STENT GRAFTS AND METHODS OF USE FOR TREATING ANEURYSMS
A stent graft includes a tubular aortic component that defines a lumen and a fenestration with a pocket at the fenestration. At least one proximal tunnel graft extends proximally within the lumen from the proximal opening of the pocket and is secured at a proximal end to the tubular component, and at least one distal tunnel graft extends distally within the lumen from the distal opening of the pocket and is secured at a distal end to the tubular aortic component. The stent graft can further include at least one branch stent graft, each of which extends through the fenestration and within at least one of the proximal tunnel graft or the distal tunnel graft. The stent graft can be implanted in a patient to thereby treat an aneurysm, such as a suprarenal or thoracoabdominal aortic aneurysm.
This application claims the benefit of U.S. Provisional Application No. 62/341,234. filed on May 25, 2016. The entire teachings of the above application are incorporated herein by reference.
BACKGROUNDSuprarenal abdominal aortic aneurysms (AAA) and thoracoabdominal aortic aneurysms (TAAA) are life-threatening conditions that represent surgical challenges. Although open surgical repair of these aneurysms can treat the diseased area of the aorta, there are considerable risks with open repair, primarily as a consequence of ischemic insult to the spinal cord, kidneys and surrounding abdominal viscera resulting from surgery. Currently, open surgical techniques to repair suprarenal AAA and TAAA include distal aortic perfusion via extracorporeal circuits, in-line shunts, and cold renal perfusion to reduce the potential of ischemic injury to the spinal cord and renovisceral areas.
Therefore, a need exits for new and improved endovascular repair devices and methods to treat suprarenal AAA and TAAA that minimize trauma to the patient, and loss of blood flow to the spinal cord and surrounding viscera.
SUMMARY OF THE INVENTIONThe present invention relates to stent grafts and methods of using stent grafts to treat aortic vascular damage, such as vascular damage associated with suprarenal AAA and TAAA, including aneurysms, penetrating ulcers and dissection.
In an embodiment, the invention is a stent graft comprising: a tubular aortic component defining a lumen having a proximal end, a distal end, a major longitudinal axis, and defining a fenestration between the proximal end and the distal end; a pocket at the fenestration, the pocket defining a pocket proximal opening and a pocket distal opening opposite the pocket proximal opening within the lumen; at least one proximal tunnel graft having a proximal tunnel graft proximal end, and at least one proximal tunnel graft distal end, and defining a proximal tunnel graft lumen, the proximal tunnel graft extending proximally within the lumen from the pocket proximal opening and being secured at its proximal end to the tubular aortic component; and at least one distal tunnel graft having a distal tunnel graft proximal end and a distal tunnel graft distal end, and defining at least one distal tunnel graft lumen, the distal tunnel graft extending distally within the lumen from the distal opening of the pocket and being secured at its distal end to the tubular aortic component.
In another embodiment, the invention is a method for treating a suprarenal or a thoracoabdominal aortic aneurysm. A stent graft is delivered through an aorta to an aneurysm site of a patient, the stent graft being radially and releasably constrained by a distal end of a control catheter of a delivery device. The stent graft includes: a tubular aortic component defining a lumen having a proximal end, a distal end, a major longitudinal axis, and defining a fenestration between the proximal end and the distal end; a pocket at the fenestration, the pocket defining a proximal opening and a distal opening opposite the proximal opening within the lumen; at least one proximal tunnel graft having a proximal tunnel graft proximal end and a proximal tunnel graft distal end, and defining at least one proximal tunnel graft lumen, the proximal tunnel graft extending proximally within the lumen from the proximal opening of the pocket and being secured at its proximal end to the tubular aortic component; and at least one distal tunnel graft having a distal tunnel graft proximal end and a distal tunnel graft distal end, and defining at least one distal tunnel graft lumen, the distal tunnel graft extending distally within the lumen from the distal opening of the pocket and being secured at its distal end to the tubular aortic component. The fenestration is aligned at the aneurysm site of the patient with at least one branch of the aorta at the aneurysm site. The tubular aortic component (stent graft) is released from the delivery device, such as by retracting a control catheter of the delivery device. Each of at least one branch stent graft is delivered through the distal end and the proximal end of the stent graft and through the distal tunnel graft or the proximal tunnel graft to the fenestration, and through the fenestration to a branch of the aorta at the aneurysm site of the patient, whereby the branch stent graft is secured into the distal tunnel graft lumen or the proximal tunnel graft lumen while being radially constrained at the opposite end of the branch stent graft by a branch delivery device. Each branch stent graft is released from the branch delivery device to thereby complete implantation of the branch stent graft and treat the suprarenal or thoracoabdominal aortic aneurysm.
The stent grafts and methods of the invention have several advantages, including, for example, defining a fenestration that reduces the profile of the stent graft which, in turn, has the advantage of accommodating branch stent grafts within tunnel grafts to minimize the diameter of a prosthesis placed in a diseased aorta. The length and diameter of the fenestration can be customized for individual patients depending upon the degree and extent of the suprarenal AAA and TAAA to permit the surgeon to minimize trauma in the area of the diseased aorta while providing the surgeon with a decreased profile for introducing branch stent grafts to branch vessels of organs and tissues in the area of the diseased aorta.
The stent grafts and methods of the invention also have the advantage of providing greater flexibility of choice to the surgeon introducing branch stent grafts, arranging them in either an antegrade or retrograde configuration, to accommodate the anatomical features specific to tissue surrounding the aneurysm. In the case of arteries, antegrade is the flow of blood away from the heart and in the case of veins antegrade is the flow of blood towards the heart. In the case of arteries, retrograde is the flow of blood towards the heart and in the case of veins retrograde is the flood of blood away from the heart. For example, antegrade placement of a branch stent graft in an aorta refers to the implantation of a branch stent graft that results in a portion of the branch stent graft extending from the fenestration in the tubular aortic component (stent graft with fenestration implanted in the aorta at the site of an aneurysm) in the same direction as the flow of blood. In contrast, retrograde placement of a branch stent graft in an aorta refers to the implantation of a branch stent graft that results in a portion of the branch stent graft extending from the fenestration in the aortic stent graft component in a direction that is opposite the flow of blood from the heart.
Further, the proximal and distal tunnel grafts are each secured to the aortic graft component at their proximal and distal ends, respectively. As a result, implantation of branch stent grafts which, in abdominal aortic aneurysms or thoracoabdominal aortic aneurysm surgeries, must be through either the proximal or distal end of the aortic stent graft component, is facilitated by relatively stable positioning of the proximal end of the proximal tunnel graft and the distal end of the distal tunnel graft within the aortic stent graft component.
The foregoing will be apparent from the following more particular description of example embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The same number in different drawings represents the same item. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating embodiments of the present invention.
The invention is generally directed to prostheses for use in treating vascular disease, such as implantation of the prostheses at a site of an aortic aneurysm.
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.
A description of example embodiments of the invention follows.
When reference is made herein to a prosthesis to be delivered, or implanted in a patient, such as a vascular repair device, the word “proximal” means that portion of the prosthesis or component of the prosthesis that is relatively close to the heart of the patient and “distal” means that portion of the prosthesis or component of the prosthesis that is relatively far from the heart of the patient.
When, however, reference is made to a delivery system or a component of a delivery system employed to deliver, or implant a vascular repair device, the word, “proximal,” as employed herein, means closer to the clinician using the delivery system. “Distal,” as that term is employed herein, means, when reference is made to a delivery system or a component of a delivery system, further away from the clinician using the delivery system.
For clarity, the word “proximate” means “close to,” as opposed to the meanings ascribed to “proximal” or “distal” above with respect to either the vascular repair device or delivery system.
One embodiment of the stent graft of the invention is shown in
Proximal tunnel graft (44) of stent graft (36) has proximal tunnel graft proximal end (46), proximal tunnel graft distal end (48) and proximal tunnel graft lumen (50). Proximal tunnel graft (44) extends proximally within the lumen of tubular aortic component (12) from pocket proximal opening (40) and is secured to proximal opening (40). Stent graft (36) also includes distal tunnel graft (52) having distal tunnel graft proximal end (54), distal tunnel graft distal end (56) and distal tunnel graft lumen (58). Distal tunnel graft (52) extends distally within the lumen of tubular aortic component (12) from pocket distal opening (42) and is secured to distal pocket opening (42).
At least one of proximal tunnel graft (44) and distal tunnel graft (52) is secured to an interior of tubular aorta component (12) by a suitable technique, such as is known to one skilled in the art, such as by a suture or biocompatible adhesive. For example, in one embodiment, proximal end (46) of proximal tunnel graft (44) is fixed to tubular aortic component (12) by proximal suture (60), and distal end (56) of distal tunnel graft (52) is fixed to tubular aortic component (12) by distal suture (61). Alternatively, at least one of proximal tunnel graft (44) and distal tunnel graft (52) can be attached to tubular aortic component (12) by more than a single suture, such as along an intermittent or continuous length (not shown), over a portion or the entire length of proximal tunnel graft (44) and distal tunnel graft (52), respectively.
As can be seen in
In another embodiment, the invention is a method for treating a suprarenal or thoracoabdominal aortic aneurysm. For example, with reference to
Vascular repair devices of the invention can be implanted, for example, by transfemoral access. Additional vascular repair devices that are directed into the vascular repair devices of the invention can be implanted, for example, by supraaortic vessel access (e.g., through the brachial artery), or by transfemoral access or access from some other branch or branches of major blood vessels, including peripheral blood vessels.
The relevant teachings of all patents, published applications and references cited herein are incorporated by reference in their entirety. The relevant teachings of U.S. Pat. Nos. 8,292,943; 7,763,063; 8,308,790; 8,070,790; 8,740,963; 8,007,605; 9,320,631; 8,062,349; 9,198,786; 8,062,345; 9,561,124; 9,173,755; 8,449,595; 8,636,788; 9,333,104; 9,408,734; 9,408,735; 8,500,792; 9,220,617; 9,364,314; 9,101,506; 8,998,970; 9,554,929; 9,439,751; 9,592,112 and 9,655,712; U.S. patent application Ser. Nos. 14/226,005; 14/575,673; 15/166,818; 15/167,055; 14/272,818; 14/861,479; 15/478,424; 15/478,737 and PCT/US2017/025849 are also 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.
Claims
1. A stent graft (10) comprising:
- a) a tubular aortic component (12) defining a lumen having a proximal end (14), a distal end (16), a major longitudinal axis (18), and defining a fenestration (20) between the proximal end (14) and the distal end (16);
- b) a pocket (38) at the fenestration, the pocket defining a pocket proximal opening (40) and a pocket distal opening (42) opposite the pocket proximal opening (40) within the lumen;
- c) at least one proximal tunnel graft (44) having a proximal tunnel graft proximal end (46) and a proximal tunnel graft distal end (48), and defining at least one proximal tunnel graft lumen (50), the proximal tunnel graft extending proximally within the lumen from the proximal opening of the pocket, and being secured at its proximal end to the tubular aortic component (12); and
- d) at least one distal tunnel graft (52) having a distal tunnel graft proximal end (54) and a distal tunnel graft distal end (56), and defining at least one distal tunnel graft lumen (58), the distal tunnel graft extending distally within the lumen from the distal opening of the pocket, and being secured at its distal end to the tubular aortic component (12).
2. The stent graft of claim 1, wherein the distal end of the tubular aortic component (12) is bifurcated (82), thereby defining two legs of the stent graft.
3. The stent graft of claim 1, wherein the fenestration (20) defines a fenestration proximal end (22) that lies in a plane orthogonal to the major longitudinal axis (18) of the tubular aortic component (12).
4. The stent graft of claim 1, wherein the fenestration (20) defines a fenestration distal end (24) that lies in a plane orthogonal to the major longitudinal axis (18) of the tubular aortic component (12).
5. The stent graft of claim 1, wherein the fenestration defines at least one of a fenestration proximal end (22) and a fenestration distal end (24) that lies in a plane orthogonal to the major longitudinal axis (18) of the tubular aortic component (12).
6. The stent graft of claim 5, wherein at least one of the fenestration proximal end (22) and the fenestration distal end (24) of the fenestration (20) lying in the plane orthogonal to the major longitudinal axis has a length greater than that of at least one of: the total diameter of the distal end of the at least one proximal tunnel graft (44); and the total diameter of the proximal end of the at least one distal tunnel graft (52).
7. The stent graft of claim 1, wherein the proximal end of the at least one proximal tunnel graft and the distal end of at least one of the at least one distal tunnel graft defines a flared opening.
8. The stent graft of claim 7, further including at least one stent (67, 77) supporting the flared opening of at least one of the proximal tunnel graft proximal end (46) and at least one of the distal tunnel graft distal end (56).
9. The stent graft of claim 7, wherein the proximal tunnel graft proximal end (66) defines a flared opening (67).
10. The stent graft of claim 7, wherein the distal tunnel graft distal end (72) defines a flared opening.
11. The stent graft of claim 10, further including at least one stent supporting the distal tunnel graft (70) and the proximal tunnel graft (64).
12. The stent graft of claim 8, wherein both the distal tunnel graft distal end (72) and the proximal tunnel graft proximal end (66) define, respectively, a flared opening.
13. The stent graft of claim 1, further including a bare stent (28) having proximal apices and distal apices, the bare stent (28) affixed to the proximal end (14) of the tubular aortic component (12) at the distal apices and wherein the proximal apices extend proximally beyond the proximal end (14) of the tubular aortic component (12).
14. The stent graft of claim 1, further including at least two branch stent grafts, each branch stent graft extending through the fenestration (20) and within at least one of the proximal tunnel graft lumen and the distal tunnel graft lumen.
15. The stent graft of claim 14, further including at least two branch stent grafts, wherein the at least two branch stent grafts each extend through the fenestration, and wherein at least one of the branch stent grafts extends through one of the proximal tunnel graft lumen and the distal tunnel graft lumen.
16. The stent graft of claim 1, wherein at least one of the proximal tunnel graft and the distal tunnel graft includes a septum (106, 108) that partitions at least one of the proximal tunnel graft lumen and the distal tunnel graft lumen into two sublumens, each sublumen having a proximal end and a distal end.
17. The stent graft of claim 16, including a plurality of septums, wherein one septum partitions the proximal tunnel graft lumen into two lumens and one septum partitions the distal tunnel graft lumen into two sublumens.
18. The stent graft of claim 16, further including at least two branch stent grafts, each branch stent graft extending through the fenestration and within one of the two sublumens of the proximal tunnel graft.
19. The stent graft of claim 16, further including at least two branch stent grafts, each extending through the fenestration and each, independently, extending within one of the sublumens of the distal tunnel graft.
20. The stent graft of claim 16, wherein both of the proximal tunnel graft and the distal tunnel graft is supported by a stent graft.
21. The stent graft of claim 20, wherein each septum partitions the proximal and distal tunnel graft lumens into two sublumens to a point proximal to the flared distal opening of the distal tunnel graft or distal to the flared proximal opening of the proximal tunnel graft lumen.
22. The stent graft of claim 20, further including four branch stent grafts, all of which extend through the fenestration, and each of which extends independently within one of the sublumens.
23. A method for treating a suprarenal or thoracoabdominal aortic aneurysm, comprising the steps of:
- a) delivering a stent graft through an aorta (83) to an aneurysm site (84) of a patient, the stent graft being radially and releasably constrained by a delivery device, the stent graft including: i) a tubular aortic component (12) having a proximal end, a distal end, and a major longitudinal axis, and defining a lumen, and defining a fenestration between the proximal end and the distal end; ii) a pocket at the fenestration and within the lumen, the pocket defining a proximal opening and a distal opening opposite the proximal opening; iii) at least one proximal tunnel graft defining a proximal tunnel graft proximal end and a proximal tunnel graft distal end, the proximal tunnel graft extending proximally within the lumen from the proximal opening of the pocket, and being secured at its proximal end to the tubular aortic component (12); and iv) at least one distal tunnel graft having a distal tunnel graft proximal end and defining a distal tunnel graft distal end, the distal tunnel graft extending distally within the lumen from the distal opening of the pocket, and being secured at its distal end to the tubular aortic component (12).
- b) aligning the fenestration at the aneurysm site (84) of the patient with at least one branch of the aorta at the aneurysm site;
- c) releasing the stent graft from the delivery device;
- d) delivering at least one branch stent graft through the distal end of the stent graft through the distal tunnel graft lumen to the fenestration, and through the fenestration to a branch of the aorta at the aneurysm site, whereby the branch stent graft is radially and releasably constrained by a first branch delivery device;
- e) releasing the branch stent graft from the first branch delivery device;
- f) retracting the first branch delivery device;
- g) delivering at least one branch stent graft through the proximal end of the stent graft through the proximal tunnel graft lumen to the fenestration, and through the fenestration to a branch of the aorta at the aneurysm site, whereby the branch stent graft is radially and releasably constrained by a second branch delivery device;
- h) releasing the branch stent graft from the second branch delivery device; and
- i) retracting the second branch delivery device, thereby treating the suprarenal or thoracoabdominal aortic aneurysm.
Type: Application
Filed: May 24, 2017
Publication Date: Nov 30, 2017
Inventor: Timothy Lostetter (Sunrise, FL)
Application Number: 15/604,032