WO1991017721A1 - Prosthetic annulus for mitral or tricuspid annuloplasty - Google Patents

Prosthetic annulus for mitral or tricuspid annuloplasty Download PDF

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Publication number
WO1991017721A1
WO1991017721A1 PCT/US1991/003423 US9103423W WO9117721A1 WO 1991017721 A1 WO1991017721 A1 WO 1991017721A1 US 9103423 W US9103423 W US 9103423W WO 9117721 A1 WO9117721 A1 WO 9117721A1
Authority
WO
WIPO (PCT)
Prior art keywords
annulus
prosthetic annulus
mitral
prosthetic
rigid part
Prior art date
Application number
PCT/US1991/003423
Other languages
French (fr)
Inventor
Jacques Seguin
Original Assignee
Omnicor Incorporated
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 Omnicor Incorporated filed Critical Omnicor Incorporated
Publication of WO1991017721A1 publication Critical patent/WO1991017721A1/en

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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • A61F2/2448—D-shaped rings
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility

Definitions

  • the invention concerns a prosthetic annulus for mitr or tricuspid annuloplasty, designed for surgical reconstruction of diseased and/or damaged mitral and tricuspid valves.
  • a cardiac valve may become insufficient due to vario diseases, and it is then sometimes necessary to repair the fibromuscular annulus surrounding the valves to palliate the distortion of the valve without replacing it with a total artificial heart valve prosthesis.
  • the Carpentier mitral ring has its open part located on the approximately straight part of the roughly bean- shaped annulus. This straight part rests on the fibrous trigone.
  • Massana flexible rings are adjustable, by pulling the free ends of a folded thread, thus allowing the choice of the proper size at the location of use, and to comply with the shape of the damaged annulus.
  • both types of ring become rigid and inflexible, which prevents their complying with the heart's movements.
  • the invention palliates this disadvantage in providin a prosthetic ring for mitral and/or tricuspid annuloplasty. It consists of a core and a cloth sheath for suturing. Th core forms a complete ring with a rigid part and a part made of elastic material. The rigid part is made to rest on the corresponding fibrous trigone.
  • the rigid part of the core corresponds to the mitral anterior leaflet implantation, against the rigid fibrous trigone, sticking approximately to the straight part.
  • Carpentier annulus is sometimes open in this area.
  • the elastic part of the core of the present invention corresponds to the mitral posterior leaflet implantation, against the contractible wall of the heart.
  • the rigid part of the prosthetic annulus according to the present invention rests on the septal leaflet against the fibrous trigone, whereas the elastic part rests on the anterior and posterior leaflets' implantation.
  • Fig. 1 is a diagrammatic view of a cross section of the heart, showing the location of the mitral and tricuspi valves
  • Fig. 2 is a section view of a mitral prosthetic annulus
  • Fig. 3 is a section view of a tricuspid prosthetic annulus.
  • Figure 1 shows the cardiac anatomy of the mitral and tricuspid valves section.
  • the mitral valve 1 consists of the anterior leaflet la and posterior leaflet lb and is surrounded by the mitral annulus 2.
  • the mitral valve 1 i limited on the side of the anterior leaflet by the right 3 and left 3b fibrous trigone.
  • the part of the prosthetic annulus which corresponds to the positioning of the posterior leaflet is the compliant one.
  • the tricuspid valve 4 is divided into three leaflets, the septal leaflet 4a, the anterior leaflet 4b and the posterior leaflet 4c. Only the septal leaflet 4a is in contact with the left fibrous trigone 3b.
  • the natural valve ring shown at 5 is not a continuous fibrous annulus.
  • the anterior and posterior leaflets are attached to the myocardium. Therefore, most often it is in this area that the tricuspid annulus strains itself and induces valvular insufficiency.
  • FIGS 2 and 3 show diagrammatically and respectivel a mitral reconstruction annulus 6, and a tricuspid reconstruction annulus 7.
  • Each of these rings has an elastic core but possesses a rigid insert 6a and 7a, respectively, inside the ring where the ring will be sutured to the fibrous trigone.
  • the fibrous trigone area is not contractible and the reconstruction annulus may be rigid in this area.
  • the remaining part of the ring which is to be in contact with the contractibl areas of the heart is elastic in order to comply with the heart completely.
  • the rings of this invention have a tubular woven cloth sheath which allows the ring to be sutured to the natural valvular annulus. (This tubular cloth sheath does not show in the figures) .
  • the elastic part of the rings is made of cloth, elastomer or a similar material, with regard to flexibility, for example silicon rubber or another elastomer.
  • the stiff part of the rings consists of any rigid material, such as titanium or alloyed titanium, clothed in a thick silicon sheath.
  • the elastic part and the rigid part of the rings may be combined together by any suitable means: encapsulation of both ends; keeping them together with a common sheath (in addition to the cloth sheath) for example of silicon; welding or gluing of the compliant part to the ends of the rigid part, the latter being completely covered with a layer of the same material which the elastic part is made of.
  • the rigi part of the rings of this invention will be provided in several different sizes.
  • the surgeo will choose, the proper annulus by measuring the distance between the two commissures for the mitral valve, and the distance between the anteroseptal and posteroseptal commissures for the tricuspid valve; he will then choose annulus with the rigid part of the size corresponding to that distance. The measure will be taken with a sizer.

Abstract

Prosthetic annulus (6, 7) for mitral or tricuspid annuloplasty, consisting of a core and cloth sheath as suture ring. The core makes a full ring with a rigid part (6a, 7a) to rest on the corresponding fibrous trigone (3a, 3b) and an elastic part.

Description

PROSTHETIC ANNULUS FOR MITRAL OR TRICUSPID ANNULOPLASTY
The invention concerns a prosthetic annulus for mitr or tricuspid annuloplasty, designed for surgical reconstruction of diseased and/or damaged mitral and tricuspid valves.
A cardiac valve may become insufficient due to vario diseases, and it is then sometimes necessary to repair the fibromuscular annulus surrounding the valves to palliate the distortion of the valve without replacing it with a total artificial heart valve prosthesis.
Two main types of prosthetic annulus are currently available: the rigid rings, open or closed, for example, FR-A 2 031 699 and FR-A 2 071 172 of Carpentier; the flexible rings, adjustable like the Massana US-A 4 290 151 Both types of annulus are cloth-covered for suturing.
The Carpentier mitral ring has its open part located on the approximately straight part of the roughly bean- shaped annulus. This straight part rests on the fibrous trigone.
The Massana flexible rings are adjustable, by pulling the free ends of a folded thread, thus allowing the choice of the proper size at the location of use, and to comply with the shape of the damaged annulus.
However, once they have been sutured to the natural valvular annulus, both types of ring become rigid and inflexible, which prevents their complying with the heart's movements.
The invention palliates this disadvantage in providin a prosthetic ring for mitral and/or tricuspid annuloplasty. It consists of a core and a cloth sheath for suturing. Th core forms a complete ring with a rigid part and a part made of elastic material. The rigid part is made to rest on the corresponding fibrous trigone.
In the case of mitral annuloplasty, the rigid part of the core corresponds to the mitral anterior leaflet implantation, against the rigid fibrous trigone, sticking approximately to the straight part. The rigid part of the
Carpentier annulus is sometimes open in this area. The elastic part of the core of the present invention corresponds to the mitral posterior leaflet implantation, against the contractible wall of the heart.
Likewise, for the tricuspid valve ring reconstruction, the rigid part of the prosthetic annulus according to the present invention rests on the septal leaflet against the fibrous trigone, whereas the elastic part rests on the anterior and posterior leaflets' implantation.
The ring of the present invention shall now be described in detail, with reference to the following figures, in which: Fig. 1 is a diagrammatic view of a cross section of the heart, showing the location of the mitral and tricuspi valves; Fig. 2 is a section view of a mitral prosthetic annulus; and
Fig. 3 is a section view of a tricuspid prosthetic annulus. Figure 1 shows the cardiac anatomy of the mitral and tricuspid valves section. The mitral valve 1 consists of the anterior leaflet la and posterior leaflet lb and is surrounded by the mitral annulus 2. The mitral valve 1 i limited on the side of the anterior leaflet by the right 3 and left 3b fibrous trigone. The part of the prosthetic annulus which corresponds to the positioning of the posterior leaflet is the compliant one.
The tricuspid valve 4 is divided into three leaflets, the septal leaflet 4a, the anterior leaflet 4b and the posterior leaflet 4c. Only the septal leaflet 4a is in contact with the left fibrous trigone 3b. The natural valve ring shown at 5 is not a continuous fibrous annulus. The anterior and posterior leaflets are attached to the myocardium. Therefore, most often it is in this area that the tricuspid annulus strains itself and induces valvular insufficiency.
Figures 2 and 3 show diagrammatically and respectivel a mitral reconstruction annulus 6, and a tricuspid reconstruction annulus 7. Each of these rings has an elastic core but possesses a rigid insert 6a and 7a, respectively, inside the ring where the ring will be sutured to the fibrous trigone. The fibrous trigone area is not contractible and the reconstruction annulus may be rigid in this area. On the other hand, the remaining part of the ring which is to be in contact with the contractibl areas of the heart is elastic in order to comply with the heart completely.
Around the core, the rings of this invention have a tubular woven cloth sheath which allows the ring to be sutured to the natural valvular annulus. (This tubular cloth sheath does not show in the figures) . The elastic part of the rings is made of cloth, elastomer or a similar material, with regard to flexibility, for example silicon rubber or another elastomer. The stiff part of the rings consists of any rigid material, such as titanium or alloyed titanium, clothed in a thick silicon sheath.
The elastic part and the rigid part of the rings may be combined together by any suitable means: encapsulation of both ends; keeping them together with a common sheath (in addition to the cloth sheath) for example of silicon; welding or gluing of the compliant part to the ends of the rigid part, the latter being completely covered with a layer of the same material which the elastic part is made of.
To comply with the morphological differences between the natural annuli which are to be reconstructed, the rigi part of the rings of this invention will be provided in several different sizes. During the operation, the surgeo will choose, the proper annulus by measuring the distance between the two commissures for the mitral valve, and the distance between the anteroseptal and posteroseptal commissures for the tricuspid valve; he will then choose annulus with the rigid part of the size corresponding to that distance. The measure will be taken with a sizer.

Claims

Claims
1. A prosthetic annulus for mitral or tricuspid annuloplasty comprising: a core including a rigid part and an elastic part in the form of a continuous ring, said rigid part being coextensive with the fibrous trigone portion of the heart where the prosthetic annulus is intended to be implanted; and a cloth suturing sheath enclosing said core.
2. A prosthetic annulus of claim 1 wherein said prosthetic annulus is adapted for mitral annuloplasty and said rigid part has a length corresponding to the implantation of the mitral anterior leaflet of the heart into which the prosthetic annulus is intended to be implanted.
3. A prosthetic annulus of claim 1 wherein said prosthetic annulus is adapted for tricuspid annuloplasty and said rigid part has a length corresponding to the implantation of the septal anterior leaflet of the heart into which the prosthetic annulus is intended to be implanted.
4. A prosthetic annulus of claim 1 wherein said rigid part is joined to said elastic part by a compliant plastic sheath which extends completely around said ring.
5. A prosthetic annulus of claim 1 wherein said rigid part is covered with a plastic layer and the ends o said plastic layer are joined to said elastic part to for said ring.
6. A prosthetic annulus of claim 1 wherein the rigidity of said rigid part is provided by a metallic member.
7. A prosthetic annulus of claim 1 wherein the elastic part is formed of silicon rubber.
PCT/US1991/003423 1990-05-17 1991-05-16 Prosthetic annulus for mitral or tricuspid annuloplasty WO1991017721A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR90/06159 1990-05-17
FR9006159A FR2662074A1 (en) 1990-05-17 1990-05-17 PROSTHETIC RING FOR MITRAL OR TRICUSPID ANNULOPLASTY.

Publications (1)

Publication Number Publication Date
WO1991017721A1 true WO1991017721A1 (en) 1991-11-28

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1991/003423 WO1991017721A1 (en) 1990-05-17 1991-05-16 Prosthetic annulus for mitral or tricuspid annuloplasty

Country Status (3)

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AU (1) AU7954391A (en)
FR (1) FR2662074A1 (en)
WO (1) WO1991017721A1 (en)

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5593435A (en) * 1994-07-29 1997-01-14 Baxter International Inc. Distensible annuloplasty ring for surgical remodelling of an atrioventricular valve and nonsurgical method for post-implantation distension thereof to accommodate patient growth
US6045576A (en) * 1997-09-16 2000-04-04 Baxter International Inc. Sewing ring having increased annular coaptation
US6183512B1 (en) 1999-04-16 2001-02-06 Edwards Lifesciences Corporation Flexible annuloplasty system
US6217610B1 (en) 1994-07-29 2001-04-17 Edwards Lifesciences Corporation Expandable annuloplasty ring
US6726716B2 (en) 2001-08-24 2004-04-27 Edwards Lifesciences Corporation Self-molding annuloplasty ring
US7371259B2 (en) 2001-03-15 2008-05-13 Medtronic, Inc. Annuloplasty band and method
US7377940B2 (en) 2001-03-15 2008-05-27 Medtronic, Inc. Implantable prosthesis
US7452376B2 (en) 2004-05-14 2008-11-18 St. Jude Medical, Inc. Flexible, non-planar annuloplasty rings
WO2010033936A2 (en) 2008-09-19 2010-03-25 Edwards Lifesciences Corporation Annuloplasty ring configured to receive a percutaneous prosthetic heart valve implantation
US7938856B2 (en) 2004-05-14 2011-05-10 St. Jude Medical, Inc. Heart valve annuloplasty prosthesis sewing cuffs and methods of making same
US8052748B2 (en) 2004-05-14 2011-11-08 St. Jude Medical, Inc. Systems and methods for holding annuloplasty rings
US8197538B2 (en) 2006-06-02 2012-06-12 Medtronic, Inc. Annuloplasty prosthesis with in vivo shape identification and related methods of use
US8920493B2 (en) 2011-09-16 2014-12-30 St. Jude Medical, Cardiology Division, Inc. Systems and methods for holding annuloplasty rings
US8961598B2 (en) 2008-01-25 2015-02-24 Medtronic, Inc. Set of annuloplasty devices with varying anterior-posterior ratios and related methods
US9283073B2 (en) 2006-06-02 2016-03-15 Medtronic, Inc. Annuloplasty ring and method

Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3130419A (en) * 1960-08-11 1964-04-28 Edwards Miles Lowell Heart valve with shielded sewing ring
US3508281A (en) * 1968-02-08 1970-04-28 Harry W Cromie Fabric covered heart valve having an improved fabric seat
US3564617A (en) * 1968-08-22 1971-02-23 Lester R Sauvage Prosthetic heart valve buried sewing ring
US3725961A (en) * 1970-12-29 1973-04-10 Baxter Laboratories Inc Prosthetic heart valve having fabric suturing element
US4042979A (en) * 1976-07-12 1977-08-23 Angell William W Valvuloplasty ring and prosthetic method
US4055861A (en) * 1975-04-11 1977-11-01 Rhone-Poulenc Industries Support for a natural human heart valve
US4164046A (en) * 1977-05-16 1979-08-14 Cooley Denton Valve prosthesis
US4204283A (en) * 1977-05-05 1980-05-27 National Research Development Corporation Prosthetic valve
US4290151A (en) * 1979-07-31 1981-09-22 Massana Miguel P Adjustable annular prosthesis for cardiac surgery
US4489446A (en) * 1982-07-14 1984-12-25 Reed Charles C Heart valve prosthesis
US4602911A (en) * 1982-08-19 1986-07-29 General Resorts S.A. Adjustable ringprosthesis
US4655773A (en) * 1984-09-21 1987-04-07 Ge. Sv. In. S.R.L. Bicuspid valve prosthesis for an auriculo-ventricular cardiac aperture

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4491986A (en) * 1976-05-12 1985-01-08 Shlomo Gabbay Heart valve
SU577022A1 (en) * 1976-06-25 1977-10-30 Всесоюзный Научно-Исследовательский Институт Клинической И Экспериментальной Хирургии Cardiac valve prosthesis
CA1303298C (en) * 1986-08-06 1992-06-16 Alain Carpentier Flexible cardiac valvular support prosthesis
US4917698A (en) * 1988-12-22 1990-04-17 Baxter International Inc. Multi-segmented annuloplasty ring prosthesis

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3130419A (en) * 1960-08-11 1964-04-28 Edwards Miles Lowell Heart valve with shielded sewing ring
US3508281A (en) * 1968-02-08 1970-04-28 Harry W Cromie Fabric covered heart valve having an improved fabric seat
US3564617A (en) * 1968-08-22 1971-02-23 Lester R Sauvage Prosthetic heart valve buried sewing ring
US3725961A (en) * 1970-12-29 1973-04-10 Baxter Laboratories Inc Prosthetic heart valve having fabric suturing element
US4055861A (en) * 1975-04-11 1977-11-01 Rhone-Poulenc Industries Support for a natural human heart valve
US4042979A (en) * 1976-07-12 1977-08-23 Angell William W Valvuloplasty ring and prosthetic method
US4204283A (en) * 1977-05-05 1980-05-27 National Research Development Corporation Prosthetic valve
US4164046A (en) * 1977-05-16 1979-08-14 Cooley Denton Valve prosthesis
US4290151A (en) * 1979-07-31 1981-09-22 Massana Miguel P Adjustable annular prosthesis for cardiac surgery
US4489446A (en) * 1982-07-14 1984-12-25 Reed Charles C Heart valve prosthesis
US4602911A (en) * 1982-08-19 1986-07-29 General Resorts S.A. Adjustable ringprosthesis
US4655773A (en) * 1984-09-21 1987-04-07 Ge. Sv. In. S.R.L. Bicuspid valve prosthesis for an auriculo-ventricular cardiac aperture

Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5593435A (en) * 1994-07-29 1997-01-14 Baxter International Inc. Distensible annuloplasty ring for surgical remodelling of an atrioventricular valve and nonsurgical method for post-implantation distension thereof to accommodate patient growth
US5888240A (en) * 1994-07-29 1999-03-30 Baxter International Inc. Distensible annuloplasty ring for surgical remodelling of an atrioventricular valve and nonsurgical method for post-implantation distension thereof to accomodate patient growth
US6217610B1 (en) 1994-07-29 2001-04-17 Edwards Lifesciences Corporation Expandable annuloplasty ring
US6391054B2 (en) 1994-07-29 2002-05-21 Edwards Lifesciences Corporation Expandable annuloplasty ring
US6045576A (en) * 1997-09-16 2000-04-04 Baxter International Inc. Sewing ring having increased annular coaptation
US6183512B1 (en) 1999-04-16 2001-02-06 Edwards Lifesciences Corporation Flexible annuloplasty system
US6503274B1 (en) 1999-04-16 2003-01-07 Edwards Lifesciences Corporation Method of implanting a flexible annuloplasty system
US7377940B2 (en) 2001-03-15 2008-05-27 Medtronic, Inc. Implantable prosthesis
US7371259B2 (en) 2001-03-15 2008-05-13 Medtronic, Inc. Annuloplasty band and method
US7063722B2 (en) 2001-08-24 2006-06-20 Edwards Lifesciences, Llc Method of implanting a self-molding annuloplasty ring
US6726716B2 (en) 2001-08-24 2004-04-27 Edwards Lifesciences Corporation Self-molding annuloplasty ring
US8052748B2 (en) 2004-05-14 2011-11-08 St. Jude Medical, Inc. Systems and methods for holding annuloplasty rings
US7938856B2 (en) 2004-05-14 2011-05-10 St. Jude Medical, Inc. Heart valve annuloplasty prosthesis sewing cuffs and methods of making same
US7452376B2 (en) 2004-05-14 2008-11-18 St. Jude Medical, Inc. Flexible, non-planar annuloplasty rings
US9289294B2 (en) 2004-05-14 2016-03-22 St. Jude Medical, Inc. Heart valve annuloplasty prosthesis sewing cuffs and methods of making same
US8197538B2 (en) 2006-06-02 2012-06-12 Medtronic, Inc. Annuloplasty prosthesis with in vivo shape identification and related methods of use
US9283073B2 (en) 2006-06-02 2016-03-15 Medtronic, Inc. Annuloplasty ring and method
US8961598B2 (en) 2008-01-25 2015-02-24 Medtronic, Inc. Set of annuloplasty devices with varying anterior-posterior ratios and related methods
WO2010033936A2 (en) 2008-09-19 2010-03-25 Edwards Lifesciences Corporation Annuloplasty ring configured to receive a percutaneous prosthetic heart valve implantation
EP2344075B1 (en) * 2008-09-19 2018-12-05 Edwards Lifesciences Corporation Annuloplasty ring configured to receive a percutaneous prosthetic heart valve implantation
US8920493B2 (en) 2011-09-16 2014-12-30 St. Jude Medical, Cardiology Division, Inc. Systems and methods for holding annuloplasty rings

Also Published As

Publication number Publication date
FR2662074A1 (en) 1991-11-22
AU7954391A (en) 1991-12-10

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