WO2022012782A1 - Annuloplasty device - Google Patents

Annuloplasty device Download PDF

Info

Publication number
WO2022012782A1
WO2022012782A1 PCT/EP2021/050600 EP2021050600W WO2022012782A1 WO 2022012782 A1 WO2022012782 A1 WO 2022012782A1 EP 2021050600 W EP2021050600 W EP 2021050600W WO 2022012782 A1 WO2022012782 A1 WO 2022012782A1
Authority
WO
WIPO (PCT)
Prior art keywords
support ring
posterior
annuloplasty device
heart valve
central axis
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/EP2021/050600
Other languages
English (en)
French (fr)
Inventor
Olli KERÄNEN
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.)
HVR Cardio Oy
Original Assignee
Medtentia International Ltd Oy
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 claimed from PCT/EP2020/069804 external-priority patent/WO2021005246A1/en
Application filed by Medtentia International Ltd Oy filed Critical Medtentia International Ltd Oy
Priority to CN202180062295.3A priority Critical patent/CN116096326A/zh
Priority to EP24195509.5A priority patent/EP4450028A3/en
Priority to US18/015,731 priority patent/US20230255771A1/en
Priority to CA3185826A priority patent/CA3185826A1/en
Priority to EP21700432.4A priority patent/EP4178487B1/en
Publication of WO2022012782A1 publication Critical patent/WO2022012782A1/en
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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0641—Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8483—Barbs
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • 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
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • 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
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Definitions

  • Some examples of the disclosure provide for a facilitated positioning of an annuloplasty device at a heart valve.
  • Fig. 2b is schematic illustration of the annuloplasty device in Fig. 2a, in a side view, according to an example
  • Fig. 5a is a schematic illustration of the annuloplasty device in Fig. 3, in a top-down view, according to an example
  • Fig. 10a is a schematic illustration of an annuloplasty device, in a perspective view, according to an example
  • the inverted section 124 may raise above the first posterior bow 113 in the axial direction 103’ along a width (wi) of the invented section 124.
  • the aforementioned width (wi) may be a fraction of a width (w 2 ) of the first or second support rings 101 , 102, in a direction essentially in parallel with the first or second anterior portions 114, 114’, as schematically illustrated in the example of Fig. 5c.
  • the fraction may be in the range 30 - 80%.
  • I.e. width wi may be 30 - 80% of width w 2 . This may provide for an advantageous compression of the tissue between the first and second anterior portions 114, 114’.
  • the width wi may in some examples be in the range 50 - 60 % of width w 2 , for a particularly advantageous and reliable positioning of the first and second anterior portions 114, 114’, on the opposite sides of the valve leaflets.
  • the inverted section 124 may extend in a direction essentially perpendicular to the second coil plane 102’. I.e. the first angle Vi may be an essentially right angle to the second coil plane 102’. This provides for an effective anchoring of the annuloplasty device 100 along the anterior side of the valve.
  • the first posterior bow 113 may be displaced a distance (I2) from the second posterior bow 113’ along a radial direction (R).
  • the radial direction (R) is perpendicular to the central axis 103.
  • the off-set between the first and second posterior bows 113, 113’ provides for an improved fixation of the annuloplasty device 100 on a downsized posterior annulus and thus a more effective anchoring of the annuloplasty device 100.
  • At least part of the first posterior bow 113 may thus extend with a greater radius (r) from the central axis 103 than the second posterior bow 113’.
  • the retention units 104, 104’ provides for shaping the annulus as desired even with a reduced pinching force, since the retention units 104, 104’, provides for fixating the shape of the annulus in the radial direction because of the mentioned retention force. This provides for a more reliable implantation at the heart valve, both in the short term and in the long term.
  • the method 200 may comprise positioning 2031 a first posterior stent 105a on the atrial side along a first posterior bow 113 of the first support ring 101 , and positioning 2032 a second posterior stent 105b on the ventricular side along a second posterior bow 113’ of the second support ring 102.
  • the method 200 may further comprise positioning an anterior stent (not shown) on the atrial side of the heart valve along a first anterior portion 114 of the first support ring 101.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)
PCT/EP2021/050600 2020-07-13 2021-01-13 Annuloplasty device Ceased WO2022012782A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CN202180062295.3A CN116096326A (zh) 2020-07-13 2021-01-13 瓣环成形术装置
EP24195509.5A EP4450028A3 (en) 2020-07-13 2021-01-13 Annuloplasty device
US18/015,731 US20230255771A1 (en) 2020-07-13 2021-01-13 Annuloplasty device
CA3185826A CA3185826A1 (en) 2020-07-13 2021-01-13 Annuloplasty device
EP21700432.4A EP4178487B1 (en) 2020-07-13 2021-01-13 Annuloplasty device

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EPPCT/EP2020/069804 2020-07-13
PCT/EP2020/069804 WO2021005246A1 (en) 2019-07-11 2020-07-13 Annuloplasty device
EP20207665.9 2020-11-13
EP20207665.9A EP4000559B1 (en) 2020-11-13 2020-11-13 Annuloplasty device

Publications (1)

Publication Number Publication Date
WO2022012782A1 true WO2022012782A1 (en) 2022-01-20

Family

ID=73451996

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/EP2021/050600 Ceased WO2022012782A1 (en) 2020-07-13 2021-01-13 Annuloplasty device
PCT/EP2021/080228 Ceased WO2022101041A1 (en) 2020-11-13 2021-10-31 Annuloplasty device

Family Applications After (1)

Application Number Title Priority Date Filing Date
PCT/EP2021/080228 Ceased WO2022101041A1 (en) 2020-11-13 2021-10-31 Annuloplasty device

Country Status (7)

Country Link
US (2) US20230255771A1 (enExample)
EP (3) EP4000559B1 (enExample)
JP (1) JP7660674B2 (enExample)
CN (2) CN116096326A (enExample)
CA (2) CA3185826A1 (enExample)
ES (1) ES3047869T3 (enExample)
WO (2) WO2022012782A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023217922A1 (en) * 2022-05-11 2023-11-16 Hvr Cardio Oy Annuloplasty device

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11234818B2 (en) * 2018-05-21 2022-02-01 Medtentia International Ltd Oy Annuloplasty device
EP4400077B1 (en) * 2023-01-15 2025-11-05 HVR Cardio Oy Annuloplasty device
WO2025019174A1 (en) * 2023-07-19 2025-01-23 Edwards Lifesciences Corporation Prosthetic valve docketing device
EP4497414A1 (en) * 2023-07-23 2025-01-29 HVR Cardio Oy Annuloplasty device

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040167620A1 (en) * 2000-07-06 2004-08-26 Medtentia Annuloplasty devices and related heart valve repair methods
WO2019223975A1 (en) * 2018-05-21 2019-11-28 Medtentia International Ltd Oy Annuloplasty device

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US7935145B2 (en) * 2001-05-17 2011-05-03 Edwards Lifesciences Corporation Annuloplasty ring for ischemic mitral valve insuffuciency
US7311730B2 (en) * 2004-02-13 2007-12-25 Shlomo Gabbay Support apparatus and heart valve prosthesis for sutureless implantation
SE530568C2 (sv) * 2006-11-13 2008-07-08 Medtentia Ab Anordning och metod för förbättring av funktionen hos en hjärtklaff
CN102438552A (zh) * 2009-03-19 2012-05-02 米利佩德有限责任公司 重构心脏特征
US8932350B2 (en) * 2010-11-30 2015-01-13 Edwards Lifesciences Corporation Reduced dehiscence annuloplasty ring
US8858623B2 (en) * 2011-11-04 2014-10-14 Valtech Cardio, Ltd. Implant having multiple rotational assemblies
CN108283534B (zh) * 2012-01-31 2019-09-24 米特拉尔维尔福科技有限责任公司 二尖瓣停放装置和系统
US9180008B2 (en) * 2012-02-29 2015-11-10 Valcare, Inc. Methods, devices, and systems for percutaneously anchoring annuloplasty rings
JP2018094430A (ja) * 2013-03-15 2018-06-21 シメティス・ソシエテ・アノニムＳｙｍｅｔｉｓ Ｓａ 経カテーテルステント弁に関する改良
WO2014179761A1 (en) * 2013-05-03 2014-11-06 Medtronic Inc. Medical devices for implanting in a valve and associated methods
ES2960716T3 (es) 2013-08-12 2024-03-06 Mitral Valve Tech Sarl Aparato para implantar una válvula cardíaca de sustitución
US10321992B2 (en) * 2016-02-01 2019-06-18 Medtronic, Inc. Heart valve prostheses having multiple support arms and methods for percutaneous heart valve replacement
US10561423B2 (en) * 2016-07-25 2020-02-18 Virender K. Sharma Cardiac shunt device and delivery system
US10722359B2 (en) * 2016-08-26 2020-07-28 Edwards Lifesciences Corporation Heart valve docking devices and systems
CR20190069A (es) * 2016-08-26 2019-05-14 Edwards Lifesciences Corp Valvulas y sistemas de acoplamiento de valvulas corazon
EP3395296B1 (en) * 2017-04-28 2019-12-18 Medtentia International Ltd Oy Annuloplasty implant
EP3476366B1 (en) * 2017-10-27 2020-12-16 Medtentia International Ltd Oy Annuloplasty implant
US10980635B2 (en) * 2018-01-07 2021-04-20 William Joseph Drasler Annuloplasty device and methods
EP3737336B1 (en) * 2018-01-08 2022-09-28 Medtentia International Ltd Oy Annuloplasty device
US11234818B2 (en) * 2018-05-21 2022-02-01 Medtentia International Ltd Oy Annuloplasty device

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040167620A1 (en) * 2000-07-06 2004-08-26 Medtentia Annuloplasty devices and related heart valve repair methods
WO2019223975A1 (en) * 2018-05-21 2019-11-28 Medtentia International Ltd Oy Annuloplasty device

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023217922A1 (en) * 2022-05-11 2023-11-16 Hvr Cardio Oy Annuloplasty device

Also Published As

Publication number Publication date
JP2024501398A (ja) 2024-01-12
EP4178487B1 (en) 2024-08-21
EP4450028A2 (en) 2024-10-23
CN116096326A (zh) 2023-05-09
CN116472010A (zh) 2023-07-21
EP4000559B1 (en) 2025-07-02
EP4000559A1 (en) 2022-05-25
CA3196820A1 (en) 2022-05-19
EP4178487A1 (en) 2023-05-17
ES3047869T3 (en) 2025-12-05
US20240016606A1 (en) 2024-01-18
EP4450028A3 (en) 2025-01-29
JP7660674B2 (ja) 2025-04-11
CA3185826A1 (en) 2022-01-20
WO2022101041A1 (en) 2022-05-19
US20230255771A1 (en) 2023-08-17

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