WO2021228003A1 - 一种穿刺针组件及穿刺系统 - Google Patents

一种穿刺针组件及穿刺系统 Download PDF

Info

Publication number
WO2021228003A1
WO2021228003A1 PCT/CN2021/092514 CN2021092514W WO2021228003A1 WO 2021228003 A1 WO2021228003 A1 WO 2021228003A1 CN 2021092514 W CN2021092514 W CN 2021092514W WO 2021228003 A1 WO2021228003 A1 WO 2021228003A1
Authority
WO
WIPO (PCT)
Prior art keywords
puncture
needle
conductor
needle body
needle assembly
Prior art date
Application number
PCT/CN2021/092514
Other languages
English (en)
French (fr)
Inventor
查飞翔
梁波
孙毅勇
宋宇文
刘梦瑶
Original Assignee
上海微创电生理医疗科技股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海微创电生理医疗科技股份有限公司 filed Critical 上海微创电生理医疗科技股份有限公司
Priority to US17/925,197 priority Critical patent/US20230190332A1/en
Priority to EP21803771.1A priority patent/EP4137074A4/en
Publication of WO2021228003A1 publication Critical patent/WO2021228003A1/zh

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • 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
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3439—Cannulas with means for changing the inner diameter of the cannula, e.g. expandable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00694—Aspects not otherwise provided for with means correcting for movement of or for synchronisation with the body
    • A61B2017/00703—Aspects not otherwise provided for with means correcting for movement of or for synchronisation with the body correcting for movement of heart, e.g. ECG-triggered
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00951—Material properties adhesive
    • 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
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3407—Needle locating or guiding means using mechanical guide means including a base for support on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2051—Electromagnetic tracking systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis

Definitions

  • the invention relates to the technical field of medical devices, in particular to a puncture needle assembly and a puncture system.
  • Interventional therapy is a more effective treatment for cardiovascular diseases.
  • interventional treatments such as atrial fibrillation and atrial flutter, puncture is often required to allow the interventional treatment device to pass through the atrial septum and reach the lesion site.
  • the dilator and puncture needle are important parts of atrial septal puncture.
  • the puncture needle utilizes the puncture ability of the stainless steel needle tube at the distal end to make the dilator and catheter sheath fitted on the puncture needle penetrate the interatrial septum.
  • the dilator uses the tapered constriction at its distal end to establish a transition between the catheter sheath and the puncture needle to reduce resistance, reduce the wound and shorten the puncture time.
  • the traditional atrial septal puncture is performed under the guidance of X-ray fluoroscopy. It is a technique under the two-dimensional perspective. Doctors can only combine X-ray imaging and operation methods to find the puncture site in the body with low accuracy. The risk is high, and mastering this technology requires long-term clinical accumulation. In recent years, the "green electrophysiological three-dimensional system" has been widely used in the field of interventional surgery. It has the characteristics of extremely low radiation, precise positioning and navigation, which greatly reduces the learning time, and also reduces the harm of radiation to both the doctor and the patient, making interventional surgery treatment more and more accurate, safe and easy. However, atrial septal puncture is still in a two-dimensional mode that combines X-ray imaging and operation methods.
  • the purpose of the present invention is to provide a puncture needle assembly and a puncture system, which can be applied to a three-dimensional interatrial septal puncture technique, which is convenient to use and has high reliability.
  • the present invention provides a puncture needle assembly, which includes a needle holder and a needle body, the needle holder has an axially penetrating channel, and at least part of the sidewall of the channel is configured as a conductive body.
  • the proximal end of the needle body extends in the channel, and the proximal end of the needle body is electrically connected to the conductor.
  • the electrical conductor has a block structure.
  • all side walls of the channel are configured as the electrical conductor.
  • a part of the sidewall of the channel is configured as the conductor, and another part of the sidewall of the channel is configured as an insulator.
  • the insulator has a first inner cavity penetrating in the axial direction, the first inner cavity forms part of the passage, and the insulator is provided with a window communicating with the first inner cavity, and the conductor It is arranged in the window, and the inner wall of the conductor and the inner wall of the first cavity jointly form the channel.
  • the insulator and the electrical conductor are arranged along the axial direction of the needle hub and connected to each other, and the channel penetrates the insulator and the electrical conductor.
  • the needle body is connected to the insulator.
  • a receiving groove is provided on the inner wall of the electrical conductor; the needle hub further includes a first elastic element disposed in the receiving groove; the first elastic element is configured to The elastic potential energy is stored to press against the needle body, so that the needle body and the conductive body maintain electrical conduction.
  • the first elastic element is a spring
  • the axis of the spring is arranged perpendicular to the axis of the needle body.
  • the conductive body is connected to the needle body through a conductive adhesive layer.
  • a slot is provided on the conductor, and the slot is used to insert a pin of a connecting wire of an external positioning device.
  • the electrical conductor includes a main body part and an extension part that are connected to each other, wherein the main body part is used to connect with the needle body, and the slot is provided on the extension part; the needle seat It also includes an insulator.
  • the insulator includes a first insulating part and a second insulating part.
  • the extension part is covered on at least a part of the first insulating part. Between the second insulating parts.
  • the present invention also provides a puncture system, including a dilator and the puncture needle assembly as described in any one of the preceding;
  • the dilator includes a dilation catheter, and the dilation catheter has an axially penetrating second inner A cavity, the distal end of the needle body is used for movably inserting into the second inner cavity.
  • the side wall of the distal end of the expansion catheter is provided with a side hole communicating with the second lumen.
  • the dilator further includes an elastic conductive component, the elastic conductive component is disposed at the side hole, and the elastic conductive component is used to contact the needle body and press against the needle by elastic force. body.
  • the elastic conductive component includes a second elastic element
  • the second elastic element includes an arc-shaped part
  • one end of the arc-shaped part is fixed at the side hole
  • the other end is a free end
  • the The arc-shaped portion at least partially protrudes from the inner surface of the expansion catheter.
  • the elastic conductive component further includes an end cover and a frame, the end cover is disposed in the side hole, the frame is connected to the end cover, and is disposed in the end cover and the second inner Between the cavities, the arc-shaped part is connected with the frame.
  • the elastic conductive component further includes a limit stopper, the limit stopper is disposed on the arc-shaped portion; when the needle body is in contact with the arc-shaped portion, the limit stopper The sheet is in contact with the end cap.
  • annular groove is further formed on the inner wall of the side hole, and the end cover includes a protruding part matching the annular groove, and the protruding part is fixed in the annular groove.
  • the aforementioned puncture needle assembly includes a needle holder and a needle body.
  • the needle holder includes a conductive body.
  • the proximal end of the needle body extends in the channel and is electrically connected to the conductor.
  • the puncture needle assembly further includes an elastic body and/or a conductive adhesive layer.
  • the connection between the needle body and the conductive body is enhanced by providing the elastic body and/or the conductive adhesive layer, thereby ensuring electrical signals during the puncture process.
  • the good delivery of the puncture improves the success rate of puncture.
  • the conductor is provided with a slot for inserting the pins of the three-dimensional positioning device, and has the advantages of convenient use and reliable connection.
  • the aforementioned puncture system includes the puncture needle assembly and a dilator, the dilator includes a dilation catheter, the dilation catheter has a second lumen penetrating along its axial direction, and the distal end of the dilation catheter is opened There is a side hole communicating with the second inner cavity, so that the needle body is electrically connected with external blood.
  • the expander may also be provided with an elastic conductive component, and the elastic conductive component is arranged in the side hole.
  • the elastic conductive component enables the distal end of the needle body to still be electrically connected to external blood, so that the three-dimensional system can still display the needle in real time.
  • the position of the distal end of the body prevents the distal end of the needle body from causing damage to human tissues.
  • Fig. 1 is a schematic structural diagram of a puncture system according to an embodiment of the present invention.
  • Fig. 2 is a schematic diagram of performing atrial septal puncture using the puncture system provided by an embodiment of the present invention.
  • Fig. 3 is a partial schematic diagram of a puncture system according to an embodiment of the present invention.
  • Fig. 4 is an A-A cross-sectional view of the puncture system shown in Fig. 3.
  • Fig. 5 is a partial schematic diagram of a puncture needle assembly of a puncture system according to an embodiment of the present invention.
  • FIG. 6 is a partial cross-sectional view of the puncture needle assembly of the puncture system according to an embodiment of the present invention.
  • the conductor is arranged in the window formed by the insulator.
  • Fig. 7 is a partial schematic diagram of the puncture needle assembly of the puncture system according to an embodiment of the present invention in one direction.
  • Fig. 8 is a schematic diagram of the puncture needle assembly of the puncture system shown in Fig. 7 in another direction. In the figure, a slot is provided on the conductor.
  • Fig. 9 is a B-B cross-sectional view of the puncture needle assembly of the puncture system shown in Fig. 8.
  • Fig. 10 is a partial cross-sectional view of a dilator of a puncture system according to an embodiment of the present invention.
  • FIG. 11 is a schematic diagram of the structure of the elastic conductive component of the dilator of the puncture system shown in FIG. 10.
  • Fig. 12 is a partial cross-sectional view of a dilator of a puncture system according to another embodiment of the present invention.
  • FIG. 13 is a schematic diagram of the structure of the elastic conductive component of the dilator of the puncture system shown in FIG. 12.
  • Fig. 14 is a schematic diagram of the distal end structure of the dilation catheter of the dilator of the puncture system according to an embodiment of the present invention, and the side hole in the figure is circular.
  • Fig. 15 is a C-C cross-sectional view of the dilator of the puncture system shown in Fig. 14.
  • Fig. 16 is a schematic diagram of the distal end structure of the dilation catheter of the dilator of the puncture system according to an embodiment of the present invention.
  • the side hole in the figure is a square hole.
  • Fig. 17 is a D-D cross-sectional view of the dilator of the puncture system shown in Fig. 16.
  • 100-puncture system 1000-puncture needle assembly; 1100-needle holder; 1110-conductor; 1111-body, 1112-extension, 1113-socket; 1120-insulator; 1130-first elastic element; 1200-needle Body; 2000-Dilator; 2100-Dilation catheter; 2110-Step, 2120-Side hole; 2200-Elastic wire assembly; 2210-Second elastic element; 2211-Curved part; 2220-End cap; 2221-Protrusion ; 2230-Frame; 2240-Limiting block; Containing groove-1131;
  • proximal and distal refer to the relative position, relative position, and direction of elements or actions relative to each other from the perspective of the doctor using the medical device, although the “proximal” and “distal” “Is not restrictive, but “proximal” usually refers to the end of the medical device that is close to the doctor during normal operation, and “distal” usually refers to the end that first enters the patient's body.
  • the puncture system 100 includes a puncture needle assembly 1000 and a dilator 2000.
  • the puncture needle assembly 1000 includes a needle holder 1100 and a needle body 1200, and the needle holder 1100 includes an electrical conductor 1110.
  • the needle seat 1100 has an axially penetrating channel, and at least a part of the sidewall of the channel is configured as an electrical conductor 1110.
  • the proximal end of the needle body 1200 extends in the channel and is connected to the conductor 1110.
  • the dilator 2000 includes a hollow dilation catheter 2100, and the distal end of the needle body 1200 enters the human tissue along the dilation catheter 2100 for puncture.
  • the distal end of the needle body 1200 is electrically connected to the blood to obtain electrical signals.
  • the proximal end of the needle body 1200 is connected to a three-dimensional positioning device 200, such as an electrical positioning device, and the three-dimensional positioning device 200 receives the electrical signal, thereby positioning the distal end of the needle body 1200.
  • a conductor 1110 on the needle base 1100, the conductor 1110 is connected to the three-dimensional positioning device to realize the connection of the needle 1200 and the three-dimensional positioning device 200 without An additional wire is provided on the needle body 1100, which further improves the operability of the puncture needle assembly 1000.
  • the conductor 1110 may be made of metal conductive materials, such as stainless steel, aluminum, and the like.
  • the needle body 1200 may be an elongated hollow structure made of a metal conductive material, and may be formed by integrally forming a section of pipe, or may be formed by connecting two sections of pipe.
  • the distal end of the needle body 1200 is bendable, and the diameter of the distal end of the needle body 1200 is smaller than the diameter of the proximal end, and may have a pointed end to facilitate piercing the human tissue.
  • the proximal end of the needle body 1200 is electrically connected to the conductor 1110 to transmit the electrical signal to the conductor 1110 and then to the three-dimensional positioning device 200.
  • the entire needle base 1100 is composed of the conductor 1110, so that all side walls of the channel are composed of the conductor 1110.
  • the entire needle base is composed of the conductor 1110, which can meet this requirement.
  • the conductor is made of metal, and its cost is relatively high.
  • the metal copper its biocompatibility is poor, and it is necessary to carry out surface coating treatment on the conductor.
  • the technical difficulty of surface coating treatment for such small channels is very high. If stainless steel with better biocompatibility is used to make electrical conductors, it is more difficult to process the ideal shape because of its poor plasticity.
  • the needle hub 1100 further includes an insulator 1120.
  • the insulator 1120 and the conductor 1110 are separately molded and then connected into one body, and the conductor 1110 constitutes a part of the side wall of the channel, and the insulator 1120 constitutes another part of the side wall of the channel.
  • the insulator 1120 can be made of a polymer material with good biocompatibility, which is safer for the human body and easy to process.
  • the specific structure of the needle seat 1100 can be set according to actual needs, but usually the conductor 1110 is designed as a block structure.
  • the design of the block structure is convenient for the doctor to hold on the one hand, and on the other hand, it increases the weight of the needle holder and improves the doctor's feel in use. Please refer to FIGS. 3 to 5.
  • the conductor 1110 and the insulator 1120 are arranged along the axial direction of the needle seat 1100.
  • the conductor 1110 is provided with a first through hole extending in the axial direction, and the insulator is provided with a second through hole penetrating in the axial direction.
  • the second through hole communicates with the first through hole to form The channel. Or, as shown in FIG.
  • the insulator 1120 is provided with an axially penetrating first inner cavity, the first inner cavity forms part of the passage, and the insulator 1120 is provided with There is a window communicating with the first inner cavity, the conductive body 1110 is disposed in the window, and the inner wall of the conductive body 1110 and the inner wall of the first inner cavity together form the channel.
  • the needle body 1200 is arranged in the channel and connected to the conductor 1110.
  • the inner diameter of the channel is larger than the outer diameter of the proximal end of the needle body 1200, but this will result in a gap between the needle body 1200 and the conductor 1110, resulting in unreliable connection between the two Condition.
  • the inner surface of the conductor 1110 and the outer surface of the needle body 1200 are also filled with conductive glue.
  • a conductive adhesive layer (not shown in the figure) is formed.
  • the connection between the conductor 1110 and the needle body 1200 is strengthened by the conductive adhesive layer, so that the electrical signals collected at the distal end of the needle body 1200 can be smoothly transmitted to the three-dimensional positioning device through the conductor 1110 200.
  • the first elastic element 1130 can also be provided to solve the problem of the conductor 1110 caused by the mismatch between the diameter of the channel and the outer diameter of the needle body 1200.
  • the connection with the needle body 1200 is unreliable.
  • the inner surface of the conductor 1110 is provided with a receiving groove 1131 (as shown in FIG. 9 ), and the first elastic element 1130 is arranged in the receiving groove 1131 and is configured to store elastic potential energy.
  • the first elastic element 1130 is pressed against the needle body 1200 under the action of elastic potential energy, so that the needle body 1200 is in close contact with the inner surface of the conductor 1110.
  • the first elastic element 1130 includes but is not limited to a spring. When the first elastic element 1130 is a spring, the axis of the spring is perpendicular to the axis of the needle body 1200.
  • the needle body 1200 is also connected with the insulator 1120 to enhance the reliability of the connection between the needle body 1200 and the needle base 1100 and prevent the needle body 1200 from loosening during use.
  • the conductor 1110 of the puncture needle assembly 100 can be connected to the connecting tail of the three-dimensional positioning device 200 through a conductive clip.
  • the way of connecting the conductor 1110 and the connection tail of the three-dimensional positioning device 200 through the conductive clip may affect the electrical signal transmission effect due to the small contact surface of the electrical connection or the unstable contact.
  • a slot 1113 is provided on the conductor 1110, and the slot 1113 is used to insert the pins of the connecting tail, not only It is easy to use and has the advantages of firm and reliable connection.
  • the electrical conductor 1110 includes a main body portion 1111 and an extension portion 1112 that are connected to each other, wherein the main body portion 1111 is used to connect with the needle body 1200, and the slot 1113 is provided on the extension portion 1112.
  • the needle seat 1100 further includes an insulator 1120.
  • the insulator 1120 includes a first insulating portion 1120a and a second insulating portion 1120b.
  • the extension portion 1112 covers at least a part of the first insulating portion 1120a, and the main body portion 1111 is disposed between the first insulating portion 1120a and the second insulating portion 1120b.
  • the pins are connected to the socket 1113, and the walls of the socket 1113 are all conductors, which can further improve the stability and reliability of signal transmission.
  • a part of the insulator is covered on the conductor, and a slot is provided on the insulator, and the slot extends to the conductor, thereby The pin inserted into the slot can be connected to the conductor, which is not limited in the present invention.
  • the dilation catheter 2100 of the dilator 2000 has an elongated structure, and the distal end of the dilation catheter 2100 is formed as a tip.
  • the dilatation catheter 2100 has a second inner cavity that penetrates axially, and the inner surface of the dilatation catheter 2100 is further provided with a step 2110, and the step 2110 is used to restrict the needle 1200 from the dilation catheter 2100.
  • the protruding length of the end prevents the needle body 1200 from protruding too long and causing danger.
  • the distal end of the expansion catheter 2100 is provided with a side hole 2120 communicating with the second lumen of the expansion catheter 2100.
  • a side hole 2120 communicating with the second lumen of the expansion catheter 2100.
  • the needle body 1200 and the blood outside the dilation catheter 2100 are electrically connected.
  • the distal end of the needle body 1200 can be hidden in the dilation catheter 2100 of the dilator 2000, and the The needle body 1200 is electrically connected to the blood through the side hole 2120 to obtain electrical signals, so as to prevent the distal end of the needle body 1200 from damaging human tissues in the process of searching for a puncture point.
  • the cross-section of the side hole 2120 can be any suitable shape, such as a circle (as shown in Figures 14 and 15), a square (as shown in Figures 16 and 17), a waist circle, Polygons, irregular shapes, etc.
  • the number of the side holes 2120 may be one, or multiple, for example, two, and the two side holes 2120 may be symmetrically arranged at the distal end of the expansion catheter 2100.
  • the expander 2000 further includes an elastic conductive component 2200, which is disposed in the side hole 2120.
  • the elastic conductive component 2200 makes the blood and the needle body 1200 electrically conduct.
  • the elastic conductive component 2200 includes a second elastic element 2210.
  • the second elastic element is formed by bending a thin metal sheet and includes an arc portion 2211. .
  • One end of the arc-shaped portion 2211 is fixed at the side hole 2120, and the other end is a free end, and the arc-shaped portion 2211 at least partially protrudes from the inner surface of the expansion catheter 2100.
  • the arc-shaped portion 2211 is pressed against the distal end of the needle body 1200 to make the needle body 1200 and the elastic conductive component 2200 effective contact.
  • the elastic conductive component 2200 further includes an end cover 2220 and a frame 2230.
  • the end cover 2220 can be integrally formed with the frame 2230, or the two can be separate structures, and are connected by a suitable connection method such as welding.
  • the end cover 2220 is fixed to the inner side of the side hole 2120, and one end of the arc-shaped portion 2211 is fixed to the inner side of the frame 2230.
  • the elastic conductive component 2200 further includes a limit stopper 2240, and the limit stopper 2240 is disposed on the arc portion 2211, preferably the limit stopper 2240 is connected to the free end of the arc-shaped portion 2211.
  • the elastic conductive component 2200 can enhance the conduction effect between the needle body 1200 and the external blood on the one hand, and on the other hand, it can also improve the feel of the doctor in use.
  • the needle body 1200 receives the resistance from the arc-shaped part 2211, and provides tactile feedback to the doctor, so as to inform the doctor of the needle body 1200 in time. The distal end has reached the side hole.
  • annular groove may be formed on the inner wall of the side hole 2120, and a protrusion 2221 matching the annular groove may be formed on the end cover 2220.
  • the end cap 2220 is fixed in the side hole 2120 through the cooperation of the protruding portion 2221 and the annular groove, thereby enhancing the firmness.
  • step S1 a guide wire is delivered along the right femoral vein to the junction of the superior vena cava and the subclavian vein.
  • step S2 the dilator 2000 cooperates with a catheter sheath 300 and enters the superior vena cava along the guide wire together.
  • step S3 the guide wire is withdrawn, and the catheter sheath 300 is flushed with heparin saline.
  • Step S4 the conductor 1110 of the puncture needle assembly 1000 is connected to the three-dimensional positioning device 200, and at the same time, the needle body 1200 is inserted into the dilation catheter 2100 of the dilator 2000, and the The distal end of the needle body 1200 reaches the side hole 2120 to contact the elastic conductive component 2200 so that the three-dimensional positioning device 200 can position the distal end of the needle body 1200.
  • Step S5 withdraw the catheter sheath 300, the dilator 2000 and the needle body 1200 and rotate the needle body 1200, and at the same time combine the image displayed in the three-dimensional positioning device 200, according to the His bundle and the tubular vein Look for the fossa ovale in the location of the antrum. After finding the fossa ovale, stop withdrawing the catheter sheath 300, the dilator 2000 and the needle body 1200.
  • step S6 a puncture point is searched for, and the puncture point is located at a position 1/3 behind the flush height of the spaced His bundle.
  • Step S7 Push the dilator 2000 and the catheter sheath 300 forward, and the pushing distance is about 2-3 mm.
  • Step S8 fix the catheter sheath 300 and the dilator 2000, and push the needle body 1200 forward about 5-10 mm according to the image displayed by the three-dimensional positioning device 200 to make the needle body 1200 farther away
  • the end protrudes from the distal end of the dilation catheter 2100 and passes through the atrial septum.
  • Step S9 fix the needle body 1200, and push the catheter sheath 300 and the dilator 2000 forward so that the distal end of the dilator 2000 enters the left atrium.
  • step S10 the needle body 1200 is withdrawn from the body, and the dilator 2000 is fixed.
  • Step S11 Push the catheter sheath 300 forward so that the distal end of the catheter sheath 300 enters the left atrium.
  • step S12 the catheter sheath 300 is fixed, and the dilator 2000 is withdrawn from the body to complete the puncture.
  • the embodiment of the present invention provides a puncture needle assembly and a puncture system.
  • the puncture needle assembly includes a needle holder and a needle body, the needle holder is provided with a conductor, and the proximal end of the needle body extends to the needle holder And connected with the conductor.
  • the electrical signal connection relationship between the needle body and the three-dimensional positioning device is realized through the conductor, and the safety and success rate of atrial septal puncture are increased.
  • the puncture system includes the puncture needle assembly and a dilator, and further, the dilator includes an expansion catheter, the expansion catheter has a lumen penetrating along its axial direction, and the distal end of the expansion catheter is provided with The side hole communicated with the inner cavity, and an elastic conductive component is arranged in the side hole.
  • the needle body is hidden in the expansion catheter and the elastic conductive component is electrically connected to the blood outside the expansion catheter, so that the three-dimensional positioning device can perform the operation on the needle body. Positioning to avoid damage to the superior vena cava and endocardium tissue and improve safety.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pathology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Robotics (AREA)
  • Surgical Instruments (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

一种穿刺针组件（1000）和穿刺系统（100），穿刺针组件（1000）包括针座（1100）和针体（1200），针座（1100）具有轴向贯通的通道，通道的至少一部分侧壁被配置为导电体（1110），针体（1200）的近端在通道内延伸并与导电体（1110）电连接。穿刺系统（100）包括穿刺针组件（1000）和扩张器（2000），扩张器（2000）包括扩张导管（2100）和可选择地设置在扩张导管（2100）上的弹性导电组件（2200）。弹性导电组件（2200）使得针体（1200）的远端隐藏于扩张导管（2100）内时仍然能够与外部血液电性导通。穿刺针组件（1000）和穿刺系统（100）具有使用安全方便，可靠性高的优点。

Description

一种穿刺针组件及穿刺系统 技术领域
本发明涉及医疗器械技术领域，具体涉及一种穿刺针组件及穿刺系统。
背景技术
心血管疾病严重威胁了人类的健康，其具有患病率高、致残及致死率高的特点。介入治疗是针对心血管疾病的较为有效的治疗手段。在进行介入治疗例如心房颤动、心房扑动的治疗时往往需要进行穿刺，以使介入治疗装置穿过房间隔而到达病灶部位。
扩张器和穿刺针是房间隔穿刺术的重要部件。穿刺针利用远端的不锈钢针管的穿刺能力，使装配在穿刺针上的扩张器和导管鞘穿过房间隔。扩张器在穿刺针穿过房间隔的过程中，利用其远端的锥形缩口在导管鞘和穿刺针之间建立过渡，以降低阻力，减小创口并缩短穿刺时间。
传统的房间隔穿刺术是在X射线透视指导下实施的，是一种二维平面视角下的技术，医生只能结合X线成像和操作方法，在体内寻找穿刺位点，准确度较低，风险较高，掌握该技术需要长时间的临床积累。近年来，“绿色电生理三维系统”在介入手术领域得到了广泛应用。它具有极低射线、精准定位和导航等特点，很大程度减少了学习时间，也降低了射线对医、患双方的伤害，使得介入手术治疗越来越精准、安全和轻松。但是，房间隔穿刺术还处在结合X线成像和操作方法的二维模式中，其在“电定位三维系统”手术领域中还未得到广泛应用而无法实现极低射线、精准定位和导航等特点。因此，在现有技术中，尚无电定位系统结合心电信号指导的穿刺系统以实现精准穿刺。
发明内容
本发明的目的在于提供一种穿刺针组件和穿刺系统，该穿刺针组件和穿刺系统可应用于三维房间隔穿刺技术，使用方便，可靠性高。
为实现上述目的，本发明提供的一种穿刺针组件，包括针座和针体，所 述针座具有轴向贯通的通道，且所述通道的至少部分侧壁被配置为导电体，所述针体的近端在所述通道内延伸，并且所述针体的近端与所述导电体电连接。
可选地，所述导电体为块状结构。
可选地，所述通道的全部侧壁被配置为所述导电体。
可选地，所述通道的一部分侧壁被配置为所述导电体，所述通道的另一部分侧壁被配置为绝缘体。
可选地，所述绝缘体具有轴向贯通的第一内腔，所述第一内腔构成部分所述通道，所述绝缘体上开设有与所述第一内腔连通的窗口，所述导电体设置于所述窗口内，所述导电体的内壁与所述第一内腔的内壁共同构成所述通道。
可选地，所述绝缘体与所述导电体沿所述针座的轴向布置并相互连接，所述通道贯穿所述绝缘体和所述导电体。
可选地，所述针体与所述绝缘体连接。
可选地，所述导电体的内壁上设有容纳槽；所述针座还包括第一弹性元件，所述第一弹性元件设置于所述容纳槽内；所述第一弹性元件被配置为存储有弹性势能以压抵所述针体，以使所述针体与所述导电体保持电性导通。
可选地，所述第一弹性元件为弹簧，且所述弹簧的轴线垂直于所述针体的轴线布置。
可选地，所述导电体通过导电胶层与所述针体连接。
可选地，所述导电体上设置有插槽，所述插槽用于插接外部定位装置的连接线的插针。
可选地，所述导电体包括相互连接的主体部和延伸部，其中，所述主体部用于与所述针体相接，所述插槽设置于所述延伸部上；所述针座还包括绝缘体，所述绝缘体包括第一绝缘部和第二绝缘部，所述延伸部包覆于所述第一绝缘部的至少一部分上，所述主体部设置于所述第一绝缘部和所述第二绝缘部之间。
为实现上述目的，本发明还提供了一种穿刺系统，包括扩张器和如前任一项所述的穿刺针组件；所述扩张器包括扩张导管，所述扩张导管具有轴向 贯通的第二内腔，所述针体的远端用于可活动地插入所述第二内腔。
可选地，所述扩张导管的远端的侧壁开设有与所述第二内腔连通的侧孔。
可选地，所述扩张器还包括弹性导电组件，所述弹性导电组件设置于所述侧孔处，且所述弹性导电组件用于与所述针体接触并通过弹性力压抵所述针体。
可选地，所述弹性导电组件包括第二弹性元件，所述第二弹性元件包括弧形部，所述弧形部的一端固定于所述侧孔处，另一端为自由端，且所述弧形部至少部分凸出于所述扩张导管的内表面。
可选地，所述弹性导电组件还包括端盖和框架，所述端盖设置于所述侧孔内，所述框架与所述端盖相连接，并设置在所述端盖与第二内腔之间，所述弧形部与所述框架连接。
可选地，所述弹性导电组件还包括限位挡片，所述限位挡片设置于所述弧形部上；当所述针体与所述弧形部接触时，所述限位挡片与所述端盖接触。
可选地，所述侧孔的内壁上还形成有环形槽，所述端盖包括与所述环形槽相匹配的凸出部，所述凸出部固定于所述环形槽内。
本发明的穿刺针组件及穿刺系统具有如下优点：
第一、前述的穿刺针组件包括针座和针体，所述针座包括导电体，所述针座具有轴向贯通的通道，所述通道的至少一部分侧壁被配置为导电体，所述针体的近端在所述通道内延伸并与所述导电体电连接。在执行房间隔穿刺术时，将所述导电体与三维定位装置连接，即可实现所述针体与所述三维定位装置的电信号连接，实现穿刺针在“电定位三维系统”手术领域中的应用。
第二、所述穿刺针组件还包括弹性体和/或导电胶层，通过设置弹性体和/或导电胶层增强所述针体与所述导电体的连接，进而确保在穿刺过程中电信号的良好传递，提高穿刺成功率。
第三、所述导电体上设有插槽，所述插槽用于插入三维定位装置的插针，具有使用方便、连接可靠的优点。
第四、前述的穿刺系统包括所述穿刺针组件和扩张器，所述扩张器包括扩张导管，所述扩张导管具有沿其轴向贯通的第二内腔，所述扩张导管的远端上开设有与所述第二内腔连通的侧孔，以使所述针体与外部血液电性导通。 可选地，所述扩张器还可设置弹性导电组件，所述弹性导电组件设置在所述侧孔中。在执行房间隔穿刺术时，所述针体的远端沿所述第二内腔延伸至所述侧孔处并与所述弹性导电组件接触，以使所述针体与所述扩张导管外部的血液电性导通。即，所述针体的远端隐藏于所述扩张器内时，所述弹性导电组件使得所述针体的远端仍然能够与外部血液电性导通，从而使得三维系统仍能够实时显示针体的远端的位置，避免所述针体的远端对人体组织造成损伤。
附图说明
图1是本发明根据一实施例所提供的穿刺系统的结构示意图。
图2是利用本发明一实施例所提供的穿刺系统执行房间隔穿刺术时的示意图。
图3是本发明根据一实施例所提供的穿刺系统的局部示意图。
图4是图3所示的穿刺系统的A-A剖视图。
图5是本发明根据一实施例所提供的穿刺系统之穿刺针组件的局部示意图。
图6是本发明根据一实施例所提供的穿刺系统之穿刺针组件的局部剖视图，图示中导电体设置在绝缘体形成的窗口内。
图7是本发明根据一实施例所提供的穿刺系统之穿刺针组件在一个方向上的局部示意图。
图8是图7所示的穿刺系统之穿刺针组件在另一个方向上的示意图，图示中导电体上设有插槽。
图9是图8所示的穿刺系统之穿刺针组件的B-B剖视图。
图10是本发明根据一实施例所提供的穿刺系统之扩张器的局部剖视图。
图11是图10所示的穿刺系统之扩张器的弹性导电组件的结构示意图。
图12是本发明根据另一实施例所提供的穿刺系统之扩张器的局部剖视图。
图13是图12所示穿刺系统之扩张器的弹性导电组件的结构示意图。
图14是本发明根据一实施例所提供的穿刺系统之扩张器的扩张导管的远 端结构示意图，图示中侧孔为圆形。
图15是图14所示的穿刺系统的扩张器的C-C剖视图。
图16是本发明根据一实施例所提供的穿刺系统之扩张器的扩张导管的远端结构示意图，图示中侧孔为方孔。
图17是图16所示的穿刺系统之扩张器的D-D剖视图。
[附图标记说明如下]：
100-穿刺系统；1000-穿刺针组件；1100-针座；1110-导电体；1111-主体部，1112-延伸部，1113-插槽；1120-绝缘体；1130-第一弹性元件；1200-针体；2000-扩张器；2100-扩张导管；2110-台阶，2120-侧孔；2200-弹性导线组件；2210-第二弹性元件；2211-弧形部；2220-端盖；2221-凸出部；2230-框架；2240-限位挡片；容纳槽-1131；
200-三维定位装置；
300-导管鞘。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
如在本说明书中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，复数形式“多个”包括两个以上的对象，除非内容另外明确指出外。如在本说明书中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外，以及术语“安装”、“相连”、“连接”“相接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接。可以是机械连接，也可以是电连接。可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件相互邻接、抵接。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。附图中相同或相似的附图标记代表相同或相似的部件。
在本文中，术语“近端”、“远端”是从使用该医疗器械的医生角度来看相对于彼此的元件或动作的相对方位、相对位置、方向，尽管“近端”、“远 端”并非是限制性的，但是“近端”通常指该医疗设备在正常操作过程中靠近医生的一端，而“远端”通常是指首先进入患者体内的一端。
本发明实施例提供了一种穿刺针组件和包括该穿刺针组件的穿刺系统，医生可利用该穿刺系统在三维界面下行穿刺术。如图1所示，所述穿刺系统100包括穿刺针组件1000和扩张器2000。其中，所述穿刺针组件1000包括针座1100和针体1200，所述针座1100包括导电体1110。所述针座1100具有轴向贯通的通道，所述通道的至少一部分侧壁被配置为导电体1110。所述针体1200的近端在所述通道内延伸，并与所述导电体1110相接。所述扩张器2000包括中空的扩张导管2100，所述针体1200的远端沿所述扩张导管2100进入人体组织中，以进行穿刺。
如图2所示，在执行穿刺术的过程中，所述针体1200的远端与血液电性导通，以获取电信号。所述针体1200的近端与三维定位装置200例如电定位装置连接，所述三维定位装置200接收所述电信号，从而对所述针体1200的远端进行定位。本实施例中，通过在所述针座1100上设置导电体1110，利用所述导电体1110与所述三维定位装置连接实现了所述针体1200与所述三维定位装置200的连接，且无需在所述针体1100上额外设置导线，进一步提高了所述穿刺针组件1000的可操作性。
请结合图1，在本发明的实施例中，所述导电体1110可以由金属导电材料例如不锈钢、铝等制作而成。所述针体1200可以是金属导电材料制成的细长的中空结构，可以是一段管一体成型，也可以是两段管连接构成。所述针体1200的远端可弯曲，且所述针体1200的远端直径小于近端直径，并可具有尖端，以便于刺穿人体组织。所述针体1200的近端与所述导电体1110电性导通，以将所述电信号传递至所述导电体1110，进而传递至所述三维定位装置200。
在一些实施例中，所述针座1100整体由所述导电体1110构成，从而所述通道的全部侧壁皆由所述导电体1110构成。对于现有的穿刺针的针座来说，医生在操作过程中，会对针座的手感有要求，也即针座必须有一定的重量。因此，将针座整体由所述导电体1110构成，可满足这个要求。但同时，导电体采用金属制备，其成本较高。此外，对于常用的金属铜来说，其生物相容 性差，需要对导电体进行表面涂层处理。然而，对于此类小腔道进行表面涂层处理，技术难度又非常的高。如果采用生物相容性较好的不锈钢制造导电体，则因为其可塑性较差，比较难以加工出理想的形状。
因此，在另一些实施例中，如图3所示，所述针座1100还包括绝缘体1120。所述绝缘体1120与所述导电体1110分别成型后再连接为一体，并且所述导电体1110构成所述通道的一部分侧壁，所述绝缘体1120构成所述通道的另一部分侧壁。这样一方面可减少金属材料的使用，降低所述穿刺针组件1000的成本，另一方面所述绝缘体1120可采用生物相容性较好的高分子材料制造，对人体较安全，也易于加工。
所述针座1100的具体结构可根据实际需要设置，但通常所述导电体1110被设计为块状结构。该块状结构的设计一方面便于医生握持，另一方面，增加了针座的重量，提升了医生的使用手感。请参考图3至图5所示，在一个实施例中，所述导电体1110和所述绝缘体1120沿所述针座1100的轴向布置。所述导电体1110上开设有沿轴向延伸的第一通孔，所述绝缘体上开设有沿轴向贯通的第二通孔，所述第二通孔与所述第一通孔连通以构成所述通道。或者，如图6所示，在另一个实施例中，所述绝缘体1120上开设有轴向贯通的第一内腔，所述第一内腔构成部分所述通道，且所述绝缘体1120上设有与所述第一内腔连通的窗口，所述导电体1110设置于所述窗口内，所述导电体1110的内壁与所述第一内腔的内壁共同构成所述通道。一般地，所述针体1200设置于所述通道内，并与所述导电体1110相连接。为便于装配，所述通道的内径大于所述针体1200之近端的外径，但这会导致所述针体1200与导电体1110的之间存在间隙，从而导致两者出现连接不可靠的情况。为解决此问题，本实施例中所述导电体1110的内表面与所述针体1200的外表面之间还灌注有导电胶。所述导电胶固化后形成导电胶层(图中未示出)。通过所述导电胶层加强所述导电体1110与所述针体1200的连接，以使所述针体1200之远端采集的电信号可顺利通过所述导电体1110传导至所述三维定位装置200。
或者，如图9所示，在一个替代性的实施例中，还可以通过设置第一弹性元件1130来解决所述通道的孔径与所述针体1200的外径不匹配而造成的导电体1110与针体1200之间的连接不可靠的问题。具体地，所述导电体1110 的内表面上设置有一容纳槽1131(如图9所示)，所述第一弹性元件1130设置于所述容纳槽1131内并被配置为存储有弹性势能。所述第一弹性元件1130在弹性势能的作用下压抵所述针体1200，以使所述针体1200与所述导电体1110的内表面紧密接触。所述第一弹性元件1130包括但不限于弹簧，当所述第一弹性元件1130为弹簧时，所述弹簧的轴线垂直于所述针体1200的轴线。
进一步地，所述针体1200还与所述绝缘体1120连接，以增强所述针体1200与所述针座1100的连接可靠性，避免所述针体1200在使用过程松动。
利用本实施例提供的穿刺系统100执行穿刺术时，所述穿刺针组件100的所述导电体1110可通过导电夹与所述三维定位装置200的连接尾线连接。
通过导电夹连接导电体1110和所述三维定位装置200的连接尾线的方式可能由于电连接的接触面小或者接触不稳定而影响电信号传输效果。有鉴于此，在进一步的改进中，如图7至图9所示，所述导电体1110上设置有插槽1113，所述插槽1113用于插设所述连接尾线的插针，不仅方便使用，还具有连接牢固可靠的优点。可选地，所述导电体1110包括相互连接的主体部1111和延伸部1112，其中所述主体部1111用于与所述针体1200相连接，插槽1113设置于所述延伸部1112上。进一步地，所述主体部1111与所述针体1200在轴向上连接。为了减少金属材料的使用，降低所述穿刺针组件1000的成本，并进一步提高生物安全性，所述针座1100还包括绝缘体1120。所述绝缘体1120包括第一绝缘部1120a和第二绝缘部1120b。所述延伸部1112包覆于所述第一绝缘部1120a的至少一部分上，所述主体部1111设置于所述第一绝缘部1120a和所述第二绝缘部1120b之间。通过该设计，既满足了与三维定位装置200连接方面的要求，也兼顾了生物安全性和成本问题。另一方面，通过插针与插槽1113相连接，插槽1113的槽壁皆为导电体，可进一步提高信号传输的稳定性和可靠性。
基于本发明的技术构思，本领域的技术人员还可以设计出多种针座结构，例如使得部分绝缘体包覆于导电体上，而绝缘体上设置插槽，所述插槽延伸至导电体，从而使得插入插槽的插针能够与导电体相导通，本发明对此不做限制。
请参考图1并结合图10及图12，所述扩张器2000的扩张导管2100为细 长的结构，且所述扩张导管2100的远端形成为尖端。所述扩张导管2100具有轴向贯通的第二内腔，所述扩张导管2100的内表面上还设置有台阶2110，所述台阶2110用于限制所述针体1200从所述扩张导管2100之远端伸出的长度，避免所述针体1200伸出的长度过长而带来危险。
进一步地，请参考图14-图17，所述扩张导管2100的远端上开设有与所述扩张导管2100之第二内腔连通的侧孔2120。通过该侧孔，以使所述针体1200与所述扩张导管2100外部的血液电性导通。这样一来，在所述穿刺系统100的远端进入到患者体内并寻找穿刺点的过程中，所述针体1200的远端可隐藏于所述扩张器2000的扩张导管2100内，且所述针体1200通过侧孔2120与血液电性导通而获取电信号，避免针体1200的远端在寻找穿刺点的过程中损伤人体组织。
本实施例中，所述侧孔2120的横截面可以是任何合适的形状，例如圆形(如图14和图15所示)、方形(如图16和图17所示)、腰圆形、多边形、不规则形状等。所述侧孔2120的数量可为一个，也可以是多个例如两个，两个所述侧孔2120可对称地布置在所述扩张导管2100的远端。
为了进一步增强针体1200与血液的电性导通性能，在另一实施例中，所述扩张器2000还包括弹性导电组件2200，其设置于在侧孔2120中。当血液与所述弹性导电组件2200接触时，通过所述弹性导电组件2200使得血液与所述针体1200电性导通。
请继续参考图10和图11，在一个示范性的实施例中，所述弹性导电组件2200包括第二弹性元件2210，所述第二弹性元件由金属薄片弯曲而成，并包括弧形部2211。所述弧形部2211的一端固定于所述侧孔2120处，另一端为自由端，且所述弧形部2211至少部分凸出所述扩张导管2100的内表面。在寻找穿刺点的过程中，所述弧形部2211压抵在所述针体1200的远端上，以使所述针体1200与所述弹性导电组件2200有效接触。
可选地，所述弹性导电组件2200还包括端盖2220和框架2230，所述端盖2220可与所述框架2230一体成型，或者两者为分体结构，并通过合适的连接方式例如焊接连接为一体。所述端盖2220固定于所述侧孔2120的内侧，所述弧形部2211的一端固定于所述框架2230的内侧。进一步地，如图12及 图13所示，所述弹性导电组件2200还包括限位挡片2240，所述限位挡片2240设置于所述弧形部2211上，优选所述限位挡片2240与所述弧形部2211的自由端连接。当所述针体1200与所述弧形部2211接触时，所述第二弹性元件2210在弹力的作用下使得所述限位挡片2240朝向所述端盖2220移动至所述限位挡片2240与所述端盖2220接触。因此，所述弹性导电组件2200一方面可增强所述针体1200与外部血液的导通效果，另一方面也可提升医生的使用手感。例如，针体1200的远端与所述弧形部2211接触时，所述针体1200受到所述弧形部2211给的阻力，向医生提供触觉反馈，从而及时告知医生所述针体1200的远端已到达所述侧孔处。
此外，所述侧孔2120的内壁上还可形成环形槽，所述端盖2220上可形成与所述环形槽相匹配的凸出部2221。通过所述凸出部2221与所述环形槽的配合将所述端盖2220固定于所述侧孔2120内，增强牢固性。
接着，本文将结合图2介绍采用本发明实施例所提供的穿刺系统100执行房间隔穿刺术的过程。所述房间隔穿刺术的过程如下：
步骤S1，沿右股静脉将一导丝输送至上腔静脉与锁骨下静脉交界处。
步骤S2，所述扩张器2000和一导管鞘300配合，并一起沿所述导丝进入上腔静脉。
步骤S3，回撤所述导丝，并采用肝素盐水冲洗所述导管鞘300。
步骤S4，将所述穿刺针组件1000的所述导电体1110与所述三维定位装置200连接，同时，将所述针体1200穿入所述扩张器2000的扩张导管2100内，并使所述针体1200的远端到达所述侧孔2120处，以与所述弹性导电组件2200接触，使得所述三维定位装置200对所述针体1200的远端进行定位。
步骤S5，回撤所述导管鞘300、所述扩张器2000和所述针体1200并转动所述针体1200，同时结合所述三维定位装置200中显示的图像，根据希氏束及管状静脉窦位置寻找卵圆窝。找到卵圆窝后，停止回撤所述导管鞘300、所述扩张器2000和所述针体1200。
步骤S6，寻找穿刺点，所述穿刺点位于间隔的希氏束的平齐高度往后1/3的位置处。
步骤S7，向前推送所述扩张器2000和所述导管鞘300，推送的距离约为 2-3mm。
步骤S8，固定所述导管鞘300和所述扩张器2000，根据所述三维定位装置200显示的图像，将所述针体1200向前推送约5-10mm，以使所述针体1200的远端伸出所述扩张导管2100的远端，并穿过房间隔。
步骤S9，固定所述针体1200，并向前推送所述导管鞘300和所述扩张器2000，以使所述扩张器2000的远端进入左心房。
步骤S10，将所述针体1200撤出体外，并固定扩张器2000。
步骤S11，向前推送所述导管鞘300，以使所述导管鞘300的远端进入左心房。
步骤S12，固定导管鞘300，并将所述扩张器2000撤出体外，以完成穿刺。
本发明实施例提供了一种穿刺针组件和穿刺系统，所述穿刺针组件包括针座和针体，所述针座上设有导电体，所述针体的近端延伸至所述针座内并与所述导电体连接。通过所述导电体实现所述针体与三维定位装置建立电信号连接关系，增加房间隔穿刺的安全性和成功率。所述穿刺系统包括所述穿刺针组件和扩张器，进一步地，所述扩张器包括扩张导管，所述扩张导管具有沿其轴向贯通的内腔，所述扩张导管的远端上设有与所述内腔连通的侧孔，所述侧孔内设置有弹性导电组件。在寻找穿刺点的过程中，所述针体隐藏于所述扩张导管内并利用所述弹性导电组件与扩张导管外部的血液电性导通，使得所述三维定位装置可对所述针体进行定位，避免对上腔静脉和心内膜组织造成损伤，提高安全性。
虽然本发明披露如上，但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (19)

  1. 一种穿刺针组件，其特征在于，包括针座和针体，所述针座具有轴向贯通的通道，且所述通道的至少部分侧壁被配置为导电体，所述针体的近端在所述通道内延伸，并且所述针体的近端与所述导电体电连接。
  2. 根据权利要求1所述的穿刺针组件，其特征在于，所述导电体为块状结构。
  3. 根据权利要求1或2所述的穿刺针组件，其特征在于，所述通道的全部侧壁被配置为所述导电体。
  4. 根据权利要求1或2所述的穿刺针组件，其特征在于，所述通道的一部分侧壁被配置为所述导电体，所述通道的另一部分侧壁被配置为绝缘体。
  5. 根据权利要求4所述的穿刺针组件，其特征在于，所述绝缘体具有轴向贯通的第一内腔，所述第一内腔构成部分所述通道，所述绝缘体上开设有与所述第一内腔连通的窗口，所述导电体设置于所述窗口内，所述导电体的内壁与所述第一内腔的内壁共同构成所述通道。
  6. 根据权利要求4所述的穿刺针组件，其特征在于，所述绝缘体与所述导电体沿所述针座的轴向布置并相互连接，所述通道贯穿所述绝缘体和所述导电体。
  7. 根据权利要求4所述的穿刺针组件，其特征在于，所述针体与所述绝缘体连接。
  8. 根据权利要求1所述的穿刺针组件，其特征在于，所述导电体的内壁上设有容纳槽；所述针座还包括第一弹性元件，所述第一弹性元件设置于所述容纳槽内；所述第一弹性元件被配置为存储有弹性势能以压抵所述针体，以使所述针体与所述导电体保持电性导通。
  9. 根据权利要求8所述的穿刺针组件，其特征在于，所述第一弹性元件为弹簧，且所述弹簧的轴线垂直于所述针体的轴线布置。
  10. 根据权利要求1或8所述的穿刺针组件，其特征在于，所述导电体通过导电胶层与所述针体连接。
  11. 根据权利要求1所述的穿刺针组件，其特征在于，所述导电体上设 置有插槽，所述插槽用于插接外部定位装置的连接线的插针。
  12. 根据权利要求11所述的穿刺针组件，其特征在于，所述导电体包括相互连接的主体部和延伸部，其中，所述主体部用于与所述针体相接，所述插槽设置于所述延伸部上；所述针座还包括绝缘体，所述绝缘体包括第一绝缘部和第二绝缘部，所述延伸部包覆于所述第一绝缘部的至少一部分上，所述主体部设置于所述第一绝缘部和所述第二绝缘部之间。
  13. 一种穿刺系统，其特征在于，包括扩张器和如权利要求1-12中任一项所述的穿刺针组件；所述扩张器包括扩张导管，所述扩张导管具有轴向贯通的第二内腔，所述针体的远端用于可活动地插入所述第二内腔。
  14. 根据权利要求13所述的穿刺系统，其特征在于，所述扩张导管的远端的侧壁开设有与所述第二内腔连通的侧孔。
  15. 根据权利要求14所述的穿刺系统，其特征在于，所述扩张器还包括弹性导电组件，所述弹性导电组件设置于所述侧孔内，且所述弹性导电组件用于与所述针体接触并通过弹性力压抵所述针体。
  16. 根据权利要求15所述的穿刺系统，其特征在于，所述弹性导电组件包括第二弹性元件，所述第二弹性元件包括弧形部，所述弧形部的一端固定于所述侧孔处，另一端为自由端，且所述弧形部至少部分凸出于所述扩张导管的内表面。
  17. 根据权利要求16所述的穿刺系统，其特征在于，所述弹性导电组件还包括端盖和框架，所述端盖设置于所述侧孔内，所述框架与所述端盖相连接，并设置在所述端盖与第二内腔之间，所述弧形部与所述框架连接。
  18. 根据权利要求17所述的穿刺系统，其特征在于，所述弹性导电组件还包括限位挡片，所述限位挡片设置于所述弧形部上；当所述针体与所述弧形部接触时，所述限位挡片与所述端盖接触。
  19. 根据权利要求18所述的穿刺系统，其特征在于，所述侧孔的内壁上还形成有环形槽，所述端盖包括与所述环形槽相匹配的凸出部，所述凸出部固定于所述环形槽内。
PCT/CN2021/092514 2020-05-12 2021-05-08 一种穿刺针组件及穿刺系统 WO2021228003A1 (zh)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US17/925,197 US20230190332A1 (en) 2020-05-12 2021-05-08 Puncture needle assembly and puncture system
EP21803771.1A EP4137074A4 (en) 2020-05-12 2021-05-08 PUNCTURE NEEDLE ARRANGEMENT AND PUNCTURE SYSTEM

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202010399181.5A CN111557713A (zh) 2020-05-12 2020-05-12 一种穿刺针组件及穿刺系统
CN202010399181.5 2020-05-12

Publications (1)

Publication Number Publication Date
WO2021228003A1 true WO2021228003A1 (zh) 2021-11-18

Family

ID=72068147

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2021/092514 WO2021228003A1 (zh) 2020-05-12 2021-05-08 一种穿刺针组件及穿刺系统

Country Status (4)

Country Link
US (1) US20230190332A1 (zh)
EP (1) EP4137074A4 (zh)
CN (1) CN111557713A (zh)
WO (1) WO2021228003A1 (zh)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111557713A (zh) * 2020-05-12 2020-08-21 上海微创电生理医疗科技股份有限公司 一种穿刺针组件及穿刺系统
CN115919431B (zh) * 2023-03-09 2023-06-09 上海微创电生理医疗科技股份有限公司 房间隔穿刺装置

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106618685A (zh) * 2015-10-30 2017-05-10 四川锦江电子科技有限公司 一种用于房间隔穿刺的鞘管
CN107280714A (zh) * 2017-06-27 2017-10-24 李毅刚 血管介入诊疗系统
CN107693089A (zh) * 2016-08-09 2018-02-16 上海交通大学医学院附属新华医院 三维房间隔穿刺系统
US20190350569A1 (en) * 2003-01-30 2019-11-21 Integrated Vascular Systems, Inc. Clip applier and methods of use
CN110547857A (zh) * 2018-05-30 2019-12-10 蔡衡 三维房间隔穿刺组件
CN111557713A (zh) * 2020-05-12 2020-08-21 上海微创电生理医疗科技股份有限公司 一种穿刺针组件及穿刺系统

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NO20010184A (no) * 2001-01-11 2002-04-22 Medinnova As Anordning for lokalisering av fossa ovalis
US10493259B2 (en) * 2003-01-21 2019-12-03 Baylis Medical Company Inc. Medical apparatus for fluid communication

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190350569A1 (en) * 2003-01-30 2019-11-21 Integrated Vascular Systems, Inc. Clip applier and methods of use
CN106618685A (zh) * 2015-10-30 2017-05-10 四川锦江电子科技有限公司 一种用于房间隔穿刺的鞘管
CN107693089A (zh) * 2016-08-09 2018-02-16 上海交通大学医学院附属新华医院 三维房间隔穿刺系统
CN107280714A (zh) * 2017-06-27 2017-10-24 李毅刚 血管介入诊疗系统
CN110547857A (zh) * 2018-05-30 2019-12-10 蔡衡 三维房间隔穿刺组件
CN111557713A (zh) * 2020-05-12 2020-08-21 上海微创电生理医疗科技股份有限公司 一种穿刺针组件及穿刺系统

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP4137074A4 *

Also Published As

Publication number Publication date
EP4137074A1 (en) 2023-02-22
EP4137074A4 (en) 2023-12-06
US20230190332A1 (en) 2023-06-22
CN111557713A (zh) 2020-08-21

Similar Documents

Publication Publication Date Title
EP2018208B1 (en) Transseptal needle assemblies and methods
CA2134909C (en) Guiding introducer for left atrium
US5911720A (en) Ablation catheter with segmented tip
US9615759B2 (en) Devices and methods for ECG guided vascular access
US5810730A (en) Guiding introducer for right atrium
US5628316A (en) Guiding introducer system for use in the right atrium
WO2021228003A1 (zh) 一种穿刺针组件及穿刺系统
BR112020022839A2 (pt) métodos e dispositivos para puncionamento de tecidos
JP4722441B2 (ja) 心中隔への穿通用及び経中隔装置の留置、特に刺激プローブの左心腔への留置用キット
CA2140389A1 (en) Guiding introducer system for use in left atrium
JPH0947513A (ja) 後退接近法で僧帽弁周辺の付属経路を処置するための誘導導入器
CN107693089A (zh) 三维房间隔穿刺系统
JP2020081884A (ja) 肥厚性心筋症手術用ｒｆ電極切除カテーテルおよび使用方法
WO2019196294A1 (zh) 三维房间隔穿刺用导丝
JP2022552175A (ja) 医療用ガイドワイヤアセンブリ及び／又は電気コネクタ
JP2002126096A (ja) 電極を備えたカテーテル装置
KR102406831B1 (ko) 비후성 심근증 시술용 ｒｆ 전극절제 카테터
CN212415859U (zh) 一种穿刺针组件及穿刺系统
JP2023547183A (ja) 感知機能を有する電気外科手術装置
KR102406833B1 (ko) 쿨링기능을 지닌 심실중격 시술용 ｒｆ 전극절제 카테터
WO2019196293A1 (zh) 三维房间隔穿刺用扩张器
CN220546307U (zh) 一种用于定位引导和穿刺的多用途电极
CN217828018U (zh) 一种三维房间隔穿刺组件
CN117481790B (zh) 一种双环高密度标测消融导管
CN220558071U (zh) 穿刺装置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21803771

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2021803771

Country of ref document: EP

Effective date: 20221118

NENP Non-entry into the national phase

Ref country code: DE