CN119488666A - Dilator and vascular sheath - Google Patents

Abstract

The application relates to a dilator and a vascular sheath, which can solve the problems of blood leakage, false aneurysm and other pain points at a puncture point in clinic. The expander comprises a head, a driving mechanism, a stitching mechanism, an electromagnetic mechanism and a sleeve, wherein the driving mechanism comprises an operating piece, a connecting rod and an opening and closing component, the proximal end of the connecting rod is connected with the operating piece, the distal end of the connecting rod is connected with the opening and closing component, when the operating piece moves relative to the head, the opening and closing component is unfolded or folded, the stitching mechanism is arranged on the opening and closing component and comprises a plurality of needle grooves and stitching needles, the sleeve comprises an outer tube and a catheter, the outer tube is sleeved outside the connecting rod, the proximal end of the outer tube is connected with the head, the catheter penetrates through the connecting rod, the proximal end of the outer tube is connected with the head, the electromagnetic mechanism is arranged on the head and comprises an electromagnetic control circuit with a control switch and an electromagnetic chuck, the electromagnetic control circuit is used for enabling the electromagnetic chuck to generate magnetism, and in an unfolded state, an opening of the needle groove faces the electromagnetic chuck, and the stitching needles are positioned at positions capable of being absorbed by the electromagnetic chuck.

Description

Dilator and vascular sheath

Technical Field

The application relates to the field of medical instruments, in particular to an expander and a vascular sheath for vascular suturing.

Background

Vascular sheaths are the most commonly used medical devices in the clinic for introducing therapeutic and diagnostic devices into the vascular system. The existing vascular sheath has the following pain point that the puncture point is managed, and the vascular access is established by the sheath mainly through wound on the vascular opening. The larger the diameter of the sheath, the more damaging the vessel, and the more likely a pseudoaneurysm will form at the wound site. The small-diameter expandable sheath can heal by pressing the wound after operation, and the large-diameter expandable sheath cannot heal directly after operation, so that the wound needs to be sutured by a stapler.

Disclosure of Invention

Based on this, it is necessary to provide a dilator for vascular sheath, which can solve the problems of blood leakage at the puncture point and false aneurysm occurrence during the application of vascular sheath. A vascular sheath is also provided.

According to one aspect of the application, the dilator comprises a head, a driving mechanism, a suturing mechanism, an electromagnetic mechanism and a sleeve, wherein the driving mechanism comprises an operation piece, a connecting rod and an opening and closing assembly, the operation piece is movably arranged on the head, the proximal end of the connecting rod is connected with the operation piece, the distal end of the connecting rod is connected with the opening and closing assembly, when the operation piece moves relative to the head, the opening and closing assembly is unfolded or folded under the control of the connecting rod, the suturing mechanism is arranged on the opening and closing assembly and comprises a plurality of needle grooves and suturing needles arranged in the needle grooves, each suturing needle is connected through a suture thread to form a plurality of pairs of suturing needles, the sleeve comprises an outer tube and a guide tube, the outer tube is sleeved outside the connecting rod, the proximal end of the outer tube is connected with the head, the guide tube is arranged in the connecting rod in a penetrating mode, the proximal end of the guide tube is connected with the head, the electromagnetic mechanism is arranged on the head and comprises an electromagnetic control circuit and an electromagnetic chuck which controls an electromagnetic switch, the electromagnetic control circuit is arranged on the electromagnetic chuck, the electromagnetic chuck is arranged on the head, and the electromagnetic control circuit is arranged on the electromagnetic chuck, and is used for enabling the electromagnetic chuck to be in an electromagnetic chuck to be unfolded and closed when the electromagnetic chuck is arranged on the position, and opened and closed.

In some embodiments, the catheter comprises a small diameter part and a large diameter part, the small diameter part penetrates through the connecting rod and is connected with the head part, the far end of the small diameter part is connected with the large diameter part and is exposed out of the connecting rod, a space is arranged between the large diameter part and the far end of the outer tube, the opening and closing assembly is positioned in the space when the opening and closing assembly is in a furled state, and the outer tube blocks the electromagnetic chuck from adsorbing the suture needle.

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

In some embodiments, the outer wall surface of the outer tube is provided with a blood flow indication hole in a longitudinal shape along the axial direction of the outer tube.

In some embodiments, a bend-adjusting structure is disposed within the conduit, the bend-adjusting structure being configured to bend the conduit.

In some embodiments, the opening and closing assembly comprises a plurality of slide chain groups distributed along the circumferential direction defined by the axis of the catheter, wherein the slide chain groups comprise an inner slide chain, an outer slide chain and support hinges, the proximal end of the inner slide chain is fixed with the connecting rod, the distal end of the inner slide chain is hinged with the distal end of the outer slide chain, the two ends of the support hinges are hinged with the middle part of the inner slide chain and the middle part of the outer slide chain, each support hinge comprises a first part and a second part which are connected in a rotating manner, the first part is hinged with the middle part of the inner slide chain, and the second part is hinged with the middle part of the outer slide chain.

In some embodiments, the inner slide chain, the outer slide chain, and the support hinge are all wrapped with a wrapping film that is used to reduce the surface coefficient of friction.

In some embodiments, the head is provided with a sliding slot, the sliding slot comprises a first channel and a second channel, the second channel is communicated with the first channel, the operating piece is configured to be slidably assembled in the sliding slot so as to be selectively clamped in the first channel or the second channel, when the operating piece is clamped in the first channel, the opening and closing assembly is in a folded state, and when the operating piece is clamped in the second channel, the opening and closing assembly is in an unfolded state.

In some embodiments, a plurality of electric suction holes are formed on one side of the electromagnetic chuck facing the opening and closing assembly, and the shape of the electric suction holes is matched with that of the suture needle.

In some embodiments, the electromagnetic chuck is provided with a plurality of electromagnetic chucks, each electromagnetic chuck is used for adsorbing one suture needle, the control switch is correspondingly provided with a plurality of electromagnetic chucks, and each switch is respectively used for controlling at least one electromagnetic chuck.

In some embodiments, each pair of the suture needles is connected by a suture, and the suture needles are arranged side by side and/or cross when in a position capable of being absorbed by the electromagnetic chuck.

In some embodiments, the suture needles are connected by a suture thread wound around the bottom of the suture needles and forming a plurality of pairs of suture needles, the suture thread having a margin in the needle slot.

According to another aspect of the present application, a vascular sheath includes the dilator, an expandable sheath including an expandable main tube, a sealing mechanism disposed at a proximal end of the expandable main tube, and a protective tube configured to be insertable into the expandable main tube and to permit passage of a catheter of the dilator.

In the application, the dilator is provided with the suture mechanism, so that the vascular sheath has a certain suture function, and pain points such as blood leakage at a puncture point, false aneurysm occurrence and the like in clinic are solved. The expandable sheath has an expandable function, and compared with a conventional sheath, the expandable sheath can realize smaller wound of a patient and lower complication incidence.

Drawings

Fig. 1 is a schematic view of a vascular sheath according to an embodiment of the present application.

Fig. 2 is an enlarged view of the internal structure at X in fig. 1.

Fig. 3 is a schematic structural view of the head of the dilator of an embodiment of the present application.

Fig. 4 is a schematic structural diagram of the direction a in fig. 3.

Fig. 5 is a schematic circuit diagram of an electromagnetic control circuit of the present application.

Fig. 6 to 11 are sequentially state diagrams of different stages in the use of the vascular sheath according to the embodiment of the present application.

Fig. 12 and 13 are schematic views of the first and second suturing effects of the vascular sheath of the present embodiment, respectively.

Fig. 14 and 15 are schematic views of a first threading mode and a second threading mode, respectively, of the suturing mechanism of the present application.

Fig. 16 and 17 are schematic views of the opening and closing assembly of the dilator of the present application in a collapsed state and an expanded state, respectively.

Fig. 18 is a schematic view of another embodiment of the electromagnetic mechanism of the present application.

Fig. 19 is a schematic circuit diagram of another embodiment of the electromagnetic mechanism of the present application.

Reference numerals:

100. A vascular sheath; 1, an expandable sheath; 11, a sealing mechanism; 111, seal cap, 112, gasket, 113, connector body, 114, display boss, 115, fixation hole, 12, flushing mechanism, 121, flushing line, 122, flushing valve, 13, expandable main tube, 2, protective tube, 3, dilator, 31, head, 311, protective cap, 312, body housing, 313, sliding slit, 3131, first channel, 3132, second channel, 32, driving mechanism, 321, operator, 322, linkage, 3221, slider, 323, opening and closing assembly, 3231, inner side slide chain, 3232, outer side slide chain, 3233, support hinge, 3233a, first portion, 32 b, second portion, 324, wound membrane, 33, suture mechanism, 331, needle slot, 332, suture needle, 333, suture, 34, electromagnetic mechanism, 341, control switch, 342, electromagnetic chuck, 3421, electrical suction hole, 343, battery, 344, main board, 345, 346, 35, sleeve, 351, outer tube, 3511, blood flow indicating hole, 35361, catheter, 352, wire, 35, 22, wire, 35, and 300.

Detailed Description

In order that the above objects, features and advantages of the application will be readily understood, a more particular description of the application will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. The present application may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the application, whereby the application is not limited to the specific embodiments disclosed below.

In the description of the present application, it should be understood that, if any, these terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., are used herein with respect to the orientation or positional relationship shown in the drawings, these terms refer to the orientation or positional relationship for convenience of description and simplicity of description only, and do not indicate or imply that the apparatus or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the application.

Furthermore, the terms "first," "second," and the like, if any, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present application, the terms "plurality" and "a plurality" if any, mean at least two, such as two, three, etc., unless specifically defined otherwise.

It is to be understood that the terms "proximal", "posterior" and "distal", "anterior" are used herein with respect to the clinician (operator) manipulating the dilator. The terms "proximal", "posterior" and "anterior" refer to the portion proximal to the clinician, and the terms "distal" and "anterior" refer to the portion distal to the clinician.

As shown in fig. 1 and 2, a vascular sheath 100 of an embodiment of the present application includes an expandable sheath 1, a protective tube 2, and a dilator 3. Dilator 3 is used in conjunction with expandable sheath 1 and protective tube 2 for introducing therapeutic and diagnostic instruments into the vascular 300 system and post-operative wound suture management.

As shown in fig. 1, the expandable sheath 1 includes a sealing mechanism 11, an irrigation mechanism 12, and an expandable main tube 13. A sealing mechanism 11, an irrigation mechanism 12, a proximal end provided to 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 interior of the expandable main tube 13. The expandable main tube 13 may be inserted with the protection tube 2 and the expander 3. The distal end of the expandable main tube 13 is tapered.

As shown in fig. 1 and 2, the dilator 3 includes a head 31, a driving mechanism 32, a suturing mechanism 33, an electromagnetic mechanism 34, and a cannula 35.

As shown in fig. 1 and 3, the head 31 is used for providing the electromagnetic mechanism 34 and the operating member 321. Alternatively, the head 31 is constituted by a protective cover 311 and a main body case 312. The protective cover 311 is a circular arc cover, and is internally provided with an electromagnetic mechanism 34, and is made of PP, ABS, PC/ABS or the like. The main body case 312 is not directly connected to the protective cover 311, but is connected to the main plate 344 of the electromagnetic mechanism 34 by adhesion. The material of the main body shell 312 is the same as that of the protective cover 311, and is PP, ABS, PC/ABS or the like.

As shown in fig. 1 to 3, the driving mechanism 32 includes an operation member 321, a link 322, and an opening and closing assembly 323. The operating member 321 is movably provided to the head 31, and a proximal end of the link 322 is connected to the operating member 321 and a distal end of the link 322 is connected to the opening/closing assembly 323. When the operating member 321 moves relative to the head 31, the opening and closing assembly 323 is opened (as shown in fig. 10, 11 and 17) or closed (as shown in fig. 9 and 16) under the control of the link 322. The sleeve 35 comprises an outer tube 351 and a catheter 352, the outer tube 351 is sleeved outside the connecting rod 322, the proximal end of the outer tube 351 is connected with the head 31, the catheter 352 is arranged in the connecting rod 322 in a penetrating mode, and the proximal end of the catheter 352 is connected with the head 31. The distal end of the catheter 352 is configured for insertion into the blood vessel 300. Optionally, the distal end in catheter 352 is tapered.

As shown in fig. 2, the suture mechanism 33 includes a plurality of needle grooves 331, suture needles 332 provided in the needle grooves 331, and sutures 333 provided on the suture needles 332. When the opening/closing member 323 is in the unfolded state, the opening of the needle groove 331 faces the electromagnetic chuck 342, and the suture needle 332 is positioned to be attracted by the electromagnetic chuck 342.

In the suture mechanism 33, the shape of the needle groove 331 is matched with the shape of the suture needle 332 to limit the suture needle 332. The bottom of the needle slot 331 may store a suture 333. When the opening and closing assembly 323 is unfolded, the bottom stored suture 333 is length compensated under tension. The suture needle 332 has a certain magnetic property, for example, the material of the suture needle is Fe, co, ni, etc., and the taper bottom of the microneedle is wound with a fixing suture 333. The suture 333 may be a non-absorbable thread made of PA, PP, or the like, or may be an absorbable thread made of polylactic acid, collagen, or the like.

Further, as shown in fig. 1 and 2, a bending structure 36 is disposed in the conduit 352, and the bending structure 36 is used to bend the conduit 352. The bend-regulating structure 36 is located within the catheter 352 and prevents damage to the blood vessel 300 when entering the blood vessel 300.

The protective tube 2 is configured to be insertable into the expandable sheath 1 and to allow passage of a catheter 352 or other instrument (e.g., balloon) of the dilator 3. The protection tube 2 is a rigid tube with a certain strength. After the instrument is introduced, the protective tube 2 may be withdrawn from the expandable sheath and attached to the proximal end of the catheter 352. The protective tube 2 can also be a tearable tube, and is torn and separated after being withdrawn. The material of the protection tube 2 is PE, pebax, PTFE or the like.

As shown in fig. 3 and 4, an electromagnetic mechanism 34 is provided to the head 31. The electromagnetic mechanism 34 includes an electromagnetic control circuit having a control switch 341, an electromagnetic chuck 34. In the electromagnetic mechanism 34, by activating the control switch 341, the electromagnetic chuck 342 can be magnetized by the electromagnetic control circuit. Alternatively, the circuit principle of the electromagnetic control circuit can be simplified as shown in fig. 5.

The electromagnetic control circuit includes a battery 343, a main board 344, a connection pipe 345, and an electric wire 346. Alternatively, the control switch 341 is a button switch that can be lighted, and is exposed to the outer surface of the protective cover 311. When the control switch 341 is pressed, the lamp is green in display color when the switch is pressed, and the electromagnetic mechanism 34 operates normally. The shell material of the button switch is PC, PP, PE, etc., and the spring and the pin material in the button switch are Cu (copper). The number of push-button switches may be 1 or more. Alternatively, the battery 343 (342) is preferably a lithium battery 343 with an electromotive force of 3V.

Alternatively, the main board 344 is a PCB. The connecting pipe 345 is a 304 stainless steel pipe or copper pipe, one end of which is connected with the main board 344 and the other end of which is connected with the electromagnetic chuck 342. The connection pipe 345 has a hollow structure in which the electric wire 346 is stored. Wire 346 is a multi-strand copper wire connecting motherboard 344 and electromagnetic chuck 342. When energized, the electromagnetic chuck 342 has magnetism. When the power is off, the electromagnetic chuck 342 is nonmagnetic. 304 stainless steel and copper have no magnetism, the electromagnetic chuck 342 has no attraction effect on the stainless steel and copper, and the suture needle 332 has certain magnetism and can be attracted by the electromagnetic chuck 342.

In order to facilitate understanding of the present application, the process of using the vascular sheath 100 of the present application will be briefly described with reference to fig. 6 to 11. The vascular sheath 100 of the present application is used as follows:

as shown in fig. 6, after the guide wire 200 is introduced into the expandable main tube 13 using the puncture needle, the dilator 3 is inserted into the expandable main tube and threaded into the blood vessel 300 along the guide wire 200. Since the diameter of the dilator 3 is relatively small, the puncture site formed is small.

As shown in fig. 7, the dilator 3 is first withdrawn from the sheath. The protection tube 2 with proper size is selected according to the instrument to be introduced, the dilator 3 is penetrated into the protection tube 2, the dilator 3 carries the protection tube 2 to be penetrated into the expandable main tube 13 again, and the puncture point is slightly enlarged.

As shown in fig. 8, the dilator 3 is withdrawn, the protective tube 2 is retained, and the instrument may then be introduced.

Suturing of the puncture site, as shown in fig. 9, often requires precise alignment. The oblique puncture dilator 3 cannot meet the suturing condition, so the bending structure 36 is bent according to the diameter of the blood vessel 300. Such as a small diameter vessel 300, may be bent at a greater angle. After the treatment is completed, the expandable sheath 1 is pulled out to retain the guide wire 200. The adjusted dilator 3 is threaded along the guidewire 200. Optionally, as shown in fig. 2, the dilator 3 is provided with a blood flow indicating hole 3511, and when a continuous flow of blood is seen in the blood flow indicating hole 3511, the dilator 3 is shown in place.

As shown in fig. 10, the guidewire 200 is removed. The movement of the link 322 is controlled by the operating member 321 such that the opening and closing assembly 323 is switched from the collapsed state to the open state.

As shown in fig. 11, the control switch 341 is activated, and the suture needle 332 is passed out of the needle groove 331, through the skin, and is attracted by the electromagnetic chuck 342 by electromagnetic induction.

Thereafter, the wound is cut using a scalpel and sutured using conventional surgery. Specifically, the stitching may be performed by a splay stitching method as shown in fig. 12 or an intermittent stitching method as shown in fig. 13.

Specifically, for example, as shown in fig. 14, when four needle grooves 331 are uniformly distributed along the circumferential direction, and one end of the suture thread 333 is connected to one side of the suture needle 332, and the other end is connected to the suture needle 332 in the opposite side of the needle groove 331, two intersecting suture threads 333 are formed, so that the splayed suture effect shown in fig. 12 can be formed. As shown in fig. 15, when two adjacent suture needles 332 are connected by a suture 333 in the circumferential direction, two sutures 333 arranged side by side are formed, and an intermittent suture effect as shown in fig. 13 can be formed.

In the present application, each pair of the sewing needles 323 is connected by one sewing thread 333, and when the sewing needles 323 are positioned to be attracted by the electromagnetic chuck 342, the plurality of sewing threads 333 are arranged side by side and/or are arranged in a crossing manner.

Specifically, as shown in fig. 14, two sutures 333 are arranged side by side. The side-by-side arrangement here means that the projections of the two sutures 333 in a plane perpendicular to the axial direction of the cannula 35 do not intersect. The intermittent stitching effect can be formed during stitching.

As shown in fig. 15, two sutures 333 are disposed to intersect. The intersection here means that the projections of the two sutures 333 in a plane perpendicular to the axial direction of the sleeve 35 are arranged crosswise. The splayed stitching effect can be formed during stitching.

In addition, it is to be noted that the formation of two sutures 333 is not limited. The number of needle grooves 331 may be greater than 4, and thus, more than 2 sutures 333 may be formed. Further, 2 or more sutures 333 may be provided side by side or may be provided in a crossing manner.

In the application, the suture mechanism 33 is arranged on the dilator 3, so that the vascular sheath 100 has a certain suture function, and the pain points such as blood leakage at a puncture point, false aneurysm occurrence and the like in clinic are solved.

In addition, in the traditional technology, large-scale puncture is needed in the treatment of diseases such as structural heart or pulmonary embolism, the bleeding problem can not be solved by pressing, and a 2-handle suture device is generally used for suturing puncture points. By arranging a plurality of needle grooves 331 in an electromagnetic magnetic attraction manner, a plurality of sutures 333 can be placed at one time, and the wound can be directly sutured in a surgical operation.

In addition, the expandable sheath 1 of the present application has an expandable function, and can achieve a smaller wound on a patient and a lower incidence of complications than conventional sheaths.

In addition, the sheath protecting tube 2 can effectively prevent the damage of the instrument when passing through the sheath, and the instrument implantation with a plurality of specifications in a certain range can be realized by changing the specifications of the protecting tube 2, so that the compatibility is better.

As described in further detail below.

As shown in fig. 1, in some embodiments, the sealing mechanism 11 of the expandable sheath 1 includes a sealing cap 111, a gasket 112, a connector body 113, a display boss 114, and a fixation hole 115. The sealing top cover 111 is ABS, PP, ABS/PC material. The sealing pad 112 is located inside the upper cover, for example, made of silica gel, and is tightly combined with the upper cover. The connector body 113 is screwed to the seal upper cover 111 and 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 range of instrument diameters, e.g., 6-8F, for which the expandable sheath 1 is adapted. The expandable sheath 1 is threaded through the fixation holes 115 and secured through the skin during use.

The flushing mechanism 12 consists of a flushing pipeline 121 and a flushing valve 122, and before the sheath is used, a doctor needs to flush the inner cavity of the sheath through the flushing mechanism 12 by using physiological saline. The flushing pipeline 121 is made of PVC and PU. The flush valve 122 is a standard three-way valve that can be filled with water or vented.

As shown in fig. 1, the expandable main tube 13 is optionally composed of a constraining membrane and an elastic tube wall. The elastic tube wall is made of TPU, silica gel, PU and other materials, the proximal end is subjected to flaring treatment, the introduction of instruments is facilitated, the distal end is of a conical rounded corner structure, and the damage to the blood vessel 300 during entering is reduced. When instruments of different sizes are entered, the elastic tube wall tightly wraps the instruments and expands to different outer diameters. The outer layer of the elastic tube wall is covered with a layer of constraint film. The film material is PP, PA, PTFE or PVDF, etc.

As shown in fig. 1 and 2, and fig. 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 with the head 31, the distal end of the small diameter portion 3521 is connected with the large diameter portion 3522 and exposes the connecting rod 322, and the large diameter portion 3522 is spaced from the distal end of the outer tube 351. When the opening and closing component 323 is in the folded state, the opening and closing component 323 is positioned in the interval, and the outer tube 351 blocks the electromagnetic chuck 342 from adsorbing the suture needle 332.

In this embodiment, the connecting rod 322 has a hollow structure. The small diameter portion 3521 of the conduit 352 extends through the linkage 322 and is connected to the head 31. In this way, the link 322 is sandwiched between the outer tube 351 and the guide tube 352, so that the link 322 can smoothly move under the guide of the outer tube 351 and the guide tube 352 when moving under the control of the operating member 321.

When the opening and closing component 323 is in the folded state, the opening and closing component 323 is located in the interval, and then the outer tube 351 blocks the electromagnetic chuck 342 from adsorbing the suture needle 332. Specifically, in the collapsed state, each needle groove 331 is not higher than the wall of the outer tube 351 in the radial direction of the outer tube 351. In other words, in the axial direction of the outer tube 351, the outer tube 351 is such that each needle groove 331 cannot face the electromagnetic chuck 342. In this way, the suture needle 332 is prevented from being sucked out due to the fact that the electromagnetic switch is started by an operator by mistake when the opening and closing assembly 323 is in the folded state, so that safety is guaranteed.

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

Further, the outer diameter of the outer tube 351 coincides 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 expansion degree for the expandable main tube 13 and the puncture point, and the stability of the insertion process of the dilator 3 is high.

In some embodiments, as shown in fig. 2, the outer wall surface of the outer tube 351 is provided with a blood flow indication hole 3511 in a longitudinal shape 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 indicating hole 3511, the blood flow continues to flow out from the proximal end of the blood flow indicating tube, thereby indicating that the dilator 3 is in place, and the next operation can be safely performed.

In some embodiments, as shown in fig. 1 and 9, the bending structure 36 is a hypotube structure having a cutout 361 in the tube wall. The cutout 361 is generally U-shaped. The bend-regulating structure 36 allows the conduit 352 to bend toward a side opposite the opening direction of the incision 361. If the opening direction of the incision 361 is left, the catheter 352 may be bent toward the right.

Optionally, the bending structure 36 is made of 304 stainless steel.

As shown in fig. 2, 16 and 17, in some embodiments, the opening and closing assembly 323 includes a plurality of slide chain sets distributed circumferentially along the axis of the catheter 352, each slide chain set including an inner slide chain 3231, an outer slide chain 3232, and a support hinge 3233, a proximal end of the inner slide chain 3231 being fixed to the link 322, a distal end of the inner slide chain 3231 being hinged to a distal end of the outer slide chain 3232, both ends of the support hinge 3233 being hinged to a middle portion of the inner slide chain 3231 and to a middle portion of the outer slide chain 3232, and the support hinge 3233 including a first portion 3233a and a second portion 3233b rotatably coupled, the first portion 3233a being hinged to a middle portion of the inner slide chain 3231, the second portion 3233b being hinged to a middle portion of the outer slide chain 3232.

In this embodiment, the sets of links are evenly distributed in a circumferential direction about the axis of the link 322. The number of the slide chain groups is 4 in total, but it is easy to understand that the number of the slide chain groups is not limited thereto, as long as the effects of expanding and collapsing can be achieved. The distal end of the link 322 is fixedly connected with a slider 3221. The slider 3221 is connected to the link 322, for example, by welding. The slider 3221 is used to connect the proximal ends of the respective inner slide chains 3231.

When the opening and closing assembly 323 is in the folded state, when the operating member 321 moves towards the distal end of the expander 3, the connecting rod 322 drives the slider 3221 to move towards the distal end of the expander 3, the inner side slide chain 3231 moves towards the distal end of the expander 3, the supporting hinge 3233 is gradually unfolded towards the horizontal, the supporting hinge 3233 plays a supporting role, the outer side slide chain 3232 is gradually opened, and each pin slot 331 moves to face the electromagnetic chuck 342. In contrast to the above procedure, when the opening and closing assembly 323 is in the unfolded state, the support hinge 3233 and the outer slide chain 3232 gradually gather to the periphery of the link 322 as the operation member 321 moves toward the proximal end of the expander 3. The B-directed view of fig. 17 may be as shown in fig. 14 or 15 when the opening and closing assembly 323 is unfolded.

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

Further, the inner slide chain 3231, the outer slide 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 FEP, PTFE, PFA or the like.

As shown in fig. 1, 3, 16 and 17, in some embodiments, the head 31 is provided with a sliding slot 313, where the sliding slot 313 includes a first channel 3131 and a second channel 3132, and the second channel 3132 is in communication with the first channel 3131. The operating member 321 is configured to slidably fit in the sliding slot 313 to be selectively clamped in the first channel 3131 or the second channel 3132, wherein the opening and closing assembly 323 is in a folded state when the operating member 321 is clamped in the first channel 3131, and the opening and closing assembly 323 is in an unfolded state when the operating member 321 is clamped in the second channel 3132.

Specifically, the operating member 321 is in the initial position when in the first passage 3131, and the operating member 321 is in the working position when the operating member 321 is engaged with the second passage 3132. The material of the operating member 321 is the same as that of the head 31, and can be fixed to the link 322 by means of a fastening or bonding.

The top of the first channel 3131 is closed to limit the initial position of the operating member 321, and the width of the first channel 3131 is slightly larger than the width of the operating member 321 along the radial direction of the connecting rod 322 to limit the initial position of the operating member 321. The width of the second channel 3132 is greater than the width of the operator 321. The size of the connection between the second channel 3132 and the first channel 3131 is smaller than the size of the operation member 321 in the radial direction of the link 322, so that the operation member 321 can be stopped in the first channel 3131 or the second channel 3132. When the operation member 321 is switched between the second channel 3132 and the first channel 3131, the operation member 321 deforms the junction between the second channel 3132 and the first channel 3131 and then passes through the junction.

In other embodiments, the first and second passages 3131 and 3132 may be offset in the radial direction of the link 322, so that the manipulator 321 can be retained in the first or second passage 3131 and 3132.

In some embodiments, as shown in fig. 3, a plurality of electric suction holes 3421 are formed on a side of the electromagnetic chuck 342 facing the opening and closing component 323, and the electric suction holes 3421 are shaped to match the shape of the suture needle 332.

In a specific arrangement, the electrosucking hole 3421 is formed by a conical front section and a cylindrical section, and the conical front end is matched with the front end of the microneedle in appearance. The suture needle 332 is sucked into the electric suction hole 3421 of the electromagnetic suction cup 342, and the tail suture 333 can be cut directly.

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, the suture needle 332 is sucked out of the nail groove 331 by the electromagnetic chuck 342, and the suture needle 332 enters into the electric suction hole 3421, so that the suture 333 is kept in a certain stretching state between the skin and the electromagnetic chuck 342, and then a thread cutting operation can be performed.

In some embodiments, as shown in fig. 18 and 19, a plurality of electromagnetic chucks 342 are provided, each electromagnetic chuck 342 is used for adsorbing one suture needle 332, a plurality of control switches 341 are provided correspondingly, and each switch is used for controlling at least one electromagnetic chuck 342.

Specifically, the number of electromagnetic chucks 342 is 4, and they are uniformly distributed in the circumferential direction. The control switches 341 are provided with two, each switch controls two electromagnetic chucks 342, and opposite sides of the two electromagnetic chucks 342 are arranged in a 180-degree staggered manner in the circumferential direction.

In the present application, unless explicitly stated and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly. For example, they may be fixedly connected, detachably connected or integrally formed, mechanically connected, electrically connected, directly connected or indirectly connected through an intermediate medium, and communicated between two elements or the interaction relationship between two elements unless clearly defined otherwise. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art according to the specific circumstances.

In the present application, unless expressly stated or limited otherwise, the meaning of a first feature being "on" or "off" a second feature, and the like, is that the first and second features are either in direct contact or in indirect contact through an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.

It will be understood that if an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. If an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein, if any, are for descriptive purposes only and do not represent a unique embodiment.

The technical features of the above embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The foregoing examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the claims. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application. Accordingly, the scope of protection of the present application is to be determined by the appended claims.

Claims (10)

1. The expander is characterized by comprising a head, a driving mechanism, a suturing mechanism, an electromagnetic mechanism and a sleeve;

The driving mechanism comprises an operating piece, a connecting rod and an opening and closing assembly, wherein the operating piece can be movably arranged on the head, the proximal end of the connecting rod is connected with the operating piece, the distal end of the connecting rod is connected with the opening and closing assembly, and when the operating piece moves relative to the head, the opening and closing assembly is unfolded or folded under the control of the connecting rod;

the suture mechanism is arranged on the opening and closing assembly and comprises a plurality of needle grooves and suture needles arranged in the needle grooves, and the suture needles are connected through suture threads to form a plurality of pairs of suture needles;

The sleeve comprises an outer tube and a catheter, the outer tube is sleeved outside the connecting rod, the proximal end of the outer tube is connected with the head, the catheter is arranged in the connecting rod in a penetrating way, and the proximal end of the catheter is connected with the head;

The electromagnetic mechanism is arranged on the head 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 unfolding state, the opening of the needle groove faces the electromagnetic chuck, and the suture needle is positioned at a position capable of being adsorbed by the electromagnetic chuck.

2. The dilator of claim 1, wherein the dilator is configured to be inserted into the body of the patient,

The catheter comprises a small-diameter part and a large-diameter part, the small-diameter part penetrates through the connecting rod and is connected with the head part, the distal end of the small-diameter part is connected with the large-diameter part and is exposed out of the connecting rod, and a gap is reserved between the large-diameter part and the distal end of the outer tube;

When the opening and closing assembly is in a furled state, the opening and closing assembly is positioned in the interval, and the outer tube blocks the electromagnetic chuck from adsorbing the suture needle.

3. The dilator of claim 2, wherein an outer diameter of the outer tube is consistent with an outer diameter of the large diameter portion.

4. The dilator of claim 2, wherein an outer wall surface of the outer tube is provided with a blood flow indicating hole in a longitudinal shape along an axial direction of the outer tube.

5. The dilator of claim 1, wherein a bend-adjusting structure is disposed within the catheter, the bend-adjusting structure being configured to bend the catheter.

6. The dilator of claim 1 wherein the shutter assembly comprises a plurality of sets of slide chains distributed circumferentially along the catheter axis, the sets of slide chains including an inner slide chain, an outer slide chain, and a support hinge, a proximal end of the inner slide chain being secured to the connecting rod, a distal end of the inner slide chain being hinged to a distal end of the outer slide chain, both ends of the support hinge being hinged to a middle portion of the inner slide chain and to a middle portion of the outer slide chain, each of the support hinges including a first portion and a second portion rotatably connected, the first portion being hinged to the middle portion of the inner slide chain, the second portion being hinged to the middle portion of the outer slide chain.

7. The dilator of claim 1, wherein the dilator is configured to be inserted into the body of the patient,

The head is provided with a sliding seam, the sliding seam comprises a first channel and a second channel, and the second channel is communicated with the first channel;

The operating piece is configured to be slidably assembled in the sliding slot so as to be selectively clamped in the first channel or the second channel, wherein when the operating piece is clamped in the first channel, the opening and closing component is in a folded state, and when the operating piece is clamped in the second channel, the opening and closing component is in an unfolded state.

8. The dilator of claim 1, wherein each pair of said needles are connected by a suture, said needles being positioned side by side and/or crosswise when in a position to be attracted by said electromagnetic chuck.

9. The dilator of claim 1, wherein a plurality of electromagnetic chucks are provided, each electromagnetic chuck being configured to adsorb one suture needle, and a plurality of control switches are provided, each switch being configured to control at least one electromagnetic chuck.

10. A vascular sheath, comprising:

the dilator of any one of claims 1-9;

an expandable sheath comprising an expandable main tube, a sealing mechanism disposed at a proximal end of the expandable main tube;

a protective tube configured to be insertable into the expandable main tube and to allow passage of a catheter of the dilator.