Landing zone marking for flow diversion stents

By introducing a proximal landing zone indicator and radiopaque markers into the delivery system, the problem of precise deployment of intravascular implants in bifurcation vessels was solved, enabling accurate positioning and deployment of stents in straight segments and reducing operational complexity.

CN117503444BActive Publication Date: 2026-03-06DEEPIN TECH LLC
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Patent Information

Application Number
CN202311278204.7
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2023-09-20
Filing Date
2023-09-28
Publication Date
2026-03-06
Estimated Expiration
2043-09-28

AI Technical Summary

Technical Problem

Existing technologies make it difficult to precisely deploy intravascular implants, especially stents, in patients with bifurcated vessels, leading to poor apposition and increased complexity.

Method used

A delivery system including a proximal landing zone indicator is used, which uses radiopaque markers to indicate the proximal and distal landing positions of the implant, providing a visual reference for deployment in vessels from the smallest to the largest diameter, ensuring accurate deployment of the implant in a straight segment.

Benefits of technology

It improves the deployment accuracy of implants in bifurcation vessels, reduces the need for poor adhesion and repositioning, and simplifies the operation process.

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Abstract

Landing zone markings for flow-directing stents are provided. An endovascular system includes an implant and a delivery system configured to deliver and deploy the implant to a treatment site in a blood vessel. The implant is radially expandable and configured to deploy in blood vessels ranging in diameter from a minimum to a maximum diameter. The delivery system includes a proximal landing zone indicator comprising a radiopaque marker having a length from a proximal end to a distal end, wherein the proximal end of the radiopaque marker indicates the position of the proximal end of the implant when deployed at a treatment site in a blood vessel with the minimum diameter, and the distal end of the radiopaque marker indicates the position of the proximal end of the implant when deployed at a treatment site in a blood vessel with the maximum diameter. A method for delivering an expandable implant to a target site in a patient's vascular system is also disclosed.
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Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 410,629, filed on September 28, 2022, entitled “Landing Zone Marking for Flow Diverting Stents,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This application generally relates to medical devices and methods of using medical devices. In particular, various embodiments of delivery systems and methods including implant landing zone indicators are described. Background Technology

[0004] Intravascular implants such as stents and diverters are known and have been used to treat a variety of vascular diseases. Generally, an intravascular implant is delivered to the treatment site in a narrow, contractile configuration, guided through the patient's vascular system using a delivery system. Once at the treatment site, the implant is released from the delivery system and unfolds in an expanded configuration. The expanded configuration of the implant is typically shorter in length than the contractile configuration of the implant constrained within the delivery system.

[0005] Precise deployment of intravascular implants is crucial, especially when treating vessels with bifurcations. For example, carotid artery stents typically deploy across the bifurcation between the common carotid and internal carotid arteries. If the stent is deployed improperly, it will exhibit mal-apposition with the vessel wall, and the stent's edges or ends may extend into the bends or turns of the bifurcation. Mal-apposition must then be corrected by shortening the stent to move the proximal end into the straight segment, which adds significant complexity, requiring stent manipulation and / or the introduction of a second device for correction. As braided stents tend to become larger and longer, they are constructed to achieve a larger braid angle to provide a smaller pore size, resulting in a significant shortening of the stent from its delivery configuration to its deployment configuration. This makes predicting the proximal landing position of the stent during deployment more difficult.

[0006] Therefore, there remains a general need for a system for delivering and deploying implants within a patient's vascular system. The desired outcome is a delivery system that can indicate the landing location of the expandable implant to facilitate precise deployment at the treatment site. Summary of the Invention

[0007] In one aspect, embodiments of this disclosure are characterized by an endovascular system. Typically, embodiments of an endovascular system include an implant and a delivery system configured to deliver and deploy the implant to a treatment site within a blood vessel. The implant is radially expandable and configured to deploy in blood vessels ranging in diameter from a minimum to a maximum diameter. The delivery system includes a proximal landing zone indicator comprising a radiopaque marker having a length from a proximal end to a distal end, wherein the proximal end of the radiopaque marker indicates the position of the proximal end of the implant when deployed at a treatment site in a blood vessel with the minimum diameter, and the distal end of the radiopaque marker indicates the position of the proximal end of the implant when deployed at a treatment site in a blood vessel with the maximum diameter.

[0008] In various embodiments of this aspect, the delivery system includes a tubular member and a delivery filament, wherein the implant is disposed between the tubular member and the delivery filament for delivery. The radiopaque marker of the proximal landing zone indicator is disposed on the delivery filament. The delivery filament may be a catheter, and the radiopaque marker may be in the form of a coil on the catheter of the delivery filament.

[0009] In various embodiments of this aspect, the implant may be configured to be deployed in a blood vessel with a diameter ranging from the minimum diameter of 5 mm to the maximum diameter of 10 mm.

[0010] In various embodiments of this aspect, the implant includes a braided stent or a braided flow diverter and is configured to unfold in a blood vessel adjacent to a bifurcation.

[0011] In various embodiments of this aspect, the delivery system includes a tubular member and a delivery filament, wherein the implant is disposed between the tubular member and the delivery filament for delivery, and the radiopaque marker is disposed on the tubular member.

[0012] In various embodiments of this aspect, the implant includes a braided stent or a braided blood flow diverter.

[0013] In another aspect, embodiments of this disclosure are characterized by a method of delivering an expandable implant to a target site in a patient's vascular system. The method includes the following steps: Determining the diameter of the vessel to be treated. Then, an intravascular system comprising a delivery system and an implant is provided. The implant has a distal and a proximal end and is radially expandable, and is configured to deploy in vessels ranging in diameter from a minimum diameter to a maximum diameter, wherein the minimum diameter is equal to or less than the diameter of the vessel to be treated, and the maximum diameter is equal to or greater than the diameter of the vessel to be treated. The delivery system includes a proximal landing zone indicator comprising a radiopaque marker having a length from the proximal end to the distal end of the radiopaque marker, wherein the proximal end of the radiopaque marker indicates the position of the proximal end of the implant when deployed in a vessel with the minimum diameter, and the distal end of the radiopaque marker indicates the position of the proximal end of the implant when deployed in a vessel with the maximum diameter. In a next step, the intravascular system is introduced into the vessel to be treated. Before deploying the implant, the landing position of the distal end of the implant in the blood vessel is determined. Then, before deploying the implant, the landing position of the proximal end of the implant in the blood vessel is determined. Determining the landing position of the proximal end of the implant includes observing the position of the proximal and / or distal ends of the transmissive marker of the proximal landing area indicator in the blood vessel, and determining the landing position of the proximal end of the implant based on the diameter of the blood vessel to be treated and the position of the proximal and / or distal ends of the transmissive marker of the proximal landing area indicator in the blood vessel. The implant is deployed if the landing position of the proximal end of the implant in the blood vessel is determined to be desirable.

[0014] In various embodiments of this aspect, the method may further include: repositioning the intravascular system before deploying the implant if it is determined that the landing position of the proximal end of the implant in the blood vessel is undesirable.

[0015] In various embodiments of this aspect, determining the diameter of the vessel to be treated includes determining the diameter of adjacent bifurcated vessels.

[0016] In various embodiments of this aspect, the delivery system includes a tubular member and a delivery filament, wherein the implant is disposed between the tubular member and the delivery filament for delivery, and a radiopaque marker is disposed on the delivery filament. The delivery filament may include a catheter, and the radiopaque marker may be in the form of a spring coil on the catheter of the delivery filament.

[0017] In various embodiments of this aspect, the implant includes a braided stent or a braided blood flow diverter.

[0018] In various embodiments of this aspect, the delivery system includes a tubular member and a delivery filament, wherein the implant is disposed between the tubular member and the delivery filament for delivery, and the radiopaque marker is disposed on the tubular member.

[0019] The content of this invention is provided to present selected aspects and embodiments of this disclosure in a simplified form and is not intended to identify key features or essential characteristics of the claimed subject matter, nor is it intended to help determine the scope of the claimed subject matter. The presented aspects and embodiments are merely intended to provide the reader with a brief overview of certain forms the invention may take, and are not intended to limit the scope of this disclosure. Other aspects and embodiments of this disclosure are described in the Detailed Description section.

[0020] These and various other aspects, embodiments, features, and advantages of this disclosure will become better understood after reading the following detailed description in conjunction with the accompanying drawings. Attached Figure Description

[0021] Figure 1 A cross-sectional view of an example intravascular system according to an embodiment of the present disclosure is shown.

[0022] Figure 2 A cross-sectional view of an example intravascular system according to an alternative embodiment of the present disclosure is shown.

[0023] Figure 3 This is a flowchart illustrating an example method according to an embodiment of the present disclosure.

[0024] Figures 4A to 4C A method of using an example intravascular system according to an embodiment of the present disclosure is shown. Detailed Implementation

[0025] Various embodiments of endovascular systems and methods will be described with reference to the accompanying drawings. The drawings are intended for illustrative purposes and are not necessarily drawn to scale. Certain specific details may be set forth in the drawings and description to provide a full understanding of this disclosure. It will be apparent to those skilled in the art that some of these specific details may not be used in practicing the embodiments of this disclosure. In other instances, structures, materials, components, systems, and / or operations typically associated with endovascular procedures may not have been shown or described in detail to avoid unnecessarily obscuring the description of embodiments of this disclosure.

[0026] It should be noted that while some embodiments of this disclosure have been shown and described in conjunction with procedures for treating diseases in the carotid artery, the devices, systems, and methods described herein can be configured to treat diseases in other vascular systems or body cavities, such as the brain and peripheral vascular systems. The term "stent" may be used interchangeably with the term "implant".

[0027] Embodiments of this disclosure provide a delivery system including a proximal landing zone indicator for deploying a braided stent or radially expandable implant in a coronary, peripheral, or other vascular system. The proximal landing zone indicator includes a radiopaque marker that, when used within the marked diameter of the stent, indicates the length of the stent. The distal end of the marker indicates the length of the stent when deployed in the largest vessel to which the stent is indicated, while the proximal end indicates the length of the stent when deployed in the smallest vessel to which the stent is indicated. While the distal landing point of a stent can be readily determined or verified using a distal radiopaque marker on the delivery system, the proximal landing zone indicator of this disclosure makes it easy and reliable to predict the proximal landing point of the stent. The distal end of the proximal landing zone indicator indicates the location where the proximal end of the stent will land in a vessel with the largest marked diameter, and the proximal end indicates the location where the proximal end of the stent will land in a vessel with the smallest marked diameter. The proximal landing zone indicator allows a user to visualize the location where the proximal end of the stent will land before deploying the distal end of the stent. The delivery system disclosed herein helps solve one of the most challenging operational challenges in deploying braided stents, such as carotid artery stents, by ensuring that the proximal stent lands in a straight segment of the vessel, or not in the middle of a bifurcation, such as not landing between the internal carotid artery (ICA) and the external carotid artery (ECA). The delivery system of this disclosure reduces or eliminates the need for stent re-coating or the introduction of another device to reposition the stent or correct malapposition.

[0028] refer to Figure 1 An example endovascular system 100 according to embodiments of the present disclosure will now be described. Generally, the endovascular system 100 includes a tubular implant 102 and a delivery system 110 configured to deliver and deploy the implant 102 to a treatment site, such as a treatment site within a patient's blood vessel or body cavity. The implant 102 includes a proximal end 104 and a distal end 106 and is radially expandable. The implant 102 may be an elastic member that can be compressed into a contractile configuration for delivery and presents an expanded configuration upon release or deployment. The delivery system 110 includes a proximal landing zone indicator 150 to determine the landing position of the proximal end of the implant 102 upon deployment at the treatment site. The delivery system 110 may also include a distal marker 128 to indicate the landing position of the distal end of the implant at the treatment site.

[0029] refer to Figure 1Implant 102 can be a stent, flow diverter, or any other embolic implant or occlusion device used to treat diseases of the vascular system or body cavities. As an example, a stent or flow diverter may include a mesh having pores of a specific pore size. For example, a carotid artery stent may have a woven mesh with pore sizes ranging from 20 to 500 nanometers. The implant may also include non-porous, impermeable biocompatible materials, coverings, etc.

[0030] The implant 102 can be constructed from memory materials of various shapes, including metallic materials, polymeric materials, or combinations of metallic and polymeric materials. Suitable metallic-shaped memory materials include, but are not limited to, nickel-titanium (NiTi) or... Alloys of CuZnAl, FeNiAl, etc. Suitable polymer shape memory materials include, but are not limited to, polytetrafluoroethylene (PTFE), polylactide (PLA), ethylene-vinyl acetate (EVA), etc.

[0031] Implant 102 can be formed in various ways. For example, implant 102 may include a mesh comprising multiple strands, threads, filaments, or strips of suitable material that are woven, spun, or otherwise formed into a desired pattern or form. Implant 102 may also be formed by cutting a pattern from a tube or etching a pattern from a sheet of suitable material. The sheet of suitable material may be cut or etched into a desired pattern and then rolled up or otherwise formed into a tubular or other shape.

[0032] Because the implant 102 can be constructed of flexible or elastic materials, or is radially expandable, it can be deployed or marked for use in blood vessels ranging from a minimum to a maximum diameter. As an example, the implant 102 can be configured as a carotid artery stent and deployed at a treatment site in a patient's carotid artery. Depending on the patient, the carotid artery can have an average diameter ranging, for example, from 5.0 mm to 7.0 mm. The expandable implant 102 can be configured for deployment at a treatment site in a carotid artery having any of the following diameters: 5 mm, 5.5 mm, 6 mm, 6.5 mm, 7 mm, or any size between these. On the other hand, the length of the implant shortens when it changes from a constricted delivery configuration to an expanded deployment configuration. The degree of shortening varies depending on the diameter of the blood vessel in which the implant is deployed. As an example, a carotid artery stent marked 7 mm × 80 mm, or a carotid artery stent having a length of 80 mm in a blood vessel with a diameter of 7 mm, can be indicated for use or deployment in blood vessels with a diameter range, for example, from 6.0 mm to 7.0 mm. In a constricted configuration constrained within the delivery catheter, a carotid stent can have a length of 160 mm. If deployed at the treatment site in a vessel with a diameter of 7 mm, the stent will be 80 mm long in an expanded configuration. If deployed in a smaller diameter vessel of 6.0 mm, the same carotid stent will be 112 mm long in an expanded configuration. Therefore, before deploying the stent, it is necessary to determine the length the expanded stent will have, or the proximal landing position of the stent, to avoid poor apposition of the stent to the bifurcation vessel or to ensure stent deployment in a straight segment.

[0033] refer to Figure 1 The conveying system 110 may include a tubular member 112 having a proximal region ( Figure 1(Not shown in the diagram) a distal region 116 and a working lumen 118 extending between the proximal and distal regions 116. The tubular member 112 may be a sheath, catheter, or microcatheter. The tubular member 112 may have dimensions and size for accessing vascular systems such as bifurcated vessels in the carotid artery to deploy the implant. The proximal region or a portion thereof may be held outside the patient and includes components, structures, or features that allow the user to operate the delivery system. The tubular member 112 may have a variable degree of rigidity or flexibility along its length to facilitate maneuvering or navigation through tortuous vascular systems. The size and / or sizing of the distal region 116 may be determined to contain or constrain the expandable implant within the working lumen. The distal region 116 of the tubular member 112 may be constructed or configured to be axially movable relative to the implant 102. For example, the tubular member 112 may retract or move proximally to deploy the implant 102 at the treatment site. The tubular member 112 may include a smooth liner, such as a PTFE or ePTFE liner or a smooth coating on the inner surface, to facilitate relative movement between the tubular member 112 and the implant 102, so as to unfold and / or re-encapsulate the implant 102.

[0034] refer to Figure 1The delivery system 110 may include a delivery filament 120 configured to facilitate deployment or re-encapsulation of the implant 102. The delivery filament 120 may extend through the entire length of the working lumen 118 of the tubular member 112, as in a filament delivery system. Alternatively, the delivery filament 120 may extend only through the distal portion of the tubular member, as in a rapid exchange delivery system. The delivery filament 120 may be in the form of a catheter, filament, etc., and may be constructed from any suitable material such as stainless steel, nitinol, or other metallic materials. The delivery filament 120 may include a damage-resistant end tip to avoid or reduce tissue damage during delivery and / or deployment of the implant 102. One or more pads 122, 124 may be coupled to the delivery filament 120 to facilitate deployment and / or re-encapsulation of the implant 102. For example, the pad 122 may be made of an expandable material and may apply an outward radial force against the tubular member 112 to the implant 102. The friction between the expandable pad 122 and the implant 102 constrained within the cavity 118 of the tubular member 112 can help retract or re-enclose the implant 102 into the tubular member 112 by moving the delivery filament 120 in the proximal direction. The friction between the expandable pad 122 and the implant 102 can also help prevent proximal movement of the implant 102 when the tubular member 112 is withdrawn proximally to deploy the implant 102. Alternatively or additionally, a buffer or stop 126 can be coupled to the delivery filament 120 to prevent proximal movement of the implant 102, for example, when the tubular member 102 moves proximally relative to the implant to deploy it. The buffer or stop 126 can be constructed of a soft material, such as silicone, to protect the implant 102, for example, from damage to the edges of the implant 102 when it is retracted or re-enclosed into the tubular member 112.

[0035] refer to Figure 1The delivery system 110 may include one or more distal radiopaque markers 128 to indicate the landing position of the distal end 106 of the implant 102. One or more distal markers 128 may be disposed on the tubular member 112, closely adjacent to the open distal end of the tubular member 112. The distal markers 128 may cover or align the distal end 106 of the implant 102 constrained within the lumen 118 of the tubular member 112 to indicate the landing position of the distal end 106 of the implant 102 upon deployment. As an example, when the tubular member 112 is removed or moved proximally relative to the implant 102 constrained within the lumen 118 of the tubular member 112, proximal movement of the implant 102 is prevented by a buffer or stop 126 and / or by friction between the implant 102 and the expandable pads 122, 124. As the distal tip of the tubular member 112 is removed past the distal end 106 of the implant 102, the distal end 106 of the implant 102 begins to expand to unfold within the blood vessel. Therefore, one or more distal markers 128 indicate the same or substantially the same location as the distal end 106 of the implant 102 when unfolded beyond the tubular member 112. The user can use the distal markers 128 to select or determine the desired distal landing position of the implant 102, for example, by observing the distal markers 128 on an X-ray fluorescence microscope and manipulating the tubular member 112 until the distal markers 128 are positioned at the desired location. Suitable radiopaque materials for the distal markers 128 include, but are not limited to, platinum, gold, tungsten, tantalum, barium, iodine, bismuth, etc., or alloys containing any of the aforementioned metals. The distal radiopaque markers 128 on the tubular member 112 may be in the form of a band, ring, or coating.

[0036] refer to Figure 1 According to embodiments of this disclosure, the delivery system 110 includes a proximal landing zone indicator 150 for determining the landing position of the proximal end 104 of the implant 102 upon deployment in a blood vessel. While distal markers(s)128 may be used to indicate the landing position of the distal end 106 of the implant 102, the proximal landing zone indicator 150 of this disclosure may be configured to indicate or predict the landing position of the proximal end 104 of the implant 102 upon deployment in a blood vessel, at which the implant 102 may change from an elongated constricted configuration to a shortened expanded configuration. The radiopaque markers 152 of the proximal landing zone indicator 150 may be constructed of a suitable radiopaque material and may be visible, for example, by X-ray fluorescence fluoroscopy. Suitable radiopaque materials for distal markings include, but are not limited to, platinum, gold, tungsten, tantalum, barium, iodine, bismuth, etc., or alloys comprising any of the aforementioned metals. The radiopaque markers 152 may be in the form of a spring coil wound around the delivery filament 120. The non-transparent marking 152 may also be in the form of a strip or coating on the conveyor thread 120.

[0037] Still referencing Figure 1The radiopaque marker 152 of the proximal landing zone indicator 150 may include a proximal end 154 and a distal end 156. The proximal end 154 of the radiopaque marker 152 may be configured to indicate the position of the proximal end 154 of the implant 102 when the implant 102 is deployed in the vessel with the smallest diameter to which the implant 102 is indicated. The distal end 156 of the radiopaque marker 152 may be configured to indicate the position of the proximal end 104 of the implant 102 when the implant 102 is deployed in the vessel with the largest diameter to which the implant 102 is indicated. As an example, a carotid artery stent may be constructed and indicated for treating vessels with a diameter range, for example, from a minimum of 5 mm to a maximum of 7 mm. The radiopaque marker 152 of the proximal landing zone indicator 150 can be configured such that the proximal end 154 of the radiopaque marker 152 indicates the landing position of the proximal end 104 of the stent 102 if deployed in a vessel with a diameter of 5 mm, and the distal end 156 of the radiopaque marker 152 indicates the landing position of the proximal end 104 of the stent 102 if deployed in a vessel with a diameter of 7 mm. Therefore, the radiopaque marker 152 can provide the user with a clear and precise indication of the landing position of the proximal end 104 of the implant when the implant 102 is deployed in a vessel with a diameter of, for example, 6 mm. If the implant 102 is to be deployed in a vessel with a diameter of, for example, 6 mm, the radiopaque marker 102 can also provide a clear and precise indication when the implant 102 is deployed, i.e., midway between the proximal end 154 and the distal end 156 of the radiopaque marker 152. In practice, the length of the radiopaque marker 152 can be configured to provide a clear and precise indication of the landing position of the proximal end 104 of the implant 102 when deployed in a vessel of any diameter within the indicated range of diameters for which the implant 102 is used. It should be noted that the above dimensions are provided for illustrative purposes only, and this disclosure and the claims are not limited thereto.

[0038] One of the advantages of this disclosure is that the delivery system 110 can provide an indication of the landing location of the entire length of the stent within the actual vessel where the stent is deployed. This makes it easier and more accurate to determine the proximal landing zone of the stent, thus solving one of the biggest problems in stent deployment. Conventionally, length is estimated using software systems based on images derived from the patient before the case is completed. However, any changes in the patient's anatomy, such as those caused by medications like vasospasm inhibitors, can alter the anatomy, making these tools less useful. Furthermore, conventional methods do not provide the user with a real-time indication of the proximal landing zone. Conventional methods use a single marker for the stent length at the maximum indicated diameter. Thus, the user must attempt to measure this marker without any visual reference to the length to estimate the variation in distance from that point in the landing zone, leading to errors in determining the actual landing location. By providing a direct visual reference to the entire length of the deployed stent, from the minimum to the maximum diameter at which the stent is indicated, the user does not need to guess where the landing zone is. The proximal landing zone indicator can provide the user with a direct visual reference under X-ray imaging, making it possible to predict the actual landing zone of the stent more accurately.

[0039] refer to Figure 2 An example intravascular system 200 according to embodiments of the present disclosure is described. Except that the proximal landing zone indicator 250 includes a radiopaque mark 252 on the tubular member 212, Figure 2 The intravascular system 200 shown in the figure is similar in many respects to Figure 1 The intravascular system 100 is shown in the figure. The radiopaque marker 252 may be in the form of a spring coil wrapped around the tubular member 212, or in the form of a band, ring or coating on the tubular member 212.

[0040] refer to Figure 3 and Figures 4A to 4C An example method 300 for delivering or deploying an implant to a treatment site will now be described. Method 300 may begin at step 302, in which the diameter of a blood vessel 402 within the patient to be treated is determined. As mentioned above, the actual length of the radially expandable implant at the treatment site is directly related to the diameter of the blood vessel deployed therein. Furthermore, the blood vessels within a patient may vary over time due to various factors, including, for example, temperature, medications taken, etc. The diameter of the blood vessel within the patient to be treated can be determined by various methods, such as using a microscope, ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), etc. Various techniques for measuring the diameter of blood vessels are known, and therefore their detailed descriptions are omitted herein to focus on the description of embodiments of this disclosure.

[0041] refer to Figure 3In step 304, a delivery system comprising an expandable implant is provided. The delivery system comprising an expandable implant can be a combination of the above. Figure 1 The described intravascular system 100 or Figure 2 The intravascular system 200 is shown in the figure. For example, the delivery system 110 may include a distal landing indicator 128 for indicating the landing position of the distal end of the implant 102 and a proximal landing zone indicator 150 for indicating the landing position of the proximal end of the implant 102. The proximal landing zone indicator 150 may include a radiopaque marker 152 having a proximal end 154 and a distal end 156, wherein the proximal end 154 of the radiopaque marker 152 is configured to indicate the position of the proximal end 104 of the implant 102 when deployed in a vessel with the smallest diameter in which the implant 102 is indicated, and the distal end 156 of the radiopaque marker 102 indicates the position of the proximal end 104 of the implant 102 when deployed in a vessel with the largest diameter in which the implant 102 is indicated.

[0042] Still referencing Figure 3 In step 306, the delivery system containing the implant is introduced into the blood vessel to be treated. For illustrative purposes, Figures 4A to 4C The image shows a vessel 402 in the patient's carotid artery with a bifurcation 404. The delivery system 110 can be introduced into the vessel 402 via an inlet, for example, in the patient's femoral artery or groin region, using an introducer sheath. A guiding catheter can be used to guide the intravascular system through the patient's vascular system. Fluorescence fluoroscopy can be used to monitor the intravascular system 100 during navigation through the patient's vascular system. The intravascular system 100 is advanced until the distal end of the implant 102 is positioned at or near the desired distal landing site, such as... Figure 4A As shown.

[0043] refer to Figure 3 In step 308, before deploying the implant, the landing position of the distal end of the implant in the blood vessel is determined or verified. This can be achieved by observing the distal landing indicator or marker 128 on the tubular component of the delivery system 110 using X-ray fluorescence fluoroscopy, such as... Figure 4B As shown. If the landing position of the distal end of the implant 102 is determined to be undesirable, such as too close to or too far from the bifurcation 404, the endovascular system 100 can be further advanced or retracted, and the landing position of the distal end of the implant 102 can be further determined or verified.

[0044] Still referencing Figure 3 In step 310, before deploying the implant 102, the landing position of the proximal end of the implant 102 in the blood vessel 402 is determined or verified. Figure 4BTaking into account the diameter of the treated vessel 402 determined in step 302, this can be achieved by observing the proximal landing zone indicator 150 on the delivery system 110 via X-ray fluorescence fluoroscopy. As an example, the delivery system 110 can be configured to deliver a carotid stent 102 indicated for use in the treatment of vessels with diameters ranging from a minimum of 5 mm to a maximum of 7 mm. The radiopaque marker 152 of the proximal landing zone indicator 150 can be configured such that the proximal end 154 of the radiopaque marker 152 indicates the landing position of the proximal end 104 of the stent 102 when deployed at a vessel diameter of 5 mm, and the distal end 156 of the radiopaque marker 152 indicates the landing position of the proximal end 104 of the stent 102 when deployed at a vessel diameter of 7 mm. Figure 4C Therefore, if the treated vessel 402 has a diameter of 5 mm as determined in step 310, then when deployed in the vessel 402, the proximal end 104 of the stent 102 will land at the location indicated by the proximal end 154 of the radiopaque marker 152. If the treated vessel 402 has a diameter of 7 mm as determined in step 302, then when deployed in the vessel 402, the proximal end 104 of the stent 102 will land at the location indicated by the distal end 156 of the radiopaque marker 152. If the treated vessel 402 has a diameter of 6 mm as determined in step 302, then when deployed in the vessel 402, the proximal end 104 of the stent 102 will land at the location indicated by the middle of the radiopaque marker 152. If the landing position of the proximal end 104 of the stent 102 is indicated as undesirable, such as too close to the bifurcation 404, the endovascular system 100 can be further advanced or retracted before the implant 102 is deployed, and the landing positions of the distal and proximal ends of the implant 102 can be determined separately.

[0045] Still referencing Figure 3 In step 312, if the indicated or determined landing position of the proximal end of the stent is desired, the user can release or deploy the implant. Figure 4C As shown, the stent 102 can be released or deployed by moving the delivery system 110 proximally relative to the stent 102. During deployment, the stent 102 can be re-encased or retracted into the tubular member 112 by moving the delivery filament 120 proximally relative to the tubular member 112. Figure 1 If the user determines that the implant needs to be adjusted or repositioned, the stent 102 may need to be re-wrapped. After the stent 102 is fully deployed, the delivery system 110, including the tubular components and delivery wires, can be removed from the patient's body.

[0046] Various embodiments of aspiration catheters have been described with reference to the accompanying drawings. It should be noted that these drawings are intended for illustrative purposes, and some drawings are not necessarily drawn to scale. Furthermore, specific details may be set forth in the drawings and description to provide a thorough understanding of this disclosure. It will be apparent to those skilled in the art that some of these specific details may not be used in practicing the embodiments of this disclosure. In other instances, well-known components or process steps may not have been shown or described in detail to avoid unnecessarily obscuring the embodiments of this disclosure.

[0047] Unless otherwise expressly defined, all technical and scientific terms used herein have the meanings commonly understood by one of ordinary skill in the art. As used in the specification and appended claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context explicitly specifies otherwise. The term “or” means “or” in a non-exclusive sense unless the context explicitly specifies otherwise. The term “proximal” and its grammatical equivalents refer to a position, direction, or orientation toward the user or physician. The term “distal” and its grammatical equivalents refer to a position, direction, or orientation away from the user or physician. The terms “first” or “second,” etc., can be used to distinguish one element from another when describing various similar elements. It should be noted that the terms “first” and “second” as used herein include references to two or more. Furthermore, the use of the terms “first” or “second” should not be construed as indicating any particular order unless the context explicitly specifies otherwise. All numerical values ​​are provided for illustrative purposes and are assumed to be modified by the term “about,” whether explicitly indicated or not. The term "approximately" generally refers to a range of values ​​that a person skilled in the art would consider equivalent to the stated value, such as those having the same function or result. The term "approximately" may include numbers rounded to the nearest significant figure. Declaring a range of values ​​by endpoints includes all values ​​within that range. For example, a range of 5 to 7 includes 5, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6, 6.5, 7, and so on.

[0048] Those skilled in the art will understand that various other modifications can be made. All such and other variations and modifications have been conceived by the inventors, and all such and other variations and modifications are within the scope of this invention.

Claims

1. An endovascular system comprising: an implant configured to be deployed in a blood vessel having a diameter ranging from a minimum diameter to a maximum diameter, the implant comprising a distal end and a proximal end and being radially expandable; the implant comprising a braided stent or a braided flow diverter; the implant being configured to be deployed in a blood vessel adjacent a bifurcation; and a delivery system configured to deliver and deploy the implant to a treatment site in a blood vessel, wherein the delivery system comprises a proximal landing zone indicator comprising a radiopaque marker having a length from a proximal end to a distal end of the radiopaque marker, wherein the proximal end of the radiopaque marker indicates a position of a proximal end of the implant in the case of deployment at a treatment site in a blood vessel having the minimum diameter, and the distal end of the radiopaque marker indicates a position of the proximal end of the implant in the case of deployment at a treatment site in a blood vessel having the maximum diameter; one or more distal radiopaque markers disposed on the tubular member in close proximity to an open distal end of the tubular member to indicate a landing position of a distal end of the implant upon deployment.

2. The intravascular system of claim 1, wherein, the delivery system comprises a delivery wire, wherein the implant is disposed between the tubular member and the delivery wire for delivery, and wherein the radiopaque marker of the proximal landing zone indicator is disposed on the delivery wire.

3. The intravascular system of claim 2, wherein, the delivery wire comprises a catheter, and the radiopaque marker is in the form of a spring coil on the catheter of the delivery wire.

4. The intravascular system of claim 2, wherein, the implant is configured to be deployed in a blood vessel having a diameter ranging from the minimum diameter of 5 mm to the maximum diameter of 10 mm.

5. The intravascular system of claim 1, wherein, the delivery system comprises a tubular member and a delivery wire, wherein the implant is disposed between the tubular member and the delivery wire for delivery, and wherein the radiopaque marker is disposed on the tubular member.

6. The intravascular system of claim 5, wherein, the implant is configured to be deployed in a blood vessel having a diameter ranging from the minimum diameter of 5 mm to the maximum diameter of 10 mm.

7. The intravascular system of claim 5, wherein, the implant comprises a braided stent or a braided flow diverter.

8. The intravascular system of claim 5, wherein, the implant is configured to be deployed in a blood vessel adjacent a bifurcation. the implant is configured to be deployed in a blood vessel adjacent a bifurcation.

Citation Information

Patent Citations

  • Implant delivery system and method of use

    US20170049596A1