ORIENTABLE INTRACRANIAL OCCLUSION DEVICE AND METHOD
20230277349 · 2023-09-07
Inventors
Cpc classification
A61F2/958
HUMAN NECESSITIES
A61F2002/823
HUMAN NECESSITIES
A61F2/966
HUMAN NECESSITIES
A61F2/94
HUMAN NECESSITIES
International classification
Abstract
A method and device to correctly orient an intracranial occlusion device, such as a stent having differential porosity, with respect to desired areas of greater or lesser blood flow (e.g., branch vessels and aneurysms, respectively), said device being particularly adapted for use in treating aneurysms in intracranial or other tortuous vasculature. An intravascular device comprising a delivery catheter having a hub and angular lumen capable of constraining a pusher wire within a packaging catheter to deploy said stent in an orientation wherein the area of least porosity abuts the aneurysm, and area of maximal porosity permits blood flow to a branch or other vessel. A method of using same.
Claims
1-70. (canceled)
71. An intravascular system configured for insertion into a blood vessel, the intravascular system comprising: a delivery catheter defining an inner lumen, the inner lumen having a first non-circular configuration; and a pusher configured for insertion into the inner lumen of the delivery catheter, the pusher having a second non-circular cross-sectional configuration configured to allow axial movement within the lumen of the delivery catheter and to inhibit rotation of the pusher within the lumen of the delivery catheter to thereby maintain a pre-determined angular orientation of the pusher within the delivery catheter.
72. The intravascular device of claim 71, wherein the first non-circular configuration and the second non-circular configuration are each defined by a plurality of linear segments.
73. The intravascular device of claim 72, wherein the delivery catheter includes radiopaque markers to identify an angular orientation of the delivery catheter within the blood vessel.
74. The intravascular device of claim 73, wherein the radiopaque markers extend along a single linear segment of the delivery catheter.
75. The intravascular device of claim 71, wherein the delivery catheter has a hub and a marker at the hub and at a marker at a distal tip.
76. The intravascular device of claim 71, wherein the first non-circular configuration of the inner lumen and the second non-circular configuration of the pusher are such that the pusher is insertable into the inner lumen in at least three distinct angular orientations.
77. The intravascular device of claim 71, wherein the first non-circular configuration and the second non-circular configuration are one of triangular rectangular, hexagonal or star shaped.
78. The intravascular device of claim 71, further comprising a packaging catheter containing the pusher, and the packaging catheter is configured to mate within a hub of the delivery catheter to deliver a stent through the lumen of the delivery catheter.
79. The intravascular device of claim 78, wherein the packaging catheter has a lumen having a non-circular configuration corresponding to the first non-circular configuration of the delivery catheter.
80. The intravascular device of claim 71, wherein the first non-circular configuration matches the second non-circular configuration.
81. The intravascular device of claim 71, wherein the cross-sectional configurations of the inner lumen and the pusher facilitate insertion of the pusher into the inner lumen in a plurality of discrete orientations separated by a defined angular increment.
82. An intravascular configured for insertion into a blood vessel, the intravascular device comprising: a delivery catheter defining an inner lumen; a pusher configured for axial movement through the inner lumen of the delivery catheter; and a stent secured to the pusher such that the stent is deployable within the blood vessel via axial movement of the pusher through the delivery catheter, the inner lumen of the delivery catheter and an outer wall of the pusher having cross-sectional configurations such that rotation of the pusher is limited within the inner lumen of the delivery catheter upon insertion of the pusher into the delivery catheter to thereby maintain a pre-determined angular orientation of a stent secured to the pusher to enable desired radial placement of the stent.
83. The intravascular device of claim 82, wherein the cross-sectional configurations of the inner lumen and the pusher facilitate insertion of the pusher into the inner lumen in a plurality of discrete orientations separated by a defined angular increment
84. The intravascular device of claim 82, wherein the inner lumen of the delivery catheter and the pusher are configured such that the defined angular increment is at least 60°.
85. The intravascular device of claim 82, wherein the stent has a free-floating cover.
86. The intravascular device of claim 82, wherein the stent has overlapping shingles.
87. The intravascular device of claim 82, wherein the stent has a cover over a circumferential segment.
88. The intravascular device of claim 82, wherein the corresponding cross-sectional configurations of the inner lumen and the pusher are selected from the group consisting of triangular, square, rectangular, hexagonal, and star-shaped.
89. The intravascular device of claim 82, wherein the stent has a non-porous side and a marker on the delivery catheter enables radial alignment of the non-porous side.
90. The intravascular device of claim 82, further comprising a packaging catheter containing the pusher, and the packaging catheter is configured to mate within a hub of the delivery catheter to deliver a stent through the lumen of the delivery catheter
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE INVENTION
[0055] The embodiments of the device and variants of the device of the present invention are set forth with reference to the above drawings.
[0056] Referring to
[0057] Now referring to
[0058] Now referring to
[0059] Now referring to
[0060] Packaging catheter 30 is joined to hub 700 at port 701 such that stent 301 and push-wire 300 are oriented as desired so as to present the minimally porous surface of said stent 301 substantially toward the target aneurysm 2000.
[0061] Now referring to
[0062] Now referring to
[0063] The orientation of lumen of delivery catheter lumen 3 must be clearly identifiable.
[0064] Now referring to
[0065] Now referring to
First Method.
[0066] Use a delivery catheter with a “12 o'clock” marker at the proximal hub of said catheter. The 12 o'clock marker may be disposed on the hub and on the delivery catheter tip (i.e., radio-opaque on the catheter tip). The user inserts the stent-packaging catheter having a differentially porous stent or occlusion device mounted on a push-wire therein. After testing, the user rotates the packaging catheter at the hub to the desired indicator.
[0067] The indicator may be disposed in any position on the hub to point to any direction on the hub, but terming this a 12 o'clock indicator or marker is convenient for describing positions relative to the marker for anyone familiar with an analog clock face. For example, instructing a user to rotate the hub to “3 o'clock”, “6 o'clock”, or “9 o'clock” intuitively suggests a quarter turn, half turn, and three-quarter turn, respectively, with other “times” referring to approximate positions between these 90° references (e.g., 2 o'clock, 5 o'clock or 11 o'clock). The same effect could be achieved by reference to a “North” marker, utilizing terminology such as East, South, and West (or interstitial positions such as ESE or NW), but “12 o'clock” is a preferred reference. The ability to rotate the relative orientation of the delivery catheter within a 360° range manually, not the terminology employed, is material.
[0068] Use a packaging catheter having a distal marker, advance a test stent or final stent at a particular orientation relative to the 12 o'clock marker on said delivery catheter. The stent (or other marked endovascular device) will generally end in a substantially similar, but unpredictable, orientation. The process may be repeated to verify that the markers on the delivery catheter and the packaging catheter are consistently aligned. Then image the markers on the test stent/device relative to the marker on the tip of the delivery catheter to determine what orientation (i.e., at what “hour” on the “clock”) the stent needs to be loaded into the delivery catheter in order to achieve the desired orientation. Or use a stent preloaded in a delivery catheter in a desired orientation relative to the “12 o'clock” marker.
[0069] Optionally, the orientation can be confirmed with an additional test stent/device which is temporarily advanced in the predicted orientation, and then imaging can confirm, before the test device is removed and a permanent device is advanced and deployed.
[0070] By way of example, a test result shows a fenestration deploys at “7 o'clock”, which is 90° clockwise relative to the target branch vessel. The treatment would then reorient the stent-packaging catheter at “4 o'clock”, to have it appear correctly oriented proximal to the target branch.
[0071] When a catheter tip orientation is imaged, the stent loaded in the appropriate orientation relative to the similarly disposed hub marker can be deployed. Once again, if desired, “test” device/stents with additional radio-opaque markers can be retrievably deployed to confirm the orientation.
Second Method
[0072] Disclosed is a second method, using the steps and markers of the above-described First Method, and in addition using a delivery catheter having throughout its cross section a unique geometrically shaped inner lumen. In a typical embodiment, the surface of the delivery catheter will be conventionally cylindrical, substantially rounded, to facilitate advancement through circulatory vessels. An unrounded lumen minimizes the rotational tendency of a deploying stent-packaging catheter, or a wire, enhancing the predictability of orientation.
[0073] The accompanying figures show, by way of example, a triangularly shaped lumen. Alternatively, a square, hexagon, octagon, pentagon, a “house” silhouette or star shape. Any style of star may be used, such as 6-pointed, “Star of David” or others, or other geometric shapes, provided a single one is used throughout the lumen.
[0074] In a further embodiment, a packaging catheter may be shaped correspondingly to the shape of the lumen of the delivery catheter. This correspondence is shown in the accompanying
[0075] Again here, a “12 O'clock” marker that is at the same orientation can be on the hub and on the catheter tip (radio-opaque on the catheter tip). So, when/if the catheter tip orientation is imaged, the stent loaded in the appropriate orientation relative to the similarly disposed hub marker can be used. Once again, if desired, “test” device/stents with additional radio-opaque markers can be retrievably deployed to confirm the orientation. When the tip marker orientation can be well imaged after delivery intracranially, or into similar tortuous vasculature, the tip marker orientation, and its relative deflection on a rotary basis from the hub marker, can most often be used to determine rotational orientation, without the need for optional retrievable test-stent devices.
Common Method
[0076] Using any of the devices and methods above, a fenestration can be accurately deployed at the origin of a branch vessel. Then a wire can be advanced through that fenestration and into the branch, and either: (a) a balloon expandable device/stent can be delivered over the wire and deployed so that the proximal end minimally overlaps with the fenestration of the first stent/device; moreover, the branch may also optionally have a taper so it is somewhat larger at the fenestration side versus the portion that extends into the branch vessel; (b) a second delivery catheter (or the first can be re-used) can be delivered into the branch (the wire can optionally be removed) and an additional branch stent, most often self-expanding, can be delivered through the delivery catheter. Again, the branch stent may also optionally have a taper so it is somewhat larger at the fenestration side versus the portion that extends into the branch vessel.
[0077] Delivery method (b), however, has difficulty accurately landing the proximal stent, especially with “woven” or “braided” stents which can significantly, and unpredictably, foreshorten during deployment (compared to their length crimped in the delivery catheter).
[0078] Another option therefore is a novel delivery device for such stents. In this embodiment, it can be loaded in a device/catheter similar to the “inner catheter with wings” of a filter-tip TAVR (transcatheter aortic valve replacement) catheter, or said another way a “central tube” and “retaining structure connected to the distal end of said central tube and extending in a direction from the distal end to the proximal end of said central tube” also described and patented by Walzman (U.S. Ser. No. 10/30,724,262). The “wings” provide the proper fixing of the orientation while being guided through the angular lumen 1 of the delivery catheter. Having a single or multiple external wires attached to a stent, in a preferred embodiment ideally attached to the proximal and distal ends of the stent (which can be “over the wire” or most ideally “rapid exchange”) once a first stent is deployed with the fenestration overlying a branch vessel origin, a second wire is advanced through the fenestration into the branch, and a second stent/device, delivered constrained within said retaining structure and having at least one second wire attached to said stent outside the central tube and/or an outer tube attached to said stent, is advanced over the wire to the desired position. The stent attached wire(s) (or, alternatively, the outer catheter) is held in place while the “inner catheter with wings” is advanced, exposing/unsheathing the stent from the proximal end first.
[0079] The present invention also discloses an unsheathing device for the branch stent. More specifically the present invention teaches a device which un-sheaths the proximal part first. In the foregoing, if the stent is attached by wires, the wires can expand with the stent. If the stent is attached to an outer catheter (which is outside the inner catheter, but still inside the stent; the wings are outside the stent), it would need to wait until entire stent is unsheathed before detaching the proximal end. Or if stent is attached circumferentially proximally to an outer catheter and also has at least one additional wire attached to the stents distal segment- or additional attachment(s) to the outer catheter at the distal stent segment, then the proximal attachments can be detached upon unsheathing the proximal segment of the stent- to ensure appropriate orientation and position overlapping minimally the fenestration but not significantly overlapping/covering the primary vessel, and then the distal stent can be detached once the entire stent is deployed.
[0080] The stent can optimally be attached only distally to the “outer catheter”, in order to advance the system, the outer catheter is pushed, which pulls the attached stent and pushes the winged portion of the inner catheter (and subsequently the entire inner catheter in unison). Then, when the stent is properly positioned, the second stent can be unsheathed by holding the outer catheter (with attached stent) in position and then advancing the inner catheter, which will unsheath the proximal stent first. Using self-expanding stents, the proximal stent will automatically expand as it is unsheathed. If position is off, the inner catheter can be pulled back again and the proximal stent can be re-sheathed, and the stent can be repositioned before unsheathing again.
[0081] Additionally, when using “braided” or “woven” stents, full expansion can be slow and unpredictable, the proximal end of stent (and optionally other parts as well) can have a nitinol wire ring to encourage more immediate opening/self-expansion to its maximal diameter. There may optionally be similar attached longitudinal wires as well to help allow smooth re-sheathing when desired. Such rings may optionally be repeated at additional intervals along the stent device.
[0082] More particularly, a preferred method may be described by the following steps, using the embodiment of the device in which the pusher wire comprises an angular shape congruent with the angular lumen of the delivery catheter (e.g., a triangularly shaped pusher wire and triangular lumen): [0083] (a) inserting said delivery catheter into a body, [0084] (b) pushing said proximal end of said delivery catheter over a delivery wire until said distal end of said delivery catheter is proximal to a target aneurysm, [0085] (c) removing said delivery wire [0086] (d) imaging the orientation of said distal end radial marker relative to said target aneurysm [0087] (e) orienting said packaging catheter relative to a 12 o'clock hub marker so as to optimize orientation of said stent relative to said target aneurysm, [0088] (f) inserting said packaging catheter into said hub, [0089] (g) pushing said pusher wire until said stent is fully within said delivery catheter [0090] (h) removing said packaging catheter [0091] (i) pushing said pusher wire until said stent is proximal to said target aneurysm, [0092] (j) deploying the majority of said differentially porous occlusion device, [0093] (k) repeating imaging to confirm expected device orientation [0094] (l) deploying fully the remainder of said differentially porous occlusion device, and [0095] (m) withdrawing said pusher wire and said delivery catheter.
Bifurcated or V-Shaped Stents
[0096] Using the foregoing procedure, a “Y” shaped stent may be assembled from two stents in vivo by reference to markers.
[0097] The present invention may employ self-expanding components.
[0098] The present invention may employ balloon-expanding components.
[0099] The present invention may optionally contain radiopaque components and/or radiopaque markers. These can be especially valuable at ends of stent and at the ends and edges of covered zone. Radio-opaque materials and markers can also be optionally present in more places, and sometimes throughout.
[0100] The present invention may have branched stent elements.
[0101] The present invention's stent elements may optionally be fully re-sheathable.
[0102] The present invention's stent elements may optionally be partly re-sheathable.
[0103] All stent elements of the present invention may be optionally be detachable.
[0104] It will be understood by those skilled in the art that the above particular embodiments are shown and described by way of illustration only. The principles and the features of the present disclosure may be employed in various and numerous embodiments thereof without departing from the scope and spirit of the disclosure as claimed. The above-described embodiments illustrate the scope of the disclosure but do not restrict the scope of the disclosure.