WO2008044958A1 - Prothèse de racine aortique sans carcasse - Google Patents

Prothèse de racine aortique sans carcasse Download PDF

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Publication number
WO2008044958A1
WO2008044958A1 PCT/RU2006/000525 RU2006000525W WO2008044958A1 WO 2008044958 A1 WO2008044958 A1 WO 2008044958A1 RU 2006000525 W RU2006000525 W RU 2006000525W WO 2008044958 A1 WO2008044958 A1 WO 2008044958A1
Authority
WO
WIPO (PCT)
Prior art keywords
aortic root
frameless
prosthesis
shape
modules
Prior art date
Application number
PCT/RU2006/000525
Other languages
English (en)
Russian (ru)
Inventor
Yevgeniy Vladimirovich Rosseykin
Original Assignee
Rosseykin Yevgeniy Vladimirovi
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 Rosseykin Yevgeniy Vladimirovi filed Critical Rosseykin Yevgeniy Vladimirovi
Priority to PCT/RU2006/000525 priority Critical patent/WO2008044958A1/fr
Publication of WO2008044958A1 publication Critical patent/WO2008044958A1/fr

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
    • 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
    • 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
    • A61F2/2475—Venous 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
    • 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

  • the invention relates to cardiac surgery and relates to the aortic root.
  • KA aortic roots
  • KG a xenograft
  • GG a homograph
  • CG and GG The disadvantages of CG and GG are: complex search and procurement, requiring large personnel and material costs, the use of expensive equipment for high-tech processes to give CG and GG immunoneutrality and anticalcium processing, special refinement of CG and GG to a form that can be used in the clinic, the difficulty of creating KG and GG cans of the required size, limited shelf life, high degree of calcification when used, limited use in children and young people due to the extremely HIGH-risk of severe calcification, high reoperation to replace them, associated with dysfunction of the valve due to calcification and development of aortic valve insufficiency
  • the disadvantages of the known bioprosthesis should include the fact that it is difficult to create a bank of bioprostheses of the required size, as well as high calcification when using them.
  • aortic valve made from the valve-aortic complex of a mammal, containing a tubular body with ends, locking a multifold element adjacent to the end of the tubular body, while the valve flaps are made symmetrical due to excision of the muscle shaft of the right coronary leaf of the complex, the base of the right coronary leaf and the lower third of the right coronary sinus of the prosthesis made of fibrous tissue, which is their inner and outer layer, and the lower third of the right coronary sinus additionally has an outer skin made of one layer of biocompatible material (see Pat. 2175858 A61F2 / 24 2001).
  • the disadvantages of the known frameless bioprosthesis are the difficulty of creating, a limited shelf life, a high probability of calcification and repeated operations in the long term.
  • the basis of the invention is the task of creating a frameless prosthesis of the aortic root from a synthetic material that does not have negative properties of biomaterials, and the shape of which is as close as possible to the shape of the natural aortic root of a person.
  • This goal is achieved by the fact that the frameless prosthesis of the aortic root, including a tubular body with protrusions, formed by a rigid connection of three modules, to the upper and lower ends of which vascular prostheses made of synthetic material are fixed.
  • each module consists of external (NEM) and internal (VEM) elements.
  • the external element of the module is made of synthetic material with a thickness of 0.6 - 1.0 mm, and the shape and size of the external element of the module corresponds to the shape and size of the sinus of the aortic root with two halves of the subcommissural space and 1/3 of the fibrous base of the aortic root.
  • the internal element of the module "is hemmed to the inner wall of the external element of the module along the line corresponding to the line of attachment of the valves of the aortic root to the line
  • SUBSTITUTE SHEET (RULE 26) fibrous ring and is made of synthetic material with a thickness of 0.1-0.3 mm.
  • the vascular prosthesis hemmed to the upper end has a diameter of 26 mm and a length L of 25 mm (Fig. 1), and the vascular prosthesis hemmed to the lower end has a diameter of 22-26 mm and a width (length I) of 5 mm (Fig. 1) )
  • the connection of modules and module elements between themselves is carried out by stitching.
  • the claimed frameless prosthesis of the aortic root meets the criteria of the invention of "novelty.”
  • a comparison of the claimed frameless prosthesis of the aortic root with the known ones shows that the biological material has been replaced with synthetic material and sashes and sinuses of the aortic root have been found with which it is only possible to construct a frameless prosthesis of the aortic root, which eliminates the degeneration of biological tissue.
  • the technical result is expressed in an increase in the operating life due to the lack of calcification of the frameless prosthesis of the aortic root due to the use of synthetic materials, in contrast to the valve-aortic complex of a mammal.
  • FIG.1 a General view of a frameless prosthesis of the aortic root
  • Fig. 2 the external element of the module (NEM) - corresponds to the shape and size of the sinus of the aortic root.
  • Fig.Z - the internal element of the module (VEM) - corresponds to the shape of the leaflet of the aortic root
  • FIG. 4 frameless prosthesis of the aortic root from above
  • the frameless prosthesis of the aortic root is a tubular body 1 with protrusions (Fig. 1), formed by a rigid connection of three modules, each of which consists of two elements: external (Fig. 2) and internal (Fig. 3).
  • the external element of the module is made in the form of a rectangle 2 (Fig. 2) of synthetic material, 0.6-1.0 mm thick with an internal marking line 3 (Fig. 2), which is the line of the fibrous ring, i.e. the line of attachment of the leaflet of the aortic root and it is applied in the form of a sine 4 of the aortic root (Fig.6).
  • the lower point 5 (figure 2) of the internal marking line 3 (figure 2) is located at a distance of 5 mm from the lower edge 6 (figure 2) of the rectangle 2 (figure 2).
  • the extreme lateral point 7, the internal marking line 3, is 2 mm from the lateral edge 8, rectangle 2.
  • the rectangular part 9, rectangle 2, which is lower than the internal marking line 3, is 1/3 of the fibrous base 10 of the aortic root (Fig. 1 )
  • the rest of the rectangle 2, under the internal marking line 3 is two Vg (half) 11 (Fig.2) of the subcommissural space 12 (Fig.l) and two Vg (halves) 13 (Fig.2) of the commissure 14 (Fig.l).
  • the internal element of the module is made in the form of the sash 15 (Fig.Z) of a synthetic material with a thickness of 0.1-0.3 mm.
  • first and third and second and third modules are stitched together.
  • a vascular prosthesis 30 (Fig. 1) is sutured with a diameter of 22-26 mm and a width of 5 mm (length /) (Fig. 1), starting with three fixing sutures, connecting the lower points of the joints of the NEM and VEM modules 31 (FIG. 1) with three points located on the vascular prosthesis 30 (FIG. 1) at an equal distance from each other. Hemming of every third goes from the junction of the NEM and the VEM modules 31 (Fig. 1) to the center from two sides, taking into account the difference in lengths of the objects being sewn together.
  • SUBSTITUTE SHEET (RULE 26)
  • a vascular prosthesis 32 (Fig. 1) with a diameter of 26 mm is hemmed to the upper end 28 (Fig. 1), starting with three fixing sutures connecting the upper points of the joints of the modules 33 (Fig. 1) and three points on the vascular prosthesis 32 (Fig. 1) equally spaced from each other.
  • the length of the vascular prosthesis 32 (Fig. 1) is 25 mm (length L).
  • the frameless prosthesis of the aortic root is completely cut out of synthetic material and all connections are made with synthetic thread.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Manufacturing & Machinery (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 la chirurgie cardiaque et notamment la racine aortique. L'invention vise à créer une racine aortique sans carcasse et faite d'une matière synthétique, qui ne présente pas de défauts propres aux matériaux biologiques et dont la forme se rapproche le plus possible à la forme d'une racine aortique humaine naturelle. La nouveauté consiste en ce que la prothèse de racine aortique sans carcasse comprend un corps tubulaire comportant des renflements et formé par la connexion rigide de trois modules; des prothèses vasculaires en matière synthétique sont fixées aux extrémités inférieure et supérieure dudit corps, chaque module étant constitué d'éléments interne et externe. L'élément interne est fait d'un matériau synthétique dont l'épaisseur est de 0,6 - 1,0 mm., la forme et la taille de l'élément externe correspondant à la forme et la taille du sinus de la racine aortique, l'élément externe étant muni de deux moitiés d'une région sous-commissurale et d'une troisième partie de la base fibreuse de la racine aortique, alors que l'élément interne est suturé à la paroi interne de l'élément externe en suivant une ligne qui correspond à la ligne de connexion des volets de la racine aortique à la ligne de l'anneau fibreux; il est fait d'un matériau synthétique ayant une épaisseur de 0,1 à 0,3 mm. La prothèse vasculaire suturée à l'extrémité supérieure a un diamètre de 26 mm et une longueur de 25 mm, et la prothèse vasculaire suturée à l'extrémité inférieure a un diamètre de 22-26 mm et une largeur de 5 mm. Les modules et leurs éléments sont connectés par suture.
PCT/RU2006/000525 2006-10-11 2006-10-11 Prothèse de racine aortique sans carcasse WO2008044958A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/RU2006/000525 WO2008044958A1 (fr) 2006-10-11 2006-10-11 Prothèse de racine aortique sans carcasse

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/RU2006/000525 WO2008044958A1 (fr) 2006-10-11 2006-10-11 Prothèse de racine aortique sans carcasse

Publications (1)

Publication Number Publication Date
WO2008044958A1 true WO2008044958A1 (fr) 2008-04-17

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/RU2006/000525 WO2008044958A1 (fr) 2006-10-11 2006-10-11 Prothèse de racine aortique sans carcasse

Country Status (1)

Country Link
WO (1) WO2008044958A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999033412A1 (fr) * 1997-12-24 1999-07-08 Edwards Lifesciences Corporation Bioprothese de valvule cardiaque sans stent avec des protuberances coronaires
WO2000000107A1 (fr) * 1998-06-26 2000-01-06 St. Jude Medical, Inc. Valvule aortique sans extenseur, a base de tissu bovin, et a suture en plan unique
US20020128703A1 (en) * 1995-01-31 2002-09-12 Ravenscroft Adrian C. Method and apparatus for intraluminally implanting an endovascular aortic graft
RU51866U1 (ru) * 2005-07-18 2006-03-10 Евгений Владимирович Россейкин Универсальный клапаносодержащий кондуит

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020128703A1 (en) * 1995-01-31 2002-09-12 Ravenscroft Adrian C. Method and apparatus for intraluminally implanting an endovascular aortic graft
WO1999033412A1 (fr) * 1997-12-24 1999-07-08 Edwards Lifesciences Corporation Bioprothese de valvule cardiaque sans stent avec des protuberances coronaires
WO2000000107A1 (fr) * 1998-06-26 2000-01-06 St. Jude Medical, Inc. Valvule aortique sans extenseur, a base de tissu bovin, et a suture en plan unique
RU51866U1 (ru) * 2005-07-18 2006-03-10 Евгений Владимирович Россейкин Универсальный клапаносодержащий кондуит

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