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WO2008018070A1 - Système et procédé pour créer un passage dans un vaisseau sanguin partiellement ou totalement bouché - Google Patents

Système et procédé pour créer un passage dans un vaisseau sanguin partiellement ou totalement bouché Download PDF

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Publication number
WO2008018070A1
WO2008018070A1 PCT/IL2007/000986 IL2007000986W WO2008018070A1 WO 2008018070 A1 WO2008018070 A1 WO 2008018070A1 IL 2007000986 W IL2007000986 W IL 2007000986W WO 2008018070 A1 WO2008018070 A1 WO 2008018070A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
balloon
expandable member
distal end
lashes
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IL2007/000986
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English (en)
Inventor
Gad Keren
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
MEDICAL RESEARCH FUND AT TEL AVIV SOURASKY MEDICAL CENTER
Original Assignee
MEDICAL RESEARCH FUND AT TEL AVIV SOURASKY MEDICAL CENTER
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Filing date
Publication date
Application filed by MEDICAL RESEARCH FUND AT TEL AVIV SOURASKY MEDICAL CENTER filed Critical MEDICAL RESEARCH FUND AT TEL AVIV SOURASKY MEDICAL CENTER
Publication of WO2008018070A1 publication Critical patent/WO2008018070A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • 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
    • 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
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • This invention relates to medical devices for treating an occluded blood vessel.
  • Arterial stenosis is the reduction in size of the lumen of an artery, such as a coronary artery, due to disease formation in the wall of the artery.
  • the underlying disease that causes the development of stenosis is atherosclerosis.
  • atherosclerotic cardiovascular disease blood flow through the stenosed vessel is decreased leading to ischemia in the heart region supplied by the vessel.
  • angina pectoris and acute myocardial infarction may ensue.
  • the extreme case of arterial disease is total occlusion of the vessel either acutely as a thrombotic event or as a chronic occlusion with long term progression of the disease.
  • Total occlusion of one or more coronary arteries accounts for approximately 30% of diagnostic cardiac catheterization procedures and for nearly 10% of percutaneous revascularization procedures (1). Although the development of collateral flow (antegrade or contralateral) may maintain myocardial viability and prevent resting ischemia, patients with CTOs (chronic total occlusions) often present with exertional symptoms due to a flow imbalance between supply and demand.
  • CTOs chronic total occlusions
  • CTOs Chronic total occlusions, thrombotic occlusion and sometimes regular high grade stenosis, have remained a longstanding challenge for percutaneous revascularization. Unlike complete vessel occlusion with thrombus during acute myocardial infarction, CTOs are histologically characterized by fibrocalcific plaque- and organized thrombus. The prolonged absence of blood flow further results in negative vessel remodeling, which may falsely contribute to the appearance of a longer diseased segment (2).
  • CTOs have been further associated with unfavorable intermediate outcomes: restenosis in 40% to 60% of cases with occlusion in 20% to 30% (1,5). Although a number of trials have established the efficacy of stenting following revascularization of CTOs compared with angioplasty alone, restenosis still occurs in more than half of patients (5,6). Despite these limitations, successful revascularization of CTOs is associated with a clinically meaningful long-term survival advantage.
  • Balloon dilatation and stent implantation are currently the state of the art of arterial stenosis treatment.
  • PCI Percutaneous coronary interventions
  • CTO chronic total occlusion
  • the primary success rate is relatively low, mainly due to the inability to traverse the occlusion with the guidewire.
  • Successful recanalization is associated with remarkably longer fluoroscopy times, and the use of more equipment and higher restenosis rates were reported.
  • technical success was reported in only 77.2% of the patients with procedural success in 73.3% of the lesions (289 patients) and failure in 87 - A -
  • the predictors for PCI failure of CTO are mainly due to the limitations of angiography in characterizing and successfully guiding the procedure.
  • a guidewire is a thin, tightly coiled spring, usually made of stainless steel, surrounding a core. Most guidewires are constructed with an inner wire or rod surrounded by a coiled springlike wire. The proximal tip is maneuverable and the distal tip is soft and flexible. In some wires, the core is moveable distally and proximally within the wire and in some may extend beyond the end of the wire to function as a dagger.
  • the guidewire is used to pave the way into the CTO and traverse it.
  • the thickness of the wires varies from 0.010 inch to 0.35 inch. Wires have different levels of stiffness and other characteristics that may help them to traverse a high grade stenosis.
  • the difficulty in passing a guidewire through an arterial occlusion has been a major obstacle to interventional cardiology especially in vessels with total occlusion.
  • Various devices have been developed to overcome the difficulty in traversing totally occluded vessels with a guidewire. Laser wires were tested and were not found to be effective or safe, and more recently the Frontrunner catheter (Lumend Inc., Redwood City, CA) was approved for the revascularization of CTO's.
  • This device is a 6 French Catheter that employs microdissection to navigate an intraluminal pathway through a CTO. Actuation of the hinged jaws (opening diameter 3-4mm) of the distal assembly in different orientations allows separation and/or fracture of the plaque.
  • this technology does not have a built-in orientation control system, and the result is entirely dependent on the subjective evaluation of the operator using angiography to determine the location of the catheter tip within the coronary vessel.
  • This method, as well as regular wire techniques and laser revascularization of CTO is limited by the difficulty to ascertain that the equipment is advanced into a true lumen and not dissected into a false lumen.
  • the present invention provides a system for treating a vascular occlusion.
  • the system of the invention comprises an expandable member mounted on the distal end of a catheter.
  • the expandable member is provided with one or more lashes that are attached to the distal end of the expandable member.
  • the lashes are in a folded configuration when the expandable member is in a small caliber configuration, and are in an extended configuration in which they extend beyond the distal end of the catheter when ehte expandable member is in its expanded state.
  • the device is delivered to a site in a blood vessel adjacent to a partial or complete occlusion of the vessel, with the lashes in their first position.
  • the distal end of the catheter is delivered to a site in the blood vessel adjacent to the occlusion with the expandable member in its small caliber configuration and the lashes in their folded configuration.
  • the expandable member is then expanded.
  • the lashes in their extended configuration may be returned to their folded configuration, and the process repeated. Repeated slashing of the occlusion by the lashes as they oscillate between their folded and extended configurations tends to microdissect the occlusion, thus reducing the size of the occlusion and possibly eliminating it completely. This movement of the lashes creates a blunt micro-dissection within the plaque of the occlusion.
  • the lashes can be structured with different designs sharp, blunt, thin or thick, large surface or narrow etc.
  • the system of the invention may be used to create a passage in a totally or partially occluded blood vessel.
  • the invention may be used in connection with revascularization, for example of a coronary artery, for creating a passage in a totally or partially occluded blood vessel.
  • the invention provides a system for treating an occluded blood vessel comprising: (a) a catheter having a distal end and a proximal;
  • an expandable member configured to be mounted on the distal end of the catheter and having a small caliber configuration and a large caliber configuration, the expandable member being provided with one or more lashes having a first position in a folded configuration when the expandable member is in its small caliber configuration and the lashes having an extended configuration when the expandable member is in its large caliber configuration.
  • the invention provides a method for treating an occlusion of a blood vessel comprising: (a) Providing a system according to any one of the previous claims;
  • FIG. Ia and Ib show a device for treating an occlusion in accordance with a first embodiment of the invention
  • Figs. 2a, 2b, and 2c show use of the device of Fig. 1 in treating an occlusion
  • Figs 3a and 3b show a device for treating an occlusion in accordance with a second embodiment of the invention
  • Fig. 4 shows a device for treating an occlusion in accordance with a third embodiment of the invention
  • Figs. 5, 6, and 7 show a device for treating an occlusion in accordance with a fourth embodiment of the invention
  • Figs. 8, 9, 10, and 11 show a device for treating an occlusion in accordance with a fifth embodiment of the invention
  • Figs. 12a and 12b show a device for treating an occlusion in accordance with a sixth embodiment of the invention
  • Figs. 13, 14, and 15 show a device for treating an occlusion in accordance with a seventh embodiment of the invention
  • FIGs. 16 and 17 show a device for treating an occlusion in accordance with an eighth embodiment of the invention.
  • Figs. 18, 19, and 20 show a device for treating an occlusion in accordance with a ninth embodiment of the invention
  • Figs. 21, 22, and 23 show a device for treating an occlusion in accordance with a tenth embodiment of the invention.
  • Figs. 24, 25, 26, 27, 28, and 29 show a device for treating an occlusion in accordance with another embodiment of the invention.
  • Fig. 1 shows a system 2 for creating a passageway in an occlusion in accordance with one embodiment of the invention.
  • the system 2 comprises a catheter 4 and an expandable stent 6.
  • the catheter 4 has a slender shaft 8 having a proximal end 5 and a distal end 7 and may be flexible or rigid, as required in any application.
  • An inflatable balloon 10 is attached to the distal end of the shaft 8.
  • the balloon 10 may be made from a compliant or non compliant material and preferably allows high pressure dilatation.
  • the shaft 6 has a lumen 9 that is used to conduct a pressurized fluid between a source (not shown) and the balloon 10 in order to inflate and deflate the balloon, as explained below.
  • the lumen 9 may also serve to mount the catheter onto a guidewire in an over the wire arrangement, as is known in the art.
  • the stent 6 is a balloon-expandable stent, and has a low caliber configuration shown in Fig. Ia, and a large caliber configuration shown in Fig. Ib.
  • the stent 6 is provided at one end with one or more lashes 12.
  • the lashes are folded back over the outer surface of the stent.
  • the large caliber configuration Fig. Ib
  • the lashes extend beyond the end of the stent.
  • the stent 6 in its low caliber configuration is mounted onto the deflated balloon 10.
  • the distal end 7 of the catheter 8 is then delivered to a site that is adjacent to a partial or complete occlusion 14 of a blood vessel 16, as shown in Fig. 2a.
  • the balloon 10 is then inflated by the delivery of the pressurized fluid in to the balloon. In the inflated state, the balloon 10 has a cylindrical shape. Inflation of the balloon 10 brings the stent 6 into its large caliber configuration. As the stent 6 attains its large caliber configuration, the lashes 12 perform a whip-like motion, moving from their folded back configuration (Fig. Ia) to their extended configuration (Fig. Ib).
  • Fig. 3 shows a system 32 for creating a passage way in an occlusion in accordance with another embodiment of the invention.
  • the system 32 has elements in common with the system 2 of Figs. 1 and 2, and similar elements are indicated in Fig.
  • the system 32 comprises a catheter 34 and an expandable stent 36.
  • An inflatable balloon 40 is attached to the distal end of the shaft 8.
  • the balloon 40 may be made from a compliant or non compliant material and preferably allows high pressure dilatation. In the inflated state of the balloon 40 shown in Fig. 3b, the balloon 40 extends beyond the distal end of the catheter shaft 8.
  • the stent 36 is a balloon expandable stent, and has a low caliber configuration shown in Fig. 3a, and a large caliber configuration shown in Fig. 3b.
  • the stent 36 is provided at one end with one or more lashes 42.
  • the lashes 42 are folded over the distal end of the stent 36.
  • the large caliber configuration Fig. 3b
  • the lashes extend beyond the end of the stent.
  • the stent 36 in its low caliber configuration is mounted onto the deflated balloon 40.
  • the distal end 7 of the catheter 34 is then delivered to a site that is adjacent to a partial or complete occlusion of a blood vessel.
  • the balloon 40 is then inflated by the delivery of the pressurized fluid in to the balloon.
  • the stent 40 is brought into its large caliber configuration.
  • Extension of the balloon 40 beyond the distal end 7 of the shaft 8 forces the lashes 42 from their folded over configuration (Fig. 3a) to their extended configuration (Fig. 3b).
  • the lashes 42 attain their extended configuration, they perform a whip-like motion.
  • the lashes 42 move from the folded over position to their extended position, the lashes 42 slash the occlusion.
  • the balloon 40 may then be deflated.
  • the lashes 42 again slash the occlusion as they return to their folded over configuration.
  • the repeated slashing of the occlusion excavates a passageway in the occlusion as the catheter 34 is continuously pushed forward.
  • Fig. 4 shows a system 43 for creating a passage way in an occlusion in accordance with another embodiment of the invention.
  • the system 43 has elements in common with the system 2 of Figs. 1 and 2, and similar elements are indicated in Fig. 4 with the same reference numeral without further comment.
  • the system 43 comprises a catheter 44 and an expandable stent 46.
  • An inflatable balloon 50 is attached to the distal end of the shaft 8. In the inflated state of the balloon 50, the balloon 50 may be cylindrical in shape, as shown in Fig. 1 or may extend beyond the distal end of the catheter shaft 8, as shown in Fig. 3.
  • the balloon 50 is shown in Fig. 4 in its undeflated state.
  • a stent 46 in its small caliber configuration is shown mounted on the deflated balloon 50.
  • the stent 46 has lashes 18 that are folded back over the surface of the stent 46, and are tucked underneath a sleeve 51.
  • the sleeve 51 can be maneuvered in a forward and backward direction to control the release of the lashes 18.
  • the stent 46 is made from a metal mesh that is expanded into a large caliber during inflation of the balloon 50.
  • the folding of the lashes 18 is "criss-cross" from one side of the stent 46 to the outer surface of the contralateral side of the stent.
  • the lashes 18 of the stent 46 whip out to extend beyond the distal end of the stent 46 to slash an adjacent occlusion, as explained above.
  • Figs. 5 to 11 show a system 62 for creating a passage way in an occlusion in accordance with another embodiment of the invention.
  • the system 62 has elements in common with the system 2 of Figs. 1 and 2, and similar elements are indicated in Fig. 5 with the same reference numeral without further comment.
  • the system 62 comprises a catheter 64 and an expandable stent 66.
  • the catheter 64 includes a shaft 4 with one or more lumens 68.
  • a pair of balloons is mounted on the distal end of the catheter 64: a proximally located balloon 70 and a distally located balloon 71.
  • the lumen 68 serves for inflating the balloons 70 and 71 and for mounting the catheter 64 onto a guidewire as explained above in reference to the previous embodiments.
  • the distally located balloon 71 is attached to the proximally located balloon 70 at a annular attachment zone 77.
  • the attachment of the balloon 71 to the balloon 70 may be by means of an adhesive or by welding of the balloons together along the attachment zone 77.
  • the shaft 4 extends into the balloon 70 and into the balloon 71.
  • a first aperture 80 delivers fluid to the proximal balloon 70, and a second aperture 81 delivers pressurized fluid to the distal balloon 33 thus allow inflating and deflating both balloons separately.
  • the balloons 70 and 71 are shown in Figs. 5 and 6 in their uninflated state.
  • Fig. 7 shows the balloons 70 and 71 in their uninflated state with the stent 66 mounted onto the balloons with the stent 66 in its small caliber configuration.
  • Lashes 68 of the stent 66 are in a folded back or a folded over configuration, as explained above.
  • Figs 8 and 9 show inflation of the balloons 70 and 71.
  • the proximal balloon 70 has been inflated, while the distal balloon 71 is still uninflated.
  • both balloons 70 and 71 have been inflated.
  • Figs. 10 and 11 show expansion of the stent 66 and extension of lashes 68.
  • the proximal balloon has been inflated.
  • inflation of the balloon 32 occurs radially outward.
  • the proximal balloon 33 has been inflated.
  • the balloon 71 is inflated, the lashes 68 of the stent 66 whip out to extend beyond the distal end of the stent 66 to slash an adjacent occlusion, as explained above.
  • Figs. 12a and 12b show a catheter 91 for creating a passageway in an occlusion in accordance with another embodiment of the invention.
  • the system 91 has elements in common with the system 2 of Figs. 1 and 2, and similar elements are indicated in Fig. 12 with the same reference numeral without further comment.
  • the catheter 91 includes a shaft 4 with one or more lumens 96.
  • a pair of balloons is mounted on the distal end of the catheter 91: a proximally located balloon 92 and a distally located balloon 95.
  • the lumen 96 is used to deliver a pressurized fluid to the balloons 92 and 95 for inflating the balloons.
  • the lumen 96 also serves for mounting the catheter 41 onto a guidewire as explained above in reference to the previous embodiments.
  • the distally positioned balloon 95 is used to deploy one or more lashes 98.
  • Each of the lashes 98 is hinged to the distal end of a central wire 100 at a hinge region 102.
  • the lashes 98 are folded back over the distal balloon 95.
  • the lashes 98 are deployed during inflation of the balloon 43, as shown in Fig. 17b.
  • Fig. 12b shows that as the balloon 43 is inflated, the lashes 98 whip out to extend beyond the distal end of the catheter 91 to slash an adjacent occlusion as explained above.
  • Figs. 13 to 15 show a system 103 for creating a passageway in an occlusion, in accordance with another embodiment of the invention.
  • the system 103 has elements in common with the system 2 of Figs. 1 and 2, and similar elements are indicated in Figs. 13 to 15 with the same reference numeral without further comment.
  • the system 103 comprises a catheter 101 having a shaft 4 with one or more lumens 106.
  • the lumen 106 serves for delivering a pre-heated or pre-cooled fluid to the distal end of the catheter under pressure, as well as for mounting the catheter on a guidewire. Pressurized fluid delivered to the distal end of the catheter escape from the lumen 106 via side ports 107 located at the distal end of the catheter.
  • the catheter 101 may be mounted on the guide wire in a monorail arrangement or an "over the wire design", as explained above in reference to the previous embodiments.
  • the system 103 further comprises a stent 104 that is mounted on the distal end of the catheter 101.
  • the stent 104 is made from shape memory material, such as Nitinol.
  • the stent material may be a one-way shape memory or a two-way shape memory material.
  • the stent 104 is shown in Fig. 19 in a small caliber configuration.
  • the stent 104 is provided with lashes 108 which, in the small caliber configuration of the stent shown in Fig. 19 are folded back onto the stent 104.
  • the stent 104 is expanded into a large caliber deployed state by exposing the stent 104 to a temperature transition.
  • the stent 104 may be stable in its undeployed configuration at body temperature.
  • the stent 104 is brought to its deployed configuration by delivering to the distal end of the catheter a fluid that has been preheated to a temperature slightly above body temperature, for example, a temperature of 40 0 C. As the heated fluid escapes through the side ports 107, the stent 104 is heated to about the temperature of the fluid and then adopts its deployed configuration, shown in Fig. 20.
  • the stent 104 may be stable in its small caliber configuration at a temperature slightly below body temperature, for example, a temperature of 30 0 C.
  • a fluid at a temperature of 30 0 C is continuously delivered to the distal end of the catheter in order to maintain the stent at this temperature and thus maintain the stent in its small caliber configuration during delivery.
  • the stent is brought to its large caliber configuration by stopping the delivery of the 30 0 C fluid to the distal end of the catheter.
  • the temperature of the stent rises to body temperature at which temperature the stent 104 adopts its deployed configuration, shown in Fig. 20.
  • the lashes 108 perform a whip-like motion to slash an adjacent occlusion, as explained above.
  • Figs. 16 and 17 show a system 110 for creating a passageway in an occlusion in accordance with another embodiment of the invention.
  • the system 110 has elements in common with the system 2 of Figs. 1 and 2, and similar elements are indicated in Fig. 21 with the same reference numeral without further comment.
  • the system 110 comprises a catheter 101 and a stent 113,
  • the stent 103 is a self-expanding stent that is formed from an elastic material.
  • the stent material may be, for example, Nitinol in its super elastic state.
  • the stent 113 is crimped onto the distal end 7 of the shaft 4 of the catheter 101 and constrained in its low caliber state by means of a constraining sleeve 116.
  • the stent 113 includes lashes 118 that are folded back onto the stent 103 and are tucked inside the sleeve 116. After delivery of the distal end 7 to a site adjacent to an occlusion, the stent 113 is deployed by sliding the sleeve 116 in a proximal direction, as shown in Fig. 17. In this configuration, the stent 113 is no longer constrained by the sleeve and it spontaneously adopts a large caliber configuration due to the self-expanding nature of the stent 113. As the stent 103 adopts its large caliber configuration, the lashes 118 perform a whip-like motion that slashes the adjacent occlusion, as explained above in reference to the other embodiments.
  • the sleeve 116 may just cover the stent 113, in which case, the sleeve 116 is moved in a distal direction by means of a wire 117 extending from the sleeve 116 to the proximal end of the catheter 101.
  • the sleeve 116 can extend along the entire length of the catheter 101 (not shown).
  • Figs. 18 to 20 show a system 120 for creating a passageway in an occlusion, in accordance with yet another embodiment of the invention.
  • the system 120 has elements in common with the system 2 of Figs. 1 and 2, and similar elements are indicated in Figs. 18 to 20 with the same reference numeral without further comment.
  • the system 120 comprises a catheter 122 having an expandable balloon 124 at its distal end.
  • a two-way fluid pump 123 is connected to the proximal end of the shaft 8 allowing a fluid to be conducted in the lumen 130 between the pump 123 and the balloon 124 in order to inflate and deflate the balloon 124.
  • the shaft 8 may optionally have a second lumen 112 extending from the proximal section of the shaft 8 to the distal section of the shaft 8 allowing introduction of a guidewire.
  • the system 120 has a spreading member 114 consisting of a plurality of levers 121. Each lever 121 has a proximal portion 116 and a distal lash portion 118. Each lever 121 has a pivot 122 located between the proximal and distal portions that is positioned at the distal end of the balloon 124. Each lever 121 is pivotable about its pivot 122 between a first position, shown in Figs. 23 and 25, in which the lever is close to the longitudinal axis of the of the catheter 122, and a second position, shown in Fig.
  • each lever 121 is displaced away from the longitudinal axis of the catheter 122.
  • the proximal portion 116 of each lever 121 is attached to the balloon 124.
  • the levers 121 are in their first position near the catheter axis, and when the balloon 124 is completely inflated, the levers 121 are in their second position displaced from the axis.
  • the lashes 118 slash an adjacent occlusion, as explained above.
  • Figs. 21 to 23 show a system 130 for creating a passageway in an occlusion in accordance with still another embodiment of the invention.
  • the system 130 has elements in common with the system 2 of Figs. 1 and 2, and similar elements are indicated in Figs. 21 to 23 with the same reference numeral without further comment.
  • the system 130 comprises a catheter 132 having an expandable balloon 134 at its distal end.
  • the catheter 132 has an elongated slender shaft 8 having a lumen 140 extending from the proximal end 5 of the shaft 8 to the distal end 9 of the shaft.
  • a two-way fluid pump 135 is connected to the proximal end 7 of the shaft 8 allowing a fluid to be conducted in the lumen 140 between the pump 135 and the balloon 134 in order to inflate and deflate the balloon 134.
  • the shaft 8 may optionally have a second lumen 142 extending from the proximal section of the shaft 38 to the distal section of the shaft 38 allowing introduction of a guidewire.
  • the system 130 has an expanding member 146 made from an elastic sheet material that is wrapped around the balloon 134. At the distal end of the expanding member 146 are one or more lashes 148.
  • the expanding member 146 When the balloon 134 is uninflated, the expanding member 146 is in a small caliber configuration in which the lashes 148 are in a first position in which they are positioned near the longitudinal axis of the catheter (as shown in Figs. 21 and 23).
  • the expanding member 146 is stretched and expanded and the expanding member 146 and the lashes 148 are in the second position in which they are displaced from the catheter axis (as shown in Fig. 22).
  • the lashes 148 slash an adjacent occlusion, as explained above.
  • Figs. 24 to 29 show a system 150 for creating a passageway in an occlusion in accordance with still another embodiment of the invention.
  • the system 150 has elements in common with the system 2 of Figs. 1 and 2, and similar elements are indicated in Figs. 24 to 29 with the same reference numeral without further comment.
  • the system 150 comprises a catheter 161 having two expandable balloons 162 and 163 (Fig. 24).
  • the catheter shaft 8 has a lumen 140 extending from the proximal end 9 of the shaft 8 to the distal end 7 of the shaft.
  • Another lumen 64 extends from the proximal end 9 to the middle of balloon 162.
  • a two-way fluid pump 154 is connected to the proximal end 9 of the shaft 8 allowing a fluid to be conducted in lumens 140 and 164 between the pump 154 and the balloons 162 and 163 in order to inflate and deflate the balloons.
  • Inflation of balloon 162 anchors the apparatus in place in a blood vessel and prevents motion of the apparatus during inflation of balloon 163 and activation of an expanding member 147 (Figs. 24-29).
  • the shaft 8 may optionally have a third lumen (not shown) extending from the proximal allowing introduction of a guidewire, as explained above.
  • the expanding member 147 is made from an elastic sheet material that is wrapped around the balloon 163 (Fig. 25). At the distal end of the expanding member 147 is an occlusion dilating member consisting of a number of lashes
  • the expanding member 147 When the balloon 163 is uninflated, the expanding member 147 is in small caliber configuration and the lashes 158 are in a first position in which they are positioned near the longitudinal axis of the catheter (Fig. 30). When the balloon 163 is inflated, the expanding member 147 is in a stretched state and the lashes

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Abstract

La présente invention concerne un système et un procédé destinés à traiter un vaisseau sanguin bouché. Le système comprend un cathéter (4) ayant un élément dilatable monté sur l'extrémité distale du cathéter. L'élément dilatable (6) est prévu une ou plusieurs ailettes (12) ayant une configuration pliée quand l'élément dilatable est dans sa configuration de petit calibre et une configuration étendue quand l'élément dilatable est dans sa configuration de grand calibre. Dans le procédé de l'invention, l'élément dilatable est monté sur l'extrémité distale du cathéter dans sa configuration de petit calibre et l'extrémité distale du cathéter est distribuée à un site adjacent à l'occlusion. L'occlusion est ensuite ouverte par la dilatation de l'élément dilatable afin d'amener les ailettes dans leur configuration étendue.
PCT/IL2007/000986 2006-08-07 2007-08-07 Système et procédé pour créer un passage dans un vaisseau sanguin partiellement ou totalement bouché Ceased WO2008018070A1 (fr)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US83587706P 2006-08-07 2006-08-07
US60/835,877 2006-08-07
US84071006P 2006-08-29 2006-08-29
US60/840,710 2006-08-29
US85201106P 2006-10-17 2006-10-17
US60/852,011 2006-10-17
US89962407P 2007-02-06 2007-02-06
US60/899,624 2007-02-06

Publications (1)

Publication Number Publication Date
WO2008018070A1 true WO2008018070A1 (fr) 2008-02-14

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Application Number Title Priority Date Filing Date
PCT/IL2007/000986 Ceased WO2008018070A1 (fr) 2006-08-07 2007-08-07 Système et procédé pour créer un passage dans un vaisseau sanguin partiellement ou totalement bouché

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Country Link
WO (1) WO2008018070A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2189150A (en) * 1986-04-21 1987-10-21 Medinvent Sa Prosthesis and process for its manufacture
WO2001005331A1 (fr) * 1999-07-16 2001-01-25 Biocompatibles Ltd Endoprothese tressee
US20040111146A1 (en) * 2002-12-04 2004-06-10 Mccullagh Orla Stent-graft attachment
US20040225349A1 (en) * 2003-05-09 2004-11-11 Thistle Robert C. Eversible locking mechanism for modular stents
DE102005050386A1 (de) * 2005-10-20 2007-04-26 Campus Gmbh & Co. Kg Temporär in einem Körperhohlgefäß ablegbarer Stent

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2189150A (en) * 1986-04-21 1987-10-21 Medinvent Sa Prosthesis and process for its manufacture
WO2001005331A1 (fr) * 1999-07-16 2001-01-25 Biocompatibles Ltd Endoprothese tressee
US20040111146A1 (en) * 2002-12-04 2004-06-10 Mccullagh Orla Stent-graft attachment
US20040225349A1 (en) * 2003-05-09 2004-11-11 Thistle Robert C. Eversible locking mechanism for modular stents
DE102005050386A1 (de) * 2005-10-20 2007-04-26 Campus Gmbh & Co. Kg Temporär in einem Körperhohlgefäß ablegbarer Stent

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