Intraoperative guiding device

Abstract

The invention provides an intraoperative guiding device which comprises a guiding pipe fitting and a control handle, and the near end of the guiding pipe fitting is connected with the far end of the control handle; the guiding pipe fitting comprises an outer pipe and an inner pipe, a bent pipe section is arranged at the far end of the outer pipe, and the inner pipe is at least partially arranged in the outer pipe and can slide in the axial direction of the outer pipe; a side hole is formed in the side wall of the outer pipe, a branch pipe is arranged on the side wall of the inner pipe, and the branch pipe of the inner pipe penetrates out of the side hole and can slide in the axial direction of the side hole. The bent tube section and the branch tube can be respectively placed in different branch blood vessels after entering the blood vessels, so that the contrast agent can quickly reach different blood vessels, the guide tube can continuously indicate the positions of the blood vessels after the contrast agent is introduced, and the use frequency and dosage of the contrast agent are reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an intraoperative guidance device. Background Art

[0002] As endovascular repair becomes more mature, more and more doctors are beginning to use endovascular interventional surgery to treat patients. Usually, during the operation, 5-6 contrast agents are needed to be used in conjunction with X-rays to confirm the condition of the blood vessels, and about 10-25 ml of contrast agent is used each time, which is used for locating the target blood vessel before the operation, locating the position of the stent after the conveyor reaches the target position, and confirming the stent anchor position and occlusion after the stent is released. If the operation requires the opening of a branch, more contrast agents are required. Usually, if the operation goes smoothly, 60-120 ml of contrast agent is required. Under normal circumstances, the maximum amount of contrast agent that the human body can tolerate is 300 ml. Even if the contrast agent is used within the tolerance range, the patient may have allergic reactions, decreased renal function, renal damage, etc., and the metabolism of the kidneys will be affected to a certain extent. Therefore, it is very necessary to reduce or even eliminate the dose of contrast agent entering the human body. Summary of the invention

[0003] Based on this, it is necessary to provide a new intraoperative guidance device that can assist the surgeon to quickly and accurately locate the blood vessel position, guide the surgeon to quickly complete the operation in real time, and improve the positioning accuracy of stent release, thereby greatly reducing the use of contrast agents and protecting the patient's renal function.

[0004] A surgical guidance device comprises a guidance tube and a control handle, wherein the guidance tube is connected to the control handle; the guidance tube comprises an outer tube and an inner tube, wherein the distal end of the outer tube is provided with a curved tube section, wherein the inner tube is at least partially disposed within the outer tube and can slide axially along the outer tube; a side hole is provided on the side wall of the outer tube, wherein the side wall of the inner tube is provided with a branch tube, wherein the branch tube of the inner tube extends out from the side hole; the side hole has an axial length, and the branch tube can slide axially along the side hole.

[0005] In one embodiment, the control handle includes an outer shell and a slider, the slider can be axially slidably inserted into the outer shell, the outer tube is connected to the outer shell, the inner tube is connected to the slider, a Luer connector is provided at the proximal end of the slider, and the proximal end of the inner tube passes through the slider and is connected to the Luer connector.

[0006] In one embodiment, a slide groove is formed on the side wall of the outer shell, and the slide groove has an axial length. The sliding block includes a protrusion, and the protrusion protrudes from the slide groove and can slide along the axial length of the slide groove.

[0007] In one embodiment, both the outer tube and the inner tube have a distal opening, and the distal opening of the inner tube is disposed between the curved tube section of the outer tube and the side hole.

[0008] In one embodiment, the end of the branch pipe away from the inner pipe is a closed end, and a baffle is provided between the branch pipe and the inner pipe. The baffle blocks the inner pipe in the radial direction and separates the branch pipe into a first pipeline and a second pipeline in the axial direction. The baffle has a notch at a position close to the closed end, and the first pipeline and the second pipeline are connected through the notch. The first pipeline and the second pipeline are respectively connected to the inner pipe on both sides of the baffle.

[0009] In one embodiment, the curved pipe section and the branch pipe are elastic.

[0010] In one embodiment, the angle between the curved pipe section and the outer pipe in a natural state is less than or equal to 90°.

[0011] In one embodiment, the angle between the curved pipe section and the outer pipe in a natural state is greater than or equal to 90°.

[0012] In one embodiment, the indexing tube is provided with a plurality of developing structures, and the plurality of developing structures are arranged at intervals along the axial direction of the outer tube, and at least partially arranged in the branch tube.

[0013] In one embodiment, a conveyor is also included, which includes a conveying sheath and a tube seat, the proximal end of the conveying sheath is connected to the distal end of the tube seat, the guiding tube can be axially slidable in the inner cavity of the conveying sheath, and at least the distal part can pass through the distal port of the conveying sheath.

[0014] In one embodiment, the axial length of the delivery sheath is smaller than the axial length of the guide tube.

[0015] The beneficial effects of the present invention are as follows: compared with the prior art, the present invention provides an intraoperative guidance device, comprising a guidance tube and a control handle, the proximal end of the guidance tube being connected to the distal end of the control handle; the guidance tube comprising an outer tube and an inner tube, the distal end of the outer tube being provided with a curved tube section, the inner tube being at least partially placed inside the outer tube and being able to slide along the axial direction of the outer tube; a side hole being provided on the side wall of the outer tube, a branch tube being provided on the side wall of the inner tube, the branch tube of the inner tube passing through the side hole and being able to slide along the axial direction of the side hole; the curved tube section and the branch tube can be placed in different branch blood vessels respectively after entering the blood vessel, so that the contrast agent can quickly reach different blood vessels, and at the same time, the guidance tube itself can continuously indicate the position of the blood vessel after the contrast agent is introduced, thereby reducing the number of times and dosage of the contrast agent used. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 This is a schematic diagram of the structure of the intraoperative guidance device in Example 1 of the present invention;

[0017] Figure 2 This is a schematic diagram of the outer tube structure in Example 1 of the present invention;

[0018] Figure 3 This is a schematic diagram of the inner tube structure in Example 1 of the present invention;

[0019] Figure 4 This is a schematic diagram of the angle between the bent pipe section and the outer pipe being less than 90° in Example 3 of the present invention;

[0020] Figure 5 This is a schematic diagram of the angle between the bent pipe section and the outer pipe being greater than 90° in Example 3 of the present invention;

[0021] Figure 6 This is a schematic diagram of the inner tube structure in Example 2 of the present invention;

[0022] Figure 7 This is an internal cross-sectional view of the intraoperative guidance device of the present invention after contrast agent is injected;

[0023] Figure 8 This is a schematic diagram of the structure of the guide tube pre-installed in the conveyor in Example 3 of the present invention;

[0024] Fig. 9 This is a schematic diagram of the structure of the guide tube pre-installed in the conveyor in another embodiment of embodiment 3 of the present invention;

[0025] Fig.10 It is a schematic structural diagram of the developing structure arrangement in Embodiment 1 of the present invention;

[0026] Fig.11 This is a schematic diagram of the structure when two inner tubes are provided in Example 1 of the present invention;

[0027] Fig.12 This is a schematic diagram of the use of the intraoperative guidance device at the aortic arch position in Example 3 of the present invention;

[0028] Fig.13 This is a schematic diagram of the use of the intraoperative guidance device at the renal artery position in Example 3 of the present invention;

[0029] Fig.14 This is a schematic diagram of the structure of the intraoperative guidance device in Example 4 of the present invention;

[0030] Fig.15 This is a schematic diagram of the branch pipe rotating along the circumferential direction in Example 4 of the present invention;

[0031] Fig.16 This is a schematic diagram of the structure in which the axial length of the side hole is equal to the diameter of the branch pipe in Example 4 of the present invention;

[0032] Fig.17 for Fig.16 A partial internal cross-sectional view at position I in the middle;

[0033] Fig.18 This is a schematic diagram of the structure of the inner tube and the traction assembly in Example 5;

[0034] Fig.19 This is a schematic diagram of the structure of one side of the inner tube and the traction assembly in Example 6;

[0035] Fig. 20 This is a schematic diagram of the structure of the other side of the inner tube and the traction assembly in Example 6. DETAILED DESCRIPTION

[0036] In order to better understand the concept of the present application, the implementation methods of the present application are specifically described below in conjunction with the accompanying drawings. The following specific embodiments are only partial embodiments of the present application and are not limitations of the present application.

[0037] For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features". Therefore, the example term "below..." can include both upper and lower orientations. The device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

[0038] Although the terms first, second, third, etc. can be used in the text to describe multiple elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.

[0039] In order to more clearly describe the structure of the present application, the terms "proximal end" and "distal end" are defined here as commonly used terms in the field of interventional medicine. Specifically, "distal end" refers to the end away from the operator, and "proximal end" refers to the end close to the operator; "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial"; "upper end" and "lower end" are two ends that are relatively far away. When one end is defined as the "upper end", the other end that is far away is the "lower end".

[0040] In order to solve the problems existing in the prior art, the present application provides a new intraoperative guidance device, which is designed to assist the operator to quickly and accurately locate the blood vessel position, guide the operator to quickly complete the operation in real time, improve the positioning accuracy of stent release, and improve the efficiency of the operation. At the same time, it can greatly reduce the use of contrast agents and protect the patient's renal function. To a certain extent, it can eliminate the use of contrast agents, so that some patients who are allergic to contrast agents can also undergo surgery under digital angiography.

[0041] Embodiment 1:

[0042] See also Figure 1 and Figure 7-Figure 9 In this embodiment, the intraoperative guidance device 100 includes a guidance tube 10 and a control handle 3, the proximal end of the guidance tube 10 is connected to the distal end of the control handle 3; the guidance tube 10 is delivered into the human blood vessel under the protection of the delivery sheath 52 of the conveyor 5, and the control handle 3 is used to operate the guidance tube 10 outside the body. After the guidance tube 10 is delivered into the human body along with the delivery sheath 52, it is pushed out from the distal end of the delivery sheath 52 for use; the guidance tube 10 includes an outer tube 1 and an inner tube 2, and a curved tube section 11 is provided at the distal end of the outer tube 1. The curved tube section 11 can extend into the first branch blood vessel 92 when the outer tube 1 of the guidance tube 10 is located in the aorta 9 blood vessel; while the contrast fluid can be perfused into the branch blood vessel, the tube body can cooperate with the contrast fluid to indicate the position of the branch blood vessel; the inner tube 2 is at least partially placed in the outer tube 1 and can slide along the axial direction of the outer tube 1; please refer to further Figure 2 A side hole 13 is provided on the side wall of the outer tube 1 in the same bending direction as the bent tube section 11, and a branch pipe 21 is provided on the side wall of the inner tube 2. The branch pipe 21 of the inner tube 2 passes through the side hole 13; please refer to Figure 3 and Fig.12The inner tube 2 is provided with a side branch tube 21, which can extend into the second branch blood vessel 91 adjacent to the first branch blood vessel 92, thereby indicating the positions of the two branch blood vessels, which is convenient for doctors to quickly determine the positional relationship between the two branch blood vessels and the positional relationship with the aorta 9 blood vessel. Secondly, the branch tube 21 of the inner tube 2 provides more contrast fluid infusion ports, so that the contrast fluid can be output and diffused in the blood vessel faster, thereby shortening the diffusion time and reducing the output amount; wherein, the side hole 13 has an axial length, and the branch tube 21 can slide along the axial direction of the side hole 13. The branch tube 21 is set to an axially movable structure, which can adjust the distance between the curved tube section 11 and the branch tube 21. In this way, the branch tube 21 can be adjusted in position to adapt to different spacings between different blood vessels. This is because the spacings between different branch blood vessels in the human body are different, and the spacings between blood vessels of different patients are also different. In this way, the guiding device of the present application has better adaptability.

[0043] Please continue reading Figure 1-3 In this embodiment, the length of the curved tube segment 11 and the branch tube 21 can be set to 1mm-10mm, and the length of the curved tube segment 11 and the branch tube 21 should not be set too long, so as to avoid the curved tube segment 11 and the branch tube 21 being released in the body. The excessively long tube body will scratch or hook the blood vessel wall, resulting in incomplete release or failure to release, or even damage to the blood vessel; it can be understood that the distal ends of the outer tube 1 and the inner tube 2 are both provided with distal openings, wherein the opening edge of the distal opening of the outer tube 1 is provided with an arc transition to avoid the sharp edge of the tube mouth from scratching the blood vessel, and the branch tube 21 is also provided with an opening, and the edge of the opening is also provided with an arc transition to avoid the tube mouth from scratching the blood vessel. The distal opening of the inner tube 2 is placed in the outer tube 1, which is used to penetrate the inner tube 2 and the outer tube 1, wherein the tube opening of the inner tube 2 is preferably between the curved tube section 11 and the side hole 13 of the outer tube 1; in this way, only a single-layer tube can be arranged at the curved tube section 11, thereby ensuring that the curved tube section 11 has better flexibility and resilience, and also facilitates the axial sliding of the inner tube 2 in the outer tube 1; in one embodiment, please continue to refer to Figure 1, there is a minimum distance L1 between the curved tube segment 11 and the branch tube 21, wherein L1 is set to 5 mm, that is, the distance between the side wall at the distal end of the side hole 13 and the curved tube segment 11 is 5 mm; since the human blood vessels themselves have thickness, and there is usually a spacing or angle between two adjacent branch blood vessels, a spacing distance less than 5 mm makes it impossible for the curved tube segment 11 and the branch tube 21 to accurately indicate the positional relationship between the two adjacent branch blood vessels. At the same time, the curved tube segment 11 and the branch tube 21 are not conducive to the deployment in the human blood vessels and the folding in the delivery sheath 52 due to the too small spacing between the curved tube segment 11 and the branch tube 21; the minimum distance setting of 5 mm can ensure that the curved tube segment 11 and the branch tube 21 can basically adapt to most of the branch blood vessels near the aorta in the human body, so that the intraoperative guidance device 100 of the present application has better adaptability; Among them, the range of the spacing between the branch tube 21 and the curved tube segment 11 that can be adjusted is 5mm-30mm; that is, the maximum distance L2 between the curved tube segment 11 and the branch tube 21 is 30mm. If the distance is set greater than 30mm, there are two branch blood vessels that are not adjacent to the branch blood vessel where the curved tube segment 11 is located when the branch tube 21 is deployed in the blood vessel, and there may be a branch blood vessel in between, resulting in an error in the relative position indication of the indicated blood vessel. Therefore, the maximum distance setting of 30mm can ensure that the intraoperative guidance device 100 provided in the present application can adapt to branch blood vessels with a larger spacing, especially the three branch blood vessels on the aortic arch, so as to adapt to most types of branch blood vessels, and at the same time avoid the branch tube 21 crossing too many branch blood vessels when released, affecting the accuracy of the indication.

[0044] Please continue reading Figure 1-Figure 3In this embodiment, the control handle 3 is used to hold the intraoperative guidance device 100 and to control the inner tube 2 to slide axially in the outer tube 1; wherein the control handle 3 includes an outer shell 31 and a slider 33, the outer shell 31 has an inner cavity, and the inner cavity is connected at both ends along the axial direction, wherein the slider 33 is placed in the inner cavity of the outer shell 31 and can be slidably penetrated in the outer shell 31 along the axial direction; the proximal end of the outer tube 1 is fixedly connected to the distal end of the outer shell 31, the slider 33 has an inner cavity that is connected along the axial direction, the proximal end of the inner tube 2 is fixedly connected to the distal end of the slider 33, and the proximal end of the slider 33 is connected to the Luer connector 4, and the Luer connector 4 is connected to the cavity of the inner tube 2; or the inner tube 2 is directly connected to the Luer connector 4 through the slider 33; preferably, in order to facilitate the user to operate the slider 33, a slide groove 32 is provided on the side wall of the outer shell 31, and the slide groove 32 has an axial length extending along the axial direction of the outer shell 31, and the slide groove 32 has an axial length extending along the axial direction of the outer shell 31. The side wall of the block 33 is provided with a protrusion 34, which protrudes and extends from the slide groove 32, and the protrusion 34 can slide along the axial length of the slide groove 32; the user can hold the outer shell 31 with the hand, and at the same time, press the protrusion 34 with the finger, push or pull the protrusion 34 to make the slider 33 slide axially in the outer shell 31, and at this time, the slider 33 will drive the inner tube 2 to slide, and the branch tube 21 at the distal end of the inner tube 2 will be synchronized along the side hole 13 to slide axially, so as to adjust the distance between the curved tube segment 11 and the branch tube 21 according to the different branch blood vessel spacings, so that the curved tube segment 11 and the branch tube 21 respectively rest on the side walls of the two adjacent branch blood vessels that are close to each other, so that when the contrast agent is introduced, the operator can also judge the morphology and relative position relationship of the two branch blood vessels by the image position of the curved tube segment 11 and the branch tube 21 in the body, without repeatedly introducing the contrast agent for identification.

[0045] Preferably, not shown in the figures, in one embodiment, anti-skid patterns are added to the surface of the protrusion 34 to increase the friction force, so that the operator can operate the control handle 3 more smoothly.

[0046] See also Fig.10In this embodiment, both the outer tube 1 and the inner tube 2 of the index tube 10 are provided with a developing structure 6, wherein the developing structure 6 can be provided along the entire outer tube 1 and the entire inner tube 2, or can be provided only in the curved tube section 11 and the branch tube 21, or multiple developing structures 6 can be provided along the axial direction of the outer tube 1 and arranged at intervals; the tube body itself is provided with the developing structure 6, so that after the tube body enters the human blood vessel, the position of the curved tube section 11 and the branch tube 21 in the blood vessel in the body can be directly observed by angiography; the developing structure 6 is provided in the curved tube section 11 and the branch tube 21, and combined with the developing structure 6 provided at intervals on the outer tube 1, the operator can measure the distance between the two branch blood vessels clamped or the inner diameter of the clamped blood vessel according to the distance between the positions of the developing structures 6 on the tube body under the image, so as to facilitate the doctor to operate and select the corresponding specification of the instrument; preferably, the developing length X1 of the developing structure 6 provided at intervals along the axial direction of the outer tube 1 can be set to 10 mm, and the interval length X2 can be 10 mm; preferably, barium sulfate is added as a developing material in the tube body with the developing structure 6.

[0047] See also Fig.11 In another embodiment, in order to extend the tube body in more branch blood vessels to achieve the purpose of quickly locating the blood vessel position and quickly releasing the contrast solution, the inner tube 2 can be provided with two, including a first inner tube 201 and a second inner tube 202. When the first inner tube 201 and the second inner tube 202 are provided, the outer tube 1 is provided with at least two side holes 13 along the axial direction, the first side hole 131 and the second side hole 132. The first inner tube 201 is placed in the outer tube 1, and the branch tube 21 extends from the first side hole. The second inner tube 202 is placed in the first inner tube 201. An inner tube side hole is provided at a position opposite to the first inner tube 201 and the second side hole. The axial length of the inner tube side hole is greater than the axial length of the second side hole. To prevent the first inner tube 201 from blocking the second side hole when the first inner tube 201 moves axially, the branch tube 21 of the second inner tube 202 passes through the inner tube side hole and the second side hole at the same time; in this way, the proximal end of the first inner tube 201 is connected to the first slider 341, and the proximal end of the second inner tube 202 is connected to the second slider 342. The outer shell 31 of the control handle 3 is provided with at least two slide grooves 32, a first slide groove 321 and a second slide groove 322. The protrusion 34 of the first slider 341 extends from the first slide groove 321, and the protrusion 34 of the second slider 342 extends from the second slide groove 322. The axial sliding of the first inner tube 201 and the second inner tube 202 are controlled respectively by the two protrusions 34.

[0048] Embodiment 2:

[0049] See also Figure 1 and Figure 6In this embodiment, the structures of the guiding tube 10 and the control handle 3 are substantially the same as those in Embodiment 1, except that the end of the branch tube 21 away from the inner tube 2 is a closed end 212, so that the contrast agent cannot flow out of the branch tube 21, and the branch tube 21 is used as a flow passage for the contrast agent; a baffle 211 is provided between the closed end 212 of the branch tube 21 and the inner tube 2, the baffle 211 blocks the inner tube 2 in the radial direction, and axially separates the branch tube 21 into a first pipeline 214 and a second pipeline 215, and a notch 213 is provided on the baffle 211 near the closed end 212, the first pipeline 214 and the second pipeline 215 are connected through the notch 213, and the first pipeline 214 and the second pipeline 215 are connected through the notch 213. A pipeline 214 and a second pipeline 215 are respectively connected to the inner tube 2 on both sides of the baffle 211; the purpose of setting the baffle 211 is to block the part from the distal end of the inner tube 2 to the branch tube 21 and the part from the proximal end to the branch tube 21 through the baffle 21. The end of the branch tube 21 is a closed end 212. After closing, the baffle 211 forms a notch 213 at the closed position, so that the branch tube 21 becomes a structure similar to a U-shaped tube. In this way, after the contrast agent enters the inner tube 2, when passing through the position of the branch tube 21, a loop will be formed and it will not flow out of the branch tube 21, thereby making the branch tube 21 a guide piece that is always filled with contrast agent, and has better development indication performance.

[0050] In another embodiment, not shown in the figure, the branch tube 21 can be a U-shaped bend formed in the middle section of the inner tube 2 between the distal port and the proximal port, and the parts close to each other after the bending are bonded together to form the branch tube 21; the branch tube 21 is perpendicular to the inner tube 2 in a natural state; such a setting can also form a loop, and no flow out of the branch tube 21, thereby making the branch tube 21 a guide piece that is always infused with contrast agent.

[0051] Example 3

[0052] See also Figure 4-5 In this embodiment, the structures of the guiding pipe 10 and the control handle 3 are substantially the same as those in Embodiments 1 and 2, except that the curved pipe section 11 and the branch pipe 21 are elastic, so that the curved pipe section 11 and the branch pipe 21 always have a force to rebound to a natural state; in this embodiment, the angle between the curved pipe section 11 and the outer pipe 1 in the natural state is less than or equal to 90 degrees, and is preferably set to be less than 90 degrees; in this case, please refer to Figure 4The purpose is that this type of guiding device can better measure the distance and positional relationship between two adjacent branch blood vessels; the curved pipe segment 11 is slightly inclined toward the branch pipe 21 in a natural state, and has the force to rebound to the initial state, and a clamping structure close to the middle position is formed between the curved pipe segment 11 and the branch pipe 21, so as to ensure that when the curved pipe segment 11 and the branch pipe 21 are clamped in cooperation with the two adjacent branch blood vessels, there is a clamping force, which increases the wall adhesion of the curved pipe segment 11 and the branch pipe 21, is not easy to fall off, and can more accurately guide the positional relationship between the two branch blood vessels; preferably, the branch pipe 21 can be set as a structure inclined toward the curved pipe segment 11.

[0053] See also Figure 4 and Figure 8 In this embodiment, when the guide tube 10 is pre-installed into the outer sheath, the bent tube section 11 is straightened in a direction away from the branch tube 21 and then sent into the delivery sheath 52, and the branch tube 21 is bent in a direction away from the bent tube section 11 and then sent into the delivery sheath 52; in this way, the bent tube section 11 and the branch tube 21 can have a rebound tendency towards each other after coming out of the delivery sheath 52, thereby forming a clamping structure.

[0054] In this embodiment, please refer to Fig.12 In an intraoperative guidance device 100 of the above structure, during an intravascular repair operation of the aortic arch 9 covering the left subclavian artery, the intraoperative guidance device 100 can enter the aortic arch 9 from the axillary artery through the left subclavian artery, etc., at this time, a syringe is used to inject contrast agent from the Luer connector 4, and the guidance tube 10 can be used to release the contrast agent to confirm the position of each branch; the tube seat 51 is used to drive the delivery sheath 52 to retreat, and during the retreat process, when the outer tube 1 slightly exposes the sheath opening of the delivery sheath 52, the curved tube section 11 will be deflected and rebounded to one side of the inner tube 2 by the rebound force of the pre-bent area 12, and at this time, the direction of the curved tube section 11 can be adjusted to face the left common carotid artery by rotating the direction of the outer shell 31. Then use the guide wire to pull the curved tube segment 11 into the left common carotid artery. After the curved tube segment 11 is completely released, the curved tube segment 11 automatically rebounds toward the proximal end due to the rebound force of the pre-bend area 12. The control handle 3 is slightly withdrawn to keep the curved tube segment 11 attached to the distal side of the vascular wall of the left common carotid artery. When the delivery sheath 52 is withdrawn to the branch tube 21 and completely released, the branch tube 21 automatically rebounds toward the distal end due to the rebound force of the pre-bend area 12 and is released in the left subclavian artery. The slider 33 is adjusted to keep the branch tube 21 attached to the proximal side of the vascular wall of the left subclavian artery. At this time, the anchoring area of ​​the aorta 9 arch can be confirmed by the mutually clamped position of the curved tube segment 11 and the branch tube 21, and the changes in the blood vessels in the anchoring area can be continuously observed. This method can reduce the release of contrast agent in the subsequent delivery device 5 access, stent positioning, etc.

[0055] See also Figure 5 and Fig.13 In another embodiment, the angle between the curved tube segment 11 and the outer tube 1 in a natural state is greater than or equal to 90 degrees, and is preferably set to be greater than 90 degrees; the purpose of such a setting is that this type of guiding device can better measure the width and positional relationship of the tube opening where a single branch blood vessel is connected to the aorta 9; the curved tube segment 11 is slightly inclined away from the branch tube 21 in a natural state, and has the force to rebound to the initial state, and a structure that is inclined and expanded in opposite directions is formed between the curved tube segment 11 and the branch tube 21, so as to ensure that when the curved tube segment 11 and the branch tube 21 enter a single branch blood vessel at the same time, they are respectively attached to the two side walls, thereby increasing the wall adhesion of the curved tube segment 11 and the branch tube 21, not easy to fall off, and can more accurately guide the width and positional relationship of the tube opening of a single branch blood vessel; preferably, the branch tube 21 can be set to a structure inclined away from the curved tube segment 11.

[0056] In this embodiment, please refer to Fig. 9 When the guiding tube 10 is pre-installed into the outer sheath, the curved tube segment 11 is folded toward the direction close to the branch tube 21 and then sent into the delivery sheath 52, and the branch tube 21 is bent toward the direction close to the curved tube segment 11 and then sent into the delivery sheath 52; in this way, the curved tube segment 11 and the branch tube 21 can have a rebound tendency in the direction away from each other after coming out of the delivery sheath 52, thereby forming a structure abutting against both sides, so as to further adapt to the structure abutting against the two side walls in a single blood vessel.

[0057] In this embodiment, please refer to Fig.13 When the guiding tube 10 of the above structure is used, the curved tube section 11 is first pulled into the left renal artery 93, and the control handle 3 is used to adjust the curved tube section 11 to fit the proximal side of the left renal artery 93. Then, the delivery sheath 52 is withdrawn to release the branch tube 21 in the left renal artery 93, and the slider 33 is adjusted to make the branch tube 21 fit the distal side of the left renal artery 93. Fig.13 The intraoperative guidance device 100 shown in FIG. 1 is held against both sides of the left renal artery 93 and continuously observed during the operation.

[0058] Similarly, another set of intraoperative guidance device 100 can be used to locate the right renal artery 93 using the same method to synchronously observe the real-time positions of the two renal arteries 93.

[0059] In this embodiment, which is not shown in the figure, the curved pipe section 11 has a pre-bending area 12 connected to the outer pipe 1, and the branch pipe 21 has a connecting area 24 connected to the inner pipe 2, and at least the pre-bending area 12 and the connecting area 24 are elastic; wherein the pre-bending area 12 and the connecting area 24 may be embedded with a pre-shaped elastic support member, so that the branch pipe 21 and the curved pipe section 11 have better bending performance. Preferably, the elastic support member may be a spring tube embedded in the pipe body.

[0060] Example 4

[0061] See also Figure 14-17 In this embodiment, the relative position and structure of the inner tube 2 and the outer tube 1 of the intraoperative guidance device 100 are substantially the same as those in Embodiments 1-3, except that the control handle 3 can control the branch tube 21 to swing and tilt in both axial directions. With this arrangement, the tilting direction of the branch tube 21 can be controlled and adjusted by the control handle 3, so that the guidance device of the present application can better adapt to the morphology and positional relationship of the blood vessels in the face of complex and changeable blood vessel types in the human body. By adjusting the relative position of the branch tube 21 and the curved tube segment 11 in vitro with the control handle 3, the intraoperative guidance device 100 can adapt to branch blood vessels with different spacings; by adjusting the angles between each other, the curved tube segment 11 and the branch tube 21 can be better clamped in the two branch blood vessels to avoid falling off.

[0062] In this example, see Fig.16 and 17In order to control the handle 3 to control the branch tube 21 to swing and tilt in different directions in the human blood vessel, a connection area 24 is provided at the connection position between the branch tube 21 and the inner tube 2. The branch tube 21 is connected to the inner tube 2 through the connection area 24. The hardness of the connection area 24 is further set to be smaller than the hardness of other areas of the branch tube 21 except the connection area 24 and the hardness of the outer tube 1. In this way, when the side walls of the branch tube 21 are against the wall of the side hole 13 at both axial ends of the side hole 13, the inner tube 2 is further pushed or pulled. The wall of the side hole 13 can generate an extrusion force on the branch tube 21, thereby forcing the branch tube 21 to deform at the position of the connection area 24, generate an inclination angle, and form an inclined branch tube 21 to adapt to different types of blood vessels; preferably, the connection area 24 can be connected with a flexible tube, which makes the branch tube 21 have better flexibility at this position, so that when the branch tube 21 is squeezed, this position is deformed first, and the upper end of the connection area 24 of the branch tube 21 The part does not deform when it is connected, so that an inclined structure rather than a bent structure can be formed; in this embodiment, it can be understood that the low hardness of the connection area 24 is mainly manifested in the low hardness in the radial direction, so the connection area 24 of the flexible tube can be a tube section with a thinner thickness, or a tube section with the same thickness but a softer texture of a different material; wherein the axial length of the side hole 13 is set to be greater than or equal to the diameter of the branch tube 21. When the axial length of the side hole 13 is slightly greater than the diameter of the branch tube 21, the distance at which the branch tube 21 abuts against the opposite wall of the side hole 13 after tilting becomes larger, so that the angle at which the branch tube 21 can be tilted by being squeezed is larger; when the axial length of the side hole 13 is equal to the diameter of the branch tube 21, the speed at which the branch tube 21 tilts in response to the control of the control handle 3 becomes faster. This is because the connection area 24 is always in contact with the side hole 13. When the inner tube 2 moves axially, the connection area 24 will be squeezed and deformed immediately, causing the branch tube 21 to tilt.

[0063] In this example, see Fig.14 and Fig.15The inner tube 2 can not only move axially relative to the outer tube 1, but also rotate relative to the outer tube 1. The side hole 13 has a circumferential width in the circumferential direction of the outer tube 1, and the circumferential width is greater than the diameter of the branch tube 21. When the inner tube 2 rotates, the branch tube 21 can rotate along the side hole 13 in the circumferential direction through a rotation angle, and the rotation angle does not exceed the range of the circumferential width; the purpose of such a setting is that the anatomical angles of blood vessels in the human body are often not on the same plane, in order to meet the needs of multiple blood vessels with different deflection angles can be marked using the guidance device; the branch tube 21 can be tilted axially and can rotate circumferentially, and can not only adapt to blood vessels at different angles, but also adapt to blood vessels in different planes. In this way, even if the bending shapes of two adjacent blood vessels are complex, the intraoperative guidance device 100 of the present application can be used to send the curved tube segment 11 and the branch tube 21 into the adjacent branch blood vessels for adaptation measurement, which can meet the needs of quickly filling contrast agents in different branch blood vessels and can indicate the positional relationship and shape of different branch blood vessels. Preferably, the angle formed by the two sides of the side hole 13 in the circumferential direction is less than or equal to 180°, that is, the maximum angle σ through which the branch tube 21 can rotate in the circumferential direction is 180°. Furthermore, the maximum angle through which the branch tube 21 can rotate in the circumferential direction can be 90° with the boundary being parallel to the curved tube section 11. In this case, the side hole 13 can be achieved by cutting off half of the outer tube 1 in the circumferential direction. In this way, it can ensure that the inner tube 2 can rotate through the maximum angle without falling out of the outer tube 1, and can adapt to two branch blood vessels with a large degree of twisting.

[0064] Example 5

[0065] Please refer to 14 and 18. In this embodiment, the relative position and structure of the inner tube 2 and the outer tube 1 of the intraoperative guidance device 100 are substantially the same as those in Examples 1-4, except that it also includes a traction assembly 8, which is used to establish a connection relationship between the two distal components to achieve a more remote control relationship. In this embodiment, the traction assembly 8 is used to establish a connection relationship between the control handle 3 and the branch tube 21; wherein the control handle 3 includes a control body 331 and an outer shell 31, the control body 331 is arranged in the inner cavity of the outer shell 31, the control body 331 is connected to the inner tube 2, and the outer shell 31 is connected to the outer tube 1; one end of the traction assembly 8 is connected to the branch tube 21, and the other end is connected to the control body 331; the control body 331 controls the swing and tilt of the branch tube 21 through the traction assembly 8; the control body 331 is used to control the inner tube 2 and its branch tube 21, and the outer shell 31 is used to control the outer tube 1; wherein the control body 331 can drag the inner tube 2 to reciprocate along the axial direction, and the control body 331 is connected to the outer tube 1 through the traction assembly 8 establishes a connection with the branch tube 21 to realize the control of the branch tube 21 swinging in the axial directions of both ends, and cooperates with its control of the axial sliding of the inner tube 2. The user can slide along the axial direction through the control body 331 first, and use the axial movement of the branch tube 21 to change the positional relationship between the curved tube section 11 and the branch tube 21, so as to adapt and determine the positions of the two branch blood vessels. Further, the branch tube 21 is controlled to tilt and swing through the control body 331, and the fit with the blood vessel wall can not only determine the positional relationship between the two branch blood vessels, but also detect the bending shape of the branch blood vessels; wherein, the control body 331 is at least partially exposed to the outer wall of the outer shell 31, so that the operator can control the control body 331 while holding the outer shell 31, so as to realize the synchronous control of the outer tube 1 and the inner tube 2 in the body, for example, the outer shell 31 can be provided with a slide groove 32, and the control body 331 is at least partially exposed to the surface of the slide groove 32 for the operator to operate; or the proximal end of the control body 331 exceeds the proximal end of the outer shell 31 for control.

[0066] In this embodiment, please refer to Fig.14 and Fig.18In order to enable the user to control the branch pipe 21 at the position of the control body 331, the branch pipe 21 includes an extension portion 7, the upper end of the extension portion 7 is connected to the branch pipe 21, and the lower end extends to between the radial sides of the inner tube 2. It should be noted here that the upper end refers to the end away from the inner tube 2, and the lower end refers to the end close to the inner tube 2; the control body 331 includes a control member 334, at least one end of the traction component 8 is connected to the extension portion 7, and the other end is connected to the control member 334, and the control member 334 controls the traction component 8 to slide along the axial direction of the inner tube 2; it can be understood that the branch pipe 21 is connected to the traction component 8 through the extension portion 7. The traction assembly 8 is connected to the control member 334 and is controlled by the control member 334. When the control member 334 controls the traction assembly 8 to pull, the lower end of the extension portion 7 is pulled to swing. At this time, since the upper end of the extension portion 7 is connected to the branch pipe 21, the branch pipe 21 uses the connection area 24 connected to the inner tube 2 as a fulcrum, and the lower end of the extension portion 7 is pulled in the opposite direction to the direction in which the lower end of the extension portion 7 is pulled, so as to achieve the swinging action in the axial direction at both ends. Preferably, the control body 331 can slide along the axial direction of the outer shell 31, so that the control body 331 as a whole can drive the inner tube 2 to slide axially. Further, the control member 334 can control the traction assembly 8 to pull the inner tube 2. The outer shell 31 is provided with a slide groove 32, and the slide groove 32 has an axial length, and the control member 334 protrudes from the slide groove 32; the outer shell 31 is provided with a slide groove 32 for avoiding the control member 334, and the control member 334 protrudes from the surface of the slide groove 32 of the outer shell 31, so that when the user holds the outer shell 31, the user can directly control the control member 334 on the control body 331 through the slide groove 32, and the slide groove 32 has an axial length, and the control member 334 protrudes from the slide groove 32. 2 has an axial length greater than or equal to the axially slidable length of the operating member 334 to avoid interference with the control stroke of the operating member 334; in a preferred embodiment, the operating body 331 can be provided with a raised bump 34, and the bump 34 is fixedly connected to the operating body 331, and the bump 34 also protrudes from the slide groove 32, so that the user can not only operate the operating member 334, but also drag the operating body 331 by dragging the bump 34, so that the operating body 331 can slide axially along the outer shell 31, thereby driving the inner tube 2 to slide axially, and adjusting the spacing between the curved pipe section 11 and the branch pipe 21.

[0067] In this embodiment, please refer to Fig.18, wherein the traction assembly 8 includes a first winding shaft 82, a second winding shaft 83 and a traction wire 81, the first winding shaft 82 is arranged on the wall of the inner tube 2 and is located at the distal end side of the branch tube 21, and the second winding shaft 83 is arranged on the control body 331 and is located at the proximal end side of the control member 334; the traction wire 81 is wrapped around the first winding shaft 82 and the second winding shaft 83, and the lower end of the extension part 7 and the control member 334 are fixedly connected with the traction wire 81; it can be understood that the arrangement of the first winding shaft 82 and the second winding shaft 83 enables the traction wire 81 to form an annular conveyor belt-like structure between the extension part 7 and the control member 334 when it is wrapped around the two winding shafts, and the traction wire 81 is in a taut state when it is wrapped around the first winding shaft 82 and the second winding shaft 83; in this way, after the extension part 7 and the control member 334 are connected to the traction wire 81, the control member 334 can pass The traction wire 81 controls the lower end of the extension part 7; it can be understood that the traction wire 81 after being wrapped is located at the upper and lower ends of the winding shaft and is distributed with an upper wire and a lower wire. The extension part 7 and the control member 334 can be selectively connected to the upper wire or the lower wire. When the lower end of the extension part 7 is connected to the upper wire and the control member 334 is connected to the lower wire, the swing direction of the lower end of the extension part 7 is opposite to the sliding direction of the control part, so that the tilting and swinging direction of the branch tube 21 is the same as the sliding direction of the control part, which makes it easier for users to quickly adapt to the control of the control body 331; and when the lower end of the extension part 7 is connected to the upper wire or the lower wire, the control member 334 is the same as the lower end of the extension part 7, and is also connected to the upper wire or the lower wire, the swing direction of the lower end of the extension part 7 is the same as the sliding direction of the control part, so that the tilting and swinging direction of the branch tube 21 is opposite to the sliding direction of the control part.

[0068] In one embodiment, not shown in the figure, the side wall of the inner tube 2 and the side wall of the control body 331 are provided with a receiving groove for accommodating the traction assembly 8. The traction assembly 8 can be arranged in the receiving groove, and the first winding shaft 82 and the second winding shaft 83 are arranged at both ends of the receiving groove; in this way, it is possible to avoid the setting of the traction assembly 8 protruding from the outer wall of the inner tube 2, thereby avoiding the generation of a large gap between the outer wall of the inner tube 2 and the outer tube 1, which affects the smoothness of the movement of the inner tube 2 in the outer tube 1.

[0069] In this embodiment, the extension portion 7 can be directly molded on the side wall of the branch pipe 21 when the branch pipe 21 is molded, and at least the upper end of the extension portion 7 is combined with the branch pipe 21, and the lower end is separated from the inner tube. Preferably, the extension portion 7 can be attached to the side wall of the branch pipe 21 by bonding, hot melting, etc. after the branch pipe 21 is molded.

[0070] Example 6

[0071] See also Fig.19 and Fig. 20In this embodiment, the relative position and structure of the inner tube 2 and the outer tube 1 of the intraoperative guidance device 100 are substantially the same as those in embodiments 1-5, except that in this embodiment, the branch tube 21 is controlled by two groups of control components. Specifically, the extension portion 7 includes a first extension portion 71 and a second extension portion 72, and the first extension portion 71 and the second extension portion 72 are respectively arranged on the opposite sides of the branch tube 21, and the two extension portions respectively control the inclination of the branch tube 21 at both ends along the axial direction; the control member 334 includes a first control member 332 and a second control member 333, and the first control member 332 and the second control member 333 are respectively arranged on the opposite sides of the control body 331, and the first control member 332 and the second control member 333 respectively control the first extension portion 71 and the second extension portion 72; the traction component 8 includes a first traction wire 811 and a second traction wire 812, and the first traction wire 811 is connected to the lower end of the first extension portion 71 at one end, and is connected to the first control member 332 at the other end wherein, the first operating member 332 and the first extension portion 71 are located on the same side, and the second operating member 333 and the second extension portion 72 are located on the same side, and both ends of the first traction wire 811 are directly connected to the lower end of the first extension portion 71 from the proximal end of the first extension portion 71, and are connected to the first operating member 332. When the user pulls the first operating member 332 at the proximal end, the lower end of the first extension portion 71 swings in the pulling direction, thereby causing the branch tube 21 to tilt and swing in the opposite direction; in order to enable the second control member on the other side to control the branch tube 21 to tilt and swing in different directions, one end of the second traction wire 812 is connected to the lower end of the second traction portion from the distal side of the second traction portion, and the other end is connected to the second operating member 333; thereby, when the second operating member 333 is pulled, the second traction wire 812 pulls the lower end of the second extension portion 72 to swing toward the distal end, causing the branch tube 21 to tilt and swing in the proximal direction, which is opposite to the control swing tilt direction of the first control member.

[0072] Preferably, please refer to Fig. 20 In order to connect the second traction wire 812 to the second extension part 72 at the distal side, a third winding shaft 84 is provided on the wall of the inner tube 2 at the distal side of the second extension part 72. One end of the second traction wire 812 is wound around the third winding shaft 84 and connected to the lower end of the second extension part 72, and the other end is connected to the second operating member 333. The second traction wire 812 is connected to the lower end of the second extension part 72 after winding around the third winding shaft 84 at the distal side, so that the pulling direction of the second traction wire 812 can be changed.

[0073] The above-mentioned specific embodiments are only some embodiments of the present invention and are not limitations of the present invention. This specification cannot be an exhaustive list of all embodiments of the present invention. Some features of the above-mentioned different embodiments may be replaced or combined with each other. Those skilled in the art may also make simple replacements according to actual needs. The concept of the present invention shall be subject to the required protection scope.

Claims

1. An intraoperative guidance device, It is characterized in that It comprises a guide tube and a control handle, wherein the guide tube is connected to the control handle; the guide tube comprises an outer tube and an inner tube, the distal end of the outer tube is provided with a bent tube section, the inner tube is at least partially disposed in the outer tube and can slide along the axial direction of the outer tube; a side hole is provided on the side wall of the outer tube, a branch tube is provided on the side wall of the inner tube, and the branch tube of the inner tube passes through the side hole; the side hole has an axial length, and the branch tube can slide along the axial direction of the side hole.

2. The intraoperative guidance device according to claim 1, It is characterized in that The control handle includes an outer shell and a slider, the slider can be axially slidably inserted into the outer shell, the outer tube is connected to the outer shell, the inner tube is connected to the slider, a Luer connector is provided at the proximal end of the slider, and the proximal end of the inner tube passes through the slider and is connected to the Luer connector.

3. The intraoperative guidance device according to claim 2, It is characterized in that A slide groove is formed on the side wall of the outer shell, and the slide groove has an axial length. The sliding block includes a protrusion, and the protrusion protrudes from the slide groove and can slide along the axial length of the slide groove.

4. The intraoperative guidance device according to claim 1, It is characterized in that The outer tube and the inner tube both have a distal opening, and the distal opening of the inner tube is placed between the curved tube section of the outer tube and the side hole.

5. The intraoperative guidance device according to claim 4, It is characterized in that The end of the branch pipe away from the inner pipe is a closed end, and a baffle is provided between the branch pipe and the inner pipe. The baffle blocks the inner pipe in the radial direction and separates the branch pipe into a first pipeline and a second pipeline in the axial direction. The baffle is provided with a notch at a position close to the closed end, and the first pipeline and the second pipeline are connected through the notch. The first pipeline and the second pipeline are respectively connected to the inner pipe on both sides of the baffle.

6. The intraoperative guidance device according to claim 1, It is characterized in that The bent pipe section includes a pre-bent area connected to the outer pipe, and the branch pipe includes a connecting area connected to the inner pipe. The bent pipe section and the branch pipe have elasticity at least in the pre-bent area and the connecting area.

7. The intraoperative guidance device according to claim 6, It is characterized in that The angle between the curved pipe section and the outer pipe in a natural state is less than or equal to 90°.

8. The intraoperative guidance device according to claim 6, It is characterized in that The angle between the curved pipe section and the outer pipe in a natural state is greater than or equal to 90°.

9. The intraoperative guidance device according to claim 1, It is characterized in that The indexing tube is provided with a plurality of developing structures, and the plurality of developing structures are arranged at intervals along the axial direction of the outer tube, and at least partially arranged in the branch tube.

10. The intraoperative guidance device according to claim 1, It is characterized in that It also includes a conveyor, which includes a conveying sheath and a tube seat, the proximal end of the conveying sheath is connected to the distal end of the tube seat, the guide tube is placed in the inner cavity of the conveying sheath and can slide axially along the conveying sheath; at least the distal part of the guide tube can pass through the distal port of the conveying sheath.

11. The intraoperative guidance device according to claim 10, It is characterized in that The axial length of the delivery sheath is smaller than the axial length of the guide tube.

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