member body 151 further includes a communication cavity 1512 and a second connecting member channel 1513 . The second connecting member channel 1513 is spaced apart from the piercing member channel 1511 , and the second connecting member channel 1513 communicates with the communication cavity 1512 . The communication cavity 1512 communicates with the piercing member channel 1511 . The second connecting member channel 1513 communicates with the piercing member channel 1511 through the communication cavity 1512 .
请参阅图1、图2、图6a，第二连接件17可用于导入第二液体介质。第二液体介质可依次经第二连接件17、第二连接件通道1513、连通腔1512及外管件21输送至体内。具体地，第二连接件17包括第二开关部171和与第二开关部171连接的第二连接部172。第二开关部171设置在手柄本体11外。第二连接件17的近端连接第二开关部171。部分第二连接部172穿过第二通道1312。第二连接部172的远端与第二连接件通道1513及连通腔1512连接。第二开关部171为常开状态时，可通过第二开关部171导入第二液体介质。第二液体介质经第二连接部172移至第二连接件通道1513、连通腔1512、及外管件21的内腔进入人体。可以理解地，第二液体介质不限于为生理盐水等，根据实际需要来确定。Please refer to FIG. 1 , FIG. 2 , and FIG. 6 a , the second connecting member 17 can be used to introduce the second liquid medium. The second liquid medium can be delivered to the body through the second connector 17 , the second connector channel 1513 , the communication cavity 1512 and the outer tube 21 in sequence. Specifically, the second connector 17 includes a second switch part 171 and a second connection part 172 connected to the second switch part 171 . The second switch portion 171 is provided outside the handle body 11 . The proximal end of the second connecting member 17 is connected to the second switch portion 171 . A portion of the second connection portion 172 passes through the second channel 1312 . The distal end of the second connecting portion 172 is connected with the second connecting member channel 1513 and the communication cavity 1512 . When the second switch portion 171 is in a normally open state, the second liquid medium can be introduced through the second switch portion 171 . The second liquid medium moves through the second connecting portion 172 to the second connecting member channel 1513 , the communication cavity 1512 , and the inner cavity of the outer pipe member 21 to enter the human body. It can be understood that the second liquid medium is not limited to physiological saline, etc., and is determined according to actual needs.
一方面，在穿刺***1排气的过程中，第一液体介质流经第一连接件16、第一连接件通道1311及穿刺件22，将第一连接件16、第一连接件通道1311及穿刺件22内的气体排出穿刺***1外。第二液体介质流经第二连接件17、第二连接件通道1513、连通腔1512及外管件21，将第二连接件17、第二连接件通道1513、连通腔1512及外管件21内的气体排出穿刺***1外。本实施例可有效地将穿刺***1中的气体排出穿刺***1外，避免在手术过程中出现气栓。可以理解地，在排气过程中，只用第一液体介质流经第一连接件16、第一连接件通道1311及穿刺件22，或者只用第二液体介质流经第二连接件17、连通腔 1512及外管件21，都无法完全将穿刺***1中的气体排出。这是因为，第一连接件16、第一连接件通道1311及穿刺件22的排气，与第二连接件17、第二连接件通道1513、连通腔1512及外管件21的排气是相互独立的。On the one hand, during the exhaust process of the puncture system 1, the first liquid medium flows through the first connector 16, the first connector channel 1311 and the puncture component 22, and the first connector 16, the first connector channel 1311 and the The gas in the puncturing member 22 is discharged out of the puncturing system 1 . The second liquid medium flows through the second connector 17 , the second connector channel 1513 , the communication cavity 1512 , and the outer tube 21 , connecting the second connector 17 , the second connector channel 1513 , the communication cavity 1512 and the outer tube 21 . The gas is expelled out of the puncture system 1 . This embodiment can effectively discharge the gas in the puncture system 1 out of the puncture system 1 to avoid air embolism during the operation. It can be understood that during the exhaust process, only the first liquid medium flows through the first connecting member 16, the first connecting member channel 1311 and the piercing member 22, or only the second liquid medium flows through the second connecting member 17, Neither the communication cavity 1512 nor the outer tube 21 can completely discharge the gas in the puncture system 1 . This is because the exhaust of the first connecting member 16 , the first connecting member channel 1311 and the piercing member 22 is mutually exclusive with the exhausting of the second connecting member 17 , the second connecting member channel 1513 , the communication cavity 1512 and the outer pipe member 21 . independent.
另一方面，当第一液体介质为造影液时，第一液体介质从穿刺件22的远端22a流出，可准确地确定穿刺件22远端22a的位置，便于医生控制穿刺件22穿刺房间隔，提高穿刺手术的精确程度。On the other hand, when the first liquid medium is contrast fluid, the first liquid medium flows out from the distal end 22a of the puncturing member 22, and the position of the distal end 22a of the puncturing member 22 can be accurately determined, which is convenient for the doctor to control the puncturing member 22 to puncture the interatrial septum , to improve the accuracy of puncture surgery.
请参阅图6a、8a、8b及图8c，第二固定件本体151的近端设置有连通槽19。连通槽19与穿刺件通道1511连通。第二固定件本体151的近端还设有接头151c。接头151c与穿刺件通道1511间隔设置。接头151c用于与第二连接部172连接。第二连接部172穿设在接头151c内部，与第二连接件通道1513连通。Please refer to FIGS. 6 a , 8 a , 8 b and 8 c , the proximal end of the second fixing member body 151 is provided with a communication groove 19 . The communication groove 19 communicates with the piercing member channel 1511 . The proximal end of the second fixing member body 151 is also provided with a joint 151c. The joint 151c is spaced apart from the piercing member channel 1511 . The joint 151c is used to connect with the second connection portion 172 . The second connecting portion 172 is penetrated inside the joint 151c and communicated with the second connecting member channel 1513 .
请参阅图6a、图8a及图8c，手柄组件10还包括密封件18。密封件18贴合并固定于第二固定件本体151的近端端面，并密封第二固定件本体151中连通槽19的开口，避免液体从连通槽19与密封件18之间的缝隙流通。密封件18贴合并固定于第二固定件本体151的近端端面的方式不限于为粘接、插接等一种或者多种的组合。Referring to FIGS. 6 a , 8 a and 8 c , the handle assembly 10 further includes a sealing member 18 . The sealing member 18 is attached to and fixed on the proximal end face of the second fixing member body 151 , and seals the opening of the communication groove 19 in the second fixing member body 151 to prevent liquid from flowing through the gap between the communication groove 19 and the sealing member 18 . The manner in which the sealing member 18 is attached to and fixed to the proximal end face of the second fixing member body 151 is not limited to one or more combinations such as bonding and plugging.
在本实施例中，密封件18整体呈立方体状，密封件18设有开口181，开口181贯穿密封件18的近端端面及远端端面，开口181与连通槽19连通。穿刺件22穿过开口181与穿刺件通道1511相连。开口181的内壁与穿刺件22过盈配合，避免液体从穿刺件22与开口181之间的空隙流过。In this embodiment, the sealing member 18 is in the shape of a cube as a whole, and the sealing member 18 is provided with an opening 181 . The piercing member 22 is connected to the piercing member channel 1511 through the opening 181 . The inner wall of the opening 181 is in an interference fit with the piercing member 22 to prevent liquid from flowing through the gap between the piercing member 22 and the opening 181 .
部分密封件18的侧壁朝向开口181所在的轴向方向内凹。该部分贴合第二固定件本体151中的接头151c的侧壁，使得密封件18与第二固定件本体151之间更加紧凑。The side wall of the partial seal 18 is concave in the axial direction in which the opening 181 is located. This part fits the side wall of the joint 151c in the second fixing member body 151 , so that the space between the sealing member 18 and the second fixing member body 151 is more compact.
请参阅图9，所述穿刺组件20可弯曲变形。具体地，穿刺组件20中的外管件21可弯曲变形。请参阅图2和图3，穿刺***1还包括调弯组件30。调弯组件30与穿刺组件20连接，调弯组件30也与手柄组件10连接。所述调弯组件30控制穿刺组件20弯曲变形。在本实施例中，外管件21通过调弯组件30调整形态。在其他实施例中，外管件21可为预制变形，即，在伸入人体内部之前，就已经呈弯曲状态。Referring to FIG. 9 , the piercing assembly 20 can be bent and deformed. Specifically, the outer tubular member 21 in the puncturing assembly 20 can be bent and deformed. Referring to FIGS. 2 and 3 , the puncturing system 1 further includes a bending assembly 30 . The bending assembly 30 is connected with the piercing assembly 20 , and the bending assembly 30 is also connected with the handle assembly 10 . The bending assembly 30 controls the bending deformation of the puncturing assembly 20 . In this embodiment, the shape of the outer tube 21 is adjusted by the bending assembly 30 . In other embodiments, the outer tubular member 21 may be prefabricated and deformed, that is, it is already in a bent state before being inserted into the human body.
具体地，调弯组件30包括调节件31、调弯件33、及连接在调节件31和调弯件33之间的牵引件32。调节件31收容在收容件113内。调节件31与第二固定件15间隔设置，且设置在第二固定件15远离第一固定件13的一侧。调节件31套接在外管件21的外壁，调节件31可在外管件21的外壁上滑动。调弯件33设置在外管件21的远端内，并固定在外管件21的远端内。调弯件33在径向向内的投影落入到穿刺件22的远端上。牵引件32的近端与调节件31连接。牵引件32的远端与调弯件33连接。Specifically, the bending assembly 30 includes an adjusting member 31 , a bending member 33 , and a pulling member 32 connected between the adjusting member 31 and the bending member 33 . The adjusting member 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 tube member 21 , and the regulating member 31 can slide on the outer wall of the outer tube member 21 . The bending member 33 is disposed in the distal end of the outer tubular member 21 and fixed in the distal end of the outer tubular member 21 . The radially inward projection of the bending element 33 falls onto the distal end of the piercing element 22 . The proximal end of the pulling member 32 is connected with the adjusting member 31 . The distal end of the pulling member 32 is connected with the bending member 33 .
调节件31与第二控制件14连接。请参阅图2、图4a、4b及4c，第一手柄件111和第二手柄件112中至少一个设置有第三限位孔300。第三限位孔300与第二限位孔1113间隔设置。第三限位孔300从手柄本体11的外壁贯穿至手柄本体11内的收容件113。部分调节件31从第三限位孔300伸出，与第二控制件14中的连接螺纹142螺接。The regulating element 31 is connected to the second control element 14 . Referring to FIG. 2 , FIGS. 4 a , 4 b and 4 c , 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 limiting hole 300 is spaced apart from the second limiting hole 1113 . The third limiting hole 300 penetrates from the outer wall of the handle body 11 to the receiving member 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 thread 142 in the second control member 14 .
第二控制件14调整调节件31的位置来使外管件21弯曲的具体过程阐述如下。例如，第二控制件14抵持缺口200在近端的侧壁，以缺口200近端的侧壁为支撑，相对手柄本体11的轴心转动，调节件31随着第二控制件14转动而相对手柄本体11在外管件21的外壁上滑动。当第二控制件14带动调节件31朝外管件21的近端滑动，调节件31拉着牵引件32、及调弯件33朝外管件21近端靠近，使得外管件21的远端朝靠近外管件21近端的方向弯曲。外管件21朝靠近外管件21近端的方向弯曲，也会使得穿刺件22朝相同的方向弯曲。在本实施例中，调弯件33呈中空的环状结构，且调弯件33可做显影点。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 described as follows. For example, the second control member 14 abuts the side wall at the proximal end of the notch 200 , is supported by the side wall at the proximal end of the notch 200 , rotates relative to the axis of the handle body 11 , and the adjusting member 31 rotates with the rotation of the second control member 14 . It slides on the outer wall of the outer tube 21 relative to the handle body 11 . When the second control member 14 drives the adjustment member 31 to slide toward the proximal end of the outer tubular member 21, the adjustment member 31 pulls the traction member 32 and the bending member 33 toward the proximal end of the outer tubular member 21, so that the distal end of the outer tubular member 21 approaches the proximal end of the outer tubular member 21. The direction of the proximal end of the outer tube 21 is bent. The bending of the outer tubular member 21 toward the proximal end of the outer tubular member 21 also causes the piercing member 22 to bend in the same direction. In this embodiment, the bending member 33 has a hollow annular structure, and the bending member 33 can be used as a developing point.
在本实施例中，外管件21可弯曲变形，便于调整外管件21在人体的形态，以便使外管件21的远端朝向预定的位置，使穿刺件22准确地穿刺预定的位置，提高穿刺件22穿刺的精确程度。In this embodiment, the outer tube member 21 can be bent and deformed, which is convenient to adjust the shape of the outer tube member 21 in the human body, so that the distal end of the outer tube member 21 faces a predetermined position, so that the puncture member 22 can accurately puncture the predetermined position, and improve the 22 Accuracy of puncture.
在本实施例中，穿刺件22可弯曲变形。具体地，穿刺件22的远端22a设有可弯曲结构211。请参阅图10，可弯曲结构211可使穿刺件22的远端22a弯曲变形，便于调节穿刺件22的远端端面的朝向。可弯曲结构211与外管件21的远端正对。在穿刺组件20处于收容状态时，可弯曲结构211收容在外管件21的远端内。可以理解地，可弯曲结构211的形状可以呈螺旋型、燕尾型。可以 理解地，在其他实施例中，可弯曲结构211的形状不作限定，以穿刺件22的远端可弯曲的为准。在本实施例中，穿刺件22通过调弯组件30调整形态。在其他实施例中，穿刺件22可为预制变形，即，在伸入人体内部之前，就已经呈弯曲状态。In this embodiment, the piercing member 22 can be bent and deformed. Specifically, the distal end 22a of the piercing member 22 is provided with a bendable structure 211 . Referring to FIG. 10 , the bendable structure 211 can bend and deform the distal end 22 a of the piercing member 22 , so as to adjust the orientation of the distal end surface of the piercing 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 in the distal end of the outer tubular member 21 . It can be understood that the shape of the bendable structure 211 can be a spiral or a dovetail. It can be understood that, in other embodiments, the shape of the bendable structure 211 is not limited, as long as the distal end of the piercing member 22 is bendable. In this embodiment, the shape of the piercing member 22 is adjusted by the bending assembly 30 . In other embodiments, the piercing member 22 may be prefabricated, that is, it is in a bent state before being inserted into the human body.
在本实施例中，穿刺件22呈中空管状。穿刺件22远端22a的端面，向穿刺件22的近端内凹，形成倾斜的穿刺面，该穿刺面设有尖锐尖角，便于应力集中，提高穿刺效率。In this embodiment, the piercing member 22 is in the shape of a hollow tube. The end surface of the distal end 22a of the puncturing element 22 is concave toward the proximal end of the puncturing element 22 to form an inclined puncturing surface.
第二实施例Second Embodiment
请参阅图11a、图11b、图11c和图12，本实施例提供的穿刺***1a与第一实施例基本相同，不同的是，在本实施例中，调弯件33a具有弹性。调弯件33a呈中空的管状结。调弯件33a设置在外管件210的远端210a内。牵引件31a连接在调节件(图未示)和调弯件33a之间。11a, 11b, 11c and 12, the puncture system 1a provided in this embodiment is basically the same as the first embodiment, the difference is that in this embodiment, the bending member 33a has elasticity. The bending member 33a is in the form of a hollow tubular knot. The bending member 33a is disposed within the distal end 210a of the outer tubular member 210 . The pulling member 31a is connected between the adjusting member (not shown) and the bending member 33a.
所述手柄组件包括调弯控制件(图未示)，调弯控制件用于控制调整外管件21的远端弯曲。调弯控制件的具体结构可参考第一实施例中的第二控制件。调弯控制件与调节件螺接，调弯控制件相对手柄组件(图未示)转动，可带动调节件及牵引件31a相对手柄组件滑动。当调弯控制件带动调节件及牵引件31a朝手柄组件的近端滑动，调弯件33a朝靠近手柄组件近端的方向弯曲，使得外管件210的远端、穿刺件220的远端朝靠近手柄组件近端的方向弯曲。可以理解的是，牵引件31a为镍钛丝等具有弹性的金属或者非金属材料形成。The handle assembly includes a bending control member (not shown), and the bending control member is used to control and adjust the bending of the distal end of the outer tubular member 21 . For the specific structure of the bending control member, reference may be made to the second control member 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 is bent toward the proximal end of the handle assembly, so that the distal end of the outer tubular member 210 and the distal end of the puncturing member 220 move closer to the proximal end of the handle assembly. The direction of the proximal end of the handle assembly is bent. It can be understood that the pulling member 31a is formed of an elastic metal or non-metal material such as nickel-titanium wire.
在本实施例中，外管件210的远端210a包括主体部2101和与主体部2101相连的支撑部2102。支撑部2102沿背离外管件210的近端突出。调弯件33a套接在支撑部2102的外表面上。调弯件33a沿径向向内的投影，落入到支撑部2102沿径向向内的投影上。In this embodiment, the distal end 210a of the outer tube 210 includes a main body portion 2101 and a support portion 2102 connected to the main body portion 2101 . The support portion 2102 protrudes along the proximal end facing away from the outer tube 210 . The bending part 33a is sleeved on the outer surface of the support part 2102 . The radially inward projection of the bending member 33 a falls on the radially inward projection of the support portion 2102 .
外管件210设有第一通孔211。第一通孔211贯穿外管件210的近端和外管件210的远端210a。即，第一通孔211贯穿主体部2101、支撑部2102。第一通孔211用于收容穿刺件220。The outer tube 210 is provided with a first through hole 211 . The first through hole 211 penetrates through the proximal end of the outer tubular member 210 and the distal end 210a of the outer tubular member 210 . That is, the first through hole 211 penetrates through the main body portion 2101 and the support portion 2102 . The first through hole 211 is used to accommodate the piercing member 220 .
外管件210还设置有外管件通道212，外管件通道212与第一通孔211间隔 设置。外管件通道212贯穿主体部2101。外管件通道212设置在外管件210内，外管件通道212的延伸方向与第一通孔211的延伸方向相同。牵引件31a的远端经外管件210的侧壁沿着外管件通道212延伸至调弯件33a，并与调弯件33a固定连接。在其他实施例中，调弯件33a可以省略不要，此时，牵引件31a直接固定在外管件210的远端210a，牵引件31a拉动外管件210的远端210a弯曲。在其他实施例中，牵引件31a直接固定在外管件210的远端210a，并未与调弯件33a相连。牵引件31a在外力作用下拉动外管件210的远端210a弯曲，调弯件33a随着外管件210一同弯曲。撤去外力作用后，调弯件33a恢复原来的形状，同时调弯件33a恢复原来形状的弹力也使外管件210原来的形状。The outer tube 210 is further provided with an outer tube channel 212, and the outer tube channel 212 is spaced from the first through hole 211. The outer tube passage 212 penetrates the main body portion 2101 . The outer tube channel 212 is disposed in the outer tube 210 , and the extension direction of the outer tube channel 212 is the same as the extension direction of the first through hole 211 . The distal end of the pulling member 31a extends to the bending member 33a through the side wall of the outer tube member 210 along the outer tube member channel 212, and is fixedly connected with the bending member 33a. In other embodiments, the bending member 33a may be omitted. In this case, the pulling member 31a is directly fixed on the distal end 210a of the outer tubular member 210, and the pulling member 31a pulls the distal end 210a of the outer tubular member 210 to bend. In other embodiments, the pulling member 31a is directly fixed on the distal end 210a of the outer tubular member 210, and is not connected with the bending member 33a. The pulling member 31a pulls the distal end 210a of the outer tubular member 210 to bend under the action of an external force, and the bending member 33a bends together with the outer tubular member 210 . After the external force is removed, the bending member 33a returns to its original shape, and at the same time, the elastic force of the bending member 33a to restore the original shape also makes the outer pipe member 210 the original shape.
在本实施例中，手柄组件还包括隔离件19a，隔离件19a呈中空的管状结构。隔离件19a设置在调弯件33a的外壁上。隔离件19a为高分子材料形成。隔离件19a内收容有部分牵引件31a。牵引件31a的远端穿过隔离件19a的内腔，与支撑部2102固定连接。In this embodiment, the handle assembly further includes a spacer 19a, and the spacer 19a is a hollow tubular structure. The spacer 19a is provided on the outer wall of the bending member 33a. The spacer 19a is formed of a polymer material. Part of the pulling member 31a is accommodated in the spacer 19a. The distal end of the pulling member 31a passes through the inner cavity of the spacer 19a and is fixedly connected with the supporting portion 2102 .
在本实施例中，外管件210的远端210a还包括覆盖部2103。覆盖部2103覆盖隔离件19a，且覆盖部2103覆盖支撑部2102露出主体部2101的部分。覆盖部2103的近端与主体部2101的远端平齐，从而避免覆盖部2103与主体部2101之间形成高度差而影响外管件210撤出人体。In this embodiment, the distal end 210a of the outer tubular member 210 further includes a covering portion 2103 . The cover part 2103 covers the spacer 19a, and the cover part 2103 covers the part of the support part 2102 exposed from the main body part 2101 . The proximal end of the covering part 2103 is flush with the distal end of the main body part 2101 , so as to avoid a height difference between the covering part 2103 and the main body part 2101 which would affect the withdrawal of the outer tube 210 from the human body.
覆盖部2103还覆盖调弯件33a的外壁，使得调弯件33a稳固地收容在外管件210内，防止调弯件33a从外管件210内脱落。The covering portion 2103 also covers the outer wall of the bending member 33a, so that the bending member 33a is stably accommodated in the outer pipe member 210 and prevents the bending member 33a from falling off from the outer pipe member 210.
在本实施例中，隔离件19a间隔开牵引件31a与覆盖部2103，牵引件31a在隔离件19a的内腔的部分可相对隔离件19a移动，从而可防止牵引件31a被覆盖部2103覆盖的部分被覆盖部2103抵持、限位而无法相对隔离件19a滑动，使得支撑部2102无法弯曲。In this embodiment, the spacer 19a separates the pulling member 31a and the covering portion 2103, and the portion of the pulling member 31a in the inner cavity of the spacer 19a can move relative to the spacer 19a, thereby preventing the pulling member 31a from being covered by the covering portion 2103. Part of it is resisted and limited by the covering part 2103 and cannot slide relative to the spacer 19a, so that the supporting part 2102 cannot be bent.
在本实施例中，制成覆盖部2103的材料，与制成主体部2101的材料相同，都是高分子材料。覆盖部2103在熔融状态下可与主体部2101融合。在其他实施例中，制成覆盖部2103的材料，可与制成主体部2101的材料不同。In this embodiment, the material for forming the cover portion 2103 is the same as the material for forming the main body portion 2101 , which is a polymer material. The cover portion 2103 may be fused with the main body portion 2101 in a molten state. In other embodiments, the material of the covering portion 2103 may be different from the material of the main portion 2101 .
在本实施例中，覆盖部2103的熔点低于隔离件19a的熔点。覆盖部2103在熔融状态与主体部2102融合的过程，隔离件19a不会被融化，从而防止熔融 的覆盖部2103将隔离件19a内的牵引丝31a与隔离件19a完全固接为一体。优选地，本实施例中，隔离件19a的近端较调弯件33a的近端更远离外管件210的远端，防止覆盖部2103覆盖隔离件19a的近端端面，更有效地防止熔融的覆盖部2103将隔离件19a内的牵引丝31a与隔离件19a完全固接为一体。In this embodiment, the melting point of the covering portion 2103 is lower than the melting point of the spacer 19a. In the process of fusion of the cover part 2103 with the main body part 2102 in a molten state, the spacer 19a will not be melted, thereby preventing the melted cover part 2103 from completely fixing the pulling wire 31a in the spacer 19a and the spacer 19a into one. Preferably, in this embodiment, the proximal end of the spacer 19a is farther away from the distal end of the outer tube 210 than the proximal end of the bending element 33a, so as to prevent the covering portion 2103 from covering the proximal end face of the spacer 19a, and more effectively prevent molten The covering portion 2103 completely secures the pulling wire 31a in the spacer 19a and the spacer 19a into one body.
在本实施例中，牵引件31a的远端穿过隔离件19a的远端，并被覆盖部2013覆盖且固定。牵引件31a被拉动时，牵引件31a可在隔离件19a内朝手柄组件的近端滑动，牵引件31a的远端拉动覆盖部2103，使调弯件33a、支撑部2102朝向手柄组件的近端弯曲。在其他实施例中，牵引件31a的远端穿过隔离件19a后与调弯件33a固定连接。牵引件31a被拉动时，牵引件31a的远端拉动调弯件33a，使得调弯件33a、支撑部2102朝向手柄组件的近端弯曲。In this embodiment, the distal end of the pulling member 31a passes through the distal end of the spacer 19a, and is covered and fixed by the covering portion 2013 . When the pulling member 31a is pulled, the pulling member 31a can slide toward the proximal end of the handle assembly within the spacer 19a, 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 face the proximal end of the handle assembly bending. In other embodiments, the distal end of the pulling member 31a is fixedly connected to the bending member 33a after passing through the spacer 19a. 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 support portion 2102 are bent toward the proximal end of the handle assembly.
请参阅图12，调弯件33a的外壁具有多个的弹性部330a和多个开口部330b。每个开口部330b连接在相邻两个弹性部330a之间。所述开口部330b为所述调弯件33a上开设的凹槽结构。所述开口部330b可降低调弯件33a的刚度，使调弯件33a更易于弯曲。Referring to FIG. 12 , the outer wall of the bending member 33a has a plurality of elastic portions 330a and a plurality of opening portions 330b. Each opening portion 330b is connected between two adjacent elastic portions 330a. The opening 330b is a groove structure formed on the bending member 33a. The opening portion 330b can reduce the rigidity of the bending part 33a, so that the bending part 33a is easier to bend.
进一步地，当第二控制件带动调节件31a朝外管件210的近端滑动，相邻的弹性部330a互相靠近，相邻两个弹性部330a之间的开口部330b逐渐缩小，使得调弯件33a整体变形弯曲。Further, when the second control member drives the adjustment member 31a to slide toward the proximal end of the outer pipe member 210, the adjacent elastic portions 330a approach each other, and the opening portion 330b between the two adjacent elastic portions 330a gradually shrinks, so that the bending member 33a is deformed and bent as a whole.
在本实施例中，单位长度上的开口部330b的分布数量，从调弯件近端331到调弯件远端332的方向上，逐渐增加。调弯件33a的刚度，从调弯件近端331到调弯件远端332的方向上，逐渐减小。从调弯件近端331到调弯件远端332的方向上，调弯件33a更加容易弯曲。在其他实施中，单位长度上的开口部330b的分布数量，在调弯件近端331到调弯件远端332的方向上，保持不变。In this embodiment, the distribution number of the openings 330b per unit length increases gradually in the direction from the proximal end 331 of the bending member to the distal end 332 of the bending member. The stiffness of the bending member 33a gradually decreases in the direction from the proximal end 331 of the bending member to the distal end 332 of the bending member. In the direction from the proximal end 331 of the bending member to the distal end 332 of the bending member, the bending member 33a is easier to bend. In other implementations, the distribution number of the openings 330b per unit length remains unchanged in the direction from the proximal end 331 of the bending member to the distal end 332 of the bending member.
第三实施例Third Embodiment
请参阅图13，本实施例提供的穿刺***1b与第二实施例基本相同，不同的是，多个开口部340b相连，并沿调弯件330的外壁螺旋延伸形成一个整体。Referring to FIG. 13 , the puncture system 1b provided in this embodiment is basically the same as that of the second embodiment, the difference is that a plurality of openings 340b are connected and spirally extend along the outer wall of the bending member 330 to form a whole.
相邻两个开口部340b的螺距，在调弯件近端3301到调弯件远端3302的方向上，逐渐减小。调弯件330的刚度，从调弯件近端3301到调弯件远端3302 的方向上，逐渐减小，调弯件330在其近端3301到其远端3302的方向上更加容易弯曲。在其他实施中，开口部340b的螺距，在调弯件330的近端3301到远端3302的方向上，保持不变。The pitches of the two adjacent openings 340b gradually decrease in the direction from the proximal end 3301 of the bending member to the distal end 3302 of the bending member. The stiffness of the bending member 330 gradually decreases from the proximal end 3301 of the bending member to the distal end 3302 of the bending member, and the bending member 330 is easier to bend in the direction from the proximal end 3301 to the distal end 3302 of the bending member. In other implementations, the pitch of the opening portion 340b remains unchanged in the direction from the proximal end 3301 to the distal end 3302 of the bending member 330 .
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity, all possible combinations of the technical features in the above-described embodiments are not described. However, as long as there is no contradiction between the combinations of these technical features, All should be regarded as the scope described in this specification.
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。The above-mentioned embodiments only represent several embodiments of the present invention, and the descriptions thereof are specific and detailed, but should not be construed as a limitation on the scope of the invention patent. It should be pointed out that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can also be made, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention should be subject to the appended claims.

Claims (11)

  1. 一种穿刺***，其特征在于，所述穿刺***包括手柄组件和穿刺组件，所述穿刺组件收容于所述手柄组件内，且与所述手柄组件固定相连，所述穿刺组件可相对手柄组件弯曲变形。A puncture system, characterized in that the puncture system comprises a handle assembly and a puncture assembly, the puncture assembly is accommodated in the handle assembly and is fixedly connected with the handle assembly, and the puncture assembly can be bent relative to the handle assembly deformed.
  2. 如权利要求1所述的穿刺***，所述穿刺组件包括穿刺件和呈中空管状的外管件，至少部分所述穿刺件收容在所述外管件内，且所述穿刺件的近端穿出所述外管件的近端，所述穿刺件的远端可相对所述外管件移动，所述外管件与所述手柄组件连接。The puncturing system according to claim 1, wherein the puncturing assembly comprises a puncturing member and a hollow tubular outer tube, at least part of the puncturing member is accommodated in the outer tube, and the proximal end of the puncturing member passes through the outer tube. The proximal end of the outer tubular member and the distal end of the puncturing member can move relative to the outer tubular member, and the outer tubular member is connected with the handle assembly.
  3. 如权利要求2所述的穿刺***，其特征在于，所述穿刺***还包括调弯组件，所述调弯组件与所述手柄组件及所述穿刺组件连接，所述调弯组件控制所述穿刺组件弯曲变形。The puncture system according to claim 2, wherein the puncture system further comprises a bend adjustment assembly, the bend adjustment assembly is connected with the handle assembly and the puncture assembly, and the bend adjustment assembly controls the puncture The component is bent and deformed.
  4. 如权利要求3所述的穿刺***，其特征在于，所述调弯组件包括调节件，所述调节件设置在所述手柄组件内，所述调节件朝所述手柄组件的近端滑动，所述外管件的远端、及所述穿刺件的远端朝靠近所述手柄组件的近端弯曲。The puncture system according to claim 3, wherein the bending assembly comprises an adjustment member, the adjustment member is disposed in the handle assembly, and the adjustment member slides toward the proximal end of the handle assembly, so that the The distal end of the outer tubular member and the distal end of the piercing member are bent toward the proximal end of the handle assembly.
  5. 如权利要求4所述的穿刺***，其特征在于，所述调弯组件还包括调弯件和牵引件，所述调弯件设置在所述外管件的远端内，所述牵引件连接在所述调弯件和所述调节件之间。The puncture system according to claim 4, wherein the bending assembly further comprises a bending member and a pulling member, the bending member is disposed in the distal end of the outer tubular member, and the pulling member is connected to the between the bending part and the adjusting part.
  6. 如权利要求5所述的穿刺***，其特征在于，所述手柄组件包括调弯控制件，所述调弯控制件与所述调节件螺接，所述调弯控制件相对所述手柄组件转动，可带动所述调节件相对所述手柄组件滑动。The puncture system according to claim 5, wherein the handle assembly comprises a bending control member, the bending control member is screwed with the adjustment member, and the bending control member rotates relative to the handle assembly , which can drive the adjusting member to slide relative to the handle assembly.
  7. 如权利要求6所述的穿刺***，其特征在于，所述调弯控制件与所述外管件连接，所述调弯控制件相对所述手柄组件滑动，可带动所述外管件相对手柄组件滑动。The puncture system according to claim 6, wherein the bending control member is connected to the outer tubular member, and the bending control member slides relative to the handle assembly to drive the outer tubular member to slide relative to the handle assembly .
  8. 如权利要求5所述的穿刺***，其特征在于，所述外管件的远端包括主体部和与所述主体部相连的支撑部，所述支撑部沿背离手柄组件的近端突出，调弯件套接在支撑部的外表面上。The puncture system according to claim 5, wherein the distal end of the outer tubular member comprises a main body portion and a support portion connected with the main body portion, the support portion protrudes along the proximal end away from the handle assembly, and adjusts the bend. The piece is sleeved on the outer surface of the support part.
  9. 如权利要求8所述的穿刺***，其特征在于，所述外管件的远端还包括覆盖部，所述覆盖部覆盖支撑部、及所述调弯件。The puncture system according to claim 8, wherein the distal end of the outer tubular member further comprises a covering portion, and the covering portion covers the supporting portion and the bending member.
  10. 如权利要求9所述的穿刺***，其特征在于，所述手柄组件还包括隔离件，所述隔离件呈中空的管状结构，所述隔离件设置在所述调弯件的外壁上，所述覆盖部覆盖所述隔离件的外壁，所述牵引件可在所述隔离件的内腔相对手柄组件滑动。The puncture system according to claim 9, wherein the handle assembly further comprises a spacer, the spacer is a hollow tubular structure, the spacer is arranged on the outer wall of the bending part, the spacer The cover part covers the outer wall of the spacer, and the traction element can slide relative to the handle assembly in the inner cavity of the spacer.
  11. 如权利要求10所述的穿刺***，其特征在于，所述覆盖部的熔点低于所述隔离件的熔点。11. The piercing system of claim 10, wherein the melting point of the cover is lower than the melting point of the spacer.
PCT/CN2022/082278 2021-03-29 2022-03-22 Puncture system WO2022206491A1 (en)

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