Dilator and blood vessel sheath

Abstract

The invention relates to a dilator and a vascular sheath, which can solve the pain points such as blood leakage of a puncture point and occurrence of pseudoaneurysm clinically. The dilator comprises a head, a driving mechanism, a suturing mechanism, an electromagnetic mechanism and a sleeve. The driving mechanism comprises an operating part, a connecting rod and an opening-closing assembly, the near end of the connecting rod is connected with the operating part, the far end of the connecting rod is connected with the opening-closing assembly, and when the operating part moves relative to the head, the opening-closing assembly is unfolded or folded; the suturing mechanism is arranged on the opening and closing assembly and comprises a plurality of needle grooves and suturing needles; the sleeve comprises an outer tube and a catheter, the connecting rod is sleeved with the outer tube, the near end of the outer tube is connected with the head, the catheter penetrates through the connecting rod, and the near end of the catheter is connected with the head; the electromagnetic mechanism is arranged on the head part and comprises an electromagnetic control circuit with a control switch and an electromagnetic chuck, and the electromagnetic control circuit is used for enabling the electromagnetic chuck to generate magnetism; when the opening and closing assembly is in an unfolded state, an opening of the needle groove faces the electromagnetic chuck, and the suture needle is located at the position where the suture needle can be attracted by the electromagnetic chuck.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a dilator and a vascular sheath for vascular suturing. Background Art

[0002] Vascular sheaths are the most commonly used medical devices in clinical practice, used to introduce therapeutic and diagnostic equipment into the vascular system. Currently, vascular sheaths have the following pain points: Puncture point management issues: The sheath mainly establishes vascular access by injuring the blood vessel opening. The larger the diameter of the sheath, the greater the damage to the blood vessel, and the easier it is to form a pseudoaneurysm at the wound site. Expandable sheaths with a small diameter can heal by pressing the wound after surgery, while expandable sheaths with a large diameter cannot heal directly after surgery and need to be sutured with a suturer. Summary of the invention

[0003] Based on this, it is necessary to propose a vascular sheath dilator that can solve the problems of bleeding at the puncture point and the occurrence of false aneurysms when the vascular sheath is used. In addition, a vascular sheath is also proposed.

[0004] According to one aspect of the present application, an expander includes a head, a driving mechanism, a suturing mechanism, an electromagnetic mechanism, and a sleeve; the driving mechanism includes an operating member, a connecting rod, and an opening and closing assembly, wherein the operating member is movably arranged on the head, the proximal end of the connecting rod is connected to the operating member, and the distal end of the connecting rod is connected to the opening and closing assembly, and when the operating member moves relative to the head, the opening and closing assembly is expanded or retracted under the control of the connecting rod; the suturing mechanism is arranged in the opening and closing assembly, and the suturing mechanism includes a plurality of needle grooves, suturing needles arranged in the needle grooves, and each of the suturing needles is suturing through the suturing needles. The connecting rod is connected with the connecting rod to form a plurality of pairs of suture needles; a sleeve comprising an outer tube and a catheter, wherein the outer tube is sleeved outside the connecting rod, the proximal end of the outer tube is connected to the head, the catheter is passed through the connecting rod, and the proximal end of the catheter is connected to the head; an electromagnetic mechanism is arranged on the head, the electromagnetic mechanism comprises an electromagnetic control circuit with a control switch and an electromagnetic suction cup, the electromagnetic control circuit is used to make the electromagnetic suction cup generate magnetism; wherein, when the opening and closing assembly is in the unfolded state, the opening of the needle groove faces the electromagnetic suction cup, and the suture needle is in a position where it can be adsorbed by the electromagnetic suction cup.

[0005] In some embodiments, the catheter includes a small diameter portion and a large diameter portion, the small diameter portion passes through the connecting rod and is connected to the head, the distal end of the small diameter portion is connected to the large diameter portion and exposes the connecting rod, and there is a gap between the large diameter portion and the distal end of the outer tube; when the opening and closing assembly is in a folded state, the opening and closing assembly is located in the gap, and the outer tube blocks the electromagnetic suction cup from adsorbing the suture needle.

[0006] In some embodiments, the outer diameter of the outer tube is consistent with the outer diameter of the large diameter portion.

[0007] In some embodiments, the outer wall surface of the outer tube is provided with a longitudinal blood flow indicating hole along the axial direction of the outer tube.

[0008] In some embodiments, a bending structure is provided in the catheter, and the bending structure is used to bend the catheter.

[0009] In some embodiments, the opening and closing assembly includes a plurality of sliding chain groups distributed circumferentially defined along the axis of the catheter, the sliding chain group including an inner sliding chain, an outer sliding chain and a support hinge, the proximal end of the inner sliding chain is fixed to the connecting rod, the distal end of the inner sliding chain is hinged to the distal end of the outer sliding chain, the two ends of the support hinge are hinged to the middle part of the inner sliding chain and to the middle part of the outer sliding chain; each of the support hinges includes a first part and a second part that are rotatably connected, the first part is hinged to the middle part of the inner sliding chain, and the second part is hinged to the middle part of the outer sliding chain.

[0010] In some embodiments, the inner sliding chain, the outer sliding chain and the supporting hinge are all wrapped with a wrapping film, and the wrapping film is used to reduce the surface friction coefficient.

[0011] In some embodiments, a sliding slot is provided on the head, and the sliding slot includes a first channel and a second channel, and the second channel is connected to the first channel; the operating member is constructed to be slidably assembled in the sliding slot to selectively get stuck in the first channel or the second channel, wherein when the operating member is stuck in the first channel, the opening and closing assembly is in a retracted state, and when the operating member is stuck in the second channel, the opening and closing assembly is in an expanded state.

[0012] In some embodiments, a plurality of electric suction holes are provided on a side of the electromagnetic suction cup facing the opening and closing assembly, and the shape of the electric suction holes matches the shape of the suture needle.

[0013] In some embodiments, the electromagnetic suction cup is provided in plurality, each of which is used to absorb a suture needle, and the control switch is provided in plurality, each of which is used to control at least one of the electromagnetic suction cups.

[0014] In some embodiments, each pair of the suture needles is connected by a suture thread, and when the suture needles are in a position to be adsorbed by the electromagnetic suction cup, a plurality of suture threads are arranged side by side and / or crosswise.

[0015] In some embodiments, the suture needles are connected by sutures to form a plurality of pairs of suture needles, the sutures are wound around the bottom of the suture needles, and the sutures have surplus in the needle grooves.

[0016] According to another aspect of the present application, a vascular sheath comprises: the dilator described above; an expandable sheath tube comprising an expandable main tube and a sealing mechanism disposed at the proximal end of the expandable main tube; and a protective tube configured to be able to be inserted into the expandable main tube and allow the catheter of the dilator to pass through.

[0017] In the present application, a suturing mechanism is provided on the dilator, so that the vascular sheath has a certain suturing function, solving the clinical pain points such as bleeding at the puncture point and the occurrence of pseudoaneurysms. The expandable sheath in the present application has an expandable function, which can achieve smaller incisions and lower complication rates for patients compared to conventional sheaths. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. 1 is a schematic diagram of a vascular sheath according to an embodiment of the present application.

[0019] FIG. 2 is an enlarged view of the internal structure at X in FIG. 1 .

[0020] FIG. 3 is a schematic structural diagram of the head of the expander according to an embodiment of the present application.

[0021] FIG. 4 is a schematic structural diagram of the A direction in FIG. 3 .

[0022] FIG5 is a circuit schematic diagram of the electromagnetic control circuit of the present application.

[0023] 6 to 11 are state diagrams of different stages during the use of the vascular sheath according to the embodiment of the present application.

[0024] FIG. 12 and FIG. 13 are schematic diagrams of the first and second suturing effects of the vascular sheath according to an embodiment of the present application, respectively.

[0025] 14 and 15 are schematic diagrams of a first threading method and a second threading method of the suturing mechanism of the present application, respectively.

[0026] FIG. 16 and FIG. 17 are schematic diagrams of the opening and closing assembly of the expander of the present application in the folded state and the expanded state, respectively.

[0027] FIG. 18 is a schematic diagram of another embodiment of the electromagnetic mechanism of the present application.

[0028] FIG. 19 is a circuit diagram of another embodiment of the electromagnetic mechanism of the present application.

[0029] Reference numerals:

[0030] 100, vascular sheath; 1, expandable sheath tube; 11, sealing mechanism; 111, sealing upper cover; 112, sealing pad; 113, connector body; 114, display boss; 115, fixing hole; 12, flushing mechanism; 121, flushing pipeline; 122, flushing valve; 13, expandable main tube; 2, protective tube; 3, dilator; 31, head; 311, protective cover; 312, main body shell; 313, sliding seam; 3131, first channel; 3132, second channel; 32, driving mechanism; 321, operating member; 322, connecting rod; 3221, slider; 323, opening and closing assembly; 3231, inner sliding chain; 3232, Outer sliding chain; 3233, supporting hinge; 3233a, first part; 3233b, second part; 324, wrapping film; 33, suturing mechanism; 331, needle groove; 332, suturing needle; 333, suture thread; 34, electromagnetic mechanism; 341, control switch; 342, electromagnetic suction cup; 3421, electric suction hole; 343, battery; 344, main board; 345, connecting tube; 346, electric wire; 35, sleeve; 351, outer tube; 3511, blood flow indicator hole; 352, catheter; 3521, small diameter part; 3522, large diameter part; 36, bending adjustment structure; 361, incision; 200, guide wire; 300, blood vessel. DETAILED DESCRIPTION

[0031] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0032] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0033] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0034] It should be understood that the terms "proximal", "posterior", "distal", and "anterior" used herein are relative to the clinician (operator) manipulating the dilator. The terms "proximal" and "posterior" refer to the part close to the clinician, and the terms "distal" and "anterior" refer to the part away from the clinician.

[0035] As shown in Figures 1 and 2, the vascular sheath 100 of the embodiment of the present application includes an expandable sheath tube 1, a protective tube 2 and a dilator 3. The dilator 3 is used in conjunction with the expandable sheath tube 1 and the protective tube 2 to introduce treatment and diagnostic equipment into the vascular 300 system and to manage postoperative wound sutures.

[0036] As shown in FIG1 , the expandable sheath tube 1 includes a sealing mechanism 11, a flushing mechanism 12, and an expandable main tube 13. The sealing mechanism 11 and the flushing mechanism 12 are arranged at the proximal end of the expandable main tube 13. The sealing mechanism 11 is used to seal the proximal end of the expandable main tube 13. The flushing mechanism 12 is used to flush the inside of the expandable main tube 13. The expandable main tube 13 can be inserted with the protective tube 2 and the dilator 3. The distal end of the expandable main tube 13 is tapered.

[0037] As shown in FIG. 1 and FIG. 2 , the dilator 3 includes a head 31 , a driving mechanism 32 , a suturing mechanism 33 , an electromagnetic mechanism 34 , and a sleeve 35 .

[0038] As shown in Fig. 1 and Fig. 3, the head 31 is used to set the electromagnetic mechanism 34 and the operating member 321. Optionally, the head 31 is composed of a protective cover 311 and a main body shell 312. The protective cover 311 is an arc cover, with the electromagnetic mechanism 34 built in, and the material is PP, ABS, PC / ABS, etc. The main body shell 312 is not directly connected to the protective cover 311, but is connected to the main board 344 of the electromagnetic mechanism 34 by bonding. The material of the main body shell 312 is consistent with that of the protective cover 311, which is PP, ABS, PC / ABS, etc.

[0039] As shown in FIGS. 1 to 3 , the driving mechanism 32 includes an operating member 321, a connecting rod 322 and an opening and closing assembly 323. The operating member 321 is movably arranged on the head 31; the proximal end of the connecting rod 322 is connected to the operating member 321, and the distal end of the connecting rod 322 is connected to the opening and closing assembly 323. When the operating member 321 moves relative to the head 31, the opening and closing assembly 323 is expanded (as shown in FIGS. 10 , 11 , and 17 ) or retracted (as shown in FIGS. 9 and 16 ) under the control of the connecting rod 322. The sleeve 35 includes an outer tube 351 and a catheter 352. The outer tube 351 is sleeved on the outside of the connecting rod 322, the proximal end of the outer tube 351 is connected to the head 31, the catheter 352 is inserted into the connecting rod 322, and the proximal end of the catheter 352 is connected to the head 31. The distal end of the catheter 352 is used to be inserted into the blood vessel 300. Optionally, the distal end of the catheter 352 is a conical structure.

[0040] As shown in Fig. 2, the suturing mechanism 33 includes a plurality of needle slots 331, suturing needles 332 disposed in the needle slots 331, and suturing threads 333 disposed on the suturing needles 332. When the opening and closing assembly 323 is in the unfolded state, the opening of the needle slots 331 faces the electromagnetic suction cup 342, and the suturing needles 332 are in a position where they can be sucked by the electromagnetic suction cup 342.

[0041] In the suturing mechanism 33, the shape of the needle groove 331 matches the shape of the suturing needle 332 to limit the suturing needle 332. The bottom of the needle groove 331 can store the suture thread 333. When the opening and closing component 323 is unfolded, under the action of tension, the suture thread 333 stored at the bottom is compensated for length. The suture needle 332 has a certain degree of magnetism, for example, its material is Fe, Co, Ni, etc., and the microneedle conical bottom is wound around and fixed with the suture thread 333. The suture thread 333 can be a non-absorbable thread made of PA, PP, etc., or an absorbable thread made of polylactic acid, collagen, etc.

[0042] 1 and 2 , a bending structure 36 is provided in the catheter 352, and the bending structure 36 is used to bend the catheter 352. The bending structure 36 is located inside the catheter 352 to prevent damage to the blood vessel 300 when entering the blood vessel 300.

[0043] The protection tube 2 is constructed to be able to be inserted into the expandable sheath 1 and allow the catheter 352 of the dilator 3 or other devices (such as a balloon) to pass through. The protection tube 2 is a rigid tube with a certain strength. After the device is introduced, the protection tube 2 can be withdrawn from the expandable sheath and attached to the proximal end of the catheter 352. The protection tube 2 can also be a tearable tube, which is torn and separated after withdrawal. The material of the protection tube 2 is PE, Pebax, PTFE, etc.

[0044] As shown in FIG3 and FIG4, the electromagnetic mechanism 34 is provided on the head 31. The electromagnetic mechanism 34 includes an electromagnetic control circuit having a control switch 341 and an electromagnetic suction cup 342. In the electromagnetic mechanism 34, by starting the control switch 341, the electromagnetic suction cup 342 can generate magnetism through the electromagnetic control circuit. Optionally, the circuit principle of the electromagnetic control circuit can be simplified as shown in FIG5.

[0045] The electromagnetic control circuit includes a battery 343, a main board 344, a connecting tube 345 and a wire 346. Optionally, the control switch 341 is a button switch that can light up, which is exposed on the outer surface of the protective cover 311. When the control switch 341 is pressed, the light is displayed in green color, and the electromagnetic mechanism 34 works normally. The shell material of the button switch is PC, PP, PE, etc., and the spring and pin material in the button switch is Cu (copper). The number of button switches can be 1 or more. Optionally, the type of battery 343 (342) is preferably a lithium battery 343, and the electromotive force is 3V.

[0046] Optionally, the main board 344 is made of a PCB board. The connecting tube 345 is a 304 stainless steel tube or a copper tube, one end of which is connected to the main board 344 and the other end is connected to the electromagnetic suction cup 342. The connecting tube 345 is a hollow structure, in which the wire 346 is stored. The wire 346 is a multi-strand copper wire, which connects the main board 344 and the electromagnetic suction cup 342. When the power is on, the electromagnetic suction cup 342 is magnetic. When the power is off, the electromagnetic suction cup 342 is non-magnetic. 304 stainless steel and copper are not magnetic, and the electromagnetic suction cup 342 has no attraction to them. The suture needle 332 has a certain magnetism and will be attracted by the electromagnetic suction cup 342.

[0047] In order to facilitate understanding of the present application, the following briefly describes the use process of the vascular sheath 100 of the present application in conjunction with Figures 6 to 11. The use process of the vascular sheath 100 of the present application is as follows:

[0048] As shown in Fig. 6, after the guide wire 200 is introduced into the expandable main tube 13 by using the puncture needle, the dilator 3 is inserted into the expansion main tube and penetrates into the blood vessel 300 along the guide wire 200. Since the diameter of the dilator 3 is relatively small, the puncture point formed is small.

[0049] As shown in Fig. 7, the dilator 3 is first withdrawn from the sheath tube. A protective tube 2 of appropriate size is selected according to the device to be introduced; the dilator 3 is then inserted into the protective tube 2, and the dilator 3 and the protective tube 2 are re-inserted into the expandable main tube 13, at which time the puncture point is slightly enlarged.

[0050] As shown in FIG. 8 , the dilator 3 is withdrawn, and the protective tube 2 is retained, after which the instrument can be introduced.

[0051] As shown in FIG9 , suturing of the puncture site often requires precise alignment. The dilator 3 with inclined puncture cannot meet the suturing conditions, so the bending adjustment structure 36 is bent according to the diameter of the blood vessel 300. For example, the bending angle of the blood vessel 300 with a small diameter needs to be larger. After the treatment is completed, the expandable sheath 1 is pulled out and the guide wire 200 is retained. The dilator 3 with the adjusted bend is inserted along the guide wire 200. Optionally, as shown in FIG2 , the dilator 3 is provided with a blood flow indicator hole 3511. When continuous blood flow is seen in the blood flow indicator hole 3511, it means that the dilator 3 is in place.

[0052] As shown in Fig. 10, the guide wire 200 is removed. The movement of the connecting rod 322 is controlled by the operating member 321, so that the opening and closing assembly 323 is switched from the retracted state to the open state.

[0053] As shown in FIG. 11 , the control switch 341 is turned on, and under the action of electromagnetic induction, the suture needle 332 passes through the needle groove 331 , penetrates the skin, and is sucked by the electromagnetic suction cup 342 .

[0054] Afterwards, utilize scalpel cutting line, and use conventional surgical operation to suture the wound.Specifically can utilize eight-character suture method as shown in Figure 12 or interrupted suture method as shown in Figure 13 to suture.

[0055] Specifically, taking four needle grooves 331 evenly distributed along the circumferential direction as an example, as shown in FIG14, when the connection mode of the suture line 333 is that one end is connected to the suture needle 332 on one side and the other end is connected to the suture needle 332 in the needle groove 331 on the opposite side, two crossed suture lines 333 are formed, and the figure-eight suture effect as shown in FIG12 can be formed. As shown in FIG15, when two adjacent suture needles 332 in the circumferential direction are connected by the suture line 333, two suture lines 333 arranged side by side are formed, and the intermittent suture effect as shown in FIG13 can be formed.

[0056] In the present application, each pair of suture needles 323 is connected by a suture thread 333. When the suture needles 323 are in a position where they can be adsorbed by the electromagnetic suction cup 342, multiple suture threads 333 are arranged side by side and / or crosswise.

[0057] Specifically, as shown in Fig. 14, two suture lines 333 are arranged side by side. Here, the side by side arrangement means that the projections of the two suture lines 333 in a plane perpendicular to the axial direction of the sleeve 35 do not cross each other. When suturing, an intermittent suturing effect can be formed.

[0058] As shown in Fig. 15, two suture lines 333 are arranged crosswise. Here, the crosswise arrangement refers to the projection of the two suture lines 333 in a plane perpendicular to the axial direction of the sleeve 35. When suturing, an eight-shaped suture effect can be formed.

[0059] In addition, it should be noted that the formation is not limited to two suture lines 333. The number of needle grooves 331 can be greater than 4, so that more than two suture lines 333 can be formed. Furthermore, the more than two suture lines 333 can be arranged side by side or crosswise.

[0060] In the present application, a suturing mechanism 33 is provided on the dilator 3, so that the vascular sheath 100 has a certain suturing function, which solves the clinical pain points such as bleeding at the puncture point and the occurrence of pseudoaneurysm.

[0061] In addition, in the conventional technology, large-scale puncture is required in the treatment of diseases such as structural heart disease or pulmonary embolism, and the bleeding problem cannot be solved by pressing, and two staplers are generally used to suture the puncture point. However, the present invention uses electromagnetic magnetic suction to set up multiple needle slots 331, so that multiple sutures 333 can be inserted at one time, and the wound can be directly sutured by surgical operation. Compared with the conventional stapler, the suture efficiency is high and the puncture frequency is reduced.

[0062] In addition, the expandable sheath 1 in the present application has an expandable function, and compared with conventional sheaths, it can achieve smaller incisions for patients and lower complication rates.

[0063] In addition, the sheath protection tube 2 in the present application can effectively prevent the instrument from being damaged when passing through the sheath, and by replacing the specifications of the protection tube 2, a certain range of multi-specification instrument implantation can be achieved, with better compatibility.

[0064] This is further elaborated below.

[0065] As shown in Figure 1, in some embodiments, the sealing mechanism 11 of the expandable sheath 1 includes a sealing upper cover 111, a sealing gasket 112, a connector body 113, a display boss 114 and a fixing hole 115. The sealing upper cover 111 is made of ABS, PP, or ABS / PC. The sealing gasket 112 is located inside the upper cover, and is made of, for example, silicone material, and is tightly combined with the upper cover. The connector body 113 is screwed to the sealing upper cover 111 through threads and is connected to the flushing mechanism 12. The material of the connector body 113 is consistent with that of the sealing upper cover 111. The display boss 114 is used to display the diameter range of the device adapted to the expandable sheath 1, such as 6-8F. During use, the expandable sheath 1 is fixed by passing a wire through the fixing hole 115 and through the skin.

[0066] The flushing mechanism 12 is composed of a flushing pipeline 121 and a flushing valve 122. Before the sheath is used, the doctor needs to use physiological saline to flush the inner cavity of the sheath through the flushing mechanism 12. The flushing pipeline 121 is made of PVC and PU. The flushing valve 122 is a standard three-way valve that can be filled with water or exhausted.

[0067] As shown in FIG1 , the expandable main tube 13 is optionally composed of a constraint membrane and an elastic tube wall. The elastic tube wall is made of TPU, silicone, PU or other materials, and the proximal end is expanded to facilitate the introduction of the instrument, and the distal end is a tapered rounded structure to reduce damage to the blood vessel 300 during entry. When instruments of different sizes enter, the elastic tube wall will tightly wrap the instrument and expand to different outer diameters. The outer layer of the elastic tube wall is covered with a constraint film. The film material is PP, PA, PTFE or PVDF, etc.

[0068] As shown in Figs. 1 and 2, 16 and 17, the catheter 352 includes a small diameter portion 3521 and a large diameter portion 3522. The small diameter portion 3521 passes through the connecting rod 322 and is connected to the head 31, and the distal end of the small diameter portion 3521 is connected to the large diameter portion 3522 and exposes the connecting rod 322; there is a gap between the large diameter portion 3522 and the distal end of the outer tube 351. When the opening and closing assembly 323 is in the retracted state, the opening and closing assembly 323 is located in the gap, and the outer tube 351 blocks the electromagnetic suction cup 342 from adsorbing the suture needle 332.

[0069] In this embodiment, the connecting rod 322 is a hollow structure. The small diameter portion 3521 of the conduit 352 passes through the connecting rod 322 and is connected to the head 31. In this way, the connecting rod 322 is sandwiched between the outer tube 351 and the conduit 352, so that when the connecting rod 322 moves under the control of the operating member 321, it can move smoothly under the guidance of the outer tube 351 and the conduit 352.

[0070] When the opening and closing assembly 323 is in the retracted state, the opening and closing assembly 323 is located in the interval, and then the outer tube 351 blocks the electromagnetic suction cup 342 from adsorbing the suture needle 332. In a specific configuration, in the retracted state, in the radial direction of the outer tube 351, each needle groove 331 is not higher than the wall of the outer tube 351. In other words, in the axial direction of the outer tube 351, the outer tube 351 prevents each needle groove 331 from facing the electromagnetic suction cup 342. In this way, the suture needle 332 can be prevented from being sucked out due to the operator's mistaken activation of the electromagnetic switch when the opening and closing assembly 323 is in the retracted state, thereby ensuring safety.

[0071] Optionally, the outer tube 351 is made of PP, PE and Pebax. The connecting rod 322 (323) is made of 304 stainless steel.

[0072] Furthermore, the outer diameter of the outer tube 351 is consistent with the outer diameter of the large diameter portion 3522. In this way, the outer tube 351 and the large diameter portion 3522 have the same degree of expansion of the expandable main tube 13 and the puncture point, and the stability of the dilator 3 insertion process is high.

[0073] In some embodiments, as shown in Fig. 2, the outer wall surface of the outer tube 351 is provided with a longitudinal blood flow indicator hole 3511 along the axial direction of the outer tube 351. As shown in Fig. 9, after the dilator 3 is inserted into the blood vessel 300, when the blood flow reaches the bottom of the blood flow indicator hole 3511, the blood flow will continue to flow out from the proximal end of the blood flow indicator tube, thereby indicating that the dilator 3 is in place and the next operation can be safely performed.

[0074] In some embodiments, as shown in FIG. 1 and FIG. 9 , the bending adjustment structure 36 is a hypotube structure having a cutout 361 on the tube wall. The cutout 361 is generally U-shaped. The bending adjustment structure 36 allows the conduit 352 to bend toward a side opposite to the opening direction of the cutout 361. If the opening direction of the cutout 361 is to the left, the conduit 352 can bend toward the right side.

[0075] Optionally, the bending adjustment structure 36 is made of 304 stainless steel.

[0076] As shown in Figures 2, 16 and 17, in some embodiments, the opening and closing assembly 323 includes a plurality of sliding chain groups distributed circumferentially defined along the axis of the catheter 352, each sliding chain group includes an inner sliding chain 3231, an outer sliding chain 3232 and a support hinge 3233, the proximal end of the inner sliding chain 3231 is fixed to the connecting rod 322, the distal end of the inner sliding chain 3231 is hinged to the distal end of the outer sliding chain 3232, both ends of the support hinge 3233 are hinged to the middle part of the inner sliding chain 3231 and to the middle part of the outer sliding chain 3232; the support hinge 3233 includes a first part 3233a and a second part 3233b that are rotatably connected, the first part 3233a is hinged to the middle part of the inner sliding chain 3231, and the second part 3233b is hinged to the middle part of the outer sliding chain 3232.

[0077] In this embodiment, the sliding chain groups are evenly distributed in the circumferential direction around the axis of the connecting rod 322. The number of sliding chain groups is 4 in total, but it is easy to understand that the number of sliding chain groups is not limited to this, as long as the effect of expansion and folding can be achieved. The distal end of the connecting rod 322 is fixedly connected with a slider 3221. The slider 3221 is, for example, welded to the connecting rod 322. The slider 3221 is used to connect the proximal ends of each inner sliding chain 3231.

[0078] When the opening and closing assembly 323 is in the folded state, when the operating member 321 moves toward the distal end of the expander 3, the connecting rod 322 drives the slider 3221 to move toward the distal end of the expander 3, the inner sliding chain 3231 moves toward the distal end of the expander 3, and the support hinge 3233 gradually unfolds and tends to be horizontal. The support hinge 3233 plays a supporting role, so that the outer sliding chain 3232 gradually opens, and each nail groove 331 moves to face the electromagnetic suction cup 342. Contrary to the above process, when the opening and closing assembly 323 is in the unfolded state, when the operating member 321 moves toward the proximal end of the expander 3, the support hinge 3233 and the outer sliding chain 3232 gradually gather to the periphery of the connecting rod 322. When the opening and closing assembly 323 is unfolded, the view in the direction B of FIG. 17 can be as shown in FIG. 14 or FIG. 15.

[0079] Optionally, the inner sliding chain 3231 , the outer sliding chain 3232 , the support hinge 3233 and the slider 3221 are all made of 304 stainless steel.

[0080] Furthermore, the inner sliding chain 3231, the outer sliding chain 3232 and the support hinge 3233 are all wrapped with a wrapping film 324, and the wrapping film 324 is used to reduce the surface friction coefficient. Optionally, the wrapping film 324 is made of FEP, PTFE, PFA, etc.

[0081] As shown in Fig. 1, Fig. 3, Fig. 16 and Fig. 17, in some embodiments, a sliding slit 313 is provided on the head 31, and the sliding slit 313 includes a first channel 3131 and a second channel 3132, and the second channel 3132 is connected to the first channel 3131. The operating member 321 is configured to be slidably assembled in the sliding slit 313, so as to be selectively stuck in the first channel 3131 or the second channel 3132, wherein when the operating member 321 is stuck in the first channel 3131, the opening and closing assembly 323 is in a retracted state, and when the operating member 321 is stuck in the second channel 3132, the opening and closing assembly 323 is in an extended state.

[0082] Specifically, the operating member 321 is in the initial position when in the first channel 3131, and is in the working position when the operating member 321 is engaged with the second channel 3132. The operating member 321 is made of the same material as the head 31, and can be fixed to the connecting rod 322 by means of engagement or bonding.

[0083] The top of the first channel 3131 is closed to limit the initial position of the operating member 321; along the radial direction of the connecting rod 322, the width of the first channel 3131 is slightly larger than the width of the operating member 321 to limit the initial position of the operating member 321. The width of the second channel 3132 is larger than the width of the operating member 321. Along the radial direction of the connecting rod 322, the size of the connection between the second channel 3132 and the first channel 3131 is smaller than the size of the operating member 321, so that the operating member 321 can be limited in the first channel 3131 or the second channel 3132. When the operating member 321 switches between the second channel 3132 and the first channel 3131, the operating member 321 deforms the connection between the second channel 3132 and the first channel 3131 and then passes through the connection.

[0084] In other embodiments, the first channel 3131 and the second channel 3132 may also be staggered in the radial direction of the connecting rod 322 , so that the operating member 321 can be limited in the first channel 3131 or the second channel 3132 .

[0085] In some embodiments, as shown in FIG. 3 , a plurality of electric suction holes 3421 are provided on one side of the electromagnetic suction cup 342 facing the opening and closing assembly 323 , and the shape of the electric suction holes 3421 matches the shape of the suture needle 332 .

[0086] When specifically configured, the electric suction hole 3421 is shaped as a conical front section and a cylindrical section, and the conical front end is consistent with the front end of the microneedle. The suture needle 332 is sucked into the electric suction hole 3421 of the electromagnetic suction cup 342, and the tail suture thread 333 can be directly cut.

[0087] In the present application, as shown in FIG. 17 , the position of the electric suction hole 3421 is specifically set to be opposite to the nail groove 331 when the opening and closing assembly 323 is unfolded, and the suture needle 332 is sucked out of the nail groove 331 by the electromagnetic suction cup 342, and the suture needle 332 enters the electric suction hole 3421, so that the suture thread 333 is maintained in a certain stretched state between the subcutaneous tissue and the electromagnetic suction cup 342, and then the thread cutting operation can be performed.

[0088] In some embodiments, as shown in FIG. 18 and FIG. 19 , a plurality of electromagnetic suction cups 342 are provided, each of which is used to absorb a suture needle 332 , and a plurality of control switches 341 are provided correspondingly, each of which is used to control at least one electromagnetic suction cup 342 .

[0089] Specifically, there are four electromagnetic suction cups 342 evenly distributed along the circumferential direction. Two control switches 341 are provided, each switch controls two electromagnetic suction cups 342, and the two electromagnetic suction cups 342 are arranged on opposite sides and staggered by 180 degrees in the circumferential direction.

[0090] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0091] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0092] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0093] The technical features of the above embodiments may be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0094] The above embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A dilator, characterized in that: It includes a head, a driving mechanism, a suturing mechanism, an electromagnetic mechanism, and a sleeve; The driving mechanism comprises an operating member, a connecting rod and an opening and closing assembly, wherein the operating member is movably arranged on the head, the proximal end of the connecting rod is connected to the operating member, and the distal end of the connecting rod is connected to the opening and closing assembly, and when the operating member moves relative to the head, the opening and closing assembly is expanded or retracted under the control of the connecting rod; A suturing mechanism is arranged in the opening and closing assembly, the suturing mechanism comprises a plurality of needle slots and suturing needles arranged in the needle slots, and the suturing needles are connected by sutures to form a plurality of pairs of suturing needles; A sleeve, comprising an outer tube and a catheter, wherein the outer tube is sleeved outside the connecting rod, the proximal end of the outer tube is connected to the head, the catheter is passed through the connecting rod, and the proximal end of the catheter is connected to the head; An electromagnetic mechanism is arranged on the head, and the electromagnetic mechanism includes an electromagnetic control circuit with a control switch and an electromagnetic chuck, and the electromagnetic control circuit is used to make the electromagnetic chuck generate magnetism; Wherein, when the opening and closing assembly is in the unfolded state, the opening of the needle slot faces the electromagnetic suction cup, and the suture needle is in a position where it can be adsorbed by the electromagnetic suction cup.

2. The dilator according to claim 1, characterized in that The catheter comprises a small diameter portion and a large diameter portion, the small diameter portion passes through the connecting rod and is connected to the head, the distal end of the small diameter portion is connected to the large diameter portion and exposed from the connecting rod, and there is a gap between the large diameter portion and the distal end of the outer tube; When the opening and closing assembly is in the folded state, the opening and closing assembly is located in the interval, and the outer tube blocks the electromagnetic suction cup from adsorbing the suture needle.

3. The expander according to claim 2, characterized in that The outer diameter of the outer tube is consistent with the outer diameter of the large diameter portion.

4. The expander according to claim 2, characterized in that The outer wall surface of the outer tube is provided with a longitudinal blood flow indicating hole along the axial direction of the outer tube.

5. The dilator according to claim 1, characterized in that A bending adjustment structure is arranged in the conduit, and the bending adjustment structure is used for bending the conduit.

6. The dilator according to claim 1, characterized in that The opening and closing assembly includes a plurality of sliding chain groups distributed circumferentially defined along the axis of the catheter, the sliding chain group including an inner sliding chain, an outer sliding chain and a supporting hinge, the proximal end of the inner sliding chain is fixed to the connecting rod, the distal end of the inner sliding chain is hinged to the distal end of the outer sliding chain, the two ends of the supporting hinge are hinged to the middle part of the inner sliding chain and to the middle part of the outer sliding chain; each of the supporting hinges includes a first part and a second part which are rotatably connected, the first part is hinged to the middle part of the inner sliding chain, and the second part is hinged to the middle part of the outer sliding chain.

7. The dilator according to claim 1, characterized in that The head is provided with a sliding seam, the sliding seam includes a first channel and a second channel, and the second channel is connected to the first channel; The operating member is constructed to be slidably assembled in the sliding slot to selectively be stuck in the first channel or the second channel, wherein when the operating member is stuck in the first channel, the opening and closing assembly is in a retracted state, and when the operating member is stuck in the second channel, the opening and closing assembly is in an extended state.

8. The dilator according to claim 1, characterized in that Each pair of suture needles is connected by a suture line. When the suture needles are in a position where they can be adsorbed by the electromagnetic suction cup, a plurality of suture lines are arranged side by side and / or crosswise.

9. The dilator according to claim 1, characterized in that There are multiple electromagnetic suction cups, each of which is used to absorb a suture needle. There are correspondingly multiple control switches, each of which is used to control at least one electromagnetic suction cup.

10. A vascular sheath, characterized in that: include: The dilator according to any one of claims 1 to 9; An expandable sheath tube, comprising an expandable main tube and a sealing mechanism disposed at the proximal end of the expandable main tube; The protective tube is configured to be inserted into the expandable main tube and allow the catheter of the dilator to pass therethrough.

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