Endovascular prosthesis delivery system

Abstract

An endovascular prosthesis delivery system is disclosed. The delivery system includes an elongated delivery device including a delivery device longitudinal axis. The elongated delivery device is coupled to an endovascular prosthesis via a connection portion. The connection portion is configured to decouple from the endovascular prosthesis or the delivery device when an electrical current is applied to the delivery device. The endovascular prosthesis and the elongated delivery device in an unsheathed state are rotatable relative to one another about the delivery device longitudinal axis.

Description

[0001] Reference to Related Applications

[0002] This application claims the benefit under 35 U.S.C., § 119(e) of provisional patent application No. 63 / 100,125, filed February 28, 2020, the contents of which are incorporated herein by reference. TECHNICAL FIELD

[0003] In one aspect, the present invention relates to an intravascular prosthesis delivery system. In another aspect, the present invention relates to a method of treating an aneurysm in a patient. Other aspects of the present invention will be apparent to those of ordinary skill in the art in view of the description herein. BACKGROUND

[0004] As known in the art, an aneurysm is an abnormal outward bulge in an artery wall. In some cases, the bulge can be in the form of a smooth bulge outward from the artery in all directions, which is referred to as a “fusiform aneurysm.” In other cases, the bulge can be a sac that bulges from a branch point of the artery or from one side of the artery, which is referred to as a “saccular aneurysm.”

[0005] While aneurysms can occur in any artery of the body, aneurysms that occur in the brain often lead to the occurrence of a stroke. Most saccular aneurysms that occur in the brain have a neck that extends from the brain blood vessel and widens into a pocket that protrudes away from the blood vessel.

[0006] The problems caused by such aneurysms can occur in a variety of different ways. For example, if an aneurysm ruptures, blood enters the brain or the subarachnoid space (i.e., the space that closely surrounds the brain) — the latter is referred to as an aneurysmal subarachnoid hemorrhage. One or more of the following symptoms can then occur: headache, nausea, vomiting, double vision, neck stiffness, and loss of consciousness. Aneurysmal subarachnoid hemorrhage is an emergency that requires immediate treatment. In fact, 10-15% of patients die before reaching the hospital for treatment. Over 50% of patients die within the first 30 days after the hemorrhage. Of the patients that survive, about half suffer a permanent stroke. Some of these strokes occur within 1-2 weeks after the cerebral vasospasm caused by the subarachnoid hemorrhage.

[0007] Aneurysms can also cause problems unrelated to hemorrhage, although this is less common. For example, an aneurysm can form a blood clot within itself that can break away from the aneurysm and be carried downstream where it can block an arterial branch and thus cause a stroke (e.g., ischemic stroke). In addition, an aneurysm can also compress nerves or adjacent brain (which can cause paralysis or abnormal sensation in one eye or face, seizures, or other neurological symptoms).

[0008] In view of the potentially fatal consequences of aneurysms, especially cerebral aneurysms, various approaches have been used in the art to address the treatment of aneurysms.

[0009] Generally, aneurysms can be treated from the outside of the blood vessel using surgical techniques, or from the inside using endovascular techniques (the latter falling within the broad category of interventional (i.e. non-surgical) techniques).

[0010] Surgical techniques generally involve craniotomy, which requires the formation of an opening in the skull of the patient through which the surgeon can insert instruments to operate directly on the brain. In one approach, the brain is retracted to expose the blood vessel from which the aneurysm has arisen, and the surgeon then clamps a clip on the neck of the aneurysm, thereby preventing arterial blood from entering the aneurysm. If there is a clot in the aneurysm, the clip also prevents the clot from entering the artery and causing a stroke. After the clip has been correctly placed, the aneurysm disappears within a few minutes. Surgical techniques have historically been the most common method of treating aneurysms. Unfortunately, surgical techniques for treating these conditions are considered to be major surgery with high risk to the patient, and require the patient to be in a state of at least a chance of surviving the operation.

[0011] As noted above, endovascular techniques are non-surgical techniques, and are generally performed in an angiographic suite using a catheter delivery system. In particular, known endovascular techniques involve filling the aneurysm with a material that prevents arterial blood from entering the aneurysm, thereby causing the aneurysm to occlude - this technique is widely known as embolisation.

[0012] One example of this approach is the use of electrolytically detachable coils, which involves endovascular occlusion of the aneurysm by a system that utilises a platinum coil attached to a stainless steel delivery wire and electrolytic detachment. Thus, once the platinum coil has been placed in the aneurysm, it detaches from the stainless steel delivery wire by electrolytic dissolution. In particular, the patient's blood and a saline infusion serve as the conductive solution. The anode is the stainless steel delivery wire, and the cathode is a ground needle placed in the patient's groin. Once current is passed through the stainless steel delivery wire, electrolytic dissolution occurs in the uninsulated segment of the stainless steel detachment zone immediately adjacent to the platinum coil (the platinum coil is of course unaffected by the electrolysis).

[0013] Other approaches to filling the aneurysm sac involve the use of materials such as cellulose acetate polymers.

[0014] While these endovascular approaches have facilitated technological development, they have drawbacks. In particular, the risks of these endovascular approaches include aneurysm rupture during the procedure or stroke (e.g., ischemic stroke) due to distal embolization from the device or aneurysm clot. In addition, long-term results of endovascular aneurysm occlusion using these techniques have also been worrisome. In particular, there is evidence of intra-aneurysmal reorganization of the filling material and reappearance of the aneurysm on follow-up angiography.

[0015] One particular type of cerebral aneurysm that has proven to be very difficult to treat, especially using the above surgical clipping or endovascular embolization techniques, is an aneurysm that occurs at a bifurcation, where the parent artery branches into two smaller branch arteries. One example of this type of aneurysm is an aneurysm that occurs at the terminal bifurcation of the basilar artery. Successfully treating bifurcation aneurysms (e.g., using surgical clips) is very difficult, at least in part because all brainstem perforating vessels must be avoided during placement of the surgical clip.

[0016] Unfortunately, sometimes the size, shape, and / or location of an aneurysm makes surgical clipping and endovascular embolization impossible for a particular patient. Generally, the prognosis for such patients is poor.

[0017] Thus, while the prior art has made progress in the field of aneurysm treatment, there is still room for improvement, especially in the area of endovascular embolization, as it is such an attractive alternative to open surgery.

[0018] In International Publication No. WO 99 / 40873 [Marotta et al. (Marotta)] published August 19, 1999, a new endovascular method is taught that can be used to occlude an aneurysm opening, particularly the opening of a saccular aneurysm, thereby causing the aneurysm to be occluded. The method is truly endovascular in that it uses an endovascular prosthesis taught by Marotta that does not require the use of a material to fill the aneurysm sac (e.g., a material used with electrolytically detachable coils). Rather, the endovascular prosthesis taught by Marotta works on the principle of plugging the opening of the aneurysm sac, thereby eliminating the need for a filling material. Thus, the endovascular prosthesis taught by Marotta is a significant advance in the art because it eliminates or mitigates many of the shortcomings of the prior art. The endovascular prosthesis taught by Marotta includes a leaflet portion that can be pushed against the aneurysm opening to thereby close the aneurysm. In the endovascular prosthesis taught by Marotta, the leaflet portion is attached to a main body that includes at least one inflatable portion and is independently movable relative to the main body. The inflatable portion is inflatable from a first, un-inflated state to a second, inflated state under the action of a radially outward force. Thus, the main body is used to secure or anchor the endovascular prosthesis in place in a target body passageway or vessel lumen near the aneurysm opening, while the leaflet portion is used to seal the aneurysm opening, thereby causing the aneurysm to be occluded. Thus, as taught by Marotta, the leaflet portion acts and moves independently of the main body of the endovascular prosthesis.

[0019] International Publication Nos. WO 2012 / 145823 Al and WO 2012 / 145836 [both in the name of Tippett et al. (Tippett #1)] teach an endovascular prosthesis and an endovascular prosthesis delivery device. The endovascular prosthesis disclosed by Tippett #1 is an improvement over the endovascular device disclosed by Marotta in that the former is designed to enable the physician to retrieve the device so that the device can be repositioned for optimal placement before the device is detached from the delivery system. The endovascular prosthesis delivery device disclosed by Tippett can take the form of a number of different embodiments.

[0020] International Announcement No. WO 2018 / 058254A1 [Fung et al. (Fung)] teaches an intravascular prosthesis delivery device, an improvement upon the device taught in Tippett #1. The intravascular prosthesis delivery device taught by Fung includes a combination of a delivery frame element and a central insert element, these elements being secured to each other by a first retaining element. A prosthesis attachment area for coupling to an intravascular prosthesis is provided at the distal portion of the delivery frame element. When disengagement of the intravascular prosthesis is required, the first retaining element is mechanically disengaged to allow relative movement between the central insert element and the delivery frame element. A traction wire assembly is fixed relative to the central insert element and includes a traction wire coupled to the intravascular prosthesis in the prosthesis attachment area of ​​the delivery frame element. Once the first retaining element is mechanically disengaged by the physician (which is done when the intravascular prosthesis is in the correct disengagement position), the physician can retract the central insert, which has the effect of retracting the traction wire from the prosthesis attachment area of ​​the delivery frame element. Now, the intravascular prosthesis and the intravascular prosthesis delivery device are detached from each other, and the latter can be removed from the patient's body.

[0021] While Fung's teaching device is a significant advancement in the field, there is still room for improvement.

[0022] First, due to the number of components located at the far end (see Fung's...) Figures 7-8 The annular design of the illustrated embodiment of the device makes it difficult to produce delivery devices with small profiles (e.g., less than 0.034 inches). With a profile of 0.034 inches, it is primarily suitable only for large vessels, such as the secondary basilar artery or primary carotid artery. This accounts for only 12-15% of the neurovascular systems where aneurysms may occur.

[0023] Secondly, during clinical development of the Fung delivery device using the delivery method taught in International Bulletin No. WO 2014 / 066982 [Tippett#2] (see paragraph

[0042] of Fung), it is necessary to use two delivery lines as described in Tippett#2. Figures 11-16 The guidewire shown. This presents problems for two reasons: (i) it adds an extra step to the surgeon's procedure of delivering the prosthesis, and (ii) delivering the second guidewire to the second key channel at the bifurcation is challenging due to the small distance (3-4 mm) from the distal end of the Hypotube delivery device to the opening of the second key channel (see Tippett #2). Figure 14 (Conveying device 200 and secondary channel 20).

[0024] Third, refer to Fung's Figure 12The axial rotational movement of the elongated endovascular prosthesis 100 about the pull wire 45 via the attachment ring 95 is relatively limited, i.e. the rotation of the longitudinal axis of the elongated endovascular prosthesis 100 about the longitudinal axis of the pull wire 45 is limited to about 130°. This limits the freedom of the physician to position the prosthesis.

[0025] While electrolytic detachment of a prosthesis from a delivery system is known, no known delivery system has been able to avoid or mitigate the above-mentioned problems while delivering an endovascular prosthesis (using electrolytic detachment or otherwise) to the best of the inventor's knowledge.

[0026] Therefore, there remains a need in the art for an endovascular prosthesis delivery device that is able to overcome at least some of the problems of the Fung delivery device described above, if not all of them. It would be even more desirable if such an endovascular prosthesis delivery device was easier to manufacture and easier to use for delivering and implanting an endovascular prosthesis. It would be highly advantageous if a simpler and more reliable mechanism was available for detaching an endovascular prosthesis from a delivery device. SUMMARY

[0027] It is an object of the present invention to eliminate or mitigate at least one of the above-mentioned drawbacks of the prior art.

[0028] It is another object of the present invention to provide a new endovascular prosthesis delivery system.

[0029] Therefore, in one aspect, the present invention relates to an endovascular prosthesis delivery system comprising an elongated delivery device having a delivery device longitudinal axis, the elongated delivery device being coupled to an endovascular prosthesis by a connection portion configured to detach from the endovascular prosthesis or the delivery device when an electric current is applied to the delivery device, the endovascular prosthesis being in an unsheathed state, the elongated delivery device being rotatable relative to each other about the delivery device longitudinal axis.

[0030] In another aspect, the present invention relates to a method for delivering an endovascular prosthesis to a bifurcated vasculature of a patient, the bifurcated vasculature comprising a primary passageway and at least one secondary passageway to define an intersection having an aneurysm opening where an aneurysm is located, the method comprising the steps of:

[0031] (i) advancing a guidewire through the primary passageway into the secondary passageway;

[0032] (ii) advancing a catheter surrounding the guidewire through the primary passageway into the secondary passageway;

[0033] (iii) removing the guidewire from the patient;

[0034] (iv) advancing the intravascular delivery system of the present application (in any of its embodiments) to the distal end portion of the catheter;

[0035] (v) retracting the catheter relative to the intravascular prosthesis to expose the anchoring portion of the intravascular prosthesis;

[0036] (vi) implanting the anchoring portion of the intravascular prosthesis into the secondary passageway;

[0037] (vii) further retracting the catheter relative to the intravascular prosthesis to expose the blood-occlusion portion of the intravascular prosthesis;

[0038] (viii) aligning the blood-occlusion portion of the intravascular prosthesis with the aneurysm opening;

[0039] (ix) implanting the blood-occlusion portion of the intravascular prosthesis to occlude the aneurysm opening;

[0040] (x) applying an electric current to the elongated delivery device;

[0041] (xi) detaching the connecting portion from the elongated delivery device; and

[0042] (xii) withdrawing the elongated delivery device and the catheter from the patient’s body.

[0043] In another aspect, the present application relates to a method for delivering an intravascular prosthesis to a bifurcated vasculature of a patient, the bifurcated vasculature comprising a primary passageway and at least one secondary passageway to define an intersection at which an aneurysm having an aneurysm opening is located, the method comprising the steps of:

[0044] (i) advancing a guidewire through the primary passageway into the secondary passageway;

[0045] (ii) advancing a catheter surrounding the guidewire through the primary passageway into the secondary passageway;

[0046] (iii) withdrawing the guidewire from the patient’s body;

[0047] (iv) abutting a distal end of the intravascular prosthesis delivery system of the present application (in any of its embodiments) comprising an encapsulating sheath against a proximal end of the catheter;

[0048] (v) advancing the elongated delivery device and the intravascular prosthesis to the distal end portion of the catheter while keeping the encapsulating sheath outside the patient’s body;

[0049] (vi) retracting the catheter relative to the intravascular prosthesis to expose the anchoring portion of the intravascular prosthesis;

[0050] (vii) implanting the anchoring portion of the intravascular prosthesis into the secondary passageway;

[0051] (viii) further retracting the catheter relative to the endovascular prosthesis to expose the blood occlusion portion of the endovascular prosthesis;

[0052] (ix) aligning the blood occlusion portion of the endovascular prosthesis with the aneurysm opening;

[0053] (x) implanting the blood occlusion portion of the endovascular prosthesis to occlude the aneurysm opening;

[0054] (xi) applying an electrical current to the elongated delivery device;

[0055] (xii) decoupling the connecting portion from the elongated delivery device; and

[0056] (xiii) withdrawing the elongated delivery device and the catheter from the patient's body.

[0057] The term "occlude" as used in this specification is intended to have a broad meaning, including block, cover, obstruct, and / or close. The endovascular prosthesis used in conjunction with the endovascular prosthesis delivery system of the present invention is generally configured to initially block the aneurysm opening of the target aneurysm. This results in the interruption or reduction of blood flow into the aneurysm, which in turn causes thrombosis within the aneurysm sac and ultimately results in the occlusion of the aneurysm.

[0058] Accordingly, the present inventors have developed a novel endovascular prosthesis delivery system. The endovascular prosthesis delivery system of the present invention comprises a combination of an elongated delivery device having a delivery device longitudinal axis. The delivery system further comprises a connecting portion at its distal end and an endovascular prosthesis coupled to the connecting portion. The connecting portion is configured to decouple from the elongated endovascular prosthesis or delivery device when an electrical current is applied to the delivery device. Importantly, the endovascular prosthesis is configured to be rotatable about the delivery device longitudinal axis in an unsheathed state. The endovascular prosthesis delivery system of the present invention has many advantages.

[0059] First, unlike conventional endovascular prosthesis delivery devices, the present system can be used to push the endovascular prosthesis to the desired location by twisting and maneuvering the elongated delivery device. This operation is accomplished without the need to use any guidewire to guide the delivery device / endovascular prosthesis to the correct location in the vasculature. In essence, the elongated delivery device of the present system functions much like a guidewire.

[0060] Second, the endovascular prosthesis delivery system of the present invention has a very small profile. For example, one preferred embodiment of the endovascular prosthesis delivery system has a profile that is much less than 0.034 inches. This allows access to almost all neural vessels where aneurysms can occur (at least much more than is possible with the Fung device described above).

[0061] Third, the requirement of using two guide wires in the above-mentioned Tippett #2 taught delivery of an endovascular prosthesis is avoided. Thus, the physician is spared an additional step in prosthesis delivery and the difficulties associated with delivering a second guide wire to a second, secondary passageway of the bifurcation are avoided.

[0062] Fourth, the endovascular prosthesis delivery system of the present invention is characterized by the ability to impart an axial rotation of the endovascular prosthesis (in an unsheathed state) to a far greater extent than is possible using the above-mentioned Fung taught endovascular prosthesis delivery device (about 130°). In a preferred embodiment, the longitudinal axis of the endovascular prosthesis can be rotated axially about the longitudinal axis of the delivery device through 360° of a full circle or greater (e.g., multiple rotations, such as 720° and 1080°).

[0063] Fifth, the combination of the following preferred features facilitates access to the secondary passageway in a bifurcated vasculature: the flexibility and / or shaped (e.g., angled to accommodate the angles to the primary and secondary passageways) distal end portion of the elongated delivery device, the hinged connection between the elongated delivery device and the prosthesis (e.g., they are in a gimbaled relationship) and the ability of the prosthesis to prolapse. The dynamic hinged (e.g., gimbaled) relationship between the endovascular prosthesis and the elongated delivery device transitions from a relatively obtuse relationship to a relatively perpendicular relationship to a relatively acute relationship. This is a particular advantage of the endovascular prosthesis delivery system of the present invention, enabling the system to be achieved without the need for an additional guide wire, while still allowing access to the second primary passageway in a bifurcated passageway coupled to the end of the endovascular prosthesis of the elongated delivery device.

[0064] Sixth, the alignment steps in step (xiii) in

[0029] and step (ix) in

[0030] are generally in a linear plane. Surprisingly, in a preferred embodiment of the endovascular prosthesis delivery system of the present invention, a second, very advantageous alignment is in a rotational plane. This preferred embodiment relates to the situation in which the endovascular prosthesis delivery system of the present invention is used to deliver a device such as the above-mentioned Tippett #1 and Tippett #2 taught endovascular prostheses, i.e., an endovascular prosthesis having a blood occlusion or lobed portion that includes a median ridge having ribs attached thereto. The inventors have unexpectedly discovered that when the endovascular prosthesis delivery system of the present invention is used to deliver such an endovascular prosthesis, a rotational alignment of the latter occurs such that the median ridge automatically aligns with the outer curvature of the microcatheter, resulting in the median ridge being positioned below the neck of the aneurysm. This occurs consistently and is a serendipitous discovery. While not wishing to be bound by any particular theory or mode of action, the inventors believe that this can be due to the combination of the non-tubular nature of the endovascular prosthesis and the asymmetric mass of the median ridge (e.g., as taught by Tippett #1 and Tippett #2) with the ribs along the semi-circumference of the device.

[0065] The intravascular prosthesis delivery system of the present application includes two general embodiments.

[0066] In the first general embodiment, the connecting portion (or at least a portion thereof) is configured to be detachable from the elongated delivery device upon application of an electric current to the elongated delivery device. In the first general embodiment, the connecting portion (or at least a portion thereof) of the elongated delivery device is configured to remain coupled to the intravascular prosthesis after the connecting portion (or at least a portion thereof) is detached from the elongated delivery device. A preferred embodiment of the first general embodiment is shown in Figures 1-9 and discussed below. In many preferred versions of the first general embodiment, the connecting portion is completely severed from the elongated delivery device when an electric current is applied to the elongated delivery device, as shown in one example of such an embodiment in Figure 9 .

[0067] In the second general embodiment, the connecting portion (or at least a portion thereof) is configured to be detachable from the intravascular prosthesis upon application of an electric current to the delivery device. In the second general embodiment, the connecting portion (or at least a portion thereof) of the elongated delivery device is configured to remain coupled to the elongated delivery device after the connecting portion (or at least a portion thereof) is detached from the intravascular prosthesis. A preferred embodiment of the second general embodiment is shown in Figures 18-21 . In many preferred versions of the second general embodiment, the retaining portion (or at least a portion thereof) included in the connecting portion is erodible upon application of an electric current to the elongated delivery device. In some preferred versions, the erodible retaining portion can be disposed at the distal end of the connecting portion, and distal to the point of connection between the elongated intravascular prosthesis and the proximal portion of the connecting portion (e.g., as shown in Figure 18 , 20 and 21). In another preferred version, the erodible retaining portion can be disposed between the proximal and distal ends of the connecting portion, e.g., contiguous with the point of connection between the elongated intravascular prosthesis and the connecting portion (e.g., as shown in Figure 19 .

[0068] The "aligning" steps (step (viii) in paragraph

[0029] and step (ix) in paragraph

[0030] ) described above can include twisting the elongated delivery device of the delivery system independently or with the catheter. For example, this can be done to find an alternative secondary passageway of a bifurcated vasculature that will accept the distal portion of the blood occlusion portion of the intravascular prosthesis.

[0069] One aspect of the invention relates to a method for delivering an intravascular prosthesis to a patient's bifurcation vascular system, the method comprising the steps of: abutting the distal end of the intravascular prosthesis delivery system of the invention, including a sheath, against the proximal end of a catheter; and advancing the elongated delivery device and the intravascular prosthesis to the distal portion of the catheter while retaining the sheath outside the patient's body. A particular advantage associated with this aspect of the invention is that the physician can optionally retract the combination of the intravascular prosthesis and the elongated delivery device back into the sheath (outside the patient's body). Once this is completed, the physician can then manually modify the elongated delivery device (e.g., at its distal end), preferably before full sheathing, to increase the overall curvature of the delivery device along its longitudinal axis, thereby optimizing the directional pathway to alternative secondary channels in the bifurcation vascular system. Attached Figure Description

[0070] Embodiments of the present invention will now be described with reference to the accompanying drawings, wherein similar reference numerals denote similar parts, in which:

[0071] Figure 1 A perspective view showing a preferred embodiment of a first general implementation of the intravascular prosthesis delivery system of the present invention;

[0072] Figure 2 It shows Figure 1 A top view of the distal portion of the elongated delivery device of the intravascular prosthesis delivery system shown.

[0073] Figure 3 It shows Figure 1 Side elevation view of the distal portion of the elongated delivery device of the intravascular prosthesis delivery system shown.

[0074] Figure 4 It shows the use in Figures 2-3 A side view of the proximal portion of the core wire element in the elongated conveying device shown.

[0075] Figure 5 It shows Figure 1 An exploded view of the distal portion of the elongated conveying device shown.

[0076] Figures 6-7 It shows Figure 1 A cross-sectional view of the distal portion of the elongated conveying device shown;

[0077] Figure 8 The intravascular prosthesis was shown before detachment. Figure 1 An exploded view of the connection of the distal portion of the elongated conveying device shown.

[0078] Figure 9 This illustrates the intravascular prosthesis and its relationship after detachment. Figure 1exploded view of the connection of the distal end portion of the elongated delivery device shown;

[0079] Figures 10-17 a sequence showing the use of Figure 1 the intravascular prosthesis delivery system shown implanting an intravascular prosthesis in a bifurcated vasculature;

[0080] Figures 18-21 a distal end region of a plurality of different preferred embodiments of a second general embodiment of the intravascular prosthesis delivery system of the present invention is shown. DETAILED DESCRIPTION

[0081] In a first aspect, the present invention relates to an intravascular prosthesis delivery system comprising an elongated delivery device having a longitudinal axis of the delivery device, the elongated delivery device being coupled to an intravascular prosthesis by a connection portion, the connection portion being configured to be detachable from the intravascular prosthesis or the delivery device when an electric current is applied to the delivery device, the intravascular prosthesis being in an unsheathed state, the elongated delivery device being rotatable relative to each other around the longitudinal axis of the delivery device.

[0082] Preferred embodiments of this first aspect of the present invention can include any one of the following features or a combination of any two or more of the following features:

[0083] • the intravascular prosthesis is configured to be rotatable relative to the elongated delivery device around the longitudinal axis of the elongated delivery device by at least 180°;

[0084] • the intravascular prosthesis is configured to be rotatable relative to the elongated delivery device around the longitudinal axis of the elongated delivery device by at least 360°;

[0085] • the intravascular prosthesis is elongated and comprises a longitudinal axis of the prosthesis;

[0086] • the intravascular prosthesis in the unsheathed state is coupled to the elongated delivery device such that the longitudinal axis of the prosthesis is rotatable around the longitudinal axis of the delivery device;

[0087] • the intravascular prosthesis in the unsheathed state is coupled to the elongated delivery device such that the longitudinal axis of the prosthesis is rotatable around the longitudinal axis of the delivery device by at least about 180°;

[0088] • the intravascular prosthesis in the unsheathed state is coupled to the elongated delivery device such that the longitudinal axis of the prosthesis is rotatable around the longitudinal axis of the delivery device by at least about 360°;

[0089] • the connection portion is configured to extend distally along the longitudinal axis of the delivery device at its distal end portion relative to a connection point between the intravascular prosthesis and the elongated delivery device;

[0090] • the connection portion comprises a retaining element configured to couple the endovascular prosthesis to the elongated delivery device during delivery of the endovascular prosthesis;

[0091] • at least a portion of the retaining portion is erodible upon application of an electric current to the delivery device, enabling detachment of the endovascular prosthesis from the endovascular prosthesis;

[0092] • the retaining portion is disposed distally relative to a point of connection between the endovascular prosthesis and the elongated delivery device;

[0093] • the retaining portion is substantially T-shaped at its distal end;

[0094] • the retaining portion is substantially spherical at its distal end;

[0095] • the retaining portion is substantially wing-shaped at its distal end;

[0096] • the retaining portion is contiguous with a point of connection between the endovascular prosthesis and the elongated delivery device;

[0097] • the retaining portion comprises a wire element;

[0098] • the connection portion of the elongated delivery device comprises a first retaining element, a second retaining element, and a spacing element for maintaining the first retaining element and the second retaining element in spaced relation;

[0099] • one or both of the first retaining element and the second retaining element is substantially spherical;

[0100] • the endovascular prosthesis comprises an attachment portion coupled to the spacing element of the connection portion of the elongated delivery device;

[0101] • the first retaining element and the second retaining element are configured to retain the attachment portion of the endovascular prosthesis therebetween;

[0102] • the connection portion is configured to detach from the endovascular prosthesis upon application of an electric current to the delivery device;

[0103] • the connection portion is configured to detach from the elongated delivery device upon application of an electric current to the elongated delivery device;

[0104] • the connection portion of the elongated delivery device is configured to remain coupled to the endovascular prosthesis after detachment of the connection portion from the elongated delivery device;

[0105] • the connection portion comprises a male portion that engages a female portion disposed on the endovascular prosthesis;

[0106] • the female portion comprises a loop for receiving the male portion;

[0107] • the connecting portion comprises a female portion that engages a male portion disposed on the endoluminal prosthesis;

[0108] • the intermediate portion of the elongated delivery device, located proximal to the connecting portion, comprises a core wire element coupled to the connecting portion of the elongated delivery device;

[0109] • the core wire element is configured to be non-tubular (i.e., solid);

[0110] • the core wire element is configured to be tubular;

[0111] • the core wire element has an outer diameter in the range of about 0.0020 inches to about 0.0140 inches;

[0112] • the core wire element has an outer diameter in the range of about 0.0025 inches to about 0.0135 inches;

[0113] • the core wire element has a variable outer diameter;

[0114] • the core wire element has a variable outer diameter that gradually decreases from a proximal end to a distal end of the elongated delivery device;

[0115] • the core wire element has a substantially constant outer diameter;

[0116] • the intermediate portion of the elongated delivery device is configured to have a higher flexibility in a direction toward the connecting portion of the elongated delivery device;

[0117] • the intermediate portion of the elongated delivery device comprises a decreasing diameter in a direction toward the connecting portion of the elongated delivery device;

[0118] • the intermediate portion of the elongated delivery device further comprises an outer tubular element that surrounds at least a portion of the core wire element;

[0119] • the outer tubular element is porous;

[0120] • the outer tubular element is configured in the form of a first coiled element;

[0121] • the outer tubular element is configured in the form of a first mesh element;

[0122] • the outer tubular element is configured to be radiopaque;

[0123] • the intermediate portion of the elongated delivery device further comprises an inner tubular element disposed between and fixed relative to the outer tubular element and the core wire element;

[0124] • the inner tubular element is porous;

[0125] • the inner tubular element is configured in the form of a second coiled element;

[0126] • the inner tubular element is configured in the form of a second mesh element;

[0127] • the intermediate portion of the elongated delivery device further comprises an elongated annular sealing portion of the outer tubular element coupled to a portion of the core wire surrounding the core wire;

[0128] • the elongated annular sealing portion is configured to expose a portion of the core wire element in the vicinity of the connection portion of the elongated delivery device;

[0129] • the distal portion of the elongated annular sealing portion has a stepped cross-section taken along the longitudinal axis of the elongated delivery device (this prevents the disengagement zone from closing and prevents electrolytic disengagement);

[0130] • the elongated annular sealing portion is substantially electrically non-conductive;

[0131] • the elongated annular sealing portion is low-friction and / or smooth;

[0132] • in the rest state of the elongated delivery device, at least the distal portion of the intermediate portion is curved with respect to the longitudinal axis of the elongated delivery device;

[0133] • the intermediate portion of the elongated delivery device is surrounded by a sheath element;

[0134] • the sheath element is composed of a polymer;

[0135] • the sheath element is substantially electrically non-conductive;

[0136] • the connection portion of the elongated delivery device is configured to remain coupled to the endovascular prosthesis after disengagement of the connection portion from the elongated delivery device;

[0137] • at least a portion of the connection portion is configured to be radiopaque;

[0138] • the connection portion is configured to be radiopaque;

[0139] • the endovascular prosthesis is configured to be self-expanding;

[0140] • the endovascular prosthesis comprises an anchoring portion and a blood-occlusive portion;

[0141] • the outer diameter of the delivery system is less than about 0.2 inch;

[0142] • the outer diameter of the delivery system is less than about 0.034 inch;

[0143] • the outer diameter of the delivery system is in the range of about 0.010 inch to about 0.030 inch;

[0144] • the outer diameter of the delivery system is about 0.014 inch;

[0145] • the outer diameter of the delivery system is about 0.018 inch;

[0146] • the outer diameter of the delivery system is about 0.024 inches;

[0147] • the elongated delivery device comprises a coating;

[0148] • the elongated delivery device comprises a hydrophilic coating; and / or

[0149] • the delivery system further comprises an encapsulation sheath element that at least surrounds the distal end portion of the elongated delivery device and surrounds the entire endovascular prosthesis.

[0150] In a second aspect, the present application relates to a method for delivering an endovascular prosthesis to a bifurcated vasculature of a patient, the bifurcated vasculature comprising a primary passageway and at least one secondary passageway to define a cross-over at which an aneurysm having an aneurysm opening is located, the method comprising the following steps:

[0151] (i) advancing a guidewire through the primary passageway into the secondary passageway;

[0152] (ii) advancing a catheter surrounding the guidewire through the primary passageway into the secondary passageway;

[0153] (iii) withdrawing the guidewire from the patient’s body;

[0154] (iv) advancing the endovascular delivery system of the present application (in any one of its embodiments) to the distal end portion of the catheter;

[0155] (v) retracting the catheter relative to the endovascular prosthesis to expose the anchoring portion of the endovascular prosthesis;

[0156] (vi) implanting the anchoring portion of the endovascular prosthesis into the secondary passageway;

[0157] (vii) further retracting the catheter relative to the endovascular prosthesis to expose the blood occlusion portion of the endovascular prosthesis;

[0158] (viii) aligning the blood occlusion portion of the endovascular prosthesis with the aneurysm opening;

[0159] (ix) implanting the blood occlusion portion of the endovascular prosthesis to occlude the aneurysm opening;

[0160] (x) applying an electric current to the elongated delivery device;

[0161] (xi) detaching the connecting portion from the elongated delivery device; and

[0162] (xii) withdrawing the elongated delivery device and the catheter from the patient’s body.

[0163] Preferred embodiments of this second aspect of the present application can include any one of the following features or a combination of any two or more of the following features:

[0164] • step (viii) comprises axially rotating the elongate delivery device to align the endovascular prosthesis with the aneurysm opening;

[0165] • step (x) comprises applying a current of about 1 milliamp at a voltage of about 12 volts for a duration of about 30 seconds to about 120 seconds;

[0166] • step (x) comprises applying a current of about 1 milliamp at a voltage of about 12 volts for a duration of about 30 seconds to about 105 seconds;

[0167] • step (x) comprises applying a current of about 1 milliamp at a voltage of about 12 volts for a duration of about 30 seconds to about 75 seconds;

[0168] • steps (i) and (ii) are performed sequentially; and / or

[0169] • steps (i) and (ii) are performed substantially simultaneously.

[0170] In a third aspect, the present application is directed to a method for delivering an endovascular prosthesis to a bifurcated vasculature of a patient, the bifurcated vasculature comprising a primary passageway and at least one secondary passageway to define an intersection at which an aneurysm having an aneurysm opening is located, the method comprising the steps of:

[0171] (i) advancing a guidewire through the primary passageway into the secondary passageway;

[0172] (ii) advancing a catheter surrounding the guidewire through the primary passageway into the secondary passageway;

[0173] (iii) removing the guidewire from the patient;

[0174] (iv) abutting a distal end of an endovascular prosthesis delivery system of the present application (in any one of its embodiments) comprising an encapsulating sheath against a proximal end of the catheter;

[0175] (v) advancing an elongate delivery device and the endovascular prosthesis to a distal portion of the catheter while maintaining the encapsulating sheath outside the patient;

[0176] (vi) retracting the catheter relative to the endovascular prosthesis to expose an anchoring portion of the endovascular prosthesis;

[0177] (vii) implanting the anchoring portion of the endovascular prosthesis into the secondary passageway;

[0178] (viii) further retracting the catheter relative to the endovascular prosthesis to expose a blood occlusion portion of the endovascular prosthesis;

[0179] (ix) aligning the blood occlusion portion of the endovascular prosthesis with the aneurysm opening; and

[0180] (x) implanting the blood occlusion portion of the endovascular prosthesis to occlude the aneurysm opening;

[0181] (xi) applying an electrical current to the elongated delivery device;

[0182] (xii) disengaging the attachment portion from the elongated delivery device; and

[0183] (xiii) withdrawing the elongated delivery device and the catheter from the patient.

[0184] Preferred embodiments of this third aspect of the application can include any one of the following features or a combination of any two or more of the following features:

[0185] • step (ix) comprises axially rotating the elongated delivery device to align the endovascular prosthesis with the aneurysm opening;

[0186] • step (xi) comprises applying an electrical current of about 1 milliamp at a voltage of about 12 volts for a duration of about 30 seconds to about 120 seconds;

[0187] • step (xi) comprises applying an electrical current of about 1 milliamp at a voltage of about 12 volts for a duration of about 30 seconds to about 105 seconds;

[0188] • step (xi) comprises applying an electrical current of about 1 milliamp at a voltage of about 12 volts for a duration of about 30 seconds to about 75 seconds;

[0189] • steps (i) and (ii) are performed sequentially; and / or

[0190] • steps (i) and (ii) are performed substantially simultaneously.

[0191] Reference is made to Figures 1-4 wherein a distal portion 100 of a preferred embodiment of an endovascular prosthesis delivery system of the application is shown.

[0192] Reference is made to Figure 5 It will be readily appreciated that Figures 1-4 components, Figure 5 components (some of which are listed in Figures 10-17 are shown in exploded view aligned relative to a longitudinal axis of the proximal portion 100 of the endovascular prosthesis delivery system:

[0193]

[0194]

[0195] Reference is made to Figure 1 wherein an endovascular prosthesis delivery system 100 is shown.

[0196] The delivery system 100 includes an elongated delivery device 60 and an endovascular prosthesis 55. Preferably, the endovascular prosthesis generally includes an anchoring portion and a blood occlusion portion connected to one another. More preferably, the endovascular prosthesis is the endovascular prosthesis disclosed in any of Tippett #1 or Tippett #2.

[0197] In one preferred embodiment of all aspects of the present application, the delivery system 100 further includes an encapsulation sheath, which is not shown for clarity. The encapsulation sheath is configured to at least surround a distal end portion of the elongated delivery device (e.g., a distal end portion of 20 to 50 centimeters) and to surround the entire endovascular prosthesis. The encapsulation sheath is of conventional type.

[0198] The elongated delivery device 60 includes a bulbous element 5 connected to a bulbous wire element 10, which is preferably connected to a proximal dumbbell-shaped coil element 15. In one preferred embodiment, the bulbous element 5 and the bulbous wire element 10 can be one integral component. Such an integral component can be produced by melting / welding the end of the bulbous wire element 10 to form the bulbous element 5. Alternatively, the elements can be produced independently and coupled in a conventional manner. Preferably, one or more of the bulbous element 5, the bulbous wire element 10 and the proximal dumbbell-shaped coil element 15 are made of a radiopaque material (e.g., platinum tungsten amalgam).

[0199] In the illustrated embodiment, the combination of the bulbous element 5, the bulbous wire element 10 and the proximal dumbbell-shaped coil element 15 define a connection portion for connecting the endovascular prosthesis 55 to the elongated delivery device 60. Preferably, for all embodiments of the present application, the proximal dumbbell-shaped coil element 15 joins the bulbous wire element 10 to the core wire element 35 by welding, preferably gold-tin solder welding, to produce a radiopaque marker.

[0200] Reference is also made to Figures 2-5 The elongated delivery device 60 includes a distal sealing element 20, which is preferably made of an electrically insulating material, more preferably a low-friction and smooth insulating material (e.g., polytetrafluoroethylene or PTFE).

[0201] A proximal portion of the distal sealing element 20 is disposed within the outer coil element 30. The outer coil element 30 is preferably made of a radiopaque material (e.g., platinum tungsten amalgam). In the illustrated embodiment, the outer coil element 30 is nominally porous. It will be apparent to those skilled in the art that other porous configurations (e.g., a mesh) can be used.

[0202] The core wire element 35 is arranged within the outer spring coil element 30. Preferably, the outer spring coil element 30 serves to prevent kinking of the core wire element 35 and / or to improve the transmission of torque to the core wire element 35 upon axial rotation of the elongated delivery device 60. For all embodiments of the present application, the outer spring coil element 30 can be replaced by another tubular element (porous or non-porous) capable of imparting such a function to the core wire element 35, for example a Hypotube.

[0203] Preferably, for all embodiments of the present application, the core wire element 35 is made of 304V stainless steel, more preferably covered with a PTFE coating for insulation and lubrication. Preferably, for all embodiments of the present application, the proximal end of the core wire element (about 8 cm) is bare, more preferably the distal portion (about 45 cm) is tapered to increase flexibility (i.e. the outer diameter of this distal portion of the core wire element decreases along a direction towards the distal end of the core wire element).

[0204] Preferably, for all embodiments of the present application, the outer spring coil element 30 is in the form of a platinum coil (about 10 cm) welded to a tapered distal end for kink resistance and visibility. Preferably, for all embodiments of the present application, the tapered distal portion of the core wire element 35 and the outer spring coil element 30 (about 45 cm) is covered with a polymer sheath for insulation and a hydrophilic coating for lubrication.

[0205] The inner spring coil element 25 is inserted between the outer spring coil element 30 and the core wire element 35. The positioning of the inner spring coil element 25 as one of the plurality of welds 50 in the elongated delivery device 60. Preferably, the solder (not shown for clarity) is made of a radiopaque material, for example gold, gold-tin amalgam, etc.

[0206] In the case of the inner spring coil element 25, once the solder is applied, the outer coil element 30 is fixed relative to the core wire element 35. A polymer sheath 40 is arranged over the outer spring coil element and the distal sealing element 20, the polymer sheath 40 preferably having a hydrophilic coating (not shown for clarity) applied thereon.

[0207] Figure 8 The endovascular prosthesis 55 coupled to the elongated delivery device 60 is shown. Figure 9 The endovascular prosthesis 55 uncoupled from the elongated delivery device 60 is shown. The uncoupling is achieved by applying an electric current to the core wire element 35.

[0208] It will be appreciated by the skilled person that the short bare portion of the core wire element 35 extends beyond the distal sealing element 20, forming an uncoupling zone A located in the vicinity of the proximal dumbbell-shaped spring coil element 15 - see Figures 2-3 .

[0209] As Figure 8As shown, the intravascular prosthesis 55 is connected to the elongated delivery device 60 at the ball-head metal wire element 10 and is held in position by the ball element 5 and the proximal dumbbell-shaped spring coil element 15.

[0210] like Figure 9 As shown, when an appropriate current is applied to the core wire element 35, partial corrosion of the core wire element 35 in the detachment zone A causes the combination of the spherical element 5, the ball-head metal wire element 10, and the proximal dumbbell-shaped spring coil element 15 coupled to the intravascular prosthesis 55 to detach from the rest of the elongated delivery device 60.

[0211] In order to achieve such Figure 9 The disengagement shown occurs when the positive terminal of the DC power supply is connected to the proximal end of the core element 35 and the negative terminal is connected to the needle inserted into the patient's groin or shoulder, forming a circuit. Preferably, for all embodiments of the invention, disengagement occurs when a DC voltage (approximately 12-15 volts) is applied to the proximal end of the core element 35, resulting in a small current (approximately 1 mA) flowing.

[0212] The DC power supply drives corrosion in the detachment area, breaking it down into metal ions, causing the combination of the spherical element 5, the ball-head wire element 10, and the proximal dumbbell-shaped coil element 15 coupled to the intravascular prosthesis 55 to detach from the rest of the elongated delivery device 60. Preferably, for all embodiments of the invention, corrosion of the spherical element 5, the ball-head wire element 10, and the proximal dumbbell-shaped coil element 15 is avoided and mitigated by using: (i) a combination of the spherical element 5, the ball-head wire element 10, and the proximal dumbbell-shaped coil element 15 fixed together with gold-tin solder, and (ii) platinum. The insulating layer on the core wire element 35 and the outer coil element 30 isolates the exposed detachment area from corrosion and reduces detachment time. The smaller size of the detachment area also minimizes detachment time.

[0213] More general details about electrolytic desorption can be found in U.S. Patent No. 5,122,136 [Guglielmi et al.].

[0214] Please refer to Figures 10-17 The sequence of steps for implanting an intravascular prosthesis 55 using the delivery system 100 will now be described.

[0215] Therefore, please refer to Figure 10 The diagram shows a bifurcation vascular system 105, which includes a primary channel 110, a secondary channel 115, and a secondary channel 120. At the intersection of the primary channel 110, the secondary channel 115, and the secondary channel 120 is an aneurysm with an aneurysm opening 126.

[0216] As shown in the figure, the guidewire 130 and microcatheter 135 advance through the main channel 110 and into the secondary channel 115. The guidewire 130 and microcatheter 135 are conventional, and their use in advancing into the second channel 115 is within the knowledge of those skilled in the art.

[0217] In such Figure 10 When the positioning guidewire 130 and microcatheter 135 are combined as shown, the guidewire 130 is withdrawn from the patient's body.

[0218] Once the guidewire 130 is withdrawn from the patient, the distal end of the aforementioned delivery system 100 abuts against the proximal end of the microcatheter 130 (not shown). This can be achieved, for example, by using a rotary hemostatic valve attached to the hub of the microcatheter 135. The abutment of the intravascular prosthesis delivery system 100 against this portion of the proximal end of the microcatheter 135 causes the sheath of the combination of the intravascular prosthesis 55 and the elongated delivery device 60 to substantially transfer from the encapsulation sheath to the microcatheter 135.

[0219] Please refer to Figure 11 The combination of the intravascular prosthesis 55 and the elongated delivery device 60 is advanced to the distal end of the microcatheter 135. The microcatheter 135 can then be retracted, exposing the anchoring portion 56 of the intravascular prosthesis 55 to the distal end of the microcatheter 135.

[0220] Please refer to Figure 12 When the anchoring portion 56 is in place, the microcatheter 135 is continuously retracted to expose the blood occlusion element 57 of the intravascular prosthesis 55. Figure 12 As shown, a small portion of the distal sealing element 20 protrudes from the distal end of the microcatheter 135.

[0221] Please refer to Figure 13 The microcatheter 135 is further retracted to expose additional lengths of the elongated device 60, namely, the entirety of the distal sealing element 20 and most of the outer spring coil element 30 (those skilled in the art will understand that, for clarity, in...). Figure 12 and 13 Polymer sheath 40 is not shown in the image.

[0222] like Figure 13 As shown, by retracting the microcatheter 135 to expose further lengths of the elongated delivery device 60, the physician can, as Figure 14 and 15 The elongated delivery device 60 is twisted axially as indicated by the middle arrow B. This produces the effect of moving the connection between the intravascular prosthesis 55 and the elongated delivery device upward, as shown in the figure, to expose the shoulder 122 of the blood vessel (or a small branch or perforator, or part of the lumen) between the main channel 110 and the secondary channel 120.

[0223] This achieves proper alignment of the blood occlusive portion 57 of the endovascular prosthesis 55 relative to the aneurysm opening 126. Upon achieving this alignment, the distal end of the elongated delivery device 60 is advanced to place the blood occlusive portion 57 of the endovascular prosthesis 55 over the aneurysm opening 126, such that the distal portion of the blood occlusive portion 57 is advanced into the secondary passageway 120 - see Figure 16 In all embodiments of the present invention, the endovascular prosthesis functions to gain access to the second branch passageway (e.g., by prolapsing), as described in paragraph

[0037] above.

[0224] Figures 13-16 The dynamic articulating (e.g., universal articulating) relationship between the endovascular prosthesis 55 and the elongated delivery device 60 is shown progressing from a relatively obtuse angle ( Figure 13 ) to a relatively perpendicular angle ( Figure 14 ) to a relatively acute angle ( Figures 15-16 ). This is a particular advantage of all embodiments of the endovascular prosthesis delivery system of the present invention, enabling the system to be achieved without the need for an additional guidewire, while still allowing access to the second host passageway 120 coupled to the end of the endovascular prosthesis 55 of the elongated delivery device 60.

[0225] At any time prior thereto, the physician can retract the endovascular prosthesis 55 into the microcatheter 135 to reposition the endovascular prosthesis in the bifurcated vasculature, as described in greater detail in Tippett #1 and Tippett #2.

[0226] Further, at any time prior thereto, the physician can retract the combination of the endovascular prosthesis 55 and the elongated delivery device 60 into an encapsulating sheath (outside the patient's body). Upon completion of this operation, the physician can then manually alter the endovascular prosthesis 55, for example, to increase the overall curvature of the endovascular prosthesis along its longitudinal axis, to optimize the directed passageway to the second passageway 120 in the bifurcated vasculature 105. Thereafter, the sequence of steps shown and described above in Figures 11-16 may be repeated.

[0227] Next, electrolytic detachment as described above is initiated, which results in detachment of the endovascular prosthesis 55 (the combination of the spherical element 5, the ball-end wire element 10, and the proximal dumbbell-shaped coil element 15 remains attached to the endovascular prosthesis 55). Upon completion of the detachment, the elongated delivery device 60 is retracted along with the microcatheter 135, leaving the implanted endovascular prosthesis 55, and occluding the aneurysm opening 126 of the aneurysm 125 - see Figure 17 .

[0228] After the use of delivery system 100 to implant endovascular prosthesis 55, it will be readily appreciated by those of ordinary skill in the art that a primary advantage of the present application is the ability to deliver an endovascular prosthesis to the correct location without the need for a guidewire. The guidewire is used only to assist in the proper positioning of microcatheter 135. Once this has been accomplished, guidewire 130 is removed and a guidewire is no longer needed to deliver endovascular prosthesis 55. This allows the construction of a delivery system that is less profiled, which allows access to much more of the vasculature than is possible using the devices taught by Fung, supra. Thus, elongated delivery device 60 functions in many respects as a guidewire.

[0229] Reference is made to Figures 18-21 which shows various preferred embodiments of the distal region of a second general embodiment of an endovascular prosthesis delivery system of the present application. In each case, the proximal portion of the second general embodiment of an endovascular prosthesis delivery system of the present application can be constructed with the details discussed above with reference to the first general embodiment of an endovascular prosthesis delivery system of the present application (see, supra). Figures 1-7

[0230] In Figure 18 , the connection portion 200 is disposed at the distal end of the endovascular prosthesis delivery system. The connection portion 200 is coupled to the distal portion of the elongated delivery device 260 by a shell 205, which can be welded or crimped, for conducting and for securing the platinum ball-tipped wire element 210. The spring coil element 215 is welded to the elongated delivery device 260.

[0231] The connection portion 200 includes a pair of inwardly curved tabs to secure the corrodible detachment wire 225. The distal end 230 of the connection portion 200 is curved and rounded, with a ball tip (not shown for clarity) secured or otherwise modified to secure the detachment wire 225 relative to the remainder of the connection portion 200.

[0232] The attachment ring 235, which is contained in the elongated endovascular prosthesis (not shown for clarity), receives the detachment wire 225 that secures the elongated endovascular prosthesis to the elongated delivery device 260.

[0233] Figure 18 The illustrated endovascular prosthesis delivery system is used to deliver an elongated endovascular prosthesis using the same general method as described above with reference to Figures 10-17 In this case, when electrical current is applied to the elongated delivery device 260, the portion of the detachment wire 260 that is connected to the attachment ring 235 corrodes, allowing the elongated endovascular prosthesis to detach from the detachment wire 260.

[0234] Figure 19 The illustrated endovascular prosthesis delivery system is used to deliver an elongated endovascular prosthesis using the same general method as described above with reference to Figure 18 ​The connection portion 200a used in Figure 19 In the following, identical elements are denoted by the same reference signs with a suffix "a". In Figure 19 In the following, identical elements are denoted by the same reference signs with a suffix "a". In

[0235] Figure 19 The intravascular prosthesis delivery system shown is used for delivering an elongated intravascular prosthesis using the same general method as described above with reference to Figures 10-17 In this case, when an electric current is applied to the elongated delivery device 260a, the handle portion 225a will corrode, thereby allowing the elongated intravascular prosthesis to be released from the release line 260a.

[0236] Figure 20 The connection portion 200b used in Figure 18 In the following, identical elements are denoted by the same reference signs with a suffix "b". In Figure 20 In the following, identical elements are denoted by the same reference signs with a suffix "b". In Figure 20 In the following, identical elements are denoted by the same reference signs with a suffix "b". In Figure 20a Various versions of the T-shaped element 222 are shown.

[0237] Figure 20 The intravascular prosthesis delivery system shown is used for delivering an elongated intravascular prosthesis using the same general method as described above with reference to Figures 10-17 In this case, when an electric current is applied to the elongated delivery device 260b, the tip protrusion of the T-shaped element 222 will corrode, thereby allowing the elongated intravascular prosthesis to be released from the release line 260b.

[0238] Figure 21 The connection portion 200c used in Figure 18 In the following, identical elements are denoted by the same reference signs with a suffix "c". In Figure 21 In the following, identical elements are denoted by the same reference signs with a suffix "c". In Figure 21 In the following, identical elements are denoted by the same reference signs with a suffix "c". In

[0239] Figure 21 The intravascular prosthesis delivery system shown is used for delivering an elongated intravascular prosthesis using the same general method as described above with reference to Figures 10-17The method of the description is the same as the general method of delivering an elongated endovascular prosthesis. In this case, when an electric current is applied to the elongated delivery device 260c, the holding element 223 corrodes, thereby allowing the elongated endovascular prosthesis to be released from the release line 260c.

[0240] Figures 18-21 The common feature is that, upon application of an electric current to the elongated delivery device, a portion of the connecting portion (200, etc.) corrodes, thereby allowing the elongated endovascular prosthesis to be released from the release line. The remaining portion of the connecting portion remains coupled to the elongated delivery device.

[0241] While the application has been described with reference to illustrative embodiments and examples, the description is not intended to be limiting. Various modifications and changes can become apparent to those skilled in the art, having the benefit of the description. Accordingly, the scope of claims appended hereto intends to encompass any such modifications or embodiments.

[0242] All documents, patents, and patent applications mentioned in this specification are hereby incorporated by reference in their entirety as if each had been individually incorporated by reference herein.

Claims

1. An endovascular prosthesis delivery system comprising an elongated delivery device having a delivery device longitudinal axis, the elongated delivery device coupled to an endovascular prosthesis via a connection portion, the connection portion configured to decouple from the endovascular prosthesis or the delivery device when an electrical current is applied to the delivery device, the endovascular prosthesis in an unsheathed state and the elongated delivery device rotatable relative to one another about the delivery device longitudinal axis, wherein (i) the endovascular prosthesis is elongated and includes a prosthesis longitudinal axis, and (ii) the endovascular prosthesis in an unsheathed state is coupled to the elongated delivery device such that the prosthesis longitudinal axis is rotatable about the delivery device longitudinal axis, wherein the endovascular prosthesis in an unsheathed state is coupled to the elongated delivery device such that the prosthesis longitudinal axis is rotatable about the delivery device longitudinal axis by at least about 360°.

2. The endovascular prosthesis as defined in claim 1, wherein the connection portion is configured to extend distally along the delivery device longitudinal axis at a distal end portion thereof relative to a connection point between the endovascular prosthesis and the elongated delivery device.

3. The delivery system as defined in claim 1 or 2, wherein the connection portion includes a retention portion configured to couple the endovascular prosthesis to the elongated delivery device during delivery of the endovascular prosthesis.

4. The delivery system as defined in claim 3, wherein at least a portion of the retention portion is corrodible upon application of the electrical current to the delivery device to allow the endovascular prosthesis to decouple from the endovascular prosthesis.

5. The delivery system as defined in claim 4, wherein the retention portion is disposed distally relative to the connection point between the endovascular prosthesis and the elongated delivery device.

6. The delivery system as defined in claim 3, wherein the retention portion is generally T-shaped at a distal end thereof.

7. The delivery system as defined in claim 3, wherein the retention portion is generally spherical at a distal end thereof.

8. The delivery system as defined in claim 3, wherein the retention portion is generally wing-shaped at a distal end thereof.

9. The delivery system as defined in claim 4, wherein the retention portion is contiguous with the connection point between the endovascular prosthesis and the elongated delivery device.

10. The delivery system as defined in claim 9, wherein the retention portion includes a wire element.

11. The delivery system as defined in claim 1 or 2, wherein the connection portion of the elongated delivery device includes a first retention element, a second retention element, and a spacing element for maintaining the first retention element and the second retention element in a spaced relationship.

12. The delivery system as defined in claim 11, wherein one or both of the first retention element and the second retention element is generally spherical.

13. The delivery system as defined in claim 11, wherein the endovascular prosthesis includes an attachment portion coupled to the spacing element of the connection portion of the elongated delivery device.

14. The delivery system as defined in claim 13, wherein the first holding element and the second holding element are configured to hold the attachment portion of the endovascular prosthesis therebetween.

15. The delivery system as defined in claim 1 or 2, wherein the connection portion of the elongated delivery device is configured to remain coupled to the endovascular prosthesis after the connection portion is detached from the elongated delivery device.

16. The endovascular prosthesis as defined in claim 1 or 2, wherein the connection portion comprises a male portion that engages a female portion disposed on the endovascular prosthesis.

17. The endovascular prosthesis as defined in claim 16, wherein the female portion comprises a loop for receiving the male portion.

18. The endovascular prosthesis as defined in claim 1 or 2, wherein the connection portion comprises a female portion that engages a male portion disposed on the endovascular prosthesis.

19. The delivery system as defined in claim 1 or 2, wherein an intermediate portion of the elongated delivery device located proximate the connection portion comprises a core element that is coupled to the connection portion of the elongated delivery device.

20. The delivery system as defined in claim 19, wherein the core element is configured to be non-tubular.

21. The delivery system as defined in claim 19, wherein the core element is configured to be solid.

22. The delivery system as defined in claim 19, wherein the intermediate portion of the elongated delivery device is configured to have a higher flexibility in a direction toward the connection portion of the elongated delivery device.

23. The delivery system as defined in claim 19, wherein the intermediate portion of the elongated delivery device comprises a decreasing diameter in a direction toward the connection portion of the elongated delivery device.

24. The delivery system as defined in claim 19, wherein the intermediate portion of the elongated delivery device further comprises an outer tubular element that surrounds at least a portion of the core element.

25. The delivery system as defined in claim 24, wherein the outer tubular element is porous.

26. The delivery system as defined in claim 24 or 25, wherein the outer tubular element is configured in the form of a first coiled element.

27. The delivery system as defined in claim 24 or 25, wherein the outer tubular element is configured to be radiopaque.

28. The delivery system as defined in claim 24 or 25, wherein the intermediate portion of the elongated delivery device further comprises an inner tubular element that is disposed between and fixed relative to the outer tubular element and the core element.

29. The delivery system as defined in claim 28, wherein the inner tubular element is porous.

30. The delivery system as defined in claim 28, wherein the inner tubular element is configured in the form of a second coiled element.

31. The delivery system as defined in claim 24 or 25, wherein the intermediate portion of the elongated delivery device further comprises an elongated annular sealing portion that is coupled to the outer tubular element that surrounds a portion of the core element.

32. The delivery system as defined in claim 31, wherein the elongated annular sealing portion is configured to expose a portion of the core wire element near the connection portion of the elongated delivery device.

33. The delivery system as defined in claim 31, wherein the elongated annular sealing portion is substantially non-conductive.

34. The delivery system as defined in claim 19, wherein at least a distal portion of the intermediate portion is curved with respect to the longitudinal axis of the delivery device in a resting state of the elongated delivery device.

35. The delivery system as defined in claim 19, wherein the intermediate portion of the elongated delivery device is surrounded by a sheath element.

36. The delivery system as defined in claim 35, wherein the sheath element is comprised of a polymer.

37. The delivery system as defined in any one of claims 35 or 36, wherein the sheath element is substantially non-conductive.

38. The delivery system as defined in claim 1 or 2, wherein at least a portion of the connection portion is configured to be radiopaque.

39. The delivery system as defined in claim 1 or 2, wherein the connection portion is configured to be radiopaque.

40. The delivery system as defined in claim 1 or 2, wherein the endovascular prosthesis is configured to be self-expanding.

41. The delivery system as defined in claim 1 or 2, wherein the endovascular prosthesis comprises an anchoring portion and a blood occlusion portion.

42. The delivery system as defined in claim 1 or 2, wherein the delivery system has an outer diameter of less than about 0.034 inches.

43. The delivery system as defined in claim 1 or 2, wherein the delivery system has an outer diameter in the range of about 0.010 inches to about 0.030 inches.

44. The delivery system as defined in claim 1 or 2, wherein the delivery system has an outer diameter of about 0.014 inches.

45. The delivery system as defined in claim 1 or 2, wherein the delivery system has an outer diameter of about 0.018 inches.

46. The delivery system as defined in claim 1 or 2, wherein the delivery system has an outer diameter of about 0.024 inches.

47. The delivery system as defined in claim 1 or 2, wherein the elongated delivery device comprises a coating.

48. The delivery system as defined in claim 1 or 2, wherein the elongated delivery device comprises a hydrophilic coating.

49. The delivery system as defined in claim 1 or 2, further comprising an encapsulation sheath element that surrounds at least a distal portion of the elongated delivery device and the entire endovascular prosthesis.

Images