Bending adjustment device and suture system

Abstract

A bending adjustment device and a suturing device system, the bending adjustment device comprising a multi-lumen tube and a first bending adjustment assembly. The multi-lumen tube has a front end and a rear end, a first chamber is provided in the multi-lumen tube, a first wire entry hole is provided on the side wall of the multi-lumen tube between the front end and the rear end, and the first wire entry hole is connected to the first chamber. The first bending adjustment assembly comprises a first turntable, a first rotating shaft and a first bending adjustment wire. The first rotating shaft is fixedly connected to the first turntable. One end of the first bending adjustment wire is fixed to the first turntable, and the other end of the first bending adjustment wire passes through the first wire entry hole and the first chamber and is fixed to the front end of the multi-lumen tube. The first rotating shaft can synchronously drive the first turntable to rotate. When the first turntable rotates, the first bending adjustment wire can be tightened, so that the portion of the multi-lumen tube near the front end of the multi-lumen tube can be bent to facilitate adjustment of the needle exit angle of the puncture needle, thereby aligning the front end of the multi-lumen tube with the tissue to be sutured, so that the needle exit angle of the puncture needle of the suturing instrument can be appropriately adjusted, thereby improving the success rate of the operation.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a bending adjustment device and a suturing device system. Background Art

[0002] The foramen ovale is a physiological passage in the atrial septum during the embryonic period. After birth, as left atrial pressure increases and pulmonary artery resistance decreases, the septum primum and septum secundum in the atrial septum converge and fuse. In most cases, the foramen ovale closes spontaneously within a year of birth. However, in those who fail to do so, a potential passage forms in the middle of the atrial septum, known as a patent foramen ovale (PFO). PFO closure is indicated.

[0003] In recent years, a suture device has been used to treat patent foramen ovale by interventional suturing. Specifically, a puncture needle in the suture device passes through the tissue around the foramen ovale, and a suture is passed out from the puncture needle. The patent foramen ovale is sutured by tightening the suture to achieve the treatment purpose.

[0004] However, when current suturing devices are used for suturing, the puncture needle is often unable to puncture the target tissue due to the problem of the needle exit angle of the instrument, which ultimately leads to medical accidents such as suture failure. Summary of the Invention

[0005] The present application provides a bending adjustment device and a suturing device system, the main purpose of which is to adjust the needle exit angle of the puncture needle.

[0006] An embodiment of the present application provides a bending adjustment device, comprising:

[0007] A multi-lumen tube having a front end and a rear end, wherein a first chamber is provided in the multi-lumen tube, and a first wire entry hole is provided on a side wall of the multi-lumen tube between the front end and the rear end, wherein the first wire entry hole is in communication with the first chamber; and

[0008] The first bending adjustment assembly includes a first turntable, a first rotating shaft, and a first bending adjustment wire; the first rotating shaft is fixedly connected to the first turntable; one end of the first bending adjustment wire is fixed to the first turntable, and the other end of the first bending adjustment wire passes through the first wire entry hole and the first chamber and is fixed to the front end of the multi-lumen tube; the first rotating shaft is used to drive the first turntable to rotate by rotating to tighten or loosen the first bending adjustment wire.

[0009] Wherein, there are two first turntables, and the first turntables, the first bending adjustment wires, and the first wire entry holes are all arranged in a one-to-one correspondence; the end of the first bending adjustment wire away from the multi-lumen tube is the first end, and the first ends of the two first bending adjustment wires are distributed on both sides of the axis of the multi-lumen tube, so that when the first rotating shaft rotates, any one of the two first bending adjustment wires is in a tightened state, and the other of the two first bending adjustment wires is in a relaxed state.

[0010] It also includes a fixed block and a first positioning bead; the first rotating shaft and the fixed block are rotatably connected, and two first turntables are located at both ends of the fixed block; a plurality of first protrusions are provided on an end face of the first turntable facing the fixed block, and the plurality of first protrusions are distributed in an array around the axis of the first turntable, and a first clamping space is formed between adjacent first protrusions; a plurality of first positioning beads are fixed on the side of the fixed block facing the first turntable, and the beads of the first positioning beads are clamped in the first clamping space, and the beads of the first positioning beads can switch to different first clamping spaces when the first rotating shaft rotates.

[0011] Particularly, the surface of the first protrusion facing one end of the fixed block is a plane, and along the radial direction of the first turntable, arc-shaped surfaces are respectively provided on both sides of the plane in the first protrusion, and the beads of the first positioning beads in the first clamping space are in contact with the arc-shaped surfaces and the end surface of the first turntable provided with the first protrusion; and / or, it also includes a fixing tube, a strip hole is provided in the fixing block, the fixing tube is sleeved and fixed in the strip hole, and part of the multi-lumen tube passes through and is fixed to the fixing tube.

[0012] Wherein, an annular groove is provided on the side wall of the first turntable, a first fixed shaft is fixed in the annular groove, and an end of the first bending adjustment wire away from the front end of the multi-lumen tube is fixed to the first fixed shaft; and / or, the first bending adjustment assembly further includes a first knob, and the first rotating shaft and the first knob are fixedly connected.

[0013] Among them, it also includes a front end seat, which is connected to the front end of the multi-lumen tube, and the front end seat is fixed with multiple front end positioning members at one end away from the multi-lumen tube, and the multiple front end positioning members have a gathered state and a dispersed state. When the front end seat is placed in the sheath tube, the multiple front end positioning members are in a gathered state, and when the front end seat is placed outside the sheath tube, the multiple front end positioning members are in a dispersed state; and / or, multiple third chambers are provided in the multi-lumen tube, and the third chamber is used to movably socket the puncture needle. Multiple needle holes are opened on the side wall of the multi-lumen tube near the front end of the multi-lumen tube. The bending adjustment device also includes multiple guide columns, which are socketed and fixed in the third chamber near the front end of the multi-lumen tube, and a guide channel is opened in the guide column. A guide hole connected to one end of the guide channel is opened on the side wall of the guide column, and the guide hole and the needle hole are correspondingly arranged. The other end of the guide channel is used for the puncture needle to enter, and the guide hole is used to assist the puncture needle to pass through the needle hole.

[0014] Wherein, a wire threading hole is provided on the front end seat, and the first bending adjustment wire passes through the wire threading hole to become a double-strand bending adjustment wire, one end of the double-strand bending adjustment wire is fixed to the wire threading hole, and the other end of the double-strand bending adjustment wire passes through the first chamber and is fixed to the first turntable; or, it also includes a transfer column, one end of the transfer column is fixed to an end of the front end seat close to the multi-lumen tube, the transfer column and the first bending adjustment wire are fixedly connected, and the transfer column is sleeved and fixed in the first chamber.

[0015] Among them, from the front end side of the multi-lumen tube to the rear end side of the multi-lumen tube, the multi-lumen tube includes a needle outlet section, a first flexible section, a second flexible section and a main body section connected in sequence, the first bending adjustment component is used to bend the first flexible section, and the bending adjustment device also includes a second bending adjustment component, the second bending adjustment component is used to bend the second flexible section, and the bending directions of the second bending adjustment component and the first bending adjustment component are opposite.

[0016] Wherein, a transfer seat is fixed between the first flexible section and the second flexible section;

[0017] A fourth chamber is provided in the multi-lumen tube, and a second wire entry hole is provided on the side wall of the multi-lumen tube between the front end and the rear end, and the second wire entry hole is communicated with the fourth chamber;

[0018] The second bending adjustment component includes a second rotating shaft, a second rotating disk and a second bending adjustment wire;

[0019] The second rotating shaft is fixedly connected to the second rotating disk;

[0020] One end of the second bending adjustment wire is fixed to the second turntable, and the other end of the second bending adjustment wire passes through the second wire feeding hole and the fourth chamber and is fixed to the adapter; the second rotating shaft is used to rotate the second turntable to tighten or loosen the second bending adjustment wire;

[0021] And / or, both the first flexible segment and the second flexible segment are pre-bent.

[0022] Wherein, the axis of the first rotating shaft, the axis of the second rotating shaft and the axis of the multi-lumen tube are perpendicular to each other;

[0023] The second bending adjustment component further includes a second positioning bead;

[0024] The second rotating shaft is rotatably connected to the fixed block;

[0025] A plurality of second protrusions are provided on one end surface of the second rotating disk facing the fixed block. The plurality of second protrusions are arranged in an array around the axis of the second rotating disk, and second engaging spaces are formed between adjacent second protrusions. A plurality of second positioning beads are fixed to the side of the fixed block facing the second rotating disk. The beads of the second positioning beads are engaged in the second engaging spaces. The beads of the second positioning beads can switch to different second engaging spaces when the second rotating shaft rotates.

[0026] The multi-lumen tube is fixed in the assembly cavity, and the front end of the multi-lumen tube passes through the assembly cavity and is located outside the handle. The first wire feeding hole and the second wire feeding hole are opened on the side wall of the multi-lumen tube located in the assembly cavity. The first turntable and the second turntable are both located in the assembly cavity. The first bending adjustment wire is wound around multiple turns, and the second bending adjustment wire is wound around multiple turns on the second turntable.

[0027] An embodiment of the present application also provides a suturing device system, including a needle ejection device, a suture control device and the above-mentioned bending adjustment device; the needle ejection device is used to push out or retract the puncture needle, the suture control device is used to push or retract the suture, and the bending adjustment device is used to bend the part of the multi-lumen tube near the front end of the multi-lumen tube.

[0028] According to the bending adjustment device of the above embodiment, one end of the first bending adjustment wire is fixed to the first turntable, and the other end of the first bending adjustment wire passes through the first wire entry hole and the first chamber and is fixed to the front end of the multi-lumen tube. The first rotating shaft in the first bending adjustment assembly can synchronously drive the first turntable to rotate. When the first turntable rotates, the first bending adjustment wire is tightened, that is, the number of turns of the first bending adjustment wire wrapped around the first turntable is increased, so that the portion of the multi-lumen tube near the front end can bend to facilitate adjustment of the puncture needle withdrawal angle. Conversely, by rotating the first rotating shaft in the first bending adjustment assembly in the opposite direction, the first bending adjustment wire is loosened, allowing the multi-lumen tube to return to its pre-bend state, and the number of turns of the first bending adjustment wire wrapped around the first turntable is correspondingly reduced. By means of the bending adjustment device of the present invention, the degree of bending of the front end of the multi-lumen tube can be adjusted according to different tissue structures to be sutured, thereby aligning the front end of the multi-lumen tube with the tissue to be sutured, so that the needle exit angle of the puncture needle of the suturing instrument can be appropriately adjusted, thereby solving the problem that the puncture needle cannot puncture the target tissue due to the limitation of the needle exit angle, which ultimately leads to medical accidents of suture failure, and at the same time improving the success rate of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 This is a schematic diagram of the exploded structure of the bending adjustment device in the embodiment of the present application;

[0030] Figure 2 Schematic diagram of the cross-sectional structure of the bending adjustment device in the embodiment of the present application;

[0031] Figure 3 Schematic diagram of the partial structure of the bending adjustment device in the embodiment of the present application;

[0032] Figure 4 This is a schematic structural diagram of the first turntable in an embodiment of the present application;

[0033] Figure 5 Schematic diagram of the multi-lumen tube structure at the front end in the embodiment of the present application;

[0034] Figure 6 This is a schematic diagram of the front end seat assembly structure in an embodiment of the present application;

[0035] Figure 7 This is a schematic structural diagram of a front end seat for fixing the first bending wire in an embodiment of the present application;

[0036] Figure 8 Schematic diagram of the partial structure of the bending adjustment device in the embodiment of the present application;

[0037] Figure 9 This is a schematic diagram of the partial structure of the bending adjustment device in an embodiment of the present application.

[0038] Explanation of the accompanying symbols: 10. Multi-lumen tube, 11. First chamber, 111. First wire entry hole, 12. Second chamber, 13. Third chamber, 131. Needle hole, 14. Fourth chamber, 141. Second wire entry hole, 15. Needle exit section, 16. First flexible section, 17. Second flexible section, 18. Main section, 20. First bending adjustment component, 21. First turntable, 211. First protrusion, 212. Plane, 213. Arc surface, 22. First rotating shaft, 23. First bending adjustment wire, 24. First positioning bead, 25. First A fixed shaft, 26. First knob, 30. Fixed block, 31. Strip hole, 32. Fixed tube, 33. Assembly plate, 40. Front end seat, 41. Front end positioning piece, 42. Threading hole, 43. Axis hole, 50. Puncture needle, 60. Guide column, 61. Guide hole, 70. Adapter column, 80. Second bending adjustment assembly, 81. Second rotating shaft, 82. Second turntable, 83. Second bending adjustment wire, 84. Second fixed shaft, 85. Second knob, 90. Adapter seat, 100. Handle, 101. Upper cover, 102. Lower cover. DETAILED DESCRIPTION

[0039] The present application will be further described in detail below through specific embodiments in conjunction with the accompanying drawings, wherein similar elements in different embodiments are numbered with similar elements.

[0040] In addition, the features, operations, or characteristics described in the specification may be combined in any appropriate manner to form various embodiments. Furthermore, the steps or actions in the method description may be reordered or adjusted in a manner readily apparent to those skilled in the art. Therefore, the various sequences in the specification and drawings are provided solely for the purpose of clearly describing a particular embodiment and are not intended to be mandatory, unless otherwise specified.

[0041] The serial numbers assigned to components herein, such as "first," "second," etc., are used solely to distinguish the objects being described and do not convey any sequential or technical meaning. References to "connection" and "coupling" herein, unless otherwise specified, include both direct and indirect connections (couplings).

[0042] like Figures 1-9 As shown, a bending adjustment device provided in an embodiment of the present invention includes a multi-lumen tube 10 and a first bending adjustment component 20.

[0043] The multi-lumen tube 10 has a front end and a rear end. A first chamber 11 is provided in the multi-lumen tube 10 . A first wire entry hole 111 is opened on the side wall of the multi-lumen tube 10 between the front end and the rear end. The first wire entry hole 111 is connected to the first chamber 11 .

[0044] The first bending adjustment assembly 20 includes a first rotating disk 21, a first rotating shaft 22, and a first bending adjustment wire 23. The first rotating shaft 22 is fixedly connected to the first rotating disk 21. For example, the first rotating shaft 22 passes through the center of the first rotating disk 21, is screwed into a threaded hole defined in a side of the first rotating disk 21, and then extends into a corresponding hole in the first rotating shaft 22, thereby fixing the first rotating shaft 22 to the first rotating disk 21.

[0045] One end of the first bending wire 23 is fixed to the first rotating disk 21, and the other end of the first bending wire 23 passes through the first wire entry hole 111 and the first chamber 11 and is fixed to the front end of the multi-lumen tube 10. The first rotating shaft 22 is used to rotate the first rotating disk 21 to tighten or loosen the first bending wire 23.

[0046] In the bending adjustment device of the embodiment of the present invention, one end of the first bending adjustment wire 23 is fixed to the first rotating disk 21, and the other end of the first bending adjustment wire 23 passes through the first wire entry hole 111 and the first chamber 11 and is fixed to the front end of the multi-lumen tube 10. The first rotating shaft 22 in the first bending adjustment assembly 20 can synchronously drive the first rotating disk 21 to rotate. When the first rotating disk 21 rotates, the first bending adjustment wire 23 is tightened, that is, the number of turns of the first bending adjustment wire 23 around the first rotating disk 21 is increased, so that the portion of the multi-lumen tube 10 near the front end can bend to facilitate adjustment of the needle withdrawal angle of the puncture needle 50. Conversely, by rotating the first rotating shaft 22 in the first bending adjustment assembly 20 in the opposite direction, the first bending adjustment wire 23 is loosened, allowing the multi-lumen tube 10 to return to its pre-bend state, and the number of turns of the first bending adjustment wire 23 around the first rotating disk 21 is correspondingly reduced.

[0047] like Figure 1-Figure 3 As shown, the first turntable 21 is configured as two, and the first turntable 21, the first bending wire 23 and the first wire entry hole 111 are all arranged in a one-to-one correspondence. The end of the first bending wire 23 away from the multi-lumen tube 10 is the first end, and the first ends of the two first bending wires 23 are distributed on both sides of the axis of the multi-lumen tube 10, for example Figure 3 The two first bending wires 23 shown in FIG. 1 have their first ends connected to the front of their corresponding first turntable 21, while the first ends of their lower first bending wires 23 are connected to the rear of their corresponding first turntable 21. The rear of the first turntable 21 and the front of the first turntable 21 are opposite each other in the figure, and the rear of the first turntable 21 is not visible. The first ends of the two first bending wires 23 are located on either side of the axis of the multi-lumen tube 10, so that when the first rotating shaft 22 rotates, one of the two first bending wires 23 is in a tightened state, while the other is in a relaxed state.

[0048] Two first rotating discs 21 and two first bending wires 23 are provided so that the bending device has forward and reverse bending functions, for example Figure 3As shown, when bending adjustment is required, the first rotating shaft 22 is rotated, the upper first bending adjustment wire 23 is tightened, and the lower first bending adjustment wire 23 is relaxed, causing the portion of the multi-lumen tube 10 near the front end of the multi-lumen tube 10 to bend upward, thereby facilitating adjustment of the needle exit angle of the puncture needle 50. When bending is no longer required, the first rotating shaft 22 is rotated in the opposite direction to assist the multi-lumen tube 10 in restoring its previous bending state. If reverse bending adjustment is required, the first rotating shaft 22 is rotated, causing the lower first bending adjustment wire 23 to be tightened and the upper first bending adjustment wire 23 to be relaxed, allowing the portion of the multi-lumen tube 10 near the front end of the multi-lumen tube 10 to bend downward. If only one first bending adjustment wire 23 is provided, only one-way bending adjustment can be achieved. When the multi-lumen tube 10 is restored to its pre-bending state, it can only rely on the mechanical memory of the multi-lumen tube 10 material. Over time, the multi-lumen tube 10 material itself may not be able to restore the pre-bending state. The present application adopts two first turntables 21 and two first bending adjustment wires 23 to cooperate with each other, which can not only realize forward and reverse bending adjustment, but also ensure that the multi-lumen tube 10 returns to its pre-bending state after bending.

[0049] like Figure 1-Figure 4 As shown, the bending adjustment device also includes a fixed block 30 and first positioning beads 24. A first rotating shaft 22 is rotatably connected to the fixed block 30, with two first rotating disks 21 located at either end of the fixed block 30. A plurality of first protrusions 211 are provided on the end surface of the first rotating disk 21 facing the fixed block 30. These first protrusions 211 are arranged in an array around the axis of the first rotating disk 21, with first engaging spaces formed between adjacent first protrusions 211. A plurality of first positioning beads 24 are fixed to the side of the fixed block 30 facing the first rotating disk 21. The beads of the first positioning beads 24 engage within the first engaging spaces. The beads of the first positioning beads 24 are compressed when subjected to force and return to their uncompressed state after the force is released. When the first rotating shaft 22 drives the first rotating disk 21 to rotate, the beads of the first positioning beads 24 can switch between different first engaging spaces, allowing the bending adjustment device to be instantly locked during the bending process. That is, after releasing the hand, the current bending state can be precisely maintained by the engagement between the beads of the first positioning beads 24 and the first engaging spaces.

[0050] When the multi-lumen tube 10 is bent, the first bending wire 23 generates a large pulling force. With the cooperation of the first positioning bead 24 and the first protrusion 211, the current position of the first turntable 21 can be firmly secured, and loosening is not likely to occur, thereby better ensuring the current bending state.

[0051] like Figure 4As shown, more preferably, the surface of the first protrusion 211 facing one end of the fixed block 30 is a plane 212 (e.g., the black filled area in the figure), and along the radial direction of the first turntable 21, the first protrusion 211 has arcuate surfaces 213 on both sides of the plane 212. The beads of the first positioning beads 24 in the first engaging space are in contact with the arcuate surfaces 213 and the end surface of the first turntable 21 provided with the first protrusion 211, so that the beads of the first positioning beads 24 can be firmly engaged in the first engaging space. And / or, it also includes a fixing tube 32, a strip hole 31 is provided in the fixing block 30, the fixing tube 32 is sleeved and fixed in the strip hole 31, and a portion of the multi-lumen tube 10 passes through and is fixed to the fixing tube 32.

[0052] The curved surfaces 213 on both sides of the plane 212 of the first protrusion 211 facilitate the first positioning bead 24 to slide over when switching between different first clamping spaces. The plane 212 of the first protrusion 211 makes it difficult for the first positioning bead 24 to pass over the first protrusion 211, making it easy to clamp the first positioning bead 24 in the corresponding first clamping space, avoiding the phenomenon of the first positioning bead 24 transitioning to the next first clamping space. In addition, the plane 212 on the first protrusion 211 can also save height, facilitating the compact design of the bending adjustment device.

[0053] The fixing tube 32 facilitates the fixing of the multi-lumen tube 10. The fixing tube 32 on the fixing block 30 is specifically as follows: Figure 1 As shown, an internal threaded hole communicating with the strip hole 31 is opened on the side wall of the fixing block 30 , and a screw is screwed into the internal threaded hole and enters the small hole on the side wall of the fixing tube 32 to fix the fixing tube 32 .

[0054] like Figure 1-Figure 3 As shown, an annular groove is defined on the side wall of the first turntable 21, and a first fixed shaft 25 is fixed in the annular groove. The end of the first bending adjustment wire 23 away from the front end of the multi-lumen tube 10 is fixed to the first fixed shaft 25. The first fixed shaft 25 fixes the first bending adjustment wire 23, ensuring that the first bending adjustment wire 23 is tightened or loosened synchronously when the first turntable 21 rotates. At the same time, because the force required for bending is relatively large, the first fixed shaft 25 is used to fix the first bending adjustment wire 23, which can ensure a more stable fixation effect and prevent the first bending adjustment wire 23 from detaching from the first turntable 21 due to excessive bending force, thereby causing bending failure. And / or, the first bending adjustment component 20 also includes a first knob 26, the first rotating shaft 22 and the first knob 26 are fixedly connected, and the first knob 26 facilitates the operator to apply hand force to indirectly rotate the first rotating shaft 22. The end of the first rotating shaft 22 can be sleeved on the first knob 26, for example, by screwing in multiple screws from the internal thread on the side of the first knob 26 and penetrating into the corresponding hole on the first rotating shaft 22 to complete the assembly of the first rotating shaft 22 and the first knob 26.

[0055] like Figure 3 as well as Figure 5-Figure 9 As shown, the bending adjustment device also includes a front end seat 40, which is connected to the front end of the multi-lumen tube 10. The front end seat 40 is fixed with multiple front end positioning members 41 at one end away from the multi-lumen tube 10. The multiple front end positioning members 41 have a gathered state and a dispersed state. When the front end seat 40 is placed in the sheath tube, the multiple front end positioning members 41 are in a gathered state. When the front end seat 40 is placed outside the sheath tube, the multiple front end positioning members 41 are in a dispersed state.

[0056] The specific structure of the front end positioning member 41 is as follows Figure 6 As shown, the front end positioning member 41 is rod-shaped, and a support head is provided at one end of the front end positioning member 41 away from the front end seat 40, and the support head is sheet-shaped, spherical, etc. A plurality of front end positioning members 41 are distributed in an array around the axis of the front end seat 40, and the number of the front end positioning members 41 is, for example, 3, 4, etc. The front end positioning member 41 can be made of a material with a developing function, which can locate the front end of the multi-lumen tube 10 or the front end seat 40, so that the surgeon can accurately judge the position of the front end of the multi-lumen tube 10 under X-rays, and adjust the position of the front end of the multi-lumen tube 10, so as to perform a precise suturing operation. The front end positioning member 41 can be made of an elastic material. On the one hand, it supports the human tissue around the foramen ovale by being in a scattered state, and on the other hand, it prevents the front end seat 40 from entering the left atrium.

[0057] The multi-lumen tube 10 has a second chamber 12 at its center, which is used to receive the inner tube and allow it to pass into the left atrium. Correspondingly, an axial hole 43 is defined in the center of the front end seat 40 to facilitate passage of the inner tube within the second chamber 12. It will be appreciated that the axial hole 43 and the second chamber 12 are coaxially disposed.

[0058] The multi-lumen tube 10 is provided with a plurality of third chambers 13, which are arranged in an array around the axis of the second chamber 12. The third chamber 13 is used to movably receive a puncture needle 50. A plurality of needle holes 131 are provided on the side wall of the multi-lumen tube 10 near the front end of the multi-lumen tube 10. The bending device also includes a plurality of guide posts 60, which are distributed one-to-one with the third chambers 13. The guide posts 60 are sleeved and fixed in the third chamber 13 near the front end of the multi-lumen tube 10. A guide channel is provided in the guide posts 60. A guide hole 61 is provided on the side wall of the guide posts 60 and is connected to one end of the guide channel. The guide hole 61 and the needle hole 131 are correspondingly arranged. The other end of the guide channel is used for the puncture needle 50 to enter, and the guide hole 61 is used to assist the puncture needle 50 in passing through the needle hole 131.

[0059] The end of the guide post 60 near the front end seat 40 is fixed to the front end seat 40, and the remaining guide post 60 is sleeved in the third chamber 13. The front end seat 40 and the front end of the multi-lumen tube 10 can be bonded or welded. It is understood that the third chamber 13, the guide post 60, and the puncture needle 50 in the third chamber 13 are coaxially arranged. The guide channel near the guide hole 61 has a certain angle to assist the puncture needle 50 in the guide channel to pass through the needle hole 131. The guide post 60 can, on the one hand, guide the puncture needle 50 for puncture, and on the other hand, protect the multi-lumen tube 10 to prevent the puncture needle 50 from piercing the multi-lumen tube 10.

[0060] like Figure 7 As shown, a wire threading hole 42 is provided on the front end seat 40, and the first bending wire 23 passes through the wire threading hole 42 to become a double-strand bending wire, which can withstand greater tension. One end of the double-strand bending wire is fixed to the wire threading hole 42, and the other end of the double-strand bending wire passes through the first chamber 11 and is fixed to the first turntable 21. In order to ensure the connection strength with the first bending wire 23, the front end seat 40 is made of metal, and the first bending wire 23 is made of steel wire to be able to withstand greater tension. The two first bending wires 23 are symmetrically distributed about the axis of the front end seat 40. When any one of the two first bending wires 23 is tightened, the other first bending wire 23 is in a relaxed state, and the multi-lumen tube 10 is bent.

[0061] like Figure 5-Figure 6 As shown, in other embodiments, the bending adjustment device further includes an adapter column 70, one end of which is fixed to the end of the front end seat 40 near the multi-lumen tube 10. The adapter column 70 is fixedly connected to the first bending adjustment wire 23, and the adapter column 70 is sleeved and fixed in the first chamber 11. In this case, the first bending adjustment wire 23 does not need to be a double-strand bending adjustment wire. The adapter column 70 is, for example, a steel sleeve with a length of about 1 cm. Specifically, one end of the first bending adjustment wire 23 is welded and / or glued to the adapter column 70, and a corresponding adapter hole is provided at the end of the front end seat 40 near the multi-lumen tube 10. The end of the adapter column 70 away from the multi-lumen tube 10 is fixed in the adapter hole by welding and / or gluing. The adapter column 70 facilitates strengthening the fixing strength of the first bending adjustment wire 23. Otherwise, the first bending adjustment wire 23 may become detached or disconnected when subjected to relatively large forces.

[0062] Better, such as Figure 8 As shown, in an embodiment of the present invention, from the front end side of the multi-lumen tube 10 to the rear end side of the multi-lumen tube 10, the multi-lumen tube 10 includes a needle outlet section 15, a first flexible section 16, a second flexible section 17 and a main body section 18 connected in sequence, and the first bending adjustment component 20 is used to bend the first flexible section 16. The bending adjustment device also includes a second bending adjustment component 80, which is used to bend the second flexible section 17. The bending directions of the second bending adjustment component 80 and the first bending adjustment component 20 are opposite.

[0063] like Figure 8 As shown, when the first flexible segment 16 bends downward, the height of the front end of the multi-lumen tube 10 and the front end seat 40 will become lower. At this time, the second flexible segment 17 is bent upward to compensate for the height change caused by the bending of the first flexible segment 16, so that the front end of the multi-lumen tube 10 bends but the height change is small or remains at the original height, which helps to align the front end seat 40 with the tissue around the foramen ovale, facilitating accurate puncture and suturing by the puncture needle 50. The first flexible segment 16 and the second flexible segment 17 can be made of nylon, and the various segments of the multi-lumen tube 10 can be connected by bonding.

[0064] like Figure 8 As shown, an adapter seat 90 is fixed between the first flexible section 16 and the second flexible section 17. A fourth chamber 14 is provided in the multi-lumen tube 10, and a second wire entry hole 141 is provided on the side wall of the multi-lumen tube 10 between the front end and the rear end. The second wire entry hole 141 is connected to the fourth chamber 14. The second bending adjustment assembly 80 includes a second rotating shaft 81, a second turntable 82, and a second bending adjustment wire 83. The second rotating shaft 81 and the second turntable 82 are fixedly connected. One end of the second bending adjustment wire 83 is fixed to the second turntable 82, and the other end of the second bending adjustment wire 83 passes through the second wire entry hole 141 and the fourth chamber 14 and is fixed to the adapter seat 90. The second rotating shaft 81 is used to drive the second turntable 82 to rotate by rotating to tighten or loosen the second bending adjustment wire 83.

[0065] The second bending adjustment assembly 80 and the first bending adjustment assembly 20 have the same design principles. The second turntable 82 and the second bending adjustment wire 83 in the second bending adjustment assembly 80 are each configured as two. Correspondingly, two second wire entry holes 141 are provided on the side wall of the multi-lumen tube 10. The second turntable 82, the second bending adjustment wire 83, and the second wire entry holes 141 are all provided in a one-to-one correspondence. At this time, the multi-lumen tube 10 has two first chambers 11 and two fourth chambers 14. The two first chambers 11 and the two fourth chambers 14 are symmetrically distributed about the axis of the multi-lumen tube 10. Furthermore, the plane formed by the axes of the two first chambers 11 and the axis of the multi-lumen tube 10 can coincide with the plane 212 formed by the axes of the two fourth chambers 14 and the axis of the multi-lumen tube 10, thereby ensuring that the first flexible segment 16 and the second flexible segment 17 produce bending effects in opposite directions.

[0066] Among them, the first chamber 11 and the fourth chamber 14 can be set throughout the entire multi-lumen tube 10. The first chamber 11 and the fourth chamber 14 can also be set according to the position of the corresponding bending wire in the multi-lumen tube 10. For example, the first chamber 11 is a chamber opened between the first wire entry hole 111 and the front end of the multi-lumen tube 10.

[0067] Preferably, both the first flexible segment 16 and the second flexible segment 17 can be pre-bent. The pre-bend directions of the first and second flexible segments 16, 17 are opposite, and the pre-bend angles are, for example, 50°-60°. After the pre-bend, the first and second flexible segments 16, 17 utilize their inherent mechanical memory to facilitate quick adjustment later, saving time.

[0068] Specifically, such as Figure 2 and Figure 8 As shown, the axis of the first rotating shaft 22, the axis of the second rotating shaft 81 and the axis of the multi-lumen tube 10 are all perpendicular to each other. The second rotating shaft 81 is rotatably connected to the fixed block 30. The second bending adjustment component 80 also includes a second positioning bead (not shown) and a second knob 85. A plurality of second protrusions (not shown) are provided on the end face of the second turntable 82 facing the fixed block 30. The plurality of second protrusions are arranged in an array around the axis of the second turntable 82, and a second clamping space is formed between adjacent second protrusions. A plurality of second positioning beads are fixed to the side of the fixed block 30 facing the second turntable 82. The beads of the second positioning beads are clamped in the second clamping space, and the beads of the second positioning beads can switch to different second clamping spaces when the second rotating shaft 81 rotates. The end of the second rotating shaft 81 is socketed and fixed with the second knob 85, and the second rotating shaft 81 can be rotated by operating the second knob 85.

[0069] The second bending adjustment component 80 can achieve instant locking of the second turntable 82 when operating the second knob 85 through the cooperation of the second protrusion and the second positioning bead, that is, the second bending adjustment component 80 has the function of being stopped and used at will, so that after the bending angle is determined, there will be no deviation in the bending angle due to the inertia of the force applied to the second bending wire 83.

[0070] like Figure 1-Figure 2 As shown, the bending adjustment device also includes a handle 100, which includes an upper cover 101 and a lower cover 102. The upper cover 101 and the lower cover 102 enclose an assembly cavity, and part of the multi-lumen tube 10 is fixed in the assembly cavity. The front end of the multi-lumen tube 10 passes through the assembly cavity and is located outside the handle 100. A first wire entry hole 111 and a second wire entry hole 141 are provided on the side wall of the multi-lumen tube 10 located in the assembly cavity. The first turntable 21 and the second turntable 82 are both located in the assembly cavity. Multiple turns of the first bending adjustment wire 23 are wound on the first turntable 21, and multiple turns of the second bending adjustment wire 83 are wound on the second turntable 82.

[0071] An annular groove is also formed on the side wall of the second turntable 82. A second fixed shaft 84 is fixed in the annular groove. One end of the second bending wire 83 is fixed to the second fixed shaft 84 to ensure that the second bending wire 83 can be synchronously released or tightened when the second turntable 82 rotates.

[0072] like Figure 9As shown, to clearly illustrate the structure within the handle 100, the upper cover 101 is omitted. The first knob 26 is located between the fixed block 30 and the upper cover 101, and the second knob 85 is located between the fixed block 30 and the side wall of the handle 100. This staggered arrangement of the first knob 26 and the second knob 85 aligns with the user's operating habits, fully utilizing the space within the handle 100 and contributing to a compact design of the bend adjustment device. To facilitate securing the second bend adjustment assembly 80, an assembly plate 33 is provided on the side of the fixed block 30 away from the lower cover 102. The second rotating shaft 81 is rotatably connected to the assembly plate 33, and a plurality of second positioning beads are secured to the side of the assembly plate 33 facing the second turntable 82. In other embodiments, the axis of the first rotating shaft 22 and the axis of the second rotating shaft 81 can also be parallel. In this case, the first knob 26 and the second knob 85 should both be located outside the upper cover 101.

[0073] In an embodiment of the present invention, in order to facilitate the rapid operation of the bending adjustment device, a marking structure corresponding to the positions of the first knob 26 and the second knob 85 can be provided on the outside of the handle 100, so that the first knob 26 and the second knob 85 can be rotated in a determined position or range, saving the time of adjusting the instrument.

[0074] In order to facilitate the fixation of the fixing block 30 in the handle 100, some concave-convex matching structures can be designed between the fixing block 30 and the handle 100 to facilitate the assembly of the fixing block 30. For example, a groove is opened on the side wall of the fixing block 30, and corresponding limiting ribs are set on the upper cover 101 and the lower cover 102. After the upper cover 101 and the lower cover 102 are fixedly connected, the fixing block 30 is fixed in the handle 100.

[0075] An embodiment of the present invention further provides a suturing device system comprising a needle ejection device, a suture control device, and the aforementioned bending device. The needle ejection device is used to push out or retract the puncture needle 50, the suture control device is used to push or retract the suture, and the bending device is used to bend the portion of the multi-lumen tube 10 near the front end thereof.

[0076] The principle of use of the suturing device system of the present invention is as follows: when using the suturing device system, the guide wire is first inserted into the human body and passes through the foramen ovale to reach the left atrium. The sheath is then inserted into the human body along the guide wire to reach the right atrium. The front end of the multi-lumen tube 10 passes through the sheath to reach the right atrium. The handle 100 in the bending device does not move, and the first knob 26 (and the second knob 85) are operated to bend the partial section of the multi-lumen tube 10 near the front end of the multi-lumen tube 10. After the bending is completed, the puncture needle 50 is pushed out through the needle removal device, and the puncture needle 50 passes through the tissue around the foramen ovale. The suture control device is operated to push the suture. After the suture is pushed out of the puncture needle 50, the suture is captured by the suture capture device. After the suture is captured, the first knob 26 (and the second knob 85) are operated to restore the state of the multi-lumen tube 10 before it was bent. The puncture needle 50 is recovered, and the multi-lumen tube 10 is withdrawn from the human body along the sheath.

[0077] The suturing device system in the embodiment of the present invention can adjust the bending angle of the multi-lumen tube 10 entering the human body through the bending adjustment device when performing foramen ovale closure surgery, thereby adjusting the needle exit angle of the puncture needle 50 to improve the suturing accuracy and increase the success rate of the surgery. The designed bending adjustment device has a simple structure, a small size, and a low cost. In addition to being used for foramen ovale suturing, the suturing device system of the present invention can also be used for atrial septal defect suturing, ventricular septal defect suturing, mitral valve suturing, arteriovenous suturing, etc., and the present invention is not limited to this.

[0078] The above specific examples are used to illustrate the present application, which is only used to help understand the present application and is not intended to limit the present application. For those skilled in the art of the present application, based on the concept of the present application, they can also make some simple deductions, modifications or substitutions.

Claims

1. A bending adjustment device, characterized in that: include: A multi-lumen tube having a front end and a rear end, wherein a first chamber is provided in the multi-lumen tube, and a first wire entry hole is provided on a side wall of the multi-lumen tube between the front end and the rear end, wherein the first wire entry hole is in communication with the first chamber; and A first bending adjustment assembly includes a first turntable, a first rotating shaft, and a first bending adjustment wire; the first rotating shaft is fixedly connected to the first turntable; one end of the first bending adjustment wire is fixed to the first turntable, and the other end of the first bending adjustment wire passes through the first wire entry hole and the first chamber and is fixed to the front end of the multi-lumen tube; the first rotating shaft is used to rotate the first turntable to tighten or loosen the first bending adjustment wire. There are two first rotating disks, and the first rotating disks, the first bending adjustment wires, and the first wire entry holes are all arranged in a one-to-one correspondence; the end of the first bending adjustment wire away from the multi-lumen tube is the first end, and the first ends of the two first bending adjustment wires are distributed on both sides of the axis of the multi-lumen tube, so that when the first rotating shaft rotates, any one of the two first bending adjustment wires is in a tightened state, and the other of the two first bending adjustment wires is in a relaxed state; It also includes a fixed block and a fixed tube. The first rotating shaft and the fixed block are rotatably connected. The two first turntables are located at both ends of the fixed block. A strip hole is opened in the fixed block. The fixed tube is sleeved and fixed in the strip hole. Part of the multi-lumen tube passes through and is fixed to the fixed tube.

2. The bending adjustment device according to claim 1, characterized in that It also includes a first positioning bead; a plurality of first protrusions are provided on an end face of the first turntable facing the fixed block, and the plurality of first protrusions are distributed in an array around the axis of the first turntable, and a first clamping space is formed between adjacent first protrusions; a plurality of first positioning beads are fixed on the side of the fixed block facing the first turntable, and the beads of the first positioning beads are clamped in the first clamping space, and the beads of the first positioning beads can switch to different first clamping spaces when the first rotating shaft rotates.

3. The bending adjustment device according to claim 2, characterized in that The surface of the first protrusion facing one end of the fixed block is a plane, and along the radial direction of the first turntable, arc-shaped surfaces are respectively provided on both sides of the plane in the first protrusion, and the beads of the first positioning beads in the first clamping space are in contact with the arc-shaped surfaces and the end surface of the first turntable on which the first protrusion is provided.

4. The bending adjustment device according to claim 1, characterized in that An annular groove is provided on the side wall of the first turntable, a first fixed shaft is fixed in the annular groove, and an end of the first bending adjustment wire away from the front end of the multi-lumen tube is fixed to the first fixed shaft; and / or the first bending adjustment assembly further includes a first knob, and the first rotating shaft and the first knob are fixedly connected.

5. The bending adjustment device according to claim 1, characterized in that: It also includes a front end seat, which is connected to the front end of the multi-lumen tube, and the front end seat is fixed with multiple front end positioning members at one end away from the multi-lumen tube, and the multiple front end positioning members have a gathered state and a dispersed state. When the front end seat is placed in the sheath tube, the multiple front end positioning members are in a gathered state, and when the front end seat is placed outside the sheath tube, the multiple front end positioning members are in a dispersed state; and / or, multiple third chambers are provided in the multi-lumen tube, and the third chamber is used to movably socket the puncture needle. Multiple needle holes are opened on the side wall of the multi-lumen tube near the front end of the multi-lumen tube. The bending adjustment device also includes multiple guide columns, which are socketed and fixed in the third chamber near the front end of the multi-lumen tube, and a guide channel is opened in the guide column. A guide hole connected to one end of the guide channel is opened on the side wall of the guide column, and the guide hole and the needle hole are correspondingly arranged. The other end of the guide channel is used for the puncture needle to enter, and the guide hole is used to assist the puncture needle to pass through the needle hole.

6. The bending adjustment device according to claim 5, characterized in that: A wire threading hole is provided on the front end seat, and the first bending adjustment wire passes through the wire threading hole to become a double-strand bending adjustment wire, one end of the double-strand bending adjustment wire is fixed to the wire threading hole, and the other end of the double-strand bending adjustment wire passes through the first chamber and is fixed to the first turntable; or, it also includes a transfer column, one end of which is fixed to an end of the front end seat close to the multi-lumen tube, the transfer column and the first bending adjustment wire are fixedly connected, and the transfer column is sleeved and fixed in the first chamber.

7. The bending adjustment device according to any one of claims 2 to 6, characterized in that: From the front end side of the multi-lumen tube to the rear end side of the multi-lumen tube, the multi-lumen tube includes a needle outlet section, a first flexible section, a second flexible section and a main body section connected in sequence. The first bending adjustment component is used to bend the first flexible section. The bending adjustment device also includes a second bending adjustment component. The second bending adjustment component is used to bend the second flexible section. The bending directions of the second bending adjustment component and the first bending adjustment component are opposite.

8. The bending adjustment device according to claim 7, characterized in that: A transfer seat is fixed between the first flexible section and the second flexible section; A fourth chamber is provided in the multi-lumen tube, and a second wire entry hole is provided on the side wall of the multi-lumen tube between the front end and the rear end, and the second wire entry hole is communicated with the fourth chamber; The second bending adjustment component includes a second rotating shaft, a second rotating disk and a second bending adjustment wire; The second rotating shaft is fixedly connected to the second rotating disk; One end of the second bending adjustment wire is fixed to the second turntable, and the other end of the second bending adjustment wire passes through the second wire feeding hole and the fourth chamber and is fixed to the adapter; the second rotating shaft is used to rotate the second turntable to tighten or loosen the second bending adjustment wire; And / or, both the first flexible segment and the second flexible segment are pre-bent.

9. The bending adjustment device according to claim 8, characterized in that: The axis of the first rotating shaft, the axis of the second rotating shaft, and the axis of the multi-lumen tube are all perpendicular to each other; The second bending adjustment component further includes a second positioning bead; The second rotating shaft is rotatably connected to the fixed block; A plurality of second protrusions are provided on one end surface of the second rotating disk facing the fixed block. The plurality of second protrusions are arranged in an array around the axis of the second rotating disk, and second engaging spaces are formed between adjacent second protrusions. A plurality of second positioning beads are fixed to the side of the fixed block facing the second rotating disk. The beads of the second positioning beads are engaged in the second engaging spaces. The beads of the second positioning beads can switch to different second engaging spaces when the second rotating shaft rotates. The multi-lumen tube is fixed in the assembly cavity, and the front end of the multi-lumen tube passes through the assembly cavity and is located outside the handle. The first wire feeding hole and the second wire feeding hole are opened on the side wall of the multi-lumen tube located in the assembly cavity. The first turntable and the second turntable are both located in the assembly cavity. The first bending adjustment wire is wound around multiple turns, and the second bending adjustment wire is wound around multiple turns on the second turntable.

10. A stapler system, characterized in that: It comprises a needle ejection device, a suture control device and a bending adjustment device as described in any one of claims 1 to 9; the needle ejection device is used to push out or retract the puncture needle, the suture control device is used to push or retract the suture, and the bending adjustment device is used to bend the part of the multi-lumen tube near the front end of the multi-lumen tube.

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