WO2022206596A1 - 穿刺装置 - Google Patents
穿刺装置 Download PDFInfo
- Publication number
- WO2022206596A1 WO2022206596A1 PCT/CN2022/083027 CN2022083027W WO2022206596A1 WO 2022206596 A1 WO2022206596 A1 WO 2022206596A1 CN 2022083027 W CN2022083027 W CN 2022083027W WO 2022206596 A1 WO2022206596 A1 WO 2022206596A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- puncture
- outer tube
- handle
- control member
- handle assembly
- Prior art date
Links
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Images
Classifications
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- 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
- A61B17/3478—Endoscopic needles, e.g. for infusion
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/003—Steerable
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
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- A61B2017/00309—Cut-outs or slits
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- A—HUMAN NECESSITIES
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/003—Steerable
- A61B2017/00318—Steering mechanisms
- A61B2017/00323—Cables or rods
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/003—Steerable
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- A61B2017/00331—Steering mechanisms with preformed bends
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0801—Prevention of accidental cutting or pricking
- A61B2090/08021—Prevention of accidental cutting or pricking of the patient or his organs
Definitions
- the invention relates to the field of medical instruments, in particular to a puncture device.
- Traditional puncture needles are made of a stainless steel tube.
- 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, which is easy to puncture the left atrium wall and cause cardiac tamponade. Alternatively, it is easy to pierce the aorta causing serious complications.
- the puncture device includes a handle assembly and a puncture assembly housed in the handle assembly and fixedly connected with the handle assembly, the puncture assembly includes a puncture element, and the handle assembly further includes a first puncture element for controlling the puncture element.
- a control member when the first control member is rotated, the first control member controls the piercing member to approach or move away from the handle assembly.
- the first control member controls the puncture member to be close to or away from the handle assembly, which facilitates the first control member to control the puncture member to pass out of the handle assembly, is easy to operate, and is convenient to control the puncture member to perform puncture surgery.
- the puncturing piece continues to travel after successful puncturing due to inertia, thereby stabbing the human body.
- FIG. 1 is a schematic structural diagram of a puncture device provided in a first embodiment of the present application.
- FIG. 2 is an exploded view of the puncturing device 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 tube 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.
- FIG. 14 is a schematic structural diagram of a puncture device provided by a fourth embodiment of the present application.
- FIG. 15 is a schematic cross-sectional view of the structure of FIG. 14 .
- FIG. 16 is an enlarged schematic view of the structure of FIG. 15 .
- FIG. 17 is a schematic structural diagram of a cross-sectional view from another angle in FIG. 14 .
- FIG. 18 is a schematic diagram of an explosion in the fourth embodiment of the application.
- FIG. 19 is a schematic structural diagram of the first control member in the fourth embodiment of the application.
- FIG. 20 is a schematic structural diagram of a false-touch prevention member in a fourth embodiment of the present application.
- FIG. 21 is a schematic cross-sectional structural diagram of the false-touch prevention member in the fifth embodiment of the present application.
- FIG. 22 is an enlarged schematic view of XX in FIG. 21 .
- FIG. 23 is an enlarged schematic view of XX in another embodiment.
- 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 device 1 is provided in the first implementation of the present application.
- the puncture device 1 is used for puncturing 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 device 1 is used for puncturing the fossa ovalis as an example for description.
- the puncture device 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 tube 23 and a piercing member 24 .
- the outer tube 23 includes the outer tube 21 .
- the piercing member 24 includes the piercing needle 22 .
- the outer tube 21 is connected to the handle assembly 10 .
- the outer tube 21 has a hollow tubular shape.
- the puncture needle 22 is inserted into the outer tube 21 . At least part of the puncture needle 22 is accommodated in the outer tube 21 .
- the extending direction of the puncture needle 22 in the outer tube 21 is the same as the extending direction of the outer tube 21 .
- the distal end 22a of the puncture needle 22 is close to the distal end 21a of the outer tube 21 .
- the proximal end 22b of the puncture needle 22 passes through the proximal end 21b of the outer tube 21 .
- the puncture needle 22 is accommodated in the outer tube 21, and the distal end 22a of the puncture needle 22 is close to the distal end 21a of the outer tube.
- the puncture needle 22 is moved into the inside of the human body together with the outer tube 21 .
- the puncture needle 22 does not need to be inserted from the proximal end 21b of the outer tube 21, and then slide to the distal end 21a of the outer tube 21, so as to avoid damage to the outer tube 21 during the sliding process of the puncture needle 22 in the outer tube 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 puncture needle 22 is close to the distal end 21a of the outer tube 21 means that the distal end 22a of the puncture needle 22 is close to the end face of the distal end 21a of the outer tube 21, and the distal end 22a of the puncture needle 22
- the end surface of the puncture needle 22 is not flush with the end surface of the distal end 21 a of the outer tube 21 , that is, the puncture needle 22 is accommodated in the outer tube 21 or part of the puncture needle 22 is exposed outside the outer tube 21 .
- the distal end 22a of the puncture needle 22 is always accommodated in the outer tube 21, and the outer tube 21 is not exposed.
- the outer tube 21 will be bent and deformed when it encounters the curved blood vessel channel of the human body, while the puncture needle 22 does not reveal the outer tube 21, so as to avoid the puncture needle 22 from stabbing the human body .
- the puncture needle 22 penetrates the outer tube 21 , and the proximal end 22 b of the puncture needle 22 is also close to the proximal end 21 b of the outer tube 21 . Specifically, the proximal end 22b of the puncture needle 22 protrudes from the proximal end 21b of the outer tube 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 puncture needle 22 and the proximal end of the outer tube 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 puncture needle 22 in the puncture 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 puncture needle 22 is exposed outside the distal end 21a of the outer tube 21 .
- the accommodated state means that the distal end 22 a of the puncture needle 22 is accommodated in the distal end 21 a of the outer tube 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 puncture needle 22 .
- the first control member 12 is used to control the puncture needle 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 puncture needle 22 to slide in the axial direction, so that the distal end 22a of the puncture needle 22 protrudes out of the outer tube 21 .
- the distal end 22 a of the puncture needle 22 can protrude into the outer tube 21 .
- the first control member 12 transmits the force to the puncture needle 22, so that the puncture needle 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 needle 22, and the first control member 12 slides with the puncture needle 22, so that the puncture needle 22 passes through the outer tube 21 to perform a puncture operation.
- the first control member 12 is indirectly connected to the proximal end of the puncture needle 22 .
- the first control member 12 may be directly connected to the puncture needle 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 piercing member 24 further includes the 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 puncture needle 22 (not shown).
- the first fixing member 13 includes a first fixing member body 131 .
- the proximal end of the puncture needle 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 puncture needle 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 puncture needle 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 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 respectively.
- 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 portions 132 is not limited, and the first control member 12 can control the sliding of the puncture needle 22 through the first fixing portion 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 puncture needle 22 .
- the sliding process of the puncture needle 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 puncture needle 22 slide in a direction away from the proximal end 11 b of the handle body 11 , and the puncture needle 22 gradually extends out of the outer tube 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 puncture needle 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 puncture needle 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 puncture needle 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 entire stroke of the puncture needle 22 in one puncture 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 puncture needle 22 . Since the puncture needle 22 is bent in the human body, the stroke of the distal end of the puncture needle 22 is less than or equal to the stroke of the entire puncture needle 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 needle 22 in the present application is pierced through the interatrial septum, it is restricted by the first limiting hole 1111 and will not continue to travel, which prevents the puncture needle 22 from continuing to puncture the left atrium wall, and improves the use of the puncture needle 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 needle 22 by pushing the two first control members 12, so that the puncture needle 22
- the acting force received by the puncture needle 22 is more uniform, the puncture needle 22 can slide smoothly in the axial direction, and the stability of the puncture needle 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 puncture needle 22 is fixed in the first connecting member channel 1311, and the puncture needle 22 is punctured in the first connecting member channel 1311.
- the lumen of the needle 22 communicates with the first connector channel 1311 .
- the piercing device 1 also includes a first connector 16 .
- the first connector channel 1311 communicates with the first connector 16 and the puncture needle 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 puncture needle 22 in sequence.
- the puncture needle 22 communicates with the first connecting member 16 through the first connecting member channel 1311 in the first fixing member body 131 .
- a portion of the puncture needle 22 is accommodated and fixed in the first fixing member 131 , and a portion of the puncturing needle 22 passing through the first fixing member body 131 communicates with the first connecting member 16 . That is, the proximal end of the puncture needle 22 is in direct communication with the first connecting member 16 .
- the first liquid medium can be directly input into the puncture needle 22 through the first connector 16 , so as to improve the efficiency of inputting the first liquid medium to the puncture needle 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 When the first switch portion 161 is in a normally closed state, it can play a role in preventing the passage of blood.
- the first switch portion 161 is a three-way valve
- 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 tube 21 through the second channel 1312 .
- the outer tube 21 is slidable 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 tube 21 can also be slid toward the direction close to the handle body 11, so that the puncture needle 22 is converted from the accommodated state to the extended state.
- the outer tube 23 further includes a second fixing member 15 located on the distal side of the first fixing member 13.
- the second fixing member 15 is used for fixing the outer tube 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 puncturing device 1 than the second fixing member 15 .
- the first fixing member 13 is fixedly connected with the proximal end 22b of the puncture needle 22, so that the distal end 22a of the puncture needle 22 can be controlled to extend out of the distal end 21a of the outer tube 21 or into the distal end of the outer tube 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 tube 21 .
- the second control member 14 is used to control the sliding of the outer tube 21 relative to the puncture needle 22 in the axial direction.
- the outer tube 21 is slidable 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 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 needle 22 again, so that the puncture needle 22 is accommodated in the hollow body of the outer tube 21 , Thereby, the risk of puncturing the inner wall of the human body by the puncture needle 22 is reduced, and the safety degree of the operation is improved.
- the first control member 12 is closer to the proximal end of the puncturing device 1 than the second control member 14 .
- the second control member 14 needs to be controlled to slide away from the proximal end of the puncture device 1 to control the outer tube 21 to cover the puncture again. Needle 22. Since the first control member 12 is closer to the proximal end of the puncture device 1 than the second control member 14 , that is, the second control member 14 is further away from the proximal end of the puncture device 1 than the first control member 12 , the second control member 12 is controlled.
- the second control part 14 is slid away from the proximal end of the puncture device 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 it is not easy to touch the second control part 14 by mistake
- To the first control part 12 avoid accidentally touching the first control part 12 to change the position of the puncture needle 22 in the human body, and avoid touching the first control part 12 to change the position of the puncture needle 22, such as the first control part 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 portion of the outer surface of the first handle member 111 or a portion of the outer surface of the second handle member 112 being concave radially inward.
- 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 tube 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 21 , and the second control member 14 is indirectly connected to the proximal end of the outer tube 21 . In other embodiments, the second control member 14 can also be directly connected with the proximal end of the outer tube 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 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 tube 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 engaged 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 tube 21 slide away from the proximal end 11 b of the handle body 11 .
- the outer tube 21 gradually covers the distal end 22 a of the puncture needle 22 .
- 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 puncture needle 22 cannot approach the handle along the Assembly 10 slides in the direction of the proximal end. In this process, the puncture needle 22 is switched 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 tube 21 is greater than or equal to the movable axial stroke of the puncture needle 22 . In this way, after the puncture needle 22 punctures the interatrial septum, the outer tube 21 slides away from the proximal end of the handle assembly 10 to completely cover the puncture needle 22 again, thereby reducing the risk of the puncture needle 22 piercing the inner wall of the human body and improving the safety of the operation.
- the movable axial stroke of the outer tube 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 puncture needle 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 tube 21 is greater than the movable axial stroke of the puncture needle 22, so that the outer tube 21 can re-cover the puncture needle 22 after the puncture needle 22 extends out of the outer tube 21.
- the movable axial stroke of the outer tube 21 is the same as the movable axial stroke of the second control member 14 .
- the movable axial stroke of the puncture needle 22 is the same as the movable axial stroke of the first control member 12 .
- the puncture needle 22 when the outer tube 21 slides away from the proximal end 11b of the handle body 11, the puncture needle 22 remains stationary relative to the proximal end 11b of the handle body 11 to ensure that the position of the puncture needle 22 in the human body remains unchanged , to avoid the movement of the puncture needle 22 to easily puncture the left atrium wall.
- the second fixing member 15 is provided with a communication cavity 1512 communicating with the inner cavity of the outer tube 21 , and a puncturing member channel 1511 communicating with the communication cavity 1512 .
- the puncture needle 22 passes through the outer tube 21 through the puncture element 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 tube 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 puncture needle 22 passes through the puncture member channel 1511 and is inserted into the outer tube 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 into 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 connection 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 tube 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 needle 22, and the first connector 16, the first connector channel 1311 and the puncture needle 22 are separated.
- the gas in the puncture needle 22 is discharged out of the puncture device 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 discharged out of the puncture device 1 .
- This embodiment can effectively discharge the gas in the puncture device 1 out of the puncture device 1 to avoid air embolism during the operation.
- the first liquid medium when the first liquid medium is contrast liquid, the first liquid medium flows out from the distal end 22a of the puncture needle 22, which can accurately determine the position of the distal end 22a of the puncture needle 22, which is convenient for the doctor to control the puncture needle 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 on 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 puncture needle 22 is connected to the puncture member channel 1511 through the opening 181 .
- the inner wall of the opening 181 is in an interference fit with the puncture needle 22 to prevent liquid from flowing through the gap between the puncture needle 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 tube 21 in the puncture assembly 20 can be bent and deformed.
- the puncturing device 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 tube 21 may be prefabricated and deformed, ie, 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 regulating member 31 is sleeved on the outer wall of the outer tube 21 , and the regulating member 31 can slide on the outer wall of the outer tube 21 .
- the bending member 33 is disposed in the distal end of the outer tube 21 and fixed in the distal end of the outer tube 21 .
- the radially inward projection of the deflection element 33 falls onto the distal end of the puncture needle 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 for the second control member 14 to adjust the position of the adjustment member 31 to bend the outer tube 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 tube 21 , so that the distal end of the outer tube 21 approaches The direction of the proximal end of the outer tube 21 is bent.
- the bending of the outer tube 21 toward the proximal end of the outer tube 21 also causes the puncture needle 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 21 can be bent and deformed, which is convenient to adjust the shape of the outer tube 21 in the human body, so that the distal end of the outer tube 21 faces the predetermined position, so that the puncture needle 22 can accurately puncture the predetermined position, and the puncture needle 22 Accuracy of puncture.
- the puncture needle 22 can be bent and deformed.
- the distal end 22a of the puncture needle 22 is provided with a bendable structure 211 .
- the bendable structure 211 can bend and deform the distal end 22 a of the puncture needle 22 , so as to adjust the orientation of the distal end surface of the puncture needle 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 tube 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 puncture needle 22 is bendable.
- the shape of the puncture needle 22 is adjusted by the bending assembly 30 .
- the puncture needle 22 may be prefabricated, that is, it is already bent before being inserted into the body.
- the puncture needle 22 has a hollow tubular shape.
- the end surface of the distal end 22a of the puncture needle 22 is concave toward the proximal end of the puncture needle 22 to form an inclined puncture surface.
- the puncturing device 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 in the distal end 210a of the outer tube 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 (ie, the second control member in the first embodiment and the manipulation member in the fifth embodiment) is used to control the adjustment of the distance of the outer tube 21 .
- the ends are bent.
- 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 rotates in the first rotation direction relative to the axial center axis of 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, and the bending member 33a rotates in the first rotation direction.
- a bending direction is bent toward the proximal end of the handle assembly, so that the distal end of the outer tube 210 and the distal end of the puncture needle 220 are bent toward the proximal end of the handle assembly in the first bending direction.
- the bending control member When the bending control member rotates in the second rotation direction (opposite to the first rotation direction) relative to the axial center axis of the handle assembly, the bending control member drives the adjustment member and the pulling member 31a to the direction away from the proximal end of the handle assembly By sliding, the bending member 33a gradually restores its original shape, so that the distal end of the outer tube 210 and the distal end of the puncture needle 220 are flush or nearly flush with the axial center axis of the handle assembly.
- 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 the proximal end of the outer tube 210 and the distal end 210 a of the outer tube 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 puncture needle 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 channel 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 210 along the outer tube 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 tube 210, and the pulling member 31a pulls the distal end 210a of the outer tube 210 to bend.
- the pulling member 31a is directly fixed on the distal end 210a of the outer tube 210, and is not connected with the bending member 33a.
- the pulling member 31a pulls the distal end 210a of the outer tube 210 to bend under the action of an external force, and the bending member 33a bends together with the outer tube 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 causes the outer tube 210 to have its 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 tube 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 tube 210 and prevents the bending member 33a from falling off from the outer tube 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 surface 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 isolation member 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 adjusting member 31a to slide toward the proximal end of the outer tube 210, the adjacent elastic portions 330a approach each other, and the opening 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 puncturing device 1b provided in this embodiment is basically the same as 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 decreases gradually 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 .
- the puncturing device 1c provided in this embodiment is basically the same as the second embodiment, wherein the components of the bending assembly, the second control member, the adjustment assembly, etc. are the same as those of the bending assembly, the second control member, the adjustment assembly, etc. in the second embodiment
- the components are basically the same; the process of adjusting the bending of the distal end of the puncture piece is also basically the same as that in the second embodiment, and will not be repeated here.
- the difference from the second embodiment is that the components such as the first control member, the first fixing member, and the second fixing member are described in detail below.
- the puncture device 1c includes a handle assembly 10c and a puncture assembly 20c accommodated in the handle assembly 10c and fixedly connected to the handle assembly 10c.
- Piercing assembly 20c includes piercing needle 22c.
- the handle assembly 10c also includes a first control 12c for controlling the puncture needle 22c. When the first control member 12c is rotated, the first control member 12c controls the puncture needle 22c to approach or move away from the handle assembly 10c.
- the first control member 12c controls the puncture needle 22c to be close to or away from the handle assembly 10c, so that the first control member 12c can control the puncture needle 22c to pass through the handle assembly 10c or extend into the handle assembly 10c, which is easy to operate, and is convenient to control the puncture needle 22c for puncture operation. It can be avoided that the puncture needle 22c continues to travel after successful puncturing due to inertia during the traditional puncture operation, thereby stabbing the human body.
- the first control member 12c is connected to the proximal end portion 221c of the puncture needle 22c. And the proximal end 221c of the puncture needle 22c is accommodated in the first control member 12c.
- the proximal end portion 221c accommodated in the first control member 12c is controlled to approach or move away from the handle assembly 10c, so that the piercing member 12c is close to or away from the handle assembly 10c.
- the first control member 12c is threadedly connected to the handle body 11c.
- the first control member 12c is sleeved on the handle body 11c.
- the proximal end 221c of the puncture needle 22c is accommodated in the handle body 11c, and the proximal end 221c is connected to the first control member 12c.
- a first screw portion 122c is formed on the inner surface of the first control member 12c.
- the inner surface of the first control member 12c is further provided with a first holding portion 121c.
- the first threaded portion 122c is provided on the distal end side of the first retaining portion 121c.
- the outer surface in the handle body 11c is provided with a second threaded portion 1114c.
- the second screw portion 1114c is provided on the distal end side of the first limiting hole 1111c.
- the handle body 11c includes a first handle member 111c.
- the second threaded portions 1114c are respectively disposed on the outer surface of the first handle member 111c, and can be threadedly connected with the first threaded portions 122c.
- the steps of operating the first control member 12c and the puncture needle 22c are as follows. First, the first control member 12c is pushed parallel to the axial direction and away from the proximal end of the handle body 11c, so that the first control member 12c drives the first fixing member 13c and the puncture needle 22c connected to the first fixing member 13c away from the proximal end of the handle body 11c. The proximal end of the handle body 11c slides, and the puncture needle 22c protrudes out of the outer tube 21c.
- the pushing force parallel to the axial direction toward the distal end of the handle body 11c cannot make the first control member 12c continue to slide.
- a rotational force is then applied to the first control member 12c to rotate the first control member 12c circumferentially around the handle body 11c, and the first threaded portion 122c in the first control member 12c cooperates with the second threaded portion 1114c.
- the first control member 12c While the first control member 12c is axially rotating around the handle body 11c, the first control member 12c continues to slide toward the distal end of the handle body 11c, and drives the first fixing member 13c and the puncture connected to the first fixing member 13c.
- the needle 22c slides smoothly away from the proximal end of the handle body 11c, and the puncture needle 22c punctures the fossa ovalis.
- the puncture needle 22c can be quickly extended out of the outer tube 21c. Then, by rotating the first control member 12c, the torque of rotating the first control member 12c is converted into the puncturing force of the puncture needle 22c, which is convenient for the puncture needle 22c to pierce the fossa ovalis, and the puncturing process of the puncture needle 22c is more stable and not easy to shift.
- the accuracy of puncturing by the puncture needle 22c is improved; after the puncture needle 22c is successfully punctured, it is not easy to continue to puncture forward under the action of inertia, so as to prevent the puncture needle 22c from puncturing the left atrium wall, and improve the safety of the puncture needle 22c for the puncture operation. degree.
- the handle body 11c is provided with a first limiting hole 1111c.
- the first limiting hole 1111c is used to limit the stroke of the first control member 12c in the axial direction.
- the axial distance between the first threaded portion 122c and the second threaded portion 1114c is smaller than the axial length of the first limiting hole 1111c, ensuring that the first control member 12c controls and drives the puncture needle 22c in the axial direction away from the handle body 11c
- the first threaded portion 111c can contact the second threaded portion 1114c, so that the first threaded portion 122c is connected to the second threaded portion 1114c.
- the first handle member 111c in this embodiment is basically the same as that in the second embodiment, and details are not repeated here. The difference is that in this embodiment, the first handle member 111c is provided with a limiting portion 110c.
- the limiting portion 110c protrudes from the surface of the first handle member 111c in a direction away from the axial direction. After the second control member 14c moves toward the proximal end of the handle body 11c in the axial direction by a predetermined distance, the proximal end of the second control member 14c abuts against the limiting portion 110c and cannot continue to move.
- the first handle member 111c includes two sub-first handle members (not shown), and the two sub-first handle members are bolted to facilitate assembly and disassembly of the first handle member 111c.
- the first threaded portion 122c may be provided on the proximal end side of the first retaining portion 121c.
- the first control member 12c rotates circumferentially around the handle body 11c to drive the first fixing member 13c and the puncture needle 22c connected to the first fixing member 13c to move axially.
- the first control member 12c continues to approach or move away from the handle assembly 10c in the axial direction, and drives the puncture needle 22c to approach or move away from the handle assembly 10c.
- the inner surface of the first control member 12c may only be provided with a first threaded portion 122c, and the first threaded portion 122c is threadedly connected to the outer wall of the handle body 11c.
- the first control member 12c rotates circumferentially around the handle body 11c to drive the first fixing member 13c and the puncture needle 22c connected to the first fixing member 13c to move in the axial direction.
- the inner surface of the first control member 12c may only be provided with a first holding portion 121c, and the first holding portion 121c is matched with the first fixing member 13c.
- the first control member 12c is close to or away from the handle assembly 10c, and drives the first clamping portion 121c, the first fixing member 13c, and the puncture needle 22c connected to the first fixing member 13c to approach or move away from the handle assembly 10c .
- the puncture needle 22c may be integrally formed with the first fixing member 13c, and the first control member 12c is connected to the puncturing needle 22c and the first fixing member 13c. Part of the puncture needle 22c penetrates through the handle body 11c and is clamped to the first clamping portion 121c. The first control member 12c can drive the puncture needle 22c to move in the axial direction.
- the piercing assembly 20c may include only the piercing needle 22c.
- the puncturing device 1c is delivered to a designated position of the human body through the delivery sheath.
- the puncture needle 22c of the first control member 12c moves relative to the handle assembly 11c to move out of the delivery sheath or into the delivery sheath of the delivery device.
- the first fixing member body 131 c of the first fixing member 13 c is provided with a first passage 100 , and the first passage 100 penetrates the distal end of the first fixing member body 131 c in the axial direction. end and the proximal end of the first fixing member body 131c.
- the second fixing member body 151c in the second fixing member 15c is provided with a second channel 200 .
- the second channel 200 penetrates through the distal end of the second fastener body 151c and the proximal end of the second fastener body 151c in the axial direction.
- the first channel 100 and the second channel 200 are disposed opposite to each other.
- the proximal end of the outer tube 21c is fixed to the distal end of the second fixing member body 151c , and the proximal end of the outer tube 21c extends into the second channel 200 and communicates with the second channel 200 .
- the piercing assembly 20c also includes a seal 18c.
- the seal 18c seals the proximal end of the second fastener body 151c. That is, the seal 18c seals the proximal side of the second channel 200 . Gas or liquid is prevented from flowing out of the second fastener body 151c from the opening at the proximal end of the second fastener body 151c.
- Piercing assembly 20c also includes connector 101c.
- the connector 101c has a hollow tubular structure.
- the proximal end of the connecting member 101c extends into the first channel 100 and is fixed to the distal end of the first fixing member body 131c.
- the proximal end of the connecting piece 101c can be fixed to the distal end of the first fixing piece body 131c by means of bonding, and the bonded material fills the gap between the outer wall of the connecting piece 101c and the inner wall of the first channel 100 to prevent gas or liquid
- the first fixing member body 131c can flow out from between the outer wall of the connecting member 101c and the inner wall of the first channel 100 .
- the distal end of the connecting piece 101c passes through the sealing piece 18c and then extends into the second passage 200 and communicates with the second passage 200 .
- the connector 101c connects the first channel 100 with the second channel 200 .
- the connecting member 101c is slidably connected in the second channel 200 .
- the distal end of the connecting piece 101c can slide along with the sliding of the first fixing piece 13c. During the sliding process of the connecting piece 101c in the second channel 200, it will not be separated from the second channel 200, which ensures that the first channel 100, the connecting piece 101c and the second channel 200 remain connected.
- the puncture needle 22c passes through the first channel 100 and the second channel 200 .
- the proximal end of the puncture needle 22c extends into the first channel 100 and is fixed in the proximal end of the first fixing member body 131c.
- the puncture needle 22c passes through the lumen of the connector 101c, extends in the second channel 200 and protrudes into the lumen of the outer tube 21c.
- the proximal end of the first fixing member body 131 c includes a first inlet 1313 and a second inlet 1314 spaced from the first inlet 1313 .
- the second inlet 1314 communicates with the lumen of the puncture needle 22c.
- the first inlet 1313 communicates with the first channel 100 .
- the first liquid medium flows in from the first inlet 1313, flows through the first channel 100, the connector 101c, and the second channel 200, and then enters the outer tube 21c, and then enters the outer tube 21c from the far side of the outer tube 21c.
- the end is discharged from the puncture device 1c, and this part of the first liquid medium discharges the gas in the outer tube 21c.
- the second liquid medium flows in from the second inlet 1314, flows through the puncture needle 22c, and is discharged to the outside of the puncture device 1c through the distal end of the puncture needle 22c to discharge the gas in the puncture needle 22c.
- This embodiment can effectively discharge the gas of the puncture needle 22c, the gas of the outer tube 21c, the gas of the first fixing member 13c, and the gas of the second fixing member 15c out of the puncture device 1c in the puncture device 1c, so as to avoid the occurrence of the gas during the operation.
- Air embolism is During the contrast process, the contrast medium flows in from the second inlet 1314 and is discharged out of the puncture device 1c through the distal end of the puncture needle 22 .
- the contrast agent is discharged from the distal end of the puncture needle 22, which facilitates the acquisition of the position of the distal end of the puncture needle 22, facilitates the doctor to perform the puncture operation, and improves the accuracy of the operation.
- the proximal end of the first fastener body 131c may include only the first inlet 1313 .
- the first inlet 1313 communicates with the lumen of the puncture needle 22c, and the first inlet 1313 communicates with the first channel 100 .
- the first liquid medium flows in from the first inlet 1313, a part of the first liquid medium enters the lumen of the puncture needle 22c, this part of the first liquid medium flows through the puncture needle 22c, and is discharged to the outside of the puncture device 1c through the distal end of the puncture needle 22c, The gas in the puncture needle 22c is discharged; another part of the first liquid medium enters the first channel 100, and this part of the first liquid medium flows through the connector 101c, the second channel 200 and the outer tube 21c and then is discharged to the puncture device 1c In addition, this part of the first liquid medium discharges the gas in the outer tube 21c. Only by injecting the first liquid medium into the puncture device 1c, the gas in the puncture needle 22c and the gas in the outer tube 21c can be exhausted at the same time, thereby improving the exhaust efficiency of the puncture device 1c.
- the handle assembly 1 c further includes a false-touch prevention member 40 c.
- the false-touch prevention member 40c includes a false-touch prevention body 41c, and a grip portion 42c connected to the false-touch prevention body 41c.
- the accidental contact prevention body 41c includes a sleeve shape having an opening.
- the accident prevention body 41c is integrally formed with the grip portion 42c, and the grip portion 42c extends in a direction away from the opening of the accident prevention body 41c.
- the anti-mistouch body 41c and the holding portion 42c may be different components, and then fixedly connected together by other components.
- the false-touch prevention member 40c is detachably connected to the handle assembly 10c.
- the anti-misoperation member 40c is used to prevent the second control member 14c from moving relative to the distal end of the handle body 11c when the second control member 14c is mis-operated. Misoperation refers to touching or operating the second control member 14c without adjusting the outer tube 21c by operating the second control member 14c; or adjusting the puncture needle without operating the first control member 12c In the case of 22c, touch or manipulate the first control member 12c.
- the proximal end of the accident prevention body 41c faces the distal end surface of the second control member 14c.
- the second control member 14c cannot axially slide relative to the handle body 11c along the proximal end away from the handle body 11c, thereby preventing During the puncturing process of the puncture needle 22c, the second control member 14c is accidentally touched and the outer tube 21c is allowed to cover the puncture needle 22c again in advance.
- the second control member 14c can slide away from the proximal end of the handle body 11c in the axial direction without the limiting effect of the false-touch prevention member 40c in the axial direction. , so that the outer tube 21c also slides away from the proximal end of the handle body 11c, and the outer tube 21c can cover the puncture needle 22c again.
- the handle assembly 1c may not include the anti-misoperation member 40c, as long as the second control member 14 is touched by mistake, the second control member 14 is resisted by other components and is not easy to slide. purpose of misuse.
- the puncture device 1d provided in this embodiment is basically the same as the fourth embodiment.
- the second control member 14d in the puncture device 1d can control the bending deformation of the distal end of the outer tube 21d, and the second control member 14d also The outer tube 21d can be controlled to move in the axial direction relative to the handle body 11d.
- the components of the first control member 12d, the second control member 14d, the outer tube 21d, etc. are basically the same as those of the first control member 12c, the second control member 14c, the outer tube 21c, etc. in the fourth embodiment, It will not be repeated here.
- the manipulation member and the second control member 14d refer to the same component.
- the main difference from the fourth embodiment is that the false-touch prevention part 40d is different from the false-touch prevention part 40c, and the following is a detailed description.
- the false-touch prevention member 40d includes a support block 41d, a blocking portion 42d, and an elastic portion 43d connected between the support block 41d and the blocking portion 42d.
- the second control member 14d is provided with a receiving portion 140 .
- the accommodating portion 140 is an elastic portion accommodating hole 140 penetrating through the inner and outer surfaces of the second control member 14d.
- the support block 41d is fixed to the side wall of the elastic portion receiving hole 140 close to the outer surface of the second control member 14d.
- the elastic portion 43d is accommodated in the elastic portion accommodating hole 140 .
- the blocking portion 42d is at least partially received in the elastic portion receiving hole 140, and the blocking portion 42d is closer to the handle body 11d than the elastic portion 43d.
- the inner diameter of the portion of the elastic portion receiving hole 140 close to the inner surface is smaller than the outer diameter of the elastic portion 43d, so that the blocking portion 42d can only be partially exposed from the elastic portion receiving hole 140 and will not be separated from the elastic portion receiving hole 140 .
- a portion of the outer surface of the handle body 11d is provided with an annular blocking portion receiving groove 110d, and the annular blocking portion receiving groove 110d surrounds the axial center axis of the handle body 11f.
- the blocking portion receiving groove 110d can receive a part of the blocking portion 42d.
- the elastic portion 43d is supported by the support block 41d, and acts its own elastic force on the blocking portion 42d, so that the blocking portion 42d abuts against the groove wall of the blocking portion receiving groove 110d.
- the blocking portion accommodating groove 110d cooperates with the blocking portion 42d to limit the axial movement of the second control member 14d.
- the blocking portion 42d will block the second control member 14d from moving relative to the handle body 11d in the axial direction, so that the external The tube 21d cannot move relative to the handle body 11d.
- the force of pushing the second control member 14d makes the blocking portion 42d retract into the elastic portion receiving hole 140, the blocking portion 42d is separated from the blocking portion receiving groove 110d, the blocking portion 42d cannot cooperate with the blocking portion receiving groove 110d, and the second control cannot be restricted.
- the member 14d moves in the axial direction.
- the blocking portion 42d moves in a direction away from the support block 41d under the elastic force of the elastic portion 43d to abut against the groove wall of the blocking portion receiving groove 110d.
- the elastic portion 43d exerts the pulling force of the blocking portion 42, and the gravity of the blocking portion 42d is greater than the pulling force of the elastic portion 43d, so as to press against the groove wall of the blocking portion receiving groove 110d.
- the cooperation between the false-touch prevention member 40d and the handle body 11d has the following beneficial effects.
- the first control member 12d controls the puncture needle 22d to move out of the outer tube 21d
- it can avoid accidentally touching the second control member 14d and let the outer tube 21d cover the puncture needle 22d in advance, affecting the puncture of the puncture needle 22d.
- the process of adjusting and deforming the distal end of the outer tube 21d by rotating the second control member 14d it is possible to avoid accidentally touching the second control member 14d and driving the outer tube 21d to move in a direction away from the proximal end of the handle body 11d.
- the outer tube 21d is moved in advance in a direction away from the proximal end of the handle body 11d, and the distance between the distal end face of the outer tube 21d and the distal end face of the puncture needle 22d increases, preventing the first control member 12d from controlling the puncture needle 22d to move away from the handle body If the proximal direction cannot protrude from the outer tube 21d, or the length of the protruding outer tube 21d is too short, the puncturing of the puncture needle 22d is affected.
- the second control member 14d can control the movement of the outer tube 21d in the axial direction, and can also control the deformation of the distal end of the outer tube 21d. In other embodiments, the second control member 14d may only control the axial movement of the outer tube 21d, or may only control the distal deformation of the outer tube 21d.
- the elastic portion receiving hole 140 of the second control member 14d is provided at the distal end thereof.
- the elastic portion accommodating hole 140 may also be disposed at other positions, such as the proximal portion, etc., as long as the elastic portion accommodating hole 140 can accommodate part of the false-touch prevention member 40d.
- the handle assembly 10d further includes a false-touch prevention member 50d, and the structure of the false-touch prevention member 50d is basically the same as that of the false-touch prevention member 40d.
- the erroneous collision prevention member 50d is accommodated in the first control member 12d.
- the anti-collision member 50d cooperates with the handle body 11d to block the axial movement of the first control member 12d, and is used to prevent the puncture needle 22d from moving relative to the handle body 11d when the first control member 12 is accidentally touched.
- the specific beneficial effects are as follows.
- the anti-collision member 50d restricts the first The axial movement of the control member 12 avoids accidental contact with the first control member 12, allowing the puncture needle 22d to extend out of the outer tube 21d in advance to stab the patient.
- the false-touch prevention part 50d may be omitted, and only the false-touch prevention part 40d is provided.
- the blocking effect of the false-touch prevention part 40d in the second control part 14d is greater than the blocking effect of the false-touch prevention part 50d in the first control part 12d (for example, the elastic part 43d in the false-touch prevention part 40d makes The elastic force of the blocking portion 42d against the blocking portion accommodating groove 110d is greater than the elastic force of the elastic portion in the anti-miscollision member 50d to make the blocking portion abut against the blocking portion accommodating groove 110d), which can further reduce the accidental contact with the first
- the needle 22d moves.
- the second control member 14d is provided with a plurality of elastic portion receiving holes 140 arranged at intervals.
- the number of the false-touch prevention members 40d is the same as the number of the elastic portion accommodating holes 140 , and is respectively accommodated in each elastic portion accommodating hole 140 .
- the plurality of anti-missing elements 40d can increase the anti-missing effect of the second control element 40d.
- a pair of opposite false-touch prevention parts 40d are symmetrical with respect to the central axis of the puncturing device 1d. This arrangement can make the distribution of the restraining effect of the plurality of anti-missing elements 40d on the second control element 14d symmetrical and uniform.
- the accommodating portion 140 may be a part of the inner surface of the second control member 14d concave outward to form an elastic portion accommodating groove 140 .
- the number of the elastic portion accommodating grooves 140 is one or more, and the number is the same as the number of the false-touch prevention members 40d.
- the elastic portion 43 d is accommodated in the elastic portion accommodating groove 140 , and part of the blocking portion 42 d is accommodated in the elastic portion accommodating groove 140 .
- the elastic portion 43d is connected between the bottom wall of the elastic portion receiving groove 140 and the blocking portion 42d.
- the receiving portion 140 may form an annular groove 140 for a part of the inner surface of the second control member 14d to be concave outward.
- the annular groove 140 is concavely formed in a part of the inner surface of the second control member 14d.
- One or more false-touch prevention members 40d are arranged on the annular groove 140 at intervals.
- the support block 41 d is fixed on the groove wall of the annular groove 140
- the elastic portion 43 d is accommodated in the annular groove 140
- a part of the blocking portion 42 d is accommodated in the annular groove 140 .
- the elastic portion 43d is connected between the bottom wall of the annular groove 140 and the blocking portion 42d.
- the false-contact preventing member 40d may only include the elastic portion 43d and the blocking portion 42d, so that the false-contact preventing member 40d can achieve the limiting effect.
- the handle body 11d may not include the blocking portion receiving groove 110d.
- the blocking portion 42d presses against the outer wall of the handle body under the action of the elastic portion 43d, and the frictional force between the blocking portion 42d and the handle body restricts the movement of the second control member 14d.
- the false-touch prevention member 40d has a hollow tubular shape.
- the false-contact preventing member 40d has elasticity.
- the material of the false-touch prevention member 40d may be silica gel.
- a portion of the inner surface of the second control member 14d is concave outward to form an annular accommodating groove 141 .
- the false-contact preventing member 40 d is fixed to the accommodating groove 141 .
- Part of the false-touch prevention member 40d is exposed outside the accommodating groove 141 and abuts against the outer wall of the handle body 11d.
- the outer tube 21d may be integrally formed with the second fixing member 15d and the second control member 14d to form an outer tube (not shown).
- the false-contact prevention member 40d is connected to the second control member 14d. The false-touch prevention member 40d restricts the movement of the integral outer tube.
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Abstract
一种穿刺装置(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)包括穿刺件(24),手柄组件(10)还包括用于控制穿刺件(24)的第一控制件(12),当第一控制件(12)转动时,第一控制件(12)控制穿刺件(24)靠近或者远离手柄组件(10)。第一控制件(12)控制穿刺件(24)靠近或者远离手柄组件(10),便于第一控制件(12)控制穿刺件(24)穿出手柄组件(10),易于操作,便于控制穿刺件(24)进行穿刺手术,能够避免传统穿刺手术过程中,穿刺件(24)因为惯性在穿刺成功后继续行进而刺伤人体。
Description
本发明涉及医疗器械领域,特别是涉及一种穿刺装置。
传统的穿刺针由一根不锈钢管制成。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。
发明内容
基于此,有必要提供穿刺装置,避免穿刺手术中,穿刺件容易在刺穿房间隔后继续行进。
所述穿刺装置包括手柄组件和收容于所述手柄组件内且与所述手柄组件固定相连的穿刺组件,所述穿刺组件包括穿刺件,所述手柄组件还包括用于控制所述穿刺件的第一控制件,当第一控制件转动时,所述第一控制件控制所述穿刺件靠近或者远离所述手柄组件。
第一控制件控制穿刺件靠近或者远离手柄组件,便于第一控制件控制穿刺件穿出手柄组件,易于操作,便于控制穿刺件进行穿刺手术。能够避免传统穿刺手术过程中,穿刺件因为惯性在穿刺成功后继续行进而刺伤人体。
图1为本申请第一实施例提供的穿刺装置的结构示意图。
图2为本申请第一实施例提供的穿刺装置的***图。
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。
图4a为本申请第一实施例中手柄本体的俯视结构示意图。
图4b为第一手柄件、第一控制件、第二控制件的示意图。
图4c为第二手柄件、第一控制件、第二控制件的示意图。
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。
图6a为第一固定件、第二固定件、外管、穿刺件的连接示意图。
图6b为第一固定件的结构示意图。
图7为部分第二控制件的结构示意图。
图8a为第二固定件的结构示意图。
图8b为第二固定件的俯视结构示意图。
图8c为密封件的结构示意图。
图9为本申请第一实施例中穿刺组件弯曲变形的示意图。
图10为本申请第一实施例中穿刺件的结构示意图。
图11a为本申请第二实施例中支撑部及主体部的示意图。
图11b为本申请第二实施例中穿刺组件远端的示意图。
图11c为图11b中X处的放大结构示意图。
图12为本申请第二实施例中调弯件的示意图。
图13为本申请第三实施例中调弯件的示意图。
图14为本申请第四实施例提供的穿刺装置的结构示意图。
图15为图14的剖视图结构示意图。
图16为图15中图X的放大结构示意图。
图17为图14中另一角度的剖视图结构示意图。
图18为本申请第四实施例中的***示意图。
图19为本申请第四实施例中的第一控制件的结构示意图。
图20为本申请第四实施例中防误触件的结构示意图。
图21为本申请第五实施例中防误触件的剖视结构示意图。
图22为图21中XX处的放大示意图。
图23为另一实施例中XX处的放大示意图。
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。
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。
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。
请参阅图1至图5,本申请第一实施提供的穿刺装置1,穿刺装置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,以穿刺装置1穿刺卵圆窝为例进行说明。
请参阅图1至图3,穿刺装置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23和穿刺件24。外管23包括外管21。穿刺件24包括穿刺针22。外管21与手柄组件10连接。外管21呈中空管状。在本实施例中,穿刺针22与外管21插接。至少部分穿刺针22收容在外管21内。在本实施例中,穿刺针22在外管21内的延伸方向,与外管21的延伸方向相同。穿刺针22的远端22a靠近外管21的远端21a。穿刺针22的近端22b穿出外管21的近端21b。
在本实施例中,至少部分穿刺针22收容在外管21内,且穿刺针22的远端22a靠近外管的远端21a。穿刺针22随着外管21一同移至人体内部。在穿刺手术过程中,穿刺针22无需先从外管21的近端21b插接,再滑至外管21的远端21a,避免在穿刺针22在外管21内滑动过程中损伤外管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。
在本实施例中,穿刺针22的远端22a靠近外管21的远端21a指的是,穿刺 针22的远端22a靠近外管21远端21a的端面,且穿刺针22的远端22a的端面与外管21远端21a的端面并未平齐,即穿刺针22收容在外管21内或者部分穿刺针22裸露在外管21外。
在本实施例中,在外管21滑至人体指定区域的过程中,穿刺针22的远端22a一直收容在外管21内,而不会显露出外管21。例如,外管21在滑至心脏卵圆窝附近的过程中,外管21遇到人体弯曲的血管通道会发生弯曲变形,而穿刺针22并没有显露出外管21,避免穿刺针22刺伤人体。
在本实施例中,穿刺针22贯穿外管21内,穿刺针22的近端22b也靠近外管21的近端21b。具体地,穿刺针22的近端22b伸出外管21的近端21b。
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收容穿刺针22的近端、及外管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。
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。
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。
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。
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中的穿刺针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,部分穿刺针22的远端22a显露在外管21的远端21a外。收容状态指的是,穿刺针22的远端22a收容在外管21的远端21a内。
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与穿刺针22的近端连接。第一控制件12用于控制穿刺针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)可控制穿刺针22在轴向滑动,使穿刺针22的远端22a伸出外管21外。请参阅图3,或者控制穿刺针22的远端22a伸入外管21内。
可以理解地,第一控制件12在接收外界的作用力后,将作用力传至穿刺针22,使穿刺针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与穿刺针22相连,第一控制件12带着穿刺针22滑动,使穿刺针22穿出外管21进行穿刺手术。可以理解地,本实施例中,第一控制件12与穿刺针22的近端间接连接。在其他实施例中,第一控制件12可与穿刺针22直接连接。
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。
请参阅图2,在本实施例中,穿刺件24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连接穿刺针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。穿刺针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及穿刺针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带动穿刺针22在轴向相对手柄本体11滑动。
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。
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。
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控制穿刺针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。
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。
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及穿刺针22在轴向的行程。穿刺针22在轴向的滑动过程具体如下。
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、穿刺针22朝远离手柄本体11近端11b的方向滑动,穿刺针22逐渐伸出外管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。穿刺针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。
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、穿刺针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。穿刺针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。
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。
第一限位部1111a和第二限位部1111b之间在轴向的距离D1,对应穿刺针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,与整体穿刺针22也在滑动的行程相同。由于穿刺针22在人体内发生弯曲,穿刺针22远端的行程小于或者等于整体穿刺针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。
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。本申请中的穿刺针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,避免穿刺针22继续刺伤左心房壁,提高了利用穿刺针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传递至穿刺针22,使得穿刺针22的受到的作用力更加均匀,穿刺针22可平稳地在轴向滑动,提高穿刺针22穿刺的稳定程度。
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。
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,穿刺针22的近端(图未示)固定在第一连接件通道1311内,且穿刺针22的内腔与第一连接件通道1311相连通。
穿刺装置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 及穿刺针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及穿刺针22输送至体内。在本实施例中,穿刺针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。
在其他实施例中,部分穿刺针22收容并固定在第一固定件131内,穿出第一固定件本体131的部分穿刺针22与第一连接件16连通。即穿刺针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可直接输入穿刺针22内,提高第一液体介质输入到穿刺针22的效率。
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。
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。再经穿刺针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。
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21连接。
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21可相对手柄组件10滑动。即,外管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21的远端21a也可朝着靠近手柄本体11的方向滑动,使穿刺针22从收容状态转换为伸出状态。
具体地,请参阅图2,外管23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更靠近穿刺装置1的近端。第一固定件13与穿刺针22的近端22b固定连接,便于通过第一固定件13来控制穿刺针22的远端22a伸出外管21的远端21a,或者伸入外管21的远端21a内。
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21连接。第二控制件14用于控制外管21在轴向上相对穿刺针22滑动。
在本实施例中,外管21可相对手柄本体11滑动,便于精准地调整外管21在人体内的位置。第二控制件14控制外管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针22,将穿刺针22收容在外管21中空的管体内,从而降低穿刺针22刺伤人体内壁的风险,提高手术的安全程度。
在本实施例中,第一控制件12相较第二控制件14更靠近穿刺装置1的近端。第一控制件12控制穿刺针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朝远离穿刺装置1近端的方向滑动,来控制外管21重新覆盖穿刺针22。由于第一控制件12相较第二控制件14更靠近穿刺装置1的近端,即,第二控制件14相较第一控制件12更加远离穿刺装置1的近端,控制第二控制件14朝远离穿刺装置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而改变穿刺针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。
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。
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。
在本实施例中,第二控制件14与外管21的近端连接,且第二控制件14与外管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21的近端直接连接。
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21的近端连接。至少部分外管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。
请参阅图2,第二固定件15包括第二固定件本体151。外管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。
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。
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。
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21朝远离手柄本体11近端11b滑动。外管21逐渐覆盖穿刺针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及穿刺针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,穿刺针22从伸出状态转换为收容状态。
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21朝靠近手柄本体11近端11b滑动,从而使得穿刺针22的远端22a逐渐显露在外管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及穿刺针22无法沿靠近手柄组件10近端的方向滑动。这个过程,穿刺针22从收容状态转换为伸出状态。
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。
在本实施例中,外管21可移动的轴向行程大于或者等于穿刺针22可移动的轴向行程。如此,待穿刺针22穿刺房间隔后,外管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针22,从而降低穿刺针22刺伤人体内壁的风险,提高手术的安全程度。
外管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。穿刺针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21可移动的轴向行程大于穿刺针22可移动的轴向行程,使得外管21在穿刺针22伸出外管21后,可重新覆盖穿刺针22。外管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。穿刺针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。
在本实施例中,外管21朝远离手柄本体11近端11b的方向滑动的过程中,穿刺针22相对手柄本体11近端11b保持静止,以保证穿刺针22在人体内的位置保持不变,避免穿刺针22移动而容易刺伤左心房壁。
请参阅图2、图6a、图8a及图8b,第二固定件15设有与外管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。穿刺针22经穿刺件通道1511及连通腔1512穿设于外管21。具体地,第二固定件本体151包括穿刺件通道1511。外管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。穿刺针22穿过穿刺件通道1511,并插接在外管21内。
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。
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。
一方面,在穿刺装置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及穿刺针22,将第一连接件16、第一连接件通道1311及穿刺针22内的气体排出穿刺装置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21,将第二连接件17、第二连接件通道1513、连通腔1512及外管21内的气体排出穿刺装置1外。本实施例可有效地将穿刺装置1中的气体排出穿刺装置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及穿刺针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21,都无法完全将穿刺装置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及穿刺针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21的排气是相互独立的。
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针22的远端22a流出,可准确地确定穿刺针22远端22a的位置,便于医生控制穿刺针22穿刺房间隔,提高穿刺手术的精确程度。
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。
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。
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。穿刺针22穿过开口181与穿刺件通道1511相连。开口181的内壁与穿刺针22过盈配合,避免液体从穿刺针22与开口181之间的空隙流过。
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。
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21可弯曲变形。请参阅图2和图3,穿刺装置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21通过调弯组件30调整形态。在其他实施例中,外管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。
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21的外壁,调节件31可在外管21的外壁上滑动。调弯件33设置在外管21的远端内,并固定在外管21的远端内。调弯件33在径向向内的投影落入到穿刺针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。
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。
第二控制件14调整调节件31的位置来使外管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21的外壁上滑动。当第二控制件14带动调节件31朝外管21的近端滑动,调节件31拉着牵引件32、及调弯件33朝外管21近端靠近,使得外管21的远端朝靠近外管21近端的方向弯曲。外管21朝靠近外管21近端的方向弯曲,也会使得穿刺针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。
在本实施例中,外管21可弯曲变形,便于调整外管21在人体的形态,以便使外管21的远端朝向预定的位置,使穿刺针22准确地穿刺预定的位置,提高穿刺针22穿刺的精确程度。
在本实施例中,穿刺针22可弯曲变形。具体地,穿刺针22的远端22a设有可弯曲结构211。请参阅图10,可弯曲结构211可使穿刺针22的远端22a弯曲变形,便于调节穿刺针22的远端端面的朝向。可弯曲结构211与外管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,以穿刺针22的远端可弯曲的为准。在本实施例中,穿刺针22通过调弯组件30调整形态。在其他实施例中,穿刺针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。
在本实施例中,穿刺针22呈中空管状。穿刺针22远端22a的端面,向穿刺针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。
第二实施例
请参阅图11a、图11b、图11c和图12,本实施例提供的穿刺装置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。
所述手柄组件包括调弯控制件(图未示),调弯控制件(即第一实施例中的 第二控制件、第五实施例中的操控件)用于控制调整外管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。具体地,当调弯控制件相对手柄组件的轴向中心轴,以第一转动方向转动时,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以第一弯曲方向朝靠近手柄组件近端弯曲,使得外管210的远端、穿刺针220的远端以第一弯曲方向朝靠近手柄组件近端弯曲。当调弯控制件相对手柄组件的轴向中心轴,以第二转动方向(与第一转动方向相反)转动时,调弯控制件带动调节件及牵引件31a朝远离手柄组件的近端的方向滑动,调弯件33a逐渐恢复原本的形状,使得外管210的远端、穿刺针220的远端与手柄组件的轴向中心轴平齐或者接***齐。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。
在本实施例中,外管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。
外管210设有第一通孔211。第一通孔211贯穿外管210的近端和外管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用于收容穿刺针220。
外管210还设置有外管通道212,外管通道212与第一通孔211间隔设置。外管通道212贯穿主体部2101。外管通道212设置在外管210内,外管通道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210的侧壁沿着外管通道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210的远端210a,牵引件31a拉动外管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210的远端210a弯曲,调弯件33a随着外管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210原来的形状。
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。
在本实施例中,外管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210撤出人体。
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210内,防止调弯件33a从外管210内脱落。
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。
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。
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。
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。
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。
进一步地,当第二控制件带动调节件31a朝外管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。
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。
第三实施例
请参阅图13,本实施例提供的穿刺装置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。
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。
第四实施例
本实施例提供的穿刺装置1c与第二实施例基本相同,其中,调弯组件、第二控制件、调整组件等的部件与第二实施例中调弯组件、第二控制件、调整组件等的部件基本相同;调整穿刺件远端弯曲的过程也与第二实施例中的基本相 同,此处不再赘述。在本实施例中,与第二实施例不同的是,第一控制件、第一固定件、第二固定件等部件,以下为详细说明。
请参阅图14至图19,穿刺装置1c包括手柄组件10c和收容于手柄组件10c内且与手柄组件10c固定相连的穿刺组件20c。穿刺组件20c包括穿刺针22c。手柄组件10c还包括用于控制穿刺针22c的第一控制件12c。当第一控制件12c转动时,第一控制件12c控制穿刺针22c靠近或者远离手柄组件10c。第一控制件12c控制穿刺针22c靠近或者远离手柄组件10c,便于第一控制件12c控制穿刺针22c穿出手柄组件10c或者伸入手柄组件10c,易于操作,便于控制穿刺针22c进行穿刺手术。能够避免传统穿刺手术过程中,穿刺针22c因为惯性在穿刺成功后继续行进而刺伤人体。
参阅图14至图17,第一控制件12c与穿刺针22c的近端部221c连接。且穿刺针22c的近端部221c收容在第一控制件12c内。第一控制件12c转动时,控制收容在第一控制件12c内的近端部221c靠近或者远离手柄组件10c,使穿刺件12c靠近或者远离手柄组件10c。
第一控制件12c与手柄本体11c可螺纹连接。第一控制件12c套设在手柄本体11c上。穿刺针22c的近端部221c收容在手柄本体11c内,且近端部221c与第一控制件12c连接。第一控制件12c的内表面形成有第一螺纹部122c。在图19中,第一控制件12c内表面还设有第一卡持部121c。第一螺纹部122c设置在第一卡持部121c远端侧。手柄本体11c中的外表面设置有第二螺纹部1114c。第二螺纹部1114c设置在第一限位孔1111c的远端侧。在本实施例中,手柄本体11c包括第一手柄件111c。第二螺纹部1114c分别设置在第一手柄件111c的外表面上,可与第一螺纹部122c螺纹连接。
在本实施例中,操作第一控制件12c和穿刺针22c的步骤如下。首先,第一控制件12c受到平行于轴向、背离手柄本体11c近端的推动力,使第一控制件12c带动第一固定件13c、及连接在第一固定件13c上的穿刺针22c背离手柄本体11c的近端滑动,穿刺针22c伸出外管21c。在第一控制件12c中的第一螺纹部122c抵持到第二螺纹部1114c后,平行于轴向、朝向手柄本体11c远端的推动力无法使第一控制件12c继续滑动。再向第一控制件12c施加转动的力,使第 一控制件12c绕着手柄本体11c周向转动,第一控制件12c中的第一螺纹部122c与第二螺纹部1114c配合。第一控制件12c在绕着手柄本体11c轴向转动的同时,第一控制件12c继续朝向手柄本体11c远端滑动,并带动第一固定件13c、及连接在第一固定件13c上的穿刺针22c平稳地背离手柄本体11c的近端滑动,穿刺针22c穿刺卵圆窝。
结合图14至图17,在穿刺手术的过程中,通过推动第一控制件12c,可快速使穿刺针22c伸出外管21c。再通过转动第一控制件12c,将转动第一控制件12c的扭矩转化为穿刺针22c的穿刺作用力,便于穿刺针22c刺穿卵圆窝,穿刺针22c穿刺过程更加平稳,不易于移位而偏离目标位置,提高穿刺针22c穿刺的准确性;穿刺针22c穿刺成功之后不易于在惯性作用下继续往前穿刺,避免穿刺针22c刺伤左心房壁,提高穿刺针22c进行穿刺手术的安全程度。
请参阅图17和图18,手柄本体11c上设有第一限位孔1111c。第一限位孔1111c用于限制第一控制件12c在轴向的行程。第一螺纹部122c与第二螺纹部1114c之间的轴向距离,小于第一限位孔1111c在轴向的长度,保证第一控制件12c控制带动穿刺针22c在轴向朝背离手柄本体11c近端滑动预设距离后,第一螺纹部111c能够接触第二螺纹部1114c,使第一螺纹部122c与第二螺纹部1114c相连。
本实施例中的第一手柄件111c与第二实施例中的基本相同,此处不再赘述。不同的是,在本实施例中,第一手柄件111c设有限位部110c。限位部110c朝背离轴向方向突出于第一手柄件111c的表面。第二控制件14c在轴向方向朝手柄本体11c的近端,移动预设距离后,第二控制件14c的近端会抵持限位部110c而无法继续移动。
在本实施例中,第一手柄件111c包括两个子第一手柄件(图未示),两个子第一手柄件之间螺栓连接,便于组装和拆卸第一手柄件111c。
在其他实施例中,第一螺纹部122c可以设置在第一卡持部121c的近端侧。第一控制件12c绕着手柄本体11c周向转动,带动第一固定件13c、及连接在第一固定件13c上的穿刺针22c在轴向移动后。第一控制件12c在轴向方向,继续靠近或者远离手柄组件10c,带动穿刺针22c靠近或者远离手柄组件10c。
在其他实施例中,第一控制件12c内表面可以仅设有第一螺纹部122c,第一螺纹部122c与手柄本体11c的外壁螺纹连接。第一控制件12c绕着手柄本体11c周向转动,带动第一固定件13c、及连接在第一固定件13c上的穿刺针22c在轴向移动。
在其他实施例中,第一控制件12c内表面可以仅设有第一卡持部121c,第一卡持部121c与第一固定件13c配合。第一控制件12c在轴向方向,靠近或者远离手柄组件10c,带动第一卡持部121c、第一固定件13c、及连接在第一固定件13c上的穿刺针22c靠近或者远离手柄组件10c。
在其他实施例中,穿刺针22c可以与第一固定件13c一体成型,第一控制件12c与穿刺针22c及第一固定件13c连接。部分穿刺针22c贯穿手柄本体11c且卡接于第一卡持部121c。第一控制件12c可带动穿刺针22c在轴向移动。
在其他实施例中,穿刺组件20c可以只包括穿刺针22c。穿刺装置1c经过输送鞘输送到人体指定位置。第一控制件12c穿刺针22c相对手柄组件11c移动,移出输送鞘或者移入输送装置的输送鞘。
请查阅图15、图16和图17,第一固定件13c中的第一固定件本体131c设有贯穿第一通道100,第一通道100在轴向方向上贯穿第一固定件本体131c的远端及第一固定件本体131c的近端。
第二固定件15c中的第二固定件本体151c设有第二通道200。第二通道200在轴向方向上贯穿第二固定件本体151c的远端及第二固定件本体151c的近端。在本实施例中,第一通道100与第二通道200相对设置。外管21c的近端固定于第二固定件本体151c的远端,外管21c的近端伸入第二通道200,与第二通道200连通。
在本实施例中,穿刺组件20c还包括密封件18c。密封件18c密封第二固定件本体151c的近端。即,密封件18c密封第二通道200的近端侧。防止气体或者液体从第二固定件本体151c的近端的开口流出到第二固定件本体151c外。
穿刺组件20c还包括连接件101c。连接件101c呈中空的管状结构。连接件101c的近端伸入第一通道100内,并固定于第一固定件本体131c的远端。连接件101c的近端可通过粘接的方式固定于第一固定件本体131c的远端,粘接的材 料填充连接件101c的外壁和第一通道100的内壁之间的间隙,防止气体或者液体可从连接件101c的外壁和第一通道100的内壁之间流出第一固定件本体131c外。
连接件101c的远端穿过密封件18c后伸入第二通道200,与第二通道200连通。连接件101c将第一通道100与第二通道200相连通。连接件101c滑动连接于第二通道200内。连接件101c的远端可随着第一固定件13c的滑动而滑动。连接件101c在第二通道200内滑动的过程,不会脱离于第二通道200,保证了第一通道100、连接件101c及第二通道200保持连通。
穿刺针22c穿过第一通道100和第二通道200。穿刺针22c的近端伸入到第一通道100,并固定于第一固定件本体131c的近端内。穿刺针22c穿过连接件101c的内腔,在第二通道200延伸并伸入到外管21c的内腔。
请查阅图15至图17,在本实施例中,第一固定件本体131c的近端包括第一入口1313和与第一入口1313间隔设置的第二入口1314。第二入口1314与穿刺针22c的内腔连通。第一入口1313与第一通道100连通。
在穿刺装置1c排气的过程中,第一液体介质从第一入口1313流入,流经第一通道100、连接件101c、第二通道200后,进入外管21c,再从外管21c的远端排出穿刺装置1c外,这部分第一液体介质将外管21c内的气体排出去。
第二液体介质从第二入口1314流入,第二液体介质流经穿刺针22c,并经穿刺针22c的远端排出到穿刺装置1c外,将穿刺针22c内的气体排出去。本实施例可有效地将穿刺装置1c中穿刺针22c的气体、外管21c的气体、第一固定件13c的气体、第二固定件15c的气体排出穿刺装置1c外,避免在手术过程中出现气栓。在造影过程中,造影剂从第二入口1314流入,经穿刺针22的远端排出到穿刺装置1c外。造影剂从穿刺针22的远端排出,便于获取穿刺针22远端的位置,便于医生进行穿刺手术,提高手术的精确度。
在其他实施例中,第一固定件本体131c的近端可以只包括第一入口1313。第一入口1313与穿刺针22c的内腔连通,且第一入口1313与第一通道100连通。第一液体介质从第一入口1313流入,一部分第一液体介质进入穿刺针22c内腔,这部分第一液体介质流经穿刺针22c,并经穿刺针22c的远端排出到穿刺 装置1c外,将穿刺针22c内的气体排出去;另一部分第一液体介质进入到第一通道100,这部分第一液体介质流过连接件101c、第二通道200内及外管21c后排出到穿刺装置1c外,这部分第一液体介质将外管21c内的气体排出去。只需在穿刺装置1c中注入第一液体介质,可同时将穿刺针22c内的气体、外管21c内的气体排出,提高穿刺装置1c排气的效率。
请参阅图14、图17、图18和图20,在本实施例中,手柄组件1c还包括防误触件40c。防误触件40c包括防误触本体41c,和与防误触本体41c连接的握持部42c。防误触本体41c包括具有开口的套筒状。防误触本体41c与握持部42c一体成型,握持部42c沿背离防误触本体41c开口的方向延伸。在其他实施例中,防误触本体41c与握持部42c可以为不同的部件,然后通过其他元件固定连接在一起。在本实施例中,防误触件40c与手柄组件10c可拆卸连接。防误触件40c用于防止第二控制件14c在被误操作情况下相对手柄本体11c的远端移动。误操作指的是,在不需要通过操作第二控制件14c来调整外管21c的情况下,触碰或者操作了第二控制件14c;或者不需要通过操作第一控制件12c来调整穿刺针22c的情况下,触碰或者操控第一控制件12c。当防误触件40c与手柄本体11c连接时,防误触本体41c套在手柄本体11c的外壁时,防误触本体41c的近端端面临近第二控制件14c远端端面。当第二控制件14c的远端端面抵持到防误触件40c的近端端面时,第二控制件14无法在轴向上相对手柄本体11c沿远离手柄本体11c的近端滑动,从而避免在穿刺针22c穿刺过程中,误触第二控制件14c而提前让外管21c重新覆盖穿刺针22c。当防误触件40c从手柄本体11c上拆离后,第二控制件14c在轴向方向上没有防误触件40c的限位作用后,可在轴向上背离手柄本体11c的近端滑动,使外管21c也背离手柄本体11c的近端滑动,外管21c可重新覆盖穿刺针22c。
在其他实施例中,手柄组件1c可以不包括防误触件40c,只要误触到第二控制件14后,第二控制件14受到其他部件的抵持而不易于滑动也可以实现本发明防止误操作的目的。
第五实施例
请参阅图21至图22,本实施例提供的穿刺装置1d与第四实施例基本相同,穿刺装置1d中第二控制件14d可控制外管21d的远端弯曲变形,第二控制件14d也可控制外管21d相对手柄本体11d在轴向移动。本实施例中,第一控制件12d、第二控制件14d、外管21d等的部件与第四实施例中第一控制件12c、第二控制件14c、外管21c等的部件基本相同,此处不再赘述。本实施例中,操控件与第二控制件14d指的是同一个部件。在本实施例中,与第四实施例最主要的不同的是,防误触件40d不同于防误触件40c,以下为详细说明。
防误触件40d包括支撑块41d、阻挡部42d、连接在支撑块41d和阻挡部42d之间的弹性部43d。第二控制件14d开设有收纳部140。本实施例中收纳部140为贯穿第二控制件14d内外表面的弹性部收容孔140。支撑块41d固定于该弹性部收容孔140靠近第二控制件14d外表面的侧壁。弹性部43d收容在弹性部收容孔140中。阻挡部42d至少部分收容在弹性部收容孔140内,阻挡部42d相较弹性部43d更靠近手柄本体11d。弹性部收容孔140靠近内表面的部分,其内径小于弹性部43d的外径,使得阻挡部42d只能部分从弹性部收容孔140露出而不至于从弹性部收容孔140脱离。手柄本体11d的部分外表面设有环形的阻挡部收容槽110d,环形的阻挡部收容槽110d环绕手柄本体11f的轴向中心轴。阻挡部收容槽110d可收容部分阻挡部42d。弹性部43d以支撑块41d为支撑,将自身的弹力作用于阻挡部42d,使得阻挡部42d抵持在阻挡部收容槽110d的槽壁。阻挡部收容槽110d与阻挡部42d配合,来限制第二控制件14d在轴向移动。当第二控制件14d被误操作时,误操作的作用力无法使阻挡部42d脱离阻挡部收容槽110d时,阻挡部42d会阻挡第二控制件14d在轴向相对手柄本体11d移动,使得外管21d无法相对手柄本体11d移动。当推动第二控制件14d的作用力使阻挡部42d缩入弹性部收容孔140内,阻挡部42d脱离阻挡部收容槽110d,阻挡部42d与阻挡部收容槽110d无法配合,无法限制第二控制件14d在轴向移动。在本实施例中,阻挡部42d在弹性部43d的弹力作用下,朝远离支撑块41d的方向移动,来抵持阻挡部收容槽110d的槽壁。在其他实施例中,弹性部43d施加阻挡部42拉力,阻挡部42d自身的重力大于弹性部43d的拉力而抵持在阻挡部收容槽110d的槽壁。当推动第二控制件14d的作用力及弹性部43d的拉力 共同作用于阻挡部42d,使阻挡部42d脱离阻挡部收容槽110d时,阻挡部42d无法阻挡第二控制件14d在轴向移动。在弹性部43d的拉力作用下,能够减小推动第二控制件14d的作用力。
在本实施例中,防误触件40d与手柄本体11d的配合,有如下有益效果。一方面,在第一控制件12d控制穿刺针22d移出外管21d的过程中,能够避免误触第二控制件14d而让外管21d提前覆盖穿刺针22d,影响穿刺针22d穿刺。另一方面,在转动第二控制件14d来调整使外管21d远端变形的过程中,能够避免误触到第二控制件14d而带动外管21d朝背离手柄本体11d近端的方向移动,而使外管21d提前朝背离手柄本体11d近端的方向移动,外管21d远端端面与穿刺针22d远端端面的距离增大,避免第一控制件12d控制穿刺针22d沿着背离手柄本体近端的方向无法伸出外管21d,或者伸出外管21d的长度过短的情形,而影响穿刺针22d穿刺。
在本实施例中,第二控制件14d可控制外管21d在轴向移动,也可控制外管21d远端变形。在其他实施例中,第二控制件14d可以仅仅控制外管21d在轴向移动,或者可以仅仅控制外管21d远端变形。
在本实施例中,第二控制件14d的弹性部收容孔140设置在其远端部。在其他实施例中,弹性部收容孔140也可以设置在其他位置,如近端部等,以弹性部收容孔140能够容纳部分防误触件40d为准。
在本实施例中,如图21,手柄组件10d还包括防误碰件50d,防误碰件50d的结构与防误触件40d结构基本相同。防误碰件50d收容在第一控制件12d。防误碰件50d与手柄本体11d配合,来阻挡第一控制件12d在轴向移动,防误碰件50d用于当误触第一控制件12时,防止穿刺针22d相对手柄本体11d移动。结合穿刺手术过程,其具体的有益效果如下。穿刺装置1d运输到目标位置的过程中,或者转动第二控制件14d使外管21d的远端弯曲并朝向待穿刺位置(如卵圆窝等)的过程中,防误碰件50d限制第一控制件12的轴向运动,避免误触到第一控制件12,让穿刺针22d提前伸出外管21d而刺伤病人。
在其他实施例中,防误碰件50d可以省略,仅仅设有防误触件40d。
在其他实施例中,第二控制件14d中的防误触件40d的阻挡作用,大于第 一控制件12d中防误碰件50d的阻挡作用(例如,防误触件40d中弹性部43d使阻挡部42d抵持在阻挡部收容槽110d的弹力,大于防误碰件50d中的弹性部使阻挡部抵持在在阻挡部收容槽110d的弹力),这样能够进一步减小因误触到第二控制件14d而移动外管21d的风险,同时在实现防误触第一控制件12d的基础上,减小第一控制件12d轴向移动的阻碍,便于推动第一控制件12d来控制穿刺针22d移动。
在其他实施例中,第二控制件14d上设置有多个间隔设置的弹性部收容孔140。防误触件40d的数量与弹性部收容孔140的数量相同,分别收容在每个弹性部收容孔140内。多个防误触件40d可增加第二控制件的40d的防误触效果。在其他实施例中,多个防误触件40d中,其中相对的一对防误触件40d关于穿刺装置1d的中心轴线对称。这样设置可以使得多个防误触件40d对第二控制件14d的限制作用分布对称、均匀。
在其他实施例中,收纳部140可以为第二控制件14d的部分内表面向外凹,形成弹性部收容槽140。弹性部收容槽140的数量为一个或者多个,且与防误触件40d的数量相同。弹性部43d收容在弹性部收容槽140内,部分阻挡部42d收容在弹性部收容槽140内。弹性部43d连接在该弹性部收容槽140的底壁与阻挡部42d之间。
在其他实施例中,收纳部140可以为第二控制件14d的部分内表面向外凹形成环形槽140。环形槽140在第二控制件14d的部分内表面内凹形成。一个或者多个防误触件40d间隔设置在环形槽140上。支撑块41d固定在环形槽140的槽壁,弹性部43d收容在环形槽140内,部分阻挡部42d收容在环形槽140内。弹性部43d连接在该环形槽140的底壁与阻挡部42d之间。
在其他实施例中,防误触件40d可以仅仅包括弹性部43d和阻挡部42d,以防误触件40d能够实现限位作用为准。
在其他实施例中,手柄本体11d可以不包括阻挡部收容槽110d。阻挡部42d在弹性部43d的作用下抵持手柄本体的外壁,阻挡部42d与手柄本体之间的摩擦力限制第二控制件14d移动。
在其他实施例中,如图23,防误触件40d呈中空的管状。防误触件40d具 有弹性。防误触件40d的材料可以为硅胶。第二控制件14d的部分内表面向外凹形成环形的容纳槽141。防误触件40d固定于容纳槽141。部分防误触件40d显露于容纳槽141外,并抵持手柄本体11d的外壁。第二控制件14d在轴向活动的过程中,防误触件40d与手柄本体11d之间存在摩擦力,摩擦力阻碍第二控制件14d移动。当误触到第二控制件14d的作用力,小于防误触件40d与手柄本体11d之间的静摩擦力时,第二控制件14d保持静止。当作用于第二控制件14d的作用力使得第二控制件14d移动,防误触件40d与手柄本体11d之间的摩擦力起到缓冲第二控制件14d移动的作用,避免第二控制件14d移动的速度过快、及第二控制件14d控制的外管21d移动速度过快。
在其他实施例中,外管21d可以与第二固定件15d、第二控制件14d一体成型形成外管(图未示)。防误触件40d与第二控制件14d连接。防误触件40d限制整体外管的移动。
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。
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。
Claims (36)
- 一种穿刺装置,其特征在于,所述穿刺装置包括手柄组件和收容于所述手柄组件内且与所述手柄组件固定相连的穿刺组件,所述穿刺组件包括外管和穿刺件,所述外管呈中空管状,至少部分所述穿刺件收容在所述外管内,且所述穿刺件的远端可从所述外管的远端露出或者收容于所述外管的远端内,所述穿刺件的近端穿出所述外管的近端。
- 如权利要求1所述的穿刺装置,其特征在于,所述手柄组件还包括第一控制件,所述第一控制件与所述穿刺件连接,用于控制所述穿刺件滑动。
- 如权利要求2所述的穿刺装置,其特征在于,所述手柄组件设置有第一限位孔,所述第一限位孔限制所述第一控制件的轴向行程。
- 如权利要求2或者3所述的穿刺装置,其特征在于,所述外管可相对手柄组件滑动。
- 如权利要求4所述的穿刺装置,其特征在于,所述手柄组件还包括第二控制件,所述第二控制件与所述第一控制件间隔设置,所述第二控制件与所述外管连接,所述第二控制件控制外管相对所述穿刺件滑动。
- 如权利要去5所述的穿刺装置,其特征在于,所述手柄组件设置有第二限位孔,所述第二限位孔限制所述第二控制件的轴向行程。
- 如权利要求5所述的穿刺装置,其特征在于,所述外管可移动的轴向行程大于或者等于所述穿刺件可移动的轴向行程。
- 如权利要求1所述的穿刺装置,其特征在于,所述手柄组件包括第一固定件及位于所述第一固定件远侧的第二固定件,所述第一固定件用于固定所述穿刺件,所述第二固定件用于固定所述外管。
- 如权利要求8所述的穿刺装置,其特征在于,所述穿刺装置还包括第一连接件,所述第一固定件设有第一连接件通道,所述第一连接件通道与所述穿刺件内部及第一连接件的内部均连通,使得第一液体介质可依次经所述第一连接件、第一连接件通道及所述穿刺件输送至体内。
- 如权利要求9所述的穿刺装置,其特征在于,所述第二固定件设有与所述外管内腔相连通的连通腔、与所述连通腔相连通的穿刺件通道,所述穿刺件经所述穿刺件通道及所述连通腔穿设于所述外管。
- 如权利要求10所述的穿刺装置,其特征在于,所述穿刺装置还包括与所述连通腔相连通的第二连接件,使得第二液体介质可依次经所述第二连接件、连通腔及外管输送至体内。
- 如权利要求1所述的穿刺装置,其特征在于,所述穿刺组件可弯曲变形。
- 一种穿刺装置,其特征在于,所述穿刺装置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,所述穿刺组件包括穿刺件,所述手柄组件还包括用于控制所述穿刺件的第一控制件,当所述第一控制件转动时,所述第一控制件控制所述穿刺件靠近或者远离所述手柄组件。
- 如权利要求13所述的穿刺装置,其特征在于,所述第一控制件与所述穿刺件近端部连接,且所述穿刺件的近端部收容在所述第一控制件内。
- 如权利要求14所述的穿刺装置,其特征在于,所述第一控制件的内表面设有第一卡持部,所述第一卡持部夹持所述穿刺件,当所述第一卡持部在轴 向相对所述手柄组件的近端移动时,所述第一卡持部带动所述穿刺件相对所述手柄组件运动。
- 如权利要求14所述的穿刺装置,其特征在于,所述第一控制件的内表面设有第一螺纹部,所述手柄组件包括手柄本体,所述第一控制件套设于所述手柄本体上,所述穿刺件的近端部收容在所述手柄本体内,且与所述第一控制件连接,当所述第一控制件绕所述手柄本体转动时,带动所述穿刺件相对手柄本体运动。
- 如权利要求16所述的穿刺装置,其特征在于,所述第一控制件内表面还设有第一卡持部,所述第一螺纹部设置在所述第一卡持部的远端侧,所述手柄本体外壁设有与所述第一螺纹部配合使用的第二螺纹部,部分所述穿刺件贯穿所述手柄本体且卡接于所述第一卡持部。
- 如权利要求17所述的穿刺装置,其特征在于,所述第一卡持部带动所述穿刺件在轴向背离所述手柄组件的近端移动预设距离后,所述第一控制件转动带动所述穿刺件继续移动背离所述手柄组件的近端。
- 如权利要求17所述的穿刺装置,其特征在于,所述手柄本体设有第一限位孔,部分所述穿刺件穿过所述第一限位孔卡接于所述第一卡持部,所述第一螺纹部的远端与所述第二螺纹部的远端之间的轴向距离,小于所述第一限位孔在轴向的长度。
- 如权利要求13所述的穿刺装置,其特征在于,所述穿刺件包括穿刺针及与所述穿刺针的近端相连的第一固定件,所述穿刺组件还包括一个外管,所述外管包括外管及与所述外管近端相连的第二固定件,所述第二固定件位于所述第二固定件的远端侧。
- 如权利要求20所述的穿刺装置,其特征在于,所述穿刺组件还包括连接件,所述连接件呈中空的管状,所述第一固定件设有第一通道,所述第二固定件设有第二通道,所述连接件与所述第一通道的内部及所述第二通道的内部均连通,使得第一液体介质可依次经第一通道、连接件、第二通道及外管输送至体内。
- 如权利要求21所述的穿刺装置,其特征在于,所述连接件的近端固定于所述第一通道内,所述连接件的远端滑动连接于所述第二通道内。
- 如权利要求21所述的穿刺装置,其特征在于,所述穿刺组件还包括密封件,所述密封件密封所述第二通道的近端侧。
- 如权利要求16所述的穿刺装置,其特征在于,所述手柄组件还包括第二控制件,所述第二控制件与所述第一控制件间隔设置,所述第二控制件与所述外管连接,所述第二控制件控制外管相对所述穿刺件滑动。
- 如权利要求24所述的穿刺装置,其特征在于,所述手柄组件还包括限位件,所述限位件与所述手柄组件可拆卸连接,当所述限位件套在所述手柄组件外壁时,所述限位件抵持所述第二控制件的远端侧,限制所述第二控制件带动所述外管,在轴向背离所述手柄组件的近端移动。
- 一种穿刺装置,其特征在于,所述穿刺装置包括手柄组件和穿刺组件,所述穿刺组件部分收容于所述手柄组件内,且与所述手柄组件固定相连,所述穿刺组件包括外管,所述手柄组件包括操控件和与所述操控件连接的防误触件,所述操控件与所述外管连接,所述操控件控制所述外管靠近或者远离所述手柄组件的近端,所述防误触件用于当误操作所述操控件时,防止所述外管相对所述手柄组件移动。
- 如权利要求26所述的穿刺装置,其特征在于,所述操控件转动时,所述外管可相对所述手柄组件弯曲变形。
- 如权利要求27所述的穿刺装置,其特征在于,所述手柄组件包括手柄本体,所述操控件套设于所述手柄本体上,所述外管的近端部收容在所述手柄本体内,且与所述操控件连接,当所述操控件相对所述手柄本体移动时,带动所述外管相对手柄本体运动。
- 如权利要求28所述的穿刺装置,其特征在于,所述防误触件与所述手柄本体可拆卸连接,当所述防误触件套设于所述手柄本体上时,所述防误触件的近端侧抵持所述操控件的远端侧。
- 如权利要求28所述的穿刺装置,其特征在于,所述防误触件与所述操控件固定相连。
- 如权利要求30所述的穿刺装置,其特征在于,所述防误触件包括阻挡部和与所述阻挡部相连的弹性部,所述弹性部收容在所述操控件内,且所述阻挡部相较所述弹性部更靠近所述手柄本体,当所述阻挡部抵接于所述手柄本体时,所述防误触件可在误操作所述操控件时防止所述外管相对所述手柄组件移动。
- 如权利要求31所述的穿刺装置,其特征在于,部分所述操控件设有弹性部收容孔,所述弹性部收容于所述弹性部收容孔中。
- 如权利要求32所述的穿刺装置,其特征在于,所述手柄本体部分外表面设有环绕所述手柄本体轴向中心轴的环形的阻挡部收容槽,所述阻挡部抵持所述阻挡部收容槽的槽壁,所述阻挡部与所述阻挡部收容槽配合来限制所述操控件移动。
- 如权利要求30所述的穿刺装置,其特征在于,所述防误触件收容于所述操控件内,所述防误触件抵持所述手柄本体,当所述操控件相对所述手柄本体移动时,所述防误触件与所述手柄本体之间的摩擦力阻碍所述操控件移动。
- 如权利要求26所述的穿刺装置,其特征在于,所述穿刺组件还包括与所述外管连接的穿刺件,所述手柄组件还包括第一控制件,所述第一控制件控制所述穿刺件移动。
- 如权利要求35所述的穿刺装置,其特征在于,所述手柄组件还包括防误碰件,所述防误碰件收容于所述第一控制件内,且与所述手柄本体连接,所述防误碰件用于当误操作所述第一控制件时,防止所述穿刺件相对所述手柄组件移动。
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