WO2009035957A1 - Balloon device for delivering and deploying ostial or bifurcation stents - Google Patents

Balloon device for delivering and deploying ostial or bifurcation stents Download PDF

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Publication number
WO2009035957A1
WO2009035957A1 PCT/US2008/075680 US2008075680W WO2009035957A1 WO 2009035957 A1 WO2009035957 A1 WO 2009035957A1 US 2008075680 W US2008075680 W US 2008075680W WO 2009035957 A1 WO2009035957 A1 WO 2009035957A1
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Prior art keywords
ostial
balloon
bifurcation
stent
delivering
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PCT/US2008/075680
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French (fr)
Inventor
Liliana Rosa Grinfeld
Roberto Rafael Grinfeld
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Liliana Rosa Grinfeld
Roberto Rafael Grinfeld
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Publication of WO2009035957A1 publication Critical patent/WO2009035957A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A—HUMAN NECESSITIES
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • A—HUMAN NECESSITIES
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels
    • A61F2002/067—Y-shaped blood vessels modular
    • A—HUMAN NECESSITIES
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/821—Ostial stents
    • A—HUMAN NECESSITIES
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
    • A—HUMAN NECESSITIES
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/005—Rosette-shaped, e.g. star-shaped
    • A—HUMAN NECESSITIES
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped
    • A—HUMAN NECESSITIES
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0073—Quadric-shaped
    • A61F2230/0078—Quadric-shaped hyperboloidal

Definitions

  • the present invention is directed to a balloon device for delivering and deploying ostial or bifurcation stents which, by means of balloons having different expansion capacity, makes it possible to deploy the stent and provide greater expansion to its end portion until the lesion is completely covered.
  • TCA has become a safer, simpler and more reproducible method with routine use of stents.
  • a new era of treatment of coronary heart diseases started with the upcoming of drug-releasing stents (SLD).
  • SLD drug-releasing stents
  • Bifurcation lesions are an unfavorable context, not only due to the risk of losing secondary vessels, but also because of the high rate of restenosis, particularly in secondary vessels.
  • SIR US Bifurcations 86 patients with bifurcation lesions were randomized to receive Cypher in the main vessel and balloon in the secondary vessel versus Cypher in both vessels 12 ( 12 Colombo A, Moses JW, Morice MC, Ludwig J, Holmes DR.. Ji, Spanos V, et al. Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions. Circulation. 2004; 109: 1244-9).
  • results may be summarized as follows: a) a high (51%) crossover rate of Cypher- balloon to Cypher-Cypher ; b) restenosis was low in the main vessel (-5% in both groups), a favorable information as compared to the classic series of conventional stent, and c) treatment with Cypher in both vessels did not provide advantages as compared to the initial treatment with balloon of the secondary vessel (new revascularization procedures of 11 % and 10%, and restenosis in secondary vessel of 22 % and 14 %, respectively). Further, all thromboses occurred in patients treated with Cypher-Cypher.
  • SLD has originated a new technique for the treatment of bifurcations (crushing), basically consisting in implanting a first SLD in the secondary branch but at about 4 mm, in the main vessel, and further implanting another SLD in the main vessel, which would have been situated there before implanting the stent in the secondary vessel.
  • this technique is finished by simultaneous inflation of both vessels with balloons (kissing balloon).
  • This stent is appropriate for bifurcation lesions involving the ostium of secondary branches (posterior descendent, latero-ventricular or obtuse marginal of anterior descendent circumflex, diagonal or septal). So far, no devices are known that would allow for an adequate and efficient deployment of this type of stents.
  • the present device allows for a perfect deployment and has great handling capacity due to the possibility of independent maneuvering of balloons and to their differential expansion capacity.
  • Figure 1 is an elevational side view of the present device.
  • Figure 2 comprises figures 2a and 2b, wherein:
  • Figure 2a is a cross-section of the proximal stretch of the catheter; and figure 2b is a cross-section of the distal stretch of the catheter.
  • Figure 3 is another elevational side view of the present device with inflated balloons.
  • Figure 4 is a elevational side view of a stent of the type having a bendable end portion for which the present device is intended.
  • Figure 5 is a longitudinal section of the bifurcation between a major vascular duct and a bifurcated one, inside which both inflated balloons may be seen, thereby expanding the stent.
  • Figure 6 is a detail of the longitudinal section of figure 5, showing with greater detail the way in which the first balloon bends the end portion of the stent.
  • a balloon device for delivering and deploying ostial or bifurcation stents comprising a means for radial or diametral expansion of stents (10) of the type comprising:
  • a tubular body capable of expanding until its external portions exert pressure against the vascular duct endothelium of interest, defining an endovascular site that maintains or increases the lumen of said duct;
  • At least one end portion of said stent (10) comprises means for conferring the capacity of expansive bending, in such a way that said end portion (11) can be placed on vascular ostial or bifurcation lesions (22);
  • the expansion of the stent (10) is carried out by inflatable means or balloons (3)(4) which, through a catheter line (1), are controlled by an extracorporeal command; characterized by comprising:
  • the balloon with greater diametral expansion capacity (3) can be placed against the expansive end portion (11) of the stent (10);
  • the present invention is directed to a balloon device for delivering and deploying ostial or bifurcation stents
  • a balloon device for delivering and deploying ostial or bifurcation stents
  • a catheter (1) with a set of balloons (3)(4) of different diametral expansion capacity provided with respective independent command paths (3a)(4a); wherein the second balloon (4) expands the main body of the stent (10), while the first balloon (3) expands the expansive bending end portion (11) thereof (10).
  • the present device may be used with stents (10) of the type comprising a tubular meshed body and which is expandable until its external portions exert pressure against the vascular duct endothelium of interest, where it remains in position to maintain or increase the lumen of said duct.
  • this type of stent (10) comprises, at least, one expansive bending end (1 1) adjustable to lesions (22a) of vascular ostial or bifurcation localization (22). More particularly, the present device comprises a catheter (1) ending in a set of balloons (3)(4) that, together with a stent (10) and with the assistance of a metallic guide wire (2) and inflow catheter, is useful for the treatment of lesions (22a) situated in areas of vascular bifurcation (22).
  • the second balloon (4) achieves less diametral expansion and does works in the main body of the stent (10). On the contrary, the first balloon (3) reaches the greatest diametral expansion and is applied to the expansive bending end portion (1 1) of the stent (10).
  • each balloon (3)(4) has its own independent command path (3a)(4a). Accordingly, the catheter (1) has different inner compartments.
  • the catheter (1) comprises an inflow line (2a) starting at a guiding opening (2b) and ending at the distal end of the device close to the end portion of second balloon (4)]. Then, the catheter (1) comprises a proximal stretch (Ia) and a distal stretch (Ib).
  • the catheter (1) In the proximal stretch (Ia), extending from the extra corporeal end up to the guiding opening (2b), the catheter (1) has a double path defined by two compartments conforming a first command path (3a) of the first balloon (3) and a second command path (4a) of the second balloon (4). From the guiding aperture (2b), the distal stretch (Ib) extends having a triple path defined by three compartments, as to the two above- mentioned first and second paths (3a)(4a) the inflow path is added (2a).
  • the first command opening (3b) inflates and deflates the first balloon of greater diametral expansion (3).
  • the second command opening (4b) inflates and deflates the second balloon of lesser diametral expansion (4).
  • An embodiment of the invention provides radiopaque marks (5a)(5b), which would facilitate operation of the device.
  • a positional radiopaque mark (5b) would be indicative of the position of the bending sector (12) of stent (10), in its normal position in a device prepared for deployment.
  • deployment of a distal radiopaque mark (5a) would indicate the distal end portion of the device.
  • the stent (10) and the device are introduced until they reach the bifurcation between the main vascular duct
  • the second balloon (4) which expands the main body of the stent (10), is inflated through the second command path (4a). Further, the first balloon (3) whose diametral expansion is greater and is used to expand the bending end portion (11) is inflated through the first command path (3a). In this site, the presence of bending sectors (12) allows for expansively bending the bendable end portions (13) under the influence of the above-mentioned first balloon (3).
  • the stent (10) remains properly deployed with its expanded bending end portion (11) covering the ostium or bifurcation (22) of the branch where the lesion (22a) is located.

Abstract

A device comprising a catheter (1) with a set of balloons (3)(4) of different diametral expansion capacity provided with respective independent command paths (3a)(4a); in which the second balloon (4) expands the main body of the stent (10), while the first balloon (3) expands the bendable end portion (11) of the stent (10). The second balloon (4), has a lower diametral expansion capacity and is inflated through the second command path (4a), while the first balloon (3), has a greater diametral expansion capacity and is inflated through the first command path (3a).

Description

BALLOON DEVICE FOR DELIVERING AND DEPLOYING OSTIAL OR BIFURCATION STENTS
Field of the Invention The present invention is directed to a balloon device for delivering and deploying ostial or bifurcation stents which, by means of balloons having different expansion capacity, makes it possible to deploy the stent and provide greater expansion to its end portion until the lesion is completely covered.
Background of the Invention
Since 1977 when Andreas Gruentzig performed the first coronary balloon angioplasty (TCA) ( Gruntzig A: Transluminal dilatation of coronary artery stenosis (abstract). Lancet 1978; 1 :263.), the use of this procedure has increased to over one million per year2 (2Graves EJ. Detailed diagnoses and procedures: National Hospital Discharge Survey. Vital Health Stat 1995;1783: 121). Later on, a stent that allowed for a significant reduction in the restenosis rate was developed and thus the scope of treatable lesions by this procedure was broadened. From their first application in humans by Sigward et al.3 (3Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med 1987; 316: 701-706.), the use of stents was initially restricted to the treatment of coronary balloon angioplasty (TCA) complications such as acute coronary occlusion or risk of occlusion. In 1994, two randomized studies using Palmar-Schatz's stent, Benthisnt4 (4Serruys P, De Jaeger P, Kemeneiji F, Macaya C, Rutsch W, Mateme P. et al. A comparision of ballon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease, N Engl. J Med. 1994; 331 : 489-495.) and Stress 5(5Fischman D, Leon M, Bairn D, Schatz R, Savage M, Nobushoshi M. et al. A randomized comparison of coronary stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl. J Med. 1994; 331:496-501), showed the efficacy of the intracoronary stent over a balloon TCA in reducing the incidence of long-term restenosis. Initially, acute or subacute occlusion rate of post-implant stenting ranged from 2 to 10%, demanding very aggressive anti-coagulating regimes which increased susceptibility to a number of major hemorrhagic complications (from 7 to 13.5%)6 (6Colombo A, Hall P, Nakamura S, Almagor AND, Maiello L, Tobis JM et al. Intracoronary stenting without anticoagulation accomplished with intravascular guidance. Circulation 1995; 91 : 1,676-1,688.). With the improvement of implants, which provided an appropriate apposition of the prosthesis to the arterial wall, i.e. without dincontinuous sectionswhich could result in very thrombogenic "pockets" and the subsequent aggressive anti-aggregating regime7 (7Bertrand ME, Legrand V, Boland J, Fleck E, Bonnier J, McFadden EP et al. Randomized multicenter comparison of conventional anticoagulation versus antiplatelet therapy in unplanned and elective coronary stenting. Circulation 1998; 98: 1,597-1,603.) ( Idem) the incidence of thrombotic and hemorrhagic complications has drastically declined. These aspects have favored an almost systematic use of stents in TCA, in both elective and urgent cases.
TCA has become a safer, simpler and more reproducible method with routine use of stents. The upcoming of more flexible designs, having a very good fixation to the balloon delivering stents to distal lesions with a very low incidence of complications, has turned the method of endovascular revascularization into one of most common use in clinical applications, overcoming surgical revascularization, even when the condition affects more than one coronary artery. A new era of treatment of coronary heart diseases started with the upcoming of drug-releasing stents (SLD). RAVEL9 (9Mourice MG, Serruys P, Fajade J J, Sousa J. Ravel study group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a Sirolimus-eluting Stent with a standard Stent for coronary revascularization. N Eng J Med 2002; 346: 1773-80.) was the first randomized, controlled and multicenter study on vessels having ideal lesions of 2.5 to 3.5 mm and a maximum length of 18 mm, wherein the clinic and angiographic restenosis at 6 months was of 0 %.
These encouraging results led to the design of multiple studies with more complex lesions, in more complex patients, such as diabetic patients, larger lesions (of more than 15 mm in length), bifurcations and many other clinical and anatomical variables with very positive results concerning restenosis reduction as compared to conventional stents. Many randomized, multicentric studies have been carried out in different subgroups of patients. As for the treatment of coronary bifurcations, much has been done since the treatment with the "kissing Balloon" described by George in 198610 (10George BS, Myler RK, Stertzer SH, et al. Balloon angioplasty of coronary bifurcation lesions: the kissing balloon technique. Cathet Cardiovasc Diagn. 86; 12: 124-138.). Different techniques, such as the culotte or crushing stent technique described by Colombo, or the T-technique described by Lefevre u(u Lefevre T, Louvard AND, Morice MC, et al. Stenting of bifurcation lesions: classification, treatments, and results. Cathet Cardiovasc Interv. 2000; 49:274-283.), were followed by other techniques for different types of lesions and angulations of the coronary anatomy. However none of them are completely effective, as the percentage of restenosis and thrombosis is greater than that observed when using only one stent or when a provisional stent technique is applied. A suggested cause for the development of restenosis and/or thrombosis is the greater number of stent layers remaining in the bifurcation after being impacted one over the other.
Bifurcation lesions are an unfavorable context, not only due to the risk of losing secondary vessels, but also because of the high rate of restenosis, particularly in secondary vessels. In SIR US Bifurcations, 86 patients with bifurcation lesions were randomized to receive Cypher in the main vessel and balloon in the secondary vessel versus Cypher in both vessels12(12Colombo A, Moses JW, Morice MC, Ludwig J, Holmes DR.. Ji, Spanos V, et al. Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions. Circulation. 2004; 109: 1244-9). The results may be summarized as follows: a) a high (51%) crossover rate of Cypher- balloon to Cypher-Cypher ; b) restenosis was low in the main vessel (-5% in both groups), a favorable information as compared to the classic series of conventional stent, and c) treatment with Cypher in both vessels did not provide advantages as compared to the initial treatment with balloon of the secondary vessel (new revascularization procedures of 11 % and 10%, and restenosis in secondary vessel of 22 % and 14 %, respectively). Further, all thromboses occurred in patients treated with Cypher-Cypher. SLD has originated a new technique for the treatment of bifurcations (crushing), basically consisting in implanting a first SLD in the secondary branch but at about 4 mm, in the main vessel, and further implanting another SLD in the main vessel, which would have been situated there before implanting the stent in the secondary vessel. Ideally, this technique is finished by simultaneous inflation of both vessels with balloons (kissing balloon).
Currently, whenever it is possible, it is advisable to use only one stent for treating bifurcation lesions (provisional stent technique)13 (13Steigen T, Maeng M, Wiseth R, Erglis A, Thuesen L. Randomized Study on Simple Versus Complex Stenting of Coronary Artery Bifurcation Lesions. The Nordic Bifurcation Study. Circulation 2006,114: 1955-1961.). Different stents are being developed for the treatment of bifurcations aiming at leaving a minimum number of metal layers on the bifurcation.
Such is the case of a stent for vascular ostial and bifurcation lesions developed by the same inventors as the present device. Said stent is disclosed in Patent document AR P050100823.
This stent is appropriate for bifurcation lesions involving the ostium of secondary branches (posterior descendent, latero-ventricular or obtuse marginal of anterior descendent circumflex, diagonal or septal). So far, no devices are known that would allow for an adequate and efficient deployment of this type of stents.
The present device allows for a perfect deployment and has great handling capacity due to the possibility of independent maneuvering of balloons and to their differential expansion capacity.
Brief Description of the Drawings
For the purpose of a greater clarity and understanding of the subject-matter of the invention, the following figures illustrate one of the preferred embodiments, by way of illustrative example, but not limitative thereof: Figure 1 is an elevational side view of the present device.
Figure 2 comprises figures 2a and 2b, wherein:
Figure 2a is a cross-section of the proximal stretch of the catheter; and figure 2b is a cross-section of the distal stretch of the catheter.
Figure 3 is another elevational side view of the present device with inflated balloons. Figure 4 is a elevational side view of a stent of the type having a bendable end portion for which the present device is intended.
Figure 5 is a longitudinal section of the bifurcation between a major vascular duct and a bifurcated one, inside which both inflated balloons may be seen, thereby expanding the stent.
Figure 6 is a detail of the longitudinal section of figure 5, showing with greater detail the way in which the first balloon bends the end portion of the stent.
In all the figures, the same reference numbers will indicate matching or identical parts, and letters are used to indicate sets of multiple elements. List of main references:
(1) Balloon catheter. (1) (Ia) Proximal stretch. (1) (Ib) Distal stretch.
(2) Metallic inflow guide wire. (2a) Inflow line.
(2b) Guiding aperture.
(3) First balloon of major diametral expansion. (3a) First command path for the first balloon (3). (3b) First command opening. (4) Second balloon [distal] of lesser diametral expansion.
(4a) Second command path for the second balloon (4).
(4b) Second command opening.
(5a) Distal radiopaque mark.
(5b) Positional radiopaque mark (10) Bendable stent.
(11) Expansive bendable portion. (12) Bending sector.
(13) Bendable ends.
(20) Main vascular duct.
(21) Secondary vascular duct or bifurcation. (22) Ostium or vascular bifurcation.
(22a) Vascular lesion.
Summary of the Invention
A balloon device for delivering and deploying ostial or bifurcation stents, comprising a means for radial or diametral expansion of stents (10) of the type comprising:
- A tubular body capable of expanding until its external portions exert pressure against the vascular duct endothelium of interest, defining an endovascular site that maintains or increases the lumen of said duct; - At least one end portion of said stent (10) comprises means for conferring the capacity of expansive bending, in such a way that said end portion (11) can be placed on vascular ostial or bifurcation lesions (22);
- The expansion of the stent (10) is carried out by inflatable means or balloons (3)(4) which, through a catheter line (1), are controlled by an extracorporeal command; characterized by comprising:
- A catheter (1) with a set of balloons (3)(4) of different diametral expansion capacity;
- The balloon with greater diametral expansion capacity (3) can be placed against the expansive end portion (11) of the stent (10); and
- Each balloon (3) (4) has its own command path (3a)(4a). Detailed Description of the Preferred Embodiment
In general terms, the present invention is directed to a balloon device for delivering and deploying ostial or bifurcation stents comprising a catheter (1) with a set of balloons (3)(4) of different diametral expansion capacity provided with respective independent command paths (3a)(4a); wherein the second balloon (4) expands the main body of the stent (10), while the first balloon (3) expands the expansive bending end portion (11) thereof (10).
The present device may be used with stents (10) of the type comprising a tubular meshed body and which is expandable until its external portions exert pressure against the vascular duct endothelium of interest, where it remains in position to maintain or increase the lumen of said duct.
Further, this type of stent (10) comprises, at least, one expansive bending end (1 1) adjustable to lesions (22a) of vascular ostial or bifurcation localization (22). More particularly, the present device comprises a catheter (1) ending in a set of balloons (3)(4) that, together with a stent (10) and with the assistance of a metallic guide wire (2) and inflow catheter, is useful for the treatment of lesions (22a) situated in areas of vascular bifurcation (22).
The second balloon (4) achieves less diametral expansion and does works in the main body of the stent (10). On the contrary, the first balloon (3) reaches the greatest diametral expansion and is applied to the expansive bending end portion (1 1) of the stent (10).
Each balloon (3)(4) has its own independent command path (3a)(4a). Accordingly, the catheter (1) has different inner compartments. In a preferred embodiment, the catheter (1) comprises an inflow line (2a) starting at a guiding opening (2b) and ending at the distal end of the device close to the end portion of second balloon (4)]. Then, the catheter (1) comprises a proximal stretch (Ia) and a distal stretch (Ib).
In the proximal stretch (Ia), extending from the extra corporeal end up to the guiding opening (2b), the catheter (1) has a double path defined by two compartments conforming a first command path (3a) of the first balloon (3) and a second command path (4a) of the second balloon (4). From the guiding aperture (2b), the distal stretch (Ib) extends having a triple path defined by three compartments, as to the two above- mentioned first and second paths (3a)(4a) the inflow path is added (2a).
The first command opening (3b) inflates and deflates the first balloon of greater diametral expansion (3). On the other hand, the second command opening (4b) inflates and deflates the second balloon of lesser diametral expansion (4).
An embodiment of the invention provides radiopaque marks (5a)(5b), which would facilitate operation of the device. For example, the inclusion of a positional radiopaque mark (5b) would be indicative of the position of the bending sector (12) of stent (10), in its normal position in a device prepared for deployment. In addition, deployment of a distal radiopaque mark (5a) would indicate the distal end portion of the device.
Operation of the assembly:
Using an inflow guide wire (2) and an inflow catheter, the stent (10) and the device are introduced until they reach the bifurcation between the main vascular duct
(20) and the bifurcated or secondary vascular duct (21), where the vascular lesion
(22a) to be treated is located. As command paths (3a)(4a) are independent, the balloons (3)(4) may be inflated separately.
Under these conditions, the second balloon (4), which expands the main body of the stent (10), is inflated through the second command path (4a). Further, the first balloon (3) whose diametral expansion is greater and is used to expand the bending end portion (11) is inflated through the first command path (3a). In this site, the presence of bending sectors (12) allows for expansively bending the bendable end portions (13) under the influence of the above-mentioned first balloon (3).
In this way, the stent (10) remains properly deployed with its expanded bending end portion (11) covering the ostium or bifurcation (22) of the branch where the lesion (22a) is located.
A person skilled in the art may readily introduce different modifications in certain details of construction and form of the invention, without departing from the main principles of the invention, such as they are clearly defined in the following claims.
Having thus specifically described and determined the nature of the present invention, and how it may be carried out, we claim the property and exclusive right on the following:

Claims

We Claim;
1. A balloon device for delivering and deploying ostial or bifurcation stents, comprising a means for radial or diametral expansion of stents (10) comprising:
- a tubular body capable of expanding until its external portions exert pressure against the vascular duct endothelium of interest, defining an endovascular site that maintains or increases the lumen of said duct;
- at least one end portion of said stent comprising means for conferring expansive bending capacity, in such a way that said end section conforms a portion that may be applied on lesions of vascular ostial or bifurcation localization; - the expansion of the stent is carried out by inflatable means or balloons which, through a catheter line, are controlled by extracorporeal command means; characterized by comprising:
- a catheter with a set of balloons of different diametral expansion capacity;
- the balloon with greater diametral expansion capacity may be applied on the expansive bending end portion of the stent; and
- each balloon has its own command path.
2. The balloon device for delivering and deploying ostial or bifurcation stents according to claim 1; characterized by comprising at least, two balloons of different diametral expansion capacity.
3. The balloon device for delivering and deploying ostial or bifurcation stents according to claim 1, characterized in that the catheter comprises a distal triple line stretch comprising the inflating lines of the balloons and an inflow guiding line and a proximal double line stretch comprising only the inflating lines.
4. The balloon device for delivering and deploying ostial or bifurcation stents, according to claim 3; characterized in that in the proximal stretch, the inflow guide wire remains outside the inflating catheter, their lines connecting the balloons with their respective means of extracorporeal command.
5. The balloon device for delivering and deploying ostial or bifurcation stents, according to claim 3; characterized in that the distal triple line stretch starts in an opening through which the inflow guide wire enters an ad-hoc line of the catheter.
6. The balloon device for delivering and deploying ostial or bifurcation stents, according to claim 1; characterized by comprising radiopaque marks.
7. The balloon device for delivering and deploying ostial or bifurcation stents, according to claim 1; characterized by comprising, at least one radiopaque mark indicating the position of the bendable part of the stent, mounted in its normal deployment position.
8. The balloon device for delivering and deploying ostial or bifurcation stents, according to claims 1; characterized by comprising at least one radiopaque mark indicating the distal end portions of the balloons.
9. The balloon device for delivering and deploying ostial or bifurcation stents, according to claim 1, characterized by comprising a set of two balloons having different diametral expansion capacities given by the different elastic moduli of the material of which they are made.
10. A kit comprising a balloon device according to claims 1 to 9 and a stent for vascular ostial and bifurcation lesions characterized in that the stent is constituted by a tubular body formed by a metal framework which, when subjected to the action of expansion of said balloon is capable of exerting tension in a direction of its diametrical expansion until outer surfaces press against an endothelium of an application vascular conduit, defining an endovascular positioning which maintains or increases the clearance of said conduit, comprising: said tubular body constituted by a succession of sections a framework of which is festoon shaped; each festoon shaped section being comprised by rows of entrances and projections; said sections and said rows being engaged by means of engaging bridges; at least one end row comprises means affording expansive bending capacity; and said expansive bending forming a portion to be attached to the ostial or bifurcation lesion.
PCT/US2008/075680 2007-09-10 2008-09-09 Balloon device for delivering and deploying ostial or bifurcation stents WO2009035957A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ARP070103984A AR063734A1 (en) 2007-09-10 2007-09-10 BALL DEVICE FOR THE TRANSPORTATION AND PLACEMENT OF OSTIAL OR FORK STENTS
ARP070103984 2007-09-10

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AT511788A1 (en) * 2011-07-29 2013-02-15 Georg Dr Gaul DEVICE FOR THE SPECIFIC ARRANGEMENT OF A STENT

Citations (2)

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Publication number Priority date Publication date Assignee Title
US5868777A (en) * 1993-12-02 1999-02-09 Advanced Cardiovascular Systems, Inc. Method for repairing a bifurcated vessel
US6780174B2 (en) * 1998-08-24 2004-08-24 Advanced Cardiovascular Systems, Inc. Bifurcated catheter assembly

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5868777A (en) * 1993-12-02 1999-02-09 Advanced Cardiovascular Systems, Inc. Method for repairing a bifurcated vessel
US6780174B2 (en) * 1998-08-24 2004-08-24 Advanced Cardiovascular Systems, Inc. Bifurcated catheter assembly

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AT511788A1 (en) * 2011-07-29 2013-02-15 Georg Dr Gaul DEVICE FOR THE SPECIFIC ARRANGEMENT OF A STENT
EP2736459B1 (en) * 2011-07-29 2017-06-28 Gaul, Georg Device for the predeterminable arrangement of a stent

Also Published As

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