Controllable puncture needle

Abstract

The invention relates to the field of medical equipment, in particular to a controllable puncture needle which comprises a needle tube, a needle tip and a control device, and the needle tube is at least provided with a flexible structure at the far end close to the end; the needle tip is fixedly connected to the far end of the needle tube. The control device is arranged at the near end of the needle tube and is configured to control the deflection angle of the needle tip relative to the needle tube so as to control the puncture direction of the needle tip in the human body. According to the controllable puncture needle, the puncture direction of the needle point of the puncture needle in the human body can be controlled through the control device, the puncture accuracy degree is high, the operation efficiency is improved, and damage to human tissue in the multiple puncture processes is reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical equipment, and in particular relates to a controllable puncture needle. Background Art

[0002] Interventional treatment is a minimally invasive medical technology that uses catheters, puncture needles, guidewires and other instruments under the guidance of imaging. Compared with traditional open surgery, this method has the advantages of less trauma, faster recovery and fewer complications.

[0003] During the puncture operation, the operator needs to perform blind puncture. Even if the operator is experienced, it usually takes multiple punctures to succeed. The existing puncture needle has a spring structure at the distal end of the needle tube to improve the flexibility of the needle tube, so that it can pass through the reinforced catheter with less resistance. During the puncture process, it is easy to change direction due to resistance and miss the target area. The needle tip is connected to the spring structure, which has the risk of falling off during the puncture and causing it to deform and fail. At the same time, the needle tip is blunt and the puncture resistance is large. Therefore, multiple punctures are likely to cause significant damage to human tissue. Summary of the invention

[0004] In order to solve the problems existing in the prior art, the present disclosure provides a controllable puncture needle.

[0005] The controllable puncture needle disclosed herein comprises: A needle tube, wherein the needle tube has a flexible structure at least near the distal end; A needle tip, the needle tip being fixedly connected to the distal end of the needle tube; A control device is disposed at the proximal end of the needle tube and is configured to control a deflection angle of the needle tip relative to the needle tube, thereby controlling a puncture direction of the needle tip in the human body.

[0006] In one embodiment of the present disclosure, the control device comprises: A housing configured to fix the proximal end of the needle tube; a first slider, the first slider being slidably disposed in the housing; a second slider, the second slider being slidably disposed in the housing; A first traction line, wherein the proximal end of the first traction line is tensioned and fixed on the first slider, and the distal end of the first traction line is inserted into the needle tube and fixedly connected to the needle tip; a second pulling wire, wherein the proximal end of the second pulling wire is tensioned and fixed on the second sliding block, and the distal end of the second pulling wire is fixedly connected to the needle tip after passing through the needle tube; The direction adjustment mechanism is disposed in the housing and is configured to control the first slider and the second slider to move in opposite directions so that the first traction line and the second traction line pull the needle tip to deflect relative to the needle tube.

[0007] In one embodiment of the present disclosure, the direction adjustment mechanism includes: A rotating shaft, the rotating shaft is rotatably disposed in the housing and is provided with a first external thread and a second external thread of opposite rotation directions, the first slider is provided with a first internal thread engaged with the first external thread, and the second slider has a second internal thread engaged with the second external thread; A rotating hand wheel is coaxially fixedly arranged on the rotating shaft and is provided with an external force by protruding from the housing portion, and is configured to drive the rotating shaft to rotate under the external force.

[0008] In one embodiment of the present disclosure, the shell is provided with a first guide hole, a second guide hole and a through hole, the proximal end of the needle tube is fixed in the shell, and the distal end extends from the shell through the through hole, the distal end of the first traction line is sequentially inserted into the first guide hole, and the needle tube is tensioned and connected to the needle tip, and the second traction line is sequentially inserted into the second guide hole, and the needle tube is tensioned and connected to the needle tip and the second slider.

[0009] In one embodiment of the present disclosure, the shell includes an upper shell and a lower shell that are spliced ​​together, and the through hole, the first guide hole, and the second guide hole are all formed by splicing through grooves on the upper shell and the lower shell.

[0010] In one embodiment of the present disclosure, the first slider and the housing are slidably matched through a matching first slide rail and a first slide groove, and one of the first slide rail and the first slide groove is provided on the first slider and the housing; The second sliding block and the housing are slidably matched through a second sliding rail and a second sliding groove that are matched, and one of the second sliding rail and the second sliding groove is arranged on the second sliding block and the housing.

[0011] In one embodiment of the present disclosure, the shell includes an upper shell and a lower shell that are spliced ​​to each other, and the first slide rail and the second slide rail are disposed on both the upper shell and the lower shell.

[0012] In one embodiment of the present disclosure, a plurality of hollow grooves are sequentially provided along the predetermined length from the distal end to the proximal end of the needle tube along the extension direction of the needle tube, and the hollow groove portion is provided to form the flexible structure.

[0013] In one embodiment of the present disclosure, along the extension direction from the distal end to the proximal end of the needle tube, a plurality of the hollow grooves are arranged from dense to sparse.

[0014] In one embodiment of the present disclosure, along the extension direction from the distal end to the proximal end of the needle tube, a plurality of the hollow grooves are arranged along a linear array.

[0015] In one embodiment of the present disclosure, along the extension direction of the needle tube, two adjacent hollow grooves are vertically arranged.

[0016] In one embodiment of the present disclosure, the circumferential length of the hollow groove along the circumferential direction is greater than the axial length along the axial direction, and the ratio of the circumferential length to the axial length is 2:1-4:1.

[0017] In one embodiment of the present disclosure, the needle tip is a multi-faceted needle tip, and the angle between the facets and the axial direction is 10°-30°; Alternatively, the needle tip is a conical needle tip, and the angle between the cone generatrix and the axial direction is 10°-30°.

[0018] In one embodiment of the present disclosure, the controllable puncture needle also includes a core needle, which extends along the direction of the needle tube, with its proximal end fixed inside the shell, and its distal end sequentially passes through the rotating shaft and the needle tube, and is fixedly connected to the end face of the needle tip close to the proximal end.

[0019] One of the beneficial effects of the controllable puncture needle disclosed herein is that the controllable puncture needle disclosed herein is used for puncture surgery. Specifically, the needle tube of the controllable puncture needle disclosed herein has a flexible structure of a preset length near the needle tip, so that the needle tube has good flexibility near the distal end. The operator then uses a control device to provide a bending moment to the needle tip, thereby causing the needle tip to deflect relative to the needle tube during puncture, thereby controlling the puncture direction of the needle tip in the human body.

[0020] In addition, the controllable puncture needle disclosed herein also has a sharp and hard needle tip, which can cut human tissue faster.

[0021] Furthermore, when the controllable puncture needle of the present invention is inside a blood vessel, the operator can use the control device to pull the needle tip to deflect relative to the needle tube, thereby adjusting the direction of the controllable puncture needle of the present invention inside the blood vessel.

[0022] When the controllable puncture needle of the present invention punctures in human tissue, for example, in liver tissue, the puncture needle is unevenly stressed because the punctured liver tissue is dense and has varying hardness. The operator can maintain the puncture direction of the controllable puncture needle of the present invention through the control device; at the same time, the operator provides a bending moment for the needle tip through the control device, and the operator pushes the controllable puncture needle of the present invention to puncture, providing an axial external force. Under the action of the bending moment, the needle tip is deflected in the liver tissue, thereby controlling the puncture direction of the needle tip in the liver.

[0023] When the controllable puncture needle disclosed in the present invention performs puncture, the puncture direction can be prevented from being lost through the action of the control device; the flexible structure at the end of the needle tube makes the flexibility at different positions different, making it easier to control the deflection of the needle tip relative to the needle tube; the needle tip with a cutting blade can cut a puncture incision when the needle tip is deflected, with less resistance, thereby improving the accuracy and efficiency of puncture and reducing damage to human tissue during multiple punctures. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is a schematic structural diagram of an embodiment of a controllable puncture needle disclosed in the present invention; Figure 2 is a schematic diagram of a first slider of an embodiment of a controllable puncture needle disclosed herein; Figure 3 is a schematic diagram of a second slider of an embodiment of a controllable puncture needle disclosed herein; Figure 4 It is a schematic diagram of an embodiment of the controllable puncture needle disclosed in the present invention without the needle tube hidden; Figure 5 It is a schematic diagram of the structure of an embodiment of the controllable puncture needle disclosed in the present invention, with the needle tube hidden; Figure 6 It is a partial three-dimensional structural schematic diagram of a needle tube of an embodiment of a controllable puncture needle disclosed in the present invention; Figure 7 It is a schematic diagram of the partial axial plane structure of the needle tube of one embodiment of the controllable puncture needle disclosed in the present invention; Figure 8 It is a schematic diagram of the distal end structure of the needle tube of an embodiment of the controllable puncture needle disclosed in the present invention; Fig. 9 is a schematic diagram of a radial plane near the distal end of an embodiment of a controllable puncture needle disclosed in the present invention; Fig. 10A This is a first schematic diagram of the intrahepatic puncture process of one embodiment of the controllable puncture needle disclosed herein; Fig. 10B is a second schematic diagram of the intrahepatic puncture process of one embodiment of the controllable puncture needle disclosed herein; Fig. 10C This is the third schematic diagram of the intrahepatic puncture process of one embodiment of the controllable puncture needle disclosed in the present invention.

[0025] Figures 1 to 10C The corresponding relationship between the component names and their reference numerals is as follows: 11 needle tube, 12 hollow groove, 13 needle tip, 14 core needle; 21 a first traction line, 22 a second traction line; 31 rotating hand wheel, 32 rotating shaft, 321 first external thread, 322 second external thread; 41 first slider, 42 second slider, 411 first internal thread, 421 second internal thread, 412 first slide groove, 422 second slide groove; 51 lower half shell, 52 upper half shell, 53 through hole, 54 first slide rail, 55 second slide rail; 61 liver local area, 62 hepatic vein, 63 portal vein, 64 target area, 65 reinforcement catheter, 66 lump. DETAILED DESCRIPTION

[0026] Various exemplary embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. It should be noted that the relative arrangement of components and steps, numerical expressions and numerical values ​​set forth in these embodiments do not limit the scope of the present disclosure unless otherwise specifically stated.

[0027] The following description of at least one exemplary embodiment is merely illustrative in nature and is in no way intended to limit the present disclosure, its application, or uses.

[0028] Technologies, methods, and equipment known to ordinary technicians in the relevant art may not be discussed in detail, but where appropriate, the technologies, methods, and equipment should be considered as part of the specification.

[0029] It should be noted that like reference numerals and letters refer to similar items in the following figures, and therefore, once an item is defined in one figure, it need not be further discussed in subsequent figures.

[0030] In this article, "first", "second", etc. are only used to distinguish each other, and do not indicate the importance and order, or the premise of each other's existence.

[0031] It should be noted that when describing the structure and working principle of the controllable puncture needle in this article, the directional words used are based on the position of the operator, among which the direction close to the operator is the proximal end of the controllable puncture needle, the direction away from the operator is the distal end of the controllable puncture needle, the direction close to the upper part of the operator is up, and the direction close to the lower part of the operator is down.

[0032] The puncture needle of the prior art has a needle tip connected to a needle tube with a spring structure. It is easy to change direction due to resistance during puncture, missing the target area. There is a risk of the needle tip falling off during puncture and causing deformation and failure. At the same time, the needle tip is blunt and the puncture resistance is large.

[0033] To this end, the present disclosure provides a controllable puncture needle, comprising a needle tube, a needle tip and a control device, wherein the proximal end of the needle tube is fixed on the control device, and the needle tip is fixedly arranged at the distal end of the needle tube.

[0034] In detail, the needle tube has a flexible structure at least near the distal end; the needle tip is fixedly connected to the distal end of the needle tube; the control device is arranged at the proximal end of the needle tube and is configured to control the deflection angle of the needle tip relative to the needle tube, thereby controlling the puncture direction of the needle tip in the human body.

[0035] The controllable puncture needle disclosed in the present invention is mainly used for interventional treatment and puncture in the human body. In detail, the needle tube of the controllable puncture needle disclosed in the present invention is provided with a flexible structure of a preset length near the distal end so that the needle tube has good flexibility near the distal end. Then, through the control device, the operator can control the deflection of the needle tip relative to the needle tube, thereby controlling the puncture direction of the needle tip in the human body.

[0036] Obviously, the control device of the controllable puncture needle disclosed in the present invention can prevent the puncture direction from being lost, and cooperate with the flexible structure at the end of the needle tube to make it easier for the operator to control the deflection of the needle tip relative to the needle tube, thereby improving the accuracy and efficiency of the puncture operation.

[0037] For ease of understanding, refer to Figures 1 to 10C , the specific structure and working principle of the controllable puncture needle provided by the present invention are described in detail in combination with an embodiment.

[0038] The controllable puncture needle disclosed in the present invention comprises a needle tube 11, a needle tip 13 and a control device, wherein the needle tube 11 has a flexible structure at least near the distal end; the needle tip 13 is fixedly connected to the distal end of the needle tube 11; the control device is disposed at the proximal end of the needle tube 11, and is configured to control the deflection angle of the needle tip 13 relative to the needle tube 11, thereby controlling the puncture direction of the needle tip 13 in the human body.

[0039] The controllable puncture needle disclosed herein is provided with a flexible structure near the distal end of the needle tube 11, and in conjunction with a control device, the operator can control the needle tip 13 fixed at the distal end of the needle tube 11 to deflect the needle tip 13 relative to the needle tube 11, thereby controlling the puncture direction of the needle tip 13 in the human body.

[0040] Obviously, compared with the prior art, the use of the controllable puncture needle disclosed in the present invention for puncture surgery, through the control device and the flexible structure at the end of the needle tube 11, makes it easier for the operator to control the deflection of the needle tip 13 relative to the needle tube 11, which can prevent the puncture direction from being lost, thereby improving the accuracy and efficiency of the puncture surgery.

[0041] like Figure 1 As shown, in one embodiment of the present disclosure, the control device includes a housing, a first slider 41, a second slider 42, a first traction line 21, a second traction line 22, and a direction adjustment mechanism. The housing is configured to fix the proximal end of the needle tube 11; the first slider 41 is slidably disposed in the housing; the second slider 42 is slidably disposed in the housing; the proximal end of the first traction line 21 is tensioned and fixed on the first slider 41, and the distal end is fixedly connected to the needle tip 13 after passing through the needle tube 11; the proximal end of the second traction line 22 is tensioned and fixed on the second slider 42, and the distal end is fixedly connected to the needle tip 13 after passing through the needle tube 11; the direction adjustment mechanism is disposed in the housing and is configured to control the first slider 41 and the second slider 42 to move in opposite directions, so that the first traction line 21 and the second traction line 22 pull the needle tip 13 to deflect relative to the needle tube 11.

[0042] In this way, the housing is constructed as a rectangular parallelepiped to set and accommodate the first slider 41, the second slider 42 and the adjustment mechanism, and fix the proximal end of the needle tube 11, so that the needle tube 11 and the needle tip 13 are stable during the puncture operation, and the operator's control is more precise. The first slider 41 and the second slider 42 are respectively arranged on both sides of the adjustment mechanism to obtain a sufficient contact area with the adjustment mechanism, and save the space inside the housing, so that the volume of the housing is as small as possible, which is convenient for the operator to use. The first traction line 21 and the second traction line 22 are tensioned and respectively fixedly connected to the first slider 41 and the needle tip 13, and the second slider 42 and the needle tip 13. When the adjustment mechanism causes the first slider 41 and the second slider 42 to move in opposite directions, the first traction line 21 and the second traction line 22 are driven to tighten or relax, and the tensioned first traction line 21 and the second traction line 22 are sensitive to react, so that the needle tip 13 generates a bending moment perpendicular to the axial direction, so that the needle tip 13 is deflected relative to the needle tube 11.

[0043] Further, in one embodiment of the present disclosure, the first traction wire 21 and the second traction wire 22 of the present disclosure are tungsten or other high elastic modulus metal materials, which have high hardness and elasticity so as to pull the needle tip 13. At the same time, the shape of the first traction wire 21 and the second traction wire 22 of the present disclosure can be round or rectangular straight wire, braided wire or twisted wire.

[0044] In one embodiment of the present disclosure, the number of traction wires can also be three or four, which are evenly distributed along the circumference of the inner wall of the needle tube 11. Correspondingly, three screw-nut mechanisms parallel to the axial direction can be arranged inside the shell, and the three traction wires are fixed on the three nuts respectively. By controlling the rotation of the three screws, the three traction wires are controlled and the deflection of the needle tip 13 relative to the needle tube 11 is adjusted; or, two adjustment mechanisms parallel to the axial direction are arranged inside the shell, and two sliders corresponding to the control of each adjustment mechanism are arranged, and the four traction wires are fixed on the four sliders respectively. By controlling the two adjustment mechanisms, the two traction wires corresponding to the control of each adjustment mechanism pull the needle tip 13 to produce a deflection in any direction relative to the needle tube 11.

[0045] In this regard, the present disclosure does not impose any limitation here, and those skilled in the art can make the traction line pull the needle tip 13 to deflect relative to the needle tube 11 according to the actual application scenario.

[0046] like Figures 1 to 5 As shown, in one embodiment of the present disclosure, the direction adjustment mechanism includes: a rotating shaft 32 and a rotating hand wheel 31. The two ends of the rotating shaft 32 are arranged on the ribs in the housing to limit the rotating shaft 32 from being displaced in the axial direction and radial direction, and can only rotate around the axis, and the rotating shaft is provided with a first external thread 321 and a second external thread 322 with opposite rotation directions, the first slider 41 is provided with a first internal thread 411 meshed with the first external thread 321, and the second slider 42 has a second internal thread 421 meshed with the second external thread 322; the rotating hand wheel 31 is coaxially fixedly arranged on the rotating shaft 32 and is provided with an external force applied by the protruding housing part, and is configured to drive the rotating shaft 32 to rotate under the external force.

[0047] In this way, both ends of the rotating shaft 32 are arranged on the housing, thereby limiting its radial position to remain unchanged and only allowing the rotating shaft 32 to rotate axially to ensure precise control of the first slider 41 and the second slider 42 , thereby ensuring the stability of the needle tip 13 .

[0048] The rotating shaft 32 is provided with a bidirectional thread, which is a first external thread 321 and a second external thread 322, which can drive the first slider 41 and the second slider 42 to move while the shaft rotates, and the first slider 41 and the second slider 42 are provided with a first internal thread 411 and a second internal thread 421 on the inner side, which are respectively engaged with the first external thread 321 and the second external thread 322 of opposite rotation directions on the rotating shaft 32, so that the first slider 41 and the second slider 42 move in opposite directions, thereby tightening the first traction line 21 and the second traction line 22 one by one and loosening the other. In addition, the first external thread 321 and the second external thread 322 are compositely arranged on the rotating shaft 32, which can make the length of the rotating shaft 32 as short as possible, reduce the weight of the control device, and reduce the pressure on the operator's hands.

[0049] The rotating hand wheel 31 is coaxially fixed to the rotating shaft 32 through spokes, and there is no intermediate transmission link between the two, which reduces the transmission error and makes the operation intuitive and convenient. The spokes have supporting force and can also reduce the weight of the rotating hand wheel 31. In addition, the rotating hand wheel 31 is arranged at the far end of the rotating shaft 32, which is convenient for the operator to apply external force to the rotating hand wheel 31 while grasping the shell with the palm, and does not affect the setting of the bidirectional thread on the rotating shaft 32 and the movement of the first slider 41 and the second slider 42. In addition, the rotating hand wheel 31 protrudes from the shell, which is easy for the operator to rotate and avoids misoperation caused by the hand wheel and the shell being at the same height. The surface of the rotating hand wheel 31 is provided with a circumferentially distributed linear rack to increase friction and improve the comfort and safety of operation.

[0050] Furthermore, the shell and the adjustment mechanism disclosed in the present invention can be constructed of PC (polycarbonate), PA (polyamide), PP (polypropylene) or other medium-to-high-strength polymer materials or metal materials. PC, PA and PP are three commonly used engineering plastics. PC has good transparency, high impact strength and good heat resistance; PA has high mechanical strength and good wear resistance; PP is lightweight, has good chemical resistance and good processability.

[0051] like Figure 1 and Figure 4 As shown, in one embodiment of the present disclosure, the shell is provided with a first guide hole, a second guide hole and a through hole 53, the proximal end of the needle tube 11 is fixed in the shell, and the distal end extends from the shell through the through hole 53, the distal end of the first traction line 21 sequentially passes through the first guide hole, and the needle tube 11 is tensioned and connected to the needle tip 13, and the second traction line 22 sequentially passes through the second guide hole, and the needle tube 11 is tensioned and connected to the needle tip 13 and the second slider 42.

[0052] In detail, the first guide hole and the second guide hole of the present invention are arranged on both sides of the rotating hand wheel 31. Since the rotating hand wheel 31 is a protruding hand wheel and is arranged at the distal end of the rotating shaft 32 for the convenience of operator control, the first traction line 21 and the second traction line 22 respectively fixed on the first slider 41 and the second slider 42 will pass through the rotating hand wheel 31 when penetrating the proximal end of the needle tube 11. The first guide hole and the second guide hole are arranged on the housing so that the first traction line 21 and the second traction line 22 avoid the rotating hand wheel 31, and the control device can function smoothly. At the same time, a through hole 53 is arranged to fix the needle tube 11 on the housing on the one hand, and on the other hand, the distal ends of the first traction line 21 and the second traction line 22 pass through the through hole 53 into the needle tube 11 and are connected to the needle tip 13.

[0053] like Figure 1 and Figure 4 As shown, in one embodiment of the present disclosure, the shell includes an upper shell 52 and a lower shell 51 that are spliced ​​together, and the through hole, the first guide hole, and the second guide hole are all formed by splicing through grooves on the upper shell 52 and the lower shell 51.

[0054] The present disclosure constructs the housing in this way, which makes it more convenient to install the control device and fix the needle tube 11. During installation, the present disclosure can bond the upper half housing 52 and the lower half housing 51 together by structural adhesive. This connection method has high connection strength, good sealing performance, and a neat appearance.

[0055] The first guide hole and the second guide hole are both formed by the through grooves on the upper half shell 52 and the lower half shell 51. The two holes are constructed on the central axis of the rotating shaft 32 and are arranged on the same horizontal plane as the through hole 53, so that the distance for the distal ends of the first traction line 21 and the second traction line 22 to enter the needle tube 11 through the two guide holes is the shortest, thereby avoiding increased friction. At the same time, the through groove of the through hole 53 is constructed along the axis of the conical base on the shell, and the length of the through hole 53 is extended through the conical base, so that the needle tube 11 extends into the base for a certain length, thereby increasing the support force for the needle tube 11 and improving the stability of fixing the needle tube 11.

[0056] In one embodiment of the present disclosure, the upper half shell 52 and the lower half shell 51 may be fixed together by using a two-way snap fastener or ultrasonic welding.

[0057] like Figures 1 to 5 As shown, in one embodiment of the present disclosure, the first slider 41 and the shell are slidably matched through the matching first slide rail 54 and the first slide groove 412, and one of the first slide rail 54 and the first slide groove 412 is set on the first slider 41 and the shell; the second slider 42 and the shell are slidably matched through the matching second slide rail 55 and the second slide groove 422, and one of the second slide rail 55 and the second slide groove 422 is set on the second slider 42 and the shell.

[0058] In detail, the present invention is provided with a first slide rail 54 and a first slide groove 412 to guide and support the first slider 41, ensuring that the first slider 41 moves smoothly and accurately along the direction of the needle tube 11, wherein the first slide groove 412 is provided on the first slider 41, which cooperates with the first slide rail 54 on the shell to guide and support the first slider 41 to move along the preset direction under the action of the adjustment mechanism.

[0059] At the same time, the present invention provides a second slide rail 55 and a second slide groove 422 to guide and support the second slider 42, ensuring that the second slider 42 moves smoothly and accurately along the direction of the needle tube 11, wherein a second slide groove 422 is provided on the second slider 42, which cooperates with the second slide rail 55 on the shell to guide and support the second slider 42 to move along the preset direction under the action of the adjustment mechanism.

[0060] In one embodiment of the present disclosure, the first slider 41 and the second slider 42 can be set as a first slide rail 54 and a second slide rail 55, which respectively cooperate with the first slide groove 412 and the second slide groove 422 on the shell to achieve the purpose of guiding the two to move in a preset direction under the action of the adjustment mechanism.

[0061] like Figure 1 , Figure 4 and Figure 5 As shown, in one embodiment of the present disclosure, the shell includes an upper shell 52 and a lower shell 51 which are spliced ​​together, and a first slide rail 54 and a second slide rail 55 are provided on both the upper shell 52 and the lower shell 51.

[0062] In this way, the upper half shell 52 and the lower half shell 51 are both provided with a first slide rail 54 and a second slide rail 55, and the two first slide rails 54 and the two second slide rails 55 are respectively arranged in parallel and slidingly cooperate with the first slider 41 and the second slider 42 to restrict the first slider 41 and the second slider 42 between the two first slide rails 54 and the two second slide rails 55 respectively.

[0063] Since the two sliders are threadedly engaged with the rotating shaft 32, when the rotating shaft 32 rotates in different directions, the two sliders will be subjected to axial force and radial force. Therefore, a first slide rail 54 and a second slide rail 55 are provided on the upper half shell 52 and the lower half shell 51, so that the first slider 41 and the second slider 42 will not be displaced perpendicular to the direction of the needle tube 11 due to the radial force under the action of the adjustment mechanism, thereby ensuring that the first slider 41 and the second slider 42 can stably move along the direction of the needle tube 11.

[0064] like Figure 1 and Figure 6 As shown, in one embodiment of the present disclosure, a plurality of hollow grooves 12 are sequentially provided along the extension direction of the needle tube 11 over a preset length from the distal end to the proximal end of the needle tube 11, and the portion with the hollow grooves 12 forms a flexible structure.

[0065] The present invention sets a plurality of hollow grooves 12 at the distal end of the needle tube 11 to form a flexible structure of 100-200 mm. The present invention sets this flexible structure so that when the control device controls the needle tip 13 to deflect relative to the needle tube 11, the distal end of the needle tube 11 can deflect under the guidance of the needle tip 13 and perform puncture together with the needle tip 13.

[0066] Among them, the preset length depends on the actual scenario, and the present disclosure does not limit it here. Those skilled in the art can set it according to the actual application scenario so that the needle tip 13 can adjust its puncture direction in the human body under the action of the control device.

[0067] At the same time, the needle tube 11 of the present invention is made of stainless steel or nickel-titanium that meets the requirements of GB / T18457, so as to have sufficient hardness to support the needle tip 13 for puncturing in the human body.

[0068] like Figure 6 and Figure 7 As shown, in one embodiment of the present disclosure, along the extension direction from the distal end to the proximal end of the needle tube 11, a plurality of hollow grooves 12 are arranged in a dense to sparse manner.

[0069] With such an arrangement, along the extension direction from the distal end to the proximal end of the needle tube 11, a plurality of hollow grooves 12 are arranged from dense to sparse, so that different positions of the flexible structure of the needle tube 11 have different flexibility, so that the distal end of the needle tube 11 has a higher degree of freedom, making it easier for the operator to control the puncture direction of the needle tip 13 fixed at the distal end of the needle tube 11 in the human body, and the hollow grooves 12 that are gradually sparse near the proximal end of the needle tube 11 make this section of the needle tube 11 not only have lower flexibility than the distal end, but also have higher rigidity, which can provide support for the deflection of the distal needle tip 13.

[0070] During the puncture operation, the needle tip 13 is deflected relative to the needle tube 11 under the action of the control device, and the puncture direction of the needle tip 13 in the human body needs to be accurately controlled. Therefore, the distal end of the needle tube 11 needs to have the highest flexibility. In addition, the gradually sparse hollow grooves 12 at the proximal end of the flexible structure still provide lower flexibility and higher supporting force, so that when the puncture needle adjusts the puncture direction in the human body, the proximal end of the flexible structure will not produce a large deflection relative to the proximal end of the needle tube 11, thereby enhancing the rigidity and stability. At the same time, the torque transmitted by the control device is more concentrated on the distal part of the needle tube 11 and the needle tip 13, making it easier to bend the needle tip 13 when puncturing in the human body.

[0071] In one embodiment of the present disclosure, the needle tube 11 can be changed into a braided tube, with high-density braiding at the proximal end to have higher supporting force, and gradually reducing the braiding density at the distal end so that the distal end has sufficient flexibility, while also achieving the purpose of different flexibility in different sections.

[0072] like Figure 6 and Figure 7 As shown, in one embodiment of the present disclosure, along the extension direction from the distal end to the proximal end of the needle tube 11, a plurality of hollow grooves 12 are arranged in a linear array.

[0073] In detail, the needle tube 11 of the present invention has a plurality of hollow grooves 12 arranged in a linear array with dense spacing at far ends and sparse spacing near ends along the extension direction from the distal end to the proximal end, and the hollow grooves 12 in two adjacent columns are cross-distributed so that the hollow grooves 12 can be as long as possible and can pass through the ends of the radial circumference of the needle tube 11 without affecting the hollow grooves 12 in adjacent columns, thereby enhancing the flexibility of the distal end of the needle tube 11.

[0074] In this way, when the needle tip 13 deflects relative to the needle tube 11, the distal end of the needle tube 11 has sufficient flexibility to make it easier to control the direction of the needle tip 13 when puncturing the human body. At the same time, the regularly arranged hollow grooves 12 are also easy to process.

[0075] In one embodiment of the present disclosure, the plurality of hollow grooves 12 on the needle tube 11 may also be arranged in a spiral array that is dense at far ends and sparse at near ends. At the same time, the spiral is relatively compact to ensure that the flexible structure at the distal end of the needle tube 11 can fully function, so that the deflection of the needle tip 13 relative to the needle tube 11 can be more easily controlled by the control device.

[0076] like Figure 6 and Figure 7 As shown, in one embodiment of the present disclosure, two adjacent hollow grooves 12 are vertically arranged along the extension direction of the needle tube 11.

[0077] In this way, a number of hollow grooves 12 are arranged in a linear array, and two adjacent hollow grooves 12 are perpendicular to each other, so that the hollow grooves 12 at the far end of the needle tube 11 are fully utilized, so that the number of hollow grooves 12 does not need to be too many, reducing the processing difficulty and ensuring the rigidity of the far end of the needle tube 11.

[0078] like Figure 6 and Figure 7 As shown, in one embodiment of the present disclosure, the circumferential length of the hollow groove 12 along the circumferential direction is greater than the axial length along the axial direction, and the ratio of the circumferential length to the axial length is: 2:1-4:1.

[0079] The hollow groove 12 disclosed in the present invention is an oblong hole, the direction of the oblong hole is arranged along the circumferential direction, and the ratio of the circumferential length to the axial length of the hollow groove 12 is: 2:1-4:1. This arrangement reduces the supporting force of the needle tube 11 along the circumferential direction. When the control device pulls the needle tip 13, the needle tube 11 is easier to bend, so that when the operator controls the puncture direction of the needle tip 13 of the puncture needle in the human body, the external force applied is smaller, thereby reducing the pressure on the operator's hand when controlling the direction of the puncture needle.

[0080] In one embodiment of the present disclosure, the shape of the hollow groove 12 can be an oblong hole, an oblong hole or other oblong holes, and the direction of the oblong hole can be perpendicular to the axial direction or at an angle of 0-45°. When the direction of the oblong hole is at an angle of 0-45° to the axial direction, the flexible structure formed by the plurality of oblong holes has higher support force while being flexible compared to the oblong hole being perpendicular to the axial direction. The present disclosure does not limit this, and those skilled in the art can determine it according to the actual situation and the operator's usage habits.

[0081] like Figure 6 and Figure 8As shown, in one embodiment of the present disclosure, the needle tip 13 is a multi-faceted needle tip 13, and the angle between the facets and the axial direction is 10°-30°; or, the needle tip 13 is a conical needle tip 13, and the angle between the cone generatrix and the axial direction is 10°-30°.

[0082] The needle tip 13 of the present invention is constructed as a four-faceted needle, so that the needle tip 13 of the present invention has four cutting edges. At the same time, the first traction line 21 and the second traction line 22 are distributed on both sides of the two opposing cutting edges. In this way, when the direction adjustment mechanism controls the two traction lines to pull the needle tip 13 relative to the needle tube 11 to deflect, the cutting edge on the corresponding side of the deflection of the needle tip 13 can quickly cut the puncture hole, which reduces the damage to human tissue and improves the accuracy of puncture compared to the stabbing of the conventional conical needle tip 13. At the same time, the angle between the section of the needle tip 13 and the axial direction is 10°-30°. In this way, the needle tip 13 is sharp enough and will not be too blunt, causing greater damage to the tissue during puncture.

[0083] Furthermore, in one embodiment of the present disclosure, depending on the number of traction lines, which can also be three or four, the needle tip 13 can be constructed as a three-faceted needle tip 13 or a four-faceted needle tip 13. At the same time, the traction line and the cutting edges of the needle tip 13 are correspondingly distributed on the same side, so that when the puncture direction of the needle tip 13 in the human body is changed, the resistance of the human tissue is reduced and the puncture port is quickly cut.

[0084] In one embodiment of the present disclosure, the needle tip 13 can also be a conical needle tip 13, and different numbers of traction lines are evenly distributed along the circumference, so that the direction adjustment mechanism can control the corresponding traction line to pull the needle tip 13, so that the needle tip 13 is deflected relative to the needle tube 11, and the angle between the cone generatrix and the axial direction is 10°-30°, so that the needle tip 13 is sharp enough to enhance the puncture efficiency of the needle tip 13.

[0085] In one embodiment of the present disclosure, the needle tip 13 may also be a beveled needle, and the first traction line 21 and the second traction line 22 are distributed on both sides of the needle tip perpendicular to the bevel direction of the needle tip. During use, the beveled needle usually produces an arc-shaped puncture path because the force direction of its cross section is at an angle to the axial direction, and it is difficult to determine its specific trajectory, but the present disclosure can adjust the puncture direction of the needle tip 13 in the human body through a control device. During the puncture process, when there is a situation where the hardness is high and it is difficult to puncture between the puncture position and the straight path of the target position, the beveled needle can bypass the obstacle in an arc-shaped path because of the uneven force on the cross section, which reduces the difficulty and complexity of the operation when the operator controls.

[0086] Furthermore, the puncture force of the multi-faceted needle tip is higher, and the material of the needle tip 13 of the present disclosure is stainless steel or nickel-titanium alloy that meets the requirements of GB / T18457. The present disclosure does not limit the type and material of the needle tip. Those skilled in the art can determine the type and material of the needle tip based on actual conditions so that the needle tip 13 can puncture the human body with higher efficiency.

[0087] like Figure 8 and Fig. 9 As shown, in one embodiment of the present disclosure, the controllable puncture needle also includes a core needle 14, which extends along the direction of the needle tube 11, with the proximal end fixed inside the shell, and the distal end sequentially passes through the rotating shaft 32 and the needle tube 11, and is fixedly connected to the end face of the needle tip 13 close to the proximal end.

[0088] In this way, the proximal end of the core needle 14 is fixed to the base inside the shell, which improves the stability of the core needle 14. The distal end of the core needle 14 passes through the through hole of the rotating shaft 32 along the axial direction and the needle tube 11, making the fixation of the needle tube 11 more stable. The distal end of the core needle 14 is fixedly connected to the needle tip 13, avoiding the needle tip 13 being fixed only to the needle tube 11. When encountering a harder and difficult-to-puncture area during the puncture process, the needle tip 13 is at risk of falling off and causing the head end to deform and fail, thereby enhancing the stability of the needle tip 13. At the same time, the cross-section of the core needle 14 is an oblong, and the first traction line 21 and the second traction line 22 are arranged on both sides of the long side so that the two traction lines have enough space to pull the needle tip 13.

[0089] In one embodiment of the present disclosure, the number of traction lines can be three or four, and the cross-section of the core needle 14 can also be correspondingly triangular or square, so that there is corresponding space in the needle tube 11 to set the traction line to avoid affecting the traction line of the control device to pull the needle tip 13.

[0090] In one embodiment of the present disclosure, the cross-section of the core needle 14 may also be a circle with axial grooves evenly distributed along its cross-sectional circle. The number of grooves depends on the number of traction lines, and the grooves should have enough space to accommodate the traction lines to avoid affecting the traction lines of the control device to pull the needle tip 13.

[0091] Furthermore, the material of the needle tip 13 of the present disclosure is stainless steel or nickel-titanium that meets the requirements of GB / T18457, and the present disclosure does not impose any limitation on this. Those skilled in the art can determine the material according to actual conditions so that the needle tip 13 and the needle tube 11 can be stably arranged.

[0092] For better understanding, refer to Figures 1 to 10C , combined with an intrahepatic puncture application scenario, the working principle of the controllable puncture needle provided by the present invention is described in detail.

[0093] The present disclosure provides a controllable puncture needle, comprising a needle tube 11, a needle tip 13 and a control device, wherein the proximal end of the needle tube 11 is fixed on the control device, and the needle tip 13 is fixedly arranged at the distal end of the needle tube 11.

[0094] Specifically, Fig. 10A and Fig. 10BIn the liver part 61 shown, the controllable puncture needle passes through the reinforcing catheter 65, through the hepatic vein 62, and punctures the portal vein 63 of the target area 64. When the external imaging device finds that the direction of the needle tip 13 is wrong, the operator operates the rotating hand wheel 31 through the control device to pull the first traction line 21 and the second traction line 22 to provide a bending moment for the needle tip 13, and cooperates with the flexible structure of the preset length near the distal end of the needle tube 11, so that when the operator pushes the puncture needle of the present disclosure, the needle tip 13 is deflected relative to the needle tube 11 under the action of the bending moment, and then the puncture direction is adjusted. At the same time, the needle tip 13 with a cutting edge cuts the human tissue and continues to puncture the target area 64 to reach the target position.

[0095] Or, if Fig. 10C In the liver part 61 shown, the controllable puncture needle passes through the reinforcing catheter 65, passes through the hepatic vein 62, and punctures the portal vein 63 of the target area 64. During the puncture process, if a hard tissue mass 66 is found in the liver tissue that is difficult to puncture, it can be bent to one side first. The operator operates the rotating hand wheel 31 through the control device to pull the first traction line 21 and the second traction line 22, so that one traction line is stretched and the other traction line is relaxed, providing a bending moment for the needle tip 13, and cooperating with the flexible structure of the needle tube 11 near the distal end, so that when the operator pushes the puncture needle of the present disclosure, the needle tip 13 is deflected relative to the needle tube 11 under the action of the bending moment, bypassing the difficult-to-puncture area, and then the control device is used again to readjust the puncture direction of the needle tip 13 in the human body, providing the needle tip 13 with a bending moment in the opposite direction, and the operator pushes the puncture needle, so that the controllable puncture needle punctures to the other side under the action of the bending moment and reaches the target position.

[0096] In this way, when the controllable puncture needle of the present invention performs puncture, the first traction line 21 and the second traction line 22 cooperate to prevent the puncture direction from being lost; the flexible structure at the end of the needle tube 11 makes it easier to control the deflection of the needle tip 13 relative to the needle tube 11; the needle tip 13 with a cutting blade can cut a puncture incision when the needle tip 13 is deflected, with less resistance, thereby improving the accuracy and efficiency of the puncture and reducing damage to liver tissue during multiple punctures.

[0097] The embodiments of the present disclosure have been described above, and the above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and changes will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The choice of terms used herein is intended to best explain the principles of the embodiments, practical applications, or technical improvements in the marketplace, or to enable other persons of ordinary skill in the art to understand the embodiments disclosed herein. The scope of the present disclosure is defined by the appended claims.

Claims

1. A controllable puncture needle, characterized in that: include: A needle tube (11), wherein the needle tube (11) has a flexible structure at least at a distal end close to the end; A needle tip (13), the needle tip (13) being fixedly connected to the distal end of the needle tube (11); A control device, the control device is arranged at the proximal end of the needle tube (11) and is configured to control the deflection angle of the needle tip (13) relative to the needle tube (11), thereby controlling the puncture direction of the needle tip (13) in the human body.

2. The controllable puncture needle according to claim 1, characterized in that: The control device comprises: A housing, the housing being configured to fix the proximal end of the needle tube (11); A first sliding block (41), the first sliding block (41) being slidably arranged in the housing; A second sliding block (42), the second sliding block (42) being slidably arranged in the housing; A first pulling wire (21), wherein the proximal end of the first pulling wire (21) is tensioned and fixed on the first sliding block (41), and the distal end of the first pulling wire (21) is inserted into the needle tube (11) and fixedly connected to the needle tip (13); A second traction line (22), wherein the proximal end of the second traction line (22) is tensioned and fixed on the second slider (42), and the distal end of the second traction line (22) is inserted into the needle tube (11) and fixedly connected to the needle tip (13); A direction adjustment mechanism is disposed in the housing and is configured to control the first slider (41) and the second slider (42) to move in opposite directions, so that the first traction line (21) and the second traction line (22) pull the needle tip (13) to deflect relative to the needle tube (11).

3. The controllable puncture needle according to claim 2, characterized in that: The steering mechanism comprises: a rotating shaft (32), the rotating shaft (32) being rotatably disposed in the housing and provided with a first external thread (321) and a second external thread (322) having opposite rotation directions, the first sliding block (41) being provided with a first internal thread (411) meshing with the first external thread (321), and the second sliding block (42) having a second internal thread (421) meshing with the second external thread (322); A rotating hand wheel (31) is coaxially fixedly arranged on the rotating shaft (32) and is provided with an external force by a portion protruding from the housing, and is configured to drive the rotating shaft (32) to rotate under the external force.

4. The controllable puncture needle according to claim 3, characterized in that: The shell is provided with a first guide hole, a second guide hole and a through hole (53); the proximal end of the needle tube (11) is fixed in the shell, and the distal end extends out of the shell through the through hole (53); the distal end of the first traction line (21) is sequentially inserted into the first guide hole, and the needle tube (11) is tensioned and connected to the needle tip (13); the second traction line (22) is sequentially inserted into the second guide hole, and the needle tube (11) is tensioned and connected to the needle tip (13) and the second slider (42).

5. The controllable puncture needle according to claim 4, characterized in that: The shell comprises an upper shell (52) and a lower shell (51) which are spliced ​​together, and the through hole (53), the first guide hole and the second guide hole are all formed by splicing through grooves on the upper shell (52) and the lower shell (51).

6. The controllable puncture needle according to claim 5, characterized in that: The first sliding block (41) and the housing are slidably matched via a matching first sliding rail (54) and a first sliding groove (412), and one of the first sliding rail (54) and the first sliding groove (412) is arranged on the first sliding block (41) and the housing; The second sliding block (42) and the housing are slidably matched via a matching second sliding rail (55) and a second sliding groove (422); one of the second sliding rail (55) and the second sliding groove (422) is arranged on the second sliding block (42) and the housing.

7. The controllable puncture needle according to claim 6, characterized in that: The shell comprises an upper half shell (52) and a lower half shell (51) which are spliced ​​to each other, and the upper half shell (52) and the lower half shell (51) are both provided with the first slide rail (54) and the second slide rail (55).

8. The controllable puncture needle according to any one of claims 3 to 7, characterized in that: A plurality of hollow grooves (12) are sequentially provided along the extending direction of the needle tube (11) over a preset length from the distal end to the proximal end of the needle tube (11), and the portion where the hollow grooves (12) are provided forms the flexible structure.

9. The controllable puncture needle according to claim 8, characterized in that: Along the extension direction from the distal end to the proximal end of the needle tube (11), the plurality of hollow grooves (12) are arranged in a dense to sparse manner.

10. The controllable puncture needle according to claim 8, characterized in that: Along the extension direction from the distal end to the proximal end of the needle tube (11), a plurality of the hollow grooves (12) are arranged along a linear array.

11. The controllable puncture needle according to claim 8, characterized in that: Along the extension direction of the needle tube (11), two adjacent hollow grooves (12) are vertically arranged.

12. The controllable puncture needle according to claim 8, characterized in that: The circumferential length of the hollow groove (12) along the circumferential direction is greater than the axial length along the axial direction, and the ratio of the circumferential length to the axial length is 2:1-4:

1.

13. The controllable puncture needle according to claim 8, characterized in that: The needle tip (13) is a multi-faceted needle tip, wherein the angle between the facets and the axial direction is 10°-30°; or, The needle tip (13) is a conical needle tip, and the angle between the cone generatrix and the axial direction is 10°-30°.

14. The controllable puncture needle according to claim 13, characterized in that: The controllable puncture needle also includes a core needle (14), which extends along the direction of the needle tube (11), with a proximal end fixed inside the shell, and a distal end passing through the rotating shaft (32) and the needle tube (11) in sequence, and is fixedly connected to the end surface of the needle tip (13) close to the proximal end.

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