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WO2015044874A1 - Dispositif pour traiter des occlusions coronaires totales chroniques ou des occlusions d'autres régions artérielles - Google Patents

Dispositif pour traiter des occlusions coronaires totales chroniques ou des occlusions d'autres régions artérielles Download PDF

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Publication number
WO2015044874A1
WO2015044874A1 PCT/IB2014/064795 IB2014064795W WO2015044874A1 WO 2015044874 A1 WO2015044874 A1 WO 2015044874A1 IB 2014064795 W IB2014064795 W IB 2014064795W WO 2015044874 A1 WO2015044874 A1 WO 2015044874A1
Authority
WO
WIPO (PCT)
Prior art keywords
ring
occlusions
microcatheter
coronary
chronic total
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/IB2014/064795
Other languages
English (en)
Inventor
Gabriele Luigi GASPARINI
Jacopo Andrea OREGLIA
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.)
K2I - KEY TO INNOVATION Srl
Original Assignee
K2I - KEY TO INNOVATION Srl
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by K2I - KEY TO INNOVATION Srl filed Critical K2I - KEY TO INNOVATION Srl
Publication of WO2015044874A1 publication Critical patent/WO2015044874A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0102—Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M2025/0042—Microcatheters, cannula or the like having outside diameters around 1 mm or less
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0177—Introducing, guiding, advancing, emplacing or holding catheters having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0194—Tunnelling catheters
    • A61M2025/0197—Tunnelling catheters for creating an artificial passage within the body, e.g. in order to go around occlusions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0293—Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube

Definitions

  • the present invention relates to a device for treating chronic total coronary occlusions or occlusions of other arterial regions.
  • the invention relates to a device for treating chronic total coronary occlusions or occlusions of other arterial regions with a so-called “retrograde” approach.
  • coronary disease is one of the main causes of mortality in industrialized countries. Its treatment allows to improve survival and quality of life and consists substantially in revascularizing the obstructed or stenotic coronary segments.
  • Revascularization can be achieved with a surgical approach (coronary bypass operation) or percutaneous approach (coronary angioplasty). This last option currently is the most frequently used one due to its safety, effectiveness and lower invasiveness.
  • coronary bypass operation coronary bypass operation
  • coronary angioplasty percutaneous approach
  • the reference numeral 1 designates a coronary artery
  • the numeral 2 designates the body of an occlusion
  • the numeral 3 designates the subintimal space or false lumen
  • the numeral 4 designates a retrograde guide
  • the numeral 5 designates an anterograde guide
  • the numeral 6 the true lumen of the artery
  • the numeral 7 designates the tunica intima
  • the numeral 8 designates a guiding catheter.
  • the retrograde approach (see Figure 1) consists in using the collateral channels to reach the distal point of the occlusion 2 with a coronary guide, allowing to connect it to the proximal point by means of a "navigation" of the guides inside the occlusion, using dedicated techniques.
  • one of the most used consists in creating a short portion of dissection of the artery, making the guide advance in the subintimal space 3, i.e., inside the wall of the artery 1 and outside the lumen 6, and subsequently connecting this space to the actual lumen 6 proximally with respect to the occlusion 2.
  • a channel is created which connects the true lumen 6 upstream and downstream of the occlusion 2 and which, once treated with the placement of one or more coronary stents, allows complete recanalization of the occluded vessel.
  • the connection between the true and false lumen is performed with methods that have been coded but without dedicated instruments.
  • the most frequent situation is the one in which the subintimal space 3, i.e., the false lumen, is dilated with a coronary balloon, thus creating a rupture of the tunica intima 7 of the artery 1, which is the membrane that separates the true lumen from the false lumen.
  • This procedure has limitations, since it is not always effective and it can cause coronary perforations, which are among the most severe procedural complications.
  • the limitations of this technique are determined by the fact that balloon dilation occurs without having a precise visualization of the space in which said balloon is inflated and that by maneuvering rigid guides in a subintimal space it is possible to enlarge in an uncontrolled manner the false lumen until the real lumen is obstructed, making it very difficult, and sometimes impossible, to reach the true lumen of the vessel with the guide.
  • IVUS intravascular ultrasound
  • the aim of the present invention is to provide a device for treating chronic total coronary occlusions or occlusions of other arterial regions that allows, by using the retrograde approach, to facilitate the retraction of the retrograde guide within the actual lumen of the artery, proximally with respect to the occlusion.
  • an object of the present invention is to provide a device for treating chronic total coronary occlusions or occlusions of other arterial regions that allows to offer the surgeon better control of the retrograde guide with respect to what is possible with devices of the known type.
  • Another object of the present invention is to provide a device for treating chronic total coronary occlusions or occlusions of other arterial regions that can be used simultaneously with imaging techniques.
  • Another object of the present invention is to provide a device for treating chronic coronary occlusions or occlusions of other arterial regions that is highly reliable, relatively simple to provide and at competitive costs.
  • a device for treating chronic total coronary occlusions or occlusions of other arterial regions characterized in that it comprises a microcatheter adapted to accommodate a stylet which ends, at a distal end, with a ring made of shape memory material, said ring being adapted to pass from a flattened closed configuration, when said ring is accommodated within said microcatheter, to an open condition when said ring is made to exit from said microcatheter.
  • Figure 1 is a schematic view of a situation of chronic total coronary occlusion in which devices of a known type are used;
  • Figure 2a is a schematic perspective view of the device according to the present invention in the closed condition
  • Figure 2b is a schematic view of a first step of the use of the device according to the invention in the open condition
  • Figure 3 is a schematic view of a step of the use of the device according to the invention.
  • Figure 4 is a schematic view of the final step of use of the device according to the invention.
  • the device according to the invention comprises a microcatheter 1 1, which is compatible with a standard coronary guide (for example of the 0.014" type) and adapted to accommodate inside it a metal stylet 12 that ends, at its distal end, with a ring 13, which preferably has a circular shape and is also made of metallic material (for example nitinol) and is radio-opaque.
  • a standard coronary guide for example of the 0.014" type
  • a metal stylet 12 that ends, at its distal end, with a ring 13, which preferably has a circular shape and is also made of metallic material (for example nitinol) and is radio-opaque.
  • the ring 13 is made of a material that has an adequate radial force and shape memory and can be of different sizes depending on the dimensions of the artery or vessel 1.
  • the ring can have a circular, elliptical, polygonal or other shape.
  • the expression "adequate radial force” is understood to mean that the force applied by the ring 13 to the inner walls of the artery 1 must be such as to prevent the propagation of the false retrograde lumen 3, therefore facilitating puncture of the intima 7 and reentry into the true lumen 6.
  • the diameter of the ring 13 is comprised preferably between 3 and 6 mm.
  • the ring 13 can have a variable thickness, depending on the radial force that one wishes to apply.
  • the ring 13 can be a tubular body having a circular, elliptical or polygonal cross-section.
  • the microcatheter 1 1 can have a length of 130 cm while the system constituted by the stylet 12 and the ring 13 must have a greater length (for example 150 cm) in order to allow the ring, 13, arranged at the distal end of the stylet 12, to exit from the distal point of the microcatheter 1 1.
  • the device 10 according to the invention is used once the retrograde guide 4 has reached the occlusion 2 and is in the subintimal space 3 beyond it.
  • the procedure for use consists in producing the advancement, by means of an anterograde standard guiding catheter 8, of an anterograde coronary guide 5 to the proximal end of the chronic total occlusion 2, inside the true lumen 6.
  • the microcatheter 1 1 is made to advance with the stylet-ring system 12, 13 inside it in a closed position to a few millimeters from the occlusion 2.
  • the exit of the ring 13 from the microcatheter 1 1 is produced.
  • the ring 13 assumes its original circular shape and adheres with its perimeter to the inner wall of the artery 1.
  • the plane of the ring 13 must lie at right angles to the long axis of the vessel 1. The system is thus in position to facilitate the reentry of the retrograde guide 4 into the true lumen 6.
  • the radio-opaque marker function allows intuitive and clear viewing of the perimeter of the coronary artery where the ring 13 is located, ideally proximate to the proximal end of the occlusion 2.
  • the device according to the invention achieves fully the intended aim and objects, since it allows to facilitate the reentry of the retrograde guide, which is in the extralumenal subintimal space, within the true lumen of the artery proximally with respect to the occlusion.
  • the device can be used advantageously to treat chronic total occlusions of arterial regions in general where a so-called retrograde approach is provided.
  • the materials used may be any according to requirements and to the state of the art.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Abstract

L'invention concerne un dispositif (10) pour traiter des occlusions coronaires totales chroniques ou des occlusions d'autres régions artérielles dont la particularité réside en ce qu'il comprend un microcathéter (11) conçu pour loger un stylet (12) qui se termine, en une extrémité distale, par un anneau (13) fabriqué en un matériau à mémoire de forme, l'anneau (13) étant conçu pour passer d'une configuration fermée aplatie, lorsque l'anneau (13) est logé dans le microcathéter (11), à un état ouvert lorsque l'anneau (13) est amené à sortir du microcathéter (11).
PCT/IB2014/064795 2013-09-24 2014-09-24 Dispositif pour traiter des occlusions coronaires totales chroniques ou des occlusions d'autres régions artérielles Ceased WO2015044874A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT001568A ITMI20131568A1 (it) 2013-09-24 2013-09-24 Dispositivo per il trattamento di occlusioni coronariche totali croniche o di altri distretti arteriosi.
ITMI2013A001568 2013-09-24

Publications (1)

Publication Number Publication Date
WO2015044874A1 true WO2015044874A1 (fr) 2015-04-02

Family

ID=49585516

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2014/064795 Ceased WO2015044874A1 (fr) 2013-09-24 2014-09-24 Dispositif pour traiter des occlusions coronaires totales chroniques ou des occlusions d'autres régions artérielles

Country Status (2)

Country Link
IT (1) ITMI20131568A1 (fr)
WO (1) WO2015044874A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1989009079A1 (fr) * 1988-03-22 1989-10-05 Brigham And Women's Hospital Appareil et procede d'anesthesie medullaire continue
WO2010075445A1 (fr) * 2008-12-23 2010-07-01 Silk Road Medical, Inc. Méthodes et systèmes pour le traitement d'un accident cérébral ischémique aigu
US20110137399A1 (en) * 2009-12-02 2011-06-09 Chomas James E Microvalve Protection Device and Method of Use for Protection Against Embolization Agent Reflux
US20110160763A1 (en) * 2007-10-17 2011-06-30 Mindframe, Inc. Blood flow restoration and thrombus management methods

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1989009079A1 (fr) * 1988-03-22 1989-10-05 Brigham And Women's Hospital Appareil et procede d'anesthesie medullaire continue
US20110160763A1 (en) * 2007-10-17 2011-06-30 Mindframe, Inc. Blood flow restoration and thrombus management methods
WO2010075445A1 (fr) * 2008-12-23 2010-07-01 Silk Road Medical, Inc. Méthodes et systèmes pour le traitement d'un accident cérébral ischémique aigu
US20110137399A1 (en) * 2009-12-02 2011-06-09 Chomas James E Microvalve Protection Device and Method of Use for Protection Against Embolization Agent Reflux

Also Published As

Publication number Publication date
ITMI20131568A1 (it) 2015-03-25

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