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
Authority
WO
WIPO (PCT)
Prior art keywords
cuff
prosthesis
aortic root
overlay
valve
Prior art date
Application number
PCT/RU2012/000729
Other languages
French (fr)
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
Priority to RU2011136909/14A priority Critical patent/RU2479288C1/en
Priority to RU2011136909 priority
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/en

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
    • 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 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

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

Valved prosthesis aortic root

The invention relates to medical engineering and can be used in cardiac surgery for replacement of the aortic root with aortic valve.

We know the roots of the aorta (CA) used in kardiohirur- ology, pick up any animals - xenografts (KG), or a human corpse - homograft (YY). (Ross DN Homograft replacement of the aortic valve Lancet 1962; 2:.. 447).

Known frameless bioprosthesis aortic valve vypolnen- ny of the aortic valve-mammalian complex soder- zhaschy tubular body and a locking element mnogostvorchaty adjacent the end of the tubular body (see. U.S. Patent 4,443,895 ^, 1984 YG).

Known frameless prosthetic aortic root (see. U.S. Patent 5,123,919, 1992.) Containing a vascular prosthesis made of synthetic fabric tion with a fixed sleeve with the proximal side, and a mechanical valve mounted in the cuff.

All of the above prostheses successfully perform its function, have a significant drawback. During suturing of the prosthesis or the prosthesis cuff to the fibrous ring, the formation of fistulas, the identification of which is possible only after the implantation of the prosthesis and filling of the heart with blood. In this case, the elimination of fistula, causing haemorrhage chenie, after implantation of the prosthesis is a complex surgical problem.

The object of the invention is to increase the reliability of the prosthesis and risk of postoperative decline of blood flow.

Proposed valved prosthetic aortic root soder- zhaschy vascular prosthesis fixed to the proximal side of the cuff, and a valve mounted in the cuff. The prosthesis is provided with an annular plate situated between the cuff and sosudi- stym prosthesis, the external diameter of which exceeds the outer diameter of the cuff. Cover made of synthetic fabric or impregnated with a sealing plate of ksenoperikarda. At the same time strip on the inner perimeter of thread sewn to the collar, and the outer perimeter sewn purse-string suture thread and fasten to a vascular prosthesis, providing access to cuff.

Known technical solutions with a combination of features similar to the features distinguishing the claimed solution of pro- prototypes, have been identified.

The proposed valved prosthesis aortic root prosthesis which minimizes the increase of reliability and risk reduction post-operational bleeding.

The presence of the valved prosthetic aortic root sosudi- grained prosthesis attached to the proximal side of the cuff, and a valve installed in the cuff enables 2012/000729

suturing of the prosthesis through the cuff to the fibrous ring udalenno- of the valve and, accordingly, is not dissected aorta. This restores the channel for the passage of blood and function klapa- on providing restoration of hemodynamic cardiovascular system.

The presence of the graft ring patch, raspolo- zhennoy between the cuff and the vascular prosthesis, creates the possibility of suturing cuff covers over hemmed to neisse- chennoy aortic wall that provides additional germetiza- tion cuff and joints.

When the outer diameter of the large gasket than the outer diameter of the cuff, the cuff increases the reliability of sealing around the outer perimeter.

When the lining of synthetic germetiziruyu- with boiling impregnated fabric or plate ksenoperikarda tightness is ensured by the very laths. The choice of material is caused by vascular prosthesis material. If a vascular prosthesis made of synthetic material, and the lining is made of synthetic fabric cal. When the vascular prosthesis is made of a biological material Skog, and the plate is made of a plate ksenope- Ricardo.

When sewing the lining of the inner perimeter of the cuff to the thread is provided with a seal lining prote- Zoom.

h When sewing lining on the outer perimeter thread ki- webbing and pull-in suture it to the graft, is ensured by access to cuff during suturing it to the fibrous ring, which facilitates the surgeon to manipulate the prosthesis when suturing a dissected aortic fibrous ring on klapa- .

The invention is illustrated by drawings, where Figure 1 shows the appearance of the prosthetic valved aortic root before im- plantation. 2 is valved prosthesis cor- nya aorta in longitudinal section after suturing it to fibro mu ring.

Valved prosthetic aortic root vascular prosthesis 1 comprises a fixed collar on the proximal side 3 and the valve 4 is mounted in the cuff 3 depicts two-folding a mechanical valve in Figure 2 for clarity. But without loss of the essence of the invention can be used by any of mechanical or biological heart valve prosthesis. 3 is sewn to the cuff ring plate 5. Cover plate 5 is made of synthetic cal fabric impregnated with a sealing plate or xenon noperikarda. Cover plate 5 is stitched on the outer perimeter purse string suture thread 6, and drawn to the vascular prosthesis 1, providing access to the cuff 3.

Valved aortic root prosthesis illustrated in Figures 1-2 operates as follows. Using standard surgical procedures, prosthodontics primenya- proxy at the aortic root is removed affected ucha- drain aortic valve, the cuff 3 sutured to the fibrous ring I bridged valve. The surgeon then cuts the thread 6 and pulls it, releasing the edge laths 5. Then the surgeon hemming edge lining 5 over the cuff 3 not to excision of the aortic sinus area, sealing compound band with fibrous cuff 3 ring I. Further sutured to a vascular surgeon pro- tezu 1 coronary vessels and sutured sosudisto distal end of the prosthesis 1 to no site of excision of the aortic arch.

The prosthesis is filled with blood. Due to impregnation of the sealing wall of the vascular prosthesis 1 and the laths 5 etsya They prevent bleeding through the prosthesis wall and its connection zone with the fibrous ring I. After removing the clamps and run in the heart valve 4 under the influence of alternating pressure by the inverse zakry- and opens direct blood flow, a vascular prosthesis 1 allows the passage of the direct blood flow from the heart into sosu- REMOTE system.

The proposed valved prosthesis aortic root, co-stores all the advantages of a prototype, provides increased reliability and reduced risk of post-operative complications associated with non-tightness of the joint prosthesis with fibrous ring dissected aortic heart valve.

Claims

CLAIM
1. valved prosthetic aortic root containing co sudisty prosthesis attached to the proximal side of the manzhe-, and a valve mounted in the cuff, characterized in that the prosthesis is provided with an annular plate situated between the mandate and zhetoy vascular prosthesis, an external diameter exceeding - an outer diameter of the cuff.
2. The valved prosthesis aortic root according to claim 1, which differs in that the plate is made of a synthetic fabric with germanium metiziruyuschey impregnation or ksenoperikarda plate.
3. The valved prosthesis aortic root according to claim 1, which differs by lining the internal thread is sewn to the perimeter of the cuff.
4. The valved prosthesis aortic root according to claim 1, which differs in patch on the outer perimeter of the netting is stitched seam thread ki- and drawn to a vascular prosthesis by providing pre mortars to the cuff.
PCT/RU2012/000729 2011-09-06 2012-09-05 Valved aortic root prosthesis WO2013036167A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
RU2011136909/14A RU2479288C1 (en) 2011-09-06 2011-09-06 Valve-containing aortic root prosthesis
RU2011136909 2011-09-06

Publications (1)

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

Family

ID=47832433

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/RU2012/000729 WO2013036167A1 (en) 2011-09-06 2012-09-05 Valved aortic root prosthesis

Country Status (2)

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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014163706A1 (en) * 2013-03-12 2014-10-09 St. Jude Medical, Cardiology Division, Inc. Paravalvular leak protection

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2664189C1 (en) * 2017-06-19 2018-08-15 Роман Николаевич Комаров Method of prosthetic repair of all structures of the root of aorta

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 (en) * 1994-04-13 1997-06-27 Научный центр сердечно-сосудистой хирургии РАМН Biological valve-comprising aorta conduit
RU5090U1 (en) * 1996-01-16 1997-10-16 Научный центр сердечно-сосудистой хирургии им.А.Н.Бакулева РАМН valved conduit
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 (en) * 1994-04-13 1997-06-27 Научный центр сердечно-сосудистой хирургии РАМН Biological valve-comprising aorta conduit
RU5090U1 (en) * 1996-01-16 1997-10-16 Научный центр сердечно-сосудистой хирургии им.А.Н.Бакулева РАМН valved conduit
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 (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014163706A1 (en) * 2013-03-12 2014-10-09 St. Jude Medical, Cardiology Division, Inc. Paravalvular leak protection
US9636222B2 (en) 2013-03-12 2017-05-02 St. Jude Medical, Cardiology Division, Inc. Paravalvular leak protection

Also Published As

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

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