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WO2012152959A1 - Kit pour annuloplastie de la valvule tricuspide - Google Patents

Kit pour annuloplastie de la valvule tricuspide Download PDF

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Publication number
WO2012152959A1
WO2012152959A1 PCT/ES2011/070782 ES2011070782W WO2012152959A1 WO 2012152959 A1 WO2012152959 A1 WO 2012152959A1 ES 2011070782 W ES2011070782 W ES 2011070782W WO 2012152959 A1 WO2012152959 A1 WO 2012152959A1
Authority
WO
WIPO (PCT)
Prior art keywords
ring
tricuspid
kit
meter
tricuspid valve
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/ES2011/070782
Other languages
English (en)
Spanish (es)
Inventor
Anas SARRAJ ASIL
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=47138816&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2012152959(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Publication of WO2012152959A1 publication Critical patent/WO2012152959A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • 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
    • A61F2/2466—Delivery devices therefor
    • 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
    • A61F2/2496—Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
    • 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
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0091—Additional features; Implant or prostheses properties not otherwise provided for transparent or translucent

Definitions

  • Kit for annuloplasty of the tricuspid valve Object of the invention rests on a kit for use in cardiac surgery, the same being integrated by; a prosthetic ring in the form of a tricuspid valve ring, a measuring element, a support for the prosthetic ring and a handle for handling.
  • This kit is intended for the surgical treatment of tricuspid ring dilation and valvular traction by the papillary muscles; anterior and posterior to an appropriate degree in each segment.
  • Sector of the technique The sector of the technique to which the present invention pertains is that of cardiac surgery, in particular, tricuspid valve repair surgery.
  • two-dimensional rings such as the classic Carpentier-Edwards ring that can re-stabilize the area of the tricuspid valve and the coaptation zone and decrease the tension in the suture line
  • two-dimensional tricuspid rings are not effective and 10% to 20% of patients have early residual tricuspid insufficiency.
  • the tricuspid ring of Edwards MC Carthy is considered three-dimensional. Its septal segment is slightly bent down to fit the tricuspid septal ring leaving a step between its ends. These two rings serve only to treat tricuspid annular dilation but do not treat valvular traction or have the physiological shape of the tricuspid valve.
  • the current tricuspid prosthetic rings do not solve the existing problems and according to the new concept of the pathophysiology of functional tricuspid insufficiency, the ideal tricuspid prosthetic ring for annuloplasty must resolve the poor coaptation of the tricuspid valve caused by both annular dilatation and Valve traction
  • the main object of this invention is an open, elliptical, asymmetric, three-dimensional tricuspid ring in the form of a saddle with the following advantages;
  • the septal segment gradually returns to its original plane and does not leave a step between its ends.
  • the septal segment is shorter to avoid possible damage to the conduction system.
  • the anteroseptal end is shorter and more flexible to sit comfortably in the corresponding area of the tricuspid ring where the tissue is very thin, thus avoiding a tear that could occur.
  • the caudal doubling of the posterseptal part decreases the anteroposterior diameter and approximates the anterior and posterior muscles to counteract the traction effect.
  • Anteroposterior and postoseptal green signals facilitate implantation.
  • the green line that separates the ring from the suture edge (1 mm) facilitates implantation.
  • Figure 1 shows a top view of the ring, marking its diameters.
  • Figure 2 shows a sectional view of the ring showing its inner layers and components; the titanium body, the silicone layer, the textile outer layer (polyester) and the suture edge.
  • Figure 3 shows table 1 which contains the technical characteristics according to ring measurements; internal diameters, external diameters, flow doubling distance and valve traction distance.
  • Figure 4 is a sectional view of the ring with a sagittal section of the ring support.
  • Figure 5 is a top view of the ring support element.
  • Figure 6 shows a top view of the ring with its segment open, marking the flexible segment, the references of the postseptral and anteroposterior areas are also marked, as well as the diagonal line of the plane bending.
  • Figure 7 shows table 2 with the different diameters of the ring meters according to the sizes.
  • Figure 8 is a top view of the ring measuring device.
  • Figure 9 A shows the caudal doubling of the postoseptal portion of the ring.
  • Figure 9 B shows the method of calculating the variable G flow doubling distance from the variable T (valve traction), data obtained from the Fukuda study.
  • Figure 10 A shows a top perspective view of the ring.
  • Figure 10 B shows a perspective side view of the ring.
  • Figure 1 1 shows the ideal form that tricuspid rings should mimic according to the Fukuda study.
  • the invention presents a kit for use in valvular cardiac surgery and specifically for surgical treatment of tricuspid ring dilation and valvular traction by the papillary muscles; anterior and posterior to an appropriate degree in each segment.
  • Said kit is composed of the following elements or components;
  • the ring consisting of an elliptical and partial ring (1) that has an open segment (H) at one of its ends and that at one of its ends has a flexible short segment (P) for its seat or adaptation.
  • the ring is constructed by a titanium body (2), dressed in a silicone layer (3) and covered by a polyester fabric (4), the ring has green markings or signs that correspond to the anteroposterior commissures (9) and post-septal (8) of the tricuspid valve that have an indicative purpose in implantation.
  • the total profile of the ring is 4mm (3mm for the ring itself and 1mm for the suture edge (5)).
  • the suture edge is the outermost part of the ring, delimited in green for reference help in the implantation of the prosthetic ring on the tricuspid valve ring.
  • the prosthetic ring is folded in its posterior post-septal portion (G mm) around the interrupted diagonal line (L) to obtain the distance of the valve traction (T mm), figures 9 A and 9 B.
  • the ring is presented in formats of different sizes of measures between 28 and 36 mm, without the variation in size in it resulting in a sufficient separation of the object of the patent, the table shown in table 1 (figure 3) shows the characteristics of the ring: internal diameters (A and C,
  • the meter is a piece of transparent, two-dimensional and low-profile plastic (2 mm) and has a complete elliptical shape (not open) and has a handle connector (M) in its center.
  • the meter has two tabs (14 and 15) that correspond to the anteroseptal and postoseptal commissures to determine which ring size to implant (Figure 8).
  • the ring to be implanted is presented on a transparent plastic support, with a low profile (2 mm) and in a three-dimensional shape like that of the ring.
  • the support helps in the procedure of implanting the ring so as not to manually manipulate the ring and is usually joined by three points to the ring, these points once the ring is placed and sutured to the tricuspid ring are cut for disconnection and removal of the support.
  • the support has the same elliptical shape as the ring without openings, has a 5mm width ( Figure 5) and has two holes (12 and 13) right and left that allow viewing the tricuspid valve and the right ventricle during the implantation procedure From the ring.
  • the diameters of the upper face of the support (6) have 4 mm more than the internal diameters of the three-dimensional ring, while its lower face (7) has the same internal diameters of the ring. ( Figure 9).
  • REPLACEMENT SHEET (Rule 26) It can be made of plastic or metal material and connects both with the support and with the meter to hold them.
  • the joining system of the support and meter parts to the handle can be operated by means of a thread system or similar.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (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 un kit pour l'annuloplastie de la valvule tricuspide. L'objet de cette invention porte sur un kit utilisé en chirurgie cardiaque, concrètement pour le traitement chirurgical de la dilation de l'anneau tricuspide et de la traction valvulaire par les muscles papillaires, antérieur et postérieur. Ce kit comprend un anneau prothétique en forme d'anneau valvulaire tricuspide elliptique et partiel qui présente un segment ouvert au niveau d'une de ses extrémités et qui, au niveau d'une de ses terminaisons, présente un segment court souple destiné à sa pose; un élément de mesure destiné à déterminer la taille de l'anneau à implanter en fonction de la mesure de la valvule tricuspide; un support d'anneau prothétique en plastique transparent, de profil bas (2 mm) et de forme tridimensionnelle comme celle de l'anneau qui facilite le procédé d'implantation de l'anneau; et une poignée de manipulation.
PCT/ES2011/070782 2011-05-06 2011-11-15 Kit pour annuloplastie de la valvule tricuspide Ceased WO2012152959A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES201130727A ES2392416B1 (es) 2011-05-06 2011-05-06 Kit para anuloplastia de la válvula tricúspide.
ESP201130727 2011-05-06

Publications (1)

Publication Number Publication Date
WO2012152959A1 true WO2012152959A1 (fr) 2012-11-15

Family

ID=47138816

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/ES2011/070782 Ceased WO2012152959A1 (fr) 2011-05-06 2011-11-15 Kit pour annuloplastie de la valvule tricuspide

Country Status (3)

Country Link
BR (1) BRPI1105210B1 (fr)
ES (1) ES2392416B1 (fr)
WO (1) WO2012152959A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102023111685A1 (de) 2022-05-09 2023-11-09 Thermo Fisher Scientific (Bremen) Gmbh Ladungsdetektion für die Steuerung der Ionenakkumulation

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6019739A (en) * 1998-06-18 2000-02-01 Baxter International Inc. Minimally invasive valve annulus sizer
US20050021135A1 (en) * 2001-03-15 2005-01-27 Ryan Timothy R. Annuloplasty band and method
WO2005122964A1 (fr) * 2004-06-14 2005-12-29 Edwards Lifesciences Corporation Anneau tridimensionnel pour annuloplastie et gabarit
ES2258839T3 (es) * 1998-03-31 2006-09-01 St. Jude Medical, Inc. Portador de anillo de anuloplastia.
US20090287303A1 (en) * 2008-05-13 2009-11-19 Edwards Lifesciences Corporation Physiologically harmonized tricuspid annuloplasty ring
US20110022169A1 (en) * 2007-01-26 2011-01-27 Ryan Timothy R Annuloplasty Device for Tricuspid Valve Repair

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2258839T3 (es) * 1998-03-31 2006-09-01 St. Jude Medical, Inc. Portador de anillo de anuloplastia.
US6019739A (en) * 1998-06-18 2000-02-01 Baxter International Inc. Minimally invasive valve annulus sizer
US20050021135A1 (en) * 2001-03-15 2005-01-27 Ryan Timothy R. Annuloplasty band and method
WO2005122964A1 (fr) * 2004-06-14 2005-12-29 Edwards Lifesciences Corporation Anneau tridimensionnel pour annuloplastie et gabarit
US20110022169A1 (en) * 2007-01-26 2011-01-27 Ryan Timothy R Annuloplasty Device for Tricuspid Valve Repair
US20090287303A1 (en) * 2008-05-13 2009-11-19 Edwards Lifesciences Corporation Physiologically harmonized tricuspid annuloplasty ring

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102023111685A1 (de) 2022-05-09 2023-11-09 Thermo Fisher Scientific (Bremen) Gmbh Ladungsdetektion für die Steuerung der Ionenakkumulation

Also Published As

Publication number Publication date
BRPI1105210A2 (pt) 2014-03-04
ES2392416A1 (es) 2012-12-10
BRPI1105210B1 (pt) 2021-03-09
ES2392416B1 (es) 2013-08-06

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