Search Images Maps Play YouTube News Gmail Drive More »
Sign in
Screen reader users: click this link for accessible mode. Accessible mode has the same essential features but works better with your reader.

Patents

  1. Advanced Patent Search
Publication numberUS20040059406 A1
Publication typeApplication
Application numberUS 10/251,031
Publication dateMar 25, 2004
Filing dateSep 20, 2002
Priority dateSep 20, 2002
Also published asCA2498176A1, CA2498176C, DE60302674D1, DE60302674T2, EP1539037A1, EP1539037B1, US20130317601, WO2004026181A1
Publication number10251031, 251031, US 2004/0059406 A1, US 2004/059406 A1, US 20040059406 A1, US 20040059406A1, US 2004059406 A1, US 2004059406A1, US-A1-20040059406, US-A1-2004059406, US2004/0059406A1, US2004/059406A1, US20040059406 A1, US20040059406A1, US2004059406 A1, US2004059406A1
InventorsEdward Cully, Warren Cutright, Craig Nordhausen, Michael Vonesh, James Walter
Original AssigneeCully Edward H., Cutright Warren J., Nordhausen Craig T., Vonesh Michael J., Walter James T.
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Medical device amenable to fenestration
US 20040059406 A1
Abstract
The present invention is directed to a device that permits a permanent aperture to be formed in a wall, or other partition, of an implantable medical device. The present invention maintains the continuity and fluid-retaining properties of the implantable medical device by providing a breachable barrier material fully covering an opening delimited by a deformable framework. The invention is accessed with conventional interventional surgical instruments that disrupt and displace the barrier material. Following disruption of the barrier material, the opening is enlarged with surgical instruments to form a permanent framed aperture in the wall of the implantable medical device. The permanent framed aperture provides fluid communication across the wall of the implantable medical device.
Images(16)
Previous page
Next page
Claims(33)
We claim:
1. An implantable medical device comprising a framework delimiting an opening having a first area and a breachable barrier material fully covering said opening, wherein a permanent aperture having a second area is formed following breach of said breachable material and said framework is adaptable to be altered in shape.
2. The implantable medical device of claim 1 wherein said framework is incorporated into a medical device.
3. The implantable medical device of claim 2 wherein said medical device is a vascular prosthesis.
4. The implantable medical device of claim 4 wherein said vascular prosthesis is a vascular graft.
5. The implantable medical device of claim 4 wherein said vascular prosthesis is a stent-graft.
6. The implantable medical device of claim 5 wherein said device is distinct from support elements of said stent-graft.
7. The implantable medical device of claim 4 wherein said vascular prosthesis is a surgical patch.
8. The implantable medical device of claim 1 wherein said breachable barrier material comprises a fluoropolymer.
9. The implantable medical device of claim 8 wherein said fluoropolymer is a polytetrafluoroethylene material.
10. The implantable medical device of claim 1 wherein said breachable barrier material comprises a bio-degradable material.
11. The implantable medical device of claim 1 wherein said breachable barrier material includes a filler material.
12. The implantable medical device of claim 1 wherein said breachable barrier material comprises an elastomer.
13. The implantable medical device of claim 1 wherein said framework is made of an implantable metal.
14. The implantable medical device of claim 1 wherein said framework is made of an implantable polymer.
15. An implantable medical device comprising a continuous wall, at least one framework in said wall delimiting an opening having a first area, a breachable barrier material fully covering said opening, wherein a permanent aperture having a second area is formed following breach of said breachable material and said framework is adaptable to be altered in shape and have a reinforced peripheral region in said continuous wall.
16. The implantable medical device of claim 15 wherein said continuous wall has a planar geometry.
17. The implantable medical device of claim 15 wherein said continuous wall has a tubular geometry.
18. The implantable medical device of claim 15 wherein said continuous wall is a vascular prosthesis.
19. The implantable medical device of claim 18 wherein said vascular prosthesis is a vascular graft.
20. The implantable medical device of claim 18 wherein said vascular prosthesis is a surgical patch.
21. The implantable medical device of claim 18 wherein said vascular prosthesis is a stent-graft.
22. The implantable medical device of claim 21 wherein said device is distinct from support elements of said stent-graft.
23. The implantable medical device of claim 15 wherein said device is a component of a vascular prosthesis.
24. The implantable medical device of claim 23 wherein said vascular prosthesis is a stent-graft.
25. The implantable medical device of claim 24 wherein said device is distinct from support elements of said stent-graft.
26. The implantable medical device of claim 15 wherein said continuous wall comprises a fluoropolymer.
27. The implantable medical device of claim 26 wherein said fluoropolymer is a polytetrafluoroethylene material.
28. The implantable medical device of claim 15 wherein said framework is made of an implantable metal.
29. The implantable medical device of claim 15 wherein said breachable barrier material comprises a fluoropolymer.
30. The implantable medical device of claim 29 wherein said fluoropolymer is a polytetrafluoroethylene material.
31. The implantable medical device of claim 15 wherein said breachable barrier material comprises a biodegradable material.
32. The implantable medical device of claim 15 wherein said breachable barrier material includes a filler material.
33. The implantable medical device of claim 15 wherein said breachable barrier material comprises an elastomer.
Description
    FIELD OF THE INVENTION
  • [0001]
    The present invention relates to implantable medical devices. More particularly, the invention relates to means for forming a framed aperture in wall portions, or other partitions, of implantable medical devices to establish and maintain fluid communication across the wall portion of the medical device. The present invention also relates to methods of making the invention.
  • BACKGROUND OF THE INVENTION
  • [0002]
    Abdominal aortic aneurysms (AAAs) and thoracic aortic aneurysms (TAAs) are diagnosed in approximately 250,000 and 20,000 patients respectively each year. Left untreated, these aneurysms commonly progress to rupture resulting in death. Prior to the advent of interventional catheter-based techniques, conventional surgical treatment has been the method of treatment for these lesions. Due to the often emergent condition of these patients and the potential for significant blood loss, high morbidity and mortality rates have been associated with this type of surgery.
  • [0003]
    With the introduction of catheter-based interventional techniques, new non-surgical therapies were made available to many patients. Since the initial animal work performed by Schatz et. al., small metallic tubes (i.e., stents) have been found to be of significant benefit for patients with coronary artery and peripheral artery disease. Schatz, R. A., Palmaz, J. C., Tio, F. O., Garcia, F., Garcia, O., Reuter, S. R. “Balloon-expandable intracoronary stents in the adult dog.” Circulation 76:450-7 (1987). In an effort to treat abdominal aortic aneurysms, Parodi et. al. reported on their experience with combining the barrier properties of synthetic vascular grafts with stent technology (i.e., stent-graft) to effectively inhibit blood flow into the aneurysm sac using catheter delivery systems. Parodi, J. C., Palmaz, J. C., Barone, H. D. “Transfemoral intraluminal graft implantation for abdominal aortic aneurysms.” Ann. Vasc. Surg 5:491-9 (1991).
  • [0004]
    This technology has continued to progress with significant improvements in successful device deployment and improved patient outcomes. Despite these improvements, there are many patients for which this technology is not applicable as a result of unique anatomical or disease conditions. Specifically, in the case of AAA disease, stent-graft devices typically require some amount of healthy vessel both proximal and distal to the aneurysm sac into which to place the stent-graft. In many patients, the proximal vessel is not long enough to achieve adequate fixation. Placement of the stent-graft in a more proximal location in these patients in order to achieve adequate fixation could partially or completely occlude the renal arteries providing blood to the kidneys. A number of different device designs have been proposed to allow device fixation to the aortic vessel proximal to the renal arteries (i.e., suprarenal fixation). Widespread applicability of supra-renal fixation devices has been limited by the flexibility of these designs, morphological variation of aneurysmal neck geometry across patients, and the coverage of the renal ostia with metallic stents which can act as a nidus for thromo-embolism of the renal circulation and/or hinder subsequent interventional access to this vasculature.
  • [0005]
    A similar situation exists for TAA disease. These aneurysmal lesions are often located in close proximity to the subclavian and carotid arterial branches. When inadequate proximal vascular tissue is available for anchoring the endoprosthesis, a suitable proximal anchoring zone can be created by performing a surgical transposition prior to the interventional procedure. This surgical approach is intended to assure continued flow to all vessels. Alternative means for achieving side-branch perfusion through the wall of a stent-graft are therefore desirable.
  • [0006]
    Other clinical conditions where there would be a benefit for fluid communication through the wall of a prosthesis are those involving cardiac surgery. Arterial blood leaving the heart serves to carry oxygen to the body. In contrast, venous blood is returned to the heart via the superior and inferior vena cava after releasing oxygen to the body and absorbing carbon dioxide and other waste products. Approximately 40,000 children are born each year with congenital heart defects. These abnormalities often involve a single functional ventricle and defects in the tissues (i.e., septum) separating the right (venous) and left (arterial) side of the heart. Mixing of arterial and venous blood in these patients results in reduced oxygen carrying capacity and often shortened life expectancies.
  • [0007]
    Cardiac surgical interventions performed for the most complex congenital heart abnormalities often require multiple surgical procedures to effect the final treatment for the patient. The Fontan procedure is an example of a staged surgical treatment that is designed to overcome these significant structural heart abnormalities and isolate systemic and pulmonary circulation at the definitive treatment. “Correction de I'atresie tricuspidienne.” Fontan, F., Mounicot, F. B., Baudet, E., Simonneau, J, Gordo, J., Gouffrant, J. M. Rapport de deux cas “corriges” par I'utilisation d'une technique chirurgicale nouvelle. [“Correction” of tricuspid atresia. 2 cases “corrected” using a new surgical technic] Ann-Chir-Thorac-Cardiovasc 10:39-47 (1971). Annecchino, F. P., Fontan, F., Chauve, A., Quaegebeur, J. “Palliative reconstruction of the right ventricular outflow tract in tricuspid atresia: a report of 5 patients.” Ann-Thorac-Surg.29:317-21 (1980). Ottenkamp, J., Rohmer, J., Quaegebeur, J. M., Brom, A. G., Fontan, F. “Nine years' experience of physiological correction of tricuspid atresia: long-term results and current surgical approach.” Thorax 37:718-26 (1982). The surgical procedures must be staged to minimize the pressure and volume loads on the remaining functional single ventricle. In the first stage procedure, a connection is created between the Superior Vena Cava (SVC) and the Pulmonary Artery (PA). This is referred to as a Hemi-Fontan or Glenn Shunt procedure. Mathur, M., Glenn, W. W. “Rational approach to the surgical management of tricuspid atresia.” Circulation 37:1162-7 (1968). This shunt reduces the degree of venous and arterial blood mixing, and improves oxygenation of the blood.
  • [0008]
    Once the pulmonary circulation and functional ventricle are sufficiently developed, a subsequent procedure is performed wherein the blood going to the right ventricle is bypassed, by routing the blood in the Inferior Vena Cava (IVC) directly to the PA by way of a baffle or tube connecting the IVC to the PA. At the time of this procedure, a small hole is typically created in the side of the connection tube to allow some flow of blood into the right ventricle. This small hole is considered a temporary connection that reduces the work for the remaining ventricle when pulmonary vascular resistance is elevated. Bridges, N. D., Mayer, J. E., Lock, J. E., Jonas, R. A., Hanley, F. L., Keane, J. F., Perry, S. B., Castaneda, A. R. “Effect of baffle fenestration on outcome of the modified Fontan operation.” Circulation 86:1762-9 (1992).
  • [0009]
    The final surgical procedure involves either surgical closure or transcatheter occlusion of the temporary hole in the IVC to PA connector tube. This multi-staged conventional surgical approach for patients with complex congenital heart disease is not optimal as it puts patients at additional risk of morbidity and mortality with each subsequent surgical intervention. This risk may be reduced if the first surgical intervention can set the stage for a future minimally invasive procedure that eliminates the need for additional open-heart surgery.
  • [0010]
    Various devices and design modifications have been proposed in an effort to provide access to anatomical structures surrounding the device or to internal spaces of the device.
  • [0011]
    U.S. Pat. No. 6,428,565, issued to Wisselink, and U.S. Pat. No. 6,395,018, issued to Castaneda, each relate to stent-graft systems with pre-formed apertures to allow for side-branch access. Neither of these devices have apertures that are closed at the time of initial implant.
  • [0012]
    U.S. Pat. No. 6,398,803, issued to Layne, et. al., relates to partially covered stents having various patterns of open apertures along the length of the device. As with the Wisselink and Castaneda devices, the apertures are fully formed prior to deployment of the device.
  • [0013]
    U.S. Pat. No. 6,432,127, issued to Kim, et. al., discloses formation of an aperture in the wall of a vascular conduit through the use of a cutting tool. The conduit does not provide a deformable framework encompassing the aperture formation site. As a result, targeting the precise location of the region in which to create the aperture is difficult to visualize using conventional imaging techniques. Moreover, the aperture is not reinforced along its peripheral regions once the aperture is formed. The absence of a framework delimiting the aperture formation site precludes precise sizing of the aperture during its formation.
  • [0014]
    There remains a need for a device that initially maintains the continuity and fluid-retaining properties of a wall portion of an implantable medical device, while providing means for forming a permanent aperture in the medical device. Such a device would permit custom sizing of the aperture in situ at the implant site during surgery.
  • SUMMARY OF THE INVENTION
  • [0015]
    The present invention is directed to a device that is amenable to transmural fenestration. In particular, the present invention permits a permanent framed aperture to be formed in a wall, or similar partition, of implantable medical devices as a means for establishing and maintaining fluid communication across the wall of the medical device following implantation. The present invention provides a breachable barrier material that initially maintains the continuity and any fluid-retaining properties of the wall of the medical device. The breachable barrier material fully covers an opening delimited by a framework. In use, the breachable barrier material is breached with a surgical instrument and the shape of the framework altered to enlarge, or otherwise alter, the area of the opening. In the process, the opening becomes uncovered and accessible to flow of fluid through the opening. The altered framework provides structural reinforcement to peripheral regions (e.g., circumferential) of the enlarged opening and forms a permanent aperture in the wall of the medical device. The altered framework can also be used to provide a secure anchoring site for ancillary medical devices. The permanent aperture can be formed in the wall of the implantable medical device at the time of surgical or catheter-based intervention or at a later date through the use of interventional or surgical techniques.
  • [0016]
    The present invention is particularly suited for use with vascular prostheses, and other implantable medical devices providing fluid containment or fluid partitioning, that can benefit from the formation of one or more permanent apertures in the devices at the implantation site. With stent-grafts spanning an aneurysm, for example, the invention can provide a framed aperture in the wall of the stent-graft for side-branches or drainage sites. Vascular grafts can be bypassed or bifurcated in-situ with the present invention. The invention can also be used with surgically implanted cardiovascular patches to provide perfusion or other access to the heart and vascular system.
  • [0017]
    The present invention can be added to an implantable medical device following its construction, or included in the manufacture of the device as an integral component. The breachable barrier material of the present invention is made of implantable polymers that are readily breached, perforated, or otherwise structurally disrupted with surgical instruments. The breachable barrier material can also be made of polymers that are structurally disrupted through degradation and absorption by the body of the implant recipient. The polymers of the breachable barrier material can be incorporated with filler materials to assist in breaching the barrier material or to facilitate visualization of the aperture region in an implant recipient.
  • [0018]
    The framework is made of implantable metallic or polymeric materials that can be altered in shape. These framework materials can be deformed or otherwise altered in shape with surgical instruments or have shape-memory properties that permit the framework to assume different shapes without the use of an instrument. The framework materials are shaped in various ways to assist in the combined roles of structurally reinforcing the breachable barrier material and the opening, being capable of reconfiguration, and providing a permanent framed aperture.
  • [0019]
    In one surgical method, an implantable medical device utilizing the present invention is placed at a surgical site with conventional or interventional surgical techniques. Once the correct position of the medical device is confirmed, a catheter guide-wire, or other surgical instrument, is used to breach the breachable barrier material and begin to uncover the covered opening. An expandable balloon catheter in a deflated configuration is then inserted into the partially uncovered opening and inflated. As the balloon catheter is inflated, it expands in diameter, altering the shape of the framework and displacing the remaining barrier material from the area of the opening. When the framework has been reconfigured as desired, the balloon catheter is deflated and removed from the opening. This leaves a permanent framed aperture in the wall of the medical device. The permanent aperture can provide immediate therapies and surgical remedies, such as branch vessel perfusion, or co-operate with other medical devices.
  • [0020]
    In one embodiment, the present invention is an implantable medical device comprising a framework delimiting an opening having a first area and a breachable barrier material fully covering said opening, wherein a permanent aperture having a second area is formed following breach of said breachable material and said framework is adaptable to be altered in shape.
  • [0021]
    In another embodiment, the present invention is an implantable medical device comprising a continuous wall, at least one framework in said wall delimiting an opening having a first area, a breachable barrier material fully covering said opening, wherein a permanent aperture having a second area is formed following breach of said breachable material and said framework is adaptable to be altered in shape and have a reinforced peripheral region in said continuous wall.
  • [0022]
    Further aspects and advantages of the present invention will be apparent to those skilled in the art after reading and understanding the detailed description of preferred embodiments set forth hereinbelow and after viewing the accompanying drawings.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0023]
    The foregoing summary, as well as the following detailed description of a preferred embodiment of the invention, will be better understood when read in conjunction with the appended drawings. For purposes of illustrating the invention, there is shown in the drawings an embodiment that is presently preferred. It should be understood, however, that the invention is not limited to the precise arrangement and instrumentality shown. In the drawings:
  • [0024]
    [0024]FIG. 1A illustrates a top view of the present invention.
  • [0025]
    FIGS. 1B-1D illustrate a side view of the present invention.
  • [0026]
    FIGS. 2A-2E illustrate the present invention in operation.
  • [0027]
    [0027]FIG. 3A illustrates an embodiment of the present invention incorporated into a wall of a tubular medical device.
  • [0028]
    [0028]FIG. 3B illustrates an embodiment of the present invention incorporated into a planar material that is attached to a wall of a tubular medical device.
  • [0029]
    [0029]FIG. 4 illustrates an embodiment of the present invention incorporated into a medical device.
  • [0030]
    [0030]FIG. 4A illustrates an embodiment of the present invention placed in a discrete location relative to scaffolding and wall elements of an implantable medical device.
  • [0031]
    [0031]FIG. 5 illustrates an abdominal aortic aneurysm.
  • [0032]
    [0032]FIG. 6 illustrates a stent-graft incorporating an embodiment of the present invention placed in the region of an abdominal aortic aneurysm.
  • [0033]
    FIGS. 7A-7D illustrate the present invention being utilized to provide perfusion to side branches of a blood vessel.
  • [0034]
    [0034]FIG. 7E illustrates an embodiment of the present invention serving as attachment means for another medical device.
  • [0035]
    FIGS. 8A-8C illustrate the framework component of the present invention in various non-limiting shapes.
  • [0036]
    [0036]FIG. 9 illustrates the framework component of the present invention in the form of an array.
  • [0037]
    [0037]FIG. 10 illustrates the framework component of the present invention in the form of an array.
  • [0038]
    [0038]FIG. 11 illustrates a method of constructing the breachable barrier material in an embodiment of the present invention.
  • [0039]
    [0039]FIG. 12 is an exploded view of an embodiment of the present invention under construction.
  • [0040]
    [0040]FIG. 13 is a perspective view of an embodiment of the present invention.
  • [0041]
    The accompanying diagrams include various anatomical structures and associated clinical pathologies that are identified as follows:
  • [0042]
    AA=Abdominal Aorta
  • [0043]
    RA=Renal Artery
  • [0044]
    IA=Iliac Artery
  • [0045]
    AAA=Abdominal Aortic Aneurysm
  • DETAILED DESCRIPTION OF THE INVENTION
  • [0046]
    The present invention can be used in combination with a variety of implantable fluid-containing medical devices to establish fluid communication across a wall, or other partition, in the devices. In many situations, the present invention is employed at the time the medical device is implanted. In other instances, the present invention is accessed and utilized after the medical device has been implanted for a period of time. The present invention can also be used before the implant procedure begins.
  • [0047]
    [0047]FIG. 1A is a top view of an embodiment of the present invention 10 incorporated into an implantable patch material 12. FIG. 1B is a side view of this embodiment generally illustrating the relationship of the components. In this embodiment, a framework 14 is surrounded by a layer of implantable polymeric material 18. The framework 14 delimits an opening 16 that is fully covered with a breachable barrier material 17. The polymer layer 18 is sandwiched between two layers of implantable patch material 12, 13 so as to reveal the framework 14, opening 16, and breachable barrier material 17 of the present invention. In similar embodiments of the present invention, the implantable patch material or other wall components are considered part of the invention. In addition to implantable medical devices having planar configurations, implantable medical devices having tubular configurations are also suitable for use with the present invention. Tubular medical devices are generally cylindrical in shape and not confined to having parallel walls. In addition, tubular medical devices have geometries with at least one inlet and at least one outlet.
  • [0048]
    The shape of the framework 14 is chosen to provide structural support to the breachable barrier material 17 while it fully covers opening 16. The shape and composition of the framework also allows the framework to be readily deformed and displaced to peripheral regions of the opening to form a permanent framed aperture. The particular shape of the framework illustrated in FIG. 1A, et. al., is preferred but not limiting. For example, FIGS. 8B and 8C illustrate frameworks having circular configurations 70 incorporating varying numbers of peaks 76 and valleys 78. It is also contemplated in the present invention that the distance between the peaks 76 and valleys 78 (i.e., amplitude) can be varied broadly, thereby enabling a wide range of framework geometries to be formed. In addition to enhancing support for the breachable barrier material with these framework designs, a wide range of aperture sizes can be achieved with these designs. Supporting leg struts 74 can also be incorporated into the framework design to enhance attachment to surrounding wall materials. Other non-circular configurations 79 of the framework 14 are also contemplated. Furthermore, FIGS. 9 and 10 illustrate that the framework can be in the form of an array of openings. These embodiments provide a choice of locations for the framed aperture as well as the number of framed apertures.
  • [0049]
    FIGS. 2A-2E illustrate the construct of FIGS. 1A and 1B in use. FIG. 2A is a perspective view of the construct as it might appear at an implantation site. FIG. 2B shows a guide wire 20 from a catheter, or other device, having penetrated and breached the breachable barrier material 17. FIG. 2C depicts an expandable balloon catheter 22 in a deflated state being introduced through the breached barrier material into opening 16 with guide wire 20. FIG. 2D illustrates inflation of the expandable balloon catheter 22 and deformation of framework 14. As the framework 14 is deformed, opening 16 is enlarged and expanded in area. Following deflation and removal of the balloon catheter, FIG. 2E shows the resulting permanent aperture 24 framed with altered framework 14 in implantable patch material 12.
  • [0050]
    [0050]FIG. 3A illustrates the present invention 15 as a component of a tubular vascular graft 30. In this embodiment, framework 14 delimiting opening 16 is fully covered by breachable barrier material 17 and incorporated into wall portion 32 of vascular graft 30. When the invention is operated, fluid communication across wall portion 32 to luminal space 34 is established.
  • [0051]
    [0051]FIG. 3B illustrates an embodiment of the present invention 19 having an implantable patch material 11 component. The implantable patch material is attached to an implantable vascular prosthesis 30 by sewing. Other suitable means of attaching the present invention to a wall of an implantable medical device include, but are not limited to, adhering, ultrasonic or radio frequency welding, lamination, stapling, and covering the medical device with a membrane or film to include the present invention.
  • [0052]
    [0052]FIG. 4 illustrates an embodiment of the present invention 44 incorporated into an implantable tubular endovascular device 40. In this embodiment, the endovascular device 40 is a bifurcated design commonly used to treat aortic aneurysms and includes a main body, or trunk, portion 50 and two leg portions 52, 54. The endovascular device has a stent frame 42 and wall means 48. Several fully covered framework elements of the present invention are incorporated into the wall means 48 of the stent-graft 40. As seen in FIG. 4, there is a longitudinal displacement between the present invention and the support elements (i.e., scaffolding) of the stent-graft. This embodiment of the present invention provides multiple sites for forming side branches in stent-grafts and other endovascular devices as means for providing selective perfusion and/or drainage of the implantation site.
  • [0053]
    In embodiments of the present invention used in combination with stent-grafts, and other implantable medical devices utilizing support elements (i.e., scaffolding), the framework component of the present invention is preferably incorporated into the device separately from the support elements. As shown in FIG. 4A, the framework of the present invention underlies and is discrete from the support elements of the implantable medical device. The location of the present invention is not limited to contact or close proximity to support elements or wall components of an implantable medical device. Indeed, the present invention can be positioned in any desired location in an implantable medical device.
  • [0054]
    A clinical application of the embodiment illustrated in FIG. 4 is depicted in FIGS. 5 and 6. A typical abdominal aortic aneurysm (AAA) is shown in FIG. 5 with the proximal aorta (AA) leading to renal artery (RA) branches and distal iliac arteries (IAs). In cases where the disease condition or aortic anatomy does not provide sufficient healthy vessel upon which to achieve device fixation at implant, it is often necessary to utilize the AA segment proximal to the RAs. In this suprarenal implant position, an appropriate stent-graft 40 fixation can be achieved and effective AAA exclusion as shown in FIG. 6. In this configuration however, the barrier properties of the stent-graft wall 48 occlude blood flow to the branching RA on both sides. In order to achieve RA perfusion, one or more units 44 of the present invention are selected and utilized.
  • [0055]
    The interventional procedure required to access and operate the present invention is illustrated in FIGS. 7A-7D. Following deployment of stent graft 40, a guide catheter 36 is positioned under fluoroscopic guidance to direct a guide-wire 20 toward the center of one of the plurality of available inventions 44 that is in appropriate alignment with the RA. Following guide-wire 20 breach of the breachable barrier material 16, the framework 14 is altered in shape to the desired aperture size using a balloon catheter 22. Further inflation of the balloon 22 achieves the desired deformation of the framework 14 and formation of a permanent framed aperture 64 having a size appropriate for the RA. Once formed, the permanent framed aperture 64 provides for RA blood perfusion 62 in accordance with normal AA blood flow 60.
  • [0056]
    The present invention can be constructed of a variety of implantable materials. The breachable barrier material has a composition, structure, and/or thickness sufficient to at least partially bar liquids, including blood and other physiological fluids, from crossing the material, yet have sufficient structural weakness to be readily breached, perforated, or otherwise structurally disrupted with surgical instruments, or the like. The breachable barrier material can be made of non-biodegradable polymers, bio-degradable polymers, and elastomers, either alone or in combination. Elastomers in the breachable barrier materials can augment uncovering of the fully covered opening following breach of the barrier material. The breachable barrier material can be provided with filler materials that also augment breaching of the barrier material or assist in locating the invention at an implantation site.
  • [0057]
    Suitable surgical instruments or tools for use in breaching the barrier material at an implantation site include, but are not limited to, guide-wires, Colapinto® needles, Rotablators®, and other ablation instruments utilizing radio-frequency energy, ultrasonic sound, microwave energy, or laser light.
  • [0058]
    Suitable non-biodegradable polymers include, but are not limited to, polyester, polytetrafluoroethylene, polyamide, and polyurethane. The preferred material for the breachable barrier material is a porous expanded, or stretched, polytetrafluoroethylene material. Suitable bio-degradable polymers include, but are not limited to, materials made of polymers or copolymers possessing one or more of the following monomeric components: glycolide (glycolic acid); lactide (d-lactide, I-lactide, d,I-lactide); trimethylene carbonate; p-dioxanone; caprolactone, and hydroxybutyrate, hydroxyvalerate. Elastomeric materials suitable for use in the present invention include, but are not limited to, fluoroelastomers, polyurethane. Suitable filler materials for incorporation into the breachable barrier material include, but are not limited to, graphite, titanium oxide (TiO), barium, vitamin E, gadolinium, lossy materials, and other radio-opaque compositions.
  • [0059]
    The breachable barrier material can be applied to the framework as a single layer or in multiple layers. When using multiple layers of breachable barrier material, it is preferred to orient the individual layers in different directions (see e.g. FIG. 11).
  • [0060]
    The framework is made of materials that are capable of supporting the breachable barrier material while the barrier material is fully covering the opening delimited by the framework. The materials of the framework permit the framework to be readily shaped, reshaped, or otherwise altered in configuration while the invention is located at an implantation site. The framework can be made of malleable materials, plastically deformable materials, and/or self-expanding (i.e., super-elastic) metals or polymers. When materials are used that do not lend themselves to visualization with fluoroscopy, x-ray imagining, magnetic resonance imaging, etc., radio-opaque or other imaging compounds can be introduced into the framework materials.
  • [0061]
    The materials of the framework also need to be sufficiently resilient to provide permanent reinforcement of peripheral regions of the aperture under physiological conditions. In addition to providing structural support to peripheral regions of the aperture portion of the invention, the framework component can serve as anchoring means for other medical devices 90 attached thereto (e.g., FIG. 7E).
  • [0062]
    Suitable materials for the framework include, but are not limited to, implantable metals such as gold, silver, tantalum, tungsten, and chromium, implantable metal alloys such as stainless steel, nitinol metal, and implantable polymers such as polyurethanes, fluorinated ethylene propylene, and polytetrafluoroethylene. The framework can be made by molding, casting, laser cutting and/or laser machining, stamping, photo-etching, wire-forming, electrical discharge machining (EDM), bent wire techniques, or other suitable fabrication method.
  • [0063]
    In embodiments of the present invention that include a patch, tube, or other walled component, essentially any implantable material can be used for the component. Suitable materials include but are not limited to, implantable metals, implantable metal alloys, implantable polymers such as polyester (Dacron®), polyamide (Nylon), polytetrafluoroethylene, silicone, and polyurethane.
  • [0064]
    The present invention can be constructed in a variety of ways. The invention can be made by attaching the breachable barrier material to the framework material with adhesives, heat, pressure, and/or ultrasonic welding. In turn, the breachable barrier material can be attached to an implantable medical device with similar methodologies. The invention can also be incorporated into an implantable medical device by molding, sewing, wrapping with a film or membrane, and/or mechanical fixation.
  • [0065]
    An implantable medical device made of an expanded polytetrafluoroethylene (ePTFE) in the form of a tube or sheet can be supplied with an embodiment of the present invention by first cutting a hole in the ePTFE slightly smaller than the largest diameter of the framework component. Next, a powder coating of fluorinated ethylene propylene (FEP) is applied to both sides of the framework material and the framework material placed over the hole in the ePTFE material. A suitably sized piece of breachable barrier material is placed over the framework component. Heat and pressure are applied to the combination to attach the materials together.
  • [0066]
    Another method of attaching the present invention to an implantable medical device involves applying an adhesive material, such a room temperature vulcanizing (RTV) silicone, to both sides of the framework material and pressing one side of the framework onto a wall of the medical device having a suitably sized hole formed therein. A suitable breachable barrier material is then pressed onto the other adhesive-coated side of the framework component. Any excess barrier material is trimmed away from the framework to complete the installation.
  • [0067]
    Yet another method of attaching the present invention to an implantable medical device involves placing a framework component over a suitably sized hole in a wall of the medical device and wrapping one or more layers of a biocompatible film over the framework component. In this embodiment, the wrapped film layer(s) can also serve as the breachable barrier material. The film wrapping material can be further secured by heating the construction.
  • [0068]
    For implantable medical devices having a wall element in the form of a meshwork, the present invention can be attached to the medical device in such a way that the opening is accessibly through holes in the meshwork. In this embodiment, an adhesive-coated framework material is placed on a breachable barrier material. Additional adhesive is placed on perimeter regions of the barrier material. A meshwork device is placed over this combination so the opening of the present invention is accessible through one or more holes in the meshwork. Pressure is applied to the construct to adhere the components together. A preferred implantable medical device is a woven mesh material commercially available from Davol, Inc. under the trade name Bard® Marlex™ Mesh—Monofilament Knitted Polypropylene (Catalog No. 011265).
  • [0069]
    These construction methodologies are exemplary and are not intended to limit the scope of the present invention.
  • EXAMPLES
  • [0070]
    Without intending to limit the scope of the present invention, the apparatus and method of production of the present invention may be better understood by referring to the following examples.
  • Example 1
  • [0071]
    A planar sheet embodiment of the present invention, approximately 8.3 cm (3.25″) by 13.3 cm (5.25″), was constructed as follows. A first layer of an expanded polytetrafluoroethylene (ePTFE) sheet material having a thickness of about 0.4 mm was obtained from the Medical Products Division of W. L. Gore & Associates, Inc., Flagstaff, Ariz. under the tradename GORE-TEX® Cardiovascular Patch as part number 1800610004 (FIG. 12, part A1).
  • [0072]
    A second layer of a fluoro-elastomeric sheet material composed of a thermoplastic copolymer of tetrafluoroethylene (TFE) and perfluoro(methyl vinyl ether) (PMVE) was constructed by compression molding the crumb form of the copolymer at a temperature of about 250° C. to form a sheet about 0.2 mm (0.008″) in thickness (FIG. 12, part A3). The resulting material had the attributes described in TABLE 1 below.
  • [0073]
    A third layer of sheet material (FIG. 12, part A4) is composed of ePTFE made according to U.S. Pat. No. 4,482,516, issued to Gore. The sheet material was approximately 0.17 mm thick with an average fibril length of greater than about 10 microns.
  • [0074]
    A sheet of medical grade 316 stainless steel was obtained from Laserage Technologies, Inc., Waukegan, Ill. for use in constructing a framework. The framework was laser machined into an undulating pattern having a continuous, generally circular, ringed configuration (FIG. 12, part A2). The thickness of the framework was about 0.4 mm (0.016″). The minimum distance between individual framework elements located opposite one another in the opening delimited by the framework was about 0.2 mm (0.008″).
  • [0075]
    These four components were aligned together as shown in FIG. 12. Components 100, 102, 103, and 104 were placed between layers of high temperature padding material and aluminum plates (FIG. 12, parts 105, 106). The aluminum plates were approximately 15.2 cm (6″) square and 0.062″ thick. The high temperature padding material 105 was made of GORE-TEX® Soft Tissue Patch having a thickness of about 2 mm (0.079″) available from the Medical Products Division of W. L. Gore & Associates, Inc., Flagstaff, Ariz. as part number 1310015020. The assembly was placed in a heated Carver press and laminated together in the arrangement shown in FIG. 12 for about 5 minutes, at about 200° C. with a pressure of about 0.5 Mpa (80 lb/in2). Following the compression cycle in the press, the padding material was discarded.
  • [0076]
    A 4 mm hole was then cut though all three layers of material at the center point of the reinforcement element using a 4 mm sharpened coring punch. Four layers of high strength ePTFE film made according to U.S. Pat. No. 5,476,589, issued to Bacino, were obtained and oriented at 90 degree angles with respect to one another (Figure C). A layer of discontinuous fluorinated ethylene propylene (FEP) coating was placed between each layer of ePTFE material. These combined materials were placed over the cutout hole and secured in place using a heated soldering iron applied around the outer perimeter of the cutout hole. Excess film material was than trimmed from the final assembly and the edges tacked down thoroughly with the heated soldering iron. The resulting article is shown in FIG. 13.
    TABLE 1
    Characteristic Target
    PMVE wt % about 60%
    TFE wt % About 40%
    100% Secant Modulus* About 2.1-2.2 MPa
    Softening Temperature <275° C.
    Thermal Degradation Temp. >300° C.
    Melt Flow Index** >2.0
    Durometer 60-80 Shore A
  • Example 2
  • [0077]
    This example describes a tubular vascular graft having the article of Example 1 incorporated into the wall of the tubular graft. The article of Example 1 was trimmed and sewn into a corresponding hole cut through the wall of an ePTFE vascular graft. The ePTFE vascular graft was a GORE-TEX® Vascular Graft available from the Medical Products Division of W. L. Gore & Associates, Inc., Flagstaff, Ariz. as part number SA1604. The article from Example 1 was sewn into the corresponding hole of the tubular construct with an ePTFE suture material obtained from Medical Products Division of W. L. Gore & Associates, Inc. Flagstaff, Ariz. under the tradename GORE-TEX® Suture as part number CV-5. The resulting article is shown in FIG. 3B.
  • [0078]
    Accurate and illustrative examples of the invention have been described in detail however, it is readily foreseen that numerous modifications may be made to these examples without departing from the nature and spirit or scope of the present invention.
Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US4482516 *Sep 10, 1982Nov 13, 1984W. L. Gore & Associates, Inc.Process for producing a high strength porous polytetrafluoroethylene product having a coarse microstructure
US4988356 *Apr 25, 1988Jan 29, 1991C. R. Bard, Inc.Catheter and guidewire exchange system
US5102403 *Jun 18, 1990Apr 7, 1992Eckhard AltTherapeutic medical instrument for insertion into body
US5135535 *Jun 11, 1991Aug 4, 1992Advanced Cardiovascular Systems, Inc.Catheter system with catheter and guidewire exchange
US5171222 *Jul 18, 1990Dec 15, 1992Scimed Life Systems, Inc.Interlocking peel-away dilation catheter
US5195978 *Dec 11, 1991Mar 23, 1993Baxter International Inc.Rapid exchange over-the-wire catheter with breakaway feature
US5205822 *Jun 10, 1991Apr 27, 1993Cordis CorporationReplaceable dilatation catheter
US5324269 *Jun 2, 1992Jun 28, 1994Baxter International Inc.Fully exchangeable dual lumen over-the-wire dilatation catheter with rip seam
US5334147 *Apr 28, 1993Aug 2, 1994Cordis CorporationRapid exchange type dilatation catheter
US5336184 *Jul 15, 1993Aug 9, 1994Teirstein Paul SRapid exchange catheter
US5380283 *Nov 22, 1993Jan 10, 1995Cordis CorporationRapid exchange type dilatation catheter
US5389087 *Jun 29, 1992Feb 14, 1995Baxter International Inc.Fully exchangeable over-the-wire catheter with rip seam and gated side port
US5395335 *Jul 30, 1993Mar 7, 1995Jang; G. DavidUniversal mode vascular catheter system
US5472425 *Apr 22, 1994Dec 5, 1995Teirstein; Paul S.Rapid exchange catheter
US5476589 *Mar 10, 1995Dec 19, 1995W. L. Gore & Associates, Inc.Porpous PTFE film and a manufacturing method therefor
US5489271 *Mar 29, 1994Feb 6, 1996Boston Scientific CorporationConvertible catheter
US5683448 *Nov 23, 1994Nov 4, 1997Boston Scientific Technology, Inc.Intraluminal stent and graft
US5807355 *Dec 9, 1996Sep 15, 1998Advanced Cardiovascular Systems, Inc.Catheter with rapid exchange and OTW operative modes
US5824043 *May 23, 1996Oct 20, 1998Cordis CorporationEndoprosthesis having graft member and exposed welded end junctions, method and procedure
US5919164 *May 22, 1998Jul 6, 1999Boston Scientific CorporationConvertible catheter and the like
US5993489 *Feb 17, 1998Nov 30, 1999W. L. Gore & Associates, Inc.Tubular intraluminal graft and stent combination
US6071307 *Sep 30, 1998Jun 6, 2000Baxter International Inc.Endoluminal grafts having continuously curvilinear wireforms
US6095990 *Aug 31, 1998Aug 1, 2000Parodi; Juan CarlosGuiding device and method for inserting and advancing catheters and guidewires into a vessel of a patient in endovascular treatments
US6245100 *Feb 1, 2000Jun 12, 2001Cordis CorporationMethod for making a self-expanding stent-graft
US6299595 *Dec 17, 1999Oct 9, 2001Advanced Cardiovascular Systems, Inc.Catheters having rapid-exchange and over-the-wire operating modes
US6327772 *Apr 13, 1999Dec 11, 2001Medtronic, Inc.Method for fabricating a planar eversible lattice which forms a stent when everted
US6355056 *Dec 21, 1998Mar 12, 2002Meadox Medicals, Inc.Implantable intraluminal prosthesis
US6395018 *Feb 9, 1998May 28, 2002Wilfrido R. CastanedaEndovascular graft and process for bridging a defect in a main vessel near one of more branch vessels
US6398799 *Feb 13, 2001Jun 4, 2002Advanced Cardiovascular Systems, Inc.Catheter system with catheter and guidewire exchange
US6398803 *Sep 2, 1999Jun 4, 2002Impra, Inc., A Subsidiary Of C.R. Bard, Inc.Partial encapsulation of stents
US6428565 *Oct 5, 1999Aug 6, 2002Medtronic Ave, Inc.System and method for edoluminal grafting of bifurcated or branched vessels
US6432127 *Nov 14, 1997Aug 13, 2002Transvascular, Inc.Devices for forming and/or maintaining connections between adjacent anatomical conduits
US6511505 *Feb 19, 2002Jan 28, 2003Advanced Cardiovascular Systems, Inc.Variable strength stent
US6579314 *Oct 29, 1999Jun 17, 2003C.R. Bard, Inc.Covered stent with encapsulated ends
US6599315 *Nov 20, 2001Jul 29, 2003Advanced Cardiovascular Systems, Inc.Stent and stent delivery assembly and method of use
US6835203 *Jan 13, 1999Dec 28, 2004Advanced Stent Technologies, Inc.Extendible stent apparatus
US6896694 *May 17, 2000May 24, 2005Fundaco Zerbini A Brazilian FoundationDevice for disobstruction of ateriosclerotic lesions which incorporate the origin of lateral branches, or which are located in bifurcation of the coronary circulation, and respective interventionist process of placing such device
US20030130720 *Jan 8, 2002Jul 10, 2003Depalma Donald F.Modular aneurysm repair system
US20040054403 *Sep 18, 2002Mar 18, 2004Israel Henry MAngular orientation of a stent
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US7105020Jan 13, 2004Sep 12, 2006The Cleveland Clinic FoundationBranched vessel endoluminal device
US7632305Dec 15, 2009Boston Scientific Scimed, Inc.Biodegradable connectors
US7637940Dec 29, 2009Boston Scientific Scimed, Inc.Stent with bioabsorbable membrane
US7678142Aug 4, 2004Mar 16, 2010Boston Scientific Scimed, Inc.Extendible stent apparatus
US7731741Sep 8, 2005Jun 8, 2010Boston Scientific Scimed, Inc.Inflatable bifurcation stent
US7758634Jul 20, 2010Boston Scientific Scimed, Inc.Bifurcated stent and delivery system
US7766955May 19, 2003Aug 3, 2010Boston Scientific Scimed, Inc.Extendible stent apparatus
US7815675Oct 19, 2010Boston Scientific Scimed, Inc.Stent with protruding branch portion for bifurcated vessels
US7833264Mar 6, 2006Nov 16, 2010Boston Scientific Scimed, Inc.Bifurcated stent
US7833266Nov 28, 2007Nov 16, 2010Boston Scientific Scimed, Inc.Bifurcated stent with drug wells for specific ostial, carina, and side branch treatment
US7842081Nov 30, 2010Boston Scientific Scimed, Inc.Stent with spiral side-branch
US7842082Nov 30, 2010Boston Scientific Scimed, Inc.Bifurcated stent
US7850725 *Jun 15, 2006Dec 14, 2010Boston Scientific Scimed, Inc.Extendible stent apparatus
US7875068Sep 30, 2003Jan 25, 2011Merit Medical Systems, Inc.Removable biliary stent
US7892279Feb 22, 2011Boston Scientific Scimed, Inc.Extendible stent apparatus
US7922758Jun 20, 2007Apr 12, 2011Boston Scientific Scimed, Inc.Nesting twisting hinge points in a bifurcated petal geometry
US7951191May 31, 2011Boston Scientific Scimed, Inc.Bifurcated stent with entire circumferential petal
US7951192Aug 25, 2009May 31, 2011Boston Scientific Scimed, Inc.Stent with protruding branch portion for bifurcated vessels
US7959668Jan 16, 2007Jun 14, 2011Boston Scientific Scimed, Inc.Bifurcated stent
US7959669Sep 12, 2007Jun 14, 2011Boston Scientific Scimed, Inc.Bifurcated stent with open ended side branch support
US7959671Jun 14, 2011Merit Medical Systems, Inc.Differential covering and coating methods
US8002816Aug 23, 2011Cleveland Clinic FoundationProsthesis for implantation in aorta and method of using same
US8007528May 23, 2007Aug 30, 2011Boston Scientific Scimed, Inc.Bifurcated stent
US8016878Jun 1, 2009Sep 13, 2011Boston Scientific Scimed, Inc.Bifurcation stent pattern
US8038706Oct 18, 2011Boston Scientific Scimed, Inc.Crown stent assembly
US8043366Sep 8, 2005Oct 25, 2011Boston Scientific Scimed, Inc.Overlapping stent
US8048140Nov 1, 2011Cook Medical Technologies LlcFenestrated intraluminal stent system
US8052741Nov 8, 2011Medtronic Vascular, Inc.Branch vessel prosthesis with a roll-up sealing assembly
US8118861Mar 28, 2007Feb 21, 2012Boston Scientific Scimed, Inc.Bifurcation stent and balloon assemblies
US8167926May 1, 2012Cook Medical Technologies LlcFenestration for stent graft arrangements and stent graft including the same
US8202310Jun 19, 2012Cordis CorporationAAA repair device with aneurysm sac access port
US8206429Nov 2, 2006Jun 26, 2012Boston Scientific Scimed, Inc.Adjustable bifurcation catheter incorporating electroactive polymer and methods of making and using the same
US8206436Jun 26, 2012Merit Medical Systems, Inc.Coated stent with geometry determinated functionality and method of making the same
US8216267Sep 12, 2006Jul 10, 2012Boston Scientific Scimed, Inc.Multilayer balloon for bifurcated stent delivery and methods of making and using the same
US8216298Jul 10, 2012Medtronic Vascular, Inc.Branch vessel graft method and delivery system
US8241349Feb 3, 2011Aug 14, 2012Boston Scientific Scimed, Inc.Extendible stent apparatus
US8257425Dec 4, 2006Sep 4, 2012Boston Scientific Scimed, Inc.Stent with protruding branch portion for bifurcated vessels
US8262721 *Sep 11, 2012Merit Medical Systems, Inc.Drainage stent and associated method
US8277501Oct 2, 2012Boston Scientific Scimed, Inc.Bi-stable bifurcated stent petal geometry
US8287586Nov 8, 2004Oct 16, 2012Cook Medical Technologies LlcFlareable branch vessel prosthesis and method
US8298278Oct 30, 2012Boston Scientific Scimed, Inc.Bifurcated stent with improvement securement
US8298280Oct 30, 2012Boston Scientific Scimed, Inc.Stent with protruding branch portion for bifurcated vessels
US8317855Nov 27, 2012Boston Scientific Scimed, Inc.Crimpable and expandable side branch cell
US8343211Dec 14, 2005Jan 1, 2013Boston Scientific Scimed, Inc.Connectors for bifurcated stent
US8353943Jan 15, 2013Cook Medical Technologies LlcVariable weave graft with metal strand reinforcement for in situ fenestration
US8425590May 31, 2011Apr 23, 2013Boston Scientific Scimed, Inc.Stent with protruding branch portion for bifurcated vessels
US8435284May 7, 2013Boston Scientific Scimed, Inc.Telescoping bifurcated stent
US8480726Feb 27, 2012Jul 9, 2013Cook Medical Technologies LlcStent graft with valve arrangement
US8480728May 26, 2005Jul 9, 2013Boston Scientific Scimed, Inc.Stent side branch deployment initiation geometry
US8523934Oct 29, 2011Sep 3, 2013Cook Medical Technologies LlcFenestrated intraluminal stent system
US8556955Jun 22, 2012Oct 15, 2013Boston Scientific Scimed, Inc.Adjustable bifurcation catheter incorporating electroactive polymer and methods of makings and using the same
US8647376Mar 30, 2007Feb 11, 2014Boston Scientific Scimed, Inc.Balloon fold design for deployment of bifurcated stent petal architecture
US8702786Feb 29, 2012Apr 22, 2014Cook Medical Technologies LlcProsthesis having pivoting fenestration
US8747456Dec 31, 2008Jun 10, 2014Boston Scientific Scimed, Inc.Bifurcation stent delivery system and methods
US8758425Sep 22, 2011Jun 24, 2014The Cleveland Clinic FoundationThoracic deployment device and stent graft
US8771336Dec 22, 2011Jul 8, 2014Cook Medical Technologies LlcEndoluminal prosthesis comprising a valve replacement and at least one fenestration
US8778008Jan 17, 2007Jul 15, 2014Aga Medical CorporationIntravascular deliverable stent for reinforcement of vascular abnormalities
US8795349Aug 19, 2011Aug 5, 2014Cook Medical Technologies LlcProsthesis having pivoting fenestration
US8808351 *Oct 12, 2004Aug 19, 2014Cook Medical Technologies LlcStretchable prosthesis fenestration
US8808355 *Mar 14, 2013Aug 19, 2014Cook Medical Technologies LlcStent graft having a closeable fenestration
US8852267 *Dec 22, 2010Oct 7, 2014Acandis GmbH & Co.Stent with flaps
US8858613Sep 20, 2011Oct 14, 2014Altura Medical, Inc.Stent graft delivery systems and associated methods
US8870939Dec 28, 2012Oct 28, 2014Cook Medical Technologies LlcProsthesis having pivoting fenestration
US8900287Jan 13, 2006Dec 2, 2014Aga Medical CorporationIntravascular deliverable stent for reinforcement of abdominal aortic aneurysm
US8932340May 29, 2008Jan 13, 2015Boston Scientific Scimed, Inc.Bifurcated stent and delivery system
US9078780 *Nov 8, 2004Jul 14, 2015Cook Medical Technologies LlcBalloon flareable branch vessel prosthesis and method
US9095461Nov 8, 2004Aug 4, 2015Cook Medical Technologies LlcAorta and branch vessel stent grafts and method
US9125733Jul 16, 2008Sep 8, 2015The Cleveland Clinic FoundationBranched vessel endoluminal device
US9168162Nov 16, 2012Oct 27, 2015Elgco, LlcMethods and apparatus for treating a type 2 endoleak from within an endoluminal stent
US9259336Jun 6, 2007Feb 16, 2016Cook Medical Technologies LlcStent with a crush-resistant zone
US9277984Jun 17, 2014Mar 8, 2016Cook Medical Technologies LlcProsthesis having pivoting fenestration
US9358141Mar 22, 2005Jun 7, 2016Cook Medical Technologies LlcStent deployment device
US9427340Feb 14, 2007Aug 30, 2016Boston Scientific Scimed, Inc.Stent with protruding branch portion for bifurcated vessels
US20030195606 *May 27, 2003Oct 16, 2003Advanced Stent Technologies, Inc., A Delaware CorporationBifurcation stent system and method
US20040117860 *Sep 19, 2003Jun 17, 2004Lg Electronics Inc.Multicast service providing method in mobile communication system
US20040127973 *Sep 30, 2003Jul 1, 2004Mangiardi Eric K.Removable biliary stent
US20040127974 *Nov 20, 2003Jul 1, 2004Mangiardi Eric K.Differential covering and coating methods
US20040193254 *Jan 13, 2004Sep 30, 2004Greenberg Roy K.Branched vessel endoluminal device
US20050102021 *Oct 12, 2004May 12, 2005Cook IncorporatedStretchable prosthesis fenestration
US20050113905 *Oct 8, 2004May 26, 2005Greenberg Roy K.Endoluminal prosthesis with interconnectable modules
US20050149166 *Nov 8, 2004Jul 7, 2005Schaeffer Darin G.Branch vessel prosthesis with anchoring device and method
US20050171597 *Nov 8, 2004Aug 4, 2005Boatman Scott E.Helical stent for branched vessel prosthesis
US20050171598 *Nov 8, 2004Aug 4, 2005Schaeffer Darin G.Aorta and branch vessel stent grafts and method
US20050222668 *Nov 8, 2004Oct 6, 2005Schaeffer Darin GFlareable branch vessel prosthesis and method
US20050222669 *Feb 22, 2005Oct 6, 2005Purdy James DFenestrated intraluminal stent system
US20060058864 *Nov 8, 2004Mar 16, 2006Schaeffer Darin GBalloon flareable branch vessel prosthesis and method
US20060085061 *Nov 4, 2005Apr 20, 2006Vardi Gil MExtendible stent apparatus and method for deploying the same
US20060241740 *Jun 15, 2006Oct 26, 2006Advanced Stent Technologies, Inc.Extendible stent apparatus
US20060271159 *May 26, 2005Nov 30, 2006Boston Scientific Scimed, Inc.Crimpable and expandable side branch cell
US20060271160 *May 26, 2005Nov 30, 2006Boston Scientific Scimed, Inc.Stent side branch deployment initiation geometry
US20060271161 *May 26, 2005Nov 30, 2006Boston Scientific Scimed, Inc.Selective treatment of stent side branch petals
US20070032855 *Oct 10, 2006Feb 8, 2007Advanced Stent Technologies, Inc.Extendible stent apparatus
US20070055351 *Sep 8, 2005Mar 8, 2007Boston Scientific Scimed, Inc.Crown stent assembly
US20070055362 *Sep 8, 2005Mar 8, 2007Boston Scientific Scimed, Inc.Overlapping stent
US20070100437 *May 12, 2006May 3, 2007Alveolus, Inc.Drainage stent and associated method
US20070112418 *Nov 14, 2005May 17, 2007Boston Scientific Scimed, Inc.Stent with spiral side-branch support designs
US20070118205 *Dec 4, 2006May 24, 2007Advanced Stent Technologies, Inc.Stent with protruding branch portion for bifurcated vessels
US20070123970 *Nov 29, 2005May 31, 2007Boston Scientific Scimed, Inc.Bifurcation stent with overlapping crimped struts
US20070135903 *Dec 14, 2005Jun 14, 2007Daniel GregorichConnectors for bifurcated stent
US20070135904 *Dec 14, 2005Jun 14, 2007Tracee EidenschinkTelescoping bifurcated stent
US20070142902 *Feb 14, 2007Jun 21, 2007Boston Scientific Scimed, Inc.Stent with protruding branch portion for bifurcated vessels
US20070142904 *Dec 20, 2005Jun 21, 2007Boston Scientific Scimed, Inc.Bifurcated stent with multiple locations for side branch access
US20070168018 *Jan 13, 2006Jul 19, 2007Aga Medical CorporationIntravascular deliverable stent for reinforcement of abdominal aortic aneurysm
US20070168019 *Jan 17, 2007Jul 19, 2007Aga Medical CorporationIntravascular deliverable stent for reinforcement of vascular abnormalities
US20070173920 *Mar 21, 2007Jul 26, 2007Boston Scientific Scimed, Inc.Bifurcation stent delivery system
US20070179592 *Nov 8, 2004Aug 2, 2007Schaeffer Darin GBranch vessel prosthesis with positional indicator system and method
US20070208256 *Mar 3, 2006Sep 6, 2007Medtronic Vascular, Inc.Multiple Branch Tubular Prosthesis and Methods
US20070208411 *Mar 6, 2006Sep 6, 2007Boston Scientific Scimed, Inc.Bifurcated stent with surface area gradient
US20070208415 *Mar 6, 2006Sep 6, 2007Kevin GrotheimBifurcated stent with controlled drug delivery
US20070208418 *Mar 6, 2006Sep 6, 2007Boston Scientific Scimed, Inc.Bifurcated stent
US20070208419 *Mar 6, 2006Sep 6, 2007Boston Scientific Scimed, Inc.Bifurcation stent with uniform side branch projection
US20070213811 *Mar 7, 2006Sep 13, 2007Boston Scientific Scimed, Inc.Bifurcated stent with improvement securement
US20070225796 *May 23, 2007Sep 27, 2007Boston Scientific Scimed, Inc.Bifurcated stent
US20070233233 *Mar 31, 2006Oct 4, 2007Boston Scientific Scimed, IncTethered expansion columns for controlled stent expansion
US20070250154 *Apr 19, 2007Oct 25, 2007William A. Cook Australia Pty Ltd.Twin bifurcated stent graft
US20070293940 *Jun 6, 2007Dec 20, 2007Cook IncorporatedStent with a crush-resistant zone
US20080065188 *Sep 12, 2006Mar 13, 2008Boston Scientific Scimed, Inc.Multilayer balloon for bifurcated stent delivery and methods of making and using the same
US20080114446 *Nov 7, 2007May 15, 2008Wiiliam A. Cook Australia Pty Ltd.Fenestration for stent graft arrangements and stent graft including the same
US20080177377 *Oct 16, 2007Jul 24, 2008Boston Scientific Scimed, Inc.Bifurcation Stent Design with Over Expansion Capability
US20080243221 *Mar 30, 2007Oct 2, 2008Boston Scientific Scimed, Inc.Balloon fold design for deployment of bifurcated stent petal architecture
US20080243232 *Mar 28, 2007Oct 2, 2008Boston Scientific Scimed, Inc.Bifurcation stent and balloon assemblies
US20090012596 *Jul 6, 2007Jan 8, 2009Boston Scientific Scimed, Inc.Stent with Bioabsorbable Membrane
US20090012599 *Jul 6, 2007Jan 8, 2009Boston Scientific Scimed, Inc.Biodegradable Connectors
US20090043377 *Jul 16, 2008Feb 12, 2009The Cleveland Clinic FoundationBranched Vessel Endoluminal Device
US20090164001 *Sep 18, 2008Jun 25, 2009Biggs David PSocket For Fenestrated Tubular Prosthesis
US20090222078 *Dec 17, 2008Sep 3, 2009Greenberg Roy KProsthesis for Implantation in Aorta and Method of Using Same
US20090259290 *Apr 14, 2008Oct 15, 2009Medtronic Vascular, Inc.Fenestration Segment Stent-Graft and Fenestration Method
US20090264985 *Apr 17, 2008Oct 22, 2009Medtronic Vascular, Inc.Branch Vessel Suture Stent System and Method
US20090287145 *May 14, 2009Nov 19, 2009Altura Interventional, Inc.Devices and methods for treatment of abdominal aortic aneurysms
US20100070023 *Mar 18, 2010Boston Scientific Scimed, Inc.Biodegradable connectors
US20100161025 *Aug 17, 2009Jun 24, 2010Cook, IncorporatedVariable weave graft with metal strand reinforcement for in situ fenestration
US20100173066 *Nov 11, 2009Jul 8, 2010Merit Medical Systems, Inc.Coated stent with geometry determinated functionality and method of making the same
US20100241218 *Sep 23, 2010Medtronic Vascular, Inc.Branch Vessel Prosthesis With a Roll-Up Sealing Assembly
US20120323309 *Dec 22, 2010Dec 20, 2012Acandis Gmbh & Co. KgStent with flaps
EP1878392A1 *Jun 28, 2007Jan 16, 2008Cordis CorporationAAA repair device with aneurysm sac access port
WO2006007389A1 *Jun 15, 2005Jan 19, 2006Cook IncorpratedThoracic deployment device and stent graft
WO2006127125A2 *Mar 29, 2006Nov 30, 2006Boston Scientific LimitedCrimpable and expandable side branch cell
WO2006127125A3 *Mar 29, 2006Apr 19, 2007Boston Scient Scimed IncCrimpable and expandable side branch cell
WO2006136145A1 *Jun 21, 2006Dec 28, 2006Charite-Universitätsmedizin BerlinStent for implanting in a human or animal vessel
WO2007064371A1 *Aug 9, 2006Jun 7, 2007Boston Scientific LimitedBifurcation stent with overlapping crimped struts
WO2007073410A1 *Aug 10, 2006Jun 28, 2007Boston Scientific LimitedBifurcated stent with multiple side branch access
WO2008057568A1 *Nov 7, 2007May 15, 2008William A. Cook Australia Pty. LtdFenestrations for stent graft arrangements and stent graft including the same
WO2008063328A1 *Oct 17, 2007May 29, 2008Boston Scientific LimitedBifurcation stent design with over expansion capability
WO2008086084A2 *Jan 3, 2008Jul 17, 2008Medtronic Vascular Inc.Branch vessel graft method and delivery system
WO2008086084A3 *Jan 3, 2008Nov 13, 2008Medtronic Vascular IncBranch vessel graft method and delivery system
WO2009009311A2 *Jun 27, 2008Jan 15, 2009Boston Scientific LimitedBifurcated stent with bioabsorbable members
WO2009009311A3 *Jun 27, 2008Mar 5, 2009Boston Scient Scimed IncBifurcated stent with bioabsorbable members
WO2009009376A2 *Jul 2, 2008Jan 15, 2009Boston Scientific ScimedStent with bioabsorbable membrane
WO2009009376A3 *Jul 2, 2008Mar 5, 2009Boston Scient Scimed IncStent with bioabsorbable membrane
WO2009017632A2 *Jul 23, 2008Feb 5, 2009Med Institute, Inc.Stent arrangement
WO2009017632A3 *Jul 23, 2008Mar 19, 2009Med Inst IncStent arrangement
WO2010024880A1 *Aug 25, 2009Mar 4, 2010Cook IncorporatedImplantable prosthesis with reduced density regions
WO2013074921A2 *Nov 16, 2012May 23, 2013Smouse Harry RobinsonMethods and apparatus for treating a type 2 endoleak from within an endoluminal stent graft
WO2013074921A3 *Nov 16, 2012Jul 4, 2013Smouse Harry RobinsonMethods and apparatus for treating a type 2 endoleak from within an endoluminal stent graft
Classifications
U.S. Classification623/1.11, 623/1.13
International ClassificationA61F2/82, A61F2/06
Cooperative ClassificationA61B17/3478, A61L27/507, A61F2002/072, A61F2002/065, A61F2002/821, A61F2/07, A61F2002/075, A61F2002/061, A61F2220/0075, A61F2220/005, A61F2220/0058, A61F2/89
European ClassificationA61F2/07
Legal Events
DateCodeEventDescription
Sep 20, 2002ASAssignment
Owner name: GORE ENTERPRISE HOLDINGS, INC., DELAWARE
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:CULLY, EDWARD H.;CUTRIGHT, WARREN J.;NORDHAUSEN, CRAIG T.;AND OTHERS;REEL/FRAME:013327/0970
Effective date: 20020919
Feb 14, 2012ASAssignment
Owner name: W. L. GORE & ASSOCIATES, INC., DELAWARE
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:GORE ENTERPRISE HOLDINGS, INC.;REEL/FRAME:027906/0508
Effective date: 20120130