Aneurysms occur in blood vessels in locations where, due to age, disease or genetic predisposition, the blood vessel strength or resiliency is insufficient to enable the blood vessel wall to retain its shape as blood flows therethrough, resulting in a ballooning or stretching of the blood vessel at the limited strength/resiliency location to thereby form an aneurysmal sac. If the aneurysm is left untreated, the blood vessel wall may continue to expand, to the point where the remaining strength of the blood vessel wall is below that necessary to prevent rupture, and the blood vessel will fail at the aneurysm location, often with fatal result.
To prevent rupture, a stent graft of a tubular construction may be introduced into the blood vessel, for example intraluminally. Typically, the stent graft is deployed and secured in a location within the blood vessel such that the stent graft spans the aneurysmal sac. The outer surface of the stent graft, at its opposed ends, is sealed to the interior wall of the blood vessel at a location where the blood vessel wall has not suffered a loss of strength or resiliency. Blood flow in the vessel is thus channeled through the hollow interior of the stent graft, thereby reducing, if not eliminating, any stress on the blood vessel wall at the aneurysmal sac location. Therefore, the risk of rupture of the blood vessel wall at the aneurysmal location is significantly reduced, if not eliminated, and blood can continue to flow through to the downstream blood vessels without interruption.
Woven fabrics are useful in the construction of grafts due to their desirable mechanical properties and the ease and low cost of manufacturing such fabrics. However, existing woven fabrics cannot include certain shapes, such as tapers, without compromising the structural integrity of such fabrics (e.g., due to the potential for fraying) and/or without adding unwanted structures (such as certain seams). In view of this background, the present disclosure provides an improved woven graft material for use in a stent graft.
The embodiments will be further described in connection with the attached drawings. It is intended that the drawings included as a part of this specification be illustrative of the exemplary embodiments and should in no way be considered as a limitation on the scope of the present disclosure. Indeed, the present disclosure specifically contemplates other embodiments not illustrated but intended to be included in the claims.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In case of conflict, the present document, including definitions, will control. Preferred methods and materials are described below, although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. All publications, patent applications, patents and other references mentioned herein are incorporated by reference in their entirety. The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting.
The term “implantable” refers to an ability of a medical device to be positioned at a location within a body, such as within a body lumen.
As used herein, the term “body vessel” means any tube-shaped body passage lumen that conducts fluid, including but not limited to blood vessels such as those of the human vasculature system, esophageal, intestinal, biliary, urethral and ureteral passages.
The term “branch vessel” refers to a vessel that branches off from a main vessel. The “branch vessels” of the thoracic and abdominal aorta include the celiac, inferior phrenic, superior mesenteric, lumbar, inferior mesenteric, middle sacral, middle suprarenal, renal, internal spermatic, ovarian (in the female), innominate, left carotid, and left subclavian arteries. As another example, the hypogastric artery is a branch vessel to the common iliac, which is a main vessel in this context. Thus, it should be seen that “branch vessel” and “main vessel” are relative terms.
The terms “about” or “substantially” used with reference to a quantity includes variations in the recited quantity that are equivalent to the quantity recited, such as an amount that is insubstantially different from a recited quantity for an intended purpose or function.
The term “stent” means any device or structure that adds rigidity, expansion force, or support to a prosthesis. The term “stent graft” as used herein refers to a prosthesis comprising a stent and a graft material associated therewith that forms a lumen through at least a portion of its length.
Woven fabrics are useful in the construction of grafts due to their desirable mechanical properties and the ease and low cost of manufacturing such fabrics. Existing woven fabrics cannot include certain shapes, such as tapers, without compromising the structural integrity of such fabrics (e.g., due to the potential for fraying) and/or without adding unwanted structures (such as certain seams). The embodiments described herein, and variations thereof, provide a novel way of forming a tapered graft with a weaving machine and the resulting graft and stent-graft structures. Such graft material may be advantageously used with stents of various shapes. These teachings are advantageous for allowing woven graft material to be used with stent grafts of various shapes and sizes (e.g., configured for deployment for particular target areas within a human or animal body). The embodiments herein, and variations thereof, may include any suitable feature described in U.S. patent application Ser. No. 16/553,394 (and corresponding Publication No. 2020/0069411), filed Aug. 28, 2019, and titled “GRAFT HAVING AT LEAST ONE WOVEN TAPER,” which is hereby incorporated by reference in its entirety.
As shown, the graft 102 may include a main tubular section 110 and a bifurcated section 112. The main tubular section 110 may be configured for deployment in a vessel or other body lumen, such as an aorta of a human (or other) patient to treat an aneurysm. To allow blood flow through the main tubular section 110, a main lumen 114 may extend through the entire tubular woven graft that is constructed in the form of woven fabric 104.
The bifurcated section 112, which also may be formed with the tubular woven fabric 104, may extend from the main tubular section 110. In exemplary embodiment, the bifurcated section 112 may include a first branch 116 and a second branch 118 for deployment within branch vessels extending from the aorta (e.g., the iliac arteries of a human or other patient). The bifurcated section 112 may extend distally from the main tubular section 110, but it may alternatively extend a different direction from the main tubular section 110 in other embodiments. The bifurcated section 112 may include a first branch 116 and a second branch 118 (and in some embodiments, more than two branches may be included). To allow blood flow through the branches, the first branch 116 and the second branch 118 may include a first branch lumen 120 and a second branch lumen 122 (respectively) in fluid communication with the main lumen 114 of the main tubular section 110.
Optionally, the main tubular section 110 may include a tapered portion 124 at its distal end 126 that extends from a cylindrical portion 128. The tapered portion 124 may be frustoconical in shape and may decrease in diameter as it extends distally from the cylindrical portion 128 of the main tubular section 110. The tapered portion 124 may be advantageous to providing a smooth transition from the main tubular section 110 to the bifurcated section 112. For example, when the graft 102 is configured for use in and around the aorta, the tapered portion 124 may provide a smooth transition between the abdominal aorta and the common iliac arteries, but tapers for other body locations are also contemplated. In other embodiments, the main tubular section 110 may lack the tapered portion 124, and thus the bifurcated section 112 may extend directly from the cylindrical portion 128. When the tapered portion 124 is included, it may be formed with a woven structure as described in more detail below.
Similarly, the bifurcated section 112 may include a tapered section (not shown) where at least one of the branches includes a tapered structure. For example, the first branch 116 may include a first branch taper and the second branch may include a second branch taper (not shown). If included, the first branch taper and the second branch taper may each include a respective frustoconical wall that surrounds the first branch lumen 120 and the second branch lumen 122, respectively. Advantageously, the first branch taper and/or the second branch taper (if included) may provide a smooth transition from a main vessel (e.g., the abdominal aorta) to smaller respective branch vessels.
Tapered sections may also be included in grafts that lack a bifurcated portion. For example,
For the above-described examples, variations thereof, and other tapered grafts, the tapered geometry may be formed with a unique and novel weaving technique, where particular warp yarns are selectively removed from the engagement with the corresponding weft threads while weaving and then re-engaged later before being permanently released. The below figures describe such a process and certain resulting structure.
In Step A, a first weft insertion 1 forms a portion of a first layer of the graft 302 with a weft yarn 308 (e.g., the first layer 140 of the graft 102 of
While only the leftmost twelve (12) warp ends W1-W12 are shown, the pattern shown in step A may be repeated to the right of warp end W1 such that a graft having a suitable width/diameter is achieved. Further, if step A is repeated, a non-tapered length of the graft may be formed. Thus, step A of
Step B of
At step C, the recently-dropped warp ends W1-W2 are re-engaged (via weft insertions 9-12), thereby re-introducing the warp ends W1-W2 into the woven structure. Advantageously, this step improves the quality of the seam between the first layer and the second layer (e.g., reduced porosity and increased durability without adding bulkiness) since the loose warp ends W1-W2 including an extra engagement with the woven structure (and therefore an additional point of securement) prior to leaving the structure entirely. Further, the re-introduced warp ends W1-W2 may be located in front of an area that may otherwise include a pore or other small opening due to the dropping of a different warp end (e.g., one or more of warp ends W3-W4 as discussed below).
Optionally, step C may drop another set of warp ends, in this instance the warp ends W3-W4. Alternatively, this step may occur further downstream in the sequence. However, advantageously, by dropping the warp ends W3-W4 with the same weft insertions (i.e., weft insertion 9-12) that re-engage the warp ends W1-W2, the re-engaged portions of the warp ends W1-W2 may at least partially cover an opening forming as a result of dropping warp ends W3-W4.
In step D (and beyond), the warp ends W1-W2 are wholly excluded. In one or more post processing steps (typically after weaving is complete), the warp ends W1-W2 may be trimmed from the graft at a location corresponding to step D (as discussed below), and in some circumstances may be heat sealed, sealed with an adhesive, or otherwise locked in place to prevent unraveling.
Step D also functions to re-engage the warp ends W3-W4 (e.g., in a manner similar to the re-engagement of warp ends W1-W2 in step C), and in step E (and beyond), the warp ends W3-W4 are wholly excluded. Thus, in a similar fashion, the warp ends W3-W4 may be trimmed from the graft at a location corresponding to step E and locked in place as needed.
Step E of
Steps F-I of
The technique described above (of
As shown in
Step E, step F, and step G repeat this sequence with the next-available warp ends while progressively moving towards the center of the graft 102. The end result is a woven taper similar to that of
In the above-depicted examples, the tapers are formed with a substantially linear profile. Other shapes are also contemplated (e.g., by altering the weaving sequences below, for example).
Without limitation, the subject matter of this disclosure may also relate to one or more of the following aspects (and combinations thereof). These aspects, and features thereof, may be combined (where suitable).
In a first aspect, a tubular graft is included for use in a stent graft. Without limitation, the graft may include one or more of the following features: a first woven layer, where the first woven layer forms a first side of the tubular graft, the first woven layer having a set of first warp ends; a second woven layer, where the second woven layer forms a second side of the tubular graft, the second woven layer having a set of second warp ends, where the set of second warp ends is distinct from the set of first warp ends; and a tapered portion having an edge, where the edge connects the first woven layer and the second woven layer, where the tapered portion includes a first weft thread, a second weft thread, and a third weft thread, the second weft thread being between the first weft thread and the third weft thread, where each of the first weft thread, the second weft thread, and the third weft thread extends through the first woven layer and the second woven layer, where the first weft thread and the third weft thread engage a first warp end at the edge of the tapered portion such that the first warp end is secured to the edge at the first weft thread and the third weft thread, and where a floating portion of the first warp end extends from the first weft thread to the third weft thread such that the floating portion bypasses the second weft thread.
A free end of the first warp end may extend from the edge of the tapered portion.
At least two weft threads may secure the first warp end to the edge at a location between the floating portion of the first warp end and the free end of the first warp end.
The edge of the tapered portion may be located between the floating portion of the first weft thread and a lumen within the tapered portion of the tubular graft.
The graft may further include a second warp end, where the second warp end engages a fourth weft thread and a sixth weft thread, where a second floating portion of the second warp end bypasses a fifth weft thread, and where the fifth weft thread is located between the fourth weft thread and the sixth weft thread.
The floating portion of the first warp end may bypass at least three weft threads.
The floating portion of the first warp end may bypass at least five weft threads.
The first warp end may be heat sealed to the edge of the tapered portion.
At least a portion of the edge of the tapered portion may be curved.
A second aspect includes a method for forming a graft. The method may include one or more of the following steps: weaving a first woven layer that forms a first side of the graft, the first woven layer having a set of first warp ends; weaving a second woven layer that forms a second side of tubular graft, the second woven layer having a set of second warp ends, where the set of second warp ends is distinct from the set of first warp ends; and weaving a tapered portion having an edge, where the edge connects the first woven layer and the second woven layer, where the tapered portion includes a first weft thread, a second weft thread, and a third weft thread, the second weft thread being between the first weft thread and the third weft thread, where each of the first weft thread, the second weft thread, and the third weft thread extends through the first woven layer and the second woven layer, where the first weft thread and the third weft thread engage a first warp end at the edge of the tapered portion such that the first warp end is secured to the edge at the first weft thread and the third weft thread, and where a floating portion of the first warp end extends from the first weft thread to the third weft thread such that the floating portion bypasses the second weft thread.
A free end of the first warp end may extend from the edge of the tapered portion.
At least two weft threads may secure the first warp end to the edge at a location between the floating portion of the first warp end and the free end of the first warp end.
The edge of the tapered portion may be located between the floating portion of the first weft thread and a lumen within the tapered portion of the graft.
The graft may further includes a second warp end, where the second warp end engages a fourth weft thread and a sixth weft thread, where a second floating portion of the second warp end bypasses a fifth weft thread, and where the fifth weft thread is located between the fourth weft thread and the sixth weft thread.
The floating portion of the first warp end may bypass at least three weft threads.
The floating portion of the first warp end may bypass at least five weft threads.
The method may further include heating the edge of the tapered portion to permanently secure the first warp end to the edge.
In a third aspect, a tubular graft for use in a stent graft may include a woven tapered portion, the woven tapered portion having an edge that extends along a decreasing-diameter portion of the tubular graft, where the tapered portion includes a first weft thread, a second weft thread, and a third weft thread, the second weft thread being between the first weft thread and the third weft thread, where the first weft thread and the third weft thread engage a first warp end at the edge of the tapered portion such that the first warp end is secured to the edge at the first weft thread and the third weft thread, and where a floating portion of the first warp end extends from the first weft thread to the third weft thread such that the floating portion bypasses the second weft thread.
A free end of the first warp end may extend from the edge of the tapered portion, where at least two weft threads secure the first warp end to the edge at a location between the floating portion of the first warp end and the free end of the first warp end.
The edge of the tapered portion may be located between the floating portion of the first weft thread and a lumen within the tapered portion of the tubular graft. While various embodiments of the invention have been described, the invention is not to be restricted except in light of the attached claims and their equivalents. Moreover, the advantages described herein are not necessarily the only advantages of the invention and it is not necessarily expected that every embodiment of the invention will achieve all of the advantages described.
This application claims the benefit of U.S. Provisional Application No. 63/016,662, filed Apr. 28, 2020, which is hereby incorporated by reference in its entirety.
Number | Name | Date | Kind |
---|---|---|---|
180790 | Van Dussen Reed | Aug 1876 | A |
444880 | Erskine | Jan 1891 | A |
2729958 | Miles | Jan 1956 | A |
2978787 | Liebig | Apr 1961 | A |
3096560 | Liebig | Jul 1963 | A |
3853462 | Smith | Dec 1974 | A |
3945052 | Liebig | Mar 1976 | A |
4166463 | Bloom | Sep 1979 | A |
4668545 | Lowe | May 1987 | A |
4771518 | LaPointe et al. | Sep 1988 | A |
4822371 | Jolly et al. | Apr 1989 | A |
5178630 | Schmitt | Jan 1993 | A |
5282846 | Schmitt | Feb 1994 | A |
5282848 | Schmitt | Feb 1994 | A |
5370682 | Schmitt | Dec 1994 | A |
5370683 | Fontaine | Dec 1994 | A |
5385580 | Schmitt | Jan 1995 | A |
5487858 | Schmitt | Jan 1996 | A |
5509931 | Schmitt | Apr 1996 | A |
5697970 | Schmitt et al. | Dec 1997 | A |
5755734 | Richter et al. | May 1998 | A |
5800514 | Nunez et al. | Sep 1998 | A |
5904714 | Nunez et al. | May 1999 | A |
5913894 | Schmitt | Jun 1999 | A |
6090137 | Schmitt | Jul 2000 | A |
6187033 | Schmitt et al. | Feb 2001 | B1 |
6280467 | Leonhardt | Aug 2001 | B1 |
6454796 | Barkman et al. | Sep 2002 | B1 |
6475232 | Babbs et al. | Nov 2002 | B1 |
6592539 | Finarsson et al. | Jul 2003 | B1 |
6626938 | Butaric et al. | Sep 2003 | B1 |
6814754 | Greenhalgh | Nov 2004 | B2 |
6974586 | Greenhalgh | Dec 2005 | B2 |
6994724 | Schmitt | Feb 2006 | B2 |
7122052 | Greenhalgh | Oct 2006 | B2 |
7226474 | Iancea et al. | Jun 2007 | B2 |
7550004 | Bahler et al. | Jun 2009 | B2 |
7582110 | Case et al. | Sep 2009 | B2 |
7758626 | Kim et al. | Jul 2010 | B2 |
8287586 | Schaeffer et al. | Oct 2012 | B2 |
8696733 | Bogert et al. | Apr 2014 | B2 |
9427306 | Shahriari | Aug 2016 | B2 |
9492268 | Winner et al. | Nov 2016 | B2 |
9827086 | Winner et al. | Nov 2017 | B2 |
20030196717 | Nunez et al. | Oct 2003 | A1 |
20050131516 | Greenhalgh | Jun 2005 | A1 |
20050154446 | Phillips et al. | Jul 2005 | A1 |
20090282908 | Homayoun | Nov 2009 | A1 |
20120165918 | Du | Jun 2012 | A1 |
20130184808 | Hall et al. | Jul 2013 | A1 |
20150320542 | Gabriele | Nov 2015 | A1 |
20160270897 | Whiting | Sep 2016 | A1 |
20160305050 | Winner | Oct 2016 | A1 |
20170105854 | Treacy et al. | Apr 2017 | A1 |
20180202082 | Van Hulle | Jul 2018 | A1 |
20200058991 | Adugna et al. | Feb 2020 | A1 |
20200289253 | Sumanasinghe | Sep 2020 | A1 |
Number | Date | Country |
---|---|---|
2422915 | May 2007 | CA |
2913510 | Oct 1979 | DE |
10043291 | Apr 2001 | DE |
0095940 | Dec 1983 | EP |
0175554 | Mar 1986 | EP |
2115776 | Sep 1983 | GB |
H 03-45743 | Feb 1991 | JP |
WO 8303349 | Oct 1983 | WO |
WO 8806026 | Aug 1988 | WO |
WO 8900031 | Jan 1989 | WO |
WO 9743983 | Nov 1997 | WO |
WO 2008008528 | Jan 2008 | WO |
WO 2017014830 | Jan 2017 | WO |
Entry |
---|
Buesgen translation of DE 10043291 (Year: 2001). |
Extended European Search Report for European Application No. 21275047.5 dated Sep. 6, 2021 (7 pages). |
Extended European Search Report for European Application No. 19194707.6 dated Jan. 21, 2020 (9 pages). |
Number | Date | Country | |
---|---|---|---|
20210330445 A1 | Oct 2021 | US |
Number | Date | Country | |
---|---|---|---|
63016662 | Apr 2020 | US |