Branched drug-loaded stent for thoracico-abdominal aortic aneurysm
By designing a branched drug-eluting stent, and utilizing a combination of an internal septal layer, a drug-eluting functional layer, and a degradation layer, the problem of high endoleak incidence after endovascular repair of thoracic and abdominal aortic aneurysms was solved, resulting in a reduction of endoleak, improved treatment efficacy, and promotion of vascular tissue regeneration.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- THE FIRST MEDICAL CENT CHINESE PLA GENERAL HOSPITAL
- Filing Date
- 2025-04-30
- Publication Date
- 2026-05-19
AI Technical Summary
In existing technologies, the incidence of endoleak after endovascular repair of thoracic and abdominal aortic aneurysms is high. In particular, persistent endoleak caused by uneven distribution of circumferential stress in the stent leads to persistently high perfusion pressure in the aneurysm cavity, which increases the postoperative mortality rate.
A branched drug-eluting stent is designed, comprising a stent body, an internal septum, a drug-eluting functional layer, and a degradation layer. Through a reasonable combination, the incidence of endoleak is reduced, the drug-eluting functional layer continuously releases drugs to promote the healing of lesions, and the degradation layer gradually degrades to avoid foreign body reactions.
It significantly reduces the incidence of endoleak, improves treatment efficacy, promotes vascular tissue regeneration, reduces complications, lowers the risk of systemic side effects, and improves quality of life.
Smart Images
Figure CN224251844U_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical device technology, and in particular to a branched drug-eluting stent for thoracic and abdominal aortic aneurysms. Background Technology
[0002] Currently, endovascular aortic repair is widely used to treat aneurysms and aortic dissections in the thoracic and abdominal aorta. However, the thoracic and abdominal aorta have complex vascular structures with numerous lateral branches, and there are significant individual differences among patients. In current clinical practice, endovascular repair of thoracic and abdominal aortic aneurysms mainly relies on customized fenestrated or branched covered stent systems, which achieve minimally invasive treatment by preserving perfusion of important branches such as the celiac trunk, superior mesenteric artery, and renal artery. However, due to the complex anatomical structure, the incidence of endoleak after endovascular repair of thoracic and abdominal aortic aneurysms remains high. In particular, persistent endoleak caused by uneven circumferential stress distribution of the stent can lead to a continuous perfusion pressure in the aneurysm cavity >50 mmHg, increasing the 2-year aneurysm-related mortality rate by 3.7 times. Utility Model Content
[0003] This application provides a branched drug-eluting stent for thoracic and abdominal aortic aneurysms to reduce the incidence of endoleak.
[0004] This application provides a branched drug-loaded stent for thoracic and abdominal aortic aneurysms, comprising: a stent body, wherein a drug-loaded coating is disposed on the stent body, wherein...
[0005] The drug-loaded coating comprises, from the inside out, an internal separating layer, a drug-loaded functional layer, and a degradation layer.
[0006] In the above technical solution, by setting a stent body, and setting a drug-loaded coating on the stent body, the drug-loaded coating includes an internal separation layer, a drug-loaded functional layer and a degradation layer arranged sequentially from the inside to the outside; the incidence of internal leakage is reduced.
[0007] In one possible implementation, the drug-loaded coating is applied to the stent body.
[0008] In one specific implementation, the stent body is a tubular stent body.
[0009] In one specific implementation scheme, the support body is provided with inner branches and outer branches, wherein,
[0010] The inner branch is connected to the support body, and the outer branch is connected to the support body.
[0011] In one specific implementation, both the inner branch and the outer branch are provided with development marks.
[0012] In one specific implementation, the angle between the inner branch and the adjacent outer branch along the circumferential direction is 60° to 80°.
[0013] In a specific feasible implementation,
[0014] The included angle of the outer branch along the circumferential direction is 170° to 180°.
[0015] The drug-loaded functional layer is made of procoagulant drugs or polymeric hemostatic materials.
[0016] In one specific implementation, the procoagulant drug is one or more of human prothrombin complex, human coagulation factor II, human coagulation factor VII, human coagulation factor IX, and human coagulation factor X.
[0017] In one possible implementation, the degradation layer is made of a biodegradable material, and the internal separation layer is made of a non-permeable material. Attached Figure Description
[0018] Figure 1 This is a schematic diagram of a branched drug-eluting stent for thoracic and abdominal aortic aneurysms provided in an embodiment of this application.
[0019] Among them, 1-stent body, 2-inner branch, 3-inner branch, 4-internal septum, 5-drug-loading functional layer, and 6-degradation layer. Detailed Implementation
[0020] The present application will now be described in further detail with reference to the accompanying drawings and embodiments. Through these descriptions, the features and advantages of the present application will become clearer and more apparent.
[0021] The term “exemplary” as used herein means “serving as an example, embodiment, or illustration.” Any embodiment illustrated herein as “exemplary” is not necessarily to be construed as superior to or better than other embodiments. Although various aspects of embodiments are shown in the accompanying drawings, the drawings are not necessarily drawn to scale unless specifically indicated otherwise.
[0022] Furthermore, the technical features involved in the different embodiments of this application described below can be combined with each other as long as they do not conflict with each other.
[0023] To facilitate understanding of the branched drug-eluting stent for thoracic and abdominal aortic aneurysms provided in this application embodiment, its application scenario is first explained. The branched drug-eluting stent for thoracic and abdominal aortic aneurysms provided in this application embodiment aims to reduce the incidence of endoleak. Currently, endovascular aortic repair is widely used in the treatment of aneurysms and aortic dissections in the thoracic and abdominal aorta. However, the thoracic and abdominal aorta has a complex vascular structure with numerous lateral branches, and significant individual patient differences. In current clinical practice, endovascular repair of thoracic and abdominal aortic aneurysms mainly relies on customized fenestrated or branched covered stent systems, which achieve minimally invasive treatment by preserving perfusion of important branches such as the celiac trunk, superior mesenteric artery, and renal artery. However, due to the complex anatomical structure, the incidence of endoleak after endovascular repair of thoracic and abdominal aortic aneurysms remains high. In particular, persistent endoleak caused by uneven circumferential stress distribution of the stent can lead to a continuous perfusion pressure in the aneurysm cavity >50 mmHg, increasing the aneurysm-related mortality rate by 3.7 times at 2 years post-procedure. Therefore, this application provides a branched drug-eluting stent for thoracic and abdominal aortic aneurysms to reduce the incidence of endoleak. The following detailed description, in conjunction with specific accompanying drawings, illustrates the embodiments.
[0024] refer to Figure 1 , Figure 1 This is a schematic diagram of a branched drug-eluting stent for thoracic and abdominal aortic aneurysms provided in an embodiment of this application.
[0025] exist Figure 1 This application provides a branched drug-eluting stent for thoracic and abdominal aortic aneurysms, comprising: a stent body 1, wherein a drug-eluting coating is disposed on the stent body, wherein...
[0026] The drug-loaded coating comprises, from the inside out, an internal separating layer 4, a drug-loaded functional layer 5, and a degradation layer 6.
[0027] In the above technical solution, by setting a stent body, and setting a drug-loaded coating on the stent body, the drug-loaded coating includes an internal separation layer, a drug-loaded functional layer and a degradation layer arranged sequentially from the inside to the outside; the incidence of internal leakage is reduced.
[0028] Specifically, the stent body: as the supporting structure of the entire drug-eluting stent, has sufficient strength and stability to ensure that it can effectively support the aortic aneurysm site after implantation and prevent the aneurysm from further expanding or rupturing.
[0029] Internal separator: This layer, located on the innermost side of the drug-eluting membrane, primarily functions to separate the stent body from the drug-eluting layer, preventing drugs from entering the bloodstream. Simultaneously, it provides support and stability, ensuring the drug-eluting membrane adheres firmly to the stent body.
[0030] Drug-loaded functional layer: This layer is the core of the drug-loaded coating, containing the drugs needed to treat aortic aneurysms. These drugs can be continuously and stably released to the lesion site for a period of time after implantation through a specific release mechanism, thereby achieving the therapeutic goal. The drug-loaded functional layer ensures uniform distribution and effective release of drugs to maximize therapeutic efficacy.
[0031] Degradation layer: This layer is located on the outermost side of the drug-loaded coating. Its main function is to gradually degrade and eventually be absorbed by the body as the drug is released and over time. The presence of the degradation layer can avoid foreign body reactions or rejection reactions that may be caused by the long-term presence of the drug-loaded coating in the body, and it also promotes the regeneration and repair of vascular tissue.
[0032] Beneficial effects include:
[0033] Reducing the incidence of endoleaks: By employing a drug-loaded coating, particularly a rational combination of an internal septum, a drug-loaded functional layer, and a degradation layer, the entry and exit points of aortic aneurysms can be sealed more effectively, thereby significantly reducing the incidence of endoleaks. The internal septum ensures isolation from the drug-loaded functional layer, avoiding potential chemical reactions or adverse effects; the drug-loaded functional layer promotes healing and repair of the lesion site through continuous drug release; and the gradual degradation of the degradation layer facilitates vascular tissue regeneration and vascular wall stability.
[0034] Improved therapeutic efficacy: The drug-loaded coating allows the medication to act directly on the lesion site, achieving a high local drug concentration and thus improving therapeutic efficacy. Compared to traditional systemic drug delivery methods, this approach not only reduces the amount of medication used but also lowers the risk of systemic side effects.
[0035] Promoting vascular tissue regeneration: As the degradation layer gradually degrades, vascular tissue can gradually regenerate and repair itself under the protection of the drug-loaded coating. This helps restore the normal structure and function of blood vessels, improving patients' quality of life.
[0036] Reducing complications: The incidence of complications can be significantly reduced through well-designed drug-eluting coatings and appropriate drug release mechanisms. For example, by minimizing endoleaks and avoiding adverse reactions such as foreign body reactions, the risk of repeat surgery or other treatments for patients can be lowered.
[0037] In one possible implementation, the drug-loaded coating is applied to the stent body.
[0038] In one specific implementation, the stent body is a tubular stent body.
[0039] In one specific implementation scheme, the support body is provided with inner branch 2 and inner branch 3, wherein,
[0040] The inner branch is connected to the support body, and the outer branch is connected to the support body.
[0041] In one specific implementation, both the inner branch and the outer branch are provided with development marks.
[0042] In one specific implementation, the angle between the inner branch and the adjacent outer branch along the circumferential direction is 60° to 80°.
[0043] In a specific feasible implementation,
[0044] The included angle of the outer branch along the circumferential direction is 170° to 180°.
[0045] The drug-loaded functional layer is made of procoagulant drugs or polymeric hemostatic materials.
[0046] In one specific implementation, the procoagulant drug is one or more of human prothrombin complex, human coagulation factor II, human coagulation factor VII, human coagulation factor IX, and human coagulation factor X.
[0047] In one possible implementation, the degradation layer is made of a biodegradable material, and the internal separation layer is made of a non-permeable material.
[0048] Specifically, refer to Figure 1 The branched drug-eluting stent for thoracic and abdominal aortic aneurysms comprises:
[0049] The stent body and the drug-loaded coating covering and fixed to the stent body are included. The drug-loaded coating comprises, from the inside out, an internal septum, a drug-loaded functional layer, and a degradable layer. The internal septum is made of a non-permeable material to prevent drugs from entering the blood vessel. The drug-loaded functional layer is composed of procoagulant drugs or polymeric hemostatic materials to promote thrombus formation between the stent and the vessel wall to prevent endoleak. The degradable layer is made of a biodegradable material to prevent premature contact of procoagulant drugs with the blood, which could lead to thrombus formation in the aorta.
[0050] The stent body is a tubular body (tubular stent body), with two inner branches and two outer branches respectively connected to the tubular body, and imaging marks for positioning the inner branches and the outer branches; the tubular body includes a first main segment, a tapered segment and a second main segment connected in sequence, the distal end of the inner branch is connected to the tapered segment, the proximal end of the outer branch is connected to the tapered segment, the two inner branches are located between the two outer branches, the angle between the inner branch and the adjacent outer branch along the circumferential direction is 60° to 80°, and the angle between the two outer branches along the circumferential direction is 170° to 180°.
[0051] Procoagulant drugs are one or more of human prothrombin complex or human coagulation factors II, VII, IX, and X, or other polymeric hemostatic materials used for hemostasis.
[0052] The length of the drug layer is shorter than that of the degradation layer and the separator layer. No drug layer is set in the drug-loaded coating area near the inner and outer branches.
[0053] In the above technical solution, by setting a stent body, and setting a drug-loaded coating on the stent body, the drug-loaded coating includes an internal separation layer, a drug-loaded functional layer and a degradation layer arranged sequentially from the inside to the outside; the incidence of internal leakage is reduced.
[0054] Those skilled in the art will know that this application can be implemented as a system, method, or computer program product.
[0055] Therefore, this disclosure can be implemented in the following forms: it can be entirely hardware, entirely software (including firmware, resident software, microcode, etc.), or a combination of hardware and software, generally referred to herein as a "circuit," "module," or "system." Furthermore, in some embodiments, this application can also be implemented as a computer program product in one or more computer-readable media, which contains computer-readable program code.
[0056] Any combination of one or more computer-readable media may be used. A computer-readable medium can be a computer-readable signal medium or a computer-readable storage medium. A computer-readable storage medium can be, for example, but not limited to, an electrical, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any combination thereof. More specific examples (a non-exhaustive list) of computer-readable storage media include: an electrical connection having one or more wires, a portable computer disk, a hard disk, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable compact disk read-only memory (CD-ROM), optical storage device, magnetic storage device, or any suitable combination thereof. In this document, a computer-readable storage medium can be any tangible medium that contains or stores a program that can be used by or in connection with an instruction execution system, apparatus, or device.
[0057] Although embodiments of this application have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting this application. Those skilled in the art can make changes, modifications, substitutions, and variations to the above embodiments within the scope of this application. Based on this, various substitutions and improvements can be made to this application, all of which fall within the protection scope of this application.
Claims
1. A branched drug-eluting stent for thoracic and abdominal aortic aneurysms, characterized in that, include: The stent body has a drug-loaded coating disposed thereon. The drug-loaded coating comprises, from the inside out, an internal partition layer, a drug-loaded functional layer, and a degradation layer; The stent body is a tubular stent body; the stent body is provided with inner branches and outer branches, wherein the inner branches are connected to the stent body and the outer branches are connected to the stent body; both the inner branches and the outer branches are provided with imaging marks; the tubular body includes a first main body segment, a tapered segment and a second main body segment connected in sequence, the distal end of the inner branch is connected to the tapered segment, the proximal end of the outer branch is connected to the tapered segment, the two inner branches are located between the two outer branches, the angle between the inner branch and the adjacent outer branch along the circumferential direction is 60° to 80°, and the angle between the outer branch and the circumferential direction is 170° to 180°.
2. The branched drug-eluting stent for thoracic and abdominal aortic aneurysms according to claim 1, characterized in that, The drug-loaded coating is applied to the scaffold body.
3. The branched drug-eluting stent for thoracic and abdominal aortic aneurysms according to claim 1, characterized in that, The drug-loaded functional layer is made of procoagulant drugs or polymeric hemostatic materials.
4. The branched drug-eluting stent for thoracic and abdominal aortic aneurysms according to claim 3, characterized in that, The procoagulant drug is one or more of the following: human prothrombin complex, human coagulation factor II, human coagulation factor VII, human coagulation factor IX, and human coagulation factor X.
5. The branched drug-eluting stent for thoracic and abdominal aortic aneurysms according to claim 4, characterized in that, The degradation layer is made of a biodegradable material, and the internal partition layer is made of a non-permeable material.