US 20080039923 A1
A positioning anchor is provided for a stent-graft for implantation to treat a damaged body lumen. The positioning anchor is generally tubular surrounding a primary fluid conduit. Arms extend laterally from the generally tubular structure of the anchor surrounding lateral fluid conduits. The form of these arms is preferably custom configured to match a particular patient's luminal geometry. The anchor thus fits within the luminal geometry to remain in a desired fixed position for implantation of the anchor and any stent-graft coupled to the anchor. The anchor is most preferably formed with two walls having a void therebetween which can be filled with fixation media to further secure the anchor at the desired implantation site. A lumen shaper balloon and delivery catheter are also disclosed for proper delivery, expansion and inflation of the positioning anchor and stent-graft elements according to this invention.
1. A method of forming a double walled anchor for an intra-luminal stent-graft, the double walled anchor having an inner wall surrounding and defining a primary fluid conduit extending through said anchor, an outer wall outboard from an exterior of said inner wall, and at least one void between said inner wall and said outer wall, said void adapted to be filled with fixation media, the steps including:
providing a sacrificial mandrel having a shape and size similar to the void of the double walled anchor; and
forming a layer of anchor wall material on surfaces of the sacrificial mandrel; and removing at least a portion of the sacrificial mandrel to form the void.
2. The forming method of
3. The forming method of
4. The forming method of
5. The forming method of
6. The forming method of
7. The forming method of
8. The forming method of
9. The forming method of
10. The forming method of
11. The forming method of
cutting the sacrificial mandrel into a plurality of separate pieces;
coating the separate pieces; reassembling the separate pieces; and
continuing to said forming step, said forming step reconnecting the separate pieces together.
12. The forming method of
13. A method of forming a custom shaped anchor for an intra-luminal stent-graft, the anchor having a first wall surrounding and defining a primary fluid conduit, said contour of said first wall having a particular geometry at least partially following a particular patient's luminal anatomy into which said anchor is adapted to be implanted, the steps of the forming method including:
providing at least one molding surface having a contour following a particular geometry of a particular patient's luminal anatomy;
forming the first wall of the anchor against the mold surface; and
removing the mold surface from the first wall.
14. The custom forming method of
imaging at least a portion of the patient's luminal anatomy;
creating a data file corresponding to the patient's luminal anatomy; building a patient luminal anatomy model from the data in the data file; and
constructing the molding surface from the model of said building step.
15. The custom forming method of
16. The custom forming method of
17. The custom forming method of
18. The custom forming method of
19. The custom forming method of
20. The custom forming method of
21. The custom forming method of
22. The custom forming method of
23. The custom forming method of
24. The custom forming method of
25. The custom forming method of
26. The custom forming method of
27. A method for deploying a double walled anchor intraluminally, the double walled anchor including an inner wall surrounding and defining a primary fluid conduit extending through said anchor, an outer wall outboard from an exterior of said inner wall, and at least one void between said inner wall and said outer wall, said void adapted to be filled with fixation media; the deployment method including the steps of:
collapsing the anchor onto a catheter;
advancing the catheter from a lumen insertion point to an implantation site for the anchor;
expanding the inner wall and the outer wall of the anchor away from the catheter to a desired position for the inner wall; and
filling the void between the inner wall and the outer wall with fixation media.
28. The deployment method of
29. The deploying method of
30. The deploying method of
31. The deploying method of
delivering fixation media into the void between the inner wall and the outer wall; and
expanding the outer wall away from the inner wall and away from the catheter to a desired position for the outer wall.
32. The deploying method of
33. The deploying method of
34. The deployment method of
35. The deployment method of
36. The deployment method of
37. The deployment method of
positioning a radially expandable stent on the arm surrounding the lateral conduit of the anchor and expanding the radially expandable stent until said radially expandable stent assists in engaging the arm of the anchor with the lateral lumen adjacent the implantation site for the anchor.
38. The deployment method of
39. The deployment method of
40. The deployment method of
41. The deployment method of
42. The deployment method of
43. An inflatable lumen shaper balloon for expanding, positioning and supporting an anchor for an intra-luminal stent-graft during expansion thereof, the inflatable lumen shaper balloon comprising in combination:
an exterior wall defining a fillable bladder;
at least one arm in the exterior wall extending away from other portions of the exterior wall;
means to attach said exterior wall to an intra-luminal delivery catheter; and
means to inflate said bladder.
44. The balloon of
45. The balloon of
46. The balloon of
47. The balloon of
48. The balloon of
49. A catheter for delivery of a stent-graft intraluminally, comprising in combination:
a guide wire;
a central conduit extending along a stent-graft delivery portion of said catheter,
said central conduit including a bypass inlet at a first end of said central conduit closer to said guide wire and a bypass outlet located at a side of said central conduit further from said guide wire than said bypass inlet;
a balloon inflation fluid pathway passing through an interior of said catheter to a balloon inflation fluid port in said stent-graft delivery portion of said catheter; and
a fixation media delivery pathway extending through said catheter to a media delivery port adjacent said stent-graft delivery portion of said catheter.
50. The catheter of
51. The catheter of
52. The catheter of
53. The catheter of
54. The catheter of
55. The catheter of
The present application is a divisional of U.S. patent application Ser. No. 10/668,901 (Attorney Docket No. 025925-000200US), filed on Sep. 22, 2003, which claimed the benefit of provisional U.S. Application No. 60/412,501 filed on Sep. 20, 2002, the full disclosures of which are incorporated herein by reference.
The following invention relates to stent-grafts for implantation into body lumens for support of the body lumens and to provide for repair and proper fluid flow through the body lumen. More particularly, this invention relates to stent-grafts which include anchors to keep the stent-grafts in a desired position, especially when implanted intraluminally, and most particularly to stent-grafts for intra-luminal implantation into the aortic artery of a human patient.
Stents are known in the surgical arts which are implanted intraluminally or otherwise and expanded to support the lumen and maintain fluid flow through the lumen. Such stents are often used in arteries where blood flow has become restricted with the stent propping the artery open to maintain proper fluid flow.
When an artery or other lumen becomes damaged, replacement of the damaged artery section with a graft may be indicated. Such grafts can be taken from other body lumens of the patient, or be in the form of an artificial prosthesis. Such grafts can replace a portion of the damaged artery or be implanted intraluminally or otherwise within the damaged section of the artery without removal of the damaged artery itself. The graft then supports blood flow within the damaged artery.
For grafts to function properly, they must be held in place where desired within the artery or other lumen. One technique for maintaining the proper position of the graft is to utilize a stent within a portion of the graft with the stent radially expanded to hold the portion of the graft adjacent the stent in position relative to the artery or other body lumen. Such a graft held in place by a stent can be provided as a single assembly for implantation, being then often referred to as a stent-graft. The stent can be coextensive with the graft or only provided at specific locations along the graft. The stent both acts to hold the graft in the desired position and also to maintain the desired open cross-section of the artery to maintain proper blood flow. When a graft is configured to both provide a substitute channel for flow of fluid through a body lumen and to keep the body lumen propped open, it can be referred to as a stent-graft also, even if it does not include a separate stent-like structure which is providing this support function.
One body lumen which is particularly suited to treatment of damage therein with a stent-graft is the aorta when it has developed an aneurysm. Such an aortic aneurysm can occur anywhere between the heart and the iliac arteries, resulting in an undesirable widening of at least a portion of the artery. Once such an aneurysm has formed, it is susceptible to rupture with a high probability of resulting mortality. It is known in the art to install a stent-graft in the aorta where the aneurysm exists. The stent-graft provides a new channel for blood flow through the region of the aneurysm, taking stress off of the arterial wall where the aneurysm exists so that the aneurysm will not rupture, and also channeling blood flow through the stent-graft so that even if the aneurysm were to rupture, internal bleeding would not result. The portion of the aorta which has the aneurysm therein can either be removed or remain in place if the stent-graft is delivered intraluminally or otherwise, within the portion of the aorta having the aneurysm.
One challenge presented by implantation of stent-grafts within the aorta is how to maintain the position of the stent-graft precisely where desired. It is desirable to avoid or minimize the need for suturing through the walls of the aorta so that the aorta walls can remain unpenetrated, and to avoid stressing the walls of the aneurysm by utilizing a stent which provides too great of radial pressure outward on the wall of the aorta. The relatively high blood flow and blood pressure existing within the aorta puts forces upon the stent-graft which present the possibility of dislodging the stent-graft from its desired position. Additionally, differing patient luminal geometries can cause a stent-graft which is well designed for an average patient to be either too large, too small or the wrong shape to be effectively held in place without damaging the aorta once implanted. Also, when the aneurysm is at a location on the aorta where a significant lateral artery is located, such as one of the renal arteries, one of the iliac arteries, or arteries extending off of the aortic arch, a typical prior art stent-graft will tend to block or limit flow to such lateral arteries, decreasing blood circulation to these portions of the patient, and decreasing the effectiveness of the procedure.
Accordingly, a need exists for implantable devices which can function effectively as a stent-graft and which can be placed within the aorta or other body lumens adjacent an aneurysm or other defect which will properly fit within the body lumen, avoid placing undesirable stress upon the body lumen, hold the stent-graft in the desired position and maintain blood flow to major lateral arteries off of the aorta, or other lateral lumens off of a primary lumen in which the device is implanted.
This invention provides a stent-graft which is configured to be securely anchored within a body lumen such as the aorta. The stent-graft can be in the form of a positioning anchor alone, or a combination of a positioning anchor and a stent-graft extending from the positioning anchor, or in the form of a stent-graft alone with some of the anchoring aspects according to this invention built into the stent-graft itself. The positioning anchor according to this invention is preferably a double walled generally tubular structure with a void between an inner wall and an outer wall of the anchor. A primary fluid conduit is thus defined by the inner wall of the anchor, providing the generally tubular structure for the anchor. Lateral fluid conduits are also preferably provided which extend laterally from the primary fluid conduit and out of the anchor.
In a preferred embodiment of this invention, the contour of the walls of the anchor is provided in a custom fashion matching the particular luminal geometry of the patient in which implantation is to occur. Hence, the size, shape and position of the lateral fluid conduits within arms extending from the anchor are preferably precisely positioned where needed to allow these arms of the anchor to extend at least partially into the lateral arteries or other lateral lumens located within the patient at the site where implantation is to occur. Radially expandable stents can circumscribe the arms of the anchor to secure the arms within lateral lumens within the patient.
The void between the inner wall and outer wall of the anchor is preferably fillable with a fixation media so that the anchor can be inflated, brining the outer wall into contact with walls of the aorta or other body lumen at the implantation site. The fixation media can provide a rigidifying effect for the anchor, helping to maintain a geometry of the anchor within the aorta. Because the contour of the anchor matches the geometry of the patient at the implantation site, the anchor resists movement of the anchor, and any stent-graft coupled thereto, away from the implantation site.
Various different manufacturing methods are provided to form the walls of the anchor with the desired geometry, either with the anchor in a single walled form or in a double walled form. In the double walled form, the void can be totally open or can be spanned by interconnections functioning as “quilting” to maintain a maximum distance that the inner wall and outer wall can be spaced from each other. The anchor and other portions of the stent-graft can optionally be lined along the inner wall with a liner if such a liner is desired for the particular implantation procedure being conducted.
To provide the anchor and optionally a stent-graft coupled thereto with the desired geometry matching that of the aorta of the patient at the implantation site, the following procedure is preferably followed. Initially, patient luminal geometry is mapped utilizing imaging technology known in the art to create a data file corresponding with the patient's luminal geometry. This data file can then be used to create a three-dimensional virtual model of the patient geometry as well as a desired geometry for the anchor, any stent-graft, and optionally a lumen shaper balloon to be utilized to precisely expand and support the anchor during expansion and inflation/fixation of the anchor. These models are then sent in digital form to a rapid prototyping (RP) machine to create actual models of these structures, such as the anchor and the shaper balloon. These models can then either be used directly as a mandrel/mold for the forming of the anchor and/or shaper balloon or used indirectly to make such mandrels/molds. Once the mandrels and/or molds have been made for the various components needed for the implantation procedure, the anchor, shaper and other equipment are formed by applying appropriate material for the formation of these structures against the mandrel and/or mold. Finally, the mandrel and/or mold is removed to provide the finished custom shaped anchor, shaper balloon or other structure for use in the implantation procedure.
Deployment can occur in any desired fashion, with intra-luminal implantation considered most preferred. With such intra-luminal implantation, the lumen shaper balloon is collapsed upon a catheter with the anchor collapsed down upon the lumen shaper balloon. The catheter is then inserted as is known in the art into the aorta or other body lumen in an intra-luminal fashion.
When the catheter is properly positioned, typically with the assistance of imaging technology to verify its position, the lumen shaper balloon is expanded to cause the anchor to be expanded with arms of the anchor extending into the lateral lumens for proper support of the anchor. The lumen shaper balloon then remains inflated while the fixation media is delivered into the void between the inner wall and outer wall of the anchor, causing inflation of the anchor. The lumen shaper balloon maintains the position of the inner wall during such filling of the void, causing the outer wall to expand away from the inner wall until it comes into contact with the luminal wall of the patient or other tissues or deposits which may have collected within the lumen and are to be abutted by the outer wall of the anchor. Once this fixation media has been delivered, and optionally has been allowed to set through a desired rigidity, the lumen shaper balloon can be deflated for removal of the lumen shaper balloon along with the catheter for completion of the procedure.
If a stent-graft is to be included along with the anchor, such a stent-graft can be implanted along with the anchor or in a secondary procedure with the stent-graft coupled to the anchor. The lumen shaper balloon can be configured to appropriately support the stent-graft and expand it into the desired position. If the stent-graft includes two walls with a void there between, fixation media can be utilized to fill this void in the stent-graft, either in a common procedure with the inflation of the anchor, or in a secondary procedure. Once any stent-graft has been properly positioned where desired and inflated with any fixation having taken place, any expansion shaper balloons on the catheter can be deflated and removed along with the catheter intraluminally out of the body lumen.
The implant including either the anchor alone, anchor and stent-graft or stent-graft alone remains in place with fluid flow through the lumen occurring through the interior tubular structure of the finally implanted structure, with the anchor or corresponding portions of the stent-graft fitting snugly within the patient's luminal geometry to maintain proper position for the anchor and/or stent-graft. Proper fluid flow is thus maintained through the primary fluid conduit of the lumen, as well as maintaining fluid flow through the lateral lumen extending from the primary lumen through lateral fluid conduits within the anchor and/or stent-graft.
Accordingly, a primary object of the present invention is to provide a stent-graft which securely maintains its position within a body lumen while avoiding or minimizing penetration of the luminal wall and avoiding or minimizing stress placed upon the luminal wall.
Another object of the present invention is to provide a stent-graft which can support fluid flow through a body lumen main pathway while also maintaining fluid flow to lateral lumens coupled to the primary lumen.
Another object of the present invention is to provide a stent-graft which can fill at least a portion of a space within an aneurysm within a body lumen and provide a channel for fluid flow past the location of the aneurysm.
Another object of the present invention is to provide a stent-graft which can be customized in shape and form to match particular luminal geometry of a particular patient.
Another object of the present invention is to provide a stent-graft which can be delivered intraluminally and remain securely affixed at an implantation site.
Another object of the present invention is to provide methods for manufacturing stent-grafts which include an inner wall and an outer wall with a void therebetween.
Other further objects of the present invention will become apparent from a careful reading of the included drawing figures, the claims and detailed description of the invention.
Referring to the drawings, wherein like reference numerals represent like parts throughout the various drawing figures, reference numeral 10 is directed to an anchor (
In essence, and with particular reference to
The arms 16, 18 of the anchor 10 extend into lateral arteries such as the renal arteries RA to further assist in maintaining the desired position for the anchor 10. The anchor 10 can be utilized alone or can have a stent-graft 40 (
More specifically, and with particular reference to
The anchor 10 preferably has a particular geometry as follows. The anchor 10 is preferably generally tubular in form surrounding a primary fluid conduit 22 between an upper end 12 and a lower end 14. Multiple arms preferably surround lateral fluid conduits 24 extending away from the primary fluid conduit 22. Such arms can include a superior messenteric artery (SMA) arm 15 (
The anchor 10 can be single walled to provide at least some of the desired function according to this invention, but is most preferably double walled in form. If the anchor 10 is single walled, it would typically be utilized in a patient which does not have an aneurysm or other defect at the location where the anchor 10 is to be implanted. The arms, such as the arms 15, 16, 18 of such a single walled anchor would be positioned into corresponding arterial pathways extending from the aorta or other lumen into which the anchor is to be implanted. Most preferably, radially expandable stents would be located adjacent these arms and radially expanded to bring such arms 15, 16, 18 of the anchor 10 into intimate contact with these lateral arteries. Additionally, a radial expandable stent can be utilized adjacent the upper end 12 and/or the lower end 14 to hold the ends 12, 14 of the anchor 10 securely in contact with the wall of the aorta A. If desired, additional attachment structures could be utilized including sutures, staples, or other attachment structures known in the art to secure such a single walled anchor at the desired implantation site. Such a single walled anchor according to this invention might support a single walled stent-graft, or a double walled stent-graft which would typically pass through a portion of the aorta A or other body lumen which is damaged. Such a single walled stent-graft would include a single wall which could merely extend the primary fluid channel away from the single walled anchor or could be provided as a separate piece configured to be attachable to such a single walled anchor, either outside of the patient or intraluminally during implantation of the single walled anchor and the stent-graft. The stent-graft 40 would typically have an upper end 42 (
According to the preferred embodiment, the anchor 10 is double walled, as particularly shown in
Specifically, after the anchor 10 has been positioned at the implantation site and oriented with the arms such as the arms 15, 16, 18, passing into corresponding lateral arteries, a fixation matrix M is delivered into the void 35 between the inner wall 20 and the outer wall 30. The inner wall 20 is preferably supported to prevent the inner wall 20 from collapsing inwardly into the primary fluid channel 22. Such support is preferably provided by a lumen shaper balloon which has been inflated inboard of the inner wall 20. One such lumen shaper balloon 110 is shown in
Because the inner wall 20 is prevented from collapsing inwardly, the void 35 can only expand to receive the fixation matrix M by having the artery wall 30 expand away from the inner wall 20, along arrow B of
As particularly shown in
For instance, the media M could be initially presented into the void 35 in the form of a gas which undergoes a phase change or other transformation into a liquid or solid form either through a temperature change, a chemical reaction with agents located within the void 35 or a sufficient time for a gaseous matrix to set into a liquid or solid form. As another alternative, the fixation media M can be originally delivered as a liquid which could either remain liquid or undergo some level of firmness enhancement, such as by setting into a gel, or hardening into a solid, either by temperature change, chemical reaction or other setting procedure.
If necessary, or desirable, the media M could be delivered with multiple different components which would react together within the void 35 to solidify the media M within the void 35 to a desired level of firmness. Such firmness can both enhance the support with which the anchor 10 supports the wall of the aorta A, and can assist in holding the anchor 10 itself and any stent-graft 40 coupled to the anchor 10 fixed at the desired position within the patient.
The anchor 10 can be formed from a variety of different materials, either being formed from a single material or multiple different materials in combination. Most preferably, the material forming the anchor 10 is at least one layer of material which is impervious to fluid migration therethrough, either directly or by the inclusion of a fluid barrier liner, such as adjacent the inner wall 20 of the anchor 10. Most preferably, and to facilitate custom shaping of the contour of the anchor 10 to match the desired patient geometry at the implantation site, the anchor 10 is formed from a layer of moldable material. Such a moldable material could be in the form of a polymeric hydrocarbon. The anchor 10 itself, and/or an accompanying stent-graft 40 could be formed from parylene with a Dacron liner. The anchor 10 could be provided without a liner or formed entirely out of Dacron. Other materials exhibiting bio-compatibility and sufficient preclusion of fluid migration therethrough would also be suitable for formation of the anchor 10 and stent-graft 40 according to this invention.
The material forming the anchor 10 preferably is flexible to facilitate collapsing of the anchor 10 and the stent-graft onto a catheter for intra-luminal implantation. Such flexibility also assists in allowing the catheter to follow curving arterial pathways during intra-luminal delivery to the implantation site. Additionally, the material forming the anchor 10 and the stent-graft 40 is preferably substantially inelastic, at least within an operating range of pressures and forces with which the material encounters during implantation and function according to this invention. Some elasticity could be accommodated, provided that such an elasticity does not interfere with the function of the anchor 10 and stent-graft 40.
For particular discussion of the attributes of parylene and other materials from which the anchor 10 might be manufactured, particular reference is made to U.S. patent application Ser. No. 09/671,550, filed on Sep. 27, 2000, incorporated herein by reference.
The anchor 10 and other portions of the stent-graft 40 can be formed of any suitable method which provides the anchor 10 with the desired geometry and from the materials having the desired functional characteristics to function properly according to this invention. If the anchor 10 is to be formed in a single walled manner, one option includes use of a two-piece cavity mold 50 (
With reference to
With particular reference to
With particular reference to
Preferably, the sacrificial mandrel 80 would be formed of a material which can be readily destroyed for removal after formation of the double walled anchor 10 about the sacrificial mandrel 80, leaving the void 35 within the anchor 1 0. For instance, the sacrificial mandrel 80 can be formed of a water soluble material, so that once it comes into contact with water it liquefies and can be removed leaving the void 35 within the anchor 10.
As another alternative, the sacrificial mandrel 80 can be formed from a material which easily dissolves when an appropriate solvent is applied. For instance, the sacrificial mandrel 80 could be formed of a foam material, such as Styrofoam, which would react with a solvent such as acetone to pass entirely into solution and be poured out of the void 35 in the form of a liquid. Such removal of the sacrificial mandrel 80 would typically occur by forming a hole somewhere in the anchor 10 leading into the void 35, or removal of the sacrificial mandrel 80 after it has been so dissolved. Other alternatives include forming the sacrificial mandrel 80 from a material which can be readily oxidized, such as by combustion or otherwise gasified by a chemical reaction to allow the sacrificial mandrel 80 to be removed in the form of a gas out of the void 35 within the anchor 10.
As another alternative, the sacrificial mandrel 80 could be formed from a solid material, such as a wax, which has a suitable melting point so that it can merely be heated until it changes phase into a liquid or gaseous form, to then be removed from the void 35 within the anchor 10.
Similarly, the sacrificial mandrel 80 could be formed from an easily fracturable solid material, such that sharp blows to the anchor 10 with the sacrificial mandrel 80 included therein would cause the sacrificial mandrel 80 to shatter into small solid pieces which could be removed from an appropriate hole leading into the void 35 within the anchor 10. Such shattering could also be provided by appropriately tuned vibrations, or ultrasonic waves, which might be directed at the sacrificial mandrel through the walls 20, 30 of the anchor 10.
While it is preferable that the sacrificial mandrel 80 be removed from the void 35, it is also conceivable that the sacrificial mandrel 80 would remain in some form within the void 35 and be implanted along with the anchor 10. For instance, if the sacrificial mandrel is formed of a collapsible foam material which has any resiliency and shape memory, it could be collapsed upon a catheter with an appropriate sheath to hold the anchor lain its collapsed form. Once reaching the implantation site, the retraction of the sheath would cause such resilient foam to expand within the void 35 to the desired expanded position. If additional expansion is required, additional material could be provided along with the material forming the sacrificial mandrel 80, to further increases the size of the void 35 and/or to solidify the material forming the sacrificial mandrel 80 further, to enhance a firmness of the anchor 10. In such an embodiment, the sacrificial mandrel 80 would not necessarily be sacrificed, but rather remain in a position within the void 35 of the anchor 10.
With particular reference to
As described above, such interconnections can assist in resisting collapse of the inner wall 20 and constriction of the primary fluid conduit 22 during inflation of the void 35 with fixation media M. The finished anchor/mandrel combination 90 has a similar form (
In accordance with a second quilting method,
When the quilting mandrel 100 is sprayed or vapor deposited with the material forming the anchor 10, some of the material passes through the slits 102 to form the quilting between the inner wall 20 and the outer wall 30 of the anchor 10. When the sacrificial quilting mandrel 100 is removed, the void 35 is provided with interconnection regions existing where the slits are provided within the quilting mandrel 100.
If desired, the anchor 10 can include a liner 104, such as adjacent the inner wall 20. Such a liner 104 is shown in
Where a double walled liner 104 is desired, a rod 109 can be utilized to double back the liner 104 upon itself. Such a rod 109 can be one portion of a circular tube such that a double walled liner 104 becomes a quadruple walled liner 104, when the rod 109 is moved downwardly such as in
The liner 104 can include holes therein adjacent where lateral arms are located within the anchor 10, or can be continuous in those locations in a fashion precluding blood flow to lateral arteries, if desired. For instance, if a lateral artery is not particularly needed for blood flow, such a lateral artery can merely be utilized as an anchoring point for the arms of the anchor 10, and not maintain blood flow therethrough. Preferably however, any liner 104 includes appropriate holes adjacent the arms of the anchor 10 so that blood flow is maintained through the lateral arteries adjacent where the anchor 10 is implanted.
With particular reference to
The shaper balloon 110 is preferably enclosed so that the top 112 and bottom 114 are enclosed with at least one access port for the delivery of an inflation fluid into the lumen shaper balloon 110. Preferably, knobs 118 are located at the ends of each of the arms 115 which are enclosed to allow the lumen shaper balloon 110 to be inflated without any holes where leakage would occur. These knobs 118 preferably inflate to a larger diameter than adjacent arms. The knobs 118 can be located adjacent where radially expandable stents are to be expanded between the anchor 10 and the lateral artery walls of the patient. The knobs 118 thus provide the radial force necessary to expand the radial expandable stent to the diameter desired. As an alternative, such radial expandable stents can be delivered in a separate procedure after general positioning of the anchor 10.
Preferably, the shaper balloon 110 is custom manufactured to a geometry matching a contour of the particular patient's body lumen geometry where the anchor 10 is to be implanted. Hence, a custom shaper balloon 110 is provided particularly adapted for expansion, inflation and proper positioning of the custom anchor 10 at the implantation site. The lumen shaper balloon 110 would typically be a single walled structure, such that the manufacturing techniques particularly illustrated in
With particular reference to
On computer displays viewing the data, the treatment planner can construct a desired geometry for the anchor 10 and/or stent-graft 40 which would match the particular patient's luminal geometry at the treatment site. Some or all of this process of constructing a desired geometry for the anchor 10 and/or the stent-graft 40 could similarly occur in an automated fashion by a computer recognizing the geometry of the patient's body lumen and taking appropriate measurements to construct a desirable anchor 10 and/or stent-graft 40.
Once such virtual models of the anchor 10 have been created, an automated or manual process can be utilized to define desired geometry for the lumen shaper balloon 110 to be utilized in positioning and expanding the anchor 10. These virtual models also digitally describe the geometry of mandrels and/or molds to be used in forming the actual devices which will be used in the implantation procedure.
Data files corresponding with the geometry of the desired anchor 10 and desired lumen shaper balloon 110 are then sent to a rapid prototyping (RP) machine, such as that provided by Z-Corp or 3-D Systems. The rapid prototyping machine then creates actual three-dimensional models, preferably of full size, for the anchor 10 and the lumen shaper balloon 110. These 3-D models of the anchor 10 and lumen shaper balloon 110 can then either be used directly or indirectly to form mandrels or other molds which will then be used in formation of the final anchor 10 and lumen shaper balloon 110.
Finally, in the case of a sacrificial mandrel 80, the mandrel is removed as is discussed in detail above to provide voids 35 where desired within the anchor 10. The final shaper balloon 110 and anchor 10 can then be collapsed upon a catheter or other deployment device for use in the implantation procedure, to be delivered to the implantation site.
With particular reference to
Initially, a delivery catheter 120 is provided which includes the shaper balloon 160 collapsed upon the delivery catheter 120 and with the anchor 150 overlying and collapsed upon the shaper balloon 160. A sheath 140 overlies the anchor 150 and shaper balloon 160 to assist in holding the shaper balloon 160 and anchor 150 in their collapsed configuration.
The delivery catheter 120 can then be fed through an insertion site, such as in the femoral artery of one of the legs of the patient, up to the aorta A or other implantation site. A guide wire 122 is preferably provided to assist in steering the delivery catheter 120 along the desired arterial pathway up to the aorta A. Once the delivery catheter 120 has reached the implantation site where an aneurysm X exists, and adjacent the lateral arteries to which the anchor 10 has been custom manufactured, the delivery catheter 120 is then rotated to the desired orientation. Radiopaque markers can be included upon the delivery catheter 120, the sheath 140 or upon the anchor 150 or shaper balloon 160 to determine both the position of the delivery catheter 120 and the orientation of the delivery catheter 120.
The sheath 140 is then retracted to expose the anchor 150. Preferably, a seal balloon 130 is provided near a tip of the delivery catheter 120. This seal balloon 130 can be initially inflated, such as through a fluid delivery conduit within the delivery catheter 120 and with an outlet at the seal balloon 130. The seal balloon 130 can thus be expanded to block off the aorta A. Preferably, a tip of the delivery catheter 120 includes a bypass inlet 124 to a hollow center of the delivery catheter 120, or other pathway extending to the bypass outlet 126. In this way, blood flow F can be diverted through the delivery catheter 120 during the positioning, expansion and inflation procedure for the anchor 150.
The shaper balloon 160 is then inflated by delivery of an appropriate inflation fluid into the shaper balloon 160. This causes the anchor 150 to be expanded to its fully expanded (but uninflated) form (
If desired, a collar 170 can be provided within the anchor 150 which is in the form of a separate void which can be initially filled to provide added structure to the anchor 150 and to further assist in preventing the anchor 150 from slipping within the aorta A. Such filling of the collar 170 can occur through a filler tube 172 leading to the collar 170. Once the expanded but uninflated anchor 150 is properly positioned with its arms 152 extending into the lateral arteries extending through the aorta A, the anchor 150 is ready for inflation.
Fixation media M is then delivered through the media delivery tube 180 (
Finally, the lumen shaper balloon, which has remained inflated to ensure that the primary fluid conduit through the anchor 150 remains fully open during setting and filling of the void 155 with the media M, can be deflated along with the seal balloon 130. The delivery catheter 120, fill balloon 130 and lumen shaper balloon 160 can then be retracted out of the anchor 150.
If portions of a stent-graft are coupled to the anchor 150, they can be inflated before movement of the delivery catheter 120, or with a balloon such as the seal balloon 130 utilized to expand the stent-graft as the delivery catheter 120 is retracted. Once the delivery catheter 120 and lumen shaper balloon 160 has been removed, blood flow F′ occurs through the anchor 150 and with blood allowed to flow through the lateral arteries coupled to the aorta A at the implantation site.
While this implantation procedure has been particularly described with regard to the anchor 150 being inflated at a junction of the aorta A and renal arteries RA, a similar procedure could be utilized for delivery of an anchor to the aortic arch, or to a location above the renal arteries, or to a location below the renal arteries, depending on the particular treatment plan indicated for the patient's condition. An analogous delivery procedure would be utilized for the expansion and inflation of a double walled stent-graft according to this invention with the exception that no arms would be included which would require positioning into lateral arteries. Such a stent-graft can be provided along with the anchor or implanted in a separate follow-up procedure after positioning of the anchor.
With particular reference to
Specifically, the anchor portion is generally in the form of a single walled anchor which includes stents 210 in arms of the anchor which extend into the renal arteries, the superior messenteric artery SMA and other lateral arteries LA. Additional stents 210 support upper and lower ends of the anchor adjacent walls of the aorta A.
A series of toroids are manufactured along with the stent-graft portion of the implant 200. These toroids are generally similar to those shown in the stent-graft with positioning anchor 600 of
With particular reference to
With particular reference to
Also, the anchor portion of the implant 400 is double walled, similar to the embodiment of
Fixation media M is utilized to expand the anchor portion of the implant 500 to fill the void adjacent the renal arteries RA. Because lower portions of the aneurysm X include a significant amount of thrombus T which is already effectively positioned to support the stent-graft portion of the implant 500, the stent-graft portion can be merely a single walled stent-graft extending entirely down from the anchor portion of the implant 500, without any toroidal sections which require any filling. In this example the stent-graft is shown with dual tubes at lower ends extending into each of the iliac arteries IA.
This disclosure is provided to reveal a preferred embodiment of the invention and a best mode for practicing the invention. Having thus described the invention in this way, it should be apparent that various different modifications can be made to the preferred embodiment without departing from the scope and spirit of this invention disclosure. When structures are identified as a means to perform a function, the identification is intended to include all structures which can perform the function specified. When structures of this invention are identified as being coupled together, such language should be interpreted broadly to include the structures being coupled directly together or coupled together through intervening structures. Such coupling could be permanent or temporary and either in a rigid fashion or in a fashion which allows pivoting, sliding or other relative motion while still providing some form of attachment, unless specifically restricted.