PERCUTANEOUS ENDOVASCULAR APPARATUS FOR REPAIR OF ANEURYSMS AND ARTERIAL BLOCKAGES
An endovascular apparatus is provided for treating the effects of vascular disease including aneurysms and arterial blockages using a percutaneous, minimally invasive technique. In one embodiment the endovascular apparatus includes a tubular sleeve having a cranial end, a first caudal branch, and a second caudal branch such that the tubular sleeve is shaped like an upside down “Y.” The apparatus further includes at least one expandable attachment device attached to the tubular sleeve for securing the endovascular apparatus to an interior wall of a vessel.
This application is a continuation of U.S. patent application Ser. No. 11/484,331, filed Jul. 10, 2006, which is a continuation-in-part of U.S. patent application Ser. No. 10/624,864, filed Jul. 22, 2003, which in turn claims priority to U.S. Provisional Application No. 60/397,745, filed Jul. 22, 2002. Each of the aforementioned priority applications are hereby incorporated by reference in its entirety.
BACKGROUND OF THE INVENTIONField of the Invention
The present invention relates generally to an endovascular apparatus for the treatment of aneurysms or arterial blockages, and more particularly, to an endovascular apparatus having an expandable attachment device for securing the endovascular apparatus to an interior wall of a lumen.
Description of the Related Art
An abdominal aortic aneurysm is an abnormal enlargement or “ballooning out” of the arterial wall of the aorta in a region that passes through the abdominal cavity, usually below the renal arteries and above the common iliac arteries. The aneurysm may also extend into the common iliac arteries. Such aneurysms are typically brought on by the weakening of the arterial wall from vascular disease. Although abdominal aortic aneurysms often do not cause pain, unless treated, an aneurysm may rupture causing a fatal hemorrhage in a patient.
In the past aortic aneurysms were treated almost exclusively by surgical repair. Specifically, the aneurysm would be resected and replaced by an artificial artery known as a prosthetic graft. Because of the substantial risks associated with such an invasive surgery, however, other treatments for aortic aneurysms have been proposed including endovascular grafting.
Endovascular grafting involves the placement of a prosthetic graft within the lumen of the artery such that the graft spans the length of the aneurysm. In this manner the aneurysm can be excluded from the circulatory system rather than resected. Using a catheter as a deployment device, the endovascular graft can be introduced into the vascular system percutaneously. Once the graft has been positioned at the site of the aneurysm it can be attached to the vascular wall both above and below the aneurysm using expandable attachment devices to prevent movement of the graft after deployment.
To introduce an endovascular graft percutaneously, the graft must be collapsible into a small profile for negotiating the vascular system. Upon reaching the site of the aneurysm the graft and its attachment devices can be expanded into a desired shape using an inflating balloon catheter or other actuator. A variety of expandable attachment devices have been proposed for securing an endovascular graft to an interior wall of a vessel most of which use stents with hooks or barbs to penetrate the intima of the vessel. None of the proposed attachment devices, however, have been found to be ideally suited for use with an endovascular graft.
Accordingly an endovascular apparatus having a new expandable attachment device is desired. The new attachment device ideally should be small with a low profile and should expand to many times its initial diameter. It also should exert enough radial force when expanded to fix into the aorta and thereby reduce blood leaks around the apparatus.
SUMMARY OF THE INVENTIONIn a first aspect, an expandable attachment device for securing an endovascular apparatus to an interior wall of a lumen is provided. The expandable attachment device may include a plurality of telescoping arms that are joined together to form an expandable ring. This ring may function similarly to stents. The expandable attachment device may be attached to an endovascular apparatus for the treatment of aneurysms or blockages, such as a graft or stent, or to a heart valve and may include barbs, hooks, or other fasteners about its perimeter for attaching to the interior wall of a lumen. Because the attachment device can be collapsed to a size that can be fed through a vessel, the attachment device and an associated endovascular apparatus can be deployed percutaneously in a patient. Once positioned at the site of an aneurysm or arterial blockage, the telescoping attachment device can be expanded to hold the endovascular apparatus in place adjacent the inner lumen wall.
In a second aspect, an endovascular apparatus is provided for treating aneurysms or arterial blockages using a minimally invasive technique. The apparatus includes a tubular sleeve having a cranial end and at least one caudal branch. If the tubular sleeve includes a first caudal branch and a second caudal branch then the tubular sleeve is shaped like an upside down “Y.” Accordingly, for the treatment of abdominal aortic aneurysms the cranial end may be positioned in the infrarenal aorta, the first caudal branch may be positioned in one of the common iliac arteries, and the second caudal branch may be positioned in the other common iliac artery. The tubular sleeve may be made from materials conventionally used to make endovascular grafts including synthetic fabrics or films, DACRONT™ or expanded polytetrafluoroethylene (ePTFE) so as to define a lumen and so as to be collapsible during percutaneous insertion into a patient's vascular system.
The endovascular apparatus further includes an expandable attachment device attached to the cranial end of the tubular sleeve for securing the apparatus to an interior wall of a vessel above an aneurysm. The expandable attachment device comprises a plurality of telescoping arms that are attached to form an expandable ring. Each telescoping arm is similar to an expandable presentation pointer. Alternatively, each telescoping arm may function like an accordion. Accordingly, during percutaneous insertion of the endovascular apparatus into a patient, the attachment device can be collapsed into a small profile. Once the apparatus is positioned at the site of the aneurysm or blockage, the expandable attachment device can be expanded to hold the endovascular apparatus in place adjacent the inner lumen wall. Fixation components may be positioned around the perimeter of the attachment device and may be partially embedded in the inner wall of the vessel to secure the attachment device.
The plurality of telescoping arms may be made from materials suitable for use in the human body including stainless steel, plastic, or an alloy of nickel and titanium generally known as NITINOL™. NITINOL is commonly used in the manufacture of medical devices that are to be deployed in a compressed state through a catheter because of its unique thermal memory properties. For example, a NITINOL part may be manufactured in a first condition and then cooled and compressed into a second condition. When heated to the body temperature of the patient the NITINOL part will expand to its original first condition.
In another aspect one or more expandable attachment devices may be attached to the one or more caudal branches of the tubular sleeve for securing the one or more caudal branches to the interior of the vessel wall.
In one aspect, an endovascular apparatus comprises tubular sleeve having a central lumen with a cranial end portion, a first caudal branch, and a second caudal branch. An M-stent is attached to the cranial end portion of the tubular sleeve extending circumferentially around the tubular sleeve to hold the sleeve open and secure the sleeve to a wall of a vessel.
An endovascular apparatus 10 according to a first aspect is shown in
The endovascular apparatus 10 further includes a first expandable attachment device 20 attached to the cranial end 14 of the tubular sleeve 12, a second expandable attachment device 22 attached to the first caudal branch 16 of the tubular sleeve 12, and a third expandable attachment device 24 attached to the second caudal branch 18 of the tubular sleeve 12. The expandable attachment devices 20, 22, 24 may include holes 26 which may be sewn or sutured to the tubular sleeve 12. Alternatively, in lieu of holes 26, the expandable attachment devices can be woven into the sleeve.
In another embodiment, the endovascular apparatus 10 may include a fourth expandable attachment device 28 that is attached to the first expandable attachment device 20 by support columns 30. The fourth expandable attachment device 28 may be positioned above a patient's renal arteries, superior mesenteric artery or celiac artery. The support columns 30, which may be made from NITINOL or stainless steel, may provide columnar support and strength for the endovascular apparatus 10 while permitting blood flow to arteries located between the first expandable attachment device 20 and the fourth expandable attachment device 28.
The support columns 30 may be either wires or tubes. If tubular, the support columns 30 may also be telescoping. For example, in another embodiment depicted in
As illustrated in
The endovascular apparatus 10 according to a second aspect is shown
Referring to
Referring to
As one of ordinary skill might appreciate, the attachment device may take variety of shapes depending upon the configuration of the telescoping arms 40 and the fixation components 36. For example, referring to
To keep the telescoping arms 40 in their final extended state after deployment in a vessel, a one-way latch may be used to lock adjacent segments 42.
Referring to
The endovascular apparatus 10 may be deployed at the site of an aneurysm percutaneously using a catheter 82 like the one shown in
During deployment the first expandable attachment device 20 may be positioned just below the renal arteries 74, 76 and seated with an expandable balloon or other actuator. The fourth expandable attachment device 28 may be positioned superior to the renal arteries 74, 76, the mesenteric artery, or the celiac artery and seated with an expandable balloon. After the first attachment device 20 is seated, the second expandable attachment device 22 may be positioned in a first iliac artery 78 and seated with an expandable balloon or other actuator. The third expandable attachment device 24 may be positioned such that it rests at a second iliac artery 80. To position and seat the third attachment device 24, access may be obtained percutaneously through the second iliac artery 80.
Claims
1-18. (canceled)
19. An endovascular apparatus comprising:
- a tubular sleeve having a central lumen with a cranial end portion longitudinally separated from a caudal end portion, the cranial end portion including a cranial end opening and the caudal end portion including at least one caudal end opening; and
- an expandable attachment device extending circumferentially around the cranial end portion of the tubular sleeve, the expandable attachment device including: a plurality of tubular segments including first and second segment openings and a tubular segment body, the tubular segment body including an acute angle forming a caudally-pointing tubular segment apex attached to the cranial end portion, the first and second segment openings being mutually circumferentially spaced and being oriented substantially in the cranial direction, and a plurality of received segments including first and second segment ends and a received segment body, the received segment body including an acute angle forming a cranially-pointing received segment apex longitudinally spaced cranially from the cranial end opening, the first and second segment ends being mutually circumferentially spaced and being oriented substantially in the caudal direction, wherein each first segment end is telescopically received into a second segment opening, and each second segment end is telescopically received into a first segment opening in an M configuration;
- wherein the expandable attachment device includes alternating telescopically arranged tubular and received segments, with each tubular segment being circumferentially spaced from the circumferentially adjacent tubular segments by a circumferentially interposed received segment.
20. The endovascular apparatus of claim 19, wherein the caudal end portion of the tubular sleeve includes a first caudal branch laterally separated from a second caudal branch, the first and second caudal branches each including a branch opening oriented in a caudal direction.
21. The endovascular apparatus of claim 20, wherein the expandable attachment device is a first expandable attachment device, and wherein at least one of the first and second caudal branches includes a branch expandable attachment device extending circumferentially therearound and attached thereto.
22. The endovascular apparatus of claim 21, wherein each branch expandable attachment device includes:
- a plurality of tubular segments including first and second segment openings and a tubular segment body, the tubular segment body including an acute angle forming a caudally-pointing tubular segment apex, the first and second segment openings being mutually circumferentially spaced and being oriented substantially in the cranial direction, and
- a plurality of received segments including first and second segment ends and a received segment body, the received segment body including an acute angle forming a cranially-pointing received segment apex longitudinally spaced cranially from the tubular segments, the first and second segment ends being mutually circumferentially spaced and being oriented substantially in the caudal direction;
- wherein each first segment end is telescopically received into a second segment opening, and each second segment end is telescopically received into a first segment opening in an M configuration.
23. The endovascular apparatus of claim 19, wherein the expandable attachment device is a first expandable attachment device, and wherein the caudal end opening includes a caudal end expandable attachment device extending circumferentially around the caudal end portion of the tubular sleeve.
24. The endovascular apparatus of claim 23, wherein the caudal end expandable attachment device includes:
- a plurality of tubular segments including first and second segment openings and a tubular segment body, the tubular segment body including an acute angle forming a caudally-pointing tubular segment apex, the first and second segment openings being mutually circumferentially spaced and being oriented substantially in the cranial direction, and
- a plurality of received segments including first and second segment ends and a received segment body, the received segment body including an acute angle forming a cranially-pointing received segment apex longitudinally spaced cranially from the tubular segments, the first and second segment ends being mutually circumferentially spaced and being oriented substantially in the caudal direction;
- wherein each first segment end is telescopically received into a second segment opening, and each second segment end is telescopically received into a first segment opening in an M configuration.
25. The endovascular apparatus of claim 19, wherein the expandable attachment device is a first expandable attachment device, and the cranial end portion includes a second expandable attachment device located caudally of the first attachment device, the second expandable attachment device extending circumferentially around the tubular sleeve.
26. The endovascular apparatus of claim 25, wherein the second expandable attachment device includes:
- a plurality of tubular segments including first and second segment openings and a tubular segment body, the tubular segment body including an acute angle forming a caudally-pointing tubular segment apex, the first and second segment openings being mutually circumferentially spaced and being oriented substantially in the cranial direction, and
- a plurality of received segments including first and second segment ends and a received segment body, the received segment body including an acute angle forming a cranially-pointing received segment apex longitudinally spaced cranially from the tubular segments, the first and second segment ends being mutually circumferentially spaced and being oriented substantially in the caudal direction,
- wherein each first segment end is telescopically received into a second segment opening, and each second segment end is telescopically received into a first segment opening in an M configuration; and
- wherein at least a portion of the plurality of tubular segments and the plurality of received segments are attached to the tubular sleeve at a location longitudinally caudally spaced from the first expandable attachment device.
27. The endovascular apparatus of claim 19, wherein the plurality of tubular segments and the plurality of received segments are each selectively collapsible in the circumferential direction to selectively and reversibly reduce a total circumference of the expandable attachment device from an expanded apparatus condition to a collapsed apparatus condition.
28. The endovascular apparatus of claim 19, wherein the plurality of tubular segments and the plurality of received segments are collectively selectively collapsible in the longitudinal direction to selectively and reversibly telescope a total length of the endovascular apparatus from an extended apparatus condition to a retracted apparatus condition.
29. The endovascular apparatus of claim 22, wherein the plurality of tubular segments and the plurality of received segments are each selectively collapsible in the circumferential direction to selectively and reversibly reduce a total circumference of the expandable attachment device from an expanded apparatus condition to a collapsed apparatus condition.
30. The endovascular apparatus of claim 22, wherein the plurality of tubular segments and the plurality of received segments are collectively selectively collapsible in the longitudinal direction to selectively and reversibly telescope a total length of the endovascular apparatus from an extended apparatus condition to a retracted apparatus condition.
31. The endovascular apparatus of claim 24, wherein the plurality of tubular segments and the plurality of received segments are each selectively collapsible in the circumferential direction to selectively and reversibly reduce a total circumference of the expandable attachment device from an expanded apparatus condition to a collapsed apparatus condition.
32. The endovascular apparatus of claim 24, wherein the plurality of tubular segments and the plurality of received segments are collectively selectively collapsible in the longitudinal direction to selectively and reversibly telescope a total length of the endovascular apparatus from an extended apparatus condition to a retracted apparatus condition.
33. The endovascular apparatus of claim 26, wherein the plurality of tubular segments and the plurality of received segments are each selectively collapsible in the circumferential direction to selectively and reversibly reduce a total circumference of the expandable attachment device from an expanded apparatus condition to a collapsed apparatus condition.
34. The endovascular apparatus of claim 26, wherein the plurality of tubular segments and the plurality of received segments are collectively selectively collapsible in the longitudinal direction to selectively and reversibly telescope a total length of the endovascular apparatus from an extended apparatus condition to a retracted apparatus condition.
35. An endovascular apparatus comprising:
- a tubular sleeve having a central lumen with a cranial end portion longitudinally separated from a caudal end portion, the cranial end portion including a cranial end opening and the caudal end portion including at least one caudal end opening; and
- an expandable attachment device extending circumferentially around the cranial end portion of the tubular sleeve, the expandable attachment device including: a plurality of fixation components positioned about the perimeter of the expandable attachment device, a plurality of circumferentially extending arms, each arm being used to attach each fixation component to a circumferentially adjacent fixation component, and at least one M spring including four angularly attached M segments, the M segments being arranged in a zig-zag configuration to form one inboard apex and two outboard apices, the M spring having two circumferentially spaced M free ends, each M spring being interposed between two selected adjacent fixation components with the M free ends each being attached to a different one of the two selected adjacent fixation components;
- wherein the M springs are graft expanders operative to hold the tubular sleeve open.
36. The endovascular apparatus of claim 35, wherein the caudal end portion of the tubular sleeve includes a first caudal branch laterally separated from a second caudal branch, the first and second caudal branches each including a branch opening oriented in a caudal direction.
37. The endovascular apparatus of claim 36, wherein the expandable attachment device is a first expandable attachment device, and wherein at least one of the first and second caudal branches includes a branch expandable attachment device extending circumferentially therearound and attached thereto.
38. The endovascular apparatus of claim 37, wherein each branch expandable attachment device includes:
- a plurality of fixation components positioned about the perimeter of the expandable attachment device;
- a plurality of circumferentially extending arms, each arm being used to attach each fixation component to a circumferentially adjacent fixation component; and
- at least one M spring including four angularly attached M segments, the M segments being arranged in a zig-zag configuration to form one inboard apex and two outboard apices, the M spring having two circumferentially spaced M free ends, each M spring being interposed between two selected adjacent fixation components with the M free ends each being attached to a different one of the two selected adjacent fixation components;
- wherein the M springs are graft expanders operative to hold the tubular sleeve open.
39. The endovascular apparatus of claim 35, wherein the expandable attachment device is a first expandable attachment device, and wherein the caudal end opening includes a caudal end expandable attachment device extending circumferentially around the caudal end portion of the tubular sleeve.
40. The endovascular apparatus of claim 39, wherein the caudal end expandable attachment device includes:
- a plurality of fixation components positioned about the perimeter of the expandable attachment device;
- a plurality of circumferentially extending arms, each arm being used to attach each fixation component to a circumferentially adjacent fixation component; and
- at least one M spring including four angularly attached M segments, the M segments being arranged in a zig-zag configuration to form one inboard apex and two outboard apices, the M spring having two circumferentially spaced M free ends, each M spring being interposed between two selected adjacent fixation components with the M free ends each being attached to a different one of the two selected adjacent fixation components;
- wherein the M springs are graft expanders operative to hold the tubular sleeve open.
41. The endovascular apparatus of claim 35, wherein at least the arms and the M springs of the expandable attachment device are selectively collapsible in the circumferential direction to selectively and reversibly reduce a total circumference of the expandable attachment device from an expanded apparatus condition to a collapsed apparatus condition.
42. The endovascular apparatus of claim 38, wherein at least the arms and the M springs of the expandable attachment device are selectively collapsible in the circumferential direction to selectively and reversibly reduce a total circumference of the expandable attachment device from an expanded apparatus condition to a collapsed apparatus condition.
43. The endovascular apparatus of claim 40, wherein at least the arms and the M springs of the expandable attachment device are selectively collapsible in the circumferential direction to selectively and reversibly reduce a total circumference of the expandable attachment device from an expanded apparatus condition to a collapsed apparatus condition.
44. The endovascular apparatus of claim 35, wherein at least one M spring is located directly adjacent to an exterior surface of the tubular sleeve.
45. The endovascular apparatus of claim 38, wherein at least one M spring is located directly adjacent to an exterior surface of the tubular sleeve.
46. The endovascular apparatus of claim 40, wherein at least one M spring is located directly adjacent to an exterior surface of the tubular sleeve.
47. The endovascular apparatus of claim 35, wherein at least one M spring is located directly adjacent to an interior surface of the tubular sleeve.
48. The endovascular apparatus of claim 38, wherein at least one M spring is located directly adjacent to an interior surface of the tubular sleeve.
49. The endovascular apparatus of claim 40, wherein at least one M spring is located directly adjacent to an interior surface of the tubular sleeve.
50. The endovascular apparatus of claim 35, wherein at least one circumferentially extending arm is a telescoping arm having a plurality of segments in slideable contact with one another.
51. The endovascular apparatus of claim 38, wherein at least one circumferentially extending arm is a telescoping arm having a plurality of segments in slideable contact with one another.
52. The endovascular apparatus of claim 40, wherein at least one circumferentially extending arm is a telescoping arm having a plurality of segments in slideable contact with one another.
53. The endovascular apparatus of claim 50, wherein each of the M free ends of a selected M spring is attached to a different segment of a selected arm.
54. The endovascular apparatus of claim 51, wherein each of the M free ends of a selected M spring is attached to a different segment of a selected arm.
55. The endovascular apparatus of claim 52, wherein each of the M free ends of a selected M spring is attached to a different segment of a selected arm.
56. The endovascular apparatus of claim 35, wherein a plurality of M segments of a single M spring are telescoping arms.
57. The endovascular apparatus of claim 38, wherein a plurality of M segments of a single M spring are telescoping arms.
58. The endovascular apparatus of claim 40, wherein a plurality of M segments of a single M spring are telescoping arms
Type: Application
Filed: Oct 19, 2016
Publication Date: Feb 9, 2017
Inventor: Timur P. Sarac (Orange Village, OH)
Application Number: 15/297,608