Intraoperative pointing device

Abstract

The application provides an intraoperative guiding device, which comprises a guiding tube and a control handle, the proximal end of the guiding tube is connected with the distal end of the control handle; the guiding tube comprises an outer tube and an inner tube, the distal end of the outer tube is provided with a curved tube segment, the inner tube is at least partially arranged in the outer tube and can slide along the axial direction of the outer tube; the side wall of the outer tube is provided with a side hole, the side wall of the inner tube is provided with a branch tube, the branch tube of the inner tube is arranged to pass through the side hole and can slide along the axial direction of the side hole; the curved tube segment and the branch tube can be respectively arranged in different branch blood vessels after entering the blood vessels, so that the contrast agent can quickly reach different blood vessels, meanwhile, the guiding tube itself can continuously indicate the position of the blood vessels after the contrast agent is passed in, and the use frequency and dosage of the contrast agent are reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an intraoperative guidance device. Background Technology

[0002] With the increasing sophistication of endovascular repair techniques, more and more doctors are using endovascular interventional surgery to treat patients. Typically, the procedure requires 5-6 contrast agent administrations in conjunction with X-rays to confirm the condition of the blood vessels, with each administration using approximately 10-25 ml of contrast agent. This is used for purposes such as preoperatively locating the target vessel, positioning the stent after the delivery device reaches the target location, and confirming the stent's anchorage and occlusion status after deployment. If the procedure requires opening a branch, more contrast agent administrations are needed, typically 60-120 ml per successful operation. The maximum amount of contrast agent the human body can generally tolerate is 300 ml. Even within this tolerance range, contrast agent use may cause allergic reactions, decreased kidney function, kidney damage, and affect kidney metabolism. Therefore, reducing or even eliminating the dose of contrast agent entering the body is essential. Summary of the Invention

[0003] Therefore, it is necessary to provide a new intraoperative guidance device that can assist surgeons in quickly and accurately locating blood vessels, guide them in real time to complete the surgery quickly, improve the positioning accuracy of stent release, thereby greatly reducing the use of contrast agents and protecting the patient's renal function.

[0004] An intraoperative guiding device includes a guiding tube and a control handle, wherein the guiding tube is connected to the control handle; the guiding tube includes an outer tube and an inner tube, the distal end of the outer tube has a curved section, the inner tube is at least partially placed inside the outer tube and is slidable along the axial direction of the outer tube; a side hole is formed on the side wall of the outer tube, and a branch tube is formed on the side wall of the inner tube, the branch tube of the inner tube extending out from the side hole; the side hole has an axial length, and the branch tube is slidable along the axial direction of the side hole.

[0005] In one embodiment, the control handle includes a housing and a slider, the slider being slidably disposed within the housing along an axial direction, the outer tube being connected to the housing, the inner tube being connected to the slider, the proximal end of the slider being provided with a Luer connector, and the proximal end of the inner tube passing through the slider and connected to the Luer connector.

[0006] In one embodiment, the side wall of the outer casing is provided with a groove having an axial length, and the slider includes a protrusion that protrudes from the groove and can slide along the axial length of the groove.

[0007] In one embodiment, both the outer tube and the inner tube have a distal opening, with the distal opening of the inner tube positioned between the curved 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 radially and divides the branch pipe into a first pipe and a second pipe axially. The baffle has a notch near the closed end, and the first pipe and the second pipe are connected through the notch. The first pipe and the second pipe are respectively connected to the inner pipes on both sides of the baffle.

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

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

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

[0012] In one embodiment, the guide tube is provided with a plurality of developing structures, which are spaced apart along the axial direction of the outer tube and are at least partially located inside the branch tube.

[0013] In one embodiment, the device further includes a delivery device comprising a delivery sheath and a seat, the proximal end of the delivery sheath being connected to the distal end of the seat, the guide tube being slidably disposed axially within the cavity of the delivery sheath, and at least a distal portion extending from the distal port of the delivery sheath.

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

[0015] The beneficial effects of this invention are as follows: Compared with the prior art, this invention provides an intraoperative guidance device, including a guiding tube and a control handle, wherein the proximal end of the guiding tube is connected to the distal end of the control handle; the guiding tube includes an outer tube and an inner tube, the distal end of the outer tube is provided with a curved section, the inner tube is at least partially placed inside the outer tube and can slide along the axial direction of the outer tube; a side hole is opened on the side wall of the outer tube, and a branch tube is provided on the side wall of the inner tube, the branch tube of the inner tube passes through the side hole and can slide along the axial direction of the side hole; the curved section and the branch tube can be placed in different branch vessels after entering the blood vessel, so that the contrast agent can quickly reach different blood vessels, and the guiding tube itself can continuously indicate the position of the blood vessel after the contrast agent is introduced, reducing the number of times and the dosage of contrast agent used. Attached Figure Description

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

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

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

[0019] Figure 4 This is a schematic diagram of the curved pipe section and the outer pipe having an angle of less than 90° in Embodiment 3 of the present invention;

[0020] Figure 5 This is a schematic diagram showing that the angle between the curved pipe section and the outer pipe is greater than 90° in Embodiment 3 of the present invention;

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

[0022] Figure 7 An internal cross-sectional view of the intraoperative guidance device of the present invention after injection of contrast agent;

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

[0024] Figure 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] Figure 10 This is a schematic diagram of the developing structure in Embodiment 1 of the present invention;

[0026] Figure 11 This is a schematic diagram of the structure when the inner tube has two sections in Embodiment 1 of the present invention;

[0027] Figure 12 This is a schematic diagram of the intraoperative guidance device used at the aortic arch position in Embodiment 3 of the present invention;

[0028] Figure 13 This is a schematic diagram of the intraoperative guidance device used at the renal artery location in Embodiment 3 of the present invention;

[0029] Figure 14 This is a schematic diagram of the intraoperative guidance device in Embodiment 4 of the present invention;

[0030] Figure 15 This is a schematic diagram of the branch pipe rotating circumferentially in Embodiment 4 of the present invention;

[0031] Figure 16 This is a schematic diagram of the structure in Embodiment 4 of the present invention where the axial length of the side hole is equal to the diameter of the branch pipe;

[0032] Figure 17 for Figure 16 A partial internal sectional view at position I;

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

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

[0035] Figure 20 This is a schematic diagram of the other side of the inner tube and traction assembly in Example 6. Detailed Implementation

[0036] To better understand the concept of this application, the implementation methods of this application will be described in detail below with reference to the accompanying drawings. The following specific embodiments are only some embodiments of this application and are not intended to limit this application.

[0037] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would 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 may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0038] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0039] To more clearly describe the structure of this application, the terms "proximal" and "distal" are used here as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end furthest from the surgeon, and "proximal" refers to the end closest to the surgeon; "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial" direction; "upper end" and "lower end" are two relatively distant ends, and when one end is defined as "upper end", the other distant end is "lower end".

[0040] To address the problems existing in the prior art, this application provides a novel intraoperative guidance device designed to assist surgeons in quickly and accurately locating blood vessels, providing real-time guidance for rapid surgical completion, improving the positioning accuracy of stent deployment, increasing surgical efficiency, and significantly reducing the use of contrast agents while protecting patients' renal function. To a certain extent, it can eliminate the use of contrast agents, allowing patients with contrast agent allergies to undergo surgery under digital angiography.

[0041] Example 1:

[0042] Please see Figure 1 and Figures 7-9 In this embodiment, the intraoperative guidance device 100 includes a guiding tube 10 and a control handle 3. The proximal end of the guiding tube 10 is connected to the distal end of the control handle 3. The guiding tube 10 is inserted into the human blood vessel under the protection of the delivery sheath 52 of the delivery device 5. The control handle 3 is used to operate the guiding tube 10 externally. After the guiding tube 10 is inserted 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 guiding tube 10 includes an outer tube 1 and an inner tube 2. The distal end of the outer tube 1 is provided with a curved section 11. The curved section 11 can extend into the first branch vessel 92 when the outer tube 1 of the guiding tube 10 is located in the aorta 9. It can indicate the position of the branch vessel while perfusing contrast fluid into the branch vessel. The inner tube 2 is at least partially placed inside the outer tube 1 and can slide along the axial direction of the outer tube 1. Please refer to further details. Figure 2 A side hole 13 is provided on the side wall of the outer pipe 1, on the side with the same bending direction as the bent pipe section 11. A branch pipe 21 is provided on the side wall of the inner pipe 2, and the branch pipe 21 of the inner pipe 2 extends out through the side hole 13; please refer to further details. Figure 3 and Figure 12The inner tube 2 is provided with a side branch tube 21, which can extend into the second branch tube 91 adjacent to the first branch vessel 92, thereby indicating the position of the two branch vessels. This facilitates the doctor to quickly determine the positional relationship between the two branch vessels and their positional relationship with the aorta 9. Secondly, the branch tube 21 of the inner tube 2 provides more infusion ports for contrast fluid, allowing the contrast fluid to be output and diffused in the blood vessel more quickly, thereby shortening the diffusion time and reducing the output amount. 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 designed to be movable along the axial direction, which allows the distance between the curved tube section 11 and the branch tube 21 to be adjusted. This allows the branch tube 21 to be positioned to adapt to different distances between different blood vessels. This is because the distance between different branch vessels in the human body is different, and the distance between blood vessels also varies between different patients. This allows the guiding device of this application to have 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. The length of the curved tube segment 11 and the branch tube 21 should not be too long, so as to avoid the tube segment 11 and the branch tube 21 from scraping or hooking the blood vessel wall when they are released in the body, resulting in incomplete or inability to release, or even damage to the blood vessel. It is understood that the distal end of the outer tube 1 and the distal end of the inner tube 2 are provided with distal openings. The distal opening edge of the outer tube 1 is provided with a rounded transition to avoid the sharp tube opening edge scratching the blood vessel. The branch tube 21 is also provided with an opening, and the edge of the opening is also provided with a rounded transition to avoid the tube opening scratching the blood vessel. The distal opening of the inner tube 2 is located inside the outer tube 1, serving to connect the inner tube 2 and the outer tube 1. Preferably, the opening of the inner tube 2 is located between the curved section 11 and the side hole 13 of the outer tube 1. This allows the curved section 11 to have only a single layer of tube, ensuring better flexibility and resilience, while also facilitating axial sliding of the inner tube 2 within the outer tube 1. In one embodiment, please refer to... Figure 1The curved tube segment 11 and the branch tube 21 have a minimum distance L1, which is set to 5mm, that is, the distance between the side wall of the distal end of the side hole 13 and the curved tube segment 11 is 5mm. Since human blood vessels have thickness and there is usually a gap or angle between two adjacent branch vessels, a gap distance of less than 5mm makes it impossible for the curved tube segment 11 and the branch tube 21 to accurately indicate the positional relationship between two adjacent branch vessels. At the same time, the small gap between the curved tube segment 11 and the branch tube 21 is not conducive to the unfolding in human blood vessels and the folding in the delivery sheath 52. The minimum distance setting of 5mm can ensure that the curved tube segment 11 and the branch tube 21 can basically adapt to most of the branch vessels near the aorta in the human body, so that the intraoperative guidance device 100 of this application has better adaptability. The adjustable distance between the branch tube 21 and the curved tube segment 11 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 greater than 30mm, when the branch tube 21 is deployed in the blood vessel, there may be two branch vessels that are not adjacent to the branch vessel where the curved tube segment 11 is located, and there may be a branch vessel in between, which may lead to the error in indicating the relative position of the indicating vessel. Therefore, the maximum distance setting of 30mm can ensure that the intraoperative guidance device 100 provided in this application can be adapted to branch vessels with a large distance, especially the three branches of the aortic arch, thereby adapting to most types of branch vessels. At the same time, it can avoid the branch tube 21 crossing too many branch vessels when it is released, which would affect the accuracy of the indication.

[0044] Please continue reading. Figures 1-3In this embodiment, the control handle 3 is used to hold the intraoperative guiding device 100 and to control the inner tube 2 to slide axially within the outer tube 1. The control handle 3 includes a housing 31 and a slider 33. The housing 31 has an inner cavity that extends through both ends axially. The slider 33 is placed within the inner cavity of the housing 31 and is axially slidably inserted within it. The proximal end of the outer tube 1 is fixedly connected to the distal end of the housing 31. The slider 33 has an axially extending inner cavity. The proximal end of the inner tube 2 is fixedly connected to the distal end of the slider 33. A Luer connector 4 is connected to the proximal end of the slider 33, and the Luer connector 4 communicates with the cavity of the inner tube 2. Alternatively, the inner tube 2 directly passes through the slider 33 and connects to the Luer connector 4. Preferably, to facilitate user operation of the slider 33, a groove 32 is provided on the side wall of the housing 31, and the groove 32 has an axial length extending axially along the housing 31. The sidewall of block 33 is provided with a protrusion 34, which protrudes from and extends from the groove 32. The protrusion 34 can slide along the axial length of the groove 32. The user can hold the outer shell 31 with his hand and press his fingers against the protrusion 34 to push or pull the protrusion 34 so that the slider 33 slides axially within the outer shell 31. 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 slide synchronously along the side hole 13. Thus, the distance between the curved tube segment 11 and the branch tube 21 can be adjusted according to the different branch vessel spacing, so that the curved tube segment 11 and the branch tube 21 abut against the sidewalls of two adjacent branch vessels that are close to each other. In this way, when the contrast agent is introduced, the operator can also judge the morphology and relative position of the two branch vessels by the image position of the curved tube segment 11 and the branch tube 21 in the body, without having to repeatedly introduce contrast agent for identification.

[0045] Preferably, not shown in the figure, in one embodiment, anti-slip texture is added to the surface of the protrusion 34 to increase friction, making it easier for the operator to operate the control handle 3 more smoothly.

[0046] Please see Figure 10In this embodiment, both the outer tube 1 and the inner tube 2 of the guiding tube 10 are provided with imaging structures 6. The imaging structures 6 can be provided along the entirety of the outer tube 1 and the inner tube 2, or they can be provided only in the curved tube section 11, the branch tube 21, or multiple structures arranged at intervals along the axial direction of the outer tube 1. The tube body itself has imaging structures 6, which allows the position of the curved tube section 11 and the branch tube 21 in the blood vessels to be directly observed by angiography after the tube body enters the human blood vessel. The imaging structures 6 are provided in the curved tube section 11 and the branch tube 21. Combined with the imaging structures 6 arranged at intervals on the outer tube 1, the operator can measure the distance between the two branch blood vessels being clamped or the inner diameter of the clamped blood vessel based on the spacing of the imaging structures 6 on the tube body under the image, which is convenient for doctors to operate and select instruments of appropriate specifications. Preferably, the imaging length X1 of the imaging structures 6 arranged 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 imaging material in the tube body with imaging structures 6.

[0047] Please see Figure 11 In another embodiment, to enable the tube to extend into more branch vessels, achieving rapid vessel location and rapid release of contrast fluid, the inner tube 2 can be provided with two tubes, 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 has at least two side holes 13 along the axial direction, namely a first side hole 131 and a second side hole 132. The first inner tube 201 is placed inside the outer tube 1, and the branch tube 21 extends out from the first side hole. The second inner tube 202 is placed inside the first inner tube 201. The first inner tube 201 has an inner tube side hole at a position opposite to the second side hole, and 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 it moves axially, the branch tube 21 of the second inner tube 202 simultaneously passes through the inner tube side hole and the second side hole. With this configuration, 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 has at least two sliding grooves 32, namely the first sliding groove 321 and the second sliding groove 322. The protrusion 34 of the first slider 341 extends from the first sliding groove 321, and the protrusion 34 of the second slider 342 extends from the second sliding groove 322. The axial sliding of the first inner tube 201 and the second inner tube 202 is controlled by the two protrusions 34 respectively.

[0048] Example 2:

[0049] Please see Figure 1 and Figure 6In this embodiment, the structure of the guide tube 10 and the control handle 3 is basically the same as in embodiment 1. The difference is that the end of the branch tube 21 away from the inner tube 2 is a closed end 212, which prevents the contrast agent from flowing out of the branch tube 21, making the branch tube 21 the flow path for the contrast agent. A baffle 211 is provided between the closed end 212 branch tube 21 and the inner tube 2. The baffle 211 blocks the inner tube 2 radially and divides the branch tube 21 into a first pipeline 214 and a second pipeline 215 axially. The baffle 211 has a notch 213 near the closed end 212. The first pipeline 214 and the second pipeline 215 are connected through the notch 213. The first tube 214 and the second tube 215 are respectively connected to the inner tubes 2 on both sides of the baffle 211. The purpose of setting the baffle 211 is to block the part of the inner tube 2 from the far end to the branch tube 21 and the part of the inner tube 2 from the proximal end to the branch tube 21. The end of the branch tube 21 is a closed end 212. After the baffle 211 is closed, a notch 213 is formed at the closed position, so that the branch tube 21 becomes a U-shaped tube structure. In this way, after the contrast agent enters the inner tube 2, when it passes through the branch tube 21, it will form a loop and will not flow out from the branch tube 21. Thus, the branch tube 21 becomes a guide that is always filled with contrast agent and has better imaging indication performance.

[0050] In another embodiment, not shown in the figure, the branch tube 21 can be formed by the inner tube 2 forming a U-shaped bend in the middle section between the distal and proximal ports, and the parts that are close to each other after the bend are bonded together to form the branch tube 21; the branch tube 21 is perpendicular to the inner tube 2 in its natural state; with this configuration, a loop can also be formed, and no contrast agent will flow out from the branch tube 21, thereby making the branch tube 21 a guide that is always filled with contrast agent.

[0051] Example 3

[0052] Please see Figure 4-5 In this embodiment, the structure of the guide tube 10 and the control handle 3 is basically the same as in embodiments 1 and 2. The difference is that the curved tube section 11 and the branch tube 21 are elastic, so that the curved tube section 11 and the branch tube 21 always have a force to spring back to their natural state. In this embodiment, the angle between the curved tube section 11 and the outer tube 1 in the natural state is less than or equal to 90 degrees, preferably less than 90 degrees. For this setting, please refer to [reference needed]. Figure 4The purpose is that this type of guiding device can better measure the distance and positional relationship between two adjacent branch vessels; so that the curved tube segment 11 is slightly tilted towards the branch tube 21 in its natural state and has the force to rebound to the initial state. The curved tube segment 11 and the branch tube 21 form a structure that clamps towards the middle position, thereby ensuring that when the curved tube segment 11 and the branch tube 21 are clamped together on two adjacent branch vessels, there is a clamping force, which increases the adhesion of the curved tube segment 11 and the branch tube 21 to the wall, making it less likely to fall off, and can more accurately guide the positional relationship between the two branch vessels; preferably, the branch tube 21 can be set to a structure that is tilted towards the curved tube segment 11.

[0053] Please see Figure 4 and Figure 8 In this embodiment, when the guide tube 10 is pre-installed into the outer sheath, the curved tube section 11 is straightened away from the branch tube 21 and then sent into the delivery sheath 52, and the branch tube 21 is bent away from the curved tube section 11 and then sent into the delivery sheath 52; in this way, the curved tube section 11 and the branch tube 21 have a spring-like tendency to move closer to each other after they come out of the delivery sheath 52, thereby forming a clamping structure.

[0054] In this embodiment, please refer to further details. Figure 12 In an endovascular repair surgery covering the left subclavian artery, the intraoperative guiding device 100 can be accessed from the axillary artery and other arteries through the left subclavian artery to the aortic arch 9. At this time, contrast agent is injected through the Luer connector 4 using a syringe, and the guiding tube 10 can be used to release the contrast agent to confirm the position of each branch. The delivery sheath 52 is retracted using the tube seat 51. During the retraction process, when the outer tube 1 slightly exposes the sheath opening of the delivery sheath 52, the bent tube segment 11 will be deflected and rebounded to the side of the inner tube 2 by the rebound force of the pre-bending zone 12. At this time, the direction of the bent tube segment 11 can be adjusted towards the left common carotid artery by rotating the direction of the outer shell 31. Next, the guidewire is used to pull the curved tube segment 11 into the left common carotid artery. After the curved tube segment 11 is completely released, it automatically rebounds proximally due to the rebound force of the pre-bending zone 12. The control handle 3 is slightly retracted to keep the curved tube segment 11 attached to the distal side of the left common carotid artery wall. When the delivery sheath 52 is retracted until the branch tube 21 is completely released, the branch tube 21 automatically rebounds distally and is released into the left subclavian artery due to the rebound force of the pre-bending zone 12. The slider 33 is adjusted to keep the branch tube 21 attached to the proximal side of the left subclavian artery wall. At this time, the anchoring zone of the aortic arch 9 can be confirmed by the mutual clamping position of the curved tube segment 11 and the branch tube 21, and the changes in the vessels in the anchoring zone can be continuously observed. This method can reduce the release of contrast agent in subsequent delivery device 5 access, stent positioning, and other situations.

[0055] Please see Figure 5 and Figure 13 In another embodiment, the angle between the curved tube segment 11 and the outer tube 1 in its natural state is greater than or equal to 90 degrees, preferably greater than 90 degrees. This is to ensure that this type of guiding device can better measure the width and positional relationship of the opening where a single branch vessel connects to the aorta 9. The curved tube segment 11 is slightly tilted away from the branch tube 21 in its natural state and has a force to rebound to the initial state. The curved tube segment 11 and the branch tube 21 form a structure that tilts and expands in opposite directions. This ensures that when the curved tube segment 11 and the branch tube 21 enter a single branch vessel at the same time, they adhere to the side walls respectively, thereby increasing the wall adhesion of the curved tube segment 11 and the branch tube 21, making them less likely to fall off, and more accurately guiding the width and positional relationship of the opening of the single branch vessel. Preferably, the branch tube 21 can be configured to tilt away from the curved tube segment 11.

[0056] In this embodiment, please refer to further details. Figure 9 When the guide tube 10 is pre-installed into the outer sheath, the curved tube section 11 is folded towards the direction of the branch tube 21 and then inserted into the delivery sheath 52. The branch tube 21 is bent towards the direction of the curved tube section 11 and then inserted into the delivery sheath 52. In this way, the curved tube section 11 and the branch tube 21 have a tendency to rebound in a direction away from each other after they come out of the delivery sheath 52, thereby forming a structure that abuts against both sides, so as to further adapt to the structure that abuts against the lateral walls in a single blood vessel.

[0057] In this embodiment, please refer to further details. Figure 13 When using the aforementioned guiding tube 10, first pull the curved tube segment 11 into the left renal artery 93, and use the control handle 3 to adjust the curved tube segment 11 to be in close contact with the proximal side of the left renal artery 93. Then, retract the delivery sheath 52 to release the branch tube 21 into the left renal artery 93, and adjust the slider 33 to make the branch tube 21 be in close contact with the distal side of the left renal artery 93. Figure 13 The intraoperative guidance device 100 shown is held against both sides of the left renal artery 93 and continuously observed during the operation.

[0058] Similarly, another set of intraoperative guidance devices 100 can be used to locate the right renal artery 93 using the same method, so that the real-time position of the two renal arteries 93 can be observed simultaneously.

[0059] In this embodiment (not shown in the figures), the bent 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. At least the pre-bending area 12 and the connecting area 24 are elastic. The pre-bending area 12 and the connecting area 24 may have pre-shaped elastic supports embedded within them, thereby giving the branch pipe 21 and the bent pipe section 11 better bending performance. Preferably, the elastic support can be a spring tube embedded inside the pipe body.

[0060] Example 4

[0061] Please see Figures 14-17 In this embodiment, the relative position and structure of the inner tube 2 and outer tube 1 of the intraoperative guiding device 100 are largely the same as in embodiments 1-3. The difference is that the control handle 3 can control the branch tube 21 to swing and tilt in the axial direction. With this setting, the tilting direction of the branch tube 21 can be controlled and adjusted by the control handle 3, so that the guiding device of this application can better adapt to the shape and position relationship of blood vessels when facing the complex and varied blood vessel types in the human body. By adjusting the relative position of the branch tube 21 and the curved tube segment 11 outside the body by controlling the handle 3, the intraoperative guiding device 100 can adapt to branch blood vessels with different spacing. Adjusting the angle between them can also make the curved tube segment 11 and the branch tube 21 better clamped in the two branch blood vessels and prevent them from falling off.

[0062] In this embodiment, please refer to Figure 16 and 17To enable the control handle 3 to control the branch tube 21 to swing and tilt in different directions within 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. Furthermore, the hardness of the connection area 24 is set to be less than the hardness of other areas of the branch tube 21 except for the connection area 24 and the hardness of the outer tube 1. This allows the sidewall of the branch tube 21 to further push or pull the inner tube 2 when it abuts against the wall of the side hole 13 at both ends of the axial direction. The wall of the side hole 13 can generate a compressive force on the branch tube 21, thereby forcing the branch tube 21 to deform at the connection area 24, creating a tilt angle and forming an tilted branch tube 21 to adapt to different types of blood vessels. Preferably, the connection area 24 can be connected using a flexible tube. The flexible tube allows the branch tube 21 to have better flexibility at this position, so that this position will deform preferentially when the branch tube 21 is compressed. The upper end of the connection area 24 of the branch tube 21... The portion does not deform when it is in motion, thus forming an inclined structure instead of a bent structure. In this embodiment, it can be understood that the low hardness of the connecting area 24 is mainly manifested in the low hardness in the radial direction. Therefore, the connecting area 24 of the flexible tube can be a pipe segment with a relatively thin thickness, or a pipe segment of the same thickness but made of a different, softer material. The axial length of the side hole 13 is set to be greater than or equal to the diameter of the branch pipe 21. When the axial length of the side hole 13 is slightly greater than the diameter of the branch pipe 21, the distance between the branch pipe 21 and the wall of the opposite side hole 13 after it tilts increases, so the branch pipe 21 can tilt at a larger angle when squeezed. When the axial length of the side hole 13 is equal to the diameter of the branch pipe 21, the branch pipe 21 tilts faster in response to the control handle 3. This is because the connecting area 24 is always in contact with the side hole 13. When the inner tube 2 moves axially, the connecting area 24 will be squeezed and deformed immediately, causing the branch pipe 21 to tilt.

[0063] In this embodiment, please refer to Figure 14 and Figure 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 by a rotation angle, and the angle rotated does not exceed the range of the circumferential width. The purpose of this setting is that the angles of blood vessels in the human body are often not on the same plane in terms of anatomical morphology. In order to meet the requirement that multiple blood vessels with different tilt angles can be marked by the guiding device, the branch tube 21 can tilt axially and rotate in the circumferential direction. It can not only adapt to blood vessels at different angles, but also to blood vessels in different planes. In this way, even if the bending shape of two adjacent blood vessels is very complex, the bending tube segment 11 and the branch tube 21 can be sent into the adjacent branch blood vessels for adaptation and measurement by the intraoperative guiding device 100 of this application. It can meet the requirement of quickly filling contrast agent into different branch blood vessels and can indicate the positional relationship and morphology of different branch blood vessels. Preferably, the included 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 that the branch tube 21 can rotate in the circumferential direction is 180°. Further, the maximum angle that can be rotated in the circumferential direction on both sides can be 90°, which can be achieved by cutting half of the outer tube 1 in the circumferential direction of the side hole 13. In this way, it can be ensured that the inner tube 2 can rotate through the maximum angle without falling out of the outer tube 1, and can be adapted to two branch blood vessels with a large degree of tortuosity.

[0064] Example 5

[0065] Please refer to 14 and 18. In this embodiment, the relative positions and structures of the inner tube 2 and outer tube 1 of the intraoperative guidance device 100 are largely the same as in embodiments 1-4. The difference is that it also includes a traction component 8. The traction component 8 is used to establish a connection between the two distal components to achieve a more remote control relationship. In this embodiment, the traction component 8 is used to establish a connection between the control handle 3 and the branch tube 21. The control handle 3 includes a control body 331 and a housing 31. The control body 331 is located in the inner cavity of the housing 31 and is connected to the inner tube 2. The housing 31 is connected to the outer tube 1. One end of the traction component 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 branch tube 21 to swing and tilt through the traction component 8. The control body 331 is used to control the inner tube 2 and its branch tube 21, and the housing 31 is used to control the outer tube 1. The control body 331 can drag the inner tube 2 to move back and forth along the axial direction, and the control body 331 is connected to the traction component. 8. A connection is established with the branch tube 21 to control the swing of the branch tube 21 in both axial directions. In conjunction with its control of the axial sliding of the inner tube 2, the user can first slide the control body 331 axially, and use the axial movement of the branch tube 21 to change the positional relationship between the curved tube segment 11 and the branch tube 21, thereby adapting to and determining the position of the two branch vessels. Furthermore, by controlling the tilting and swinging of the branch tube 21 through the control body 331, it can fit against the vessel wall, which can determine the positional relationship between the two branch vessels and also detect the bending shape of the branch vessels. The control body 331 is at least partially exposed on the outer wall of the outer shell 31. In this way, the operator can control the control body 331 while holding the outer shell 31, thereby achieving 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 groove 32, and the control body 331 is at least partially exposed on the surface of the groove 32 for the operator to operate; or the proximal end of the control body 331 extends beyond the proximal end of the outer shell 31 for control.

[0066] In this embodiment, please refer to further details. Figure 14 and Figure 18To enable the user to control the branch pipe 21 from the position of the control body 331, the branch pipe 21 includes an extension 7. The upper end of the extension 7 is connected to the branch pipe 21, and the lower end extends to the radial sides of the inner pipe 2. It should be noted that the upper end refers to the end away from the inner pipe 2, and the lower end refers to the end closer to the inner pipe 2. The control body 331 includes a control element 334. At least one end of the traction assembly 8 is connected to the extension 7, and the other end is connected to the control element 334. The control element 334 controls the traction assembly 8 to slide axially along the inner pipe 2. It can be understood that the branch pipe 21 is connected to the traction assembly through the extension 7. The traction assembly 8 is connected to the control component 334 and is controlled by the control component 334. When the control component 334 controls the traction assembly 8 to pull, it pulls the lower end of the extension 7 to swing. At this time, since the upper end of the extension 7 is connected to the branch pipe 21, the branch pipe 21 uses the connection area 24 connected to the inner pipe 2 as a fulcrum and will swing in the opposite direction to the direction in which the lower end of the extension 7 is pulled, realizing the swinging action in both axial directions. Preferably, the control body 331 can slide along the axial direction of the outer shell 31, so that the entire control body 331 can drive the inner pipe 2 to slide axially. Furthermore, the control component 334 can slide along the axial direction of the control body 331, so that when the control body 331 is stationary, the traction component 8 can be controlled to slide axially through the control member 334, thereby causing the lower end of the extension 7 to swing. The outer shell 31 has a groove 32 with an axial length, and the control member 334 protrudes from the groove 32. The outer shell 31 also has a groove 32 that avoids the control member 334. The control member 334 protrudes from the surface of the groove 32 of the outer shell 31, allowing the user to directly control the control member 334 located on the control body 331 through the groove 32 when holding the outer shell 31. The axial length of 2 is greater than or equal to the axial sliding length of the control element 334 to avoid interfering with the control stroke of the control element 334; in a preferred embodiment, the control body 331 can be provided with a protruding bump 34, the bump 34 is fixedly connected to the control body 331, and the bump 34 also protrudes from the slide groove 32, so that the user can not only control the control element 334, but also drag the control body 331 by dragging the bump 34, so that the control body 331 can slide along the axial direction of the outer shell 31, thereby driving the inner tube 2 to slide along the axial direction, and adjusting the distance between the curved pipe section 11 and the branch pipe 21.

[0067] In this embodiment, please refer to further details. Figure 18The 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 disposed on the wall of the inner tube 2 and located at the distal end of the branch tube 21. The second winding shaft 83 is disposed on the control body 331 and located at the proximal end of the control member 334. The traction wire 81 is wrapped around the first winding shaft 82 and the second winding shaft 83. The lower end of the extension 7 and the control member 334 are fixedly connected to the traction wire 81. It can be understood that the arrangement of the first winding shaft 82 and the second winding shaft 83 allows the traction wire 81 to form a ring-shaped, conveyor belt-like structure between the extension 7 and the control member 334 when wrapped around the two winding shafts. The traction wire 81 is taut when wrapped around the first winding shaft 82 and the second winding shaft 83. Thus, after the extension 7 and the control member 334 are connected to the traction wire 81, the control member 334 can... The traction wire 81 controls the lower end of the extension 7. Understandably, the traction wire 81, after being wrapped around the shaft, has upper and lower wires distributed at the upper and lower ends. The extension 7 and the control member 334 can selectively connect to the upper or lower wire. When the lower end of the extension 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 7 is opposite to the sliding direction of the control member, so that the tilting swing direction of the branch pipe 21 is the same as the sliding direction of the control member, making it easier for the user to quickly adapt to the control of the control body 331. When the lower end of the extension 7 is connected to the upper or lower wire and the control member 334 is the same as the lower end of the extension 7, it is also connected to the upper or lower wire. The swing direction of the lower end of the extension 7 is the same as the sliding direction of the control member, so that the tilting swing direction of the branch pipe 21 is opposite to the sliding direction of the control member.

[0068] In one embodiment (not shown in the figure), the sidewalls of the inner tube 2 and the control body 331 are provided with receiving grooves for accommodating the traction component 8. The traction component 8 can be disposed in the receiving groove, and the first rotating shaft 82 and the second rotating shaft 83 are disposed at both ends of the receiving groove. In this way, the traction component 8 can be prevented from protruding from the outer sidewall of the inner tube 2, thereby avoiding a large gap between the outer sidewall of the inner tube 2 and the outer tube 1, which would affect the smoothness of the movement of the inner tube 2 in the outer tube 1.

[0069] In this embodiment, the extension 7 can be formed directly on the side wall of the branch pipe 21 during the forming of the branch pipe 21, and at least the upper end of the extension 7 is combined with the branch pipe 21, while the lower end is separated from the inner pipe. Preferably, the extension 7 can be attached to the side wall of the branch pipe 21 by means of bonding, hot melting or other methods after the branch pipe 21 is formed.

[0070] Example 6

[0071] Please see Figure 19 and Figure 20In this embodiment, the relative positions and structures of the inner tube 2 and outer tube 1 of the intraoperative guidance device 100 are largely the same as in embodiments 1-5. The difference is that this embodiment controls the branch tube 21 through two sets of control components. Specifically, the extension 7 includes a first extension 71 and a second extension 72, which are respectively located on opposite sides of the branch tube 21. The two extensions control the tilt of the branch tube 21 along the axial direction at both ends. The control component 334 includes a first control component 332 and a second control component 333, which are respectively located on opposite sides of the control body 331. The first control component 332 and the second control component 333 control the first extension 71 and the second control component 333 respectively. The traction component 8 includes a first traction wire 811 and a second traction wire 812. One end of the first traction wire 811 is connected to the lower end of the first extension 71, and the other end is connected to the first control component 332. The first control member 332 and the first extension 71 are located on the same side, and the second control member 333 and the second extension 72 are located on the same side. The two ends of the first traction wire 811 are directly connected from the proximal end of the first extension 71 to the lower end of the first extension 71, and to the first control member 332. When the user pulls the first control member 332 at the proximal end, the lower end of the first extension 71 swings in the pulling direction, thereby causing the branch tube 21 to tilt and swing in the opposite direction. In order for 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 from the distal end of the second traction member to the lower end of the second traction member, and the other end is connected to the second control member 333. Thus, when the second control member 333 is pulled, the second traction wire 812 pulls the lower end of the second extension 72 to swing in the distal direction, causing the branch tube 21 to tilt and swing in the proximal direction, which is opposite to the tilting direction controlled by the first control member.

[0072] For preferred options, please refer to further information. Figure 20 In order to connect the second traction wire 812 to the distal end of the second extension 72, the inner tube 2 is provided with a third winding shaft 84 on the distal end of the second extension 72. One end of the second traction wire 812 is wound around the third winding shaft 84 and then connected to the lower end of the second extension 72, and the other end is connected to the second control member 333. The second traction wire 812 can change the pulling direction of the second traction wire 812 by passing around the third winding shaft 84 on the distal end and then connecting to the lower end of the second extension 72.

[0073] The above specific embodiments are only some embodiments of the present invention and are not intended to limit the present invention. This specification cannot exhaustively describe all embodiments of the present invention concept, and some features of the different embodiments described above can be substituted for or combined with each other. Those skilled in the art can also make simple substitutions according to actual needs. The concept of the present invention is subject to the claimed protection scope.

Claims

1. An intraoperative guidance device, characterized in that, The device includes a guiding tube and a control handle, the guiding tube being connected to the control handle; the guiding tube includes an outer tube and an inner tube, the distal end of the outer tube having a curved section, the inner tube being at least partially placed inside the outer tube and slidable along the axial direction of the outer tube; a side hole is formed on the side wall of the outer tube, and a branch tube is formed on the side wall of the inner tube, the branch tube of the inner tube extending out 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, thereby adjusting the positional relationship between the curved section and the branch tube, and thus adapting and determining the positional relationship between the two branch blood vessels.

2. The intraoperative guidance device according to claim 1, characterized in that, The control handle includes a housing and a slider. The slider is slidably inserted into the housing along the axial direction. The outer tube is connected to the housing, and the inner tube is connected to the slider. The slider has a Luer connector at its proximal end, 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, characterized in that, The outer casing has a groove on its side wall, the groove has an axial length, and the slider includes a protrusion that protrudes from the groove and can slide along the axial length of the groove.

4. The intraoperative guidance device according to claim 1, characterized in that, Both the outer tube and the inner tube have distal openings, with the distal opening of the inner tube positioned between the curved section of the outer tube and the side hole.

5. The intraoperative guidance device according to claim 4, characterized in that, The end of the branch pipe away from the inner pipe is a closed end. A baffle is provided between the branch pipe and the inner pipe. The baffle blocks the inner pipe radially and divides the branch pipe into a first pipe and a second pipe axially. The baffle has a notch near the closed end. The first pipe and the second pipe are connected through the notch. The first pipe and the second pipe are respectively connected to the inner pipes on both sides of the baffle.

6. The intraoperative guidance device according to claim 1, characterized in that, The curved pipe segment includes a pre-bending area connected to the outer pipe, and the branch pipe includes a connection area connected to the inner pipe. The curved pipe segment and the branch pipe are elastic at least in the pre-bending area and the connection area.

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

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

9. The intraoperative guidance device according to claim 1, characterized in that, The guide tube is provided with multiple developing structures, which are spaced apart along the axial direction of the outer tube and are at least partially located inside the branch tube.

10. The intraoperative guidance device according to claim 1, characterized in that, It also includes a conveyor, which comprises a conveying sheath and a tube seat, the proximal end of the conveying sheath being connected to the distal end of the tube seat, and a guide tube being placed in the inner cavity of the conveying sheath and slidable along the axial direction of the conveying sheath; at least the distal portion of the guide tube can extend out from the distal port of the conveying sheath.

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

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