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WO2018122621A1 - Ballonnet en parapluie pour micro-embolie - Google Patents

Ballonnet en parapluie pour micro-embolie Download PDF

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Publication number
WO2018122621A1
WO2018122621A1 PCT/IB2017/050002 IB2017050002W WO2018122621A1 WO 2018122621 A1 WO2018122621 A1 WO 2018122621A1 IB 2017050002 W IB2017050002 W IB 2017050002W WO 2018122621 A1 WO2018122621 A1 WO 2018122621A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
balloon
heart
surgery
umbrella
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/IB2017/050002
Other languages
English (en)
Inventor
Ans GHAZI FAKIHA
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to PCT/IB2017/050002 priority Critical patent/WO2018122621A1/fr
Publication of WO2018122621A1 publication Critical patent/WO2018122621A1/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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7545—General characteristics of the apparatus with filters for solid matter, e.g. microaggregates
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system
    • A61M2210/125—Heart
    • 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
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape

Definitions

  • This invention relates generally to medical devices. More particularly, the present invention relates to surgical tool to prevent embolism caused by falling debris inside the heart during valve surgeries.
  • valve replacement is typically an open-heart surgery.
  • the artificial valve might be mechanical. Others are made out of animal tissue, often from a pig.
  • blood contaminates such as air emboli, atherosclerotic material, mural thrombi, and micro aggregates that either form or are dislodged into the general circulatory system during cardiac surgery.
  • blood contaminates typically cause the greatest damage if they migrate to the brain where blood contaminates can cause central nervous system complications that include stroke and subtle cognitive changes.
  • Cognitive decline evident in as many as three quarters of patients at the time of hospital discharge, was present in 30-45% of patients after five years in one longitudinal study.
  • calcium embolization resulted from valve debridement is a recognized complication of aortic valve operations in patient with calcified aortic valve that may leads to devastating outcomes like brain stroke and end organ ischemia (kidney, heart).
  • the true incidence of calcium embolization during open-heart surgery is unknown, since movement of emboli to areas other than the heart, brain, or kidneys is usually asymptomatic.
  • Central nervous system (CNS) impairment ranging from stroke or coma to cognitive deficits is a major cause of morbidity after successful heart surgery.
  • Cognitive deficits after heart surgery have been observed in 33% to 83% of patients during the first weeks after surgery. Both stroke and cognitive disturbance are thought to be related to macro-embolism and micro- embolism during surgery.
  • Calcium embolization is a recognized complication of aortic valve operations. Careful suction and monitoring of debris by the surgeon's assistant is generally used to prevent such complications.
  • the gauze may obstruct both the field of vision and the actual removal of calcifications that extend into the base of the anterior mitral valve leaflet.
  • the present invention generally provides an embolic protection device used to collect emboli during the treatment of a stenotic lesion when deployed within the vasculature of a patient.
  • the embolic protection device is relatively easy to deploy past the stenotic area and to be retrieved after the risk of releasing blood clots and thrombi within the vasculature has passed.
  • the embolic protection device includes a core wire, a plurality of attachment cables and filter struts, and a filter member. The distal end of the attachment cables and the proximal end of the filter struts are coupled to the proximal end of the filter member.
  • the proximal end of the attachment cables are coupled to the core wire, while the distal ends of the filter struts form a cage or basket structure.
  • the distal end of the filter member is closed, thereby, forming an annular chamber useful for collecting emboli during treatment of the stenotic area.
  • the emboli are forced by the blood flow to move into the most distal part of the annulus chamber where it is caught or held.
  • an embolic protection device comprising a conical filter element having a distal opening; an elongated filter wire disposed along a generatrix of the conical filter element; and a support structure fixedly attached to a distal end of the elongated filter wire and to the conical filter element at the distal opening thereof, wherein the support structure forms a partial circumferential arch along and attached to the distal opening, and further wherein the conical filter element includes a split distal region having an edge which together with the partial circumferential arch of the support structure defines a generally cylindrical passage through at least a portion of the conical filter element, said generally cylindrical passage lying parallel to a longitudinal axis of the conical filter element and along a wall of a vessel in which the embolic protection device is deployed.
  • the goal of the invention is to reduce blood contaminates such as embolized calcium and particulate matter from being released during heart valve surgery into the general circulatory system which can result in end organ infarction.
  • the second goal is to provide a blood free surgical field by obstructing the blood inside the heart or suctioning the blood from the ventricles (venting the heart) to any suction source during heart valves surgery.
  • FIG. 1 umbrella shape with the tip pointing distally
  • FIG. 2 deflated umbrella balloon
  • FIG. 3 embolism umbrella balloon catheter in aortic valve
  • FIG. 4 inflated umbrella balloon under the aortic valve
  • FIG. 5 shapes of the occlusive umbrella balloon
  • the method uses a double lumen catheter that has an inflation lumen and a suction lumen.
  • the inflation lumen has an occlusive balloon (umbrella shape with the tip pointing distally) connected to the distal end. ( Figure- 1)
  • Figure- 1 the deflated umbrella balloon
  • the balloon When the occlusive balloon is inflated, ( Figure-2) the balloon occludes the ventricular outflow tract (in case of aortic/pulmonary valve surgery) or in the subvalvular apparatus (in case of mitral/tricuspid valves surgery).
  • the suction lumen has distal small openings at the end for venting the heart (suctioning any blood coming from the heart to keep blood free surgical field) and a proximate end connected to a suction source (wall suction/ cardiopulmonary bypass machine). Note: this invention can be made without the suction features.
  • Figure-2 inflated umbrella balloon
  • the embolism umbrella balloon catheter is used in the following manner: after stopping the heart during heart surgery and exposing the diseased valve, the embolism umbrella shield is inserted under the valve (ventricular side) ( Figure-3).
  • Figure-3 inserting the umbrella balloon under the aortic valve
  • the umbrella shaped balloon will trap any dislodged particles during the procedure inside and will be trapped inside the umbrella after deflating it).
  • the occlusive umbrella balloon is deflated and removed from the patient's body.
  • the occlusive umbrella balloon is positioned as circular outer layer to the suction lumen distal end suction opening.
  • the heart valve is separated from underlining ventricles so the suction opening at the tip communicates the ventricles and the suctioning source. It has oneway valve that allow surgeons to inflate and deflate the balloon with syringe.
  • This embodiment is designed for use on any heart valve surgery. I refer to this embodiment as the occlusive umbrella balloon.
  • This balloon diameter comes in deferent sizes and shapes ( Figure-5). Sizes will be determent based on measuring the ventricles outflow tract diameter and subvalvular apparatus measured by echocardiography before the surgery.
  • the suction lumen of the catheter with distal end opening passes through a central umbrella balloon opening.
  • the proximal end is connected to any suctioning source.
  • This embodiment is designed for use in any heart valve surgery. I refer to this embodiment as the suctioning line.
  • All parts of the invention should be made out of silicon, polyvinyl chloride, polyurethane latex rubber, latex free rubber, polyethylene, Teflon or any safe, nontoxic, non allergic materials approved for medical uses to insure its safety on patient's health. Additionally, it should be flexible and ensure easy mobilization and fixation during the surgery as it should not obstruct the surgeons operative field.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une opération chirurgicale pour remplacer des valvules cardiaques qui est effectuée pour une sténose valvulaire ou une régurgitation valvulaire. Pendant ces opérations, la valve endommagée est retirée et remplacée par une valve artificielle. Le remplacement de la valve est typiquement une opération à cœur ouvert. La valve artificielle peut être mécanique. D'autres sont réalisées en tissu animal, souvent à partir de cochon. L'objet de l'invention est d'éviter que les contaminants sanguins tels que le calcium embolisé et la matière particulaire soient libérés pendant une opération de valve cardiaque dans le système circulatoire général, ce qui peut conduire à un infarctus de l'organe cible. Le second objet de l'invention est de fournir un champ chirurgical exempt de sang en obstruant le sang à l'intérieur du cœur ou en aspirant le sang des ventricules (mise à l'air libre du cœur) vers n'importe quelle source d'aspiration pendant une opération de valves cardiaques.
PCT/IB2017/050002 2017-01-02 2017-01-02 Ballonnet en parapluie pour micro-embolie Ceased WO2018122621A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IB2017/050002 WO2018122621A1 (fr) 2017-01-02 2017-01-02 Ballonnet en parapluie pour micro-embolie

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2017/050002 WO2018122621A1 (fr) 2017-01-02 2017-01-02 Ballonnet en parapluie pour micro-embolie

Publications (1)

Publication Number Publication Date
WO2018122621A1 true WO2018122621A1 (fr) 2018-07-05

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2017/050002 Ceased WO2018122621A1 (fr) 2017-01-02 2017-01-02 Ballonnet en parapluie pour micro-embolie

Country Status (1)

Country Link
WO (1) WO2018122621A1 (fr)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100211094A1 (en) * 2009-02-18 2010-08-19 Cook Incorporated Umbrella distal embolic protection device

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100211094A1 (en) * 2009-02-18 2010-08-19 Cook Incorporated Umbrella distal embolic protection device

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