Intraoperative stent delivery devices and intraoperative stent systems

Abstract

The present invention relates to the field of medical devices, and provides an intraoperative stent delivery device and an intraoperative stent system. The intraoperative stent delivery device is used to assemble and release a branch-type intraoperative stent, which includes a main stent and a side branch stent. The intraoperative stent delivery device includes a side branch liner for supporting the main stent and a side branch liner for supporting the side branch stent, a soft membrane for restraining the side branch stent, and a retraction member. The side branch liner is a through structure, and the retraction member is movable in the side branch liner. The soft membrane is connected to the distal end of the retraction member after being concentrated at the distal end of the side branch liner. Among them, the soft membrane can also be used as a branch blocking component to prevent the backflow of branch blood vessels at the target position, ensure a clear field of vision within the stent operation range, facilitate the doctor's operation, and the blocking process does not need to be operated separately in steps, shortening the operation time, and improving the success rate of the operation and the postoperative effect. The intraoperative stent system includes the above-mentioned intraoperative stent delivery device.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an intraoperative stent delivery device and an intraoperative stent system comprising the intraoperative stent delivery device. Background Art

[0002] In recent years, the method of implanting the stent used in the intraluminal isolation technology into the aortic lesion under surgical conditions has been widely used in many lesions of the thoracic aorta, abdominal aorta, iliac blood vessels, etc. due to its low trauma and high success rate. Among them, the stent is implanted into the corresponding lesion position through surgery, so this stent is usually called an intraoperative stent. The intraoperative stent needs to be implanted into the corresponding lesion position with the help of a delivery device, that is, the diameter of the intraoperative stent is reduced by the delivery device, and the intraoperative stent is released after being delivered to the corresponding lesion position. If necessary, the intraoperative stent and the artificial blood vessel are sutured, and finally the delivery device is withdrawn. However, due to the complexity of the anatomical structure of the aorta, the current delivery device still has many problems when delivering intraoperative stents.

[0003] Taking aortic disease as an example, aortic aneurysm or dissection often widely affects the ascending aorta, aortic arch and descending aorta. Surgical resection and vascular reconstruction are quite complicated. The common treatment method is to replace the body's own ascending and arch diseased blood vessels through surgical implantation. Traditional elephant trunk surgery (ET) inserts a section of artificial blood vessel (commonly known as elephant trunk) into the true lumen of the descending aorta while performing aortic arch replacement surgery to reduce the difficulty of distal reoperation. It is usually completed in two stages. Traditional elephant trunk surgery can cause complications such as brain and spinal cord injury, embolism, blood circulation disorders, and bleeding due to extracorporeal circulation and deep hypothermic circulatory arrest.

[0004] At present, stent elephant trunk surgery is commonly used in clinical practice. The structural principle of stent elephant trunk surgery is as follows: Figure 1 As shown. The artificial blood vessel 110 is connected to the intraoperative stent 130 through the suture port 120. The intraoperative stent 130 is implanted into the descending aorta 10 and released by a delivery device under direct vision in the first-stage operation. After the release, the proximal membrane segment of the intraoperative stent 130 is emptied, and the distal end of the artificial blood vessel 110 is anastomosed with the aortic wall or the blood vessel of the replacement arch. This stent-elephant trunk surgery combines the elephant trunk principle and the concept of interventional stent blood vessels, and can be completed through the median sternotomy at the same time. Its advantage is that it can be anchored at a specific level of the descending aortic aneurysm wall, promoting thrombosis between the elephant trunk blood vessel and the aneurysm wall, thus avoiding the second-stage surgery that may be performed due to late aneurysm or rupture of the descending aorta. Compared with the traditional elephant trunk surgery, it can simplify the operation and reduce complications.

[0005] Figure 1The intraoperative stent shown is a straight-tube stent, which has the problem of being difficult to completely match the branches of human blood vessels. Therefore, a branch-type intraoperative stent is currently more commonly used for implantation. When aortic disease surgery is performed using a branch-type intraoperative stent and an artificial blood vessel, it is often necessary to free, block and anastomose the brachiocephalic branch vessels on the arch. There are many important tissue structures around the aortic arch, including the trachea, esophagus, nerves, thoracic duct, etc., so very high technical requirements are put forward for the freeing of the brachiocephalic blood vessels, which increases the difficulty of freeing the branch vessels on the arch. The prior art (such as CN104873305A) proposes to block the aortic blood vessels and the branch vessels on the aortic arch by adding a flexible sheet or a fillable balloon at the connection between the branch coated stent and the main artificial blood vessel or in the cavity of the branch coated stent. However, the blocking device using a flexible sheet needs to pass the release line from the outside of the main artificial blood vessel cavity along the inner hole of the folded suture in sequence. When released, it is easy to cause the release line to tighten the side branch stent, causing the side branch stent to twist and deform, and cause occlusion in the long term. The use of balloon-fillable occlusion devices not only increases the overall cross-section of the side branch stent, but also requires the balloon to be filled and withdrawn, which increases the operation time. Therefore, when using intraoperative stents for aortic disease surgery, how to make the suture between the branch stent and the artificial blood vessel clear, reduce the difficulty of the operation, and shorten the operation time, so as to improve the success rate of the operation and the postoperative effect, is still an important problem that needs to be solved in this field. Summary of the invention

[0006] In order to provide a clear view of the suture between the main stent and the artificial blood vessel after placement of the intraoperative stent during open-chest surgery, reduce the difficulty of the surgery and shorten the operation time, and increase the success rate and postoperative effect of aortic disease surgery, the present invention provides an intraoperative stent delivery device and an intraoperative stent system.

[0007] According to one aspect of the present invention, there is provided an intraoperative stent delivery device for delivering and releasing a branch-type intraoperative stent, wherein the branch-type intraoperative stent comprises a main stent and a side branch stent, and the intraoperative stent delivery device comprises a main body lining for supporting the main stent and a side branch liner for supporting the side branch stent, a soft membrane for restraining the side branch stent, and a retraction member, wherein the side branch liner is a hollow structure, the retraction member is movable within the side branch liner, and the soft membrane is connected to the distal end of the retraction member after the distal end of the side branch liner is tightened.

[0008] Optionally, the proximal pore size of the side branch liner is smaller than the distal pore size.

[0009] Optionally, the retraction member includes a retraction guide wire.

[0010] Optionally, the proximal pore diameter of the side branch liner is larger than the diameter of the withdrawal guide wire but smaller than or equal to twice the diameter of the withdrawal guide wire.

[0011] Optionally, the intraoperative stent delivery device further includes a control end and a support rod connected to the control end, the main body lining is connected to the distal end of the support rod, the side branch lining is arranged on the support rod, and the support rod is a hollow tubular structure.

[0012] Optionally, the intraoperative stent delivery device further comprises a retraction track, which passes through the connected interior of the support rod and the side branch liner and is arranged between the control end and the distal end of the side branch liner.

[0013] Optionally, the control end includes a first wire puller, and the proximal end of the retraction member is connected to the first wire puller.

[0014] Optionally, the control end further includes a second wire puller for releasing the main body support.

[0015] Optionally, the control end further includes a handle and a slider slidably disposed on the handle, wherein the slider is connected to the side branch liner to control the angle between the side branch liner and the support rod.

[0016] Optionally, the material of the side branch lining includes at least one of soft silicone, rubber, nylon elastomer, low-density polyethylene, polyester, ultra-high molecular polyethylene, stainless steel, and nickel titanium; the material of the soft membrane includes at least one of polyester, polytetrafluoroethylene and its derivatives, polyethylene terephthalate and its derivatives.

[0017] According to another aspect of the present invention, an intraoperative stent system is also provided, which includes a branch-type intraoperative stent and the above-mentioned intraoperative stent delivery device, wherein the branch-type intraoperative stent includes a main stent and a side branch stent, wherein the main stent is sleeved on the outside of the main body lining of the delivery device, and the side branch stent is sleeved on the outside of the side branch lining of the intraoperative stent delivery device, and the side branch stent is constrained in the soft membrane of the intraoperative stent delivery device before release.

[0018] Optionally, the branch-type intraoperative stent further includes an artificial blood vessel connected to and communicated with the proximal end of the main stent.

[0019] The intraoperative stent delivery device provided by the present invention is used for delivering and releasing a branch-type intraoperative stent, especially a side branch stent. The intraoperative stent delivery device comprises a side branch liner for supporting the side branch stent, a soft membrane for restraining the side branch stent, and a retraction member. The side branch liner is a hollow structure. The retraction member is movable in the side branch liner. The soft membrane is connected to the distal end of the retraction member after the distal end of the side branch liner is tightened. The intraoperative stent delivery device has the following advantages:

[0020] First, a retraction piece is provided on the delivery device, and is connected to the soft membrane used to restrain the side branch stent at the distal end of the side branch liner. After the side branch stent is delivered to the target position, the proximal end of the side branch stent is released first, and the soft membrane covers the distal end of the side branch liner and the partially released side branch stent. Thus, the soft membrane can also serve as a branch blocking component to prevent reflux of the branch blood vessels at the target position, thereby ensuring a clear field of vision within the surgical range of the stent, facilitating doctors to perform operations such as releasing the main stent and suturing artificial blood vessels, shortening the operation time, and improving the success rate of the operation and postoperative effects.

[0021] Secondly, as part of the intraoperative stent delivery device, the retraction piece and the soft membrane can be used to block and conduct the branch blood vessels at the target location as needed during the release of the branch-type intraoperative stent and the withdrawal of the intraoperative stent delivery device. The blocking process does not require separate step-by-step operations, which is easy to operate and helps shorten the operation time.

[0022] Again, through the linkage of the retraction piece and the soft membrane, the side branch stent is gradually released from the proximal end to the distal end. This release method can prevent the side branch stent from shortening and avoid long-term stent stenosis or even occlusion.

[0023] The intraoperative stent system provided by the present invention includes a branch-type intraoperative stent and the above-mentioned intraoperative stent delivery device, and has the same or similar advantages as the above-mentioned intraoperative stent delivery device. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 This is the structural principle diagram of the stent elephant trunk surgery.

[0025] Figure 2 It is a schematic diagram of a branched intraoperative stent.

[0026] Figure 3 Schematic diagram of an intraoperative stent delivery device according to an embodiment of the present invention.

[0027] Figure 4 It is an enlarged schematic diagram of a side branch liner in an intraoperative stent delivery device according to an embodiment of the present invention.

[0028] Figure 5 It is a schematic diagram of the tightened state of the side branch liner after assembling the side branch stent using an embodiment of the present invention.

[0029] Figure 6 It is a schematic diagram of blocking a branch blood vessel during surgery using a stent delivery device according to an embodiment of the present invention.

[0030] Figure 7 Schematic diagram of an intraoperative stent system according to an embodiment of the present invention.

[0031] Figure 8 It is a schematic diagram of releasing a branch-type stent using an intraoperative stent system according to an embodiment of the present invention.

[0032] Fig. 9 It is a schematic diagram of suturing an artificial blood vessel using the intraoperative stent system according to one embodiment of the present invention.

[0033] Description of reference numerals:

[0034] 110, 210-artificial blood vessels; 120, 220-suture opening; 130-intraoperative stent; 200-branched intraoperative stent; 230-main stent; 240-side branch stent; 10-descending aorta;

[0035] 300-intraoperative stent delivery device; 310-side branch lining; 320-soft membrane; 330-withdrawal piece; 20-connection point between the withdrawal piece and the soft membrane; 331-withdrawal track; 340-main body lining; 341-main body guide head; 342-guide wire hole; 350-control end; 351-handle; 352-slider; 353-first wire puller; 354-second wire puller; 360-support rod; 400-intraoperative stent system. DETAILED DESCRIPTION

[0036] The intraoperative stent delivery device and intraoperative stent system of the present invention are further described in detail below in conjunction with the accompanying drawings and specific embodiments. The advantages and features of the present invention will become clearer according to the following description. It should be noted that the accompanying drawings are all in a very simplified form and are not in precise proportions, and are only used to conveniently and clearly assist in explaining the embodiments of the present invention.

[0037] Figure 2 This is a schematic diagram of a branched intraoperative stent. Figure 2 The branch type intraoperative stent 200 includes a main stent 230 and a side branch stent 240, and the main stent 230 is sutured with the artificial blood vessel 210 through the suture port 220. Taking the aortic arch replacement surgery as an example, the main stent 230 needs to be implanted in the descending aorta 10, and the side branch stent 240 needs to be implanted in the left subclavian artery. Since the left subclavian artery is located deep, it is difficult to dissect and suture it freely, and the operation is difficult. Adding the side branch stent 240 can avoid the time of dissecting and suturing the left subclavian artery during the operation, reduce the difficulty of the operation, reduce the operation time, and reduce the degree of damage to the surrounding tissues caused by the free dissection.

[0038] In order to further solve the problems of high difficulty in freeing branch vessels and long operation time faced when performing surgery using a branch-type intraoperative stent, the present invention proposes an intraoperative stent delivery device and an intraoperative stent system including the intraoperative stent delivery device, with the purpose of providing a component with a branch blocking function in the delivery device of the branch-type intraoperative stent, preventing reflux of branch vessels during the release of the branch-type intraoperative stent and the withdrawal of the intraoperative stent delivery device, ensuring a clear field of view within the stent surgery range, facilitating the doctor's operation, shortening the operation time, and improving the success rate of the operation and the postoperative effect.

[0039] Figure 3 Schematic diagram of an intraoperative stent delivery device according to an embodiment of the present invention. Figure 4 FIG. 1 is an enlarged schematic diagram of a side branch liner in a stent delivery device during surgery according to an embodiment of the present invention. Figures 2 to 4 In an embodiment of the present invention, an intraoperative stent delivery device 300 is used to deliver and release a branch-type intraoperative stent 200, wherein the branch-type intraoperative stent 200 includes a main stent 230 and a side branch stent 240, and the intraoperative stent delivery device 300 includes a side branch liner 310 for supporting the side branch stent 240, a soft membrane 320 for restraining the side branch stent 240, and a retraction member 330, wherein the side branch liner 310 is a hollow structure, and the retraction member 330 is movable in the side branch liner 310, and the soft membrane 320 is connected to the distal end of the retraction member 330 after the distal end of the side branch liner 310 is tightened.

[0040] Hereinafter, the end of the branch type intraoperative stent 200 facing the implanted descending aorta is regarded as the distal end, and the end away from the implanted descending aorta is regarded as the proximal end. Accordingly, the connection between the side branch stent 240 and the main stent 230 is regarded as the proximal end of the side branch liner 310, and the opposite end is regarded as the distal end of the side branch liner 310. That is, Figure 3 In the embodiment, the end close to the delivery device body is the proximal end of the side branch liner 310 , and the end away from the delivery device body is the distal end of the side branch liner 310 .

[0041] The intraoperative stent delivery device 300 may also include a main body lining 340, which is used to support the main stent 230. A main body guide head 341 and a guide wire hole 342 are provided at the distal end of the main body lining 340. The main body guide head 341 is the distal end of the intraoperative stent delivery device 300, and has a streamlined surface, which is convenient for delivering the branch type intraoperative stent 200. In the process of delivering the main stent 230 to the target position, one end of the main body guide wire (not shown) penetrates into the true lumen of the diseased aorta (e.g., the descending aorta), and the other end penetrates into the guide wire hole 342. Then, the intraoperative stent delivery device 300 passes through the true lumen of the diseased aorta (e.g., the descending aorta) along the main body guide wire as a whole, and implants the main stent 230 into the true lumen of the diseased aorta. The main body guide head 341 can be made of a polymer material with good biocompatibility, such as a low-density polyethylene (LDFE) material, a nylon elastomer (Pebax) and other materials, or other polymer materials with the same performance.

[0042] When the branch type intraoperative stent delivery device 300 is used to deliver the branch type intraoperative stent 200, the main body liner 340 is inserted into the main body stent 230, and the side branch liner 310 is inserted into the side branch stent 240, or the main body stent 230 is sleeved on the outside of the main body liner 340, and the side branch stent 240 is sleeved on the outside of the side branch liner 310. Usually, a restraining component is provided on the outside of the branch type intraoperative stent 200, which is used to make the stent adhere to the outer surface of the main body liner 340 and the side branch liner 310 under the action of compression force, so that the branch type intraoperative stent 200 is delivered to the target position by means of the intraoperative stent delivery device 300, for example, the main body stent 230 is delivered to the lumen of the descending aorta 10, and the side branch stent 240 is delivered to the left subclavian artery, and then the compression force of the restraining component on the main body stent 230 and the side branch stent 240 is released at the target position, so that the branch type intraoperative stent 200 is released at the target position.

[0043] Continue to refer to Figure 2 and Figure 3 In this embodiment, the intraoperative stent delivery device 300 further includes a control end 350 and a support rod 360 connected to the control end 350, and the side branch liner 310 is arranged on the outside of the support rod 360. The main body liner 340 is preferably bendable to facilitate adjustment of the relative position and angle of the main body liner 340 and the side branch liner 310 of the intraoperative stent delivery device 300, and to match the structure of the target position to be released by the branch-type intraoperative stent 200. The support rod 360 can be a tubular structure to facilitate the setting of the connection parts between the control end 350 and the main body liner 340, the side branch liner 310, the main stent 230 and the side branch stent 240. In some embodiments, the support rod 360 is a hollow tubular structure.

[0044] The control end 350 is controlled by the operator to control the position of the side branch liner 310. After the branch type intraoperative stent 200 is delivered to the target position, the operator can control the release of the branch type intraoperative stent 200 through the control end 350. Figure 3 As shown, in the intraoperative stent delivery device 300 of the present embodiment, the control end 350 includes a handle 351, and the handle 351 can be designed to be a shape that is convenient for the operator to grasp, and can be connected to the interior of the support rod 360, the main body lining 340 and the side branch lining 310 to set specific control components to perform installation, transmission, release and other operations related to the implantation of the branch-type intraoperative stent 200.

[0045] Exemplarily, in order to control the angle between the side branch liner 310 and the support rod 360, a slider 352 is slidably provided on the handle 351, and the angle between the side branch liner 310 and the main body liner 340 (or the support rod) can be adjusted by sliding the slider 352 in a slide groove on the handle 351. The slider 352 and the side branch liner 310 can be connected by, for example, a connecting rod mechanism.

[0046] Reference Figure 4 In this embodiment, the intraoperative stent delivery device 300 uses a soft film 320 to restrain the side branch stent 240. When the branch type intraoperative stent 200 is delivered, the soft film 320 is located outside the side branch liner 310 to wrap the side branch stent 240. The material of the soft film 320 may include at least one of polyester, polytetrafluoroethylene (PTFE) and its derivatives, polyethylene terephthalate (PET) and its derivatives. In this embodiment, the material of the soft film is, for example, expanded polytetrafluoroethylene (expanded PTFE). After the branch type intraoperative stent 200 is delivered to the target position, the side branch stent 240 covered by the soft film 320 can be released in the corresponding blood vessel. It should be noted that this embodiment focuses on how to prevent branch blood vessel reflux, facilitate doctor operation, and shorten the operation time in the process of using the intraoperative stent delivery device of the present invention to deliver and release the branch type intraoperative stent, but the soft film can also be set in other areas to achieve corresponding other functions. For example, in another embodiment, another soft film may be provided outside the main body liner 340 to cover the main body stent 230. By covering the branch type intraoperative stent with a soft film for delivery, the smoothness of the whole stent can be increased to avoid scratching the blood vessels and facilitate the pushing of the stent.

[0047] Figure 5 FIG. 1 is a schematic diagram of a side branch liner in a tightened state after assembling a side branch stent using an embodiment of the present invention. Figures 3 to 5In this embodiment, the side branch liner 310 is a hollow structure, where hollow means that the side branch liner 310 as a whole is pierceable, for example, one can enter the side branch liner 310 from the distal end (proximal end) of the side branch liner 310 and pass out from the proximal end (distal end), so that the connection point 20 between the retractor 330 and the soft membrane 320 can be led out from the proximal end of the side branch liner 310, and then connected to the control end 350, for example, so that the movement of the retractor 330 in the side branch liner 310 (for example, the movement of the retractor 330 between the distal end and the proximal end of the side branch liner 310 as needed) can be controlled by the control end 350. Hereinafter, the front end of the retractor 330 when moving toward the distal end of the side branch liner 310 is referred to as the distal end of the retractor 330, and the end of the retractor 330 opposite to the distal end (or the end close to the control end) is referred to as the proximal end of the retractor 330.

[0048] For example, before assembling the above-mentioned side branch stent 240, the soft membrane 320 is arranged outside the side branch liner 310 to restrain the side branch stent 240 assembled outside the side branch liner 310. In this embodiment, the soft membrane 320 is connected to the distal end of the retraction member 330 after the distal end of the side branch liner 310 is tightened (for example, closed without gaps). The retraction member 330 is located inside the side branch liner 310 and is movable inside the side branch liner 310. When the retraction member 330 moves toward the distal direction away from the side branch liner 310, the soft membrane 320 can be driven into the side branch liner 310, and at the same time, the part of the soft membrane 320 close to the proximal side of the side branch liner 310 moves toward the distal end of the side branch liner 310, so that the side branch stent 240 can be gradually released from the proximal end to the distal end through the movement of the retraction member 330. This release method from near to far can prevent the side branch stent from shortening and avoid long-term stent stenosis or even occlusion.

[0049] The process of delivering the branch type intraoperative stent 200 to the target position and releasing it by using the intraoperative stent delivery device 300 can be completed under the control of the control end 350. Specifically, the control end 350 may include a first wire puller 353, which is, for example, disposed at an end of the handle 351 away from the support rod 360, and the first wire puller 353 may pass through the handle 351 and be connected to the proximal end of the retraction member 330, so that the movement of the retraction member 330 in the side branch liner 310 can be restrained by pulling the first wire puller 353. Correspondingly, the control end 350 may also include a second wire puller 354 for releasing the above-mentioned main body bracket 230. The second wire puller 354 may also be arranged at the end of the handle 351 away from the support rod 360. The second wire puller 354 may specifically be a detachable component arranged on the side of the handle 351 away from the support rod 360. Its distal end toward the main body lining 340 is connected to a binding component used to bind the main body bracket 230 outside the main body lining 340. When the second wire puller 354 (or the detachable component) moves in a direction away from the handle 351, the binding component releases the binding on the main body bracket 230 to release the main body bracket 230.

[0050] The intraoperative stent delivery device 300 of this embodiment utilizes the linkage between the retraction member 330 and the soft membrane 320 to not only complete the release of the branch-type intraoperative stent 200, but also can use the soft membrane 320 as a branch blocking component to block the blood flow of the branch blood vessels according to surgical needs, thereby preventing reflux during surgery. Figure 6 FIG. 2 is a schematic diagram of using a stent delivery device in an embodiment of the present invention to block a branch vessel during surgery. Figure 6 After the branch-type intraoperative stent 200 is delivered to the target position, the method of using the above-mentioned soft membrane 320 as a branch blocking component to block the branch blood flow at the target position is as follows: when the distal end of the retraction member 330 moves in the direction away from the distal end of the side branch liner 310, the portion of the soft membrane 320 located on the proximal side of the side branch liner 310 moves a distance toward the distal end of the side branch liner 310 (or the side branch stent 240). At this time, only the proximal end of the side branch stent 240 is released, and the soft membrane 320 is stretched open by the partially released side branch stent 240, and covers the distal end of the side branch liner 310 and the side branch stent 240 (continuously covering the surface of the side branch stent 240 facing the distal end of the side branch liner 310), thereby having the effect of blocking the branch blood flow at the target position and achieving the effect of preventing reflux.

[0051] When the blood flow of the branch vessels at the target position is blocked by the above blocking method during the release of the side branch stent 240, in order to prevent the soft membrane 320 from falling out of the side branch liner 310 as the retraction member 330 moves, and to improve the blocking effect of the soft membrane 320, in this embodiment, the proximal aperture of the side branch liner 310 is preferably smaller than the distal aperture. Specifically, the side branch liner 310 can be a trumpet-shaped structure or a structure surrounded by the side of a frustum or a prism, but is not limited thereto. The side branch liner 310 can also have other regular or irregular shapes. For example, the side branch liner 310 can also include a wavy surface. The material of the side branch liner 310 can include any one of polymer materials such as soft silicone, rubber, nylon elastomer, low-density polyethylene, polyester, and ultra-high molecular polyethylene, and can also include any one of metal materials such as stainless steel, nickel titanium, etc. The material of the main body liner 340 can be selected from the same material as the side branch liner 310. It can be understood that the intraoperative stent delivery device 300 is preferably made of a material with good biocompatibility.

[0052] In this embodiment, the retraction member 330 is connected to the soft membrane 320 at its distal end, so that the side branch stent 240 can be gradually released by pulling the retraction soft membrane 320, and the vascular reflux at the target position can be blocked according to the needs of the operation. The part of the soft membrane 320 concentrated at the distal end of the side branch liner 310 and the distal end of the retraction member 330 located in the side branch liner 310 can be connected by binding, clamping, clamping, etc., or an intermediate connecting member can be set between the two to connect them. For example, the part of the soft membrane 320 located on the distal side of the side branch liner 310 can be tightened and then bound to the distal end of the retraction member 330.

[0053] The withdrawal member 330 may include a withdrawal guide wire, a connecting wire, etc., and may also include other transmission or linkage components. For example, the withdrawal member 330 may also include components such as pulleys, gears, and conveyor belts. In this embodiment, the withdrawal member 330 includes a withdrawal guide wire, and the diameter and length of the withdrawal guide wire can be specifically selected according to the purpose and overall structure of the stent delivery device 300 during the operation. Specifically, the distal end of the withdrawal guide wire can be connected to the soft membrane 320, and the proximal end of the withdrawal guide wire preferably extends to the outside of the side branch lining 310, and extends to the control end 350 through the support rod 360, so that the operator can control the movement of the distal end of the withdrawal guide wire in the side branch lining 310 through the control end 350. In order to facilitate the recovery of the soft membrane 320 through the withdrawal guide wire without falling out of the side branch lining 310, in the preferred embodiment, the part of the side branch lining 310 close to the proximal end of the support rod 360 is thin enough to easily pass through the withdrawal guide wire. Optionally, the proximal pore size of the side branch liner 310 is greater than one diameter of the withdrawal guidewire and less than or equal to two diameters of the withdrawal guidewire.

[0054] The intraoperative stent delivery device 300 of this embodiment may also include a withdrawal track 331 for moving the withdrawal member 330, the withdrawal track 331 runs through the connected interior of the support rod 360 and the side branch liner 310, and is arranged between the control end 350 and the distal end of the side branch liner 310 to limit the movement range of the withdrawal member 330 and improve the operation accuracy. For example, when a withdrawal guide wire is used as the withdrawal member 330, the withdrawal guide wire can be moved along the withdrawal track 331 in the side branch liner 310 and between the proximal end of the side branch liner 310 and the control end 350. For the portion between the proximal end of the side branch liner 310 and the control end 350, the withdrawal track 331 can be arranged inside the tubular structure of the support rod 360.

[0055] The use of the intraoperative stent delivery device 300 to assemble and release the branch type intraoperative stent 200 has the following advantages: first, a retraction member 330 is provided on the intraoperative stent delivery device 300, and is connected to the soft membrane 320 used to bind the side branch stent 240 at the distal end of the side branch liner 310. After the side branch stent 240 is delivered to the target position, the proximal end of the side branch stent 240 is released first, and the soft membrane 320 covers the distal end of the side branch liner 310 and the partially released side branch stent 240, so that the soft membrane 320 can also be used as a branch blocking component to prevent the branch blood vessels at the target position from flowing back, ensuring a clear field of view within the stent operation range, and facilitating the doctor to perform operations such as suturing the artificial blood vessel 210 (see Figure 2 ) and other operations, shortening the operation time and improving the success rate of the operation and the postoperative effect; secondly, the retraction piece 330 and the soft membrane 320 are part of the intraoperative stent delivery device 300. During the release of the branch-type intraoperative stent 200 and the withdrawal of the intraoperative stent delivery device 300, their functions of blocking and conducting the branch blood vessels at the target position can be used as needed. The blocking and conducting process does not require separate step-by-step operations, is easy to operate, and is conducive to shortening the operation time; thirdly, through the linkage of the retraction piece 330 and the soft membrane 320, the side branch stent 240 is gradually released from the proximal end to the distal end. This release method can prevent the side branch stent 240 from shortening and avoid long-term stent stenosis or even occlusion.

[0056] The present embodiment also includes an intraoperative stent system, including the intraoperative stent delivery device 300 and a branch-type intraoperative stent 200 . Figure 7 Schematic diagram of a stent system during surgery according to an embodiment of the present invention. Figures 2 to 7In the intraoperative stent system 400 of this embodiment, the branch type intraoperative stent 200 includes a side branch stent 240, which is sleeved on the outside of the side branch liner 310 of the intraoperative stent delivery device 300, and the side branch stent 240 is restrained in the soft membrane 320 of the intraoperative stent delivery device 300 before being released. Generally, the branch type intraoperative stent 200 also includes a main stent 230 and an artificial blood vessel 210 connected and communicated with the proximal end of the main stent 230, and the artificial blood vessel 210 is configured to be sleeved on the main liner 340.

[0057] The above-mentioned branch-type intraoperative stent 200 can be a coated stent. Specifically, the main stent 230 may include a main stent body and a main coated tube (not shown) covering the main stent body, and the side branch stent 240 may include a side branch stent body and a side branch coated tube (not shown) covering the side branch stent. During assembly, the soft film 320 in this embodiment may cover the outer surface of the side branch coated tube. In another embodiment, the outer surface of the main coated tube may also be covered with another soft film.

[0058] Taking aortic arch replacement surgery as an example, using the intraoperative stent delivery device 300 of this embodiment to deliver the intraoperative stent system 400 to the target position, release the branch type intraoperative stent 200 therein, and withdraw the intraoperative stent delivery device 300 may include the following operation process:

[0059] First, the curvature of the aortic arch and the descending aorta is evaluated before the operation, and the main body liner 340 is adjusted according to the curvature of the descending aorta so that the main body liner 340 is at an angle to obtain a corresponding matching curvature;

[0060] Then, after making an incision through the ascending aorta or the aortic arch, the position of the left subclavian artery is observed, and the angle between the side branch support 240 and the main support 230 is adjusted by moving the slider 352 on the handle 351 forward and backward;

[0061] Next, the intraoperative stent system 400 is delivered to the target location (or lesion site). More specifically, refer to Figures 3 to 7 , insert one end of the main body guide wire into the guide wire hole 342 in the main body guide head 341, deliver the above intraoperative stent system 400 along the main body guide wire to the target position (here, for example, the descending aorta cavity), and position the side branch stent 240 into the branch blood vessel (here, for example, the left subclavian artery);

[0062] Then, the branch type intraoperative stent 200 is released, and the release order is the main stent 230, the artificial blood vessel 210 and the proximal end of the side branch stent 240. For more details, refer to Figure 3 , Figure 5 and Figure 8First, the main stent 230 and the artificial blood vessel 210 are released by the second puller 354, and then the withdrawal guide wire of the withdrawal member 330 is pulled by the first puller 353 to move it away from the distal end of the side branch liner 310, so as to release the proximal end of the side branch stent 240 and then stop pulling the first puller 353;

[0063] Next, the side branch liner 310, the withdrawal guide wire and the withdrawal track 331 are kept stationary, and the other parts of the delivery device are withdrawn. At this time, the branch blood vessel where the side branch stent 240 is placed is blocked by the soft membrane 320 and is in a blocked state, and no blood flows back. Figure 6 As shown;

[0064] Then, the four-branch artificial blood vessel or the artificial blood vessel of other shapes (i.e., the artificial blood vessel 210) is put on the outer ring of the withdrawal guide wire of the withdrawal member 330, and then the end-to-end anastomosis (or suturing) is performed with the autologous blood vessel and the artificial blood vessel at the proximal end of the main stent 230. At this time, the artificial blood vessel has been sutured with the ascending aorta, and the suturing is stopped after 3-5 stitches away from the starting point. Fig. 9 As shown;

[0065] Next, the side branch stent 240 is fixed and the soft membrane 320 is withdrawn from the distal end into the side branch liner 310 through the withdrawal guide wire, and the side branch stent 240 is released from the proximal end to the distal end;

[0066] Finally, the side branch liner 310 is withdrawn together with the entire intraoperative stent delivery device 300, and the remaining artificial blood vessels are sutured with 3-5 stitches, and the surgical suturing part is completed. By implanting the intraoperative stent and artificial blood vessels, a new blood flow channel is formed at the lesion site. More specifically, the tumor cavity can be isolated from the blood circulation system, so that the wall of the hemangioma is no longer subjected to blood pressure, thereby avoiding tumor rupture and achieving the purpose of treatment.

[0067] The intraoperative stent system 400 of this embodiment includes the above-mentioned intraoperative stent delivery device 300. During the assembly, implantation, and release of the branch-type intraoperative stent 200, the surrounding area (or the stent surgery area) where the branch-type stent 200 is placed can be clearly visible, the suction time can be reduced, the suturing effect can be improved, and the suturing time can be reduced, thereby facilitating thoracotomy treatment, reducing operation time, and reducing operation difficulty, which is beneficial to improving the success rate of thoracotomy and postoperative effects.

[0068] It should be noted that this embodiment is described in a progressive manner, and the later structure is mainly described with respect to the differences from the previous structure, and the related parts can be referred to each other.

[0069] The above description is only a description of the preferred embodiment of the present invention, and is not any limitation on the scope of rights of the present invention. Any technical personnel in this field can make possible changes and modifications to the technical solution of the present invention by using the methods and technical contents disclosed above without departing from the spirit and scope of the present invention. Therefore, any simple modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention shall fall within the protection scope of the technical solution of the present invention.

Claims

1. An intraoperative stent delivery device, characterized in that: Used for delivering and releasing a branch-type intraoperative stent, the branch-type intraoperative stent includes a main stent and a side branch stent, the intraoperative stent delivery device includes a main body lining for supporting the main stent and a side branch lining for supporting the side branch stent, a soft membrane for restraining the side branch stent, and a retraction member, the side branch lining is a hollow structure, the retraction member is movable in the side branch lining, the soft membrane is connected to the distal end of the retraction member after the distal end of the side branch lining is tightened, and the proximal aperture of the side branch lining is smaller than the distal aperture; The intraoperative stent delivery device also includes a control end, a support rod connected to the control end, and a retraction track. The main body lining is connected to the distal end of the support rod, and the side branch lining is arranged on the support rod. The support rod is a hollow tubular structure. The retraction track passes through the connected interior of the support rod and the side branch lining, and is arranged between the control end and the distal end of the side branch lining.

2. The intraoperative stent delivery device according to claim 1, characterized in that: The retrieval member includes a retrieval guide wire.

3. The intraoperative stent delivery device according to claim 2, characterized in that: The proximal pore size of the side branch liner is larger than the diameter of the withdrawal guide wire and smaller than or equal to twice the diameter of the withdrawal guide wire.

4. The intraoperative stent delivery device according to claim 1, characterized in that: The control end includes a first wire puller, and the proximal end of the retraction member is connected to the first wire puller.

5. The intraoperative stent delivery device according to claim 1, characterized in that: The control end also includes a second wire puller for releasing the main body support.

6. The intraoperative stent delivery device according to claim 1, characterized in that: The control end also includes a handle and a slider slidably arranged on the handle, and the slider is connected to the side branch liner to control the angle between the side branch liner and the support rod.

7. The intraoperative stent delivery device according to any one of claims 1 to 6, characterized in that: The material of the side branch lining includes at least one of soft silicone, rubber, nylon elastomer, low-density polyethylene, polyester, ultra-high molecular polyethylene, stainless steel, and nickel titanium; the material of the soft film includes at least one of polyester, polytetrafluoroethylene, and polyethylene terephthalate.

8. An intraoperative stent system, characterized in that: The intraoperative stent system includes a branch-type intraoperative stent and an intraoperative stent delivery device as described in any one of claims 1 to 7, wherein the branch-type intraoperative stent includes a main stent and a side branch stent, wherein the main stent is sleeved on the outside of the main lining of the delivery device, and the side branch stent is sleeved on the outside of the side branch lining of the intraoperative stent delivery device, and the side branch stent is constrained in the soft membrane of the intraoperative stent delivery device before being released.

9. The intraoperative stent system according to claim 8, characterized in that: The branch-type intraoperative stent also includes an artificial blood vessel connected to and communicated with the proximal end of the main stent.

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