Flow transfer device
By configuring a blocking balloon and a filter on the transfer device, the problem of blood clots and blood spots entering the upper branch of the aortic arch during the operation is solved, and safer blood flow is achieved and the risk of surgical complications is reduced.
Patent Information
- Application Number
- CN202421539688.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-07-01
- Publication Date
- 2025-06-24
- Estimated Expiration
- 2034-07-01
AI Technical Summary
In the aortic cavity repair surgery, existing transfer devices are prone to influx of impurities such as blood clots and blood spots into the upper branch of the aortic arch, increasing the risk of brain damage.
By co-configuring the sealing balloon and filter on the transfer device, the sealing balloon and the channel form a transfer channel when the balloon expands and blocks, and impurities are prevented from entering the upper branch of the aortic arch.
It effectively avoids impurities such as blood clots and blood spots pouring into the upper branch of the aortic arch, reducing the risk of brain damage during the operation, and can be used in combination with other devices to shorten the surgical time and reduce the risk of complications.
Smart Images
Figure CN223009617U_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical devices, and particularly to a bypass device. Background Art
[0002] Endovascular Aortic Repair (EVAR) is an endovascular intervention for treating aortic aneurysms or aortic dissections. Compared with traditional open aortic surgery, EVAR has less trauma, shorter recovery time, and lower complication risk.
[0003] During EVAR surgery, the doctor makes a small incision at a position such as the thigh or armpit, inserts a catheter into the patient's vascular system. The catheter is guided into the aorta, and then one or more stents, called endovascular stents or repair devices, are delivered to the location of the aortic aneurysm or dissection through a guide wire. The stent is mainly a covered stent. Once the stent is in the correct position, the doctor expands the stent to cover the aneurysm or dissection, and then perforates the membrane. Before perforating the membrane, the covered stent blocks the branches on the aortic arch, and the blood in the aorta cannot flow to the branches on the arch. The lack of blood supply for a long time will greatly increase the risk of cerebral infarction. Therefore, a bypass device is needed during the operation to perform extracorporeal circulation of blood to ensure cerebral blood supply.
[0004] In the prior art, the bypass device usually has a relatively large blood flow outlet on the sheath tube to allow blood to pass through. However, during the operation, blood clots and blood plaques are likely to form, and these impurities will flow towards the head along the blood flow direction, which is likely to cause secondary damage to the brain. Summary of the Utility Model
[0005] This application provides a bypass device that, through the synergistic effect of a blocking balloon and a filter, avoids impurities such as blood clots and blood plaques from flowing into the branches on the aortic arch.
[0006] This application provides a bypass device, including an inner sheath tube. The inner sheath tube includes a tube body, the tube body has a distal end and a proximal end, the distal end of the tube body is successively provided with a blocking balloon and a filter from far to near, a channel is provided inside the tube body. When the blocking balloon expands and blocks, the channel and the filter form a bypass channel that flows in from the distal end of the tube body and flows out from the filter.
[0007] Furthermore, the bypass device further includes an outer sheath tube. The outer sheath tube is movably nested outside the inner sheath tube. The filter can be retracted into the outer sheath tube or released outside the outer sheath tube to control the on / off of the bypass channel.
[0008] Further, a balloon inflation cavity is further included inside the tube body. The proximal end of the tube body is connected to an inner sheath base equipped with a balloon inflation port. One end of the balloon inflation cavity communicates with the balloon inflation port, and the other end communicates with the occluding balloon to form a fluid passage. When the balloon inflation cavity is filled with fluid, the occluding balloon expands.
[0009] Further, a side branch tube is further included. One end of the side branch tube is connected to the inner sheath base, and the other end is connected to a three-way valve. The channel communicates the side branch tube and the three-way valve.
[0010] Further, a radiopaque ring is further provided at the distal end of the tube body.
[0011] Further, the distance d1 between the end of the occluding balloon close to the distal end of the inner sheath and the farthest end of the radiopaque ring is 10 - 15 mm.
[0012] Further, the distance d2 between the end of the filter net close to the distal end of the inner sheath and the farthest end of the radiopaque ring is 40 - 60 mm.
[0013] Further, the filter net is cylindrical, and both ends of the cylinder are fixedly connected to the tube body.
[0014] Further, the aperture of the filter net is 120 μm, and the length of the filter net along the axis direction of the inner sheath is 15 - 25 mm.
[0015] Further, the diameter of the occluding balloon after inflation is 16 - 18 mm.
[0016] The technical solution provided by the embodiment of the present application may include the following beneficial effects:
[0017] By coordinately configuring an occluding balloon and a filter net on the bypass device, impurities such as blood clots and blood plaques are prevented from flowing into the upper branch of the aortic arch.
[0018] In addition, the bypass device of the present application can be used in combination with other instruments to integrate functions such as access, anchoring, maintaining blood supply, filtering, and providing support for in-situ fenestration and dilation of the covered stent, greatly shortening the operation time of in-situ fenestration of the aortic covered stent and further reducing the risk of various complications.
[0019] It should be understood that the above general description and the following detailed description are only exemplary and explanatory, and cannot limit the present application. BRIEF DESCRIPTION OF THE DRAWINGS
[0020] Figure 1 is a schematic diagram of the use of the bypass device in the aortic endovascular repair surgery;
[0021] Figure 2 is an embodiment of the bypass device of the present application;
[0022] Figure 3 is Figure 2 an enlarged view of part A in
[0023] Figure 4 is Figure 3 a schematic diagram of an embodiment of the cross-section of the inner sheath tube body in
[0024] Figure 5 a schematic diagram of the blood flow direction in the bypass device.
[0025] Reference numerals:
[0026] 100, tube body; 11, radiopaque ring; 12, occluding balloon; 13, filter; 14, channel; 15, balloon inflation cavity; 16, distal end; 17, proximal end; 200, inner sheath base; 21, balloon inflation port; 300, outer sheath tube body; 400, outer sheath base; 500, side branch tube; 600, three-way valve. Detailed Description of the Embodiment
[0027] The following will describe the embodiments of the present application in detail with reference to the accompanying drawings. Without conflict, the features in the following embodiments can be combined with each other.
[0028] Under normal circumstances, the aortic blood flow will be supplied to the three branches above the aortic arch through the aortic arch. However, during an endovascular aortic repair surgery, once the stent graft is delivered and supported in the aortic arch, the branches above the aortic arch will be blocked, and the blood flow will not be able to flow upward to supply blood to the brain. At this time, a bypass device is needed to assist blood circulation. As Figure 1 shown, the bypass device is an auxiliary tool that provides blood circulation for the branches above the aortic arch when the stent graft is supported in the aortic arch, ensuring that the organs on the branches are not irreversibly damaged due to ischemia. Figure 1 In
[0029] As Figure 2 shown, the present application discloses a bypass device that can be used for blood bypass during endovascular aortic repair surgery, including an inner sheath tube and an outer sheath tube. Among them, the inner sheath tube is composed of a tube body 100 and an inner sheath base 200. The tube body 100 has a distal end 16 and a proximal end 17. The proximal end 17 is connected to the inner sheath base 200, and the distal end 16 is sequentially provided with a radiopaque ring 11, an occluding balloon 12, and a filter 13 from far to near.
[0030] The radiopaque ring 11 is nested at the outermost distal end of the tube body 100 and is a metal ring, such as a platinum-iridium alloy, etc., which can be highly visible under X-rays and indicate the position of the instrument to the surgeon.
[0031] After the developing ring 11, the tube body 100 is also fixedly welded with a blocking balloon 12. The blocking balloon 12 has an inner layer and an outer layer, and a cavity is provided between the inner layer and the outer layer for filling a fluid to make the blocking balloon 12 inflated. The blocking balloon 12 includes two states, namely a contracted state and an inflated state. Before entering the blood vessel, the blocking balloon 12 is in the contracted state; when the position is determined, the balloon can be filled with fluid to make the blocking balloon 12 in the inflated state. The diameter of the balloon in the inflated state is preferably 16-18 mm. In addition, after the blocking balloon 12 is fenestrated and ruptured in situ, the window can be dilated without introducing other instruments, reducing unnecessary window tearing. Because if instruments are continuously replaced during the operation, the shape of the window will be damaged during the insertion and retrieval processes.
[0032] After the blocking balloon 12, a filter screen 13 is also provided on the tube body 100. The filter screen 13 can be woven from a material with good biocompatibility such as nylon wire. After being wound into a cylindrical shape, the two ends of the filter screen are respectively fixedly welded to the tube body 100. The aperture is usually in the order of hundreds of micrometers, preferably 120 μm. Its purpose is to allow blood to flow through the filter screen 13, but impurities and wastes such as plaques that may cause vascular surgery complications cannot pass through the filter screen 13 and are intercepted inside the lumen, thereby reducing the risk of surgical complications. In order to avoid too low blood flow rate and inability to provide sufficient branch blood supply, considering the blood flow rate, the length of the filter screen 13 along the axis direction of the inner sheath tube is preferably 15-25 mm.
[0033] For endovascular aortic repair surgery, when the blocking balloon 12 is inflated, it is mainly placed outside the proximal covered stent or between the covered stent and the aortic intima, and can be located at Figure 1 the positions B and C shown (the blocking balloon 12 is not specifically shown in the figure). At this time, the inflated balloon 12 abuts against the aortic intima and the covered stent, preventing blood from flowing from the outside of the inner sheath tube to the branches on the aortic arch, thereby reducing the entry of impurities such as blood clots during the operation into the branches on the arch. Of course, the proper position of the blocking balloon 12 is also very important. If the distance between the blocking balloon 12 and the developing ring 11 is appropriate, as long as the position of the developing ring 11 is determined, it can be ensured that the blocking balloon 12 is located at the designated position, which will greatly reduce the insertion operation time of the bypass device. As Figure 3 shown, the distance d1 between the end of the blocking balloon 12 close to the distal end 16 of the inner sheath tube and the most distal end of the developing ring 11 is preferably 10-15 mm. In addition, the position of the filter screen 13 will also directly affect the filtering effect. Therefore, the distance d2 between the end of the filter screen 13 close to the distal end 16 of the inner sheath tube and the most distal end of the developing ring 11 is preferably 40-60 mm.
[0034] As Figure 4As shown, the tube body 100 is a tube with a certain support strength. In this example, the interior of the tube body 100 is designed with a double-chamber structure, including a channel 15 and a balloon inflation chamber 14. The channel 15 can accommodate instruments with an outer diameter within a certain range, such as guide wires. The channel 15 can serve as part of the blood bypass channel during the use of the bypass device. In aortic cavity surgery, blood enters the channel 15 from the most distal end of the tube body 100 and then reaches the upper branches of the aortic arch through the filter 13. The balloon inflation chamber 14 communicates with the occlusion balloon 12 to send fluid to the occlusion balloon 12. The tube body 100 can also be a sleeve design, and the balloon inflation chamber 14 is sleeved outside the channel 15.
[0035] A proximal end 17 of the tube body 100 is fixedly provided with an inner sheath base 200. The tube body 100 is physically riveted and fitted with the inner sheath base 200. A hemostatic valve (not shown in the figure) and a balloon inflation port 21 are designed on the inner sheath base 200. The balloon inflation port 21 is connected to the balloon inflation chamber 14 on the tube body 100 to allow fluid to pass through.
[0036] The outer sheath is composed of an outer sheath tube body 300 and an outer sheath base 400. The tube body is designed as a common medical multi-layer braided wire tube. Commonly used materials include PEBAX, stainless steel wire, PTFE film, etc. It has a certain strength and bend resistance. The inner diameter of the tube cavity matches the outer diameter of the inner sheath, and can accommodate the inner sheath to penetrate and retract, and provide stable support for the inner sheath. During use, as the relative movement between the inner sheath and the outer sheath, the filter 13 located on the inner sheath can be retracted into the outer sheath or released outside the outer sheath to realize the on-off of the blood bypass channel. When blood bypass is not required, the inner sheath can be retracted to retract the filter 13 into the outer sheath; when blood bypass is required, the outer sheath can be retracted to release the filter 13 outside the outer sheath. The outer sheath base is a common medical vascular sheath base structure, usually made of PC material. It is provided with a hemostatic valve (not shown in the figure) inside. The outer sheath tube body 300 is physically riveted and fitted with the outer sheath base 400 for convenient hand-held operation.
[0037] The inner sheath base 200 is also connected to one end of a side branch tube 500. The inner cavity of the side branch tube 500 communicates with the channel 15 of the inner sheath to realize the connection between the inner cavity of the inner sheath and other instruments, vascular accesses, etc. In this embodiment, blood can flow from the inner sheath channel 15 to the side branch tube 500 and then be bypassed to other vascular branches. A three-way valve 600 is also provided at the other end of the side branch tube 500. The three-way valve 600 can realize the connection or occlusion of the pipeline, and drugs can also be injected through the three-way valve 600.
[0038] Steps for using the bypass device:
[0039] 1. Establish a vascular access through a guide wire.
[0040] 2. Remove the inner and outer sheath tubes. When the occlusion balloon 12 is in a contracted state, insert the inner sheath tube through the base 400 of the outer sheath tube into the inner cavity of the outer sheath tube, and push the inner sheath tube forward until the imaging ring 11 at the distal end 16 of the inner sheath tube, the occlusion balloon 12, and the filter net 13 are all released.
[0041] 3. Deliver the bypass device into the target blood vessel via the guide wire, and determine whether the bypass device reaches the target position through the imaging ring 11.
[0042] 4. After the bypass device reaches the target position, inject normal saline or other fluid into the balloon filling port 21 to inflate the balloon until the blood vessel is blocked.
[0043] 5. When the filter net 13 is in an open state, blood flows in from the distal end 16 of the inner sheath tube and flows out from the filter net 13. At the same time, impurities in the blood are intercepted by the filter net 13 in the inner sheath tube channel 15, as Figure 5 shown.
[0044] 6. Push the outer sheath tube forward or pull back the inner sheath tube backward so that the filter net 13 is completely covered. At this time, the filter net 13 is closed, and blood can no longer flow out from the filter net 13.
[0045] 7. Release the pressure and contract the occlusion balloon 12, and retract it into the inner cavity of the outer sheath tube.
[0046] 8. Withdraw the inner and outer sheath tubes from the body synchronously.
Claims
1. A flow diversion device, comprising an inner sheath tube, the inner sheath tube comprising a tube body (100), the tube body (100) having a distal end (16) and a proximal end (17), characterized in that: The distal end (16) of the tube body (100) is provided with a blocking balloon (12) and a filter screen (13) in sequence from far to near, and a channel (15) is provided inside the tube body (100). When the blocking balloon (12) is expanded and blocked, the channel (15) and the filter screen (13) form a diversion channel that flows in from the distal end (16) of the tube body (100) and flows out from the filter screen (13).
2. A flow conversion device according to claim 1, characterized in that: The diversion device also includes an outer sheath tube, which can be movably nested on the outside of the inner sheath tube. The filter (13) can be put into the outer sheath tube or released outside the outer sheath tube to control the opening and closing of the diversion channel.
3. A flow conversion device according to claim 1, characterized in that: The tube body (100) further comprises a balloon filling cavity (14) inside, and the proximal end (17) of the tube body (100) is connected to an inner sheath tube base (200) equipped with a balloon filling port (21), one end of the balloon filling cavity (14) is connected to the balloon filling port (21), and the other end is connected to the blocking balloon (12) to form a fluid channel, and when the balloon filling cavity (14) is filled with fluid, the blocking balloon (12) expands.
4. A flow conversion device according to claim 3, characterized in that: It also includes a side branch tube (500), one end of which is connected to the inner sheath tube base (200) and the other end is connected to the three-way valve (600), and the channel (15) connects the side branch tube (500) and the three-way valve (600).
5. A flow conversion device according to claim 1, characterized in that: A developing ring (11) is also provided at the end of the distal end (16) of the tube body (100).
6. A flow conversion device according to claim 5, characterized in that: The distance d1 between the end of the blocking balloon (12) close to the distal end (16) of the inner sheath tube and the farthest end of the developing ring (11) is 10 to 15 mm.
7. A flow conversion device according to claim 5, characterized in that: The distance d2 between the end of the filter (13) close to the inner sheath tube distal end (16) and the farthest end of the developing ring (11) is 40 to 60 mm.
8. The flow diversion device according to any one of claims 1 to 7, characterized in that: The filter screen (13) is cylindrical, and both ends of the cylinder are respectively connected and fixed to the tube body (100).
9. A flow conversion device according to claim 8, characterized in that: The pore size of the filter screen (13) is 120 μm, and the length of the filter screen (13) along the axial direction of the inner sheath tube is 15 to 25 mm.
10. The flow diversion device according to any one of claims 1 to 7, characterized in that: The diameter of the blocking balloon (12) after expansion is 16 to 18 mm.