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WO2012114360A1 - Dispositif de fixation pour fermer le sternum après une sternotomie et instrument pour appliquer un tel dispositif - Google Patents

Dispositif de fixation pour fermer le sternum après une sternotomie et instrument pour appliquer un tel dispositif Download PDF

Info

Publication number
WO2012114360A1
WO2012114360A1 PCT/IT2011/000051 IT2011000051W WO2012114360A1 WO 2012114360 A1 WO2012114360 A1 WO 2012114360A1 IT 2011000051 W IT2011000051 W IT 2011000051W WO 2012114360 A1 WO2012114360 A1 WO 2012114360A1
Authority
WO
WIPO (PCT)
Prior art keywords
fixing device
sternum
staple
instrument
clamping
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/IT2011/000051
Other languages
English (en)
Inventor
Igino Romolo Gazzani
Piero Cavigliasso
Moreno Carvani
Roberto PARAVICINI
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.)
NTPLAST Srl
Original Assignee
NTPLAST Srl
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 NTPLAST Srl filed Critical NTPLAST Srl
Priority to EP11714857.7A priority Critical patent/EP2677951A1/fr
Priority to PCT/IT2011/000051 priority patent/WO2012114360A1/fr
Publication of WO2012114360A1 publication Critical patent/WO2012114360A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/82—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
    • A61B17/823—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage for the sternum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • A61B17/8076—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones for the ribs or the sternum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8869—Tensioning devices
    • 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
    • A61B17/0643—Surgical staples, i.e. penetrating the tissue with separate closing member, e.g. for interlocking with staple
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/809—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with bone-penetrating elements, e.g. blades or prongs

Definitions

  • the present invention refers to a fixing device for closing the sternum after a sternotomy in the case of heart surgery or torax surgery, and to an instrument for applying such device, in addition to the use of such device and instrument.
  • NITINOL® like those disclosed in patents US-A-6 783 531 in the name of Allen Drew, US-A-6 969 391 in the name of the Applicant and FR-A-2 874 166 in the name of SURGE FOOT
  • the components made of NITINOL® in fact have the feature of being malleable at low temperatures and to get their original shape again at body temperature.
  • EP-A-2063799 discloses a fixing device according to the preamble of claim 1.
  • object of the present invention is the creation of a system able to solve the above prior art problems, by providing a device that can be applied for closing the sternum after a sternotomy without the need of a previous bone cortex removal in spaces between ribs and able to comply with physiological micro-movements.
  • Another object of the present invention is providing a fixing device that is cheaper than what has been proposed by the art and therefore can be used on a, large scale.
  • a further object of the present invention is providing a process and instruments for an easy application of the fixing * device as cited above.
  • Figure 1 shows a perspective view of a preferred embodiment of the fixing device according to the present invention
  • Figure 1A shows a perspective view of a variation of the fixing device of Figure 1;
  • Figure 2 shows an exploded view of the fixing device of Figure 1; -
  • Figure 2A shows an exploded view of the fixing device of Figure 1A
  • Figure 3 shows a lateral view of the fixing device of Figure 1;
  • Figure 4 shows a front sectional view of the fixing device of Figure 1; • Figure 4A shows a detail of part of Figure 4;
  • Figures 5 and 6 show a perspective and a side view of a first embodiment of the instrument to tighten the device of Figure 1;
  • Figures 5A and 6A show two perspective views of a second embodiment of the instrument in ita opening and closing positions
  • Figure 7 shows a schematic front view of a human sternum before a sternotomy intervention
  • Figures 8 to 14 show perspective views of a human sternum during some steps of the process according to the present invention.
  • the fixing device 10 substantially comprises the following elements:
  • a staple 11 made of plastic material, comprising an outer contact element 12 substantially with an elliptic shape, equipped with at least two transverse rods 13, preferably extending along the minor radius of the ellipse, and with not more than two first sharpened tips 14 perpendicular to the contact element 12.
  • Each first sharpened tip 14 has a small cavity 15 used as a guide for an instrument 21;
  • the fixing device can further comprise a handle 21' made of plastic material, connected with the vertical stem 19 of the clamping element 16 and provided with a counterpart 22' to be grasped by a suitable instrument (not shown) .
  • Figures 5 and 6 show a preferred embodiment of an instrument for tightening the fixing device 10.
  • Such instrument in general, consists in special pliers 21 formed of levers 25 and equipped with a base 22 to push down the staple 11 and an upper part 23 for grasping the clamping stem 19.
  • the base 22 reproduces the shape of the staple 11 and is provided with two thin plates 24 to be inserted in the respective small cavities 15 of the staple 11.
  • the present invention also refers to a process for applying at least one fixing device for closing a sternum S opened due to a sternotomy.
  • the process according to the ⁇ present invention comprises the steps of:
  • element 17 in contact with the inner side of the sternum S. This leads the small second sharpened tips 18 in the lower contact element 17 to grip the soft tissues surrounding the bone ;
  • step f) for each fixing device 10; h) matching the instrument 21 to each fixing device 10: inserting the clamping stem 19 into the upper part 23 and coupling the base 22 with the outer contact element 12 and the thin plates 24 with the cavities 15 of the first sharpened tips 14; i) starting the action on the levers 25 of the pliers 21, until the clamping stem 19 is grasped into the upper part 23 of the pliers 21;
  • the staples 11 according to the present invention further determine, in the cortex segment, a minimum encumbrance and avoid disturbances to patients;
  • the fixing device 10 does not create image distortions in radiologic surveys (RX, CAT, RMN) ;
  • the fixing device 10 shows unmatched easiness of application and removal in respect to previously known fastening systems.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Neurology (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un dispositif de fixation (10) constitué de matière plastique pour fermer un sternum (S) après une sternotomie, comprenant : au moins une agrafe (11) ; au moins un élément de clampage (16) fonctionnellement couplé avec l'agrafe (11) ; et facultativement au moins un manche (21') fonctionnellement couplé avec l'élément de clampage (16). La présente invention concerne en outre un instrument (21) pour appliquer, par serrage, ce dispositif de fixation (10) à un sternum (S), constitué de pinces (21) constitué de leviers (25) équipés d'une base (22) adaptée pour pousser vers le bas l'agrafe (11) et une partie supérieure (23) pour saisir la tige (19) de l'élément de clampage (16), la base (22) reproduisant la forme de l'agrafe (11) et étant pourvue de deux plaques minces (24) à insérer dans les petites cavités respectives (15) de l'agrafe (11). La présente invention concerne en outre l'utilisation de l'instrument (21) ci-dessus pour fixer un sternum (S) avec le dispositif de fixation (10) ci-dessus.
PCT/IT2011/000051 2011-02-24 2011-02-24 Dispositif de fixation pour fermer le sternum après une sternotomie et instrument pour appliquer un tel dispositif Ceased WO2012114360A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP11714857.7A EP2677951A1 (fr) 2011-02-24 2011-02-24 Dispositif de fixation pour fermer le sternum après une sternotomie et instrument pour appliquer un tel dispositif
PCT/IT2011/000051 WO2012114360A1 (fr) 2011-02-24 2011-02-24 Dispositif de fixation pour fermer le sternum après une sternotomie et instrument pour appliquer un tel dispositif

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IT2011/000051 WO2012114360A1 (fr) 2011-02-24 2011-02-24 Dispositif de fixation pour fermer le sternum après une sternotomie et instrument pour appliquer un tel dispositif

Publications (1)

Publication Number Publication Date
WO2012114360A1 true WO2012114360A1 (fr) 2012-08-30

Family

ID=44625850

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IT2011/000051 Ceased WO2012114360A1 (fr) 2011-02-24 2011-02-24 Dispositif de fixation pour fermer le sternum après une sternotomie et instrument pour appliquer un tel dispositif

Country Status (2)

Country Link
EP (1) EP2677951A1 (fr)
WO (1) WO2012114360A1 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014078265A1 (fr) * 2012-11-15 2014-05-22 DePuy Synthes Products, LLC Élément de verrouillage pour un dispositif de fixation osseuse
JP2016506834A (ja) * 2013-03-15 2016-03-07 ホウフ，ルイス 胸骨固定装置および方法
US9597132B2 (en) 2013-01-12 2017-03-21 Louis Houff Sternum fixation device and method
US11191578B2 (en) 2016-02-10 2021-12-07 Scandinavian Real Heart Ab Split sternum prosthesis
WO2022173651A1 (fr) * 2021-02-09 2022-08-18 Zimmer Biomet CMF and Thoracic, LLC Fixation sternale rigide
US12290295B2 (en) 2020-06-19 2025-05-06 Circumfix Solutions, Inc. Bone repair devices and methods
US12402924B2 (en) 2021-07-29 2025-09-02 Circumfix Solutions, Inc. Bone repair devices and methods

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6783531B2 (en) 1999-04-26 2004-08-31 Drew Allen, DPM Compression bone staple, apparatus and method
US6969391B1 (en) 1999-04-21 2005-11-29 Romolo Igino Gazzani Semi-rigid compressive clamp for use in sternotomy, and forceps for its application
FR2874166A1 (fr) 2004-08-11 2006-02-17 Surge Foot Agrafe chirurgicale
EP2063799A1 (fr) 2006-09-22 2009-06-03 Aesculap AG Dispositif de fermeture sternale
US20090234357A1 (en) * 2006-09-22 2009-09-17 Aesculap Ag Sternum closure device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6969391B1 (en) 1999-04-21 2005-11-29 Romolo Igino Gazzani Semi-rigid compressive clamp for use in sternotomy, and forceps for its application
US6783531B2 (en) 1999-04-26 2004-08-31 Drew Allen, DPM Compression bone staple, apparatus and method
FR2874166A1 (fr) 2004-08-11 2006-02-17 Surge Foot Agrafe chirurgicale
EP2063799A1 (fr) 2006-09-22 2009-06-03 Aesculap AG Dispositif de fermeture sternale
US20090234357A1 (en) * 2006-09-22 2009-09-17 Aesculap Ag Sternum closure device

Cited By (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9622784B2 (en) 2012-11-15 2017-04-18 DePuy Synthes Products, Inc. Locking member for a bone fixation device
KR20150085835A (ko) * 2012-11-15 2015-07-24 신세스 게엠바하 골 고정 장치를 위한 로킹 부재
CN104918568A (zh) * 2012-11-15 2015-09-16 新特斯有限责任公司 用于骨固定装置的锁定构件
JP2015534879A (ja) * 2012-11-15 2015-12-07 シンセス・ゲーエムベーハーＳｙｎｔｈｅｓ ＧｍｂＨ 骨固定器具のための係止部材
KR102205052B1 (ko) 2012-11-15 2021-01-22 신세스 게엠바하 골 고정 장치를 위한 로킹 부재
US9433438B2 (en) 2012-11-15 2016-09-06 DePuy Synthes Products, Inc. Locking member for a bone fixation device
WO2014078265A1 (fr) * 2012-11-15 2014-05-22 DePuy Synthes Products, LLC Élément de verrouillage pour un dispositif de fixation osseuse
CN104918568B (zh) * 2012-11-15 2018-06-01 新特斯有限责任公司 用于骨固定装置的锁定构件
US10010360B2 (en) 2013-01-12 2018-07-03 Louis Houff Sternum fixation device and method
US9597132B2 (en) 2013-01-12 2017-03-21 Louis Houff Sternum fixation device and method
US11439448B2 (en) 2013-01-12 2022-09-13 Circumfix Solutions, Inc. Sternum fixation device and method
US12433651B2 (en) 2013-01-12 2025-10-07 Circumfix Solutions, Inc. Sternum fixation device and method
EP2953563A4 (fr) * 2013-02-07 2016-10-26 Louis Houff Dispositif et procédé de fixation pour sternum
US10154864B2 (en) 2013-02-07 2018-12-18 Louis Houff Sternum fixation device and method
JP2016506834A (ja) * 2013-03-15 2016-03-07 ホウフ，ルイス 胸骨固定装置および方法
US11241264B2 (en) 2013-03-15 2022-02-08 Circumfix Solutions, Inc. Sternum fixation device and method
US11944362B2 (en) 2013-03-15 2024-04-02 Circumfix Solutions, Inc. Sternum fixation device and method
US11191578B2 (en) 2016-02-10 2021-12-07 Scandinavian Real Heart Ab Split sternum prosthesis
US12290295B2 (en) 2020-06-19 2025-05-06 Circumfix Solutions, Inc. Bone repair devices and methods
WO2022173651A1 (fr) * 2021-02-09 2022-08-18 Zimmer Biomet CMF and Thoracic, LLC Fixation sternale rigide
US12226134B2 (en) 2021-02-09 2025-02-18 Zimmer Biomet CMF and Thoracic, LLC Rigid sternal fixation
US12402924B2 (en) 2021-07-29 2025-09-02 Circumfix Solutions, Inc. Bone repair devices and methods

Also Published As

Publication number Publication date
EP2677951A1 (fr) 2014-01-01

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