The present application relates to an intra-vascular device and method. More particularly, the present application relates to a device for treatment of intra-vascular diseases.
A conventional stent-graft typically includes a radially expandable reinforcement structure, formed from a plurality of annular stent rings, and a cylindrically shaped layer of graft material defining a lumen to which the stent rings are coupled. Stent-grafts are well known for use in tubular shaped human vessels.
To illustrate, endovascular aneurysmal exclusion is a method of using a stent-graft to exclude pressurized fluid flow from the interior of an aneurysm, thereby reducing the risk of rupture of the aneurysm and the associated invasive surgical intervention.
Stent-grafts can migrate from the intended implant location and can also foreshorten over time. To avoid these complications, stent-grafts are sutured to the vessel wall by surgically opening a patient.
In accordance with one embodiment, a method of anchoring a prosthesis includes deploying the prosthesis in a vessel. A delivery system including an anchor constrained within a delivery sheath is advanced to the prosthesis. The prosthesis and a vessel wall of the vessel are penetrated with a leading tip of an exterior tine of the anchor, wherein the exterior tine unfolds upon passing through the prosthesis and the vessel wall. An interior tine is deployed within the prosthesis and vessel wall. In the final deployed state, the exterior tine is exterior to and adjacent the vessel wall, the interior tine is interior to and adjacent the prosthesis, and a tine connector of the anchor extends through the vessel wall and the prosthesis.
The anchor anchors the prosthesis to the vessel wall. This prevents migration and foreshortening, e.g., in vivo, of the prosthesis.
Embodiments are best understood by reference to the following detailed description when read in conjunction with the accompanying drawings.
FIGS. 4B1, 4B2, 4B3 are enlarged side views of a region IVB of the anchor of
Common reference numerals are used throughout the drawings and detailed description to indicate like elements.
As an overview and in accordance with one embodiment, referring to
Anchor 100 anchors prosthesis 502 to vessel wall 702 and more generally to primary vessel 506. This prevents migration and foreshortening, e.g., in vivo, of prosthesis 502. Prosthesis 502 is secured to vessel wall 702 by anchor 100 without open surgery. By increasing confidence in the securement and use of prosthesis 502, prosthesis 502 can be used in applications otherwise not possible or feasible.
Now in more detail,
Referring now to
Exterior tine 104 includes a lead tip 110 and a rear tip 112. Exterior tine 104 extends between lead tip 110 and rear tip 112. In accord with this embodiment, lead tip 110 includes a sharp point 114 similar to the point of a pin. However, in other embodiments, lead tip 110 is blunt.
Interior tine 106 includes a lead tip 116 and a rear tip 118. Interior tine 106 extends between lead tip 116 and rear tip 118. In one embodiment, the length of interior tine 106, e.g., the distance between lead tip 116 and rear tip 118, is equal to the length of exterior tine 104, e.g., the distance between lead tip 110 and rear tip 112. However, in other embodiments, exterior tine 104 and interior tine 106 have different lengths and/or different shapes.
Tine connector 108 includes exterior tine end 120 and an interior tine end 122. Exterior tine end 120 is connected to exterior tine 104 between lead tip 110 and rear tip 112, e.g., in the middle of exterior tine 104. Similarly, interior tine end 122 is connected to interior tine 106 between lead tip 116 and rear tip 118, e.g., in the middle of interior tine 106.
When anchor 100 is in its relaxed state as illustrated in
Although various features may be discussed as being parallel, perpendicular, or having other relationships, in light of this disclosure, those of skill in the art will understand that the features may not be exactly parallel, perpendicular, etc., but only substantially parallel, perpendicular, etc., e.g., to within manufacturing tolerances.
In accordance with this embodiment, anchor 100 is integral, i.e., is a single piece and not a plurality of separate pieces connected together. For example, anchor 100 is formed of a super elastic material, e.g., metal, a metal wire, a polymer, a polymer bead, or other flexible resilient material. As used herein, superelastically deformed means being capable of returning to its original form, sometimes called relaxed (undeformed) state, after being deformed. In one embodiment, anchor 100 is made of a shape memory material such as nickel titanium alloy, sometimes called nitinol.
Anchor 100 can be superelastically deformed and then returns to its original form when released. For example,
When anchor 100 is in a compressed and pre-deployment state as illustrated in
Paying particular attention now to
In accordance with this particular embodiment, pushrod connection feature 402 is a ball and anchor connection feature 404 is a socket containing pushrod connection feature 402 therein. Anchor connection feature 404 is held in a compressed state around pushrod connection feature 402, e.g., by the delivery sheath. When released, e.g., upon exiting the delivery sheath, anchor connection feature 404 expands thus releasing pushrod connection feature 402. In other embodiments, pushrod connection feature 402 and anchor connection feature 404 are a complimentary lock and key structure interconnected with one another.
Although one example of anchor coupling 406 is provided, in other embodiments, other releasable couplings between anchor 100 and pushrod 102 are used. For example, anchor coupling 406 is similar to a connection between a pushrod and an embolic coil. In yet another embodiment, there is no direct connection between anchor 100 and pushrod 102, e.g., pushrod 102 simply pushes on anchor 100 during deployment.
FIGS. 4B1, 4B2, 4B3 are enlarged side views of a region IVB of anchor 100 of
Paying particular attention now to FIG. 4B2, in another embodiment, lead tip 116 of interior tine 106 includes a ball end 410. Ball end 410 is a ball and includes no corners or sharp edges. Accordingly, ball end 410 does not dig into a vessel or prosthesis during delivery. In one embodiment, ball end 410 has a diameter greater than a diameter of interior tine 106.
Paying particular attention now to FIG. 4B3, in yet another embodiment, lead tip 116 of interior tine 106 includes a deflected end 412. Deflected end 412 is a curved end that deflects (curves) away from exterior tine 104 when in the relaxed state, e.g., in the view of
Generally, rounded end 408, ball end 410, and deflected end 412 of FIGS. 4B1, 4B2, 4B3, respectively, are referred to as a non-penetration feature.
Emanating from primary vessel 506 is a first branch vessel 510 and a second branch vessel 512, sometimes called visceral branches of the abdominal aorta. The location of branch vessels 510, 512 vary from patient to patient. Examples of branch vessels 510, 512 include the renal arteries (RA).
Aneurysm exclusion stent-graft 502 is deployed into primary vessel 506 to exclude aneurysm 508 using any one of a number of techniques well known to those of skill in the art. Aneurysm exclusion stent-graft 502 is deployed distal to branch vessels 510, 512 and thus exposes and maintains perfusion of branch vessels 510, 512. In other embodiments, aneurysm exclusion stent-graft 502 covers one or more of branch vessels 510, 512 and has openings and or other structures to maintain perfusion of branch vessels 510, 512. In either embodiment, once anchored within primary vessel 506, blood flows through a lumen 514 of aneurysm exclusion stent-graft 502 thus excluding aneurysm 508.
In one embodiment, aneurysm exclusion stent-graft 502, sometimes generally called a prosthesis 502, includes graft material 516 and one or more stents. Although one example of prosthesis 502 is described, in other embodiments, other prostheses are deployed depending upon the particular application. For example, prosthesis 502 is a stent.
In one embodiment, aneurysm exclusion stent-graft 502 must be anchored to primary vessel 506 to prevent migration of aneurysm exclusion stent-graft 502. For example, aneurysm 508 is a short neck aneurysm having little to no healthy tissue between branch vessels 510, 512 and aneurysm 508. Accordingly, aneurysm exclusion stent-graft 502 is anchored to primary vessel 506 as described below.
As used herein, the proximal end of a prosthesis such as aneurysm exclusion stent-graft 502 is the end closest to the heart via the path of blood flow whereas the distal end is the end furthest away from the heart during deployment. In contrast and of note, the distal end of the delivery system such as anchor delivery system 504 is usually identified to the end that is farthest from the operator (handle) while the proximal end of the delivery system is the end nearest the operator (handle). However, those of skill in the art will understand that depending upon the access location, the prosthesis and delivery system description may be consistent or opposite in actual usage.
In
Distal end 604 is slightly spaced apart from aneurysm exclusion stent-graft 502. In another embodiment, distal end 604 contacts and presses on aneurysm exclusion stent-graft 502. Distal end 604 can include one or more radiopaque markers to allow visualization of the location of distal end 604 and/or is partially or completely radiopaque.
Delivery sheath 602 is a hollow tube and includes an anchor delivery lumen 606 therein. Anchor 100 is compressed and constrained within anchor delivery lumen 606 with leading tip 110 of exterior tine 104 being the most distal part of anchor 100 and pointing outward of delivery sheath 602 and towards a distal sheath opening 607 of delivery sheath 602. Pushrod 102 extends through anchor delivery lumen 606 and pushes anchor 100, e.g., at rear tip 118 of interior tine 106. Generally, anchor 100 is held in the compressed and pre-deployment state such as that illustrated in
Tine connector 108 extends from exterior tine 104 through vessel wall 702 and aneurysm exclusion stent-graft 502. Interior tine 106 does not penetrate aneurysm exclusion stent-graft 502. For example, leading tip 116 is blunt to prevent leading tip 116 from penetrating aneurysm exclusion stent-graft 502 but to slide thereon as illustrated in the view of
In its final deployed condition as illustrated in
Anchor 100 anchors aneurysm exclusion stent-graft 502 to vessel wall 702 and more generally to primary vessel 506. This prevents migration and foreshortening, e.g., in vivo, of aneurysm exclusion stent-graft 502. Aneurysm exclusion stent-graft 502 is secured to vessel wall 702 by anchor 100 without open surgery. By increasing confidence in the securement and use of aneurysm exclusion stent-graft 502, aneurysm exclusion stent-graft 502 can be used in applications otherwise not possible or feasible.
In one embodiment, the operations illustrated in
Needle 1002 is a hollow tube similar to a hypodermic needle and includes and anchor delivery lumen therein. During delivery and prior to deployment, anchor 100 is compressed and constrained within the anchor delivery lumen of needle 1002 with leading tip 110 of exterior tine 104 being the most distal part of anchor 100. Pushrod 102 extends through the anchor delivery lumen of needle 1002 and pushes anchor 100, e.g., at rear tip 118 of interior tine 106. Generally, anchor 100 is held in the compressed and pre-deployment state such as that illustrated in
As illustrated in
After needle 1002 penetrates aneurysm exclusion stent-graft 502 and vessel wall 702, anchor 100 is advanced out of needle 1002. More particularly, anchor 100 is pushed by pushrod 102 to exit needle 1002. This causes exterior tine 104 to completely exit needle 1002. After exiting needle 1002, exterior tine 104 of anchor 100 returns to its relaxed state. In its final deployed state, exterior tine 104 is exterior to and adjacent vessel wall 702.
As illustrated in
In one embodiment, pushrod 102 is advanced (moved distally) to advance interior tine 106 from needle 1002. As pushrod 102 exits needle 1002, pushrod 102 releases anchor 100, for example, as described above in reference to
In its final deployed condition as illustrated in
Anchor 100 anchors aneurysm exclusion stent-graft 502 to vessel wall 702 and more generally to primary vessel 506. This prevents migration and foreshortening, e.g., in vivo, of aneurysm exclusion stent-graft 502. Aneurysm exclusion stent-graft 502 is secured to vessel wall 702 by anchor 100 without open surgery. By increasing confidence in the securement and use of aneurysm exclusion stent-graft 502, aneurysm exclusion stent-graft 502 can be used in applications otherwise not possible or feasible.
In one embodiment, the operations illustrated in
This disclosure provides exemplary embodiments. The scope is not limited by these exemplary embodiments. Numerous variations, whether explicitly provided for by the specification or implied by the specification or not, such as variations in structure, dimension, type of material and manufacturing process may be implemented by one of skill in the art in view of this disclosure.
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EP19163445.0, Extended European Search Report, 8pgs, dated Aug. 20, 2019. |
Number | Date | Country | |
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20190290419 A1 | Sep 2019 | US |