WO2018103570A1 - 一种两半双模式无刀穿刺针和穿刺器 - Google Patents

一种两半双模式无刀穿刺针和穿刺器 Download PDF

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Publication number
WO2018103570A1
WO2018103570A1 PCT/CN2017/113726 CN2017113726W WO2018103570A1 WO 2018103570 A1 WO2018103570 A1 WO 2018103570A1 CN 2017113726 W CN2017113726 W CN 2017113726W WO 2018103570 A1 WO2018103570 A1 WO 2018103570A1
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WIPO (PCT)
Prior art keywords
distal end
movable
fixed
puncture
distal
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PCT/CN2017/113726
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English (en)
French (fr)
Inventor
朱莫恕
Original Assignee
成都五义医疗科技有限公司
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Publication date
Application filed by 成都五义医疗科技有限公司 filed Critical 成都五义医疗科技有限公司
Publication of WO2018103570A1 publication Critical patent/WO2018103570A1/zh
Priority to US16/435,454 priority Critical patent/US20190321078A1/en

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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
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
    • A61B17/3496—Protecting sleeves or inner probes; Retractable tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
    • 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
    • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3419—Sealing means between cannula and body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3454—Details of tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3454—Details of tips
    • A61B2017/3456—Details of tips blunt

Definitions

  • the present invention relates to a minimally invasive surgical instrument, and more particularly to a puncture needle structure.
  • a trocar is a surgical instrument used to create an artificial passage into a body cavity during minimally invasive surgery (especially for hard laparoscopic surgery).
  • the trocar usually consists of a cannula assembly and a puncture needle.
  • the general clinical use is as follows: firstly cut a small mouth on the patient's skin, and then pass the puncture needle through the cannula assembly, the distal end of the puncture needle exceeds the distal end of the cannula assembly, and then penetrates through the body wall through the skin opening. Body cavity.
  • the puncture needle usually includes a protective sleeve that can be selectively moved axially and an automatic locking device, which is called a knife-proof automatic protection puncture needle (hereinafter referred to as a protective puncture needle).
  • the protective puncture needle has a locked state and a released state: when in the released state, the protective sleeve can be retracted from the distal end to the proximal end to expose the blade; when in the protective state, the protective cover cannot be moved from the distal end to the distal end The proximal end is retracted and the blade is covered by a protective sleeve.
  • the automatic locking device is triggered almost simultaneously, thereby quickly and automatically switching from the released state to the protected state. That is, at the moment of penetrating the body wall, the protective cover moves almost to the distally covering blade and locks, thereby preventing the blade from being exposed to cause accidental damage.
  • the protective sleeve moves from the proximal end to the distal end to cover the blade and The process of locking is also delayed.
  • the delay in stopping the puncture operating force increases the risk of damage to the internal organs or tissues of the patient by the distal end of the puncture needle.
  • the process of using a puncture needle to penetrate a patient's body wall is complicated and hides many risks.
  • a comprehensive analysis of the abdominal wall anatomy and puncture mechanics helps to find a better solution.
  • the abdominal wall anatomy in general, the abdominal wall of the human body is skin, fat layer, muscle layer and peritoneum from the outside to the body.
  • the blade 10 protecting the needle extends beyond the distal end 20 of the sheath, the distal end 20 extending beyond the distal end 30 of the cannula assembly.
  • the puncturing device and the abdominal wall form an angle of 30 to 60°.
  • the skin has good elasticity and strength.
  • the skin at the puncture site is usually cut first, and the width of the incision is about 1.5 times the maximum diameter of the puncture device, and the puncture and swelling resistance of the skin at the time of puncture is not or Very small.
  • the thickness of the peritoneum is thin, about 1 mm, and the thickness of the muscle layer is usually 10 to 15 mm.
  • the thickness of the fat layer varies greatly depending on the degree of obesity, and is usually 15 to 40 mm.
  • the fat layer is relatively loose, the strength of puncturing and expanding the fat layer is moderate; the muscle layer is relatively dense, the strength of puncturing and expanding the muscle layer is greater; the peritoneal elasticity is better, and the strength of puncturing and expanding the peritoneum is greater.
  • the process of penetrating the abdominal wall can be subdivided into seven stages: Stage 1, the blade 10 pierces and expands the fat layer (resistance F T10 ), the distal end of the sheath 20 and the distal end of the cannula assembly 30 is bare on the outside of the skin; in stage 2, the blade 10 pierces and expands the muscle layer (resistance F T10 ), the distal end 20 expands the fat layer (resistance FT20 ), the distal end 30 is exposed on the outside of the skin; in the third stage, the blade 10 continues Completely pierce the muscle layer (resistance F T10 ), the distal end 20 expands the muscle layer (resistance F T20 ), the distal end 30 expands the fat layer (resistance F T30 ); in the fourth stage, the blade 10 pierces the peritoneum (resistance F T10 ), The distal end 20 continues to expand the muscle layer (resistance F T10 ), the peritone
  • F i F T10 + F T20 + F T30
  • F T10 resistance to the blade 10
  • F T10 resistance to the distal end 20
  • F T10 resistance to the distal end 30
  • F T10 resistance to the distal end 30
  • the puncture operating force F i applied by the doctor is equal to the resistance received by the puncture needle, and the movement of the puncture needle is smooth or approximately uniform.
  • the doctor needs to gradually increase the puncture operation force F i to overcome the resistance and force the puncture needle to continue to penetrate into the tissue; to the fifth stage, due to the blade 10 has penetrated the peritoneum into the abdominal cavity, the resistance of the puncture needle is reduced, and the puncture operation force F i applied at this time should be correspondingly reduced.
  • the doctor cannot perceive the moment when the distal end pierces the peritoneum, the actual puncture operation force is applied.
  • the Fr continues to increase, causing the distal end 20 and the distal end 30 to accelerate the completion of the sixth stage, resulting in an increase in the speed and depth of the entire stage 7 puncture needle and cannula assembly into the abdominal cavity, resulting in impact of the protective sleeve on the internal organs and tissues of the patient. Larger, which increases the risk of injury.
  • a blade-free puncture needle (hereinafter referred to as a knife-free puncture needle) is advantageous in reducing damage to the patient.
  • a knife-free puncture needle As described above, when the abdominal wall puncture is performed with a knife-protecting puncture needle, the blade pierces and cuts muscles and tissues; and when the puncture needle is used for abdominal wall puncture, since the blade is not sharp, the distal end of the puncture Break muscles and tissue and tear apart muscle fibers and inflate the wound until the needle and cannula assembly pass through the abdominal wall as a whole.
  • the knifeless puncture needle reduces the cutting damage to the muscle tissue relative to the protective puncture needle, is beneficial to postoperative recovery, and is beneficial to reduce the probability of incisional hernia complications.
  • a knifeless puncture needle in one aspect of the invention, includes a handle portion and a distal portion and a stem portion therebetween, the stem portion including a central axis.
  • the distal portion includes a fixed half and an active half.
  • the fixed half extends proximally from the distal end and is secured to the stem portion or handle portion, and the movable half is movable relative to the fixed half edge in the central axis direction.
  • the fixed half includes a fixed base and a fixed angled distal end joined thereto and extending to a fixed tip, the movable half comprising a movable base and an active inclined distal end connected thereto and extending to the movable tip, the movable half comprising blunt Separation edge and blunt tip.
  • the fixed half includes both a sharp separating edge and a sharp tip.
  • the fixed half comprises a sharp separating edge and a blunt tip.
  • the fixed half comprises a blunt separating edge and a sharp tip.
  • the movable half is moved from the proximal end to the distal end along the central axis until the movable tip completely exceeds the fixed tip, and any transverse plane perpendicular to the central axis is simultaneously
  • the fixed inclined distal end and the movable inclined distal end intersect to form a fixed inclined distal end cross section and a movable inclined distal end cross section, the fixed inclined distal end cross section having a width dimension smaller than a width dimension of the movable inclined distal end cross section
  • the thickness of the fixed oblique distal end cross section is smaller than the thickness dimension of the active inclined distal end cross section.
  • the movable half is moved from the distal end to the proximal end along the central axis until the fixed tip completely exceeds the movable tip, and any transverse plane perpendicular to the central axis is simultaneously
  • the fixed inclined distal end and the movable inclined distal end intersect to form a fixed oblique distal end cross section and a movable inclined distal end cross section, the fixed oblique distal end cross section having a width dimension greater than a width dimension of the movable inclined distal end cross section
  • the thickness of the fixed oblique distal end cross section is smaller than the thickness dimension of the active inclined distal end cross section.
  • the knifeless needle distal portion further includes a coupling device, the distal portion further comprising a coupling device that connects the fixed half and the movable half together
  • the connecting means allows a translational movement of the movable half in the direction of the central axis while limiting the displacement of the movable half in a direction perpendicular to the central axis.
  • the puncture needle includes a locked state and a released state, the locked state That is, the movable half is locked from being movable from the distal end to the proximal end, and the released state, that is, the movable half is movable from the distal end to the proximal end; wherein the locked state and the released state are achieved by a locking mechanism, the locking The mechanism includes at least a locking portion, a releasing portion and a trigger portion.
  • the puncture needle includes a sharp mode and a blunt mode; in the sharp mode, the movable half moves proximally along the central axis until the sharp separation blade and/or sharp a blunt separating edge and a blunt tip that extend beyond the corresponding movable half; in the blunt mode, the movable half moves distally along the central axis until the blunt separating edge and the blunt tip of the movable half are completely After the corresponding sharp separation edge and/or sharp tip is covered, the active half is locked.
  • a trocar includes a cannula assembly and any of the aforementioned lancets.
  • a trocar includes a dual mode knifeless needle and a cannula assembly that penetrates the cannula assembly and together performs a puncturing operation through a skin incision at a patient puncture point, the working state of the puncture needle including a sharp mode And the blunt mode, when the doctor predicts that the puncture force is large, the sharp mode can be used for puncture; when the doctor predicts that the puncture force is small, the puncture mode is used for puncture.
  • Figure 1 is a cross-sectional view of a human abdominal wall and a puncture diagram
  • Figure 2 is a force analysis diagram of the puncture process
  • Figure 3 is a side elevational view of the trocar assembly of the first embodiment of the present invention.
  • Figure 4 is a rear perspective view of the trocar assembly of the first embodiment of the present invention.
  • Figure 5 is a perspective exploded view of the puncture needle shown in Figure 4.
  • Figure 6 is a detailed perspective view of the distal half of the fixed half of the puncture needle shown in Figure 5;
  • Figure 7 is a detailed perspective view of the movable half of the puncture needle shown in Figure 5;
  • Figure 8 is a perspective assembled view of the initial locking state of the puncture needle shown in Figure 5;
  • Figure 9 is a perspective assembled view of the release state of the puncture needle shown in Figure 5;
  • Figure 10 is a longitudinal cross-sectional view of the puncture needle shown in Figure 8.
  • Figure 10A is a schematic cross-sectional view of 10A-10A of Figure 10;
  • Figure 10B is a schematic cross-sectional view of 10B-10B of Figure 10;
  • Figure 10C is a schematic cross-sectional view of 10C-10C of Figure 10;
  • Figure 10D is a schematic cross-sectional view of 10D-10D of Figure 10;
  • Figure 10E is a schematic cross-sectional view of 10E-10E of Figure 10;
  • Figure 11 is a longitudinal cross-sectional view of the puncture needle of Figure 5 in a sharp mode
  • Figure 11A is a schematic cross-sectional view of 11A-11A of Figure 11;
  • Figure 11B is a schematic cross-sectional view of 11B-11B of Figure 11;
  • Figure 11C is a schematic cross-sectional view of 11C-11C of Figure 11;
  • Figure 11D is a schematic cross-sectional view of 11D-11D of Figure 11;
  • Figure 11E is a schematic cross-sectional view of 11E-11E of Figure 11;
  • Figure 12 is a front elevational view of the puncturing device of Figure 3 in a sharp mode
  • Figure 13 is a side elevational view of the puncturing device of Figure 3 in a sharp mode
  • Figure 14 is a partial enlarged view of the distal half of the movable half in the further connection scheme
  • Figure 15 is a perspective view of the locking piece in still another connection scheme
  • Figure 16 is a partial enlarged view of the distal half of the fixed half in the further connection scheme
  • Figure 17 is a perspective partial cross-sectional view of the distal end portion of the puncture needle in still another connection scheme
  • Figure 18 is a partial enlarged view of the distal half of the fixed half in still another embodiment
  • Figure 19 is a partial enlarged view of the distal half of the fixed half in still another embodiment
  • Figure 20 is a partial enlarged view of the distal half of the fixed half in still another embodiment
  • Figure 21 is a partial enlarged view of the distal half of the fixed half in still another embodiment
  • Figure 22 is a partial enlarged view of the distal half of the fixed half in still another embodiment
  • Figure 22A is a schematic cross-sectional view of 22A-22A of Figure 22;
  • Figure 23 is a partial enlarged view of the distal half of the fixed half in still another embodiment
  • Figure 23A is a schematic cross-sectional view of 23A-23A of Figure 23;
  • Figure 24 is a partial enlarged view of the distal half of the fixed half in still another embodiment
  • Figure 24A is a schematic cross-sectional view of 24A-24A of Figure 24;
  • Figure 25 is a partial enlarged view of the distal half of the movable half in still another embodiment
  • Figure 25A is an axial cross-sectional view of the movable half of Figure 25;
  • Figure 26 is a partial enlarged view of the distal half of the movable half in still another embodiment
  • Figure 26A is an axial cross-sectional view of the movable half of Figure 26;
  • Figure 27 is a partial enlarged view of the distal half of the movable half in still another embodiment
  • Figure 27A is an axial cross-sectional view of the movable half of Figure 27.
  • FIG. 3-4 depict the overall structure of the trocar.
  • a typical trocar includes a cannula assembly 100 and a puncture needle 200.
  • the cannula assembly 100 includes a sealed cartridge 110 and a venting valve 120.
  • the sealed chamber 110 includes a casing top surface 111 (not shown) and a central through hole 113 (not shown), typically a zero seal (also known as an automatic seal) and a sealing membrane (also known as an instrument seal) from the distal end to the near end
  • the ends are sequentially installed in the sealed chamber 110.
  • the zero seal typically does not provide a seal for the insertion instrument and automatically closes and forms a seal when the instrument is removed.
  • the sealing film tightens the instrument and forms a seal when the instrument is inserted.
  • the sleeve 130 includes an open distal end 131 and a hollow tube 133 that communicates with the sealed cartridge 110.
  • the puncture needle 200 can be primarily divided into a handle portion 202, a stem portion 204 and a distal portion 206.
  • the handle portion includes a handle top surface 291 and a handle bottom surface 213.
  • the puncture needle 200 extends through the cannula assembly 100, and the cannula top surface 111 is in contact with the handle bottom surface 213.
  • One side of the sleeve assembly 100 that defines the venting valve 120 is a front side 107, the opposite side of which is a back side 108, and sides of which are sides 109.
  • the front face 207, the rear face 208, and the left and right side faces 209 of the puncture needle are defined in accordance with the positional relationship when the puncture needle 200 is mated with the cannula assembly 100.
  • the doctor's finger grips the sealed chamber 110, and the palm is placed against the top surface 291 and the rear surface 208 of the handle, and the puncture operation force is continuously applied to penetrate the patient's body wall. Once the body wall is completely penetrated, the puncture needle is removed, leaving the cannula assembly as a passage for the instrument to enter and exit the body cavity.
  • the subsequent one that is close to the operator is defined as the proximal end, and the side that is remote from the operator is defined as the distal end, and the central axis defining the puncture needle bar portion 204 is the axis 201 (not shown), and subsequently the substantially parallel axis
  • the direction of 201 is referred to as the axial direction, and the direction of the substantially vertical axis 201 is referred to as the lateral direction.
  • Figures 5-10 detail the structural and assembly relationship of the two-half dual mode knifeless needle 200 of the first embodiment of the present invention.
  • the distal end portion 206 of the puncture needle 200 includes a fixed half 210 and a movable half 240.
  • the fixed half 210 includes a proximal flange 212 and a fixed distal half 218.
  • the distal half 218 includes a base 220 and a sharpened tip 229 and a fixed angled distal end 221 that connects the two.
  • the central plane 222 is generally parallel to the axis 201 and intersects the base 220, the angled distal end 221 and the sharpened tip 229.
  • the base body 220, the inclined distal end 221 and the sharp top end 229 are all located on the same side of the central plane 222.
  • the base body 220 includes a cylindrical outer surface 223, that is, the outer shape of the base body 220 is approximately half of a cylinder.
  • the angled distal end 221 includes an outer curved surface 224 and a transition curved surface 225.
  • the outer curved surface 224 is connected to the outer surface 223 and extends obliquely toward the sharp top end 229. Referring to FIG. 10, the longitudinal section of the axis 201 intersects the outer curved surface 224, and the intersection line has a concave surface. The arc.
  • the outer curved surface 224 includes a laterally convex curved surface that is substantially perpendicular to the axis
  • An arbitrary cross section of line 201 intersects said angled distal end 221 to form a fixed oblique distal end cross section (as in Figures 10A, 10B, 10C, 10D) comprising an approximately elliptical arc and the width and thickness of its cross section. Gradually increasing from the distal end to the proximal end.
  • the transition surface 225 is connected to the outer surface 223 and extends toward the sharp tip 229 and its lateral width gradually decreases.
  • the transition surface 225 side intersects the central plane 222 and the other side intersects the outer curved surface 224 to form two generally symmetrical separation edges 226.
  • the separation blade 226 has a small thickness in the vicinity of the sharp tip 229, and its outer shape is approximately a blade shape, which is called a sharp separation blade; and the region away from the sharp tip 229 has a larger thickness of the separation blade 226.
  • the shape is not like a blade shape, called a blunt separating edge.
  • the center plane 222 extends from the sharp tip 229 toward the base 220, its lateral width gradually increases, that is, the spacing between the two separating blades 226 gradually widens from the distal end to the proximal end.
  • the center plane 222 further includes a recess 227 from which two approximately symmetrical snaps 228 extend laterally outwardly and beyond the center plane 222.
  • the buckle 228 includes a hook 228a and a straight arm 228b.
  • the distal half 218 also includes a distal limit 219.
  • the movable half 240 includes a proximal end 242 and a movable distal half 248.
  • the distal half 248 includes a base 250 and a blunt tip 259 and a movable angled distal end 251 connecting the two.
  • the center plane 252 is generally parallel to the axis 201 and intersects the base 250, the angled distal end 251 and the blunt tip 259.
  • the base body 250, the inclined distal end 251 and the blunt tip 259 are all located on the same side of the central plane 252.
  • the base 250 comprises a cylindrical outer surface 253, i.e. the outer shape of the base 250 is approximately half of a cylinder.
  • the angled distal end 251 includes an outer curved surface 254 and a transition curved surface 255.
  • the outer curved surface 254 is connected to the outer surface 253 and extends obliquely toward the blunt tip 259. Referring to FIG. 10, the longitudinal section of the axis 201 intersects the outer curved surface 224, and the intersection line has a concave surface.
  • the outer curved surface 254 includes a laterally convex curved surface, i.e., an arbitrary oblique cross-section substantially perpendicular to the axis 201 intersecting the inclined distal end 251 to form a movable oblique distal cross-section (Fig. 10A, 10B, 10C).
  • the transition curved surface 255 is connected to the outer surface 253 and extends toward the blunt tip 259 and its lateral width gradually decreases.
  • the transition surface 255 side intersects the central plane 252 and the other side intersects the outer curved surface 254 to form two generally symmetrical blunt blunt separating edges 256.
  • the central plane 252 gradually increases in lateral width as it extends from the blunt tip 259 toward the base 250, i.e., the spacing between the two blunt separating edges 256 gradually widens from the distal end to the proximal end.
  • the center plane 252 further includes a recess 257 from which the two approximately symmetrical slots 258 penetrate laterally outwardly from the central recess 227 and the cylindrical outer surface 253.
  • the card slot 258 includes a mating plane 258a.
  • the fixed half 210 further includes a hollow stem 214 that extends from the distal half 218 to the proximal flange 212.
  • the hollow rod 214 includes an axial bore that axially penetrates the proximal flange 212 215.
  • the first U-shaped groove 216a transversely cuts the hollow rod 214 and communicates with the shaft hole 215.
  • the second U-shaped groove 216c transversely cuts the hollow rod 214 and communicates with the first U-shaped groove 216a, and the second U-shaped groove 216c
  • the depth is greater than the depth of the first U-shaped groove 216a, and the first U-shaped groove 216a and the second U-shaped groove 216c intersect to form a step 216b.
  • the second U-shaped groove 216c extends to the distal stop surface 217.
  • the first U-shaped groove 216a and the second U-shaped groove 216c constitute an open hollow tube 216.
  • the proximal flange 212 includes an upper surface 211 and a handle bottom surface 213.
  • the proximal flange 212 further includes a reset mount 231 protruding from the upper surface 211 toward the proximal end, a guide rib 232, a lock tooth 234, and a fixing post 236.
  • the locking teeth 234 include a locking surface 233 and a pushing surface 235, and the locking surface 233 is tangent to the shaft hole 215.
  • the proximal flange 212 also includes a lock guide slot 237 and a notch 238.
  • the movable half 240 further includes a transverse wall 249 that intersects the distal half 248.
  • One end of the shaft 242 intersects the transverse wall 249 to form a limit 245, and the other end extends axially to the proximal end 241.
  • One end of the U-shaped block 244 intersects the transverse wall 249 and the other end thereof extends proximally and parallel and partially intersects the axis 242.
  • the stop 246 is connected at one end to the U-shaped block 244 and at the other end to the proximal end 247.
  • the stop 246 is generally parallel to and does not intersect the shaft 242, which intersects the U-shaped block 244 to form a step 243.
  • a thrust spring 281 is mounted to the shaft 242 of the movable half 240 and mounted together into the fixed half 210.
  • the shaft 242 mates with a shaft bore 215 that mates with the second U-shaped groove 216c that matches the center plane 222.
  • Pressing the distal half 248 firmly causes the buckle 228 to elastically deform and completely pass through the slot 258, and then the buckle 228 rebounds, the hook 228a and the mating plane 258a match (refer to FIG. 10E)
  • the distal half 248 is not laterally disengaged.
  • the length of the slot 258 in the axial direction is greater than the length of the buckle 228 in the axial direction, so that the movable half 240 can move in the axial direction.
  • the proximal end is moved distally and locked such that the distal half 248 completely covers the distal half 218, referred to as a blunt mode (see Figures 3, 4 and 10).
  • the sharp tip 229 and the separation edge 226 are exposed outside of the distal half 248, referred to as a sharp mode (see Figure 11).
  • the thrust spring 281 is mounted between the step 216b and the step 243 and is in a compressed state.
  • the distal half 248 When the distal half 248 does not receive an axial compressive force from the distal end to the proximal end (or a small force), the distal end The half 248 moves from the proximal end to the distal end under the axial thrust generated by the thrust spring 281 and completely covers the distal half 218.
  • the puncture needle 200 also includes a locking mechanism 280 for effecting switching between a blunt mode and a sharp mode.
  • the lock member 270 has a proximal end surface 271 and a distal end surface 279.
  • the lock member 270 includes a release end 273 and a locking end 274.
  • the two guide walls 272 connect the release end 273 and the locking end 274 together to form an approximately rectangular cavity that includes at the locking end 274 Semi-circular through hole.
  • the release end 273 includes a trigger arm 276 that extends from the release end 273 toward the interior of the cavity, the trigger arm 276 including release Hook 277.
  • the release end 273 also includes a button 278.
  • the locking end 274 includes a transverse axis 275.
  • the handle compartment 290 includes a handle top surface 291, a side wall 292 and a button cutout 293.
  • the handle compartment 290 also includes four hollow posts 296 with blind holes (see Figure 8) and a plurality of axial stop ribs.
  • the lock member 270 is mounted to the proximal flange 212, wherein the guide wall 272 mates with the guide rib 232, the distal end face 279 mates with the upper face 211 to cause a lock
  • the piece 270 is slidable along the guide rib 232 in the plane defined by the upper surface 211.
  • One end of the return spring 282 is mounted in the fixed seat 231, and the other end thereof is mounted on the horizontal shaft 275 and is in a compressed state.
  • the handle housing is mounted to the proximal flange 212, the four fixing posts 236 are aligned with the blind holes of the four hollow posts 296 and are interference fit, and the plurality of axial limiting ribs respectively define the locking member 270 And axial displacement of the return spring 282.
  • the axial limit ribs can be made to achieve the function that the lock member 270 can slide along the guide rib 232 in the plane defined by the upper surface 211 and The axial direction (direction of the parallel axis 201) is sufficiently small; the return spring 282 is free to stretch and deform and its axial direction (direction of the parallel axis 201) is sufficiently small. Due to space limitations and to simplify the description, the structure of the axial stop ribs is not disclosed in detail in the drawings of the present invention.
  • the return spring 282 is in a compressed state with a lateral relief tension that urges the lock member 270 to slide along the guide rib 232 toward the outermost direction of the handle compartment 290 to the extreme end. And the locking end 274 just blocks the shaft hole 215, and the release hook 277 is not in contact with the locking tooth 234. Call it the locked state.
  • the movable half 240 moves in the axial direction from the proximal end to the distal end and is locked, the distal half 248 completely covering the distal half 218, ie the distal end of the puncture needle 200 206 is in blunt mode (ie, does not trigger the locking mechanism).
  • the locking end 274 has been removed to expose the shaft hole 215, and the proximal end 241 of the movable half 240 can be moved from the distal end to the proximal end, which is called a release state.
  • the relaxation tension of the return spring 282 pushes the lock member 270 to slide along the direction of the guide rib 232 toward the outside of the handle housing 290, and the lock is caused by the hook 277 engaging the locking surface 233.
  • Piece 270 cannot slide and is in a steady state.
  • Puncture state in sharp mode Referring to Figures 3 and 4, the knifeless puncture needle 200 penetrates through the cannula assembly 100 and then punctures together through the skin incision at the puncture site. Pressing button 278 as described above causes the puncture needle The 200 is in a released state, and when the distal half 248 is subjected to an axial compressive force, the movable half 240 moves from the distal end to the proximal end to expose the sharp tip 229 and the separation edge 226 of the distal half 218.
  • the proximal end 241 of the movable half 240 contacts the release hook 277, and continued motion forces the trigger arm 276 to deform and release the hook 277 to produce axial displacement from the distal end to the proximal end to disengage from the lock tooth 234, ie, the lock member Released; state 2, with reference to Figure 11, the proximal end 241 continues to move from the distal end to the proximal end of the stroke, at which point the release hook 277 has been completely disengaged from the lock retaining position 224, and the lock member 270 is at the return spring 282.
  • the thrust is slid along the direction of the guide rib 232 toward the outside of the handle compartment 290 until the locking end 274 is blocked by the proximal end 241; the distal end portion 206 of the puncture needle 200 in state 1 and state 2 is in a sharp mode.
  • State 3 once the puncture needle has completely penetrated the body wall, the lateral pressure and axial resistance experienced by the distal half 248 disappear, and the movable half 240 rapidly moves distally to the end under the thrust of the thrust spring 281.
  • the locking member 270 slides along the guiding rib 232 toward the outer direction of the handle housing 290 under the action of the return spring 282 until the locking end 274 blocks the axial hole 215, so that the proximal end 241 cannot be distally to the proximal end.
  • the distal portion 206 of the puncture needle transitions from a sharp mode to a blunt mode. That is, when the puncture needle continues to move toward the body cavity and contacts the organ or tissue in the body cavity, the sharp tip 229 and the separation blade 226 are not exposed, and only the blunt tip 259 and the blunt separating blade 256 contact the organ or tissue in the cavity.
  • the locking mechanism 280 is comprised of a lock member 270 and a lock tooth 234 that enable mutual switching between the blunt mode and the sharp mode.
  • the locking mechanism 280 can be implemented in a variety of ways. Since the first protection of the puncture needle has been disclosed in US Pat. No. 4,453,773, the designers have successively disclosed a large number of protection modes for protecting the puncture needle (ie, the protective sleeve protecting the puncture needle is locked) and the release mode (ie, protection puncture).
  • a locking mechanism for switching between the protective sleeves of the needles it will be readily understood by those skilled in the art that a simple adaptive modification of the disclosed locking mechanism can be used between the sharp mode and the blunt mode of the present invention. Switch between each other. Other similar locking mechanisms are also conceivable to those skilled in the art.
  • the fixed distal half 218 has a cross-sectional thickness that is less than the cross-sectional thickness of the distal half 248, and the distal half 218 has a cross-sectional width that is less than The cross-sectional width of the distal half 248 is described. Referring to FIG. 10A, cross section 10B and cross section 10C, the fixed distal half 218 has a cross-sectional thickness that is less than the cross-sectional thickness of the distal half 248, and the distal half 218 has a cross-sectional width that is less than The cross-sectional width of the distal half 248 is described. Referring to FIG.
  • the axis 201 substantially perpendicular to the transverse plane Y 1 as the inclined distal end 221 and the base 250 that intersects the intersection of the cross-section 10D, the distal end of the cross-sectional thickness less than half of the 218
  • the cross-sectional thickness of the distal distal half 248 is described, and the cross-sectional width of the distal half 218 is approximately equal to the cross-sectional width of the distal half 248 (when the cross-sectional thickness and width are compared, the dimples 227 and concave are ignored)
  • the gap formed by the pit 257) is described, and the cross-sectional width of the distal half 218 is approximately equal to the cross-sectional width of the distal half 248 (when the cross-sectional thickness and width are compared, the dimples 227 and concave are ignored)
  • the knifeless puncture needle 200 passes through the cannula assembly 100 and is in a blunt mode, and then together into the body through the skin incision at the puncture site puncture.
  • the blunt tip 259 helps to pierce or separate tissue
  • the blunt separating edge 256 helps to tear tissue.
  • the cross-sectional width and thickness of the distal half 218 as described above is less than the width and thickness of the corresponding cross-section of the distal half 248, which is advantageous when the blunt tip 259 pierces the tissue or the blunt separating edge 256 tears the tissue.
  • the resistance of the inclined distal end 221 and the inclined distal end 251 to expand the tissue in the same time is reduced, thereby reducing the overall puncture operation force.
  • the inclined distal end 221 and the inclined distal end 251 have a structure that gradually increases from the distal end to the proximal end, contributing to reducing the resistance of the expanded tissue. More specifically, the cross-sectional thickness of the distal half 218 is smaller than the corresponding cross-sectional thickness of the distal half 248, and the structure gradually increases from the distal end to the proximal end, which is advantageous for dispersing the puncture force and the tearing force. Expansion power.
  • the blunt-ended knifeless puncturing device disclosed in the prior art generally has no dispersing puncture force, tearing force, and expansion force structure, and thus has a large puncture force, and is usually only used for cutting by Hansson and has been cut by a doctor. Muscle tissue.
  • a substantially transverse plane X 2 is substantially perpendicular to the inclined distal end 221 and the inclined distal end 251 to form a cross section 11B and a cross section 11C.
  • the fixed distal half 218 has a cross-sectional thickness that is less than the cross-sectional thickness of the movable distal half 248, but the distal half 218 has a cross-sectional width that is greater than the distal end.
  • the cross-sectional width of the half 248 Referring to FIG. 11 and FIG.
  • the knifeless puncture needle 200 extends through the cannula assembly 100, as described above, by pressing a button 278 to cause the puncture
  • the needle 200 is in a released state and then punctures together through the skin incision at the puncture site.
  • the distal half 248 is subjected to an axial force from the distal end to the proximal end, and the movable half 240 is moved from the distal end to the proximal end to the end of the stroke, exposing Sharp tip 229 and separation blade 226.
  • the sharp tip 229 helps to pierce or separate tissue, and the separation blade 226 helps to tear tissue.
  • the cross-sectional thickness of the distal half 218 is less than the corresponding cross-sectional thickness of the distal half 248, and when the sharp tip 229 pierces the tissue or the separation edge 226 tears the tissue, it is advantageous to reduce the same time.
  • the inclined distal end 221 and the inclined distal end 251 expand the resistance of the tissue, thereby reducing the overall puncture operating force.
  • the inclined distal end 221 and the inclined distal end 251 have a structure that gradually increases from the distal end to the proximal end, contributing to reducing the resistance of the expanded tissue.
  • the cross-sectional thickness of the distal half 218 is smaller than the corresponding cross-sectional thickness of the distal half 248, and the structure gradually increases from the distal end to the proximal end, which is advantageous for dispersing the puncture force and the tearing force.
  • Expansion power More specifically, when the sharp tip 229 pierces the muscle or tissue, the separation blade 226 is reduced to tear the muscle or tissue load; and when the separation blade 226 tears the muscle or tissue, the inclined distal end 221 and the inclined distal end 251 are reduced. Squeeze and inflate the tissue's load to avoid large spikes, providing a better operating experience and improved controllability of the puncture operation.
  • the core hole 215 is such that the proximal end 241 cannot be retracted proximally from the distal end, and the distal end portion 206 is transitioned from a sharp mode (released state) to a blunt mode (locked state). Then, even if the puncture needle 200 continues to move into the body and contacts the organ or tissue in the cavity after the puncture needle 200 penetrates the body wall, the sharp tip 229 and the separation blade 226 are not exposed, and only the blunt tip 259 and the blunt separating blade 256 are in contact with the cavity. Organs or tissues to reduce the risk of accidental injury.
  • distal end half 248 of the puncturing needle 200 with its movable half 240 is only half of a cone or cylinder, as will be understood by those skilled in the art, which helps to reduce the muscle and tissue of the puncturing background.
  • the resistance therefore, can reduce the delay time for the distal half 248 to move from the proximal end to the distal end to cover the distal half 218 and lock, helping to reduce the risk of accidental injury.
  • the present invention proposes a dual mode puncture needle and method of use thereof.
  • the puncture needle includes a blunt mode and a sharp mode.
  • Experienced physicians can judge the difficulty of puncture and the risk of accidental injury according to their professional knowledge, and choose the appropriate puncture mode for puncture.
  • the puncture in the blunt mode (in the case of not triggering the locking mechanism), can be used for relatively easy puncture
  • the site, or the site where the risk of accidental injury to the internal organs of the patient is small. For example, during Hansson surgery, or for puncture under direct endoscopy.
  • the sharp mode puncture (in the case of a trigger locking mechanism) can be used for a site that is relatively difficult to puncture, or a site that poses a greater risk of accidental injury to a patient's internal organs, such as when a first puncture channel is established.
  • the knifeless puncture needle structure of the present invention is advantageous for dispersing the puncture force, the tearing force, and the expansion force.
  • both the sharp mode and the blunt mode are beneficial for reducing the puncture.
  • the operation force increases the controllability of the puncture operation, helps to reduce the risk of accidental injury, and optimizes the practicability of the dual mode puncture.
  • FIG. 7 detail the attachment mechanism of the buckle 228 and the latching groove 258 to allow axial movement of the distal half 248 relative to the distal half 218 and to limit lateral direction thereof. Relative movement function.
  • Figures 14-16 depict another connection mechanism.
  • the locking tab 260 includes 2 approximately symmetric long arms 261 and a short arm 262 therebetween, the long arms 261 and the short arms 262 collectively defining a rectangular aperture 263.
  • the distal half 248 includes a stop tab retention location 264 to which the locking tab 260 is bonded.
  • the locking tab 260 can also be coupled to the distal half 248 by well-known joining techniques such as riveting, welding, threading, snapping, and the like.
  • the distal half 218 includes a latch 267 that includes an intermediate slot 266 and two approximately symmetrical hooks 268. As described above, when the movable half 240 is mounted on the fixed half 210, the distal half 248 is pressed hard, and the buckle 267 is pressed by the long arm 261 to be elastically deformed. That is, the hook 268 is elastically deformed and the intermediate groove 266 is narrowed.
  • the buckle 267 After the buckle 267 completely passes through the rectangular hole 263, the buckle 267 is elastically restored, and the hook 268 is fastened on the long arm 261, thereby limiting the distal half 248 with respect to the distal half 218 produces a lateral displacement. Since the length of the rectangular hole 263 in the axial direction is larger than the thickness dimension of the lock 267 in the axial direction, the movable half 240 can slide in the axial direction with respect to the fixed half 210. There are many other connection mechanisms that can achieve the aforementioned functions, which cannot be exhausted due to space limitations. One of ordinary skill in the art would appreciate other attachment mechanisms or adapting the aforementioned mechanisms to improve workability or assemblability.
  • the fixed half 310 is similar to the fixed half 210.
  • the distal half of the fixed half 310 includes a base 311, a slanted distal end 312, a sharpened tip 319 and a separating edge 318.
  • the main distinguishing feature of the fixed half 310 is that the two separating edges 318 form an approximately circular arc shape, that is, in the vicinity of the sharp top end, the spacing between the two separating edges 318 is greater than the spacing between the two separating edges 226. And thus have a better tearing effect.
  • the fixed half 320 is similar in construction to the fixed half 210.
  • the distal half of the fixed half 320 includes a base 321 , a sloped distal end 322, a blunt tip 329 and a separation edge 328.
  • the main distinguishing feature of the fixed half 320 is that the blunt tip 329 is relatively blunt and less vulnerable to muscle or tissue damage.
  • the fixed half 330 is similar in construction to the fixed half 210.
  • the distal half of the fixed half 330 includes a base 331, a slanted distal end 332, a sharpened tip 339 and a separating edge 338.
  • the primary distinguishing feature of the fixed half 330 is that the separation blade 338 also includes a thinner, sharper wing 337 that has a better function of tearing muscle or tissue.
  • the fixed half 340 is similar in construction to the fixed half 330.
  • the distal half of the fixed half 340 includes a base 341, a slanted distal end 342, a tip 349 and a splitter 338.
  • the separation blade 338 also includes a thinner, sharper wing 337 that has a better function of tearing muscle or tissue.
  • a feature of the fixed half 240 that is different from the fixed half 330 is that the tip 349 is cylindrical.
  • the fixed half 350 is similar in construction to the fixed half 210.
  • the distal half of the fixed half 350 includes a base 351, a slanted distal end 352, a sharpened tip 359 and a separating edge 358.
  • the center plane 357 is generally parallel to the central axis of the fixed half 350 and intersects the base 351, the angled distal end 352 and the sharpened tip 359.
  • the base body 351, the inclined distal end 352 and the sharp top end 359 are all located on the same side of the central plane 357.
  • the base 351 comprises a cylindrical outer surface 353, i.e. the outer shape of the base 351 is approximately half of a cylinder.
  • the angled distal end 352 includes two approximately symmetrical outer curved surfaces 354.
  • the outer curved surface 354 is connected to the outer surface 353 and extends obliquely toward the sharp top end 359.
  • the outer curved surface 354 includes a laterally convex curved surface intersecting the inclined distal end 352 with an arbitrary cross section substantially perpendicular to the central axis of the fixed half 350, and the formed cross section (as shown in FIG. 22A) includes two convex portions.
  • the arc, and the width and thickness of its cross section gradually increase from the distal end to the proximal end.
  • the outer curved surface 354 intersects the central plane 357 to form a sharp separating edge 358.
  • the sharp tip 359, the angled distal end 352 and the sharp separating edge 358 form a structure similar in shape to the tip of the spear, facilitating penetration and separation of tissue.
  • the fixed half 360 is similar in construction to the fixed half 210.
  • the distal half of the fixed half 360 includes a base 361, a sloped distal end 362, a sharpened tip 369 and a splitter edge 368.
  • the central plane 367 is generally parallel to the central axis of the fixed half 360 and intersects the base 361, the angled distal end 362 and the sharpened tip 369.
  • the base body 361, the inclined distal end 362 and the sharp tip 369 are all located on the same side of the central plane 367.
  • the base 361 includes a cylindrical outer surface 363, that is, the outer shape of the base 361 is approximately half of a cylinder.
  • the angled distal end 362 includes two approximately symmetric first curved surfaces 364 and two approximately symmetric second curved surfaces 365.
  • the first curved surface 364 and the second curved surface 365 are connected to the outer surface 363 and extend obliquely toward the sharp top end 369.
  • One side of the second curved surface 365 intersects the central plane 367 to form a sharp separating edge 368, the other side of which intersects the first curved surface 364.
  • An arbitrary cross section substantially perpendicular to the central axis of the fixed half 360 intersects the inclined distal end 362 to form a cross section 23A.
  • the section The thickness of 23A gradually increases from the both sides toward the middle, and abruptly changes at the intersection of the first curved surface 364 and the second curved surface 365, and the rate at which the thickness of the section increases increases. And along the axial direction, the width and thickness of its cross section gradually increase from the distal end to the proximal end.
  • the fixed half 370 is substantially identical in construction to the fixed half 360.
  • the distal half of the fixed half 370 includes a base 371, a sloped distal end 372, a sharpened tip 379 and a separation blade 378.
  • the central plane 377 is generally parallel to the central axis of the fixed half 370 and intersects the base 371, the angled distal end 372 and the sharpened tip 379.
  • the base body 371, the inclined distal end 372 and the sharp top end 379 are all located on the same side of the central plane 377.
  • the base 371 comprises a cylindrical outer surface 373, i.e. the outer shape of the base 371 is approximately half of a cylinder.
  • the angled distal end 372 includes a first curved surface 374 and two approximately symmetrical second curved surfaces 375.
  • the first curved surface 374 and the second curved surface 375 are connected to the outer surface 373 and extend obliquely toward the sharp top end 379.
  • One side of the second curved surface 375 intersects the central plane 377 to form a sharp separating edge 378, the other side of which intersects the first curved surface 374.
  • a cross section 24A is formed by intersecting the inclined distal end 372 with an arbitrary cross section substantially perpendicular to the central axis of the fixed half 370. Referring to FIG.
  • the thickness of the section 24A gradually increases from the both sides toward the middle, and at the intersection of the first curved surface 374 and the second curved surface 375, the rate of increase in the thickness of the section increases. And along the axial direction, the width and thickness of its cross section gradually increase from the distal end to the proximal end.
  • the main technical feature of the fixed half 370 being different from the fixed half 360 is that the first curved surface 374 and the second curved surface 375 have an overall laterally convex configuration.
  • the movable half 410 is similar in construction to the movable half 240.
  • the distal half of the movable half 410 includes a base 411, a slanted distal end 412, a blunt tip 419 and a blunt separating edge 418.
  • the center plane 417 is generally parallel to the central axis of the movable half 410 and intersects the base 411, the angled distal end 412 and the blunt tip 419.
  • the base body 411, the inclined distal end 412 and the blunt tip end 419 are all located on the same side of the central plane 417.
  • the base body 411 comprises a cylindrical outer surface 413, that is, the outer shape of the base body 411 is approximately half of a cylinder.
  • the angled distal end 412 includes a conical surface 414.
  • the conical surface 414 is connected to the outer surface 413 and extends obliquely toward the blunt tip end 419.
  • the conical surface 414 intersects the central plane 417 to form a blunt separating edge 418. That is, the shape of the inclined distal end 412 of the movable half 410 is approximately half of the truncated cone.
  • the movable half 420 is similar in construction to the movable half 240.
  • the distal half of the movable half 420 includes a base 421, a slanted distal end 422, a blunt tip 429 and a blunt separating edge 428.
  • the central plane 427 is generally parallel to the central axis of the movable half 420 and intersects the base 421, the angled distal end 422 and the blunt tip 429.
  • the base body 421, the inclined distal end 422 and the blunt tip end 4219 are all located on the same side of the central plane 427.
  • the base 421 includes a cylindrical outer surface 423, that is, the outer shape of the base 421 is approximately half of a cylinder.
  • the angled distal end 422 includes a spherical shell surface 444.
  • the spherical shell surface 444 is connected to the outer surface 423 And extending obliquely toward the blunt tip 429.
  • the spherical shell surface 444 intersects the central plane 427 to form a blunt separating edge 428.
  • the sloping distal end 422 of the movable half 420 has an outer shape that is approximately one quarter of the spherical shell, and the blunt tip 429 is fused integrally with the slanted distal end 422, i.e., the blunt tip 429 is absent.
  • the movable half 430 is similar in construction to the movable half 240.
  • the distal half of the movable half 430 includes a base 431, a slanted distal end 432, a blunt tip 439 and a blunt separating edge 438.
  • the central plane 437 is generally parallel to the central axis of the movable half 430 and intersects the base 431, the angled distal end 432 and the blunt tip 439.
  • the base body 431, the inclined distal end 432 and the blunt tip 439 are all located on the same side of the central plane 437.
  • the base body 31 comprises a cylindrical outer surface 433, i.e. the outer shape of the base body 431 is approximately half of a cylinder.
  • the angled distal end 432 includes a first curved surface 434, a second curved surface 435, and a third curved surface 436.
  • the third curved surface 436 intersects the central plane 437 to form a blunt separating edge 438.
  • the thickness and width of the inclined distal end 432 gradually increase along the axial direction, and the thickness increases in a region adjacent to the blunt tip 439, and the thickness is increased in the region adjacent to the base 431. The trend is increasing faster. In the lateral direction, the thickness and width of the inclined distal end 432 gradually increase, and in the region adjacent to the blunt separating edge 438, the tendency to increase in thickness is slow.
  • the present invention has repeatedly referred to the concept of a knifeless needle, a sharp separation blade, a sharp tip, a blunt separation and a blunt tip.
  • the puncture needle used in endoscopic surgery can be generally divided into two categories: a knife puncture needle and a knifeless puncture needle.
  • the "knife-in” refers to a metal-containing blade
  • the "knife-free” refers to a metal-free blade.
  • Puncture needles containing plastic blades are often referred to as knifeless needles, which is customary in the art.
  • a structure containing a plastic blade, or a sharp edge, or a blunt edge is disclosed in the present invention, and those skilled in the art will appreciate that the degree of damage to the patient's body wall from the blade or the side of the patient's body wall is large.
  • the same sharp tip and blunt tip damage the patient's body wall from large to small, sharp tip > blunt tip.
  • bluntness and sharpness are a relative concept, and in the present invention the sharp refers to a relatively sharp structure and the blunt refers to a relatively blunt structure.

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Abstract

一种两半双模式无刀穿刺针（200）和穿刺器。无刀穿刺针（200），包含手柄部分（202）和远端部分（206）以及其间的杆部分（204），杆部分（204）包含中心轴线（201），远端部分（206）包含固定半边（210,310,320,330,340,350,360, 370）和活动半边（240,410,420,430）；固定半边（210,310,320,330,340,350,360,370）由远端向近端延伸并与杆部分（204）或手柄部分（202）固定在一起，而活动半边（240,410,420,430）可相对于固定半边（210,310,320,330,340,350,360,370）沿中心轴线（201）方向移动；固定半边（210,310,320,330,340,350,360,370）包含固定基体（220,321,331,341,351,361,371）和与之连接并延伸至固定顶端的固定倾斜远端（221,312,322,332,342,352,362,372）；活动半边（240,410,420,430）包含活动基体（250,411,421,431）和与之连接并延伸至活动顶端的活动倾斜远端（251, 412,422,432）；固定半边（210,310,320,330,340,350,360,370）包含锋利分离刃（226,318,328,338,348,358,368,378）和/或锋利顶端（229,319,329,339, 349,359,369,379），活动半边（240,410,420,430）包含钝分离刃（256,418,428,438）和钝顶端（259,419,429,439）。无刀穿刺针（200）结构有利于分散刺破力，撕裂力，扩张力，增加了穿刺操作可控性，有助于减小意外损伤的风险。

Description

一种两半双模式无刀穿刺针和穿刺器 技术领域
本发明涉及微创手术器械，尤其涉及一种穿刺针结构。
背景技术
穿刺器是一种微创手术中(尤其是硬管腔镜手术)，用于建立进入体腔的人工通道的手术器械。穿刺器通常包含套管组件和穿刺针两部分。其临床的一般使用方式为：先在患者皮肤上切开小口，再将穿刺针贯穿套管组件，穿刺针的远端超过套管组件的远端，再一起经由皮肤开口处穿透体壁进入体腔。
穿透体壁的过程中，手术医生握持穿刺器并施加较大的穿刺操作力，用于克服刺破和割开组织的阻力，以及扩张和胀大组织的阻力。穿刺针的远端通常包含锋利的刀片，有助于减小刺破和割开组织的力。而穿透体壁的瞬间所述阻力突然消失，医生来不及停止施力或由于惯性作用，所述刀片可能意外损伤患者内部组织。因此穿刺针通常包含可选择性的轴向移动的保护套和自动锁定装置，称之为带刀自动保护穿刺针(后文简称保护穿刺针)。所述保护穿刺针具有锁定状态和释放状态：处于所述释放状态时，所述保护套可由远端向近端退回而露出所述刀片；处于保护状态时，所述保护套不能由远端向近端退回，所述刀片被保护套所包覆。而且，穿透体壁的瞬间，几乎同时触发所述自动锁定装置，从而迅速的自动的从释放状态切换为保护状态。即穿透体壁的瞬间，所述保护套几乎同时的，迅速的移动至远端包覆刀片并锁定，从而防止刀片露出造成意外损伤。
已经商业化的保护穿刺针通常提供视觉或听觉的提示来提醒手术医生其穿刺针远端已经穿透体壁。所述视觉或听觉的提示通常与保护套由近端向远端移动而包覆刀片并锁定的过程同时发生。然而当手术医生进行穿刺时，其注意力往往集中于患者的身体特征及其症状变化情形，某些情形下容易忽视所述视觉或听觉提示。更重要的，即便手术医生看到视觉的提示或听到听觉的提示，还需经过大脑分析判断后再输出指令停止穿刺操作力，从而导致动作延迟。本领域的技术人员应该可以理解，穿刺针刀片及保护套穿透体壁的瞬间，由于体壁的肌肉和组织与保护套间存在阻力，因此保护套由近端向远端移动而包覆刀片并锁定的过程也会延迟。停止穿刺操作力的延迟增加了穿刺针远端对患者内部器官或组织造成损伤的风险。
即便在前述保护套的有效保护作用下，因医生经验欠缺，或因医生施加的穿刺操作力过大，或因医生没有及时停止施加穿刺操作力等因素，仍然可能发生意外损伤患者内 部器官的情形。特别是使用保护穿刺针建立第一个穿刺通道时，手术医生无法看到或精确的感知穿刺针远端是否已穿透体壁，往往在感受到穿刺针和套管组件整体穿透体壁的落空感之后，才停止施加操作力。然而通常为时已晚，由于操作力过大和惯性作用，所述穿刺针远端的保护套以冲击的方式接触患者内部器官或组织，仍然可能对患者造成不同程度的难以预测的损伤。而且由于内窥镜手术视野受限，这种损伤通常难以被发现。近年来，随着内窥镜手术的广泛推广和大量应用，前述保护套以冲击的方式接触患者内脏器官从而造成的意外损伤的临床案例逐渐增多，并引起了医学界的重视。然而到目前为止，尚无针对此问题的穿刺针解决方案。
应用穿刺针穿透患者体壁的过程很复杂，隐藏诸多风险。从腹壁解剖学和穿刺力学角度综合分析，有助于找到更好的解决方案。参考图1，基于腹壁解剖学，大体的，人体腹壁从体外向体内依次为皮肤，脂肪层，肌肉层和腹膜。穿刺针贯穿套管组件并穿透腹壁的过程中，保护穿刺针的刀片10超出保护套的远端20，所述远端20超出套管组件的远端30。为了减小腹壁疝孔并发症概率，通常优选穿刺器与腹壁成30～60°夹角的方位进行穿刺。皮肤具有很好的弹性和强度，建立穿刺通道时通常先将穿刺位置的皮肤切开，其切口宽度约为穿刺器最大直径的1.5倍，则穿刺时皮肤处的刺破和胀大阻力没有或者很小。腹膜的厚度较薄，约为1mm，肌肉层的厚度通常为10～15mm，脂肪层的厚度因肥胖程度不同而差异很大，通常为15～40mm。脂肪层相对较疏松，刺破和扩张脂肪层的力度适中；肌肉层相对较致密，刺破和扩张肌肉层的力度较大；腹膜弹性较好，刺破和扩张腹膜的力度较大。
参考图1-2，穿透腹壁的过程可细分成7个阶段：第1阶段，刀片10刺破和扩张脂肪层(阻力FT10)，保护套的远端20和套管组件的远端30裸露在皮肤外侧；第2阶段，刀片10刺破和扩张肌肉层(阻力FT10)，远端20扩张脂肪层(阻力FT20)，远端30裸露在皮肤外侧；第3阶段，刀片10继续完全刺破肌肉层(阻力FT10)，远端20扩张肌肉层(阻力FT20)，远端30扩张脂肪层(阻力FT30)；第4阶段，刀片10刺破腹膜(阻力FT10)，远端20继续扩张肌肉层(阻力FT20)，远端30扩张肌肉层(阻力FT30)；第5阶段，刀片10进入腹腔，远端20扩张腹膜(阻力FT20)，远端30继续扩张肌肉层(阻力FT30)；第6阶段，远端20进入腹腔并触发锁定装置使得远端20包覆刀片10，远端30扩张腹膜(阻力FT30)；第7阶段，远端30进入腹腔，停止穿刺。
参考图1-2，理想状态下，医生施加的穿刺操作力Fi满足下述公式：
Fi＝FT10+FT20+FT30其中：FT10＝刀片10受到的阻力；FT10＝远端20受到的阻力；FT10＝远端30受到的阻力；
理想状态下，医生施加的穿刺操作力Fi等于穿刺针受到的阻力，则穿刺针的移动平稳或近似匀速。结合图2，因为第1，2，3，4阶段中穿刺针的阻力逐渐增加，医生需逐渐增加穿刺操作力Fi才能克服阻力迫使穿刺针继续刺入组织中；到第5阶段，由于刀片10已刺破腹膜进入腹腔，穿刺针受到的阻力减小，此时施加的穿刺操作力Fi应相应的减小，然而由于医生无法感知远端刺破腹膜的瞬间，实际施加的穿刺操作力Fr持续增加，使远端20和远端30加速的完成第6阶段，导致第7阶段穿刺针及套管组件整体进入腹腔的速度和深度增加，导致保护套对于患者内部器官和组织的冲击力较大，从而增加了损伤风险。
为了减小损伤内部器官的风险，临床应用中医生握持穿刺器进行穿刺操作时，不是以简单直线运动的方式向体内刺入，而是一边小范围的来回旋转一边向体内刺入。这种来回旋转式的刺入方法，这有利于撕裂和胀大肌肉组织，同时有利于控制刺入速度和减小前述惯性作用。然而这种来回旋转式的刺入方法，所述保护穿刺针的刀片随着来回旋转并切割肌肉组织，导致创口不规则，从而额外增大了对于患者的损伤，并增加了切口疝并发症的发生概率。
研究表明，采用不含刀片的穿刺针(后文称为无刀穿刺针)有利于减小对于患者的损伤。如前文所述，使用带刀保护穿刺针进行腹壁穿刺时，其刀片刺破和切割肌肉和组织；而使用所述无刀穿刺针进行腹壁穿刺时，由于不含锋利的刀片，其远端刺破肌肉和组织，并撕裂分离肌肉纤维和胀大创口直到穿刺针和套管组件整体穿过腹壁。可见，所述无刀穿刺针相对于保护穿刺针，减小了对于肌肉组织的切割损伤，有利于术后恢复，有利于减小切口疝并发症的概率。通常据此得出使用无刀穿刺针比使用有刀(保护)穿刺针对于患者损伤更小的结论。然而使用所述无刀穿刺针进行腹壁穿刺，其穿刺针力通常大于所述带刀保护穿刺针的穿刺力，所以更难控制，反而增加了损伤患者内部器官和组织的风险。
前文从腹壁解剖学的角度分析了腹壁结构和穿刺过程，然而人体不同部位或者腹部的不同位置，其脂肪，肌肉，筋膜等的含量比例和厚度等各有不同，其穿刺的难易程度也不相同，对于患者内部器官造成意外损伤的风险大小也不同。经验丰富的医师通常可依据其专业知识判断穿刺难易程度和意外损伤风险大小，并选择相适宜的穿刺针进行穿刺。前文已经阐述使用无刀穿刺针可减小对于患者的损伤但其穿刺力较大。因此，对于难以穿 刺的部位，经验丰富的医师倾向选用锋利的，可以减小穿刺力的无刀穿刺针；而对于较容易穿刺的部位，或意外损伤概率较小的部位，例如Hansson手术时，或者用于在内窥镜直视下的穿刺情形，经验丰富的医生更倾向选择较钝的，损伤更小的无刀穿刺针。目前尚无同时满足前述两种需求的无刀穿刺针。
发明内容
因此，本发明的一个目的是提供一种可减小穿刺力的双模式无刀穿刺针，且穿刺针结构紧凑，零件生产制造经济，产品组装方便快捷。
在本发明的一个方面，一种无刀穿刺针，包含手柄部分和远端部分以及其间的杆部分，所述杆部分包含中心轴线。所述远端部分包含固定半边和活动半边。所述固定半边由远端向近端延伸并与所述杆部分或手柄部分固定在一起，而所述活动半边可相对于所述固定半边沿所述中心轴线方向移动。所述固定半边包含固定基体和与之连接并延伸至固定顶端的固定倾斜远端，所述活动半边包含活动基体和与之连接并延伸至活动顶端的活动倾斜远端，所述活动半边包含钝分离刃和钝顶端。一种实施方案中，所述固定半边同时包含锋利分离刃和锋利顶端。另一种实施方案中，所述固定半边包含锋利分离刃和钝顶端。又一种实施方案中，所述固定半边包含钝分离刃和锋利尖端。
在一种实施方案中，所述活动半边沿着所述中心轴线由近端向远端移动直到所述活动顶端完全超过所述固定顶端，作垂直于所述中心轴线的任意横平面同时与所述固定倾斜远端和活动倾斜远端相交，形成固定倾斜远端横截面和活动倾斜远端横截面，所述固定倾斜远端横截面的宽度尺寸小于所述活动倾斜远端横截面的宽度尺寸，所述固定倾斜远端横截面的厚度尺寸小于所述活动倾斜远端横截面的厚度尺寸。
另一种实施方案中，所述活动半边沿着所述中心轴线由远端向近端移动直到所述固定顶端完全超过所述活动顶端，作垂直于所述中心轴线的任意横平面同时与所述固定倾斜远端和活动倾斜远端相交，形成固定倾斜远端横截面和活动倾斜远端横截面，所述固定倾斜远端横截面的宽度尺寸大于所述活动倾斜远端横截面的宽度尺寸，所述固定倾斜远端横截面的厚度尺寸小于所述活动倾斜远端横截面的厚度尺寸。
在本发明的另一个方面，所述无刀穿刺针远端部分还包括连接装置，所述远端部分还包括连接装置，所述连接装置将所述固定半边和活动半边连接在一起，且所述连接装置允许所述活动半边沿所述中心轴线方向的平移运动，而限制所述活动半边在垂直于所述中心轴线方向上的位移。
在本发明的又一个方面，所述穿刺针包含含锁定状态和释放状态，所述锁定状态 即所述活动半边被锁定而不能由远端向近端移动，所述释放状态即所述活动半边可由远端向近端移动；其中所述锁定状态和释放状态由锁定机构实现，所述锁定机构至少包含锁定部分，释放部分和触发部分。
在本发明的又一个方面，所述穿刺针包含锋利模式和钝模式；在所述锋利模式下，所述活动半边沿所述中心轴线向近端移动，直到所述锋利分离刃和/或锋利顶端超出对应的所述活动半边的钝分离刃和钝顶端；在所述钝模式下，所述活动半边沿所述中心轴线向远端移动，直到所述活动半边的钝分离刃和钝顶端完全覆盖对应的所述锋利分离刃和/或锋利顶端之后，所述活动半边被锁定。
一种穿刺器包含套管组件和前述任一所述穿刺针。
一种穿刺器包含双模式无刀穿刺针和套管组件，所述穿刺针贯穿所述套管组件并一起经由患者穿刺点的皮肤切口处进行穿刺工作，所述穿刺针的工作状态包括锋利模式和钝模式，当医生预判所述穿刺力较大时，可采用锋利模式进行穿刺；当医生预判所述穿刺力较小时，则采用钝模式进行穿刺。
附图说明
为了更充分的了解本发明的实质，下面将结合附图进行详细的描述，其中：
图1是人体腹壁横断面及穿刺示意图；
图2是穿刺过程受力分析图；
图3是本发明第一个实施例的穿刺器组件的侧面投影视图；
图4是本发明第一个实施例的穿刺器组件的背面投影视图；
图5是图4所示穿刺针的立体的分解图；
图6是图5所示穿刺针的固定半边的远端半边的详细立体图；
图7是图5所示穿刺针的活动半边的详细立体图；
图8是图5所示穿刺针的初始锁定状态的立体组合图；
图9是图5中所示穿刺针的释放状态的立体组合图；
图10是图8中所示穿刺针的纵向剖视图；
图10A是图10的10A-10A横截面示意图；
图10B是图10的10B-10B横截面示意图；
图10C是图10的10C-10C横截面示意图；
图10D是图10的10D-10D横截面示意图；
图10E是图10的10E-10E横截面示意图；
图11是图5所示穿刺针的锋利模式下的纵向剖视图；
图11A是图11的11A-11A横截面示意图；
图11B是图11的11B-11B横截面示意图；
图11C是图11的11C-11C横截面示意图；
图11D是图11的11D-11D横截面示意图；
图11E是图11的11E-11E横截面示意图；
图12是图3中所示穿刺器的锋利模式下的正面投影视图；
图13是图3中所示穿刺器的锋利模式下的侧面投影视图；
图14是又一连接方案中活动半边的远端半边的局部放大图；
图15是又一连接方案中锁片的立体图；
图16是又一连接方案中固定半边的远端半边的局部放大图；
图17是又一连接方案中穿刺针远端部分的立体的局部剖视图；
图18是又一实施方案中固定半边的远端半边的局部放大图；
图19是又一实施方案中固定半边的远端半边的局部放大图；
图20是又一实施方案中固定半边的远端半边的局部放大图；
图21是又一实施方案中固定半边的远端半边的局部放大图；
图22是又一实施方案中固定半边的远端半边的局部放大图；
图22A是图22的22A-22A横截面示意图；
图23是又一实施方案中固定半边的远端半边的局部放大图；
图23A是图23的23A-23A横截面示意图；
图24是又一实施方案中固定半边的远端半边的局部放大图；
图24A是图24的24A-24A横截面示意图；
图25是又一实施方案中活动半边的远端半边的局部放大图；
图25A是图25所述活动半边的轴向剖视图；
图26是又一实施方案中活动半边的远端半边的局部放大图；
图26A是图26所述活动半边的轴向剖视图；
图27是又一实施方案中活动半边的远端半边的局部放大图；
图27A是图27所述活动半边的轴向剖视图。
在所有的视图中，相同的标号表示等同的零件或部件。
具体实施方式
这里公开了本发明的实施方案，但是，应该理解所公开的实施方案仅是本发明的示例，本发明可以通过不同的方式实现。因此，这里公开的内容不是被解释为限制性的，而是仅作为权利要求的基础，以及作为教导本领域技术人员如何使用本发明的基础。
图3-4描绘了穿刺器的整体结构。一种典型穿刺器包含套管组件100和穿刺针200。套管组件100包含密封仓110和通气阀120。所述密封仓110包含套管顶面111(未示出)和中心通孔113(未示出)，通常零密封(亦称自动密封)和密封膜(亦称器械密封)由远端向近端依次安装在密封仓110中。所述零密封通常不提供对于插入器械的密封，而在器械移走时自动关闭并形成密封。所述密封膜在器械插入时箍紧器械并形成密封。所述套管130包含开放的远端131以及联通密封仓110的中空管133。所述穿刺针200可主要划分成手柄部分202，杆部分204和远端部分206。所述手柄部分包含手柄顶面291和手柄底面213。
参考图3-4，所述穿刺针200贯穿套管组件100，所述套管顶面111和手柄底面213相接触。定义所述套管组件100含有通气阀120的一侧为正面107，其相对面为背面108，其两侧为侧面109。根据穿刺针200与套管组件100匹配时的位置关系，定义穿刺针的前面207，后面208和左右侧面209。当进行穿刺动作时，医生手指紧握密封仓110，而手掌紧贴手柄顶面291和后面208，持续的施加穿刺操作力使其穿透患者体壁。一旦完全穿透体壁，穿刺针被取走，留下套管组件作为器械进出体腔的通道。为方便表述，后续凡接近操作者的一方定义为近端，而远离操作者的一方定义为远端，定义穿刺针杆部分204的中心轴线为轴线201(未示出)，后续凡大致平行轴线201的方向称为轴向，而大致垂直轴线201的方向称为横向。
图5-10详细描绘了本发明的第一个实施例，两半双模式无刀穿刺针200的结构组成和装配关系。首先参考图5-7，所述穿刺针200的远端部分206包含固定半边210和活动半边240。所述固定半边210包含近端凸缘212和固定远端半边218。所述远端半边218包含基体220和锋利顶端229以及连接二者的固定倾斜远端221。中心平面222大致平行于所述轴线201，并与所述基体220，倾斜远端221和锋利顶端229相交。且所述基体220，倾斜远端221和锋利顶端229全部位于所述中心平面222的同一侧。所述基体220包含圆柱外表面223，即所述基体220的外形近似为圆柱体的一半。所述倾斜远端221包含外部曲面224和过渡曲面225。所述外部曲面224与所述外表面223相连并朝向锋利顶端229逐渐内凹的倾斜延伸；参考图10，即作过轴线201的纵向剖与所述外部曲面224相交，其交线具有内凹的弧形。所述外部曲面224包含横向外凸的曲面，即作大致垂直于所述轴 线201的任意横截面与所述倾斜远端221相交，形成的固定倾斜远端横截面(如图10A，10B，10C，10D)包含一段近似椭圆形弧线，且其横截面的宽度和厚度由远端向近端逐渐增大。所述过渡曲面225与所述外表面223相连并朝向锋利顶端229延伸且其横向宽度逐渐减小。所述过渡面225一侧与所述中心平面222相交，其另一侧与所述外部曲面224相交，从而形成2个大致对称的分离刃226。在所述锋利顶端229的临近区域所述分离刃226的厚度较小，其外形近似为刀刃状，称为锋利分离刃；而远离锋利顶端229的区域所述分离刃226的厚度较大，其外形不似刀刃状，称为钝分离刃。所述中心平面222从锋利顶端229向基体220延伸时其横向宽度逐渐增大，即两所述分离刃226之间的间距从远端向近端逐渐增宽。参考图5，所述中心平面222还包括内凹坑227，两个近似对称的卡扣228从所述内凹坑227横向向外延伸并超出所述中心平面222。所述卡扣228包含钩228a和直臂228b。所述远端半边218还包含远端限位219。
参考图5和图7，所述活动半边240包含近端242和活动远端半边248。所述远端半边248包含基体250和钝顶端259以及连接二者的活动倾斜远端251。中心平面252大致平行于所述轴线201，并与所述基体250，倾斜远端251和钝顶端259相交。且所述基体250，倾斜远端251和钝顶端259全部位于所述中心平面252的同一侧。所述基体250包含圆柱外表面253，即所述基体250的外形近似为圆柱体的一半。所述倾斜远端251包含外部曲面254和过渡曲面255。所述外部曲面254与所述外表面253相连并朝向钝顶端259逐渐内凹的倾斜延伸；参考图10，即作过轴线201的纵向剖与所述外部曲面224相交，其交线具有内凹的弧形。所述外部曲面254包含横向外凸的曲面，即作大致垂直于所述轴线201的任意横截面与所述倾斜远端251相交，形成的活动倾斜远端横截面(如图10A，10B，10C，10D)包含部分椭圆形弧线或部分圆弧线，且其横截面的宽度和厚度由远端向近端逐渐增大。所述过渡曲面255与所述外表面253相连并朝向钝顶端259延伸且其横向宽度逐渐减小。所述过渡面255一侧与所述中心平面252相交，其另一侧与所述外部曲面254相交，从而形成2个大致对称的钝形的钝分离刃256。所述中心平面252从钝顶端259向基体250延伸时其横向宽度逐渐增大，即两所述钝分离刃256之间的间距从远端向近端逐渐增宽。参考图7，所述中心平面252还包括内凹坑257，两个近似对称的卡槽258从所述内凹坑227横向向外穿透中心平面252和圆柱外表面253。所述卡槽258包含配合平面258a。
参考图5，图8和图10。所述固定半边210还包括从所述远端半边218延伸至所述近端凸缘212的中空杆214。所述中空杆214包含轴向穿透所述近端凸缘212的轴心孔 215。第一U型槽216a横向切开中空杆214并与轴心孔215联通，第二U型槽216c横向切开中空杆214并与第一U型槽216a联通，且第二U型槽216c的深度大于第一U型槽216a的深度，则第一U型槽216a和第二U型槽216c相交处形成台阶216b。所述第二U型槽216c延伸至远端止面217。所述第一U型槽216a和第二U型槽216c构成开口中空管216。所述近端凸缘212包含上面211和手柄底面213。所述近端凸缘212还包括从上面211朝向近端凸起的复位固定座231，导向筋232，锁齿234，固定柱236。所述锁齿234包含锁定面233和推挤面235，且所述锁定面233与所述轴心孔215相切。所述近端凸缘212还包括锁件导向槽237和缺口238。
参考图5和图7，所述活动半边240还包含与所述远端半边248相交的横壁249，轴242一端与所述横壁249相交形成限位245，而另一端轴向延伸至近端241。U型块244一端与所述横壁249相交而其另一端朝向近端延伸并与轴242平行且部分相交。挡块246一端连接U型块244而另一端朝向近端延伸至面247。挡块246大致与轴242平行且不与之相交，所述挡块246与U型块244相交形成台阶243。
参考图5，图8和10，推力弹簧281安装到所述活动半边240的轴242上，再一起安装到所述固定半边210中。所述轴242与轴心孔215匹配，所述U型块244与所述第二U型槽216c匹配，所述中心平面252与所述中心平面222匹配。用力按压远端半边248使得所述卡扣228弹性变形并完全穿过所述卡槽258，然后所述卡扣228回弹，所述钩228a和所述配合平面258a相匹配(参考图10E)，使所述远端半边248不能横向脱出。同时卡槽258沿轴线方向的长度大于所述卡扣228沿轴向长度，因此所述活动半边240可沿着轴线方向运动。由近端向远端移动并锁定，使得所述远端半边248完全覆盖所述远端半边218，称之为钝模式(参考图3，图4和图10)。由远端向近端移动，所述锋利顶端229和分离刃226露出在所述远端半边248之外，称之为锋利模式(参考图11)。推力弹簧281安装在台阶216b和台阶243之间并处于压缩状态，当所述远端半边248不承受由远端向近端的轴向压缩力(或受力很小)时，所述远端半边248在推力弹簧281产生的轴向推力的作用下由近端向远端运动并完全覆盖所述远端半边218。
所述穿刺针200还包含用以实现钝模式和锋利模式之间相互切换的锁定机构280。参考图5，图8和图10，锁件270具有近端面271和远端面279。所述锁件270包含释放端273和锁定端274。2个导向壁272将释放端273和锁定端274连接在一起，形成近似矩形的空腔，所述矩形的空腔在锁定端274处包含半圆形通孔。所述释放端273包含触发臂276，所述触发臂276从释放端273朝向所述空腔内部延伸，所述触发臂276包含释放 钩277。所述释放端273还包括按钮278。所述锁定端274包含横轴275。参考图5，所述手柄仓290包括手柄顶面291，侧壁292和按钮缺口293。所述手柄仓290还包括4个具有盲孔的中空柱296(参加图8)以及多个轴向限位筋。
参考图8和图10，所述锁件270安装到所述近端凸缘212上，其中所述导向壁272与所述导向筋232匹配，所述远端面279与上面211匹配，使锁件270在上面211限定的平面内，可沿着导向筋232滑动。复位弹簧282的一端安装在所述固定座231中，而其另一端安装在横轴275上，并处于压缩状态。所述手柄仓安装到近端凸缘212上，所述4个固定柱236与4个中空柱296的盲孔对齐并过盈配合，且所述多个轴向限位筋分别限制锁件270和复位弹簧282的轴向位移。本领域一个普通的技术人员可以稍作适应性修改，很容易理解和运用轴向限位筋实现如下功能：所述锁件270可以在所述上面211限定的平面内沿着导向筋232滑动且其轴向(平行轴线201的方向)位移足够小；所述复位弹簧282可自由伸缩变形且其轴向(平行轴线201的方向)位移足够小。限于篇幅和为简化表述，本发明的图示中并未详细披露所述轴向限位筋的结构。
初始锁定状态：参考图8和10，所述复位弹簧282处于压缩状态而具有横向舒张力，其舒张力推动所述锁件270沿着导向筋232朝向手柄仓290的外部方向滑动至最远端，而所述锁定端274刚好堵住所述轴心孔215，所述释放钩277不与所述锁齿234接触。称之为锁定状态。处于锁定状态时，所述活动半边240沿着轴线方向运动由近端向远端移动并锁定，所述远端半边248完全覆盖所述远端半边218，即所述穿刺针200的远端部分206处于钝模式(即不触发锁定机构)。
释放状态：参考图9和10，施加外力按下按钮278，使锁件270沿着导向筋232朝向手柄仓290内部的方向滑动，所述复位弹簧282被继续压缩，直到所述释放钩277接触所述倾推挤面235；继续滑动则所述倾推挤面235挤压所述释放钩277，使得所述触发臂276产生弹性变形和释放钩277产生由远端向近端的轴向位移；继续滑动使所述释放钩277跨过所述锁齿234，所述触发臂276回弹使得所述钩277与所述锁定面233咬合。此时所述锁定端274已移开，露出所述轴心孔215，所述活动半边240的近端241可以从远端向近端移动，称之为释放状态。停止施加外力，所述复位弹簧282的舒张力推动所述锁件270沿着导向筋232朝向手柄仓290外部的方向滑动，而由于所述钩277与所述锁定面233咬合，使得所述锁件270不能滑动而处于稳定状态。
锋利模式下的穿刺状态：参考图3和图4，所述无刀穿刺针200贯穿套管组件100然后一起经由穿刺点的皮肤切口处向体内穿刺。如前文所述按下按钮278使所述穿刺针 200处于释放状态，当远端半边248受到轴向压缩力作用时，所述活动半边240从远端向近端运动至露出远端半边218的锋利顶端229和分离刃226。状态1，所述活动半边240的近端241接触释放钩277，继续运动迫使触发臂276变形和释放钩277产生由远端向近端的轴向位移而与锁齿234脱开，即锁件被释放；状态2，参考图11，近端241继续由远端向近端运动到行程终点，此时释放钩277已与锁件固定位224完全脱开，所述锁件270在复位弹簧282推力作用下沿着导向筋232朝向手柄仓290外部的方向滑动，直到锁定端274被近端241挡住；状态1和状态2所述穿刺针200的远端部分206处于锋利模式。状态3，一旦穿刺针完全穿透体壁，所述远端半边248所受到的横向压力和轴向阻力消失，所述活动半边240在推力弹簧281的推力作用下迅速向远端移动至尽头。而锁件270在复位弹簧282推力作用下沿着导向筋232朝向手柄仓290的外部方向滑动，直到锁定端274挡住所述轴心孔215，使得所述近端241不能由远端向近端退回，穿刺针的远端部分206由锋利模式转变成钝模式。即穿刺针穿透腹壁后继续向体腔运动并接触体腔内器官或组织时，所述锋利顶端229和分离刃226不会露出，仅钝顶端259和钝分离刃256接触腔内器官或组织。
在本实例中，所述锁定机构280由锁件270和锁齿234组成，实现钝模式和锋利模式之间的相互切换。然而所述锁定机构280可以多种方式实现。自美国专利US4535773披露第一个保护穿刺针至今，其后设计者们陆续披露了大量的用于实现保护穿刺针的保护模式(即保护穿刺针的保护套被锁定)和释放模式(即保护穿刺针的保护套可移动)之间相互切换的锁定机构，本领域的技术人员容易理解，对已披露的锁定机构做简单的适应性修改，即可用于本发明的锋利模式和钝模式之间的相互切换。对于本领域的技术人员，其他类似的锁定机构也是可以想到的。
参考图3，图4和图10，当所述穿刺针200处于锁定状态时，即所述远端部分206处于钝模式，所述远端半边248完全覆盖所述远端半边218，所述锋利顶端229和分离刃226没有露出。参考图10，大致垂直所述轴线201作任意横平面X1与所述倾斜远端221和所述倾斜远端251同时相交，形成横截面10A，10B和10C。在横截面10A，横截面10B和横截面10C中，所述固定远端半边218的横截面厚度小于所述远端半边248的横截面厚度，且所述远端半边218的横截面宽度小于所述远端半边248的横截面宽度。参考图10和图10D，大致垂直所述轴线201作横平面Y1与所述倾斜远端221和所述基体250相交同时相交形成横截面10D，所述远端半边218的横截面厚度小于所述活动远端半边248的横截面厚度，且所述远端半边218的横截面宽度近似等于所述远端半边248的横截 面宽度(在比较横截面厚度和宽度时，忽略凹坑227和凹坑257形成的缺口)。
钝模式下穿刺优点：参考图3，图4，图10A，图10B和图10C，所述无刀穿刺针200贯穿套管组件100并处于钝模式，然后一起经由穿刺点的皮肤切口处向体内穿刺。所述钝顶端259有助于刺破或分开组织，所述钝分离刃256有助于撕裂组织。前文所述远端半边218的横截面宽度和厚度小于远端半边248相应横截面的宽度和厚度，则当所述钝顶端259刺破组织或所述钝分离刃256撕裂组织时，有利于减小同一时间中所述倾斜远端221和倾斜远端251扩张组织的阻力，从而减小整体的穿刺操作力。所述倾斜远端221和倾斜远端251具有从远端向近端逐渐增大的结构，有助于减小扩张组织的阻力。更具体的，所述远端半边218的横截面厚度小于远端半边248相应横截面厚度，且从远端向近端逐渐增大的结构，有利于合理的分散刺破力，撕裂力，扩张力。更细致的，即当钝顶端259刺破肌肉或组织时，减少钝分离刃256撕裂肌肉或组织负荷；而当钝分离刃256撕裂肌肉或组织时，减小倾斜远端221和倾斜远端251挤压和胀大组织的负荷，避免较大的尖峰操作力，从而提供更好的操作体验和改善穿刺操作的可控性，降低损伤患者内部组织或器官的风险。而现有技术披露的钝头无刀穿刺器，通常无分散刺破力，撕裂力，扩张力的结构，因而其穿刺力很大，通常仅仅用在Hansson手术时拨开已被医生切割开的肌肉组织。
参考图11，图12和图13，当所述穿刺针200处于释放状态且所述远端半边248受到从远端向近端的轴向推力时，所述活动半边240从远端向近端移动至行程终点，所述锋利顶端229和分离刃226露出，即所述远端部分206处于锋利模式。参考图11，大致垂直所述轴线201作任意横平面X2与所述倾斜远端221和所述倾斜远端251同时相交，形成横截面11B和横截面11C。在横截面11B和横截面11C中，所述固定远端半边218的横截面厚度小于所述活动远端半边248的横截面厚度，但所述远端半边218的横截面宽度大于所述远端半边248的横截面宽度。参考图11和图11D，大致垂直所述轴线201作横平面Y2与所述倾斜远端221和所述基体250相交同时相交形成横截面11D，所述远端半边218的横截面厚度小于所述活动远端半边248的横截面厚度，且所述远端半边218的横截面宽度近似等于所述远端半边248的横截面宽度(在比较横截面厚度和宽度时，忽略凹坑227和凹坑257形成的缺口)。
锋利模式下穿刺优点：参考图11，图12，图13，图11A，图11B和图11C，所述无刀穿刺针200贯穿套管组件100，如前文所述按下按钮278使所述穿刺针200处于释放状态，然后一起经由穿刺点的皮肤切口处向体内穿刺。当进行穿刺时，所述远端半边248受到从远端向近端的轴向力作用，所述活动半边240从远端向近端运动至行程终点，露出 锋利顶端229和分离刃226。所述锋利顶端229有助于刺破或分开组织，所述分离刃226有助于撕裂组织。前文所述远端半边218的横截面厚度小于远端半边248相应横截面厚度，则当所述锋利顶端229刺破组织或所述分离刃226撕裂组织时，有利于减小同一时间中所述倾斜远端221和倾斜远端251扩张组织的阻力，从而减小整体的穿刺操作力。所述倾斜远端221和倾斜远端251具有从远端向近端逐渐增大的结构，有助于减小扩张组织的阻力。更具体的，所述远端半边218的横截面厚度小于远端半边248相应横截面厚度，且从远端向近端逐渐增大的结构，有利于合理的分散刺破力，撕裂力，扩张力。更细致的，即当锋利顶端229刺破肌肉或组织时，减少分离刃226撕裂肌肉或组织负荷；而当分离刃226撕裂肌肉或组织时，减小倾斜远端221和倾斜远端251挤压和胀大组织的负荷，避免较大的尖峰操作力，从而提供更好的操作体验和改善穿刺操作的可控性。当所述倾斜远端221完全刺破患者体壁且所述倾斜远端251完全进入患者体内时，所述倾斜远端251和远端半边248所受到的横向压力和轴向阻力消失，活动半边240在推力弹簧281的推力作用下迅速向远端移动至尽头；而锁件270在复位弹簧282推力作用下沿着导向筋232朝向手柄仓290的外部方向滑动，直到锁定端274挡住所述轴心孔215，使得所述近端241不能由远端向近端退回，所述远端部分206由锋利模式(释放状态)转变成钝模式(锁定状态)。则即使所述穿刺针200穿透体壁后继续向体内运动并接触腔内器官或组织时，所述锋利顶端229和分离刃226不会露出，仅钝顶端259和钝分离刃256接触腔内器官或组织，从而减小意外损伤的风险。另外，所述穿刺针200，其活动半边240的远端半边248仅为圆锥或圆柱的一半，本领域的技术人员应该可以理解，这有助于减小背景所述穿刺时肌肉和组织对其的阻力，因此可减少远端半边248由近端向远端移动覆盖远端半边218并锁定的过程的延迟时间，有助于减小意外损伤的风险。
如背景所述，人体不同部位或者腹部的不同位置，其脂肪，肌肉，筋膜等的含量比例和厚度等各有不同，其穿透的难易程度也不相同，而其造成内脏器官或组织意外损伤的风险高低也不同。较难穿刺的部位或造成意外损伤风险大的情形下，通常选择锋利的，有保护措施的无刀穿刺针进行穿刺，虽然这加大了对于患者穿刺点处的损伤，但其穿刺力较小而便于控制，从而减小了意外损伤的风险。较容易穿刺的部位或造成意外损伤风险小的情形下，通常选择较钝的无刀穿刺针进行穿刺，以减小对于患者穿刺点处的损伤。本发明提出了一种双模式穿刺针及其使用方法。所述穿刺针包含钝模式和锋利模式。经验丰富的医师可依据其专业知识来判断穿刺难易程度和意外损伤风险大小，来选择相适宜的穿刺模式进行穿刺。所述钝模式下穿刺(不触发锁定机构的情形下)，可用于相对较容易穿刺 的部位，或者对于患者内部器官造成意外损伤风险较小的部位。例如Hansson手术时，或者用于在内窥镜直视下的穿刺情形。所述锋利模式下穿刺(触发锁定机构的情形下)，可用于相对难以穿刺的部位，或者对于患者内部器官造成意外损伤风险较大的部位，例如建立第一个穿刺通道时。如前文所述，本发明所述无刀穿刺针结构有利于分散刺破力，撕裂力，扩张力，相对现有技术的无刀穿刺器，其锋利模式和钝模式均有利于减小穿刺操作力，增加了穿刺操作可控性，有助于减小意外损伤的风险，进而优化了双模式穿刺的实用性。
所述活动半边240相对于所述固定半边210沿着轴线方向滑动时，通常需要防止产生横向位移。图6，图7，图10和图10E详细披露了卡扣228与卡槽258相配合组成的连接机构，实现允许所述远端半边248相对所述远端半边218轴向运动和限制其横向相对运动的功能。图14-16描绘了另一种连接机构。锁片260包含2近似对称的长臂261及其之间的短臂262，所述长臂261和短臂262共同限定出矩形孔263。所述远端半边248包括限位片固定位264，所述锁片260粘接在所述固定位264之上。本领域的技术人员应该可以理解，也可以采用铆接，焊接，螺纹固定，卡扣固定等公知的连接技术将所述锁片260连接到所述远端半边248之上。所述远端半边218包含锁扣267，所述锁扣267包含中间槽266和两个近似对称的钩268。如前文所述，当将所述活动半边240安装到所述固定半边210之上时，用力挤压所述远端半边248，则所述锁扣267被所述长臂261压迫而发生弹性变形，即所述钩268发生弹性变形而所述中间槽266变窄。当所述锁扣267完全穿过矩形孔263之后，所述锁扣267弹性恢复，所述钩268扣在所述长臂261上，从而限制所述远端半边248相对于所述远端半边218产生横向位移。由于所述矩形孔263沿轴向的长度大于所述锁扣267沿轴线方向的厚度尺寸，因此所述活动半边240可相对于所述固定半边210沿着轴线方向滑动。还有很多可以实现前述功能的连接机构，限于篇幅而无法穷尽，本领域的一个普通的技术人员，可以想到其他连接机构或对前述机构进行适应性修改，以改善可加工性或可装配性。
参考图18，又一个实施例固定半边310与前述固定半边210相似，所述固定半边310的远端半边包含基体311，倾斜远端312，锋利顶端319和分离刃318。所述固定半边310的主要区别特征在于，两分离刃318构成近似圆弧形，即在锋利顶端的临近区域，所述两分离刃318之间的间距大于所述两分离刃226之间的间距，因而具有更好的撕裂作用。
参考图19，又一个实施例固定半边320与前述固定半边210结构相似，所述固定半边320的远端半边包含基体321，倾斜远端322，钝顶端329和分离刃328。所述固定半边320的主要区别特征在于所述钝顶端329相对较钝，对于肌肉或组织的破坏能力更弱。
参考图20，又一个实施例固定半边330与前述固定半边210结构相似，所述固定半边330的远端半边包含基体331，倾斜远端332，锋利顶端339和分离刃338。所述固定半边330的主要区别特征在于，所述分离刃338还包括更薄更锋利的翼337，所述翼337具有更好的撕裂肌肉或组织的作用。
参考图21，又一个实施例固定半边340与前述固定半边330结构相似，所述固定半边340的远端半边包含基体341，倾斜远端342，尖端349和分离刃338。所述分离刃338还包括更薄更锋利的翼337，所述翼337具有更好的撕裂肌肉或组织的作用。所述固定半边240区别于所述固定半边330的技术特征在于，所述尖端349为圆柱形。
参考图22，又一个实施例固定半边350与前述固定半边210的结构相似，所述固定半边350的远端半边包含基体351，倾斜远端352，锋利顶端359和分离刃358。中心平面357大致平行于所述固定半边350的中心轴线，并与所述基体351，倾斜远端352和锋利顶端359相交。且所述基体351，倾斜远端352和锋利顶端359全部位于所述中心平面357的同一侧。所述基体351包含圆柱外表面353，即所述基体351的外形近似为圆柱体的一半。所述倾斜远端352包含两个近似对称的外部曲面354。所述外部曲面354与所述外表面353相连并朝向锋利顶端359逐渐内凹的倾斜延伸。所述外部曲面354包含横向外凸的曲面，作大致垂直于所述固定半边350中心轴线的任意横截面与所述倾斜远端352相交，形成的横截面(如图22A)包含两段外凸的弧线，且其横截面的宽度和厚度由远端向近端逐渐增大。所述外部曲面354与所述中心平面357相交形成锋利的分离刃358。所述锋利顶端359，倾斜远端352和锋利的分离刃358构成了外形类似从长矛尖端的结构，有利于刺入和分离组织。
参考图23，又一个实施例固定半边360与前述固定半边210的结构相似，所述固定半边360的远端半边包含基体361，倾斜远端362，锋利顶端369和分离刃368。中心平面367大致平行于所述固定半边360的中心轴线，并与所述基体361，倾斜远端362和锋利顶端369相交。且所述基体361，倾斜远端362和锋利顶端369全部位于所述中心平面367的同一侧。所述基体361包含圆柱外表面363，即所述基体361的外形近似为圆柱体的一半。所述倾斜远端362包含两个近似对称的第一曲面364和两个近似对称的第二曲面365。所述第一曲面364和第二曲面365与所述外表面363相连并朝向锋利顶端369逐渐内凹的倾斜延伸。所述第二曲面365的一侧与所述中心平面367相交形成锋利的分离刃368，其另一侧与所第一曲面364相交。作大致垂直于所述固定半边360中心轴线的任意横截面与所述倾斜远端362相交，形成的横截面23A。参考图23A，沿着横向，所述截面 23A的厚度由两侧向中间逐渐增大，且在所述第一曲面364和第二曲面365的交线处突变，截面厚度增加的速率增大。且沿着轴向，其横截面的宽度和厚度由远端向近端逐渐增大。
参考图24，又一个实施例固定半边370与前述固定半边360的结构大致相同。所述固定半边370的远端半边包含基体371，倾斜远端372，锋利顶端379和分离刃378。中心平面377大致平行于所述固定半边370的中心轴线，并与所述基体371，倾斜远端372和锋利顶端379相交。且所述基体371，倾斜远端372和锋利顶端379全部位于所述中心平面377的同一侧。所述基体371包含圆柱外表面373，即所述基体371的外形近似为圆柱体的一半。所述倾斜远端372包含第一曲面374和两个近似对称的第二曲面375。所述第一曲面374和第二曲面375与所述外表面373相连并朝向锋利顶端379逐渐内凹的倾斜延伸。所述第二曲面375的一侧与所述中心平面377相交形成锋利的分离刃378，其另一侧与所第一曲面374相交。作大致垂直于所述固定半边370中心轴线的任意横截面与所述倾斜远端372相交，形成的横截面24A。参考图24A，沿着横向，所述截面24A的厚度由两侧向中间逐渐增大，且在所述第一曲面374和第二曲面375的交线处突变，截面厚度增加的速率增大。且沿着轴向，其横截面的宽度和厚度由远端向近端逐渐增大。所述固定半边370区别于所述固定半边360的主要技术特征在于，所述第一曲面374和第二曲面375具有整体横向外凸的结构。
参考图25，又一个实施例活动半边410与前述活动半边240的结构相似，所述活动半边410的远端半边包含基体411，倾斜远端412，钝顶端419和钝分离刃418。中心平面417大致平行于所述活动半边410的中心轴线，并与所述基体411，倾斜远端412和钝顶端419相交。且所述基体411，倾斜远端412和钝顶端419全部位于所述中心平面417的同一侧。所述基体411包含圆柱外表面413，即所述基体411的外形近似为圆柱体的一半。所述倾斜远端412包含圆锥曲面414。所述圆锥曲面414与所述外表面413相连并朝向钝顶端419倾斜延伸。所述圆锥曲面414与所述中心平面417相交形成钝分离刃418。即所述活动半边410的倾斜远端412的外形近似为截圆锥的一半。
参考图26，又一个实施例活动半边420与前述活动半边240的结构相似，所述活动半边420的远端半边包含基体421，倾斜远端422，钝顶端429和钝分离刃428。中心平面427大致平行于所述活动半边420的中心轴线，并与所述基体421，倾斜远端422和钝顶端429相交。且所述基体421，倾斜远端422和钝顶端4219全部位于所述中心平面427的同一侧。所述基体421包含圆柱外表面423，即所述基体421的外形近似为圆柱体的一半。所述倾斜远端422包含球壳曲面444。所述球壳曲面444与所述外表面423相连 并朝向钝顶端429倾斜延伸。所述球壳曲面444与所述中心平面427相交形成钝分离刃428。所述活动半边420的倾斜远端422的外形近似为球壳的四分之一，且所述钝顶端429与倾斜远端422中融合为一体，即所述无明显的钝顶端429。
参考图27，又一个实施例活动半边430与前述活动半边240的结构相似，所述活动半边430的远端半边包含基体431，倾斜远端432，钝顶端439和钝分离刃438。中心平面437大致平行于所述活动半边430的中心轴线，并与所述基体431，倾斜远端432和钝顶端439相交。且所述基体431，倾斜远端432和钝顶端439全部位于所述中心平面437的同一侧。所述基体31包含圆柱外表面433，即所述基体431的外形近似为圆柱体的一半。所述倾斜远端432包含第一曲面434，第二曲面435和第三曲面436。所述第三曲面436与所述中心平面437相交形成钝分离刃438。沿着轴线方向，所述倾斜远端432的厚度和宽度逐渐增大，且在临近所述钝顶端439的区域，其厚度增加的趋势较慢，而在临近所述基体431的区域，其厚度增加的趋势较快。沿着横向，所述倾斜远端432的厚度和宽度逐渐增大，且在临近所述钝分离刃438的区域，其厚度增加的趋势较慢。
本发明多次提到无刀穿刺针，锋利分离刃，锋利顶端，钝分离和钝顶端的概念。内窥镜手术中使用的穿刺针通常可分为有刀穿刺针和无刀穿刺针两个大类。所述“有刀”指含金属刀刃，所述“无刀”指不含金属刀刃。含有塑胶刃的穿刺针通常被称为无刀穿刺针，这是本领域约定俗成的。本发明中披露了含有塑胶刃，或锋利边，或钝边的结构，本领域的技术人员应该可以理解，穿刺患者体壁的过程中，所述刃或边对于患者体壁的损伤程度从大到小为，金属刀刃＞塑胶刃＞锋利边＞钝边。同样锋利顶端和钝顶端对于患者体壁的损伤程度从大到小为，锋利顶端＞钝顶端。因此，所述钝和锋利是一个相对的概念，本发明中所述锋利指相对较锋利的结构，而所述钝指相对较钝的结构。
已经展示和描述了本发明的很多不同的实施方案和实例。本领域的一个普通技术人员，在不脱离本发明范围的前提下，通过适当修改能对所述方法和器械做出适应性改进。例如其他发明中披露的锁定机构和连接机构，或者对所述锁定结构和限位结构做适应性修改，或者修改所述远端半边的外部形态，或者采用弹片替代弹簧等。好几种修正方案已经被提到，对于本领域的技术人员来说，其他修正方案也是可以想到的。因此本发明的范围应该依照附加权利要求，同时不应被理解为由说明书及附图显示和记载的结构，材料或行为的具体内容所限定。

Claims (8)

  1. 一种两半双模式无刀穿刺针，包含手柄部分和远端部分以及其间的杆部分，所述杆部分包含中心轴线，其特征在于：
    所述远端部分包含固定半边和活动半边；
    所述固定半边由远端向近端延伸并与所述杆部分或手柄部分固定在一起，而所述活动半边可相对于所述固定半边沿所述中心轴线方向移动；
    所述固定半边包含固定基体和与之连接并延伸至固定顶端的固定倾斜远端；所述活动半边包含活动基体和与之连接并延伸至活动顶端的活动倾斜远端；
    所述固定半边包含锋利分离刃和/或锋利顶端，所述活动半边包含钝分离刃和钝顶端。
  2. 如权利要求1所述的两半双模式无刀穿刺针，其特征在于，所述活动半边沿着所述中心轴线由近端向远端移动直到所述活动顶端完全超过所述固定顶端，作垂直于所述中心轴线的任意横平面同时与所述固定倾斜远端和活动倾斜远端相交，形成固定倾斜远端横截面和活动倾斜远端横截面，所述固定倾斜远端横截面的宽度尺寸小于所述活动倾斜远端横截面的宽度尺寸，所述固定倾斜远端横截面的厚度尺寸小于所述活动倾斜远端横截面的厚度尺寸。
  3. 如权利要求1所述的两半双模式无刀穿刺针，其特征在于，所述活动半边沿着所述中心轴线由远端向近端移动直到所述固定顶端完全超过所述活动顶端，作垂直于所述中心轴线的任意横平面同时与所述固定倾斜远端和活动倾斜远端相交，形成固定倾斜远端横截面和活动倾斜远端横截面，所述固定倾斜远端横截面的宽度尺寸大于所述活动倾斜远端横截面的宽度尺寸，所述固定倾斜远端横截面的厚度尺寸小于所述活动倾斜远端横截面的厚度尺寸。
  4. 如权利要求1所述的两半双模式无刀穿刺针，其特征在于，所述远端部分还包括连接装置，所述连接装置将所述固定半边和活动半边连接在一起，且所述连接装置允许所述活动半边沿所述中心轴线方向的平移运动，而限制所述活动半边在垂直于所述中心轴线方向上的位移。
  5. 如权利要求1所述的两半双模式无刀穿刺针，其特征在于，还包含锁定状态和释放状态，所述锁定状态即所述活动半边被锁定而不能由远端向近端移动，所述释放状态即所述活动半边可由远端向近端移动；其中所述锁定状态和释放状态由锁定机构实现，所述锁定机构至少包含锁定部分，释放部分和触发部分。
  6. 如权利要求5所述的两半双模式无刀穿刺针，其特征在于，所述穿刺针包含锋利模式和钝模式；在所述锋利模式下，所述活动半边沿所述中心轴线向近端移动，直到所述锋利分离刃和/或锋利顶端超出对应的所述活动半边的钝头分离刃和钝头顶端；在所述钝模式下，所述活动半边沿所述中心轴线向远端移动，直到所述活动半边的钝头分离刃和钝头顶端完全覆盖对应的所述锋利分离刃和/或锋利顶端之后，所述活动半边被锁定。
  7. 一种穿刺器，其特征在于，包含套管组件和如权利要求1-6任一项所述的两半双模式无刀穿刺针。
  8. 如权利要求7所述的穿刺器，其特征在于，所述穿刺针贯穿所述套管组件并一起经由患者穿刺点的皮肤切口处进行穿刺工作，所述穿刺针的工作状态包括锋利模式和钝模式，当医生预判穿刺力较大时，可采用锋利模式进行穿刺；当医生预判穿刺力较小时，则采用钝模式进行穿刺。
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