EP4583820A2 - Dispositifs médicaux et méthode de reconstruction de valvules cardiaques semi-lunaires - Google Patents

Dispositifs médicaux et méthode de reconstruction de valvules cardiaques semi-lunaires

Info

Publication number
EP4583820A2
EP4583820A2 EP23863926.4A EP23863926A EP4583820A2 EP 4583820 A2 EP4583820 A2 EP 4583820A2 EP 23863926 A EP23863926 A EP 23863926A EP 4583820 A2 EP4583820 A2 EP 4583820A2
Authority
EP
European Patent Office
Prior art keywords
medical device
leaflet
artery
shaping
sutures
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.)
Pending
Application number
EP23863926.4A
Other languages
German (de)
English (en)
Inventor
Ignacio LUGONES
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.)
Avatar Medtech Corp
Original Assignee
Avatar Medtech Corp
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 Avatar Medtech Corp filed Critical Avatar Medtech Corp
Publication of EP4583820A2 publication Critical patent/EP4583820A2/fr
Pending legal-status Critical Current

Links

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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2415—Manufacturing methods
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Definitions

  • Aortic stenosis is usually the consequence of degenerative remodeling in a normal tricuspid aortic valve or a congenitally abnormal valve, particularly a bicuspid aortic valve.
  • the degenerative changes that lead to aortic stenosis, whether they occur in a bicuspid aortic valve or a normal tricuspid valve, are caused by an active remodeling process involving inflammation and calcification.
  • the pulmonary valve is compromised in several congenital heart diseases, such as tetralogy of Fallot, pulmonary valve stenosis, or pulmonary atresia. Pulmonary valve insufficiency is very frequent in the evolution of patients operated on for Tetralogy of Fallot or truncus arteriosus.
  • Treatment of semilunar valve disease consists of valve repair or replacement, sometimes concurrently with repair of other heart defects.
  • Open heart surgery is one of the treatments of choice, although in certain cases the percutaneous approach can be used.
  • Conventional surgery is performed under general anesthesia, usually through an incision in the sternum and with the aid of a cardiopulmonary bypass machine. This machine performs the functions of the heart and lungs, oxygenating blood and distributing it throughout the body, allowing surgeons to stop the heart and repair it.
  • valve replacement In case of having to perform a valve replacement, mechanical or biological prostheses can be used, the latter generally made of cow or pig tissue. Human pericardium can also be used for valve reconstruction.
  • the heart valve replacement method comprises the steps of: cutting a portion of the pericardium; if the pericardium is human, place it in a substance that fixes it (if it is pericardium of another origin, it is already fixed); select a template or mold sized to fit the size needed for a patient based on previously made measurements; cut the parts of the pericardium to form the leaflets using the template as a guide; and suturing the leaflets to the artery to form the heart valve.
  • the valve replacement method described by Ozaki targets aortic heart valves, is designed for adult patients, and involves the individual replacement of each leaflet.
  • the size of each leaflet for replacement is calculated based on the size of the native leaflet to be replaced (measuring the intercommissural distance).
  • reconstruction using the method proposed by Ozaki is asymmetrical, leaving the point where the three leaflets meet not necessarily in the center of the artery. This determines an asymmetry in size between the three sinuses of Valsalva and an uneven distribution of pressure between them.
  • a method for the reconstruction of a semilunar heart valve comprising the steps of: a) securing a portion of biological or synthetic tissue, which is extended using a first medical device, thereby firmly andtautly holding said portion of tissue, said first medical device comprising a shaping and marking part comprising two surfaces with an exterior configuration resembling that of a semilunar valve leaflet, designed to shape biological or synthetic tissue, said first surfaces having first grooves arranged to mark positions at which surgical sutures should be placed on the leaflet; and a fastening means for the shaping and marking part configured to maintain it in place, securing the tissue in a stretched and immobilized manner between the two surfaces; b) generating a replacement leaflet from the tissue by cutting it around the shaping and marking part of the first medical device, which has a semilunar valve leaflet-shaped configuration; c) placing sutures in the replacement leaflet at positions indicated by the first grooves of the first medical device; d
  • a fastening means for the shaping and marking component configured to maintain it in place, securing the tissue in a stretched and immobilized manner between the two surfaces.
  • FIG. 1 illustrates a possible embodiment of the first medical device according to the present invention.
  • FIG. 2 illustrates a possible embodiment of the second medical device according to the present invention.
  • FIG. 7 is a schematic view of part of a patient's body in which the replacement leaflet is being cut around the shaping and marking part of the first medical device.
  • FIG. 8 is a schematic view of the opening of a patient's artery, in this case the aorta.
  • FIG. 9 is a schematic view of a patient's artery with the second medical device in place.
  • FIG. 11 is a schematic view of a patient's artery after the first and second medical devices have been removed.
  • the semilunar heart valve reconstruction method of the present invention consists of the replacement of a diseased native valve having one, two, three or four leaflets by a symmetrical replacement valve with three leaflets 402, adapted to accommodate growth of the patient.
  • synthetic materials can comprise polymeric materials such as polytetrafluoroethylene (i.e. expanded polytetrafluoroethylene), polyethylene terephthalate, polyurethane, polyvinyl chloride, among others.
  • polymeric materials such as polytetrafluoroethylene (i.e. expanded polytetrafluoroethylene), polyethylene terephthalate, polyurethane, polyvinyl chloride, among others.
  • the replacement leaflets 402 are made from autologous pericardium 400, that is, from the same patient.
  • the invention pertains to a first medical device 10 comprising:
  • the surfaces of the shaping and marking part 100 are flat. Tn another embodiment, the surfaces are concavely or convexly curved.
  • the first grooves 102 are located on the surfaces of the shaping and marking part 100, preferably at positions corresponding to the commissures, adjacent margins and nadir of the leaflet 402.
  • the first grooves 102 located in positions corresponding to the commissure and adjacent margins of the leaflet 402 are internal (located a few millimeters from the edge of the leaflet 402) and the first groove 102 corresponding to the nadir of the leaflet 402 (central groove) is external.
  • the shaping and marking part 100 has a lower arched margin that corresponds to the suture margin 104, in which the sutures 500 that will fix the leaflet 402 to the artery 404 will be placed, and an upper margin, called the free margin 106, in which no suture will be placed.
  • the latter corresponds to the mobile margin of the apposition zone that contacts the adjacent leaflet 402 to close the valve during diastole.
  • first grooves 102 there are two types of first grooves 102. Some are wider, since two sutures 500 are placed there, the highest corresponding to the upper U and the lowest corresponding to the lower U. Therefore, of the first grooves 102, the upper and lower ones are narrower (only one needle passes through there), while the middle ones are wider because two sutures 500 pass through there.
  • At least one of the surfaces of the shaping and marking part 100 has a roughness or fine teeth on at least one of its faces arranged to help hold the biological or synthetic tissue 400 when exerting pressure by means of the fastening means 300.
  • the surfaces of the shaping and marking part 100 are additionally provided with second grooves 108 designed to facilitate fracture and removal once the leaflet 402 has been placed in position and partially sutured within the aorta or pulmonary artery 404.
  • the fastening means 300 is incorporated into the surfaces of the shaping and marking part 100 so as to lock them together and symmetrically compress the biological or synthetic tissue 400 that will be used to construct the leaflet 402.
  • the fastening means 300 can be incorporated into the surfaces of the shaping and marking part 100 by magnetizing both surfaces in opposite ways (positive-negative).
  • a clamp is used as the fastening means 300.
  • a second medical device comprising a mold capable of indicating the exact positions of the surgical sutures 500 that are used to implant the replacement leaflets 402.
  • the mold of said second medical device 20A is a semiring for insertion or implantation, which consists of an arched surface comprising:
  • second grooves 204 arranged to indicate positions in which the surgical sutures 500 previously passed through the positions indicated by the first grooves 102 of the first medical device 10 must be placed.
  • the attachment half-ring 20A may comprise at least a third groove 206 designed to be fractured and allow the broken parts of the device 20A to be removed without getting tangled in the sutures 500 as soon as the leaflet 402 has been placed in position and partially sutured within the artery 404.
  • it comprises at least one third groove 206 located at the nadir, which may be the same one used to fix the device 20A (first groove 202).
  • the size of the leaflet 402 and its position within the artery 404 are chosen based on the diameter of the patient's artery 404 (aorta or pulmonary artery, depending on the pathology) at the level of the sinotubular junction, preferably measured by echocardiography or computed tomography in the preoperative period. Therefore, the size of the first medical device 10 and the second medical device 20A or 20B will vary according to the size of the patient's native artery 404 to be treated.
  • the replacement leaflet 402 is cut around the shaping and marking part 100 that has its shape, as illustrated in Figure 7.
  • This cut can be made just before the replacement leaflet 402 needs to be placed. This is especially useful when fresh autologous pericardium 400 is used, in order to keep it without irrigation for as short a time as possible.
  • the cutting can be performed at least partially automatically, such as in cases where the first medical device 10 is designed to perform the cut through an electrically conductive wire that can be powered by an electrosurgical unit, for example, or manually, using a scalpel or scissors.
  • an electrosurgical unit for example, or manually, using a scalpel or scissors.
  • the free edge 106 of the shaping and marking part 100 will coincide with the edge of the pericardium 400.
  • the sutures 500 are then passed through the replacement leaflet 402 at the positions indicated by the first grooves 102. This can be done manually, stitch by stitch, or by using the third medical device 30 to pass the sutures 500 simultaneously.
  • the second medical device 20A or 20B is used to mark the positions in the artery 404 where the surgical sutures 500 must pass through.
  • the second medical device 20A When the second medical device 20A is used, it is placed inside the artery 404, as depicted in Figure 9, and anchored to the wall using fine sutures passed through the first grooves 202. The exact location of the device 20A is established in such a way that it does not obstruct the coronary ostia 410. Subsequently, as illustrated in Figure 10, U-stitches 500 that have already been passed through the commissures and adjacent margins of the replacement leaflet 402 are passed through the artery 404 wall at the positions indicated by the second grooves 204.
  • the second medical device 20B when used, it is placed inside the artery 404 and infused with a dye fluid, thus marking it at the positions where the sutures 500 that will anchor the leaflets 402 will be placed. Subsequently, the U-stitches 500 that had already been passed through the commissures and adjacent areas of the replacement leaflet 402 are now passed through the positions indicated by the dye fluid.
  • the process of passing the sutures 500 can be done manually, stitch by stitch, or by using the third medical device 30 to pass at least a plurality of sutures 500 simultaneously.
  • the U-stitches 500 are tied on the outer surface of the artery 404.
  • the nadir suture 500 is then used to complete the implantation of the leaflet 402 using a running suture technique.
  • Figure 12 illustrates the artery 404 with the leaflet 402 already implanted.
  • next two leaflets 402 are implanted in a similar way, repeating the aforementioned procedure.
  • the use of the second medical device 20 may not be necessary, since the commissures of the adjacent leaflets 402 could be used as a reference.
  • a first feature of this oversizing is that the replaced valve has a windmill shape.
  • a second feature is that the coaptation zone, that is, the zone of apposition between leaflets 402, is increased.
  • the coaptation zone is higher than normal to allow the valve to remain competent despite the reduction in coaptation height that occurs as the diameter of the artery 404 increases.
  • Athird feature is a downward elongation of the leaflet 402 below the annular plane (also known as valve prolapse) when the oversizing is marked.
  • a coordinated replacement of the three leaflets 402 is carried out, completely removing the native valve and always obtaining a symmetrical valve with three identical leaflets 402 that meet in the center of the artery 404 during valve closure.
  • the three sinuses of Valsalva that are generated are then equal in size, causing an equal distribution of pressure during diastole.
  • the method and medical devices described in this invention for the reconstruction of a semilunar heart valve contribute to the automation and the efficiency of the surgical procedure, thus reducing its duration and minimizing possible risks.
  • they have other advantages: a) they can be used in adult and pediatric patients (children), b) they allow valve replacement with autologous tissue 400, c) they allow the replacement of native valves of any characteristic and number of leaflets, always achieving a symmetrical trileaflet valve, d) there is no need for anticoagulation after the procedure, and e) the new valve does not stop annulus growth and does not interfere with future valve replacement.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Prostheses (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

L'invention concerne des dispositifs médicaux et une méthode qui les utilise pour reconstruire des valvules cardiaques semi-lunaires chez des patients présentant des maladies cardiaques congénitales ou acquises, à l'aide d'un tissu biologique ou synthétique, applicables à des patients adultes et pédiatriques.
EP23863926.4A 2022-09-06 2023-09-05 Dispositifs médicaux et méthode de reconstruction de valvules cardiaques semi-lunaires Pending EP4583820A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263404007P 2022-09-06 2022-09-06
PCT/US2023/073462 WO2024054794A2 (fr) 2022-09-06 2023-09-05 Dispositifs médicaux et méthode de reconstruction de valvules cardiaques semi-lunaires

Publications (1)

Publication Number Publication Date
EP4583820A2 true EP4583820A2 (fr) 2025-07-16

Family

ID=90191866

Family Applications (1)

Application Number Title Priority Date Filing Date
EP23863926.4A Pending EP4583820A2 (fr) 2022-09-06 2023-09-05 Dispositifs médicaux et méthode de reconstruction de valvules cardiaques semi-lunaires

Country Status (5)

Country Link
EP (1) EP4583820A2 (fr)
CN (1) CN119907650A (fr)
AR (1) AR130393A1 (fr)
MX (1) MX2025002668A (fr)
WO (1) WO2024054794A2 (fr)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6719785B2 (en) * 2001-05-17 2004-04-13 St. Jude Medical, Inc. Aortic heart valve prosthesis implantation tool
US7462156B2 (en) * 2005-04-11 2008-12-09 Zan Mitrev Replacement aortic valve leaflets and related technology
US20110251598A1 (en) * 2010-04-13 2011-10-13 Shigeyuki Ozaki Instrument of patterning cusp for cardiac valve reconstruction and component thereof
US10492904B2 (en) * 2016-05-27 2019-12-03 Terumo Cardiovascular Systems Corporation Equipment for preparing valve leaflet from membrane

Also Published As

Publication number Publication date
WO2024054794A2 (fr) 2024-03-14
WO2024054794A3 (fr) 2024-04-25
CN119907650A (zh) 2025-04-29
AR130393A1 (es) 2024-12-04
MX2025002668A (es) 2025-04-02

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