Methods of implanting covered stents with side branch

[0001] This application claims priority from provisional patent application No. 60/240,009, filed Oct. 13, 2000 and provisional patent application No. 60/278,361, filed Mar. 23, 2001, the entire contents of both applications incorporated herein by reference.

[0002] 1. Technical Field

[0003] This application relates to a vascular stent and graft and more particularly to methods of implanting a covered stent having a side branch to accommodate a branching vessel.

[0004] 2. Background of Related Art

[0005] The vascular disease of arteriosclerosis, also referred to as hardening of the arteries, is caused when fatty substances and plaque build up inside the artery walls over time and reduce the size of the arterial lumen (passageway), thereby restricting proper blood flow through the artery. This buildup which causes restriction of the vessel is called stenosis.

[0006] The right and left common carotid arteries arise from the aorta and are the principal blood supply to the head and neck. Each of the two common arteries divides to form external and internal carotid arteries to supply the blood to the head and neck. Arteriosclerosis of the carotid arteries if left untreated, will constrict the arterial passageway to such an extent as to prevent adequate supply of blood to the brain or ultimately will fully occlude the artery to cut off blood flow entirely, causing a stroke resulting in paralysis or even death.

[0007] Several methods are currently being utilized to treat arteriosclerosis of the carotid arteries. One method is an invasive surgical procedure where the vessel wall is cut open and the portion containing the plaque is removed. This procedure is traumatic, complex, and requires a long recovery time for the patient. It also results in weakening of the vessel wall since a portion of the wall is removed. A weakened wall can ultimately result in an aneurysm which is a dilatation (expansion) of the artery, which adversely affects vessel function and if not surgically treated could be life threatening to the patient.

[0008] With the advent of minimally invasive procedures, and particularly intraluminal (within the vessel) procedures for many types of surgeries in order to reduce trauma to the patient, reduce the patient recovery time and reduce hospital costs, the industry has been attempting to develop ways to minimally invasively treat arteriosclerosis of the carotid arteries. Initially, balloon angioplasty, a procedure used for treating coronary arteries, was attempted. In angioplasty, a balloon is placed in the stenosed (restricted) portion or the vessel and inflated to compress the plaque against the vessel (arterial) wall, thereby increasing the opening in the vessel to improve blood flow. However, angioplasty of the carotid arteries was found to create grave risks because plaque, rather than just being compressed, could inadvertently be dislodged from the arterial wall and travel up through the internal carotid artery to the brain, causing a stroke.

[0009] To help maintain the enlarged opening created by an angioplasty balloon in coronary arteries, stenting has become widespread. Stenting involves the placement of a structural support (a stent), typically composed of metal, in the stenosed region either after balloon angioplasty is completed or in conjunction with the angioplasty. The stent is expanded in the vessel to provide a radial force against the vessel wall in an attempt to maintain the opening in the vessel created by the angioplasty balloon. Although stents may reduce the chance of dislodgement and flow of plaque to the brain, stents provide their own risks. For example, thrombus can build on the stent structure over time, which can eventually become dislodged and travel through the internal carotid arteries to the brain causing embolic stroke. Also, intimal hyperplasia (buildup of scar tissue) around the stent can occur, resulting in restenosis (re-constriction of the vessel) within or juxtaposed to the stent.

[0010] To avoid the flow of dislodged plaque or thrombotic material to the brain, covered stents have begun to be utilized in the common carotid arteries. The stents are covered with graft material, such as PTFE, and compressed against the vessel (arterial) wall, thereby sandwiching any dislodged plaque between the graft and vessel wall to prevent dislodgement. Thrombotic material can also be captured between the graft and wall. Although these covered stents reduce the dislodgement problem discussed above, the placement of the graft material can create other problems. If the covered stent is placed in a portion of the common carotid artery which does not have any vessels branching off, blood flow is maintained. However, problems can arise if the stenosis is adjacent a region of the carotid artery adjacent to a branching vessel because implantation of the graft will require closing off blood flow to the branching vessel as the graft material will extend past the branch opening. For example, if the graft of a covered stent is placed in the common carotid artery extending into the internal carotid artery, the graft will cover the juncture of the external carotid artery, thereby cutting off blood flow through the external carotid artery to the brain. Thus, although the problems associated with the stenosis in the common carotid artery might be alleviated by the covered stent, the patient will still have reduced blood flow because the external carotid artery will no longer transport blood to the brain. Since the overall blood flow is reduced, the likelihood of stroke will increase.

[0011] Additionally, by cutting off the opening to the external carotid artery, future access to this artery for treatment is prevented. Therefore, if an aneurysm or stenosis develops in this artery, the covered stent would prevent intraluminal access to the target region.

[0012] It would therefore be advantageous to provide a covered stent that could be used in the carotid arteries which would not adversely affect blood flow in branching vessels. Such covered stent would thereby advantageously enlarge the restriction (stenosis) in the common carotid artery to improve blood flow therethrough without disadvantageously reducing blood flow through connecting arteries.

[0013] It would also be advantageous to provide a delivery system to facilitate implantation of such covered stent. Such system would require intraluminal implantation of a covered stent to accommodate the target vessel and branching vessel.

[0014] The present invention overcomes the disadvantages and deficiencies of the prior art by providing a stent or covered stent to accommodate branching vessels and by providing methods of insertion of such stents. The covered stents of the present application are also disclosed in co-pending commonly owned provisional patent application Ser. No. 60/240,009, filed Oct. 13, 2000, the entire contents of which are incorporated herein by reference. The covered stents can advantageously be used in branching areas, such as the carotid artery at the junction of the external and internal carotid arteries, without adversely affecting blood flow. The provisional application disclosed a delivery system and method for inserting the main stent and a branching stent connected to the main stent. The present application further discloses a delivery system and method for inserting the bifurcated stent in the main and branching vessel. Thus, the present application discloses delivery systems and methods for implanting bifurcated stents and connected branching stents.

[0015] One method of implanting first and second stents with associated grafts within first and second vessel regions extending at an angle with respect to each other, is provided which comprises:

• • [0016] inserting a first guidewire to guide a first stent with an associated first graft to the first vessel region;
  • [0017] inserting a second guidewire to guide a second stent with an associated second graft to the second vessel region;
  • [0018] inserting a first delivery sheath containing the first stent with the associated first graft over the first guidewire to the first target vessel region;
  • [0019] removing the first delivery sheath to enable the first stent with the associated first graft to expand against the wall of the first vessel region;
  • [0020] inserting a second delivery sheath containing the second stent with the associated second graft over the second guidewire to the second vessel region; and
  • [0021] removing the second delivery sheath to enable the second stent with the associated second graft to expand against the wall of the second vessel region and fluidly communicate with the first stent and associated first graft.

[0022] The step of inserting the second delivery sheath preferably includes the step of inserting the delivery sheath through an opening in a sidewall of the first graft to enable the first and second grafts to fluidly communicate. The step of removing the second delivery sheath preferably comprises removing the sheath through the expanded first stent.

[0023] The present invention also provides a method of implanting a first and second graft within the carotid arteries comprising:

• • [0024] inserting a first guidewire into a common carotid artery and extending into an internal carotid artery to guide a first stent having a first graft to a target region of the common carotid artery;
  • [0025] inserting a second guidewire into the common carotid artery and extending into an external carotid artery to guide a second stent having a second graft to the external carotid artery;
  • [0026] inserting the first stent and first graft over the first guidewire to a stenosed region in the carotid artery to enable the first stent and first graft to expand against the stenosed region, the first graft extending into the internal common artery past the juncture of the common carotid artery and the external carotid artery; and
  • [0027] inserting the second stent with the second graft over the second guidewire to the external carotid artery to enable the second stent and second graft to expand against the wall of the external carotid artery, thereby maintaining flow between the common carotid artery and the external carotid artery.

[0028] The step of inserting the second stent and graft preferably comprises the step of inserting the second stent and graft through an opening in the sidewall of, and through, the first stent and graft. Preferably, withdrawal of a first sheath exposes the first stent and graft to allow expansion thereof and withdrawal of a second sheath exposes the second stent and graft to allow expansion thereof.

[0029] The present invention also provides a method of implanting a stent within first and second vessel regions extending at an angle with respect to each other, the method comprising:

• • [0030] inserting a first guidewire to guide a first stent and first graft portion to the first vessel region;
  • [0031] inserting a second guidewire to guide a second stent and second graft portion to a second vessel region;
  • [0032] inserting a delivery sheath containing the first and second stent and graft portions over the first and second guidewires, respectively, to the vessel regions; and
  • [0033] removing the delivery sheath to enable the first stent and graft portion to expand against the wall of the first vessel and to enable the second stent and graft portion to expand against the wall of the second vessel.

[0034] This method preferably further comprises the steps of folding the second graft portion towards the first graft portion and inserting the stent and graft portions inside the delivery sheath in the folded condition prior to inserting the delivery device over the guidewires.

[0035] A method of implanting a stent with associated grafts within first and second vessel regions extending at an angle with respect to each other wherein the stent has a first portion and a second portion extending at an angle to the first portion is also provided. The method comprises the steps of:

• • [0036] inserting a first guidewire to guide the first stent portion with an associated first graft to the first vessel region;
  • [0037] inserting a second guidewire to guide the second stent portion with an associated second graft to the second vessel region;
  • [0038] inserting a first delivery sheath containing the first stent portion with the associated first graft over the first guidewire to the first vessel region and a second delivery sheath containing the second stent portion with the associated second graft over the second guidewire to the second vessel region;
  • [0039] removing the first delivery sheath to enable the first stent portion with the associated first graft to expand against the wall of the first vessel region; and
  • [0040] removing the second delivery sheath to enable the second stent portion with the associated second graft to expand against the wall of the second vessel region and fluidly communicate with the first stent and associated graft.

[0041] Preferably, the second delivery sheath is contained within the first delivery sheath so that the step of removing the first delivery sheath includes the step of withdrawing the first delivery sheath over the second delivery sheath and the step of inserting the second delivery sheath includes the step of inserting the second delivery sheath through an opening in the first delivery sheath. In one embodiment, the second guidewire is a dummy wire and the step of inserting the second guidewire into the second vessel region occurs after the first delivery sheath is inserted into the patient.

[0042] The present invention also provides a method of implanting within the carotid arteries a bifurcated graft having a first graft portion and a second graft portion, the method comprising:

• • [0043] inserting a first guidewire into a common carotid artery and extending into an internal carotid artery to guide a first graft portion into the internal carotid artery;
  • [0044] inserting a second guidewire into the common carotid artery and extending into an external carotid artery to guide the second graft portion to the external carotid artery; and
  • [0045] inserting the first and second graft portions over the first and second guidewires, respectively, so the first graft portion extends into the internal common artery past the juncture of the common carotid artery and the external carotid artery and inserting the second graft portion over the second guidewire into the external carotid artery to enable the second stent graft portion to expand against the wall of the external carotid artery, thereby maintaining flow between the common carotid artery and the external carotid artery.

[0046] Preferably, this method further comprises the step of withdrawing a first sheath positioned over the first graft portion to allow expansion of the first graft portion and the step of withdrawing a second sheath positioned over the second graft portion to allow expansion of the second graft portion. The method may further comprise the step of inserting an insertion tube into the common carotid artery wherein the first and second sheaths are positioned within the insertion tube.

[0047] In the foregoing methods of the present invention, preferably removal of the sheath enables the stent and graft to expand automatically due to exposure to body temperature because the stent is composed of shape memory material with its memorized configuration in the expanded state. Alternatively, removal of the sheath enables the stent and graft to expand because the sheath will no longer block expansion and a balloon catheter can be utilized wherein the balloon is inserted within the stent and inflated to radially expand the stent to engage the vessel walls.

[0048] The present invention also provides a delivery system for a bifurcated stent comprising:

• • [0049] a bifurcated stent having a first portion and a second portion extending at an angle to the first portion;
  • [0050] a first delivery sheath having a first diameter, the first stent portion being positioned within the first delivery sheath;
  • [0051] a second delivery sheath having a second diameter smaller than the first diameter of the first delivery sheath, the second delivery sheath being at least partially positioned within an axial opening in the first delivery sheath and having a distal end portion positioned at an angle to a distal end portion of the first delivery sheath; and
  • [0052] an insertion member having a third diameter greater than the second diameter, the first and second delivery sheaths positioned within the insertion member, the insertion member maintaining the distal end portions of the first and second delivery sheaths in closer proximity, wherein removal of the insertion member enables the distal end portions to move further apart for positioning within first and second blood vessel portions extending at an angle to each other.

[0053] Preferably, the second delivery sheath has a lumen dimensioned to receive a guidewire therethrough and the first delivery sheath has a side opening for extension of the second delivery sheath therethrough. The bifurcated stent can include one or more longitudinal spine segments with a series of curved ribs extending from the spine(s).

[0108] Referring now in detail to the drawings wherein like reference numerals identify similar or like components throughout the several views, several embodiments of covered stents are illustrated to accommodate a branch of a target vessel. The covered stent includes a side branch, which can be either integral as shown in FIGS. 1A and 1B or a separate “branch” stent attached to a “main” stent as shown in FIGS. 2-4 and 7. The side branch extends into a vessel branching from the target vessel. The stent functions to expand the constricted passage, i.e. the stenosis, created by plaque buildup inside the vessel wall. A graft, composed of material such as PTFE or other known materials, is positioned over the stent (referred to as a “covered stent”), as shown in FIGS. 23A and 23B, so when the stent is expanded the graft is pushed against and retained against the inside vessel wall, thereby compressing the plaque, which might otherwise become dislodged, between the graft and the vessel wall. The stent retains the graft in place which creates a passageway for blood flow.

[0109] Currently, a covered stent having only a longitudinal directional component is placed inside the vessel wall. However, if the covered stent is placed adjacent a branching vessel, then that branching vessel will be closed off, preventing blood flow therethrough. For example, if in treating stenosis in the common carotid artery, a covered stent is placed in the common carotid artery extending to the internal carotid artery, the graft will extend past the juncture of the external carotid artery, thereby undesirably blocking blood flow to the external carotid artery. The covered stent of the present invention has an angled side branch which extends into the branching vessel, e.g. the external carotid artery, thereby allowing blood flow through the branching vessel which would otherwise be blocked if an elongated covered stent was placed in the artery across the juncture.

[0110] The covered stent of the present invention is described herein for use in carotid arteries by way of example. However, it should be understood that it is contemplated that the stent can be utilized in other vessels such as the coronary arteries, the descending aorta and renal arteries, the external iliac and internal iliac arteries and the common femoral and deep femoral arteries. Thus, the covered stent of the present invention, as can be appreciated, has application for vessels where a stenosis is adjacent a branching vessel. The covered stent of the present invention can also be utilized for other vascular procedures where it would extend past the juncture of the target vessel and a branching vessel.

[0111] With reference now to FIGS. 1A-1D, and with reference to use in the carotid arteries by way of example, two embodiments of the covered stent of the present invention having an integral side branch are disclosed. In the first embodiment, shown in FIG. 1A, bifurcated covered stent 10 includes a graft 12 and an underlying main stent 20 and branch or side stent 22, only partially and schematically shown for clarity. Graft 12 includes a main portion 16 and a side branch portion 18 integral therewith. Main stent 20 underlies main graft portion 16 and branch stent 22 underlies side branch graft portion 18. Side branch portion 18 extends from an intermediate portion 17 of the covered stent 10 as shown. The branch portion 18 ensures that blood can continue to flow through the right external carotid artery “c”, in the direction of the arrows, once the graft portions 16, 18 and underlying stents are positioned in the right common carotid artery “a”, right internal carotid artery “b”, and right external carotid artery “c”.

[0112] FIG. 1B illustrates an alternate embodiment of the covered stent having an integral branch portion. Covered stent 30 includes a graft 31 bifurcated at its distal end portion 32 to form a first or main graft leg 34 and a second or side (branch) graft leg 36. Stent 40 underlies main leg 34 and stent 42 underlies side leg 36. Like covered stent 10, covered stent 30 is shown positioned to treat a stenosis in the right common carotid artery “a” with the main leg 34 extending into the internal carotid artery “b” and the side leg 36 extending into the right external carotid artery “c”. It should be appreciated that the bifurcated covered stent 30 of FIG. 1B is more versatile in that it can accommodate various anatomies. The presence of gap “g” adjacent the bifurcation does not affect the desired blood flow.

[0113] Grafts 12 and 31 have petals at their ends as shown, the function of which is described below in conjunction with alternate embodiments.

[0114] Covered stents 10 and 30 are inserted in similar manners with FIG. 1C depicting insertion of covered stent 10 and FIG. 1D depicting insertion of covered stent 30. Two separate guidewires 43, 45 are inserted intraluminally, one extending through the right common carotid artery “a” into the internal carotid artery “b” and the other extending through the right common carotid artery into the external carotid artery “c”. The covered stent 10 or 30 has its respective side branch graft portion 18 or side graft leg 36 folded towards the main graft portion 16 or main graft leg 34. The covered stent with the folded branch is then placed in a delivery catheter or sheath (not shown) with the stents positioned over the respective guidewires. The delivery catheter is advanced intraluminally to the target region, and then withdrawn, allowing the branch portion 18 or side leg 36 to unfold into the external carotid artery “c” and the respective stents 20, 22 and 40, 42 to expand to a larger diameter configuration. In the larger configuration, the stents apply a radial force against the vessel wall, thereby retaining the graft 12 or 31 against the vessel wall. As can be appreciated, blood can continue to flow through the graft from the common carotid artery through the external carotid artery.

[0115] FIGS. 2-7 illustrate a different approach for accommodating the vessel branch. Instead of an integral branch as in FIGS. 1A and 1B, a separate covered stent branch is attached, preferably in situ, to the covered main stent. More specifically, and initially with reference to FIG. 2A, a covered main stent 50 is illustrated comprising a graft 52 and an underlying stent 57. It should be noted that in FIGS. 1-11, the stent is shown schematically and only partially for the sake of clarity. In all embodiments, the underlying stent can extend the length of the graft or only along part or its length. Also, more than one stent can be utilized to retain the main graft portion and to retain the branch graft portion. Additionally, the stent can be composed of metallic or polymeric material, and include an opening in an intermediate portion to align with the opening in the graft as described below.

[0116] Referring back to FIG. 2A, graft 52 includes an opening 54 in its sidewall, in an intermediate portion, to accommodate a branch stent described below. Radiopaque discs or markers 55 are positioned adjacent the side opening 54 to facilitate locating the opening 54 during surgery to in turn facilitate attachment of the branch stent. Although disc shaped, other shaped radiopaque markers or other indicators at various locations can be used to facilitate proper orientation of the opening 54. Leaflets or petals 56, 58 are positioned on the distal and proximal end portions 60, 62, respectively, of graft 52 to reduce stress on the vessel wall by reducing the radial force against the wall. FIG. 2B illustrates how the covered stent 50 can be rotated to orient the side opening 54 towards the branching vessel. Side opening 54 has a diameter “A” dimensioned to receive a branch stent as discussed below. The stent 57 also includes an opening, such as that shown in FIG. 25, which aligns with the side opening 54 in graft 52 to ensure blood flow therethrough.

[0117] FIG. 3 illustrates an alternate embodiment of the covered main stent, designated by reference numeral 70. Covered stent 70 is similar to stent 50 in that it has an underlying metallic stent 75 and a graft 73 having a radiopaque indicator discs 77, side opening 76 having diameter “A” to receive a branch stent, and petals 74, 78. However, covered stent 70 additionally has an extension 72 at a distal end, which is unsupported by stent 75. This unstented extension reduces the radial force against the vessel wall in that region and may also allow placement of a portion of the graft in a vessel region where stenting is ill advised. Stent 75 also includes an opening (not shown) in a sidewall to align with side opening 76 of graft 73.

[0118] A first embodiment of the independent covered branch stent, illustrated in FIG. 4, is designated by reference numeral 80 and has a graft 81 and underlying stent 87. Graft 81 has a first end portion 82, a flange 84 at a second end portion 86, and a waist or reduced diameter portion 88. Underlying stent 87 would similarly have a conforming narrowed portion or otherwise configured or designed so that upon expansion, graft 81 retains its waist 88. As indicated, waist 88 has an external diameter “A”, equal to the diameter of the opening 54 or 76 in the sidewall of covered main stents 50 or 70. The flange 84 and the portion of the covered stent distal of the waist 88 have diameters larger than diameter “A” to ensure the covered branch stent 80 does not slip through or out of opening 54 or 76 in covered main stent 50 or 70, respectively. Petals or leaflets 83, 85 function to reduce the radial force as described above.

[0119] FIG. 7 illustrates an alternate embodiment of the covered branch stent having a graft 91 and underlying stent 97. Branch stent 90 has a flange 94 with a smooth portion 95 and a smooth distal end 92. Waist portion 98 has a diameter “A” less than diameter “B” and equal to the diameter “A” of the opening 54 or 76 of covered main stents 50 or 70. The larger diameter “B” and the larger diameter of the flange 94 ensure the branch stent 90 is retained within the covered main stent.

[0120] The method of inserting the covered stent of FIGS. 2A and 4 of the present invention in the left carotid arteries will now be described with reference to FIGS. 8A-9C. A first guidewire 120 is inserted through the common carotid artery, preferably through an entry point in the femoral artery, and extends to the internal carotid artery as shown in FIG. 8A, past the target region of stenosis having plaque “P”. A second guidewire 122 extends through the common carotid artery into the external carotid artery. (An angioplasty balloon (not shown) is introduced over the guidewire 120 to pre-dilate the vessel). A delivery catheter or sheath 130 containing the covered main stent 50 of FIG. 2A therein, is threaded over the guidewire as shown in FIG. 8B, with the proximal end of the guidewire 120 extending beyond the proximal end 132 of the sheath 130. The main covered stent is thus positioned inside the sheath 130 and over the guidewire 122. Sheath 130 has a longitudinally extending slot 134, of sufficient size to accommodate a second guidewire 122. The slot 134 extends a sufficient distance proximally so at least a portion of the slot is in alignment with the external carotid artery “c” as shown. This allows withdrawal of the sheath 130 as described below. Once the sheath 130 is advanced into the internal carotid artery “b” so the covered stent 50 is aligned with the target vessel region, i.e. the portion of the vessel having the stenosis, the sheath 130 is withdrawn in the direction of arrow D in FIG. 9A, thereby allowing the stent 57 to expand to press the graft 52 against the vessel wall. The stent is preferably composed of shape memory material, such as Nitinol, that expands from a smaller configuration to its larger memorized configuration inside the body. As the sheath 130 is pulled proximally, the second guidewire 122 remains in place within the external carotid artery. The longitudinal slot 134 allows for this proximal movement without interfering with the guidewire 122.

[0121] Upon full withdrawal of the sheath 130, leaving the covered main stent 50 positioned as shown in FIG. 9B, the sheath 130 is removed from the patient, leaving the second guidewire 122 in place as shown. Note that with the visual aid (e.g. X-ray) of the radiopaque markers, the covered main stent 50 can be rotated, if necessary, to ensure alignment of the opening 54 with the lumen (passageway) of the branching external carotid artery “c”.

[0122] A second delivery catheter or sheath 140, containing the covered branch stent 80 of FIG. 4 is then inserted over the second guidewire 122 and through the expanded covered main stent 50, exiting through opening 54 and into the branching vessel, e.g. the common carotid artery. (FIG. 9B) The sheath 140 is withdrawn proximally allowing the covered branch stent 80 to expand against the vessel wall. Note that only a portion of the covered branch stent 80 is advanced through the side opening 54, leaving the flanged proximal portion within the interior of the covered main stent 50, (see FIG. 9C) abutting the internal walls of the main stent 50 adjacent the side opening 54, to ensure the branch stent 80 does not become detached.

[0123] The sheath 140 is then fully withdrawn and removed from the body, allowing the stent 87 to expand and press the graft 81 against the wall of the external carotid artery as shown in FIG. 9C. (The stent 87 is also preferably composed of shape memory material and expands to its memorized configuration). Note that the diameter of the distal end 60 of the graft 52 is smaller than the diameter of the proximal end 62 to conform to the anatomical diameter differences of the carotid arteries. This difference can be achieved by a smaller or tapered graft and stent or merely by the restriction of the vessel wall providing a counterforce against the stent.

[0124] FIG. 10 shows an alternate embodiment of a covered branch stent positioned in the external carotid artery. The branch stent 100 has petals 106 similar in configuration and function to the petals of branch stent 80 of FIG. 4 but has a smooth proximal flanged end (shown in phantom) similar to branch stent 90 of FIG. 7. It should be appreciated that a branch stent having petals only at its proximal flanged end and a smooth surface at its distal end can also be utilized. Likewise, the main stent can optionally have petals on the distal end, proximal end or both the distal and proximal ends. The petals preferably flare out so they have a greater diameter than the other graft portions to ensure contact with the vessel wall if the vessel wall dilates. Various configurations of the petals are contemplated such as providing a narrowed waist portion and length greater than the waist portion.

[0125] FIG. 11 illustrates the main covered stent 70 of FIG. 3 implanted in the left common and internal carotid arteries. This covered stent 70 can be utilized with any of the aforedescribed covered branch stents.

[0126] FIGS. 12-21 are directed to a delivery system and methods for insertion of a bifurcated covered stent of the present invention, such as stents 10 and 30 of FIGS. 1A and 1C. For convenience, covered stent will be designated by reference numeral 110, with main stent or stent portion 121, main graft portion or leg 116, side branch stent or stent portion 123, and side branch graft portion or leg 118. Covered stent 110 can optionally have petals, in the form described above, as shown. As can be appreciated, as with the embodiments of FIG. 1, either a single stent with various stent portions cooperating with the respective main and side graft portions or multiple stents, each cooperating with a respective portion of the graft, can be utilized.

[0127] With reference first to FIGS. 12A-12C, the delivery system includes a delivery catheter 61. The delivery catheter 61 is inserted through the femoral artery and extends to the right common carotid artery “a”. Contained within delivery catheter 61, is a concentric insertion tube 62 which contains main stent delivery sheath 63 and branch stent delivery sheath 64. These delivery sheaths 62, 63 are preferably tubular with delivery sheath 63 having a larger diameter than the diameter of delivery sheath 64 so that sheath 64 is positioned inside. Branch delivery sheath 64 extends outwardly thought slot 69 (see e.g. FIG. 16B) in main delivery sheath 63, and at an angle thereto, to access the branching vessel.

[0128] Main graft leg 116 and underlying stent 121 of covered stent 110 are retained inside main delivery sheath 63; branch graft leg 118 and underlying stent 123 are retained within branch delivery sheath 64. Withdrawal of delivery sheath 63 consequently exposes main graft leg 116 to allow expansion of leg 116 and underlying stent 121 against the target vessel wall. Similarly, withdrawal of delivery sheath 64 exposes branch graft leg 118 to allow expansion of leg 118 and underlying stent 123 against the wall of the branching vessel.

[0129] Turning now to FIGS. 13-21 the method of inserting the bifurcated stent utilizing the delivery system of FIG. 12 will now be described. With reference first to FIG. 13, guidewires 19a, 19b are both inserted through the femoral artery in the patient's leg, through the aorta and around the aortic arch “d” into the right common carotid artery “a”. Guidewire 19a extends through the common carotid artery “a” into the right internal artery “b”, past the target region of stenosis containing plaque “P”. Guidewire 19b extends through the common carotid artery “a” into the right external artery “c”. An angioplasty balloon (not shown) is introduced over the guidewire 19a to pre-dilate the vessel.

[0130] After insertion of the guidewires 19a, 19b, the delivery catheter 61 containing the insertion tube 62, main stent delivery sheath 63 and branch stent delivery sheath 64 are inserted over the guidewires 19a, 19b respectively, into the right common carotid artery “a” as shown in FIG. 14. Note the delivery catheter 61 is removed from FIGS. 14-21 for clarity. Insertion tube 62 is advanced over the guidewires 19a, 19b, in the direction of the arrow of FIG. 14 through the common carotid artery “a” toward the juncture of the right internal carotid and right external carotid arteries to the position of FIG. 15 where the distal end 67 of insertion tube 62 is adjacent the juncture.

[0131] The insertion tube 62 is then withdrawn proximally as shown in FIGS. 16A and 16b, to uncover the main and branch delivery sheaths 63, 64. This uncovering allows the sheaths 63, 64 to branch towards their target vessels as shown. As can be appreciated, delivery sheath 64 extends inside sheath 63, emerging through slot 69 towards the branching vessel, e.g. the external carotid artery. The insertion tube 62 is further withdrawn in the direction of the arrow of FIG. 16B, and removed through the femoral access artery, leaving the delivery sheaths 63, 64 in position as shown. The delivery sheaths 63, 64 are then advanced so that sheath 63 continues to advance over guidewire 19a into the stenosed region of the right internal carotid artery “b” adjacent plaque “P” and sheath 64 continues to advance over guidewire 19b into the right external carotid artery “c”. The delivery system is now in position for deployment of the bifurcated covered stent 110.

[0132] Delivery sheath 63 is withdrawn proximally in the direction of the arrow of FIG. 18, exposing covered stent main graft leg 116 (with underlying stent 121) allowing it to expand against the vessel wall. The underlying stent 121 (shown partially and schematically) is preferably composed of shape memory material, such as Nitinol, that expands from a smaller configuration to a larger memorized configuration inside the body. Further withdrawal of delivery sheath 63 as depicted in FIG. 19 fully exposes main graft leg 116 so the stent and graft expand against the vessel wall in the desired position. Note that the main leg 116 extends through a slit 71 in branch stent delivery sheath 64. Main leg 116 is now in position to treat the stenosed region while providing fluid communication between internal and common carotid arteries “b”, “a”, respectively.

[0133] To deploy branch graft leg 118, delivery sheath 64 is withdrawn in the direction of the arrow of FIG. 20A, thereby exposing leg 118 and allowing the graft and underlying branch stent 123 to expand against the vessel wall. Delivery sheath 64 is then fully withdrawn leaving the bifurcated covered stent 110 implanted as shown in FIG. 20B. As can be appreciated, the bifurcated covered stent 110 advantageously allows blood flow though the external carotid artery “c” and common carotid artery “a” which would otherwise be cut off.

[0134] FIG. 20C illustrates an alternate method of covered stent insertion. Instead of the automatic expansion of the stent in FIGS. 14-20B due to their shape memory material, the stent is expanded by a conventional balloon catheter. As shown in FIG. 20C, which is a view similar to FIG. 17, balloon catheter 150, shown in phantom, is inserted within the sheath 163, so that the balloon 152 underlies the stent. Inflation of the balloon, radially expands the covered stent against the vessel wall. Two methods of utilizing the balloon catheter for stent deployment are contemplated. In one embodiment, after the balloon 152 of balloon catheter 150 is used to expand the stent in the internal carotid artery “b”, balloon 152 is deflated, catheter 150 is withdrawn from the internal carotid artery, and advanced into the external carotid artery “c”. Balloon 152 is then inflated to expand the stent into position in the external carotid artery. In an alternate method, balloon catheter 152 is used to expand the stent in internal carotid artery “b” and a similar balloon catheter with an inflation balloon (not shown) is used to expand the stent in the external carotid artery “c”. When using two balloon catheters, the balloons can be inflated sequentially or simultaneously for sequential or simultaneous deployment of the stents in the internal and external carotid arteries.

[0135] FIGS. 20D and 20E are views similar to FIG. 17, except showing guidewires 119a and 119b extending into the internal and external carotid arteries, respectively. Guidewires 119a, 119b differ from guidewires 19a, 19b in that distal protection devices 124a and 124b for capturing embolic plaque are positioned on the distal ends of the guidewires 119a, 119b. These distal protection devices 124a, 124b are configured to capture embolic plaque which may become dislodged during the stent insertion surgical procedure.

[0136] FIGS. 21A-21C illustrate an alternate method of inserting the bifurcated stent of the present invention. This method is similar to the method of FIGS. 13-20, except that instead of two guidewires initially inserted and extending up into the external and internal carotid arteries, a single guidewire extends into the internal carotid artery “b” and a “dummy wire” 15 is utilized for guidance to the external carotid artery “c”. More specifically, guidewire 19a is inserted in FIG. 21A in the same manner as FIG. 14. Wire 15, as shown, extends towards, but not into the external carotid artery “c”. When delivery sheaths 63, 64 are advanced as in FIG. 21B, the wire 15 is likewise advanced into the external carotid artery “c”. Delivery sheath 63 is withdrawn as shown in FIG. 21C, exposing the main graft leg 116. Delivery sheath 64 is then withdrawn in the same manner as described above in FIGS. 19-20 as the remaining implantation steps are identical to FIGS. 19-20.

[0137] It should be appreciated that the foregoing methods can be utilized to insert the covered stent in the left carotid arteries, or other branching vessel junctures. Also, alternatively, the stent and graft for the external carotid artery “c” can be uncovered first, followed by uncovering of the internal carotid artery “b”.

[0138] FIGS. 22-24 illustrate three versions of the stent and associated graft of the present invention. Only a portion of the stent and graft are shown for convenience, it being understood that the stent and graft will have a sidewall opening, the graft can optionally have petals at the proximal and/or distal end, etc. as in the covered stents described in the aforementioned embodiments.

[0139] FIGS. 23A and 23B reflect the covered stent configuration described in the FIGS. 1-11 above, but has been provided with new reference numerals for convenience. Covered stent 200 of FIG. 23 has an outer graft material or layer 202 and inner stent 204. When stent 204 is expanded, outer graft layer 202 is compressed between the inner stent 204 and the vessel wall.

[0140] In FIGS. 22A and 22B, a stent 210 has a graft material or layer 212 on the inside of the stent 214 as shown. The graft material can be attached to stent 210, for example, by adhesive, over molding or suture. When stent 210 expands, the attached graft material (layer) is carried by the overlying stent 214 to an expanded condition. The stent 214 is therefore positioned between the graft 212 and the vessel wall and does not come in contact with the blood. The blood contacts the underlying graft material 212.

[0141] In FIGS. 24A and 24B, the covered stent 220 has two layers of graft material, namely outer layer 222 and inner layer 224. The stent 226 can either be embedded in the graft material layers or attached by various methods such as adhesive, over molding or suture. When expanded, the outer layer 222 will be sandwiched between the expanded stent 226 and the vessel wall and the inner layer 224 will contact the blood and prevent blood contact with stent 226.

[0142] FIG. 25 illustrates a stent 300 having a side opening 302 in an intermediate portion. This illustration is provided to show the positioning of an opening in the stent as described above which would align with the respective opening in the graft of the above-described embodiments to enable insertion of a branch stent and maintenance of blood flow through the branching vessel.

[0143] FIGS. 28 and 29 illustrate an alternate configuration for treating bifurcated vessels. A pair of coil spring style stents 602, 612, each having a large diameter region 603, 613 and a smaller diameter region 605, 615 are intertwined to form a coil 600. The distal end of the larger diameter regions terminates at the juncture of the branching vessel, with the smaller diameter region 605 extending into the main vessel “x” and the smaller diameter region 615 extending into the branching vessel “y”. If desired the coils 602, 612 can be used with graft material. In this case, both smaller diameter regions 605, 615 would include graft material, but only one of the larger diameter regions 603, 613 would have graft material to expose the other coiled region to enable these larger diameter regions to intermesh to secure the coils 602, 612 together.

[0144] FIGS. 30-32 illustrate several different tube like stents for treating bifurcated vessels. These bifurcated stents, shown in their expanded configuration, are preferably formed from a tube which is cut, e.g. laser cut, to the configuration shown. One advantage of these bifurcated stents of FIGS. 30-32 is that they do not change in axial length when they are compressed for insertion or change in axial length when expanded for placement in the vessel. The bifurcation is shown only in FIG. 30, it being understood that the embodiments of FIGS. 31 and 32 are similarly bifurcated.

[0145] In the first embodiment of the tubular stents, shown in FIG. 30, stent 700 is cut to form a main portion 708 and a bifurcated portion 707 extending distally from intermediate region 705 and at an angle to main portion 708. Stent 700 is shown in the expanded configuration. Stent 700 is cut to form a longitudinally extending spine 702 on bifurcated portion 707 and main portion 708 with a series of radial ribs or loops 704 terminating at tips 706. Each of the radial ribs 704 forms a C-shape with the opposing tips or tangs 706 terminating opposite one another. When compressed, each tip 706 overrides the opposing tip. Additionally, as shown, the tips 706 of ribs 704 of bifurcated portion 707 interleave with tips 706 of ribs 704 of main portion 708 to reduce the cross-sectional area in the collapsed configuration to aid insertion. Thus, the ratio between the unexpanded delivery configuration and the expanded configuration is improved.

[0146] In the embodiment of FIG. 31, the radial ribs 904, extending from linear spine 902, are offset as shown so the opposing adjacent tips 906 interleave, resulting in a smaller cross-sectional area, i.e. smaller diameter, to facilitate insertion. Only a portion of the main portion of the stent is shown, since the remaining main portion, as well as the bifurcated portion, follows the same spine/rib pattern.

[0147] In the embodiment of FIGS. 32A and 32B, increased uniform rigidity of the tube-like stent 800 is achieved by alternating the radial position of the spine rather than the continuous linear configuration of spine 702 or 902 of stents 700 or 900. FIG. 32 illustrates a segment of the stent 800 (in the expanded configuration) to show the staggering of spine 802. The remaining portion of the stent 800 follows the same staggered spine/rib configuration and stent 800 is bifurcated (not shown), i.e. a portion extends distally at an angle to the main portion, in the same manner as tube-like stents 700, 900 to accommodate bifurcated vessels. A transition portion similar to the configuration of FIG. 30 can optionally be formed in an intermediate region to help form the bifurcation. As can be seen, the spine 802 has longitudinally extending segments, for example segments 802a, 802b, 802c, that are spaced both radially and axially. Bifurcated stent 800 is consequently not only less flexible then stents 700 and 900 but also is symmetrically (uniformly) flexible in that it will have the same degree of flexibility in all orientations. Tips 806 of ribs 804 will overlap when stent 800 is compressed in a similar manner as tip 706 of stent 700. Portions of the stents 700, 800, and 900 of FIGS. 30-32, if desired, can be used with graft material.

[0148] FIGS. 33A and 33B illustrate another embodiment of a bifurcated stent, in the form of a spring like element 650 with a supporting spine 652. The spine 652 is axially and radially staggered similar to the spine of FIG. 32. However, the stent has a helical spring configuration which will elongate when radially compressed and reduce in length when expanded. Stent 650 is shown in a compressed configuration with adjacent tips or tangs 656 interleaving in a similar fashion as will tips 906 of stent 900. Only a portion of the stent 650 is shown, it being understood that the remainder of the main portion as well as the bifurcated portion of the stent (which extends at an angle like the bifurcation of the stent of FIG. 30) will have the same spine/rib pattern. A transition portion similar to the configuration of FIG. 30 can optionally be formed in an intermediate region to help form the bifurcation. Stent 650 can be laser cut from a tube. Portions of the stent 650 can be provided with graft material.

[0149] FIG. 26 is a perspective view of an alternative approach to accommodate a branching vessel which utilizes a pair of juxtaposed covered stents with angled adjacent ends to accommodate blood flow from a branching vessel. This is a different approach than the aforedescribed approaches which involve implantation and utilization of a stent, either covered or uncovered, having an integral or independently attachable branch extending from the main portion. In the previous approaches, the main portion was placed in one vessel and the branch extended into a branching vessel to provide fluid communication with the main vessel and branching vessels.

[0150] In the approach of FIG. 26, a pair of covered stents 400, 410 each having angled ends 402, 412 is provided to prevent blocking off the branching vessel. Covered stent 400 is placed adjacent the juncture of the branching vessel, e.g. the common carotid artery “a”, at the upstream end. Covered stent 410 is also placed adjacent the juncture, but extends downstream of the juncture, e.g. into the internal carotid artery “b”. The covered stents 400, 410 preferably abut at edges 404, 414, with angled ends 402, 412 extending towards the branching vessel, thereby creating an opening for the passage of blood to the branching vessel, e.g. the external carotid artery “c.” The angle preferably ranges from about 30 degrees to about 60 degrees, although other angles to accommodate blood flow are also contemplated. Also, by angling the ends of these covered or uncovered stents, intraluminal access to the branching vessel is enabled. It is also contemplated that a single covered or uncovered stent can be utilized, placed upstream of the juncture, e.g. in the common carotid artery “a”, as shown in FIG. 27, so the angled end 504 of covered stent 500 will enable blood flow into the branching vessel, e.g. the external carotid artery “c”.

[0151] As can also be appreciated, even though covered stents 400, 410, 500 are shown with underlying stents 406, 416, 516 and overlying graft material 408, 418, 518 respectively, the covered stents can alternatively have the graft material on the inside or both the outside or inside as described above with the other covered stent embodiments.

[0152] In yet another approach, stent 300 of FIG. 25 can be used without a graft material and placed in the vessel such that the opening 302 aligns with the lumen (passageway) in the branching vessel. If an uncovered stent is placed at the juncture of a branching vessel, although blood flow will not be completely closed off, it will be restricted because the blood will need to flow through the links or wires of the stent. Such uncovered stents would also limit future access to the branching vessel, as described above, because intraluminal access would be restricted by the links or wires. The opening 302 in stent 300 overcomes these problems. For example, stent 300 can be placed in the common carotid artery, extending into the internal carotid artery, across the juncture of the external carotid artery. The opening 302 can be aligned with the external carotid artery to allow unobstructed flow between the common carotid and external carotid arteries. This may also reduce the buildup of thrombotic material which might otherwise occur if the blood flowed through the wire mesh 304 into the external carotid artery.

[0153] Stent 300 can also be utilized in another approach wherein it has a graft material, either on the inside, outside, or both the inside and outside as described above, and is implanted without a branch portion or branch stent. For example, the stent would extend from the common carotid artery into the internal carotid artery. The opening 302 would align with the opening in the graft material and allow fluid communication with the branching vessel, e.g. the external carotid artery, as well as intraluminal access to the branching vessel.

[0154] While the above description contains many specifics, those specifics should not be construed as limitations on the scope of the disclosure, but merely as exemplifications of preferred embodiments thereof. For example, although use of a single stent is described for the main graft portion, it is also contemplated that more than one stent can be utilized to retain the main graft portion. Additionally, optionally multiple layers of graft material can be placed on the inside, outside or both the inside and outside of the stent. Also, the foregoing covered and uncovered stents of the present invention were described for use in carotid arteries, however as noted above, it is clearly contemplated that these covered and uncovered stents can be utilized in other vessels such as the coronary arteries, the descending aorta and renal arteries, the external iliac and internal iliac arteries and the common femoral and deep femoral arteries. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the disclosure as defined by the claims appended hereto.