Patent Application
20240033068
The present disclosure relates to endovascular stent graft cover with torsion layer. The torsion layer may include braided first flat wires and second round wires.
Endovascular procedures are minimally invasive techniques to deliver clinical treatments in a patient's vasculature. One example of a clinical treatment used in an endovascular procedure is deployment of a stent graft. A stent graft is an implantable device made of a tube-shaped surgical graft material and an expanding (e.g., self-expanding) stent frame. The stent graft is placed inside a patient's vasculature (e.g., blood vessel) to bridge a diseased blood vessel segment (e.g., an aneurismal, dissected, or torn blood vessel segment), and thereby excluding hemodynamic pressures of blood flow from the diseased blood vessel segment.
The diseased blood vessel segment may extend into vasculature having blood vessel bifurcations or segments of the aorta from which smaller branch arteries extend. For example, thoracic aortic aneurysms may include aneurysms present in the ascending thoracic aorta, the aortic arch, and/or branch arteries that emanate therefrom (e.g., the left subclavian, left common carotid, or the brachiocephalic arteries).
The stent graft may be delivered and deployed to the patient's vascular using a stent graft delivery system. The stent graft delivery system may include a stent graft sheath configured to hold the stent graft in a radially compressed state during delivery to a target deployment site. The stent graft sheath may also be configured for relative axial movement to transition the stent graft from the radially compressed state to a radially expanded state at the target deployment site.
In some cases, a branched stent graft may be used to treat aneurysms. A branched stent graft may be deployed in a main blood vessel (e.g., aortic arch) with a coupling extending therefrom and aligning with a branched artery (e.g., left subclavian). A secondary stent graft may be connected to the coupling aligned to the branched artery to deploy the secondary stent graft in the branched artery.
In an embodiment, an endovascular stent graft cover for delivering a stent graft to a target deployment site is disclosed. The endovascular stent graft cover includes a tubular inner layer, a tubular outer layer, and a tubular torsion layer disposed between the tubular inner layer and the tubular outer layer. The tubular torsion layer includes first wires and second wires. The first wires have a flat profile along a first longitudinal axis of the first wires. The second wires have a circular profile along a second longitudinal axis of the second wires.
The tubular torsion layer may include a braided configuration braising together the first wires and the second wires. The braided configuration may be a herringbone pattern (e.g., a two over, two under herringbone pattern). The thickness of the tubular outer layer may be greater than a thickness of the tubular inner layer. The tubular outer layer may include a distal region formed of a first material and a proximal region formed of a second material. The flexibility of the first material may be higher than a flexibility of the second material, and a tensile strength of the second material may be higher than a tensile strength of the first material.
In another embodiment, an endovascular stent graft cover for delivering a stent graft to a target deployment site is disclosed. The endovascular stent graft cover includes a tubular inner layer, a tubular outer layer, and a tubular torsion layer disposed between the tubular inner layer and the tubular outer layer. The stent graft cover includes a proximal end portion and distal end portion and a stent graft cover length extending therebetween. The tubular torsion layer extends along the stent graft cover length from the proximal end portion to the distal end portion. The tubular torsion layer may be formed of braided wires.
In this embodiment, the proximal end portion is a proximal end of the stent graft cover, and a distalmost portion of the endovascular stent graft cover does not include the tubular torsion layer. The endovascular stent graft cover may further include a marker band extending around an outer circumference of the tubular outer layer and disposed proximal a distal end of the endovascular stent graft cover. The endovascular stent graft cover may further include a protective distal band situated between the tubular outer layer and the tubular torsion layer and disposed proximal a distal end of the endovascular stent graft cover. The protective distal band may be configured to obstruct the braided wires from penetrating the outer layer during a fusing operation for fusing the marker band to the tubular outer layer. The protective distal band may extend around a circumference of the tubular torsion layer. The protective distal band may be formed of a polyethylene terephthalate (PET) material. The braided wires include a braided configuration braiding together first wires and second wires. The first wires may have a flat profile along a first longitudinal axis of the first wires and the second wires may have a circular profile along a second longitudinal axis of the second wires.
In yet another embodiment, an endovascular stent graft cover assembly for delivering a stent graft to a target deployment site is disclosed. The endovascular stent graft cover assembly includes a stent graft T-tube having an inner surface defining a cavity. The stent graft cover has a proximal portion having an outer surface and a proximal portion diameter, a distal portion having a distal portion diameter, and a tapered portion extending between the proximal portion and the distal portion. The distal portion diameter is greater than the proximal portion diameter. The tapered portion tapers from the distal portion diameter to the proximal portion diameter in a proximal direction. The stent graft cover and the stent graft T-tube are connected to each other along the inner surface of the stent graft T-tube and the outer surface of the proximal portion of the stent graft cover.
In this embodiment, the proximal portion of the stent graft cover terminates within the cavity of the stent graft T-tube. The endovascular stent graft cover of this embodiment may further include a seal tube extending proximal the stent graft T-tube. The stent graft T-tube may include a proximal end portion including a snap fit connection configured to connect the seal tube to the proximal end portion of the graft T-tube. The stent graft T-tube may include an annular shoulder extending into the cavity of the stent graft T-tube and having a ledge. The stent graft cover may have a proximal end contacting the ledge. An inner diameter of the stent graft cover may be less than or equal to an inner diameter of the ledge.
Embodiments of the present disclosure are described herein. It is to be understood, however, that the disclosed embodiments are merely examples and other embodiments can take various and alternative forms. The figures are not necessarily to scale; some features could be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the embodiments. As those of ordinary skill in the art will understand, various features illustrated and described with reference to any one of the figures can be combined with features illustrated in one or more other figures to produce embodiments that are not explicitly illustrated or described. The combinations of features illustrated provide representative embodiments for typical applications. Various combinations and modifications of the features consistent with the teachings of this disclosure, however, could be desired for particular applications or implementations.
Directional terms used herein are made with reference to the views and orientations shown in the exemplary figures. A central axis is shown in the figures and described below. Terms such as “outer” and “inner” are relative to the central axis. For example, an “outer” surface means that the surfaces faces away from the central axis, or is outboard of another “inner” surface. Terms such as “radial,” “diameter,” “circumference,” etc. also are relative to the central axis. The terms “front,” “rear,” “upper” and “lower” designate directions in the drawings to which reference is made.
Unless otherwise indicated, for the delivery system the terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to a treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician. For the stent-graft prosthesis, “proximal” is the portion nearer the heart by way of blood flow path while “distal” is the portion of the stent-graft further from the heart by way of blood flow path.
The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Although the description is in the context of treatment of blood vessels such as the aorta, coronary, carotid, and renal arteries, the invention may also be used in any other body passageways (e.g., aortic valves, heart ventricles, and heart walls) where it is deemed useful.
Current stent graft covers may not adequately provide torsional responsiveness to rotate a loaded stent graft (e.g., a stent graft in a radially compressed state) to align a stent graft feature (e.g., a stent graft external coupling or side branch) with one or more of the blood vessels (e.g., great blood vessels) in an aortic arch of a patient. For instance, one current proposal has a proximal portion formed of a first material (e.g., a VESTAMID® material available from Evonik Industries AG) while having a distal portion formed of a second material (e.g., a PEBAX® material available from the Arkema Group) where the distal portion has an inner layer of wires having a circular profile. The proximal portion formed of the first material is configured to possess adequate tensile strength for deploying the stent graft cover within a patient's vasculature. The distal portion having the inner braided layer is configured to radially constrain the loaded stent graft while increasing overall flexibility of the stent graft cover. While adequate for its intended purposes, such structure of a stent graft cover may not provide sufficient torsional responsiveness to rotate a loaded stent graft. What is needed is a stent graft cover having enough torsional responsiveness to rotate a loaded stent graft to align features of stent graft (e.g., align a coupling with a branch vessel).
In one or more embodiments, a stent graft cover is disclosed in which the stent graft cover is configured to rotate a loaded stent graft cover about a longitudinal axis of the stent graft cover in response to rotation of the stent graft cover. In some embodiments, the stent graft cover may have a torqueability ratio of 1:1 or about 1:1. The torqueability ratio may refer to the amount of rotation at the distal end of the stent graft cover compared to the proximal end (e.g., within the handle) when the handle is rotated. A torqueability ratio of 1:1 may mean that the distal end rotates the same amount as the proximal end. There may be a lag or a wind up period before a torqueability ratio of 1:1 is achieved—e.g., an initial degree of rotation where the ratio is below 1:1 but after which the 1:1 ratio is achieved. In one embodiment, the wind up period may be from 5 to 180 degrees, or any sub-range therein, such as 10 to 150 degree, 30 to 120 degrees, 60 to 120 degrees, or about 90 degrees (e.g., +/−5 degrees). However, in one embodiment, there is substantially no wind up period (e.g., less than 5 degrees). In one or more embodiments, the shaft of the stent graft cover may be braided along substantially or about its entire length. The term “substantially” or “about” may be used herein to describe disclosed or claimed embodiments. The term “substantially” or “about” may modify a value or relative characteristic disclosed or claimed in the present disclosure. In such instances, “substantially” or “about” may signify that the value or relative characteristic it modifies is within ±0%, 0.1%, 0.5%, 1%, 2%, 3%, 4%, 5%, or 10% of the value or relative characteristic.
As shown in
Prior to delivery of the branched stent graft 10, primary guidewire 26 may be inserted into aorta 12. Secondary guidewire 28 may be inserted into aorta 12 separately from the primary guidewire 26, and into a target branch where coupling 22 is to be positioned (e.g., left subclavian artery 20 as shown on
During deployment, main body 24 expands from a radially compressed state (not shown) outwardly to a radially expanded state (shown in
Graft cover T-tube 104 may also be referred to as a graft hub, a hub, a central hub, or a handle hub. Graft cover T-tube 104 may be situated within an internal cavity formed by delivery system 50. Graft cover T-tube 104 may be a multi-lumen port having a first port (e.g., a main lumen port) configured to receive a main lumen and a second port (e.g., a branched lumen port) configured to receive a branched lumen. Graft cover T-tube 104 may be over molded onto stent graft cover 102 such that operation of the handle to retract graft cover T-tube 104 correspondingly retracts stent graft cover 102 to expose a stent graft (not shown), thereby transitioning it from a loaded, compressed state to an expanded, deployed state. The first and second ports may be located at a proximal end of graft cover T-tube 104. Graft cover T-tube 104 has wings 108 extending radially outward from graft cover T-tube 104. Wings 108 provide location of contact or force such that as external slider 62 is rotated about screw gear 56, graft cover T-tube 104 is forced to move linearly along the central axis of screw gear 56. In one embodiment, wings 108 have an external surface (e.g., facing radially outwardly) in rotational connection (e.g., directly or indirectly) with an internal surface of external slider 62. As shown in
In one or more embodiments, stent graft cover 102 has a multiple layer construction. For instance, a stent graft cover may have an outer jacket layer facing radially outward the stent graft cover, an inner liner layer facing radially inward the stent graft cover, and a torsion layer extending therebetween. The outer jacket layer may be formed of a polyether block amide polymer (e.g., a PEBAX® material). The outer jacket layer may have a thickness of any of the following values or in a range of any two of the following values: 0.008, 0.009, and 0.010 inches. The inner liner layer may be formed of a polyamide polymer (e.g., a VESTAMID® material). The inner liner layer may have a thickness of any of the following values or in a range of any two of the following values: 0.002, 0.003, and 0.004 inches. In one or more embodiments, the inner liner layer thickness is less than the outer jacket layer thickness.
The outer jacket layer may be formed of first and second materials along the length of the stent graft cover. In one embodiment, a distal end portion of outer jacket layer may be formed of the first material. The length of the distal end region may correspond to the length of a loaded stent graft within the stent graft cover. The first material may be configured to provide greater flexibility to the loaded stent graft. A proximal end portion of outer jacket layer may be formed of the second material. The length of the proximal region may correspond to the remaining length of the stent graft cover proximal the loaded stent graft. The second material may be configured to provide tensile strength to the stent graft cover. The first material may have a relatively high flexibility (e.g., about 22% yield strain and about 2,610 to 2,760 psi yield stress). A non-limiting example of the first material may be a PEBAX® 6333 material. The second material may have a relatively high tensile strength (e.g., about 26 MPa). A non-limiting example of the second material may be a PEBAX® 7233 material. Accordingly, in one embodiment, the first and second materials are both polyether block amide materials, but having different properties. The first material may be more flexible than the second material and the second material may be stiffer than the first material. The inner jacket layer may be formed of a third material, which may be the same throughout the entire (or substantially/about entire) length of the stent graft cover. The third material may also be a polyether block amide material, which may have the same properties as one of the first or second materials or may be different than both.
The torsion layer may be laminated between the inner liner layer and the outer jacket layer. In one or more embodiments, the torsion layer includes first and second wires. The first wires may have a flat profile along a first longitudinal axis of the first wires. The second wires may have a circular profile along a second longitudinal axis of the second wires. The torsion layer may include a braided configuration braiding together the first wires and the second wires. The braided configuration may include a herringbone pattern. Alternatively, the braided configuration may include a diamond pattern.
In one embodiment, the braided configuration includes a combination of flat wires and round wires. The flat wires may have a width of about 0.010 inches and a thickness of about 0.003 inches. The width to thickness ratio of the flat wires may be any of the following values or in a range of any two of the following values: 3.0, 3.1, 3.2, 3.33, 3.4, 3.5, or 3.6. The round wires may have a diameter of about 0.003 inches. The flat wire width may be any of the following values or be in a range of any two of the following values: 0.005, 0.006, 0.007, 0.008, 0.009, 0.010, 0.011, 0.012, 0.013, 0.014 and 0.015 inches. The flat wire thickness may be any of the following values or in a range of any two of the following values: 0.001, 0.002, 0.003, 0.004, and 0.005 inches. The round wire diameter may be any of the following values or in a range of any two of the following values: 0.001, 0.002, 0.003, 0.004, and 0.005 inches. The ultimate tensile strength of the flat wires may be any of the following values or in a range of any two of the following values: 300, 310, 320, 330, 340, and 350 kpsi. The ultimate tensile strength of the round wires may be any of the following values or in a range of any two of the following values: 300, 310, 320, 330, 340, and 350 kpsi.
The number of flat wires in the braided configuration may be a higher multiple of four (4) than the number of round wires in the braided configuration. For instance, the number of flat wires may be twelve (12) flat wires and the number of round wires may be four (4) round wires. The flat wires and the round wires may be configured in a two over, two under herringbone pattern where a single strand goes under two other strands and then over two other strands. The herringbone pattern may include a clockwise braid pattern and a counterclockwise braid pattern. The clockwise braid pattern may be flat strand, flat strand, flat strand, round strand, flat strand, flat strand, flat strand, and round strand. The counterclockwise braid pattern may be flat strand, flat strand, flat strand, round strand, flat strand, flat strand, flat strand, and round strand. The braided configuration also includes a braid density, which can be measured by picks per inch (PPI). The PPI of the braided configuration may be any of the following values or in a range of any two of the following values: 11, 12, 13, 14, and 15 PPIs.
In another embodiment, the braided configuration may be a one over one under braid pattern where one single strand alternately passes under, then over another single stand. In yet another embodiment, the braided configuration may be a diamond braid pattern where two strands (e.g., side by side) alternately pass under two strands, then over two strands.
As further described herein, stent graft cover 102 includes marker band 112 and distal end region 114, both at a distal region of stent graft cover 102. Marker band 112 is configured to provide visualization to a clinician during deployment of a stent graft. Marker band 112 may be formed of a radiopaque material. The length of distal end region 114 may be about 0.09 inches plus up to about 0.08 inches or minus up to 0.04 inches.
Graft cover T-tube 104 has open proximal end 120 configured to create a snap fit connection with seal tube 122 as shown in
As shown in
As shown in
While exemplary embodiments are described above, it is not intended that these embodiments describe all possible forms encompassed by the claims. The words used in the specification are words of description rather than limitation, and it is understood that various changes can be made without departing from the spirit and scope of the disclosure. As previously described, the features of various embodiments can be combined to form further embodiments of the invention that may not be explicitly described or illustrated. While various embodiments could have been described as providing advantages or being preferred over other embodiments or prior art implementations with respect to one or more desired characteristics, those of ordinary skill in the art recognize that one or more features or characteristics can be compromised to achieve desired overall system attributes, which depend on the specific application and implementation. These attributes can include, but are not limited to cost, strength, durability, life cycle cost, marketability, appearance, packaging, size, serviceability, weight, manufacturability, ease of assembly, etc. As such, to the extent any embodiments are described as less desirable than other embodiments or prior art implementations with respect to one or more characteristics, these embodiments are not outside the scope of the disclosure and can be desirable for particular applications.
This application claims the benefit of U.S. provisional application Ser. No. 63/393,034 filed Jul. 28, 2022, the disclosure of which is hereby incorporated in its entirety by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63393034 | Jul 2022 | US |
