JP2011183218A - Endovascular aneurysm repair system - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a method and apparatus for implanting radially expandable prostheses (14) in the body lumens rely on tacking or anchoring of the prostheses with separately introduced fasteners (28). <P>SOLUTION: The prostheses may be self-expanding or balloon expandable. After initial placement, a fastener applier system (27) is introduced within the expanded prostheses to deploy a plurality of fasteners at at least one prosthesis end, usually at each end of the prosthesis. The fasteners are usually helical fasteners which are delivered from a helical track in the fastener applier by rotation with a rotator wire. The fasteners are applied singly, typically in circumferentially spaced-apart patterns about the interior of each end of the prosthesis. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

(Related application)
This application claims the benefit of co-pending US Provisional Application No. 60 / 333,937, filed Nov. 28, 2001.

(Background of the Invention)
The present invention relates generally to attachment of a vascular prosthesis to a native blood vessel, and in particular to a system of methods and devices for repairing affected and / or damaged sections of blood vessels.

(Description of related technology)
Vulnerability of the vessel wall due to injury or morbidity can lead to vessel dilation and aneurysm formation. If left untreated, the aneurysm can become large and eventually rupture.

  For example, an aortic aneurysm occurs primarily in the abdominal region (usually the lower renal region between the renal artery and the aortic bifurcation). An aneurysm can also occur in the thoracic region between the aortic arch and the renal artery. Aortic aneurysm rupture causes massive bleeding and has a high mortality rate.

  Open surgical replacement of diseased or damaged vascular sections can eliminate the risk of vascular rupture. In this procedure, the affected or damaged vascular section is removed and an artificial graft (made in either a straight configuration or a branched configuration) is placed and then sutured to the end of the native vessel Permanently attached and sealed. Artificial implants for these procedures are usually unsupported braided tubes and are typically made from polyester, ePTFE or other suitable material. These implants are not longitudinally supported to accommodate changes in aneurysm and native vessel morphology. However, these procedures require large surgical incisions and have high morbidity and mortality. Furthermore, many patients are unsuitable for this type of major surgery due to other co-morbidities.

  Intravascular aneurysm repair has been introduced to overcome the problems associated with open surgical repair. The aneurysm is bridged with a vascular graft placed in the lumen. Typically, these prosthetic implants for aortic aneurysms are delivered through the femoral artery and collapsed onto the catheter. These implants are usually designed with a fabric material attached to a metabolic scaffold (stent) structure that expands or expands to contact the inner diameter of the blood vessel. Unlike open surgical aneurysm repair, a graft deployed in a lumen is not sutured to the native vessel, but expands from the stent (which penetrates into the native vessel during deployment) or Depending on which radial expansion of the stent itself is utilized to maintain the graft in place. These graft attachment means do not provide the same level of attachment as compared to suture and can damage native blood vessels during deployment.

  Thus, an endovascular aneurysm repair system that initially provides an artificial graft that can adapt to changes in aneurysm morphology and is deployed without damaging native blood vessels, and There is a need for a second, separate endovascular fixation system that provides permanent graft attachment to the vessel wall.

(Summary of the Invention)
A method and apparatus for implanting a radially expandable prosthesis in a body lumen is described. In particular, the present invention provides improved methods and systems for implanting vascular stents and stent-grafts into blood vessels (including both arterial and venous systems). In an exemplary embodiment, a stent-graft is placed in the vasculature to reinforce an aneurysm, particularly an abdominal aortic aneurysm. Accordingly, the present invention provides the following.
(1) A method of implanting a radially expandable prosthesis into a body cavity, the method comprising:
Expanding at least one scaffold of the prosthesis at an implantation site within the body cavity; and introducing a plurality of fasteners through the prosthesis in the region of the scaffold and anchoring the scaffold in place;
Including the method.
(2) The method according to item 1, wherein the scaffold is elastic, and the expanding step includes releasing the scaffold from restraint and allowing the scaffold to self-expand at the implantation site. A method comprising enabling.
(3) The method according to item 1, wherein the scaffold is malleable, and the expanding step causes expansion by applying a radial expansion force in the scaffold. Including the method.
(4) The method according to item 1, wherein the expanding step includes expanding at least two scaffolds at spaced positions on the prosthesis.
5. The method of item 1, wherein the expanding step includes expanding at least three spaced apart prostheses on the prosthesis.
(6) The method according to item 1, wherein the expanding step includes expanding a scaffold structure over the entire length of the prosthesis.
(7) The method of item 1, wherein the prosthesis comprises a fabric covering at least a portion of the scaffold, wherein the introducing step includes at least some of the fasteners, Introducing the fabric through, but not through the scaffold.
(8) The method according to item 1, wherein the prosthesis comprises a fabric covering at least a part of the scaffold, wherein the introducing step includes at least some of the fasteners, Introducing into the entire element of the scaffold.
(9) The method according to item 1, wherein the fastener is a spiral through fastener.
(10) A method according to item 9, wherein the introducing step comprises introducing one fastener into a circumferentially spaced column on the inner wall of the prosthesis. .
(11) The method according to item 10, wherein the introducing step includes introducing 2 to 12 helical fasteners in each region where the fasteners are disposed. Method.
(12) Intraluminal fastener applier, the following:
A tubular body with a deflectable distal end;
A stabilizer configured to engage the vessel wall to hold the distal end of the tubular body in place;
A control handle at the proximal end of the tubular body, the control handle deflecting away from the distal end and deploying a stabilizer that holds the deflected distal end in place. A handle; and means for advancing the fastener from the distal end to the vessel wall engaging the distal end;
An intraluminal fastener applier.
(13) The intraluminal fastener applier of item 12, wherein the means for advancing the fastener comprises a fastener delivery device, the fastener delivery device comprising the tubular body An intraluminal fastener applier that can be introduced through and transports at least one fastener.
(14) The intraluminal fastener applier according to item 13, wherein the fastener delivery device comprises a flexible shaft and means, the flexible shaft comprising one helical fastener An intraluminal fastener applier that transports the tool at its distal end and the means is a means for rotating and advancing the helical fastener to penetrate tissue.
(15) The intraluminal fastener applier according to item 14, wherein the flexible shaft has a spiral track and a rotor wire, and the spiral track transports the spiral fastener. And the rotor wire engages and rotates the helical fastener to advance it from the distal end of the body.
(16) A method for implanting a radially expandable prosthesis at a target site in a body cavity, the method comprising:
Advancing a guide wire from a remote access site to the target site;
Introducing a prosthesis deployment catheter over the guidewire into the target site;
Deploying the prosthesis from the deployment catheter at the target site;
Exchanging an intraluminal fastener applier over the deployment catheter and the guidewire; and introducing a plurality of fasteners from the intraluminal fastener applier through the prosthesis and anchoring the prosthesis;
Including the method.
(17) The method according to item 16, wherein the prosthesis is self-expanding, and the deploying step releases the prosthesis from restraint and causes the prosthesis to self-expand at the target site. Including the method.
(18) The method according to item 16, wherein the prosthesis is malleable, and the expanding step is performed by applying a radial expansion force in the prosthesis. The method of inclusion.
(19) A method according to item 16, wherein one fastener is applied from the intraluminal fastener applier, and the applier is pulled away from the vasculature and a new fastener is A method wherein the applier is loaded into a catheter and then the applier is returned to the target location.

  In a first aspect of the present invention, a radially expandable prosthesis is provided at or near the implantation site in a body lumen, for example in or from the vasculature on one side of an aneurysm. The at least one scaffold is first expanded into the body lumen. After expanding the prosthetic scaffold, a plurality of fasteners are introduced through the prosthesis into that region of the scaffold to anchor the scaffold in place. The scaffold can be elastic and can typically be composed of a shape memory alloy, elastic stainless steel, or the like. For elastic scaffolds, expansion typically involves releasing the scaffold from restraint and allowing the scaffold to self-expand at the site of implantation. This constraint can be a radial constraint (ie, placement of a tubular catheter, delivery sheath, etc. on the scaffold to maintain the scaffold in a radially contracted configuration). Expansion is then accomplished by pulling back on the catheter sheath and returning the scaffold to its larger diameter configuration. Alternatively, the scaffold may be elongated in the axial direction, for example, by attaching either end of the scaffold to an internal tube, rod, catheter, etc. to maintain the scaffold in an elongated reduced diameter configuration. Can be constrained in configuration. The scaffold can then be released from such axial restraint to allow self-expansion.

  Alternatively, the scaffold can be formed from a malleable material (eg, malleable stainless steel or other metal). The expansion then includes applying a radial expansion force within the scaffold to cause expansion (eg, inflating the scaffold delivery catheter on the side of the scaffold to affect expansion). obtain.

Vascular prostheses can have a wide variety of conventional configurations. In a preferred deployment of the vascular stent graft, the prosthesis typically includes a fabric other than a blood semi-impermeable flexible barrier, typically supported by a stent-form scaffold. The stent can be of any conventional stent configuration (eg, zigzag, serpentine, expanding diamond).
diamond) or a combination thereof. The stent structure can span the entire length of the implant and in some cases is longer than the fabric element of the implant. Alternatively, the stent covers only a small portion of the prosthesis (eg, present at one, two, or three ends). The stent has three or more ends when configured to treat bifurcated vascular regions (eg, abdominal aortic aneurysm treatment when the stent-graft is expanded into the iliac artery). Can do. In certain instances, the stent may be spaced along the entire length of the stent-graft or at least a major portion of the length, where the individual stent structures are not directly connected to each other and the graft fabric or Connected to other flexible elements.

  The introduction of the fastener is typically provided after the prosthesis is initially placed. That is, the initial placement is achieved by self-expansion or balloon expansion, after which the prosthesis is rotated into a plurality of individual fasteners (preferably rotated and “screwed” into the prosthesis and the vessel wall). Fixed or moored in place by introduction. The fasteners can be placed through the fabric only, ie avoiding the scaffold structure. Alternatively, the fasteners can be introduced into the scaffold structure or through a portion of the scaffold structure, and optionally via a receptacle or aperture that is specifically configured to receive the fasteners. . Of course, in some cases, the fasteners are introduced both through the fabric and the scaffold structure.

  In the exemplary embodiment, the fasteners are helical fasteners that are introduced one at a time (ie, one at a time) in a spaced pattern on the outer wall of the prosthesis. Is done. Typically, this fastener is introduced using a fastener applier that carries a single fastener. Fastener appliers that carry a single fastener may have a lower profile and are more effective and less traumatic than fastener appliers that carry multiple fasteners. However, the present invention contemplates that in certain embodiments, a fastener applier may carry multiple fasteners. Furthermore, the fastener applier can simultaneously deploy a plurality of fasteners in a pattern spaced above the preferred perimeter. Usually 2 to 12 fasteners are applied to each end of the prosthesis to be anchored. The 2-12 fasteners are spaced apart on a single perimeter that can be applied in one or more rows using individual fasteners that are axially aligned or twisted around the perimeter. Usually applied in a row. In a preferred embodiment, the intraluminal fastener applier of the present invention comprises a guide element and an applier element. For example, the guide element comprises a tubular body having a deflectable distal tip and, optionally, for maintaining the deflected tip relative to the position in the implant to which the fastener is applied. Provide ballast. The applier element is insertable through the lumen of the guide element and carries at least one helical fastener or other fastener. A rotating driver is provided to rotate and advance the helical fastener so that the helical fastener penetrates the graft and the underlying vessel wall to securely anchor the graft in place .

  The invention will be understood from the following detailed description of preferred embodiments in conjunction with the accompanying drawings.

FIG. 1 is a perspective view of one embodiment of an endovascular graft delivery device shown positioned within an abdominal aortic aneurysm. FIG. 2 is a perspective view of one embodiment of deployment of an endovascular graft within the aneurysm of FIG. FIG. 3 is a perspective view of the fully deployed straight endovascular graft of FIG. FIG. 4 is a perspective view of a fully deployed bifurcated endovascular graft cut at one end to show the anchoring scaffold. FIG. 5 is a perspective view similar to FIG. 5 showing an alternative scaffold structure. FIG. 6 is a perspective view of one embodiment of a device for directing a fastener applier. FIG. 7 is a perspective view of the device of FIG. 6 upon insertion within the deployed endovascular graft of FIG. 3 with both the graft and scaffold cut away. FIG. 8 is a perspective view of the device of FIG. 6 showing the activation of one embodiment of the stabilization device attached to the orientation device. FIG. 9 is a perspective view of the control assembly in FIG. 8 demonstrating the orientation device of FIG. FIG. 10 is a perspective view of an alternative embodiment of the stabilization device of FIG. FIG. 11 is a perspective view illustrating activation of the alternative stabilization device of FIG. FIG. 12 is a perspective view showing another embodiment of the stabilization device of FIG. FIG. 13 is a perspective view showing activation of the stabilization device of FIG. FIG. 14 is one embodiment of a fastener applier. 15 is a perspective view of the fastener applier of FIG. 14 disposed within the orientation device of FIG. 16 is an enlarged cross-sectional view of one embodiment of the fastener applier of FIG. FIG. 17 is an enlarged cross-sectional view of the mounting applier showing one embodiment of the proximal end of the helical fastener and the drive mechanism. 18 is an enlarged perspective view of one embodiment of the helical fastener of FIG. FIG. 19 is an enlarged view of the mounting applier showing one embodiment of a control assembly that activates the fastener applier. FIG. 20 is an enlarged view of the mounting applier activated with the graft and fasteners implanted into the vessel wall. 21 is an enlarged view of the completion of attachment of the proximal graft of FIG. 3 to the vessel wall using a fastener. 22 is a perspective view of the implant of FIG. 4 fully attached to a blood vessel.

(Detailed description of the invention)
FIG. 1 shows an endovascular graft delivery catheter 10 covering a guide wire 12 that is placed in an abdominal aortic aneurysm 11. FIG. 2 shows the initial stage of graft deployment within the vessel. The delivery catheter 10 has a movable cover 13 that covers the graft. When this cover is pulled proximally, the graft 14 expands into contact with the inner wall of the vessel. It is contemplated that the implant can be self-expanding or can utilize an expansion member such as a balloon or mechanical dilator. The process of graft deployment continues until the graft is fully deployed within the vessel. It is contemplated that the implant can be either linear or bifurcated. FIG. 3 shows a fully deployed linear graft 14 and FIG. 4 shows a fully deployed bifurcated graft 15. Guidewire 11 is used to deliver and place the graft remaining in the vessel for access to the fastener attachment system. One embodiment (stent) of graft scaffold 16 is shown in the excised area in FIG. Although the stent is in the form of a simple zigzag pattern, it is contemplated that the stent design may include a more complex pattern 17 as shown in FIG. Although only one stent structure is shown in the graft, it is contemplated in FIGS. 4 and 5 that multiple independent stent structures can be incorporated into the graft. FIG. 6 shows one embodiment of an orienting device 18 that is positioned within the lumen of the orienting device and extends beyond the distal end of the orienting device tip. It has. The obturator has a lumen over the guidewire to allow delivery. FIG. 7 shows an orientation device placed in the deployed endovascular graft over the guidewire 12. The orientation device has an integrated stabilization device to help maintain the position of the orientation device in the vessel. In one embodiment, the stabilization device 20 is spring loaded and arranged for use when the obturator in the orientation device is removed (FIG. 8). The orientation device is activated through the control assembly 21 as seen in FIG. In one embodiment, the control assembly 21 features a movable wheel or lever 22, which moves the distal tip 23 of the orienting device 18 as desired, as seen in FIG. Deflect to position. It is contemplated that the control assembly for the orientation device can be activated mechanically, electrically, hydraulically or aerobically. The control assembly has a through lumen to allow passage of obturator and fastener applier. FIG. 10 shows another embodiment, a stabilizing device as the movable strut assembly 24. This movable strut assembly is activated by the lever 25 of the control assembly (FIG. 11). In both embodiments (FIGS. 7 and 10), the stabilization device is distal to the end of the orientation device. In another embodiment, the stabilization device may be in the form of an expandable member 26 adjacent the distal tip of the orientation device (FIG. 12). In one embodiment, the expandable member 26 is shown activated by the lever 25 of the control assembly (FIG. 13). However, this type of stabilization device is also contemplated to be inflatable. In all embodiments, the stabilization device may be used to stabilize the orientation member within the vessel, either coaxially or eccentrically.

  In another embodiment of the present invention, a separate tubular device can be used in conjunction with the orientation device and access the vessel. This separate tubular device may incorporate the stabilizing device used above with the orientation device.

  FIG. 14 shows an embodiment of the fastener applier 27. FIG. 14A is a detailed view of the distal end of the fastener applier. FIG. 15 shows the fastener applier being placed through the lumen of the orientation device at the site where the fastener is attached.

  FIG. 16 is an enlarged cross-sectional view of the fastener applier 27 and the orientation device 18. In one embodiment of the fastener applier, the helical fastener 28 is rotated by a fastener driver 29 that passes through a drive shaft 30 that is connected to a control assembly 31. The drive shaft 30 can be made from any material that allows both bending and rotation. The drive shaft is connected to a fastener driver 29 that engages and imparts torque to the helical fastener. FIG. 16 shows the coil of the helical fastener 28 engaged with the inner groove 32 in the fastener applier. It is contemplated that this groove may be disposed along the entire length of the fastener or within a portion of its length. FIG. 17 is an enlarged cross-sectional view of the fastener applier 27 and a cross-sectional view of the fastener driver 29, which shows one embodiment of the engagement between the fastener driver and the helical fastener 28. . In this embodiment, the proximal coil of the helical fastener is formed to produce a diagonal member 33 that traverses the diameter of the helical fastener. Similar helical fasteners are described in US Pat. Nos. 5,964,772; 5,824,008; 5,582,616; and 6,296,656. All disclosures are incorporated herein by reference.

  FIG. 18 represents one embodiment of the helical fastener 28, which shows a diagonal member 33. FIG. 19 shows one embodiment of the fastener applier 27 during activation of the fastener applier control assembly. Activation of the control assembly rotates the drive shaft, fastener driver and helical fastener. This rotation causes the helical fastener 28 to move into the fastener applier inner groove 32 and into the graft 14 and vessel wall 34 (FIG. 20). It is contemplated that the control assembly for the fastener applier can be activated mechanically, electrically, hydraulically or aerated.

  FIG. 21 shows the completed helical fastener 28 attachment of the graft 14 to the vessel wall 34. It is contemplated that one or more fasteners are required to provide a secure attachment of the graft to the vessel wall.

  FIG. 22 shows a perspective view with the graft prosthesis attached to the vessel wall both proximally and distally. It is contemplated that the present invention can be used to attach grafts of both straight and bifurcated grafts 15 in the aorta and other branch vessels.

  Although the components and / or features of the preferred embodiments described herein may be used together or separately, the methods and devices shown may be combined or wholly or partially It is understood that it can be modified. It is contemplated that the orientation device components, fastener applier and helical fastener may be alternately oriented relative to each other (eg, offset, biaxial, etc.). In addition, various embodiments may be used in additional procedures not described herein (eg, vascular trauma, arteriotomy, attachment of prosthetic heart valves and attachment of vasculature and other prosthetic devices in the body in general). It is understood that can be used for

  Preferred embodiments of the present invention are described above in detail for the purpose of providing a complete disclosure and for the sake of explanation and clarity. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure.

Claims (1)

Invention described in the specification .

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