WO2018103571A1

WO2018103571A1 - Puncture needle comprising damage-free protection device

Info

Publication number: WO2018103571A1
Application number: PCT/CN2017/113727
Authority: WO
Inventors: 朱莫恕
Original assignee: 成都五义医疗科技有限公司
Priority date: 2016-12-09
Filing date: 2017-11-30
Publication date: 2018-06-14
Also published as: CN106618688A

Abstract

A puncture needle comprising a damage-free protection device. The puncture needle comprises a handle part (202), a distal part (206), and a rod part (204) therebetween. The distal part (206) comprises a fixed part (210) and a movable part (260). The fixed part (210) comprises working edge (220). The fixed part (210) extends from a distal end to a proximal end and is fixed together with the rod part (204) or the handle part (202), while the movable part (210) is movable with respect to the fixed part (260) along the axial direction of the rod part (204). The movable part (206) comprises a protective sheath (280); the protective sheath (280) comprises an inclined distal end (286) and a blade groove (287); the inclined distal end (286) comprises a rigid part (291) and a flexible part (296). The flexible part (296) is attached to the surface of the rigid part (291) to constitute a sharp structure. The protective sheath is made of at least two materials, i.e., the protective sheath comprises the rigid part and the flexible part. The lower the hardness of the flexible part, the smaller the damage capability thereof to the muscle of a patient, and the better the effect of impact force absorption.

Description

Puncture needle containing non-destructive protection device

Technical field

The present invention relates to a minimally invasive surgical instrument, and more particularly to a puncture needle structure.

Background technique

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.

During the penetration of the body wall, the surgeon holds the trocar and applies a large puncturing force to overcome the resistance to puncturing and severing the tissue, as well as the resistance to expansion and swelling of the tissue. The distal end of the needle typically contains a sharp blade that helps reduce the force of puncturing and cutting the tissue. The resistance suddenly disappears at the moment of penetrating the body wall, and the doctor may not accidentally apply force or due to inertia, the blade may accidentally damage the internal tissue of the patient. Therefore, 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 cover. Moreover, the moment of penetrating the body wall, 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 distal end to cover the blade and lock, thereby preventing the blade from being exposed to cause accidental damage.

Commercially available protective needles typically provide visual or audible prompts to alert the surgeon that the distal end of the needle has penetrated the body wall. The visual or audible cue typically coincides with the process of the protective cover moving from the proximal end to the distal end to cover the blade and lock. However, when a surgeon performs a puncture, his attention is often focused on the patient's physical characteristics and changes in his or her symptoms, and in some cases the visual or audible cues are easily overlooked. More importantly, even if the surgeon sees a visual prompt or hears an auditory prompt, it needs to be analyzed by the brain and then output an instruction to stop the puncture operation force, resulting in a delay in operation. It should be understood by those skilled in the art that the moment the puncture needle blade and the protective sleeve penetrate the body wall, the protective sleeve moves from the proximal end to the distal end to cover the blade and lock due to the resistance between the muscle wall and the tissue of the body wall and the protective sleeve. The process will also be 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.

Even under the effective protection of the aforementioned protective cover, accidental injury may occur in the patient due to lack of doctor experience, excessive manipulation of the puncture force applied by the doctor, or due to the doctor's failure to stop the puncture operation force in time. The condition of the organs. In particular, when using the protective puncture needle to establish the first puncture channel, the surgeon cannot see or accurately perceive whether the distal end of the puncture needle has penetrated the body wall, and often feels that the puncture needle and the cannula assembly penetrate the body wall as a whole. After the feeling of falling out, the application of the operating force is stopped. However, it is usually too late, due to excessive operating force and inertia, the protective sleeve at the distal end of the puncture needle contacts the internal organs or tissues of the patient in an impact manner, and may still cause different degrees of unpredictable damage to the patient. And because of the limited field of view of endoscopic surgery, such damage is often difficult to detect. In recent years, with the extensive promotion and extensive application of endoscopic surgery, the clinical cases of accidental injury caused by the aforementioned protective cover contacting the internal organs of the patient in an impact manner have gradually increased, and have attracted the attention of the medical community. However, so far, there is no puncture needle solution for this problem.

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. Referring to Fig. 1, based on 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. During insertion of the needle through the cannula assembly and through the abdominal wall, 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. In order to reduce the probability of abdominal wall complication, it is generally preferred that the puncturing device and the abdominal wall form an angle of 30 to 60°. The skin has good elasticity and strength. When the puncture channel is established, 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.

Referring to Figures 1-2, 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 _T20 ), the distal end 30 expands the muscle layer (resistance F _T30 ); in the fifth stage, the blade 10 enters the abdominal cavity, the distal end 20 expands the peritoneum (resistance F _T20 ), and the distal end 30 continues to expand Muscle layer (resistance F _T30 ); stage 6, distal end 20 enters the abdominal cavity and triggers the locking device such that the distal end 20 covers the blade 10, the distal end 30 expands the peritoneum (resistance F _T30 ); and in the seventh stage, the distal end 30 enters the abdominal cavity, Stop puncture.

Referring to Figure 1-2, under ideal conditions, the puncture operating force F _i applied by the doctor satisfies the following formula:

F _i =F _T10 +F _T20 +F _T30

among them:

F _T10 = resistance to the blade 10;

F _T10 = resistance to the distal end 20;

F _T10 = resistance to the distal end 30;

Ideally, 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. In combination with Figure 2, because the resistance of the needle in the first, second, third, and fourth stages is gradually increased, 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. However, since 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.

In order to reduce the risk of damaging the internal organs, in the clinical application, when the doctor holds the puncturing device for the puncture operation, it does not penetrate into the body in a simple linear motion, but penetrates into the body while rotating in a small range. This round-robin piercing method facilitates tearing and swelling of muscle tissue while facilitating control of the penetration speed and reduction of the aforementioned inertia. However, in the back-and-forth rotary piercing method, the blade for protecting the puncture needle rotates back and forth and cuts the muscle tissue, resulting in irregular wounds, thereby additionally increasing the damage to the patient and increasing the complications of the incisional hernia. The probability of occurrence.

Studies have shown that the use of a blade-free puncture needle (hereinafter referred to as a knife-free puncture needle) is advantageous in reducing damage to the patient. 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. It can be seen that 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. It is generally concluded that the use of a knifeless puncture needle is less conducive to patient injury than the use of a knife (protection) puncture. However, the use of the knifeless puncture needle for abdominal wall puncture is generally greater than the puncture force of the knife-protecting puncture needle, so it is more difficult to control, and instead increases the risk of damaging the internal organs and tissues of the patient.

In order to solve the aforementioned problem or problems, the present invention proposes a puncture needle including a non-destructive protection device.

Summary of the invention

Accordingly, it is an object of the present invention to provide a puncture needle comprising a non-destructive protection device.

In one aspect of the invention, a puncture needle includes a handle portion and a distal portion and a stem portion therebetween. The distal portion includes a fixed portion and a movable portion. The fixed portion includes a working edge. The fixed portion extends proximally from the distal end and is fixed to the rod portion or the handle portion, and the movable portion is movable relative to the fixed portion in the axial direction of the rod portion. The movable portion includes a protective sleeve including a slanted distal end and a sipe, the slanted distal end including a rigid portion and a flexible portion. The flexible portion is attached to the surface of the rigid portion and constitutes a sharp structure.

In one embodiment, the material of the flexible portion is a semi-rigid material or a soft material. In another preferred embodiment, the range of Shore Hardness HD of the flexible portion is: 70A < HD < 90A.

In one embodiment, the flexible portion is attached to the top of the sharp structure. In another embodiment the flexible portion encases the entire angled distal end. In still another aspect, the flexible portion can also extend to the sipe surface.

In one embodiment, the working edge comprises a metal blade and a metal blade. In another embodiment, the working edge comprises a plastic separating edge (plastic blade). In yet another embodiment, the distal end of the fixed portion further includes a sharp tip.

In still another aspect of the invention, the puncture needle includes a locked state and a released state. The locked state, that is, the protective cover is locked from being movable from the distal end to the proximal end, and the released state, that is, the protective cover can be moved from the distal end to the proximal end. Wherein the locked state and the released state are implemented by a locking mechanism. The locking mechanism includes at least a locking portion, a releasing portion and a trigger portion. The locking portion implements a locked state, the release portion effects a release state, and the trigger portion effects a transition to a locked state when the release portion is triggered. In one embodiment, the handle portion of the puncture needle includes a handle base, a lock member and a return spring. The handle base includes a central through hole and a locking tooth that is circumscribed with the central through hole. The lock member includes a locking end and a release end, the release end including a trigger arm and a lock hook. The return spring is mounted to the release end of the lock and is mounted together in the handle base. The puncture needle is in a locked state when the locking end blocks the central through hole. When the lock member is driven to move so that the lock hook engages with the lock tooth, the lock end moves away to expose the center through hole, and the puncture needle is in a released state. When the protective sleeve is moved from the distal end to the proximal end to force the trigger arm to elastically deform, thereby disengaging the locking hook from the locking tooth, and the return spring drives the locking member to perform a resetting motion, the puncture needle Transition from the released state to the locked state.

In still another aspect of the invention, the puncture needle comprises a lossy mode and a lossless mode. In the lossy mode, the protective sleeve moves proximally along the axis until the working edge extends beyond the corresponding protective sleeve. In the lossless mode, the protective sleeve moves distally along the axis until the working edge is completely covered, and the movable portion is locking.

A trocar includes a cannula assembly and any of the foregoing lancets.

DRAWINGS

In order to more fully understand the essence of the present invention, a detailed description will be made with reference to the accompanying drawings, in which:

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 perspective view of the trocar assembly;

Figure 4 is a perspective view of a puncture needle of a first embodiment of the present invention;

Figure 5 is a perspective exploded view of the puncture needle shown in Figure 4;

Figure 6 is an exploded view of the protective sleeve of the puncture needle shown in Figure 5;

Figure 7 is a sectional view showing the combination of the protective cover shown in Figure 6;

Figure 8 is a perspective detailed view of the lock of the puncture needle shown in Figure 5;

Figure 9 is a plan view of the puncture needle shown in Figure 5 assembled;

Figure 10 is a cross-sectional view taken along line 10-10 of the puncture needle shown in Figure 9;

Figure 11 is a cross-sectional view showing the moment when the locking mechanism of the puncture needle shown in Figure 10 is triggered;

Figure 12 is a cross-sectional view of the puncture needle of Figure 10 in a damaged state;

Figure 13 is a perspective exploded view of a second embodiment of the present invention;

Figure 14 is a perspective detailed view of the plastic body of the puncture needle shown in Figure 13;

Figure 15 is an exploded view of the protective sleeve of the puncture needle shown in Figure 13;

Figure 16 is a sectional view showing the combination of the protective cover shown in Figure 15;

Figure 17 is a projection view of the puncture needle shown in Figure 13 after assembly;

Figure 18 is a cross-sectional view of the puncture needle shown in Figure 17;

Figure 19 is a perspective view of a fixed half of a third embodiment of the present invention;

Figure 20 is a perspective view of a movable half of a third embodiment of the present invention;

Figure 21 is a partial cross-sectional view showing a distal end portion of a third embodiment of the present invention.

In all the views, the same reference numerals indicate equivalent parts or parts.

detailed description

Embodiments of the present invention are disclosed herein, but it should be understood that the disclosed embodiments are merely examples of the invention, which may be implemented in various ways. Therefore, the disclosure herein is not to be construed as limiting. Rather, it is only the basis of the claims and the basis of the teachings of the invention.

Figures 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 351 and a handle bottom surface 243.

Referring to Figures 3-4, the puncture needle 200 extends through the cannula assembly 100, and the cannula top surface 111 is in contact with the handle bottom surface 243. 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. When the puncture action is performed, the doctor's finger grips the sealed chamber 110, and the palm is pressed against the top surface 351 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. For convenience of presentation, 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.

4-10 illustrate in detail the structural and assembly relationship of the first embodiment of the present invention with the knife automatic protection puncture needle 200. Referring to Figures 4-5, the distal end portion 206 of the puncture needle 200 includes a fixed portion 210 and a movable portion 260. The fixed portion 210 includes a working edge 220, a shank 230 and a body 240, and the movable portion 260 includes a pin 90, a push rod 270 and a protective sleeve 280.

The working edge 220 includes a planar cutter body 222, a cutting edge 223 and two cutting edges 224 that are at an acute angle to each other. Those skilled in the art will appreciate that the working blade 220 can be mounted to the shank 230 by a variety of well known joining techniques, such as bonding, welding, mechanical fastening, and the like. The shank 230 in this example includes a post 239 that passes through a through hole 226 in the working edge 220 and that is deformed by hot pressing to mount the working edge 220 to the fixed step 238 on the shank 230. It is firmly fixed on the top. The shank 230 further includes a proximal cylinder 232 and a distal cylinder 236 and a boss 234 therebetween. The shank 230 further includes a central blind bore 233 that includes a via 235 that communicates with the central blind bore 233. The via 235 is approximately rectangular and includes a short side 235a and a long side 235b, and the long side 235b is substantially parallel to the axis of the central blind hole 233. The outer surface of the proximal cylinder 234 includes a plurality of bumps 231.

Referring to Figures 5, 9 and 10, the body 240 includes a flange 242 and a distally extending hollow tube 244 coupled thereto. The hollow tube 244 includes a second through hole 248 that penetrates the distal end of the flange 242 through the first through hole 246. The inner diameter of the second through hole 248 is larger than the first through hole 246, and the first and second through hole intersections form a platform 247. The distal end of the body 240 further includes a plurality of through holes 249 that transversely penetrate the hollow tube 244 and communicate with the second through hole 248. Those skilled in the art will appreciate that the shank 230 and body 240 can be secured together by a variety of well known joining techniques, such as bonding, welding, mechanical fastening, and the like. In the present example, the shape and size of the proximal cylinder 232 and the second through hole 248 match, and the bump 231 matches the shape and size of the through hole 249, thereby firmly fixing the shank 230 and the body 240 together.

The flange 242 of the body 240 includes an upper surface 241 and a handle bottom surface 243. The flange 242 also includes a mounting seat 251 that projects from the upper surface 241 toward the proximal end, a guide rib 252, a guide slot 253, a notch 254, a locking tooth 256 and four approximately uniform posts 258. The locking tooth 256 includes a locking surface 255 and a pushing surface 257 , and the locking surface 255 is tangent to the first through hole 246 .

Referring to FIG. 5, the push rod 270 includes a proximal rod 272 and a distal rod 276 and a boss 274 therebetween, the boss 274 having a diameter greater than the diameter of the proximal rod 272. The proximal rod 272 includes a proximal tip 271 that includes a distal tip 277 that includes a pin bore 275.

Referring to Figures 5, 6 and 7, the protective sleeve 280 is generally bullet-shaped, the protective sleeve comprising a slanted proximal end 282 and a slanted distal end 286 with a cylindrical portion 284 therebetween. The angled distal end 286 includes a slot 287 that matches the shape and size of the working edge 220. The protective sleeve 280 also includes a central aperture 283 extending from the proximal end to the distal end and in communication with the sipe 287, the central aperture 283 including a first inner aperture 283a and a second inner aperture 283b. The cylindrical portion 284 also includes a side aperture 285 that communicates with the central aperture 283. The angled distal end 286 includes a rigid portion 291 and a flexible portion 296. The rigid portion includes a smooth outer surface 292 and a mating end 293. The flexible portion 296 includes a mating end 297 and a top end 299 and an outer curved surface 298 extending therebetween. The mating end 297 is shaped and sized to match the mating end 293. It will be appreciated by those skilled in the art that the flexible portion 296 and the rigid portion can be employed in a variety of well known joining techniques, such as bonding, welding, mechanical securing, and the like. Portion 291 is fixed together. This example uses a double injection molding method to firmly secure the flexible portion 296 and the rigid portion 291 together. The outer curved surface 298 and the outer surface 292 are shaped and sized to match each other and smoothly transition, and are generally bullet-shaped. The protective sleeve 280 is made of at least two different materials, wherein the rigid portion 291 is usually made of a hard plastic such as polycarbonate or nylon or a medium hardness plastic, and may also be made of a metal material. The flexible portion 296 may be made of a semi-rigid material or a soft material such as polyvinyl chloride, a thermoplastic elastomer (for example, a polyurethane elastomer, a heat vulcanized rubber), a thermosetting elastomer (for example, a silica gel, a natural rubber).

Referring to Figures 5-10, reference is primarily made to Figure 10. The push rod 270 is mounted inside the shank 230 and the main body 240, and the proximal rod 272 is matched with the first through hole 246, the distal rod 276 is matched with the central blind hole 233, and the pin hole 275 and the through hole 235 are matched. Basic alignment. A thrust spring 80 is mounted over the proximal rod 272 of the push rod 270 between the platform 247 and the boss 274 and in a compressed state. The central aperture 283 of the protective sleeve 280 mates with the distal cylinder 236, and the side aperture 285 is substantially aligned with the pin aperture 275. Pin 90 includes a long side 92, a wide side 94 and a high side 96. The pin 90, the pin hole 275, the through hole 235 and the side hole 285 are matched in shape and size, and the pin 90 passes through the side hole 285, the through hole 235 and the pin hole 275 in order from the outside to the inside, and the pin 90 and the side hole 285 pass. The fit fits to securely secure the boot 280 and the push rod 270 together. The size of the long side 235b of the via 235 is larger than the size of the wide side 94 of the pin 90, and the protective sleeve 280 and the push rod 270 can move together in the axial direction. When the protective sleeve 280 and the push rod 270 are moved from the distal end to the proximal end to expose the cutting edge 223 or the cutting edge 224, the distal end portion 206 is said to be in a lossy mode (or working mode); when the protective sleeve 280 and the push rod 270 are When the proximal end moves distally to cover the blade tip 223 and the blade edge 224 and is locked (ie, the protective sleeve 280 and the push rod 270 are not movable from the distal end to the proximal end), the distal end portion 206 is said to be in a lossless mode (or protected mode). ).

The puncture needle 200 also includes a locking mechanism 300 for effecting mutual switching between a lossy mode and a lossless mode. Referring to Figures 5 and 8, the lock 310 has a proximal plane 311 and a distal plane 319. The lock member 310 includes a release end 313 and a locking end 314. The two guide walls 312 connect the release end 313 and the lock end 314 together to form an approximately rectangular cavity 315 at the locking end 314. A semi-circular aperture 316 is included. The locking end 314 includes a transverse axis 317. The release end 313 includes a button 318 and a trigger arm 321 . The trigger arm 321 extends from the release end 313 toward the interior of the cavity 315, and the trigger arm 321 includes a release hook 323. The release hook 323 includes a straight face 322 and a slope 324. The distal plane 319 includes a guide block 325. Referring to FIG. 5, the handle compartment 350 includes a handle top surface 351, a side wall 352 and a button notch 353. The handle compartment 350 also includes four stationary posts 358 (not shown) having a central blind bore and a plurality of axial stop ribs.

Referring to Figures 5-10, reference is primarily made to Figure 10. The lock member 310 is mounted on the flange 242, wherein the guide wall 312 mates with the guide rib 252, the distal end plane 319 mates with the upper surface 241, such that the lock member 310 is defined at the upper portion 241 In the plane, it can slide along the guiding rib 252. One end of the button spring 70 is mounted in the fixed seat 251, and the other end thereof is mounted on the horizontal shaft 317 and is in a compressed state. Those skilled in the art will appreciate that the handle bin 350 can be mounted to the body 240 by a variety of well known joining techniques, such as bonding, welding, mechanical securing, and the like. In the present example, the four posts 258 are aligned with the central blind holes of the four fixed posts 358 (not shown) and are interference fit to securely secure the body 240 and the handle compartment 350 together, and the plurality The axial limit ribs limit the axial displacement of the lock member 310 and the button spring 70, respectively. A person skilled in the art can make a slight adaptation, and it is easy to understand and apply the axial limiting rib to realize the function that the locking member 310 can be on the above The plane defined by 241 slides along the guide rib 252 and its axial direction (direction of the parallel axis 201) is sufficiently small; the button spring 70 is freely telescopically deformable 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.

Initial lock state: Referring to FIGS. 9 and 10, the button spring 70 is in a compressed state and has a comfortable tension, and the comfortable tension urges the lock member 310 to slide along the guide rib 252 toward the outermost direction of the handle pocket 350 to the farthest end. The locking end 314 just blocks the first through hole 246, and the release hook 323 does not contact the locking tooth 256, which is called a locked state. When in the locked state, the protective sleeve 280 and the push rod 270 are moved from the proximal end to the distal end under the axial diastolic force of the thrust spring 80 until the protective sleeve 280 completely covers the working blade 220 and is locked, that is, the puncture The distal end portion 206 of the needle is in a lossless mode.

Release state: Referring to FIG. 11, an external force is applied to press the button 318 to slide the lock member 310 in the direction toward the inside of the handle pocket 350 along the guide rib 252, and the button spring 70 is continuously compressed until the slope 324 of the release hook 323 is continued. Contacting the pushing surface 257 of the locking tooth 256; when the sliding continues, the pushing surface 257 presses the inclined surface 324, so that the triggering arm 321 generates elastic deformation and the release hook 323 generates axial displacement from the distal end to the proximal end. Sliding continues to cause the release hook 323 to straddle the lock tooth 256, and the trigger arm 321 rebounds such that the locking surface 255 engages the straight face 322. At this time, the locking end 314 has been removed to expose the first through hole 246, and the protective sleeve 280 and the push rod 270 can be moved from the distal end to the proximal end, which is called a released state. Stopping the application of an external force, the relaxation tension of the button spring 70 urges the lock member 310 to slide along the guide rib 252 toward the outside of the handle cartridge 350, and the release hook 323 is engaged with the lock tooth 256, so that the The lock member 310 cannot slide and is in a stable state.

Action procedure for mutual conversion of lossless mode and lossy mode: Referring to Figures 3 and 4, the puncture needle 200 penetrates through the cannula assembly 100 and then punctures together through the skin incision at the puncture site. Pressing the button 318 as described above causes the puncture needle 200 to be in a released state. Referring to Figure 11, when the protective sleeve 280 is subjected to an axial compressive force, the protective sleeve 280 and the push rod 270 and from the distal end to the proximal end The blade tip 223 and the blade edge 224 (not shown) that expose the working blade 220 are moved. State 1, referring to Figure 11, the proximal end 271 of the push rod 270 contacts the ramp 324 of the release hook 323, and continued motion forces the trigger arm 321 to deform and release the hook 323 to produce axial displacement from the distal end to the proximal end with the lock The tooth 256 is disengaged, i.e., the lock is released; state 2, referring to Figure 12, the proximal end 271 continues to move from the distal end to the proximal end of the stroke, at which point the release hook 323 has been completely disengaged from the lock tooth 256, The lock member 270 slides in the direction of the guide rib 252 toward the outside of the handle cartridge 350 under the action of the push of the button spring 70 until the lock end 314 is blocked by the proximal end 271; the distal end portion 206 of the puncture needle 200 in state 1 and state 2 In lossy mode. State 3, once the puncture needle 200 completely penetrates the body wall, the lateral pressure and axial resistance experienced by the protective sleeve 280 disappear, and the protective sleeve 280 and the push rod 270 rapidly move distally under the thrust of the thrust spring 80. Move to the end. The lock member 270 is made by the thrust of the button spring 70. Quickly sliding downward along the guiding rib 252 toward the outer direction of the handle compartment 350 until the locking end 314 blocks the first through hole 246 so that the proximal end 271 cannot be retracted from the distal end to the proximal end, and the puncture needle is Distal portion 206 transitions from lossy mode to lossless mode. That is, when the puncture needle continues to move toward the body cavity and contacts the organ or tissue in the body cavity after the puncture needle penetrates the abdominal wall, the blade tip 223 and the blade edge 224 are not exposed, and only the flexible portion 296 contacts the organ or tissue in the cavity.

In the present example, the locking mechanism 300 is comprised of a lock member 310 and a lock tooth 256 that effect mutual switching between lossy mode and lossless mode. However, the locking mechanism 300 can be implemented in a variety of ways. Since the first protection puncture needle has been disclosed in US Pat. No. 4,453,773, the designers have successively disclosed a large number of protection states for protecting the puncture needle (ie, the protective sleeve of the puncture needle is locked) and the release state (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 lossy mode and the lossless mode of the present invention. Switching between each other. Other similar locking mechanisms are also conceivable to those skilled in the art.

13-18 illustrate in detail a second embodiment of the present invention, the structural composition and assembly relationship of the knifeless automatic protection puncture needle 400. The numerical designations of the geometrical structures in Figures 13-18 are the same as the corresponding numerical references in Figures 5-12, indicating that the structures of the same numerical reference numerals in Example 2 and Example 1 are substantially identical. Referring primarily to Figures 13 and 17, the puncture needle 400 can be largely divided into a handle portion 202, a stem portion 204 and a distal portion 406. That is, the handle portion and the rod portion of the puncture needle 400 are substantially identical to the corresponding portions of the puncture needle 200. Referring to Figures 13 and 18, the distal end portion 406 of the puncture needle 400 includes a fixed portion 410 and a movable portion 450. The fixing portion 410 includes a plastic cutter body 430 and a main body 240, and the movable portion 450 includes a pin 90, a push rod 270 and a protective sleeve 460.

The plastic body 430 includes a proximal cylinder 232 and a distal cylinder 236 and a boss 234 therebetween. The proximal cylinder 232 includes a central blind bore 233 that includes a via 235 that communicates with the central blind bore 233. The via 235 is approximately rectangular and includes a short side 235a and a long side 235b, and the long side 235b is substantially parallel to the axis of the central blind hole 233. The outer surface of the proximal cylinder 234 includes a plurality of bumps 231. The plastic cutter body 430 further includes a cutter head 431 including a tilting tip 433, a separating blade 435 and a cylindrical tip 436, one end of the transition cylinder 432 is connected to the distal cylinder 236 and the other end is connected to the tilt Tip 433. In the present example, the cutter head 431 includes two separating edges 435 and a cylindrical cutting edge 436 extending from the cylindrical cutting edge 436 toward the proximal end along the outer surface of the inclined tip 433 and Intersecting with the transition cylinder 432. However, the cutter head 431 may also include only one separating edge and does not include a cylindrical cutting edge, i.e., a separating blade extends from the distal end of the inclined tip 433 toward the proximal end.

Referring to Figures 13, 15 and 16, the protective sheath 460 includes a sloped proximal end 282 and a sloped distal end 470 with a cylindrical portion 284 therebetween. The angled distal end 470 includes a rigid portion 480 and a flexible portion 490. The rigidity Portion 480 includes a hollow cylinder 484 and a hollow cone 486. The hollow cone 486 includes a top end 489 and a sipe 487 that matches the shape and size of the separating edge 435. The protective sleeve 460 further includes a central aperture 283 extending from the proximal end to the distal end and in communication with the slot 487, the central aperture 283 including a first inner aperture 283a and a second inner aperture 283b. The cylindrical portion 284 also includes a side aperture 285 that communicates with the central aperture 283. The flexible portion 490 includes a hollow cylinder 494 and a hollow cone 496. The hollow cone 496 includes a top end 499 and a slot 497 that matches the shape and size of the separating edge 435. The hollow cylinder 494 and hollow cone 496 are shaped and sized to match the hollow cylinder 484 and hollow 486. Those skilled in the art will appreciate that the rigid portion 480 and the flexible portion 490 can be secured together by a variety of well known joining techniques, such as bonding, welding, mechanical fastening, and the like. This example uses a glued method to securely hold the rigid portion 480 and the flexible portion 490 together. The protective sleeve 460 is made of at least two different materials, wherein the rigid portion 480 is typically made of a hard plastic such as polycarbonate, nylon or a medium hardness plastic, or a metal material. The flexible portion 490 may be made of a semi-rigid material or a soft material such as polyvinyl chloride, a thermoplastic elastomer (for example, a polyurethane elastomer, a heat-vulcanized rubber), a thermosetting elastomer (for example, a silica gel, a natural rubber).

Referring to FIG. 10, FIG. 17 and FIG. 18, the plastic cutter body 430 and the main body 240 are fixed in a manner substantially identical to the fixing manner of the shank 230 and the main body 240; the fixing manner of the protective sleeve 460 and the push rod 270, and The protective sleeve 280 is substantially identical to the manner in which the push rod 270 is fixed. Moreover, the puncture needle 400 and the puncture needle 200 have the same handle portion 202 and the rod portion 204, and therefore will not be described again.

The puncture needle 400 also includes a lossy mode and a lossless mode. When the protective sleeve 460 and the push rod 270 are moved from the distal end to the proximal end to expose the tip 436 and the separating edge 435, the distal portion 406 is said to be in a lossy mode (or operational mode); when the protective sleeve 460 and the push rod 270 When the proximal end distal movement covers the blade tip 436 and the separation blade 435 and is locked (ie, the protective sleeve 460 and the push rod 270 are not movable from the distal end to the proximal end), the distal portion 406 is said to be in a lossless mode (or Protection mode). In the present example, the locking mechanism 300 implements mutual switching between lossy mode and lossless mode. The composition, assembly and operation of the locking mechanism 300 have been described in detail above and will not be described herein.

The present invention has repeatedly mentioned the concept of a knife-proof automatic puncture needle and a knife-free automatic protection puncture needle, a lossy mode and a lossless mode. It should be readily understood by those skilled in the art that the puncture needle used in endoscopic surgery can be generally divided into two major categories: a knife puncture needle and a knifeless puncture needle. The "knife-in" refers to a metal-containing blade, and 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. The knifed and non-knife generally represent the extent of damage to the patient's muscles. As described in the background, the knife puncture needle working mode is usually mainly to puncture and cut muscles, while the knifeless puncture needle working mode is usually mainly to puncture and tear muscles. The knife-pierced needle has a relatively large degree of damage to the patient's muscle, and its puncture force is relatively small. The degree of no puncture is related to the degree of muscle damage in the patient, and also depends on the sharpness of the shape of the working part and the hardness of the material itself. For example, equivalent In the case of volume, a spear-shaped object is more likely to penetrate into the muscle than a conical-shaped object; a thin-walled structure having an approximately triangular shape is more likely to penetrate the muscle. For example, a metal blade of the same shape is more likely to penetrate the muscle than a plastic blade.

The protective needle-containing puncture needle, which penetrates the body wall, includes a working edge (ie, a cutting edge or a separating blade) that pierces and cuts (or tears) the tissue, and the protective sleeve expands and expands the tissue. Usually, the distal end of the puncture needle protector and its working edge are well transitioned, especially the portion of the protective sleeve adjacent to the working edge should be thin enough and pointed as close as possible to the working edge to reduce the resistance of the expanded and swollen tissue. For example, referring to Figures 7 and 12, the protective cover 280, wherein the top end 299, the outer curved surface 298 and the sipe 287 form a sharp structure that helps to reduce the resistance of the expanded and swollen tissue. For example, referring to Figures 17 and 18, the protective cover 460, wherein the top end 499, the hollow cone 496 and the sipe 497 form a sharper configuration that helps reduce the resistance of the expanded and inflated tissue. As mentioned above, the greater the damage of the sharp structure to the patient's muscles or tissues, as described in connection with the background, the greater the risk of accidental injury when the protective cover containing the sharp distal end contacts the patient's internal organs or tissue in an impact manner. Big. The use of a relatively blunt, non-smooth transition structure, although it can reduce the damage capacity of the protective sleeve, but will inevitably increase the resistance of the expansion and expansion of the tissue, thereby increasing the puncture operation force. The operating experience is poor and the operational controllability is degraded, which may increase the impact of the protective cover described in the background on the internal organs or tissues of the patient, and may increase the risk of injury.

Plastic materials can be roughly divided into four categories according to their hardness (hardness hardness), hard plastic (hardness≥86D), medium hard plastic (83D≥hardness≥65D), semi-rigid plastic (98A≥hardness≥90A), soft Plastic (86A≥hardness≥10A). The hardness of the material can be measured in accordance with the relevant provisions of ASTM D 2240-97. As described above, reducing the hardness of the material under the same shape can reduce its ability to damage muscles. The present invention discloses a solution in which the protective cover is made of at least two materials, that is, the protective cover protects the rigid portion and the flexible portion. Wherein the rigid portion is made of hard plastic or medium hard plastic, and the distal end of the protective sleeve is in contact with the sorting blade in whole or in part as a flexible portion made of semi-rigid plastic or soft plastic. The lower the hardness of the flexible portion, the smaller the damage ability to the patient's muscle, and the better the effect of absorbing the impact force. However, the hardness of the material is reduced, and its strength and stiffness are also reduced in response. If the hardness is too low, the lower the strength and rigidity of the material, the phenomenon that the flexible portion is rolled up or torn during the puncture process, and the hardness is too high, so the risk of damage is greater. Studies have shown that the flexible portion of the flexible portion HD range: 60A ≤ HD ≤ 98A can play a protective role. Preferably, the flexible portion has a Shore hardness HD range of 70 A ≤ HD ≤ 90 A. The flexible portion has a material hardness of 70 A or more when the flexible portion has sufficient rigidity and strength to prevent being rolled up or torn during the puncture; when the material hardness of the flexible portion is less than or equal to At 90A, the material of the flexible portion is soft enough to reduce the damage. The effect is better when the Shore hardness of the flexible portion is HD=80±5A. However, it will be understood by those skilled in the art that changing the size of the flexible portion (eg, changing the overall thickness of the flexible material attached to the rigid portion), then The strength, stiffness, and ability to damage muscles of the flexible portion can vary within a certain range, and therefore it is not attempted to limit the hardness of the flexible portion of the present invention to a certain value or a small range.

19-21 depict a third embodiment of the puncture needle 600 of the present invention. The puncture needle 600 includes a handle portion 202 (not shown) and a distal end portion 606 with a stem portion 204 (not shown) therebetween. That is, the handle portion and the rod portion of the puncture needle 600 are substantially identical to the corresponding portions of the puncture needle 200, and will not be described herein. The distal portion 606 includes a fixed half 610 and a movable half 650. The fixed half 610 includes a proximal flange 242 and a fixed distal half 620 and a connecting shaft portion therebetween. The fixed distal half 620 includes a fixed base 622 and a fixed angled distal end 626 coupled thereto and extending to the fixed tip 629. The fixed angled distal end 626 includes a sharpened separation edge 627. The movable half 650 includes a proximal cylinder 272 and a movable distal half 660 and a connecting shaft portion therebetween. The movable distal half 660 includes a fixed base 662 and a movable angled distal end 666. The active tilted distal end 666 includes a rigid portion 670 and a flexible portion 680. The flexible portion 680 is attached to the rigid portion 670. The fixed half 610 includes a connecting buckle 630 and the movable half 650 includes a connecting card slot 690. The connecting buckle 630 and the connecting card slot 690 cooperate to form a connecting device 700. The fixed half 610 and the movable half 650 are thereby coupled together, and the connecting device 700 allows translational movement of the movable half 610 in the axial direction while limiting the movable half 610 in a direction perpendicular to the axis The displacement on. The puncture needle 600 includes a handle portion and a stem portion that are substantially identical to the puncture needle 200, i.e., the puncture needle 600 is substantially identical to the puncture needle 200. The puncture needle 600 also includes a lossy mode and a lossless mode, and the action process of the lossless mode and the lossy mode is substantially the same as the response process of the puncture needle 200, and is not described herein.

Many different embodiments and examples of the invention have been shown and described. One of ordinary skill in the art can make adaptations to the methods and apparatus by appropriate modifications without departing from the scope of the invention. For example, the locking mechanism and the connecting mechanism disclosed in other inventions may be adapted to the locking structure and the limiting structure, or modify the external shape of the distal half, or use a spring to replace the spring or the like. Several corrections have been mentioned, and other modifications are also conceivable to those skilled in the art. Therefore, the scope of the invention should be construed in the appended claims and the claims

Claims

A puncture needle comprising a non-destructive protection device comprising a handle portion and a distal portion and a stem portion therebetween; the distal portion comprising a fixed portion and a movable portion; the fixed portion comprising a working edge, characterized in that:

The fixing portion extends proximally from the distal end and is fixed to the rod portion or the handle portion, and the movable portion is movable relative to the fixed portion in the axial direction of the rod portion;

The movable portion includes a protective sleeve including a slanted distal end and a sipe, the slanted distal end including a rigid portion and a flexible portion attached to the surface of the rigid portion and forming a sharp structure.
A puncture needle comprising a non-destructive protection device according to claim 1, wherein the material of the flexible portion is a semi-rigid material or a soft material, and the range of the Shore hardness HD of the flexible portion is: 70 A ≤ HD ≤ 90A.
A puncture needle comprising a non-destructive protection device according to claim 1 wherein the flexible portion is attached to the top of the sharp structure or wraps the entire oblique distal end.
A puncture needle comprising a non-destructive protection device according to claim 1 wherein said working edge comprises a metal blade or a plastic separation blade.
A puncture needle comprising a non-destructive protection device according to claim 3, wherein said flexible portion is further extendable to said sipe surface.
A puncture needle comprising a non-destructive protection device according to claim 1, wherein the puncture needle further comprises a locked state, that is, the movable portion is locked and cannot be moved from the distal end Proximal movement, the release state, ie the movable portion is movable from the distal end to the proximal end; wherein the locked state and the released state are achieved by a locking mechanism comprising at least a locking portion, a release portion and a trigger portion.
A puncture needle comprising a non-destructive protection device according to claim 6 wherein said puncture needle comprises a lossy mode and a lossless mode; in said lossy mode, said protective sheath is oriented along said axis The proximal end moves until the working edge extends beyond the corresponding protective sleeve; in the lossless mode, the protective sleeve moves distally along the axis until the working edge is completely covered, and the movable portion is locked.