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WO2013036167A1 - Prothèse de racine aortique munie d'une valve - Google Patents

Prothèse de racine aortique munie d'une valve Download PDF

Info

Publication number
WO2013036167A1
WO2013036167A1 PCT/RU2012/000729 RU2012000729W WO2013036167A1 WO 2013036167 A1 WO2013036167 A1 WO 2013036167A1 RU 2012000729 W RU2012000729 W RU 2012000729W WO 2013036167 A1 WO2013036167 A1 WO 2013036167A1
Authority
WO
WIPO (PCT)
Prior art keywords
cuff
prosthesis
valve
aortic root
overlay
Prior art date
Application number
PCT/RU2012/000729
Other languages
English (en)
Russian (ru)
Inventor
Владлен Владленович БАЗЫЛЕВ
Сергей Васильевич ЕВДОКИМОВ
Евгений Владимирович РОССЕЙКИН
Original Assignee
Закрытое Акционерное Общество Научно-Производственное Предприятие "Мединж"
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 Закрытое Акционерное Общество Научно-Производственное Предприятие "Мединж" filed Critical Закрытое Акционерное Общество Научно-Производственное Предприятие "Мединж"
Publication of WO2013036167A1 publication Critical patent/WO2013036167A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2412Heart 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069Sealing means

Definitions

  • the invention relates to medical equipment and can be used in cardiac surgery to replace the affected aortic root with an aortic valve.
  • Aortic roots (KA) used in cardiac surgery are known, taken either from animals - a xenograft (KG), or from a human corpse - a homograph (GG). (Ross DN. Homograft replacement of the aortic valve. Lancet 1962; 2: 447).
  • a frameless aortic valve bioprosthesis is known, made of a valve-aortic complex of a mammal, containing a tubular body and locking a multi-leaf element adjacent to the end of the tubular body (see US Pat. No. 4,443,895, 1984).
  • a frameless aortic root prosthesis is known (see US Pat. No. 5,123,919, 1992), comprising a vascular prosthesis made of synthetic tissue with a cuff fixed to the proximal side and a mechanical valve installed in the cuff.
  • the objective of the invention is to increase the reliability of the prosthesis and reduce the risks of postoperative bleeding.
  • a valve-containing prosthesis of the aortic root containing a vascular prosthesis with a cuff fixed to the proximal side, and a valve installed in the cuff.
  • the prosthesis is provided with an annular patch located between the cuff and the vascular prosthesis, the outer diameter of which exceeds the outer diameter of the cuff.
  • the overlay is made of synthetic fabric with sealing impregnation or from a xenopericardium plate. At the same time, the overlay along the inner perimeter is sewn with a thread to the cuff, and along the outer perimeter it is sewn with a purse string suture and pulled to the vascular prosthesis, providing access to the cuff.
  • the proposed valve-containing prosthesis of the aortic root provides an increase in the reliability of the prosthesis and a decrease in the risks of postoperative bleeding.
  • annular lining located between the cuff and the vascular prosthesis in the vascular prosthesis makes it possible to stitch the lining over the stitched cuff to the unexplained aortic wall, which provides additional sealing of the cuff and connecting sutures.
  • a patch When a patch is made of synthetic fabric with a sealing impregnation or from a xenopericardium plate, the patch itself is sealed.
  • the choice of material is determined by the material of the vascular prosthesis. If the vascular prosthesis is made of synthetic material, then the patch is made of synthetic tissue. If the vascular prosthesis is made of biological material, then the patch is made of a xenopericardium plate.
  • the thread to the cuff ensures a tight connection between the patch and the prosthesis.
  • Fig. 1 shows the appearance of a valve-containing prosthesis of the aortic root before implantation.
  • Figure 2 shows a valve-containing prosthesis of the aortic root in a longitudinal section after it is sutured to the fibrous ring.
  • the valve-containing prosthesis of the aortic root contains a vascular prosthesis 1 with a cuff 3 fixed on the proximal side, and a valve 4 installed in the cuff 3.
  • figure 2 shows a two-leaf mechanical valve.
  • An annular overlay 5 is sewn to the cuff 3.
  • the overlay 5 is made of synthetic fabric with a sealing impregnation or from a xenopericard plate.
  • the patch 5 on the outer perimeter is stitched with thread 6 with a purse string suture and pulled to the vascular prosthesis 1, providing access to the cuff 3.
  • Valve-containing prosthesis of the aortic root works as follows. Using standard surgical procedures used for prosthetics of the aortic root, the affected aortic area with valve is removed, cuff 3 is sutured to the fibrous ring I of the prosthetic valve. Then the surgeon cuts the thread 6 and pulls it out, freeing the edges of the lining 5. After that, the surgeon sews the edges of the lining 5 over the cuff 3 to the not excised portion of the aortic sinus, sealing the junction of the cuff 3 with the fibrous ring I. Next, the surgeon sews to the vascular prosthesis 1 coronary vessels and hem the distal edge of the vascular prosthesis 1 to the non-excised portion of the aortic arch.
  • the prosthesis is filled with blood. Thanks to the sealing impregnation of the walls of the vascular prosthesis 1 and the lining 5, bleeding is prevented through the walls of the prosthesis and the zone of its connection with the fibrous ring I. After removing the clamps and starting the heart, valve 4 closes the reverse under the influence of alternating pressure and opens a direct blood flow, and vascular prosthesis 1 allows a direct flow of blood from the heart to the vascular system.
  • the proposed valve-containing prosthesis of the aortic root while preserving all the advantages of the prototype, provides increased reliability and reduced risks of postoperative complications associated with leaks in the connection of the prosthesis with the fibrous ring of the excised aortic valve of the heart.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (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 des techniques médicales et peut s'utiliser en chirurgie cardiaque pour remplacer la racine aortique endommagée comportant la valve aortique. La prothèse de la racine aortique comportant une valve comprend une prothèse vasculaire (1) dotée d'une manchette (3) fixée du côté proximal et d'une valve (4) montée sur la manchette (3). Une garniture annulaire (5) est cousue à la manchette (3). Cette garniture (5) est faite d'un tissu synthétique ou d'étanchéité ou d'une plaquette en xénopéricarde. La garniture (5) est cousue sur son périmètre extérieur d'un fil (6) suivant une suture en bourse et tirée vers la prothèse vasculaire (1) de manière à assurer l'accès à la manchette (3). Au moyen de procédures chirurgicales standard utilisées pour la réalisation d'une racine aortique, la manchette (3) est cousue à l'anneau fibreux I de la valve à remplacer par une prothèse. Le chirurgien coupe ensuite le fil (6) et l'extrait en libérant les bords de la garniture (5). Après cela, le chirurgien coud les bords de la garniture par dessus la manchette à la zone non incisée du sinus de l'aorte et assure l'étanchéité de la zone de connexion de la manchette (3) à l'anneau fibreux I. La prothèse sans carcasse de la racine aortique assure une meilleure fiabilité et une réduction des risques de complications consécutives à une opération, liées à une étanchéité insuffisante de connexion de la prothèse à l'anneau fibreux de la valve faisant l'objet de montage d'une prothèse.
PCT/RU2012/000729 2011-09-06 2012-09-05 Prothèse de racine aortique munie d'une valve WO2013036167A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RU2011136909 2011-09-06
RU2011136909/14A RU2479288C1 (ru) 2011-09-06 2011-09-06 Клапаносодержащий протез корня аорты

Publications (1)

Publication Number Publication Date
WO2013036167A1 true WO2013036167A1 (fr) 2013-03-14

Family

ID=47832433

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/RU2012/000729 WO2013036167A1 (fr) 2011-09-06 2012-09-05 Prothèse de racine aortique munie d'une valve

Country Status (2)

Country Link
RU (1) RU2479288C1 (fr)
WO (1) WO2013036167A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014163706A1 (fr) * 2013-03-12 2014-10-09 St. Jude Medical, Cardiology Division, Inc. Protection de fuite paravalvulaire
CN110522534A (zh) * 2019-09-21 2019-12-03 中山大学附属第一医院 一种带裙边的人工血管管道及缝合方法
WO2025138317A1 (fr) * 2023-12-28 2025-07-03 金仕生物科技(常熟)有限公司 Prothèse vasculaire et conduit à valve, et leur méthode de préparation

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2664189C1 (ru) * 2017-06-19 2018-08-15 Роман Николаевич Комаров Способ протезирования всех структур корня аорты
RU2734748C2 (ru) * 2018-09-04 2020-10-22 Роман Николаевич Комаров Способ протезирования всех структур корня аорты

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4443895A (en) * 1981-06-22 1984-04-24 American Hospital Supply Corporation Low-pressure fixation of valvular tissue intended for implantation
US5123919A (en) * 1991-11-21 1992-06-23 Carbomedics, Inc. Combined prosthetic aortic heart valve and vascular graft
RU2082352C1 (ru) * 1994-04-13 1997-06-27 Научный центр сердечно-сосудистой хирургии РАМН Биологический клапаносодержащий аортальный кондуит
RU5090U1 (ru) * 1996-01-16 1997-10-16 Научный центр сердечно-сосудистой хирургии им.А.Н.Бакулева РАМН Клапаносодержащий кондуит
US5891195A (en) * 1996-05-24 1999-04-06 Sulzer Carbomedics Inc. Combined prosthetic aortic heart valve and vascular graft with sealed sewing ring

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4443895A (en) * 1981-06-22 1984-04-24 American Hospital Supply Corporation Low-pressure fixation of valvular tissue intended for implantation
US5123919A (en) * 1991-11-21 1992-06-23 Carbomedics, Inc. Combined prosthetic aortic heart valve and vascular graft
RU2082352C1 (ru) * 1994-04-13 1997-06-27 Научный центр сердечно-сосудистой хирургии РАМН Биологический клапаносодержащий аортальный кондуит
RU5090U1 (ru) * 1996-01-16 1997-10-16 Научный центр сердечно-сосудистой хирургии им.А.Н.Бакулева РАМН Клапаносодержащий кондуит
US5891195A (en) * 1996-05-24 1999-04-06 Sulzer Carbomedics Inc. Combined prosthetic aortic heart valve and vascular graft with sealed sewing ring

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014163706A1 (fr) * 2013-03-12 2014-10-09 St. Jude Medical, Cardiology Division, Inc. Protection de fuite paravalvulaire
US9636222B2 (en) 2013-03-12 2017-05-02 St. Jude Medical, Cardiology Division, Inc. Paravalvular leak protection
US10537424B2 (en) 2013-03-12 2020-01-21 St. Jude Medical, Cardiology Division, Inc. Paravalvular leak protection
US11202705B2 (en) 2013-03-12 2021-12-21 St. Jude Medical, Cardiology Division, Inc. Paravalvular leak protection
CN110522534A (zh) * 2019-09-21 2019-12-03 中山大学附属第一医院 一种带裙边的人工血管管道及缝合方法
WO2025138317A1 (fr) * 2023-12-28 2025-07-03 金仕生物科技(常熟)有限公司 Prothèse vasculaire et conduit à valve, et leur méthode de préparation

Also Published As

Publication number Publication date
RU2479288C1 (ru) 2013-04-20

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