Patent Application
20250195246
In at least one aspect, the present invention is related to endovascular stents.
The majority of abdominal aortic aneurysms (AAAs) are now repaired using endovascular stent grafts delivered through percutaneous punctures of the femoral arteries. This minimally invasive approach offers several significant advantages over traditional open aortic repairs, including a markedly lower risk of major perioperative complications and a considerably faster postoperative recovery time. These benefits have made endovascular techniques the preferred method for treating most AAAs.
However, approximately 20-30% of AAAs involve segments of the aorta that include branch arteries supplying critical organs such as the kidneys, liver, and intestines. These complex cases are classified as complex AAAs (cAAAs) or thoracoabdominal aortic aneurysms (TAAAs). Treating such aneurysms poses unique challenges due to the involvement of these vital branch vessels. Currently, the market offers only limited solutions for managing cAAAs and TAAAs. The sole commercially available device designed for this purpose is the Zenith Fenestrated stent graft (Cook Medical, Bloomington, IN), which can accommodate up to three branch vessels. This device achieves this by using custom-manufactured fenestrations or holes that allow branch stents to be inserted into the branch vessels.
While effective in some cases, the Zenith Fenestrated stent graft has notable limitations. The number of fenestrations is restricted, limiting its applicability for aneurysms involving more than three branch vessels. Moreover, the process of custom manufacturing and shipping the device can be time-intensive, delaying critical treatment for patients in need. These drawbacks highlight the unmet need for more versatile and readily available stent graft solutions for the management of complex aortic aneurysms.
Accordingly, there is a need for improved methods for treating aortic aneurysms.
In at least one aspect, an endovascular branch coupler stent graft is provided. The endovascular branch coupler stent graft includes a tubular stent assembly defining a central opening and four branch channels disposed in the central opening and attached to the tubular stent assembly. Each of the four branch channel extend along the length of tubular stent assembly. Each branch channel is configured to receive a covered stent for catheterizing a branch vessel. Characteristically, the central opening configured to receive a primary stent graft for reinforcing weakened sections of a subject's aorta.
In another aspect, a method for deploying the endovascular branch coupler stent graft described herein is provided. The method includes a step of loading the endovascular branch coupler stent graft into a dedicated sheath with preloaded wires through each of the four branch channels to facilitate catheterization of the four branch channels. The endovascular branch coupler stent graft is delivered to a treatment zone. The endovascular branch coupler stent graft is deployed proximal to target branch vessels using a pin-and-pull maneuver. The method also includes a step of sequentially catheterizing and stenting the branch vessel. The primary stent graft is deployed for reinforcing weakened sections of the subject's aorta into endovascular branch coupler stent graft.
Advantageously, the Endovascular Branch Coupler (EBC) Stent Graft provides a transformative solution to several limitations of prior art, offering significant advantages in endovascular repair procedures. Unlike custom-manufactured alternatives, the EBC is an off-the-shelf stent graft, eliminating the delays and expenses associated with bespoke fabrication. Its innovative design accommodates up to four branch vessels, enabling seamless incorporation during the repair of complex abdominal aortic aneurysms (AAA) and thoracoabdominal aortic aneurysms (TAAA). Furthermore, the EBC is engineered for compatibility with existing commercial devices, ensuring integration without the need for specialized equipment or modifications. Additionally, the EBC extends its utility to the aortic arch, facilitating endovascular repairs that incorporate arch branch vessels, thus addressing a critical challenge in advanced aortic interventions. This comprehensive approach enhances procedural efficiency, reduces patient risk, and expands the scope of endovascular treatment options.
The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description.
For a further understanding of the nature, objects, and advantages of the present disclosure, reference should be had to the following detailed description, read in conjunction with the following drawings, wherein like reference numerals denote like elements and wherein:
Reference will now be made in detail to presently preferred compositions, embodiments and methods of the present invention, which constitute the best modes of practicing the invention presently known to the inventors. The Figures are not necessarily to scale. However, it is to be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various and alternative forms. Therefore, specific details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for any aspect of the invention and/or as a representative basis for teaching one skilled in the art to variously employ the present invention.
Except in the examples, or where otherwise expressly indicated, all numerical quantities in this description indicating amounts of material or conditions of reaction and/or use are to be understood as modified by the word “about” in describing the broadest scope of the invention. Practice within the numerical limits stated is generally preferred. Also, unless expressly stated to the contrary: percent, “parts of,” and ratio values are by weight; the description of a group or class of materials as suitable or preferred for a given purpose in connection with the invention implies that mixtures of any two or more of the members of the group or class are equally suitable or preferred; description of constituents in chemical terms refers to the constituents at the time of addition to any combination specified in the description, and does not necessarily preclude chemical interactions among the constituents of a mixture once mixed; the first definition of an acronym or other abbreviation applies to all subsequent uses herein of the same abbreviation and applies mutatis mutandis to normal grammatical variations of the initially defined abbreviation; and, unless expressly stated to the contrary, measurement of a property is determined by the same technique as previously or later referenced for the same property.
It is also to be understood that this invention is not limited to the specific embodiments and methods described below, as specific components and/or conditions may, of course, vary. Furthermore, the terminology used herein is used only for the purpose of describing particular embodiments of the present invention and is not intended to be limiting in any way.
It must also be noted that, as used in the specification and the appended claims, the singular form “a,” “an,” and “the” comprise plural referents unless the context clearly indicates otherwise. For example, reference to a component in the singular is intended to comprise a plurality of components.
The term “comprising” is synonymous with “including,” “having,” “containing,” or “characterized by.” These terms are inclusive and open-ended and do not exclude additional, unrecited elements or method steps.
The phrase “consisting of” excludes any element, step, or ingredient not specified in the claim. When this phrase appears in a clause of the body of a claim, rather than immediately following the preamble, it limits only the element set forth in that clause; other elements are not excluded from the claim as a whole.
The phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps, plus those that do not materially affect the basic and novel characteristic(s) of the claimed subject matter.
With respect to the terms “comprising,” “consisting of,” and “consisting essentially of,” where one of these three terms is used herein, the presently disclosed and claimed subject matter can include the use of either of the other two terms.
The phrase “composed of” means “including” or “comprising.” Typically, this phrase is used to denote that an object is formed from a material.
It should also be appreciated that integer ranges explicitly include all intervening integers. For example, the integer range 1-10 explicitly includes 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10. Similarly, the range 1 to 100 includes 1, 2, 3, 4 . . . 97, 98, 99, 100. Similarly, when any range is called for, intervening numbers that are increments of the difference between the upper limit and the lower limit divided by 10 can be taken as alternative upper or lower limits. For example, if the range is 1.1. to 2.1 the following numbers 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, and 2.0 can be selected as lower or upper limits.
Throughout this application, where publications are referenced, the disclosures of these publications in their entireties are hereby incorporated by reference into this application to more fully describe the state of the art to which this invention pertains.
Referring to
Strategically positioned within the central opening are four branch channels, designated as 14, 16, 18, and 20, which are securely attached to the tubular stent assembly 12. These branch channels 14, 16, 18, and 20 extend along the full length of the tubular stent section 12, ensuring uniform support and precise alignment. In a refinement, the branch channels 14, 16, 18, and 20 are arranged to be substantially parallel, optimizing spatial configuration and functionality. Each branch channel is specifically designed to accommodate a covered stent, enabling efficient catheterization of branch vessels during deployment. In a refinement, each of the four branch channels are reinforced with nitinol stents and fabric.
Furthermore, the central opening of the tubular stent assembly 12 is engineered to receive a primary stent graft, such as a thoracic endovascular aortic repair (TEVAR) or endovascular aneurysm repair (EVAR) device, for reinforcing weakened sections of a subject's aorta. This modular design enhances the versatility of the EBC Stent Graft, making it adaptable to various complex anatomical scenarios.
In another aspect, the Endovascular Branch Coupler (EBC) Stent Graft 10 is characterized by a length d ranging from 4 to 6 cm, with a preferred length of approximately 5 cm in one refinement. The tubular stent assembly 12 is further refined to include two rows of Z stents: a first Z stent row 22 and a second Z stent row 24. Z stents are vascular stents with a zigzag structural design, providing flexibility and radial strength for various medical applications. Therefore, these rows provide structural support and stability for the stent graft. The first Z stent row 22 and the second Z stent row 24 are designed with first predetermined length d1 and second predetermined length d2, respectively. Typically, both d1 and d2 independently range from about 18 mm to 25 mm, with an optimized length of approximately 22 mm in one refinement. To ensure proper separation and flexibility between the rows, a fabric section 30 is interposed, defining a third predetermined length d3. Therefore, the first predetermined length d1 and the second predetermined length d2 are separated by fabric section of a third predetermined length d3. This fabric section 30 enhances the device's adaptability and overall performance.
In another aspect, the length d3 of the fabric section 30 is between 3 mm and 8 mm, with a preferred length of approximately 6 mm. These precise dimensional specifications contribute to the EBC Stent Graft's robust design, enabling reliable deployment and optimal integration with vascular anatomy.
In another aspect, the diameter of the endovascular branch coupler stent graft 10 can be from about 30 mm to 40 mm. In a refinement, the endovascular branch coupler stent graft 10 has a diameter of about 34 mm or 38 mm. Similarly, each of the four branch channels 14, 16, 18, and 20 has a diameter from 6 to 10 mm and optimally about 8 mm.
In another aspect, each of the four branch channels 14, 16, 18, and 20 is reinforced with the nitinol stents and fabric. Moreover, gap spaces between each of the four branch channels 14, 16, 18, and 20 are covered with fabric 32. EBC will be loaded in a sheath with a preloaded wire mechanism for delivery and deployment of the stent from any suitable vascular access sites.
In another aspect, the Endovascular Branch Coupler (EBC) Stent Graft may include one or more additional branch channels, enhancing its versatility and adaptability for complex vascular anatomies. These additional branch channels can be strategically integrated into the stent graft to accommodate more extensive branching arteries, such as those supplying critical organs or regions with high anatomical variability. This configuration allows the EBC Stent Graft to address a broader range of clinical scenarios, including aneurysms involving multiple visceral or peripheral branch vessels beyond the standard four-channel design. The additional branch channels may be reinforced with materials such as Nitinol and ePTFE to maintain structural integrity and prevent complications such as kinking or collapse during deployment. Furthermore, the inclusion of these channels can facilitate the incorporation of advanced covered stents, providing robust and reliable support to the extended vascular network. This expanded capability makes the EBC Stent Graft a highly flexible solution for endovascular repair, catering to both routine and complex cases with equal efficacy.
Advantageously, the Endovascular Branch Coupler (EBC) Stent Graft is designed as an off-the-shelf solution, eliminating the need for custom manufacturing and the associated delays, while providing unparalleled versatility for complex aortic repairs. This innovative stent graft enables the seamless incorporation of visceral and renal arteries during endovascular procedures by effectively linking commercially available thoracic and abdominal bifurcated endovascular aortic stent grafts with covered stents. The modular design ensures compatibility with existing devices, allowing clinicians to customize the treatment approach based on individual patient anatomy and clinical requirements. This flexibility permits the treatment of a wide range of complex abdominal aortic aneurysms (cAAAs) and thoracoabdominal aortic aneurysms (TAAAs), as depicted in
Moreover, the Endovascular Branch Coupler (EBC) Stent Graft extends its utility to the treatment of aortic arch aneurysms and dissections, offering a streamlined, off-the-shelf solution that eliminates the need for custom devices. This innovative design enables the incorporation of arch branch arteries by effectively linking commercially available thoracic endovascular aortic stent grafts with covered stents. This capability allows for precise and reliable repair of complex aneurysms and dissections in the aortic arch, as illustrated in
The following examples illustrate the various embodiments of the present invention. Those skilled in the art will recognize many variations that are within the spirit of the present invention and scope of the claims.
A prototype of EBC was successfully utilized in a 77 year old patient with symptomatic extent IV thoracoabdominal aortic aneurysm. The patient was successfully treated with total endovascular repair using the EBC concept. After a full disclosure of the off-label nature of this procedure to the patient and her family, an urgent endovascular repair was performed. The EBC prototype was constructed by modifying a standard commercially available 28 mm×109 mm Zenith Alpha Thoracic stent grafts (Cook Medical, Bloomington, IN) as the aortic component of EBC, and using 8 mm×50 mm Viabahn covered stents (W.L. Gore & Associates, Flagstaff, AZ) (
While exemplary embodiments are described above, it is not intended that these embodiments describe all possible forms of the invention. Rather, the words used in the specification are words of description rather than limitation, and it is understood that various changes may be made without departing from the spirit and scope of the invention. Additionally, the features of various implementing embodiments may be combined to form further embodiments of the invention.
This application claims the benefit of U.S. provisional application Ser. No. 63/611,949 filed Dec. 19, 2023, the disclosure of which is hereby incorporated in its entirety by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 63611949 | Dec 2023 | US |
