US20110319976A1 - Device and method for preventing stenosis at an anastomosis site - Google Patents

Device and method for preventing stenosis at an anastomosis site Download PDF

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US20110319976A1
US20110319976A1 US13/015,571 US201113015571A US2011319976A1 US 20110319976 A1 US20110319976 A1 US 20110319976A1 US 201113015571 A US201113015571 A US 201113015571A US 2011319976 A1 US2011319976 A1 US 2011319976A1
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stent
drug
curvature
degrees
approximately
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Sriram Iyer
Gerald Dorros
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Vascular Therapies Inc
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Individual
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Priority to US13/015,571 priority Critical patent/US20110319976A1/en
Publication of US20110319976A1 publication Critical patent/US20110319976A1/en
Priority to US13/850,450 priority patent/US20140088681A1/en
Priority to US15/284,234 priority patent/US20170020651A1/en
Assigned to VASCULAR THERAPIES, INC. reassignment VASCULAR THERAPIES, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DORROS, GERALD, IYER, SRIRAM
Priority to US16/983,893 priority patent/US20200360126A1/en
Abandoned legal-status Critical Current

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Definitions

  • the present invention relates generally to therapeutic implants, devices, and methods useful for preventing, suppressing, or treating stenosis(es) at and around the site of an anastomosis.
  • the invention also relates to stents specifically configured for placement at an anastomosis or a fistula, and methods for combining those sites with extravascular therapeutic implants comprising a matrix material and a therapeutic agent.
  • the specifically configured stents are also useful for treatment of stenosis or narrowings remote from an anastomosis, e.g., treatment of an ostial stenosis in a side branch, treatment of a stenosis in a central vein (e.g. cephalic arch) and the like.
  • Vascular procedures such as construction of arterio-venous grafts and arterio-venous fistulae are performed to provide vascular access to facilitate hemodialysis in patients with end stage renal disease. Interventions like angioplasty are performed to treat, for example, narrowing (stenosis) or occlusion resulting from vasculoproliferative conditions such as obstructive intimal hyperplasia or atherosclerosis.
  • Vascular access for hemodialysis can be constructed as an arterio-venous fistula (AVF) (e.g., Brecisa-Cimino), or as a graft (AVG) interposing prosthetic material (e.g., polytetrafluoroehtylene, “PTFE”) between an artery and a vein.
  • AVG graft
  • prosthetic material e.g., polytetrafluoroehtylene, “PTFE”
  • a vein in the forearm, arm or thigh is joined or attached to an adjacent artery so that there is a direct communication between the arterial and venous lumen.
  • the severed end of the vein is dislodged from its natural location and the vein curved along its longitudinal axis so that the vein may be connected directly to the artery.
  • the site(s) of vascular union e.g. artery and vein or graft and artery or graft and vein are referred to as the vascular anastomotic(s) site or vascular anastomosis.
  • the anastomosis can be completed using sutures or clips, or with the help of devices specially designed for creation and completion of such anastomosis.
  • the graft can be made of synthetic materials, like polytetrafluoroethylene (PTFE) for example, or can be comprised of autologous tissue (e.g. saphenous vein, mammary artery, etc.).
  • the anastomotic site connecting the artery and the vein e.g. in case of a fistula
  • the graft/artery and the graft/venous anastomotic sites e.g. in case of AV graft
  • undergo healing e.g. in case of AV graft
  • a certain proportion of these vascular access and vascular graft surgeries fail as a result of narrowing or stenosis at and around the anastomotic sites.
  • AV fistulae As many as 60 percent of AV fistulae do not develop (“failure to mature”) into a vascular access suitable to support dialysis; an important reason for this maturation failure is luminal narrowing, or an obstructive stenosis, at and around the venous end, commonly referred to as a Juxta Anastomotic Stenosis (JAS). Stenosis can also occur at sites remote from the anastomosis (e.g. cephalic arch stenosis, stenosis at the site of needle punctures, etc).
  • the anastomotic site of the PTFE graft and the vein often develop a stenosis resulting in slow flow and thrombosis of the graft making it unusable as a vascular access for dialysis.
  • Similar lesions develop in grafts placed in the arterial circulation, (e.g. peripheral arterial bypass using prosthetic PTFE grafts or coronary artery or peripheral artery bypass using biological tissue conduits like saphenous vein).
  • grafts used in coronary artery bypass graft surgery as well as peripheral vascular surgery (e.g., aorta-iliac, femoral-femoral, femoral-popliteal, femoral-tibial, etc.) are also well known.
  • peripheral vascular surgery e.g., aorta-iliac, femoral-femoral, femoral-popliteal, femoral-tibial, etc.
  • stenosis in grafts used to bypass pathology in the arterial system develops at a slower rate when compared to the failure of hemodialysis access grafts or fistulae described above.
  • vascular grafts An important cause of failure of vascular grafts is usually related to luminal narrowing of the vessel or prosthetic conduit, at or around the vascular anastomotic site(s).
  • One reason for this narrowing is a consequence of a vasculoproliferative response and frequently results in graft thrombosis and fistula failure.
  • Other pathologies can also affect the performance of a graft or fistula, e.g. infection, pseudo-aneurysm, bleeding etc.
  • anastomosis involving blood vessels vascular anastomosis
  • other examples of anastomosis which in broad terms includes the site or region of union of two hollow tubes or conduits include: anastomosis involving the ureter, trachea/bronchi, fallopian tubes, segments of bowel, etc., and problems of luminal narrowing can also be seen at and around these anastomotic sites.
  • the methods and devices described in this application are intended for use in both vascular as well as these non-vascular applications.
  • Neointimal hyperplasia a manifestation of the vasculoproliferative response, affects the anastomotic orifice and adjacent vessel.
  • the vessel wall thickens and the lumen narrows often due to migration and proliferation of smooth muscle cells.
  • stenosis eventually leads to occlusion and graft or fistula failure.
  • the etiology of graft and fistula failures may relate to a variety of physical stimuli (e.g., shear stress causing hemodynamic disturbances such as increased resistance from a non-dilated vein, turbulent flow replacing laminar flow), chemical stimuli, or biological stimuli, as well as infection or foreign body rejection.
  • grafts connecting two arteries e.g. grafts used for coronary artery bypass graft surgery or peripheral arterial bypass surgery
  • ischemia blood supply
  • Balloon angioplasty involves deployment of a balloon catheter at the site of the blockage, and inflating the balloon to increase the minimum luminal diameter (MLD) of the vessel by compressing the material causing the restriction against the interior of the vessel wall.
  • MLD minimum luminal diameter
  • the balloon may have to be repositioned and inflated and deflated more than once in order to attain optimal lumen expansion.
  • the balloon catheter is withdrawn from the system.
  • a stent is an expandable scaffolding or support device which is placed within the vasculature (endovascular implant).
  • endovascular implant a vasculature
  • An endovascular stent is effective in countering recoil and also very effective in preventing a dissection flap, which can result following balloon angioplasty of the restriction or stenosis, from falling back into the vascular lumen.
  • Such a dissection flap has the potential to completely obstruct blood flow soon after angioplasty, resulting in acute vessel closure.
  • the stent is very effective in preventing acute closure.
  • the stents known in the prior art are either “balloon expandable” or “self expanding,” and when deployed endovascularly, the stent after expansion abuts directly against the inner lining of the vessel wall (intimal surface).
  • Balloon-expandable stents are disclosed in U.S. Pat. No. 4,733,665 to Palmaz.
  • Self-expanding stents are disclosed in U.S. Pat. No. 5,443,500 to Sigwart, U.S. Pat. No. 4,655,771 to Wallsten, U.S. Pat. No.
  • Drug eluting stents are, for example, disclosed generally in U.S. Pat. No. 5,545,208 to Wolff, U.S. Pat. No. 6,899,731 to Li et al., U.S. Pat. No. 6,273,913 to Wright et al., and U.S. Pat. Pub. No. 2009/0182404 to Shookoohi.
  • graft or fistula failure tends to follow.
  • an immediate/urgent endovascular procedure i.e., a non-surgical, catheter-based percutaneous procedure such as a thrombectomy
  • declot retract the thrombus within
  • undergo repeat vascular surgery to place another vascular access, which could be another graft or fistula, at a different site, or undergo placement of a catheter, unless the patient receives a kidney transplant.
  • the configurations of traditional stents have limitations for treating stenosis at and adjacent to an anastomosis site of fistula and grafts. Adjacent to the anastomotic orifice of an arterio-venous fistula or graft, the vein or graft protrudes from the artery or blood vessel at an angle, curving along its longitudinal axis toward its origin in the body (“candy cane configuration”). ( FIGS. 1-3 ). Because currently available stents are not curved along the longitudinal axis, they are not well suited for placement at and adjacent to the anastomotic site of a fistula or graft because they cannot extend into the curvature of the blood vessel.
  • these stents cannot be easily maneuvered through the graft orifice and into the artery at an arterio-venous fistula because of the angulation, U-turn or hairpin configuration of the vessels at the anastomotic site.
  • FIG. 1A Two blood vessels, or a graft and a blood vessel, can be joined at a right angle (see FIG. 1A ). If the anastomosis is at a right angle, the edge of a cylindrical stent can be positioned such that the stent edge can be aligned and lined up to match the edge of the blood vessel at the right angle anastomosis (see FIG. 1B ). However, in most instances, the operator bevels the edge of the blood vessel prior to creating the anastomosis (see FIG. 1C ). In this case, it can be appreciated that a cylindrical stent edge cannot be exactly lined up against the edge of the beveled blood vessel.
  • Either the stent will be a “little short” of the anastomosis (see FIG. 2D , 16 A) or it will protrude across the anastomosis into the other vessel (see FIG. 16B ). Accordingly, there is a need for a stent that will address both undesirable conditions related to the placement of a stent having a square-cut, right angled end/edge at the site of an anastomosis where the vessels of the anastomosis are not perpendicular to each other.
  • the diameter of the two blood vessels that are being joined at the anastomosis may be different; similarly the diameter of the blood vessel at the level of the anastomosis and the diameter at a point away from the anastomosis may be different.
  • the stents used herein may need to be tapered.
  • tapered indicates that the diameter of the expanded stent at one end differs when compared to the diameter of the expanded stent at the opposite end. This difference in diameter may occur gradually over the length of the stent or it may occur abruptly at some point along the length of the stent.
  • a prosthetic device or “sleeve” on the outer surface of the vessel or graft which then elutes antivasculoproliferative drugs or agents such as rapamycin (sirolimus), paclitaxel, tacrolimus, everolimus, zotarolimus and other cell cycle inhibitors or similarly-functioning agents.
  • rapamycin sirolimus
  • paclitaxel tacrolimus
  • tacrolimus everolimus
  • zotarolimus cell cycle inhibitors or similarly-functioning agents.
  • Such a sleeve is disclosed in U.S. Pat. No. 6,726,933, entitled “Apparatus and Methods for Preventing or Treating Failure of Hemodialysis Vascular Access and Other Vascular Grafts,” and co-pending U.S. Patent Application Publication No. 2005/0004158, entitled “Medical Implants and Methods For Regulating the Tissue Response to Vascular Closure Devices,” filed on Jun. 18, 2004.
  • a stent that can be used together with the above-described wrap or sleeve to prevent, suppress or treat stenosis at and around an anastomosis site or fistula. And there is a need for methods for combining such extravascular therapeutic implants comprising a matrix material together with an endovascular stent implant. There is also a need to combine a traditional self expanding nitinol stent or a balloon expandable stent together with a perivascular drug eluting sleeve. Any of the stents described herein can be used in combination with a perivascular wrap in order to prevent, suppress, or treat stenosis. (See FIGS. 18 and 19 ).
  • the present invention is a stent that is specially configured for placement at an anastomosis site in that the stent is curved along the longitudinal axis for placement at and/or adjacent to the anastomosis.
  • a stent can also be used away from an anastamosis site; for example, at a curved part of a vessel remote from the anastomosis, or at the bifurcation of a vessel.
  • the stent is specially configured for placement at an anastomosis site in that the stent is beveled, flared or trumpeted at the edge to facilitate deployment at the anastomosis.
  • the stent is tapered so that the diameter at one end of the expanded stent is different from the other end.
  • the stent is coated with a polymer like PTFE; the coating may extend along the entire length and circumference of the stent or it may partially cover the stent.
  • the stent is drug coated to allow local delivery of anti-vasculoproliferative drugs directly to the vicinity at and around the site of anastomosis.
  • a combination of a drug eluting balloon expandable stent and a self expandable is used; the balloon expandable drug eluting stent is sandwiched between the self expanding stent and the vessel wall.
  • a wire or wire like delivery system with a handle is attached to the exterior surface of the stent in its compacted state, wherein manipulating the wire or another release mechanism pulls the exterior surface of the stent toward the interior surface of the vessel, resulting in expansion and deployment of the stent.
  • a combination of a balloon expandable drug eluting stent and a non drug coated self expanding stent is used.
  • the balloon expandable drug eluting stent is first deployed at and around the anastomosis of an AV fistula or graft.
  • the self expanding nitinol stent is then deployed such that the balloon expandable drug eluting stent is sandwiched between the expanded self expanding nitinol stent and the inner lining of the graft and/or the inner wall of the blood vessel.
  • the balloon expandable drug eluting stent can be made of a biodegradable material or a biostable material like stainless steel or cobalt chromium.
  • the balloon expandable or self expandable stent may be partially or completely covered by a polymer, fabric or biological coating.
  • a polymer, fabric or biological coating An example of such a covering that may be used for the stent is polytetrafluoroethylene (PTFE).
  • the present invention is a kit comprising a stent specially configured for placement at an anastomosis site in that the stent is curved along the longitudinal axis (endovascular implant), together with a sleeve comprising a biocompatible matrix material and a pharmaceutical agent, wherein the sleeve is applied to the external surface of the vessel or graft (perivascular implant), resulting in extravascular delivery of a pharmaceutical agent.
  • the biocompatible matrix may be applied after the stent is deployed by a simple delivery device that permits folding of the limbs of the matrix to enable covering of the anastomosis.
  • both the endovascular stent and the perivascular drug eluting biocompatible matrix material can be implanted during the time of surgery for creation of the anastomosis (e.g. AV graft, AV Fistula)
  • the present invention is a kit comprising a stent specially configured for placement at an anastomosis site in that the stent is beveled, flared or trumpeted at the edge, together with a sleeve comprising a biocompatible matrix material and a pharmaceutical agent, wherein the sleeve is applied to the external surface of the vessel or graft, resulting in extravascular delivery of a pharmaceutical agent.
  • the biocompatible matrix may be applied after the stent is deployed by a simple delivery device that permits folding of the limbs of the matrix to enable covering of the anastomosis.
  • both the endovascular stent and the perivascular drug eluting biocompatible matrix material can be implanted during the time of surgery for creation of the anastomosis (e.g. AV graft, AV Fistula).
  • the present invention is a kit comprising a stent specially configured for placement at an anastomosis site in that the stent is tapered together with a sleeve comprising a biocompatible matrix material and a pharmaceutical agent, wherein the sleeve is applied to the external surface of the vessel or graft, resulting in extravascular delivery of a pharmaceutical agent.
  • the biocompatible matrix may be applied after the stent is deployed by a simple delivery device that permits folding of the limbs of the matrix to enable covering of the anastomosis.
  • both the endovascular stent and the perivascular drug eluting biocompatible matrix material can be implanted during the time of surgery for creation of the anastomosis (e.g. AV graft, AV Fistula).
  • the present invention is a kit comprising a stent specially configured for placement at an anastomosis site in that the stent is a covered stent (e.g. covered by PTFE) together with a sleeve comprising a biocompatible matrix material and a pharmaceutical agent, wherein the sleeve is applied to the external surface of the vessel or graft, resulting in extravascular delivery of a pharmaceutical agent.
  • the biocompatible matrix may be applied after the stent is deployed by a simple delivery device that permits folding of the limbs of the matrix to enable covering of the anastomosis.
  • both the endovascular stent and the perivascular drug eluting biocompatible matrix material can be implanted during the time of surgery for creation of the anastomosis (e.g. AV graft, AV Fistula).
  • the present invention is a kit comprising a drug eluting balloon expandable stent and a self expanding nitinol stent specially configured for placement at an anastomosis site.
  • the special features of the stent may include one or more of the following: curvature along the long axis of the stent, beveled, flared or trumpeted edge(s), tapered design, covering with a fabric (e.g. PTFE).
  • a fabric e.g. PTFE
  • balloon expandable stents such as stainless steel or cobalt chromium balloon expandable stents, self expanding stents such as nitinol self expanding stents, partially or completely biodegradable stents, stents that are partially or completely covered with a synthetic material such as PTFE or other biodegradable or non biodegradable polymers, or stents that are covered with a segment of biological tissue like a segment of vein, etc.) that do not have any of the features described above may also be included in the kit.
  • self expanding stents such as nitinol self expanding stents, partially or completely biodegradable stents, stents that are partially or completely covered with a synthetic material such as PTFE or other biodegradable or non biodegradable polymers, or stents that are covered with a segment of biological tissue like a segment of vein, etc.
  • the stent is inserted in its contracted state and manipulating a wire attached to the external surface of the stent pulls the exterior surface of the stent toward the interior wall of the vessel, resulting in expansion of the stent.
  • the stent is inserted in its contracted state and covered with a sheath, wherein retracting the sheath results in expansion of the stent.
  • the system may be configured such that retraction of the sheath starts from the distal end (i.e.
  • the stent may be held in its compact, restrictive (non-expanded) state by other means (e.g. a wire wrapped around the stent, a membrane restricting expansion of the stent) prior to deployment.
  • the stent is a balloon-expandable stent. In another embodiment, the stent is self-expanding.
  • the stent delivery device permits the proximal end of the stent (closest to the operator's fingers) to be deployed first. Once the proximal end is released, it enables the operator to pull back and recognize that a few millimeters of the partially deployed stent are now on the arterial side of the anastomosis. At this point, the second mechanism of release allows the remaining portion of the stent to be released. In one iteration, the proximal end of the stent is released first, while in another iteration the distal end of the stent is released first.
  • the delivery system containing the stent may be introduced into the body percutaneously.
  • the delivery system containing the stent may be introduced into the body during an open surgical procedure.
  • the delivery system containing the stent may be introduced into the body using a robotic system
  • the sleeve comprising a biocompatible matrix material and a pharmaceutical agent may be implanted at the intended position during an open surgical procedure.
  • the sleeve comprising a biocompatible matrix material and a pharmaceutical agent may also be implanted percutaneously.
  • the sleeve comprising a biocompatible matrix material and a pharmaceutical agent may be implanted using a robotic system
  • FIGS. 1A-1D illustrate the difference between a “non beveled” right angled anastomosis ( FIGS. 1A and 1B ) and a beveled, angled anastomosis ( FIGS. 1C and 1D ).
  • FIGS. 2A-2E illustrate how the stent design requirements ( FIGS. 2A and 2B ) are different for a right angled, non beveled anastomosis ( FIG. 2C ) and a beveled angled anastomosis ( FIGS. 2D and 2E ).
  • FIG. 3 is a side view of an arterio-venous fistula.
  • FIG. 4 is a side view of one embodiment of the stent of the present invention.
  • FIGS. 5-7 are side views of embodiments of the stent of the present invention in place at an arterio-venous fistula or across the anastomotic site of a graft, which has been transected along the longitudinal axis.
  • FIG. 8 is a side view of the kit of the present invention in use at an arterio-venous fistula, where the fistula and the wrap have been transected along the longitudinal axis to reveal placement of the stent.
  • FIG. 9 is a side view of one embodiment of the method of the present invention, where the arterio-venous fistula has been transected to reveal placement of the stent delivery system.
  • FIG. 10 is a side view of a covered stent, which has been transected along the longitudinal axis.
  • FIG. 11 is a side view of the embodiment of the stent of the present invention in place at a natural bend in a vessel, which has been transected along the longitudinal axis.
  • FIGS. 12-13 show the results described in the Therapeutic Examples.
  • FIGS. 14 and 15 show the results described in the Therapeutic examples.
  • FIG. 16A-16D shows the difference between a beveled stent edge and a traditional right angled stent edge and illustrates why the beveled edge provides optimal coverage of the anastomosis.
  • FIG. 17 illustrates the difference between the traditional, conventional deployment system for a self expanding stent (distal end deployed first, proximal end deployed last) and the proposed deployment system, which allows “proximal end first distal end last” deployment of the stent.
  • FIGS. 18A-18B and 19 A- 19 B illustrate the concept of combining an endovascular stent together with a perivascular drug eluting matrix, both implants placed at and around the anastomosis.
  • some of the factors to be considered may include the criticality of the element and/or the effect a given amount of variation will have on the performance of the claimed subject matter, as well as other considerations known to those of skill in the art.
  • “about” or “approximately” broaden the numerical value, yet cannot be given a precise limit.
  • “about” or “approximately” may mean ⁇ 5%, or ⁇ 10%, or ⁇ 20%, or ⁇ 30% depending on the relevant technology.
  • the disclosure of ranges is intended as a continuous range including every value between the minimum and maximum values.
  • the medical devices of the present invention broadly comprise stents and sleeves used for treating stenosis at and around an anastomosis site.
  • the present invention is unique in at least six respects: (1) the stent of the present invention is curved along its longitudinal axis (“candy cane shape”) for special placement at a fistula or an anastomosis site, or to accommodate a vessel remote from the anastomosis site that has a curve (e.g.
  • the stent of the present invention is beveled, flared or trumpeted for special placement and to facilitate alignment at a beveled anastomosis site, vessel origin (ostium) or vessel bifurcation wherein the side branch vessel originates at an angle other than a right angle from the parent vessel, (3) the stent of the present invention is tapered to facilitate placement wherein the diameter of the two structures are different, (4) the present invention includes a combination of drug-eluting balloon expandable or self-expanding stent and a plain, non-drug-eluting balloon expandable or self-expanding stent, (5) the stents of the present invention may be partially or completely covered with a fabric or polymer (e.g.
  • the methods and kits of the present invention combine the specially-configured stent with a sleeve that elutes a pharmaceutical agent directed to preventing stenosis.
  • the drug-eluting sleeve may be used in combination with other self expanding and/or balloon expandable stents (i.e. it is not necessary to have a specifically configured stent to practice this invention).
  • the edge 10 of the vessel or graft 15 may be cut (shown with the dashed lines) perpendicular to the longitudinal axis of the blood vessel or graft 10 .
  • the anastomosis created by joining the two vessels, or a vessel and a graft, 15 and 20 will be at right angles.
  • FIG. 1C shows that the edge 25 of the vessel or graft 15 may be also cut at an angle—this confers a beveled configuration to the end of the vessel 15 . Notice that because of this bevel, the eventual size of the anastomosis (shown in FIG.
  • FIG. 1D is larger in terms of both length as well as the area of the anastomosis when compared to the right angled anastomosis shown in FIG. 1B .
  • FIGS. 2A-2E illustrate some of the stent designs discussed in the present disclosure, that make the stent particularly suited for implant at and around the anastomosis.
  • FIG. 2A shows a stent 30 that is essentially a tubular body with a longitudinal axis and a circular cross-section. The stent 30 has a degree of curvature along the longitudinal axis.
  • the stent 30 has a first, proximal end 35 and a second, distal end 40 , each of the ends 30 , 35 having a different diameter 45 , 50 , conferring a tapered appearance to the stent 30 .
  • FIG. 2B shows the first end 35 of the stent 30 is flared or trumpeted.
  • FIG. 2C illustrates how the stent 30 shown in FIG. 2A can be implanted in a right angled anastomosis.
  • FIG. 2D illustrates that the stent 30 shown in FIG. 2A is not well suited for implantation around an anastomosis wherein the vein or graft 15 is beveled.
  • FIG. 3 illustrates an anastomosis viewed from the side.
  • the structure marked A represents an artery.
  • the structure marked V represents a graft or vein.
  • a and V can represent any hollow tube or conduit in the body undergoing an anastomosis.
  • the stent 30 of the present invention has a web-like structure 55 defining an essentially tubular body having a tubular wall 60 with a longitudinal central axis 65 and a first end diameter 70 , the web structure 55 being expandable from a contracted configuration to an expanded configuration, wherein the stent 30 is specially configured for placement at a fistula or an anastomosis site or a vessel with a curvature.
  • the stent has a degree of curvature 75 along the longitudinal axis 65 between about 5 and 160 degrees.
  • the stent 30 is placed in the internal lumen 80 of the vein, graft or blood vessel 15 and the proximal end 35 of the stent 30 holds open the anastomosis orifice 85 at the junction of the vein, graft or blood vessel 15 and the artery, graft or blood vessel 20 .
  • the exact degree of curvature 75 of the stent 30 may be determined based upon the degree of curvature occurring in the vein 15 .
  • reference numeral 15 can represent a graft or other blood vessel or conduit.
  • the stent 30 is thus specially configured to maintain the structure of the anastomotic orifice 85 and the curvature of the vein or artery or other blood vessel 15 at a fistula or graft anastomosis site.
  • the curved portion of the stent 30 may also be placed across the anastomosis or the graft orifice 85 .
  • the stent 30 passes from the vein, graft or blood vessel 15 , through the anastomosis orifice 85 , and into the artery, graft or blood vessel 20 .
  • the structure labeled 20 will be a vein and the structure labeled 15 will be the prosthetic graft.
  • the stent 30 extends from the graft 15 across the anastomosis 85 and into the vein 20 .
  • the structure labeled 15 represents a prosthetic graft (e.g. PTFE), arterial conduit (e.g. the mammary artery) or a venous conduit (e.g. saphenous vein) and the structure marked 20 represents the recipient artery which may be a coronary artery or peripheral artery that is being bypassed.
  • the degree of curvature 75 of the stent is between about 5 and 160 degrees and is selected based upon the degree of orientation between the vein, blood vessel or graft 15 and the artery, graft or other vascular structure 20 . All embodiments described herein apply to either stent placement.
  • the body of the stent 30 can also be placed at the natural bend of a blood vessel 15 at a location away from an anastomosis site.
  • the degree of curvature 75 is between about 5 and 160 degrees and is selected based upon the degree of curvature in the vessel.
  • the stent 30 is tapered so that the diameter decreases along the longitudinal axis 65 of the stent 30 .
  • the stent 30 is comprised of a first proximal end 35 and a second, distal end 40 opposite the proximal end 35 .
  • the diameter of the stent 30 at the proximal end 35 is greater than the diameter of the stent at the opposite, distal end 40 .
  • this embodiment is particularly suited for placement in vessels where the diameter of the vessel changes from one segment to another.
  • the stent has a “beveled,” “flared,” or “trumpeted” edge 25 .
  • the stent 30 is comprised of a first proximal end 35 and a second, distal end 40 opposite the proximal end 35 .
  • the web structure 55 expands outwardly, resulting in an increased diameter 45 at that end 35 of the stent 30 , giving the proximal end 35 of the stent 30 a “beveled,” “flared,” or “trumpeted” appearance.
  • FIG. 2E such an embodiment is particularly suited for placement at an anastamotic orifice 85 .
  • the beveled edge 25 allows the stent to abut the orifice 85 without protruding into the artery, vessel, or graft 20 .
  • the stent elutes anti-vasculoproliferative drugs or agents such as rapamycin, paclitaxel, tacrolimus, everolimus, zotarolimus and other cell cycle inhibitor or similarly-functioning agents.
  • anti-vasculoproliferative drugs or agents such as rapamycin, paclitaxel, tacrolimus, everolimus, zotarolimus and other cell cycle inhibitor or similarly-functioning agents.
  • the stent 30 in its contracted state 90 is equipped with an external wire (“rip cord”) to release and expand the stent.
  • rip cord an external wire
  • the stent 30 in its contracted state is attached to a guidewire 95 .
  • a further wire 100 is attached to the external surface of the stent in its contracted state 90 .
  • Wire 100 may also be attached to the leading edge of the stent and not its surface.
  • This wire 100 is configured so that, after the stent 30 is placed at the graft orifice or at the anastomosis site 85 , manipulating the attached wire 100 pulls the external surface of the stent 30 toward the interior surface of the vessel or graft 15 , causing the stent to expand and abut the interior surface 105 of the vessel or graft wall.
  • a further embodiment of the present invention is a kit for treating or preventing stenosis at an anastomosis site containing the previously described curved stent 30 specially configured for placement in an anastomosis site (bevel, flaring or trumpeting, tapering not shown in this figure) or any other type of balloon expandable or self-expanding stent, together with a wrap or sleeve 110 , or an implantable prosthetic device for placement on the area surrounding the anastomotic orifice 85 and anastomosis site, on the outer surface of the vessel or graft 15 or 20 , wherein the sleeve then elutes one or more antivasculoproliferative drugs or agents such as rapamycin (sirolimus), paclitaxel, tacrolimus, everolimus, zotarolimus and other cell cycle inhibitor or similarly-functioning agents.
  • rapamycin sirolimus
  • paclitaxel tacrolimus
  • this implantable device contains, optionally, agents that inhibit collagen accumulation in the tunica media and adventitia of the vascular wall and pharmaceuticals that help reduce calcification of the vascular wall.
  • Rapamycin is a preferred drug with antiproliferative properties for use with the present invention. The rapamycin diffuses from the outside and through the vessel and/or graft wall to the interior of the vein and/or artery and/or graft. Elution of rapamycin (and other drugs with antiproliferative effect) into and through the vascular wall from the outside starts soon after the device is implanted and the drug will inhibit smooth muscle cell proliferation at the anastomosis site.
  • the kit of the present invention thus improves the treatment and/or prevention of stenosis by providing a novel treatment originating from within the vascular or graft lumen in combination with an extravascular pharmaceutical application.
  • This combination can prevent stenosis of the vein, graft, artery and anastomotic orifice as well as treat the restenosis that commonly follows stent implantation.
  • the specially configured stent is drug eluting, resulting in intravascular delivery of pharmaceutical agents directly to the vicinity of the graft orifice in addition to the extravascular pharmaceutical treatment provided by the sleeve.
  • the method of the present invention discloses providing a stent 30 that is specially configured for placement at an anastomosis site as described above, providing a sleeve 110 comprising a biological matrix imbibed with a pharmaceutical agent, applying the sleeve to the extravascular surface of an anastomosis site, and inserting the stent 30 to the vein, vessel and graft 15 and orifice 85 of an anastomosis site.
  • the stent 30 is configured with an external wire 100 affixed to the outer surface of the stent 30 .
  • the stent 30 in its contracted state 90 is then inserted into the vein, graft or blood vessel 15 through the use of a guide wire 95 .
  • the wire 100 affixed to the external surface of the stent is manipulated, pulling the external surface of the stent toward the interior surface 105 of the vessel, causing the stent 30 to expand and abut the interior surface 105 of the wall of the vessel or graft 15 .
  • the stent 30 is inserted its contracted state 90 , and is held in its contracted state by a sheath 115 surrounding the contracted stent 90 .
  • the sheath 115 is retracted. Retraction of the sheath 115 causes the stent 30 to expand and abut the interior surface 105 of the wall of the vessel or graft 15 .
  • the sheath 115 is removed, leaving the expanded stent 30 in place at the anastomosis site.
  • the stent is a balloon-expandable stent. In anther embodiment, the stent is a self-expanding stent.
  • the external surface of the web structure 55 of the balloon expandable or self expandable stent 30 may be partially or completely covered by a polymer, fabric or biological coating 120 .
  • a polymer, fabric or biological coating 120 An example of such a covering that may be used for the stent is polytetrafluoroethylene (PTFE).
  • the invention relates to the use of a plain stent (i.e., non-drug coated self-expanding or balloon expanding stent) at and around the anastomotic site of an AV fistula as a stand-alone treatment for fistula outflow stenosis.
  • a plain stent i.e., non-drug coated self-expanding or balloon expanding stent
  • Such method may be used to treat outflow stenosis prophylactically shortly after the surgery with a plain stent without the perivascular application of a drug-eluting sleeve.
  • the use of the sleeve is optional.
  • Such plain stent can be an existing stent design or any of the novel stent designs described elsewhere herein.
  • FIGS. 16A-16D show the difference between a beveled stent edge and a traditional right angled, square-cut stent edge and illustrates why the beveled edge provides optimal coverage of the anastomosis when the vessels of the anastomosis are not joined perpendicular to each other. Since neither of the situations in FIG. 16A (i.e. the square ended stent is placed at a location such that it is too short to completely contact the full circumference of the anastomosis orifice and does not extend all the way down to the site of the anastomosis) or FIG. 16 B (i.e.
  • a stent with a “beveled,” “flared” or “trumpeted” edge can overcome this problem.
  • the “bevel” helps in providing optimal coverage of the anastomosis and will facilitate stent deployment such that the anastomosis is completely covered without protrusion into the adjacent vessel (see FIG. 16C ).
  • FIG. 17 illustrates the difference between the traditional, conventional deployment system for a self expanding stent (distal end deployed first, proximal end deployed last) and proposed system which allows “proximal end first distal end last” deployment of the stent
  • FIG. 18 illustrates how an endovascular stent 30 will be used with a perivascular drug eluting matrix 110 with an AV Graft.
  • the AV graft is constructed by anastomosing a piece of PTFE graft 15 between an artery 20 and a vein 20 .
  • the stent 30 is placed internally at and around the site of anastomosis (see FIG. 18A ).
  • the drug eluting matrix 110 is placed on the external aspect of the blood vessel 20 and graft 15 (see FIG.
  • FIG. 18 illustrates this use at the graft venous anastomosis.
  • the implants can also be done at the graft arterial anastomosis or elsewhere in the AV graft system.
  • This stent 30 and dug eluting matrix 110 configuration was used in the therapeutic example discussed in Sections 64-73 under Therapeutic Example (AV Graft)
  • FIG. 19 illustrates how an endovascular stent will be used with a perivascular drug eluting matrix for an AV Fistula.
  • the AV fistula is constructed by anastomosing the end of a segment of vein 15 to the side of an artery 20 .
  • the stent 30 shown in this illustration is a traditional non beveled stent, placed internally at and around the site of anastomosis and extending into the outflow vein 15 (see FIG. 19A ).
  • the drug eluting matrix 110 is placed on the external aspect of the blood vessel (see FIG. 19B ).
  • a proof of principle study was performed using an ovine model.
  • a 6 mm PTFE vascular graft was anastomosed between the carotid artery on one side and the contralateral jugular vein, creating an arterio venous (AV) loop graft that is similar in construction to the human hemodialysis access loop.
  • AV arterio venous
  • the sirolimus eluting collagen matrix was implanted on the external surface of the PTFE graft venous anastomosis location, such that the matrix on the external aspect roughly corresponded to the location of the endovascular nitinol endovascular stent.
  • the stent used was a self expanding nitinol stent, 30 mm in length and fully expanded had a diameter of 8.0 mm.
  • the collagen matrix was combined with a known dose of sirolimus (approximately 75 microgram/cm 2 ).
  • Contrast Angiography was performed to assess status of the graft, stent and the vessel at 28 and 56 ⁇ 1 day after initial surgery.
  • FIGS. 12A , 12 B Angiograms from the two animals that received the endovascular self expanding nitinol stent, without the sirolimus eluting collagen matrix. Narrowing within the stent is seen in both animals.
  • FIGS. 12C , 12 D Angiograms are from the two animals that received the endovascular self expanding nitinol stent plus the Sirolimus eluting collagen matrix. There is no angiographically obvious narrowing in FIG. 1C and minimal narrowing of the stent lumen in FIG. 1D .
  • FIGS. 13A , 13 B Angiograms from the two animals that received the endovascular self expanding nitinol stent without the Sirolimus eluting collagen matrix. Narrowing of the stent is seen and is more pronounced compared to the appearance at 28 days.
  • FIGS. 13C , 13 D Angiograms from the two animals that received the endovascular self expanding nitinol stent plus the Sirolimus eluting collagen matrix. There is minimal narrowing of the stent.
  • Treated fistulae received an endovascular self expanding nitinol stent starting from the anastomosis and extending out to the outflow vein (in this instance covering the juxta-anastomotic segment) plus a perivascular sirolimus (rapamycin) eluting collagen matrix.
  • the sirolimus eluting collagen matrix was implanted on the external surface of the fisulae, such that the matrix on the external aspect roughly corresponded to the anastomotic location of the endovascular nitinol endovascular stent.
  • a sirolimus eluting matrix was also implanted at the anastomosis such that the matrix wrapped both the artery as well as the vein at that location.
  • the illustrative example discussed below shows the use of a self-expanding stent 30 mm or 40 mm in length and a fully expanded diameter of 6 mm.
  • the collagen matrix was combined with a known dose of sirolimus (approximately 75 microgram/cm 2 ).
  • Contrast Angiography was performed to assess status of the fistulae, anastomosis, stent and the vessel (controls and treated) on day 0 (day of surgery) and 28 days after surgery.
  • An angiogram was also performed 62 day after surgery in the treated animal example discussed below.
  • FIGS. 14A , 14 B Angiograms of control AV fistulae on day of surgery (Day 0)
  • FIGS. 14C , 14 D Angiograms on day of surgery (Day 0) of Animal treated with endovascular self-expanding stent (6 mm ⁇ 30 mm, for the left and 6 mm ⁇ 40 mm for the right) and Perivascular Sirolimus Eluting Matrix.
  • FIGS. 15A , 15 B Angiograms of control AV fistulae 28 days following surgery shows severe stenosis of the outflow vein as well as the anastomosis.
  • FIGS. 15C , 15 D Angiograms of left AV fistula performed on day 28 ( FIG. 15C ) and day 62 ( FIG. 15D ) in animal treated with endovascular self-expanding stent (6 mm ⁇ 30 mm and Perivascular Sirolimus Eluting Matrix.
  • endovascular self-expanding stent (6 mm ⁇ 30 mm and Perivascular Sirolimus Eluting Matrix.
  • endovascular self-expanding stent 6 mm ⁇ 30 mm and Perivascular Sirolimus Eluting Matrix.

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US15/284,234 US20170020651A1 (en) 2010-01-27 2016-10-03 Device and method for preventing stenosis at an anastomosis site
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Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140242144A1 (en) * 2012-02-10 2014-08-28 Abbott Cardiovascular Systems Inc. Drug eluting scaffold for kidney-related disease
US20140303657A1 (en) * 2011-11-01 2014-10-09 The Asan Foundation Vascular anastomosis device using a self-expandable material or body, and anastomosis method for blood vessels using same
US20160007997A1 (en) * 2014-07-14 2016-01-14 Chengxiong Gu Bridge vessels-proximal anastomosis supporting device for coronary artery bypass grafting and manufacturing method thereof
US20170156845A1 (en) * 2012-06-18 2017-06-08 Board Of Regents Of The University Of Nebraska Stent to assist in arteriovenous fistula formation
US9687239B2 (en) 2014-04-15 2017-06-27 Abbott Cardiovascular Systems Inc. Intravascular devices supporting an arteriovenous fistula
US9956384B2 (en) 2014-01-24 2018-05-01 Cook Medical Technologies Llc Articulating balloon catheter and method for using the same
US10045817B2 (en) 2010-11-16 2018-08-14 Tva Medical, Inc. Devices and methods for forming a fistula
US20180242971A1 (en) * 2015-08-28 2018-08-30 University Of Cincinnati Arteriovenous Fistula Implant Effective for Inducing Laminar Blood Flow
US10603040B1 (en) * 2015-02-09 2020-03-31 Tva Medical, Inc. Methods for treating hypertension and reducing blood pressure with formation of fistula
US10646666B2 (en) 2014-08-27 2020-05-12 Tva Medical, Inc. Cryolipolysis devices and methods therefor
US10695534B2 (en) 2014-03-14 2020-06-30 Tva Medical, Inc. Fistula formation devices and methods therefor
US10821217B2 (en) 2013-03-14 2020-11-03 Tva Medical, Inc. Fistula formation devices and methods therefor
US10869717B2 (en) 2012-10-11 2020-12-22 Tva Medical, Inc. Devices and methods for fistula formation
US10874422B2 (en) 2016-01-15 2020-12-29 Tva Medical, Inc. Systems and methods for increasing blood flow
US11026743B2 (en) 2016-01-15 2021-06-08 Tva Medical, Inc. Devices and methods for forming a fistula
US11285028B2 (en) 2016-09-25 2022-03-29 Tva Medical, Inc. Vascular stent devices and methods
US20220296400A1 (en) * 2011-08-19 2022-09-22 Khalid Al-Saadon Stent system deployment apparatus for bifurcated lesion
US11590322B2 (en) 2016-01-15 2023-02-28 Tva Medical, Inc. Devices and methods for advancing a wire

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0419954D0 (en) 2004-09-08 2004-10-13 Advotek Medical Devices Ltd System for directing therapy
US20130190676A1 (en) 2006-04-20 2013-07-25 Limflow Gmbh Devices and methods for fluid flow through body passages
US20110319976A1 (en) * 2010-01-27 2011-12-29 Sriram Iyer Device and method for preventing stenosis at an anastomosis site
WO2013114358A1 (en) * 2012-01-30 2013-08-08 Hipokrat Negatively charged vascular stent
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CN107432762B (zh) 2013-03-08 2021-04-13 林弗洛公司 提供或维持通过身体通道的流体流的方法和系统
US9545263B2 (en) 2014-06-19 2017-01-17 Limflow Gmbh Devices and methods for treating lower extremity vasculature
WO2017011402A1 (en) * 2015-07-10 2017-01-19 Rox Medical, Inc. Methods, systems and devices for creating a blood flow pathway to treat a patient
CN106333722A (zh) * 2015-07-10 2017-01-18 洛克斯医药公司 用于创建血液流动通路以治疗患者的方法、系统和装置
WO2018189593A2 (en) 2017-04-10 2018-10-18 Limflow Gmbh Devices and methods for treating lower extremity vasculature
CN112955207A (zh) 2018-10-09 2021-06-11 林弗洛公司 用于导管对准的设备和方法
WO2020185851A1 (en) * 2019-03-11 2020-09-17 The Board Of Supervisors Of Louisiana State University And Agricultural And Mechanical College Anastomosing stent and methods of use
WO2021087294A1 (en) 2019-11-01 2021-05-06 Limflow Gmbh Devices and methods for increasing blood perfusion to a distal extremity
WO2024024946A1 (ja) * 2022-07-29 2024-02-01 慶應義塾 吻合補助具

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6726923B2 (en) * 2001-01-16 2004-04-27 Vascular Therapies, Llc Apparatus and methods for preventing or treating failure of hemodialysis vascular access and other vascular grafts
US20080082159A1 (en) * 2006-09-28 2008-04-03 Cook Incorporated Stent for Endovascular Procedures
US20090099640A1 (en) * 2006-03-30 2009-04-16 Ning Weng Axial Pullwire Tension Mechanism for Self-Expanding Stent
US20090110713A1 (en) * 2007-10-31 2009-04-30 Florencia Lim Biodegradable polymeric materials providing controlled release of hydrophobic drugs from implantable devices

Family Cites Families (56)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE445884B (sv) 1982-04-30 1986-07-28 Medinvent Sa Anordning for implantation av en rorformig protes
US4733665C2 (en) 1985-11-07 2002-01-29 Expandable Grafts Partnership Expandable intraluminal graft and method and apparatus for implanting an expandable intraluminal graft
SE453258B (sv) 1986-04-21 1988-01-25 Medinvent Sa Elastisk, sjelvexpanderande protes samt forfarande for dess framstellning
US5019085A (en) * 1988-10-25 1991-05-28 Cordis Corporation Apparatus and method for placement of a stent within a subject vessel
CH678393A5 (ja) 1989-01-26 1991-09-13 Ulrich Prof Dr Med Sigwart
US5425739A (en) * 1989-03-09 1995-06-20 Avatar Design And Development, Inc. Anastomosis stent and stent selection system
US5545208A (en) * 1990-02-28 1996-08-13 Medtronic, Inc. Intralumenal drug eluting prosthesis
AU678350B2 (en) 1992-05-08 1997-05-29 Schneider (Usa) Inc. Esophageal stent and delivery tool
US6090115A (en) * 1995-06-07 2000-07-18 Intratherapeutics, Inc. Temporary stent system
CA2566929C (en) * 1995-03-10 2009-04-21 Bard Peripheral Vascular, Inc. Endoluminal encapsulated stent and methods of manufacture and endoluminal delivery
EP0840577B1 (en) * 1995-07-07 2005-08-24 W.L. GORE & ASSOCIATES, INC. Interior liner for tubes, pipes and blood conduits
US20040106985A1 (en) * 1996-04-26 2004-06-03 Jang G. David Intravascular stent
US6726933B2 (en) 1996-09-30 2004-04-27 Shiseido Co., Ltd. Rod-shaped mesoporous powder, humectant adsorbing powder, and cosmetic preparation using the same
US6019788A (en) * 1996-11-08 2000-02-01 Gore Enterprise Holdings, Inc. Vascular shunt graft and junction for same
US6026814A (en) * 1997-03-06 2000-02-22 Scimed Life Systems, Inc. System and method for percutaneous coronary artery bypass
US5911732A (en) * 1997-03-10 1999-06-15 Johnson & Johnson Interventional Systems, Co. Articulated expandable intraluminal stent
US6273913B1 (en) 1997-04-18 2001-08-14 Cordis Corporation Modified stent useful for delivery of drugs along stent strut
US5957929A (en) * 1997-05-02 1999-09-28 Micro Therapeutics, Inc. Expandable stent apparatus and method
US6165195A (en) * 1997-08-13 2000-12-26 Advanced Cardiovascylar Systems, Inc. Stent and catheter assembly and method for treating bifurcations
US6330884B1 (en) * 1997-11-14 2001-12-18 Transvascular, Inc. Deformable scaffolding multicellular stent
AU1923999A (en) * 1998-01-30 1999-08-16 Vascular Science Inc. Medical graft connector or plug structures, and methods of making and installingsame
JP2002518082A (ja) * 1998-06-10 2002-06-25 コンバージ メディカル， インコーポレイテッド 縫合なし吻合システム
US20020019660A1 (en) * 1998-09-05 2002-02-14 Marc Gianotti Methods and apparatus for a curved stent
US6152937A (en) * 1998-11-06 2000-11-28 St. Jude Medical Cardiovascular Group, Inc. Medical graft connector and methods of making and installing same
US7578828B2 (en) * 1999-01-15 2009-08-25 Medtronic, Inc. Methods and devices for placing a conduit in fluid communication with a target vessel
US7025773B2 (en) * 1999-01-15 2006-04-11 Medtronic, Inc. Methods and devices for placing a conduit in fluid communication with a target vessel
US6364903B2 (en) * 1999-03-19 2002-04-02 Meadox Medicals, Inc. Polymer coated stent
WO2001049338A1 (en) * 1999-12-30 2001-07-12 Li Wei Pin Controlled delivery of therapeutic agents by insertable medical devices
US20160287708A9 (en) * 2000-03-15 2016-10-06 Orbusneich Medical, Inc. Progenitor Endothelial Cell Capturing with a Drug Eluting Implantable Medical Device
NZ525519A (en) * 2000-09-25 2005-01-28 Cohesion Tech Inc Resorbable anastomosis stents for insertion into an opening in a lumen of a vessel or tissue of a patient
US6579308B1 (en) * 2000-11-28 2003-06-17 Scimed Life Systems, Inc. Stent devices with detachable distal or proximal wires
JP2002272855A (ja) * 2001-03-14 2002-09-24 Piolax Medical Device:Kk ステント
ATE272369T1 (de) * 2001-03-27 2004-08-15 Cook William Europ Gefässtransplantat für die aorta
US6716238B2 (en) * 2001-05-10 2004-04-06 Scimed Life Systems, Inc. Stent with detachable tethers and method of using same
US7115136B2 (en) * 2001-06-20 2006-10-03 Park Medical Llc Anastomotic device
AU2002327358A1 (en) * 2001-07-26 2003-02-17 Avantec Vascular Corporation Methods and devices for delivery of therapeutic capable agents with variable release profile
US20060224234A1 (en) * 2001-08-29 2006-10-05 Swaminathan Jayaraman Drug eluting structurally variable stent
US7108701B2 (en) * 2001-09-28 2006-09-19 Ethicon, Inc. Drug releasing anastomosis devices and methods for treating anastomotic sites
US7758881B2 (en) * 2004-06-30 2010-07-20 Advanced Cardiovascular Systems, Inc. Anti-proliferative and anti-inflammatory agent combination for treatment of vascular disorders with an implantable medical device
WO2004100836A1 (en) * 2003-05-12 2004-11-25 Cook Incorporated Stent graft
US7226473B2 (en) * 2003-05-23 2007-06-05 Brar Balbir S Treatment of stenotic regions
PL1638624T3 (pl) 2003-06-19 2014-06-30 Vascular Therapies Llc Wyrób do zamykania naczyń krwionośnych
JP2005211293A (ja) * 2004-01-29 2005-08-11 Piolax Medical Device:Kk 管状器官の治療具
US20050203606A1 (en) * 2004-03-09 2005-09-15 Vancamp Daniel H. Stent system for preventing restenosis
US20050278013A1 (en) * 2004-05-26 2005-12-15 Matthew Rust Method for endovascular bypass stent graft delivery
JP2008522735A (ja) * 2004-12-08 2008-07-03 パーバシス セラピューティクス， インコーポレイテッド 血管アクセスを強化するための方法および組成物
US9101500B2 (en) * 2005-01-10 2015-08-11 Trireme Medical, Inc. Stent with self-deployable portion having wings of different lengths
CN101102728B (zh) * 2005-01-10 2011-06-22 曲利姆医疗股份有限公司 具有可自展开部分的支架
EP1933785B1 (en) * 2005-10-14 2015-04-22 Abbott Laboratories Compositions, systems, kits, and methods of administering rapamycin analogs with paclitaxel using medical devices
US7722665B2 (en) * 2006-07-07 2010-05-25 Graft Technologies, Inc. System and method for providing a graft in a vascular environment
US7914552B2 (en) * 2006-11-09 2011-03-29 Ethicon Endo-Surgery, Inc. Method of performing an end-to-end anastomosis using a stent and an adhesive
EP2173293A1 (en) * 2007-07-16 2010-04-14 Hemcon Medical Technologies, Inc. Absorbable tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chistosan
US8303650B2 (en) * 2008-01-10 2012-11-06 Telesis Research, Llc Biodegradable self-expanding drug-eluting prosthesis
US20120277774A1 (en) * 2009-11-13 2012-11-01 The Brigham And Women's Hospital, Inc. Method and Apparatus for Vascular Anastomosis
US20110319976A1 (en) * 2010-01-27 2011-12-29 Sriram Iyer Device and method for preventing stenosis at an anastomosis site
US9345484B2 (en) * 2010-11-11 2016-05-24 Asfora Ip, Llc Deployment tool for sutureless vascular anastomosis connection

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6726923B2 (en) * 2001-01-16 2004-04-27 Vascular Therapies, Llc Apparatus and methods for preventing or treating failure of hemodialysis vascular access and other vascular grafts
US20090099640A1 (en) * 2006-03-30 2009-04-16 Ning Weng Axial Pullwire Tension Mechanism for Self-Expanding Stent
US20080082159A1 (en) * 2006-09-28 2008-04-03 Cook Incorporated Stent for Endovascular Procedures
US20090110713A1 (en) * 2007-10-31 2009-04-30 Florencia Lim Biodegradable polymeric materials providing controlled release of hydrophobic drugs from implantable devices

Cited By (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11986236B2 (en) 2010-11-16 2024-05-21 Tva Medical, Inc. Devices and methods for forming a fistula
US10045817B2 (en) 2010-11-16 2018-08-14 Tva Medical, Inc. Devices and methods for forming a fistula
US11051880B2 (en) 2010-11-16 2021-07-06 Tva Medical, Inc. Devices and methods for forming a fistula
US20220296400A1 (en) * 2011-08-19 2022-09-22 Khalid Al-Saadon Stent system deployment apparatus for bifurcated lesion
US20140303657A1 (en) * 2011-11-01 2014-10-09 The Asan Foundation Vascular anastomosis device using a self-expandable material or body, and anastomosis method for blood vessels using same
US8840678B2 (en) * 2012-02-10 2014-09-23 Abbott Cardiovascular Systems Inc. Drug-eluting bioabsorbable renal artery stent for renal cancer and inflammatory disorders
US20140242144A1 (en) * 2012-02-10 2014-08-28 Abbott Cardiovascular Systems Inc. Drug eluting scaffold for kidney-related disease
US10772718B1 (en) 2012-06-18 2020-09-15 Board Of Regents Of The University Of Nebraska Stent to assist in arteriovenous fistula formation
US20170156845A1 (en) * 2012-06-18 2017-06-08 Board Of Regents Of The University Of Nebraska Stent to assist in arteriovenous fistula formation
US11701216B2 (en) 2012-06-18 2023-07-18 Board Of Regents Of The University Of Nebraska Stent to assist in arteriovenous fistula formation
US10034739B2 (en) * 2012-06-18 2018-07-31 Board Of Regents Of The University Of Nebraska Stent to assist in arteriovenous fistula formation
US10869717B2 (en) 2012-10-11 2020-12-22 Tva Medical, Inc. Devices and methods for fistula formation
US10821217B2 (en) 2013-03-14 2020-11-03 Tva Medical, Inc. Fistula formation devices and methods therefor
US11707562B2 (en) 2013-03-14 2023-07-25 Tva Medical, Inc. Fistula formation devices and methods therefor
US9956384B2 (en) 2014-01-24 2018-05-01 Cook Medical Technologies Llc Articulating balloon catheter and method for using the same
US11219745B2 (en) 2014-03-14 2022-01-11 Tva Medical, Inc. Fistula formation devices and methods therefor
US10695534B2 (en) 2014-03-14 2020-06-30 Tva Medical, Inc. Fistula formation devices and methods therefor
US9687239B2 (en) 2014-04-15 2017-06-27 Abbott Cardiovascular Systems Inc. Intravascular devices supporting an arteriovenous fistula
US20160007997A1 (en) * 2014-07-14 2016-01-14 Chengxiong Gu Bridge vessels-proximal anastomosis supporting device for coronary artery bypass grafting and manufacturing method thereof
US10646666B2 (en) 2014-08-27 2020-05-12 Tva Medical, Inc. Cryolipolysis devices and methods therefor
US11207070B2 (en) 2015-02-09 2021-12-28 Tva Medical, Inc. Methods for treating hypertension and reducing blood pressure with formation of fistula
US10603040B1 (en) * 2015-02-09 2020-03-31 Tva Medical, Inc. Methods for treating hypertension and reducing blood pressure with formation of fistula
US20180242971A1 (en) * 2015-08-28 2018-08-30 University Of Cincinnati Arteriovenous Fistula Implant Effective for Inducing Laminar Blood Flow
US10849627B2 (en) * 2015-08-28 2020-12-01 University Of Cincinnati Arteriovenous fistula implant effective for inducing laminar blood flow
US11026743B2 (en) 2016-01-15 2021-06-08 Tva Medical, Inc. Devices and methods for forming a fistula
US10874422B2 (en) 2016-01-15 2020-12-29 Tva Medical, Inc. Systems and methods for increasing blood flow
US11590322B2 (en) 2016-01-15 2023-02-28 Tva Medical, Inc. Devices and methods for advancing a wire
US11826093B2 (en) 2016-01-15 2023-11-28 Tva Medical, Inc. Devices and methods for forming a fistula
US11285028B2 (en) 2016-09-25 2022-03-29 Tva Medical, Inc. Vascular stent devices and methods

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EP2528537A4 (en) 2016-09-07
JP2018020104A (ja) 2018-02-08
JP6172704B2 (ja) 2017-08-02
US20140088681A1 (en) 2014-03-27
JP2013517906A (ja) 2013-05-20
EP2528537A1 (en) 2012-12-05
WO2011094459A1 (en) 2011-08-04
US20170020651A1 (en) 2017-01-26
EP3878403A1 (en) 2021-09-15
US20200360126A1 (en) 2020-11-19
JP2019150584A (ja) 2019-09-12
JP6506350B2 (ja) 2019-04-24

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