Patent Application
20240207037
This invention relates to a delivery system for intraluminal or endovascular delivery of a prosthesis.
The deployment of a medical device, such as an endoluminal prosthesis, into the vessel of a patient from a remote location by the use of a delivery system is generally known. The term prosthesis may include, for example and without limitation, a stent, stent graft, filter, valve, balloon, embolization coil, and the like. A delivery system carrying an endoluminal prosthesis is delivered into a vessel over a guide wire previously placed within the vessel. Once the delivery system is positioned, the prosthesis is released and expanded to repair the vessel.
An endoluminal prosthesis can be used, for example, to repair diseased and/or damaged conduits, such as blood vessels, the esophagus, the trachea, and the like. Over the past decade, endoluminal prostheses have become a popular option for treating damage and disease to blood vessels, such as abdominal aortic and/or thoracic aneurysms.
In some cases, it may be necessary to deploy an endoluminal prosthesis in a major vessel (e.g., the aorta) at or near an intersecting branch vessel (e.g., innominate, carotid, subclavian, celiac, SMA, and renal arteries). In these cases, an endoluminal prosthesis may be provided with one or more fenestrations so that the prosthesis can overlap the branch vessels without blocking flow to these vessels. For example, Fenestrated and Branched Endovascular Repair (F-BEVAR) is used to treat complex aortic aneurysms such as juxtarenal, pararenal, and thoracoabdominal aneurysms. In F-BEVAR, critical vessels are perfused via bridging stents placed in the fenestration of the main body stent graft.
Once the prosthesis is placed in the main vessel, it may be necessary to provide interventional access between the main vessel and a branch vessel. For example, a physician may desire to deliver additional interventional catheters carrying balloons, stents, grafts, imaging devices, and the like through the fenestration.
Before such a catheter device can be delivered through the fenestration to a target vessel, however, a guide wire must be provided and delivered through the fenestration to the target vessel. Typically, this requires multiple steps. First, the physician must deliver and navigate a set of catheters and wires to pass a guide wire through the fenestration. Once the fenestration is cannulated, the physician must then deliver and navigate a separate set of catheters and wires to pass a guide wire into the target vessel.
Preloaded delivery systems may be used, where wires and/or catheters may be preloaded through the fenestration(s) of the delivery system. Currently, the tip of the preloaded delivery system needs to be retracted prior to the deployment of bridging stents to avoid contact with or interference by the tip with elements of the preloaded system.
One general aspect of the present disclosure includes a delivery system for a stent graft, where the delivery system includes: a stent graft having a proximal end, a distal end, a proximal portion, a distal portion, an internal lumen between the proximal end and the distal end, a graft material tube, a graft material sidewall and a plurality of longitudinally spaced apart self-expanding stents attached to the graft material sidewall and including at least an end stent and a plurality of intermediate stents; a guidewire catheter extending longitudinally through the lumen of the stent graft; and a first wire extending longitudinally along only a first side of the graft material tube in an undulating pattern of successive curves in alternate directions, the first wire repeatedly extending through the graft material sidewall from inside the graft material tube to outside the graft material tube such that a portion of the first wire extends over the guidewire catheter over and along a longitudinal length of the guidewire catheter to secure the guidewire catheter at least partially to an internal wall of the stent graft, where the first wire has a plurality of successive curves in the proximal portion and a plurality of successive curves in the distal portion, each of the plurality of successive curves in the proximal portion and the distal portion have an X-displacement and a Y-displacement, where the X-displacement of the plurality of successive curves in the distal portion is greater than the X-displacement of the plurality of successive curves in the proximal portion, and where the Y-displacement of the plurality of successive curves in the distal portion is greater than the Y-displacement of the plurality of successive curves in the proximal portion.
Another general aspect of the present disclosure includes a delivery system for a fenestrated stent graft, where the delivery system includes a stent graft having a proximal end, a distal end, a proximal portion, a distal portion, an internal lumen between the proximal end and the distal end, a graft material tube, a graft material sidewall, at least two fenestrations, and a plurality of longitudinally spaced apart self-expanding stents attached to the graft material sidewall and including at least an end stent and a plurality of intermediate stents; a guidewire catheter extending longitudinally through the lumen of the stent graft; and a first wire extending longitudinally along only a first side of the graft material tube in an undulating pattern of successive curves in alternate directions, the first wire repeatedly extending through the graft material sidewall from inside the graft material tube to outside the graft material tube such that a portion of the first wire extends over the guidewire catheter over and along a longitudinal length of the guidewire catheter to secure the guidewire catheter at least partially to an internal wall of the stent graft, where the first wire has a plurality of successive curves in the proximal portion and a plurality of successive curves in the distal portion, each of the plurality of successive curves in the proximal portion and the distal portion have an X-displacement and a Y-displacement, where the X-displacement of the plurality of successive curves in the distal portion is greater than the X-displacement of the plurality of successive curves in the proximal portion, and where the Y-displacement of the plurality of successive curves in the distal portion is greater than the Y-displacement of the plurality of successive curves in the proximal portion.
Another general aspect of the present disclosure includes a delivery system for a stent graft, where the delivery system includes a stent graft having a proximal end, a distal end, a proximal portion, a distal portion, an internal lumen between the proximal end and the distal end, a graft material tube, a graft material sidewall, at least two fenestrations, and a plurality of longitudinally spaced apart self-expanding stents attached to the graft material sidewall and including at least an end stent and a plurality of intermediate stents; a guidewire catheter extending longitudinally through the lumen of the stent graft; and a first wire extending longitudinally along only a first side of the graft material tube in an undulating pattern of successive curves in alternate directions, the first wire repeatedly extending through the graft material sidewall from inside the graft material tube to outside the graft material tube such that a portion of the first wire extends over the guidewire catheter over and along a longitudinal length of the guidewire catheter to secure the guidewire catheter at least partially to an internal wall of the stent graft, where the first wire has a plurality of successive curves in the proximal portion and a plurality of successive curves in the distal portion, each of the plurality of successive curves in the proximal portion and the distal portion have an X-displacement and a Y-displacement, where the X-displacement of the plurality of successive curves in the distal portion is greater than the X-displacement of the plurality of successive curves in the proximal portion, where the Y-displacement of the plurality of successive curves in the distal portion is greater than the Y-displacement of the plurality of successive curves in the proximal portion, and where the plurality of stents each comprise a series of struts and the first wire crosses over two adjacent struts of each of the plurality of stents at an angle to a longitudinal axis of the stent graft.
A delivery system according to the present disclosure may include any combination of the features described above and/or the original as-filed claims.
The foregoing paragraphs have been provided by way of general introduction, and are not intended to limit the scope of the following claims. The various preferred embodiments, together with further advantages, will be best understood by reference to the following detailed description taken in conjunction with the accompanying drawings.
The present disclosure can be better understood with reference to the following drawings and description. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the present disclosure, although certain figures may be illustrated to scale and relied upon as such. Moreover, in the figures, like-referenced numerals designate corresponding parts throughout the different views.
Various aspects are described below with reference to the drawings in which like elements generally are identified by like numerals. The relationship and functioning of the various elements of the aspects may better be understood by reference to the following detailed description. However, aspects are not limited to those illustrated in the drawings or explicitly described below. It also should be understood that the drawings are not necessarily to scale (although certain drawings may be drawn to scale and relied upon as such), and in certain instances details may have been omitted that are not necessary for an understanding of aspects disclosed herein, such as conventional material, construction, and assembly.
For purposes of promoting an understanding of the presently disclosed embodiments, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It should nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.
Throughout this specification the term “distal” with respect to a portion of the aorta, a delivery device, or a stent graft is intended to mean the portion of the aorta, delivery device, or stent graft further away in the direction of blood flow away from the heart, and the term “proximal” is intended to mean the portion of the aorta, delivery device, or the stent graft nearer to the heart. The term “configured to” is used to describe structural limitations in a particular manner that requires specific construction to accomplish a stated function and/or to interface or interact with another component(s), and is not used to describe mere intended or theoretical uses. Relative terminology and broader terms such as “generally,” “substantially,” and the like will be understood by those of skill in the art as providing clear and definite scope of disclosure and/or claiming. For example, the term “generally vertical to the longitudinal axis 75 of the stent graft 12” will be understood as not requiring exactly 90.00 degrees to the longitudinal axis 75 of the stent graft 12, but rather including that and functional equivalents.
The connector valve 26 may include a silicone disk (not shown) for preventing the backflow of fluids therethrough. The disk may include a slit for the insertion of the nose cone dilator 18 and the delivery catheter 22. The connector valve 26 also includes a side arm 32 to which a tube 34 may be connected for introducing and aspirating fluids therethrough. The nose cone dilator 18 includes a tapered proximal end (e.g., delivery system tip 36) for accessing and dilating a vascular access site over a wire guide (not shown).
The wire guide is inserted in a body vessel with an introducer needle using, for example, the percutaneous vascular access Seldinger technique. A male luer lock connector hub 30 is attached at the distal end of the guidewire catheter 14 for connection to syringes and other medical apparatus. The handle 16 at the distal end of the delivery catheter 22 remains outside a patient in use and carries the trigger wire release handle mechanisms 38, 40, and 42 used to release the various portions of the stent graft 12. In some embodiments, the proximal end of the stent graft 12 may be retained on the delivery system 10 by the use of trigger wires (not shown) connected to the release handle 38. The distal end of the stent graft 12 may be retained on the delivery system 10 by the use of trigger wires (not shown) connected to the release handle 40. The longitudinal portion of the stent graft 12 may be retained on the delivery system 10 by the use of trigger wires (not shown) connected to the release handle 42.
As shown in
The stent graft 12 may be any suitable selected diameter and may be constructed of any biocompatible graft material which is suitable for facilitating repair of an injured or diseased body vessel. The graft material may be synthetic and/or naturally-derived material. Synthetic biocompatible polymers may include but are not limited to polyethylene terephthalate, polyurethane, nylon, polyester, high molecular weight polyethylene, polytetrafluoroethylene, or combinations thereof. The graft material can be porous or non-porous and also may be impregnated or coated with one or more therapeutic substances. The graft material should have sufficient flexibility to allow for navigation of the vasculature and delivery to a targeted area in the body.
In some embodiments, the stent graft 12 may have a plurality of longitudinally spaced apart self-expanding stents attached to the graft material sidewall 56 and include at least an end stent and a plurality of intermediate stents. A self-expanding stent may be manufactured from a shape-memory alloy, such as nickel titanium alloy (Nitinol). If the stent comprises a self-expanding material such as Nitinol, the stent may be heat-set into the desired expanded state whereby the stent can assume a relaxed radially expanded configuration. The stent may be made from other metals and alloys that allow the stent to return to its original expanded configuration upon deployment, such as, for example, stainless steel, cobalt-chrome alloys, amorphous metals, and/or non-metallic materials as would be recognized by one of ordinary skill in the art.
One or more stents may be located on an interior surface, exterior surface, or both of the graft material tube 54 of the stent graft 12. In some embodiments, the proximal portion 48 of the stent graft 12 may have at least two adjacent stents (e.g., stents 62 and 64, as shown in
For example, as shown in
In some embodiments, the stents may be in a ring configuration. In one example, as shown in
In some embodiments, as shown in
For example, referring to
The wire 78 then passes through the graft material sidewall 56 to outside the graft material tube 54, extends proximally, and then passes through the graft material sidewall 56 into the lumen 52 of the stent graft 12, traverses across (e.g., from left to right) two struts of the stent 70 and the guidewire catheter 14 at a fourth angle (e.g., acute angle) to the longitudinal axis 75 of the stent graft 12. The wire 78 then passes through the graft material sidewall 56 to outside the graft material tube 54, extends proximally, and then passes through the graft material sidewall 56 into the lumen 52 of the stent graft 12, traverses across (e.g., from right to left) two struts of the stent 68 and the guidewire catheter 14 at a fifth angle (e.g., acute angle) to the longitudinal axis 75 of the stent graft 12. The first, second, third, fourth, and fifth angles may be the same or different, and the cross-over sections of the wire 78 at each stent (68-76) may be longitudinally aligned or offset, without departing from the scope of the present invention.
Then, the wire 78 continues to extend proximally to the proximal portion 48 of the stent graft 12. The wire 78 passes through the graft material sidewall 56 into the lumen 52 of the stent graft 12, extends proximally, and then passes through the graft material sidewall 56 to outside the graft material tube 54. The wire 78 then extends proximally, passes through the graft material sidewall 56 into the lumen 52 of the stent graft 12, traverses across (e.g., from right to left) two struts of the stent 66 and the guidewire catheter 14 at a sixth angle (e.g., acute angle) to the longitudinal axis of the stent graft 12. The wire 78 then passes through the graft material sidewall 56 to outside the graft material tube 54, extends proximally, and then passes through the graft material sidewall 56 into the lumen 52 of the stent graft 12, traverses across (e.g., from left to right) two struts of the stent 64 and the guidewire catheter 14 at a seventh angle (e.g., acute angle) to the longitudinal axis 75 of the stent graft 12.
The wire 78 then passes through the graft material sidewall 56 to outside the graft material tube 54, extends proximally, and then passes through the graft material sidewall 56 into the lumen 52 of the stent graft 12, traverses across (e.g., from right to left) two struts of the stent 62 and the guidewire catheter 14 at an eighth angle (e.g., acute angle) to the longitudinal axis 75 of the stent graft 12. The sixth, seventh, and eighth angles may be the same or different, and the cross-over sections of the wire 78 at each stent (62-66) may be longitudinally aligned or offset, without departing from the scope of the present invention. It will be appreciated that the wire diameter, wire material, pitch of the wire (e.g., run from right to left or run from left to right), number of the cross-over sections, number of the internal wire portions, and location of the internal wire portions may be varied, as desired and/or needed, without departing from the scope of the present invention, as long as the guidewire catheter 14 is held by the wire 78 against a selected longitudinal portion of the stent graft 12 in the lumen 52 of the stent graft 12.
The wire 78 repeatedly penetrates the graft material sidewall 56 from inside the graft material tube 54 to outside the graft material tube 54 and then penetrate the graft material sidewall 56 back from outside the graft material tube 54 to inside the graft material tube 54, thereby forming a plurality of external wire portions and internal wire portions (e.g., cross-over sections) as a result of the repeated penetrations. For example, as shown in
In some embodiments, referring to
In some embodiments, the plurality of stents each may have a series of struts and the wire 78 may cross over two adjacent struts (e.g., struts 70e of the stent 70) and one apex (e.g., the apex 70c of the stent 70) of each of the plurality of stents at an angle (e.g., an acute angle) to the longitudinal axis 75 of the stent graft 12. For example, as shown in
Referring to
It will be appreciated that in some embodiments, the X-displacement 118 of the plurality of successive curves 79 in the distal portion 50 may be smaller than the X-displacement 114 of the plurality of successive curves 77 in the proximal portion 48, and the Y-displacement 120 of the plurality of successive curves 79 in the distal portion 50 may be smaller than the Y-displacement 116 of the plurality of successive curves 77 in the proximal portion 48, without departing from the scope of the present invention. Having the Y-displacement 116 of the plurality of successive curves 77 in the proximal portion 48 greater than the X-displacement 114 of the plurality of successive curves 77 in the proximal portion 48 is advantageous for making sure the curves 77 are not too stiff. Similarly, having the Y-displacement 120 of the plurality of successive curves 79 in the distal portion 50 greater than the X-displacement 118 of the plurality of successive curves 79 in the distal portion 50 is advantageous for making sure the curves 79 are not too stiff.
In some embodiments, as shown in
In some embodiments, as shown in
Referring to
This arrangement of the wire 78 is advantageous for constraining and controlling the guidewire catheter 14 traveling through the inner lumen 52 of the stent graft 12 from unwanted movement. For example, when one or more bridging stents 60 are deployed in one or more fenestrations 58, the guidewire catheter 14 is constrained by the internal wire portions formed by the wire 78 such that the guidewire catheter 14 is less likely to have unwanted incidental contact with the bridging stent(s) 60 that may be disposed in the lumen 52 of the stent graft 12, and therefore less likely to cause undesired movement or damage (e.g. denting or compression) to the bridging stent(s) 60. Currently, to avoid the unwanted incidental contact with the bridging stents 60 by the guidewire catheter 14, the delivery system 10 (with the delivery system tip 36) is retracted prior to the deployment of the bridging stent(s) 60 to avoid contact/damage from the tip 36. With the arrangement of the wire 78 disclosed in this application, the delivery and deployment process can be simplified by removing the additional step to retract the tip 36 prior to deployment of bridging stent(s), while protecting bridging stent integrity and patency. It will be appreciated that the arrangement of the wire 78 disclosed above may be incorporated in other types of stent grafts, which may or may not have fenestrations, to constrain and control the movement of the guidewire catheter 14, as discussed above.
In some embodiments, as shown in
Referring to
Referring to
While various embodiments of the present disclosure have been described, the present disclosure is not to be restricted except in light of the attached claims and their equivalents. One skilled in the relevant art will recognize that numerous variations and modifications may be made to the embodiments described above without departing from the scope of the present invention, as defined by the appended claims. Moreover, the advantages described herein are not necessarily the only advantages of the present disclosure and it is not necessarily expected that every embodiment of the present disclosure will achieve all of the advantages described.
This application claims priority from U.S. Provisional Application No. 63/432,500, filed Dec. 14, 2022, which is hereby fully incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63432500 | Dec 2022 | US |
