WO2022076366A1

WO2022076366A1 - Systems and methods for preventing endovascular leaks

Info

Publication number: WO2022076366A1
Application number: PCT/US2021/053506
Authority: WO
Inventors: Andrew Kerr; David C. Majercak
Original assignee: Major Medical Devices Inc
Priority date: 2020-10-06
Filing date: 2021-10-05
Publication date: 2022-04-14

Abstract

Systems and methods for reducing or preventing endoleaks in a blood vessel, for example, following an aortic aneurysm repair are provided. Systems comprising a plurality of sealing stents configured to be deployed in a blood vessel are provided wherein each of the plurality of sealing stents comprises a plurality of receptacles for receiving a plurality of connectors, wherein when the plurality of connectors are received by the plurality of receptacles, each of the plurality of sealing stents is associated with another of the plurality of sealing stents, and wherein the associated plurality of sealing stents substantially conform to a curvature of a blood vessel when deployed in a blood vessel. Methods of deploying such sealing stents in a blood vessel, an endograft, or an endograft component are also provided.

Description

SYSTEMS AND METHODS FOR PREVENTING ENDOVASCULAR LEAKS

[0001] All references cited herein, including but not limited to patents and patent applications, are incorporated by reference in their entirety.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63/088,041 filed October 6, 2020, which is hereby incorporated by reference in its entirety.

BACKGROUND

[0003] An aneurysm is an abnormal enlargement or bulge in a blood vessel. Aortic aneurysms can cause embolization into branch vessels, aortic thrombosis, and aortic rupture. Damaged blood vessels can be treated or repaired by surgery or by endovascular graft placement.

[0004] The aorta is the largest artery in the body originating from the left ventricle of the heart and extending into the abdomen. It bifurcates into the two iliac arteries. Arterial aneurysms (AA) occur in every part of the aorta and its branches. Sabiston Textbook of Townsend, et al., Surgery: The Biological Basis of Modem Surgical Practice 20th Edition, pp.1722-1753 (2017).

[0005] AAs are typically repaired with open surgery or endovascular aneurysm repair (EVAR). EV AR is touted as a minimally invasive procedure that utilizes stent- graft devices to repair an AA. A stent-graft device is a combination device that includes a stent portion and a graft portion connected to each other such that they can be deployed together to repair damage to a blood vessel.

[0006] A stent is typically an expandable metal lattice device inserted into a blood vessel and expanded to open a constricted, damaged or occluded blood vessel. In addition to opening the blood vessel, a stent can provide a rigid structural support to prevent the blood vessel from re-closing. Stents are often used together with balloon angioplasty or can be self expanding.

[0007] A prosthetic graft is a medical device that can be used to replace or repair a diseased blood vessel. The graft can be made of a synthetic material (e.g., ePTFE, polyester) that can be expanded to approximate the diameter of the blood vessel in need of repair. The graft material provides a blood-tight seal such that it can support normal blood flow without leakage.

[0008] A stent-graft device can provide a combination of substantially blood-tight seal from the graft with the support structure of a stent to prevent the stent-graft device from dislodgment under the pressure of normal blood flow. However, connecting and deploying stent-graft devices has proved to be challenging because the delivery system profile (e.g., outer diameter of the delivery sheath) of a stent-graft device can be high, making the device more difficult to insert and deploy. Low-profile stent-graft devices have been developed by an inventor herein and include, for example in U.S. Pat. Nos. 10,105,209; 9,050,182; 8,257,423; 7,105,017; 7,175,651; 6,981,982; 6,015,422; 6,102,918; and 6,168,620.

[0009] AAs are often asymptomatic and occur most often in person over the age of 65 years. The mortality rate of ruptured AAs, if untreated, is high. Early detection and repair is therefore important. EV AR is preferred to open surgery as a less invasive alternative for those aortic aneurysm patients who are appropriate candidates. Although safer, faster, and less invasive than open surgical repair, EVAR can still be difficult, lengthy, and produce post procedure morbidity.

[0010] One common complication of EVAR is an endoleak (i.e., residual blood flow between aortic wall and the wall of a stent-graft). A Type I endoleak permits blood flow along the side of the graft into the aneurysm sac which increases pressure and can result in sac rupture. Type I endoleaks can be due to the anatomy of the aorta or use of unsuitable devices for repair of the aneurysm.

[0011] Type II endoleaks result from increased pressure in the side branches of the aorta cause blood to leak back in the aneurysm sac, increasing pressure and leading to risk of sac rupture.

[0012] Type III endoleaks result from a defect or misalignment of endograft components or tears in the graft material.

[0013] Type IV endoleaks result from porosity of graft materials and can occur shortly after an EVAR procedure.

[0014] What is needed are systems and methods for preventing endoleaks. SUMMARY

[0015] Sealing stents that adapt and conform to the curvature of the aorta to reduce the risk of endoleaks following an EVAR procedure, and methods of using the sealing stents, are described herein.

[0016] Aspects described herein provide a first stent sealing system comprising a plurality of sealing stents configured to be deployed in a blood vessel, wherein each of the plurality of sealing stents comprises a plurality of receptacles for receiving a plurality of connectors. When the plurality of connectors are received by the plurality of receptacles, each of the plurality of sealing stents is associated with another of the plurality of sealing stents, and the plurality of sealing stents substantially conform to a curvature of a blood vessel when deployed in a blood vessel.

[0017] Aspects described herein provide a second stent-graft cardiovascular sealing system comprising a plurality of sealing stents configured to be deployed in a blood vessel, wherein each of the plurality of sealing stents is connected by a plurality of connectors disposed between apices of a plurality of struts of the plurality of sealing stents, and wherein the plurality of sealing stents substantially conform to the curvature of a blood vessel.

[0018] Aspects described herein provide a first method of deploying a plurality of sealing stents comprising deploying a main body endograft into an aorta in need of repair for an aortic aneurysm, deploying a first limb endograft into a first limb of an iliac artery, deploying a second limb endograft into a second limb of an iliac artery, and deploying a plurality of sealing stents across the top of the main body endograft, wherein each of the plurality of sealing stents comprises a plurality of receptacles for receiving a plurality of connectors. When the plurality of connectors are received by the plurality of receptacles, each of the plurality of sealing stents is associated with another of the plurality of sealing stents, and the plurality of sealing stents substantially conform to a curvature of a blood vessel.

[0019] Aspects described herein provide a second method of deploying a plurality of sealing stents comprising deploying a main body endograft into an aorta in need of repair for an aortic aneurysm, deploying a plurality of sealing stents across the top of the main body endograft, wherein each of the plurality of sealing stents comprises a plurality of receptacles for receiving a plurality of sutures, wherein the plurality of sutures connects the plurality of sealing stents, and wherein the plurality of sealing stents conform to a curvature of a blood vessel, deploying a first limb endograft into a first limb of an iliac artery, and deploying a second limb endograft into a second limb of an iliac artery.

[0020] Aspects described herein provide a third method of deploying a plurality of sealing stents comprising deploying a stent-graft device into an aorta in need of repair for an aortic aneurysm, and deploying a plurality of sealing stents across the top of the stent-graft device, wherein each of the plurality of sealing stents comprises a plurality of receptacles for receiving a plurality of connectors. When the plurality of connectors are received by the plurality of receptacles, each of the plurality of sealing stents is associated with another of the plurality of sealing stents, and the plurality of sealing stents substantially conform to a curvature of a blood vessel.

[0021] Aspects described herein provide a third stent system for preventing endoleaks, comprising a stent having a plurality of struts, the plurality of struts comprising a plurality of apices, and a protective cover, wherein the protective cover is associated with at least one of the plurality of apices.

[0022] Aspects described herein provide a fourth method of preventing endoleaks, comprising deploying a stent-graft device into an aorta in need of repair for an aortic aneurysm, and deploying at least one stent across the top of the stent-graft device, wherein the stent comprises a plurality of struts, the plurality of struts comprising a plurality of apices, and wherein a protective cover is associated with at least one of the plurality of apices.

BRIEF DESCRIPTION OF DRAWINGS

[0023] Figure 1 shows an exemplary drawing of four sealing stents and associated four sets of receptacles and four sets of sutures;

[0024] Figure 2 shows an exemplary placement of a sealing stent in an endograft deployed in an aortic aneurysm;

[0025] Figure 3 shows an exemplary placement of four sealing stents across the top of the main body endograft in an aorta;

[0026] Figure 4 shows an exemplary placement of apices and suture loops in phase on two sealing stents;

[0027] Figure 5 shows exemplary configurations of receptacles, suture loops, and sealing stents in accordance with aspects described herein; [0028] Figure 6 shows an exemplary method for deploying sealing stents in a more controlled manner to optimize deployment from an introducer;

[0029] Figure 7 shows an exemplary method for deploying sealing stents in a more controlled manner to optimize deployment in an endograft; and

[0030] Figure 8 shows an exemplary view of stent struts having apices covered by a protective cover.

DETAILED DESCRIPTION

[0031] Sealing stent systems and methods are provided herein to prevent, reduce, and inhibit the development of endoleaks (e.g., Types LIV) following, for example, the deployment of an endograft to repair an aortic aneurysm. It is understood that the sealing stent systems and methods can be used in association with devices other than endografts.

[0032] Previous methods of addressing endoleaks include lifelong surveillance with serial radiologic imaging and the possibility of secondary interventions. Saqib et al., Managing Type II Endoleaks, Endovascular Today, pp. 45-50 (Feb. 2013). The advantages of EVAR can be offset by such surveillance and secondary interventions. Therefore, it would be advantageous to use systems and methods at the time of performing the EVAR to reduce or prevent endoleaks, reducing the need for frequent surveillance, and reducing the need for secondary interventions.

[0033] Thus, in accordance with aspects described herein, sealing stent systems and methods configured to be deployed in a main body or leg portion of an endograft after deployment reduce the incidence of or prevent development of endoleaks. As described herein, the sealing stents can include one or more stents (e.g., Z stents) having receptacles and attached to each other using connectors, for example, sutures or suture loops. The configuration of one or more sealing stents in such a manner can conform to or follow the contours of the aorta or an iliac artery (or other blood vessel) because the connections between each sealing stent and the next sealing stent are flexible. Such a configuration provides better support to the endograft reducing the incidence of or preventing the development of endoleaks.

[0034] Figure 1 shows an exemplary configuration of first sealing stent 1, first receptacles 3, first suture loops 5, second receptacles 7, second sealing stent 9, third receptacles 11, second suture loops 13, fourth receptacles 15, third sealing stent 17, fifth receptacles 19, third suture loops 21, sixth receptacles 23, and fourth sealing stent 25.

[0035] It is understood that any suitable number of sealing stents can be used depending on the application. In this example, the suture loops alternate between longer suture loops (e.g., first suture loops 5, third suture loops 21) and shorter suture loops (e.g., second suture loops 13). This alternating configuration of long and short suture loops can be selected to conform to the anatomy and placement of an endograft in a patient. For example, the suture loop length can be adjusted to account for a longer or shorter distance between areas in the endograft where additional support is needed. It is understood that another patient or another procedure may be best suited to a different configuration as determined by a doctor or health care professional.

[0036] It is understood that first suture loops 5, second suture loops 11, and third suture loops 13 can also be any suitable connector other than a suture loop. Connectors can be constructed of metal, plastic, or other material and can be shaped such that in cross section the connector is circular, oval, rectangular, square, or another shape.

[0037] The interior space within the receptacles to which the connectors connect, may or may not have the same shape as the connector (e.g., circular, oval, rectangular, square or another shape). Non-circular shapes may serve to limit motion or rotation of the connectors and stents in one or more directions. Restraining the motion in one or more directions can optionally be used to, for example, prevent graft fabric from crumpling or to allow the stents to share radial force with each other.

[0038] Figure 2 shows an exemplary placement of a sealing stent in an aorta. The left panel of Figure 2 shows aorta 27, renal arteries 29, and aortic aneurysm 35. The right panel of Figure 2 shows an exemplary placement of a sealing stent 31 across the top of endograft 33 deployed in the aortic aneurysm 35.

[0039] Figure 3 shows an exemplary placement of first sealing stent 1, first receptacles 3, first suture loops 5, second receptacles 7, second sealing stent 9, third receptacles 11, second suture loops 13, fourth receptacles 15, third sealing stent 17, fifth receptacles 19, third suture loops 21, sixth receptacles 23, and fourth sealing stent 25. In this example, first sealing stent 1 is placed above renal arteries 29 in aorta 29 having a deployed endograft 33. Second sealing stent 9, third sealing stent 17, and fourth sealing stent 25 are placed below with alternating longer and shorter suture loops (i.e., first suture loops 5 (long), second suture loops 13 (short), and third suture loops 21 (long)).

[0040] Figure 4 shows an exemplary configuration of first sealing stent 1 and second sealing stent 9 where receptacles and loops of adjacent sealing stents are aligned at apices 37. In this aspect the sealing stent system is flexible, but still allows each sealing stent to be close to each other, with little or no axial space between individual stents.

[0041] Figure 5 shows three exemplary configurations of adjacent sealing stents, loops and receptacle. In panel 1, sealing stents, and loops are aligned in an end-to-end configuration permitting sutures to slide and allowing compression of the sealing stents around the curve of a curved blood vessel. In this example, the distance LI around the outer curve is longer than the distance L2 around the inner curve.

[0042] In Figure 5, panel 2, an alternative to suture loops termed suture “hoops” permits adjacent sealing stents to be crimped resulting in separation but no overlap. However, when expanded, the sealing stents are able to "nest" closely together for increased vessel coverage.

[0043] Figure 5, panel 3 shows an alternative configuration of the configuration of Figure 4 where the receptacles are disposed in the middle of the stent struts permitting the sealing stents to be crimped.

[0044] Figure 6 shows an exemplary configuration and method of deploying the sealing stents where the diameter of first sealing stent 1 in its constrained configuration is narrow (i.e., tall and thin) in introducer sheath 39 and wider after deployment (e.g., deployed first sealing stent 41).

[0045] Figure 7 shows an exemplary configuration and method of deployment for sealing stents where the total stent cylinder height remains unchanged between the narrow configuration shown in introducer sheath 39 and the wider deployed configuration 41 by adjusting suture loops tension following deployment of the sealing stents.

[0046] Figure 8 shows an exemplary stent lattice (e.g., from a Z-stent) having stent struts 42 with apices 44 where stent struts 42 are connected. In accordance with aspects described herein, protective cover 46 can be place at one or more of apices 44. After implantation of a stent graft device in the aorta, cardiac pulsations can cause a metal stent to contact the graft material repeatedly (e.g., estimated 200 million cardiac pulses over five years). Repeated contact between metal apices and the graft material can erode the graft material. As described herein, protective cover 46 can be placed over one or more apices to reduce or minimize erosion of the graft material over time.

[0047] Protective cover 46 can be made of any suitable material (e.g., fabric, polymer, mesh, and metal), and can be placed on one or more surfaces of an apex 44. In one aspect, protective cover 46 can be made of absorbable (e.g., collagens, monocryl, vinyl, PDS (polydioxanone)) and non-absorbable (e.g., ethilon, prolene, cotton, silk, steel) materials. In another aspect, protective cover 46 can be placed around an apex like a glove to cover all outer surfaces of the apex.

[0048] Protective cover 46 can be any suitable shape (e.g., circular, semi-circle, square, rectangle, or triangle). Protective cover 46 can be of an suitable thickness to provide sufficient protection of the graft material without interfering with the flexibility of the stent (e.g., when stent is being deployed).

[0049] Protective cover 46 can be attached to an apex 44 by any suitable mechanism (e.g., glue, welding, chemical, electrostatic, and hydrophobic association). In one aspect, protective cover 46 is attached to apex 44 such that protective cover 46 will remain affixed to apex 44 during and after deployment of the stent.

[0050] Aspects described herein provide a first stent sealing system comprising a plurality of sealing stents configured to be deployed in a blood vessel, wherein each of the plurality of sealing stents comprises a plurality of receptacles for receiving a plurality of connectors, wherein when the plurality of connectors are received by the plurality of receptacles, each of the plurality of sealing stents is associated with another of the plurality of sealing stents, and the plurality of sealing stents substantially conform to a curvature of a blood vessel when deployed in a blood vessel.

[0051] The term “stent” refers to a mesh or lattice tube structure made of, for example, super-elastic nitinol thin wire or laser cut from tubing, that can be inserted into a blood vessel in a constrained state and deployed in an unconstrained state. In one aspect, the stent is a Z stent. The term “sealing stent” refers to one or more stents or stent rings connected by sutures. In this aspect, the sealing stent ring is capable of sealing (i.e., preventing or reducing endoleaks in an endograft or another device.

[0052] The term “connector” refers to a flexible material suitable for associating with or attaching one portion or component of the exemplary stent-graft systems to another (e.g., a stent to another stent, a stent to a graft, a connector to another connector, a connector to a receptacle, etc.). In some instances, the connector can be a thread-like or rope-like material or a wire with sufficient flexibility and tensile strength to maintain a connection between components under conditions during deployment and placement of the exemplary stent-graft systems and devices and under blood flow conditions in a blood vessel. Connectors can be made of any suitable material including, but not limited to, absorbable (e.g., collagens, monocryl, vinyl, PDS (polydioxanone)) and non-absorbable (e.g., ethilon, prolene, cotton, silk, steel) materials.

[0053] The term “receptacle” refers to a structure attached to a component (e.g., a sealing stent) and configured to receive a connector. For example, a receptacle can be a metal loop with a central hole adapted to receive a connector (e.g., a suture loop, a wire) and attach or associate the receptacle with the connector.

[0054] In some instances, “receptacles” can include grooves, raised areas, or cleats in the stents that facilitate securing a suture or suture loop to the stent. In some instances, a suture or suture loops can be connected to a stent using glue or other bonding material. Any suitable connecting structure or mechanism can be used to flexibly adjoin a suture to a stent or one stent to another stent.

[0055] The term “conform to the curvature of the blood vessel” refers to the outer portions of the plurality of sealing stents substantially having the same curvature of the blood vessel the sealing stents are deployed in when the sealing stents are in their unconstrained configuration. As used herein, the term “substantially” refers to greater than 50%, 60%, 70%, 80%, 90%, or 100%. It is understood that, in one aspect, when the plurality of sealing stents are deployed in a blood vessel and substantially conform to the curvature of the blood vessel, the incidence of and extent of endoleaks are reduced or eliminated. Each of the plurality of sealing stents can be adjusted (e.g., length of connectors) to conform to the curvature of a blood vessel.

[0056] In some aspects of the first system, the plurality of sealing stents comprise a first sealing stent associated with a second sealing stent by at least one connector disposed through the plurality of receptacles.

[0057] In one aspect of the first system, the plurality of sealing stents can substantially prevent endovascular leaks from a stent-graft device when the plurality of sealing stents are deployed in a blood vessel. [0058] Connectors can be selected from the group consisting of, for example, sutures, wires, tethers, and loops. In one aspect, the connectors are disposed through the receptacles. In another aspect, the connectors are flexible or rigid.

[0059] In another aspect of the first system, the plurality of sealing stents are self expanding nitinol stents. In another aspect, the plurality of sealing stents are Z- stents. In a further aspect, each of the plurality of sealing stents can be the same or a different type of stent from another sealing stent.

[0060] In some aspects of the first system, the plurality of receptacles on each of the plurality of sealing stents are configured to provide an axial space between each of the plurality of sealing stents. In this aspect, the spacing of the plurality of sealing stents can be adjusted to conform to a target blood vessel or be placed in a particular anatomical location (e.g., a sealing stent above the renal artery and another sealing stent below the renal artery.

[0061] In some aspects of the first system, the plurality of receptacles on each of the plurality of sealing stents are crimped.

[0062] In some aspects of the first system, the plurality of sealing stents do not substantially overlap when the plurality of sealing stents are in a constrained configuration.

[0063] In some aspects of the first system, the plurality of receptacles on the first sealing stent are aligned in phase with the plurality of receptacles on the second sealing stent.

[0064] In a further aspect of the first system, the plurality of connectors comprise at least one suture loop. The suture loop can be a short suture loop (e.g., 1-10 mm, 5-10 mm) or a long suture loop (e.g., no longer than 40 mm, 30-50 mm). A shorter connector (e.g., a short suture loop) can alternate with a longer connector (e.g., a long suture loop) in order to adjust the placement of sealing stents to conform to the curvature of a blood vessel.

[0065] In some aspects of the first system, the plurality of receptacles are disposed on an upstream end of the first sealing stent and on a downstream end of the first sealing stent. In further aspects, the plurality of receptacles are disposed on an upstream end of subsequent sealing stents and on a downstream end of subsequent sealing stents.

[0066] In one aspect of the first system, the first sealing stent is connected to the second sealing stent by a plurality of first connectors disposed between a first plurality of receptacles disposed on the downstream end of the first sealing stent and a second plurality of receptacles disposed on the upstream end of the second sealing stent. [0067] This aspect can further comprise a third sealing stent, the third sealing stent being connected to the second sealing stent by a plurality of second connectors disposed between a third plurality of receptacles disposed on the upstream end of the third sealing stent and a fourth plurality of receptacles disposed on the downstream end of the second sealing stent.

[0068] This aspect can further comprise a fourth sealing stent, the fourth sealing stent being connected to the third sealing stent by a third plurality of connectors disposed between a fifth plurality of receptacles disposed on the upstream end of the fourth sealing stent and a sixth plurality of receptacles disposed on the downstream end of the third sealing stent. It is understood that any suitable number of sealing stents can be deployed, depending on the target blood vessel, and subsequent sealing stents can be connected in the system as described herein for the first, second, third, and fourth sealing stents.

[0069] The first system can be configured to be deployed at the upstream end of a stentgraft deployed in an aorta, and wherein at least the first sealing stent is configured to be deployed upstream to a renal artery.

[0070] In one aspect of the first system, the first sealing stent, the second sealing stent, the third sealing stent, and the fourth sealing stent overlap an aortic neck and a suprarenal aorta.

[0071] Aspects described herein provide a second stent-graft sealing system comprising a plurality of sealing stents configured to be deployed in a blood vessel, wherein each of the plurality of sealing stents is connected by a plurality of connectors disposed between apices of a plurality of struts of the plurality of sealing stents, and wherein the plurality of sealing stents substantially conform to the curvature of a blood vessel.

[0072] In some aspects of the second system, the connectors are selected from the group consisting of, for example, sutures, wires, tethers, and loops.

[0073] In another aspect of the second system, the plurality of sealing stents comprises at least a first sealing stent and a second sealing stent.

[0074] In a further aspect of the second system, the system is configured to be deployed at the upstream end of a stent-graft deployed in an aorta, and wherein at least the first sealing stent is configured to be deployed upstream to a renal artery.

[0075] In one aspect of the second system, the first sealing stent and the second sealing stent, overlap an aortic neck and a suprarenal aorta. [0076] Aspects described herein provide a first method of deploying a plurality of sealing stents, comprising deploying a main body endograft into an aorta in need of repair for an aortic aneurysm, deploying a first limb endograft into a first limb of an iliac artery, deploying a second limb endograft into a second limb of an iliac artery, and deploying a plurality of sealing stents across the top of the main body endograft, wherein each of the plurality of sealing stents comprises a plurality of receptacles for receiving a plurality of connectors, wherein when the plurality of connectors are received by the plurality of receptacles, each of the plurality of sealing stents is associated with another of the plurality of sealing stents, and wherein the associated plurality of sealing stents substantially conform to a curvature of a blood vessel.

[0077] In some instances of the first method, the plurality of sealing stents comprise a first sealing stent connected to a second sealing stent by at least one of the plurality of connectors disposed through the plurality of receptacles. In another aspect, the connectors can be selected from the group consisting of sutures, wires, tethers, and loops. In one aspect, the connectors are disposed through the receptacles.

[0078] In some instances of the first method, the plurality of sealing stents are self expanding nitinol stents.

[0079] In some instances of the first method, the plurality of receptacles on each of the plurality of sealing stents are configured to have an axial space between each of the plurality of sealing stents.

[0080] In some instances of the first method, the plurality of receptacles on each of the plurality of sealing stents are crimped.

[0081] In some instances of the first method, the plurality of sealing stents do not substantially overlap when the plurality of sealing stents are in a compressed state.

[0082] The plurality of receptacles on the first sealing stent can be aligned in phase with the plurality of receptacles on the second sealing stent.

[0083] The connectors can be suture loops including a long suture loop or a short suture loop.

[0084] The plurality of sealing stents can have the plurality of receptacles disposed on an upstream end and a downstream end of the plurality of sealing stents. [0085] In some instances of the first method, the plurality of sealing stents comprises a first sealing stent and a second sealing stent, the first sealing stent being connected to the second sealing stent by a plurality of first suture loops disposed between a first plurality of receptacles disposed on the downstream end of the first sealing stent and a second plurality of receptacles disposed on the upstream end of the second sealing stent.

[0086] In some instances of the first method, the plurality of sealing stents can comprise a third sealing stent, the third sealing stent being connected to the second sealing stent by a second plurality of suture loops disposed between a third plurality of receptacles disposed on the upstream end of the third sealing stent and a fourth plurality of receptacles disposed on the downstream end of the second sealing stent.

[0087] In some instances of the first method, the plurality of sealing stents can comprise a fourth sealing stent, the fourth sealing stent being connected to the third sealing stent by a third plurality of suture loops disposed between a fifth plurality of receptacles disposed on the upstream end of the fourth sealing stent and a sixth plurality of receptacles disposed on the downstream end of the third sealing stent.

[0088] In some instances of the first method, the plurality of sealing stents are configured to be deployed at the upstream end of a stent-graft deployed in an aorta, and wherein at least the first sealing stent is configured to be deployed upstream to the renal artery.

[0089] In some instances of the first method, the combination of the first sealing stent, the second sealing stent, the third sealing stent, and the fourth sealing stent overlap the aortic neck and suprarenal aorta.

[0090] Aspects described herein provide a second method of deploying a plurality of sealing stents comprising deploying a main body endograft into an aorta in need of repair for an aortic aneurysm, deploying a plurality of sealing stents across the top of the main body endograft, wherein each of the plurality of sealing stents comprises a plurality of receptacles for receiving a plurality of sutures, wherein the plurality of sutures connects the plurality of sealing stents, and wherein the plurality of sealing stents conform to a curvature of a blood vessel, deploying a first limb endograft into a first limb of an iliac artery, and deploying a second limb endograft into a second limb of an iliac artery.

[0091] Aspects described herein provide a third method of deploying a plurality of sealing stents comprising deploying a stent-graft device into an aorta in need of repair for an aortic aneurysm, and deploying a plurality of sealing stents across the top of the stent-graft device, wherein each of the plurality of sealing stents comprises a plurality of receptacles for receiving a plurality of connectors, wherein when the plurality of connectors are received by the plurality of receptacles, each of the plurality of sealing stents is associated with another of the plurality of sealing stents, and wherein the associated plurality of sealing stents substantially conform to a curvature of a blood vessel.

[0092] Aspects described herein provide a third stent system for preventing endoleaks, comprising: a stent having a plurality of struts, the plurality of struts comprising a plurality of apices, and a protective cover, wherein the protective cover is associated with at least one of the plurality of apices.

[0093] In one aspect of the third system, the protective cover comprises a material selected from the group consisting of fabric, polymer, mesh, and metal.

[0094] In another aspect of the third system, the protective cover is disposed around at least one of the plurality of apices.

[0095] In a further aspect of the third system, the protective cover is disposed on at least one surface of at least one of the plurality of apices.

[0096] In yet another aspect of the third system, a shape of the protective cover is selected from the group consisting of a circle, a half circles, a square, a rectangle, and a triangle.

[0097] In another aspect of the third system, the system further comprises an endograft, wherein the endograft comprises graft material, and wherein the protective cover can substantially prevent a tear in the graft material and the endograft and the stent is deployed.

[0098] The protective cover can be disposed on a surface of each of the plurality of apices exposed to the graft material.

[0099] Aspects described herein provide a fourth method of preventing endoleaks, comprising deploying a stent-graft device into an aorta in need of repair for an aortic aneurysm, and deploying at least one stent across the top of the stent-graft device, wherein the stent comprises a plurality of struts, the plurality of struts comprising a plurality of apices, and wherein a protective cover is associated with at least one of the plurality of apices.

[00100] In some instances of the fourth method, the protective cover comprises a material selected from the group consisting of fabric, polymer, mesh, and metal. In some instances, the protective cover can be made of graft material. [00101] In some instances of the fourth method, the protective cover is disposed around at least one of the plurality of apices.

[00102] In some instances of the fourth method, the protective cover is disposed on at least one surface of at least one of the plurality of apices.

[00103] In some instances of the fourth method, a shape of the protective cover is selected from the group consisting of a circle, a half circles, a square, a rectangle, and a triangle.

[00104] In some instances of the fourth method, the method further comprises an endograft, wherein the endograft comprises graft material, and wherein the protective cover can substantially prevent a tear in the graft material and the endograft and the stent is deployed.

[00105] The protective cover can be disposed on a surface of each of the plurality of apices exposed to the graft material.

[00106] Aspects described herein provide stent-graft vascular sealing systems comprising a plurality of sealing stents configured to be deployed in a blood vessel. In this aspect, each of the plurality of sealing stents having a plurality of receptacles for receiving a plurality of sutures. The plurality of sutures connects the plurality of sealing stents, and the plurality of sealing stents are adapted to conform to the curvature of the blood vessel.

[00107] In some instances, the plurality of sealing stents comprise a first sealing stent connected to a second sealing stent by at least one suture loop disposed through the plurality of receptacles. In one aspect, the plurality of sealing stents are self expanding nitinol stents.

[00108] In some instances, the plurality of receptacles on each of the plurality of sealing stents can have an axial space between them. In this aspect, the axial space can be adjusted by adjusting the suture length and depending on the flexibility needed to fit a particular vascular region. In some instances, the axial gap can be adjusted, for example, to be small such that the plurality of sealing stents are nearly but not in an end-to-end configuration. In this aspect, each of the plurality of sealing stents can adapt to the curvature of a blood vessel but remain in nearly an end-to-end configuration.

[00109] In some instances, the plurality of receptacles on each of the plurality of sealing stents are crimped. The term “crimped” refers to having pressure applied to a receptacle.

[00110] In some instances, the plurality of sealing stents do not substantially overlap when the plurality of sealing stents are in a compressed state. In some instances, the plurality of receptacles on the first sealing stent are aligned in phase with the plurality of receptacles on the second sealing stent.

[00111] The at least one suture loop can be a short suture loop, a long suture loop, or a suitable size in between. In one aspect, the length of the suture loop (e.g., long or short) can alternate between sealing stents or be the same length, or can be progressively longer or shorter.

[00112] In some instances, each of the plurality of sealing stents has the plurality of receptacles disposed on an upstream end and a downstream end of the plurality of sealing stents. The term “upstream end” refers to the upper most point on the sealing stent and the “downstream end” refers to lower most point on the sealing stent. It is understood that the plurality of receptacles can be disposed at any suitable location along the stent struts (e.g., in the middle).

[00113] In some instances, the plurality of sealing stents comprises a first sealing stent and a second sealing stent. In this aspect, the first sealing stent can be connected to the second sealing stent by a plurality of first suture loops disposed between a first plurality of receptacles disposed on the downstream end of the first sealing stent and a second plurality of receptacles disposed on the upstream end of the second sealing stent.

[00114] The plurality of sealing stents can further comprise a third sealing stent, the third sealing stent being connected to the second sealing stent by a second plurality of suture loops disposed between a third plurality of receptacles disposed on the upstream end of the third sealing stent and a fourth plurality of receptacles disposed on the downstream end of the second sealing stent.

[00115] The plurality of sealing stents can further comprise a fourth sealing stent, the fourth sealing stent being connected to the third sealing stent by a third plurality of suture loops disposed between a fifth plurality of receptacles disposed on the upstream end of the fourth sealing stent and a sixth plurality of receptacles disposed on the downstream end of the third sealing stent.

[00116] In some instances, the system is configured to be deployed at the upstream end of a stent-graft deployed in an aorta, and wherein at least the first sealing stent is configured to be deployed upstream to the renal artery.

[00117] In some instances, the first sealing stent, the second sealing stent, the third sealing stent, and the fourth sealing stent overlap the aortic neck and suprarenal aorta. [00118] Aspects described herein provide a plurality of sealing stents configured to be deployed in a blood vessel, wherein each of the plurality of sealing stents is connected by a plurality of suture loops disposed between apices of a plurality of struts of the plurality of sealing stents, and wherein the plurality of sealing stents can substantially conform to the curvature of a blood vessel.

[00119] Further aspects provide methods of deploying a plurality of sealing stents, by deploying a main body endograft into an aorta in need of repair for an aortic aneurysm; deploying a first limb endograft into a first limb of an iliac artery; deploying a second limb endograft into a second limb of an iliac artery; and deploying a plurality of sealing stents across the top of the main body endograft, wherein each of the plurality of sealing stents comprises a plurality of receptacles for receiving a plurality of sutures, wherein the plurality of sutures connects the plurality of sealing stents, and wherein the plurality of sealing stents are adapted to conform to the curvature of the blood vessel.

[00120] The term “deploying” refers to introducing a sealing stent into an already deployed main body endograft or a limb endograft and opening the stent from a constrained to an unconstrained configuration.

[00121] The term “main body endograft” refers to a portion of an endograft configured to be deployed in an aorta (e.g., during an EVAR procedure). The term “limb endograft” refers to a portion of an endograft configured to be deployed in an “iliac leg” of an iliac artery (e.g., ipsilateral or contralateral).

[00122] It is understood that the plurality of sealing stents can be deployed only in the main body endograft, only in one or both iliac limbs, across the main body endograft and one or both iliac limbs, and can be deployed in any desired order.

[00123] In some instances, the plurality of sealing stents comprise a first sealing stent connected to a second sealing stent by at least one suture loop disposed through the plurality of receptacles.

[00124] In some instances, the plurality of sealing stents are self expanding nitinol stents.

[00125] In one aspect, the plurality of receptacles on each of the plurality of sealing stents are configured to have an axial space between each of the plurality of sealing stents. In some instances, the plurality of receptacles on each of the plurality of sealing stents are crimped. In a further aspect, the plurality of sealing stents do not substantially overlap when the plurality of sealing stents are in a compressed state. [00126] In some instances, the plurality of receptacles on the first sealing stent are aligned in phase with the plurality of receptacles on the second sealing stent.

[00127] In a further aspect, the at least one suture loop is a short suture loop or a long suture loop.

[00128] In some instances, each of the plurality of sealing stents has the plurality of receptacles disposed on an upstream end and a downstream end of the plurality of sealing stents.

[00129] In a further aspect, the plurality of sealing stents comprise a first sealing stent and a second sealing stent, the first sealing stent being connected to the second sealing stent by a plurality of first suture loops disposed between a first plurality of receptacles disposed on the downstream end of the first sealing stent and a second plurality of receptacles disposed on the upstream end of the second sealing stent.

[00130] The plurality of sealing stents can further comprise a third sealing stent, the third sealing stent being connected to the second sealing stent by a second plurality of suture loops disposed between a third plurality of receptacles disposed on the upstream end of the third sealing stent and a fourth plurality of receptacles disposed on the downstream end of the second sealing stent.

[00131] The plurality of sealing stents can further comprise a fourth sealing stent, the fourth sealing stent being connected to the third sealing stent by a third plurality of suture loops disposed between a fifth plurality of receptacles disposed on the upstream end of the fourth sealing stent and a sixth plurality of receptacles disposed on the downstream end of the third sealing stent.

[00132] In one aspect, the system can be configured to be deployed at the upstream end of a stent-graft deployed in an aorta, and wherein at least the first sealing stent is configured to be deployed upstream to the renal artery.

[00133] In another aspect, the combination of the first sealing stent, the second sealing stent, the third sealing stent, and the fourth sealing stent overlap the aortic neck and suprarenal aorta.

[00134] Further aspects provide methods of deploying a plurality of sealing stents, by deploying a main body endograft into an aorta in need of repair for an aortic aneurysm; deploying a plurality of sealing stents across the top of the main body endograft, wherein each of the plurality of sealing stents comprises a plurality of receptacles for receiving a plurality of sutures, wherein the plurality of sutures connects the plurality of sealing stents, and wherein the plurality of sealing stents are adapted to conform to the curvature of the blood vessel; deploying a first limb endograft into a first limb of an iliac artery; and deploying a second limb endograft into a second limb of an iliac artery.

[00135] The term “positioned” or “deployed” refers to using a positioning system to permit the stent-graft device to be moved (e.g., in a constrained or partially constrained configuration) through blood vessels to the desired location in a blood vessel. The positioning system can comprise a guide wire, a sheath over the guidewire, a catheter, a trigger wire, and other components capable of pushing, pulling, and deploying the stent-graft device. A doctor can visualize the progress of the positioning system and stent-graft device with an angiogram, fluoroscope, or other visualization system via radio-opaque markers not shown in detail but located as appropriate.

[00136] While the aspects described herein have been disclosed with reference to certain embodiments, numerous modifications, alterations, and changes to the described aspects are possible without departing from the sphere and scope of the present invention, as defined in the appended claims. Accordingly, it is intended that the present invention not be limited to the described aspects, but that it has the full scope defined by the language of the following claims, and equivalents thereof.

Claims

CLAIMS WHAT IS CLAIMED IS:

1. A stent sealing system comprising a plurality of sealing stents configured to be deployed in a blood vessel, each of the plurality of sealing stents comprising a plurality of receptacles for receiving a plurality of connectors, wherein when the plurality of connectors are received by the plurality of receptacles, each of the plurality of sealing stents is associated with another of the plurality of sealing stents, and the plurality of sealing stents substantially conform to a curvature of a blood vessel when deployed in a blood vessel.

2. The system of claim 1, wherein the plurality of sealing stents comprise a first sealing stent associated with a second sealing stent by at least one connector disposed through the plurality of receptacles.

3. The system of claim 1, wherein the plurality of sealing stents can substantially prevent endovascular leaks from a stent-graft device when the plurality of sealing stents are deployed in a blood vessel.

4. The system of claim 1, wherein the connectors are selected from the group consisting of sutures, wires, tethers, and loops.

5. The system of claim 1, wherein the connectors are disposed through the receptacles.

6. The system of claim 1, wherein the connectors are flexible.

7. The system of claim 1, wherein the plurality of sealing stents are self expanding nitinol stents.

8. The system of claim 2, wherein the plurality of receptacles on each of the plurality of sealing stents are configured to provide an axial space between each of the plurality of sealing stents.

9. The system of claim 2, wherein the plurality of receptacles on each of the plurality of sealing stents are crimped.

10. The system of claim 2, wherein the plurality of sealing stents do not substantially overlap when the plurality of sealing stents are in a constrained configuration.

11. The system of claim 2, wherein the plurality of receptacles on the first sealing stent are aligned in phase with the plurality of receptacles on the second sealing stent.

12. The system of claim 2, wherein the plurality of connectors comprise at least one suture loop.

13. The system of claim 12, wherein the suture loop is a short suture loop.

14. The system of claim 12, wherein the suture loop is a long suture loop.

15. The system of claim 2, where the plurality of receptacles are disposed on an upstream end of the first sealing and on a downstream end of the first sealing stent.

16. The system of claim 15, wherein the first sealing stent is connected to the second sealing stent by a plurality of first connectors disposed between a first plurality of receptacles disposed on the downstream end of the first sealing stent and a second plurality of receptacles disposed on the upstream end of the second sealing stent.

17. The system of claim 16, further comprising a third sealing stent, the third sealing stent being connected to the second sealing stent by a plurality of second connectors disposed between a third plurality of receptacles disposed on the upstream end of the third sealing stent and a fourth plurality of receptacles disposed on the downstream end of the second sealing stent.

18. The system of claim 17, further comprising a fourth sealing stent, the fourth sealing stent being connected to the third sealing stent by a third plurality of connectors disposed between a fifth plurality of receptacles disposed on the upstream end of the fourth sealing stent and a sixth plurality of receptacles disposed on the downstream end of the third sealing stent.

19. The system of claim 18, wherein the system is configured to be deployed at the upstream end of a stent-graft deployed in an aorta, and wherein at least the first sealing stent is configured to be deployed upstream to a renal artery.

20. The system of claim 19, wherein the first sealing stent, the second sealing stent, the third sealing stent, and the fourth sealing stent overlap an aortic neck and a suprarenal aorta.

21. A stent-graft sealing system comprising a plurality of sealing stents configured to be deployed in a blood vessel, wherein each of the plurality of sealing stents is connected by a plurality of connectors disposed between apices of a plurality of struts of the plurality of sealing stents, and wherein the plurality of sealing stents substantially conform to a curvature of a blood vessel.

22. The system of claim 21, wherein the connectors are selected from the group consisting of sutures, wires, tethers, and loops.

23. The system of claim 21, wherein the plurality of sealing stents comprises at least a first sealing stent and a second sealing stent.

24. The system of claim 23, wherein the system is configured to be deployed at an upstream end of a stent-graft deployed in an aorta, and wherein at least the first sealing stent is configured to be deployed upstream to a renal artery.

25. The system of claim 23, wherein the first sealing stent and the second sealing stent, overlap an aortic neck and a suprarenal aorta.

26. A method of deploying a plurality of sealing stents, comprising: deploying a main body endograft into an aorta in need of repair for an aortic aneurysm; deploying a first limb endograft into a first limb of an iliac artery; deploying a second limb endograft into a second limb of an iliac artery; and deploying a plurality of sealing stents across the top of the main body endograft, wherein each of the plurality of sealing stents comprises a plurality of receptacles for receiving a plurality of connectors, wherein when the plurality of connectors are received by the plurality of receptacles, each of the plurality of sealing stents is associated with another of the plurality of sealing stents, and the plurality of sealing stents substantially conform to a curvature of a blood vessel.

27. The method of claim 26, wherein the plurality of sealing stents comprise a first sealing stent connected to a second sealing stent by at least one of the plurality of connectors disposed through the plurality of receptacles.

28. The method of claim 26, wherein the plurality of sealing stents are self expanding nitinol stents.

29. The method of claim 27, wherein the plurality of receptacles on each of the plurality of sealing stents are configured to have an axial space between each of the plurality of sealing stents.

30. The method of claim 27, wherein the plurality of receptacles on each of the plurality of sealing stents are crimped.

31. The method of claim 27, wherein the plurality of sealing stents do not substantially overlap when the plurality of sealing stents are in a compressed state.

32. The method of claim 27, wherein the plurality of receptacles on the first sealing stent are aligned in phase with the plurality of receptacles on the second sealing stent.

33. The method of claim 27, wherein the at least one of the plurality of connectors is a short suture loop.

34. The method of claim 27, wherein the at least one of the plurality of connectors is a long suture loop.

35. The method of claim 26, where each of the plurality of sealing stents has the plurality of receptacles disposed on an upstream end and a downstream end of the plurality of sealing stents.

36. The method of claim 35, wherein the plurality of sealing stents comprises a first sealing stent and a second sealing stent, the first sealing stent being connected to the second sealing stent by a plurality of first suture loops disposed between a first plurality of receptacles disposed on the downstream end of the first sealing stent and a second plurality of receptacles disposed on the upstream end of the second sealing stent.

37. The method of claim 36, further comprising a third sealing stent, the third sealing stent being connected to the second sealing stent by a second plurality of suture loops disposed between a third plurality of receptacles disposed on the upstream end of the third sealing stent and a fourth plurality of receptacles disposed on the downstream end of the second sealing stent.

38. The method of claim 37, further comprising a fourth sealing stent, the fourth sealing stent being connected to the third sealing stent by a third plurality of suture loops disposed between a fifth plurality of receptacles disposed on the upstream end of the fourth sealing stent and a sixth plurality of receptacles disposed on the downstream end of the third sealing stent.

39. The method of claim 38, wherein the plurality of sealing stents are configured to be deployed at the upstream end of a stent-graft deployed in an aorta, and wherein at least the first sealing stent is configured to be deployed upstream to a renal artery.

40. The method of claim 39, wherein the combination of the first sealing stent, the second sealing stent, the third sealing stent, and the fourth sealing stent overlap an aortic neck and a suprarenal aorta.

41. A method of deploying a plurality of sealing stents, comprising: deploying a main body endograft into an aorta in need of repair for an aortic aneurysm; deploying a plurality of sealing stents across the top of the main body endograft, wherein each of the plurality of sealing stents comprises a plurality of receptacles for receiving a plurality of sutures, wherein the plurality of sutures connects the plurality of sealing stents, and wherein the plurality of sealing stents conform to a curvature of a blood vessel; deploying a first limb endograft into a first limb of an iliac artery; and deploying a second limb endograft into a second limb of an iliac artery.

42. A method of deploying a plurality of sealing stents, comprising: deploying a stent-graft device into an aorta in need of repair for an aortic aneurysm; and deploying a plurality of sealing stents across the top of the stent-graft device, wherein each of the plurality of sealing stents comprises a plurality of receptacles for receiving a plurality of connectors, wherein when the plurality of connectors are received by the plurality of receptacles, each of the plurality of sealing stents is associated with another of the plurality of sealing stents, and wherein the associated plurality of sealing stents substantially conform to a curvature of a blood vessel.

43. A stent system for preventing endoleaks, comprising: a stent having a plurality of struts, the plurality of struts comprising a plurality of apices; and a protective cover, wherein the protective cover is associated with at least one of the plurality of apices.

44. The stent system of claim 43, wherein the protective cover comprises a material selected from the group consisting of fabric, polymer, mesh, and metal.

45. The stent system of claim 43, wherein the protective cover is disposed around at least one of the plurality of apices.

46. The stent system of claim 43, wherein the protective cover is disposed on at least one surface of at least one of the plurality of apices.

47. The stent system of claim 43, wherein a shape of the protective cover is selected from the group consisting of a circle, a half circles, a square, a rectangle, and a triangle.

48. The stent system of claim 43, further comprising an endograft, wherein the endograft comprises graft material, and wherein the protective cover can substantially prevent a tear in the graft material and the endograft and the stent is deployed.

49. The stent system of claim 48, wherein the protective cover is disposed on a surface of each of the plurality of apices exposed to the graft material.

50. A method of preventing endoleaks, comprising: deploying a stent-graft device into an aorta in need of repair for an aortic aneurysm; and deploying at least one stent across the top of the stent-graft device, wherein the stent comprises a plurality of struts, the plurality of struts comprising a plurality of apices, and wherein a protective cover is associated with at least one of the plurality of apices.

51. The method of claim 50, wherein the protective cover comprises a material selected from the group consisting of fabric, polymer, mesh, and metal.

52. The method of claim 50, wherein the protective cover is disposed around at least one of the plurality of apices.

53. The method of claim 50, wherein the protective cover is disposed on at least one surface of at least one of the plurality of apices.

54. The method of claim 50, wherein a shape of the protective cover is selected from the group consisting of a circle, a half circles, a square, a rectangle, and a triangle.

55. The method of claim 50, further comprising an endograft, wherein the endograft comprises graft material, and wherein the protective cover can substantially prevent a tear in the graft material and the endograft and the stent is deployed.

56. The method of claim 55, wherein the protective cover is disposed on a surface of each of the plurality of apices exposed to the graft material.