Aortic aneurysms are life-threatening conditions. Surgical interventions used to treat aortic aneurysms include endovascular repair by transluminal placement of one or more endografts across the longitudinal extent of the lesion. The endograft is placed in the aorta with the intention of bridging the aneurysmal sac to exclude it from the high-pressure of aortic blood flow, which can permit remodeling of the aortic wall in and around the aneurysm site. In certain regions of the aorta accurate placement of the endograft is critical to maintain blood flow to vessels branching from the aorta to minimize compromised blood flow to organs. For example, currently, if aortic devices are placed within the aortic arch in a manner that offsets the aperture for the left carotid artery, the artery can be occluded, which can result in ischemia to the brain. Most surgical methods of treating aneurysms at or near the aortic arch generally involve sternotomy or thoracotomy and may require cardio-pulmonary bypass, often resulting in high morbidity rates.
Further, trauma associated with implantation of endografts, particularly in regions of diseased tissue, poses a risk of stroke that may be associated with emboli created during the surgical procedure of deployment.
Thus, there is a need to develop new and useful devices and methods of treating aortic aneurysms by endovascular methods.
The present invention relates to vascular repair systems, delivery systems and methods of using the delivery systems and its components to treat aortic vascular damage, in particular, vascular damage associated with aortic disease, such as, aneurysms, penetrating atherosclerotic ulcers and dissection.
In an embodiment, the invention is an aortic graft assembly that includes a tubular aortic component having a proximal end and a distal end connected by a wall of the tubular aortic component, the wall defining a wall aperture that is between the proximal and distal ends, the wall aperture having a proximal end and a distal end. A tunnel graft is connected to the wall of the tubular aortic component and extends from the wall aperture toward the proximal end of the tubular aortic component. The tunnel graft has a proximal end and a distal end, and defines a tunnel graft lumen that extends between the distal end and the proximal end of the tunnel graft lumen, the distal end of the tunnel graft lumen being at the wall aperture of the tubular aortic component. A proximal stent supports proximal end of the tubular aortic component. A distal stent supports the distal end of the tubular aortic component. At least one filter spans at least one of the aperture and the tunnel graft.
In another embodiment, the invention is a method for implanting a prosthesis that includes delivering an aortic graft assembly that includes a tubular aortic component through an aorta to an aneurysm site of a patient, the tubular aortic component defining a tunnel lumen and having a proximal end and a distal end connected by a wall, the wall defining a wall aperture that is between the proximal end and the distal end, the wall aperture having a proximal end and a distal end, the aortic graft assembly further including a tunnel graft extending from the wall aperture and within the tunnel lumen of the tubular aortic component toward the proximal end of the tubular aortic component, wherein at least one filter spans at least one of the aperture and the tunnel graft. The wall aperture is aligned over at least one vessel ostium at the aneurysm site of the patient. The outer tube is retracted, thereby releasing the tubular aortic component from the distal and proximal clasps, thereby deploying the tubular aortic component at the aneurysm site in the patient.
The aortic assembly systems and methods of the invention include a filter that sequesters, traps, or otherwise captures emboli that form, or become dislodged during implantation of aortic prostheses and branch prostheses, such as at the aortic arch. During implantation of a tubular aortic component into, for example, an aortic arch of a patient, emboli (i.e. a blood clot, air bubble, piece of fatty deposit, or other object that can be carried in the bloodstream to lodge in a vessel and cause an embolism), are formed that can escape the surgical site and be transported to other parts of the patient's anatomy and thereby cause stroke and, possibly, death. The filter component of the aortic assembly system of the invention captures emboli, thereby preventing their transport away from the surgical site.
The aortic assembly systems and methods of the invention can be employed to treat aortic aneurysms, such as aortic aneurysms at, near or around the arch of the aorta, or branches from the abdominal aorta (e.g., celiac artery, superior mesenteric artery and renal arteries). The aortic assembly systems of the invention have a relatively large aperture tapered into a tunnel graft that provides the surgeon with a relatively large margin of error in placement of the system, facilitates cannulation and permits alignment of a single aperture for at least one blood vessel. Aortic assembly systems of the invention that include a tunnel graft having one aperture extending proximally with two openings permit for easy alignment in the aorta, particularly in regions of the aorta that branch to peripheral and major vessels. The size of the aperture allows blood to flow to target vessels during the procedure. The aortic graft assembly of the invention generally does not restrict blood flow acutely or chronically, in part, because of a relatively large diameter of the tunnel graft and the stent or stents supporting the tunnel graft.
The invention can be used to treat various aortic pathologies, including aortic aneurysms, penetrating atherosclerotic ulcers, dissections and, therefore, avoid complications and death consequent to life-threatening vascular conditions.
The features and other details of the invention, either as steps of the invention or as combinations of parts of the invention will now be more particularly described and pointed out in the claims. It will be understood that the particular embodiments of the invention are shown by way of illustration and not as limitations of the invention. The principle features of this invention can be employed in various embodiments without departing from the scope of the invention.
“Proximal” means, when reference is made to a delivery system or a component of a delivery system, such as an apex clasp and a nose cone, closest to the clinician using device. Likewise, “distal” means, when reference is made to a delivery system or a component of a delivery system, such as an apex clasp and a nose cone, away from the clinician using the device.
When reference is made to a prosthesis to be delivered, such as an aortic graft assembly, tubular aortic component, tunnel graft, branch graft and stent, the word “proximal” means that portion of the prosthesis or component of the prosthesis that is towards the heart of the patient and “distal” means that portion of the prosthesis or component of the prosthesis that is away from the heart of the patient. For clarity, the word “proximate” means close to as opposed to “proximal” or “distal.”
Aortic graft assemblies of the invention can be implanted, for example, by trans femoral access. Tubular branch components can be implanted, for example, by supra aortic vessel access (e.g., brachial artery), or by trans femoral or trans apical access.
The invention is generally directed to an aortic graft assembly and a method for deploying the aortic graft assembly. The invention is also directed to methods of implanting at least one tubular branch graft into a patient and the aortic graft assembly. In one embodiment of the aortic graft assembly of the invention, represented in
Tunnel graft 28, shown, for example, in
Referring back to
Optionally, radiopaque markers 38 are located along a line parallel to major longitudinal axis 24 of tubular aortic component 12. In one embodiment, radiopaque marker 38 is at a proximal apex of wall aperture distal stent 50 abutting wall aperture 20. Another radiopaque marker is at a distal apex 48 of proximal stent 34. Further, radiopaque marker 38 is at least one of proximal end 14 and distal end 16 of tubular aortic component 12. Also optionally, radiopaque markers 40 extend about the circumference of wall aperture 20 at tubular aortic component 12. Radiopaque markers 38, 40 can be made of any suitable material such as platinum, iridium, gold, etc. Examples of radiopaque markers are described in the U.S. Pat. Nos. 8,062,345 and 10,105,248, the entire teachings of which are incorporated herein by reference.
Proximal stent 34 in one embodiment, shown in
In one embodiment, crown stent 60 is located between clasping stent 56 and proximal end 14 of tubular aortic component 12. Crown stent 60 and clasping stent 56 can be nested, as shown in
In one embodiment, at least one stent 64 is located at tubular aortic component 12 between proximal stent 34 and distal stent 36. At least a portion of stents 64 include proximal apices 66 and distal apices 68 connected by struts 70. In one embodiment, at least one partial stent 72 is located at tubular aortic component 12 between stents 34, 50 abutting proximal end 22 and distal end 26 of wall aperture 20, respectively, as shown in
Stents employed in the invention are constructed of a suitable material. In one embodiment, the stents employed by the invention include a suitable shape memory alloy, such as nitinol. Further description of suitable materials for construction of stents for use in the invention can be found in U.S. Pat. Nos. 7,763,063 and 8,062,345, the teachings of which are incorporated herein by reference in their entirety.
In one embodiment, tubular portion includes stents 88, 90 at each of a proximal 92 and distal end 94 of tubular portion 86, as shown in
Filter 95 spans tunnel graft 28 between stents 88 and 90, to avoid interference by stents 88 and 90. Filter 95 is sewn into tunnel graft 28. Filter 95, in one embodiment, has a mesh pattern and a porosity that will capture emboli, but allow passage of red blood cells. The diameter of the pores is suitable to for capture of emboli, while allowing passages of red blood cells. Examples of suitable ranges of pore sizes in the mesh include, for example, a range of between about 80 μm and about 90 μm, between a range of between about 90 μm and 100 μm, a range of between about 100 μm and 110 μm, and a range of between about 80 μm and about 110 μm. Filter 95 typically is biocompatible, since it will generally be left behind, in the body, following implantation of the aortic prosthesis system and any branch stent grafts into tunnel graft 28. Filter 95 also is sufficiently thin to allow perforation by a delivery device, such as a guidewire catheter, during implantation of branch stent grafts into tunnel 28, without allowing particles captured by filter 95 to be released into the patient's bloodstream. Filter 95 is also sufficiently stable to survive gamma sterilization. In one embodiment, the filter 95 is circumferentially sewn into the tunnel, and the caudal half of the sewn mesh is loosely sewn so that when the branch limb delivery system tip pushes on it, it breaks on the caudal portion. Examples of suitable materials of filter 95 include nylon, nitinol, and polyester, such as 50 polyester. During implantation of tubular aortic component 12 into, for example, an aortic arch of a patient, emboli (i.e. a blood clot, air bubble, piece of fatty deposit, or other object that can be carried in the bloodstream to lodge in a vessel and cause an embolism), can form, escape from the surgical site and be transported to other parts of the patient's anatomy, thereby increasing the likelihood of stroke and, possibly, death. Filter 95 captures emboli, thereby preventing their transport away from the surgical site, to decrease the likelihood of or prevent stroke, or other consequent injury.
In one embodiment, the arc length of proximal end 22 of wall aperture 20 is equal to or less than one-half the circumference of tubular aortic component 12. Examples of suitable arc lengths of proximal end 22 of wall aperture 20 include arc lengths equal to one member selected from the group consisting of about 6 mm, about 8 mm, about 10 mm, about 12 mm or about 14 mm. In one embodiment, a longitudinal length of wall aperture 20 is equal to or less than about 90 mm. In another embodiment, the longitudinal length of wall aperture 20 is equal to or greater than about 14 mm.
Referring to
In one embodiment, shown in
In one embodiment, shown in
In a specific embodiment, inferior portion 83 is on one side of tubular aortic component 12 opposite wall aperture 20 and is essentially parallel to major longitudinal axis 24 of tubular aortic component 12, shown in
As can be seen in
In another embodiment, shown in
As can also be seen in
Preferably, tubular portion 86 has a major longitudinal axis that is parallel to major longitudinal axis 24 of tubular aortic component 12. Proximal end 92 of tubular portion 86 is distal to the most proximal edge of proximal end 14 of tubular aortic component 12. In one embodiment, not shown, proximal end 92 of tubular portion 86 is coterminous with the most proximal edge of proximal end 14 of tubular aortic component 12 or, alternatively, as shown in
In one embodiment, at least one radiopaque marker 99 is located at at least one of proximal end 92 of tunnel graft 28 and distal end 94 of tubular portion 86 of tunnel graft 28, as shown in
In an embodiment, represented in
Thereafter, at least one tubular branch component 124 is implanted in at least one of an innominate artery 122, as shown in
Suitable systems, delivery devices and components of systems, stent grafts as described in U.S. application Ser. No. 11/699,700, filed on Jan. 30, 2007 (now abandoned); Ser. No. 11/828,653, filed on Jul. 26, 2007 (now abandoned); Ser. No. 12/137,592, filed on Jun. 12, 2008 (now abandoned); and Ser. No. 11/701,876, filed on Feb. 1, 2007 (now abandoned); and U.S. Pat. Nos. 7,763,063; 8,007,605; 8,062,345; 8,062,349; 8,070,790; 8,292,943 and U.S. Pat. Nos. 8,308,790, 8,740,963, 9,198,786, 9,320,631, 9,364,314, and 9,592,112, the relevant teachings of all of which are hereby incorporated by reference in their entirety, can be employed to deliver the aortic graft assembly of the invention by the method of the invention.
The relevant teachings of all patents, published applications and references cited herein are incorporated by reference in their entirety.
While this invention has been particularly shown and described with references to example embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims.
This is a Continuation of International Application PCT/US22/38295, filed on Jul. 26, 2022, which claims the benefit of U.S. Provisional Patent Application No. 63/225,789, filed Jul. 26, 2021, the entire contents of each prior applications are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63225789 | Jul 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US22/38295 | Jul 2022 | US |
| Child | 18420205 | US |