FIELD OF INVENTIONThis invention relates to a delivery device or deployment device for intraluminal or endovascular delivery of a stent graft.
BACKGROUND OF THE INVENTIONIt is important when delivering a stent graft by intraluminal or endovascular methods to know the exact location of the device in the vasculature particularly in relation to branch vessels which could be adversely occluded by stent graft placement. To avoid occlusion, fenestrations have been proposed along the length of a stent graft and scalloping at the proximal and distal ends of the stent graft to allow flow from a main vessel to a branch vessel through the fenestration or scallop.
The use of radiopaque markers around the periphery of the fenestration or scallop in this regard has been proposed, but it would be advantageous if a more certain or reliable method could be devised to assist with stent placement.
Particularly when deploying a graft into a curved vessel, it is known that a deployment device will take up a position in the vessel on the outside or greater radius side of the curved vessel. If a stent graft could be retained onto a deployment device so that a fenestration or scallop on the stent graft is in a selected position with respect to a portion of the deployment device when it is curved, then more accurate positioning may be possible.
As a particular example, the aorta of a patient comprises an ascending aorta from the aortic heart valve, a thoracic arch and a descending aorta. Major branch vessels extend from the thoracic arch and occlusion of one or more of these upon placement of a stent graft in the thoracic arch could have serious consequences. The major vessels generally extend from the outside or greater radius side of the curved thoracic arch. If a stent graft retained onto a deployment device such that a scallop on the stent graft was on the outside of the deployment device when it is curved, then correct placement would be more certain.
It is known to retain the proximal and distal ends of a stent graft onto a deployment device to facilitate relative longitudinal and rotational movement of the ends. Vessel tortuosity through which a deployment device must be progressed and the rotation necessary to achieve progression of the final rotational position of a stent graft, however, may not be fully known. In addition, in the process of positioning the stent graft, oftentimes attachment wires with the stent graft can become tangled with other objects in the deployment device.
It is an object of this invention to provide a retention mechanism for a stent graft onto a deployment device for more accurate deployment of the stent graft therefrom providing a practitioner with a useful alternative.
SUMMARY OF THE INVENTIONIn one aspect, an endovascular delivery device is disclosed, comprising: a nose cone dilator, a guide wire catheter having inner and outer surfaces, the inner surface defining a passageway with a longitudinal axis, and the outer surface having a plurality of openings radially located from the longitudinal axis; a stent graft comprising a tubular body of a biocompatible material with a lumen therethrough, the tubular body having first and second ends, and a plurality of stents, the stent graft being mounted onto the delivery device for deployment therefrom and being positioned on the guide wire catheter, passes through the lumen of the stent graft; a cannula attachment wire for releasably fastening a side of the stent graft to the guide wire catheter whereby the stent graft is temporarily affixed to the guide wire catheter along a length of the guide wire catheter defined by the length of the stent graft; wherein the cannula attachment wire weaves in and out of the plurality of openings.
In some embodiments, the guide wire catheter comprises at least three pairs of openings. In some embodiments, the cannula attachment wire and guide wire catheter conform a shape of the stent graft. In some embodiments, the cannula attachment wire weaves in and out of the stent graft. In some embodiments, the cannula attachment wire is substantially parallel to the longitudinal axis. In some embodiments, the plurality of openings are linearly arranged and substantially parallel to the longitudinal axis. In some embodiments, the delivery catheter comprises a longitudinal lumen therethrough, the guide wire catheter extending through the longitudinal lumen so that the guide wire catheter is movable longitudinally and rotationally with respect to the delivery catheter. In some embodiments, the endovascular delivery device also comprises a delivery catheter further comprising a flexible sheath over the delivery catheter and extending to the nose cone dilator and thereby retaining the stent graft in a contracted conformation on the guide wire catheter. In some embodiments, the endovascular delivery device further comprising a release mechanism operably connected to the cannula attachment wire. In some embodiments, the guide wire catheter has a pre-formed curve located near the nose cone dilator. In some embodiments, the flexible sheath has a pre-formed curve located near the nose cone dilator.
In another aspect, an endovascular delivery device is disclosed, comprising: a delivery catheter; a nose cone dilator, a guide wire catheter comprising: a passageway with a longitudinal axis, a plurality of openings radially located from the longitudinal axis; a stent graft comprising: a tubular body of a biocompatible material with a lumen therethrough having first and second ends, a plurality of stents, wherein the stent graft is operably connected to the delivery device for deployment therefrom and being positioned on the guide wire catheter, wherein the guide wire catheter passes through the lumen of the stent graft; a cannula attachment wire operably connected to guide wire catheter and stent graft, wherein the cannula attachment wire weaves in and out of the plurality of openings.
In some embodiments, the endovascular device comprises at least three pairs of openings including one pair located substantially away from the first and second ends of the stent graft. In some embodiments, the cannula attachment wire and guide wire catheter conform a shape of the stent graft. In some embodiments, the cannula attachment wire weaves in and out of the stent graft. In some embodiments, the cannula attachment wire is substantially parallel to the longitudinal axis. In some embodiments, the plurality of openings is linearly arranged and substantially parallel to the longitudinal axis. In some embodiments, the delivery catheter comprises a lumen through which the guide wire catheter extends so that the guide wire catheter is movable longitudinally and rotationally with respect to the delivery catheter. In some embodiments, the delivery catheter comprises a flexible sheath located over the delivery catheter and extending to the nose cone dilator and thereby retaining the stent graft in a contracted conformation on the guide wire catheter; wherein the guide wire catheter has a pre-formed curve located near the nose cone dilator, and the flexible sheath has a pre-formed curve located near the nose cone dilator.
In another aspect, a method of deploying a stent graft to a patient in need thereof is disclosed, comprising: providing an endovascular delivery device, comprising: a nose cone dilator, a guide wire catheter having inner and outer surfaces, the inner surface defining a passageway with a longitudinal axis, and the outer surface having a plurality of openings radially located from the longitudinal axis; a stent graft comprising a tubular body of a biocompatible material with a lumen therethrough, the tubular body having first and second ends, and a plurality of stents, the stent graft being mounted onto the delivery device for deployment therefrom and being positioned on the guide wire catheter, which passes through the lumen of the stent graft; a cannula attachment wire for releasably fastening a side of the stent graft to the guide wire catheter whereby the stent graft is temporarily affixed to the guide wire catheter along a length of the guide wire catheter defined by the length of the stent graft; wherein the aligned openings substantially conform in shape to the cannula attachment wire; removing the cannula attachment wire.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 depicts a introducer or delivery device according to one embodiment of the present invention.
FIG. 2 depicts the introducer or delivery device ofFIG. 1 with the sheath withdrawn to show the components underneath it.
FIG. 3A shows a longitudinal sectional view of a cannula attachment wire weaving in and out of a guide wire catheter.
FIG. 3B shows a longitudinal sectional view of a cannula attachment wire weaving in and out of a stent graft and guide wire catheter.
FIG. 4 shows a cross sectional view of a cannula attachment wire in a stent graft and guide wire catheter.
FIG. 5 shows a perspective view of the embodiment shown inFIGS. 3A,3B, and4.
FIG. 6 shows a schematic view of an aorta of a patient with a deployment device and stent graft deployed therein.
FIG. 7 shows an alternative embodiment of an introducer or delivery device.
FIG. 8 shows the embodiment ofFIG. 7 with the sheath withdrawn to show the components underneath that embodiment.
DETAILED DESCRIPTIONThroughout this specification the term distal with respect to a portion of the aorta, a deployment device or a stent graft is intended to mean the portion of the aorta, deployment device or stent graft further away in the direction of blood flow away from the heart and the term proximal is intended to mean the portion of the aorta, deployment device or end of the stent graft nearer to the heart. When applied to other vessels similar terms such as caudal and cranial should be understood.
The invention will be discussed generally with respect to deployment of a stent graft into the thoracic aorta but is not so limited and may apply to deployment into other body lumens.
FIGS. 1-4 depict adelivery device2. Thedelivery device2 has aguide wire catheter3 which extends from adistal handle7 to a proximal taperednose cone dilator11 longitudinally through alumen5 of adelivery catheter4 which is connected to thehandle7 at its distal end. An introducersheath10 fits coaxially around thedelivery catheter4 and extends from a taperedproximal end13 which optionally includes a radiopaque marker to a connector valve andmanipulator14 attached aboutdistal end15 of theintroducer sheath10. Theintroducer sheath10 extends proximally to thenose cone dilator11 and covers thestent graft6 during introduction of the deployment device into a patient and is withdrawn distally to expose thestent graft6 during deployment when the deployment device is in a selected position within a patient's vasculature.
The stent graft orimplantable device6 is carried on theguide wire catheter3 proximally of thedelivery catheter4 and distally of thenose cone dilator11.Connector valve14 includes a silicone disk (not shown) for preventing the backflow of fluids therethrough. The disk includes a slit for the insertion of thenose cone dilator11 anddelivery catheter4.Connector14 also includesside arm16 to which atube17 is connected for introducing and aspirating fluids therethrough. Nosecone dilator11 includes a taperedproximal end19 for accessing and dilating a vascular access site over a well-known and commercially available wire guide (not shown).
The wire guide is inserted in the vessel with an introducer needle using, for example, a percutaneous vascular access Seldinger technique. A male Luerlock connector hub18 is attached at the distal end of theguide wire catheter3 for connection to syringes and other medical apparatus. Thehandle7 at the distal end of thedelivery catheter4 remains outside a patient in use and carries the trigger wirerelease handle mechanisms8,9, and12 used to release the various portions of the stent graft. The proximal end thestent graft6 is retained on the delivery device by the use of trigger wires (not shown) connected to therelease device9. The distal end of thestent graft6 is retained on the delivery device by the use of trigger wires (not shown) connected to therelease device8. The handle also includes arelease mechanism12 for a cannula attachment wire for the longitudinal portion of the stent graft as discussed more below.
Thestent graft6 comprises atubular body22 of a biocompatible material and a plurality of self-expandingstents27. The tubular body has first andsecond openings32 and34. Acannula attachment wire20 extends from therelease mechanism12 on thehandle7 through thelumen5 in thedelivery catheter4 and exits at the proximal end of thedelivery catheter4 as shown inFIG. 2.
Thecannula attachment wire20 weaves through a plurality ofopenings28 on theouter surface29 of theguide wire catheter3 and through the material of thetubular body22 in an arrangement so that there arelengths24 ofcannula attachment wire20 outside thetubular body22 and, as can be particularly seen inFIGS. 3A,3B, andFIG. 4,lengths26 ofcannula attachment wire20 in theguide wire catheter3. Theinner surface30 of the catheter forms a passageway with a longitudinal axis. The plurality ofopenings28 are radially located about the longitudinal axis.
In some embodiments, the plurality ofopenings28 include aligned, paired openings through which thelengths24 ofcannula attachment wire20 pass in and out of the guide wire catheter. In some embodiments, the cannula attachment wire passes through at three paired openings. In some embodiments, at least one pair of openings is located substantially away from the first andsecond openings32 and34 of thestent graft6. In some embodiments, the cannula attachment wire passes through as least three paired openings. In some embodiments, the alignment of the paired openings is linear such as that depicted inFIGS. 3A and 3B.
These various arrangements hold theguide wire catheter3 against a selected longitudinal portion of the stent graft. When the stent graft is deployed into the vasculature of a patient and the device is deployed into a curved vessel, the guide wire catheter of the deployment device will normally take up a position in the greater radius side of the curve owing to its relative rigidity. Hence the longitudinal portion of the stent graft which is releasably bound to the guide wire catheter will also take up a position at the greater radius side of the curve. This means that a stent graft with a fenestration or scallop which is to be deployed on the greater radius side of the curve can be mounted onto the deployment device with the fenestration or scallop adjacent the guide wire and once deployed the scallop or fenestration will be easier to correctly position.
When it is desired to release the stent graft, thecannula attachment wire20 can be withdrawn by removal of therelease wire mechanism12 which will release the stent graft from its engagement with theguide wire catheter3 as well as thestent graft6. The linear arraignment of the plurality ofopenings28 ease removal of thecannula attachment wire20 as compared to configurations where a wire is spirally disposed about stent graft and guide wire catheter.
In the depicted embodiment, the order of placement of therelease handle mechanisms8,9, and12 on the handle of the introducer is such that the order of release is the proximal end of the stent graft, the distal end of the stent graft and then the longitudinal portion. In other embodiments and assemblies the order of placement may be different. For instance it may be desirable to release the proximal end, the longitudinal portion and then the distal end.
FIG. 5 shows an embodiment when a guide wire catheter is curved such as when it is placed into a curved vessel such as the thoracic aorta of a patient. It will be noted that thestent graft6 when not constrained by thesheath10 has a longitudinal portion retained against theguide wire catheter3 and otherwise extends out to one side of the guide wire catheter. The stent graft has ascallop21 at its proximal end and the scallop is aligned with the guide wire catheter. When theguide wire catheter3 is bent, the longitudinal portion of the stent graft with ascallop21 is deployed on the greater radius side of the curve.
If by suitable imaging techniques the great vessel such as the left subclavian artery is seen to be off center at the top of the curve of the thoracic arch then the stent graft can be mounted onto the deployment device with its scallop similarly off center from the longitudinal portion aligned with the guide wire catheter of the deployment device.
FIG. 6 shows a cross sectional view of a thoracic aorta. It will be seen that thethoracic aorta40 comprises an ascendingaorta41 which receives blood from the heart though anaortic valve42. At the upper end of the ascending aorta, there are branches for the great vessels, theinnominate artery43, the left commoncarotid artery44 and the leftsubclavian artery45. The aorta after these great vessels is referred to as the descendingaorta46 and it is in this region that a thoracicaortic aneurysm47 can occur. In a thoracic aortic aneurysm part of thewall48 of the descending aorta swells and can burst with serious consequences. The dottedline48ashows what would be the normal curved wall of the descending aorta.
As shown inFIG. 6, adeployment device50 has been deployed up through the descending aorta over aguide wire52. The proximal end of the deployment device extends over thethoracic arch54 and into the ascendingaorta41. Thesheath56 has been withdrawn to partially release thestent graft58, but it is still retained by thecannula attachment wire60 onto theguide wire catheter62 of thedeployment device50. Thecannula attachment wire60 weaves linearly in and out of a plurality ofopenings76 of anouter surface78 of theguide wire catheter62 and through the material of thestent graft58. It will be noted that as the thoracic arch is curved the guide wire catheter of the deployment device has taken up a position on the greater radius side of the curve and hence the longitudinal portion of the stent graft which is releasably bound to the guide wire catheter has also take up a position at the greater radius side of the curve. This enables thescallop64 at the proximal end of thestent graft58, which is positioned adjacent theguide wire catheter62, to be adjacent the leftsubclavian artery45 so that the stent graft does not occlude that artery. At the stage shown, both the proximal and distal ends of the stent graft have been released, but as discussed earlier, the distal end may be retained and not released until the longitudinal portion retention has been released.
Withdrawal of thecannula attachment wire60 by removal of the release handle mechanism12 (seeFIG. 1) enables thenose cone dilator66 to be retracted to thesheath56 and the entire deployment device can be withdrawn.
FIGS. 7 and 8 show an alternative embodiment. The embodiment is similar to that shown inFIG. 1, and the same reference numerals are used for corresponding items.
Thedeployment device70 has aguide wire catheter3 which extends from adistal handle7 to a proximal taperednose cone dilator11 longitudinally through a passageway orlumen5 of adelivery catheter4 which is connected to thehandle7 at its distal end. Anintroducer sheath10 fits coaxially around thedelivery catheter4 and extends from a taperedproximal end13 which optionally includes a radiopaque marker to a connector valve andmanipulator14 attached aboutdistal end15 of the sheath. Theintroducer sheath10 extends proximally to thenose cone dilator11 and covers thestent graft6 during introduction of the deployment device into a patient. Theintroducer sheath10 is withdrawn distally to expose thestent graft6 during deployment when the deployment device is in a selected position within the vasculature of a patient.
The sheath in this embodiment is flexible but has a preformedcurve10atowards its proximal end so that the delivery device can more easily conform to the shape of the thoracic arch without putting an unacceptable stress against the wall of the thoracic arch. The preformed curved portion of theintroducer sheath10ais sufficiently flexible, however, that when it is retracted back to thedelivery catheter4 as shown inFIG. 8, thecurved portion10aof theintroducer sheath10 straightens out.
Theguide wire catheter3 also has a preformedcurve3ajust distal of thenose cone dilator11 again so that the delivery device can more easily conform to the shape of the thoracic arch without putting an unacceptable stress against the wall of the thoracic arch.
Thestent graft6 is carried on theguide wire catheter3 proximally of thedelivery catheter4 and distally of thenose cone dilator11. Thestent graft6 is not shown inFIG. 7 but can be seen inFIG. 8 in which thesheath10 is shown retracted to thedelivery catheter4. Thestent graft6 comprises atubular body22 of a biocompatible material and a plurality of self-expanding stents (not shown for clarity). In this embodiment, the stent graft has ascallop72 at itsproximal end74. When correctly deployed, the scallop will allow access to the left subclavian artery from the thoracic arc while still allowing a sufficient sealing region or landing zone between the thoracic arch and the aneurysm.
Connector valve14 includes a silicone disk (not shown) for preventing the backflow of fluids therethrough. The disk includes a slit for the insertion of thenose cone dilator11 anddelivery catheter4.Connector14 also includesside arm16 to which atube17 is connected for introducing and aspirating fluids therethrough.Nose cone dilator11 includes a taperedproximal end19 for accessing and dilating a vascular access site over a well-known and commercially available wire guide (not shown).
To deploy the stent graft, a wire guide is inserted in the vessel with an introducer needle using, for example, a percutaneous vascular access Seldinger technique. A male Luerlock connector hub18 is attached at the distal end of theguide wire catheter3 for connection to syringes and other medical apparatus. Thehandle7 at the distal end of thedelivery catheter4 remains outside a patient in use and carries the trigger wirerelease handle mechanisms8,9, and12 used to release the various portions of thestent graft6. The proximal end thestent graft6 is retained on the delivery device by the use of trigger wires (not shown) connected to therelease handle9. The distal end of the stent graft is retained on the delivery device by the use of trigger wires (not shown) connected to therelease handle8. The handle also includes arelease mechanism12 for a release wire for the longitudinal portion of the stent graft as discussed below.
Acannula attachment wire20 extends from therelease mechanism12 on thehandle7 through thelumen5 in thedelivery catheter4 and exits at the proximal end of thedelivery catheter4 as shown inFIG. 2. Therelease wire20 is threaded through theguide wire catheter3 viaopenings28 and through the material of thetubular body22 in a spiral fashion so that there arelengths24 ofrelease wire20 outside the tubular body andlengths26 ofrelease wire20 inside theguide wire catheter3. This arrangement holds theguide wire catheter3 against a selected longitudinal portion of the stent graft.
When the stent graft is deployed into the vasculature of a patient and the device is deployed into a curved vessel the curvedguide wire catheter3aof the deployment device will take up a position in the greater radius side of the curve. Hence the longitudinal portion of the stent graft which is releasably bound to the guide wire catheter will also take up a position at the greater radius side of the curve. This means that a stent graft with a fenestration or scallop which is to be deployed on the greater radius side of the curve can be mounted onto the deployment device with the fenestration or scallop adjacent the guide wire and once deployed the scallop or fenestration will be easier to correctly position. When it is desired to release the stent graft, thecannula attachment wire20 can be withdrawn by removal of therelease wire mechanism12 which will release the stent graft from its engagement with the guide wire catheter.
In one aspect, methods of manufacturing an endovascular delivery device are disclosed. The method includes (a) providing a guide wire having inner and outer surfaces, the inner surface defining a passageway with a longitudinal axis, and the outer surface having a plurality of openings radially located from the longitudinal axis; (b) providing a stent graft having a tubular body made of a biocompatible material with a lumen therethrough with first and second ends and a plurality of stents, the stent graft being mounted onto the delivery device for deployment therefrom and being positioned on the guide wire catheter wherein the guide wire catheter passes through the lumen of the stent graft; (c) providing a cannula attachment wire that weaves in and out of the plurality of openings.
In various manufacturing method embodiments, the delivery device can be adapted and provided with the features as described above for the various physical embodiments.
Throughout this specification, various indications have been given as to the scope of this invention, but the invention is not limited to any one of these but may reside in two or more of these combined together. The examples are given for illustration only and not for limitation.
Throughout this specification and the claims that follow unless the context requires otherwise, the words ‘comprise’ and ‘include’ and variations such as ‘comprising’ and ‘including’ will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.