CN106510813B

CN106510813B - Knife-free puncture needle capable of being deformed locally

Info

Publication number: CN106510813B
Application number: CN201611125664.6A
Authority: CN
Inventors: 朱莫恕
Original assignee: 5r Med Technology Chengdu Co ltd
Current assignee: 5r Med Technology Chengdu Co ltd
Priority date: 2016-12-09
Filing date: 2016-12-09
Publication date: 2023-05-26
Anticipated expiration: 2036-12-09
Also published as: CN106510813A

Abstract

The invention relates to a knife-free puncture needle capable of being deformed locally. The needle includes a proximal handle and a distal tip, and a rigid rod extending proximally from the tip and connected to the handle, the rigid rod including a central axis. The knife-free puncture needle also comprises a rigid movable rod and a deformation ring. The rigid movable rod is movable relative to the rigid fixed rod. The deformation ring comprises an annular wall and a central hole, the distal end of the annular wall is fixed with the rigid fixed rod, and the deformation ring and the rigid fixed rod smoothly transition. The deformation ring has flexibility and elasticity, the material of the deformation ring is semi-rigid material or soft material, and the deformation ring enables the puncture needle and the sleeve assembly to have no fit clearance and to be smooth in transition.

Description

Knife-free puncture needle capable of being deformed locally

Technical Field

The invention relates to a minimally invasive surgical instrument, in particular to a puncture needle structure.

Background

A puncture device is a surgical instrument used in minimally invasive surgery (especially hard endoscopic surgery) to create an artificial channel into a body cavity. The penetrator typically comprises a cannula assembly and a needle. The clinical general use mode is as follows: a small opening is firstly cut on the skin of a patient, then a puncture needle penetrates through the sleeve assembly, the distal end of the puncture needle exceeds the distal end of the sleeve assembly, and then the puncture needle penetrates through the body wall through the skin opening and enters the body cavity.

In the process of penetrating the body wall, the surgeon holds the puncture outfit and applies larger puncture operating force for overcoming the resistance of puncturing and cutting the tissues and the resistance of squeezing and swelling the tissues. The distal end of the needle typically contains a sharp blade that helps reduce the force required to puncture and sever tissue. While the resistance suddenly disappears at the moment of penetration through the body wall, the doctor may not get to stop applying force or the blade may accidentally damage the internal tissues of the patient due to inertia. The lancet therefore typically comprises a selectively axially movable protective sheath and an automatic locking device, known as an automatic protective lancet. The protective lancet has a locked state and a released state. In the released state, the protective sheath is retractable proximally from the distal end to expose the blade; in the protected state, the protective sheath cannot be retracted from the distal end to the proximal end, and the blade is covered by the protective sheath. Moreover, the instant of penetration through the body wall, almost simultaneously, triggers the automatic locking means, thus rapidly and automatically switching from the released state to the protected state. I.e., the moment of penetration through the body wall, the protective sheath is moved from the proximal end to the distal end and locks over the blade at about the same time, thereby preventing accidental injury from the blade exposure. However, even under the effective protection of the protective cover, accidental damage to internal organs still occurs easily due to lack of experience of a doctor, or excessive puncture operation force applied by the doctor, or failure of the doctor to stop applying the puncture operation force in time, or due to difference of patient conditions, etc.

In order to reduce the risk of damaging internal organs, a doctor does not pierce the body in a simple linear motion mode but pierces the body while rotating back and forth in a small range when holding the puncture outfit for a puncturing operation in clinical application. This back and forth rotary penetration method facilitates tearing and distending the muscle tissue, as well as controlling the penetration rate and reducing the aforementioned inertial effects. However, in this back and forth rotary penetration method, the blade of the protective needle rotates and cuts the muscle tissue as it goes back and forth, resulting in irregular wounds, which additionally increases injury to the patient and increases the occurrence probability of incisional hernia complications.

Studies have shown that the use of a blade-free lancet (hereinafter referred to as a bladeless lancet) is advantageous in reducing trauma to the patient. As previously described, when a protective lancet is used for abdominal wall puncture, its blade punctures and cuts muscle and tissue; while using the knife-free lancet for abdominal wall puncture, the tip of the knife-free lancet pierces the muscles and tissue and tears the separated muscle fibers and swells the wound until the lancet and cannula assembly is integrated through the abdominal wall. It can be seen that the knife-free lancet reduces the cutting damage to muscle tissue, facilitates post-operative recovery, and reduces the probability of incisional hernia complications relative to the protective lancet. It is generally concluded that the use of a bladeless lancet is less damaging to the patient than the use of a bladed (protected) lancet. However, the use of the knife-less lancet for abdominal wall puncture typically requires a greater lancet force than the knife (guard) lancet, and is therefore more difficult to control, rather than increasing the risk of damaging the patient's internal organs and tissues.

In addition to the aforementioned risks, because there is a mating gap between the distal end of the needle and the distal end of the cannula assembly as it penetrates the cannula assembly, the epidermis or tissue of the patient may be easily caught in the mating gap during penetration of the patient's body wall, resulting in an abnormally increased penetration resistance and thus an increased risk of damaging the patient's internal organs and tissues. The defect and risk of patient epidermis being caught in the mating gap between the needle and cannula is discussed in detail in US5824002 and discloses a needle and cannula distal end well-transitioned penetrator.

The invention provides a simpler and more economical mechanism for achieving smooth transition of the distal end of the needle and cannula assembly.

Disclosure of Invention

It is therefore an object of the present invention to provide a bladeless lancet that is flexible at the distal end and that is compact, economical in manufacturing of the parts and easy and quick to assemble.

In one aspect of the invention, a bladeless lancet includes a proximal handle and a distal tip, and a rigid fixed shaft extending proximally from the tip and connected to the handle, the rigid fixed shaft including a central axis. The knife-free puncture needle also comprises a rigid movable rod and a deformation ring. The rigid movable rod is movable relative to the rigid fixed rod. The deformation ring comprises an annular wall and a central hole, the distal end of the annular wall is fixed with the rigid fixed rod, and the deformation ring and the rigid fixed rod smoothly transition. The deformation ring has flexibility and elasticity, and the material is semi-rigid material or soft material.

In one embodiment, the proximal handle comprises a base and a movable cover, wherein the base is coupled to a rigid fixed rod; the movable cover is connected with the rigid movable rod; and the movable cover and the rigid movable rod can move together relative to the rigid fixed rod. In another embodiment, the proximal handle comprises a base and a stationary cover, and the rigid movable rod is not connected to the proximal handle.

In one embodiment, the proximal end of the deformation ring is not fixed to the rigid moving rod, while in another embodiment, the proximal end of the deformation ring is fixed to the rigid moving rod.

It is another object of the present invention to provide a puncture outfit comprising a puncture needle and a cannula assembly, wherein a distal mating portion of the puncture needle and the cannula assembly has no gap, and when the puncture needle penetrates the cannula assembly and punctures together through a skin incision at the puncture site, a maximum diameter of a distal end of the puncture needle is equal to or larger than an inner diameter of a distal end of the cannula assembly, i.e., the distal mating portion of the puncture needle and the cannula assembly has no gap and transitions smoothly, thereby reducing a puncture force.

In another aspect of the invention, a puncture instrument comprises a cannula assembly comprising a sealed cartridge and a hollow cannula connected thereto, a distal end of the hollow cannula comprising a lip having an inner bore, and any of the foregoing puncture needles. In one embodiment, the deformation ring has a maximum outer diameter dimension that is greater than the inner bore aperture dimension of the lip. The puncture outfit comprises two states: in a first state, the rigid movable rod moves from the distal end to the proximal end, a cavity is formed in the annular wall between the distal end of the rigid movable rod and the rigid fixed rod, and the deformation ring can shrink and deform to enable the maximum outer diameter size of the deformation ring to be smaller than or equal to the inner hole aperture size of the lip. And in a second state, the rigid movable rod moves from the proximal end to the distal end and fills the cavity, and the deformation ring cannot shrink and deform, so that the maximum outer diameter size of the deformation ring is larger than the bore diameter size of the inner bore of the lip, and the puncture needle and the sleeve assembly have no fit clearance and are smooth in transition.

In yet another aspect of the present invention, a puncture instrument comprises a cannula assembly comprising a sealed cartridge and a hollow cannula connected thereto, a distal end of the hollow cannula comprising a lip having an inner bore, and any of the foregoing puncture needles. In one embodiment, the deformation ring has a maximum outer diameter dimension that is less than or equal to the inner bore aperture dimension of the lip. The puncture outfit comprises two states: in state one, the annular wall between the distal end of the rigid movable rod and the rigid stationary rod forms a cavity. And in the second state, the rigid movable rod moves from the proximal end to the distal end and fills the cavity, and the annular wall is extruded to bulge outwards, so that the maximum outer diameter of the deformation ring is larger than the bore diameter of the inner bore, and the puncture needle and the sleeve component have no fit clearance and are smooth in transition.

Drawings

For a fuller understanding of the nature of the present invention, reference should be made to the following detailed description taken in conjunction with the accompanying drawings in which:

FIG. 1 is a perspective view of a penetrator assembly;

FIG. 2 is a perspective view of the puncture needle according to the first embodiment of the present invention;

FIG. 3 is an exploded view of the lancet of FIG. 2;

FIG. 4 is a detailed view of the rigid stator bar of the lancet of FIG. 3;

FIG. 4A is a schematic cross-sectional view of 4A-4A of FIG. 4;

FIG. 4B is a schematic cross-sectional view of 4B-4B of FIG. 4;

FIG. 4C is a schematic cross-sectional view of 4C-4C of FIG. 4;

FIG. 5 is a cross-sectional view of the deformed ring of the lancet of FIG. 3;

FIG. 6 is a cross-sectional view of the handle base of the lancet of FIG. 3;

FIG. 7 is a side projection view of the lancet of FIG. 3;

FIG. 8 is a cross-sectional view 8-8 of the lancet of FIG. 7;

FIG. 9 is a side elevational view of the penetrator of FIG. 1;

FIG. 10 is an enlarged partial cross-sectional view of the distal end of the penetrator of FIG. 9;

FIG. 11 is a side elevational view of the puncture instrument illustrated in FIG. 9 in a puncturing state;

FIG. 12 is an enlarged partial cross-sectional view of the distal end of the penetrator of FIG. 11;

FIG. 13 is an exploded perspective view of a second embodiment of the lancet of the present invention;

FIG. 14 is a cross-sectional view of the deformed ring of the lancet of FIG. 13;

FIG. 15 is a side elevational view of the lancet of FIG. 13;

FIG. 16 is a cross-sectional view 16-16 of the lancet of FIG. 15;

FIG. 17 is a side elevational view of the needle and cannula assembly of FIG. 15 shown mated;

FIG. 18 is an enlarged partial cross-sectional view of the distal end of the penetrator of FIG. 17;

FIG. 19 is a side elevational view of the spike of FIG. 17 in a spike state;

FIG. 20 is an enlarged partial cross-sectional view of the distal end of the penetrator of FIG. 19;

FIG. 21 is a side elevational view of a penetrator in accordance with another embodiment of the present invention;

FIG. 22 is an enlarged partial cross-sectional view of the distal end of the penetrator of FIG. 21;

FIG. 23 is a side elevational view of the puncture instrument illustrated in FIG. 21 in a puncturing state;

fig. 24 is an enlarged partial cross-sectional view of the distal end of the penetrator of fig. 23.

Throughout the drawings, like reference numerals designate identical parts or elements.

Description of the embodiments

Embodiments of the present invention are disclosed herein, however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, the disclosure herein is not to be interpreted as limiting, but merely as a basis for the claims and as a basis for teaching one skilled in the art how to employ the invention.

Fig. 1-2 depict the overall structure of the puncture instrument. A typical penetrator includes a cannula assembly 100 and a needle 200. The cannula assembly 100 includes a seal cartridge 110 and a vent valve 120. The cartridge 110 includes a proximal sleeve top surface 111 (not shown) and a central throughbore 113 (not shown), with normally zero seal (also known as an auto seal) and a sealing membrane (also known as an instrument seal) mounted in the cartridge 110 in sequence from distal to proximal. The zero seal typically does not provide a seal to the inserted instrument, but automatically closes and forms a seal when the instrument is removed. The sealing membrane grips the instrument and forms a seal when the instrument is inserted. The cannula 130 includes an open distal end 132 and a hollow tube 133 that communicates with the sealed cartridge 110. The distal end 132 includes an angled lip 131. The needle 200 may be divided primarily into a handle portion 202, a shaft portion 204 and a distal portion 206. The handle portion includes a handle top surface 291 and a handle bottom surface 213.

Referring to fig. 1-2, the needle 200 extends through the cannula assembly 100, with the proximal cannula top surface 111 and the handle bottom surface 213 in contact. The sleeve assembly 100 is defined as having a front 107 on one side thereof containing a vent valve 120, a back 108 on the opposite side thereof, and side 109 on both sides thereof. The front 207, rear 208 and left and right sides 209 of the needle are defined according to the positional relationship of the needle 200 when mated with the cannula assembly 100. When performing the lancing operation, the physician's fingers grasp the seal cartridge 110 with the palm of the hand against the top 291 and the rear 208 of the handle, and the lancing operation is continually applied to penetrate the patient's body wall. Once completely penetrating the body wall, the needle is removed, leaving the cannula assembly as a passageway for instruments to enter and exit the body cavity. For convenience of description, the side closer to the operator is defined as the proximal end and the side farther from the operator is defined as the distal end, the central axis defining the lancet shaft portion 204 is defined as the axis 201 (not shown), the direction generally parallel to the axis 201 is referred to as the axial direction, and the direction generally perpendicular to the axis 201 is referred to as the lateral direction.

Fig. 3-8 depict in detail the structural composition and assembly relationship of the first embodiment of the bladeless lancet 200 of the present invention. Referring first to fig. 3, the bladeless lancet 200 includes a rigid fixed shaft 210, a deforming collar 230, a rigid movable shaft 250, a base 270, and a handle housing 290.

Referring to fig. 3, 4 and 7, the rigid stator bar 210 includes a proximal cylinder 214 and a piercing head 218 and a connecting shaft 216 therebetween. The connecting shaft 216 includes a proximal shaft 216a and a distal shaft 216c that are coaxial, i.e., have a common axis 211. The proximal shaft 216a has a smaller diameter than the distal shaft 216c and intersects to form a shoulder 216b. The piercing head 218 includes a base 224 and a tip 229 and a beveled distal end 226 extending from the base to the tip. The outer curved surface 225 and the outer curved surface 227 extend axially from the tip 229 toward the base 224, and the outer curved surface 225 and the outer curved surface 227 intersect in a transverse direction to form a separating edge 228. In this example, the intersection of the outer curved surface 225 and the outer curved surface 227 is rounded, so that the separating edge 228 is blunt. However, the intersection of the outer curved surface 225 and the outer curved surface 227 may also form a sharp separating edge. In this example, the outer curved surface 225 and the outer curved surface 227 are smooth nonlinear curved surfaces, i.e., the angled distal end 226 is comprised of two nonlinear curved surfaces. However, it will be readily apparent to those skilled in the art that 2 or more linear planes are possible. Referring primarily to fig. 4, 4A,4B and 4C, a longitudinal section 212 is taken through the axis 211 just separating the outer curved surface 225 and the outer curved surface 227, and then any cross-section (e.g., cross-sections 4A,4B, 4C) is taken generally perpendicular to the axis 211. The cross-sections (e.g., cross-sections 4a,4b,4 c) increase in width and thickness from distal to proximal; and the cross section is divided into left and right parts by an axial section 212, referring to fig. 4A,4B and 4C, the thickness of the left half is smaller than that of the right half. The base 224 further includes a proximal mating surface 223 and an annular rib 221 and a cylindrical portion 222 therebetween, the annular rib 221 including an annular flat surface 221a and an annular beveled surface 221b, the proximal mating surface 223, the cylindrical portion 222 and the annular flat surface 221a collectively forming the annular recess 220. The proximal cylinder 214 comprises a proximal stop surface 215 and 2 approximately symmetrical snaps 213. The catch 213 comprises a hook 213a and a cantilever 213b.

Referring to fig. 5, the deformation ring 230 includes a flexible proximal end 232 and a flexible distal end 238 and an annular wall 234 therebetween. The deforming ring 230 further includes a first bore 231, a second bore 235, and a third bore 239. One end of the first bore 231 extends through the flexible proximal end 232 and the other end thereof is connected to the second bore 235 via a first annular inner recess 233. One end of the third bore 239 extends through the flexible distal end 238, and the other end thereof is connected to the second bore 235 via the second annular inner recess 237. The annular inner recess 233 includes a first side wall 233a, a second side wall 233c and a top surface 233b. The second annular inner recess 237 includes a third sidewall 237a, a fourth sidewall 237c and an arcuate top surface 237b. And the annular wall 234 has an annular arcuate projection 236 corresponding to the arcuate top surface 237b.

Referring to fig. 3, the rigid movable rod 250 includes a proximal flange 252 and a movable distal end 258 and a hollow rod 256 extending proximally to distally, the hollow rod 256 including a central bore 255 extending proximally to distally. The central hole 255 comprises a first central hole 255a and a second central hole 255c, wherein the diameter of the first central hole 255a is smaller than the diameter of the second central hole 255c, and a step 255b is formed at the intersection of the two holes. At the movable distal end 258, an annular groove 257 separates an annular rib 259 from the hollow stem 256. The proximal flange 252 includes a proximal face 251 and a distal face 253 and 2 approximately symmetrical through holes 254.

Referring to fig. 3 and 6, the base 270 includes a proximal face 271 and a distal face 279, and a base 272 extending from the proximal end to the distal end. The first through hole 274, the second through hole 275, the third through hole 276 and the fourth through hole 277 are substantially coaxial, and are in communication with each other in sequence and penetrate the base 272. Wherein the inner diameters of the first through-hole 274 and the third through-hole 276 are the same, the inner diameter of the second through-hole 275 is smaller than the inner diameter of the first through-hole 274, and the inner diameter of the fourth through-hole 277 is larger than the inner diameter of the third through-hole 276. From the proximal face 271, 2 generally symmetrical through holes 273 penetrate the base 272 until communicating with the fourth through holes 277. The second through hole 275 includes a proximal face 275a and a distal face 275b. The base 270 also includes 2 orientation pins 278 projecting distally from the distal face 279.

Referring to fig. 3 and 8, the handle housing 290 includes a handle top surface 291 and an inner compartment 293 defined by a housing 292. Extending distally from the bottom of the housing 292 are 2 approximately symmetrical fixation posts 294. The fixed post 294 includes a cylindrical wall 295, a distal stop surface 296, and two approximately symmetrical catches 297. The latch 297 comprises a latch hook 298 and a cantilever 299.

Referring to fig. 7 and 8, a deformation ring 230 is mounted to the distal end of the rigid stator bar 210, wherein the cylindrical portion 222 mates with a third bore 239 and the distal shaft 216c mates with a second bore 235; the annular rib 221 is internally received in the second annular recess 237, and the flexible distal end 238 abuts the proximal mating surface 223, while the side wall 237c abuts the annular flat surface 221a, thereby firmly securing the rigid rod 210 and the deformable ring 230 together. Wherein the annular chamfer 221b is not in contact with the arcuate top surface 237b, i.e., a gap is reserved therebetween. The second central bore 255c of the rigid movable rod 250 mates with the distal shaft 216c, the annular groove 257 mates with the first bore 231, and the annular rib 259 is internally received within the annular internal recess 233, thereby connecting the rigid movable rod 250 and the deformation ring 230 together.

Referring to fig. 7 and 8, the base 270 is mounted to the rigid rod 210 with the proximal shaft 216a mated with the third throughbore 276, the proximal stop surface 215 contacting the distal surface 275b and the hook 213a contacting the proximal surface 275a, thereby securing the rigid rod 210 and the base 270 together. The handle housing 290 is mounted to the rigid movable rod 250 with the 2 fixation posts 294 passing through two through holes 273, the catches 297 mating with the through holes 254 with the distal stop surface 296 contacting the proximal surface 251 and the latch hooks 298 contacting the distal surface 253, thereby securing the handle housing 290 and the rigid movable rod 250 together. The thrust spring 240 is mounted over the proximal shaft 216a of the rigid stator bar 210, between the step 255b and the shoulder 216b and in compression. The push spring 240 pushes the rigid moving rod 250 to move distally and proximally, and the handle housing 290 moves distally and proximally to disengage from the base 270.

The rigid fixed rod 210 and the rigid movable rod 250 may be made of rigid plastic such as polycarbonate, nylon, or metal material. The deforming ring 230 may be made of a semi-rigid material or soft material such as polyvinyl chloride, a thermoplastic elastomer (e.g., polyurethane elastomer, heat vulcanized rubber), a thermosetting elastomer (e.g., silicone rubber, natural rubber), or the like. The connection between the deformation ring 230 and the rigid fixed rod 210 (or the rigid movable rod 250) in this example uses the elastic deformation characteristic of the deformation ring 230 to realize the interference fit between the rigid protruding ribs and the flexible inner grooves. However, known mechanical connection methods such as glue bonding, riveting, ultrasonic welding, screw connection, and the like may also be employed. In this example, the rigid fixed rod 210 is connected to the base 270, and the rigid movable rod 250 is connected to the handle housing 290 by elastic fastening, however, known mechanical connection methods such as glue bonding, riveting, ultrasonic welding, and threaded connection may be used.

The needle 200 includes two states. State one, referred to as the inactive state, may also be referred to as the natural state in this example. The second state is referred to as an operating state and may also be referred to as a puncturing state.

Referring to fig. 9 and 10, a needle 200 extends through the cannula assembly 100. In the inactive state (natural state), the handle housing 290 and the rigid movable rod 250 are moved from the distal end to the proximal end to the stroke apex by the urging force of the urging spring 240. In a natural state, the outer diameter of the arc-shaped protrusion 236 is larger than the inner diameter of the hollow tube 133, the deformation ring 230 is made of a semi-rigid or flexible material, and a gap is reserved between the annular inclined surface 221b and the arc-shaped top surface 237b, so that the arc-shaped protrusion 236 can radially shrink toward the axis to an outer diameter smaller than or equal to the inner diameter of the hollow tube 133. The puncture needle 200 can be smoothly inserted into or withdrawn from the cannula assembly 100.

Referring to fig. 11 and 12, the puncture needle 200 penetrates the cannula assembly 100, in an operating state (puncture state), the fingers of the operator grip the sealing cartridge 110 and the palm is closely attached to the top surface 291 of the handle, so that the handle housing 290 and the rigid movable rod 250 are forced to move from the proximal end to the distal end, and simultaneously the distal end of the rigid movable rod 250 pushes and compresses the deformation ring 230, the gap between the annular inclined surface 221b and the arc-shaped top surface 237b is reduced, the arc-shaped protrusion 236 is pressed to protrude beyond the lip 131 of the cannula assembly 100, and the outer diameter of the arc-shaped protrusion 236 is larger than the inner diameter of the hollow tube 133. Since the gap between the annular bevel 221b and the arcuate top surface 237b is filled or small, the projection 236 cannot radially collapse, and the outer diameter of the needle is larger than the inner diameter of the cannula assembly at the transition between the needle and the lip of the cannula assembly. Thus, when the needle 200 is held through the cannula assembly 100 and is pierced through the puncture site, the skin or tissue adjacent the wound as described in the background is not involved in the gap between the needle and the cannula assembly, and the transition is smoother, which helps to reduce the piercing force.

Fig. 13-16 depict a second embodiment of a lancet 300 of the present invention. The numerals of the geometric structures in fig. 13-16 are the same as the corresponding numerals in fig. 3-8, meaning that the structures of the same numerals in example two and example one are substantially identical. Referring primarily first to fig. 13, the knife-free lancet 300 comprises a rigid fixed shaft 310, a deforming collar 330, a rigid movable shaft 350, a base 270, and a handle housing 290.

Referring to fig. 13, the rigid fixation rod 310 includes a proximal cylinder 214 and a piercing tip 318 with a connecting shaft 216 therebetween. The connecting shaft 216 includes a proximal shaft 216a and a distal shaft 216c that are coaxial, i.e., have a common axis 211. The proximal shaft 216a has a smaller diameter than the distal shaft 216c and intersects to form a shoulder 216b. The piercing tip 318 includes a base 324 and a tip 329, and an angled distal end 326 extending from the base to the tip. The base 324 includes a proximal mating surface 322 and the angled distal end 326 is generally conical. The rigid dynamic stem 350 includes a proximal flange 252 and a movable distal end 358 and a hollow stem 356 extending proximally to distally, the hollow stem 356 including a central bore 355 extending proximally to distally. The center hole 355 includes a first center hole 355a and a second center hole 355c, wherein the diameter of the first center hole 355a is smaller than that of the second center hole 355c, and a step 355b is formed at the intersection of the first center hole 355a and the second center hole 355 c. The proximal flange 252 includes a proximal face 251 and a distal face 253 and 2 approximately symmetrical through holes 254.

Referring to fig. 13 and 14, and to fig. 5, the deformation ring 330 includes a flexible proximal end 332 and a flexible distal end 338 and an annular wall 334 therebetween. The deformation ring 330 further includes a first bore 335 and a second bore 337. The first bore 335 extends through the flexible proximal end 332 and the second bore 337 extends through the flexible distal end 338, the first bore 335 having an inner diameter greater than the inner diameter of the second bore 337, the two intersecting to form a step 336. An annular triangular outer protrusion 339 is included at the distal end of the annular wall 334, the outer protrusion 339 including a straight face 339a and a beveled face 339b.

Referring to fig. 15 and 16, deformation ring 330 is mounted to the distal end of rigid stator bar 310, wherein distal shaft 216c mates with second bore 337, and distal surface 322 and flexible distal end 338 are bonded together, thereby securely securing rigid stator bar 310 and deformation ring 330 together. The second central bore 355c of the rigid dynamic rod 350 mates with the distal shaft 216c and the hollow rod 356 mates with the first inner bore 335.

Referring to fig. 15 and 16, base 270 is mounted to rigid rod 310 with proximal shaft 216a mated with third throughbore 276, proximal stop surface 215 contacting distal surface 275b, and hook 213a contacting proximal surface 275a, thereby securing rigid rod 210 and base 270 together. The handle housing 290 is mounted to the rigid movable rod 350 with the 2 fixation posts 294 passing through the two through holes 273, the catches 297 mating with the through holes 254 with the distal stop surface 296 contacting the proximal surface 251 and the latch hooks 298 contacting the distal surface 253, thereby securing the handle housing 290 and the rigid movable rod 350 together. The thrust spring 240 is mounted over the proximal shaft 216a of the rigid stator bar 310, between the step 255b and the shoulder 216b and in compression. The thrust spring 240 urges the rigid moving rod 350 to move distally and proximally, and the handle housing 290 moves distally and proximally to disengage from the base 270; without the movable distal end 358 and the step 336 contacting, i.e., a cavity 335a is formed between the movable distal end 358 and the step 336.

Referring to fig. 17 and 18, a cannula assembly 400 includes a seal cartridge 110, a vent valve 120, and a cannula 430. The sleeve 430 includes an open distal end 432 and a hollow tube 433 that communicates with the sealed cartridge 110, the distal end 432 including a lip 431. In the inactive state (natural state), the puncture needle 300 penetrates the sleeve assembly 400, and the handle housing 290 and the rigid movable rod 350 are moved from the distal end to the proximal end to the stroke peak under the force of the thrust spring 240. In a natural state, the outer diameter of the outer protrusion 339 is larger than the inner diameter of the hollow tube 433. The deformation ring 330 is made of a semi-rigid or flexible material. When the needle 300 is inserted into the cannula assembly 400 or withdrawn outwardly from the interior of the cannula assembly 400, the outer projection 339 may radially retract toward the hub to an outer diameter equal to the inner diameter of the hollow tube 433 due to the cavity 335a formed between the movable distal end 358 and the step 336. The puncture needle 300 can be smoothly inserted into or withdrawn from the cannula assembly 400. In an operating state (puncturing state), referring to fig. 19 and 20, when performing a puncturing operation, a doctor holds the seal cartridge 110 with his fingers and holds the palm close to the handle top surface 291 of the handle housing 290, thereby pushing the handle housing 290 and the rigid movable rod 350 to move from the proximal end to the distal end until the movable distal end 358 contacts the step 336, the cavity 335a is filled with the rigid movable rod 350, the outer protrusion 339 is not contractible, and the outer diameter of the outer protrusion 339 is larger than the inner diameter of the hollow tube 433 and is equal to or larger than the outer diameter of the lip 431. In the puncturing process, as a gap is not formed between the puncture needle and the sleeve assembly, the condition that skin or tissue near the wound is rolled into the gap between the puncture needle and the sleeve assembly can not occur, and the transition is smoother, so that the puncture force can be reduced.

Fig. 21-22 depict a third embodiment of a lancet 500 of the present invention. The numerical designations of the geometric structures in fig. 13-16 are the same as the corresponding numerical designations in fig. 13-16, meaning that the structures of example two and example one that are the same numerical designations are substantially identical. The knife-free lancet 500 includes a rigid fixed shaft 310, a deforming ring 530, a rigid movable shaft 350, a base 270, and a handle housing 290.

Referring primarily to fig. 22, the flexible ring 530 includes a flexible proximal end 332 and a flexible distal end 338 and an annular wall 334 therebetween. The deformation ring 330 further includes a first bore 335 and a second bore 337. The first bore 335 extends through the flexible proximal end 332 and the second bore 337 extends through the flexible distal end 338, the first bore 335 having an inner diameter greater than the inner diameter of the second bore 337, the two intersecting to form a step 336. A deformation ring 530 is mounted to the distal end of the rigid stator bar 310, wherein the distal shaft 216c mates with the second bore 337, and the distal surface 322 and the flexible distal end 338 are bonded together, thereby firmly securing the rigid stator bar 310 and the deformation ring 530 together. The second central bore 355c of the rigid movable rod 350 mates with the distal shaft 216c, the hollow rod 356 is inserted into the first inner bore 335, and the movable distal end 358 and the step 336 are not in contact, i.e., a cavity 335b is formed between the movable distal end 358 and the step 336. And the distal end of the hollow rod 356 and the first bore 335 are securely fastened together. In this example, glue is used for bonding and fixing, however, known mechanical connection methods such as secondary injection molding, riveting, ultrasonic welding, threaded connection and the like can also be used.

The lancet 500 includes two states. State one, referred to as the inactive state, may also be referred to as the natural state in this example. The second state is referred to as an operating state and may also be referred to as a puncturing state.

In the inactive state (natural state), referring to fig. 21-22, the movable distal end 358 and the step 336 are not in contact, i.e., a cavity 335b is formed between the movable distal end 358 and the step 336. The maximum outer diameter of the distal end of the needle 500 is smaller than the inner diameter of the hollow tube 433. 23-24, the needle 500 is passed through the cannula assembly 400, and when performing a lancing operation, the physician's finger grips the seal housing 110 and the palm is in close proximity to the top surface 291 of the handle housing 290, thereby pushing the handle housing 290 and the rigid movable bar 350 distally from the proximal end until the movable distal end 358 contacts the step 336. The cavity 335b is filled with the rigid movable bar 350, and the annular wall 334 between the movable distal end 358 and the step 336 is deformed outwardly to form a ridge 339 and deposited on the mouth of the lip 431. While the protuberance 339 is non-collapsible, the outer diameter of the outer protuberance 339 is greater than the inner diameter of the hollow tube 433 and greater than or equal to the outer diameter of the lip 431. In the puncturing process, as a gap is not formed between the puncture needle and the sleeve assembly, the condition that skin or tissue near the wound is rolled into the gap between the puncture needle and the sleeve assembly can not occur, and the transition is smoother, so that the puncture force can be reduced.

While the first, second and third embodiments are both movable and coupled to the rigid movable bar, it will be appreciated by those skilled in the art that the handle housing may be stationary and the rigid movable bar may be uncoupled from the handle housing or from the handle. Although the first embodiment, the second embodiment and the third embodiment use springs, elastic sheets may be used, or the rigid movable rod may be manually moved instead of using an elastic return mechanism.

Many different embodiments and examples of the invention have been shown and described. One of ordinary skill in the art will be able to make adaptations to the method and apparatus by appropriate modifications without departing from the scope of the invention. For example, the shapes of the distal end of the rigid fixed rod and the deformation ring are changed, the fixing mode between the deformation ring and the rigid fixed rod is changed, the shape and the moving driving mode of the rigid movable rod are changed, the materials of the deformation ring are detailed, or the accurate size of the deformation ring is obtained through limited times of test. Several modifications have been mentioned, and other modifications are conceivable to the person skilled in the art. The scope of the present invention should therefore be determined with reference to the appended claims, rather than with reference to the structures, materials, or acts illustrated and described in the specification and drawings.

Claims

1. A bladeless lancet comprising a proximal handle and a distal tip, and a rigid fixed shaft extending proximally from the tip and connected to the handle, the rigid fixed shaft comprising a central axis, characterized in that:

the knife-free puncture needle also comprises a rigid movable rod and a deformation ring;

the rigid movable rod can move relative to the rigid fixed rod;

the deformation ring comprises a flexible proximal end and a flexible distal end and an annular wall therebetween,

the deformation ring further comprises a first inner hole, a second inner hole and a third inner hole, one end of the first inner hole penetrates through the flexible proximal end, the other end of the first inner hole is connected with the second inner hole through a first annular inner groove, one end of the third inner hole penetrates through the flexible distal end, the other end of the third inner hole is connected with the second inner hole through a second annular inner groove, the flexible distal end is fixed with the rigid fixed rod, and the deformation ring and the rigid fixed rod are in smooth transition;

the rigid fixed rod comprises a proximal cylinder, a puncture head and a connecting shaft therebetween, wherein the connecting shaft comprises a proximal shaft and a distal shaft which are coaxially connected, and the puncture head comprises a proximal matching surface, an annular rib and a cylindrical part therebetween;

the deformation ring is mounted to the distal end of the rigid stator bar, wherein the cylindrical portion mates with a third bore, and the distal shaft mates with a second bore; the annular rib is embedded into the second annular inner groove, so that the rigid fixed rod and the deformation ring are fixed;

the second central hole of the rigid movable rod is matched with the far-end shaft, the annular groove of the rigid movable rod is matched with the first inner hole, and the annular rib is embedded into the first annular inner groove to connect the rigid movable rod and the deformation ring;

the deformation ring has flexibility and elasticity, and the material is semi-rigid material or soft material.

2. The needle of claim 1, wherein the handle comprises a base and a movable cover, wherein the base is secured to the rigid fixed rod and the movable cover is secured to the rigid movable rod.

3. The needle of claim 1, wherein the proximal end of the deformable ring is secured to the rigid plunger.

4. A puncture outfit comprising a cannula assembly and the puncture needle of claim 2, said cannula assembly comprising a sealed cartridge and a hollow cannula connected thereto, said hollow cannula distal end comprising a lip having an inner bore, said deformation ring having a maximum outer diameter dimension greater than said lip inner bore aperture dimension.

5. The puncture device according to claim 4, comprising two states:

the rigid movable rod moves from the distal end to the proximal end, a cavity is formed in the annular wall between the distal end of the rigid movable rod and the rigid fixed rod, and the deformation ring can shrink and deform to enable the maximum outer diameter size of the deformation ring to be smaller than or equal to the inner hole aperture size of the lip;

and in a second state, the rigid movable rod moves from the proximal end to the distal end and fills the cavity, and the deformation ring cannot shrink and deform, so that the maximum outer diameter size of the deformation ring is larger than the bore diameter size of the inner bore of the lip, and the puncture needle and the sleeve assembly have no fit clearance and are smooth in transition.

6. A puncture outfit comprising a cannula assembly and the puncture needle of claim 3, wherein the cannula assembly comprises a sealed cartridge and a hollow cannula connected with the sealed cartridge, the distal end of the hollow cannula comprises a lip with an inner hole, and the maximum outer diameter dimension of the deformation ring is less than or equal to the inner hole aperture dimension of the lip.

7. The puncture device according to claim 6, comprising two states:

in the first state, a cavity is formed by the annular wall between the distal end of the rigid movable rod and the rigid fixed rod;

and in a second state, the rigid movable rod moves from the proximal end to the distal end and fills the cavity, and the annular wall is extruded to bulge outwards, so that the maximum outer diameter size of the deformation ring is larger than the aperture size of the inner hole, and the puncture needle and the sleeve assembly have no fit clearance and are smooth in transition.