GB2471855A - Resiliently deformable sternal clamp suture - Google Patents

Resiliently deformable sternal clamp suture Download PDF

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Publication number
GB2471855A
GB2471855A GB0912207A GB0912207A GB2471855A GB 2471855 A GB2471855 A GB 2471855A GB 0912207 A GB0912207 A GB 0912207A GB 0912207 A GB0912207 A GB 0912207A GB 2471855 A GB2471855 A GB 2471855A
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United Kingdom
Prior art keywords
fastening device
engagement portions
instrument
sternum
connecting portion
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.)
Withdrawn
Application number
GB0912207A
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GB0912207D0 (en
Inventor
Benjamin Stephen Wright
Wayne Edward Wright
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.)
CARDIO SOLUTIONS (UK) LIMITED
Original Assignee
CARDIO SOLUTIONS
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 CARDIO SOLUTIONS filed Critical CARDIO SOLUTIONS
Priority to GB0912207A priority Critical patent/GB2471855A/en
Publication of GB0912207D0 publication Critical patent/GB0912207D0/en
Publication of GB2471855A publication Critical patent/GB2471855A/en
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061Cortical 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
    • A61B17/8076Cortical 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/82Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
    • A61B17/823Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage for the sternum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8861Apparatus for manipulating flexible wires or straps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8863Apparatus for shaping or cutting osteosynthesis equipment by medical personnel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/083Clips, e.g. resilient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00862Material properties elastic or resilient

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  • 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

A fastening device for use in sternal closure, comprising two engagement portions 10, 12 engageable with respective intercostal spaces on opposite sides of the sternum, and a connecting portion 14 extending between the engagement portions which is elastically deformable to enable the engagement portions to be displaced away from one another and to exert a force to return the engagement portions to their original position. The sternum clamp may be made of steel wire, and the connecting portion may be U-shaped, with the plane of the U at right angles to the plane of the engagement hooks. There may be apertures either side of the connecting portion (see fig 2) to enable the suture to be expanded for placement over the breastbone. Also provided is a clamp in combination with an instrument adapted for use in expanding the engagement portions, which may comprise forceps or pliers, a wedge or prongs.

Description

Title: Sternal Closure Device
Description of Invention.
This invention r&ates to a device for effecting sternal closure, i e closing the sternum following mid-kne sternotomy Sternotomy represents the standard approach to the heart and adjacent organs and vessels in most card jo-thoracic surgical procedures In essence, mid-line sternotomy involves cutting of the sternum down its centre, so that the two halves of the sternum can be drawn away from one another to allow access to the heart After completion of the required procedure, the sternum must be closed by the drawing back together of its two side parts and holding them in place.
Traditionally, the two parts of the sternum are closed together by use of a number of stainless steel wire sutures. Each suture is passed through holes provided opposite one another in the two halves of the sternum, and force is applied to the suture to draw the halves of the sternum together and hold them in place by twisting together the ends of the wire Then the twisted joint between the ends of the wire is cut and the cut end folded down The overlying skin is closed over the joined sternum halves, and it is usual for the wire sutures to remain in place permanently This method is good but it is difficult to get uniform twisted joints between the ends of the sutures, and it is time-consuming to install them. Further, because the wire suture is of relatively small diameter it can cut into the sternal tissue allowing the wire to become loose over the course of time, particularly if the post-operative patient moves in a way which causes stress on the sternum. In addition, the process of piecing the sternum to take the sutures can itself cause or risk causing damage to the sternum, particularly in osteopototic or diabetic patients.
Alternative techniques for sternal closure including banding or metal plate fixation techniques and devices. These can cause problems when the sternum is relatively weak due to the age of the patient or illness, so the bone material cannot bear the localised stresses imparted by anchors, screws, clamping devices or the like Anything which reduces bone mass may lead to weakness in the bone tissue.
The use of fastening devices made of a thermally-responsive "memory metal has also been proposed One such fastening device, used to a significant extent, compnses two opposed hook formations joined by a shank including a somewhat (0) omega-shaped portion so that the hooks are able to become displaced relative to one another by deformation pnmarily in the omega-shaped portion. The hook portions are sized to be inserted into the intercostal spaces between ribs on opposite sides of the sternum. In use, a size of fastener is selected which suits the width of the closed sternum with which it is to be used (the width of the intact sternum less some 1.5mm to allow for the removal of bone as the sternum is cut). With the halves of the sternum drawn together, the fastener is stretched, while cooled to a temperature below about 5°C -10°C, and manipulated to engage its hook formations with the intercostal spaces It is set with its omega-shaped portion lying generally parallel to the sternum in front thereof. Finally, the fastener is heated with warm saline solution until it reaches a temperature, generally about 27°C to about 35°C, at which it returns to its original dimensions to hold the halves of the sternum together Subsequently, the fastener remains in-situ in the patient but, if necessary in subsequent surgical procedures it can be removed by coolinq and by use of special forceps to stretch the clip again, or by cutting It does not integrate in bone.
Such a fastener is satisfactory, but extremely expensive, and the necessity for temperature control to make use of its memory' properties adds an additional complication to the already-demanding nature of cardio-thor'acic surgery.
According to one aspect of the invention, we provide a fastening device for use in sternal closure, comprising two engagement portions engageable with respective intercostal spaces of the sternum on opposite sides thereof; and a connecting portion extending between the engagement portions, wherein the connecting portion is resiliently, preferably elastically, deformable to enable the engagement portions to be displaced away from one another and to exert a farce to return the engagement portions to their original position.
The connecting portionS may comprise a generally U-shaped formation compnsing a base portion and two limbs extending from the base portion, the Umbs being connected to the respective engagement portions at positions remote from the base portion.
The engagement portions may comprise opposed hook formations, which hook formations lie, when the fastening device is not deformed, substantially in the same plane as one another. The generally U-shaped engagement portion preferably lies in a plane generally at right angles to the plane of the engagement portions.
The fastener has, of course, to be of a material which is able to remain in the human body without adverse consequences An appropriate grade of stainless steel would be preferred, since it meets the requirement for compatibility with implantation in the human body while affording the necessary ability elastically to be deformed.
At least the connecting portion of the fastening device may be subjected to heat treatment to impart the required elastic deformability.
The fastening device may be provided with formations adapted for engagement by an instrument to effect the displacement of the engagement portions away from one another. Such formations may comprise apertures through which prongs of an, e.g. pliers-type, instrument may be engaged, for effecting the deformation.
The device may be formed from wire of the stainless steel materiaL A part thereof, e g in the connecting portion may be of a reduced thickness, to ailow for easier cutting thereof to facilitate removal of the device if it is necessary in an emergency I he device may be available in a range of sizes to suit a wide range of sizes of sternum.
A fastening device in accordance with the invention provides many of the advantages of the memory metal' device described above, in terms of use without the necessity for piercing the halves of the sternum to take wire sutures, and with a reduced risk of damage to the sternum since the device will be of relatively thick wire material compared with wire sutures. It is also less expensive, and does not introduce the complications of temperature control to the surgical procedures.
Devices in accordance with the invention will normally be provided for surgery in a kit comprising a plurality of the devices in a range of sizes suitable for use at different points in a range of typical sternum sizes.
According to another aspect of the invention, we provide a fastening device according to the first aspect of the invention, in combination with an instrument for effecting displacement of the engagement portions from one another. The instrument may be a wedge-type device, including a wedge element for introduction between the limbs of the connecting portion and thereby displacing the limbs away from one another, or altornatively in the case of a fastening device provided with aperture formations, the instrument may be provided with prongs for engagement with such apertures.
According to yet a further aspect of the invention, we provide a kit comprising a plurality of fastening devices in accordance with the invention, in a range of sizes, together with an instrument for effecfing displacement of the engagement portions away from one another.
The kit may also include a measuring device, e.g. :a calliper, for determining each size of fastening device Which is to be used.
The invention wul now be descnbed by way of example with reference to the accompanying drawings, of which: Figure 1 is a perspective view of a first embodiment of the invention; Figure 2 is a perspective view, as figure 1, of a second embodiment of the invention; Figure 3 is diagrammatic view of a device in accordance with the inventlion, in-situinrelationtoastemurn; Figure 4 is a diagrammatic view of a pliers-type instrument for effecting deformation of the fastening device of figure 2.
Figure 5 is a view of a measunng calliper device for use with a the fastening device.
Referring firstly to figure 1 of the drawings, the fastening device there illustrated comprising two engagement porhons 10, 12 and a connecting portion indicated generally at 14 therebetween The engagement portion 10 is in the general form of a hook of approximately semicircular configuration, with its free end 16 rounded and pointing towards the free end 18 of the engagement portion 12 The opposite ends 20, 22 of the engagement portions 10, 12 extend to the connecting portion 14.
The connection portion 14 comprises a base 24 and is generally U-shaped with parallel limbs 26, 28 whose ends extend into the parts 20, 22 at right-angled bends, The entire fastening device is of metal wire of about 2 -2.5 mm thickness, preferably a grade of stainless steel which is bio-cornpatible and presents the required properties described hereafter.
The engagement portions 10, 12 substantially lie in a common plane, which is at substantially at right angles to a plane occupied by the connecting portion 14.
It will be appreciated from consideration of the configuration of the fastening devce that the engagement portions 10, 12 are able to be moved away from one another (in the course of which they ill progressively depart from lying in their common plane) by deformation of thefl connecting portion 14. Such deformation to the extent required in use as described hereafter is within the elastic range of deformatiob of the material of which the device is made. Such deformation may he effected by engagement of a suitable instrument with the connecting portion 14; for example the instrument may include a wedge which is forced between the limbs 26, 28 of the connecting portion to displace them away from one another and hence move the engagement portions 10, 12 away from one another, the deformation in this case taking place pnmanly in the base portion 24 of the connecting portion 14.
In an alternative embodiment of the invention shown in figure 2 of the drawings, gusset plates 30, 32 are provided between the limb 26 and part 20, and limb 28 and part 22, respectively Apertures are provided in the gusset plates 30 32 for engagement by prongs of a pliers-type instrument for displacing the limbs 26, 28 away from one another.
Figure 4 of the drawings illustrates such an instrument. It comprises two components 40, 42 connected to one another at a pivot 44. The component has a handle part 46 and a nose part 48 while the component 42 has a handle part 50 and a nose part 52. The nose parts 48, 52 have end portions 54, 56 respectively, extending at an inclination, more or less at a right angle to the remainder of the instrument and generally parallel to the pivot axis given by the pivot 44. The free ends of the parts 54, 56 have respective prongs as indicated at 58 for the component 42, able to be inserted through the apertures of a fastening device as shown in figure 2. When the handle parts 46, 50 are squeezed together, the end parts 54, 56 move away from one another to deform the fastening device and move its engagement portions away from one another.
Figure 3 shows a sternum 60 with nbs 62a, 62, 62ç 62d, 62e 62! extending therefrom at one side and corresponding nbs on the opposite side ln mid-line sternotomy, the sternum is separated from top to bottom into two halves, along a line 64. In figure 3 a fastening device in accordance with the invention is shown at 66, in-situ between the ribs 62?, 62! and their opposite ribs, while the locations of further such fastening devices are shown at broken lines 68, 70.
Prior to cutting of the sternum, the lateral distance between the intercostal spaces of the ribs 62a, 62 and their opposite ribs is measured by a calliper device or other measuring instrument such as that shown in figure 5, and a deduction of 1.0mm to 1.5mm, e.g. 1.1 to 1.2mm, made to allow for the thickness of tissue removed when the cut 64 is made depending on the thickness of the saw blade used for this purpose. From this dimension, a suitable size of fastening device is selected from the range available. Similar measurements are made for the fastening devices to be used at 66 and 70 After the completion of the procedure behind the sternum, the separate halves of the sternum are drawn together by a suitable contracting instrument, after which the fastening devices are expanded by use of an instrument such as that shown in figure 4 then placed in-situ, and released by the instrument to hold the halves of the sternum altogether. The fastening devices remain in-situ subsequently.
When a fastening device in accordance with the invention has been applied to a sternum, the connecting portion lies substantially parallel and close to the front surface of the sternum. Hence it can remain in position without disadvantage to the patient. If a further surgical procedure becomes necessary, in which access is required to the chest cavity behind the sternum, the fastening devices may be remoyed by cutting them and to facilitate this a portion of reduced crosssectional area may be incorporated in the fastening device Such a portion may be provided in the connecting portion of the device where it is most readily accessible, or in another part thereof, preferably one of those parts extending from the connection portion to the hooked parts of the engagement portions.
When used in this specification and claims, the terms "comprises" and "comprising" and variations thereof mean that the specified features, steps or integers are included. The terms are not to be interpreted to exclude the presence of other features, steps or components.
The features disclosed in the foregoing description, or the following claims, or the accompanying drawings, expressed in their specific forms or in terms of a *means for performing the disclosed function, or a method or process for attaining the disclosed result, as appropriate, may, separately, or in any combination of such features, be utilised for realising the invention in diverse fOrms thereof.

Claims (8)

  1. Claims 1. A fastening device for use in sternal closure, comprising two engagement portions engageable with respective intercostal spaces of the sternum on opposite sides thereof; and a connecting portion extending between the engagement portions) wherein the connecting portion is resiliently deformable to enable the engagement portions to be disp'aced away from one another and to exert a force to return the engagement portions to their original position.
  2. 2. A fastening device according to claim I wherein the con necting portion comprises a generally U-shaped formation comprising a base portion and two limbs extending from the base portion, the limbs being connected to the respective engagement portions at positions remote from the base portion.
  3. 3. A fastening device according to claim 2 wherein the engagement portions comprise opposed hook formations, Which formations lie, when the fastening device is not deformed, substantially in the same plane as one another.
  4. 4. A fastening device according to claim 3 wherein the engagement portion lies in a plane generally at right angles to tne plane of the engagement portions.
  5. 5 A fastening device according to any one of the preceding claims which is of a suitable grade of stainless steel.
  6. 6. A fastening device according to claim 5 wherein at Least the connection portion of the fastening device has been subjected to heat treatment:
  7. 7. A fastening device according to any one of the preceding claims, comprising formations adapted for engagement by an instrument to effect said displacement of the engagement portions away from one another.
  8. 8. A fastening device according to claim 7 wherein said formations comprise apertures.9 A fastening device according to any one of the preceding claims, formed from wirematerial.10. A fastening device according to claim 9 wherein a part thereof is of reduced thickness compared with the remainder of the device.Ii. A fastening device according to claim 10 wherein said reduced thickness part is in the connecting portion.12. A fastening deviceaccording to any one of the preceding claims in combination with an instrument for effecting displacement of the engagement portions away from one another.13 The combination of claim 12 wherein the fastening device is as claimed in claim 8, and the instrument compnses prongs engageable with the apertures.14 The combination of claim 13 wherein the instrument is of pliers type 15. The combination of claim 12 wherein the fastening device is as claimed in claim 2, and the instrument comprises a wedge element and teens for urging the wedge element between the limbs of the connecting portion of the device.16. A kit of parts comprising a plurality of fastening devices according to any one of claims I to 11, and at east one of: an instrument for constituting, with one of the fastening devices, the combination of any one of daims 12 to 16, and a measuring device for measuring the distance between a corresponding pair of intercosta spaces on opposite sides of the sternum.17. A fastening device substantiafly as hereinbefore described with reference to and as shown in the accompanying drawings.18. A combination of a fastening device and an instrument for effecting deformaton of the fastening device substantially as hereinbefore described with reference to and as shown in the accompanying drawings.19. Any novet feature or novel combination of features described herein and/or in the accompanying drawings.
GB0912207A 2009-07-14 2009-07-14 Resiliently deformable sternal clamp suture Withdrawn GB2471855A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
GB0912207A GB2471855A (en) 2009-07-14 2009-07-14 Resiliently deformable sternal clamp suture

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GB0912207A GB2471855A (en) 2009-07-14 2009-07-14 Resiliently deformable sternal clamp suture

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GB0912207D0 GB0912207D0 (en) 2009-08-26
GB2471855A true GB2471855A (en) 2011-01-19

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014114602A1 (en) * 2013-01-22 2014-07-31 Medxpert Gmbh Sternum osteosynthesis system

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0958786A2 (en) * 1998-05-18 1999-11-24 Heinz Robert Dr. med. Zurbrügg Sternal closure technique and kit for performing same
US6051007A (en) * 1998-03-02 2000-04-18 Corvascular, Inc. Sternal closure device and instruments therefor
WO2000064366A1 (en) * 1999-04-21 2000-11-02 Romolo Igino Gazzani Semi-rigid compressive clamp for use in sternotomy, and forceps for its application
WO2008022261A2 (en) * 2006-08-18 2008-02-21 Intelifuse, Inc. Shape-transforming implant device
WO2008148283A1 (en) * 2007-06-07 2008-12-11 Fangqin Liu Sternal fastening clip

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6051007A (en) * 1998-03-02 2000-04-18 Corvascular, Inc. Sternal closure device and instruments therefor
EP0958786A2 (en) * 1998-05-18 1999-11-24 Heinz Robert Dr. med. Zurbrügg Sternal closure technique and kit for performing same
WO2000064366A1 (en) * 1999-04-21 2000-11-02 Romolo Igino Gazzani Semi-rigid compressive clamp for use in sternotomy, and forceps for its application
WO2008022261A2 (en) * 2006-08-18 2008-02-21 Intelifuse, Inc. Shape-transforming implant device
WO2008148283A1 (en) * 2007-06-07 2008-12-11 Fangqin Liu Sternal fastening clip

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014114602A1 (en) * 2013-01-22 2014-07-31 Medxpert Gmbh Sternum osteosynthesis system
EP2756815A3 (en) * 2013-01-22 2014-09-10 MedXpert GmbH Sternum osteosynthesis system
US9504509B2 (en) 2013-01-22 2016-11-29 Medxpert Gmbh System for osteosythesis of the sternum

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Publication number Publication date
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COOA Change in applicant's name or ownership of the application

Owner name: CARDIO SOLUTIONS (UK) LIMITED

Free format text: FORMER OWNERS: BENJAMIN STEPHEN WRIGHT; WAYNE EDWARD WRIGHTIGHT

WAP Application withdrawn, taken to be withdrawn or refused ** after publication under section 16(1)