Blood vessel dilation device and use method thereof
By designing a bilayer structured vasodilator device, using dense metal grids to disperse radial forces and reduce friction, the existing tools are solved by scratching the endothelium and poor dilation effect, achieving effective vasodilation and compliance maintenance.
Patent Information
- Application Number
- CN202411114887.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-08-14
- Publication Date
- 2024-12-27
AI Technical Summary
The existing vasodilator tools are prone to scratch the weak endothelium during dragging, and have poor dilation effect, making it difficult to effectively open the true cavity of the aortic dissection, which may lead to reduced vascular compliance or further damage.
A vasodilator device is designed, including an outer tube, an inner tube and a stent expansion tube. The stent expansion tube is a double-layer structure, and a dense metal grid is used to disperse the radial force evenly, and the stent slides axially through the driving component to Reduce friction with the vessel wall and withdraw the device after dilation to place endovascular prosthesis with low radial force.
It effectively reduces the damage to blood vessels by the vasodilator device, maintains vascular compliance, ensures the dilation of the vascular lumen and the fit between the prosthesis and the blood vessel wall, and reduces long-term damage.
Smart Images
Figure CN119185761A_ABST
Abstract
Description
Technical Field
[0001] The present invention belongs to the technical field of vascular stents, and in particular relates to a vascular expansion device and a method for using the same. Background Art
[0002] Aortic dissection refers to a disease in which the middle layer of the blood vessel is damaged due to bleeding in the aortic vessel wall, resulting in the separation of the vessel wall layers, and the subsequent formation of true lumens or false lumens that are interconnected or not. In most cases, aortic dissection starts with an intimal tear, and blood enters the middle layer through the intimal tear, eventually leading to aortic rupture or re-entering the true lumen through a second intimal tear.
[0003] Among the existing methods, interventional endovascular repair is used for treatment. Specifically, a catheter loaded with an intravascular prosthesis is inserted into a blood vessel, and the catheter is moved along the blood vessel to the location of the lesion. The loaded intravascular prosthesis is released by relative movement of the catheter and the intravascular prosthesis. The released intravascular prosthesis automatically expands in the blood, and finally adheres to the inner wall of the blood vessel to complete the repair of the vascular cavity, and the catheter is withdrawn from the body. However, if the intravascular prosthesis is released directly in the ascending aorta with dissection, there are the following problems: if the radial force of the intravascular prosthesis is insufficient, it is difficult to open the true lumen of the narrow dissection, and the reconstruction of the vascular cavity cannot be completed; if the radial force of the intravascular prosthesis is strong, enough to open the true lumen of the dissection, the strong radial force may cause the blood vessel to lose its original compliance, thereby increasing the burden on the heart, and excessive radial force may also cause further damage to the diseased ascending aorta, which may eventually lead to rupture of the dissection and death of the patient. The existing methods for preventing decreased vascular compliance include intraoperative pre-dilation of the blood vessels. Before implantation of the prosthesis, pre-dilation of the blood vessels is the most convenient and effective way to prevent decreased vascular compliance. However, there is currently a lack of specific devices and instruments for pre-dilation of the aorta in clinical practice. At the same time, if traditional dilation tools are used, not only is the dilation effect poor, but the weak vascular endothelium is also easily scratched during the dragging process. Summary of the invention
[0004] In view of the above shortcomings of the prior art, the purpose of the present invention is to provide a vascular dilation device and a method of use thereof, so as to improve the problem of using traditional dilation tools in the prior art, which not only have poor dilation effects but are also very likely to scratch the weak vascular endothelium during the dragging process.
[0005] To achieve the above-mentioned and other related purposes, the present invention provides a vascular dilation device, comprising:
[0006] External pipe;
[0007] An inner tube, arranged inside the outer tube and slidable relative to the outer tube along the axial direction;
[0008] A stent expansion tube, which is arranged between the outer tube and the inner tube;
[0009] The expandable stent comprises an inner expandable stent and an outer expandable stent, one end of the inner expandable stent and the outer expandable stent are connected to the stent expansion tube, and the other ends are connected to each other, and the stent expansion tube can drive the inner expandable stent and the outer expandable stent to move synchronously or individually.
[0010] In one embodiment of the present invention, the stent expansion tube includes an inner stent expansion tube and an outer stent expansion tube, the outer stent expansion tube is arranged between the inner stent expansion tube and the outer tube, and the inner stent expansion tube and the outer stent expansion tube can move synchronously or independently.
[0011] In one embodiment of the present invention, one end of the inner stent is connected to the inner stent expansion tube, and the outer stent is connected to the outer stent expansion tube. The inner stent expansion tube and the outer stent expansion tube can slide relative to each other along their axial directions.
[0012] In one embodiment of the present invention, the inner layer expansion stent and the outer layer expansion stent are respectively connected to the inner layer stent expansion tube and the outer layer stent expansion tube by bonding, hot melting or welding.
[0013] In one embodiment of the present invention, the inner layer expansion stent and the outer layer expansion stent are nickel-titanium alloy stents or polymer materials.
[0014] In one embodiment of the present invention, the inner layer expandable stent and the outer layer expandable stent are an integrated structure.
[0015] In one embodiment of the present invention, when the expandable stent is in a released state, the outer expandable stent expands and abuts against the blood vessel wall, and the inner expandable stent abuts against the inner tube.
[0016] In one embodiment of the present invention, when the expandable stent contracts, the portion of the expandable stent that adheres to the blood vessel wall is relatively stationary with respect to the blood vessel wall in the axial direction, and is separated from the blood vessel wall in the radial direction.
[0017] In one embodiment of the present invention, it further comprises a driving assembly, wherein the driving assembly is connected to the inner layer stent expansion tube and the outer layer stent expansion tube.
[0018] The present invention also provides a method for using a vascular dilation device, including: a dilation process and a recovery process, wherein the dilation process includes:
[0019] Inserting the vasodilator in a compressed state into the blood vessel, and pushing the vasodilator to the location of the lesion along the established pathway;
[0020] Axially moving the outer tube in the vascular expansion device to the rear side to release the expanded stent compressed between the outer tube and the inner tube;
[0021] The expansion stent automatically expands and adheres closely to the inner wall of the blood vessel, restoring the lumen of the blood vessel to normal and completing the expansion process;
[0022] The recycling process includes:
[0023] Ensure that the outer stent expansion tube and the blood vessel wall remain relatively still, and axially move the rear side of the inner stent expansion tube in the blood vessel expansion device so that the expansion stent is radially separated from the blood vessel wall until the expansion stent is completely separated from the blood vessel wall;
[0024] Pushing the outer tube of the vascular expansion device forward along the axial direction so that the expanded stent separated from the vascular wall is compressed back between the outer tube and the inner tube;
[0025] The vasodilator device in the recovery state is removed from the body to complete the recovery process.
[0026] The present invention provides a vascular expansion device and a method for using the same. The device is a temporary device for pre-expanding a blood vessel at a narrowed true lumen of a dissection. The device uses dense metal grids to evenly disperse the radial force of the device for expanding the blood vessel on each metal grid, so as to reduce the pressure of the vascular expansion device on the entire blood vessel. In addition, by designing the expansion stent as a double-layer structure, the expansion tube of the outer stent and the blood vessel wall are relatively stationary during recovery, and the rear side of the expansion tube of the inner stent in the vascular expansion device is axially expanded to make the expansion stent detach from the blood vessel wall in the radial direction until the expansion stent is completely detached from the blood vessel wall, thereby reducing friction between the expansion stent and the blood vessel, thereby reducing damage to the blood vessel by the vascular expansion device. After the blood vessel is expanded, an intravascular prosthesis with a small radial force is placed at the lesion position of the blood vessel, and then the temporary device is withdrawn from the body, so as to finally expand the narrowed true lumen of the blood vessel, maintain the compliance of the blood vessel itself, enhance the fit between the prosthesis and the blood vessel wall, and reduce long-term damage to the blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS
[0027] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for describing the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying creative work.
[0028] Figure 1FIG. 1 is a schematic diagram of the structure of a vascular dilation device in one embodiment of the present invention.
[0029] Figure 2 FIG. 1 is a schematic diagram of a vascular dilation device extending into a lesion in one embodiment of the present invention.
[0030] Figure 3 This is a schematic diagram of the completion of the expansion stent release of the vascular expansion device in one embodiment of the present invention.
[0031] Figure 4 The figure is a schematic diagram of the expansion stent recovery process of the vascular expansion device in one embodiment of the present invention.
[0032] Figure 5 This is a schematic diagram of the completion of the recovery of the expansion stent of the vascular expansion device in one embodiment of the present invention.
[0033] Figure 6 It is a schematic diagram showing the completion of release in one embodiment of the present invention.
[0034] Figure 7 FIG. 1 is a flow chart of a method for using a vascular dilation device during dilation in one embodiment of the present invention.
[0035] Figure 8 FIG. 1 is a flow chart of a method for using a vascular dilation device during recovery in one embodiment of the present invention.
[0036] Description of labels:
[0037] 100. Vascular dilation device; 10. Outer tube; 20. Inner tube; 30. Stent dilation tube; 40. Dilation stent; 31. Inner stent dilation tube; 32. Outer stent dilation tube; 41. Inner dilation stent; 42. Outer dilation stent; 101. Vascular wall; 102. Prosthesis. DETAILED DESCRIPTION
[0038] The following describes the embodiments of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention.
[0039] It should be noted that the illustrations provided in this embodiment are only used to illustrate the basic concept of the present invention in a schematic manner. Therefore, the drawings only show components related to the present invention rather than being drawn according to the number, shape and size of components in actual implementation. In actual implementation, the type, quantity and proportion of each component may be changed arbitrarily, and the component layout may also be more complicated.
[0040] See also Figures 1 to 8 As shown, the present invention proposes a vascular expansion device and a method of using the same to improve the problem that the conventional expansion tools used in the prior art not only have poor expansion effects but are also very likely to scratch the weak vascular endothelium during the dragging process. Specifically, the vascular expansion device 100 includes an outer tube 10, an inner tube 20, a stent expansion tube 30 and an expansion stent 40, wherein the inner tube 20 is arranged on the inner side of the outer tube 10, the stent expansion tube 20 and the expansion stent 40 are arranged between the outer tube 10 and the inner tube 20, the expansion stent 40 is connected to the stent expansion tube 30, and the expansion stent 40 is arranged as a double-layer structure, the stent expansion tube 30 can drive any one layer of the expansion stent 40 designed as a double-layer structure to move independently, and the outer tube 10 and the inner tube 20 can slide relative to each other along the axial direction to release the expansion stent 40.
[0041] See also Figure 1 As shown, in this embodiment, the expandable stent 40 includes an inner expandable stent 41 and an outer expandable stent 42. One end of the inner expandable stent 41 and the outer expandable stent 42 are connected to the stent expansion tube 30, and the other ends are connected to each other. The stent expansion tube 30 can drive the inner expandable stent 41 and the outer expandable stent 42 to move synchronously or individually. Specifically, in this embodiment, the stent expansion tube 30 includes an inner stent expansion tube 31 and an outer stent expansion tube 32, the outer stent expansion tube 32 is disposed between the inner stent expansion tube 31 and the outer tube 10, one end of the inner stent expansion tube 42 is connected to the inner stent expansion tube 32, the outer stent expansion tube 41 is connected to the outer stent expansion tube 31, the inner stent expansion tube 31 and the outer stent expansion tube 32 can move synchronously or individually, that is, the inner stent expansion tube 31 and the outer stent expansion tube 32 can slide relative to each other along their axial direction, thereby driving the inner stent expansion tube 41 and the outer stent expansion tube 42 to move synchronously or individually. In this embodiment, the vascular expansion device further includes a driving component, the driving component is connected to the inner stent expansion tube 31 and the outer stent expansion tube 32, so as to drive the inner stent expansion tube 31 and the outer stent expansion tube 32 to move axially.
[0042] See also Figure 1 As shown, in this embodiment, the inner layer expansion stent 41 and the outer layer expansion stent 42 are an integrated structure, that is, one end of the expansion stent 40 is respectively connected to the inner layer stent expansion tube 31 and the outer layer stent expansion tube 32, and the other end is arc-shaped to avoid the appearance of sharp-angled structures that may cause damage to the blood vessels.
[0043] See also Figure 1As shown, in this embodiment, the inner layer expansion stent 41 and the outer layer expansion stent 42 are grid-shaped self-expanding stents, that is, the expansion stent 40 uses a dense metal grid to evenly disperse the radial force of the device to expand the blood vessel on each metal grid, so as to reduce the pressure of the vascular expansion device on the entire blood vessel. In this embodiment, the material of the inner layer expansion stent 41 and the outer layer expansion stent 42 is metal, preferably nickel-titanium alloy, and the inner layer expansion stent 41 and the outer layer expansion stent 42 can be connected to the inner layer stent expansion tube 31 and the outer layer stent expansion tube 32 respectively by bonding, hot melting or welding, preferably rigidly connected, so that the inner layer stent expansion tube 31 and the outer layer stent expansion tube 32 can drive the inner layer expansion stent 41 and the outer layer expansion stent 42 to move. Of course, in other embodiments together, the inner layer expansion stent 41 and the outer layer expansion stent 42 can also be set to be made of polymer materials. It is understandable that the expansion stent 40 is in the shape of a metal grid. When the expansion stent 40 is expanded, its grid structure enables the device to expand the blood vessel without blocking the blood flow in the blood vessel cavity, thereby maintaining the smooth blood flow in the blood vessel cavity.
[0044] See also Figures 2 to 6 As shown, in this embodiment, when the outer tube 10 is withdrawn to release the expansion stent 30, so that the expansion stent 30 is in a released state, the outer expansion stent 42 expands and abuts against the blood vessel wall 101, and the inner expansion stent 41 abuts against the outer circumferential surface of the inner tube 20. At this time, since the expansion stent 40 is in the shape of a metal grid, when the expansion stent 40 expands, the vascular expansion device can achieve vascular expansion while maintaining the patency of blood flow in the blood vessel cavity. When the expansion stent 30 is recovered, the portion of the expansion stent 40 that is in contact with the vascular wall 101 remains relatively still in the axial direction with respect to the vascular wall 101, and detaches from the vascular wall 101 in the radial direction. For example, the expansion tube 32 of the inner stent at the rear side can be used to apply a radial force to the inside of the blood vessel to the expansion stent 40, so that the expansion stent 40 detaches from the vascular wall 101 in the radial direction and is then recovered between the outer tube 10 and the inner tube 20. The expansion stent 40 and the vascular wall 101 remain relatively still in the axial direction, so as to avoid friction between the expansion stent 40 and the blood vessel, thereby reducing damage to the blood vessel caused by the vascular expansion device.
[0045] See also Figures 2 to 8As shown, the present invention also proposes a method for using a vascular expansion device, which is applied to the vascular expansion device described in the above embodiment, including: an expansion process and a recovery process, wherein the expansion process refers to the process of delivering the vascular expansion stent to the lesion site and releasing the expansion stent 40 to complete the vascular expansion, and the recovery process refers to the process of recovering the expansion stent that has completed the vascular expansion in the released state and moving the vascular expansion device out of the body.
[0046] See also Figure 7 As shown, in this embodiment, the expansion process includes:
[0047] S11. Insert a vasodilator in a compressed state into a blood vessel, and push the vasodilator to the location of the lesion along the established pathway; for the convenience of explanation, the aortic arch area is simplified into a straight tube-type blood vessel with an intimal rupture. Blood enters the intimal rupture to form an unconnected, localized false lumen.
[0048] S12. Axially withdraw the outer tube in the vascular expansion device to release the expansion stent compressed between the outer tube and the inner tube; it should be noted that when the outer tube 10 is withdrawn axially to release the expansion stent 40, it is necessary to ensure that the remaining components in the vascular expansion device remain relatively fixed with the vascular stent, and during the withdrawal of the outer tube 10, the expansion stent 40 gradually expands.
[0049] S13. The expansion stent automatically expands and adheres to the inner wall of the blood vessel, so that the blood vessel lumen returns to normal and the expansion process is completed; the expansion stent automatically expands in the blood and adheres to the inner wall of the blood vessel, so that the originally narrow lumen returns to normal and the false lumen disappears.
[0050] See also Figure 8 As shown, in this embodiment, the recycling process includes:
[0051] S21, ensuring that the outer stent expansion tube 32 and the blood vessel wall 101 remain relatively still, and axially withdrawing the inner stent expansion tube 31 in the blood vessel expansion device, so that the expansion stent 40 is radially separated from the blood vessel wall until the expansion stent 40 is completely separated from the blood vessel wall;
[0052] S22. Push the outer tube 10 in the vascular expansion device forward axially so that the expanded stent 40 that has detached from the blood vessel wall is compressed back between the outer tube 10 and the inner tube 20; for example, after the rear inner layer stent expansion tube 31 causes the expanded stent 40 to detach from the blood vessel wall, the outer tube 10 and other structures can be pushed forward axially so that the expanded stent 40 is compressed between the outer tube 10 and the inner tube 20 again.
[0053] S23. Remove the vasodilator device in the recovery state from the body to complete the recovery process.
[0054] It can be understood that in this embodiment, after the expansion process is completed, the interventional device loaded with the intravascular prosthesis 102 with small radial force can be transported to the lesion site through the inner cavity of the inner tube 20, and the intravascular prosthesis 101 can be gradually released from the proximal end to the distal end, for example, the inner stent expansion tube 32 and the inner tube 20 are pulled toward the distal end, and the expansion stent 40 is gradually recovered. At this time, the vascular expansion device is in a semi-released and semi-recovered state. With the gradual recovery of the vascular expansion device and the gradual release of the intravascular prosthesis of the interventional device loaded with the intravascular prosthesis with small radial force, the vascular expansion device is finally in a completely recovered (compressed) state, and the intravascular prosthesis is also completely released and adheres to the inner wall of the blood vessel. The vascular expansion device in the recovered (compressed) state is withdrawn from the body, and the delivery system of the interventional device that releases the intravascular prosthesis is withdrawn from the body, and the intravascular prosthesis remains in the body. Finally, the expansion of the stenotic blood vessel is completed, and an intravascular prosthesis with small radial force is released, the compliance of the blood vessel is retained, the fit between the prosthesis and the blood vessel wall is enhanced, and the long-term damage to the blood vessel is reduced.
[0055] It can be understood that the proximal end and the distal end described in the above embodiment are: the aorta is derived from the left ventricle of the heart and gradually branches into blood vessels of various levels in the body. The end of a certain blood vessel close to the heart is called the proximal end of the blood vessel, and the end of a certain blood vessel away from the heart is called the distal end of the blood vessel.
[0056] The present invention provides a vascular dilation device and a method for using the same, which is a temporary device for pre-dilation of blood vessels at the narrow part of the true lumen of a dissection. The device uses dense metal grids to evenly disperse the radial force of the device to dilate the blood vessels on each metal grid, so as to reduce the pressure of the vascular dilation device on the entire blood vessel.
[0057] The present invention provides a vascular expansion device and a method for using the same. The expansion stent is designed to have a double-layer structure so that the expansion tube of the outer stent and the blood vessel wall remain relatively still during recovery, and the expansion tube of the inner stent in the vascular expansion device is withdrawn axially so that the expansion stent is radially separated from the blood vessel wall until the expansion stent is completely separated from the blood vessel wall, thereby reducing friction between the expansion stent and the blood vessel, thereby reducing damage to the blood vessel by the vascular expansion device.
[0058] The present invention provides a vascular dilation device and a method for using the same. After dilating the blood vessel, an intravascular prosthesis with low radial force is placed at the diseased position of the blood vessel, and then the temporary device is withdrawn from the body, thereby ultimately achieving the goal of dilating the narrowed true lumen of the blood vessel, maintaining the compliance of the blood vessel itself, and reducing long-term damage to the blood vessel.
[0059] The embodiments described above are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. Such modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention, and should all be included in the protection scope of the present invention.
[0060] Except for the technical features described in the specification, the remaining technical features are known technologies to those skilled in the art. In order to highlight the innovative features of the present invention, the remaining technical features will not be described here in detail.
Claims
1. A vasodilator, characterized in that: include: External pipe; An inner tube, arranged inside the outer tube and slidable relative to the outer tube along the axial direction; A stent expansion tube, which is arranged between the outer tube and the inner tube; The expandable stent comprises an inner expandable stent and an outer expandable stent, one end of the inner expandable stent and the outer expandable stent are connected to the stent expansion tube, and the other ends are connected to each other, and the stent expansion tube can drive the inner expandable stent and the outer expandable stent to move synchronously or individually.
2. The vasodilator according to claim 1, characterized in that: The stent expansion tube comprises an inner stent expansion tube and an outer stent expansion tube, the outer stent expansion tube is arranged between the inner stent expansion tube and the outer tube, and the inner stent expansion tube and the outer stent expansion tube can move synchronously or independently.
3. The vasodilator according to claim 2, characterized in that: One end of the inner layer expansion stent is connected to the inner layer expansion tube, and the outer layer expansion stent is connected to the outer layer expansion tube. The inner layer expansion tube and the outer layer expansion tube can slide relative to each other along their axial directions.
4. The vasodilator according to claim 3, characterized in that: The inner layer expansion stent and the outer layer expansion stent are respectively connected to the inner layer stent expansion tube and the outer layer stent expansion tube by bonding, hot melting or welding.
5. The vasodilator according to claim 1, characterized in that: The inner layer expansion stent and the outer layer expansion stent are nickel-titanium alloy stents or polymer materials.
6. The vasodilator according to claim 1, characterized in that: The inner layer expansion stent and the outer layer expansion stent are an integrated structure.
7. The vasodilator according to claim 3, characterized in that: When the expandable stent is in a released state, the outer-layer expandable stent expands and abuts against the blood vessel wall, and the inner-layer expandable stent abuts against the inner tube.
8. The vasodilator according to claim 3, characterized in that: When the expandable stent contracts, the portion of the expandable stent that adheres to the blood vessel wall is relatively stationary with respect to the blood vessel wall in the axial direction, and is separated from the blood vessel wall in the radial direction.
9. The vasodilator according to claim 2, characterized in that: It also includes a driving component, which is connected to the inner layer stent expansion tube and the outer layer stent expansion tube.
10. A method for using a vasodilator, characterized in that: include: Expansion process and recovery process, wherein the expansion process includes: Inserting the vasodilator in a compressed state into the blood vessel, and pushing the vasodilator to the location of the lesion along the established pathway; Retracting the outer tube in the vascular expansion device axially to release the expanded stent compressed between the outer tube and the inner tube; The expansion stent automatically expands and adheres closely to the inner wall of the blood vessel, restoring the lumen of the blood vessel to normal and completing the expansion process; The recycling process includes: Ensure that the outer stent expansion tube and the blood vessel wall remain relatively still, and withdraw the inner stent expansion tube in the blood vessel expansion device axially so that the expansion stent is radially separated from the blood vessel wall until the expansion stent is completely separated from the blood vessel wall; Pushing the outer tube of the vascular expansion device forward along the axial direction so that the expanded stent separated from the vascular wall is compressed back between the outer tube and the inner tube; The vasodilator device in the recovery state is removed from the body to complete the recovery process.