Internal bypass catheter in aortic arch covered stent in-situ fenestration
By using an intra-aortic bypass catheter to create a temporary blood flow channel between the aortic true lumen and the branch aorta during in-situ fenestration of the aortic arch stent graft, the problem of insufficient cerebral blood flow perfusion before branch stent implantation is solved, reducing the risk of cerebral ischemia and stroke and improving surgical safety.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2026-03-13
- Publication Date
- 2026-04-10
AI Technical Summary
During the implantation of aortic arch covered stents, current technology lacks effective means to maintain cerebral blood flow perfusion before the implantation of branch stents, leading to a high risk of cerebral ischemia and stroke.
A novel intraoperative bypass catheter for aortic arch fenestration using a covered stent graft is designed, comprising a main channel and a bypass channel. It is precisely located using proximal and distal imaging structures to establish a temporary blood flow channel between the aortic true lumen and the aortic arch branches, providing continuous cerebral blood flow perfusion.
It significantly shortened the time of branch occlusion of the arch, reduced the risk of intraoperative cerebral ischemia and stroke, and improved the safety and efficiency of the operation.
Smart Images
Figure CN224099806U_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The utility model relates to a film covered support technical field especially relates to a kind of inside rotation flow catheter in aortic arch film covered support in situ fenestration. BACKGROUND
[0002] The pathological feature of aortic dissection (AD) is that a break occurs in the intima of the aorta, blood enters the media of the aorta through the break, and expands along the longitudinal axis of the aorta, forming a dissecting hematoma that separates the aorta into a true lumen and a false lumen. The main principle of thoracic endovascular aortic repair (TEVAR) is to deliver a film covered stent to the aortic lesion through a femoral artery or other access to release, thereby covering the break, isolating the false lumen, promoting the expansion of the true lumen of the aorta and thrombosis of the false lumen, and achieving aortic remodeling.
[0003] The aortic arch is an important segment of the aorta, and the aortic arch sends three key arch branches to the head, neck and upper limbs, respectively: the brachiocephalic trunk (innominate artery), the left common carotid artery and the left subclavian artery. To ensure complete isolation of the break, the film covered stent often needs to cover part or all of the openings of the arch branches. This inevitably blocks the blood flow of these arch branches, leading to acute ischemia of the brain and upper limbs, with a high risk of stroke.
[0004] To solve this problem, in situ fenestration technology has emerged as the key strategy for reconstructing arch branches during TEVAR. The basic steps of this technology are: first, release the film covered stent in the aorta to completely cover the lesion and the opening of the arch branch; then, the doctor performs fenestration on the film corresponding to the position of the target arch branch (such as the innominate artery, left common carotid artery, left subclavian artery) opening by laser, mechanical puncture or radiofrequency; finally, a balloon is sent through the window for expansion, and a branch stent is implanted, thereby successfully reconstructing the blood flow of the arch branch while maintaining the isolation of the break.
[0005] From the release of the film covered stent to the completion of the branch stent reconstruction, it takes a long time, and there is a lack of effective means to maintain cerebral blood perfusion before the implantation of the branch stent. UTILITY MODEL CONTENT
[0006] The utility model aims at the deficiency in the prior art, and provides a kind of inside rotation flow catheter in aortic arch film covered support in situ fenestration, establishes the temporary passage of aortic true lumen and arch branch before the implantation of branch stent, and provides continuous blood perfusion for brain.
[0007] To achieve the above-mentioned purpose, the utility model provides the following technical scheme:
[0008] An endovascular bypass catheter for in-situ fenestration of an aortic arch stent-graft, comprising:
[0009] a tube body having a main channel and a bypass channel defined therein;
[0010] the main channel extends through the tube body in an axial direction;
[0011] the bypass channel is located at a radial side of the main channel and includes a proximal opening, a distal opening defined in a side wall of the tube body, and a flow passage connecting the proximal opening and the distal opening;
[0012] a proximal radiopaque structure is disposed on the side wall of the tube body and surrounds an edge of the proximal opening;
[0013] a distal radiopaque structure is disposed on the side wall of the tube body and surrounds an edge of the distal opening;
[0014] the proximal radiopaque structure and the distal radiopaque structure have different shapes from each other.
[0015] As a preferred embodiment, the main channel includes:
[0016] a first main flow passage extending from a proximal end of the tube body to the proximal opening;
[0017] a second main flow passage extending from the proximal opening to a distal end of the tube body;
[0018] the flow passage is located at a radial side of the second main flow passage;
[0019] a bore diameter of the first main flow passage is larger than a bore diameter of the second main flow passage.
[0020] As a preferred embodiment, a cross section of the flow passage is elliptical.
[0021] As a preferred embodiment, the tube body includes:
[0022] a hard tube segment constituting a proximal portion of the tube body;
[0023] a soft tube segment constituting a distal portion of the tube body;
[0024] the main channel extends through the hard tube segment and the soft tube segment.
[0025] As a preferred embodiment, the proximal opening is defined in a side wall of the hard tube segment, and the distal opening is defined in a side wall of the soft tube segment.
[0026] As a preferred embodiment, the distance between the proximal opening and the distal opening is greater than 20 cm.
[0027] As a preferred embodiment, the edges of the proximal opening and the distal opening are provided with a hydrophilic coating.
[0028] As a preferred embodiment, the proximal visualization structure is circular, and the distal visualization structure is square.
[0029] Compared with the prior art, the technical scheme has the following advantages:
[0030] Before the branch stent is implanted, a temporary blood flow channel from the true lumen of the aorta to the branch of the arch is established through the shunt channel in the tube, thereby reducing the risk of stroke during the operation.
[0031] The proximal visualization structure and the distal visualization structure adopt different shapes, so that the doctor can instantly determine the position of the catheter under fluoroscopy, and the positioning accuracy and the safety of the operation are improved. BRIEF DESCRIPTION OF DRAWINGS
[0032] Figure 1 It is a sectional view of the internal shunt catheter in the in-situ fenestration of the aortic arch covered stent of the utility model;
[0033] Figure 2 It is a structural schematic view of the internal shunt catheter in the in-situ fenestration of the aortic arch covered stent of the utility model;
[0034] Figure 3 It is a sectional view along A-A direction in the internal shunt catheter in the in-situ fenestration of the aortic arch covered stent of the utility model; Figure 2 It is a sectional view along B-B direction in the internal shunt catheter in the in-situ fenestration of the aortic arch covered stent of the utility model.
[0035] Figure 4 It is a sectional view along B-B direction in the internal shunt catheter in the in-situ fenestration of the aortic arch covered stent of the utility model. Figure 2
[0036] In the figure: 100 is a tube, 100a is a main channel, 100a1 is a first main flow channel, 100a2 is a second main flow channel, 100b is a shunt channel, 100b1 is a proximal opening, 100b2 is a distal opening, 100b3 is a flow channel, 110 is a hard tube segment, 120 is a soft tube segment, 200 is a proximal visualization structure, 300 is a distal visualization structure, and 400 is a guide wire. DETAILED DESCRIPTION
[0037] The following description is used to disclose the utility model so that those skilled in the art can implement the utility model. The preferred embodiments in the following description are only as examples, and other obvious variants can be thought of by those skilled in the art. The basic principles of the utility model defined in the following description can be applied to other implementation schemes, variant schemes, improved schemes, equivalent schemes and other technical schemes without departing from the spirit and scope of the utility model.
[0038] Referring to Figure 1 and Figure 2 The embodiment of the utility model provides a kind of in-situ fenestration of aortic arch stent graft internal bypass catheter, comprising:
[0039] The pipe body 100 is equipped with main channel 100a and bypass channel 100b isolated from each other in the pipe body 100;
[0040] The main channel 100a penetrates the pipe body 100 along the axial direction, for the guide wire 400 to pass through;
[0041] The bypass channel 100b is located on the radial side of the main channel 100a, which includes a proximal end aperture 100b1, a distal end aperture 100b2 and a flow passage 100b3, which are arranged on the side wall of the pipe body 100, and the flow passage 100b3 communicates the proximal end aperture 100b1 and the distal end aperture 100b2;
[0042] The proximal end imaging structure 200 is arranged on the side wall of the pipe body 100 and surrounds the edge of the proximal end aperture 100b1;
[0043] The distal end imaging structure 300 is arranged on the side wall of the pipe body 100 and surrounds the edge of the distal end aperture 100b2;
[0044] The proximal end imaging structure 200 and the distal end imaging structure 300 have different shapes from each other, so as to clearly distinguish the positions of the proximal end imaging structure 200 and the distal end imaging structure 300 under X-ray fluoroscopy.
[0045] In use, before the stent graft is released, the distal end of the pipe body 100 is inserted into the target arch branch through the fenestration under the guidance of the proximal end imaging structure 200 and the distal end imaging structure 300, so that the distal end aperture 100b2 is located in the target arch branch and the proximal end aperture 100b1 is located in the true lumen of the aorta outside the proximal end of the stent graft. Thus, a temporary blood flow passage is established between the true lumen of the aorta and the target arch branch through the bypass channel 100b. The temporary passage can maintain continuous cerebral blood perfusion, so that the physician can perform subsequent operations under the protection of bypass, including releasing the stent graft body, balloon expansion and branch stent implantation. This design significantly shortens the blocking time of the arch branch and effectively reduces the risk of intraoperative cerebral ischemia and stroke.
[0046] As shown in Figure 1 and Figure 2 The pipe body 100 comprises:
[0047] The hard pipe segment 110 constitutes the proximal end portion of the pipe body 100;
[0048] a soft tube segment 120, which constitutes a distal end portion of the tube body 100;
[0049] The main channel 100a penetrates through the hard tube segment 110 and the soft tube segment 120.
[0050] The proximal end portion refers to the part of the instrument close to the operator. The distal end portion refers to the part of the instrument away from the operator.
[0051] The hard tube segment 110 is made of high-hardness material, such as polyether block amide or similar high-hardness medical polymer material, for providing sufficient support force to ensure the stability of the catheter in the aorta.
[0052] The soft tube segment 120 is made of soft material, such as low-hardness polyether block amide or flexible medical polymer material such as silicone rubber, which can conform to physiological bending and facilitate safe extension into the target arch branch.
[0053] The hard tube segment 110 and the soft tube segment 120 can be connected by hot melt butt joint or injection molding process.
[0054] The proximal end opening 100b1 is provided on the side wall of the hard tube segment 110, and the distal end opening 100b2 is provided on the side wall of the soft tube segment 120. This structure design makes the proximal end opening 100b1 located in the true lumen of the aorta and the distal end opening 100b2 located in the target arch branch when the catheter is in place, thereby establishing an effective temporary blood flow path through the shunt channel 100b.
[0055] The main channel 100a is used for the guide wire 400 to pass through and provides a delivery path for subsequent interventional instruments (such as balloon catheters and branch stents). In operation, the guide wire 400 is first inserted into the target arch branch through the fenestration of the covered stent to establish a delivery track, and then the tube body 100 is pushed along the guide wire 400 to the designated position. After the catheter positioning is completed, the subsequent balloon dilation catheter and branch stent can be sent into the target arch branch through the main channel 100a along the same guide wire 400 for operation.
[0056] As shown in Figures 2 to 4 The main channel 100a includes:
[0057] a first main flow passage 100a1 extending from the proximal end of the tube body 100 to the proximal end opening 100b1;
[0058] a second main flow passage 100a2 extending from the proximal end opening 100b1 to the distal end of the tube body 100;
[0059] The flow channel 100b3 is located on the radial side of the second main flow channel 100a2.
[0060] The first main flow channel 100a1 and the second main flow channel 100a2 are both circular in cross section. The inner diameter of the first main flow channel 100a1 is larger than that of the second main flow channel 100a2. The inner diameter of the second main flow channel 100a2 is calculated to ensure that it can not only smoothly pass the guide wire 400, but also accommodate the passage of the balloon catheter and branch stent in the folded state.
[0061] As shown in Figure 1 and Figure 4 , the cross section of the flow channel 100b3 is oval.
[0062] As shown in Figure 1 and Figure 2 , the distance between the proximal opening 100b1 and the distal opening 100b2 is greater than 20 cm to meet the span requirements of the aortic arch anatomical morphology of most adults, enhancing the applicability of the catheter.
[0063] The orifice edges of the proximal opening 100b1 and the distal opening 100b2 are both subjected to surface smoothing treatment. In addition, the outer wall of the tube body 100 and the orifice edges of the proximal opening 100b1 and the distal opening 100b2 are both provided with a hydrophilic coating to reduce the frictional resistance during delivery.
[0064] The inner wall of the flow channel 100b3 is provided with a heparin anticoagulant coating to prevent blood from coagulating and forming thrombus in the flow channel, thereby ensuring continuous unobstructed blood flow. The coating can be coated on the inner wall of the flow channel 100b3 by pressure infusion process.
[0065] As shown in Figure 2 , the proximal opening 100b1 and the distal opening 100b2 are generally circular. The proximal imaging structure 200 and the distal imaging structure 300 have different shapes from each other, for example, the proximal imaging structure 200 is circular, and the distal imaging structure 300 is square. The proximal imaging structure 200 and the distal imaging structure 300 can be made of imaging materials such as platinum-iridium alloy, and are fixed on the side wall of the tube body 100 by insert injection molding process.
[0066] The use method of the endovascular stent graft in situ fenestration catheter in the aortic arch is as follows:
[0067] An interventional pathway was established via the femoral artery. Following the standard thoracic endovascular aortic repair (TEVAR) procedure, a covered stent was delivered to the lesion in the aortic arch. The stent was not deployed immediately to avoid obscuring the opening of the target arch branch. Subsequently, a guidewire 400 was advanced into the target arch branch through this fenestration. Next, the catheter 100 was advanced along the guidewire 400. Under X-ray fluoroscopy, precise positioning was achieved by observing the different shapes of the proximal and distal imaging structures 200 and 300, ensuring that the distal opening 100b2 of the catheter 100 was located within the target arch branch, while the proximal opening 100b1 was located within the aortic true lumen proximal to the stent. After confirming correct positioning, a temporary blood flow pathway was established between the aortic true lumen and the target arch branch via the bypass channel 100b. At this point, along... Figure 1 In the direction of the middle arrow, blood flow can continuously perfuse the target arch branch through the proximal opening 100b1, flow channel 100b3, and distal opening 100b2. Under this bypass protection, the physician can comfortably perform subsequent procedures, including releasing the covered stent body, balloon dilation, and branch stent implantation. In-situ fenestration is performed at the covered stent site corresponding to the reconstructed target arch branch. After the covered stent is released, the tube body 100 is located between the covered stent and the vessel wall, and its bypass channel 100b continues to function as a blood flow channel between the aortic true lumen and the target arch branch.
[0068] After the branch stent is implanted, the tube 100 is withdrawn along the guide wire 400.
[0069] The embodiments described above are only used to illustrate the technical ideas and features of this utility model. Their purpose is to enable those skilled in the art to understand the content of this utility model and implement it accordingly. The scope of patent application of this utility model should not be limited by these embodiments. That is, any equivalent changes or modifications made in accordance with the spirit disclosed in this utility model still fall within the patent scope of this utility model.
Claims
1. An intraoperative bypass catheter for in-situ fenestration of aortic arch covered stent, characterized in that, The application relates to a medical tube, which comprises the following parts: a tube body (100) provided with a main channel (100a) and a diversion channel (100b) which are isolated from each other; the main channel (100a) extends through the tube body (100) in the axial direction; the diversion channel (100b) is located on the radial side of the main channel (100a) and comprises a proximal opening (100b1), a distal opening (100b2) and a flow channel (100b3) connecting the proximal opening (100b1) and the distal opening (100b2); a proximal radiopaque structure (200) is arranged on the side wall of the tube body (100) and surrounds the edge of the proximal opening (100b1); a distal radiopaque structure (300) is arranged on the side wall of the tube body (100) and surrounds the edge of the distal opening (100b2); the proximal radiopaque structure (200) and the distal radiopaque structure (300) have different shapes.
2. The in-situ fenestrated aortic arch covered stent graft catheter of claim 1, wherein, the main channel (100a) comprises: a first main flow channel (100a1) extending from the proximal end of the tube body (100) to the proximal opening (100b1); a second main flow channel (100a2) extending from the proximal opening (100b1) to the distal end of the tube body (100); the flow channel (100b3) is located on the radial side of the second main flow channel (100a2); the aperture of the first main flow channel (100a1) is larger than that of the second main flow channel (100a2).
3. The in-situ fenestrated aortic arch covered stent graft catheter of claim 1, wherein, the cross section of the flow channel (100b3) is elliptical.
4. The endovascular stent-graft in-situ fenestration catheter of claim 1, wherein the catheter is configured to be used in conjunction with a catheter for creating a fenestration in the aortic arch. the tube body (100) comprises: a hard tube segment (110) constituting the proximal end part of the tube body (100); a soft tube segment (120) constituting the distal end part of the tube body (100); the main channel (100a) extends through the hard tube segment (110) and the soft tube segment (120).
5. The endovascular stent-graft in-situ fenestration catheter of claim 4, wherein the catheter is configured to be inserted into the aortic arch and to be advanced to the innominate artery. the proximal opening (100b1) is arranged on the side wall of the hard tube segment (110) and the distal opening (100b2) is arranged on the side wall of the soft tube segment (120).
6. The endovascular stent-graft in-situ fenestration catheter of claim 1, wherein the catheter is configured to be used in conjunction with a catheter for creating a fenestration in the aortic arch. the distance between the proximal opening (100b1) and the distal opening (100b2) is greater than 20 cm.
7. The endovascular stent-graft in-situ fenestration catheter of claim 1, wherein the catheter is configured to be used in conjunction with a catheter for creating a fenestration in the aortic arch. the edges of the proximal opening (100b1) and the distal opening (100b2) are provided with a hydrophilic coating.
8. The endovascular stent-graft in-situ fenestration catheter of claim 1, wherein, the proximal radiopaque structure (200) is circular and the distal radiopaque structure (300) is square.