WO2013036167A1 - Valved aortic root prosthesis - Google Patents

Valved aortic root prosthesis Download PDF

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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
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WIPO (PCT)
Prior art keywords
cuff
prosthesis
valve
aortic root
overlay
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PCT/RU2012/000729
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French (fr)
Russian (ru)
Inventor
Владлен Владленович БАЗЫЛЕВ
Сергей Васильевич ЕВДОКИМОВ
Евгений Владимирович РОССЕЙКИН
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Закрытое Акционерное Общество Научно-Производственное Предприятие "Мединж"
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Publication of WO2013036167A1 publication Critical patent/WO2013036167A1/en

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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.

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  • 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

The invention relates to medical technology and can be used in cardiac surgery to replace a damaged aortic root and aortic valve. The valved aortic root prosthesis comprises a vascular prosthesis (1) with a cuff (3) fastened to the proximal end thereof, and a valve (4) mounted in the cuff (3). An annular overlay (5) is stitched to the cuff (3). The overlay (5) is made from a synthetic fabric impregnated with a sealing agent or from a sheet of xenopericardium. The overlay (5) is stitched around its outside perimeter with a thread (6) using a purse-string suture and is drawn to the vascular prosthesis (1), providing access to the cuff (3). With the aid of standard surgical procedures used in aortic root replacement, the cuff (3) is sewn to the fibrous ring I of the valve undergoing replacement. The surgeon then cuts the thread (6) and withdraws it, releasing the edges of the overlay (5). Next, the surgeon sews the edges of the overlay (5) over the cuff (3) to the non-excised portion of the aortic sinus, hermetically sealing the region where the cuff (3) is joined to the fibrous ring I. The proposed stentless aortic root prosthesis provides increased reliability and reduced risk of post-operative complications arising from leaks in the join between the prosthesis and the fibrous ring of the replaced valve.

Description

Клапаносодержащий протез корня аорты  Valve-containing prosthesis of the aortic root
Изобретение относится к медицинской технике и может быть использовано в кардиохирургии для замены пораженного корня аорты с аортальным клапаном. The invention relates to medical equipment and can be used in cardiac surgery to replace the affected aortic root with an aortic valve.
Известны корни аорты (КА), используемые в кардиохирур- гии, забранные либо у животных - ксенографт (КГ), либо у трупа человека - гомографт (ГГ). (Ross DN. Homograft replacement of the aortic valve. Lancet 1962; 2:447).  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).
Известен бескаркасный биопротез клапана аорты, выполнен- ный из клапанно-аортального комплекса млекопитающего, содер- жащий трубное тело и запирающий многостворчатый элемент, примыкающий к концу трубчатого тела (см. патент США ^4,443,895, 1984 г.).  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).
Известен бескаркасный протез корня аорты (см. патент США 5,123,919, 1992г.), содержащий сосудистый протез из синтетиче- ской ткани с закрепленной с проксимальной стороны манжетой, и механический клапан, установленный в манжете.  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.
Все вышеперечисленные протезы, успешно выполняющие свое функциональное назначение, обладают существенным недостатком. Во время подшивания протеза или манжеты протеза к фиброзному кольцу возможно образование фистул, выявление которых возмож- но только после завершения имплантации протеза и заполнения сердца кровью. При этом устранение фистул, вызывающих кровоте- чение, после имплантации протеза является сложной хирургической проблемой. All of the above prostheses that successfully fulfill their functional purpose have a significant drawback. During hemming of the prosthesis or prosthesis cuff to the fibrous ring, fistula formation is possible, the detection of which is possible only after the implantation of the prosthesis is completed and the heart is filled with blood. In this case, the elimination of fistulas that cause bleeding after implantation of the prosthesis is a complex surgical problem.
Задачей предлагаемого изобретения является повышение надежности протеза и снижение рисков послеоперационных крово- течений.  The objective of the invention is to increase the reliability of the prosthesis and reduce the risks of postoperative bleeding.
Предложен клапаносодержащий протез корня аорты, содер- жащий сосудистый протез с закрепленной с проксимальной стороны манжетой, и клапан, установленный в манжете. Протез снабжен кольцевой накладкой, расположенной между манжетой и сосуди- стым протезом, внешний диаметр которой превышает внешний диаметр манжеты. Накладка выполнена из синтетической ткани с герметизирующей пропиткой или из пластины ксеноперикарда. При этом накладка по внутреннему периметру пришита нитью к манже- те, а по внешнему периметру прошита нитью кисетным швом и притянута к сосудистому протезу, обеспечивая доступ к манжете.  A valve-containing prosthesis of the aortic root is proposed, 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.
Известных технических решений с сочетанием признаков, сходных с признаками, отличающими заявляемое решение от про- тотипа, не выявлено.  There are no known technical solutions with a combination of features similar to those distinguishing the claimed solution from the prototype.
Предложенный клапаносодержащий протез корня аорты обес- печивает повышение надежности протеза и снижение рисков после- операционных кровотечений.  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.
Наличие у клапаносодержащего протеза корня аорты сосуди- стого протеза с закрепленной с проксимальной стороны манжетой, и клапана, установленного в манжете, обеспечивает возможность 2012/000729 The presence of a vascular prosthesis in the valve-containing prosthesis of the aortic root with a cuff fixed on the proximal side and a valve installed in the cuff allows 2012/000729
подшивания протеза через манжету к фиброзному кольцу удаленно- го клапана и, соответственно, не иссеченной части аорты. При этом восстанавливается канал для прохождения крови и функция клапа- на, обеспечивающая восстановление гемодинамики сердечно- сосудистой системы. hemming of the prosthesis through the cuff to the fibrous ring of the removed valve and, accordingly, of the not excised part of the aorta. At the same time, the channel for the passage of blood and the valve function are restored, which ensures the restoration of the hemodynamics of the cardiovascular system.
Наличие у сосудистого протеза кольцевой накладки, располо- женной между манжетой и сосудистым протезом, создает возмож- ность подшивания накладки поверх подшитой манжеты к неиссе- ченной стенке аорты, что обеспечивает дополнительную герметиза- цию манжеты и соединительных швов.  The presence of an 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.
При выполнении внешнего диаметра прокладки большим, чем внешний диаметр манжеты, повышается надежность герметизации манжеты по всему внешнему периметру.  When the outer diameter of the gasket is larger than the outer diameter of the cuff, the reliability of sealing the cuff along the entire outer perimeter is increased.
При выполнении накладки из синтетической с герметизирую- щей пропиткой ткани или из пластины ксеноперикарда обеспечива- ется герметичность самой накладки. Выбор материала обусловлен материалом сосудистого протеза. Если сосудистый протез выполнен из синтетического материала, то и накладка выполняется из синте- тической ткани. Если сосудистый протез выполнен из биологиче- ского материала, то и накладка выполняется из пластины ксенопе- рикарда.  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.
При пришивании накладки по внутреннему периметру нитью к манжете обеспечивается герметичное соединение накладки с проте- зом.  When sewing the patch on the inner perimeter, the thread to the cuff ensures a tight connection between the patch and the prosthesis.
з При прошивании накладки по внешнему периметру нитью ки- сетным швом и притягивании ее к сосудистому протезу, обеспечи- вается доступ к манжете во время подшивания ее к фиброзному кольцу, что облегчает хирургу манипуляцию с протезом при его подшивании к фиброзному кольцу иссеченного аортального клапа- на. s When a patch is sewn along the outer perimeter with a filament of a suture suture and pulled to a vascular prosthesis, access to the cuff is provided while it is sutured to the fibrous ring, which makes it easier for the surgeon to handle the prosthesis when it is sutured to the fibrous ring of the excised aortic valve.
Изобретение поясняется чертежами, где на фиг.1 представлен внешний вид клапаносодержащего протеза корня аорты перед им- плантацией. На фиг.2 представлен клапаносодержащий протез кор- ня аорты в продольном разрезе после подшивания его к фиброзно- му кольцу.  The invention is illustrated by drawings, in which 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.
Клапаносодержащий протез корня аорты содержит сосудистый протез 1 с закрепленной с проксимальной стороны манжетой 3, и клапан 4, установленный в манжете 3. Для наглядности на фиг.2 изображен двухстворчатый механический клапан. Но, без ограниче- ния сущности изобретения, может быть использован любой механи- ческий или биологический протез клапана сердца. К манжете 3 пришита кольцевая накладка 5. Накладка 5 выполнена из синтети- ческой с герметизирующей пропиткой ткани или из пластины ксе- ноперикарда. Накладка 5 по внешнему периметру прошита нитью 6 кисетным швом и притянута к сосудистому протезу 1, обеспечивая доступ к манжете 3.  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. For clarity, figure 2 shows a two-leaf mechanical valve. But, without limiting the essence of the invention, any mechanical or biological prosthetic valve of the heart valve can be used. 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.
Клапаносодержащий протез корня аорты, изображенный на фиг.1-2, работает следующим образом. С помощью стандартных хирургических процедур, применя- емых при протезировании корня аорты, удаляется пораженный уча- сток аорты с клапаном, манжета 3 подшивается к фиброзному кольцу I протезируемого клапана. Затем хирург разрезает нить 6 и выдергивает ее, освобождая края накладки 5. После этого хирург подшивает края накладки 5 поверх манжеты 3 к не иссеченному участку синуса аорты, герметизируя зону соединения манжеты 3 с фиброзным кольцом I. Далее хирург подшивает к сосудистому про- тезу 1 коронарные сосуды и подшивает дистальный край сосудисто- го протеза 1 к не иссеченному участку дуги аорты. Valve-containing prosthesis of the aortic root, shown in Fig.1-2, 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.
Протез заполняется кровью. Благодаря герметизирующей пропитке стенок сосудистого протеза 1 и накладки 5 предотвраща- ется кровотечение через стенки протеза и зоны его соединения с фиброзным кольцом I. После снятия зажимов и запуска в работу сердца клапан 4 под действием знакопеременного давления закры- вает обратный и открывает прямой ток крови, а сосудистый протез 1 обеспечивает прохождение прямого потока крови из сердца в сосу- дистую систему.  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.
Предложенный клапаносодержащий протез корня аорты, со- храняя все преимущества прототипа, обеспечивает повышение надежности и снижение рисков послеоперационных осложнений, связанных с не герметичностью соединения протеза с фиброзным кольцом иссеченного аортального клапана сердца.  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.

Claims

ФОРМУЛА ИЗОБРЕТЕНИЯ CLAIM
1. Клапаносодержащий протез корня аорты, содержащий со- судистый протез с закрепленной с проксимальной стороны манже- той, и клапан, установленный в манжете, отличающийся тем, что протез снабжен кольцевой накладкой, расположенной между ман- жетой и сосудистым протезом, внешний диаметр которой превыша- ет внешний диаметр манжеты. 1. A valve-containing prosthesis of the aortic root, comprising a vascular prosthesis with a cuff fixed to the proximal side, and a valve installed in the cuff, characterized in that the prosthesis is provided with an annular pad located between the cuff and the vascular prosthesis, the outer diameter of which is greater than - is the outer diameter of the cuff.
2. Клапаносодержащий протез корня аорты по п.1, отличаю- щийся тем, что накладка выполнена из синтетической ткани с гер- метизирующей пропиткой или из пластины ксеноперикарда.  2. The valve-containing prosthesis of the aortic root according to claim 1, characterized in that the patch is made of synthetic fabric with a sealing impregnation or from a xenopericardium plate.
3. Клапаносодержащий протез корня аорты по п.1, отличаю- щийся тем, накладка по внутреннему периметру пришита нитью к манжете.  3. The valve-containing prosthesis of the aortic root according to claim 1, characterized in that the patch along the inner perimeter is sewn with a thread to the cuff.
4. Клапаносодержащий протез корня аорты по п.1, отличаю- щийся тем, накладка по внешнему периметру прошита нитью ки- сетным швом и притянута к сосудистому протезу, обеспечивая до- ступ к манжете.  4. The valve-containing prosthesis of the aortic root according to claim 1, characterized in that the patch on the outer perimeter is stitched with a filament suture and pulled to the vascular prosthesis, providing access to the cuff.
PCT/RU2012/000729 2011-09-06 2012-09-05 Valved aortic root prosthesis WO2013036167A1 (en)

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